Land: Storbritannien
Språk: engelska
Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)
Gemcitabine hydrochloride
Accord-UK Ltd
L01BC05
Gemcitabine hydrochloride
100mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010300; GTIN: 5055565704653
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 • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor, nurse or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist. IN THIS LEAFLET: 1. What Gemcitabine Concentrate for solution for infusion is and what it is used for 2. 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. Further information 1. WHAT GEMCITABINE CONCENTRATE FOR SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR The name of your medicine is ‘ GEMCITABINE 100 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION ’ but in the rest of the leaflet it will be called ‘Gemcitabine concentrate for solution for infusion’. Gemcitabine Concentrate for solution for infusion belongs to a group of medicines called “cytotoxics”. These medicines kill dividing cells, including cancer cells. Gemcitabine Concentrate for solution for infusion may be given alone or in combination with other anti-cancer medicines, depending on the type of cancer. Gemcitabine 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. BEFORE YOU ARE GIVEN GEMCITABINE CONCENTRATE FOR SOLUTION FOR INFUSION YOU SHOULD NOT BE GIVEN GEMCITABINE CONCENTRATE FOR Läs hela dokumentet
OBJECT 1 GEMCITABINE 100 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 01-Nov-2012 | Accord Healthcare Limited 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: 8.87 mg/ml (0.39 mmol/ml) sodium. 440 mg/ml ethanol anhydrous For a full list of excipients, see section 6.1. 3. Pharmaceutical form Concentrate for solution for infusion Clear, colourless to slightly yellow solution 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 Läs hela dokumentet