Leucogen

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Feline leukemia virus envelope antigen p45

Available from:

Virbac S.A.

ATC code:

QI06AA01

INN (International Name):

Feline leukemia virus envelope antigen p45

Dosage:

.

Pharmaceutical form:

Suspension for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cats

Therapeutic area:

feline leukaemia virus

Therapeutic indications:

Immunological - Inactivated Vaccine

Authorization status:

Authorised

Authorization date:

2007-09-21

Summary of Product characteristics

Health Products Regulatory Authority
18 July 2017
CRN000VVS
Page 1 of 4
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Leucogen
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (1.0 ml) contains:
ACTIVE SUBSTANCE:
FeLV recombinant p45 antigen Minimum:
97
micrograms
Target
102 micrograms
ADJUVANT:
Aluminium hydroxide gel (3%)
0.1 ml
Quil A
10
micrograms
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of healthy cats to prevent persistent feline
leukaemia-virus
viraemia and any associated clinical signs of feline leucocis.
The onset of protection begins 2 weeks after immunisation and the
duration of
protection lasts one year after the basic vaccination.
Health Products Regulatory Authority
18 July 2017
CRN000VVS
Page 2 of 4
4.3 CONTRAINDICATIONS
Refer to Section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The vaccine should be administered in accordance with the usual
aseptic conditions
for vaccination.
Vaccinate only healthy animals.
It is recommended that animals be treated for intestinal parasites at
least 10 days
prior to vaccination.
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 insert or the label to the physician.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Transient and small thickening or nodule, approximately 5-10 mm in
size, may be
observed at the injection site and disappear within 2 to 6 weeks
without treatment.
Occasionally, systemic reactions (hyperthermia, anorexia, lethargy)
may occur within
one or two days after vaccine administration.
4.7 USE DURING PREGNANCY, LACTATION OR LAY
In the absence of supporting data, the vaccine should not be used in
pregnant or
lactating cats.
4.8