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  药店国别: 德国药房
产地国家: 美国
所属类别: 抗癌药物->升血小板药物
处方药:处方药
包装规格: 10毫克 10毫克/小瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
赛诺菲
生产厂家英文名:
Sanofi Aventis Germany
该药品相关信息网址1:
https://www.cablivi.com/?gclid=CMnN6cat5eECFcGhxQIdyJsHRg
该药品相关信息网址2:
https://news.genzyme.com/press-release/fda-approves-cablivi-caplacizumab-yhdp-first-nanobody-based-medicine-adults-acquired-t
原产地英文商品名:
Cablivi 10mg powder and solvent for solution for injection 10mg/vial
原产地英文药品名:
caplacizumab
中文参考商品译名:
Cablivi 10毫克粉末和溶剂用于注射液 10毫克/小瓶
中文参考药品译名:
caplacizumab
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP)
临床试验期:
完成
中文适应病症参考翻译1:
获得性血栓性血小板减少性紫癜(aTTP)发作的成人
药品信息:

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详细处方信息以本药内容附件PDF文件(201942221225217.pdf)的“原文Priscribing Information”为准
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部分中文Cablivi处方资料(仅供参考)

【英文名称】Cablivi

【适用证】

Cablivi适用于治疗出现获得性血栓性血小板减少性紫癜(aTTP)发作的成人,并结合血浆置换和免疫抑制。

【用法用量】

使用Cablivi治疗应由具有血栓性微血管病患者管理经验的医生发起和监督。

剂量学:

第一剂:

在血浆交换之前静脉注射10mg的capslacizumab。

后续剂量: 在每次血浆交换完成后每日皮下施用10mg的caplacizumab,持续每日血浆交换处理,然后在停止每日血浆交换处理后每日皮下注射10mg的caplacizumab 30天。

如果在此期间结束时有证据表明未解决的免疫疾病,建议优化免疫抑制方案,并继续每日皮下注射10 mg caplacizumab,直至出现潜在免疫疾病的迹象(例如持续正常化) ADAMTS13活动水平)。

在临床开发计划中,每天给予caplacizumab长达65天。没有关于用caplacizumab再治疗的数据。

错过剂量:

如果错过了一剂Cablivi,可以在12小时内给药。如果已经给药剂量超过12小时,则不应给药错过的剂量,并且应按照通常的给药方案给予下一剂量。

【药物形式】

用于注射溶液的粉末和溶剂。

白色冻干粉末。

溶剂是透明无色液体。

【禁忌】

对活性物质或6.1节中列出的任何赋形剂过敏。

【Therapeutic indications】

Cablivi is indicated for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression.

【Posology and method of administration】

Treatment with Cablivi should be initiated and supervised by physicians experienced in the management of patients with thrombotic microangiopathies.

Posology

First dose:

Intravenous injection of 10 mg of caplacizumab prior to plasma exchange.

Subsequent doses:

Daily subcutaneous administration of 10 mg of caplacizumab after completion of each plasma exchange for the duration of daily plasma exchange treatment, followed by daily subcutaneous injection of 10 mg of caplacizumab for 30 days after stopping daily plasma exchange treatment.

If at the end of this period there is evidence of unresolved immunological disease, it is recommended to optimise the immunosupression regimen and continue daily subcutaneous administration of 10 mg of caplacizumab until the signs of underlying immunological disease are resolved (e.g. sustained normalisation of ADAMTS13 activity level).

In the clinical development program, caplacizumab has been administered daily for up to 65 days. No data on re-treatment with caplacizumab are available.

Missed dose:

If a dose of Cablivi is missed, it can be administered within 12 hours. If more than 12 hours have passed since the dose was to have been given, the missed dose should NOT be administered and the next dose should be administered per the usual dosing schedule.

【Contraindications】

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

【PHARMACEUTICAL FORM】

Powder and solvent for solution for injection.

White lyophilised powder.

The solvent is a clear, colourless liquid.

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详细处方信息以本药内容附件PDF文件(201942221225217.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期:  2019-4-22
附件:
201942221225217.pdf    

 
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