Gemcitabin Ebewe concentrate for solution for i/v infusion

Land: Armenía

Tungumál: enska

Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Virkt innihaldsefni:

gemcitabine (gemcitabine hydrochloride)

Fáanlegur frá:

Fareva Unterach GmbH

ATC númer:

L01BC05

INN (Alþjóðlegt nafn):

gemcitabine (gemcitabine hydrochloride)

Skammtar:

10mg/ml

Lyfjaform:

concentrate for solution for i/v infusion

Einingar í pakka:

glass vial 100ml

Gerð lyfseðils:

Prescription

Leyfisstaða:

Registered

Leyfisdagur:

2022-11-03

Vara einkenni

Safety Update: AT_H_0224_001_FI_19-04-03
SPCPIL~3
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
GEMCITABINE EBEWE®
10 MG/ML
Concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 11.4 mg gemcitabine hydrochloride which corresponds to
10 mg of the active ingredient
gemcitabine (10 mg/ml).
Each 20 ml vial contains 200 mg gemcitabine (as hydrochloride).
Each 50 ml vial contains 500 mg gemcitabine (as hydrochloride).
Each 100 ml vial contains 1000 mg gemcitabine (as hydrochloride).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion
Product description:
clear, colourless to pale yellow solution, free of visible particles.
pH: 5.0 – 6.0.
Osmolality: 121.7 mOsmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gemcitabine is indicated for the treatment of locally advanced or
metastatic bladder cancer in
combination with cisplatin.
Gemcitabine is indicated for treatment of patients with locally
advanced or metastatic adenocarcinoma of
the pancreas.
Gemcitabine, in combination with cisplatin is indicated as first line
treatment of patients with locally
advanced or metastatic non-small cell lung cancer (NSCLC). Gemcitabine
monotherapy can be
considered in elderly patients or those with performance status 2.
Gemcitabine is indicated for the treatment of patients with locally
advanced or metastatic epithelial
ovarian carcinoma, in combination with carboplatin, in patients with
relapsed disease following a
recurrence-free interval of at least 6 months after platinum-based,
first-line therapy.
Gemcitabine, in combination with paclitaxel, is indicated for the
treatment of patients with unresectable,
locally recurrent or metastatic breast cancer who have relapsed
following adjuvant/neoadjuvant
chemotherapy. Prior chemotherapy should have included an anthracycline
unless clinically
contraindicated.
Safety Update: AT_H_0224_001_FI_19-04-03
SPCPIL~3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Gemcitabine should onl