Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline calicivirosis antigens (FCV 431 and G1 strains), attenuated feline panleucopenia virus (PLI IV), FeLV recombinant canarypox virus (vCP97), attenuated Chlamydophila felis (905 strain)
Boehringer Ingelheim Vetmedica GmbH
QI06AJ05
vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia, feline leukeamia and feline Chlamydophila infections
Cats
Immunologicals for felidae,
Active immunisation of cats aged 8 weeks and older:against feline viral rhinotracheitis to reduce clinical signs;against calicivirus infection to reduce clinical signs;against Chlamydophila felis infection to reduce clinical signs;against feline panleucopenia to prevent mortality and clinical signs;against leukaemia to prevent persistent viraemia and clinical signs of the related disease.Onsets of immunity are 1 week after primary vaccination course for rhinotracheitis, calicivirus, Chlamydophila felis and panleucopenia components, and 2 weeks after primary vaccination course for feline leukaemia component.The duration of immunity is one year after the last re-vaccination for the chlamydiosis and feline leukaemia components, and one year after primary vaccination course and three years after the last re-vaccination for the rhinotracheitis, calicivirosis and panleucopenia components.
Revision: 15
Authorised
2005-02-23
15 B. PACKAGE LEAFLET 16 PACKAGE LEAFLET: PUREVAX RCPCH FELV LYOPHILISATE AND SOLVENT FOR 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 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 Purevax RCPCh FeLV lyophilisate and solvent for suspension for injection 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Per dose of 1 ml or 0.5 ml: LYOPHILISATE: ACTIVE SUBSTANCES: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................... ≥ 10 4.9 CCID 50 1 Inactivated feline calicivirus (FCV 431 and FCV G1 strains) antigens ........... ≥ 2.0 ELISA U. Attenuated _Chlamydophila felis_ (905 strain) ................................................... ≥ 10 3.0 EID 50 2 Attenuated feline panleucopenia virus (PLI IV) ............................................. ≥ 10 3.5 CCID 50 1 EXCIPIENT: Gentamicin, at most .......................................................................................... 34 µg SOLVENT: ACTIVE SUBSTANCE: FeLV recombinant canarypox virus (vCP97) .................................................. ≥ 10 7.2 CCID 50 1 1 cell culture infective dose 50%. 2 egg infective dose 50%. Lyophilisate: homogeneous beige pellet. Solvent: clear colourless liquid with presence of cell debris in suspension. 4. INDICATION(S) Active immunisation of cats aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs, - against C _hlamydophila felis_ infection to reduce clinical signs, - against feline panleucopenia to prevent mortality and clinical signs, 17 - against leukaemia to prevent persistent viraemia and clin Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Purevax RCPCh FeLV lyophilisate and solvent for suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 1 ml or 0.5ml: Lyophilisate : ACTIVE SUBSTANCES: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................... ≥ 10 4.9 CCID 50 1 Inactivated feline calicivirus (FCV 431 and G1 strains) antigens .................... ≥ 2.0 ELISA U. Attenuated _Chlamydophila felis_ (905 strain) ................................................... ≥ 10 3.0 EID 50 2 Attenuated feline panleucopenia virus (PLI IV) ............................................. ≥ 10 3.5 CCID 50 1 EXCIPIENT: Gentamicin, at most .......................................................................................... 34 µg Solvent : ACTIVE SUBSTANCE: FeLV recombinant canarypox virus (vCP97) .................................................. ≥ 10 7.2 CCID 50 1 1 cell culture infective dose 50% 2 egg infective dose 50% For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. Lyophilisate: homogeneous beige pellet. Solvent: 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 aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs, - against _Chlamydophila felis_ infection to reduce clinical signs, - against feline panleucopenia to prevent mortality and clinical signs, - against leukaemia to prevent persistent viraemia and clinical signs of the related disease. Onset of immunity: Rhinotracheitis, calicivirus, _ Chlamydophila felis_ and panleucopenia components: 1 week after primary vaccination course. Feline leukaemia component: 2 weeks after primary vaccination course. 3 Duration of immunity: - Rhinotrache Aqra d-dokument sħiħ