Rispoval 3 Suspension for Injection for Cattle (5 Doses)

Rispoval 3 BRSV Pi3 BVD Lyophilisate and suspension for suspension for injection for cattle
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 from 12 weeks of age to:

•reduce virus excretion and the clinical signs caused by PI3 virus,

•reduce virus excretion caused by BRSV infection, reduce virus excretion and the severity of leucopenia induced by BVDV type 1 infection

Onset of immunity: 3 weeks after vaccination.

Duration of immunity: 6 months (demonstrated by challenge studies) after vaccination for BRSV and BVDV Type 1. Duration of immunity has not been established for PI3.

Efficacy has not been demonstrated against BVDV Type 2 strains.

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. If ongoing protection against BRSV and BVDV Type 1 is required, then animals should be re-vaccinated after 6 months.

Contra-indications, warnings, etc

Do not use in 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. In very rare cases, the vaccine may cause hypersensitivity reactions. In case of anaphylactic reaction, symptomatic treatment should be provided.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be decided on a case by case basis.

Operator warnings

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

Withdrawal periods

Zero days.

Pharmaceutical precautions

Store and transport refrigerated (+2°C to +8°C). Do not freeze. Protect from heat and light.

Once reconstituted, use within 2 hours.

Do not mix with any other veterinary medicinal 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 and sight of children.

Legal category

POM-V

Packaging Quantities

Cardboard carton containing a 5 dose vial of freeze dried component supplied together with a 5 dose vial of liquid fraction.