Indications for use, specifying the target species
For active immunisation of cattle in the absence of maternally derived antibodies against:
- parainfluenza 3 virus, to reduce virus excretion due to infection
- bovine respiratory syncytial virus, to reduce virus excretion due to infection
- bovine viral diarrhoea virus, to reduce virus excretion due to infection
- Mannheimia haemolytica serotype A1, to reduce clinical signs and lung lesions.
Onset of immunity:
Duration of immunity:
Special warnings for each target species
Vaccinate healthy animals only
Special precautions for use in animals
Safety and efficacy studies were performed in sero-negative calves. The efficacy of the vaccination has not been demonstrated in presence of antibodies. The level of antibody response may be reduced by the presence of maternal antibodies. In the presence of maternal antibodies, timing of initial vaccination of calves should be planned accordingly.
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)
A localised swelling may be very commonly observed at the injection site after vaccination. This swelling could reach up to 10cm or more in diameter and may be associated with pain and usually progressively reduces and disappears within 6 weeks after vaccination.
A transient slight increase in body temperature may commonly appear which is higher after the second injection (1.5°C at most) lasting up to 3 days after vaccination.
Anaphylactic-type reactions may very rarely occur after vaccination. In such cases, appropriate symptomatic treatment should be administered.
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, lactation or lay
Can be used 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
Dose: 2 ml administered subcutaneously.
Warm before use to a temperature of 15 °C to 25 °C and shake the contents of the bottle.
Calves from non-immune dams: two doses three weeks apart from 2 weeks of age
For calves from immune dams or where the immune status of the dam is unknown, the vaccination scheme should be adapted at the discretion of the veterinarian to take into account potential interference of maternally derived antibodies with the response to vaccination.
Administer one dose six months after completion of the primary vaccination scheme.
The efficacy of revaccination was demonstrated by measurement of the serological response and has not been assessed by challenge.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse effects other than those mentioned in the "Adverse Reactions" section were observed.