Target species
Cattle, goats and sheep.
Indications for use for each target species
Cattle:
For the active immunisation of cattle to lower the risk for non-infected animals vaccinated when non-pregnant to become shedder (5 times lower probability in comparison with animals receiving a placebo), and to reduce shedding of Coxiella burnetii in these animals via milk and vaginal mucus.
Onset of immunity: not established.
Duration of immunity: 280 days after completion of the primary vaccination course.
Goats:
For the active immunisation of goats to reduce abortion caused by Coxiella burnetii and to reduce shedding of the organism via milk, vaginal mucus, faeces and placenta.
Onset of immunity: not established.
Duration of immunity: 1 year after completion of the primary vaccination course.
Sheep:
For the active immunisation of sheep against Coxiella burnetii, to reduce shedding of the organism via milk, vaginal mucus and faeces.
Onset of immunity: not established
Duration of immunity: 4 months
Contraindications
Do not use in cases of hypersensitivity to the active substance(s) or to any of the excipient(s).
Special warnings
Vaccinate healthy animals only.
Vaccination of animals already infected at the time of vaccination will have no adverse reaction.
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, goats and sheep is not known.
Special precautions for use
Special precautions for safe use in the target species:
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.
Special precautions for the protection of the environment:
Not applicable.
Other precautions:
None
Adverse events
Cattle:
Very common (>1 animal / 10 animals treated): | Injection site swelling* |
Rare (1 to 10 animals / 10,000 animals treated): | Lethargy, Hyperthermia, Anorexia |
* Palpable, of 9 to 10 cm diameter maximum, which may last for 17 days, reduces gradually and disappears without need for treatment.
Goats:
Very common (>1 animal / 10 animals treated): | Injection site swelling* |
Uncommon (1 to 10 animals / 1,000 animals treated): | Lethargy, Malaise, Anorexia |
Rare (1 to 10 animals / 10,000 animals treated): | Diarrhoea |
* Palpable, of 3 to 4 cm diameter maximum, which may last for 14 days, reduces and disappears without need for treatment.
** For 4 days post-vaccination.
Sheep:
Very common (>1 animal / 10 animals treated): | Injection site inflammation, application site thickening* |
Rare (1 to 10 animals / 10,000 animals treated) | Lethargy, Hyperthermia, Anorexia |
* Palpable, of 5 cm diameter maximum, which may last for 14 days, reduces and disappears without need for treatment. Reactions are expected to be more severe after the second injection.
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 section “Contact details” of the package leaflet.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Cattle and goats:
The safety of the veterinary medicinal product has not been established during pregnancy.
The vaccine can be used during lactation.
Under field conditions, vaccination with COXEVAC has been followed by a decrease in milk production, commonly in goats and rarely in cattle. 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.
Sheep:
The safety of the veterinary medicinal product has not been established 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.
Administration routes and dosage
Subcutaneous use.
Shake well before use.
Administer the vaccine as follows:
Cattle: 4 ml in the neck region.
Goats: 2 ml in the neck region.
Sheep: 2 ml in the neck region.
Cattle from 3 months of age:
Primary vaccination:
Two doses should be given subcutaneously with an interval of 3 weeks. Under normal conditions the timing of vaccination should be planned so that the primary course is completed by 3 weeks before artificial insemination or mating.
Re-vaccination:
Every 9 months, as described for primary vaccination, based on duration of immunity of 280 days.
Goats from 3 months of age:
Primary vaccination:
Two doses should be given subcutaneously with an interval of 3 weeks. Under normal conditions the timing of vaccination should be planned so that the primary course is completed by 3 weeks before artificial insemination or mating.
Re-vaccination:
One dose should be given yearly.
Sheep from 4 months of age:
Primary vaccination:
Two doses should be given subcutaneously with an interval of 3 weeks. The vaccination should be done as late as possible, but the primary course needs to be completed by 3 weeks before artificial insemination or mating.
Re-vaccination:
Prior to each artificial insemination or mating, two doses, 3 weeks apart; the vaccination course should be done as late as possible but needs to be completed at least 3 weeks before the intended start of the reproduction phase.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
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.
Sheep:
With double dose, a moderate palpable reaction of diameter of less than 2 cm was observed at the injection site, lasting for 12 days. The reaction reduced and disappeared without need for treatment.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Meat and offal: Zero days
Milk: Zero days