Enterisol Ileitis lyophilisate and solvent for oral suspension for pigs

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

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Letöltés Termékjellemzők (SPC)
12-06-2017

Aktív összetevők:

Attenuated live bacteria lawsonia intracellularis (ms b3903)

Beszerezhető a:

Boehringer Ingelheim Ltd

ATC-kód:

QI09AE04

INN (nemzetközi neve):

Attenuated live bacteria lawsonia intracellularis (ms b3903)

Adagolás:

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

Gyógyszerészeti forma:

Lyophilisate + solvent for suspension

Recept típusa:

POM: Prescription Only Medicine as defined in relevant national legislation

Terápiás csoport:

Pigs

Terápiás terület:

lawsonia

Terápiás javallatok:

Immunological - Live Vaccine

Engedélyezési státusz:

Authorised

Engedély dátuma:

2005-07-07

Termékjellemzők

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