PROSPECTUS
"ONLY USED FOR ANIMAL HEALTH"
Biocan Lsuspension for injection
PHARMACEUTICAL FORM
Suspension for Injection
NAME AND STRENGTH OF ACTIVE INGREDIENTS AND NAME AND AMOUNT OF OTHER AUXILIARY COMPONENTS
Biocan L suspension for injection
Inactivated vaccine against leptospirosis in dogs
Active ingredient:
1 ml contains:
Inactivated Leptospira icterohaemorrhagiae _cc583194-identified by _cc583194_min titer 32*)
Inactivated Leptospira canicola _cc781905-5cdecf58-313594 with MATcdecf-136bad5bb3b-136bad5cf58d_ _cc781905_badcdec58-313594-identified with bb3b-136bad5cf58d_ _cc781905_badcde58-313594 min. titer 32*)
with inactivated Leptospira grippotyphosa _cc781905-bbcde78-3194-identified with _cc781905-bbcde58-3194bad_bbcde58-3194 min. titer 32*)
*) Geometric mean of titers of specific antibodies identified by microagglutination test
Adjuvant:
Aluminum hydroxide suspension
Excipients:
Leprospira Nutrium cultivation medium
INDICATIONS
For active immunization of dogs from 8 weeks of age against leptospira serovars contained in the vaccine.
CONTRAINDICATIONS
Its use is contraindicated in all febrile diseases.
SIDE EFFECTS
Appropriate local reaction (usually pea-sized) may develop at the injection site of the vaccine, which usually disappears on its own within 3 weeks. Hypersensitivity may occur rarely.
If you notice any serious adverse reactions or other effects not mentioned in this package insert, please inform your veterinarian.
LEGAL PURIFICATION PERIOD FOR ANIMALS WITH FOOD VALUE
Not intended for animals bred for food.
COMMERCIAL PACKAGING FORMS (TOTAL DOSAGE AND FILLING VOLUME FORMS)
A) Lidded plastic box with 10 eyes
10 x 1 ml Biocan L vaccine
B) Lidded plastic box with 20 compartments
20 x 1 ml Biocan L vaccine
C) Lidded plastic box with 100 eyes
50 x 1 ml Biocan L vaccine
100 x 1 ml Biocan L vaccine
noteNot all pack sizes may be marketed.
STORAGE CONDITIONS AND SHELF LIFE
Keep out of reach or sight of children.
Store in a dark and dry place under temperature between 2°C and 8°C.
Avoid vaccine freezing!
Do not use this veterinary medicinal product after the expiry date stated on the label.
Shelf life from the date of manufacture is 2 years.
Use the vaccine immediately after opening the vaccine.
PRECAUTIONS TO BE TAKEN AND RECOMMENDATIONS FOR PHYSICIANS
To the user:
Not applicable.
DISPOSAL OF WASTE AND UNUSED PRODUCTS,
The unused veterinary medicinal product or the waste materials generated by the use of this product must be disposed of as medical waste in accordance with the law.
Veterinary medicinal products should not be mixed with household waste and wastewater.
"KEEP IT OUT OF THE REACH OF CHILDREN".
“IF AN UNEXPECTED EFFECT IS OBSERVED, CONSULT YOUR VETERINARY PHYSICIAN”.
Biocan L
Inactivated vaccine against leptospirosis in dogs