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 fraction containing modified live PI3 (Parainfluenza 3) virus, strain RLB103 (between 105.0 and 108.6 CCID50) and modified live BRSV (Bovine Respiratory Syncytial virus) strain 375 (between 105.0 and 107.2 CCID50), supplied with a liquid fraction containing inactivated BVDV (Bovine Viral Diarrhoea Virus) type 1, strains 5960 (cytopathic) and 6309 (non-cytopathic) (to induce a SN titre in guinea pigs of at least 3.0 log2) and the adjuvant Alhydrogel 2% 0.8ml (equivalent to 24.36mg of aluminium hydroxide).

* CCID50 = Cell Culture Infectious Dose 50%

Uses

For the active immunisation of calves for:

•the reduction of virus excretion and the clinical signs caused by PI3 virus,

•the reduction of virus excretion caused by BRSV infection,

•and the reduction of virus excretion and the severity of leucopenia induced by BVDV type 1 infection.

Dosage and administration

Dose

4ml

Administration

Reconstitute the vaccine by mixing the freeze-dried component with the liquid fraction and shake well. Administer the reconstituted vaccine by the intramuscular route.

Vaccination Programme

For cattle from 12 weeks of age two doses three to four weeks apart.

Animals should preferably be vaccinated at least 3 weeks before a period of stress or high infection risk like re-grouping, transport of animals or the start of the autumn season.

Duration of Immunity

A duration of immunity of 6 months has been demonstrated by challenge studies for BRSV and BVD type 1 virus. If protection in excess of this period is required, then animals should be re-vaccinated after 6 months.

Contra-indications, warnings, etc

Do not vaccinate unhealthy animals. Do not use during pregnancy and lactation.

The administration of the vaccine can lead to a transient and mild hyperthermia which can last for 2 days and to a transient, minor local inflammation reaction of up to 0.5cm which disappears within 15 days.

Withdrawal periods

Zero days.

Pharmaceutical precautions

Store 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 reach of children.

Legal category

POM-V

Packaging Quantities

5 dose vial of freeze dried component together with a 5 dose vial of liquid fraction.

Further information

Rispoval 3 also has a broad cross-neutralising ability against various current European strains of BVDV type 1 as measured by virus neutralization in vitro. Cross-neutralisation at a lower level is also demonstrated to BVDV type 2 strains. Clinical efficacy to BVDV type 2 strains has not been demonstrated.

The onset of immunity has been demonstrated from 3 weeks after the second vaccination against BRSV, PI3 and BVDV type 1. A duration of immunity has not been established for PI3.

No adverse effects, other than those already mentioned, have been observed following an overdose of ten times the modified live fraction (powder) and two times the inactivated fraction (liquid) of the vaccine.

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