Description
Bovituberculin, solution for injection for cattle
Statement of the active substance(s) and other ingredient(s)
Each ml contains:
Active substance: Bovine tuberculin, purified protein derivative from Mycobacterium bovis strain AN5 32 500 IU
Excipient: phenol 5mg
Clear, colourless or straw-yellow solution
Target species
Cattle
Indications for use
Product intended for use in detecting bovine tuberculosis in cattle older than 6 weeks of age infected with Mycobacterium bovis.
Contraindications
None
Special warnings
Do not use the veterinary medicinal product in animals less than 6 weeks of age.
Do not repeat the tuberculin test earlier than after 42 days of the last administration of the product.
Do not use the product within 2 weeks before and 2 weeks after parturition.
Do not use the product simultaneously with glucocorticoids.
Special precautions for safe use in the target species:
None.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Avoid contact with skin and mucous membranes. In case of accidental spillage, flush the contaminated areas thoroughly with clean water. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Pregnancy and lactation:
No adverse effect on pregnancy and lactation was identified.
Due to a higher risk of false negative results, tuberculin testing should not be performed in the period within 2 weeks before and 2 weeks after parturition.
Interaction with other medicinal products and other forms of interaction:
Using the product simultaneously with glucocorticoids or other immunosuppressants may reduce the reaction to tuberculin and produce false negative results.
Overdose:
The only effect of multiple administrations of the product is decreased animal susceptibility to subsequent tuberculin doses. This poses no threat to animal health or life.
Major incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Adverse events
None reported.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. If you notice any side effects, even those not already listed in this package leaflet, or you think that the medicine has not worked, please contact, in the first instance, your veterinarian. You can also report any adverse events to the marketing authorization holder using the contact details found at the end of this leaflet, or via your national reporting system: Department for Documentation Assessment and Pharmacovigilance of Veterinary Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, PL-02-222 Warsaw
Tel.: +48 22 49-21-687, Fax: +48 22 49-21-605
https://smz.ezdrowie.gov.pl
Dosage for each target species, route(s) and method(s) of administration
The product is injected intradermally in a dose of 0.1 ml, which corresponds to 3250 IU of tuberculin.
Advice on correct administration
Tuberculin test procedure
When administering a single tuberculin test, the injection site should be situated at the border of the anterior and middle thirds of one side of the neck, about 10 cm below the crest.
When administering the comparative (double) tuberculin test, avian and bovine tuberculin should be used simultaneously. The tuberculin injection should be made on both sides of the neck or alternatively, on one selected side of the animal’s neck. In case of performing the tuberculin test on one side of the neck, the injection site for the avian tuberculin should be situated at the border of the anterior and middle thirds of one side of the neck, about 10 cm below the crest, whereas the injection site for the bovine tuberculin should be situated about 12.5 to 15.0 cm below, on a line roughly parallel with the line of the shoulder. In young animals in which there is no room to separate the sites sufficiently on one side of the neck, each injection must be made separately on each side of the neck at identical sites in the centre of the middle half of the neck.
No pathological lesions should be present on the skin within 5 cm from the planned injection site. Before administering the product, the injection site should be marked by clipping the hair in the form of a cross with arms 2-3 cm long. Next, the fold of skin within each clipped area should be taken between the forefinger and thumb, its thickness measured with callipers graduated in millimetres. A dose of tuberculin should be injected intradermally. A needle, bevel edge outwards, should be inserted obliquely into the deeper layers of the skin. A correct injection is confirmed by palpating a small pea-like swelling at the site of the injection.
Tuberculin reactions should be interpreted 72 (± 4) hours after injection of the product. The site of the injection should be inspected and skin-fold thickness re-measured.
Interpretation
Interpretation of reactions to administration of tuberculin in cattle should be based on clinical observations and differences found in skin-fold thickness at the injection site.
Single tuberculin test – single intradermal injection of bovine tuberculin and interpretation of the reaction:
a). positive reaction (+): if clinical lesions, such as diffuse or extensive oedema, exudation, necrosis, pain or inflammation of lymphatic ducts or lymph nodes in that area are observed or if the increase in skin fold thickness at the injection site is 4.0 mm or greater;
b). inconclusive reaction (+/-): if no clinical signs listed in item a) are observed, and if the increase in skin fold thickness is greater than 2.0 mm but less than 4.0 mm;
c). negative reaction (-): if only limited callous oedema is observed with the increase in skin fold thickness not greater than 2.0 mm, without clinical signs.
Comparative tuberculin test – a single intradermal injection of bovine tuberculin simultaneously with a single intradermal injection of avian tuberculin, and interpretation of the reaction:
a). positive reaction (+): a positive reaction to bovine tuberculin which means that the increase in skin thickness is more than 4 mm greater than the reaction to avian tuberculin, or the presence of clinical signs;
b). inconclusive reaction (+/-): a positive or inconclusive reaction to bovine tuberculin which means that the increase in skin thickness is 1 mm to 4 mm greater than the reaction to avian tuberculin, with absence of clinical signs;
c). negative reaction (-): a negative reaction to bovine tuberculin, or positive or inconclusive reaction to bovine tuberculin which means that the increase in skin thickness 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 handling of animals is regulated by the instructions of the Chief Veterinary Officer.
Withdrawal periods
Meat and offal – zero days.
Milk – zero hours.
Special storage precautions
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 package: 24 hours.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Special precautions for disposal
Medicines should not be disposed of via wastewater or household waste.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any applicable national collection systems. These measures should help to protect the environment.
Ask your veterinary surgeon how to dispose of medicines no longer required.
Classification of veterinary medicinal products
Veterinary medicinal product subject to prescription
Marketing authorisation numbers and pack sizes
2628/17
Pack sizes
1 x 25 doses
5 x 25 doses
Date on which the package leaflet was last revised
09/12/2024
Detailed information on this veterinary medicinal product is available in the Union Product Database (https://medicines.health.europa.eu/veterinary).
Contact details
Marketing authorisation holder and manufacturer responsible for batch release:
Biowet Puławy Sp. z o.o.
Henryka Arciucha 2
24-100 Puławy
Poland
Tel./Fax: + 48 (81) 886 33 53, Tel.: + 48 (81) 888 91 00
e-mail: sekretariat@biowet.pl
Contact details to report suspected adverse events:
Biowet Puławy Sp. z o.o.
Henryka Arciucha 2
24-100 Puławy
Poland
Tel: + 48 (81) 888 91 33, + 48 509 750 444
e-mail: biowet@biowet.pl
SPC 2024-12-09
2025-03-21