Leucofeligen FeLV/RCP

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

purified p45 feline leukaemia virus envelope antigen, live feline calicivirus (strain F9), live feline viral rhinotracheitis virus (strain F2), live feline panleucopenia virus

Saatavilla:

Virbac S.A.

ATC-koodi:

QI06AH07

INN (Kansainvälinen yleisnimi):

feline calicivirosis, feline viral rhinotrachieitis, feline infectious enteritis (feline panleucopenia) vaccine (live), feline leukaemia vaccine (inactivated)

Terapeuttinen ryhmä:

Cats

Terapeuttinen alue:

live feline panleucopenia virus / parvovirus + live feline rhinotracheitis virus + live feline calicivirus + inactivated feline leukaemia virus

Käyttöaiheet:

For active immunisation of cats from eight weeks of age against:feline calicivirosis to reduce clinical signs.feline viral rhinotracheitis to reduce clinical signs and viral excretion.feline panleucopenia to prevent leucopenia and to reduce clinical signs.feline leukaemia to prevent persistent viraemia and clinical signs of the related disease.Onset of immunity: 3 weeks after the primary vaccination for the panleucopenia and leukaemia components, and 4 weeks after the primary vaccination for the calicivirus and rhinotracheitis virus components.Duration of immunity: one year after the primary vaccination for all components.

Tuoteyhteenveto:

Revision: 9

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2009-06-24

Pakkausseloste

15
B. PACKAGE LEAFLET
16
PACKAGE LEAFLET
LEUCOFELIGEN FELV/RCP LYOPHILISATE AND SUSPENSION FOR 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 LID
06516 Carros
FRANCE
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
LEUCOFELIGEN FeLV/RCP lyophilisate and suspension for suspension for
injection for cats
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Per dose of 1 ml:
Lyophilisate
_: _
ACTIVE SUBSTANCES:
Live attenuated feline calicivirus (strain F9):
10
4.6
–10
6.1
CCID
50
*
Live attenuated feline viral rhinotracheitis virus (strain F2):
10
5.0
–10
6.6
CCID
50
*
Live attenuated feline panleucopenia virus (strain LR 72):
10
3.7
–10
4.5
CCID
50
*
* Cell culture infectious dose 50%.
EXCIPIENT:
Stabilizing buffer containing gelatin: to
1.3 ml before freeze-drying
Suspension
_: _
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
EXCIPIENT:
Buffered isotonic solution to
1 ml.
VISUAL ASPECT:
Lyophilisate: White pellet.
Suspension: Opalescent liquid.
4.
INDICATION(S)
For active immunisation of cats from eight weeks of age against:
- feline calicivirosis to reduce clinical signs,
- feline viral rhinotracheitis to reduce clinical signs and viral
excretion,
- feline panleucopenia to prevent leucopenia and to reduce clinical
signs,
17
- feline leukaemia to prevent persistent viraemia and clinical signs
of the related disease.
The onset of immunity has been demonstrated from:
-
3 weeks after the first injection of primary vaccination for the
calicivirus component
-
3 weeks after the primary vaccination for the panleucopenia and
leukaemia components
-
4 weeks after the primary vaccination for the rhinotracheitis virus
compo

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
LEUCOFELIGEN FeLV/RCP lyophilisate and suspension for suspension for
injection for cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 1 ml:
_Lyophilisate: _
ACTIVE SUBSTANCES:
Live attenuated feline calicivirus (strain F9)
10
4.6
–10
6.1
CCID
50
*
Live attenuated feline viral rhinotracheitis virus (strain F2)
10
5.0
–10
6.6
CCID
50
*
Live attenuated feline panleucopenia virus (strain LR 72)
10
3.7
–10
4.5
CCID
50
*
* Cell culture infectious dose 50%.
EXCIPIENT:
Stabilizing buffer containing gelatin
to 1.3 ml before
freeze-drying
_Suspension: _
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
EXCIPIENT:
Buffered isotonic solution to
1 ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and suspension for suspension for injection.
VISUAL ASPECT:
Lyophilisate: White color.
Suspension: Opalescent liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of cats from eight weeks of age against:
- feline calicivirosis to reduce clinical signs,
- feline viral rhinotracheitis to reduce clinical signs and viral
excretion,
3
- feline panleucopenia to prevent leucopenia and to reduce clinical
signs,
- feline leukaemia to prevent persistent viraemia and clinical signs
of the related disease.
The onset of immunity has been demonstrated from:
- 3 weeks after the first injection of primary vaccination for the
calicivirus component
- 3 weeks after the primary vaccination for the panleucopenia and
leukaemia components,
- 4 weeks after the primary vaccination for the rhinotracheitis virus
component.
After the primary vaccination course, the duration of immunity lasts
for one year for all components.
Following a first booster vaccination one year after the primary
vaccina