Pajjiż: Armenja
Lingwa: Ingliż
Sors: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
axitinib
Pfizer Manufacturing Deutschland GmbH
L01XE17
axitinib
1mg
tablets film-coated
(56/4x14/) blisters
Prescription
Registered
2015-04-16
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Inlyta 1 mg film-coated tablets Inlyta 3 mg film-coated tablets Inlyta 5 mg film-coated tablets Inlyta 7 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Inlyta 1 mg film-coated tablets Each film-coated tablet contains 1 mg of axitinib. _ _ Inlyta 3 mg film-coated tablets Each film-coated tablet contains 3 mg of axitinib. Inlyta 5 mg film-coated tablets Each film-coated tablet contains 5 mg of axitinib. Inlyta 7 mg film-coated tablets Each film-coated tablet contains 7 mg of axitinib. _ _ Excipients with known effect _Inlyta 1 mg film-coated tablet _ Each film-coated tablet contains 33.6 mg of lactose monohydrate. _Inlyta 3 mg film-coated tablet_ Each film-coated tablet contains 35.3 mg of lactose monohydrate. _Inlyta 5 mg film-coated tablet _ Each film-coated tablet contains 58.8 mg of lactose monohydrate. _Inlyta 7 mg film-coated tablet _ Each film-coated tablet contains 82.3 mg of lactose monohydrate. _ _ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Inlyta 1 mg film-coated tablets Red oval film-coated tablet debossed with “Pfizer” on one side and “1 XNB” on the other. Inlyta 3 mg film-coated tablets Red round film-coated tablet debossed with “Pfizer” on one side and “3 XNB” on the other. Inlyta 5 mg film-coated tablets Red triangular film-coated tablet debossed with “Pfizer” on one side and “5 XNB” on the other. 3 Inlyta 7 mg film-coated tablets Red diamond shaped film-coated tablet debossed with “Pfizer” on one side and “7 XNB” on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Treatment with Inlyta should be conducted by a physician experienced in the use of anticancer therapies. Posology _ _ The recommended Aqra d-dokument sħiħ