Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Attenuated live bacteria lawsonia intracellularis (ms b3903)
Boehringer Ingelheim Ltd
QI09AE04
Attenuated live bacteria lawsonia intracellularis (ms b3903)
1x10^4.9 to 1x10^6.1 tissue culture infective dose 50/dose
Lyophilisate + solvent for suspension
POM: Prescription Only Medicine as defined in relevant national legislation
Pigs
lawsonia
Immunological - Live Vaccine
Authorised
2005-07-07
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: 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 protection occurs as early as 3 weeks post vaccination and lasts for at least 17 weeks. 4.3 CONTRAINDICATIONS None. ACTIVE SUBSTANCE: QUANTITY: Live attenuated_ Lawsonia intracellularis (MS B3903)_: At least: 1 x 10 TCID * Maximum: 1 x 10 TCID * * Tissue Culture Infective Dose 50% 4.9 50 6.1 50 H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _3_ _/_ _1_ _2_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _3_ _4_ _3_ _6_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The vaccine has not been tested in breeding boa read_full_document