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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
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