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当前本网站药物产品种数共 8524 处方药 8148 非处方药 269 保健品/医疗用具 107

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  药店国别: 英国药房
产地国家: 英国
所属类别: 抗癌药物->治疗肺癌药物
处方药:处方药
包装规格: 200毫克/瓶
计价单位:
  点击放大  
生产厂家英文名:
Teva
该药品相关信息网址1:
http://www.gemzar.com/Pages/index.aspx
该药品相关信息网址2:
http://www.drugs.com/gemzar.html
该药品相关信息网址3:
http://www.rxlist.com/gemzar-drug.htm
原产地英文商品名:
GEMCITABINE (GEMZAR GENERIC) 200mg/Vial
原产地英文药品名:
GEMCITABINE HCL
中文参考商品译名:
吉西他滨(健择仿制药) 200毫克/瓶
中文参考药品译名:
盐酸吉西他滨
中文参考化合物名称:
2,2-二氟脱氧胞嘧啶核苷
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Non-small cell lung cancer
英文适应病症2:
Lung Cancer
英文适应病症3:
Cancer
临床试验期:
完成
中文适应病症参考翻译1:
非小细胞肺癌
中文适应病症参考翻译2:
肺癌
中文适应病症参考翻译3:
癌症
药品信息:

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 详细处方信息以本药内容附件PDF文件(20113817193820.pdf)的“原文Priscribing Information”为准
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部分中文盐酸吉西他滨处方资料(仅供参考)

【药品名称】
通用名称:盐酸吉西他滨
商品名称:健择
英文名称:Gemcitabine Hydrochloride for Injection
汉语拼音:Zhusheyong Yansuan Jixitabin

【适应症】
适用于治疗中、晚期非小细胞肺癌。

【用法用量】
成人推荐吉西他滨剂量为1000mg/m2静脉滴注30分钟,每周一次,连续三周,随后休息一周,每四周重复一次。依据病人的毒性反应相应减少剂量。
配制方法:每瓶(含吉西他滨200mg)至少注入0.9%氯化钠注射液5ml(含吉西他滨浓度≤40mg/ml),振摇使溶解,给药时所需药量可用0.9%氯化钠注射液进一步稀释,配制好的吉西他滨溶液应贮存在室温并在24小时内使用,吉西他滨溶液不得冷藏,以防结晶析出。
高龄患者:65岁以上的高龄患者也能很好耐受。尽管年龄对吉西他滨的清除率和半衰期有影响,但并没有证据表明高龄患者需要调整剂量。 儿童:未研究过儿童使用吉西他滨。

【不良反应】
血液系统:由于吉西他滨具有骨髓抑制作用,因此应用吉西他滨后可出现贫血、白细胞降低和血小板减少。骨髓抑制常常为轻到中度,多为中性粒细胞减少。血小板减少也比较常见。
消化系统:约2/3的病人发生肝脏氨基转移酶的异常,但多为轻度,非进行性损害,无需停药。肝功能受损的病人使用吉西他滨应特别警慎(参见剂量和使用方法)。据报道,约1/3的病人出现恶心和呕吐反应,20%的病人需药物治疗,极少是剂量限制性毒性,并且很容易用抗呕吐药物控制。肾脏:近一半的病人用药后可出现轻度蛋白尿和血尿,但极少伴有临床症状和血清肌酐与尿素氮的变化,然而,报告有部分病例出现不明原因的肾衰。因此,对于已有肾功能损害的病人,使用吉西他滨应特别谨慎(参见剂量和使用方法)。
过敏:约25%的病人可有皮疹,10%的病人可出现瘙痒,通常皮疹轻度,非剂量限制性毒性,局部治疗有效,极少报道有脱皮,水泡和溃疡。滴注吉西他滨过程中,不到1%的病人可发生支气管痉挛,痉挛一般为轻度,且持续短暂,但可能需要胃肠道外的给药治疗,已知对本药高度敏感的病人应严禁使用(参见禁忌)。有报告约10%的病人在用药后数小时内发生呼吸困难,这种呼吸困难常常持续短暂、症状轻,几乎很少需要调整剂量,大多无需特殊治疗,其发病机制不清,与吉西他滨的关系也不清楚。
其他:大约20%的病人有类似于流感的表现,大多症状较轻,短暂,且为非剂量限制性,仅1.5%的病人表现较重,发热、头痛、背痛、寒战、肌痛、乏力和厌食是最常见的症状,咳嗽、鼻炎、不适、出汗和失眠也有发生。有些仅表现为发热和乏力。此类症状的发病机制尚不清楚,有报告证实水杨酸类药物可减轻症状。水肿/周围性水肿的发生率约为30%,部分病人可出现面部水肿。肺水肿的发生率约1%。水肿/周围性水肿常常由轻到中度、几乎不影响用药剂量,部分病人伴有局部疼痛、停止用药(吉西他滨)后常自行逆转。引起这种毒性的机制尚不清楚,没任何证据表明与心脏、肝、肾功能受损有关。以下的不良反应亦常见报道,13%的病人脱发(常为轻度),10%病人嗜睡,8%病人腹泻,7%的病人有口腔毒性(主要为溃疡及红斑),6%病人有便秘。曾有低血压的病例报告,有的研究报告有心肌梗塞、充血性心力衰竭及心律失常,但无明确的表明是吉西他滨引起的心脏毒性。

