Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Bayer
SURAMIN SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): SURAMIN Injection COMPOSITION: Each vial contains 1 g SURAMIN B.P.C. PHARMACOLOGICAL CLASSIFICATION: A 20.2.6 Medicines against protozoa PHARMACOLOGICAL ACTION: SURAMIN is active against the early stages of trypanosomiasis. INDICATIONS: Trypanosomiasis (African Sleeping Sickness) caused by Trypanosoma gambiense or rhodesiense. Onchocerciasis caused by Onchocerca volvulus. CONTRA-INDICATIONS: Pathological urinary conditions e.g. granular casts, symptoms indicating organic kidney damage. DOSAGE AND DIRECTIONS FOR USE: 1. Preparation of the solution: SURAMIN is a stable, white, loose powder. With vigorous shaking it dissolves in water and physiological sodium chloride solution. The solution for injection must always be freshly prepared. To do this withdraw from an ampoule 10 mL water for injections (using a sterile syringe and needle) and inject into the vial containing 1 g SURAMIN. The solutions are odourless, almost tasteless and show neutral reaction when tested with litmus paper. 2. Administration: SURAMIN is injected intravenously in 10 % solution. Only if intravenous administration is impossible may it be given by intramuscular injection (local irritation). 3. Dosage a) Trypanosomiasis (Sleeping Sickness) Prophylaxis: For individual and mass prophylaxis it is sufficient to give injections of 1-2 g SURAMIN and repeat these every three months as long as there is a possibility of infection, in general prophylactic campaigns every 6 months. The best method is to inject 1 g IV and a second dose of 1 g the following day or within three weeks. The dosage for children and adolescents is 0,2-0,75 g according to age, for infants 0,1-0,15 g. Another injection of 1 g (children correspondingly less) after three Read the complete document