Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
equine influenza-virus strains: A/equine-2/South Africa/4/03, A/equine-2/Newmarket/2/93
Intervet International BV
QI05AA01
vaccine against equine influenza in horses
Horses
equine influenza virus
Active immunisation of horses from six months of age against equine influenza to reduce clinical signs and virus excretion after infection.
Revision: 9
Authorised
2005-07-08
14 B. PACKAGE LEAFLET 15 PACKAGE LEAFLET: Equilis Prequenza suspension for injection for horses 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis Prequenza suspension for injection for horses 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Each dose of 1 ml contains: ACTIVE SUBSTANCES: Equine influenza virus strains: A/equine-2/ South Africa/4/03 50 AU 1 A/equine-2/ Newmarket/2/93 50 AU 1 Antigenic ELISA units ADJUVANT: Iscom-Matrix containing: Purified saponin 375 micrograms Cholesterol 125 micrograms Phosphatidylcholine 62.5 micrograms Clear opalescent suspension. 4. INDICATION(S) Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs and virus excretion after infection. Influenza Onset of immunity: 2 weeks after the primary vaccination course Duration of immunity: 5 months after the primary vaccination course 12 months after the first revaccination 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS 16 A diffuse hard or soft swelling (max. diameter 5 cm) may rarely occur at the injection site, regressing within 2 days. Pain at the injection site can occur in rare cases, which may result in temporary functional discomfort (stiffness). A local reaction exceeding 5 cm and possibly persisting longer than 2 days may occur in very rare cases. Fever, sometimes accompanied by lethargy and inappetence, may in very rare cases occur for 1 day, and up to 3 days in exceptional circumstances. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis Prequenza suspension for injection for horses 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains: ACTIVE SUBSTANCES: Equine influenza virus strains: A/equine-2/ South Africa/4/03 50 AU 1 A/equine-2/ Newmarket/2/93 50 AU 1 Antigenic units ADJUVANT: Iscom-Matrix containing: Purified Saponin 375 micrograms Cholesterol 125 micrograms Phosphatidylcholine 62.5 micrograms For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Clear opalescent suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs and virus excretion after infection. Influenza Onset of immunity: 2 weeks after the primary vaccination course Duration of immunity: 5 months after the primary vaccination course 12 months after the first revaccination 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES 3 Foals should not be vaccinated before the age of 6 months, especially when born to mares that were revaccinated in the last two months of gestation, because of possible interference by maternally derived antibodies. Vaccinate healthy animals only. 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, seek medical advice immediately and show the package leaflet or the label to the physician. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) A diffuse hard or soft swelling (max. diameter 5 cm) may rarely occur at the injection site, regressing within 2 days. Pain at the injection site can occur in rare cases, which may result in temporary functional discomfort (stiffness). A local reaction exceeding 5 cm and possibly persisting longer than 2 days ma Aqra d-dokument sħiħ