Land: Europese Unie
Taal: Engels
Bron: EMA (European Medicines Agency)
Live non-pathogenic Escherichia coli O141:K94 (F18ac) and O8:K87 (F4ac)
Elanco GmbH
QI09AE03
porcine post-weaning diarrhoea vaccine (live)
Pigs
Immunologicals for suidae, Live bacterial vaccines
For active immunisation of pigs from 18 days of age against enterotoxigenic F4-positive and F18-positive Escherichia coli in order to reduce the incidence of moderate to severe post-weaning E. coli diarrhoea (PWD) in infected pigs and to reduce the faecal shedding of enterotoxigenic F4-positive and F18-positive E. coli from infected pigs.
Revision: 5
Authorised
2017-01-09
14 B. PACKAGE LEAFLET 15 PACKAGE LEAFLET: COLIPROTEC F4/F18 LYOPHILISATE FOR ORAL SUSPENSION FOR PIGS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Elanco GmbH Heinz-Lohmann-Str. 4 27472 Cuxhaven GERMANY Manufacturer responsible for batch release: Klifovet AG Geyerspergerstr. 27 80689 München GERMANY Lohmann Animal Health GmbH Heinz-Lohmann-Str. 4 27472 Cuxhaven GERMANY 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Coliprotec F4/F18 lyophilisate for oral suspension for pigs 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of vaccine contains: Live non-pathogenic _E. coli_ O8:K87 * (F4ac):.......................1.3x10 8 to 9.0x10 8 CFU ** Live non-pathogenic _E. coli_ O141:K94 * (F18ac):.................2.8x10 8 to 3.0x10 9 CFU ** * not attenuated ** CFU – colony forming units White or whitish powder. 4. INDICATION(S) For active immunisation of pigs from 18 days of age against enterotoxigenic F4-positive and F18- positive _E. coli_ in order to: - reduce the incidence of moderate to severe post-weaning _E. coli_ diarrhoea (PWD) in infected pigs; - reduce the faecal shedding of enterotoxigenic F4-positive and F18-positive _E. coli_ from infected pigs. Onset of immunity: 7 days after vaccination Duration of immunity: 21 days after vaccination 5. CONTRAINDICATIONS 16 None 6. ADVERSE REACTIONS No adverse reactions have been observed. If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon. 7. TARGET SPECIES Pigs 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Oral use. Administer a single dose of vaccine from 18 days of age. 9. ADVICE ON CORRECT ADMINISTRATION All materials used in preparing and administering the vaccine must be free of antimicrobials, detergent or disinfectant residues to prevent inactivation. Vaccination schedule Lees het volledige document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Coliprotec F4/F18 lyophilisate for oral suspension for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of vaccine contains: ACTIVE SUBSTANCES: Live non-pathogenic _Escherichia coli_ O8:K87 * (F4ac):.......................1.3x10 8 to 9.0x10 8 CFU ** Live non-pathogenic _Escherichia coli_ O141:K94 * (F18ac): ...............2.8x10 8 to 3.0x10 9 CFU ** * not attenuated ** CFU – colony forming units EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate for oral suspension. White or whitish powder. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of pigs from 18 days of age against enterotoxigenic F4-positive and F18- positive _Escherichia coli_ in order to: - reduce the incidence of moderate to severe post-weaning _E. coli_ diarrhoea (PWD) in infected pigs; - reduce the faecal shedding of enterotoxigenic F4-positive and F18-positive _E. coli_ from infected pigs. Onset of immunity: 7 days after vaccination Duration of immunity: 21 days after vaccination 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES It is not recommended to vaccinate animals undergoing immunosuppressive treatment or to vaccinate animals undergoing antibacterial treatment effective against _E. coli. _ _ _ Vaccinate healthy animals only. 4.5 SPECIAL PRECAUTIONS FOR USE 3 Special precautions for use in animals The vaccine strains may be excreted by vaccinated piglets for at least 14 days following vaccination. The vaccine strains readily spread to other pigs in contact to vaccinated pigs. Unvaccinated pigs in contact with vaccinated pigs will harbour and shed the vaccine strains similarly to vaccinated pigs. During this time, the contact of immunosuppressed pigs with vaccinated pigs should be avoided. Special precautions to be taken by the person administering the veterinary medicinal product to animals Per Lees het volledige document