Cattle.

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

- reduce virus excretion and the clinical signs caused by bovine Pi3 virus,

- reduce virus excretion caused by BRSV infection and

- reduce virus excretion and the severity of the leucopenia induced by BVDV Type 1 infection.

Efficacy has not been demonstrated against BVDV Type 2 strains.

None.

Vaccinate healthy animals only.

Not applicable.

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

Not applicable.

Cattle:

Very common (>1 animal / 10 animals treated):	Hyperthermia1 Injection site inflammation2
Very rare (<1 animal / 10,000 animals treated, including isolated reports):	Hypersensitivity reaction, anaphylactic-type reaction3

1Transient and mild; can last for 2 days.

2Transient and minor; up to 0.5 cm which disappears within 15 days.

3In case of anaphylactic reaction, symptomatic treatment should be provided.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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

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 made on a case by case basis.

Dose: 4 ml.

Route: intramuscular.

Reconstitution of the vaccine:

Reconstitute the vaccine by adding the suspension to the vial containing the lyophilisate.

When the lyophilisate and suspension are filled in equally sized vials, inject the entire suspension into the vial containing the lyophilisate.

When the lyophilisate is filled in a smaller vial size than the suspension, the reconstitution of the vaccine is carried out in 2 steps:

1. Inject 10 ml of the suspension on the lyophilised plug in the vial containing the lyophilisate.

2. Shake well and extract the reconstituted lyophilised fraction from the vial and mix with the remaining suspension in the liquid fraction vial.

Shake well before use.

Reconstituted product is a slightly coloured turbid liquid which might contain a loose sediment which is easily resuspended on shaking well.

Administer one dose (4 ml) of the reconstituted vaccine according to the following vaccination scheme:

Basic immunisation: two doses, each of 4 ml, 3-4 weeks apart from 12 weeks of age.

Booster vaccinations: if protection against BRSV and BVDV Type 1 is required, then animals should be revaccinated after 6 months.

Animals should be preferably vaccinated at least 3 weeks before a period of stress or high infection risk like re-grouping or transport of animals, or the start of autumn season. The duration of immunity of the Pi3 component is not known.

No adverse events other than those mentioned in section "Adverse events" were observed after administration of an overdose of the vaccine.

Not applicable.

Zero days.