Land: Europeiska unionen
Språk: engelska
Källa: EMA (European Medicines Agency)
cabazitaxel
Accord Healthcare S.L.U.
L01CD04
cabazitaxel
Antineoplastic agents
Prostatic Neoplasms, Castration-Resistant
Treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.
Revision: 5
Authorised
2020-08-28
31 B. PACKAGE LEAFLET 32 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CABAZITAXEL ACCORD 20 MG/ML CONCENTRATE 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 Cabazitaxel Accord is and what it is used for 2 What you need to know before you are given Cabazitaxel Accord 3 How to use Cabazitaxel Accord 4 Possible side effects 5 How to store Cabazitaxel Accord 6 Contents of the pack and other information 1. WHAT CABAZITAXEL ACCORD IS AND WHAT IT IS USED FOR The name of your medicine is Cabazitaxel Accord. Its common name is cabazitaxel. It belongs to a group of medicines called “taxanes” used to treat cancers. Cabazitaxel Accord is used to treat adults with 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 CABAZITAXEL ACCORD DO NOT USE CABAZITAXEL ACCORD 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 too low (neutrophil counts less than or equal to 1,500/mm 3 ), • you have severe abnormal liver function, • you have recently received or are about to receive a vaccine against yellow fever. You should not be given Cabazitaxel Accord if any of the above apply to you. If you are not sure, talk to your doctor before having Cab Läs hela dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Cabazitaxel Accord 20 mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of concentrate contains 20 mg cabazitaxel. One vial of 3 ml of concentrate contains 60 mg cabazitaxel. Excipient with known effect The finished product contains 395 mg/ml of ethanol anhydrous, thus each 3 ml vial contains 1,185 mg ethanol anhydrous. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). The concentrate is a clear colourless to pale yellow or brownish yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cabazitaxel Accord 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 cabazitaxel 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 cabazitaxel with the following intravenous medicinal products to mitigate the risk and severity of hypersensitivity: • antihistamine (dexchlorpheniramine 5 mg or diphenhydramine 25 mg or equivalent), • corticosteroid (dexamethasone 8 mg or equivalent), and • H2 antagonist (ranitidine or equivalent) (see section 4.4). Antiemetic prophylaxis is recommended and can be given orally or intravenously as needed. Throughout the treatment, adequate hydration of the patient needs to be ensured, in order to prevent complications like renal failure. P Läs hela dokumentet