Contra-indications: Do not use in cases of hypersensitivity to the active substances, to the adjuvants or to any of the excipients.
Special warnings for the target species: Vaccinate healthy animals only. In farms with recurring reproductive disorders caused by Chlamydia abortus and/or Salmonella Abortusovis, it would be advisable to maintain a high level of immunity within the flock.
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: A palpable local reaction at the injection site, which may appear approximately 1 week post-vaccination, occurred very commonly in studies. In most cases, the reaction is slight or moderate and subsides within 2 weeks without treatment. In some isolated cases, these reactions can reach up to 6 cm but rapidly decrease in diameter within 2 days without need for treatment. An increase in temperature of up to 1.0 °C occurred very commonly 1 day after vaccination in studies. This slight increase subsided spontaneously within 24 hours.
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: Safety of the vaccine during pregnancy and lactation has been established, as well as efficacy during the second third of gestation. The use is not recommended during the last month of gestation.
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 (symptoms, emergency procedures, antidotes), if necessary: No information is available
Withdrawal period: Zero days.