Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: HMA (Heads of Medicines Agencies)
mycobacterium bovis purified 25000 IU/ml
CZ VETERINARIA
QI02AR01
Solution for injection
Bovine tuberculin PPD
Cattle
2012-10-02
PACKAGE LEAFLET PACKAGE LEAFLET CZV BOVINE TUBERCULIN PPD Solution for injection 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. P.O. Box 16 36400 Porriño (Pontevedra) SPAIN 2. NAME OF THE VETERINARY MEDICINAL PRODUCT CZV BOVINE TUBERCULIN PPD Solution for injection Purified protein derivative from culture of _Mycobacterium bovis_, strain AN-5. 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) CZV Bovine Tuberculin PPD is a transparent colourless or yellowish solution containing per dose of 0.1 ml ACTIVE SUBSTANCE: Purified protein derivative from culture of _Mycobacterium bovis_, strain AN-5 ………… 2,500 IU* *IU: International units. EXCIPIENTS: Phenol (preservative) …………………………………………………………………… 0,5 mg 4. INDICATIONS _‘In vivo_ diagnosis of cattle from 6 weeks of age that have generated an immune response against _Mycobacterium bovis_, the causative agent of bovine tuberculosis (single intradermal tuberculin test). When used together with CZV Avian PPD Tuberculin, _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).’ 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS A transitory increase Perskaitykite visą dokumentą
_[Version 7.3.1, 11/2010] _ SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT CZV BOVINE TUBERCULIN PPD 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 0.1 ml ACTIVE SUBSTANCE: Purified protein derivative from culture of _Mycobacterium bovis_, strain AN-5 2,500 IU* *IU: International units. EXCIPIENTS: Phenol (preservative) 0.5 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Transparent colourless or yellowish solution for injection 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES _‘In vivo_ diagnosis of cattle from 6 weeks of age that have generated an immune response against _Mycobacterium bovis_, the causative agent of bovine tuberculosis (single intradermal tuberculin test). When used together with CZV Avian PPD Tuberculin, _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 None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES 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 desensitisation. _ _ When used in chronically infected animals with Perskaitykite visą dokumentą