Product for the diagnosis of tuberculosis in cattle
Solution for injection for cattle

The content of the active substance and other substances
1 ml contains:

The active substance:
Bovine tuberculin, purified protein derivatives from cultures of Mycobacterium bovis AN5 32 500 IU

Excipient:
Phenol 5 mg

Therapeutic indications
The product is used to diagnose tuberculosis in cattle over 6 weeks of age infected with Mycobacterium bovis.

Contraindications
Lack

Side effects
Not found.

About the occurrence of side effects after administering this product or observing any disturbing symptoms not listed in the leaflet (including symptoms in humans as a result of contact with the drug), please notify the competent veterinarian, the responsible entity or the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. . The application form should be downloaded from the website https://www.urpl.gov.pl (Department of Veterinary Medicinal Products).

Target animal species
Cattle

Dosage for each species, route and method of administration
The product is administered intradermally in a dose of 0.1 ml, corresponding to 3250 IU of tuberculin.

Recommendations for correct administration

The technique of tuberculinization
In the case of single tuberculinization, the application site should be on the border of the front and middle 1/3 of the neck, approximately 10 cm from the upper edge of the animal’s neck.
When performing comparative tuberculinization, the site of injection of avian tuberculin should be approximately 10 cm from the top of the animal’s neck, and the site of injection of bovine tuberculin approximately 12.5 cm lower. In young animals, when there is insufficient space on one side of the neck, each injection should be given separately in the middle 1/3 of the neck, symmetrically on both sides of the neck.
The skin within 5 cm of the intended injection site should be free from any lesions. Before administering the product, mark the injection site by trimming the hair in the form of a cross with scissors, 2-3 cm long. Then the skin fold in the cut area should be placed between the index finger and thumb and measured with a caliper with an accuracy of 0.1 mm. The dose of tuberculin should be injected in such a way as to ensure that the tuberculin is deposited intradermally. The needle should be inserted obliquely and intradermally with the shear plane facing outwards from the skin surface. Correctly performed injection is confirmed by palpating a small, spherical nodule at the injection site.
Tuberculinization results should be read 72 (± 4) hours after injection of the product. The injection site should be inspected and the skin fold should be re-measured.

Interpretation of the results
Interpretation of the response to tuberculin administration in cattle should be based on clinical observations and identified differences in skin fold thickness at the injection site.

Single tuberculinization – single intradermal injection of bovine tuberculin and reading the result:

positive (+) reaction: if there are clinical changes such as diffuse or excessive swelling, exudation, necrosis, pain or inflammation in the lymphatic vessels or lymph nodes in this area, or if the skin fold thickness at the injection site is 4.0 mm or more;
doubtful reaction (+/-): if the clinical symptoms mentioned in point a), and if the increase in skin fold thickness is more than 2.0 mm but less than 4.0 mm;
negative reaction (-): if only limited hard swelling is observed with an increase in the thickness of the skin fold of no more than 2.0 mm without clinical symptoms.
Comparative tuberculinization – a single intradermal injection of bovine tuberculin and a single intradermal injection of avian tuberculin at the same time and reading the result:

positive (+): positive bovine tuberculin test greater than 4.0 mm greater than avian tuberculin test or the presence of clinical signs;
questionable result (+/-): positive or doubtful bovine tuberculin test, 1.0 to 4.0 mm greater than avian tuberculin test, no clinical signs;
negative (-): bovine tuberculin reaction negative or positive, or bovine tuberculin test less than or equal to avian tuberculin reaction and no clinical signs.
The official method of assessing the results of tuberculinization and handling the animals is regulated by the instructions of the Chief Veterinary Officer.

Grace period
Edible tissues – zero days.
Milk – zero hours.

Special precautions for storage
Keep out of the sight and reach of children.
Store in a refrigerator (2 ° C – 8 ° C). Protect from light. Do not freeze.
Shelf life after first opening the immediate packaging: 24 hours.
Do not use this veterinary medicinal product after the expiry date stated on the label.

Special warnings

Special warnings for each target species:
Do not use the product in animals under 6 weeks of age.
It is not recommended to perform re-tuberculinization within 42 days from the last administration of the product.
Do not use in the period from 2 weeks before delivery to 2 weeks after delivery.
Do not use during treatment with glucocorticosteroids.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Contact of the product with the skin and mucous membranes should be avoided. In the event of accidental spillage, contaminated areas should be thoroughly washed with clean water. In the event of accidental injection of the product, seek medical advice and show the package leaflet or the package to the physician.

Pregnancy and lactation:
There was no negative effect of the product on the course of pregnancy and lactation.
Due to the greater risk of false-negative results, tuberculinization should not be performed in the period from 2 weeks before delivery to 2 weeks after delivery.

Interaction with other medicinal products and other forms of interaction:
Concomitant use of glucocorticoids or other immunosuppressive substances may reduce the tuberculin response and lead to false negative results.

Overdose (symptoms, emergency procedures, antidotes):
The only consequence of repeated administration of the product is that the reactivity of the animals to subsequent doses of tuberculin decreases. It does not pose any threat to the health or life of the animals.

Pharmaceutical Incompatibilities:
As no compatibility studies have been performed, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Special precautions for the disposal of unused veterinary medicinal products or waste materials
Medicines should not be disposed of via wastewater or with household waste.
Ask your veterinarian about how to remove useless drugs. They will allow for better protection of the environment.

Other informations
For information about this veterinary medicinal product, please contact the Marketing Authorization Holder.

Available packages:
Cardboard box with 5 vials of 25 doses.

Period of validity: 2 years

For animals only
To be supplied on a prescription – Rp
To be administered under the supervision of a veterinarian.