Contraindications
None.
Special warnings
Vaccinate healthy animals only.
Do not vaccinate animals which are receiving treatment with antimicrobials effective against Lawsonia spp. (see section "Interaction with other medicinal products and other forms of interaction")
Efficacy of revaccination is unknown.
Special precautions for use
Special precautions for safe use in the target species.
In case of anaphylactic reactions, appropriate symptomatic treatment including the administration of glucocorticoids, adrenaline, or antihistamines is recommended.
The vaccine has not been tested in breeding boards. Therefore, the vaccination of breeding boars is not recommended.
The vaccine is an attenuated live vaccine and the potential for spreading to non-vaccinated animals cannot be excluded. However, based on the studies conducted with sentinel pigs, the apparent frequency of spreading and associated risk is very low. Lawsonia intracellularis DNA could be detected up to 3 days post vaccination in faecal samples of more than half of vaccinated animals, therefore transmission to pen-mates cannot be excluded in this time period.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Avoid accidental contact with the skin. In the event of accidental skin contact, wash with soap or antibacterial wash and rinse well.
Special precautions for the protection of the environment:
Not applicable.
Adverse reactions
Pigs:
None known.
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 its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy:
No adverse reaction was observed after administration of the vaccine in pregnant sows.
Fertility:
No adverse reaction was observed after administration of the vaccine in breeding sows.
Interaction with other medicinal products and other forms of interaction
Since the vaccine isolate is a live bacterium, simultaneous use of antimicrobials which are effective against Lawsonia spp. should be avoided for a minimum of 3 days before and after vaccination (see section "Special warnings").
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
No adverse reactions have been observed following administration of a 10-fold overdose.
Withdrawal period
Zero days.