NOBIVAC RABIES
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
29-09-2015
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Virkt innihaldsefni:
RABIES VIRUS STRAIN PASTEUR RIV INACTIVATED
Fáanlegur frá:
Intervet Ireland Limited
ATC númer:
QI07AA02
INN (Alþjóðlegt nafn):
RABIES VIRUS STRAIN PASTEUR RIV INACTIVATED
Skammtar:
Unknown
Lyfjaform:
Suspension for Injection
Gerð lyfseðils:
POM
Meðferðarhópur:
Canine, Feline
Lækningarsvæði:
Rabies virus vaccine
Ábendingar:
Immunological - Inactivated vaccine
Leyfisstaða:
Authorised
Leyfisdagur:
2004-08-10
Vara einkenni
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
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_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
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