Ülke: Avrupa Birliği
Dil: İngilizce
Kaynak: EMA (European Medicines Agency)
Vcp 2242 virus / Vcp1529 virus / Vcp1533 virus / vCP3011 virus
Boehringer Ingelheim Vetmedica GmbH
QI05AD02
Equine influenza vaccine (live recombinant)
Horses
Immunologicals, Live viral vaccines equine influenza virus
Active immunisation of horses of four months of age or older against equine influenza to reduce clinical signs and virus excretion after infection.
Revision: 14
Authorised
2003-03-06
13 B. PACKAGE LEAFLET 14 PACKAGE LEAFLET PROTEQFLU 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 responsible 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 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 * * vCP content checked by global FAID 50 (fluorescent assay infectious dose 50%) and qPCR ratio between vCP. 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. Onset of immunity: 14 days after primary vaccination course. Duration of immunity induced by the vaccination scheme: 5 months after primary vaccination course and 1 year after the third vaccination. 5. CONTRAINDICATIONS None. 15 6. ADVERSE REACTIONS A transient swelling which usually regresses within 4 days may appear at the injection site. In rare occasions, swelling can reach a diameter up to 15–20 cm, with duration up to 2–3 weeks, that may require symptomatic treatment. Pain, local hyperthermia and muscle stiffness can occur in rare cases. In very rare occasions, abscessation may be observed. A slight increase in temperature (max. 1.5 °C) may occur for 1 day, exceptionally 2 days. Belgenin tamamını okuyun
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ProteqFlu 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 * * vCP content checked by global FAID 50 (fluorescent assay infectious dose 50%) and qPCR ratio between vCP. 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. Onset of immunity: 14 days after primary vaccination course. Duration of immunity induced by the vaccination scheme: 5 months after primary vaccination course and 1 year after the third vaccination. 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 or the label to the physician. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) A transient swelling which usually regresses within 4 days may appear at the injection site. In rare occasions swelling can reach a diameter up to 15–20 cm, with duration up to 2–3 weeks, that may require symptomatic treatment. Pain, local hyperthermia and muscle stiffness can occur in rare cases. In very rare occasions, a Belgenin tamamını okuyun