Country: Ireland
Language: English
Source: HMA (Heads of Medicines Agencies)
mycobacterium avium purified 25000 IU
CZ VETERINARIA
QI02AR02
Solution for injection
Avian tuberculin PPD
Cattle Food
2012-10-02
PACKAGE LEAFLET CZV AVIAN TUBERCULIN PPD – CLEAR PINKISH-RED SOLUTION FOR INJECTION- BOVINE 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT CZ Veterinaria, S.A. Aptdo. 16 Porriño (Pontevedra) E36400 SPAIN 2. NAME OF THE VETERINARY MEDICINAL PRODUCT CZV Avian tuberculin PPD 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Purified protein derivative of _Mycobacterium avium,_ strain D4 ER ................................................... 25,000 IU/ ml Contains phenol and Ponceau Red (E124) 4. INDICATION(S) 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. 5. CONTRAINDICATIONS Not applicable 6. ADVERSE REACTIONS Not described. 7. TARGET SPECIES Bovine 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Dose 0.1 mL Shake well before use Administration Injection site shall be clipped and cleansed. A fold of skin within clipped area shall be taken between the forefinger and thumb and measured with callipers and recorded. The dose of CZV Avian tuberculin PPD shall then be injected by the intradermal route into the deeper layers of the skin, in a defined area between the first and second third of the neck. A correct injection shall be confirmed by palpating a small pea-like swelling at each si Read the complete document
_[Version 7.3.2, 10/2011] _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 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 a 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 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. 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. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS The results obtained with this test should be interpreted by taking into account others result obtai Read the complete document