Land: Malta
Taal: Engels
Bron: Medicines Authority
GEMCITABINE
Accord Healthcare Limited
L01BC05
GEMCITABINE
CONCENTRATE FOR SOLUTION FOR INFUSION
GEMCITABINE 1000 mg
POM
ANTINEOPLASTIC AGENTS
Authorised
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER GEMCITABINE 100 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Gemcitabine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet See section 4. WHAT IS IN THIS LEAFLET 1. What Gemcitabine 100 mg/ml Concentrate for Solution for Infusion is and what it is used for 2. What you need to know before you take Gemcitabine 100 mg/ml Concentrate for Solution for Infusion 3. How to take Gemcitabine 100 mg/ml Concentrate for Solution for Infusion 4. Possible side effects 5. How to store Gemcitabine 100 mg/ml Concentrate for Solution for Infusion 6. Contents of the pack and other information 1. WHAT GEMCITABINE 100 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR Gemcitabine 100 mg/ml Concentrate for Solution for Infusion belongs to a group of medicines called “cytotoxics”. These medicines kill dividing cells, including cancer cells. Gemcitabine 100 mg/ml Concentrate for Solution for Infusion may be given alone or in combination with other anti-cancer medicines, depending on the type of cancer. Gemcitabine 100 mg/ml Concentrate for Solution for Infusion is used in the treatment of the following types of cancer: - non-small cell lung cancer (NSCLC), alone or together with cisplatin. - pancreatic cancer. - breast cancer, together with paclitaxel. - ovarian cancer, together with carboplatin. - bladder cancer, together with cisplatin. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GEMCITABINE 100 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION DO NOT TAKE GEMCITABINE 100 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION - if you are allergic to Gemcitabine or any of the other ingredients of this medicine (listed in section 6). - if you are Lees het volledige document
Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Gemcitabine 100 MG/ML Concentrate for Solution for Infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains Gemcitabine hydrochloride equivalent to 100 mg gemcitabine. Each vial of 2 ml concentrate for solution for infusion contains Gemcitabine hydrochloride equivalent to 200 mg gemcitabine. Each vial of 10 ml concentrate for solution for infusion contains Gemcitabine hydrochloride equivalent to 1000 mg gemcitabine Each vial of 15 ml concentrate for solution for infusion contains Gemcitabine hydrochloride equivalent to 1500 mg gemcitabine Each vial of 20 ml concentrate for solution for infusion contains Gemcitabine hydrochloride equivalent to 2000 mg gemcitabine Excipients with known effect: 9.192 mg/ml (0.4 mmol/ml) sodium. 440 mg/ml (44 % w/v) ethanol anhydrous For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, colourless to slightly yellow solution. pH in the range of approximately 6.0 to 7.5 and osmolarity in the range of approximately 270 to 330 mOsmol/Litre after dilution with 0.9 % sodium chloride solution at 0.1 mg/ml concentration. 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 Lees het volledige document