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

A freeze-dried fraction containing modified live Bovine parainfluenza 3 (PI3) virus, thermosensitive strain RLB103, between 105.0 and 108.6 CCID50 and modified live Bovine Respiratory Syncytial virus (BRSV), strain 375, between 105.0 and 107.2 CCID50, supplied with sterile diluent (water for injection and sodium chloride, 18mg per 2ml) for reconstitution.

Uses

For active immunisation of maternally derived antibody positive or negative calves from 3 weeks of age against BRSV and PI3, to reduce the mean titre and duration of excretion of both viruses.

Onset of immunity has been demonstrated at 10 days after a single vaccination. A statistical reduction of the amount of BRSV shed was also observed 5 days after vaccination in seronegative animals.

The duration of immunity is at least 9 weeks following a single dose.

Dosage and administration

Dose

2ml

Administration

Reconstitute the vaccine by aseptically adding all the liquid to the vial containing the freeze-dried components. Shake well.

A single dose of reconstituted vaccine should be given intranasally to cattle from the age of 3 weeks, using the applicators provided. It is recommended to change applicators between animals to avoid transmitting infectious organisms.

Contra-indications, warnings, etc

Do not use during pregnancy/lactation. Vaccinate only healthy animals.

Published evidence shows that on rare occasions repeated exposure to BRSV may trigger hypersensitivity reactions.

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

Withdrawal period

Zero days.

Pharmaceutical precautions

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

Once reconstituted use within 2 hours.

Do not mix with any other vaccine/immunological product. 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 the reach of children.

Legal category

POM-V

Packaging Quantities

A box containing a 5 dose vial of freeze-dried fraction together with a 5 dose vial of sterile diluent (10ml).

Further information

Viruses can spread from vaccinated to non-vaccinated calves and may cause a serological response, but without causing clinical signs. In laboratory experiments, shedding was observed for BRSV and PI3 viruses up to 11 and 7 days respectively after vaccination with one dose containing the maximal virus content.

Animals should preferably be vaccinated at least 10 days before a period of stress or high infection risk like re-grouping or transport of animals, or at the start of the autumn season. To achieve optimal results, it is recommended to vaccinate all the calves within the same herd.

Administration of a 10x overdose of the product resulted in no adverse reaction.

Marketing authorisation number

Vm 00057/4231.