CZV Avian Tuberculin PPD

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: VMD (Veterinary Medicines Directorate)

Ingredjent attiv:

Mycobacterium avium subsp. avium

Disponibbli minn:

CZ Veterinaria S.A.

Kodiċi ATC:

QI02AR02

INN (Isem Internazzjonali):

Mycobacterium avium subsp. avium

Għamla farmaċewtika:

Solution for injection

Tip ta 'preskrizzjoni:

POM-V - Prescription Only Medicine – Veterinarian

Grupp terapewtiku:

Cattle

Żona terapewtika:

Diagnostic Preparation

L-istatus ta 'awtorizzazzjoni:

Authorized

Data ta 'l-awtorizzazzjoni:

2007-07-24

Karatteristiċi tal-prodott

Revised: August 2023
AN: 00753/2023 & 00758/2023
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
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 a 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.
Revised: August 2023
AN: 00753/2023 & 00758/2023
Page 2 of 6
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 infect