מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Purified protein derivative from culture of Mycobacterium avium, subsp. avium strain D4 ER
CZ Vaccines S.A.U.
QI02AR02
Purified protein derivative from culture of Mycobacterium avium, subsp. avium strain D4 ER
25000 international unit(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle
avian tuberculin PPD
Immunological
Authorised
2007-07-06
1. NAME OF THE VETERINARY MEDICINAL PRODUCT CZV Avian Tuberculin PPD 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per ml: ACTIVE SUBSTANCE: Purified protein derivative from culture of _Mycobacterium avium_ , subsp. a _vium _ strain D4 ER ………… 25 000 IU EXCIPIENTS: Phenol………………………………………………………….………5 mg Ponceau red (E124)…………………………………………………….0.05 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Clear pinkish-red solution for injection 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Bovine 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES SINGLE INTRADERMAL TEST For use in bovine animals from 6 weeks of age or older where, as a consequence of exposure to slow growing mycobacteria in the environment, cross sensitisation to bovine tuberculin is suspected. INTRADERMAL COMPARATIVE TEST When used together with CZV Bovine Tuberculin PPD, _in vivo _ diagnosis of cattle from 6 weeks of age that have generated an immune response against _M. bovis_ , differentiating animals reacting to _M._ _bovis _ from those that have become sensitised to bovine tuberculin as a result of exposure to other mycobacteria or related genera (single intradermal comparative tuberculin test). 4.3 CONTRAINDICATIONS Not applicable. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Although field experience suggests that there may be no adverse effect when the product is used in cattle sensitised to _M. avium subsp. avium_ , safety in such animals has not been specifically tested and established, therefore careful monitoring should be done. It is not recommended to repeat the test until at least 42 days have passed since the previous test in order to avoid false negatives due to a loss of skin responsiveness during a period of post-test desensitization. When used in chronically infected animals with severe pathology, the tuberculin test may be unresponsive. Newly infected animals may not react to the tuberculin test until the cell medi קרא את המסמך השלם