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  药店国别: 德国药房
产地国家: 德国
所属类别: 抗癌药物->治疗卵巢癌药物
处方药:处方药
包装规格: 150毫克 112片薄膜包衣片/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
阿斯利康
生产厂家英文名:
AstraZeneca
该药品相关信息网址1:
https://www.lynparza.com/
原产地英文商品名:
Lynparza 150mg 112coated tablet /box
原产地英文药品名:
olaparib
中文参考商品译名:
奥拉帕利 150毫克 112片薄膜包衣片/盒
中文参考药品译名:
奥拉帕尼
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Ovarian cancer
英文适应病症2:
Breast cancer
临床试验期:
完成
中文适应病症参考翻译1:
卵巢癌
中文适应病症参考翻译2:
乳腺癌
药品信息:

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 详细处方信息以本药内容附件PDF文件(201912719185938.pdf)的“原文Priscribing Information”为准
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 部分中文奥拉帕利处方资料(仅供参考)


【英文名称】
Lynparza


【中文名称】
奥拉帕利

【适应症和用途】

Lynparza是一种聚(ADP-核糖)聚合酶(PARP)抑制剂,表明:

卵巢癌:

•对复发性上皮性卵巢癌,输卵管癌或原发性腹膜癌患者进行维持治疗,这些患者对铂类化疗有完全或部分反应。 (1.1)

用于治疗患有有害或疑似有害生殖系统的BRCA突变(gBRCAm)晚期卵巢癌的成年患者,这些患者已接受过三次或更多次化疗前的治疗。根据FDA批准的Lynparza伴随诊断选择患者进行治疗。 (1.2,2.3)

乳腺癌:

•对于先前在新辅助,辅助或转移性环境中接受过化疗的人类表皮生长因子受体2(HER2)阴性转移性乳腺癌的有害或疑似去除gBRCAm的患者。激素受体(HR)阳性乳腺癌患者应该接受先前的内分泌治疗或被认为不适合进行内分泌治疗。根据FDA批准的Lynparza伴随诊断选择患者进行治疗。 (1.3,2.4)

【剂量和用量】

•为避免替代错误和过量服用,不要将Lynparza片剂替换为毫克至毫克的Lynparza胶囊,因为每种制剂的剂量和生物利用度不同。(2.1)

•推荐的片剂剂量为300毫克,每日两次口服,含或不含食物。(2.2)

•继续治疗直至疾病进展或不可接受的毒性。(2.2)

•对于不良反应,请考虑剂量中断或剂量减少。(2.5)

•对于中度肾功能损害(CLcr 31-50 mL / min),每日两次减少剂量至200 mg。(2.7)

【警告和注意事项】

•骨髓增生异常综合征/急性髓细胞白血病(MDS / AML):<1.5%接触Lynparza单药治疗的患者发生,大多数事件都有致命的结果。 在基线和之后每月监测患者的血液毒性。 如果确认MDS / AML,则停止。(5.1)

•肺炎:在接触Lynparza的患者中发生率<1%,有些病例是致命的。 怀疑是肺炎的中断治疗。 如果确诊肺炎则停止。(5.2)

•胚胎 - 胎儿毒性:Lynparza可导致胎儿伤害。 建议胎儿的潜在风险并使用有效的避孕措施。 (5.3,8.1,8.3)

【INDICATIONS AND USAGE 】

Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:

Ovarian cancer

• for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. (1.1)

• for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. (1.2, 2.3)

Breast cancer:

• in patients with deleterious or suspected deleteriou gBRCAm, human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. (1.3, 2.4)
 

【DOSAGE AND ADMINISTRATION】

• To avoid substitution errors and overdose, do not substitute Lynparza tablets with Lynparza capsules on a milligram-to-milligram basis due to differences in the dosing and bioavailability of each formulation. (2.1)

• Recommended tablet dose is 300 mg taken orally twice daily with or without food. (2.2)

• Continue treatment until disease progression or unacceptable toxicity. (2.2)

• For adverse reactions, consider dose interruption or dose reduction. (2.5)

• For moderate renal impairment (CLcr 31-50 mL/min), reduce dose to 200 mg twice daily. (2.7)
 

【WARNINGS AND PRECAUTIONS】

• Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in <1.5% of patients exposed to Lynparza monotherapy and the majority of events had a fatal outcome. Monitor patients for hematological toxicity at baseline and monthly thereafter. Discontinue if MDS/AML is confirmed. (5.1)

• Pneumonitis: Occurred in <1% of patients exposed to Lynparza, and some cases were fatal. Interrupt treatment if pneumonitis is suspected. Discontinue if pneumonitis is confirmed. (5.2)

• Embryo-Fetal Toxicity: Lynparza can cause fetal harm. Advise of the potential risk to a fetus and to use effective contraception. (5.3, 8.1, 8.3)
 

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 详细处方信息以本药内容附件PDF文件(201912719185938.pdf)的“原文Priscribing Information”为准
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更新日期: 2019-1-26
附件:
201912719185938.pdf    

 
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