Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
GEMCITABINE
Actavis Group PTC ehf
L01BC05
GEMCITABINE
40 Mg/Ml
Concentrate for Soln for Inf
Product subject to prescription which may not be renewed (A)
Pyrimidine analogues
Authorised
2010-12-17
1 PACKAGE LEAFLET: INFORMATION FOR THE USER GEMCITABINE 40 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. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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 is and what it is used for 2. What you need to know before you use Gemcitabine 3. How to use Gemcitabine 4. Possible side effects 5. How to store Gemcitabine 6. Contents of the pack and other information 1. WHAT GEMCITABINE IS AND WHAT IT IS USED FOR Gemcitabine belongs to a group of medicines called “cytotoxics”. These medicines kill dividing cells, including cancer cells. Gemcitabine may be given alone or in combination with other anti-cancer medicines, depending on the type of cancer. Gemcitabine 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 USE GEMCITABINE DO NOT TAKE GEMCITABINE: - if you are allergic to gemcitabine or any of the other ingredients of this medicine (listed in section 6) - if you are breast-feeding WARNINGS AND PRECAUTIONS Before the first infusion you will hav Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gemcitabine 40 mg/ml Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate for solution for infusion contains 40 mg gemcitabine (as gemcitabine hydrochloride). Each 5 ml vial contains 200 mg gemcitabine (as gemcitabine hydrochloride). Each 25 ml vial contains 1 g gemcitabine (as gemcitabine hydrochloride). Each 50 ml vial contains 2 g gemcitabine (as gemcitabine hydrochloride). Excipients with known effect: Sodium 3.95 mg/ml and ethanol anhydrous 395 mg/ml. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, colourless or pale 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, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have in Read the complete document