Purevax Rabies

Kraj: Wielka Brytania

Język: angielski

Źródło: VMD (Veterinary Medicines Directorate)

Składnik aktywny:

Rabies virus

Dostępny od:

Boehringer Ingelheim Vetmedica Gmbh

Kod ATC:

QI06AD08

INN (International Nazwa):

Rabies virus

Forma farmaceutyczna:

Suspension for injection

Typ recepty:

POM-V - Prescription Only Medicine – Veterinarian

Grupa terapeutyczna:

Cats

Dziedzina terapeutyczna:

Live Viral Vaccine

Status autoryzacji:

Authorized

Data autoryzacji:

2011-02-18

Charakterystyka produktu

Revised: October 2023
AN: 02322/2022
Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Purevax Rabies suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCE:
Rabies recombinant canarypox virus (vCP65)
≥ 10
6.8
FAID*
50
*Fluorescent assay infectious dose 50 %
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Light pink to pale yellow homogenous suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of cats 12 weeks of age and older to prevent
mortality due to rabies
infection.
Onset of immunity: 4 weeks after the primary vaccination course.
Duration of immunity after primary vaccination: 1 year.
Duration of immunity after revaccination: 3 years.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Revised: October 2023
AN: 02322/2022
Page 2 of 5
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
Canarypox recombinants are known to be safe for humans. Mild local
and/or systemic
adverse reactions related to the injection itself may be observed
transitorily.
In 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)
Cats:
Very rare
(<1 animal / 10,000 animals treated,
including isolated reports):
Apathy
1-2
, mild anorexia
2
, hyperthermia
2-3
Injection site reactions (pain, swelling,
warmth and erythema)
4
Hypersensitivity reaction
5
1
Slight
2
Usually lasting 1 or 2 days. Most of these reactions were noted during
the 2 days
following the vaccine injection.
3
Above 39.5°C
4
Pain at palpation; limited swelling that may become nodular; usually
disappearing
within 1 or 2