Enterisol Ileitis
Country: Greece
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
20-10-2012
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Active ingredient:
lawsonia intracellularis 79433 IU
Available from:
Boehringer Ingelheim Vetmedica GmbH
ATC code:
QI09AE
Pharmaceutical form:
Oral lyophilisate
Therapeutic group:
Live bacterial vaccines
Therapeutic area:
Pigs Food
Authorization date:
2012-05-01
Summary of Product characteristics
Page 1 of 6
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 6
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Enterisol Ileitis lyophilisate and diluent for oral suspension for pigs
Enterisol Ileitis vet. (DK, NO, SV) lyophilisate and diluent for oral suspension for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Attenuated live bacteria _Lawsonia intracellularis_ (MS B3903).
One 2 ml dose of reconstituted vaccine contains:
ACTIVE SUBSTANCE:
_Lawsonia intracellularis_:
At least:
1 x 10
4.9
TCID
50
*
_ _
_ _
Maximum:
1 x 10
6.1
TCID
50
*
*: Tissue Culture Infective Dose
DILUENT:
Sterile water for oral administration:
q.s. ad 2.0 ml
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and diluent for oral suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (weaned pigs from 3 weeks of age).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of 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
The vaccine has not been tested in breeding boars, therefore do not vaccinate breeding boars.
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Do not vaccinate animals which are receivin
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