Versiguard Rabies Suspension for Injection

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Rabies virus

Saatavilla:

Zoetis UK Limited

ATC-koodi:

QI07AA02

INN (Kansainvälinen yleisnimi):

Rabies virus

Lääkemuoto:

Suspension for injection

Prescription tyyppi:

POM-V - Prescription Only Medicine – Veterinarian

Terapeuttinen ryhmä:

Cats, Cattle, Dogs, Ferrets, Goats, Horses, Pigs, Sheep

Terapeuttinen alue:

Inactivated Viral Vaccine

Valtuutuksen tilan:

Authorized

Valtuutus päivämäärä:

2015-12-03

Valmisteyhteenveto

Revised: November 2023
AN: 02952/2022
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Versiguard Rabies suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml dose contains:
ACTIVE SUBSTANCE:
Inactivated rabies virus, strain SAD Vnukovo-32>
5 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.
The visual appearance is as follows: slightly pink suspension, 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 immunisation 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.
Revised: November 2023
AN: 02952/2022
Page 2 of 7
Duration of immunity:
DOGS: three years following the primary vaccination course.
CATS, CATTLE, PIGS, SHEEP, GOATS, HORSES AND FERRETS:
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.
Do not use in cases of hypersensitivity to the adjuvant or to any of
the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Not applicable.
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
the package leaflet or the label to the physician.
Special precautions for the protection of the environment
Not applicable.
Other precautions
Not applicable.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS