Gembio

País: Armènia

Idioma: anglès

Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

ingredients actius:

gemcitabine (gemcitabine hydrochloride)

Disponible des:

Bioprofarma S.A.

Designació comuna internacional (DCI):

gemcitabine (gemcitabine hydrochloride)

Dosis:

200mg

formulario farmacéutico:

powder lyophilized for solution for injection

tipo de receta:

Prescription

Fitxa tècnica

GEMBIO 200 MG
GEMCITABINE FOR INJECTION
SUMMARY OF PRODUCT CHARACTERISTICS
(PRODUCT DATA SHEET)
GEMBIO 200 MG
GEMBIO 200 MG
GEMCITABINE FOR INJECTION
GEMCITABINE FOR INJECTION
BIOPROFARMA S. A.
BIOPROFARMA S. A.
BAGÓ GROUP
BAGÓ GROUP
A
A
RGENTINA
RGENTINA
GEMBIO 200 MG
GEMCITABINE FOR INJECTION
1.
NAME OF THE MEDICINAL PRODUCT
1.1 PRODUCT NAME
Gembio
Gemcitabine
1.2 STRENGTH
GEMBIO 200mg Lyophilized powder for injection.
GEMBIO 1g Lyophilized powder for injection.
1.3 PHARMACEUTICAL DOSAGE FORM
Lyophilized powder for injection.
2.
QUALITY AND QUANTITATIVE COMPOSITION
2.1
QUALITATIVE DECLARATION
Each vial contains:
Gemcitabine (as Hydrochloride)
Mannitol
Sodium Acetate
2.2 QUANTITATIVE DECLARATION
Each vial contains:
Gemcitabine (as
Hydrochloride)………………………………...........................…200
mg
Mannitol…………………………………………………………….………..…….200
mg
Sodium
Acetate……………………………………………….…………..................15
mg
3.
PHARMACEUTICAL FORM
GEMBIO Lyophilized powder for injection is supplied in a single dose
vial.
The following strengths are available:
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non-Small Cell Lung Cancer
GEMBIO is indicated for the treatment of patients with inoperable,
locally advanced (Stage IIA
or IIIB), or metastatic (Stage IV) non-small cell lung cancer.
PAGE 1 / 18
GEMBIO 200 MG
GEMCITABINE FOR INJECTION
Pancreatic Cancer
GEMBIO is indicated for the treatment of patients with locally
advanced nonresectable (Stage II
or Stage III) or metastatic (Stage IV) pancreatic cancer. GEMBIO is
also indicated for patients
previously treated with 5-FU.
Breast Cancer
GEMBIO in combination with paclitaxel is indicated for the treatment
of patients with
nonresectable, locally recurrent or metastatic breast cancer after
failure of prior anthracycline-
containing adjuvant chemotherapy, unless anthracyclines were
clinically contraindicated.
Ovarian Cancer
GEMBIO is indicated in combination with