Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Gemcitabine
Fresenius Kabi Oncology Plc
L01BC; L01BC05
Gemcitabine
200 milligram(s)
Powder for solution for infusion
Product subject to prescription which may not be renewed (A)
Pyrimidine analogues; gemcitabine
Marketed
2010-04-23
Black GEMCITABINE - PACK INSERT - IRELAND (BORDON) (Travesh Sharma) \\fre-kp-fp01\PDD-Artworks\EU\Gemita\2013\Ireland\20 Jan 2017\Gemcitabine - Pack Insert - Ireland (Bordon).indd xxxxxxxx V003/IE FONT SIZE: 10 PT TIMES NEW ROMAN DATE: 24 APRIL 2017 11:55 AM VERSION: 02 FINAL PACKAGING SITE: BORDON MFG. SITE: BADDI-2 DIMENSION: 592 X 300 MM FOLDING SIZE: 60 X 33 MM (OUTLINE OF FOLDING SIZE FOR INDICATION PURPOSE ONLY, IT SHOULD BE REMOVED BEFORE FINAL PRINTING.) Form No.: SOP/PDD/014-02 Rev. 00 PACKAGE LEAFLET: INFORMATION FOR THE USER GEMCITABINE 200 MG POWDER FOR SOLUTION FOR INFUSION GEMCITABINE 1 G POWDER FOR SOLUTION FOR INFUSION GEMCITABINE 2 G POWDER 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 further questions, please ask your doctor, nurse or pharmacist. - 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 USE GEMCITABINE: - if you are Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gemcitabine 200 mg powder for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of reconstituted solution contains 38 mg gemcitabine Each vial contains gemcitabine hydrochloride equivalent to 200 mg gemcitabine for reconstitution in 5 ml of solvent. Excipients(s) with known effect: Each 200 mg vial contains 3.5 mg (<1 mmol) sodium. For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for infusion. White to off-white plug or powder. 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 older 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 included an anthracycline unless clinically contraindicated. 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 _Bladder cancer_ _Combination use_ The recommended dose for gemcitabine is 1,000 mg/m², given by 30-minute infusion. The dose should be given on Days 1, 8 and 15 of each Read the complete document