Versiguard Rabies, suspension for injection

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Inactivated rabies virus, strain vnukovo-32

Fáanlegur frá:

Zoetis Belgium S.A.

ATC númer:

QI07AA02

INN (Alþjóðlegt nafn):

Inactivated rabies virus, strain vnukovo-32

Skammtar:

Minimum 2.0 international unit(s)

Lyfjaform:

Suspension for injection

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Meðferðarhópur:

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

Lækningarsvæði:

rabies virus

Ábendingar:

Immunological - Inactivated Vaccine

Leyfisstaða:

Authorised

Leyfisdagur:

2015-11-13

Vara einkenni

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Versiguard Rabies suspension for injection
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (1 ml) contains:
ACTIVE SUBSTANCE:
Inactivated rabies virus, strain SAD Vnukovo-32
≥ 5 IU*
* IU – international units.
ADJUVANT:
Aluminium hydroxide
2.0 mg.
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION
IS ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
Thiomersal
0.1 mg
Water for injections
The visual appearance is as follows: slightly pink suspension, which
might contain fine sediments.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs, cats, cattle, pigs, sheep, goats, horses and ferrets.
3.2
INDICATIONS FOR USE FOR EACH 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.
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.
3.3
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.
3.4
SPECIAL WARNINGS
Vaccinate healthy animals only.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
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.
3.6
ADVERSE EVENTS
DOGS:
Very rare
(<1 animal / 10,000 animals treated,
including isolated reports):
Injection si