The presence of maternal antibodies can influence the efficacy of the vaccination. Therefore it is recommended to ascertain the immune status of calves before vaccination is started.
Vaccinate healthy animals only.
Special precautions for use in animals
In some cases, the vaccine virus may be excreted after intranasal administration from vaccinated animals. After intranasal administration of a 10-fold overdose, the vaccine virus was detected for up to 9 days after vaccination. In very young calves and in rare cases, vaccine virus was excreted until day 18 post intramuscular vaccination with a 10-fold overdose. Exceptional transmission of the virus from intranasally-vaccinated animals to non-vaccinated in-contact animals may occur due to the nature of the vaccine even though no verified data available would indicate that spreading of the vaccine virus occurs in a group of animals.
It is recommended to vaccinate all the cattle in the herd.
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.
Pregnancy and lactation:
Can be used during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
Immunosuppressive substances e.g. corticosteroids or Bovine Viral Diarrhoea modified live vaccines, should be avoided for a period of 7 days prior to and after vaccination as this may impair the development of the immunity.
Interferon sensitive products should not be applied intranasally following 5 days after intranasal vaccination.
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 decided on a case by case basis.
Do not mix with any other veterinary medicinal product except diluent supplied for use with the product.
Overdose
After intranasal administration of a 10-fold overdose, a transient hyperthermia (> 39.5°C) was observed in some calves for up to 3 consecutive days. After intramuscular administration of a 10-fold overdose, a transient hyperthermia (> 39.5°C) was observed in some calves for up to 4 consecutive days. In another study, a transient (one day) slight serous ocular discharge was observed in some calves after intramuscular administration of a 10-fold overdose.
Otherwise reactions after administration of an overdose of the vaccine are not different from those after the single dose.
Adverse reactions
Cattle:
Rare (1 to 10 animals / 10,000 animals treated): | Nasal discharge1 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Injection site swelling2, Hypersensitivity reaction3 |
1Slight transient, serous discharge may occur for up to 7 days following intranasal inoculation.
2Transient swelling up to 3 cm which generally subsides within 7 days; when injected intramuscularly.
3Vaccinated animals should be observed for approximately 30 minutes following immunisation. If such reactions occur, antiallergics should be administered.
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 the package leaflet for respective contact details.
Withdrawal periods
Zero days.