SALMOVAC 440 LYOPHILISATE FOR USE IN DRINKING WATER
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-03-2016
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Active ingredient:
DOUBLE-ATTENUATED (ADENINE-HISTIDINE AUXOTROPHIC) SALMONELLA ENTERTIDIS MUTANT STRAIN 441/014
Available from:
IDT Biologika GmbH
ATC code:
QI01AE01
INN (International Name):
DOUBLE-ATTENUATED (ADENINE-HISTIDINE AUXOTROPHIC) SALMONELLA ENTERTIDIS MUTANT STRAIN 441/014
Pharmaceutical form:
Oral Lyophilisate
Prescription type:
POM
Therapeutic group:
Fowl - Chicken
Therapeutic area:
Salmonella vaccine
Therapeutic indications:
Immunological - Live Vaccine
Authorization status:
Authorised
Authorization date:
2016-03-11
Summary of Product characteristics
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 11/03/2016_
_CRN 7021823_
_page number: 1_
4.5 SPECIAL
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