البلد: الاتحاد الأوروبي
اللغة: الإنجليزية
المصدر: EMA (European Medicines Agency)
attenuated feline panleucopenia virus (PLI IV)
Boehringer Ingelheim Vetmedica GmbH
QI06AH09
vaccine against feline viral rhinotracheitis, feline calicivirosis and feline panleucopenia
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;against feline panleucopenia to prevent mortality and clinical signs.Onset of immunity is one week after primary vaccination course The duration of immunity is one year after the primary vaccination course and three years after the last re-vaccination.
Revision: 17
Authorised
2005-02-23
14 B. PACKAGE LEAFLET 15 PACKAGE LEAFLET PUREVAX RCP 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 Manufacturer responsible for the 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 RCP 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: LYOPHILISATE: ACTIVE SUBSTANCES: 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. Attenuated feline panleucopenia virus (PLI IV) ............................................................ ≥ 10 3.5 CCID 50 1 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, - against feline panleucopenia to prevent mortality and clinical signs. Onset 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 we اقرأ الوثيقة كاملة
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Purevax RCP 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. Attenuated feline panleucopenia virus (PLI IV) ............................................................ ≥ 10 3.5 CCID 50 1 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, - against feline panleucopenia to prevent mortality and clinical signs. Onset of immunity: 1 week after primary vaccination course. Duration of immunity: 1 year after the 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 اقرأ الوثيقة كاملة