Cattle (pregnant heifers and cows).

Active immunisation of pregnant heifers and cows in order to stimulate the development of antibodies against bovine rotavirus, bovine coronavirus and E. coli expressing F5 (K99) adhesin and to increase the level of passive immunity of calves against neonatal diarrhoea caused by bovine rotavirus, bovine coronavirus and E. coli expressing F5 (K99) adhesin.

In calves fed with colostrum and milk from vaccinated cows for the first week of life, laboratory studies conducted with heterologous challenge strains (a G6 BRV strain, a BCV strain, and a K99 E. coli strain) have demonstrated that these antibodies:

- prevent neonatal diarrhoea caused by bovine rotavirus and E. coli expressing F5 (K99) adhesin,

- reduce the incidence and severity of neonatal diarrhoea caused by bovine coronavirus,

- reduce faecal shedding of virus in calves infected with bovine rotavirus and bovine coronavirus.

Onset of immunity:

In calves fed with colostrum from vaccinated heifers or cows, passive immunity commences with colostrum feeding and is dependent on calves receiving sufficient colostrum after birth.

Calves fed with colostrum and milk from vaccinated dams for the first week of life are protected against bovine rotavirus for 7 days and against bovine coronavirus for 14 days. The duration of immunity against infections caused by E. coli expressing F5 (K99) adhesin was not studied since such disease is usually observed in calves less than 3 days of age and susceptibility to enterotoxigenic E.coli is age dependent.

None.

Vaccinate healthy animals only.

To achieve optimum results and to reduce infection pressure on the farm, a whole herd cow vaccination policy should be adopted, as well as standard infectious diseases control practices.

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

An increase in mean body temperature of 1.0°C was very commonly observed in laboratory and field studies; in individual cases, the maximum increase may reach 2.1°C, with body temperatures resolving to normal levels within 2 days without impairing the general health status of the vaccinated animals.

A localised mild swelling (≤ 5 cm in diameter) at the injection site resolving within 2 days was commonly observed in field studies.

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

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

Can be used during pregnancy.

The effect of vaccination on pre- or post-partum lactation was not studied.

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.

Slowly warm up to room temperature and gently shake the content of the vial before administration.

One dose of 2 ml by intramuscular injection.

A single injection should be given during each pregnancy between 12 and 3 weeks before the expected calving.

Colostrum feeding:

Calves are born without protection from antibodies. Immunity against calf diarrhoea is provided by rapid uptake of colostral antibodies from vaccinated dams. The first colostrum intake should take place as soon as possible, ideally within 2 hours and at most 6 hours after birth. In dairy calves, it should represent a volume equivalent to approximately 10% of the body weight, followed by a similar volume within 12 hours. Beef calves should stand and suckle within 2 hours of calving.

Not applicable.

Zero days.