Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Gemcitabine hydrochloride
Accord Healthcare Ireland Ltd.
L01BC; L01BC05
Gemcitabine hydrochloride
2 gram(s)
Powder for solution for infusion
Pyrimidine analogues; gemcitabine
Not marketed
2011-09-23
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 RECEIVING 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. See section 4 IN THIS LEAFLET : 1. What Gemcitabine powder for solution for infusion is and what it is used for 2. Before you are given Gemcitabine powder for solution for infusion 3. How Gemcitabine powder for solution for infusion is given 4. Possible side effects 5. How to store Gemcitabine powder for solution for infusion 6. Further information 1. WHAT GEMCITABINE POWDER FOR SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR Gemcitabine powder for solution for infusion belongs to a group of medicines called “cytotoxics”. These medicines kill dividing cells, including cancer cells. Gemcitabine powder for solution for infusion may be given alone or in combination with other anti-cancer medicines, depending on the type of cancer. Gemcitabine powder 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 POWDER FOR SOLUTION FOR INFUSION YOU SHOULD NOT BE GIVEN GEMCITABINE POWDER FOR SOLUTION FOR INFUSION: - if you are allergic (hypersensitive) to gemcitabine or any of the other ingredients of Gemcitabine powder for solution for infu Aqra d-dokument sħiħ
Health Products Regulatory Authority 07 February 2024 CRN00F3S3 Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gemcitabine 2g Powder for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains gemcitabine hydrochloride equivalent to 2 g gemcitabine. After reconstitution, the solution contains 38 mg/ml of gemcitabine. Excipients Each 2 g vial contains 35 mg (1.52 mmol) sodium. For a 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 the 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 a performance status of 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 unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. The Prior chemotherapy must have included an anthracycline unless clinically contraindicated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Gemcitabine can only be prescribed by a physician qualified in the use of anti-cancer therapy. Recommended posology _ _ _Bladder cancer_ _Combination use_ The recommended dose for gemcitabine is 1000 mg/m 2 , as a 30-minute intravenous infusion. The dose must be administered on D Aqra d-dokument sħiħ