Versiguard Rabies Suspension for Injection

Kraj: Wielka Brytania

Język: angielski

Źródło: VMD (Veterinary Medicines Directorate)

Składnik aktywny:

Rabies virus

Dostępny od:

Zoetis UK Limited

Kod ATC:

QI07AA02

INN (International Nazwa):

Rabies virus

Forma farmaceutyczna:

Suspension for injection

Typ recepty:

POM-V - Prescription Only Medicine – Veterinarian

Grupa terapeutyczna:

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

Dziedzina terapeutyczna:

Inactivated Viral Vaccine

Status autoryzacji:

Authorized

Data autoryzacji:

2015-12-03

Charakterystyka produktu

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