देश: दक्षिण अफ़्रीका
भाषा: अंग्रेज़ी
स्रोत: South African Health Products Regulatory Authority (SAHPRA)
Pharmacare Limited û Woodmead
See ingredients
INJECTION
EACH 5,0 ml SOLUTION CONTAINS CARBOPLATIN 50,0 mg
Registered
2015-01-10
_ _ _ _ _ Page 1 of 8 _ 1.3.2 PATIENT INFORMATION LEAFLET SCHEDULING STATUS S4 PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM ASPLATA 50 MG/5 ML (injection) ASPLATA 150 MG/15 ML (injection) ASPLATA 450 MG/45 ML (injection) ASPLATA 600 MG/60 ML (injection) ASPLATA 1000 MG/100 ML (injection) Carboplatin 10 mg/ ml READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN ASPLATA Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. ASPLATA 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. _ _ _ _ _ Page 2 of 8 _ WHAT ASPLATA CONTAINS Each millilitre (ml) of injection solution contains 10 milligrams (mg) of the active ingredient, carboplatin. The other ingredient is water for injection. WHAT ASPLATA IS USED FOR ASPLATA is an anti-cancer medicine in the form of solution for injection (a solution that can be given as a slow injection via a drip). It contains platinum. Carboplatin is used in the treatment of certain types of lung cancer and ovarian cancer. BEFORE YOU RECEIVE ASPLATA (INJECTION) DO NOT RECEIVE ASPLATA (INJECTION) If you are: - hypersensitive (allergic) to carboplatin or any similar medicines on previous occasions - suffer from severe kidney disease - suffer from hearing impairment - Bone marrow depressed - Pregnant, trying to become pregnant or breast-feeding your baby. TAKE SPECIAL CARE WITH ASPLATA (INJECTION) If you have a history of allergic reactions with platinum containing products To ensure the number of cells in your blood does not drop too low. Your doctor will regularly check for this If you have mild renal or liver disease If you are being given other anti-cancer medicines If you have been given other medicines that may affect your kidneys or hearing If you are older than 65 years old and experience tingling or burning of the skin _ _ _ _ _ Page 3 of 8 _ PREGNANCY AND BREASTFEE पूरा दस्तावेज़ पढ़ें
_ _ _ _ _Page 1 of 12 _ 1.3.1.1 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE SCHEDULING STATUS S4 PROPRIETARY NAME (and dosage form) ASPLATA 50 MG/5 ML (injection) ASPLATA 150 MG/15 ML (injection) ASPLATA 450 MG/45 ML (injection) ASPLATA 600 MG/60 ML (injection) ASPLATA 1000 MG/100 ML (injection) COMPOSITION Each 1 ml of solution contains 10 mg carboplatin Other ingredient: Water for injection PHARMACOLOGICAL CLASSIFICATION Cytostatic agent PHARMACOLOGICAL ACTION PHARMACODYNAMIC PROPERTIES Carboplatin is a platinum co-ordination compound with antitumour properties. Carboplatin has biochemical properties similar to that of cisplatin, thus producing predominantly interstrand and intrastrand DNA crosslinks. The effect is cell-cycle phase non-specific. PHARMACOKINETIC PROPERTIES _ _ _ _ _Page 2 of 12 _ Following IV administration, carboplatin exhibits biphasic elimination. Carboplatin exhibits linear, dose-independent pharmacokinetics. Carboplatin is mainly eliminated by the kidneys with about 70 % of the dose being excreted in the urine within 24 hours (about 12- 16 hours). Platinum slowly becomes protein bound and is subsequently excreted with a half life of 5 days or more. The terminal half life of intact carboplatin is reported to be about 3 to 6 hours. INDICATIONS ASPLATA is indicated for the treatment of: Advanced ovarian carcinoma of epithelial origin in: a) first line therapy b) second line therapy, after other treatments have failed Small cell carcinoma of the lung. CONTRAINDICATIONS ASPLATA is contraindicated in: Patients with hypersensitivity to the carboplatin or to any of the excipients in ASPLATA (see COMPOSITION). Patients with severe pre-existing renal impairment (creatinine clearance at or below 20 ml/minute). In hearing impairment, bone marrow depression and in patients with localised tumoural bleeding. Pregnancy is contraindicated hence patients with child bearing or conceiving potential should exercise adequate contraception control. Safety in lactation has not been पूरा दस्तावेज़ पढ़ें