Introduction

Pfizer

Company name: Pfizer Limited

Address: Ramsgate Road

Sandwich

Kent CT13 9NJ

Telephone: 0845 300 8034 (Out of hours: 01304 616161)

Fax: 01737 332521

Email: UKVetLine@pfizer.com

Website: www.only4vets.co.uk

Presentation

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

One dose (2 ml) contains: Bovine herpes virus type 1 (BHV-1), attenuated strain of IBR-Marker virus gE negative min. 105.0 CCID50 plus stabiliser 6.0 mg.

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 BHV-1 infection. A reduction in abortions associated with BHV-1 infection has been demonstrated during the second trimester of gestation following challenge 28 days after vaccination.

Dosage and administration

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 spray canula supplied in the package.

Shake the vaccine well before use.

Vaccination scheme

Cattle over 2 weeks of age

Irrespective of the maternal antibodies status a full vaccination course consists of two doses. The first vaccination should be applied intranasally, followed by a second vaccination intramuscularly 3-5 weeks later. Calves should receive their first booster vaccination at the age of 6 months.

Cattle over 3 months of age

Seropositive calves: two intramuscular doses, 3-5 weeks apart.

Seronegative calves: one intramuscular dose.

Pregnant cattle: two intramuscular doses, 3 to 5 weeks apart.

In all cases, vaccination will induce immunity lasting for 6 months. Booster vaccinations are therefore performed every 6 months.

Beef cattle and fattening bulls should be vaccinated preferably just prior to housing (crowding) or when transferred 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 that the first vaccination is given 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.

Vaccine reconstitution

Using the sterile diluent provided, reconstitute the freeze-dried product aseptically as follows: transfer approximately one quarter of the solvent into the freeze-dried powder with a sterile syringe; mix thoroughly. Transfer this solution back to the remaining diluent and mix. Following reconstitution the vaccine remains potent for a maximum of 8 hours when the product is withdrawn aseptically and refrigerated.. 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.

Contra-indications, warnings, etc

Diseased cattle and cattle infested heavily with parasites should be excluded from vaccination.

In very rare cases (when injected intramuscularly) a minor, transient swelling up to walnut size, which generally subsides within 7 days, may occur at the injection site. In rare cases following intranasal inoculation a slight, transient serous nasal discharge may occur. 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.

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.

Do not mix with any other vaccine/immunological product or veterinary medicinal product.

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

Withdrawal periods

Zero days.

Pharmaceutical precautions

Store at +2°C to +8°C. Protect from frost, heat and light. Once opened, use within 8 hours.

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

For animal treatment only. Keep out of reach of children.

Legal category

POM-V

Packaging Quantities

20 ml (10 dose) vial freeze dried vaccine with diluent.

Further information

Can be used during pregnancy and lactation.

Glycoprotein gE is absent in virus particles of Rispoval IBR-Marker Live. Therefore the vaccine virus, and the antibodies against it, can be clearly differentiated from field strains, or antibodies against the latter by serological methods. The product induces antibodies in vaccinated cattle, which are detectable in serum neutralizing tests and in conventional ELISA tests. With specific gE test kits these antibodies can be differentiated from those of field virus infected animals or animals infected with conventional IBR vaccines.

The vaccine induces immunity in cattle against clinical respiratory symptoms caused by the IBR virus. After a single dose vaccination, a significant reduction of virus shedding duration has been demonstrated upon challenge. After two doses of vaccine, the intensity and duration of clinical symptoms as well as the titre and duration of virus shedding are significantly reduced following infection. As with other vaccines, vaccination may not completely prevent but does reduce the risk of infection.

Vaccination of the whole herd, including both infected and uninfected cattle, is recommended. Following use of Rispoval IBR-Marker Live the risk of infection, titre and duration of virus shedding are all reduced. The duration of a programme to achieve the status of a BHV-1 free herd is dependent on the initial level of BHV-1 infection in the herd and the sale or culling of remaining BHV-1 positive animals.