Enterisol Ileitis Lyophilisate and Solvent for Oral Suspension for Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Lawsonia intracellularis

Available from:

Boehringer Ingelheim Limited

ATC code:

QI09AE04

INN (International Name):

Lawsonia intracellularis

Pharmaceutical form:

Oral lyophilisate

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Pigs

Therapeutic area:

Live Bacterial Vaccine

Authorization status:

Authorized

Authorization date:

2005-05-16

Summary of Product characteristics

Revised: December 2016
AN: 01767/2015
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Enterisol Ileitis lyophilisate and solvent for oral suspension for
pigs
DK, NO, SE and IS:
Enterisol Ileitis vet. 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 protection occurs as early as 3 weeks post vaccination and
lasts for at least
17 weeks.
4.3
CONTRAINDICATIONS
None.
1/6
Revised: December 2016
AN: 01767/2015
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 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
Vaccinate only clinically healthy animals.
In case of anaphylactic reactions, appropriate symptomatic treatment
including the
administration of glucocorticoids, adrenaline, or antihis