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 freeze dried pellet, each dose containing live attenuated Parainfluenza type 3 (PI3) virus, strain ts RLB 103, minimum 105.2 CCID50 and live attenuated Infectious Bovine Rhinotracheitis (IBR) virus, strain ts RLB 106, minimum 105.5 CCID50 supplied together with a vial of sterile diluent for reconstitution. Also contains traces of neomycin sulphate and gentamycin sulphate (not exceeding 25 µg).

Uses

For the active immunisation of calves and growing cattle to reduce the clinical signs and viral shedding associated with Infectious Bovine Rhinotracheitis (Bovine Herpesvirus type 1) and to reduce PI3 viral shedding from infected animals.

Onset of immunity occurs by 4 days after vaccination.

Duration of protection has been demonstrated for up to 6 months after vaccination for the IBR virus component and for up to 5 months after vaccination for the PI3 virus component.

Dosage and administration

Reconstitute the entire contents of the vaccine with the entire contents of the sterile diluent, using the needle and syringe provided. For each animal, withdraw 2ml of reconstituted vaccine, substitute the needle with the nasal applicator and administer 2ml into one nostril, holding the head up gently but firmly. One applicator is supplied for each dose.

Take care to avoid the introduction of contamination while reconstituting and withdrawing the vaccine. The vaccine should be used immediately after reconstitution and not stored.

Vaccination Programme:

Animals older than 10 weeks of age:

A single dose of vaccine should be administered.

Animals from 3 weeks to 10 weeks of age:

Since maternal antibodies may interfere with the development of immunity in very young calves, it is advisable to give two doses of vaccine, at least 14 days apart. The first dose may be given at any time from 3 weeks of age. The second dose should not be given until at least 10 weeks of age.

Revaccination:

In order to maintain immunity, animals should be revaccinated every 6 months with a single dose of vaccine.

Contra-indications, warnings, etc

Do not vaccinate unhealthy or pregnant animals.

Vaccination may be followed by pyrexia, which may last from 1 to 4 days and will usually resolve without medication.

Do not vaccinate animals for at least one month after cessation of corticosteroid treatment. If an anaphylactic response occurs, institute appropriate antihistaminic therapy.

The vaccine virus may spread to susceptible contact animals, which may cause these animals to seroconvert to IBR virus and/or PI3 virus. It is therefore recommended to vaccinate all animals housed together at the same time. Unvaccinated pregnant animals should not be housed with recently vaccinated stock. No special precautions are needed for other livestock, vaccinators or stock handlers.

Do not mix with any other immunological product except the diluent supplied.

Withdrawal Period

Zero days.

Pharmaceutical precautions

Store and transport vaccine between +2°C and +8°C away from light. Do not freeze.

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

Do not mix with any other immunological product except the diluent provided.

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 of children.

Legal category

POM-V

Packaging Quantities

Cardboard carton containing a 5 dose vial supplied together with a 10ml vial of sterile diluent. Also supplied in a cardboard carton containing 20 x 5 dose vials supplied together with 20 x 10 ml vials of sterile diluent. Not all pack sizes may be marketed. Needles and syringes for reconstitution and nasal applicators for vaccination are provided in separate accessory packs.