SALMOVAC 440 LYOPHILISATE FOR USE IN DRINKING WATER

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

DOUBLE-ATTENUATED (ADENINE-HISTIDINE AUXOTROPHIC) SALMONELLA ENTERTIDIS MUTANT STRAIN 441/014

Boleh didapati daripada:

IDT Biologika GmbH

Kod ATC:

QI01AE01

INN (Nama Antarabangsa):

DOUBLE-ATTENUATED (ADENINE-HISTIDINE AUXOTROPHIC) SALMONELLA ENTERTIDIS MUTANT STRAIN 441/014

Borang farmaseutikal:

Oral Lyophilisate

Jenis preskripsi:

POM

Kumpulan terapeutik:

Fowl - Chicken

Kawasan terapeutik:

Salmonella vaccine

Tanda-tanda terapeutik:

Immunological - Live Vaccine

Status kebenaran:

Authorised

Tarikh kebenaran:

2016-03-11

Ciri produk

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