Contraindications
Do not use in case of hypersensitivity to the active substances, to the adjuvants or to any of the excipients
Special warnings for each target species
Vaccinate healthy animals only.
Special precautions for use
Special precautions for use in animals
Not applicable
Special precautions to be taken by the person administering the veterinary medicinal product to animals
To the user:
This veterinary medicinal product contains mineral oil. Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.
To the physician:
This veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Adverse reactions (frequency and seriousness)
A transient increase in body temperature (maximum 2°C) can be observed between 4–24 hours after vaccination, this event is very common. Temperatures return to normal values within 24–48 hours. The vaccine can produce short term apathy between 1 and 2 days post-vaccination, this event is common. Apathy may last for up to 7 days after vaccination, however this event is uncommon. Injection site reactions (swelling and reddening) occurred rarely, with a maximum of 3 cm of diameter and a maximum of 10 days of duration.
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. The vaccine should not be given in the 4 week period before the expected farrowing date.
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
After administration of a double vaccine dose, a slightly higher transient temperature increase may be observed compared to that after a single vaccine dose (e.g. temperature increase of up to 2.5 °C after a double dose).
Withdrawal period: Zero days.
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.