Nobivac Rabies

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Inactivated rabies virus antigen suspension

Dostupné z:

Intervet Ireland Limited

ATC kód:

QI07AA02

INN (Medzinárodný Name):

Inactivated rabies virus antigen suspension

Dávkovanie:

2-6 International Units/dose

Forma lieku:

Suspension for injection

Typ predpisu:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutické skupiny:

Cats, Dogs

Terapeutické oblasti:

rabies virus

Terapeutické indikácie:

Immunological - Inactivated Vaccine

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2004-08-10

Súhrn charakteristických

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