Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
recombinant omega interferon of feline origin
Virbac S.A.
QL03AB
interferon (omega)
Dogs; Cats
Immunostimulants,
DogsReduction of mortality and clinical signs of parvovirosis (enteric form) in dogs from one month of age.CatsTreatment of cats infected with feline leukaemia virus (FeLV) and / or feline immunodeficiency virus (FIV), in non-terminal clinical stages, from the age of nine weeks. In a field study conducted, it was observed that there was:a reduction of clinical signs during the symptomatic phase (four months);a reduction of mortality:in anaemic cats, mortality rate of about 60% at four, six, nine and 12 months was reduced by approximately 30% following treatment with interferon;in non-anaemic cats, mortality rate of 50% in cats infected by FeLV was reduced by 20% following treatment with interferon. In cats infected by FIV, mortality was low (5%) and was not influenced by the treatment.
Revision: 12
Authorised
2001-11-05
26 B. PACKAGE LEAFLET 27 PACKAGE LEAFLET VIRBAGEN OMEGA 5 MU FOR DOGS AND CATS VIRBAGEN OMEGA 10 MU FOR DOGS AND 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 batch release VIRBAC 1ère Avenue - 2065 m - L.I.D. 06516 CARROS France 2. NAME OF THE VETERINARY MEDICINAL PRODUCT VIRBAGEN OMEGA 5 MU for dogs and cats VIRBAGEN OMEGA 10 MU for dogs and cats 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of 1ml contains: ACTIVE SUBSTANCE: Lyophilisate: 5 MU presentation: Recombinant Omega interferon of feline origin 5 MU* 10 MU presentation: Recombinant Omega interferon of feline origin 10 MU* *MU : Million Units SOLVENT: Isotonic sodium chloride solution 1 ml Lyophilisate: white pellet Solvent: colourless liquid 4. INDICATION(S) Dogs: Reduction of mortality and clinical signs of parvovirosis (enteric form) in dogs from one month of age. Cats: Treatment of cats infected with FeLV and/or FIV, in non-terminal clinical stages, from the age of 9 weeks. In a field study conducted, it was observed that there was: - a reduction of clinical signs during the symptomatic phase (4 months) - a reduction of mortality : • in anaemic cats, mortality rate of about 60% at 4, 6, 9 and 12 months was reduced by approximately 30% following treatment with interferon. 28 • in non-anaemic cats, mortality rate of 50 % in cats infected by FeLV was reduced by 20% following treatment with interferon. In cats infected by FIV, mortality was low (5%) and was not influenced by the treatment. 5. CONTRAINDICATIONS Dogs: Vaccination during and after V IRBAGEN O MEGA treatment is contra-indicated, until the dog appears to have recovered. Cats: as vaccination is contra-indicated in the symptomatic phase of FeLV/FIV infections, the effect of V IRBAGEN O MEGA on cat vaccination has not been evaluated. 6. ADVERSE REACTIONS In some cases, during treatment, the fol Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT VIRBAGEN OMEGA 5 MU for dogs and cats VIRBAGEN OMEGA 10 MU for dogs and cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains: ACTIVE SUBSTANCE: Lyophilisate: 5 MU presentation: Recombinant Omega interferon of feline origin 5 MU* 10 MU presentation: Recombinant Omega interferon of feline origin 10 MU* *MU : Million Units SOLVENT: Isotonic sodium chloride solution 1 ml EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. Lyophilisate: white pellet. Solvent: colourless liquid. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. Cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Dogs: Reduction of mortality and clinical signs of parvovirosis (enteric form) in dogs from one month of age. Cats: Treatment of cats infected with FeLV and/or FIV, in non-terminal clinical stages, from the age of 9 weeks. In a field study conducted, it was observed that there was: - a reduction of clinical signs during the symptomatic phase (4 months) - a reduction of mortality: • in anaemic cats, mortality rate of about 60% at 4, 6, 9 and 12 months was reduced by approximately 30% following treatment with interferon. 3 • in non-anaemic cats, mortality rate of 50 % in cats infected by FeLV was reduced by 20% following treatment with interferon. In cats infected by FIV, mortality was low (5%) and was not influenced by the treatment. 4.3 CONTRAINDICATIONS Dogs: Vaccination during and after V IRBAGEN O MEGA treatment is contra-indicated, until the dog appears to have recovered. Cats: as vaccination is contra-indicated in the symptomatic phase of FeLV/FIV infections, the effect of V IRBAGEN O MEGA on cat vaccination has not been evaluated. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES No information on the induction of long-term side effects is available in dog and cat, especially for autoimmune disorders. Such side effects have been desc Lesen Sie das vollständige Dokument