VERSIGUARD RABIES, SUSPENSION FOR INJECTION

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

INACTIVATED RABIES VIRUS, STRAIN VNUKOVO-32

Saatavilla:

Zoetis Ireland Limited

ATC-koodi:

QI07AA02

INN (Kansainvälinen yleisnimi):

INACTIVATED RABIES VIRUS, STRAIN VNUKOVO-32

Annos:

Unknown

Lääkemuoto:

Suspension for Injection

Prescription tyyppi:

POM

Terapeuttinen ryhmä:

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

Terapeuttinen alue:

Rabies virus vaccine

Käyttöaiheet:

Immunological - Inactivated vaccine

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2015-11-13

Valmisteyhteenveto

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
________________________________________________________________________________________________________________________
_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