Rispoval IBR-Marker Live

Rispoval IBR-Marker Live
A live, freeze-dried, Infectious Bovine Rhinotracheitis Marker (gE negative) vaccine.

One dose (2 ml) contains: Bovine Herpes Virus type 1 (BoHV-1), strain Difivac (gE-negative) modified live (attenuated) virus min. 105.0 CCID50, max 107.0 CCID50. Diluent: water for injections.

Uses

For the active immunisation of cattle against Infectious Bovine Rhinotracheitis (IBR), to reduce virus shedding and clinical signs including, in female cattle, abortions associated with BoHV-1 infection. A reduction in abortions associated with BoHV-1 infection has been demonstrated during the second trimester of gestation following challenge 28 days after vaccination.

Onset of immunity: 7 days after a single dose via intranasal administration or 21 days after a single dose via intramuscular administration as demonstrated in seronegative calves.

Duration of immunity: following vaccination before 3 months of age: After intranasal vaccination of calves aged 2 weeks or older without maternally derived antibodies, immunity lasts until at least 3 months of age, when the animals should be revaccinated via intramuscular injection. A proportion of young calves may have maternally derived antibodies to BoHV-1, which may affect the immune response to vaccination. Consequently, the protection afforded by the vaccine may not be complete until the revaccination at 3 months of age.

Duration of immunity: following vaccination at or after 3 months of age: 6 months

Dosage and administration

Dose

2 ml reconstituted vaccine.

Route of administration

Intranasal and/or intramuscular inoculation. The vaccine must be administered aseptically via the intramuscular route (2 ml) or sprayed into the nostrils (1 ml per nostril during aspiration) with the intranasal applicator available from Zoetis.

Shake the vaccine well before use.

Vaccine reconstitution

The freeze-dried product should be reconstituted aseptically just prior to use. The vaccine is prepared as follows: For 10 and 50 dose vials, approximately 4 ml of the diluent is transferred into the vial containing freeze-dried pellet and then mixed. The reconstituted virus fraction is then transferred back into the remaining diluent and mixed well. The product is then ready for use. The needles and syringes used for application of the vaccine must not be sterilised by chemical disinfectants as this may impair the efficacy of the vaccine.

Vaccination scheme

Calves of 2 weeks to 3 months of age at first vaccination

The first vaccination should be applied intranasally, followed by a second vaccination intramuscularly at 3 months of age. A proportion of young calves may have maternally derived antibodies to BoHV-1, which may affect the immune response to vaccination. Consequently, the protection afforded by the vaccine may not be complete until the revaccination at 3 months of age. As an extra precaution in situations of high challenge with BoHV-1, maternal antibody positive animals that have been initially vaccinated at around 2 weeks of age may be given an additional vaccination between the first vaccination and vaccination at 3 months of age. This additional vaccination may be given via either intranasal or intramuscular administration and may be given from 3 weeks after the first vaccination.

Cattle at 3 months of age or older

Animals should be given one intramuscular vaccination. To prevent abortions associated with BoHV-1 female cattle require a primary course of two intramuscular doses of vaccine 3-5 weeks apart.

Booster vaccinations

Animals should be given a single dose booster vaccination 6 months after their initial vaccination course. Animals initially vaccinated with Rispoval IBR-Marker Live may be given a single dose booster vaccination with either Rispoval IBR-Marker Live to provide 6 months of protection or Rispoval IBR-Marker Inactivated to provide a duration of protective immunity of 12 months. Thereafter, single dose booster vaccinations should be administered every 6 months (if using Rispoval IBR-Marker Live) or every 12 months (if using Rispoval IBR-Marker Inactivated).

Advice on correct administration

Beef cattle and fattening bulls are vaccinated preferably just prior to housing (crowding) or at transfer to new groups.

Cattle at immediate risk of IBR

In order to stimulate local immunity in cattle already exposed to IBR or under immediate risk of infection, (including pregnant cattle) it is recommended to administer the first vaccination intranasally. In this case, the second vaccination should be given intramuscularly 3 to 5 weeks later to complete the initial course.

It is recommended that all the cattle in the herd are vaccinated.

Contra-indications, warnings, etc

Do not use in unhealthy animals.

When injected intramuscularly in very rare cases minor, transient swelling up to 3 cm in diameter, which generally subsides within 7 days, may occur at the injection site. Following intranasal inoculation slight, transient, serous nasal discharge may occur in very rare cases for up to 7 days.

In very rare cases, allergic reactions may occur as with other vaccines, therefore vaccinates should be observed for approximately 30 minutes following immunisation. In those cases, anti-allergics should be administered.

In some cases, the vaccine virus may be excreted after intranasal administration from vaccinated animals. Exceptional transmission of the virus from intranasally-vaccinated animals to non-vaccinated in-contact animals may occur due to the nature of the vaccine even though no verified data available would indicate that spreading of the vaccine virus occurs in a group of animals.

It is recommended to vaccinate all the cattle in the herd.

The presence of maternal antibodies can influence the efficacy of the vaccination. Therefore it is recommended to ascertain the immune status of calves before vaccination is started.

The vaccine can be used during pregnancy and lactation.

Immunosuppressive substances e.g. corticosteroids or Bovine Viral Diarrhoea modified live vaccines, should be avoided for a period of 7 days prior to and after vaccination as this may impair the development of the immunity.

Interferon sensitive products should not be applied intranasally following 5 days after intranasal vaccination.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be decided on a case by case basis.

Do not mix with any other veterinary medicinal product except diluent supplied for use with the product.

Reactions after administration of an overdose of vaccine are not different from those after the single dose.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

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

Withdrawal periods

Zero days.

Pharmaceutical precautions

Store in a refrigerator (+2°C to +8°C). Protect from heat and light. Do not freeze.

Do not use after the expiry date which is stated on the label.

When product is withdrawn aseptically from broached vials, which are thereafter kept at +2°C to +8°C, the reconstituted vaccine can be used for one working day (8 hours).

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

For animal treatment only.

Keep out of reach and sight of children.

Legal category

POM-V

Packaging Quantities

Cartons containing a vial containing a 10 dose or 50 dose freeze-dried pellet, supplied together with a vial containing 20 or 100 ml diluent. Not all pack sizes may be marketed.