Leucogen Suspension for Injection for Cats

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Feline leukemia virus

Available from:

Virbac

ATC code:

QI06AA01

INN (International Name):

Feline leukemia virus

Pharmaceutical form:

Suspension for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats

Therapeutic area:

Inactivated Viral Vaccine

Authorization status:

Authorized

Authorization date:

2009-06-17

Summary of Product characteristics

Issued: September 2023
AN: 00161/2023
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
LEUCOGEN suspension for injection for cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 1 ml:
ACTIVE SUBSTANCE:
Minimum quantity of purified p45 FeLV-envelope antigen
102 µg
ADJUVANTS:
3% aluminium hydroxide gel expressed as mg Al
3+
1 mg
Purified extract of _Quillaja saponaria_
10 µg
EXCIPIENTS:
Buffered isotonic solution to
1 ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Opalescent liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of cats from eight weeks of age against feline
leukaemia for the
prevention of persistent viraemia and clinical signs of the related
disease.
The onset of immunity has been demonstrated from 3 weeks after the
primary
vaccination.
After the primary vaccination course, the duration of immunity lasts
for one year.
Following a first booster vaccination one year after the primary
vaccination course, a
duration of immunity of 3 years has been demonstrated.
4.3
CONTRAINDICATIONS
None.
Issued: September 2023
AN: 00161/2023
Page 2 of 5
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
De-worming at least 10 days prior to vaccination is recommended.
Only feline leukaemia virus (FeLV) negative cats should be vaccinated.
Therefore, a
test for presence of FeLV before vaccination is recommended.
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 moderate and transient local reaction (<2 cm) is commonly observed
after the first
injection. This local reaction could be a swelling, an oedema or a
nodu