Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Carboplatin 10 mg/mL; ;
Pfizer New Zealand Limited
Carboplatin 10 mg/mL
10 mg/mL
Solution for injection
Active: Carboplatin 10 mg/mL Excipient: Nitrogen Water for injection
Vial, plastic, 1 x 5 mL, 5 mL
Prescription
Prescription
Johnson Matthey Pharmaceutical Materials
Package - Contents - Shelf Life: Vial, plastic, 1 x 5 mL - 5 mL - 24 months from date of manufacture stored at or below 25°C - Vial, plastic, 1 x 15 mL - 15 mL - 24 months from date of manufacture stored at or below 25°C - Vial, plastic, 1 x 45 mL - 45 mL - 24 months from date of manufacture stored at or below 25°C
1991-01-23
CARBOPLATIN Page 1 CARBOPLATIN INJECTION _Carboplatin _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Carboplatin Injection. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Carboplatin Injection against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET_._ You may need to read it again. WHAT CARBOPLATIN INJECTION IS USED FOR Carboplatin belongs to a group of anticancer medicines known as platinum complexes. Carboplatin works by preventing the growth of cancer cells and eventually destroying them. It is used for cancer of the ovary. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN CARBOPLATIN INJECTION _WHEN YOU MUST NOT BE GIVEN _ _IT _ DO NOT USE CARBOPLATIN INJECTION IF: you have an allergy to carboplatin, cisplatin or other medicines containing platinum you have kidney disease or poor kidney function you have a low blood count DO NOT USE THIS MEDICINE IF YOU ARE PREGNANT OR PLANNING TO BECOME PREGNANT. It may affect your developing baby if you take it during pregnancy. DO NOT BREAST FEED IF YOU ARE USING THIS MEDICINE. IF YOU ARE NOT SURE YOU SHOULD BE GIVEN CARBOPLATIN, TALK TO YOUR DOCTOR. _BEFORE YOU ARE GIVEN IT _ TELL YOUR DOCTOR IF YOU HAVE ALLERGIES TO ANY OTHER MEDICINES, FOODS, PRESERVATIVES OR DYES. TELL YOUR DOCTOR IF YOU ARE PREGNANT OR PLAN TO BECOME PREGNANT. TELL YOUR DOCTOR IF YOU ARE BREAST- FEEDING OR PLAN TO BREAST-FEED. TELL YOUR DOCTOR IF YOU HAVE OR HAVE HAD ANY OF THE FOLLOWING MEDICAL CONDITIONS: any sort of infection e.g. sinusitis, tooth abscess, etc abnormal or heavy bleeding bleeding gums unusual Read the complete document
Version: pfdcarbo10120 Supersedes: pfdcarbo10919 Page 1 of 10 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Carboplatin Injection, 50 mg/5 mL, 150 mg/15 mL and 450 mg/45 mL. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Carboplatin is a sterile, hypotonic, preservative-free solution of carboplatin 10 mg/mL in Water for Injections. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of advanced ovarian carcinoma of epithelial origin. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE The recommended dosage for previously untreated adults (normal renal function) is 400mg/m² as a single intravenous infusion over 15-60 minutes. Therapy should not be repeated again until four weeks have elapsed. In patients with risk factors such as previous myelosuppressive therapy or in the aged, the initial dosage may need to be reduced to 20-25%. Determination of the haematological nadir by weekly blood counts is recommended for adjusting future doses and scheduling of carboplatin. DOSE ADJUSTMENTS PATIENTS WITH IMPAIRED RENAL FUNCTION As carboplatin is excreted by the kidney and is nephrotoxic the optimum dosage should be determined by frequent monitoring of the haematological nadir and renal function. The suggested dosage schedule for patients with impaired renal function based on creatinine clearance is: Creatinine Clearance Carboplatin Dose > 40 mL/min 400 mg/m² 20-39 mL/min 250 mg/m² Version: pfdcarbo10120 Supersedes: pfdcarbo10919 Page 2 of 10 0-19 mL/min 150 mg/m² PAEDIATRIC POPULATION Insufficient information is available to make specific recommendations. COMBINATION THERAPY Carboplatin may be used in combination with other anti-neoplastic agents and hence the dosage will vary according to the protocol used. The optimal use of carboplatin in combination with other myelosuppressive drugs will require dosage adjustments and frequent haematological monitoring. METHOD OF ADMINISTRATION Aluminium reacts with carboplatin causing Read the complete document