No information is available on the safety of this vaccine in breeding boars. Do not use in breeding boars.
The safety of the veterinary medicinal product has not been established during pregnancy or lactation. Do not use during pregnancy and lactation.
Vaccinate only healthy animals.
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.
Do not mix with any other veterinary medicinal product.
Adverse reactions
A transient increase in body temperature (on average 1°C) was very commonly observed during the first 24 hours after vaccination in laboratory and field trials. In individual pigs the temperature increase compared to pre-treatment may commonly exceed 2°C. This resolves spontaneously within 48 hours without treatment.
Local tissue reactions in the form of swelling at the injection site, which may be associated with local heat, redness and pain at palpation are very common and may last for up to 2 days (based on laboratory safety studies). The area of local tissue reactions is in general below 2 cm in diameter. In a laboratory study, a post-mortem examination of the injection site, performed 4 weeks after the administration of a repeated single dose of the vaccine, very commonly revealed a mild inflammatory response, as evidenced by the absence of tissue necrosis and little fibrosis.
Immediate mild hypersensitivity-like reactions were uncommonly observed after vaccination, resulting in transient clinical signs such as vomiting, diarrhoea or depression, in field efficacy trials. These clinical signs normally resolve without treatment. Anaphylaxis may occur in very rare cases. In case of such reactions, appropriate treatment is recommended.
The frequency of possible adverse effects is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
A transient increase in body temperature (on average 0.8°C) was observed 4 hours after administration of a 2-fold overdose. This resolved spontaneously within 24 hours without treatment. Local tissue reaction in the form of swelling (below 2 cm in diameter) at the injection site was commonly observed and resolved within 2 days.
Withdrawal period
Zero days.
User warnings
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.