Leucogen
Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Uputa o lijeku
(PIL)
07-10-2021
Svojstava lijeka
(SPC)
07-10-2021
Izvješće o ocjeni javnog
(PAR)
19-10-2018
Aktivni sastojci:
purified p45 FeLV-envelope antigen
Dostupno od:
Virbac S.A.
ATC koda:
QI06AA01
INN (International ime):
Feline leukaemia vaccine (inactivated)
Terapijska grupa:
Cats
Područje terapije:
Inactivated viral vaccines, feline leukaemia virus, Immunologicals for felidae,
Terapijske indikacije:
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.
Proizvod sažetak:
Revision: 8
Status autorizacije:
Authorised
Datum autorizacije:
2009-06-17
Uputa o lijeku
13
B. PACKAGE LEAFLET
14
PACKAGE LEAFLET:
LEUCOGEN SUSPENSION FOR INJECTION FOR CATS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer responsible for the
batch release:
Virbac,
1
ère
avenue – 2065 m – L.I.D.,
06516 Carros Cedex
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
LEUCOGEN suspension for injection for cats
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
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.
Opalescent liquid.
4.
INDICATION(S)
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.
5.
CONTRAINDICATIONS
None.
15
6.
ADVERSE REACTIONS
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 nodule and resolves
spontaneously within from 3 to
4 weeks at the most. After the second injection, and subsequent
administrations, this reaction is
markedly reduced.,
The transient signs following vaccination such as hyperthermia
(lasting 1 to 4 days), apathy and
digestive disturbances may also be commonly observed,
Pain at palpation, sneezing or conjunctivitis may be noted in rare
cases. This resolves without any
treatment.
Anaphylactic reactions have been reported in very rare cases. In case
of anaphylactic shock,
appropri
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Svojstava lijeka
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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.
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.
3
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 nodule and resolves
spontaneously within from 3 to
4 weeks at the most. After the second
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