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  药店国别: 香港药房
产地国家: 美国
所属类别: 抗癌药物->治疗黑色素瘤药物
处方药:处方药
包装规格: 50毫克/4毫升/瓶 1瓶
计价单位:
  点击放大  
生产厂家英文名:
MERCK
该药品相关信息网址1:
http://www.keytruda.com/?utm_source=google&utm_medium=cpc&utm_term=keytruda&utm_campaign=Branded_+Day+1+2014&utm_content=sPCs1N3Ts|dc_pcrid_47308881806
原产地英文商品名:
KEYTRUDA 50mg/4ml/vial 1 vial
原产地英文药品名:
PEMBROLIZU PEMBROLIZUMAB
中文参考商品译名:
KEYTRUDA 50毫克/4毫升/瓶 1瓶
中文参考药品译名:
PEMBROLIZU PEMBROLIZUMAB
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Melanoma
临床试验期:
完成
中文适应病症参考翻译1:
恶性黑色素瘤
药品信息:
批准日期:2014年9月4日 剂量和给药方法 推荐给药 KEYTRUDA的推荐剂量是2mg/kg给药作为历时30分钟静脉输注每3周给予直至疾病进展或不可接受毒性。 剂量调整 对以下任何不给KEYTRUDA: ●2级肺炎[见警告和注意事项(5.1)] ● 2或3级结肠炎[见警告和注意事项(5.2)] ● 症状性垂体炎[见警告和注意事项(5.4)] ●2级肾炎[见警告和注意事项(5.5)] ● 3级 甲状腺功能亢进[见警告和注意事项(5.6)] ● 谷草转氨酶(AST)或丙氨酸氨基转移酶(ALT)大于3和直至5倍正常上限(ULN)或总胆红素大于1.5和直至ULN3倍。 ● 任何其他严重或3级治疗-相关不良事件[见警告和注意事项(5.7)] 在患者其不良反应恢复至0-1级恢复 KEYTRUDA. 对以下任何永远终止 KEYTRUDA: ●任何危及生命不良事件 ● 3或4级肺炎[见警告和注意事项(5.1)] ● 3或4级肾炎[见警告和注意事项(5.5)] ● AST或ALT大于5倍ULN或总胆红素大于 3倍ULN o 对有肝转移患者开始治疗有2级AST或ALT,如AST或ALT增加相对于基线大于或等于50%和持续共至少1周 ● 3或4级输注-相关反应 ●12 周内不能减低皮质激素剂量至10 mg或低于泼尼松[prednisone]或等价物每天 ● 持续2或3级不良反应KEYTRUDA末次剂量后12周内不恢复至0-1级 ● 任何严重或3级治疗-相关不良事件再发生[见警告和注意事项(5.7)] 制备和给药 制备 ● 通过沿着小瓶壁注射注射水添加2.3 mL注射用无菌水,USP和不直接在冻干粉上(造成浓度25 mg/mL)。 ● 为清除泡沫缓慢地旋转小瓶。允许至5 分钟。不要摇动小瓶。 ● 给药前肉眼观察重建溶液是否有颗粒物质和变色。重建KEYTRUDA是一个透明至略微不透明,无色至略黄色溶液。如观察到外来颗粒物质不是透明至白色蛋白状颗粒,遗弃重建小瓶。 ● 从KEYTRUDA小瓶抽吸需要的容积和转移至一个含0.9%注射用氯化钠,USP静脉(IV)袋。通过轻轻倒置混合稀释溶液。最终稀释溶液浓度应在1 mg/mL至10 mg/mL间。 ● 遗弃在小瓶中任何未使用部分。 重建和稀释溶液的贮存 产品不含防腐剂。 重建和稀释的KEYTRUDA溶液贮存在以下任一: ● 在室温不超过从重建时间4个小时。这包括室温贮存重建小瓶,IV袋中输注溶液的贮存,和输注时间。 ● 在冰箱在2°C至8°C (36°F至46°F)共从重建时间不超过24小时。如冰箱,允许给药前稀释好溶液至室温。 不要冻结。 给药 ● 通过一个输注线历时30分钟静脉给予含无菌,无-热原,低-蛋白结合0.2 μm至5 μm在-线或附加的过滤器的输注溶液。 ● 不要通过相同输注线共-给予其他药物。 剂型和规格 注射用: 为重建50mg冻干粉在一次性使用小瓶中。 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KEYTRUDA safely and effectively. See full prescribing information for KEYTRUDA. KEYTRUDA® (pembrolizumab) for injection, for intravenous use Initial U.S. Approval: 2014 INDICATIONS AND USAGE KEYTRUDA is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. (1) DOSAGE AND ADMINISTRATION •Administer 2 mg/kg as an intravenous infusion over 30 minutes every 3 weeks. (2.1) •Reconstitute and dilute prior to intravenous infusion. (2.3) DOSAGE FORMS AND STRENGTHS For injection: 50 mg, lyophilized powder in single-use vial for reconstitution (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS •Immune-mediated adverse reactions: Administer corticosteroids based on the severity of the reaction. (5.1, 5.2, 5.3, 5.4, 5.5, 5.6) ◦Immune-mediated pneumonitis: Withhold for moderate, and permanently discontinue for severe or life-threatening pneumonitis. (5.1) ◦Immune-mediated colitis: Withhold for moderate or severe, and permanently discontinue for life-threatening colitis. (5.2) ◦Immune-mediated hepatitis: Monitor for changes in hepatic function. Based on severity of liver enzyme elevations, withhold or discontinue. (5.3) ◦Immune-mediated hypophysitis: Withhold for moderate, withhold or discontinue for severe, and permanently discontinue for life-threatening hypophysitis. (5.4) ◦Immune-mediated nephritis: Monitor for changes in renal function. Withhold for moderate, and permanently discontinue for severe or life-threatening nephritis. (5.5) ◦Immune-mediated hyperthyroidism and hypothyroidism: Monitor for changes in thyroid function. Withhold for severe and permanently discontinue for life-threatening hyperthyroidism. (5.6) •Embryofetal Toxicity: KEYTRUDA may cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus. (5.8) ADVERSE REACTIONS Most common adverse reactions (reported in ≥20% of patients) included fatigue, cough, nausea, pruritus, rash, decreased appetite, constipation, arthralgia, and diarrhea. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. USE IN SPECIFIC POPULATIONS Nursing mothers: Discontinue nursing or discontinue KEYTRUDA. (8.3) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 9/2014 FULL PRESCRIBING INFORMATION
更新日期: 2018-08-17
附件:
201491019121824.pdf    

 
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