Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
purified p45 feline leukaemia virus envelope antigen, live feline calicivirus (strain F9), live feline viral rhinotracheitis virus (strain F2), live feline panleucopenia virus
Virbac S.A.
QI06AH07
feline calicivirosis, feline viral rhinotrachieitis, feline infectious enteritis (feline panleucopenia) vaccine (live), feline leukaemia vaccine (inactivated)
Cats
live feline panleucopenia virus / parvovirus + live feline rhinotracheitis virus + live feline calicivirus + inactivated feline leukaemia virus
For active immunisation of cats from eight weeks of age against:feline calicivirosis to reduce clinical signs.feline viral rhinotracheitis to reduce clinical signs and viral excretion.feline panleucopenia to prevent leucopenia and to reduce clinical signs.feline leukaemia to prevent persistent viraemia and clinical signs of the related disease.Onset of immunity: 3 weeks after the primary vaccination for the panleucopenia and leukaemia components, and 4 weeks after the primary vaccination for the calicivirus and rhinotracheitis virus components.Duration of immunity: one year after the primary vaccination for all components.
Revision: 9
Authorised
2009-06-24
15 B. PACKAGE LEAFLET 16 PACKAGE LEAFLET LEUCOFELIGEN FELV/RCP LYOPHILISATE AND SUSPENSION FOR SUSPENSION FOR INJECTION FOR CATS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and manufacturer responsible for the batch release: VIRBAC 1 ère avenue 2065 m LID 06516 Carros FRANCE 2. NAME OF THE VETERINARY MEDICINAL PRODUCT LEUCOFELIGEN FeLV/RCP lyophilisate and suspension for suspension for injection for cats 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Per dose of 1 ml: Lyophilisate _: _ ACTIVE SUBSTANCES: Live attenuated feline calicivirus (strain F9): 10 4.6 –10 6.1 CCID 50 * Live attenuated feline viral rhinotracheitis virus (strain F2): 10 5.0 –10 6.6 CCID 50 * Live attenuated feline panleucopenia virus (strain LR 72): 10 3.7 –10 4.5 CCID 50 * * Cell culture infectious dose 50%. EXCIPIENT: Stabilizing buffer containing gelatin: to 1.3 ml before freeze-drying Suspension _: _ ACTIVE SUBSTANCE: Minimum quantity of purified p45 FeLV-envelope antigen: 102 µg ADJUVANTS: 3% aluminium hydroxide gel expressed as mg Al 3+ : 1 mg Purified extract of _Quillaja saponaria_ : 10 µg EXCIPIENT: Buffered isotonic solution to 1 ml. VISUAL ASPECT: Lyophilisate: White pellet. Suspension: Opalescent liquid. 4. INDICATION(S) For active immunisation of cats from eight weeks of age against: - feline calicivirosis to reduce clinical signs, - feline viral rhinotracheitis to reduce clinical signs and viral excretion, - feline panleucopenia to prevent leucopenia and to reduce clinical signs, 17 - feline leukaemia to prevent persistent viraemia and clinical signs of the related disease. The onset of immunity has been demonstrated from: - 3 weeks after the first injection of primary vaccination for the calicivirus component - 3 weeks after the primary vaccination for the panleucopenia and leukaemia components - 4 weeks after the primary vaccination for the rhinotracheitis virus compo Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT LEUCOFELIGEN FeLV/RCP lyophilisate and suspension for suspension for injection for cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 1 ml: _Lyophilisate: _ ACTIVE SUBSTANCES: Live attenuated feline calicivirus (strain F9) 10 4.6 –10 6.1 CCID 50 * Live attenuated feline viral rhinotracheitis virus (strain F2) 10 5.0 –10 6.6 CCID 50 * Live attenuated feline panleucopenia virus (strain LR 72) 10 3.7 –10 4.5 CCID 50 * * Cell culture infectious dose 50%. EXCIPIENT: Stabilizing buffer containing gelatin to 1.3 ml before freeze-drying _Suspension: _ ACTIVE SUBSTANCE: Minimum quantity of purified p45 FeLV-envelope antigen 102 µg ADJUVANTS: 3% aluminium hydroxide gel expressed as mg Al 3+ 1 mg Purified extract of _Quillaja saponaria_ 10 µg EXCIPIENT: Buffered isotonic solution to 1 ml. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and suspension for suspension for injection. VISUAL ASPECT: Lyophilisate: White color. Suspension: Opalescent liquid. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of cats from eight weeks of age against: - feline calicivirosis to reduce clinical signs, - feline viral rhinotracheitis to reduce clinical signs and viral excretion, 3 - feline panleucopenia to prevent leucopenia and to reduce clinical signs, - feline leukaemia to prevent persistent viraemia and clinical signs of the related disease. The onset of immunity has been demonstrated from: - 3 weeks after the first injection of primary vaccination for the calicivirus component - 3 weeks after the primary vaccination for the panleucopenia and leukaemia components, - 4 weeks after the primary vaccination for the rhinotracheitis virus component. After the primary vaccination course, the duration of immunity lasts for one year for all components. Following a first booster vaccination one year after the primary vaccina Pročitajte cijeli dokument