Bovituberculin

Solution for injection for cattle

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Description

Bovituberculin
Solution for injection for cattle

Statement of the active substance(s) and other ingredient(s)
1 ml contains:

Active substance:
Bovine tuberculin, purified protein derivative from culture of Mycobacterium bovis, strain AN32 500 IU

Excipient: phenol 5 mg

Indications
To be used for identification of tuberculosis in cattle over 6 weeks old, infected with Mycobacterium bovis.

Contraindications
None

Adverse reactions
None declared.
The occurrence of adverse reactions after the administration of this product, or any observed worrying symptoms not mentioned in the leaflet (including human reactions due to contact with the medicine), must be reported to the competent veterinarian, the holder of the authorisation or the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. A notification form is to be downloaded at https://www.urpl.gov.pl (Veterinary Medicinal Products Division).

Target species
Cattle

Dosage for each species, route(s) and method of administration
The product is administered intradermally, at a dose of 0.1 ml, which is equivalent to 3250 IU of tuberculin.

Advice on correct administration
Tuberculin test technique
The injection sites for a single tuberculin test should be situated at the border of the anterior and middle thirds of either side of the neck, approximately four inches (10 cm) below the neck crest.
In the case of comparative tuberculin test, the injection site for avian tuberculin should be situated approximately four inches (10 cm) from the neck crest, and the injection site for bovine tuberculin is approximately five inches (12.5 cm) below. In young animals where there is insufficient space on the same side of the neck, the injections should be made separately on each side of the neck, at corresponding sites in the centre of the middle third of the neck.
There should be no pathological lesions on the skin within two inches (5 cm) from the planned injection site. Before administration of the product, the injection site should be marked by clipping the hair away with scissors to form a cross with arms 0.8-1.2 inches (2-3 cm) long. Then, a fold of skin at each of the intended injection sites and within the clipped area must be taken between the forefinger and thumb and accurately measured to the 0.1 mm using callipers The dose of tuberculin shall then be injected by a method that ensures that the tuberculin is delivered intradermically. The needle should be inserted obliquely into the deeper layers of the skin, bevel edge outwards. A correct injection shall be confirmed by palpating a small, pea-like nodule at each site of injection.

The interpretation of reactions should be performed after 72 (± 4) hours from injection of the product. The injection site should be examined, and the skin-fold thickness should be re-measured.

Interpreting the results
The interpretation of reactions to tuberculin in cattle should be based on clinical observations and the recorded increase in skin-fold thickness at the sites of injection.

Single tuberculin test: a single intradermal injection of bovine tuberculin and interpretation of the result:

a) positive reaction (+): if clinical signs are observed, such as diffuse or extensive oedema, exudation, necrosis, pain or inflammation of the lymphatic ducts in that region or of the lymph nodes, or if the skin-fold thickness in the injection site is 0.16 inch (4.0 mm) or more;

b) inconclusive reaction (+/-): if no clinical signs such as mentioned in a) are observed and if the increase in skin-fold thickness is more than 0.8 inch (2 mm) and less than 0.16 inch (4 mm);

c) negative reaction (-): if only limited swelling is observed, with an increase of not more than 0.8 inch (2 mm) in the thickness of the fold of skin, without clinical signs.

Single intradermal comparative cervical tuberculin test: a simultaneous single intradermal injection of bovine tuberculin and single intradermal injection of avian tuberculin, followed by interpretation of the results:

a) positive reaction (+): a positive reaction to bovine tuberculin test which is more than 0.16 inch (4 mm) greater than the reaction to avian tuberculin test, or the presence of clinical signs;

b) inconclusive reaction (+/-): a positive or inconclusive reaction to bovine tuberculin test which is more than 0.04 inch (1 mm) to 0.16 inch (4 mm) greater than the reaction to avian tuberculin test, with absence of clinical signs;

c) negative reaction (-): a negative reaction to bovine tuberculin, or positive or inconclusive reaction to bovine tuberculin which is equal to or less than the reaction to avian tuberculin , and the absence of clinical signs.

The official interpretation of the results of tuberculin tests and management of animals are regulated by the instruction of the Chief Official Veterinarian.

Withdrawal period(s)
Edible tissues – zero days.
Milk – zero hours.

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

Special warnings
Special warnings for each target species
The product should not be used in animals under 6 weeks of age.
The use of the tuberculin test in cattle should be avoided within 42 days following a previous administration of tuberculin.
The product should not be used within 2 weeks before or after parturition.
The product should not be used concurrently with glucocorticosteroids.

Special precautions for persons administering the veterinary medicinal product to animals:
Contact with skin and mucosal membranes should be avoided. Following accidental spillage, the contaminated site should be washed thoroughly with clean water. After accidental self-injection, medical assistance should be sought immediately, and the package information leaflet or package should be presented to the doctor.

Pregnancy and lactation:
No adverse effect of the product on pregnancy and lactation was demonstrated.

Due to an increased risk of false negative results, the tuberculin test should not be performed within 2 weeks before or after parturition.

Interaction with other medicinal products and other forms of interactions:
Concurrent use of glucocorticosteroids or other substances with immunosuppressive potential may weaken the reaction to tuberculin, and lead to in false negative test results.

Overdose (symptoms, emergency procedures, antidotes):
 The only effect of multiple administrations of the product is reduced reactivity to subsequent doses of tuberculin in animals. This is not associated with any threat to the health or life of animals.

Incompatibilities:
Since no compatibility studies have been conducted on this veterinary medicinal product, it must not be combined with other veterinary medicinal products.

Special precautions for the disposal of unused product or waste materials
Medicines should not be disposed of via wastewater or with household waste.
Ask your veterinary surgeon how to dispose of unusable medicines. They will ensure better environmental protection.

Available containers: 1 x 25 doses, 5 x 25 doses.
Not all packaging sizes may be available on the market.

Shelf life  2 years 

For animals only.
Prescription drug – Rx
To be administered under a supervision of a veterinary specialist.

For any information about this veterinary medicinal product, please contact the marketing authorisation holder.

Marketing authorisation holder and manufacturer responsible for batch release:
Biowet Puławy Sp. z o.o.;  Arciucha str. 2, 24-100 Puławy, Poland
phone/fax: + 48 81 886 36 11; 81 888 91 55; email:export@biowet.pl

2017-02-27 SPC
Marketing authorisation 2628/17

2021-06-16