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  药店国别: 美国药房
产地国家: 美国
所属类别: 造影剂->X线造影剂
处方药:处方药
包装规格: 300毫克/毫升 50毫升/瓶 10瓶/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
通用医疗集团
生产厂家英文名:
GE Healthcare Inc.
该药品相关信息网址1:
http://www.omnipaque.com/
该药品相关信息网址2:
http://www.drugs.com/pro/omnipaque-injection.html
原产地英文商品名:
OMNIPAQUE 300mg/ml 50ml/bottle 10bottle/box
原产地英文药品名:
Iohexol
中文参考商品译名:
欧乃派克 300毫克/毫升 50毫升/瓶 10瓶/盒
中文参考药品译名:
碘海醇
中文参考化合物名称:
5-[N-(2,3-二羟丙基)乙酰胺基]-N,N’-双(2,3-二羟丙基)-2,4,6-三碘-1,3-苯二甲酰胺
原产地国家批准上市年份:
1985/12/26
英文适应病症1:
Cardiovascular imaging, angiography, urography, venography, CT contrast enhancement
英文适应病症2:
Cervical, thoracic and lumbar myelography by spinal subarachnoid injection of CT cisternography
英文适应病症3:
Ticulare radiography, after endoscope pancreas cholangiography (ERCP)
英文适应病症4:
Hernia or fistula imaging, hysterosalpingography, sialography, percutaneous transhepatic cholangiography (PTC), sinus imaging, gastrointestinal imaging
英文适应病症5:
"T"-tube imaging
临床试验期:
完成
中文适应病症参考翻译1:
心血管造影、动脉造影、尿路造影、静脉造影、CT增强检查
中文适应病症参考翻译2:
颈、胸和腰段椎管造影、经椎管蛛网膜下腔注射后CT脑池造影
中文适应病症参考翻译3:
关节腔造影、经内窥镜胰胆管造影(ERCP)
中文适应病症参考翻译4:
疝或瘘道造影、子宫输卵管造影、涎腺造影、经皮肝胆管造影(PTC)、窦道造影、胃肠道造影
中文适应病症参考翻译5:
“T”型管造影
药品信息:

---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件(201811723392120.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------
部分中文Omnipaque处方资料(仅供参考)

【药品名称】
通用名:碘海醇注射液
商品名:欧乃派克 (Omnipaque )
英文名:Iohexol Injection
汉语拼音:Dianhaichun Zhusheye
本品主要成份为碘海醇,其化学名为:5-[N-(2,3-二羟丙基)乙酰胺基]-N,N’-双(2,3-二羟丙基)-2,4,6-三碘-1,3-苯二甲酰胺。

【结构式】
分子式:C19H26I3N3O9
分子量:821.14

【性状】本品为无色至淡黄色澄明溶液。

【药理毒理】动物试验结果表明本品对犬肝脏、腹主动脉、CT扫描影像有增强效应。另据文献报道,本品的毒性较非离子型造影剂,如Metrizamide低;静注造影时,大鼠、兔子及犬主要从尿中排出,小部分(大鼠5%、犬1%)从粪便中排出。尚未发现任何器官吸收的现象,也未在动物中检测到任何代谢产物。本品蛋白结合率少于2%;犬肾动脉造影时有蛋白尿发生的现象。

【药代动力学】通过静脉注射到体内的碘海醇,于24小时内以原状在尿液中排出的近乎百分之百,尿液中碘海醇浓度最高的情况,出现在注射后的一小时内,没有代谢物产生。

【适应症】X线造影剂。可用于心血管造影、动脉造影、尿路造影、静脉造影、CT增强检查;颈、胸和腰段椎管造影、经椎管蛛网膜下腔注射后CT脑池造影;关节腔造影、经内窥镜胰胆管造影(ERCP),疝或瘘道造影、子宫输卵管造影、涎腺造影、经皮肝胆管造影(PTC)、窦道造影、胃肠道造影和“T”型管造影等。

【用法与用量】给药剂量取决于检查的种类、病人的年龄、体重、心输出量和全身情况及使用的技术。一般而言,该药的常用碘浓度和容量与目前使用的其它含碘造影剂相似。和其它造影剂一样,在用药前后都必须保证体内有充足的水份。以下的剂量可作为临床指导。
1、静脉注射指南
适用范围浓度用量说明
尿路造影
成人
儿童7kg
7kg 300mgl/ml
或 350mgl/ml
300 mgl/ml
300 mgl/ml40-80ml
40-80 ml
3ml/kg
2ml/kg
(最高40ml)在大剂量的尿路造影中可高于90ml
下肢静脉造影 300mgl/ml20-100ml/每腿
数字减影造影
(DSA) 300mgl/ml
或 350mgl/ml20-60ml/次注射
20-60ml/次注射
CT增强
成人
儿童 300mgl/ml
或 350mgl/ml
300mgl/ml 100-200ml
100-150ml
1.5-2ml/kg体重通常总碘量为30-80g
2、 动脉注射指南
适用范围浓度用量说明
动脉造影
主动脉血管造影
选择性脑动脉造影
下肢动脉造影
各种动脉造影
300mgl/ml
300mgl/ml
350 mgl/ml
300 mgl/ml
或 350 mgl/ml
300 mgl/ml
30-40ml/次注射
5-80 ml/次注射
40-60ml/次注射
30-50ml/次注射
取决于检查的类型
根据注射部位选择每次注射的用量
心血管造影
成人
左心室和主动脉根注射
选择性冠状动脉造影
儿童
350mgl/ml
350mgl/ml
300mgl/ml
或 350mgl/ml
30-60ml/次注射
4-8ml/次注射
取决于年龄、体重和病情(最高8ml/kg)
数字减影造影
(DSA) 300mgl/ml1-15ml/次注射取决于注射部位。偶尔可用大剂量—最高达30ml
3、脊髓造影指南
适用范围浓度用量说明
椎管造影300mgI/ml7-10ml为减少可能的副反应,不应使用总量超过3g的碘
4、体腔内使用指南
适用范围浓度用量说明
关节腔造影 300mgI/ml
或350mgI/ml5-15ml
或5-10ml
子宫输卵管造影300mgI/ml15-25ml
涎管造影300mgI/ml0.5-2ml
胃肠道检查
口服
成人
儿童
因人而异的
因人而异的
可稀释
CT-增强
口服
成人:
儿童:
直肠使用
儿童
用水稀释至约
6mgI/ml
用水稀释至约
6mgI/ml
用水稀释至约
6mgI/ml
一次800-2000ml
稀释液
一次15-20ml
稀释液
因人而异的
举例:
用水稀释300或350mgI/ml欧乃派克,比例为1:50

【不良反应】
1、 常见的不良反应为轻度的感觉异常,如热感或暂时性的金属味觉。腹部不适或疼痉很罕见(发病率1:1000),胃肠道反应如恶心、呕吐也很少见(发病率1:100,但1:1000)。过敏样反应较少见,通常表现为轻度的呼吸道和皮肤反应,如呼吸困难、皮疹、红斑、荨麻疹、搔痒和血管性水肿,它们可在注射后立即出现也可在几天后出现。严重的反应如喉头水肿、支气管痉挛或肺水肿非常少见。过敏样反应可能与剂量和用药途径无关。严重反应的最初症状可能仅是轻微的过敏症状,必须马上停止继续使用造影剂,必要时应立即通过血管给药进行相应的治疗。使用β受体阻滞剂的病人其过敏反应的症状可能不典型,容易误为迷走神经反应。迷走神经反应可引起低血压和心律过缓,很少见。严重皮肤反应如多行渗出性红斑或中毒性表皮坏死溶解症很少见。偶可发热伴寒战。碘中毒或“碘中毒性腮腺炎”是一种罕见的与使用碘造影剂有关的并发症,表现为腮腺的肿胀和触痛,可在检查后持续达10天。
2、 和含碘造影剂有关的不良反应本质上一般都为轻到中度且为暂时性的,非离子型造影剂的不良反应要比离子型造影剂更少。重度反应和致死反应非常罕见。
3、 在动脉内注射造影剂所引起的不良反应性质与注射的部位和剂量有关。
选择性动脉造影或其它相应的技术操作可使目标器官处于高浓度造影剂状态,可能会引起相应器官的并发证。外周血管造影常会引起远端的热感和疼痛(发症率1:10)。短暂性S-肌酐上升也很常见,但通常无临庆意义。肾功能衰竭非常罕见。不过有致死病例的报道。冠脉、脑或肾动脉注射后会引起动脉痉挛并导致局部缺血。神经系统反应非常罕见。它们可为癫痫发作或短暂性运动或感觉障碍。偶可在随防的CT扫描时见到造影剂通过血脑屏障为脑皮质取,有时可伴短暂性意识模糊或皮层盲。严重的心脏并发症如心律紊乱、心功能减退心肌缺血都很少见。
4、 静脉造影后的血栓性静脉炎和静脉内血栓形成很少见。曾有极个别关节痛的病例报道。
5、 鞘内注射后的不良反应可能在检查后几小时甚至几天后延尺出现。其发生率与单独腰穿相似。头痛、恶心、呕吐和头晕很常见,主要与穿刺点脑脊液渗漏引起蛛网膜下腔压力下降有关。有些病人会有严重的头痛并持续几天。不要抽出太多的脑脊液以避免压力过度下降。轻度的局部疼痛、外周感觉异常和根性疼痛偶可发生在注射的部位(发生率1:10,但1:100)。下肢疼痛和痛性痉挛偶有见到。脑膜刺激所致的畏光和假性脑膜炎偶有发生。症状明显的化学性脑膜炎非常罕见,也应考虑有感染性脑膜炎的可能。非常少见的反应还有短暂性脑功能失调,包括癫痫发作、短暂性意识丧失、运动和感觉障碍。少数病人有EEG的改变。
6、 体腔内使用时,全身性过敏反应少见。
ERCP:淀粉酶水平略有升高比较常见。ERCP检查后偶可在肾脏内见到造影剂,此情况提示ERCP后胰腺炎的危险性大为增加。也有发生坏死性胰腺炎的个案报道。
口服造影剂偶可发生胃肠道不适。
子宫输卵管造影:常下腹部短暂性轻度疼痛。
关节腔造影:造影术后疼痛比较常见。症状明显的关节炎罕见,此种病人应考虑感染性关节炎的可能。
疝造影:轻度的术后疼痛较常见。

【禁忌】有严重的甲状腺毒症表现的患者禁用;对本品过敏者禁用。

【注意事项及预防措施】
1、 有过敏、哮喘和对含碘制剂有过不良反应的需特别注意。对这些病例可考虑使用预防用药,如类固醇,H1,H2组胺受体拮抗剂等。
2、 碘造影剂可激发过敏样反应或其它过敏反应的表现。因此应预先进行急救措施的训练和预备必须的抢救药物和器械以应付可能出现的严重反应。
3、 在整个X线检查过程中应始终保持静脉输液通路畅通。
4、 体外试验中,非离子型造影剂对凝血系统的影响较离子型造影剂为轻。在施行血管造影术时,应十分小心在血管内的技术操作,不时地用肝素化的生理盐水灌洗导管以减少与操作技术相关的血栓形成和栓塞。
5、 在用造影剂前后必须保证体内有足够的水分。这一点尤其适合患有多发性骨髓瘤、糖尿病、肾功能不全的病人及婴幼儿和老年人。小于1岁的婴儿,特别是新生儿易引起电解质紊乱和血液动力学失调。对有严重心脏病和肺动脉高压的病人需特别注意。因为他们易发展为血液动力学失调和心律紊乱。
6、 急性脑病、脑瘤或有癫痫病史的病人要预防癫痫发作并需特别的注意。酗酒和吸毒者其癫痫发作和神经系统反应危险性大为增加。少数病人在椎管造影后发生短暂性听力丧失或耳聋,这可能是腰穿后脑脊液压力下降所致。
7、 为预防使用造影剂后的急性肾功能衰竭,对已有肾功能损害和糖尿病的病人需要特别注意,因为他们的危险性较大。异型球蛋白血症(多发性骨髓瘤病和Waldenstrom巨球蛋白血症)的病人危险性也较大。
8、 预防措施包括:
-证实有高危险因素的病人。
-确保体内有足够的水分。如有必要,可在检查前由静脉维持输液直到造影剂从肾脏清除。
-在造影剂清除之前避免任何加重肾脏负担的肾毒性药物、口服胆囊造影剂、动脉钳闭术、肾动脉成形术或其它大型手术。
-延迟重复的造影检查直到肾功能恢复到检查前水平。
严重肝肾功能不全的病人需特别注意,因为这些病人清除造影剂的时间明显延长。血透的病人在接受造影剂检查后应立即进行血液透析。
含碘造影剂可加重重症肌无力的症状。嗜铬细胞瘤病人在介入治疗时应给予预防高血压危象的α受体阻滞剂。甲亢病人也需特别注意。多发结节性甲状腺肿的病人在使用碘造影剂后有发展成甲亢的可能。应清楚地认识到早产儿在使用造影剂后有短暂性甲减的可能。
造影剂外渗时偶然会引起局部的疼痛和水肿,它们会逐渐消退,不留后遗症。不过,偶可见发生炎症甚至组织坏死的病例。常规处理方法为抬高患肢和局部冷敷。万一发生隔室综合症需手术减压。
9、观察时间:
使用造影剂后的病人应至少观察30分钟以上,因为大多数的严重不良反应都发生在这段时间。不过,仍有发生延迟反应的可能。
10、鞘内注射:
在椎管造影后,病人应休息1小时,头、胸抬高20°。然后可小心下床行走但不要弯腰。如仍躺在床上,应保持头胸抬高位6小时。对癫痫发作阈较低的病人在此期间应密切观察。门诊病人最初的24小时内不能独处。
11、对驾驶和操作机器能力的影响:
在鞘内注射后24小时内不应驾驶和操作机器。
12、象所有的非胃肠道药品本品应在使用前目检,以检查是否有微粒、变色和与容器的粘连现象。
药品应在使用前才被抽入针筒,每本品瓶仅供单次使用,丢弃未用部分。

