CZV BOVINE TUBERCULIN PPD, solution for injection

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Purified protein derivative from culture of mycobacterium bovis, strain an-5

Beszerezhető a:

CZ Vaccines S.A.U.

ATC-kód:

QI02AR01

INN (nemzetközi neve):

Purified protein derivative from culture of mycobacterium bovis, strain an-5

Adagolás:

2500 International Units/dose

Gyógyszerészeti forma:

Solution for injection

Recept típusa:

POM: Prescription Only Medicine as defined in relevant national legislation

Terápiás csoport:

Cattle

Terápiás terület:

bovine tuberculin PPD

Terápiás javallatok:

Immunological

Engedélyezési státusz:

Authorised

Engedély dátuma:

2011-10-28

Termékjellemzők

ANNEX I
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.
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 severe pathology, the
tuberculin test may be
unresponsive.
Newly infected animals may not react to the tuberculin test until the
cell mediated immune response
has developed (for most animals this is between 3–6 weeks
post-infection).
Post-partum immunosuppression may give rise to false negative results
in cattle that have recently
calved.
A lack of sen