NOBIVAC RABIES

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

RABIES VIRUS STRAIN PASTEUR RIV INACTIVATED

MAH:

Intervet Ireland Limited

ATC_code:

QI07AA02

INN:

RABIES VIRUS STRAIN PASTEUR RIV INACTIVATED

dosage:

Unknown

pharmaceutical_form:

Suspension for Injection

prescription_type:

POM

therapeutic_group:

Canine, Feline

therapeutic_area:

Rabies virus vaccine

therapeutic_indication:

Immunological - Inactivated vaccine

authorization_status:

Authorised

authorization_date:

2004-08-10

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac Rabies
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Per 1 ml dose:
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 14/09/2015_
_CRN 7021069_
_page number: 1_
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.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL P