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 VETERINARY MEDICINAL PRODUCT
Biocan RSuspenion for Injection
Inactivated vaccine against rabies

3-STATEMENT OF THE ACTIVE INGREDIENTS AND OTHER SUBSTANCES

Composition-1 mL:

Active ingredient

                      -Virus rabieiinactivatum, strain SAD Vnukovo min.2 IU

Excipients      - 32 Nutrimentum MEM

                       -Algedratum

                       -Thiomersalum

Cell culture used for vaccine production:BHK-21 derived from hamster kidney

4-INDICATIONS
For active immunisation of target animal species against rabies.

5.CONTRAINDICATIONS
Systemic febrile disease.Non-vaccinated animals, injured or in contact with rabies-infected animals.Animals,which bit or injured a human, may be vaccinated only after the termination of an observation period.

6.ADVERSE EFFECTS
Adequate local reaction (usually sized as a pea) may develop in the administration site of the vaccine, and it disappearswithin 3 weeks.Hypersensitivity develops rarely.

7-TARGET ANIMAL SPECIES
Dogs, cats, fur animals,cattle, horses, sheep, goats, pigs.

8-POSOLOGY FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
Dosage-1 ml regardless of age, weight and breed of the individual; but at the earliest in the 12thweek of age.
Method of administration:
subcutaneous, best in the region behind scapula.
intramuscular, best to the muscle of the rear limb.
Animals are vaccinated from the age of 3 months.The onset of protective immunity is within 14 days after immunisation.Animals vaccinated earlier than at the ageof 3 months must be revaccinated after reaching this age (minimal 14 day interval between vaccinations must be observed).Animals vaccinated for the first time, at the age of 3–12 months, must be revaccinated in 1 year after the first application of thevaccine.Revaccination

performed one year after the first vaccine protects animals against rabies for at least 2 years.In order to maintain immunity, it is recommended to revaccinate in accordance with veterinary regulations of each country.
Interactionwith other medicinal products and other forms of interaction
Biocan R vaccine may be used separately, simultaneously or in combination with other Biocan vaccines:
A-Biocan R vaccine may be used as a diluent for other lyophilised Biocan vaccines (for exampleDHPPi, DP,P).
B-Biocan R vaccine may be administered simultaneously or with liquid vaccines Biocan C, Biocan B, Biocan M and Biocan L.
Recommended vaccination scheme for Biocan

Note:
Vaccines in the brackets indicate a possibility of an alternative vaccination instead of Biocan Puppy vaccine.
Vaccines labelled +C, +L, +LR indicate a possibility of simultaneous or combined usage with other Biocan vaccines(e.g.DHPPi, DHP, DP, DH, P, Puppy).
Additional possible vaccinations:Biocan M–vaccine against Microsporum canis of dogs and cats for usage from theage of 12 weeks.

9-INSTRUCTIONS FOR PROPER ADMINISTRATION
The content of the vial has to be shaken prior to use.

Vaccinate only clinically healthy individuals in a proper nutritional condition.Possible anti-parasitic treatment shouldprecede vaccination at least ten days.One week after the vaccination, it is not recommended to perform anytraining with the vaccinated animals or any other straining performances.

10-WITHDRAWAL PERIOD
No withdrawal periods.

11.SPECIAL PRECAUTIONS FOR STORAGE
Store in a dry and dark place at a temperature 2–8°C.Do not freeze!
To be used within 8 hours after the first opening.

12-SPECIAL WARNINGS
Not applicable.

13-Special PRECAUTIONS for the disposal of unused product or waste, if necessary
All unused veterinary medicinal product or waste from this product must be disposed of according to the localregulations.

14-OTHER INFORMATION
For animal treatment only

This veterinary medical product is available only on prescription..