ENTERISOL ILEITIS LYOPHILISATE AND SOLVENT FOR ORAL SUSPENSION FOR PIGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
07-01-2017
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Active ingredient:
ATTENUATED LIVE BACTERIA LAWSONIA INTRACELLULARIS (MS B3903)
Available from:
Boehringer Ingelheim Ltd
ATC code:
QI09AE04
INN (International Name):
ATTENUATED LIVE BACTERIA LAWSONIA INTRACELLULARIS (MS B3903)
Dosage:
Unknown
Pharmaceutical form:
Lyophilisate + solvent for suspension
Prescription type:
POM
Therapeutic group:
Porcine
Therapeutic area:
Lawsonia vaccine
Therapeutic indications:
Immunological - Live Vaccine
Authorization status:
Authorised
Authorization date:
2005-07-07
Summary of Product characteristics
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
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 23/12/2016_
_CRN 7023436_
_page number: 1_
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 three days before and three days after the day of vaccination (see
sectio
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