Riik: Euroopa Liit
keel: inglise
Allikas: EMA (European Medicines Agency)
purified Rp-45 FeLV-envelope antigen
Virbac S.A.
QI06AA01
Feline leukaemia vaccine (inactivated)
Cats
Inactivated viral vaccines
Active immunisation of cats from eight weeks of age against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease.
Revision: 3
Authorised
2017-11-06
13 B. PACKAGE LEAFLET 14 PACKAGE LEAFLET NOBIVAC LEUFEL 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 Nobivac LeuFel suspension for injection for cats 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Per dose of 1 ml: 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 EXCIPIENTS: Buffered isotonic solution to 1 ml. Opalescent liquid. 4. INDICATION(S) Active immunisation of cats from eight weeks of age against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease. The onset of immunity has been demonstrated from 3 weeks after the primary vaccination. After the primary vaccination course, the duration of immunity lasts for one year. Following a first booster vaccination one year after the primary vaccination course, a duration of immunity of 3 years has been demonstrated. 5. CONTRAINDICATIONS None. 15 6. ADVERSE REACTIONS A moderate and transient local reaction (<2 cm) is commonly observed after the first injection. This local reaction could be a swelling, an oedema or a nodule and resolves spontaneously within from 3 to 4 weeks at the most. After the second injection, and subsequent administrations, this reaction is markedly reduced., The transient signs following vaccination such as hyperthermia (lasting 1 to 4 days), apathy and digestive disturbances may also be commonly observed. Pain at palpation, sneezing or conjunctivitis may be noted in rare cases. This resolves without any treatment. Anaphylactic reactions have been reported in very rare cases. In case of anaphylactic shock, appropriate symptomat Lugege kogu dokumenti
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac LeuFel suspension for injection for cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 1 ml: 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 EXCIPIENTS: Buffered isotonic solution to 1 ml. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Opalescent liquid. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of cats from eight weeks of age against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease. The onset of immunity has been demonstrated from 3 weeks after the primary vaccination. After the primary vaccination course, the duration of immunity lasts for one year. Following a first booster vaccination one year after the primary vaccination course, a duration of immunity of 3 years has been demonstrated. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. 3 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals De-worming at least 10 days prior to vaccination is recommended. Only feline leukaemia virus (FeLV) negative cats should be vaccinated. Therefore, a test for presence of FeLV before vaccination is recommended. Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) A moderate and transient local reaction (<2 cm) is commonly observed after the first injection. This local reaction could be a swelling, an oedema or a nodule and resolves spontaneously within from 3 to 4 weeks at the most. After the se Lugege kogu dokumenti