Država: Velika Britanija
Jezik: engleski
Izvor: VMD (Veterinary Medicines Directorate)
Rabies virus
Boehringer Ingelheim Vetmedica Gmbh
QI06AD08
Rabies virus
Suspension for injection
POM-V - Prescription Only Medicine – Veterinarian
Cats
Live Viral Vaccine
Authorized
2011-02-18
Revised: October 2023 AN: 02322/2022 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 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 homogenous 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. Revised: October 2023 AN: 02322/2022 Page 2 of 5 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Not applicable. 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. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Cats: Very rare (<1 animal / 10,000 animals treated, including isolated reports): Apathy 1-2 , mild anorexia 2 , hyperthermia 2-3 Injection site reactions (pain, swelling, warmth and erythema) 4 Hypersensitivity reaction 5 1 Slight 2 Usually lasting 1 or 2 days. Most of these reactions were noted during the 2 days following the vaccine injection. 3 Above 39.5°C 4 Pain at palpation; limited swelling that may become nodular; usually disappearing within 1 or 2 Pročitajte cijeli dokument