GALLIMUNE SE + ST, WATER-IN-OIL EMULSION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
18-04-2024
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Active ingredient:
INACTIVATED SALMONELLA ENTERITIDIS PT4, AT LEAST, INACTIVATED SALMONELLA TYPHIMURIUM DT 104, AT LEAST
Available from:
Merial Animal Health Limited
ATC code:
QI01AB01
INN (International Name):
INACTIVATED SALMONELLA ENTERITIDIS PT4, AT LEAST, INACTIVATED SALMONELLA TYPHIMURIUM DT 104, AT LEAST
Dosage:
Unknown
Pharmaceutical form:
Emulsion for Injection
Prescription type:
POM
Therapeutic group:
Fowl - Chicken
Therapeutic area:
Salmonella vaccine
Therapeutic indications:
Immunological - Inactivated vaccine
Authorization status:
Authorised
Authorization date:
2007-06-22
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Gallimune Se + St, water-in-oil emulsion for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.3-ml dose of vaccine contains:
ACTIVE SUBSTANCES:
Inactivated _Salmonella _Enteritidis PT4, at least..........................................................171 SAT.U
Inactivated _Salmonella _Typhimurium DT 104, at least................................................ 149 SAT.U
ADJUVANT:
Paraffin oil...................................................................................................................... q.s. 0.3 ml
EXCIPIENT:
Thiomersal, at most................................................................................................................ 30 µg
The concentrations are expressed by the antibody titre obtained during the potency test. One unit (U) corresponding to an antibody titre of 1.
SAT: Slow Agglutination Test .
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Water-in-oil emulsion for injection.
White emulsion.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens (layer pullets).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of layer pullets to:
-
reduce _Salmonella _Enteritidis dissemination in the ovary, as demonstrated 4 days after challenge;
This has been tested 25 weeks after vaccination and has been demonstrated to persist until 58 weeks of age.
-
reduce _Salmonella _Typhimurium and _Salmonella _Enteritidis dissemination in the intestinal tract.
This has been tested 4 weeks after vaccination and has been demonstrated to persist until 61 weeks of age for
_Salmonella _Typhimurium and 52 weeks of age for _Salmonella _Enteritidis.
4.3 CONTRAINDICATIONS
Please refer to section 4.7 “Use during pregnancy, lactation or lay”.
4.4 SPECIAL WARNINGS FOR E
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