Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Teva Pharmaceuticals (Pty) Ltd
See ingredients
INJECTION
EACH 1 ml CONTAINS CARBOPLATIN 10 mg
Registered
1997-01-05
PAGE 1 OF 6 SCHEDULING STATUS S4 PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM CARBOSIN 50 Solution for Injection contains 50 mg CARBOPLATIN CARBOSIN 150 Solution for Injection contains 150 mg CARBOPLATIN CARBOSIN 450 Solution for Injection contains 450 mg CARBOPLATIN CARBOSIN 600 Solution for Injection contains 600 mg CARBOPLATIN READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE CARBOSIN Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. CARBOSIN has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. 1. WHAT CARBOSIN CONTAINS: _Active ingredients:_ CARBOSIN 50 contains 50 mg carboplatin (10 mg/ml) as the active ingredient. CARBOSIN 150 contains 150 mg carboplatin (10 mg/ml) as the active ingredient. CARBOSIN 450 contains 450 mg carboplatin (10 mg/ml) as the active ingredient. CARBOSIN 600 contains 600 mg carboplatin (10 mg/ml) as the active ingredient. _Inactive ingredients:_ Mannitol and water for injection 2. WHAT CARBOSIN IS USED FOR: Carboplatin belongs to a group of medicines known as alkylating agents. It has anti-tumour properties and it is used to treat patients with advanced or recurrent ovarian cancer. There is limited evidence to support the use of CARBOSIN in small lung cancer and cancer of the head and neck. PAGE 2 OF 6 CARBOSIN is to be administered only by or under the immediate supervision of your doctor. 3. BEFORE RECEIVING CARBOSIN: ALWAYS TELL YOUR HEALTHCARE PROFESSIONAL IF YOU ARE TAKING ANY OTHER MEDICINE. (THIS INCLUDES COMPLEMENTARY OR TRADITIONAL MEDICINES.) IF YOU ARE PREGNANT OR BREASTFEEDING YOUR BABY, PLEASE CONSULT YOUR DOCTOR, PHARMACIST OR OTHER HEALTH CARE PROFESSIONAL FOR ADVICE BEFORE TAKING THIS MEDICINE. The following should be considered before you start treatment with CARBOSIN: ALLERGIES- Tell your doctor if you have ever had any unusual or allergic reaction to carboplatin, cisplatin, or a Read the complete document
PAGE 1 OF 12 SCHEDULING STATUS: S4 PROPRIETARY NAMES AND DOSAGE FORMS: CARBOSIN 50 Solution for Injection CARBOSIN 150 Solution for Injection CARBOSIN 450 Solution for Injection CARBOSIN 600 Solution for Injection COMPOSITION: _Active ingredients: _ CARBOSIN 50 contains 50 mg carboplatin (10 mg/ml) CARBOSIN 150 contains 150 mg carboplatin (10 mg/ml) CARBOSIN 450 contains 450 mg carboplatin (10 mg/ml) CARBOSIN 600 contains 600 mg carboplatin (10 mg/ml) _Inactive ingredients: _ Mannitol and water for injection_ _ _ _ PHARMACOLOGICAL CLASSIFICATION: A 26 Cytostatic agents PAGE 2 OF 12 PHARMACOLOGICAL ACTION: Carboplatin [cis-diammine (1,1-cyclobutane-dicarboxylato) platinum] is a platinum co-ordination compound with anti-tumour properties. It is soluble in water at concentrations below 15 mg/ml. Carboplatin has biochemical properties similar to that of cisplatin, thus producing predominantly interstrand and intrastrand DNA crosslinks. PHARMACOKINETICS: In patients with creatinine clearances of 60 ml/min or greater given carboplatin at doses of 300 to 500 mg/m 2 , the plasma concentrations of carboplatin decay in a biphasic manner with mean alpha and beta half- lives of 1,6 hours and 3,0 hours, respectively. The total body clearance, apparent volume of distribution, and mean residence time for carboplatin are 73 ml/min, 16 L, and 3,5 hours, respectively. Carboplatin exhibits linear, dose-independent pharmacokinetics in patients with creatinine clearances > 60 ml/min. The major route of elimination of carboplatin is renal excretion. Patients with creatinine clearances of about 60 ml/min or greater, excrete 70 % of the dose of carboplatin in the urine, with most of this occurring within 12 to 16 hours. In patients with creatinine clearances of less than 60 ml/min, carboplatin renal and total body clearances decrease progressively. Doses of carboplatin, therefore, should be reduced in patients with creatinine clearance < 60 ml/min (see “DOSAGE AND DIRECTIONS FOR USE”). INDICATIONS: Carboplatin is indicated for the t Read the complete document