Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline calicivirosis antigens (FCV 431 and G1 strains), attenuated Chlamydophila felis (905 strain), attenuated feline panleucopenia virus (PLI IV)
Boehringer Ingelheim Vetmedica GmbH
QI06AJ03
vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline Chlamydophila infections
Cats
Immunologicals for felidae,
Active immunisation of cats aged eight 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.Onsets of immunity have been demonstrated one week after primary vaccination course for rhinotracheitis, calicivirus, Chlamydophila felis and panleucopenia components.The duration of immunity is one year after the last re-vaccination for the chlamydiosis component, and oneyear after primary vaccination and three years after the last re-vaccination for the rhinotracheitis, calicivirosis and panleucopenia components.
Revision: 17
Authorised
2005-02-23
15 B. PACKAGE LEAFLET 16 PACKAGE LEAFLET: PUREVAX RCPCH 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 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 .......................................................................................................................... 28 µg SOLVENT: Water for injection....................................................................................................... q.s. 1 ml or 0.5 ml. 1 cell culture infective dose 50% 2 egg infective dose 50% Lyophilisate: homogeneous beige pellet. Solvent: clear colourless liquid. 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 _Chlamydophila felis_ infection to reduce clinical signs, - against feline panleucopenia to prevent mortality and clinical signs. 17 Onsets Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Purevax RCPCh lyophilisate and solvent for suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 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 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 .......................................................................................................................... 28 µg Solvent: Water for injections ..................................................................................................... q.s. 1 ml or 0.5 ml. 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. 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. Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus, _Chlamydophila felis_ and panleucopenia components. Duration of immunity: - Rhinotracheitis, calicivirosis and panleucopenia components: 1 year after primary vaccination Pročitajte cijeli dokument