Description
Bovitrichovac suspension for injection for cattle
Statement of the active substance(s) and other ingredient(s)
Each ml contains:
Inactivated Trichophyton verrucosum strain 43 with concentration of not less than 20%
Yellow to brown suspension with sediment at the bottom, homogeneous after shaking.
Target species
Cattle
Indications for use
Active immunisation of cattle to reduce mortality and clinical signs of ringworm caused by Trichophyton verrucosum.
Therapeutic use of the vaccine in animals with skin affected by cattle ringworm to accelerate the healing process.
Onset of immunity: 3 to 4 weeks after the second injection.
Duration of immunity after 2 injections: 9 to 12 months
Contraindications
None.
Special warnings
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Pregnancy and lactation:
The product can be used during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction:
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product, therefore a decision to use this vaccine before or after any other veterinary medicinal product needs to be made on a case-by-case basis.
Overdose:
No side effects other than listed in the adverse events section have been observed after administration of a double dose.
Major incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Adverse events
Cattle
| Frequency unknown (cannot be determined based on the available data): | Oedema1 |
1 Minor restricted oedema emerging at the vaccine injection site, resolving spontaneously within a few days.
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:
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
E-mail: pw@urpl.gov.pl
Website: https://smz.ezdrowie.gov.pl
Dosage for each target species, route(s) and method(s) of administration
Intramuscular use.
The vaccine should be administered twice with an interval of 10 to 14 days.
Administer intramuscularly in the gluteal region, according to the following dosage regimen:
| Preventively | from 1 week to 4 months of age | 5 ml |
| from 4 weeks to 8 months of age | 5 ml to 6 ml | |
| 8 months of age or older | 6 ml to 7 ml |
| Therapeutically | from 1 week to 4 months of age | 7.5 ml |
| from 4 weeks to 8 months of age | 7.5 ml to 9 ml | |
| 8 months of age or older | 9 ml to 10.5 ml |
Advice on correct administration
None.
Withdrawal period(s)
Zero days.
Special precautions for storage
Keep out of the sight and reach of children.
Store in a refrigerator (2°C – 8°C). Do not freeze.
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.
Shelf-life after first opening the immediate packaging: 14 days.
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 a veterinary prescription.
Marketing authorisation numbers and pack sizes
480/98
Pack sizes: 250 ml
Date on which the package leaflet was last revised
20/03/2025
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, Tel: +48 509 750 444
e-mail: biowet@biowet.pl
SPC: 2025-03-20
2025-07-17
