Country: Netherlands
Language: English
Source: HMA (Heads of Medicines Agencies)
tuberculin 0 IU
Prionics Lelystad B.V
QI02AR01
Solution for injection
Avian tuberculin PPD
Cattle
2012-01-24
Revised: November 2012 AN: 00636/2012 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE IMMUNOLOGICAL VETERINARY MEDICINAL PROCUCT Tuberculin PPD Kit 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Bovine Tuberculin PPD 3000: Per 0.1 ml (1 dose): ACTIVE SUBSTANCE: Bovine Tuberculin purified protein derivative from culture of _Mycobacterium _ _bovis_, strain AN5 3000 IU* OTHER EXCIPIENTS: Phenol: 0.4 – 0.5 mg For a full list of excipients, see section 6.1 Avian Tuberculin PPD 2500: Per 0.1 ml (1 dose): ACTIVE SUBSTANCE: Avian Tuberculin purified protein derivative from culture of _Mycobacterium _ _avium_ subspecies _avium_, strain D4ER 2500 IU* OTHER EXCIPIENTS: Phenol: 0.4 – 0.5 mg Ponceau 4R (E 124): 5 microgram For a full list of excipients, see section 6.1 (*IU: International Units according to Ph. Eur.) 3. PHARMACEUTICAL FORM Solution for injection 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. Revised: November 2012 AN: 00636/2012 Page 2 of 8 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES To be used for the _in-vivo_ identification of cattle which have been exposed to _Mycobacterium _ species causing bovine tuberculosis. Simultaneous administration of Bovine Tuberculin PPD 3000 and Avian Tuberculin PPD 2500 and comparing the degree of skin swelling of the two injection sites enables differentiation between the specific reaction in target species exposed to _Mycobacterium _species causing bovine tuberculosis_ _and the non-specific reaction in target species, which have been e Read the complete document