Inlyta 1mg tablets film-coated

국가: 아르메니아

언어: 영어

출처: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

유효 성분:

axitinib

제공처:

Pfizer Manufacturing Deutschland GmbH

ATC 코드:

L01XE17

INN (International Name):

axitinib

복용량:

1mg

약제 형태:

tablets film-coated

패키지 단위:

(56/4x14/) blisters

처방전 유형:

Prescription

승인 상태:

Registered

승인 날짜:

2015-04-16

제품 특성 요약

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