Target species
Cattle.
Indications for use
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
Contraindications
None.
Special warnings for each target species
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.
Special precautions for use
Vaccinated calves may excrete the vaccine strains up to 12 days following vaccination.
It is recommended to vaccinate all calves of the herd.
Operator warnings
Not applicable.
Adverse reactions
A mild and transient nasal discharge may very commonly occur during two days following vaccination. Mild and transient spontaneous coughing may commonly occur which normally resolves in three days. A mild and transient ocular discharge may commonly occur which normally resolves in two days. A transient rise in respiration rate may commonly occur which normally resolves within four days. A transient minor rise in body temperature may very commonly occur following vaccination (very rarely up to 41.1 °C) which normally resolves within four days.
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).
Use during pregnancy or lactation
Do not use during pregnancy and lactation.
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 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.
Amounts to be administered and administration route
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 off-pink or pink coloured suspension.
Administer a single dose of 2 ml reconstituted vaccine per animal, 1 ml in each nostril.
Instructions for reconstitution:
1, 5 and 10 dose presentations 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 and 20 ml for the 10 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.
20, 25 and 50 dose presentations
For proper reconstitution of the lyophilisate, transfer 20 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 (40 ml for the 20 dose, 50 ml for the 25 dose and 100 ml for the 50 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.
Doses per vial | Solvent volume required | Dose volume |
1 | 2 ml | 2 ml |
5 | 10 ml | 2 ml |
10 | 20 ml | 2 ml |
20 | 40 ml | 2ml |
25 | 50 ml | 2 ml |
50 | 100 ml | 2 ml |
Overdose
At 10-fold overdose, no other signs than those described under section 4.6 have been observed. In individual calves exposed to very high vaccine dosages (150-fold maximum dose) signs of moderate to severe respiratory disease have been observed.
Withdrawal period(s)
Zero days.