Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Inactivated rabies virus antigen suspension
Intervet Ireland Limited
QI07AA02
Inactivated rabies virus antigen suspension
2-6 International Units/dose
Suspension for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cats, Dogs
rabies virus
Immunological - Inactivated Vaccine
Authorised
2004-08-10
Health Products Regulatory Authority 27 February 2020 CRN00967H Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Rabies 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Per 1 mldose: ACTIVE SUBSTANCE: Inactivated rabies virus strain Pasteur RIV inducing at least 2 IU as measured in the potency test. ADJUVANT: Aluminium phosphate 0.15 ml EXCIPIENTS: Thiomersal (preservative) 0.10 mg For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunisation of dogs and cats to reduce mortality and clinical signs of rabies. Onset of immunity Protective levels of circulating antibody are seen in all species within 30 days of vaccination. Duration of immunity Studies indicate a minimum duration of protection in dogs and cats of 3 years. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES A good immune response is reliant on the reaction of an immunogenic agent and a fully competent immune system. Immunogenicity of the vaccine antigen will be reduced by poor storage or inappropriate administration. Immunocompetence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Only healthy animals should be vaccinated. The vaccine may not be effective in animals incubating the disease at the time of vaccination. Health Products Regulatory Authority 27 February 2020 CRN00967H Page 2 of 4 SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS In the case of accidental self-injection, wash the area immediately with water. If symptoms develop, seek medical attention and show the package leaflet or the label to the physician. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Transient local reacti Прочитајте комплетан документ