【孕妇及哺乳期妇女用药】
人类妊娠期间使用本品的安全性并未确立。实验性动物研究的结果并不直接或间接表明在人类生殖、胚胎或胎儿发育中的损害作用。因为在妊娠的任何时候都应避免射线的照射,所以在考虑对妊娠妇女使用造影检查时必须慎重权衡利弊。欧乃派克不应用于妊娠妇女除非临床医生认为利远大于弊时。
造影剂在人类的乳汁中排出极少,再者通过胃肠道吸收的量也极少。因此对吃奶的婴儿损害的可能性很小。

【药物的相互作用】
1、使用造影剂可能会导致短暂性肾功能不全,这可使服用双胍类降糖药(二甲双胍)的糖尿病人发生乳酸性酸中毒。作为预防,在使用造影剂前48小时应停服双胍类降糖药,只有肾功能稳定后再恢复用药。
2、二周内用血细胞介素-2治疗的病人其延迟反应的危险性会增加(感冒样症状和皮肤反应)。
3、所有的碘造影剂都会影响甲状腺功能的测定,甲状腺碘结合能力下降会持续几周。
4、血清和尿中高浓度的造影会影响胆红素、蛋白或无机物(如铁、铜、钙和磷)的实验室测定结果。在使用造影剂的当天不应做这些检查。
5、虽然没有明确的配伍禁忌,碘海醇仍不应与其它药物直接混合使用。应使用单独的注射器。

【药物过量】
临床前的实验数据提示欧乃派克有高度的安全范围,在日常血管内使用时还未制定出固定的剂量上限水平。全身性过量使用的可能性很小,除非病人接受高达2000mgI/公斤体重的剂量且超过限定时间。检查的持续时间很重要。因为肾脏耐受高浓度造影剂的能力有限(t1/2~2小时)。偶然的过量使用最可能发生在对儿童施行复杂的血管检查,特别是多次反复注射高浓度的造影剂。


Omnipaque Injection
Generic Name: iohexol
Dosage Form: injection

OMNIPAQUE™ (iohexol) Injection
140   180   240   300   350
140   350   NOT FOR INTRATHECAL USE
OMNIPAQUE in REDIFLO™ (prefilled cartridges) NOT FOR INTRATHECAL USE
Section I — Intrathecal
Section II — Intravascular
Section III — Oral/Body Cavity Use

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Omnipaque Injection Description
Iohexol,N,N′ - Bis(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)-acetamido]-2,4,6-triiodo-isophthalamide, is a nonionic, water-soluble radiographic contrast medium with a molecular weight of 821.14 (iodine content 46.36%). In aqueous solution each triiodinated molecule remains undissociated.

OMNIPAQUE is provided as a sterile, pyrogen-free, colorless to pale-yellow solution, in the following iodine concentrations: 140, 180, 240, 300, and 350 mgI/mL. OMNIPAQUE 140 contains 302 mg of iohexol equivalent to 140 mg of organic iodine per mL; OMNIPAQUE 180 contains 388 mg of iohexol equivalent to 180 mg of organic iodine per mL; OMNIPAQUE 240 contains 518 mg of iohexol equivalent to 240 mg of organic iodine per mL; OMNIPAQUE 300 contains 647 mg of iohexol equivalent to 300 mg of organic iodine per mL; and OMNIPAQUE 350 contains 755 mg of iohexol equivalent to 350 mg of organic iodine per mL. Each milliliter of iohexol solution contains 1.21 mg tromethamine and 0.1 mg edetate calcium disodium with the pH adjusted between 6.8 and 7.7 with hydrochloric acid or sodium hydroxide. All solutions are sterilized by autoclaving and contain no preservatives. Unused portions must be discarded. Iohexol solution is sensitive to light and therefore should be protected from exposure.

OMNIPAQUE 140, OMNIPAQUE 180, OMNIPAQUE 240, OMNIPAQUE 300, and OMNIPAQUE 350 have osmolalities from approximately 1.1 to 3.0 times that of plasma (285 mOsm/kg water) or cerebrospinal fluid (301 mOsm/kg water) as shown in the above table and are hypertonic under conditions of use.

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CLINICAL PHARMACOLOGY—Intrathecal
Iohexol is absorbed from cerebrospinal fluid (CSF) into the bloodstream and is eliminated by renal excretion. No significant metabolism, deiodination, or biotransformation occurs.

In five adult patients receiving 16 to 18 milliliters of iohexol (180 mgI/mL) by lumbar intrathecal injection, approximately 88 (73.1-98.2) percent of the injected dose was excreted in the urine within the first 24 hours after administration. The renal and body clearances were 99 (47-137) milliliters per minute and 109 (52-138) milliliters per minute. The mean maximal plasma concentration was 119 (72-177) micrograms of iohexol per milliliter and occurred after 3.8 (2-6) hours. The volume of distribution was 557 (350-849) milliliters per kilogram. In one patient with a large spinal cord tumor, excretion was delayed (67 percent of the dose appeared in the urine within the first 24 hours) with no difference in the total overall recovery in the urine after 48 hours. The delay in excretion appeared to be related to a decrease in the rate of transfer of iohexol from the cerebrospinal fluid to the blood (plasma maximal concentration was approximately 30 micrograms/mL).

The initial concentration and volume of the medium, in conjunction with appropriate patient manipulation and the volume of CSF into which the medium is placed, will determine the extent of the diagnostic contrast that can be achieved.

Following intrathecal injection in conventional radiography, OMNIPAQUE 180, OMNIPAQUE 240, and OMNIPAQUE 300 will continue to provide good diagnostic contrast for at least 30 minutes. Slow diffusion of iohexol takes place throughout the CSF with subsequent absorption into the bloodstream. Once in the systemic circulation, iohexol displays little tendency to bind to serum or plasma proteins. At approximately 1 hour following injection, contrast of diagnostic quality will no longer be available for conventional myelography. If computerized tomographic (CT) myelography is to follow, consideration should be given to a delay of several hours to allow the degree of contrast to decrease.

After administration into the lumbar subarachnoid space, computerized tomography shows the presence of contrast medium in the thoracic region in about 1 hour, in the cervical region in about 2 hours, and in the basal cisterns in 3 to 4 hours.

In patients with renal impairment, depending on the degree of impairment, prolonged plasma iohexol levels may be anticipated due to decreased renal elimination.

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INDICATIONS AND USAGE—Intrathecal
OMNIPAQUE 180, OMNIPAQUE 240, and OMNIPAQUE 300 are indicated for intrathecal administration in adults including myelography (lumbar, thoracic, cervical, total columnar) and in contrast enhancement for computerized tomography (myelography, cisternography, ventriculography).

OMNIPAQUE 180 is indicated for intrathecal administration in children including myelography (lumbar, thoracic, cervical, total columnar) and in contrast enhancement for computerized tomography (myelography, cisternography).

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CONTRAINDICATIONS—Intrathecal
OMNIPAQUE should not be administered to patients with a known hypersensitivity to iohexol.

Myelography should not be performed in the presence of significant local or systemic infection where bacteremia is likely.

Intrathecal administration of corticosteroids with OMNIPAQUE is contraindicated.

Because of the possibility of overdosage, immediate repeat myelography in the event of technical failure is contraindicated (see DOSAGE AND ADMINISTRATION).

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WARNINGS—General
SEVERE ADVERSE EVENTS—INADVERTENT INTRATHECAL ADMINISTRATION
Serious adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use. These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Special attention must be given to insure that OMNIPAQUE 140 and 350 are not administered intrathecally. (All other concentrations of OMNIPAQUE are approved for intrathecal administration.)

If grossly bloody CSF is encountered, the possible benefits of a myelographic procedure should be considered in terms of the risk to the patient.

Caution is advised in patients with a history of epilepsy, severe cardiovascular disease, chronic alcoholism, or multiple sclerosis.

Elderly patients may present a greater risk following myelography. The need for the procedure in these patients should be evaluated carefully. Special attention must be paid to dose and concentration of the medium, hydration, and technique used.

Patients who are receiving anticonvulsants should be maintained on this therapy. Should a seizure occur, intravenous diazepam or phenobarbital sodium is recommended. In patients with a history of seizure activity who are not on anticonvulsant therapy, premedication with barbiturates should be considered.

Prophylactic anticonvulsant treatment with barbiturates should be considered in patients with evidence of inadvertent intracranial entry of a large or concentrated bolus of the contrast medium since there may be an increased risk of seizure in such cases.

Drugs which lower the seizure threshold, especially phenothiazine derivatives, including those used for their antihistamine properties, are not recommended for use with OMNIPAQUE. Others include MAO inhibitors, tricyclic antidepressants, CNS stimulants, and psychoactive drugs described as analeptics, major tranquilizers, or antipsychotic drugs. While the contributory role of these medications has not been established, the use of such drugs should be based on physician evaluation of potential benefits and potential risks. Physicians have discontinued these agents at least 48 hours before and for at least 24 hours postprocedure.

Care is required in patient management to prevent inadvertent intracranial entry of a large dose or concentrated bolus of the medium. Also, effort should be directed to avoid rapid dispersion of the medium causing inadvertent rise to intracranial levels (eg, by active patient movement). Direct intracisternal or ventricular administration for standard radiography (not CT) is not recommended.

In most reported cases of major motor seizures with nonionic myelographic media, one or more of the following factors were present. Therefore avoid:
Deviations from recommended procedure or in myelographic management.
Use in patients with a history of epilepsy.
Overdosage.
Intracranial entry of a bolus or premature diffusion of a high concentration of the medium.
Medication with neuroleptic drugs or phenothiazine antinauseants.
Failure to maintain elevation of the head during the procedure, on the stretcher, or in bed.
Excessive and particularly active patient movement or straining.

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PRECAUTIONS—General
Diagnostic procedures which involve the use of radiopaque diagnostic agents should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular procedure to be performed. Appropriate facilities should be available for coping with any complication of the procedure, as well as for emergency treatment of severe reactions to the contrast agent itself. After parenteral administration of a radiopaque agent, competent personnel and emergency facilities should be available for at least 30 to 60 minutes since severe delayed reactions have occurred. (See ADVERSE REACTIONS.)

Preparatory dehydration is dangerous and may contribute to acute renal failure in patients with advanced vascular disease, diabetic patients, and in susceptible nondiabetic patients (often elderly with preexisting renal disease). Dehydration in these patients seems to be enhanced by the osmotic diuretic action of contrast agents. Patients should be well hydrated prior to and following administration of any contrast medium, including iohexol.

The possibility of a reaction, including serious, life-threatening, fatal, anaphylactoid, cardiovascular or central nervous system reactions, should always be considered (see ADVERSE REACTIONS). Therefore, it is of utmost importance that a course of action be carefully planned in advance for the immediate treatment of serious reactions, and that adequate and appropriate facilities and personnel be readily available in case of any reaction.

The possibility of an idiosyncratic reaction in susceptible patients should always be considered (see ADVERSE REACTIONS). The susceptible population includes, but is not limited to, patients with a history of a previous reaction to contrast media, patients with a known sensitivity to iodine per se, and patients with a known clinical hypersensitivity: bronchial asthma, hay fever, and food allergies.

The occurrence of severe idiosyncratic reactions has prompted the use of several pretesting methods. However, pretesting cannot be relied upon to predict severe reactions and may itself be hazardous for the patient. It is suggested that a thorough medical history with emphasis on allergy and hypersensitivity, prior to the injection of any contrast media, may be more accurate than pretesting in predicting potential adverse reactions.

A positive history of allergies or hypersensitivity does not arbitrarily contraindicate the use of a contrast agent where a diagnostic procedure is thought essential, but caution should be exercised (see ADVERSE REACTIONS). Premedication with antihistamines or corticosteroids to avoid or minimize possible allergic reactions in such patients should be considered. Recent reports indicate that such pretreatment does not prevent serious life-threatening reactions, but may reduce both their incidence and severity.

In patients with severe renal insufficiency or failure, compensatory biliary excretion of the drug is anticipated to occur, with a slow clearance into the bile. Patients with hepatorenal insufficiency should not be examined unless the possibility of benefit clearly outweighs the additional risk.

Administration of contrast media should be performed by qualified personnel familiar with the procedure and appropriate patient management (see PATIENT MANAGEMENT). Sterile technique must be used with any spinal puncture.

When OMNIPAQUE is to be injected using plastic disposable syringes, the contrast medium should be drawn into the syringe and used immediately.

If nondisposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.

Parenteral products should be inspected visually for particulate matter and discoloration prior to administration. If particulate matter or discoloration is present, do not use.

Repeat Procedures: If in the clinical judgment of the physician sequential or repeat examinations are required, a suitable interval of time between administrations should be observed to allow for normal clearance of the drug from the body (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY).

Information for Patients (or if applicable, children)
Patients receiving injectable radiopaque diagnostic agents should be instructed to:
Inform your physician if you are pregnant (see CLINICAL PHARMACOLOGY).
Inform your physician if you are diabetic or if you have multiple myeloma, pheochromocytoma, homozygous sickle cell disease or known thyroid disorder (see WARNINGS).
Inform your physician if you are allergic to any drugs, food, or if you had any reactions to previous injections of dyes used for x-ray procedures (see PRECAUTIONS—General).
Inform your physician about any other medications you are currently taking, including nonprescription drugs, before you are administered this drug.

