Target species
Cattle.
Indications for use, specifying the target species
For the active immunisation of calves from the age of 10 days against bovine respiratory syncytial virus (BRSV) and bovine parainfluenza 3 virus (PI3V), to reduce the quantity and duration of nasal excretion of both viruses.
Onset of immunity: 10 days after vaccination
Duration of immunity: 12 weeks after vaccination.
Contraindications
None.
Special warnings for each target species:
The laboratory efficacy studies have demonstrated that the presence of maternally derived antibodies at the time of vaccination had no impact on vaccine efficacy in young animals.
Vaccinate healthy animals only.
Special precautions for use
Special precautions for use in animals
Vaccinated calves can excrete the vaccine strains BRSV and PI3V for up to 6 days after vaccination. Therefore, the spread of the vaccine virus from vaccinated to unvaccinated calves cannot be excluded. Animals should be vaccinated at least 10 days before the critical period of stress or high risk of infection, such as rearrangement or transport of animals, or in early autumn. To achieve optimal results, it is recommended to vaccinate all calves of the herd.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Not applicable.
Special precautions for the protection of the environment:
Not applicable.
Adverse reactions (frequency and seriousness)
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Hypersensitivity reaction* |
*may require appropriate symptomatic treatment
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 the last section of the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
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 products. 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.
Reconstitute the vaccine by aseptically adding the supplied solvent into the vial containing the lyophilised component. Mix well. Appearance after reconstitution: opalescent liquid of yellowish to pinkish colour.
Required volume of the reconstituted vaccine is either drawn up from the bottle by syringe with a needle, the needle is then replaced by the intranasal applicator provided and the vaccine is administered or left in the bottle and administered via a multi-dose applicator that can deliver each dose through the intranasal applicator. The intranasal applicator is used to spray the required volume of the vaccine into the animal´s nostrils. The applicator used should spray the vaccine in the form of 30 µm to 100 µm droplets.
Vaccination schedule:
Administer one dose (2 ml) of the reconstituted vaccine intranasally (1 ml of the vaccine into each nostril) to calves from 10 days of age using an intranasal applicator. It is recommended to use a new applicator for each animal, in order to prevent the transmission of infection.
Overdose (symptoms, emergency procedures, antidotes), if necessary
A slight and transient nasal discharge was observed the first three days after the administration of a 10-fold overdose without any adverse consequence for in-contact animals.
Withdrawal periods
Zero days.