盐酸吉西他滨,盐酸吉西他滨冻干粉注射剂(Gemzar 1g Vial)

药店国别:

产地国家:加拿大

处方药:

所属类别: 1克/瓶

包装规格: 1克/瓶

计价单位:

生产厂家中文参考译名:

生产厂家英文名:Eli Lilly

原产地英文商品名:GEMZAR Injection 1g/Vial

原产地英文药品名:Gemcitabine Hydrochloride

中文参考商品译名:健择注射剂 1克/瓶

中文参考药品译名:盐酸吉西他滨

曾用名:

简介

部份中文健择处方资料(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

生产厂家:Eli Lilly 法国礼来有限公司

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。任何疑问,请遵医嘱!

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。

规 格:200mg; 1g

英文版说明

General InformationGemzar has been approved for the treatment of locally advanced or metastatic pancreatic cancer.Clinical ResultsGemzar improved median survival in people with advanced and metastatic pancreatic cancer, as demonstrated by data from a study comparing Gemzar with 5-Fluorouracil (5-FU), which has been the most common treatment of pancreatic cancer. A second study followed subjects treated with Gemzar who had previously been treated with 5-FU.The Phase III study of Gemzar involved 126 pancreatic cancer subjects–63 of these subjects received Gemzar therapy and the other 63 subjects received treatment with 5-FU. Of these subjects, more than 70% entered the study with metastatic disease, the most advanced stage of pancreatic cancer. Gemzar demonstrated a statistically significant advantage in survival over 5-FU. Gemzar subjects had a 5.7 month median survival as compared with 4.2 months for 5-FU subjects. From this trial, the six-month probability estimate for survival of subjects treated with Gemzar is 46% (30 patients), compared with 29% (19 subjects) for 5-FU subjects. After one year, the survival probability estimate was 18% (9 subjects) for Gemzar subject, compared with 2% (two subjects) for 5-FU subjects. (Survival probability estimates take results from the clinical trial and, using a mathematical equation, generalize them to the larger population of pancreatic cancer subjects.)This study also demonstrated that 24% of previously untreated subjects who received Gemzar experienced a clinical benefit response, compared with 5% of subjects treated with 5-FU. This difference also is statistically significant.A phase II trial of Gemzar, conducted among 63 subjects who had previously been treated with 5-FU, showed median survival time of 3.9 months. In this trial, 87% of subjects entered the study with metastatic disease. Of these subjects, 31% survived for six months, and 4% survived for one year. In addition, clinical benefit response was observed in 27% of subjects.Side EffectsGemzar's side effects were generally manageable with less than 1% of subjects discontinuing their therapy for any of the following side effects. A decrease in some infection-fighting white blood cells, called neutropenia, was observed in 63% of subjects, with moderate to severe decreases in 25% of subjects. This effect on the blood was the most frequent reason for reducing or limiting the dose of Gemzar. Common adverse effects in clinical trials included nausea and vomiting (69%), fever (41%), edema or fluid retention (up to 34%), rash (30%), and flu-like symptoms (19%). Only about 10% of all subjects participating in Gemzar clinical trials discontinued therapy due to side effects.Hair loss was reported in 15% of subjects. This side effect was reversible, and none of the subjects experienced complete hair loss from their treatment.Mechanism of ActionGemzar is a nucleoside analogue that mimics a natural building block of DNA.Additional InformationPancreatic cancer, one of the most difficult cancers to treat, is hard to detect because subjects remain asymptomatic until late in the course of the disease. Currently, less than 10% of all pancreatic cancer patients live more than one year after diagnosis. An estimated 26,000 people in the United States will be diagnosed with pancreatic cancer in 1996.Given the difficulty in diagnosing pancreatic cancer, traditional means for establishing the activity of a chemotherapy agent, such as the rate of tumor growth or shrinkage, often cannot provide a useful measurement of a drug's effectiveness. Recognizing the unique needs associated with caring for pancreatic cancer patients, Lilly designed a clinical endpoint that would provide an objective, quantitative measurement of Gemzar's effect on several important disease-related symptoms experienced by subjects.Clinical benefit response is a measure of symptomatic improvement based on the following: level of pain; consumption of pain medication; ability to perform daily activities; weight change. Subjects were considered to be clinical benefit responders only if they experienced improvement in at least one measurement without deterioration in any of the others. This improvement must have reached an established level for at least four consecutive weeks.

 

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