Versiguard Rabies Suspension for Injection

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

Rabies virus

Διαθέσιμο από:

Zoetis UK Limited

Φαρμακολογική κατηγορία (ATC):

QI07AA02

INN (Διεθνής Όνομα):

Rabies virus

Φαρμακοτεχνική μορφή:

Suspension for injection

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

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

Θεραπευτική περιοχή:

Inactivated Viral Vaccine

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2015-12-03

Αρχείο Π.Χ.Π.

Revised: December 2022
AN: 02368/2021 + 02369/2021
Page 1 of 6
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
≥ 5 IU*/ml
* 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 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 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.
Revised: December 2022
AN: 02368/2021 + 02369/2021
Page 2 of 6
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.
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_._
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A transient swelling may occur at the injection site following
subcutaneous
administration