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)
Boehringer Ingelheim Vetmedica GmbH
QI06AH08
vaccine against feline viral rhinotracheitis and feline calicivirosis
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.Onsets of immunity isone week after primary vaccination course.The duration of immunity is one year after primary vaccination course and three years after the last re-vaccination.
Revision: 16
Authorised
2005-02-23
14 B. PACKAGE LEAFLET 15 PACKAGE LEAFLET PUREVAX RC 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 Manufacturing authorisation holder responsible for 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 RC 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: ACTIVE SUBSTANCES: LYOPHILISATE: 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. EXCIPIENT: Gentamicin, at most ....................................................................................................................... 16.5 µg SOLVENT: Water for injection....................................................................................................... q.s. 1 ml or 0.5 ml. 1 cell culture 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. Onsets of immunity: 1 week after primary vaccination course. Duration of immunity: 1 year after primary vaccination course and 3 years after the last re-vaccination. 16 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS Transient apathy and anorexia as well as hyperthermia (lasting usually for 1or 2 days) were commonly observed during safety and field studies. A local reaction (slight pain at palpation, itching or limited oede Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Purevax RC 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. EXCIPIENT: Gentamicin, at most ....................................................................................................................... 16.5 µg Solvent: Water for injections ..................................................................................................... q.s. 1 ml or 0.5 ml. 1 cell culture 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. Onsets of immunity: 1week after primary vaccination course. Duration of immunity: 1 year after primary vaccination course and 3 years after the last re-vaccination. 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 None. 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) Transient apathy and anorexia as well as hyperthermia (lasting usually for 1 or 2 days Прочетете целия документ