Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
cabazitaxel
Sanofi Winthrop Industrie
L01CD
cabazitaxel
Antineoplastic agents
Prostatic Neoplasms
Jevtana in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.
Revision: 23
Authorised
2011-03-17
33 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL FOR SOLVENT 1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION SOLVENT for JEVTANA 2. METHOD OF ADMINISTRATION USE THE ENTIRE CONTENT FOR DILUTION (see package leaflet) . 3. EXPIRY DATE EXP 4. BATCH NUMBER Lot 5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 4.5 ml ( ethanol 96% and water for injections ) . 6. OTHER This vial contains an overfill. 34 B. PACKAGE LEAFLET 35 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT JEVTANA 60 MG CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION cabazitaxel 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. • 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 JEVTANA is and what it is used for 2. What you need to know before you are given JEVTANA 3. How to use JEVTANA 4. Possible side effects 5. How to store JEVTANA 6. Contents of the pack and other information 1. WHAT JEVTANA IS AND WHAT IT IS USED FOR The name of your medicine is JEVTANA. Its common name is cabazitaxel. It belongs to a group of medicines called “taxanes” used to treat cancers. JEVTANA is used to treat prostate cancer that has progressed after having had other chemotherapy. It works by stopping cells from growing and multiplying. As part of your treatment, you will also take a corticosteroid medicine (prednisone or prednisolone) by mouth every day. Ask your doctor to give you information about this other medicine. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN JEVTANA DO NOT USE JEVTANA IF • you are allergic (hypersensitive) to cabazitaxel, to other taxanes, or polysorbate 80 or any of the other excipients of this medicine (listed in section 6), • the number of your white blood cells is Pročitajte cijeli dokument
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT JEVTANA 60 mg concentrate and solvent for solution for infusion. _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of concentrate contains 40 mg cabazitaxel. One vial of 1.5 ml (nominal volume) of concentrate contains 60 mg cabazitaxel. After initial dilution with the entire solvent, each ml of solution contains 10 mg cabazitaxel. Note: Both the JEVTANA 60 mg/1.5 ml concentrate vial (fill volume: 73.2 mg of cabazitaxel/1.83 ml) and the solvent vial (fill volume: 5.67 ml) contain an overfill to compensate for liquid loss during preparation. This overfill ensures that after dilution with the ENTIRE contents of the accompanying solvent, there is solution containing 10 mg/ml cabazitaxel. _ _ Excipient with known effect One vial of solvent contains 573.3 mg of ethanol 96%. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate and solvent for solution for infusion (sterile concentrate). The concentrate is a clear yellow to brownish-yellow oily solution. The solvent is a clear and colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS JEVTANA in combination with prednisone or prednisolone is indicated for the treatment of adult patients with metastatic castration resistant prostate cancer previously treated with a docetaxel-containing regimen (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The use of JEVTANA should be confined to units specialised in the administration of cytotoxics and it should only be administered under the supervision of a physician experienced in the use of anticancer chemotherapy. Facilities and equipment for the treatment of serious hypersensitivity reactions like hypotension and bronchospasm must be available (see section 4.4). Premedication The recommended premedication regimen should be performed at least 30 minutes prior to each administration of JEVTANA with the following intravenous medicinal products to mitigate the risk and severity of hypersensi Pročitajte cijeli dokument