Special warnings for each target species
Vaccination of animals already infected at the time of vaccination will have no adverse effect.
No efficacy data are available concerning the use of COXEVAC in male animals. However, in safety laboratory trials, the use of COXEVAC in males proved to be safe. In the case that it is decided to vaccinate the whole herd, it is advisable to vaccinate the male animals at the same time.
There are no benefits of the vaccine (as described in the indications for cattle), when used in infected and/or pregnant cows.
The biological significance of the levels of reduction shown in shedding in cattle and goats is not known.
Special precautions for use in animals
It is advisable to vaccinate all the animals in the herd at the same time.
Under field conditions, vaccination with COXEVAC has commonly been followed by a decrease in milk production in goats. Since stress could contribute to this adverse reaction, appropriate precautions should be taken to reduce stress as much as possible during the administration of the product.
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
Cattle:It was very common to see in laboratory trials a palpable reaction of maximum diameter of 9 to 10 cm at the injection site, which may last for 17 days. The reaction gradually reduces and disappears without need for treatment.
Goats:It was very common to see in laboratory trials a palpable reaction of 3 to 4 cm diameter at the injection site which may last for 6 days. The reaction reduces and disappears without need for treatment.
It was very common to observe in laboratory trials a slight increase of rectal temperature for 4 days post-vaccination .
Systemic signs as lethargy, malaise and/or anorexia have been observed uncommonly in post marketing safety experience.
Diarrhoea has been observed rarely in post marketing safety experience.
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
Lactation:In cattle and goats the vaccine can be used during lactation.
Under field conditions, vaccination with COXEVAC has commonly been followed by a decrease in milk production in goats. Since stress could contribute to this adverse reaction, appropriate precautions should be taken to reduce stress as much as possible during the administration of the product.
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
Cattle: With double dose, a palpable reaction of maximum diameter of 10 cm was observed at the injection site, lasting for 16 days. The reaction gradually reduced and disappeared without need for treatment.
Goats: With double dose, a moderate palpable reaction of diameter of 4 to 5 cm was observed at the injection site, lasting for 4 days. The reaction reduced and disappeared without need for treatment.
Withdrawal periods
Meat, milk and offal: Zero hours
Do not mix with any other veterinary medicinal product.