AVITUBAL 28 000 solution for injection

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Pharmaceutical form

Injection.

Composition

Avian tuberculin – 28 000 IU

Active substance:        Proteinum tuberculini Mycobacterii avium (strain D 4 ER) – 28 000 IU

Excipients:                    Phenolum

           Solutio stabilisata purificata

Indication

For simple tuberculization of poultry and pigs and for comparative tuberculization of cattle.

Target animals

Poultry, cattle, pigs.

Dosage and application

Apply 0.1 ml dose intradermally.

Poultry tuberculization:

Apply 0.1 ml dose intradermally to the auricle, preferably to its lower edge, while the second auricle is used as a control. Use only thin needles without a lateral orifice. A lentil-shaped swelling appears at the site of puncture after a properly performed inoculation.

Evaluation: Evaluate the reaction 48 hours after the application. Inflammatory auricle swelling (an apparent difference in comparison with the control auricle) means a positive.

Cattle tuberculization:

In the case of comparable intradermal tuberculization bovine tuberculin and avian tuberculin are applied simultaneously. The test is carried out not earlier than 42 days after the evaluation of the results obtained from the simple tuberculinization. It is intended for verification of preceding results obtained with the simple tuberculinization. 0.1 ml of tuberculins are applied intradermally. The site for injection of avian tuberculins shall be about 10 cm from the crest of the neck and the site for the injection of bovine tuberculin about 12.5 cm lower on a line roughly parallel with the line of the shoulder or on different sides of the neck; in young animals in which there is not room to separate the sites sufficiently on one side of the neck, one injection shall be made on each side of the neck at identical sites in the centre of the middle third of the neck.

The technique of tuberculin testing and interpretation of reactions:

Injection sites shall be clipped and cleansed. A fold of skin within each clipped area shall be taken between the forefinger and thumb and measured with callipers and recorded. A short sterile needle, bevel edge outwards, with graduated syringe charged with tuberculin, inserted obliquely into the deeper layers of the skin may be used. A correct injection shall be confirmed by palpating a small pea-like swelling at each site of injection.

Evaluation: Comparable tuberculinization shall be evaluated 72 (± 4) hours after the tuberculin application. Both tuberculins are evaluated according to the special table used for simple tuberculinization with bovine tuberculin.

The interpretation of the tuberculinization results in the case of Mycobact. bovis infection:

Positive: Reaction number to bovine tuberculin exceeds the reaction to avian tuberculin by more than 4 mm; or, clinical symptoms, such as diffuse or extensive oedema, exudation, necrosis, soreness or inflammatory reaction of relevant lymphatics or lymph-nodes, are discovered in the application place of bovine tuberculin.

Dubious: Positive or dubious reactions to the bovine tuberculin, reaction number is from 1 to 4 mm greater than the reaction to avian tuberculin, no clinical symptoms are discovered.

Negative: Positive, dubious or negative reactions to bovine tuberculin, but reaction number is the same or lower than for avian tuberculin, no clinical symptoms are discovered in either case.

A further allergic examination should be carried out a minimum of 42 days after the first examination in those animals showing dubious results after comparable tuberculinization. Animals for which the results of the second tuberculinization are not negative are considered to react positively to bovine tuberculin.

Control (diagnostic) slaughter and the laboratory examination of the relevant organs and lymph-nodes or further examination should be carried out in disputable cases.

Pigs tuberculization:

Intradermal tuberculization is carried out on the dorsal side of the auricle, at the point where the head turns into the auricle, namely, approx. 2 - 3 cm from the auricle base.

Evaluation: Evaluation is carried out 48 hours after application. Characteristic inflammatory swelling often accompanied by erythema and sometimes even with central necrosis in the site of puncture is apparent when the reaction is positive. Skin swelling accompanied by necrosis in some cases shall be considered as the main symptom of the inflammatory reaction in pigmented pigs. In breedings free of tuberculosis, swellings of a diameter exceeding 20 mm mean a positive reaction whereas with swellings of a diameter of 10 - 20 mm the reaction is dubious. In those breedings where tuberculosis has been diagnosed, inflammatory changes in diameter exceeding 10 mm are considered as positive reactions and changes up to 10 mm in diameter to be dubious.

Storage

Store in a refrigerator (2 °C – 8 °C).

Store in a dry place.

Protect from light.

Withdrawal period

Zero days.

Shelf life

2 years.

Shelf life after the first opening – 10 hours.

Package

Cardboard box: 1×5 ml, 5×5 ml, 10×5 ml, 1×10 ml, 1×20 ml, 5×20 ml, 10×20 ml.

Plastic box: 2×1 ml, 5×1 ml, 10×1 ml, 2×2 ml, 5×2 ml, 10×2 ml, 20 ×2 ml, 5×10 ml, 10×10ml.

Not all pack sizes may be marketed.