Krajina: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
GEMCITABINE AS HYDROCHLORIDE
NOVARTIS ISRAEL LTD
L01BC05
CONCENTRATE FOR SOLUTION FOR INFUSION
GEMCITABINE AS HYDROCHLORIDE 40 MG / 1 ML
I.V
Required
EBEWE PHARMA GES.M.B.H NFG. KG, AUSTRIA
GEMCITABINE
GEMCITABINE
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.
2016-04-30
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 Prečítajte si celý dokument