Χώρα: Ευρωπαϊκή Ένωση
Γλώσσα: Αγγλικά
Πηγή: EMA (European Medicines Agency)
vCP65 virus
Boehringer Ingelheim Vetmedica GmbH
QI06AX
rabies recombinant canarypox virus (vCP65)
Cats
Immunologicals
Active immunisation of cats 12 weeks of age and older to prevent mortality due to rabies infection.Onset of immunity: 4 weeks after the primary vaccination course.Duration of immunity after primary vaccination: 1 year.Duration of immunity after revaccination: 3 years.
Revision: 7
Authorised
2011-02-18
13 B. PACKAGE LEAFLET 14 PACKAGE LEAFLET: PUREVAX RABIES 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 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 Rabies suspension for injection 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT Each dose of 1 ml contains: ACTIVE SUBSTANCE: Rabies recombinant canarypox virus (vCP65) ≥ 10 6.8 FAID* 50 *Fluorescent assay infectious dose 50 % Light pink to pale yellow homogeneous suspension 4. INDICATION Active immunisation of cats 12 weeks of age and older to prevent mortality due to rabies infection. Onset of immunity: 4 weeks after the primary vaccination course. Duration of immunity after primary vaccination: 1 year. Duration of immunity after revaccination: 3 years. 5. CONTRAINDICATIONS None 6. ADVERSE REACTIONS In very rare cases, transient and slight apathy may occur, as well as mild anorexia or hyperthermia (above 39.5 °C), usually lasting 1 or 2 days. Most of these reactions were noted during the 2 days following the vaccine injection. 15 A transient local reaction may very rarely occur (pain at palpation, limited swelling that may become nodular, heat at the injection site, and in some cases erythema), that usually disappears within 1 or 2 weeks at most. Very rarely, a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more th Διαβάστε το πλήρες έγγραφο
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Purevax Rabies suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains: ACTIVE SUBSTANCE: Rabies recombinant canarypox virus (vCP65) ≥ 10 6.8 FAID* 50 *Fluorescent assay infectious dose 50 % EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Light pink to pale yellow homogeneous suspension 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of cats 12 weeks of age and older to prevent mortality due to rabies infection. Onset of immunity: 4 weeks after the primary vaccination course. Duration of immunity after primary vaccination: 1 year. Duration of immunity after revaccination: 3 years. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. 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 Canarypox recombinants are known to be safe for humans. Mild local and/or systemic adverse reactions related to the injection itself may be observed transitorily. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. 3 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) In very rare cases, transient and slight apathy may occur, as well as mild anorexia or hyperthermia (above 39.5 °C), usually lasting 1 or 2 days. Most of these reactions were noted during the 2 days following the vaccine injection. A transient local reaction may very rarely occur (pain at palpation, limited swelling that may become nodular, heat at the injection site, and in some cases erythema), that usually disappears within 1 or 2 weeks at most. Very rarely, a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment Διαβάστε το πλήρες έγγραφο