Tuberculin PPD Kit

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Avian tuberculin PPD; Bovine tuberculin PPD

Boleh didapati daripada:

Prionics Lelystad - B.V.,

Kod ATC:

QI02AR01; QI02AR02

INN (Nama Antarabangsa):

Avian tuberculin PPD; Bovine tuberculin PPD

Dos:

.

Borang farmaseutikal:

Solution for injection

Jenis preskripsi:

POM: Prescription Only Medicine as defined in relevant national legislation

Kumpulan terapeutik:

Cattle

Kawasan terapeutik:

bovine tuberculin PPD; avian tuberculin PPD

Tanda-tanda terapeutik:

Immunological

Status kebenaran:

Authorised

Tarikh kebenaran:

2010-11-26

Ciri produk

Health Products Regulatory Authority
31 May 2019
CRN008T25
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
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.
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 tuberculosisand 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.
Health Products Regulatory Authority
31 May 2019
CRN008T25
Page 2 of 6
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
For a reliable result of the Single Intradermal Comparative Cervical
Tuberculin (SICCT) test the use of t