Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
carboplatin, Quantity: 10 mg/mL
Pfizer Australia Pty Ltd
Injection, solution
Excipient Ingredients: water for injections
Intravenous
1 X 15mL
(S4) Prescription Only Medicine
For the treatment of advanced ovarian carcinoma of epithelial origin.
Visual Identification: Clear, colourless solution, free from visible particles.; Container Type: Vial; Container Material: PP; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1994-06-23
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 FEMALES: DO NOT USE THIS MEDICINE IF YOU ARE PREGNANT OR PLANNING TO BECOME PREGNANT. AVOID BECOMING PREGNANT BY USING EFFECTIVE CONTRACEPTION DURING TREATMENT AND UP TO 6 MONTHS AFTER THERAPY. IT MAY AFFECT YOUR DEVELOPING BABY IF YOU TAKE IT DURING PREGNANCY. MALES: TELL YOUR DOCTOR OR PHARMACIST IF YOUR PARTNER INTENDS TO BECOME PREGNANT WHILE YOU ARE BEING GIVEN CARBOPLATIN INJECTION, OR SHORTLY AFTER YOU HAVE STOPPED TREATMENT WITH CARBOPLATIN. Carboplatin may cause birth defects if either the male or female is using it at the time of conception. It is recommended that you use some kind of birth control while you are using Carboplatin Injection and for at least 3 months after you stop treatment. A barrier metho Preberite celoten dokument
Version: pfpcarbo10320 Supersedes: pfpcarbo11119 Page 1 of 11 AUSTRALIAN PRODUCT INFORMATION – CARBOPLATIN INJECTION (CARBOPLATIN) 1. NAME OF THE MEDICINE Carboplatin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Carboplatin Injection is a sterile, hypotonic, preservative-free solution containing carboplatin 10 mg/mL in Water for Injections. 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 DOSAGE The recommended dosage for previously untreated adults (with normal renal function) is 400mg /m 2 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 by 20-25%. Determination of the haematological nadir by weekly blood counts is recommended for adjusting future doses and scheduling of carboplatin therapy. METHOD OF ADMINISTRATION Prior to administration, carboplatin solutions should be inspected visually for particulate matter. Dilutions may be made in Glucose 5% Intravenous Infusion to concentrations as low as 0.1 mg/mL. The product and admixture contain no antimicrobial agent. In order to reduce microbiological hazards it is recommended that further dilution should be effected immediately prior to use and infusion commenced as soon as practicable after preparation of the admixture. Infusion should be completed within 24 hours of preparation and any residue discarded (see Section 6.6 Special precautions for disposal). Version: pfpcarbo10320 Supersedes: pfpcarbo11119 Page 2 of 11 Aluminium reacts with carboplatin causing precipitate formation and loss of potency, therefore aluminium-containing equipment should not be used for preparation or administration of carboplatin. DOSAGE ADJUSTMENT RENAL IMPAIRMENT As carboplatin is excreted by the kidney and is nephrotoxic, the Preberite celoten dokument