Drug Interactions
Drugs which lower seizure threshold, especially phenothiazine derivatives including those used for their antihistaminic or antinauseant properties, are not recommended for use with OMNIPAQUE. Others include monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, CNS stimulants, psychoactive drugs described as analeptics, major tranquilizers, or antipsychotic drugs. Such medications should be discontinued at least 48 hours before myelography, should not be used for the control of nausea or vomiting during or after myelography, and should not be resumed for at least 24 hours postprocedure. In nonelective procedures in patients on these drugs, consider prophylactic use of anticonvulsants.

Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenesis, or whether OMNIPAQUE can affect fertility in men or women.

Pregnancy Category B
Reproduction studies have been performed in rats and rabbits with up to 100 times the recommended human dose. No evidence of impaired fertility or harm to the fetus has been demonstrated due to OMNIPAQUE. There are, however, no studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers
It is not known to what extent iohexol is excreted in human milk. However, many injectable contrast agents are excreted unchanged in human milk. Although it has not been established that serious adverse reactions occur in nursing infants, caution should be exercised when intravascular contrast media are administered to nursing women. Bottle feedings may be substituted for breast feedings for 24 hours following administration of OMNIPAQUE.

Pediatric Use
Pediatric patients at higher risk of experiencing adverse events during contrast medium administration may include those having asthma, a sensitivity to medication and/or allergens, congestive heart failure, a serum creatinine greater than 1.5 mg/dL or those less than 12 months of age.

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ADVERSE REACTIONS—Intrathecal
The most frequently reported adverse reactions with OMNIPAQUE are headache, mild to moderate pain including backache, neckache and stiffness, nausea, and vomiting. These reactions usually occur 1 to 10 hours after injection, and almost all occur within 24 hours. They are usually mild to moderate in degree, lasting for a few hours, and usually disappearing within 24 hours. Rarely, headaches may be severe or persist for days. Headache is often accompanied by nausea and vomiting and tends to be more frequent and persistent in patients not optimally hydrated.

Transient alterations in vital signs may occur and their significance must be assessed on an individual basis. Those reactions reported in clinical studies with OMNIPAQUE are listed below in decreasing order of occurrence, based on clinical studies of 1531 patients.

Headaches: The most frequently occurring adverse reaction following myelography has been headache, with an incidence of approximately 18%. Headache may be caused by either a direct effect of the contrast medium or by CSF leakage at the dural puncture site. However, in managing the patient, it is considered more important to minimize intracranial entry of contrast medium by postural management than attempting to control possible CSF leakage (see PATIENT MANAGEMENT).

Pain: Mild to moderate pain including backache, neckache and stiffness, and neuralgia occurred following injection with an incidence of about 8%.

Nausea and Vomiting: Nausea was reported with an incidence of about 6%, and vomiting about 3% (see PATIENT MANAGEMENT). Maintaining normal hydration is very important. The use of phenothiazine antinauseants is not recommended. (See WARNINGS—General.) Reassurance to the patient that the nausea will clear usually is all that is required.

Dizziness: Transient dizziness was reported in about 2% of the patients.

Other Reactions: Other reactions occurring with an individual incidence of less than 0.1% included: feeling of heaviness, hypotension, hypertonia, sensation of heat, sweating, vertigo, loss of appetite, drowsiness, hypertension, photophobia, tinnitus, neuralgia, paresthesia, difficulty in micturition, and neurological changes. All were transient and mild with no clinical sequelae.

Pediatrics
In controlled clinical trials involving 152 patients for pediatric myelography by lumbar puncture, adverse events following the use of OMNIPAQUE 180 were generally less frequent than with adults.

Headache:       9%
Vomiting:        6%
Backache:    1.3%

Other Reactions: Other reactions occurring with an individual incidence of less than 0.7% included: fever, hives, stomachache, visual hallucination, and neurological changes. All were transient and mild with no clinical sequelae.

General Adverse Reactions to Contrast Media
Physicians should remain alert for the occurrence of adverse effects in addition to those discussed above, particularly the following reactions which have been reported in the literature for other nonionic, water-soluble myelographic media, and rarely with iohexol. These have included, but are not limited to, convulsion, aseptic and bacterial meningitis, and CNS and other neurological disturbances.

An aseptic meningitis syndrome has been reported rarely (less than 0.01%). It was usually preceded by pronounced headaches, nausea and vomiting. Onset usually occurred about 12 to 18 hours postprocedure. Prominent features were meningismus, fever, sometimes with oculomotor signs and mental confusion. Lumbar puncture revealed a high white cell count, high protein content often with a low glucose level and with absence of organisms. The condition usually started to clear spontaneously about 10 hours after onset, with complete recovery over 2 to 3 days.

Allergy or Idiosyncrasy: Chills, fever, profuse diaphoresis, pruritus, urticaria, nasal congestion, dyspnea, and a case of Guillain-Barre syndrome.

CNS Irritation: Mild and transitory perceptual aberrations such as hallucinations, depersonalization, amnesia, hostility, amblyopia, diplopia, photophobia, psychosis, insomnia, anxiety, depression, hyperesthesia, visual or auditory or speech disturbances, confusion and disorientation. In addition, malaise, weakness, convulsion, EEG changes, meningismus, hyperreflexia or areflexia, hypertonia or flaccidity, hemiplegia, paralysis, quadriplegia, restlessness, tremor, echoacousia, echolalia, asterixis, cerebral hemorrhage, and dysphasia have occurred.

Profound mental disturbances have also rarely been reported. They have usually consisted of various forms and degrees of aphasia, mental confusion, or disorientation. The onset is usually at 8 to 10 hours and lasts for about 24 hours, without aftereffects. However, occasionally they have been manifest as apprehension, agitation, or progressive withdrawal in several instances to the point of somnolence, stupor, and coma. In a few cases these have been accompanied by transitory hearing loss or other auditory symptoms and visual disturbances (believed subjective or delusional), including unilateral or bilateral loss of vision which may last for hours. In one case, persistent cortical loss of vision has been reported in association with convulsions. Ventricular block has been reported; amnesia of varying degrees may be present for the reaction event.

Rarely, persistent though transitory weakness in the leg or ocular muscles has been reported.

Peripheral neuropathies have been rare and transitory. They include sensory and/or motor or nerve root disturbances, myelitis, persistent leg muscle pain or weakness, 6th nerve palsy, or cauda equina syndrome. Muscle cramps, fasciculation or myoclonia, spinal convulsion, or spasticity is unusual and has responded promptly to a small intravenous dose of diazepam.

In general, the reactions which are known to occur upon parenteral administration of iodinated contrast agents are possible with any nonionic agent. Approximately 95 percent of adverse reactions accompanying the use of water-soluble contrast agents are mild to moderate in degree. However, severe, life-threatening, anaphylactoid and fatal reactions, mostly of cardiovascular origin and central nervous system origin, have occurred.

Adverse reactions to injectable contrast media fall into two categories: chemotoxic reactions and idiosyncratic reactions.

Chemotoxic reactions result from the physicochemical properties of the contrast media, the dose, and speed of injection. All hemodynamic disturbances and injuries to organs or vessels perfused by the contrast medium are included in this category.

Idiosyncratic reactions include all other reactions. They occur more frequently in patients 20 to 40 years old. Idiosyncratic reactions may or may not be dependent on the amount of dose injected, the speed of injection, and the radiographic procedure. Idiosyncratic reactions are subdivided into minor, intermediate, and severe. The minor reactions are self-limited and of short duration; the severe reactions are life-threatening and treatment is urgent and mandatory.

The reported incidence of adverse reactions to contrast media in patients with a history of allergy is twice that of the general population. Patients with a history of previous reactions to a contrast medium are three times more susceptible than other patients. However, sensitivity to contrast media does not appear to increase with repeated examinations.

Most adverse reactions to injectable contrast media appear within 1 to 3 minutes after the start of injection, but delayed reactions may occur.

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Overdosage
Clinical consequences of overdosage with OMNIPAQUE have not been reported. However, based on experience with other nonionic myelographic media, physicians should be alert to a potential increase in frequency and severity of CNS-mediated reactions. Even use of a recommended dose can produce effects tantamount to overdosage, if incorrect management of the patient during or immediately following the procedure permits inadvertent early intracranial entry of a large portion of the medium.

The intracisternal LD50 value of OMNIPAQUE (in grams of iodine per kilogram body weight) is greater than 2.0 in mice.

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DOSAGE AND ADMINISTRATION — Intrathecal
The volume and concentration of OMNIPAQUE 180, OMNIPAQUE 240, or OMNIPAQUE 300 to be administered will depend on the degree and extent of contrast required in the area(s) under examination and on the equipment and technique employed.

OMNIPAQUE 180 at a concentration of 180 mgI/mL, OMNIPAQUE 240 at a concentration of 240 mgI/mL, or OMNIPAQUE 300 at a concentration of 300 mgI/mL is recommended for the examination of the lumbar, thoracic, and cervical regions in adults by lumbar or direct cervical injection and is slightly hypertonic to CSF.

OMNIPAQUE 180 at a concentration of 180 mgI/mL is recommended for the examination of the lumbar, thoracic, and cervical regions in children by lumbar injection and is slightly hypertonic to CSF.

A total dose of 3060 mg iodine or a concentration of 300 mgI/mL should not be exceeded in adults and a total dose of 2700 mg iodine or a concentration of 180 mgI/mL should not be exceeded in children in a single myelographic examination. This is based on clinical trial evaluation to date. As in all diagnostic procedures, the minimum volume and dose to produce adequate visualization should be used. Most procedures do not require either maximum dose or concentration.

Anesthesia is not necessary. Premedication sedatives or tranquilizers are usually not needed (see PRECAUTIONS). Patients should be well hydrated prior to and following contrast administration. Seizure-prone patients should be maintained on anticonvulsant medication.

Many radiopaque contrast agents are incompatible in vitro with some antihistamines and many other drugs; therefore, concurrent drugs should not be physically admixed with contrast agents.

Rate of Injection: To avoid excessive mixing with CSF and consequent dilution of contrast, injection should be made slowly over 1 to 2 minutes.

Depending on the estimated volume of contrast medium which may be required for the procedure a small amount of CSF may be removed to minimize distention of the subarachnoid spaces.

The lumbar or cervical puncture needle may be removed immediately following injection since it is not necessary to remove OMNIPAQUE after injection into the subarachnoid space.

Pediatrics: The usual recommended total doses for lumbar, thoracic, cervical, and/or total columnar myelography by lumbar puncture in children are 0.36 gI to 2.7 gI (see table below). Actual volumes administered depend largely on patient age and the following guidelines are recommended.

Age            Conc. (mgI/mL)   Volume (mL)    Dose (gI)
0 to < 3 mos.       180            2-4         0.36-0.72
3 to < 36 mos.      180            4-8         0.72-1.44
3 to < 7 yrs.       180            5-10        0.9-1.8
7 to < 13 yrs.      180            5-12        0.9-2.16
13 to 18 yrs.       180            6-15        1.08-2.7

Withdrawal of contrast agents from their containers should be accomplished under aseptic conditions with sterile syringes. Spinal puncture must always be performed under sterile conditions.

Parenteral products should be inspected visually for particulate matter or discoloration prior to administration. If particulate matter or discoloration is present, do not use.

Repeat Procedures: If in the clinical judgment of the physician sequential or repeat examinations are required, a suitable interval of time between administrations should be observed to allow for normal clearance of the drug from the body. An interval of at least 48 hours should be allowed before repeat examination; however, whenever possible, 5 to 7 days is recommended.

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PATIENT MANAGEMENT—Intrathecal
Suggestions for Usual Patient Management

Good patient management should be exercised at all times to minimize the potential for procedurally related complications.

Preprocedure
Discontinuance of neuroleptic drugs (including phenothiazines, eg, chlorpromazine, prochlorperazine, and promethazine) at least 48 hours beforehand should be considered.
Maintain normal diet up to 2 hours before procedure.
Ensure hydration-fluids up to procedure.

During Procedure
Use minimum dose and concentration required for satisfactory contrast (see DOSAGE AND ADMINISTRATION).
In all positioning techniques keep the patient's head elevated above highest level of spine.
Do not lower head of table more than 15° in moving contrast medium cranially.
In patients with excessive lordosis, consider lateral position for injection and movement of the medium cephalad.
Inject slowly (over 1 to 2 minutes) to avoid excessive mixing.
To maintain as a bolus, move medium to distal area very slowly. Use fluoroscopic monitoring.
Avoid intracranial entry of a bolus.
Avoid early and high cephalad dispersion of the medium.
Avoid abrupt or active patient movement to minimize excessive mixing of medium with CSF. Instruct patient to remain passive. Move patient slowly and only as necessary.

Postprocedure
Raise head of stretcher to at least 30° before moving patient onto it.
Movement onto and off the stretcher should be done slowly with the patient completely passive, maintaining head-up position.
Before moving patient onto bed, raise head of bed 30° to 45°.
Advise patient to remain still in bed, in a sitting or semisitting position, especially in the first few hours.
Maintain close observation for at least 12 hours after myelogram.
Obtain visitors' cooperation in keeping the patient quiet and in head-up position, especially in first few hours.
Encourage oral fluids. Diet as tolerated.
If nausea or vomiting occurs, do not use phenothiazine antinauseants. Persistent nausea and vomiting will result in dehydration. Therefore, prompt consideration of replacement by intravenous fluids is recommended.

Alternative Postprocedure Method
Recent evidence with nonionic, water-soluble contrast media suggests that maintaining the patient postmyelography in an upright position (via wheelchair or ambulation) may help minimize adverse effects. The upright position may help to delay upward dispersion of the medium and to maximize the spinal arachnoid absorption.

