吉西他滨,健择注射液GEMZAR(GEMCITABINE HCL)

药店国别:无

产地国家:美国

处方药:

所属类别: 200毫克/瓶

包装规格: 200毫克/瓶

计价单位:

生产厂家中文参考译名:

生产厂家英文名:Lilly

原产地英文商品名:GEMZAR 200mg/Vial

原产地英文药品名:GEMCITABINE HCL

中文参考商品译名:健择 200毫克/瓶

中文参考药品译名:吉西他滨

曾用名:

简介

【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。

英文版说明

Important Safety Information for GEMZAR® (gemcitabine for injection)What is the most important information that I should know about GEMZAR?GEMZAR can suppress bone marrow function, which may cause low blood cell counts.GEMZAR may not be appropriate for some patients.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 (for example, feeling tired), 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 now have or have had in the past kidney or liver problems, 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.Patients who receive radiation therapy before, during, or after receiving GEMZAR may sometimes experience more side effects, especially at the site of the radiation.The safety and effectiveness of GEMZAR in children has not been established.Who should not receive GEMZAR?If you are allergic to GEMZAR, tell your doctor because you should not receive it.What should I tell my doctor before receiving GEMZAR?If you think you are pregnant, are planning to become pregnant, or are nursing, please tell your healthcare team. 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.Tell your doctor if you are taking other medicines, including prescription and nonprescription medicines, vitamins, and herbal supplements.What are the possible side effects of GEMZAR?There is a risk of side effects associated with GEMZAR therapy.Call your healthcare team right away if you have fever or chills.These symptoms could mean you have an infection.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. Lab work may identify additional side effects.These are not all the side effects of GEMZAR. Talk with your doctor, nurse, or pharmacist about any side effect that bothers you or that doesn’t go away.How is GEMZAR given?GEMZAR is given (injected) into a vein. The injection will last about 30 minutes

我们希望人人都能吃的起药,看得起病! 我们希望让患者有权利选择自己经济能力范围内的药! 我们希望给国人提供一个能了解药品常识的平台,不再一无所知! 我们经过一年多时间反复深入的分析、研究,咨询了很多医学专家,药学专家,对比了近2000种重大疾病用药,总结了数百万字的药品知识。 我们建立医生China,是全国首个药品知识型公益社区。 www.yschn.com-医生China
药品价格查询,专业药品查询网站,药品说明书查询,药品比价 » 吉西他滨,健择注射液GEMZAR(GEMCITABINE HCL)

提供最优质的资源集合

立即查看 了解详情