Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
TUBERCULIN PPD
AJ Vaccines A/S
V04CF01
TUBERCULIN PPD
10 T.U. /0.1 ml
Solution for Injection
Product subject to prescription which may not be renewed (A)
Tuberculosis diagnostics
Authorised
2017-01-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tuberculin PPD RT23 "SSI" 10 T.U./0.1 mL, solution for injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tuberculin PPD RT 23. One single dose of 10 T.U./0.1 mL contains 0.2 micrograms of Tuberculin PPD RT 23. EXCIPIENTS Disodium phosphate dihydrate 0.76 mg Potassium dihydrogen phosphate 0.145 mg Sodium chloride 0.48 mg Potassium hydroxyquinoline sulphate 10 µg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection (injection). Clear, colourless to pale-yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tuberculin PPD RT23 "SSI" is used for Mantoux tuberculin skin testing to diagnose if an individual has ever been infected with_ Mycobacterium tuberculosis_. Some countries also recommend Mantoux tuberculin skin testing in conjunction with BCG vaccination, either to ensure that only tuberculin-negative individuals are vaccinated or as a post-vaccination test. Tuberculin PPD RT23 "SSI" is indicated for all age groups. This medicinal product is for diagnostic use only. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage is always 0.1 mL regardless of the strength used. Tuberculin PPD RT23 "SSI" is injected intradermally. The strength 2 T.U./0.1 mL is recommended. If low tuberculin reactivity is expected 10 T.U./0.1 mL may be used. METHOD OF ADMINISTRATION In the following a detailed description of administration of Tuberculin PPD RT23 "SSI" is given: 0.1 mL is administered with a 1 mL graduated syringe fitted with a short bevel needle (gauge 25 or 26). The injection must be given intradermally in the middle third of the forearm. Administration near the wrist or the elbow joint may weaken the reaction. The skin is slightly stretched, and the needle is held almost parallel with the skin surface with the bevel upwards. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Citiți documentul complet