Presentation

Freeze-dried vaccine containing > 10^5.6 TCID₅₀  ; ≤ 10^7.2 TCID₅₀  live attenuated IBR virus (strain INT 1) per dose.   Prior to use the powder must be reconstituted in Unisolve, Vm 01708/4269.

Uses

For the active immunisation of cattle to reduce clinical signs resulting from infection with infectious bovine rhinotracheitis (IBR) virus, and to reduce virus excretion in infected animals.

Cattle have been shown to be protected from the worst clinical effects of IBR within 2 days of intranasal and 7 days of intramuscular vaccination.   The vaccine may be used for emergency vaccination in an outbreak of respiratory disease caused by Infectious Bovine Rhinotracheitis in an attempt to prevent or reduce the severity of the disease.   The vaccine should be used intranasally for this purpose.

Annual revaccination is recommended to maintain the immune status.

Dosage and administration

The vaccine should be reconstituted immediately before use with the diluent supplied (Unisolve, Vm 01708/4269) thus:

5 dose vial of vaccine

All 10 ml of the diluent is syringed into the vaccine vial and this is agitated until the plug is fully dissolved.

25 dose vial of vaccine

About 10 ml of the 50 ml vial of diluent is syringed into the vaccine vial and this is agitated until the plug is fully dissolved.   The entire contents of the vaccine vial are then syringed into the diluent vial and mixed with the remaining diluent.

The preferred route of administration is by intranasal application.   If intranasal administration is not possible, e.g. cattle not used to being handled, the vaccine may be given as an intramuscular injection.  

The degree of protection afforded by use of the intramuscular route is slightly less than following intranasal administration.

Use clean equipment for administration but avoid contamination of vaccine with traces of disinfectant or spirit.

Intranasal administration:

Reconstituted vaccine should be drawn into a suitable syringe and the applicator provided should be attached.   The dose per animal is 2 ml of reconstituted vaccine administered intranasally, instilling 1 ml of vaccine into each nostril. The applicator can be inserted by guiding it medially and ventrally along the nasal septum. Care should be taken to avoid spillage by holding up the head of the animal during administration and by ensuring that the applicator is inserted fully into the nostril.

Intramuscular injection:
A single injection of 2 ml reconstituted vaccine, observing the normal aseptic precautions.

Vaccination programme:

Can be used during pregnancy.

Calves can be vaccinated at any age over 4 weeks, but animals vaccinated below the age of 12 weeks should receive a further vaccination at or after reaching this age.

Animals over 12 weeks of age should be given a single dose of vaccine.

Annual revaccination is recommended.

Contra-indications, warnings, etc.

Only healthy animals should be vaccinated.

Bovine respiratory disease may be caused by more than one infectious agent.   This vaccine will only protect against the effects of IBR virus infection.

No information is available on the safety of this vaccine together with any other vaccine within common vaccination programmes, except with the inactivated Intervet vaccine against BRSV, PI3V and Pasteurella haemolytica Type A1 (the efficacy has not been investigated).   It is therefore recommended that no other vaccines than these, should be administered within 14 days before or after vaccination with Bovilis IBR.

Do not mix with any product other than the diluent (Unisolve) supplied.

After administration of an overdose, adverse reactions with the exception of the possibility of a transient (1-2 days) slight (<1°C) pyrexia, are not expected.

Most animals will become or remain seropositive after vaccination.   Following intranasal vaccination the IBR virus has been shown to be present in the nose for a few days although there is no evidence that it can spread to in-contact animals.

A good immune response is reliant on the reaction of an immunogenic agent and a fully competent immune system.   Immunogenicity of the vaccine antigen will be reduced by poor storage or inappropriate administration.   Immuno-competence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress.

Withdrawal periods:

Zero days.

FOR ANIMAL TREATMENT ONLY.  KEEP OUT OF REACH AND SIGHT OF CHILDREN.


Pharmaceutical precautions

Store between +2^oC and +8^oC.   Do not freeze.   Protect from light.

Shelf life after opening:   Reconstituted vaccine should be used immediately.

Disposal advice:

Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.

Legal category

POM-V                                    To be supplied only on veterinary prescription.

Package quantities

Type I glass vials, halogen rubber stopper with aluminium crimp, containing freeze-dried vaccine, 5, 10 or 25 doses.

Not all presentations may be marketed.

Further information

Nil.

Marketing Authorisation number

Vm 01708/4326                                   UK Authorised veterinary medicinal product.

Marketing Authorisation holder

Intervet UK Ltd.

Walton Manor

Walton

Milton Keynes

Bucks. MK7 7AJ

Distributed in Northern Ireland by:

Intervet Ireland Ltd.

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

Date of text preparation

15/08/06