Enterisol Ileitis lyophilisate and solvent for oral suspension for pigs

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Attenuated live bacteria lawsonia intracellularis (ms b3903)

Saatavilla:

Boehringer Ingelheim Vetmedica GmbH

ATC-koodi:

QI09AE04

INN (Kansainvälinen yleisnimi):

Attenuated live bacteria lawsonia intracellularis (ms b3903)

Annos:

. tissue culture infective dose 50/dose

Lääkemuoto:

Lyophilisate and solvent for oral suspension

Prescription tyyppi:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeuttinen alue:

lawsonia

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2005-07-07

Valmisteyhteenveto

Health Products Regulatory Authority
25 February 2021
CRN009Q76
Page 1 of 5
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:
QUANTITY:
Live attenuated _Lawsonia intracellularis (MS B3903)_:
At least:
1 x 10
4.9
TCID50*
Maximum:
1 x 10
6.1
TCID50*
* 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 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 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
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 three days before and three days
after the day of vaccination (see section 4.8).
Health Products Regulatory Authority
25 February 2021
CRN009Q76
Page 2 of 5
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,