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CLINICAL PHARMACOLOGY—Intravascular
Following intravascular injection, iohexol is distributed in the extracellular fluid compartment and is excreted unchanged by glomerular filtration. It will opacify those vessels in the path of flow of the contrast medium permitting radiographic visualization of the internal structures until significant hemodilution occurs.

Approximately 90% or more of the injected dose is excreted within the first 24 hours, with the peak urine concentrations occurring in the first hour after administration. Plasma and urine iohexol levels indicate that the iohexol body clearance is due primarily to renal clearance. An increase in the dose from 500 mgI/kg to 1500 mgI/kg does not significantly alter the clearance of the drug. The following pharmacokinetic values were observed following the intravenous administration of iohexol (between 500 mgI/kg to 1500 mgI/kg) to 16 adult human subjects: renal clearance—120 (86-162) mL/min; total body clearance—131 (98-165) mL/min; and volume of distribution—165 (108-219) mL/kg.

Renal accumulation is sufficiently rapid that the period of maximal opacification of the renal passages may begin as early as 1 minute after intravenous injection. Urograms become apparent in about 1 to 3 minutes with optimal contrast occurring between 5 to 15 minutes. In nephropathic conditions, particularly when excretory capacity has been altered, the rate of excretion may vary unpredictably, and opacification may be delayed after injection. Severe renal impairment may result in a lack of diagnostic opacification of the collecting system and, depending on the degree of renal impairment, prolonged plasma iohexol levels may be anticipated. In these patients, as well as in infants with immature kidneys, the route of excretion through the gallbladder and into the small intestine may increase.

Iohexol displays a low affinity for serum or plasma proteins and is poorly bound to serum albumin. No significant metabolism, deiodination or biotransformation occurs.

OMNIPAQUE probably crosses the placental barrier in humans by simple diffusion. It is not known to what extent iohexol is excreted in human milk.

Animal studies indicate that iohexol does not cross an intact blood-brain barrier to any significant extent following intravascular administration.

OMNIPAQUE enhances computed tomographic imaging through augmentation of radiographic efficiency. The degree of density enhancement is directly related to the iodine content in an administered dose; peak iodine blood levels occur immediately following rapid intravenous injection. Blood levels fall rapidly within 5 to 10 minutes and the vascular compartment half-life is approximately 20 minutes. This can be accounted for by the dilution in the vascular and extravascular fluid compartments which causes an initial sharp fall in plasma concentration. Equilibration with the extracellular compartments is reached in about ten minutes; thereafter, the fall becomes exponential.

The pharmacokinetics of iohexol in both normal and abnormal tissue have been shown to be variable. Contrast enhancement appears to be greatest immediately after bolus administration (15 seconds to 120 seconds). Thus, greatest enhancement may be detected by a series of consecutive two-to-three second scans performed within 30 to 90 seconds after injection (ie, dynamic computed tomographic imaging). Utilization of a continuous scanning technique (ie, dynamic CT scanning) may improve enhancement and diagnostic assessment of tumor and other lesions such as abscess, occasionally revealing unsuspected or more extensive disease. For example, a cyst may be distinguished from a vascularized solid lesion when precontrast and enhanced scans are compared; the nonperfused mass shows unchanged x-ray absorption (CT number). A vascularized lesion is characterized by an increase in CT number in the few minutes after a bolus of intravascular contrast agent; it may be malignant, benign, or normal tissue, but would probably not be a cyst, hematoma, or other nonvascular lesion.

Because unenhanced scanning may provide adequate diagnostic information in the individual patient, the decision to employ contrast enhancement, which may be associated with risk and increased radiation exposure, should be based upon a careful evaluation of clinical, other radiological, and unenhanced CT findings.

CT SCANNING OF THE HEAD
In contrast enhanced computed tomographic head imaging, OMNIPAQUE does not accumulate in normal brain tissue due to the presence of the normal blood-brain barrier. The increase in x-ray absorption in normal brain is due to the presence of contrast agent within the blood pool. A break in the blood-brain barrier such as occurs in malignant tumors of the brain allows for the accumulation of contrast medium within the interstitial tissue of the tumor. Adjacent normal brain tissue does not contain the contrast medium.

Maximum contrast enhancement in tissue frequently occurs after peak blood iodine levels are reached. A delay in maximum contrast enhancement can occur. Diagnostic contrast enhanced images of the brain have been obtained up to 1 hour after intravenous bolus administration. This delay suggests that radiographic contrast enhancement is at least in part dependent on the accumulation of iodine containing medium within the lesion and outside the blood pool, although the mechanism by which this occurs is not clear. The radiographic enhancement of nontumoral lesions, such as arteriovenous malformations and aneurysms, is probably dependent on the iodine content of the circulating blood pool.

In patients where the blood-brain barrier is known or suspected to be disrupted, the use of any radiographic contrast medium must be assessed on an individual risk to benefit basis. However, compared to ionic media, nonionic media are less toxic to the central nervous system.

CT SCANNING OF THE BODY
In contrast enhanced computed tomographic body imaging (nonneural tissue), OMNIPAQUE diffuses rapidly from the vascular into the extravascular space. Increase in x-ray absorption is related to blood flow, concentration of the contrast medium, and extraction of the contrast medium by interstitial tissue of tumors since no barrier exists. Contrast enhancement is thus due to the relative differences in extravascular diffusion between normal and abnormal tissue, quite different from that in the brain.

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INDICATIONS AND USAGE, GENERAL—Intravascular
OMNIPAQUE 350 is indicated in adults for angiocardiography (ventriculography, selective coronary arteriography), aortography including studies of the aortic root, aortic arch, ascending aorta, abdominal aorta and its branches, contrast enhancement for computed tomographic head and body imaging, intravenous digital subtraction angiography of the head, neck, abdominal, renal and peripheral vessels, peripheral arteriography, and excretory urography.

OMNIPAQUE 350 is indicated in children for angiocardiography (ventriculography, pulmonary arteriography, and venography; studies of the collateral arteries and aortography, including the aortic root, aortic arch, ascending and descending aorta).

OMNIPAQUE 300 is indicated in adults for aortography including studies of the aortic arch, abdominal aorta and its branches, contrast enhancement for computed tomographic head and body imaging, cerebral arteriography, peripheral venography (phlebography), and excretory urography.

OMNIPAQUE 300 is indicated in children for angiocardiography (ventriculography), excretory urography, and contrast enhancement for computed tomographic head imaging.

OMNIPAQUE 240 is indicated in adults for contrast enhancement for computed tomographic head imaging and peripheral venography (phlebography).

OMNIPAQUE 140 is indicated in adults for intra-arterial digital subtraction angiography of the head, neck, abdominal, renal and peripheral vessels.

OMNIPAQUE 240 is indicated in children for contrast enhancement for computed tomographic head imaging.

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Contraindications
OMNIPAQUE should not be administered to patients with a known hypersensitivity to iohexol.

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WARNINGS—General
Nonionic iodinated contrast media inhibit blood coagulation, in vitro, less than ionic contrast media. Clotting has been reported when blood remains in contact with syringes containing nonionic contrast media.

Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events. Numerous factors, including length of procedure, catheter and syringe material, underlying disease state, and concomitant medications, may contribute to the development of thromboembolic events. For these reasons, meticulous angiographic techniques are recommended including close attention to guidewire and catheter manipulation, use of manifold systems and/or three-way stopcocks, frequent catheter flushing with heparinized saline solutions and minimizing the length of the procedure. The use of plastic syringes in place of glass syringes has been reported to decrease but not eliminate the likelihood of in vitro clotting.

OMNIPAQUE should be used with extreme care in patients with severe functional disturbances of the liver and kidneys, severe thyrotoxicosis, or myelomatosis. Diabetics with a serum creatinine level above 3 mg/dL should not be examined unless the possible benefits of the examination clearly outweigh the additional risk. OMNIPAQUE is not recommended for use in patients with anuria.

Radiopaque contrast agents are potentially hazardous in patients with multiple myeloma or other paraproteinemia, particularly in those with therapeutically resistant anuria. Although neither the contrast agent nor dehydration has separately proven to be the cause of anuria in myeloma, it has been speculated that the combination of both may be causative factors. The risk in myelomatous patients is not a contraindication; however, special precautions are necessary. Partial dehydration in the preparation of these patients prior to injection is not recommended since this may predispose the patient to precipitation of the myeloma protein in the renal tubules. No form of therapy, including dialysis, has been successful in reversing the effect. Myeloma, which occurs most commonly in persons over age 40, should be considered before instituting intravascular administration of contrast agents.

Ionic contrast media, when injected intravenously or intra-arterially, may promote sickling in individuals who are homozygous for sickle cell disease.

Administration of radiopaque materials to patients known or suspected of having pheochromocytoma should be performed with extreme caution. If, in the opinion of the physician, the possible benefits of such procedures outweigh the considered risks, the procedures may be performed; however, the amount of radiopaque medium injected should be kept to an absolute minimum. The patient's blood pressure should be assessed throughout the procedure and measures for the treatment of hypertensive crisis should be readily available.

Reports of thyroid storm following the use of iodinated, ionic radiopaque contrast media in patients with hyperthyroidism or with an autonomously functioning thyroid nodule suggest that this additional risk be evaluated in such patients before use of any contrast medium.

Urography should be performed with caution in patients with severely impaired renal function and patients with combined renal and hepatic disease.

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PRECAUTIONS—General
Diagnostic procedures which involve the use of radiopaque diagnostic agents should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular procedure to be performed. Appropriate facilities should be available for coping with any complication of the procedure, as well as for emergency treatment of severe reactions to the contrast agent itself. After parenteral administration of a radiopaque agent, competent personnel and emergency facilities should be available for at least 30 to 60 minutes since severe delayed reactions have occurred (see ADVERSE REACTIONS: Intravascular—General).

Preparatory dehydration is dangerous and may contribute to acute renal failure in patients with advanced vascular disease, diabetic patients, and in susceptible nondiabetic patients (often elderly with preexisting renal disease), infants and small children. Dehydration in these patients seems to be enhanced by the osmotic diuretic action of urographic agents. It is believed that overnight fluid restriction prior to excretory urography generally does not provide better visualization in normal patients. Patients should be well hydrated prior to and following administration of any contrast medium, including iohexol.

Acute renal failure has been reported in diabetic patients with diabetic nephropathy and in susceptible non-diabetic patients (often elderly with preexisting renal disease) following excretory urography. Therefore, careful consideration of the potential risks should be given before performing this radiographic procedure in these patients.

Immediately following surgery, excretory urography should be used with caution in renal transplant recipients.

The possibility of a reaction, including serious, life-threatening, fatal, anaphylactoid or cardiovascular reactions, should always be considered (see ADVERSE REACTIONS: Intravascular—General). It is of utmost importance that a course of action be carefully planned in advance for immediate treatment of serious reactions, and that adequate and appropriate personnel be readily available in case of any reaction.

The possibility of an idiosyncratic reaction in susceptible patients should always be considered (see ADVERSE REACTIONS: Intravascular—General). The susceptible population includes, but is not limited to, patients with a history of a previous reaction to contrast media, patients with a known sensitivity to iodine per se, and patients with a known clinical hypersensitivity: bronchial asthma, hay fever, and food allergies.

The occurrence of severe idiosyncratic reactions has prompted the use of several pretesting methods. However, pretesting cannot be relied upon to predict severe reactions and may itself be hazardous for the patient. It is suggested that a thorough medical history with emphasis on allergy and hypersensitivity, prior to the injection of any contrast media, may be more accurate than pretesting in predicting potential adverse reactions.

A positive history of allergies or hypersensitivity does not arbitrarily contraindicate the use of a contrast agent where a diagnostic procedure is thought essential, but caution should be exercised (see ADVERSE REACTIONS: Intravascular—General). Premedication with antihistamines or corticosteroids to avoid or minimize possible allergic reactions in such patients should be considered and administered using separate syringes. Recent reports indicate that such pretreatment does not prevent serious life-threatening reactions, but may reduce both their incidence and severity.

Even though the osmolality of OMNIPAQUE is low compared to diatrizoate- or iothalamate-based ionic agents of comparable iodine concentration, the potential transitory increase in the circulatory osmotic load in patients with congestive heart failure requires caution during injection. These patients should be observed for several hours following the procedure to detect delayed hemodynamic disturbances.

General anesthesia may be indicated in the performance of some procedures in selected adult patients; however, a higher incidence of adverse reactions has been reported in these patients, and may be attributable to the inability of the patient to identify untoward symptoms, or to the hypotensive effect of anesthesia which can reduce cardiac output and increase the duration of exposure to the contrast agent.

Angiography should be avoided whenever possible in patients with homocystinuria, because of the risk of inducing thrombosis and embolism.

In angiographic procedures, the possibility of dislodging plaques or damaging or perforating the vessel wall should be borne in mind during the catheter manipulations and contrast medium injection. Test injections to ensure proper catheter placement are recommended.

Selective coronary arteriography should be performed only in those patients in whom the expected benefits outweigh the potential risk. The inherent risks of angiocardiography in patients with chronic pulmonary emphysema must be weighed against the necessity for performing this procedure.

When OMNIPAQUE is to be injected using plastic disposable syringes, the contrast medium should be drawn into the syringe and used immediately.

If nondisposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.

Parenteral products should be inspected visually for particulate matter and discoloration prior to administration. If particulate matter or discoloration is present, do not use.

