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  药店国别: 美国药房
产地国家: 美国
所属类别: 维生素类及微量元素药物->补钙
处方药:处方药
包装规格: 98毫克/毫升 10毫升/小瓶 25小瓶/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
费森尤斯-卡比美国有限公司
生产厂家英文名:
Fresenius Kabi USA, LLC
该药品相关信息网址1:
https://ndclist.com/ndc/63323-360/package/63323-360-19
原产地英文商品名:
Calcium Gluconate SOLUTION FOR INJECTION 98mg/mL 10ml/vial 25vial/box (Minimum order qty:5)
原产地英文药品名:
Calcium Gluconate
中文参考商品译名:
用于注射的葡萄糖酸钙溶液 98毫克/毫升 10毫升/小瓶 25小瓶/盒 (最低购买量:5)
中文参考药品译名:
葡萄糖酸钙
原产地国家批准上市年份:
2017/06/15
英文适应病症1:
for the treatment of acute symptomatic hypocalcemia.
临床试验期:
完成
中文适应病症参考翻译1:
治疗急性症状性低钙血症
药品信息:

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 详细处方信息以本药内容附件PDF文件(20191821580938.pdf)的“原文Priscribing Information”为准
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 部分中文葡萄糖酸钙溶液处方资料(仅供参考)


【英文名称】
Calcium Gluconate

【适用证】

•葡萄糖酸钙注射液是一种钙,适用于儿科和成人患者,用于治疗急性症状性低钙血症。

•使用限制:长期使用葡萄糖酸钙注射液的安全性尚未确定。
 

【用法用量】

•每毫升含有100毫克葡萄糖酸钙,含有9.3毫克(0.465 mEq)元素钙(2.1)

•通过安全的静脉注射线静脉注射(推注或连续输注)(2.1)

•有关稀释说明,给药率和适当监测,请参阅完整处方信息(FPI)(2.1)

•根据低钙血症症状的严重程度,血清钙水平和低钙血症发作的敏锐度,在成人和儿科患者的剂量范围内个别化剂量。参见FPI中的表1,以mg mg葡萄糖酸钙的剂量给药 适用于新生儿,儿科和成人患者。 (2.2)

•每4至6小时间歇性输注和每1至4小时连续输注期间测量血清钙。 (2.3)

•葡萄糖酸钙注射液与含磷酸盐或碳酸氢盐的液体不相容。如果混合,可能会导致沉淀。有关所有药物不相容性,请参阅FPI。 (2.5)

•以单剂量小瓶或药房散装包装(PBP)提供。对于PBP,在药房外加剂计划中为许多患者分配单剂量;穿刺后4小时内使用(2.6)
 

【禁忌】

•高钙血症

•接受头孢曲松治疗的新生儿(28日龄或更小)
 

【警告和注意事项】

•伴有心肌糖苷使用的心律失常:如果需要同时进行治疗,应少量缓慢注射葡萄糖酸钙,建议进行密切的心电监护(5.1)

•血管内头孢曲松 - 钙沉淀物导致的器官损害:同时使用静脉注射头孢曲松可能会导致危及生命的沉淀物。发生了新生儿致命结局的病例。 (4,5.2)

•组织坏死和钙质沉着症:皮质钙质沉着症可伴有或不伴有葡萄糖酸钙注射液外渗。组织坏死,溃疡和继发感染是最严重的并发症。如果发生外渗或注意到皮肤钙质沉着症的临床表现,立即停止在该部位静脉内给药并根据需要进行治疗。 (5.3)

•快速给药引起的低血压,心动过缓和心律失常:为了避免快速静脉给药后出现不良反应,葡萄糖酸钙注射液应用5%葡萄糖或生理盐水稀释并缓慢注入,仔细监测心律失常心电图。 (5.4)

•铝毒性:本产品含有铝,每升高达400 mcg,可能有毒。 (5.5)
 

【DOSAGE AND ADMINISTRATION 】

• Contains 100 mg of calcium gluconate per mL which contains 9.3 mg (0.465 mEq) of elemental calcium (2.1)

• Administer intravenously (bolus or continuous infusion) via a secure intravenous line (2.1)

• See Full Prescribing Information (FPI) for dilution instructions, administration rates, and appropriate monitoring (2.1)

• Individualize the dose within the recommended range in adults and pediatric patients depending on the severity of symptoms of hypocalcemia, the serum calcium level, and the acuity of onset of hypocalcemia. See Table 1 in the FPI for dosing recommendations in mg of calcium gluconate for neonates, pediatric and adult patients. (2.2)

• Measure serum calcium during intermittent infusions every 4 to 6 hours and during continuous infusion every 1 to 4 hours. (2.3)

• Calcium Gluconate Injection is not physically compatible with fluids containing phosphate or bicarbonate. Precipitation may result if mixed. See FPI for all drug incompatibilities. (2.5)

• Supplied in a single-dose vial or pharmacy bulk package (PBP). For PBP, dispense single doses to many patients in a pharmacy admixture program; use within 4 hours of puncture (2.6)
 

【CONTRAINDICATIONS】

• Hypercalcemia (4)

• Neonates (28 days of age or younger) receiving ceftriaxone
 

【WARNINGS AND PRECAUTIONS 】

• Arrhythmias with Concomitant Cardiac Glycoside Use: If concomitant therapy is necessary, Calcium Gluconate Injection should be given slowly in small amounts and close ECG monitoring is recommended (5.1)

• End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates: Concurrent use of intravenous ceftriaxone may cause life-threatening precipitates. Cases of fatal outcomes in neonates have occurred. (4, 5.2)

• Tissue Necrosis and Calcinosis: Calcinosis cutis can occur with or without extravasation of Calcium Gluconate Injection. Tissue necrosis, ulceration, and secondary infection are the most serious complications. If extravasation occurs or clinical manifestations of calcinosis cutis are noted, immediately discontinue intravenous administration at that site and treat as needed. (5.3)

• Hypotension, Bradycardia, and Cardiac Arrhythmias with Rapid Administration: To avoid adverse reactions that may follow rapid intravenous administration, Calcium Gluconate Injection should be diluted with 5% dextrose or normal saline and infused slowly, with careful ECG monitoring for cardiac arrhythmias. (5.4)

• Aluminum Toxicity: This product contains aluminum, up to 400 mcg per liter, that may be toxic. (5.5)

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 详细处方信息以本药内容附件PDF文件(20191821580938.pdf)的“原文Priscribing Information”为准
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更新日期: 2019-1-9
附件:
20191821580938.pdf    

 
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