Country: Greece
Language: English
Source: HMA (Heads of Medicines Agencies)
salmonella enteritidis 100000000 IU/ml
Merial GmbH
QI01AE01
Oral lyophilisate
Salmonella vaccine
Chicken Food
2011-06-04
Repeat-Use D89-PI-en Page 1 of 5 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 Read the complete document
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 Read the complete document