CZV Avian Tuberculin PPD

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Purified protein derivative from culture of Mycobacterium avium, subsp. avium strain D4 ER

Boleh didapati daripada:

CZ Vaccines S.A.U.

Kod ATC:

QI02AR02

INN (Nama Antarabangsa):

Purified protein derivative from culture of Mycobacterium avium, subsp. avium strain D4 ER

Dos:

25000 international unit(s)/millilitre

Borang farmaseutikal:

Solution for injection

Jenis preskripsi:

POM: Prescription Only Medicine as defined in relevant national legislation

Kumpulan terapeutik:

Cattle

Kawasan terapeutik:

avian tuberculin PPD

Tanda-tanda terapeutik:

Immunological

Status kebenaran:

Authorised

Tarikh kebenaran:

2007-07-06

Ciri produk

1. NAME OF THE VETERINARY MEDICINAL PRODUCT
CZV Avian Tuberculin PPD
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Per ml:
ACTIVE SUBSTANCE:
Purified protein derivative from culture
of
_Mycobacterium avium_
, subsp. a
_vium _
strain D4 ER ………… 25 000 IU
EXCIPIENTS:
Phenol………………………………………………………….………5
mg
Ponceau red
(E124)…………………………………………………….0.05
mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Clear pinkish-red solution for injection
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Bovine
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
SINGLE INTRADERMAL TEST
For use in bovine animals from 6 weeks of age or older where, as a
consequence of exposure to slow
growing mycobacteria in the environment, cross sensitisation to bovine
tuberculin is suspected.
INTRADERMAL COMPARATIVE TEST
When used together with CZV Bovine Tuberculin PPD,
_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
Not applicable.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Although field experience suggests that there may be no adverse effect
when the product is used in
cattle sensitised to
_M. avium subsp. avium_
, safety in such animals has not been specifically tested and
established, therefore careful monitoring should be done.
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
desensitization.
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 medi