Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
cabazitaxel, Quantity: 60 mg
Dr Reddys Laboratories Australia Pty Ltd
Injection, concentrated
Excipient Ingredients: polysorbate 80; citric acid
Intravenous Infusion
1
(S4) Prescription Only Medicine
CABAZITAXEL JUNO in combination with prednisone or prednisolone is indicated for the treatment of patients with metastatic castration resistant prostate cancer previously treated with a docetaxel containing regimen.
Visual Identification: Clear yellow to brownish-yellow viscous solution.; Container Type: Multiple containers; Container Material: Glass; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2018-07-23
CABAZITAXEL JUNO _Cabazitaxel (ca-ba-zi-tax-el)_ _ _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Cabazitaxel Juno. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you being given this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR. Keep this leaflet in a safe place as you may need to read it again. WHAT CABAZITAXEL JUNO IS USED FOR The name of your medicine is Cabazitaxel Juno. It belongs to a group of medicines called 'taxanes' used to treat cancers. Cabazitaxel Juno is used to treat prostate cancer that has progressed after having had other chemotherapy. It works by stopping cells from growing and multiplying. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor's prescription. There is no evidence that this medicine is addictive. BEFORE YOU ARE GIVEN CABAZITAXEL JUNO DO NOT RECEIVE CABAZITAXEL JUNO IF: • the number of your white blood cells is too low (neutrophil counts of 1,500 per cubic millimetre, or less - your doctor will advise you on this), • you have a liver disease • you are pregnant or breast- feeding • you have recently received or are about to receive a vaccine against yellow fever. DO NOT RECEIVE CABAZITAXEL JUNO IF YOU ARE ALLERGIC TO IT OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing. DO NOT RECEIVE CABAZITAXEL JUNO IF YOU ARE PREGNANT OR INTEND TO BECOME PREGNANT. Cabazitaxel Juno may affect your developing baby if you are given Cabazitaxel Juno during pregnancy. If your partner is pregnant or is planning on becoming pregnant, ensure to Przeczytaj cały dokument
AUSTRALIAN PRODUCT INFORMATION – CABAZITAXEL JUNO (CABAZITAXEL) INJECTION CONCENTRATE 1 NAME OF THE MEDICINE Cabazitaxel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION CABAZITAXEL JUNO injection concentrate contains 60 mg cabazitaxel in 1.5 mL. The diluent for CABAZITAXEL JUNO contains ethanol in water for injections. Excipients with known effect: diluent contains alcohol as 16.4% v/v ethanol. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM CABAZITAXEL JUNO (cabazitaxel) 60 mg/1.5 mL concentrate is a sterile, non-pyrogenic, clear yellow to brownish-yellow viscous solution, free from visible extraneous matter. The diluent for CABAZITAXEL JUNO is a clear, colourless, sterile, and non-pyrogenic, solution, free from visible extraneous matter. . 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS CABAZITAXEL JUNO in combination with prednisone or prednisolone is indicated for the treatment of patients with metastatic castration resistant prostate cancer previously treated with a docetaxel containing regimen. 4.2 D OSE 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. Do not use PVC infusion containers (bags or bottles) for the preparation of the infusion solution. Do not use polyurethane infusion sets (tubing, filter, pumps) for the administration of the infusion solution. PREMEDICATION Premedicate at least 30 minutes prior to each administration of cabazitaxel with the following intravenous medications to reduce the risk and severity of a hypersensitivity reaction: • antihistamine (equivalent to dexchlorpheniramine 5 mg or diphenhydramine 25 mg), • corticosteroid (dexamethasone 8 mg or equivalent) and with • H 2 antagonist (ranitidine or equivalent). • Antiemetic prophylaxis is recommended and can be given orally or intravenously as needed (see 4.4 SPECIAL WARNINGS AND PR Przeczytaj cały dokument