Tuberculin PPD Kit

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Avian Tuberculin PPD, Bovine Tuberculin PPD

Available from:

Prionics Lelystad B.V.

ATC code:

(s)Bovin

INN (International Name):

Avian Tuberculin PPD, Bovine Tuberculin PPD

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle

Therapeutic area:

Diagnostic Preparation

Authorization status:

Authorized

Authorization date:

2010-11-24

Summary of Product characteristics

Revised: April 2019
AN: 01367/2018
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 the 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 the full list of excipients, see Section 6.1
(*IU: International Units according to Ph. Eur.)
3.
PHARMACEUTICAL FORM
Solution for injection.
Bovine Tuberculin PPD 3000 is a clear, colourless to light yellow
aqueous solution
with a pH between 6.5 and 7.5. Avian Tuberculin PPD 2500 is a clear,
red
aqueous solution with a pH between 6.5 and 7.5.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle.
Revised: April 2019
AN: 01367/2018
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 exposed to other species of Mycobacteria or related genera,
causing
cross sensitisation to Bovine Tuberculin PPD 3000.
4.3
CONTRA-INDICATIONS
None.
4.4
SPECIAL WARNINGS
For a reliable result of the Single Intradermal Comparative Cervical
Tuberculin
(SICCT) test the use of the Tuberculin PPD Kit in cattle should be
avoided