Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Biovac
JAPAN FREEZE-DRIED TUBERCULIN REGISTRATION NUMBER: T645 (Act 101/1965) T646 (Act 101/1965) PROPRIETARY NAME (and dosage form): JAPAN FREEZE-DRIED TUBERCULIN PURIFIED PROTEIN DERIVATIVE DESCRIPTIVE NAME OF MEDICINE: TUBERCULIN P.P.D. PHARMACOLOGICAL CLASSIFICATION: A. 30.3 Biologicals. Other SCHEDULING STATUS: S1 COMPOSITION: Each set consists of 1 vial and 1 ampoule. Each vial contains 1 µg of Tuberculin P.P.D. equivalent to 50 Tuberculin Units (50 TU). Each ampoule contains 2 mL diluent. IDENTIFICATION: Vial: Contains white, dried, crystalline powder. Ampoule: Contains clear, colourless diluent. PHARMACOLOGICAL ACTION OF THE MEDICINE: Tuberculin P.P.D. is a white dried product obtained from culture filtrate of Mycobacterium tuberculosis. The active substances are the proteins of tubercle bacilli which cause a specific skin response of the delayed type in individuals infected with tuberculosis. INDICATIONS: Intradermal Mantoux test. The skin reactions are characterised by a well-defined easily palpable induration. (This product is sufficient to make a solution for 20 Mantoux tests of 2,5 TU or 10 Mantoux tests of 5 TU.) Interpretation of the test: The test is judged 3 days after the injection. The largest diameter of induration is measured in millimetres and fractions of millimetres. For interpretation the revised criteria of the American Thoracic Society are employed. Classification criteria No reaction or induration of less than 5 mm Negative Induration measures between 5 and 9,9 mm Doubtful Induration measures 10 mm or more Positive CONTRA-INDICATIONS: Known hypersensitivity to the test. DOSAGE AND DIRECTIONS FOR USE: Skin tests with 2,5 TU: Reconstitute powder with 2 mL of diluent. Skin tests with 5 TU: Reconstitute powder with 1 mL of diluent. Method of reconstitution 1. Remove the c Read the complete document