Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Lawsonia intracellularis
Boehringer Ingelheim Animal Health UK Ltd
QI09AE04
Lawsonia intracellularis
Oral lyophilisate
POM-V - Prescription Only Medicine – Veterinarian
Pigs
Live Bacterial Vaccine
Authorized
2005-05-16
Revised: March 2021 AN: 00062/2020 Page 1 of 6 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: Live attenuated _Lawsonia intracellularis _(MS B3903): 10 4.9 - 10 6.1 TCID 50 * * 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 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 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 Revised: March 2021 AN: 00062/2020 Page 2 of 6 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 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. 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 Read the complete document