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 Respi 4, injection suspension  for cattle
 3-STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One vaccination dose (2 ml) contains:
Active substances:
Virus respiratoris syncytialis bovis inactivatum, strain BIO-24   RP1*Virus parainfluensis 3 bovis inactivatum, strain BIO-23     RP1*Virus diarrhoeae bovis inactivatum., strain BIO-25   RP1*
Mannheimia (Pasteurella) haemolyticainactivata, strain DSM 5283, serovar 1A   RP1*
*) Relative efficiency (RP) is given by the comparison of the antibody levels in serum prepared with thereference vaccine batch complying with the challenge test in target animals.
Adjuvants:
Hydrated aluminium hydroxide for absorption 2%  0.4 ml
Quillaja saponin (Quil A) 1%                                  0.04 ml
Excipients:
Thiomersal           0.01 %
Formaldehyde   35% solution                                    0.05 %
Pinkish liquid with sediment.
4. INDICATION
For active immunisation of cattle against:
 bovine parainfluenza 3 virus, do reduce infection,
 bovine respiratory syntytial virus, to reduce infection and clinical symptoms,
 bovine viral diarrhoea virus, do reduce infection,
 germs of Mannheimia (Pasteurella) haemolytica serotype A1, to reduce clinical symptoms and pulmonary lesions.
Onset of immunity:
Antibody response against BRS virus, PI 3 virus, BVD virus and Mannheimia haemolytica reaches the highest level in 3 weeks after full immunisation programme. Another revaccination is recommended as required within an interval of 6 months after performance of the basic immunisation.
Duration of immunity:
Immunity persists after revaccination for at least 6 months.

5. CONTRAINDICATIONS
Vaccinate only healthy animals.
Do not use in animals, that present with signs of the disease.
6. ADVERSE REACTIONS
In relation to the performed vaccination, it is possible to observe development of local swelling, which relates to the content of adjuvant substances in the vaccine. This swelling, which could reach up to 6 cm, usually subsides within 2 – 3 weeks after vaccination.
In some cases, there may be temporary mild elevation of body temperature lasting up to 3 days after vaccination.If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
 7-TARGET SPECIES Cattle from the age of 2 weeks.
8- DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
Vaccine dose – 2 ml
The vaccine is administered subcutaneously.
Basic immunisation (vaccination with subsequent revaccination):
We recommend vaccination of calves from 8 weeks of age with revaccination in 2 – 4 weeks (it is possible to vaccinate calves from the age of 2 weeks).
Revaccination:
In problematic breeds, another revaccination is recommended within a period of 6 months after basicimmunisation, possibly before risky period in particular breed (e.g. transfer of animals, change of thestabling system, etc.).
Pregnant cows and heifers:
Vaccination with subsequent revaccination within 7– 5 weeks and 4 – 2 weeks before expected date of labour due to increased resistance of the offspring via colostrum.
9. ADVICE ON CORRECT ADMINISTRATION
Heat up the vaccine before use to a temperature of 15 to 25 °C and shake the content of the vial.Vaccinate only healthy animals.
10- WITHDRAWAL PERIOD Zero days.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.Store in a refrigerator (2C – 8C)
Shelf-life of the veterinary medicinal product as packaged for sale 2 years.Shelf-life after first opening the immediate packaging: 10 hours.