ENTERISOL ILEITIS LYOPHILISATE AND SOLVENT FOR ORAL SUSPENSION FOR PIGS

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

ATTENUATED LIVE BACTERIA LAWSONIA INTRACELLULARIS (MS B3903)

Tilgjengelig fra:

Boehringer Ingelheim Ltd

ATC-kode:

QI09AE04

INN (International Name):

ATTENUATED LIVE BACTERIA LAWSONIA INTRACELLULARIS (MS B3903)

Dosering :

Unknown

Legemiddelform:

Lyophilisate + solvent for suspension

Resept typen:

POM

Terapeutisk gruppe:

Porcine

Terapeutisk område:

Lawsonia vaccine

Indikasjoner:

Immunological - Live Vaccine

Autorisasjon status:

Authorised

Autorisasjon dato:

2005-07-07

Preparatomtale

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