Information for Patients
Patients receiving injectable radiopaque diagnostic agents should be instructed to:
Inform your physician if you are pregnant (see CLINICAL PHARMACOLOGY—Intravascular).
Inform your physician if you are diabetic or if you have multiple myeloma, pheochromocytoma, homozygous sickle cell disease, or known thyroid disorder (see WARNINGS).
Inform your physician if you are allergic to any drugs, food, or if you had any reactions to previous injections of dyes used for x-ray procedures (see PRECAUTIONS—General).
Inform your physician about any other medications you are currently taking, including nonprescription drugs, before you are administered this drug.

Drug/Laboratory Test Interaction
If iodine-containing isotopes are to be administered for the diagnosis of thyroid disease, the iodine-binding capacity of thyroid tissue may be reduced for up to 2 weeks after contrast medium administration. Thyroid function tests which do not depend on iodine estimation, eg, T3 resin uptake or direct thyroxine assays, are not affected.

Many radiopaque contrast agents are incompatible in vitro with some antihistamines and many other drugs; therefore, no other pharmaceuticals should be admixed with contrast agents.

Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenesis, or whether OMNIPAQUE can affect fertility in men or women.

Pregnancy Category B
Reproduction studies have been performed in rats and rabbits with up to 100 times the recommended human dose. No evidence of impaired fertility or harm to the fetus has been demonstrated due to OMNIPAQUE. There are, however, no studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers
It is not known to what extent iohexol is excreted in human milk. However, many injectable contrast agents are excreted unchanged in human milk. Although it has not been established that serious adverse reactions occur in nursing infants, caution should be exercised when intravascular contrast media are administered to nursing women. Bottle feedings may be substituted for breast feedings for 24 hours following administration of OMNIPAQUE.

Pediatric Use
Pediatric patients at higher risk of experiencing adverse events during contrast medium administration may include those having asthma, a sensitivity to medication and/or allergens, congestive heart failure, a serum creatinine greater than 1.5 mg/dL or those less than 12 months of age.

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ADVERSE REACTIONS: Intravascular—General
Adverse reactions following the use of OMNIPAQUE 140, OMNIPAQUE 240, OMNIPAQUE 300, and OMNIPAQUE 350 are usually of mild to moderate severity. However, serious, life-threatening and fatal reactions, mostly of cardiovascular origin, have been associated with the administration of iodine-containing contrast media, including OMNIPAQUE. The injection of contrast media is frequently associated with the sensation of warmth and pain, especially in peripheral angiography; pain and warmth are less frequent and less severe with OMNIPAQUE than with many contrast media.

Cardiovascular System: Arrhythmias including PVCs and PACs (2%), angina/chest pain (1%), and hypotension (0.7%). Others including cardiac failure, asystole, bradycardia, tachycardia, and vasovagal reaction were reported with an individual incidence of 0.3% or less. In controlled clinical trials involving 1485 patients, one fatality occurred. A cause and effect relationship between this death and iohexol has not been established.

Nervous System: Vertigo (including dizziness and lightheadedness) (0.5%), pain (3%), vision abnormalities (including blurred vision and photomas) (2%), headache (2%), and taste perversion (1%). Others including anxiety, fever, motor and speech dysfunction, convulsion, paresthesia, somnolence, stiff neck, hemiparesis, syncope, shivering, transient ischemic attack, cerebral infarction, and nystagmus were reported, with an individual incidence of 0.3% or less.

Respiratory System: Dyspnea, rhinitis, coughing, and laryngitis, with an individual incidence of 0.2% or less.

Gastrointestinal System: Nausea (2%) and vomiting (0.7%). Others including diarrhea, dyspepsia, cramp, and dry mouth were reported, with an individual incidence of less than 0.1%.

Skin and Appendages: Urticaria (0.3%), purpura (0.1%), abscess (0.1%), and pruritus (0.1%).

Individual adverse reactions which occurred to a significantly greater extent for a specific procedure are listed under that indication.

Pediatrics
In controlled clinical trials involving 391 patients for pediatric angiocardiography, urography, and contrast enhanced computed tomographic head imaging, adverse reactions following the use of OMNIPAQUE 240, OMNIPAQUE 300, and OMNIPAQUE 350 were generally less frequent than with adults.

Cardiovascular System: Ventricular tachycardia (0.5%), 2:1 heart block (0.5%), hypertension (0.3%), and anemia (0.3%).

Nervous System: Pain (0.8%), fever (0.5%), taste abnormality (0.5%), and convulsion (0.3%).

Respiratory System: Congestion (0.3%) and apnea (0.3%).

Gastrointestinal System: Nausea (1%), hypoglycemia (0.3%), and vomiting (2%).

Skin and Appendages: Rash (0.3%).

General Adverse Reactions to Contrast Media
Physicians should remain alert for the occurrence of adverse effects in addition to those discussed above.

The following reactions have been reported after administration of other intravascular iodinated contrast media, and rarely with iohexol. Reactions due to technique: hematomas and ecchymoses. Hemodynamic reactions: vein cramp and thrombophlebitis following intravenous injection. Cardiovascular reactions: rare cases of cardiac arrhythmias, reflex tachycardia, chest pain, cyanosis, hypertension, hypotension, peripheral vasodilatation, shock, and cardiac arrest. Renal reactions: occasionally, transient proteinuria, and rarely, oliguria or anuria. Allergic reactions: asthmatic attacks, nasal and conjunctival symptoms, dermal reactions such as urticaria with or without pruritus, as well as pleomorphic rashes, sneezing and lacrimation and, rarely, anaphylactic reactions. Rare fatalities have occurred, due to this or unknown causes. Signs and symptoms related to the respiratory system: pulmonary or laryngeal edema, bronchospasm, dyspnea; or to the nervous system: restlessness, tremors, convulsions. Other reactions: flushing, pain, warmth, metallic taste, nausea, vomiting, anxiety, headache, confusion, pallor, weakness, sweating, localized areas of edema, especially facial cramps, neutropenia, and dizziness. Rarely, immediate or delayed rigors can occur, sometimes accompanied by hyperpyrexia. Infrequently, "iodism" (salivary gland swelling) from organic iodinated compounds appears two days after exposure and subsides by the sixth day.

In general, the reactions which are known to occur upon parenteral administration of iodinated contrast agents are possible with any nonionic agent. Approximately 95 percent of adverse reactions accompanying the use of water-soluble intravascularly administered contrast agents are mild to moderate in degree. However, severe, life-threatening anaphylactoid reactions, mostly of cardiovascular origin, have occurred. Reported incidences of death range from 6.6 per 1 million (0.00066 percent) to 1 in 10,000 (0.01 percent). Most deaths occur during injection or 5 to 10 minutes later; the main feature being cardiac arrest with cardiovascular disease as the main aggravating factor. Isolated reports of hypotensive collapse and shock are found in the literature. The incidence of shock is estimated to be 1 out of 20,000 (0.005 percent) patients.

Adverse reactions to injectable contrast media fall into two categories: chemotoxic reactions and idiosyncratic reactions.

Chemotoxic reactions result from the physicochemical properties of the contrast media, the dose, and speed of injection. All hemodynamic disturbances and injuries to organs or vessels perfused by the contrast medium are included in this category.

Idiosyncratic reactions include all other reactions. They occur more frequently in patients 20 to 40 years old. Idiosyncratic reactions may or may not be dependent on the amount of dose injected, the speed of injection, and the radiographic procedure. Idiosyncratic reactions are subdivided into minor, intermediate, and severe. The minor reactions are self-limited and of short duration; the severe reactions are life-threatening and treatment is urgent and mandatory.

The reported incidence of adverse reactions to contrast media in patients with a history of allergy are twice that of the general population. Patients with a history of previous reactions to a contrast medium are three times more susceptible than other patients. However, sensitivity to contrast media does not appear to increase with repeated examinations.

Most adverse reactions to injectable contrast media appear within 1 to 3 minutes after the start of injection, but delayed reactions may occur.

Regardless of the contrast agent employed, the overall estimated incidence of serious adverse reactions is higher with angiocardiography than with other procedures. Cardiac decompensation, serious arrhythmias, angina pectoris, or myocardial ischemia or infarction may occur during angiocardiography and left ventriculography. Electrocardiographic and hemodynamic abnormalities occur less frequently with OMNIPAQUE than with diatrizoate meglumine and diatrizoate sodium injection.

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Overdosage
Overdosage may occur. The adverse effects of overdosage are life-threatening and affect mainly the pulmonary and cardiovascular systems. The symptoms include: cyanosis, bradycardia, acidosis, pulmonary hemorrhage, convulsions, coma, and cardiac arrest. Treatment of an overdosage is directed toward the support of all vital functions, and prompt institution of symptomatic therapy.

The intravenous LD50 values of OMNIPAQUE (in grams of iodine per kilogram body weight) are 24.2 in mice and 15.0 in rats.

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DOSAGE AND ADMINISTRATION — General
As with all radiopaque contrast agents, the lowest dose of OMNIPAQUE necessary to obtain adequate visualization should be used. A lower dose may reduce the possibility of an adverse reaction. Most procedures do not require use of either the maximum volume or the highest concentration of OMNIPAQUE. The combination of volume and concentration of OMNIPAQUE to be used should be carefully individualized accounting for factors such as age, body weight, size of the vessel and the rate of blood flow within the vessel. Other factors such as anticipated pathology, degree and extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed should be considered.

Sterile technique must be used in all vascular injections involving contrast media.

Withdrawal of contrast agents from their containers should be accomplished under aseptic conditions with sterile equipment. Sterile techniques must be used with any invasive procedure.

If nondisposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.

It may be desirable that solutions of radiopaque diagnostic agents be used at body temperature when injected.

Parenteral products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Solutions of OMNIPAQUE should be used only if clear and within the normal colorless to pale yellow range. If particulate matter or discoloration is present, do not use.

INDIVIDUAL INDICATIONS AND USAGE
ANGIOCARDIOGRAPHY
Pharmacology—Hemodynamic Changes
OMNIPAQUE 350 at a concentration of 350 mgI/mL is indicated in adults for angiocardiography (ventriculography, aortic root injections, and selective coronary arteriography).

OMNIPAQUE 350 at a concentration of 350 mgI/mL is indicated in children for angiocardiography (ventriculography, pulmonary arteriography, and venography, and studies of the collateral arteries).

OMNIPAQUE 300 at a concentration of 300 mgI/mL is indicated in children for angiocardiography (ventriculography).

After both ventricular and coronary injection, decreases in systolic pressure were less pronounced and returned to baseline values earlier with OMNIPAQUE 350 than with diatrizoate meglumine and diatrizoate sodium injection.

OMNIPAQUE 350 produced less Q-T interval prolongation than seen with diatrizoate meglumine and diatrizoate sodium injection.

In children, after injection of all sites, but particularly following ventricular and pulmonary artery injections, decreases in both systolic and diastolic intravascular pressure were significantly less pronounced with OMNIPAQUE 350 than with diatrizoate meglumine and diatrizoate sodium injection. In children, OMNIPAQUE 350 produced significantly less shortening of the R-R interval than seen with diatrizoate meglumine and diatrizoate sodium injection.

If repeat injections are made in rapid succession, all these changes are likely to be more pronounced. (See DOSAGE AND ADMINISTRATION.)

Precautions
During administration of large doses of OMNIPAQUE 350, continuous monitoring of vital signs is desirable. Caution is advised in the administration of large volumes to patients with incipient heart failure because of the possibility of aggravating the preexisting condition. Hypotension should be corrected promptly since it may induce serious arrhythmias.

Special care regarding dosage should be observed in patients with right ventricular failure, pulmonary hypertension, or stenotic pulmonary vascular beds because of the hemodynamic changes which may occur after injection into the right heart outflow tract. (See PRECAUTIONS—General.)

Pediatric patients at higher risk of experiencing adverse events during contrast medium administration may include those having asthma, a sensitivity to medication and/or allergens, congestive heart failure, a serum creatinine greater than 1.5 mg/dL or those less than 12 months of age.

Adverse Reactions
Cardiovascular system reactions in angiocardiography included angina (8%), hypotension (2.5%), bradycardia (1.0%), and tachycardia (1.0%). (See ADVERSE REACTIONS: Intravascular—General.)

Dosage and Administration
The individual dose or volume is determined by the size of the structure to be visualized, the anticipated degree of hemodilution, and valvular competence. Weight is a minor consideration in adults, but must be considered in infants and young children. The volume of each individual injection is a more important consideration than the total dosage used. When large individual volumes are administered, as in ventriculography and aortography, it has been suggested that several minutes be permitted to elapse between each injection to allow for subsidence of possible hemodynamic disturbances.

The recommended single injection volume of OMNIPAQUE 350 for angiocardiographic procedures in adults and the recommended single injection volumes of OMNIPAQUE 350 and OMNIPAQUE 300 for angiographic procedures in children are as follows:

Ventriculography
Adults: The usual adult volume for a single injection is 40 mL with a range of 30 mL to 60 mL. This may be repeated as necessary. When combined with selective coronary arteriography, the total administered volume should not exceed 250 mL (87.5 gI).

Pediatrics: The usual single injection dose of OMNIPAQUE 350 is 1.25 mL/kg of body weight with a range of 1.0 mL/kg to 1.5 mL/kg. For OMNIPAQUE 300 the usual single injection dose is 1.75 mL/kg with a range of 1.5 mL/kg to 2.0 mL/kg. When multiple injections are given, the total administered dose should not exceed 5 mL/kg up to a total volume of 250 mL of OMNIPAQUE 350 or up to a total volume of 291 mL of OMNIPAQUE 300.

Selective Coronary Arteriography
The usual adult volume for right or left coronary arteriography is 5 mL (range 3 mL to 14 mL) per injection.

