Coxevac suspension for injection for cattle & goats 40ml

Target species
Cattle and goats
Indications for use, specifying the 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: one year after completion of the primary vaccination course.
Contraindications
None.
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
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 (frequency and seriousness)
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.
Systemic signs as lethargy, hyperthermia, and/or anorexia have been observed rarely in post marketing safety experience.
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.
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 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.
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
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.
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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
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 period(s)
Meat, milk and offal: Zero days.

Pharmaceutical particulars
List of excipients
Thiomersal, Sodium chloride, Disodium hydrogen phosphate, Potassium dihydrogen phosphate, Water for injections
Major incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 10 hours.
Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Protect from light.
Nature and composition of immediate packaging
Carton box with 1 plastic (LDPE) bottle, containing 40 ml of suspension.
Carton box with 1 plastic (LDPE) bottle, containing 100 ml of suspension.
Each container is closed with a 20 mm bromobutyl rubber stopper and a central tear-off aluminium-plastic cap.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.