Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
inactivated influenza-A virus, swine
Merial S.A.S.
QI09AA03
inactivated influenza-A virus, swine
Pigs
Immunologicals
Active immunisation of pigs from the age of 56 days onwards including pregnant sows against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection.Onset of immunity: 7 days after primary vaccination.Duration of immunity: 4 months in pigs vaccinated between the age of 56 and 96 days and 6 months in pigs vaccinated for the first time at 96 days and above.Active immunisation of pregnant sows after finished primary immunisation by administration of a single dose 14 days prior to farrowing to develop high colostral immunity which provides clinical protection of piglets for at least 33 days after birth.
Revision: 1
Withdrawn
2010-01-14
Medicinal product no longer authorised 16 B. PACKAGE LEAFLET Medicinal product no longer authorised 17 PACKAGE LEAFLET FOR: GRIPOVAC 3 Suspension for injection 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: MERIAL 29 avenue Tony Garnier 69007 Lyon, France Manufacturer responsible for batch release : IDT Biologika GmbH Am Pharmapark 06861 Dessau-Rosslau Germany 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Gripovac 3 suspension for injection for pigs 3. STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS Clear, yellowish orange to pink colored suspension for injection. Each dose of 2 ml contains: ACTIVE SUBSTANCES: Strains of inactivated Influenza A virus/swine/ Bakum/IDT1769/2003 (H3N2) ≥ 10.53 log 2 GMNU 1 Haselünne/IDT2617/2003 (H1N1) ≥ 10.22 log 2 GMNU 1 Bakum/1832/2000 (H1N 2 ) ≥ 12.34 log 2 GMNU 1 1 GMNU = Geometric mean of neutralizing units induced in Guinea pigs after twice immunisation with 0.5 ml of this vaccine. ADJUVANT: Carbomer 971 P NF 2.0 mg EXCIPIENT: Thiomersal 0.21 mg 4. INDICATION(S) Active immunisation of pigs from the age of 56 days onwards including pregnant sows against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection. Onset of immunity: 7 days after primary vaccination Duration of immunity: 4 months in pigs vaccinated between the age of 56 and 96 days and 6 months in pigs vaccinated for the first time at 96 days and above. Medicinal product no longer authorised 18 Active immunisation of pregnant sows after finished primary immunisation by administration of a single dose 14 days prior to farrowing to develop high colostral immunity which provides clinical protection of piglets for at least 33 days after birth. 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS A transient slight swelling may occur on very rare occasions after vaccination at the site of injection, regressing wit Прочетете целия документ
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Gripovac 3 suspension for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 2 ml contains: ACTIVE SUBSTANCES: Strains of inactivated Influenza A virus/swine/ Bakum/IDT1769/2003 (H3N2) ≥ 10.53 log 2 GMNU 1 Haselünne/IDT2617/2003 (H1N1) ≥ 10.22 log 2 GMNU 1 Bakum/1832/2000 (H1N2) ≥ 12.34 log 2 GMNU 1 1 GMNU = Geometric mean of neutralizing units induced in Guinea pigs after twice immunisation with 0.5 ml of this vaccine ADJUVANT: Carbomer 971 P NF 2.0 mg EXCIPIENT: Thiomersal 0.21 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Clear, yellowish orange to pink colored suspension for injection. 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES Pigs 4.2. INDICATION FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of pigs from the age of 56 days onwards including pregnant sows against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection. Onset of immunity: 7 days after primary vaccination Duration of immunity: 4 months in pigs vaccinated between the age of 56 and 96 days and 6 months in pigs vaccinated for the first time at 96 days and above. Active immunisation of pregnant sows after finished primary immunisation by administration of a single dose 14 days prior to farrowing to develop high colostral immunity which provides clinical protection of piglets for at least 33 days after birth. Medicinal product no longer authorised 3 4.3. CONTRAINDICATIONS None. 4.4. SPECIAL WARNINGS FOR THE TARGET SPECIES None. 4.5. SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Not applicable. Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of accidental self-injection only a minor injection site reaction is expected. 4.6. ADVERSE REACTIONS (FREQUENCY AND SERIOUSNES Прочетете целия документ