Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Special warnings for each target species
Longlasting 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.
Special precautions for use
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.
Adverse reactions (frequency and seriousness)
Target species: cattle
Common (1 to 10 animals / 100 animals treated): | Elevated temperature* |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Injection site swelling or Injection site nodule** Hypersensitivity reaction including anaphylactic-type reaction. |
*within the physiological range is common within 4 hours of vaccination, resolving within 24 hours
**≤ 3 cm in diameter, resolving within 4 days after vaccination
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
Pregnancy and lactation:
It is recommended to vaccinate before pregnancy to ensure protection against persistent infection of the foetus. While persistent infection of the foetus caused by the vaccine was not observed, transmission of vaccine virus to the foetus may occur. Therefore, use during pregnancy should only be on a case-by-case basis decided by the responsible veterinarian, taking into consideration e.g. the BVD immunological status of the animal, the time-span between vaccination and mating/insemination, the stage of pregnancy and the risk of infection.
Can be used during lactation.
Studies have shown that vaccine virus may be excreted in milk up to 23 days after vaccination at low amounts (~ 10 TCID50/ml), although when such milk was fed to calves, no seroconversion occurred in those calves.
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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Mild swellings or nodules up to 3 cm diameter were observed at the injection site after administration of a 10-fold overdose and disappeared within 4 days post vaccination.
Furthermore, an increase of the rectal body temperature was common within 4 hours following administration and spontaneously resolves within 24 hours (see 'Adverse reactions' section)
Withdrawal period
Zero days.
Prohibition of sale, supply and/or use
Any person intending to manufacture, import, possess, distribute, sell, supply and use this veterinary medicinal product must first consult the relevant country’s competent authority on the current vaccination policies, as these activities may be prohibited in a country on the whole or part of its territory pursuant to national legislation.