Land: Storbritannien
Språk: engelska
Källa: VMD (Veterinary Medicines Directorate)
Rabies virus
Zoetis UK Limited
QI07AA02
Rabies virus
Suspension for injection
POM-V - Prescription Only Medicine – Veterinarian
Cats, Cattle, Dogs, Ferrets, Goats, Horses, Pigs, Sheep
Inactivated Viral Vaccine
Authorized
2015-12-03
Revised: December 2022 AN: 02368/2021 + 02369/2021 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Versiguard Rabies suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (1 ml) contains: ACTIVE SUBSTANCE: Inactivated rabies virus, strain SAD Vnukovo-32 ≥ 5 IU*/ml * IU – international units. ADJUVANT: Aluminium hydroxide 2.0 mg EXCIPIENTS: Thiomersal 0.1 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Slightly pink suspension, which might contain fine sediments. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs, cats, cattle, pigs, sheep, goats, horses and ferrets. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunization of dogs, cats, cattle, pigs, sheep, goats, horses and ferrets (12 weeks of age and older) to prevent infection and mortality caused by rabies virus. Onset of immunity: 14–21 days after primary vaccination. Revised: December 2022 AN: 02368/2021 + 02369/2021 Page 2 of 6 DURATION OF IMMUNITY: DOGS: At least three years following the primary vaccination course. CATS, CATTLE, PIGS, SHEEP, GOATS, HORSES AND FERRETS: At least one year after primary vaccination, and two years after booster vaccinations. 4.3 CONTRAINDICATIONS Do not use in animals that are showing signs of rabies or that are suspected of being infected with rabies virus. Do not use in cases of hypersensitivity to the adjuvant or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. 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 In the 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 transient swelling may occur at the injection site following subcutaneous administration Läs hela dokumentet