1- NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Bioveta, a. s., Komenského 212, 683 23 Ivanovice na Hané, Czech Republic
2. NAME OF THE VETERINARY MEDICINAL PRODUCT
BioBos IBR marker inact., suspension for injection for cattle
3-STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One vaccination dose (2 ml)contains :Active ingrediets:
Bovine herpesvirus type 1 (BHV-1) inactivated, strain Bio-27: IBR gE-RP ≥1*
*) RP = Relative efficacy (ELISA test) compared with the reference serum obtained after vaccination of the guinea pigs by the vaccine batch thathas passed the challenge test in the target species of animals.
Adjuvant: Aluminium hydroxide, hydrated, for adsorption 6 mgQuillaja saponaria 0.4 mg
Excipiens: Thiomersal 0,17–0,23 mg
4. INDICATION
For active immunization of cattle to reduce intensity and term of the clinical symptoms caused by infection by the BHV-1 (IBR) virus and to reduce excretion of the field virus.
Onset of immunity: 3 weeks after the basic vaccination. Duration of immunity: 6 months after the basic vaccinations.
5. CONTRAINDICATIONS
None.
6. ADVERSE REACTIONS
Hypersensitive reactions may occur in connection with the performed vaccination. In such cases the adequate symptomatic therapy has to be applied. Vaccine contains adjuvant which can cause temporary local swelling of the size up to 2 cm in diameter. This swelling disappears within 4 days after vaccination.
If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
7. TARGET SPECIES
Cattle

8- DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Intramuscular injection, 2 ml per animal. The cattle can be vaccinated from the age of 3 months.
Basic vaccination:
Two applications in the 3-week interval.
Revaccination:
One application every 6 months.
9. ADVICE ON CORRECT ADMINISTRATION
Before use, the vaccine should be heated to a temperature of 15-25 ° C and the contents of bottle should be shaken.
10. WITHDRAWAL PERIOD
Zero days.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of reach of children.

Store in refrigerator (2C–8C). Protect from frost!

Do not use this veterinary medicinal product after the expiry date which is stated on the label.Shelf life after first opening the container: 10 hours.

12- SPECIAL WARNING(S)
Special warnings for each target species:
Vaccinate only healthy animals.
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.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Can be used during pregnancy and lactation.
Efficacy has not been demonstrated in the presence of maternal antibodies.
13- SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
15. OTHER INFORMATION
Package size:
Plastic boxes: 10 x 5 doses (10 x 10 ml)
Cardboard boxes: 1 x 5 doses (1 x 10 ml), 1 x 25 dávek (1 x 50 ml), 1 x 50 dávek (1 x 100 ml)Not all pack sizes maybe marketed.
Veterinary medicinal product subject to prescription.