A slightly whitish to yellowish freeze dried pellet (lyophilisate) 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 pinkish to orange-brown turbid liquid fraction containing the adjuvant Aluminium hydroxide gel 0.8 ml (equivalent to 24.36 mg 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 after the basic vaccination scheme for BRSV. Duration of immunity has not been established for bovine Pi3 virus.

Reconstitute the vaccine by adding the liquid fraction to the vial containing the lyophilised pellet.

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.

Reconstituted product: pink-orange turbid suspension with loose sediment.

Two doses of 4 ml of reconstituted vaccine should be given 3-4 weeks apart from 12 weeks of age, via the intramuscular route.

If continued protection against BRSV is required, then animals should be revaccinated after 6 months. The duration of immunity of the Pi3 component is not known.

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.

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.

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 liquid fraction recommended for use with the veterinary medicinal product.

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:

Reactions after administration of an overdose of vaccine are not different from those after the single dose.

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

Zero days.

Shelf-life after reconstitution according to directions: use immediately.

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

For animal treatment only.

Keep out of the sight and reach of children.

Cardboard box with 1 vial of lyophilisate (5 doses) and 1 vial of liquid fraction (20 ml).

Cardboard box with 1 vial of lyophilisate (25 doses) and 1 vial of liquid fraction (100 ml).

Not all pack sizes may be marketed.

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