Gallimune Se + St, Water-in Oil Emulsion for Injection

Država: Velika Britanija

Jezik: angleščina

Source: VMD (Veterinary Medicines Directorate)

Aktivna sestavina:

Salmonella enteritidis, Salmonella typhimurium

Dostopno od:

Boehringer Ingelheim Animal Health UK Ltd

Koda artikla:

QI01AB01

INN (mednarodno ime):

Salmonella enteritidis, Salmonella typhimurium

Farmacevtska oblika:

Emulsion for injection

Tip zastaranja:

POM-V - Prescription Only Medicine – Veterinarian

Terapevtska skupina:

Chickens

Terapevtsko območje:

Inactivated Bacterial Vaccine

Status dovoljenje:

Authorized

Datum dovoljenje:

2007-06-11

Lastnosti izdelka

Revised: November 2018
AN: 01034/2018
Page 1 of 5
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.
Revised: November 2018
AN: 01034/2018
Page 2 of 5
4.3
CONTRAINDICATIONS
Please refer to section 4.7 “Use during pregnancy, lactation or
lay”.
4.4
SPECIAL WARNINGS
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Vaccinate only healthy animals.
Vaccination causes a serological re