Rispoval IBR-Marker Inactivated

Introduction

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

An inactivated Infectious Bovine Rhinotracheitis Marker (gE negative) vaccine.

One dose (2 ml) contains: Bovine herpes virus type 1 (BHV-1), IBR Marker virus, gE negative prior to chemical inactivation min. 108.0 CCID50, Aluminum hydroxide 18.6 mg, Saponine 0.25 mg, Thimerosal max. 0.2 mg.

Uses

For the active immunisation of cattle against Infectious Bovine Rhinotracheitis (IBR) to reduce the clinical signs and virus shedding and, in female cattle, to prevent abortions associated with BHV-1 infection. The vaccination of pregnant cattle will prevent abortion associated with BHV-1 infection as demonstrated during the second trimester of gestation following challenge 28 days after vaccination.

Dosage and administration

Dose

Cattle over 3 months of age: 2 ml.

Route

Subcutaneous injection.

Shake the vaccine well before use.

Vaccination Scheme

The vaccination scheme consists of basic immunisation and booster vaccinations.

Basic Immunisation

Two doses, each of 2 ml, 3-5 weeks apart.

Booster vaccinations

One dose of 2 ml at 6 monthly intervals.

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

Use only sterile needles and syringes for administration.

Avoid the introduction of contamination during use.

Due to the presence of maternal antibodies, the development of immunity in calves under 3 months of age may be impaired. These animals should be re-vaccinated at 3 months.

Contra-indications, warnings, etc

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

Transient subcutaneous swelling up to the size of a palm, which subsides within 14 days, may occur at the injection site. 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 immunity.

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

Do not mix with any other vaccine/immunological product.

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: Any unused product or waste material should be disposed of 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.

Further information

Can be used during pregnancy and lactation.

Glycoprotein gE is absent in virus particles of Rispoval IBR-Marker Inactivated. 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. Following infection the intensity of clinical symptoms as well as the titre and duration of virus shedding are significantly reduced. 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 Inactivated 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.

Marketing authorisation number

Vm 00057/4222.

Significant Changes

Rispoval IBR-Marker Inactivated

Pfizer Limited

Additional indication: protection against BHV-1 associated abortions

01/03/2007