Cattle.

For active immunisation of calves from the day of birth onwards to reduce clinical signs of respiratory disease and viral shedding from infection with BRSV and PI3.

Onset of immunity: BRSV: 6 days (for calves vaccinated from the day of birth onwards);

5 days (for calves vaccinated from the age of 1 week onwards);

PI3: 1 week.

Duration of immunity: 12 weeks.

None.

Vaccinate healthy animals only.

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

The efficacy against BRSV may be reduced by presence of maternally derived antibodies.

Vaccinated calves may excrete the vaccine strains up to 12 days following vaccination.

It is recommended to vaccinate all calves of the herd.

Not applicable.

Cattle:

2 Minor and transient (very rarely up to 41.1 °C); normally resolves within four days.

3 Mild and transient. Normally resolves in three days.

4 Transient. Normally resolves within four 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 its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

Pregnancy and lactation:

Can be used during pregnancy.

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

Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Bovilis Nasalgen-C. 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.

Calves can be vaccinated from the day of birth onwards.

Reconstitute lyophilisate with solvent as described below. Ensure that the lyophilisate is completely reconstituted before use. The reconstituted vaccine is an orange/brown to off-pink or pink coloured suspension.

Administer a single dose of 2 ml reconstituted vaccine per animal in one nostril.

For proper reconstitution of the lyophilisate, transfer the solvent to the vial with the lyophilisate (2 ml for the 1 dose, 10 ml for the 5 dose; also see the table below) using a needle and syringe. The vacuum in the vaccine vial will allow quick emptying of the syringe. Then resuspend by shaking. The vaccine suspension can be drawn up in a syringe with a clean tip. The vaccine in the syringe is now ready for administration, directly from the tip of the syringe. A spraying device is not required.

For proper reconstitution of the lyophilisate, transfer 10 ml of the solvent to the vial with the lyophilisate using a needle and syringe. The vacuum in the vaccine vial will allow quick emptying of the syringe. Then resuspend by shaking. Completely draw up the vaccine suspension and transfer it back to the solvent vial in order to get the correct dose/volume ratio for the respective presentation (20 ml for the 10 dose, 40 ml for the 20 dose; also see the table below). The vaccine suspension can be drawn up in a syringe with a clean tip. The vaccine in the syringe is now ready for administration, directly from the tip of the syringe. A spraying device is not required.

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

At a 10-fold maximum dose, no other signs than those described under section ‘Adverse reactions’ have been observed. In individual calves exposed to very high maximum dosages (150-fold maximum dose) signs of moderate to severe respiratory disease have been observed.

Zero days.