Inlyta 1mg tablets film-coated

Kraj: Armenia

Język: angielski

Źródło: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Składnik aktywny:

axitinib

Dostępny od:

Pfizer Manufacturing Deutschland GmbH

Kod ATC:

L01XE17

INN (International Nazwa):

axitinib

Dawkowanie:

1mg

Forma farmaceutyczna:

tablets film-coated

Sztuk w opakowaniu:

(56/4x14/) blisters

Typ recepty:

Prescription

Status autoryzacji:

Registered

Data autoryzacji:

2015-04-16

Charakterystyka produktu

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