Package Insert
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BoviTuberculin 30 000 inj. A. u. v.
Intravitally diagnostic preparation for simple or simultaneous tuberculinisation of cattle sheep, goats horses and
another animal species
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of preparation contains:
Tuberculinum Mycobacterii bovis
min. 30 000 I. U.
3. INDICATIONS
Intravitally diagnostic of tuberculosis.
4. TARGET SPECIES
Cattle, sheep, goats, horses, dogs
5.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
0,1 ml strictly intradermally
Cattle
The place of inoculation is area of neck into the front border of scapula abreast prescapularis
ganglion. The skin must to be free of chronic changes equally strong with possibility to create
cutaneous fold. The place of tuberculin application - area 2 x 2 cm should be totally shear
and clean. Thickness of cutaneous fold in the application area is measured by cutimetre and
recorded. Dose of 0,1 ml of preparation is determined strictly intradermally.
It is necessary to detect correct intradermally application – find out the creation of carbuncle
in the application place. If the tuberculin was not applied correct intradermally, it is possible
to repeat the application in the same place in the prescribed dose. If the skin was damaged
during shear or if the changes are observed before application of
tuberculin , it is necessary to inoculated tuberculin in the other place on the same side of neck
and primal place is cancelled by shearing of hair.
Reading results
The reaction is regarded 72 hours after inoculation of tuberculin by adspection, skin palpation
an by measuring of skin fold by cutimetre. Animals which have no changes in the place of
inoculation are regarded as negative. In the case of there is determined skin blowing in the
application place , the reaction number is defined for a consideration of difference of
thickness of skin before and after inoculation .
Evaluation
a)
Negative reaction – if the bounded blowing with coarsening of skin fold maximally
2 mm, and no clinical signs such as diffuse or extensive swell, exudation, necrosis,
painfulness or inflammatory reaction of corresponding ganglions are determined
b)
Dubious reaction – if no clinical signs listed in the point a) are determined but
coarsening of skin fold exceed 2mm but is lower than 4 mm .
c)
Positive reaction – if the clinical signs listed in the point a) are observed or if the
coarsening of skin fold in the application place exceeds 4 mm.
Sheep
Tuberculinisation is performed on the dorsal side of auricula after its shear.
Reading results
The reaction is regarded 48 - 72 hours after tuberculinisation . If in the place of application
the inflammatory changes such as blowing, slice, painfulness and increase of skin temperature
are observed, the reaction is positive.
Goats
Tuberculinisation is performed on the neck alike in the cattle.
Reading results
The reaction is regarded 48 - 72 hours after inoculation. If in the place of application the
inflammatory changes such as blowing, slice, painfulness and increase of skin temperature are
observed, the reaction is positive.
Pigs
Tuberculinisation is performed on the dorsal side of auricular. The place of application is the
skin flexion on the transition from head to dorsal part of ear, eventually 2-3 cm from base of
auricula.
Reading results
The reaction is regarded 48 hours after tuberculinisation .If in the application place the
characteristic inflammatory blowing following with erythema or central necrosis the reaction
is positive. In pigmented pigs it is necessary to regard inflammatory swell of skin with
possible necrosis as mainly symptom.
In the rearing free of tuberculosis the swell with diameter up to 20 mm is regarded as positive
reaction and swell with diameter 10-20 mm is regarded as dubious result.
In rearing, where the tuberculosis was acknowledged, the size of inflammatory changes up to
10 mm is regarded as positive result and inflammatory changes to 10 mm are regarded as
dubious reaction.
Horses
The tuberculin is intradermally applied in to the area of neck.
Reading results
The reaction is regarded 72 hours after application of tuberculin.
The diagnostic importance is attributed only to negative result – in the place of inoculation no
inflammatory reaction occurs.
Dogs
Tuberculin is inoculated on the dorsal side of auricula after it’s shearing.
Reading results
The reaction is regarded 24 - 48 hours after inoculation. The diagnostic importance is
attributed only to negative result – in the place of inoculation no inflammatory reaction
occurs.
6. EXPIRY DATE
12 months