Description
Avituberculin
Solution for injection for cattle
Statement of the active substance(s) and other ingredient(s)
Each ml contains:
Active substance:
Avian tuberculin, purified protein derivative from Mycobacterium avium strain D4ER, 25 000 IU
Excipient: phenol 5 mg
Clear, colourless or straw-yellow solution
Target species
Cattle
Indications for use
Product intended for use in comparative tuberculin tests for detecting bovine tuberculosis.
Contraindications
None
Special warnings
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, wash 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 delivery.
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 2500 IU of tuberculin.
Advice on correct administration
Tuberculin test procedure
When administering comparative tuberculin test, the injection site for avian tuberculin should be situated approximately 10 cm from the neck crest, and the injection site for bovine tuberculin is approximately 12.5 cm below. In young animals in which there is no room to separate the sites sufficiently on one side of the neck, one injection must be made on each side of the neck at identical sites in the centre of the middle third 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.
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 period(s)
Meat and offal – zero days.
Milk – zero days.
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
2627/17
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