Cattle.

For the active immunisation of cattle from the day of birth onwards to reduce clinical signs of upper respiratory tract disease and nasal viral shedding from infection with bovine coronavirus.

Onset of immunity: 5 days.

Duration of immunity: 12 weeks.

None.

Vaccinate healthy animals only.

Animals should preferably be vaccinated at least 5–7 days before a period of stress or increased infection pressure.

Vaccinated cattle may excrete the vaccine strain nasally or orally following vaccination. Excretion has been observed for up to 9 days following vaccination but may persist longer. The vaccine strain can spread to other cattle. Spread to other species has not been investigated and cannot be excluded.

It is recommended to vaccinate all calves of the herd.

Appropriate biosecurity procedures to limit the risk of introduction and spread of bovine coronavirus infection in premises should be part of management tools.

Not applicable.

Cattle:

1Elevated temperature up to 40.7 °C which normally resolves within three 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 also section “Contact details” of the package leaflet.

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Bovilis INtranasal RSP Live. The vaccines should be given into different nostrils. The product information of that veterinary medicinal product should be consulted before administration.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above. 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.

Nasal use.

Administer a single dose of 2 ml reconstituted vaccine to the calf from the day of birth onwards in one nostril.

Reconstitute the lyophilisate with the solvent (Unisolve) supplied as described below. Ensure that the lyophilisate is completely reconstituted before use.

The reconstituted product is a colourless or off-yellow suspension.

For proper reconstitution of the lyophilisate, transfer the solvent to the vial with the lyophilisate using a transfer needle or using a needle and syringe.

The 10-, 20-, and 50-dose presentations require a two-step reconstitution of the solvent to the vial with the lyophilisate and back to the solvent vial.

See the table below for the appropriate volumes. The vacuum in the vaccine vial will allow quick insertion of the solvent into the lyophilisate vial. Ensure complete resuspension by shaking the vial. The vaccine suspension can be drawn up in a syringe with a clean tip. Alternatively, the vial with reconstituted vaccine can be put in a multi-dose applicator.

The vaccine is now ready for administration into the nostril, directly from the tip of the syringe or applicator. A spraying device is not required.

When vaccinating animals, it is recommended to change syringes or tips of a multi-dose applicator between animals to avoid transmission of pathogens.

No adverse events other than those mentioned in Adverse reactions were observed after administration of a 10-fold overdose of the vaccine.

Zero days.