Gallimune Se + St, water-in-oil emulsion for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Inactivated Salmonella Enteritidis PT4; Inactivated Salmonella Typhimurium DT 104

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QI01AB01

INN (International Name):

Inactivated Salmonella Enteritidis PT4; Inactivated Salmonella Typhimurium DT 104

Dosage:

.

Pharmaceutical form:

Emulsion for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Chickens

Therapeutic area:

salmonella

Therapeutic indications:

Immunological - Inactivated Vaccine

Authorization status:

Authorised

Authorization date:

2007-06-22

Summary of Product characteristics

Health Products Regulatory Authority
01 October 2020
CRN009Z3S
Page 1 of 4
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 EACH TARGET SPECIES
None.
Health Products Regulatory Authority
01 October 2020
CRN009Z3S
Page 2 of 4
4.5 SPECIAL PRECAUTIONS