Purevax FeLV

Land: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Feline leukemia virus

Fáanlegur frá:

Boehringer Ingelheim Vetmedica Gmbh

ATC númer:

QI06AD07

INN (Alþjóðlegt nafn):

Feline leukemia virus

Lyfjaform:

Suspension for injection

Gerð lyfseðils:

POM-V - Prescription Only Medicine – Veterinarian

Meðferðarhópur:

Cats

Lækningarsvæði:

Live Viral Vaccine

Leyfisstaða:

Authorized

Leyfisdagur:

2000-04-13

Vara einkenni

Issued: April 2022
AN: 02837/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Purevax FeLV suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml or 0.5 ml contains:
ACTIVE SUBSTANCE:
FeLV recombinant Canarypox virus
(vCP97)...............................≥ 10
7.2
CCID50
1
1
cell culture infective dose 50%
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Clear colourless liquid with presence of cell debris in suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of cats of 8 weeks of age or older against feline
leukaemia for
the prevention of persistent viraemia and clinical signs of the
related disease.
Onset of immunity: 2 weeks after primary vaccination course.
Duration of immunity: 1 year after the last vaccination.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Issued: April 2022
AN: 02837/2021
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
It is recommended that a test for FeLV antigenaemia be carried out
prior to vaccination.
Vaccination of FeLV positive cats is of no benefit.
Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
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)
A temporary small (< 2 cm) nodule, which regresses within 1 to 4
weeks, was very
commonly observed at the site of injection during safety and field
studies.
Transient lethargy and hyperthermia were very commonly observed during
safety
and field studies and lasted usually for 1 day, exceptionally for 2
days.
Anorexia and emesis have been reported very rarely based on post
marketing safety
experience.
A hypersensitivity reaction may occur in ver