Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
cabazitaxel, Quantity: 60 mg
Interpharma Pty Ltd
Injection, concentrated
Excipient Ingredients: polysorbate 80; ethanol absolute; macrogol 300; citric acid
Intravenous
1
(S4) Prescription Only Medicine
CABAZITAXEL EVER PHARMA 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: The concentrate is a clear slightly yellow oily solution; Container Type: Vial; Container Material: Glass; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2020-10-27
CABAZITAXEL EVER PHARMA® 1 CABAZITAXEL EVER PHARMA® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine. 1. WHY AM I BEING GIVEN CABAZITAXEL EVER PHARMA? CABAZITAXEL EVER PHARMA contains the active ingredient cabazitaxel. CABAZITAXEL EVER PHARMA is used to treat prostate cancer that has progressed after having had other chemotherapy. For more information, see Section 1. Why am I taking CABAZITAXEL EVER PHARMA? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I AM GIVEN CABAZITAXEL EVER PHARMA? Do not take CABAZITAXEL EVER PHARMA if you have ever had an allergic reaction to cabazitaxel or any of the ingredients listed at the end of this CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT, ARE BREASTFEEDING OR PLANNING TO BREASTFEED. For more information, see Section 2. What should I know before I take CABAZITAXEL EVER PHARMA? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with CABAZITAXEL EVER PHARMA and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW WILL I BE GIVEN CABAZITAXEL EVER PHARMA? • CABAZITAXEL EVER PHARMA will be given by infusion into one of your veins (intravenous use). The infusion will last approximately 1 hour during which you will be in the hospital. • The dose will depend on your height and weight. Your doctor will calculate your body surface area in square meters (m 2 ) and will determine the dose you should receive. More instructions can be found in Section 4. How do I take CABAZITAXEL EVER PHARMA? in the full CMI. 5. WHAT SHOULD I KNOW WHILE TAKING CABAZITAXEL EVER PHARMA? THINGS YOU SHOULD DO • Remind any doctor, surgeon, dentist or pharmacist you visit t Lugege kogu dokumenti
CABAZITAXEL EVER PHARMA PI, 27 OCTOBER 2020 Page 1 of 26 AUSTRALIAN PRODUCT INFORMATION – CABAZITAXEL EVER PHARMA (CABAZITAXEL ) CONCENTRATE FOR INJECTION 1 NAME OF THE MEDICINE Cabazitaxel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION NOMINAL VOLUME ACTIVE INGREDIENT (CABAZITAXEL) 4.5 mL 45 mg 5 mL 50 mg 6 mL 60 mg EXCIPIENTS WITH KNOWN EFFECT Each vial of 4.5 mL concentrate contains 888.8 mg of ethanol 100%. Each vial of 5 mL concentrate contains 987.5 mg of ethanol 100%. Each vial of 6 mL concentrate contains 1,185 mg of ethanol 100%. For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Concentrate solution for injection. The concentrate is a clear slightly yellow oily solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CABAZITAXEL EVER PHARMA 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 DOSE AND METHOD OF ADMINISTRATION The use of CABAZITAXEL EVER PHARMA 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 SPECIAL WARNINGS AND PRECAUTIONS FOR CABAZITAXEL EVER PHARMA PI, 27 OCTOBER 2020 Page 2 of 26 USE). 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 EVER PHARMA with the following intravenous medications to reduce the risk and severity of a hypersensitivity reaction: • antihistamine (dexchlorpheniramine 5 mg or diphenhydramine 25 mg or equivalent), • corticosteroid ( Lugege kogu dokumenti