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%

For the active immunisation of calves from 12 weeks of age to:

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.

Reconstitute the vaccine by adding the liquid fraction to the freeze dried vial containing the lyophilised plug.

When the lyophilised plug and liquid fraction are in equally sized vials:

When the lyophilised plug is in a smaller sized vial than the liquid fraction, the reconstitution of the vaccine is carried out in 2 steps:

Shake well before use.

For cattle from 12 weeks of age two doses of 4 ml of reconstituted vaccine should be given three to four weeks apart, via the intramuscular route.

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.

Vaccinate healthy animals only. The safety and efficacy of the veterinary medicinal product has not been established during pregnancy and lactation. Do not use during pregnancy and lactation.

Transient and mild hyperthermia which can last for 2 days and a transient, minor local inflammation reaction of up to 0.5cm which disappears within 15 days can occur very commonly after administration of the vaccine. Very rarely, the vaccine may cause hypersensitivity reactions. In case of anaphylactic reaction, symptomatic treatment should be provided.

The frequency of adverse reactions is defined using the following convention:

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.

Do not mix with any other veterinary medicinal product, except the solvent recommended for use with the veterinary medicinal product.

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

Zero days.

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

Once reconstituted, use within 2 hours.

For animal treatment only.

Keep out of the sight and reach of children.

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

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 has also been demonstrated to BVDV Type 2 strains.

Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements.