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Alecensa 150 mg Hard Capsules
2017-09-13 15:23:37 来源: 作者: 【 】 浏览:565次 评论:0
1. Name of the medicinal product

Alecensa 150 mg hard capsules

2. Qualitative and quantitative composition

Each hard capsule contains alectinib hydrochloride equivalent to 150 mg alectinib.

Excipients with known effect

Each hard capsule contains 33.7 mg lactose (as monohydrate) and 6 mg sodium (as sodium laurilsulfate).

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Hard capsule.

White hard capsule of 19.2 mm length, with “ALE” printed in black ink on the cap and “150 mg” printed in black ink on the body.

4. Clinical particulars
 
4.1 Therapeutic indications

Alecensa as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.

4.2 Posology and method of administration

Treatment with Alecensa should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.

A validated ALK assay is necessary for the selection of ALK-positive NSCLC patients. ALK-positive NSCLC status should

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上一篇Tygacil 50mg powder for solutio.. 下一篇INSPRA 50 mg film-coated tablet..

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