Aortic Root and Arch Study When Used Alone
The usual adult single injection volume is 50 mL, with a range of 20 mL to 75 mL.

Pulmonary Angiography
Pediatrics: The usual single injection dose is 1.0 mL/kg of OMNIPAQUE 350.

Combined Angiocardiographic Procedures
Multiple Procedures
Adults: The visualization of multiple vascular systems and target organs is possible during a single radiographic examination of the patient.

Large doses of OMNIPAQUE 350 were well tolerated in angiographic procedures requiring multiple injections.

The maximum total volume for multiple procedures should not exceed 250 mL of 350 mgI/mL (87.5 gI).

Pediatrics: Visualization of multiple vascular systems and target organs is possible during a single radiographic examination of the patient.

The maximum total dose for multiple injection procedures should not exceed 5.0 mL/kg up to a total volume of 250 mL of OMNIPAQUE 350 or 6.0 mL/kg up to a total volume of 291 mL of OMNIPAQUE 300.

AORTOGRAPHY AND SELECTIVE VISCERAL ARTERIOGRAPHY
OMNIPAQUE 300 at a concentration of 300 mgI/mL and OMNIPAQUE 350 at a concentration of 350 mgI/mL are indicated in adults for use in aortography and selective visceral arteriography including studies of the aortic arch, ascending aorta, and abdominal aorta and its branches (celiac, mesenteric, renal, hepatic and splenic arteries).

OMNIPAQUE 350 at a concentration of 350 mgI/mL is indicated in children for use in aortography including studies of the aortic root, aortic arch, ascending and descending aorta.

Precautions
Under conditions of slowed aortic circulation there is an increased likelihood for aortography to cause muscle spasm. Occasional serious neurologic complications, including paraplegia, have also been reported in patients with aortoiliac obstruction, femoral artery obstruction, abdominal compression, hypotension, hypertension, spinal anesthesia, and injection of vasopressors to increase contrast. In these patients the concentration, volume and number of repeat injections of the medium should be maintained at a minimum with appropriate intervals between injections. The position of the patient and catheter tip should be carefully monitored.

Entry of a large aortic dose into the renal artery may cause, even in the absence of symptoms, albuminuria, hematuria, and an elevated creatinine and urea nitrogen. Rapid and complete return of function usually follows. (See PRECAUTIONS—General.)

Adverse Reactions
See ADVERSE REACTIONS: Intravascular—General, and ADVERSE REACTIONS—ANGIOCARDIOGRAPHY.

Dosage and Administration
Adults: The usual adult volume as a single injection is 50 mL to 80 mL for the aorta, 30 mL to 60 mL for major branches including celiac and mesenteric arteries, and 5 mL to 15 mL for renal arteries. Repeated injections may be performed if indicated, but the total volume should not exceed 291 mL of OMNIPAQUE 300 or 250 mL of OMNIPAQUE 350 (87.5 gI).

Pediatrics: The usual single injection dose is 1.0 mL/kg of OMNIPAQUE 350 and should not exceed 5.0 mL/kg up to a total volume of 250 mL of OMNIPAQUE 350.

CEREBRAL ARTERIOGRAPHY
OMNIPAQUE 300 at a concentration of 300 mgI/mL is indicated in adults for use in cerebral arteriography.

The degree of pain and flushing as the result of the use of OMNIPAQUE 300 in cerebral arteriography is less than that seen with comparable injections of many contrast media.

In cerebral arteriography, patients should be appropriately prepared consistent with existing or suspected disease states.

Precautions
Cerebral arteriography should be undertaken with extreme care with special caution in elderly patients, patients in poor clinical condition, advanced arteriosclerosis, severe arterial hypertension, recent cerebral embolism or thrombosis, and cardiac decompensation.

Since the contrast medium is given by rapid injection, the patient should be monitored for possible untoward reactions. (See PRECAUTIONS—General.)

Adverse Reactions
Cerebral arteriography with water-soluble contrast media has been associated with temporary neurologic complications including seizures, drowsiness, transient paresis, and mild disturbances in vision such as photomas of 1-second or less duration.

Central nervous system reactions in cerebral arteriography included photomas (15%), headache (5.5%), and pain (4.5%). (See ADVERSE REACTIONS: Intravascular—General.)

Dosage and Administration
OMNIPAQUE 300 is recommended for cerebral arteriography at the following volumes: common carotid artery (6 mL to 12 mL), internal carotid artery (8 mL to 10 mL), external carotid artery (6 mL to 9 mL), and vertebral artery (6 mL to 10 mL).

CONTRAST ENHANCED COMPUTED TOMOGRAPHY
OMNIPAQUE 240 at a concentration of 240 mgI/mL, OMNIPAQUE 300 at a concentration of 300 mgI/mL, and OMNIPAQUE 350 at a concentration of 350 mgI/mL are indicated in adults for use in intravenous contrast enhanced computed tomographic head and body imaging by rapid injection or infusion technique.

OMNIPAQUE 240 at a concentration of 240 mgI/mL and OMNIPAQUE 300 at a concentration of 300 mgI/mL are indicated in children for use in intravenous contrast enhanced computed tomographic head imaging by rapid bolus injection.

CT SCANNING OF THE HEAD
OMNIPAQUE may be used to redefine diagnostic precision in areas of the brain which may not otherwise have been satisfactorily visualized.

Tumors
OMNIPAQUE may be useful to investigate the presence and extent of certain malignancies such as: gliomas including malignant gliomas, glioblastomas, astrocytomas, oligodendrogliomas and gangliomas, ependymomas, medulloblastomas, meningiomas, neuromas, pinealomas, pituitary adenomas, carniopharyngiomas, germinomas, and metastatic lesions. The usefulness of contrast enhancement for the investigation of the retrobulbar space and in cases of low grade or infiltrative glioma has not been demonstrated. In calcified lesions, there is less likelihood of enhancement. Following therapy, tumors may show decreased or no enhancement. The opacification of the inferior vermis following contrast media administration has resulted in false-positive diagnosis in a number of otherwise normal studies.

Nonneoplastic Conditions
OMNIPAQUE may be beneficial in the image enhancement of nonneoplastic lesions. Cerebral infarctions of recent onset may be better visualized with contrast enhancement, while some infarctions are obscured if contrast medium is used. The use of iodinated contrast media results in enhancement in about 60 percent of cerebral infarctions studied from one to four weeks from the onset of symptoms.

Sites of active infection may also be enhanced following contrast medium administration.

Arteriovenous malformations and aneurysms will show contrast enhancement. For these vascular lesions the enhancement is probably dependent on the iodine content of the circulating blood pool. Hematomas and intraparenchymal bleeders seldom demonstrate contrast enhancement. However, in cases of intraparenchymal clot, for which there is no obvious clinical explanation, contrast media administration may be helpful in ruling out the possibility of associated arteriovenous malformation.

CT SCANNING OF THE BODY
OMNIPAQUE may be useful for enhancement of computed tomographic images for detection and evaluation of lesions in the liver, pancreas, kidneys, aorta, mediastinum, pelvis, abdominal cavity, and retroperitoneal space.

Enhancement of computed tomography with OMNIPAQUE may be of benefit in establishing diagnoses of certain lesions in these sites with greater assurance than is possible with CT alone. In other cases, the contrast agent may allow visualization of lesions not seen with CT alone (ie, tumor extension) or may help to define suspicious lesions seen with unenhanced CT (ie, pancreatic cyst).

For information regarding the use of dilute oral plus intravenous OMNIPAQUE in CT of the abdomen, see INDIVIDUAL INDICATIONS AND USAGE—Oral Use.

Precautions
See PRECAUTIONS—General.

Adverse Reactions
Immediately following intravascular injection of contrast medium, a transient sensation of mild warmth is not unusual. Warmth is less frequent with OMNIPAQUE than with ionic media. (See ADVERSE REACTIONS: Intravascular—General.)

Dosage and Administration
The concentration and volume required will depend on the equipment and imaging technique used.

OMNIPAQUE (iohexol) Injection
The dosage recommended for use in adults for contrast enhanced computed tomography is as follows:
Head Imaging by Injection: 70 mL to 150 mL (21 gI to 45 gI) of OMNIPAQUE 300 (300 mgI/mL)
80 mL (28 gI) of OMNIPAQUE 350 (350 mgI/mL)
Head Imaging by Infusion: 120 mL to 250 mL (29 gI to 60 gI) of OMNIPAQUE 240 (240 mgI/mL)
Body Imaging by Injection: 50 mL to 200 mL (15 gI to 60 gI) of OMNIPAQUE 300 (300 mgI/mL)
60 mL to 100 mL (21 gI to 35 gI) of OMNIPAQUE 350 (350 mgI/mL)

The dosage recommended for use in children for contrast enhanced computed tomographic head imaging is 1.0 mL/kg to 2.0 mL/kg for OMNIPAQUE 240 or OMNIPAQUE 300. It should not be necessary to exceed a maximum dose of 28 gI with OMNIPAQUE 240 or 35 gI with OMNIPAQUE 300.

DIGITAL SUBTRACTION ANGIOGRAPHY
Intravenous Administration
OMNIPAQUE 350 at a concentration of 350 mgI/mL is indicated in adults for use in intravenous digital subtraction angiography (I.V.DSA) of the vessels of the head, neck, and abdominal, renal and peripheral vessels.

Arteriograms of diagnostic quality can be obtained following the intravenous administration of contrast media employing digital subtraction and computer imaging enhancement techniques. The intravenous route of administration using these techniques has the advantage of being less invasive than the corresponding selective catheter placement of medium. The dose is administered into a peripheral vein, the superior vena cava or right atrium, usually by mechanical injection although sometimes by rapid manual injection. The technique has been used to visualize the ventricles, aorta and most of its larger branches, including the carotids, cerebrals, vertebrals, renal, celiac, mesenterics, and the major peripheral vessels of the limbs. Radiographic visualization of these structures is possible until significant hemodilution occurs.

OMNIPAQUE 350 can be injected intravenously as a rapid bolus to provide arterial visualization using digital subtraction radiography. Preprocedural medications are not considered necessary. OMNIPAQUE 350 has provided diagnostic arterial radiographs in about 95% of patients. In some cases, poor arterial visualization has been attributed to patient movement. OMNIPAQUE 350 is very well tolerated in the vascular system. Patient discomfort (general sensation of heat and/or pain) following injection is less than with various other contrast media.

Precautions
Since the contrast medium is usually administered mechanically under high pressure, rupture of smaller peripheral veins can occur. It has been suggested that this can be avoided by using an intravenous catheter threaded proximally beyond larger tributaries or, in the case of the antecubital vein, into the superior vena cava. Sometimes the femoral vein is used. (See PRECAUTIONS—General.)

Adverse Reactions
Cardiovascular system reactions in digital arteriography included transient PVCs (16%) and PACs (6.5%). (See ADVERSE REACTIONS: Intravascular—General.)

Dosage and Administration
The usual injection volume of OMNIPAQUE 350 for the intravenous digital technique is 30 mL to 50 mL of a 350 mgI/mL solution. This is administered as a bolus at 7.5 to 30 mL/second using a pressure injector. The volume and rate of injection will depend primarily on the type of equipment and technique used.

Frequently three or more injections may be required, up to a total volume not to exceed 250 mL (87.5 gI).

Intra-arterial Administration
OMNIPAQUE 140 at a concentration of 140 mgI/mL is indicated for use in intra-arterial digital subtraction angiography of head, neck, abdominal, renal and peripheral vessels. The intra-arterial route of administration has the advantages of allowing a lower total dose of contrast agent since there is less hemodilution than with the intravenous route of administration. Patients with poor cardiac output would be expected to have better contrast enhancement following intra-arterial administration as compared with intravenous administration. A higher concentration of contrast agent may be needed to facilitate catheter placement under fluoroscopic control.

Precautions
High pressure intra-arterial injections may cause the rupture of smaller peripheral arteries. (See PRECAUTIONS—General.)

Adverse Reactions
Central nervous system reactions in intra-arterial digital angiography include transient ischemia attacks (1.6%) and cerebral infarctions (1.6%). These occurred in high risk patients having a cerebral examination and the relationship to the contrast medium was uncertain. (See ADVERSE REACTIONS—General.) Headache occurred in 6.3% of the patients, all of whom were having cerebral examinations.

Dosage and Administration
Mechanical or hand injection can be used to administer one or more bolus intra-arterial injections of OMNIPAQUE 140. The volume and rate of injection will depend on the type of equipment, technique used, and the vascular area to be visualized. The following volumes and rates of injection have been used with OMNIPAQUE 140.

PERIPHERAL ANGIOGRAPHY
OMNIPAQUE 300 at a concentration of 300 mgI/mL or OMNIPAQUE 350 at a concentration of 350 mgI/mL is indicated in adults for use in peripheral arteriography. OMNIPAQUE 240 at a concentration of 240 mgI/mL or OMNIPAQUE 300 at a concentration of 300 mgI/mL is indicated in adults for use in peripheral venography.

Sedative medication may be employed prior to use. Anesthesia is not considered necessary.

Patient discomfort during and immediately following injection is substantially less than that following injection of various other contrast media. Moderate to severe discomfort is very unusual.

Precautions
Pulsation should be present in the artery to be injected. In thromboangiitis obliterans, or ascending infection associated with severe ischemia, angiography should be performed with extreme caution, if at all. (See PRECAUTIONS—General.)

Adverse Reactions
A transient sensation of mild warmth is usual, immediately following injection. This has not interfered with the procedure.

In phlebography the incidence of leg pain was 21%. This usually was mild and lasted a short time after injection. (See ADVERSE REACTIONS: Intravascular—General.)

