Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Attenuated live bacteria lawsonia intracellularis (ms b3903)
Boehringer Ingelheim Vetmedica GmbH
QI09AE04
Attenuated live bacteria lawsonia intracellularis (ms b3903)
. tissue culture infective dose 50/dose
Lyophilisate and solvent for oral suspension
POM: Prescription Only Medicine as defined in relevant national legislation
lawsonia
Authorised
2005-07-07
Health Products Regulatory Authority 25 February 2021 CRN009Q76 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Enterisol Ileitis lyophilisate and solvent for oral suspension for pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (2 ml) contains: Lyophilisate: ACTIVE SUBSTANCE: QUANTITY: Live attenuated _Lawsonia intracellularis (MS B3903)_: At least: 1 x 10 4.9 TCID50* Maximum: 1 x 10 6.1 TCID50* * Tissue Culture Infective Dose 50% For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lyophilisate and solvent for oral suspension. Lyophilisate: light yellow to gold. Solvent: clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of weaned pigs from three 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 immunity: as early as 3 weeks post vaccination. Duration of immunity: for at least 17 weeks. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. 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 three days before and three days after the day of vaccination (see section 4.8). Health Products Regulatory Authority 25 February 2021 CRN009Q76 Page 2 of 5 Efficacy of revaccination is unknown. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals. In case of anaphylactic reactions, appropriate symptomatic treatment including the administration of glucocorticoids, Les hele dokumentet