【禁 忌】
对本品成份过敏者禁用。

【注意事项】
警告:已证明滴注药物时间延长和增加用药频率可增大药物的毒性。吉西他滨可抑制骨髓,表现为白细胞和血小板减少及贫血。然而,由于骨髓抑制时间短,通常并不影响以后的用药剂量(参见用药剂量和方法及不良反应)。
高敏反应:曾报告极个别病人发生过敏反应。
注意:一般情况,接受吉西他滨治疗的病人需密切观察,包括实验室的监测,在出现药物毒性反应时,应能够及时处理。使用吉西他滨的病人应定期检查肝、肾功能,包括氨基转移酶和血清肌酐。对驾驶和操作机器能力的影响——据报道,吉西他滨可引起轻至中度的困倦。病人在此期间必须禁止驾驶和操纵机器,直到经鉴定已不再倦怠。

【孕妇及哺乳期妇女用药】
B3类,该药物对孕妇的安全性不详。动物实验表明,该药具有生殖毒性,如生殖缺陷或对胚胎及胎儿发育、妊娠和分娩前后的其它毒性作用。吉西他滨对胎儿和婴儿有潜在的危险,故孕妇及哺乳期的妇女应避免使用。

Indications and Important Safety Information for GEMZAR
GEMZAR is approved by the FDA in combination with cisplatin (another type of chemotherapy) for the first-line treatment of patients (for whom surgery is not possible) with locally advanced (stage IIIA or stage IIIB) or metastatic (stage IV or cancer that has spread) non-small cell lung cancer.

GEMZAR is approved by the FDA in combination with carboplatin (another type of chemotherapy) for the patient with advanced ovarian cancer that has returned at least 6 months after the patient had finished platinum-based therapy.

GEMZAR is approved by the FDA in combination with paclitaxel for the first-line treatment of patients with metastatic breast cancer after they have received another type of chemotherapy called an anthracycline, unless their medical condition did not allow them to receive an anthracycline.

GEMZAR is approved by the FDA as a single agent (given alone) as the first-line treatment for patients with locally advanced (stage II or stage III when surgery is not an option) or metastatic (stage IV) adenocarcinoma of the pancreas. GEMZAR is also indicated for patients previously treated with 5-FU (another type of chemotherapy).

GEMZAR can suppress bone marrow function, which may cause low blood cell counts.

GEMZAR may not be appropriate for some patients.

If you are allergic to GEMZAR, tell your doctor because you should not receive it.

GEMZAR given for longer than 60 minutes or more than once a week has caused increased side effects.

You should call your doctor right away if you have any symptoms of infection, such as a fever or chills. If you notice bleeding, unexplained bruising, or symptoms of anemia, contact your healthcare team, as these can be symptoms of low blood cell counts.

Serious lung problems, sometimes fatal, have been reported with GEMZAR. Tell your healthcare team if you develop breathing problems.

There have been reports of serious kidney or liver damage including failure with GEMZAR treatment, sometimes fatal. If you have had kidney or liver problems or impairment, please tell your healthcare team. GEMZAR may not be right for you.

You will have regular blood tests before and during your treatment with GEMZAR. Your doctor may adjust your dose of GEMZAR or delay your treatment based on the results of your blood tests and on your general condition.

If you think you are pregnant, are planning to become pregnant, or are nursing, please tell your healthcare team.

Patients who receive radiation therapy before, during, or after receiving GEMZAR may sometimes experience more side effects, especially at the site of the radiation.

Tell your doctor if you are taking other medicines, including prescription and nonprescription medicines, vitamins, or herbal supplements.

There is a risk of side effects associated with GEMZAR therapy. The most common side effects are low blood cell counts (red blood cells, white blood cells, and platelets); fever; infection; hair loss; tiredness; nausea; vomiting; constipation; diarrhea; rash; shortness of breath; muscle aches; blood in urine; hearing changes and numbness or tingling in your toes or fingers. These are not all of the side effects of GEMZAR. Lab work may identify additional side effects. If you have any side effect that bothers you or that does not go away, be sure to talk with your doctor. Call your healthcare team right away if you have fever or chills. These symptoms could mean you have an infection.

If you are pregnant, GEMZAR may cause fetal harm to your unborn baby. It is not known if GEMZAR passes into breast milk; because of the potential for serious side effects in nursing infants, discuss breast feeding and GEMZAR with your doctor. The safety and effectiveness of GEMZAR in children have not been established.

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 详细处方信息以本药内容附件PDF文件(20113817193820.pdf)的“原文Priscribing Information”为准
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更新日期: 2014-07-30
附件:
 
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