Dosage and Administration
The volume required will depend on the size, flow rate, and disease state of the injected vessel and on the size and condition of the patient, as well as the imaging technique used.

The dosage recommended for use in peripheral angiography is as follows:

Aortofemoral runoffs: 20 mL to 70 mL of OMNIPAQUE 350 (350 mgI/mL)
30 mL to 90 mL of OMNIPAQUE 300 (300 mgI/mL)
Selective arteriograms: (femoral/iliac) 10 mL to 30 mL of OMNIPAQUE 350 (350 mgI/mL)
10 mL to 60 mL of OMNIPAQUE 300 (300 mgI/mL)
Venography (per leg): 20 mL to 150 mL of OMNIPAQUE 240 (240 mgI/mL)
40 mL to 100 mL of OMNIPAQUE 300 (300 mgI/mL)

EXCRETORY UROGRAPHY
OMNIPAQUE 300 at a concentration of 300 mgI/mL or OMNIPAQUE 350 at a concentration of 350 mgI/mL is indicated for use in adults in excretory urography to provide diagnostic contrast of the urinary tract.

OMNIPAQUE 300 at a concentration of 300 mgI/mL is indicated in children for excretory urography. (See Section III for information on voiding cystourethrography.)

For pharmacokinetics of excretion in adults, see CLINICAL PHARMACOLOGY—Intravascular.

Precautions
Preparatory dehydration is not recommended in the elderly, infants, young children, diabetic or azotemic patients, or in patients with suspected myelomatosis.

Pediatric patients at higher risk of experiencing adverse events during contrast medium administration may include those having asthma, a sensitivity to medication and/or allergens, congestive heart failure, a serum creatinine greater than 1.5 mg/dL or those less than 12 months of age.

Since there is a possibility of temporary suppression of urine formation, it is recommended that a suitable interval elapse before excretory urography is repeated, especially in patients with unilateral or bilateral reduction in renal function. (See PRECAUTIONS—General.)

Adverse Reactions
See ADVERSE REACTIONS: Intravascular—General.

Dosage and Administration
Adults: OMNIPAQUE 300 and OMNIPAQUE 350 at dosages from 200 mgI/kg body weight to 350 mgI/kg body weight have produced diagnostic opacification of the excretory system in patients with normal renal function.

Pediatrics
Excretory Urography
OMNIPAQUE 300 at doses of 0.5 mL/kg to 3.0 mL/kg of body weight has produced diagnostic opacification of the excretory tract. The usual dose for children is 1.0 mL/kg to 1.5 mL/kg. Dosage for infants and children should be administered in proportion to age and body weight. The total administered dose should not exceed 3 mL/kg.

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CLINICAL PHARMACOLOGY—Oral/Body Cavity Use
For most body cavities, the injected iohexol is absorbed into the surrounding tissue and eliminated by the kidneys and bowel as previously described in SECTION II, CLINICAL PHARMACOLOGY—Intravascular. Examinations of the uterus (hysterosalpingography) and bladder (voiding cystourethrography) involve the almost immediate drainage of contrast medium from the cavity upon conclusion of the radiographic procedure.

Orally administered iohexol is very poorly absorbed from the normal gastrointestinal tract. Only 0.1 to 0.5 percent of the oral dose was excreted by the kidneys. This amount may increase in the presence of bowel perforation or bowel obstruction. Iohexol is well tolerated and readily absorbed if leakage into the peritoneal cavity occurs.

Visualization of the joint spaces, uterus, fallopian tubes, peritoneal herniations, pancreatic and bile ducts, and bladder can be accomplished by direct injection of contrast medium into the region to be studied. The use of appropriate iodine concentrations assures diagnostic density.

Orally administered OMNIPAQUE produces good visualization of the gastrointestinal tract. OMNIPAQUE is particularly useful when barium sulfate is contraindicated as in patients with suspected bowel perforation or those where aspiration of contrast medium is a possibility.

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INDICATIONS AND USAGE, GENERAL—Oral/Body Cavity Use
OMNIPAQUE 240, OMNIPAQUE 300, and OMNIPAQUE 350 have osmolalities from approximately 1.8 to 3.0 times that of plasma (285 mOsm/kg water) and are hypertonic under conditions of use.

Adults: OMNIPAQUE 350 is indicated in adults for arthrography and oral pass-thru examination of the gastrointestinal tract.

OMNIPAQUE 300 is indicated in adults for arthrography and hysterosalpingography.

OMNIPAQUE 240 is indicated in adults for arthrography, endoscopic retrograde pancreatography and cholangiopancreatography, herniography, and hysterosalpingography.

OMNIPAQUE diluted to concentrations from 6 mgI/mL to 9 mgI/mL administered orally in conjunction with OMNIPAQUE 300 at a concentration of 300 mgI/mL administered intravenously is indicated in adults for contrast enhanced computed tomography of the abdomen.

Children: OMNIPAQUE 300 is indicated in children for examination of the gastrointestinal tract.

OMNIPAQUE 240 is indicated in children for examination of the gastrointestinal tract.

OMNIPAQUE 180 is indicated in children for examination of the gastrointestinal tract.

OMNIPAQUE diluted to concentrations from 50 mgI/mL to 100 mgI/mL is indicated in children for voiding cystourethrography.

OMNIPAQUE diluted to concentrations from 9 mgI/mL to 21 mgI/mL administered orally in conjunction with OMNIPAQUE 240 at a concentration of 240 mgI/mL or OMNIPAQUE 300 at a concentration of 300 mgI/mL administered intravenously is indicated in children for use in contrast enhanced computed tomography of the abdomen.

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Contraindications
OMNIPAQUE should not be administered to patients with a known hypersensitivity to iohexol.

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WARNINGS—General
See SECTION II, WARNINGS—General.

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PRECAUTIONS—General
See SECTION II, PRECAUTIONS—General.

Orally administered hypertonic contrast media draw fluid into the intestines which, if severe enough, could result in hypovolemia. Likewise, in infants and young children, the occurrence of diarrhea may result in hypovolemia. Plasma fluid loss may be sufficient to cause a shock-like state which, if untreated, could be dangerous. This is especially pertinent to the elderly, cachectic patients of any age as well as infants and small children.

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ADVERSE REACTIONS: Oral/Body Cavity Use—General
Body Cavities
In controlled clinical trials involving 285 adult patients for various body cavity examinations using OMNIPAQUE 240, 300, and 350, the following adverse reactions were reported.

Cardiovascular System

  Incidence > 1%: None

  Incidence ≤ 1%: Hypertension

Nervous System

  Incidence > 1%: Pain (26%)

  Incidence ≤ 1%: Headache, somnolence, fever, muscle weakness, burning, unwell feeling, tremors, lightheadedness, syncope

Respiratory System

  None

Gastrointestinal System

  Incidence > 1%: None

  Incidence ≤ 1%: Flatulence, diarrhea, nausea, vomiting, abdominal pressure

Skin and Appendages

  Incidence > 1%: Swelling (22%), heat (7%)

  Incidence ≤ 1%: Hematoma at injection site

The most frequent reactions, pain and swelling, were almost exclusively reported after arthrography and were generally related to the procedure rather than the contrast medium. Gastrointestinal reactions were almost exclusively reported after oral pass-thru examinations. For additional information on adverse reactions that may be expected with specific procedures, see INDIVIDUAL INDICATIONS AND USAGE. For information on general adverse reactions to contrast media, see SECTION II, ADVERSE REACTIONS: Intravascular—General.

No adverse reactions associated with the use of OMNIPAQUE for VCU procedures were reported in 51 pediatric patients studied.

Oral Use
See INDIVIDUAL INDICATIONS AND USAGE: Oral Use—Adverse Reactions.

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Overdosage
See also SECTION II, OVERDOSAGE.

The recommended dose of OMNIPAQUE 350 at a concentration of 350 mgI/mL for adult oral pass-thru examination of the gastrointestinal tract is 50 mL to 100 mL. In a Phase I study, 150 mL of OMNIPAQUE 350 was administered orally to 11 healthy male subjects. The incidence of diarrhea was 91% (10 of 11) and abdominal cramping was 27% (3 of 11). Despite all of these events being mild and transient the occurrences were more than double that seen at the recommended doses. It is apparent from this finding that larger volumes of hypertonic contrast media, like OMNIPAQUE, increase the osmotic load in the bowel, which may result in greater fluid shifts.

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DOSAGE AND ADMINISTRATION—General
See SECTION II, DOSAGE AND ADMINISTRATION—General.

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INDIVIDUAL INDICATIONS AND USAGE
Oral Use
Adults: OMNIPAQUE 350 at a concentration of 350 mgI/mL is indicated in adults for use in oral pass-thru examination of the gastrointestinal tract.

OMNIPAQUE diluted to concentrations from 6 mgI/mL to 9 mgI/mL administered orally in conjunction with OMNIPAQUE 300 at a concentration of 300 mgI/mL administered intravenously is indicated in adults for use in contrast enhanced computed tomography of the abdomen. Dilute oral plus intravenous OMNIPAQUE may be useful when unenhanced imaging does not provide sufficient delineation between normal loops of the bowel and adjacent organs or areas of suspected pathology.

Children: OMNIPAQUE 300 at a concentration of 300 mgI/mL administered orally or rectally is indicated in children for use in examination of the gastrointestinal tract.

OMNIPAQUE 240 at a concentration of 240 mgI/mL administered orally or rectally is indicated in children for use in examination of the gastrointestinal tract.

OMNIPAQUE 180 at a concentration of 180 mgI/mL administered orally or rectally is indicated in children for use in examination of the gastrointestinal tract.

OMNIPAQUE diluted to concentrations from 9 mgI/mL to 21 mgI/mL administered orally in conjunction with OMNIPAQUE 240 at a concentration of 240 mgI/mL or OMNIPAQUE 300 at a concentration of 300 mgI/mL administered intravenously is indicated in children for use in contrast enhanced computed tomography of the abdomen.

Precautions
See PRECAUTIONS—General.

Adverse Reactions
Oral administration of OMNIPAQUE is most often associated with mild, transient diarrhea especially when high concentrations and large volumes are administered. Nausea, vomiting, and moderate diarrhea have also been reported following orally administered OMNIPAQUE, but much less frequently. For CT examinations using dilute oral plus intravenous contrast medium, adverse events are more likely to be associated with the intravenous injection than the hypotonic oral solution. It should be noted that serious or anaphylactoid reactions that may occur with intravascular iodinated media are possible following administration by other routes.

Adults: In controlled clinical trials involving 54 adult patients for oral pass-thru examination of the gastrointestinal tract using OMNIPAQUE 350, the following adverse reactions were reported: diarrhea (42%), nausea (15%), vomiting (11%), abdominal pain (7%), flatulence (2%), and headache (2%).

In controlled clinical studies involving 44 adult patients for dilute oral plus intravenous CT examination of the gastrointestinal tract using OMNIPAQUE 300, adverse reactions were limited to a single report of vomiting (2%).

Children: In controlled clinical studies involving 58 pediatric patients for examination of the gastrointestinal tract at concentrations of 180 and 300 mgI/mL, the following adverse reactions were reported: diarrhea (36%), vomiting (9%), nausea (5%), fever (5%), hypotension (2%), abdominal pain (2%), and urticaria (2%). In clinical studies an increased frequency and severity of diarrhea was noted with an increase in the administered concentration and dose of the radiocontrast agent.

In controlled clinical studies involving 69 pediatric patients for dilute oral plus intravenous CT examination of the gastrointestinal tract using OMNIPAQUE 240 and OMNIPAQUE 300, adverse reactions were limited to a single report of vomiting (1.4%).

Dosage and Administration
Adults: The recommended dosage of undiluted OMNIPAQUE 350 at a concentration of 350 mgI/mL for oral pass-thru examination of the gastrointestinal tract in adults is 50 mL to 100 mL depending on the nature of the examination and the size of the patient.

The recommended oral dosage of OMNIPAQUE diluted to concentrations of 6 mgI/mL to 9 mgI/mL for contrast enhanced computed tomography of the abdomen in adults is 500 mL to 1000 mL. Smaller administered volumes are needed as the concentration of the final solution is increased (see Table below). In conjunction with dilute oral administration, the recommended dosage of OMNIPAQUE 300 administered intravenously is 100 mL to 150 mL. The oral dose is administered about 20 to 40 minutes prior to the intravenous dose and image acquisition.

Children: The dosage of undiluted OMNIPAQUE 300 at a concentration of 300 mgI/mL, OMNIPAQUE 240 at a concentration of 240 mgI/mL or OMNIPAQUE 180 at a concentration of 180 mgI/mL for oral pass-thru examination of the gastrointestinal tract in children is dependent on the nature of the examination and the size of the patient. Based on clinical experience, it is recommended that OMNIPAQUE 180 be used in children less than 3 months of age. OMNIPAQUE 180, OMNIPAQUE 240 or OMNIPAQUE 300 may be used in children 3 months of age and older. The following dosage guidelines are recommended:

Age                       Volume of OMNIPAQUE
Less than 3 months            5 – 30 mL
Three months to 3 years       Up to 60 mL
Four years to 10 years        Up to 80 mL
Greater than 10 years         Up to 100 mL

When given rectally, larger volumes may be used.

The recommended oral dosage of OMNIPAQUE diluted to concentrations of 9 mgI/mL to 21 mgI/mL for contrast enhanced computed tomography of the abdomen in children is 180 mL to 750 mL. Smaller administered volumes are needed as the concentration of the final solution is increased (see Table below). The total oral dose in grams of iodine should generally not exceed 5 gI for children under 3 years of age and 10 gI for children from 3 to 18 years of age. The oral dosage may be given all at once or over a period of 30 to 45 minutes if there is difficulty in consuming the required volume.

