Enterisol Ileitis lyophilisate and solvent for oral suspension for pigs

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Attenuated live bacteria lawsonia intracellularis (ms b3903)

זמין מ:

Boehringer Ingelheim Ltd

קוד ATC:

QI09AE04

INN (שם בינלאומי):

Attenuated live bacteria lawsonia intracellularis (ms b3903)

כמות:

1x10^4.9 to 1x10^6.1 tissue culture infective dose 50/dose

טופס פרצבטיות:

Lyophilisate + solvent for suspension

סוג מרשם:

POM: Prescription Only Medicine as defined in relevant national legislation

קבוצה תרפויטית:

Pigs

איזור תרפויטי:

lawsonia

סממני תרפויטית:

Immunological - Live Vaccine

מצב אישור:

Authorised

תאריך אישור:

2005-07-07

מאפייני מוצר

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
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4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The vaccine has not been tested in breeding boa