PROSPECTUS
"ONLY USED FOR ANIMAL HEALTH"
BIOCAN B  INJECTION SUSPENSION FOR DOGS
PHARMACEUTICAL FORM
Suspension for Injection
NAME AND STRENGTH OF ACTIVE INGREDIENTS AND NAME AND AMOUNT OF OTHER AUXILIARY COMPONENTS  _cc781905-5cde-3194_cb3b-                    
Active ingredient:
at 1 ml
Inactive Borrelia burgdorferi:   Borrelia garinii  RP ≥ 1*
    Borrelia afzelii_cc781905-5cde-3194_cb-b3b3b-136bad5cf58d_Borrelia afzelii_cc781905-5cde-3194_cb3b3b3bd_cc781905- 136badc58d
* relative potency (RP) is given by comparison with reference serum from animals vaccinated with the batch that has passed the challenge test in the target animal species.
 
Excipients:
1 ml
Aluminum oxide 2%
sodium chloride solution
 
INDICATIONS
It is designed for active immunization of dogs against Lyme disease aged 12 weeks and older.
CONTRAINDICATIONS
It should not be used in cases of general febrile condition, clinically evident Lyme disease.
SIDE EFFECTS
No undesirable effects were detected during testing of the Biocan B vaccine.
After Biocan B vaccination, a local reaction (pea sized) may be observed, which spontaneously disappears within three weeks after vaccination. In a limited number of vaccinated animals, an individual hypersensitivity reaction cannot be excluded, which can be treated using general conservative therapy. 
 
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) Plastic box with 10 slots:
10 x 1 ml Biocan B vaccine
  2 x 1 ml Biocan B vaccine
B) Plastic box with 20 slots:
20 x 1 ml Biocan B vaccine
C) Plastic box with 100 slots:
100 x 1 ml Biocan B vaccine
50 x 1 ml Biocan B vaccine
 
Note: Not all pack sizes may be marketed.
For animal treatment only. Sold only with veterinary prescription
 
STORAGE CONDITIONS AND SHELF LIFE
Shelf life is 36 months.
Store in a refrigerator (between 2°C and 8°C).  Do not freeze. Protect from light. Store dry.
Keep out of reach or sight of children.
Do not use after the expiry date stated on the box.
 
WARNINGS
Dogs with antibodies to Lyme borreliosis may be vaccinated to protect against possible infection and clinical manifestation of borreliosis.
From a vaccination point of view, risk groups include dogs with clinical manifestation of Lyme disease confirmed, eg, by culturing borrelia in infected individuals, . Such animals should not be vaccinated because there is no improvement in the condition of vaccinated animals (B. burgdorferi microbes remain in well-protected areas, eg in the articular cartilages, throughout the dog's entire life regardless of therapy and/or vaccination)  and therefore such vaccination is useless because, despite vaccination, disease caused by borrelia can develop (stress, other infectious diseases, etc.).
 
Drug interactions (compatibility and incompatibility with other  interactions)
It is possible to administer this vaccine simultaneously with other Biocan-type vaccines, but each vaccine will be administered separately (preferably on the other side of the body).
 
Overdose symptoms, precautions and  antidote
A double dose of the vaccine has been proven to cause no adverse reactions in target animals.
 
Use in Pregnancy
It is not used during pregnancy.
 
PRECAUTIONS TO BE TAKEN AND RECOMMENDATIONS FOR PHYSICIANS
To the user:
Not applicable.
DISPOSAL OF WASTE AND UNUSED PRODUCTS
Any unused veterinary medicinal product or waste material resulting from the use of such veterinary medicinal product should be disposed of in accordance with local requirements.
 
"KEEP IT OUT OF THE REACH OF CHILDREN".
“IF AN UNEXPECTED EFFECT IS OBSERVED, CONSULT YOUR VETERINARY PHYSICIAN”.
 
NAME, ADDRESS OF THE MARKETING PERMIT OWNER AND MANUFACTURING PLACE FOR IMPORTED PRODUCTSİNTERMED PHARMACEUTICAL WAREHOUSE İTH.İHR.TİC.TAAH.LTD. STI. HealthSok. no. 32/8 Kızılay/ANKARA, Tel: (312) 435 95 60  Fax: (312) 435 73 51
Manufacturer's name and Address:Bioveta, as, Komenskeho 212, 683 23 IvanovicenaHaneCzech Republic Tel: 420 517 318 500 Fax: 420 517 318 653e-mail: comm@bioveta.cz
 
MINISTRY OF AGRICULTURE AND FORESTRY MARKETING PERMISSION DATE AND NUMBER
16.12.2003
 
DATE OF LAST APPROVAL OF THE PROSPECTUS:30.07.2018