Inlyta 1mg tablets film-coated

Nchi: Armenia

Lugha: Kiingereza

Chanzo: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Viambatanisho vya kazi:

axitinib

Inapatikana kutoka:

Pfizer Manufacturing Deutschland GmbH

ATC kanuni:

L01XE17

INN (Jina la Kimataifa):

axitinib

Kipimo:

1mg

Dawa fomu:

tablets film-coated

Vitengo katika mfuko:

(56/4x14/) blisters

Dawa ya aina:

Prescription

Idhini hali ya:

Registered

Idhini ya tarehe:

2015-04-16

Tabia za bidhaa

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