Nazione: Unione Europea
Lingua: inglese
Fonte: EMA (European Medicines Agency)
feline leukaemia virus recombinant canarypox virus (vCP97)
Boehringer Ingelheim Vetmedica GmbH
QI06AD
vaccine against feline leukaemia
Cats
Immunologicals for felidae,
Active immunisation of cats of 8 weeks of age or older against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease.Onset of immunity has been demonstrated 2 weeks after primary vaccination course.The duration of immunity is one year after the last vaccination.
Revision: 12
Authorised
2000-04-13
14 B. PACKAGE LEAFLET 15 PACKAGE LEAFLET: PUREVAX FELV SUSPENSION FOR INJECTION 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 Manufacturing authorisation holder responsible for 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 Purevax FeLV suspension for injection 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of 1 ml or 0.5ml contains: ACTIVE SUBSTANCE: FeLV recombinant Canarypox virus (vCP97) ................................................. ≥ 10 7.2 CCID50 1 1 cell culture infective dose 50% Clear colourless liquid with presence of cell debris in suspension. 4. INDICATION(S) Active immunisation of cats of 8 weeks of age or older against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease. Onset of immunity: 2 weeks after primary vaccination course. Duration of immunity: 1 year after the last vaccination. 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS A temporary small (< 2 cm) nodule, which regresses within 1 to 4 weeks, was very commonly observed at the site of injection during safety and field studies. Transient lethargy and hyperthermia were very commonly observed during safety and field studies and lasted usually for 1 day, exceptionally for 2 days. 16 Anorexia and emesis have been reported very rarely based on post marketing safety experience. A hypersensitivity reaction may occur in very rare cases. Such reactions may evolve to a more severe condition (anaphylaxis). If such reactions occur, appropriate treatment is recommended. 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 Leggi il documento completo
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Purevax FeLV suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml or 0.5 ml contains: ACTIVE SUBSTANCE: FeLV recombinant Canarypox virus (vCP97) ................................................. ≥ 10 7.2 CCID50 1 1 cell culture infective dose 50% EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Clear colourless liquid with presence of cell debris in suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of cats of 8 weeks of age or older against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease. Onset of immunity: 2 weeks after primary vaccination course. Duration of immunity: 1 year after the last vaccination. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals It is recommended that a test for FeLV antigenaemia be carried out prior to vaccination. Vaccination of FeLV positive cats is of no benefit. 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. 3 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) A temporary small (< 2 cm) nodule, which regresses within 1 to 4 weeks, was very commonly observed at the site of injection during safety and field studies. Transient lethargy and hyperthermia were very commonly observed during safety and field studies and lasted usually for 1 day, exceptionally for 2 days. Anorexia and emesis have been reported very rarely based on post marketing safety experience. A hypersensitivity reaction may occur in very rare cases. Such reactions may evolve to a more severe c Leggi il documento completo