A powder containing modified live Bovine parainfluenza type 3 virus (PI3V) virus, thermosensitive strain RLB103, between 105.0 and 108.6 CCID50* and modified live Bovine Respiratory Syncytial virus (BRSV), strain 375, between 105.0 and 107.2 CCID50*, supplied with sterile diluent (water for injection and sodium chloride, 18 mg per 2 ml) for reconstitution.

*CCID50 : Cell Culture Infective Dose 50%

For active immunisation of maternally derived antibody positive or negative calves from 9 days of age against BRSV and PI3V, to reduce the mean titre and duration of excretion of both viruses.

Onset of immunity: 5 days for BRSV and 10 days for PI3V after a single vaccination.

Duration of protective immunity: 12 weeks following a single dose. The duration of protective immunity against the PI3V fraction may be reduced in MDA positive calves vaccinated before 3 weeks of age.

Reconstitute the 1 dose and 5 dose presentations by aseptically adding all the liquid to the vial containing the powder components. Shake well before use.

Reconstitute the 25 dose presentation by mixing the lyophilised fraction with the solvent in 2 steps:

Shake well before use.

A single dose of 2ml of reconstituted vaccine should be given intranasally using the intranasal applicators provided to cattle from the age of 9 days. It is recommended to change applicators between animals to avoid transmitting infectious organisms.

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

Viruses can spread from vaccinated to non-vaccinated calves and may cause a serological response, but without causing clinical signs. In laboratory experiments based on the data using 3 week-old animals, shedding was observed for BRSV and PI3V up to 11 and 7 days respectively after vaccination with one dose containing the maximal virus content.

Animals should preferably be vaccinated at least 10 days before a period of stress or high infection risk like re-grouping or transport of animals, or at the start of the autumn season. To achieve optimal results, it is recommended to vaccinate all the calves within the same herd.

Published evidence shows that on rare occasions repeated exposure to BRSV may trigger hypersensitivity reactions. In colostrum-deprived animals vaccinated before 3 weeks of age with a 10x overdose of vaccine, transient temperature increase, nutritional scour, abnormal faeces and demeanour were observed.

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.

Do not mix with any other veterinary medicinal product.

Zero days.

Store and transport refrigerated (2°C - 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.

Box containing a 5 or 25 dose vial of powder together with a 5 or 25 dose vial of sterile diluent (10 or 50 ml).

Box containing 5 vials of 1 dose of powder with 5 vials of sterile diluent (2 ml).

Not all pack sizes may be marketed.

Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.