Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Tuberculin ppd
AJ Vaccines A/S
V04CF; V04CF01
Tuberculin ppd
2 T.U. /0.1 ml
Solution for injection
Product subject to prescription which may not be renewed (A)
Tuberculosis diagnostics; tuberculin
Marketed
1997-04-23
2 PACKAGE LEAFLET: INFORMATION FOR THE USER TUBERCULIN PPD RT23 AJV 2 T.U./0.1 ML SOLUTION FOR INJECTION Tuberculin PPD RT 23 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE SKIN TESTED BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU . Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Tuberculin PPD RT23 AJV is and what it is used for 2. What you need to know before you are skin tested 3. How you are skin tested 4. Possible side effects 5. How to store Tuberculin PPD RT23 AJV 6. Contents of the pack and other information 1. WHAT TUBERCULIN PPD RT23 AJV IS AND WHAT IT IS USED FOR Tuberculin PPD RT23 AJV is used as a skin test to diagnose if you have ever been infected with a bacteria causing tuberculosis. This medicine is for diagnostic use only. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE SKIN TESTED YOU SHOULD NOT BE TESTED: if you are allergic to Tuberculin PPD RT 23 or any of the other ingredients of Tuberculin PPD RT23 AJV (listed in section 6). if you have experienced a severe local reaction to tuberculin products. A severe local reaction may include blistering and ulceration at the injection site and skin necrosis at the centre widespread tuberculin reaction. The necrosis will generally disappear after a few days. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before being tested with Tuberculin PPD RT23 AJV. Inform your doctor: if you have had a tuberculin skin test within the last year. if you have been vaccinated within the last 4–6 weeks against tuberculosis or any other disease. OTHER MEDICINES AND TUBERCULIN PPD RT23 AJV Tell your doctor or pharmaci Leggi il documento completo
Health Products Regulatory Authority 10 January 2022 CRN00CPK8 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tuberculin PPD RT23 AJV 2 T.U./0.1 mL, solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tuberculin PPD RT 23. One single dose of 2 T.U./0.1 mL contains 0.04 micrograms of Tuberculin PPD RT 23. Excipients with known effect Disodium phosphate dehydrate 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. Clear, colourless to pale-yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tuberculin PPD RT23 AJV 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 AJV 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 0.1 mL. Tuberculin PPD RT23 AJV is injected intradermally. Method of administration In the following a detailed description of administration of Tuberculin PPD RT23 AJV 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. The tip of the needle is inserted into the superficial layer of the dermis. The needle should be visible through the epidermis during insertion. The 0.1 mL is slowly injected and a small, blanched papule of 8–10 mm in diameter Leggi il documento completo