Injectable Suspension
PHARMACEUTICAL FORM:Suspension
COMPOSITION: One dose of vaccine (2 ml) contains:
Active ingredient: Inactivated Bovine herpesvirusType 1 (BHV-1), Bio-27:IBR gE-strainRP ≥ 1*
(*) RP= Relative potency; (ELISA test), relative efficacy compared to the reference serum obtained after vaccination of guinea pigs using the vaccine series that has passed the challenge test in target animals.
Adjuvants:
Aqueous aluminum hydroxide, for adsorption   _cc781905cf58d__cc781905-bb31363b-bb3153bd_cc781905-bb31394
Quillaja saponin (Quil A)      _cc781905-bbcdebb-36bad5cf58d_   _cc781905-bbcdebb-3194 136bad5cf58d_       _cc781905_bb3b-136bad5cf58d_   _cc781905_bb3cf-3135359_bb3b-136bad5cf58d_ _cc781905_bb3cf-313659 3194-bb3b-136bad5cf58d_     _cc781905-5cde-3194-bb3b-136bad5cf5cf58d_ _cc58-7831594-5bb3b-136bad5cf58d_ _cc781905-5cde-3194-bb3b-136bad5cf5cf58d__cc58-7831594_cdebbc-58dcf13635b_cc58dcf13635cf36359cf36359c       _cc781905-5cde-3194-bb3b3b-136bad  _cc781905-5cde-3194- ccde-3194cf13631365c5cf3b31994cbdc13653155cf -bb3b-136bad5cf58d_0.4mg
Other auxiliary components
Thiomersal      _cc781905-5cde-3194_bb358- 19358d 136 -bb3b-136bad5cf58d_       _cc5819_f58cf31365cde-cc5819_f583353bbd_cc581994-bb335359cde-3194-bb3b-136bad5cf58d_cc-5819_f58cf313353bd_cc581934-bb3153bd -5cde-3194-bb3b-136bad5cf58d_      136bad5cf1905cde_cc781905-5cde-3194-bb3b-136bad5cf1931305c_ bb3b-136bad5cf58d_       _cc5819_f583bd_cc781904-bb3353b_cc581905cf335359cde-3194-bb3b-136bad5cf58d_ _cc5819_f58cf313353b_cc581994-bb3353bd_cc581994-bb3353b3b3b-136bad5cf58d_ _cc781905 5cde-3194-bb3b-136bad5cf58d_     _cc781905-5cde- 3194-bb3b-136bad5cf58d_     _cc781905-5cde-3194-bb3b-136bad5cf5cf58d_ _cc58-7831594-5bb3b-136bad5cf58d_ _cc781905-5cde-3194-bb3b-136bad5cf5cf58d__cc58-7831594_cdebbc-58dcf13635b_cc58dcf13635cf36359cf36359c       _cc781905-5cde-3194-bb3b-136_bad5c - 0
INDICATIONS
It is used for active immunization of cattle in order to reduce the severity and duration of clinical symptoms caused by BHV-1 (IBR) virus infection, and to reduce the distribution and spread of the virus in the field.
Beginning of immunity:3 weeks after basic vaccination.
Duration of immunity:6 months after basic vaccination.
 
CONTRAINDICATIONS
Not available.
 
SIDE EFFECTS
Hypersensitivity reactions may occur in susceptible animals in connection with vaccination.
may come. In such cases, adequate symptomatic treatment should be administered. The vaccine contains an adjuvant that can cause temporary local swelling up to 2 cm in diameter. This swelling disappears within 4 days after vaccination. Inform your veterinarian if any serious side effects not mentioned in this leaflet occur.
 
LEGAL PURIFICATION PERIOD FOR ANIMALS WITH FOOD VALUE
Zero days
COMMERCIAL PACKAGING SHAPES
Packing quantity:
Plastic cans: 10x10 ml (10x5 doses)
Cardboard boxes: 1 x 10 ml (1 x 5 doses), 1 x 50 ml (1 x 25 doses), 1 x 100 ml (1 x 50 doses)
Not all packaging sizes may be marketed.
 
STORAGE CONDITIONS AND SHELF LIFE
It should be stored between +2 °C and +8 °C, transported in the cold chain and the vaccine must be frozen.
When these conditions are met, the effective shelf life of the vaccine in the unopened bottle is 24 months.
The shelf life of the bottle opened for use is 10 hours after opening.
 
PRECAUTIONS TO BE TAKEN AND RECOMMENDATIONS FOR PHYSICIANS
In case of accidental self-injection by the practitioner, immediate medical attention should be sought and the product leaflet or label should be shown to the physician.
 
DISPOSAL OF WASTE AND UNUSED PRODUCTS
Unused veterinary medicinal product or waste from its use should be disposed of in accordance with local regulations.
 
GENERAL WARNINGS
“Keep out of reach of children”
“Consult your Veterinarian in case of an unexpected effect”
 
PLACE AND CONDITIONS OF SALE
Sold in veterinary clinics, outpatient clinics, animal hospitals and pharmacies with a veterinary prescription (VHR).
 
NAME OF MARKETING PERMISSION
ÎNTERMED Pharmaceutical Warehouse, Import, Export Trade and Contracting Ltd. Sti.
Health St. No: 32 KIZILAY /ANKARA
Tel: (312) 435 95 60 Fax: (312) 435 73 51intermed@interhas.com.tr
 
NAME, ADDRESS OF MANUFACTURING PLACE
BIOVETA as,Komenskeho 212, 683 23 Ivanovicena Hane, Czech Republic
MINISTRY OF FOOD, AGRICULTURE AND LIVESTOCK MARKETING PERMISSION DATE AND NUMBER: 19.09.2014-P0071
LAST APPROVAL OF THE PROSPECTUS:31.10.2014