Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Clostridium tetani toxoid / Vcp 2242 virus / Vcp1529 virus / Vcp1533 virus / vCP3011 virus
Boehringer Ingelheim Vetmedica GmbH
QI05AI01
equine influenza (live recombinant) and tetanus vaccine
Horses
Immunologicals for equidae, Live viral and inactivated bacterial vaccines, equine influenza virus + clostridium
Active immunisation of horses of four months of age or older against equine influenza to reduce clinical signs and virus excretion after infection, and against tetanus to prevent mortality.
Revision: 16
Authorised
2003-03-06
13 B. PACKAGE LEAFLET 14 PACKAGE LEAFLET: PROTEQFLU-TE 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 Marketing authorisation holder: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY Manufacturer for the batch release: Boehringer Ingelheim Animal Health France SCS Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRANCE 2. NAME OF THE VETERINARY MEDICINAL PRODUCT ProteqFlu-Te suspension for injection for horses 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One dose of 1 ml contains: ACTIVE SUBSTANCES: Influenza A/eq/Ohio/03 [H 3 N 8 ] recombinant canarypox virus (vCP2242) ........... ≥ 5.3 log10 FAID 50 * Influenza A/eq/Richmond/1/07 [H 3 N 8 ] recombinant canarypox virus (vCP3011) ≥ 5.3 log10 FAID 50 * _Clostridium tetani_ toxoid ......................................................................................................... ≥ 30 IU** * vCP content checked by global FAID 50 (fluorescent assay infectious dose 50 %) and qPCR ratio between vCP. ** antitoxic antibody titre induced after repeated vaccination in guinea pig sera according to Ph. Eur. ADJUVANT: Carbomer ......................................................................................................................................... 4 mg. 4. INDICATION(S) Active immunisation of horses of 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection, and against tetanus to prevent mortality. Onset of immunity: 14 days after primary vaccination course. Duration of immunity induced by the vaccination scheme: - 5 months after the primary vaccination course; - after the primary vaccination course and the booster injection 5 months later: 1 year with regard to equine influenza and 2 years with regard to tetanus. 5. CONTRAINDICATIONS None. 15 6. ADVERSE REACTIONS • A transient swelling which usually regres Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ProteqFlu-Te suspension for injection for horses 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose of 1 ml contains: ACTIVE SUBSTANCES: Influenza A/eq/Ohio/03 [H 3 N 8 ] recombinant Canarypox virus (vCP2242) .......... ≥ 5.3 log10 FAID 50 * Influenza A/eq/Richmond/1/07 [H 3 N 8 ] recombinant Canarypox virus (vCP3011) ≥ 5.3 log10 FAID 50 * _Clostridium tetani_ toxoid ......................................................................................................... ≥ 30 IU** * vCP content checked by global FAID 50 (fluorescent assay infectious dose 50 %) and qPCR ratio between vCP. ** antitoxic antibody titre induced after repeated vaccination in guinea pig sera according to Ph. Eur. ADJUVANT: Carbomer ......................................................................................................................................... 4 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of horses of 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection, and against tetanus to prevent mortality. Onset of immunity: 14 days after primary vaccination course. Duration of immunity induced by the vaccination scheme: - 5 months after the primary vaccination course; - after the primary vaccination course and the booster injection 5 months later: 1 year with regard to equine influenza and 2 years with regard to tetanus. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Only healthy animals should be vaccinated. 3 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 Lesen Sie das vollständige Dokument