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

Inactivated, adjuvanted Pasteurella haemolytica vaccine. An off-white freeze-dried pellet containing antigens of Pasteurella haemolytica biotype A, serotype 1, together with an oil-in-water adjuvant.

Uses

Intended for active immunisation of cattle to reduce lesions and respiratory disease caused by Pasteurella haemolytica biotype A, serotype 1.

Dosage and administration

Reconstitute the vaccine by first shaking the vial containing the liquid, and then aseptically withdraw and add all of the liquid to the vial containing the freeze-dried components.

Shake well and aseptically administer 2 ml intramuscularly.

Studies carried out on the vaccine showed that a single dose is sufficient to confer protection from challenge by Pasteurella haemolytica within 7 days of vaccination.

Vaccination programme

A single two ml dose of vaccine to be given to healthy cattle over the age of 3 months.

Ideally, calves should be vaccinated at least 7 days before transport, mixing animals of different origins, housing or any other event which may cause the animals to be stressed or exposed to new infections.

Calves are usually most susceptible during early autumn.

The vaccine will protect animals for at least 17 weeks, which will cover the period of risk from pasteurellosis.

Should cattle be at risk from pasteurellosis at a subsequent time, a single vaccination is recommended at least 7 days prior to the period of expected disease challenge.

Contra-indications, warnings, etc

Do not vaccinate unhealthy animals, pregnant animals or heifers at the time of breeding.

A mild, transient fever might be observed 24 to 48 hours after vaccination in some animals. Temperatures return to normal in the following 24 to 48 hours without remedial action.

A mild, transient local swelling might be observed at the site of injection 24 to 48 hours after vaccination in a small number of animals. These swellings do not cause discomfort to the animals even on palpation. In the majority of cases site reactions are undetectable by 14 days after vaccination but occasionally might be observed for up to 48 days. The average size of any reaction 48 hours after intramuscular vaccination was 5 cm in diameter reducing to about half that size by day 5.

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

To the user

This product is a mineral oil-based compound. Accidental self-injection may result in severe pain and swelling and could result in loss of the affected finger or thumb if prompt medical attention is not given.

Ensure that the method of restraint, handling and administration, e.g. by the use of guarded needles, minimises the risk of accidental injection/self injec- tion.

If you are accidentally injected with this product, clean and disinfect the wound immediately. Go AT ONCE to the nearest accident and emergency (casualty) department of a hospital and show the information printed below to the doctor (or nurse) on duty.

If pain persists for more than 12 hours after medical examination, seek further medical advice.

To the doctor

Even if very tiny amounts have been injected, accidental injection with this oil-based product is particularly irritating. The accidental injection can cause intense swelling which may, for example, result in ischaemic necrosis and the loss of a digit in exceptional cases. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.

Withdrawal period

Zero days.

Pharmaceutical precautions

Do not use chemically sterilised syringes or needles.

Unused product and empty vials are to be disposed of safely by incineration or by immersion in an approved disinfectant before disposal.

Storage conditions

Store away from light between +2°C and +8°C.

Do not freeze.

Reconstituted vaccine should be used immediately.

Unused vaccine should be discarded.

Legal category

POM-V

Packaging Quantities

5 and 25 dose vials of freeze-dried component are available, together with an equal number of vials of liquid component in 5 and 25 doses.

Further information

No information is available on the safety and efficacy from the concurrent use of this vaccine with any other product except Rispoval RS or Rispoval 4. It is therefore recommended that no other vaccines than these should be administered within 14 days before or after vaccination with the product.

Marketing authorisation number

Vm 00057/4202.