BioBos IBR marker live, lyophilisate and solvent for suspension

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Pharmaceutical form

Lyophilisate and solvent for suspension.

The lyophilisate has a spongy consistency, a cream to yellowish colour.

The solvent is clear, colourless solution.

Composition

Live attenuated Bovine herpesvirus type 1 (BHV-1), strain Bio-27: IBR gE -  10^5.7–10^7.5 TCID₅₀

*TCID₅₀ – tissue culture infectious dose – 50%.

Indication

For active immunisation of cattle to reduce the severity and duration of clinical symptoms of viral infection caused by BHV-1 (IBR - Infectious Bovine Rhinotracheitis) and to reduce the excretion of field virus.

Onset of immunity: The onset of immunity was demonstrated 7 days after intranasal vaccination and 14 days after intramuscular vaccination of animals without maternally derived antibodies.

Duration of immunity: 6 months after primary vaccination. The duration of immunity after intranasal administration from 2 weeks of age was demonstrated by challenge only in animals without maternally derived antibodies to be 10 weeks until the intramuscular administration of the second dose from 3 months of age.

Dosage, application and vaccination scheme

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.

Dosage: 2 ml of reconstituted vaccine per animal.

Method of administration:

• Intranasally: from 2 weeks up to 3 months of age
• Intramuscularly: from 3 months of age

Administer one dose (2 ml) of the reconstituted vaccine intranasally to calves from 14 days of age using an intranasal applicator. It is recommended to use a new or cleaned by cellulose applicator for each animal to prevent the transmission of infection.

Primary vaccination:

Calves from 2 weeks of age without maternal antibodies up to 3 months of age:

The first administration (intranasal) from 2 weeks of age, the second administration (intramuscular) from the age of 3 months.

Cattle from 3 months of age:

One intramuscular administration of one dose per animal from 3 months of age.

Revaccination:

Revaccination is always intramuscular with one dose every 6 months after completion of primary vaccination.

Sterile equipment free of disinfectants should be used for vaccination as disinfectants could reduce the efficacy of vaccination.

Can be used during pregnancy and lactation.

Storage

Store in a refrigerator (2 °C–8 °C).

Protect from light.

Store the reconstituted vaccine below 25 °C (for max. 8 hours).

Withdrawal period

Zero days.

Shelf life

Shelf-life of the veterinary medicinal product (lyophilisate) as packaged for sale: 2 years.

Shelf-life of the solvent as packaged for sale: 4 years.

Shelf life after reconstitution according to directions: 8 hours.

Package

5 x 5 doses – (5x5 doses of lyophilised vaccine + 5 x 10 ml of solvent).

1 x 25 doses – (1x25 doses of lyophilised vaccine + 1 x 50 ml of solvent).

Intranasal applicators are not included in package.

Not all pack sizes may be marketed.