Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
recombinant inactivated avian influenza virus
Pfizer Limited
QI01AA23
recombinant inactivated avian influenza virus
Chicken; Ducks
Immunologicals
For active immunisation of chickens and ducks against avian influenza virus type A, subtype H5.Chickens:Reduction of mortality and virus excretion after challenge.Onset of immunity: 3 weeks after the second injection.Duration of immunity in chickens has not been established yet.Ducks: Reduction of clinical signs and virus excretion after challenge.Onset of immunity: 3 weeks after the second injection.Duration of immunity in ducks : 14 weeks after the second injection.
Revision: 8
Withdrawn
2006-09-01
Medicinal product no longer authorised B. PACKAGE LEAFLET 18 Medicinal product no longer authorised PACKAGE LEAFLET FOR: POULVAC FLUFEND H5N3 RG EMULSION FOR INJECTION FOR CHICKENS AND DUCKS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing Authorisation Holder: Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom Manufacturer for the batch release: Pfizer Global Manufacturing Weesp CJ van Houtenlaan 36 1381 CP Weesp The Netherlands 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Poulvac FluFend H5N3 RG Emulsion for injection for chickens and ducks 3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS One dose of 0.5 ml contains: ACTIVE SUBSTANCE : Inactivated recombinant avian influenza virus of H5N3 subtype (strain rg-A/ck/VN/C58/04) > 1:40 HI Units ADJUVANTS: White Oil Sorbitan sesquioleate Polysorbate 80 EXCIPIENTS: Thiomersal Phosphate Buffer Saline 4. INDICATIONS For active immunisation of chickens and ducks against avian influenza virus type A, subtype H5. CHICKENS : Reduction of mortality and virus excretion after challenge. Onset of immunity: 3 weeks after the second injection. Duration of immunity in chickens has not been established yet. 19 Medicinal product no longer authorised DUCKS: Reduction of clinical signs and virus excretion after challenge. Onset of immunity: 3 weeks after the second injection. Duration of immunity in ducks : 14 weeks after the second injection. 5. CONTRAINDICATIONS None 6. ADVERSE REACTIONS A transient local site reaction (swelling) may occasionally occur as is normal with oil adjuvanted vaccines. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. 7. TARGET SPECIES Chickens and ducks 8. DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION CHICKENS 3 weeks of age or older: 0.5 ml intramuscularly in the breast muscle. Revaccinate after 3 weeks. The vaccination schedule should be Aqra d-dokument sħiħ
Medicinal product no longer authorised ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Poulvac FluFend H5N3 RG emulsion for injection for chickens and ducks 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose of 0.5 ml contains: ACTIVE SUBSTANCE : Inactivated recombinant avian influenza virus of H5N3 subtype (strain rg-A/ck/VN/C58/04) > 1:40 HI units per dose ADJUVANTS: White Oil Sorbitan sesquioleate Polysorbate 80 EXCIPIENTS: Thiomersal Phosphate Buffer Saline For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens and ducks. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of chickens and ducks against avian influenza virus type A, subtype H5. Chickens: Reduction of mortality and virus excretion after challenge. Onset of immunity: 3 weeks after the second injection. Duration of immunity in chickens has not been established yet. Ducks: Reduction of clinical signs and virus excretion after challenge. Onset of immunity: 3 weeks after the second injection. Duration of immunity in ducks : 14 weeks after the second injection. 4.3 CONTRAINDICATIONS None 2 Medicinal product no longer authorised 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The level of efficacy attained may vary depending on the degree of antigenic homology between the vaccine strain and circulating field strains. No information is available on the interference of maternally derived antibodies on vaccination for both target species. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Avoid stress in the birds around the time of vaccination. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS TO THE USER:_ _ This product contains mineral oil. Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases co Aqra d-dokument sħiħ