Enterisol Ileitis 100Ml (50Dose)

4.1 Target species Pigs 4.2 Indications for use, specifying the target species For active immunisation of weaned pigs from 3 weeks of age and older to reduce the intestinal lesions caused by Lawsonia intracellularis infection and to reduce growth variability and loss of weight gain associated with the disease. Under field conditions, the difference in average daily weight gain was seen to be up to 30 g/day when vaccinated pigs were compared to unvaccinated pigs. Onset of protection occurs as early as 3 weeks post vaccination and lasts for at least 17 weeks. 4.3 Contraindications None. 4.4 Special warnings for each target species The vaccine has not been tested in breeding boars. Therefore the vaccination of breeding boars is not recommended. Do not vaccinate animals which are receiving treatment with antimicrobials effective against Lawsonia spp. Such antimicrobials should be withheld for a minimum of 3 days before and 3 days after the day of vaccination (see section 4.8). Efficacy of revaccination is unknown. 4.5 Special precautions for use Special precautions for use in animals. Vaccinate only clinically healthy animals. In case of anaphylactic reactions, appropriate symptomatic treatment including the administration of glucocorticoids, adrenaline, or antihistamines is 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 can not 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. 4.6 Adverse reactions (frequency and seriousness) None known. 4.7 Use during pregnancy, lactation or lay No adverse reaction was observed after administration of the vaccine in breeding and pregnant animals. 4.8 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 4.4). 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.