VERSIGUARD RABIES, SUSPENSION FOR INJECTION

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

INACTIVATED RABIES VIRUS, STRAIN VNUKOVO-32

Dostopno od:

Zoetis Ireland Limited

Koda artikla:

QI07AA02

INN (mednarodno ime):

INACTIVATED RABIES VIRUS, STRAIN VNUKOVO-32

Odmerek:

Unknown

Farmacevtska oblika:

Suspension for Injection

Tip zastaranja:

POM

Terapevtska skupina:

Bovine, Canine, Caprine, Equine - Food, Feline, Ferret, Ovine, Porcine

Terapevtsko območje:

Rabies virus vaccine

Terapevtske indikacije:

Immunological - Inactivated vaccine

Status dovoljenje:

Authorised

Datum dovoljenje:

2015-11-13

Lastnosti izdelka

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 min. 2.0 IU*
* 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 solution, 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.
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 17/11/2016_
_CRN 7021968_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccinate healthy animals only.
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