CZV BOVINE TUBERCULIN PPD, SOLUTION FOR INJECTION

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PURIFIED PROTEIN DERIVATIVE FROM CULTURE OF MYCOBACTERIUM BOVIS, STRAIN AN-5

Available from:

CZ Veterinaria, S.A.

ATC code:

QI02AR01

INN (International Name):

PURIFIED PROTEIN DERIVATIVE FROM CULTURE OF MYCOBACTERIUM BOVIS, STRAIN AN-5

Dosage:

25000 IU/ML

Pharmaceutical form:

Solution for Injection

Prescription type:

VPO-Vet.Practitioner Only

Therapeutic group:

Bovine

Therapeutic area:

Bovine tuberculin PPD

Therapeutic indications:

Immunological

Authorization status:

Authorised

Authorization date:

2011-10-28

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
CZV BOVINE TUBERCULIN PPD, solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose of 0.1 ml contains:
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 the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Transparent colourless or yellowish solution.
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 23/11/2016_
_CRN 7023107_
_page number: 1_
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