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Repeat-Use D89-PI-en
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December 2007
B. PACKAGE LEAFLET
2
PACKAGE LEAFLET
GALLIVAC SE
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND
OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder:
MERIAL
29, avenue Tony Garnier, 69007 LYON
France
Manufacturer for the batch release:
Impfstoffwerk Dessau-Tornau GmbH
PSF 400214
D-6855 Rosslau
GERMANY
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
GALLIVAC SE
Lyophilisate for oral suspension.
Light beige to brownish light gray lyophilisate.
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One dose of vaccine contains:
ACTIVE SUBSTANCE:
1 to 8 x 10
8
CFU* of a double-attenuated (adenine-histidine auxotrophic) _Salmonella_ Enteritidis
mutant, strain 441/014.
* CFU = Colony Forming Unit
EXCIPIENT(S): q.s. 1 dose
4.
INDICATION(S)
Active immunization of chickens to reduce colonization, persistence and invasion of the intestinal tract
and internal organs by _Salmonella_ Enteritidis._ _
Onset of immunity within 6 days after first vaccination.
The duration of immunity after two step vaccination is demonstrated 35 weeks after second
vaccination according to the recommended programme.
The duration of immunity after the three step vaccination is demonstrated 63 weeks after third
vaccination according to the recommended programme.
5.
CONTRAINDICATIONS
Do not vaccinate unhealthy chickens or chickens under heavy stress conditions. Do not use in broilers._ _
6.
ADVERSE REACTIONS
3
None known.
If you notice any serious ef
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Repeat-Use D89-PI-en
Page 1 of 6
December 2007
_[TEM-006 Version 01/2006] _
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
GALLIVAC SE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose of vaccine contains:
ACTIVE SUBSTANCE:
1 to 8 x 10
8
CFU* of a, double-attenuated (adenine-histidine auxotrophic) _Salmonella_ Enteritidis
mutant, strain 441/014.
* CFU = Colony Forming Unit
EXCIPIENT(S): q.s. 1 dose
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for oral suspension.
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 immunization of chickens to reduce colonization, persistence and invasion of the intestinal tract
and internal organs by _Salmonella_ Enteritidis._ _
Onset of immunity within 6 days after first vaccination.
The duration of immunity after two step vaccination is demonstrated 35 weeks after second
vaccination according to the recommended programme.
The duration of immunity after the three step vaccination is demonstrated 63 weeks after third
vaccination according to the recommended programme.
4.3
CONTRAINDICATIONS
Do not vaccinate unhealthy chickens or chickens under heavy stress conditions. Do not use in broilers._ _
4.4
SPECIAL WARNINGS
Vaccinated chickens excrete the vaccine strain up to six weeks post vaccination. The vaccine may
thus spread to susceptible birds in contact with vaccinate
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