In conjunction with dilute oral administration the recommended dosage of OMNIPAQUE 240 and OMNIPAQUE 300 is 2.0 mL/kg when administered intravenously with a range of 1.0 mL/kg to 2.0 mL/kg. Dosage for infants and children should be administered in proportion to age and body weight. The total intravenously administered dose should not exceed 3 mL/kg. The oral dose is administered about 30 to 60 minutes prior to the intravenous dose and image acquisition.

Dilutions of OMNIPAQUE should be prepared just prior to use and any unused portion discarded after the procedure.

VOIDING CYSTOURETHROGRAPHY (VCU)
OMNIPAQUE diluted to concentrations from 50 mgI/mL to 100 mgI/mL is indicated in children for voiding cystourethrography. VCUs are often performed in conjunction with excretory urography.

Precautions
See PRECAUTIONS—General.

Since the VCU procedure requires instrumentation, special precautions should be observed in those patients known to have an acute urinary tract infection. Filling of the bladder should be done at a steady rate, exercising caution to avoid excessive pressure. Sterile procedures are essential.

Adverse Reactions
See ADVERSE REACTIONS—General.

Dosage and Administration
OMNIPAQUE may be diluted, utilizing aseptic technique, with Sterile Water for Injection to a concentration of 50 mgI/mL to 100 mgI/mL for voiding cystourethrography. The concentration may vary depending upon the patient's size and age and also with the technique and equipment used. Sufficient volume of contrast medium should be administered to adequately fill the bladder. The usual volume ranges from 50 mL to 300 mL of OMNIPAQUE at a concentration of 100 mgI/mL and 50 mL to 600 mL of OMNIPAQUE at a concentration of 50 mgI/mL.

Dilutions of OMNIPAQUE should be prepared just prior to use and any unused portion discarded after the procedure.

ARTHROGRAPHY
OMNIPAQUE 240 at a concentration of 240 mgI/mL or OMNIPAQUE 300 at a concentration of 300 mgI/mL or OMNIPAQUE 350 at a concentration of 350 mgI/mL is indicated in radiography of the knee joint in adults, and OMNIPAQUE 240 at a concentration of 240 mgI/mL or OMNIPAQUE 300 at a concentration of 300 mgI/mL is indicated in radiography of the shoulder joint in adults, and OMNIPAQUE 300 at a concentration of 300 mgI/mL is indicated in radiography of the temporomandibular joint in adults. Arthrography may be helpful in the diagnosis of posttraumatic or degenerative joint diseases, synovial rupture, the visualization of communicating bursae or cysts, and in meniscography.

Precautions
See PRECAUTIONS—General.

Strict aseptic technique is required to prevent infection. Fluoroscopic control should be used to ensure proper needle placement, prevent extracapsular injection, and prevent dilution of contrast medium. Undue pressure should not be exerted during injection.

Adverse Reactions
Injection of OMNIPAQUE into the joint is associated with transient discomfort, ie, pain, swelling. However, delayed, severe or persistent discomfort may occur occasionally. Severe pain may often result from undue use of pressure or the injection of large volumes. Joint swelling after injection is less with OMNIPAQUE than with high osmolar ionic contrast medium. These types of reactions are generally procedurally dependent and of greater frequency when double-contrast technique is employed.

Nervous system: Swelling sensation (42%), pain (29%), heat sensation (13%), and muscle weakness (0.7%).

Skin and appendages: Hematoma at injection site (0.7%).

Dosage and Administration
Arthrography is usually performed under local anesthesia. The amount of OMNIPAQUE injected is dependent on the size of the joint to be examined and the technique employed. Lower volumes of contrast medium are usually injected for knee and shoulder arthrography when double-contrast examinations using 15 mL to 100 mL of air are performed.

The following concentrations and volumes are recommended for normal adult knee, shoulder, and temporomandibular joints but should serve as guidelines since joints may require more or less contrast medium for optimal visualization.

Passive or active manipulation is used to disperse the medium throughout the joint space.

ENDOSCOPIC RETROGRADE PANCREATOGRAPHY (ERP)/ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP)
OMNIPAQUE 240 at a concentration of 240 mgI/mL is indicated in adults for use in ERP/ERCP.

Precautions
See PRECAUTIONS—General.

Adverse Reactions
Injection of OMNIPAQUE in ERP/ERCP is associated with transient pain. However, delayed, severe or persistent pain may occur and can persist for 24 hours. The cause of the pain may be due as much to the procedure itself as to the contrast medium injected, therefore, attention should be paid to the injection pressure and total volume injected to minimize disruptive distention of the ducts examined.

Cardiovascular system: Hypertension (1%).

Nervous system: Pain (17%), somnolence (1%), and burning (1%).

Gastrointestinal system: Vomiting, diarrhea, and pressure, each with an individual incidence of 1%.

Dosage and Administration
The recommended dose of OMNIPAQUE 240 at a concentration of 240 mgI/mL is 10 mL to 50 mL but may vary depending on individual anatomy and/or disease state.

HYSTEROSALPINGOGRAPHY
OMNIPAQUE 240 at a concentration of 240 mgI/mL or OMNIPAQUE 300 at a concentration of 300 mgI/mL is indicated in radiography of the internal group of adult female reproductive organs: ovaries, fallopian tubes, uterus, and vagina. Hysterosalpingography is utilized as a diagnostic and therapeutic modality in the treatment of infertility and other abnormal gynecological conditions.

Contraindications
The procedure should not be performed during the menstrual period or when menstrual flow is imminent, nor should it be performed when infection is present in any portion of the genital tract, including the external genitalia. The procedure is also contraindicated for pregnant women or for those in whom pregnancy is suspected. Its use is not advised for 6 months after termination of pregnancy or 30 days after conization or curettage.

Precautions
In patients with carcinoma or in those in whom the condition is suspected, caution should be exercised to avoid possible spreading of the lesion by the procedure.

Adverse Reactions
Injection of OMNIPAQUE in hysterosalpingography is associated with immediate but transient pain. The cause of the pain may be due as much to the procedure itself as to the contrast medium injected, therefore attention should be paid to the injection pressure and volume instilled to avoid disruptive distention of the uterus and fallopian tubes. Fluoroscopic monitoring is recommended.

Nervous system: Pain (49%), somnolence and fever each with an individual incidence of 3%.

Gastrointestinal system: Nausea (3%).

Dosage and Administration
The recommended dosage of OMNIPAQUE 240 is 15 mL to 20 mL and of OMNIPAQUE 300 is 15 mL to 20 mL but will vary depending on individual anatomy and/or disease state.

HERNIOGRAPHY
OMNIPAQUE 240 at a concentration of 240 mgI/mL is indicated in adults for use in herniography.

Precautions
See PRECAUTIONS—General.

Adverse Reactions
Nervous system: Pain (7%), headache (3%), and unwell feeling (3%).

Gastrointestinal system: Diarrhea (3%) and flatulence (10%).

Dosage and Administration
The recommended dosage of OMNIPAQUE 240 is 50 mL but may vary depending on individual anatomy and/or disease state.

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How is Omnipaque Injection Supplied
OMNIPAQUE 140
50 mL glass vial, 140 mgI/mL, boxes of 10 (NDC 0407-1401-50)
50 mL glass bottle, 140 mgI/mL, boxes of 10 (NDC 0407-1401-51)
50 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1401-52)

OMNIPAQUE 180
10 mL glass vial, 180 mgI/mL, boxes of 10 (NDC 0407-1411-10)
20 mL glass vial, 180 mgI/mL, boxes of 10 (NDC 0407-1411-20)

OMNIPAQUE 240
10 mL glass vial, 240 mgI/mL, boxes of 10 (NDC 0407-1412-10)
20 mL glass vial, 240 mgI/mL, boxes of 10 (NDC 0407-1412-20)
50 mL glass vial, 240 mgI/mL, boxes of 10 (NDC 0407-1412-50)
50 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1412-30)
75 mL fill in 100 mL in +PLUSPAK™ (polymer bottle) boxes of 10 (NDC 0407-1412-32)
100 mL glass bottle, 240 mgI/mL, boxes of 10 (NDC 0407-1412-60)
100 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1412-33)
150 mL glass bottle, 240 mgI/mL, boxes of 10 (NDC 0407-1412-49)
150 mL fill in 200 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1412-34)
200 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1412-35)
125 mL in REDIFLO™ (prefilled cartridge), boxes of 10 (NDC 0407-1412-91) FLS-1
150 mL in REDIFLO™ (prefilled cartridge), boxes of 10 (NDC 0407-1412-90) FLS-1

OMNIPAQUE 300
  10 mL glass vial, 300 mgI/mL, boxes of 10 (NDC 0407-1413-10)
  30 mL glass vial, 300 mgI/mL, boxes of 10 (NDC 0407-1413-30)
  50 mL glass vial, 300 mgI/mL, boxes of 10 (NDC 0407-1413-50)
  50 mL glass bottle, 300 mgI/mL, boxes of 10 (NDC 0407-1413-51)
  50 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1413-61)
  75 mL fill in 100 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1413-62)
  100 mL glass bottle, 300 mgI/mL, boxes of 10 (NDC 0407-1413-60)
  100 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1413-63)
  125 mL fill in 150 mL glass bottle, 300 mgI/mL, boxes of 10 (NDC 0407-1413-53)
  150 mL glass bottle, 300 mgI/mL, boxes of 10 (NDC 0407-1413-90)
  150 mL fill in 200 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1413-65)
  200 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1413-66)
  50 mL prefilled syringe, 300 mgI/mL, boxes of 10 (NDC 0407-1413-25)
  100 mL in REDIFLO™ (prefilled cartridge), boxes of 10 (NDC 0407-1413-74) FLS-2
  125 mL in REDIFLO™ (prefilled cartridge), boxes of 10 (NDC 0407-1413-75) FLS-2
  150 mL in REDIFLO™ (prefilled cartridge), boxes of 10 (NDC 0407-1413-72) FLS-1
  150 mL in REDIFLO™ (prefilled cartridge), boxes of 10 (NDC 0407-1413-76) FLS-2

OMNIPAQUE 350
  50 mL glass vial, 350 mgI/mL, boxes of 10 (NDC 0407-1414-50)
  50 mL glass bottle, 350 mgI/mL, boxes of 10 (NDC 0407-1414-51)
  50 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1414-89)
  75 mL fill in 100 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1414-90)
  100 mL glass bottle, 350 mgI/mL, boxes of 10 (NDC 0407-1414-60)
  100 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1414-91)
  125 mL fill in 150 mL glass bottle, 350 mgI/mL, boxes of 10 (NDC 0407-1414-76)
  150 mL glass bottle, 350 mgI/mL, boxes of 10 (NDC 0407-1414-03)
  150 mL fill in 200 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1414-93)
  200 mL fill in 250 mL glass bottle, 350 mgI/mL, boxes of 10 (NDC 0407-1414-04)
  200 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1414-94)
  250 mL glass bottle, 350 mgI/mL, boxes of 10 (NDC 0407-1414-80)
  50 mL prefilled syringe, 350 mgI/mL, boxes of 10 (NDC 0407-1414-26)
  100 mL in REDIFLO™ (prefilled cartridge), boxes of 10 (NDC 0407-1414-36) FLS-2
  125 mL in REDIFLO™ (prefilled cartridge), boxes of 10 (NDC 0407-1414-37) FLS-2

REDIFLO™ (prefilled cartridges) FLS-1 are supplied with connector tubing.

REDIFLO™ (prefilled cartridges) FLS-1 are covered under one or more of the following U.S. Patents Numbers: 5,383,858, 5,997,502, 6,322,535, and 6,402,718.

REDIFLO™ (prefilled cartridges) FLS-2 are covered under U.S. Patents Number 6,652,489.

FEDERAL GOVERNMENT CODES
OMNIPAQUE 240
  50 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1412-29)
  100 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1412-26)
  150 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1412-27)
  200 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1412-28)

OMNIPAQUE 300
  10 mL glass vial, 300 mgI/mL, boxes of 10 (NDC 0407-1413-11)
  50 mL glass bottle, 300 mgI/mL, boxes of 10 (NDC 0407-1413-95)
  50 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1413-98)
  75 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1413-99)
  100 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1413-91)
  150 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1413-92)
  200 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1413-93)

OMNIPAQUE 350
  50 mL glass bottle, 350 mgI/mL, boxes of 10 (NDC 0407-1414-52)
  100 mL glass bottle, 350 mgI/mL, boxes of 10 (NDC 0407-1414-53)
  50 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1414-21)
  75 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1414-20)
  100 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1414-22)
  150 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1414-23)
  200 mL in +PLUSPAK™ (polymer bottle), boxes of 10 (NDC 0407-1414-24)

Protect vials and glass or polymer bottles of OMNIPAQUE from strong daylight and direct exposure to sunlight. Do not freeze. OMNIPAQUE should be stored at controlled room temperature, 20°-25°C (68°- 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Omnipaque Injection in all presentations may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).

SPECIAL HANDLING AND STORAGE FOR POLYMER BOTTLES ONLY:
DO NOT USE IF TAMPER-EVIDENT RING IS BROKEN OR MISSING.

Rx ONLY

Distributed by GE Healthcare Inc.
Princeton, NJ 08540

Manufactured by GE Healthcare AS, Oslo, Norway

OMNIPAQUE is a trademark of GE Healthcare.
GE and the GE Monogram are trademarks of General Electric Company of General Electric Company

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 详细处方信息以本药内容附件PDF文件(201811723392120.pdf)的“原文Priscribing Information”为准
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更新日期: 2019-1-10
附件:
201811723392738.jpeg    

201811723392120.pdf    







 
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