GEMCITABINE EBEWE 40MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

GEMCITABINE AS HYDROCHLORIDE

Available from:

NOVARTIS ISRAEL LTD

ATC code:

L01BC05

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

GEMCITABINE AS HYDROCHLORIDE 40 MG / 1 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

EBEWE PHARMA GES.M.B.H NFG. KG, AUSTRIA

Therapeutic group:

GEMCITABINE

Therapeutic area:

GEMCITABINE

Therapeutic indications:

Palliative treatment of patients with locally advanced or metastatic non-small cell lung cancer and locally advanced or metastatic adenocarcinoma of the pancreas and for patients with 5-FU refractory pancreatic cancer. Gemcitabine is indicated for the treatment of patients with bladder cancer at the invasive stage. Breast cancer: 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. Ovarian cancer: Gemcitabine in combination with carboplatin is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma whom have relapsed at least six months after platinum - based therapy.

Authorization date:

2016-04-30

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Gemcitabine “Ebewe” 40 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml concentrate for solution for infusion contains 40 mg
gemcitabine (as hydrochloride).
Each vial of 5 ml contains 200 mg gemcitabine (as hydrochloride).
Each vial of 25 ml contains 1000 mg gemcitabine (as hydrochloride).
Each vial of 50 ml contains 2000 mg gemcitabine (as hydrochloride).
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ Non-Small Cell Lung Cancer:_
Gemcitabine is indicated for the palliative treatment of patients with
locally advanced or
metastatic non-small cell lung cancer.
_Pancreatic Cancer:_
_ _
Gemcitabine is indicated for the palliative treatment of patients with
locally advanced or
metastatic adenocarcinoma of the pancreas and for patients with 5-FU
refractory pancreatic
cancer.
_Bladder Cancer: _
Gemcitabine is indicated for the treatment of patients with bladder
cancer at the invasive
stage.
_Breast cancer:_
_ _
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.
_Ovarian cancer:_
_ _
Gemcitabine in combination with carboplatin, is indicated for the
treatment of patients with
recurrent epithelial ovarian carcinoma who have relapsed at least six
months after
platinum-based therapy.
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Gemcitabine should only be prescribed by a physician qualified in the
use of anti-cancer
chemotherapy.
_Recommended posology: _
_Non-Small Cell Lung Cancer:_
_ _
_Single-agent use: _Adults: The recommended dose of gemcitabine is
1,000 mg/m
2
,
given by
30- minute intravenou