Страна: Европейски съюз
Език: английски
Източник: 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)
Merial
QI06AH
vaccine against feline viral rhinotracheitis, feline calicivirosis 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 and excretion;against Chlamydophila felis infection to reduce clinical signs.Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus and Chlamydophila felis components.The duration of immunity is 1 year after the last (re-)vaccination.
Revision: 8
Withdrawn
2005-02-22
Medicinal product no longer authorised B. PACKAGE LEAFLET 14 Medicinal product no longer authorised PACKAGE LEAFLET FOR: PUREVAX RCCH 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 : MERIAL 29, avenue Tony Garnier F-69007 Lyon France Manufacturer for the batch release : MERIAL Laboratoire Porte des Alpes Rue de l'Aviation F-69800 Saint Priest France 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Purevax RCCh Lyophilisate and solvent for suspension for injection. 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Per dose of 1ml: LYOPHILISATE: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ...................................... ≥ 10 4.9 CCID 50 1 Inactivated feline Calicivirosis antigens (FCV 431 and FCV G1 strains) ..................... ≥ 2.0 ELISA U. Attenuated _Chlamydophila felis_ (905 strain) .................................................................... ≥ 10 3.0 EID 50 2 EXCIPIENT: Gentamicin, at most.......................................................................................................................... 28 µg SOLVENT: Water for injection ....................................................................................................................... q.s. 1 ml 1 : cell culture infective dose 50% 2 : egg infective dose 50% 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 and excretion, _ _ - _against Chlamydophila felis_ infection to reduce clinical signs. 15 Medicinal product no longer authorised Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus and _Chlamydophila felis_ components. The duration of immunity is 1 year after the last (re-)vaccination. 5. CONTRAIND Прочетете целия документ
Medicinal product no longer authorised ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Purevax RCCh lyophilisate and solvent for suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 1 ml LYOPHILISATE: ACTIVE SUBSTANCES: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ...................................... ≥ 10 4.9 CCID 50 1 Inactivated feline Calicivirosis antigens (FCV 431 and G1 strains) .............................. ≥ 2.0 ELISA U. Attenuated _Chlamydophila felis_ (905 strain) .................................................................... ≥ 10 3.0 EID 50 2 EXCIPIENT: Gentamicin, at most.......................................................................................................................... 28 µg SOLVENT: Water for injection ....................................................................................................................... q.s. 1 ml 1 : cell culture infective dose 50% 2 : egg infective dose 50% For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats. 4.2 INDICATIONS FOR USE Active immunisation of cats aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs and excretion, _ _ - _against Chlamydophila felis_ infection to reduce clinical signs. Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus and _Chlamydophila felis_ components. The duration of immunity is 1 year after the last (re-)vaccination. 4.3 CONTRAINDICATIONS Do not use in pregnant animals. The use is not recommended during lactation. 2 Medicinal product no longer authorised 4.4 SPECIAL WARNINGS None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Use only in healthy animals. SPECIAL PRECAUTION Прочетете целия документ