Presentation

Bovilis IBR Marker live is a live, attenuated marker vaccine per dose containing at least 5.7 log₁₀ TCID₅₀ of gE¯ BHV-1 strain GK/D.

Traces of antibiotics and cell debris can be present as remnant from the antigen production.

Uses

For the active immunisation of cattle to reduce the intensity and duration of the clinical respiratory signs induced by an infection with BHV-1 and to reduce nasal excretion of field virus.

Onset of immunity:

An increase in immunity has been demonstrated 4 days after intranasal vaccination and 14 days after intramuscular vaccination of 3 month old seronegative animals.

Duration of immunity:

After intranasal administration to 2 week old calves without maternal antibodies, immunity lasts at least until the age of 3-4 months, when the animals should be revaccinated. In the presence of maternally derived antibodies, the protection of the vaccine may not be complete until this revaccination.

Revaccination at 3-4 months of age results in protective immunity that lasts for at least 6 months.

Single intranasal or intramuscular vaccination of 3 months old animals provides protective immunity (reduction of clinical signs and reduction of viral excretion), which has been demonstrated via challenge 3 weeks after vaccination. Reduction of viral excretion is maintained for at least 6 months after single vaccination.

Dosage and administration

Dosage: a single dose of 2 ml reconstituted vaccine per animal.

For intranasal or intramuscular administration.

Reconstitute the vaccine immediately before use with Unisolve (10 ml per 5 doses). Inject a few ml of solvent into the vaccine vial and shake gently until the vaccine pellet is completely dissolved. Then transfer the concentrated vaccine to the rest of the solvent and mix well.

Method of administration:

- from the age of 3 months onward: intranasal or intramuscular.

- at an age between 2 weeks and 3 months: intranasal.

For intranasal administration (1 ml in each nostril), the use of a nozzle is recommended.

Vaccination schedule:

-        Basic vaccination:

Vaccinate each animal with one single dose.

-        Revaccination:

When the first vaccination is given between the age of 2 weeks and 3 months, the animals should be revaccinated with a single dose at the age of 3-4 months. To maintain immunity, revaccinate every 6 months.

When vaccination is started after the animals are 3 months old, to maintain immunity the animals should be revaccinated with a single dose every 6 months.

When Bovilis IBR Marker live is administered concurrently with Bovilis Bovipast RSP, the products must not be mixed.

Use sterile vaccination equipment free from disinfectants. To prevent the spread of any infective agents, the intranasal equipment should be changed at each animal.

Can be used during pregnancy and lactation.

The presence of maternal antibodies can influence the efficacy of the vaccination. To assess the likely benefit of early vaccination in an individual, it is therefore recommended to ascertain the immune status of calves before vaccination is started.

Contra-indications, warnings, etc.

Do not vaccinate unhealthy animals.

No information is available on the use of this vaccine in breeding bulls.

A slight transient rise in temperature (1°C) can occur up to 5 days post vaccination.

An increase of nasal discharge can be observed after intranasal vaccination.

After intranasal administration, the vaccine virus may spread to in-contact cattle. Cattle which need to remain totally free from all detectable antibodies to BHV-1 should be separated from intranasally vaccinated animals.

No information is available on the safety and efficacy for the concurrent use of this vaccine with any other vaccine except with Bovilis Bovipast RSP. It is therefore recommended that no other vaccines should be administered within 14 days before and after vaccination with this product.

Do not use together with immunosuppressive agents.

User warning:

In the case of accidental self-injection, seek medical advice immediately and show the package insert or the label to the physician.

Withdrawal periods:

Meat/Milk: Zero days

For animal treatment only.  Keep out of THE reach AND SIGHT of children.

Pharmaceutical precautions

Store between +2°C and +8°C in the original packaging.

Reconstituted vaccine should be stored below 25°C and should be used within 3 hours.

Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant in accordance with national requirements.

Legal category 

POM-V                       To be supplied only on veterinary prescription.

Package quantities

5 dose vials packed with 10ml of solvent.

10 dose vials packed with 20ml of solvent.

Further information

No information is available on the efficacy of the vaccine to prevent a latent wild virus infection or to prevent wild virus re-excretion in the latent carrier.

Marketing Authorisation number

Vm 06376/4032

Marketing Authorisation Holder

Intervet International B.V.

Represented by:

Intervet UK Ltd.

Walton Manor

Walton

Milton Keynes 

MK7 7AJ

Distributed in Northern Ireland by:

Intervet Ireland Ltd.

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

Date of text preparation:

May 2007.

Item code: 045795                                                                               75225.May 2007