Onset of immunity:	3 weeks.
Duration of immunity:	6 months (demonstrated by challenge studies) for BRSV and BVDV Type 1. Duration of immunity has not been established for bovine Pi3 virus.

Efficacy has not been demonstrated against BVDV Type 2 strains.

Dose to be administered and administration route

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.

Vaccination scheme:

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.

Adverse reactions

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.

³ In 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.