SALMOVAC 440 Lyophilisate for use in drinking water

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Double-attenuated (adenine-histidine auxotrophic) salmonella entertidis mutant strain 441/014

Dostupné z:

IDT Biologika GmbH

ATC kód:

QI01AE01

INN (Medzinárodný Name):

Double-attenuated (adenine-histidine auxotrophic) salmonella entertidis mutant strain 441/014

Dávkovanie:

.

Forma lieku:

Oral lyophilisate

Typ predpisu:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutické skupiny:

Chickens

Terapeutické oblasti:

salmonella

Terapeutické indikácie:

Immunological - Live Vaccine

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2016-03-11

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
SALMOVAC 440
Lyophilisate for use in drinking water
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose of vaccine contains:
ACTIVE SUBSTANCE:
Double-attenuated (adenine-histidine auxotrophic)
_Salmonella_ Enteritidis mutant, strain 441/014
1-8 x 10
8
CFU*
* CFU = Colony Forming Unit
EXCIPIENT(S): q.s. 1 dose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate for use in drinking water.
Light beige to brownish light gray lyophilisate.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens from one day old (breeders and layers).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of chickens to reduce colonization,
persistence and invasion of the intestinal
tract
and internal
organs by_ Salmonella_ Enteritidis and_ Salmonella_ Typhimurium.
Onset of immunity within 6 days after first vaccination.
Duration of
immunity for
_Salmonella_ Enteritidis is 35 weeks after
second vaccination and 63 weeks after
third
vaccination when used according to the recommended vaccination
schedule.
Duration of immunity for_ Salmonella_ Typhimurium is 60 weeks after
third vaccination when used according to the
recommended vaccination schedule.
4.3 CONTRAINDICATIONS
Do not vaccinate unhealthy chickens or chickens under heavy stress
conditions. Do not use in broilers.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinated chickens excrete the vaccine strain up to six weeks post
vaccination.
The vaccine may thus spread to
susceptible birds in contact with vaccinated chickens or their manure.
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