BioBos IBR marker live lyophilisate and solvent for suspension for cattle
Live intranasal vaccine for immunisation of cattle to reduce the intensity and duration of the clinical signs of infection with BHV-1 (IBR) and to reduce field virus excretion.
|type of preparative:||Vaccines|
|target species animals:||Cattle|
1 dose (2 ml) contains:
Bovine herpesvirus type 1 (BHV-1), strain Bio-27: IBR gE - negative, attenuated 105.7 - 107.5 TCID50
TCID50 – 50% infectious dose for tissue culture
Indications for use, specifying the target species
For active immunisation of cattle to reduce the intensity and duration of the clinical signs of infection with BHV-1 (IBR) and to reduce field virus excretion.
Onset of immunity:
The onset of immunity was demonstrated 7 days after intranasal vaccination and 14 days after intramuscular vaccination of seronegative animals.
Duration of immunity:
6 months after basic vaccination.
The duration of immunity after intranasal administration from 2 weeks of age was demonstrated by challenge test as 10 weeks in animals without maternal antibodies only, i.e. until the administration of the 2nd intramuscular dose at 3 months of age.
Immediately prior to use, aseptically add the solvent provided (diluent A) to the vial containing the lyophilised component. Mix (shake) thoroughly.
In case of intranasal administration, the required volume of reconstituted vaccine (1 ml of reconstituted vaccine in each nostril) is drawn from the vial with a needle and syringe; the needle is then replaced with an applicator and the vaccine administered. The applicator is used to administer the required amount of vaccine from the syringe into the nostrils of vaccinated calves in the form of an aerosol.
2 ml of reconstituted vaccine per animal.
Method of administration:
Intranasal: from 2 weeks to 3 months of age
Intramuscular: from 3 months of age onward
For intranasal administration, one dose (2 ml) of reconstituted vaccine is administered to calves from 14 days of age using the intranasal applicator. The use of a new applicator for each animal is recommended to prevent the transmission of infection.
Calves from 2 weeks of age without maternal antibodies up to 3 months of age
The first dose of vaccine is administered (intranasally) from 2 weeks of age; the second dose intramuscularly, at 3 months of age.
Cattle from 3 months of age onward
Basic vaccination of animals
Administration of one dose, intramuscularly, per animal from 3 months of age.
Revaccination with one dose, intramuscularly, every 6 months after basic vaccination. Sterile equipment, free of disinfectants, should be used, as disinfectants may reduce the effectiveness of vaccination.
Adverse reactions (frequency and seriousness)
No adverse effects were observed in preclinical studies.
Special precautions for storage
Store in a refrigerator at 2 – 8 °C. Protect from light. After reconstitution (8 hours), store below 25 °C.
Special warnings for each target species.
Maternal antibodies may have a negative effect on the efficacy of vaccination. It is therefore recommended that the immune status of calves be determined prior to commencing vaccination.
Special precautions for use
Special precautions for use in animals
Vaccinate healthy animals only. Given the nature of the vaccine, the possibility of transmitting the virus from intranasally vaccinated animals to unvaccinated animals in contact with them cannot be entirely ruled out. For this reason, it is recommended to either vaccinate all animals in the herd, or to keep cattle that need to remain free of rhinotracheitis (IBR) antibodies separate from intranasally vaccinated animals.
Special precautions to be taken by the person(s) administering the veterinary medicinal product to animals.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the physician.
Shelf life of the veterinary medicinal product (lyophilisate) as packaged for sale: 2 years
Shelf life of the solvent (diluent A) as packaged for sale: 4 years
Shelf life after reconstitution according to directions: 8 hours
5 x 5 doses – glass vials, hydrolytic class type I (Ph.Eur.): 3 ml vial of lyophilisate and 10 ml vial of solvent
1 x 25 doses – glass vials, hydrolytic class type I (Ph.Eur.): 10 ml vial of lyophilisate and glass vials, hydrolytic class type II (Ph.Eur.): 50 ml vial of solvent
Intranasal applicator not included in package. Applicators are distributed with the vaccine.
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