Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
vinflunine
Pierre Fabre Medicament
L01CA05
vinflunine
Antineoplastic agents
Carcinoma, Transitional Cell; Urologic Neoplasms
Javlor is indicated in monotherapy for the treatment of adult patients with advanced or metastatic transitional-cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen.Efficacy and safety of vinflunine have not been studied in patients with performance status ≥ 2.
Revision: 10
Authorised
2009-09-21
7 B. PACKAGE LEAFLET 8 PACKAGE LEAFLET: INFORMATION FOR THE USER JAVLOR 25 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION vinflunine 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. - If you get any side effects talk to your doctor. This includes any possible side effects not listed in this leaflet. See Section 4. WHAT IS IN THIS LEAFLET 1. What Javlor is and what it is used for 2. What you need to know before you use Javlor 3. How to use Javlor 4. Possible side effects 5. How to store Javlor 6. Content of the pack and other information 1. WHAT JAVLOR IS AND WHAT IT IS USED FOR Javlor contains the active substance vinflunine, which belongs to a group of anticancer medicines called vinca alkaloids. These medicines affect cancer cell growth by stopping cell division, leading to cell death (cytotoxicity). Javlor is used to treat advanced or metastatic cancer of the bladder and urinary tract when a previous therapy with platinum-containing medicines has failed. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE JAVLOR DO NOT USE JAVLOR - if you are allergic to the active substance (vinflunine) or to other vinca alkaloids (vinblastine, vincristine, vindesine, vinorelbine), - if you have had (in the last 2 weeks) or currently have a severe infection, - if you are breast-feeding, - if your levels of white blood cells and/or platelets are too low WARNINGS AND PRECAUTIONS Tell your doctor: - if you have liver, kidney or heart problems, - if you experience any neurological symptoms such as headaches, changed mental state which may lead to confusion and coma, convulsions, blurred vision and high blood pressure as you may need to stop taking this medicine, - if you are taking other medicines mentioned in “Using other medicines” below, - if you have constipation, or if you are treated with medicines against pain (opioids), or if you have an abdominal cancer, Lesen Sie das vollständige Dokument
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Javlor 25 mg/mL concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One mL of concentrate contains 25 mg of vinflunine (as ditartrate). One 2 mL vial contains 50 mg of vinflunine (as ditartrate). One 4 mL vial contains 100 mg of vinflunine (as ditartrate). One 10 mL vial contains 250 mg of vinflunine (as ditartrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). Clear, colourless to pale yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Javlor is indicated in monotherapy for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen Efficacy and safety of vinflunine have not been studied in patients with performance status ≥ 2. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Vinflunine treatment should be initiated under the responsibility of a physician qualified in the use of anticancer chemotherapy and is confined to units specialised in the administration of cytotoxic chemotherapy. Before each cycle, adequate monitoring of complete blood counts should be conducted to verify the absolute neutrophil count (ANC), platelets and haemoglobin as neutropenia, thrombocytopenia and anaemia are frequent adverse reactions of vinflunine. Posology The recommended dose is 320 mg/m² vinflunine as a 20 minute intravenous infusion every 3 weeks. In case of WHO/ECOG performance status (PS) of 1 or PS of 0 and prior pelvic irradiation, the treatment should be started at the dose of 280 mg/m². In the absence of any haematological toxicity during the first cycle causing treatment delay or dose reduction, the dose will be increased to 320 mg/m² every 3 weeks for the subsequent cycles. _Recommended co-medication _ In order to prevent constipation, laxatives and dietary measures including oral hydration are recomm Lesen Sie das vollständige Dokument