1- NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OFTHE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCHRELEASE, IF DIFFERENT
Bioveta, a.s.
Komenského 212, 683 23 Ivanovice na HanéCzech Republic
2. NAME OF THE VETERINARY MEDICINAL PRODUCT
BIOCAN M Plus injection solution
Vaccine against Microsporum canis in dogs and cats inactivated
3. STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS
Composition - 1 ml (1 dose) contains:

Active substance:                         

Microsporum canis inact.      min 1 million of vegetative forms

Excipients:   

 Formaldehyde max 0.05%, Buffer saline solution

. INDICATIONS
From the 2 months of age for the prevention and therapy of dermal mycoses in dogs and cats induced by the dermatophyte Microsporum canis. Animals should be vaccinated at the age of 2 months and above.
5. CONTRAINDICATIONS
Total pyrexial disease. Pregnant bitches should not be vaccinated.
Other immunoprophylactic interventions should not be carried out during one week before the first vaccination up to 14 days after the second (or, if relevant, the third) vaccination (except of the cases when the vaccine BIOCAN series is applied).
6. ADVERSE REACTIONS
Appropriate local reaction, usually pea-sized, may occur in the spot of vaccine application. This reaction disappears within 3 weeks. Exceptionally, hypersensivity may occur.
7. TARGET SPECIES
Dogs, cats.

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

Dosage:

1 ml regardless of the age, weight and race of the individual.

Application:

Dog: deep intramuscularly into the musculature of the pelvis extremity.

Cats: the vaccine shall be applied subcutaneously behind the blade-bone or intramuscularly into the musculature of the pelvis extremity.
The vaccination should be carried out into the left body side and the revaccination into the right body side.
9. ADVICE ON CORRECT ADMINISTRATION
Preventive, therapeutic: The animals that were vaccinated for the first time shall be re-vaccinated at least once at the interval of 10–21 days. In case of the therapeutic vaccination the third vaccination
dose shall be applied (if necessary) 10–21 days after the re-vaccination.Immunity is formed within 1 month after the re-vaccination and lasts at least 1 year.
10. WITHDRAWAL PERIOD
Not intended for food animals.
11. SPECIAL STORAGE PRECAUTIONS
Store in a dry and dark place at a temperature of 2 to 8oC. The vaccine must not freeze!Keep out of the reach and sight of children.
The preparation must not be used after the lapse of the applicability period, indicated on the package.
12. SPECIAL WARNINGS
Only clinically healthy and properly nourished individuals should be vaccinated. Possible anti-parasitic treatment should be carried out at least 10 days before the vaccination. The vaccinated animals should not be trained or exercised for one week after the vaccination.
Pregnant bitches and cats should not be vaccinated.
The vaccine BIOCAN M Plus shall be applied always separately (it shall not be used as a dilutor for the lyophilized vaccines or mixed with the liquid vaccines).
Any other vaccine BIOCAN series can be applied simultaneously with the vaccine BIOCAN M Plus(preferably on the opposite body side).
 13-SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT ORWASTE MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
15. OTHER INFORMATION
Pharmaceutical form: Solution for injection.Indication group: Veterinary immunopreparation.
The vaccine does not infect environment with the virulent spores of Microsporum canis and therefore it is suitable for elimination of the invader from the population of sensitive animals and environment.
Package size:

A/ plastic box with a cup and 20 hallows:

20 x 1 ml of the vaccine Biocan M Plus