Target species
Cattle (pregnant heifers and cows).
Indications for use, specifying the target species
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.
Duration of immunity:
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.
Contraindications
None.
Special warnings
Vaccinate healthy animals only.
Special precautions for use
Special precautions for the safe use in the target species:
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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
In case of adverse reactions following accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Cattle (pregnant heifers and cows)
Very common (>1 animal / 10 animals treated): Elevated temperature1.
Common (1 to 10 animals / 100 animals treated): Injection site swelling2.
1. Mean increaseof 1.0°C that may reach 2.1°C in individual cases, resolving within 2 days.
2. Localised (diameter ≤ 5 cm) mild, resolving within 2 days.
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.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Can be used during pregnancy.
The effect of vaccination on pre- or post-partum lactation was not studied.
Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this vaccine when used with any other immunological veterinary medicinal product. A decision to use this vaccine before or after any other immunological veterinary medicinal product therefore needs to be made on a case-by-case basis.
Administration routes and dosage
Intramuscular use.
Slowly warm up to room temperature and gently shake the content of the vial before administration.
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.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Not applicable.
Withdrawal periods
Zero days.