Bovela Lyophilisate and Solvent for Suspension for Injection for Cattle

Long lasting viremia has been observed after vaccination, in particular in pregnant
seronegative heifers (10 days in a study). This may result in transplacental
transmission of the vaccine virus, but no adverse effects on foetus or pregnancy was
observed in studies.
Shedding of the vaccine virus by body fluids cannot be excluded.
The vaccine strains are able to infect sheep and swine when administered
intranasally, but no adverse reactions or spreading to in-contact animals has been
demonstrated.
The vaccine has not been tested in breeding bulls and should therefore not be used
in breeding bulls.

i) Special precautions for use in animals
Vaccinate healthy animals only.
To ensure the protection of animals introduced to the herd where BVDV is
circulating, vaccination has to be completed 3 weeks before introduction.
The cornerstone of bovine viral diarrhoea (BVD)-eradication is identification and
culling of persistently infected animals. A definitive diagnosis of persistent infection
can only be established upon re-testing in blood after an interval of at least 3 weeks.
In some limited cases with newborn calves, positive ear notches for BVDV vaccine
strain were reported by molecular diagnostic tests. Additional laboratory tests to
differentiate vaccine strain virus from field strain are available upon request from the
marketing authorisation holder.
The field studies to investigate the efficacy of the vaccine were done in herds where
persistently infected animals had been removed.
ii) Special precautions to be taken by the person administering the veterinary
medicinal product to animals
In case of accidental self-injection, seek medical advice immediately and show the
package leaflet or the label to the physician.

Amended pages: March 2026
AN: 04071/2024