Страна: Мальта
Язык: английский
Источник: Medicines Authority
GEMCITABINE
Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece
L01BC05
GEMCITABINE 38 mg/ml
CONCENTRATE FOR SOLUTION FOR INFUSION
GEMCITABINE 38 mg/ml
POM
ANTINEOPLASTIC AGENTS
Authorised
2011-03-28
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER GEMCITABINE 38 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION GEMCITABINE READ ALL OF THIS LEAFLET CAREFULLY, BEFORE YOU START RECEIVING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have further questions, please 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 Concentrate for Solution for Infusion is and what it is used for 2. What you need to know before you are given Gemcitabine Concentrate for Solution for Infusion 3. How Gemcitabine Concentrate for Solution for Infusion is given 4. Possible side effects 5. How to store Gemcitabine Concentrate for Solution for Infusion 6. Contents of the pack and other information 1. WHAT GEMCITABINE CONCENTRATE FOR SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR Gemcitabine Concentrate for Solution for Infusion (Gemcitabine) belongs to a group of medicines called ‘cytotoxics’. These medicines kill dividing cells, including cancer cells. Gemcitabine may be given on its own or in combination with other anti-cancer medicines (e.g. cisplatin, paclitaxel, carboplatin), depending on the type of cancer you have. Gemcitabine is used in the treatment of the following types of cancer: • NON-SMALL CELL LUNG CANCER (NSCLC), when given alone or together with cisplatin • PANCREATIC CANCER • BREAST CANCER , when given together with paclitaxel • OVARIAN CANCER, when given together with carboplatin • BLADDER CANCER , when given together with cisplatin 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GEMCITABINE CONCENTRATE FOR SOLUTION FOR INFUSION YOU SHOULD NOT BE GIVEN GEMCITABINE IF: • you are allergic to gemcitabine or any of the other ingredients of this medicine (listed in section 6). • you are breast-feeding Page 2 of 8 WARNINGS AND PRECAUTIONS Be Прочитать полный документ
Page 1 of 20 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Gemcitabine 38 mg/ml Concentrate for Solution for Infusion _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of Gemcitabine Concentrate for Solution for Infusion contains gemcitabine hydrochloride, equivalent to 38 mg gemcitabine. The quantitative composition of each presentation is provided in the table below: Presentation Strength Quantity of gemcitabine (as hydrochloride) Volume of Solution 200mg/5.3 ml 38 mg/ml 200 mg 5.3 ml 1g/26.3 ml 38 mg/ml 1 g 26.3 ml 2g/52.6 ml 38 mg/ml 2 g 52.6 ml For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion A clear, colourless or light straw-coloured solution, practically free from visible particles. pH: 2.0-3.0 Osmolarity: 266 mOsmol/L 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. Page 2 of 20 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Gemcitabine sho Прочитать полный документ