Virbagen Omega

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

recombinant omega interferon of feline origin

Saatavilla:

Virbac S.A.

ATC-koodi:

QL03AB

INN (Kansainvälinen yleisnimi):

interferon (omega)

Terapeuttinen ryhmä:

Dogs; Cats

Terapeuttinen alue:

Immunostimulants,

Käyttöaiheet:

DogsReduction of mortality and clinical signs of parvovirosis (enteric form) in dogs from one month of age.CatsTreatment of cats infected with feline leukaemia virus (FeLV) and / or feline immunodeficiency virus (FIV), in non-terminal clinical stages, from the age of nine weeks. In a field study conducted, it was observed that there was:a reduction of clinical signs during the symptomatic phase (four months);a reduction of mortality:in anaemic cats, mortality rate of about 60% at four, six, nine and 12 months was reduced by approximately 30% following treatment with interferon;in non-anaemic cats, mortality rate of 50% in cats infected by FeLV was reduced by 20% following treatment with interferon. In cats infected by FIV, mortality was low (5%) and was not influenced by the treatment.

Tuoteyhteenveto:

Revision: 12

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2001-11-05

Pakkausseloste

26
B. PACKAGE LEAFLET
27
PACKAGE LEAFLET
VIRBAGEN OMEGA 5 MU FOR DOGS AND CATS
VIRBAGEN OMEGA 10 MU FOR DOGS AND 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 batch
release
VIRBAC
1ère Avenue - 2065 m - L.I.D.
06516 CARROS
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
VIRBAGEN OMEGA 5 MU for dogs and cats
VIRBAGEN OMEGA 10 MU for dogs and cats
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of 1ml contains:
ACTIVE SUBSTANCE:
Lyophilisate:
5 MU presentation:
Recombinant Omega interferon of feline origin 5 MU*
10 MU presentation:
Recombinant Omega interferon of feline origin 10 MU*
*MU : Million Units
SOLVENT:
Isotonic sodium chloride solution
1 ml
Lyophilisate: white pellet
Solvent: colourless liquid
4.
INDICATION(S)
Dogs:
Reduction of mortality and clinical signs of parvovirosis (enteric
form) in dogs from one month of age.
Cats:
Treatment of cats infected with FeLV and/or FIV, in non-terminal
clinical stages, from the age of 9
weeks. In a field study conducted, it was observed that there was:
- a reduction of clinical signs during the symptomatic phase (4
months)
- a reduction of mortality :
•
in anaemic cats, mortality rate of about 60% at 4, 6, 9 and 12 months
was reduced by
approximately 30% following treatment with interferon.
28
•
in non-anaemic cats, mortality rate of 50 % in cats infected by FeLV
was reduced by 20%
following treatment with interferon. In cats infected by FIV,
mortality was low (5%) and
was not influenced by the treatment.
5.
CONTRAINDICATIONS
Dogs: Vaccination during and after V
IRBAGEN
O
MEGA
treatment is contra-indicated, until the dog
appears to have recovered.
Cats: as vaccination is contra-indicated in the symptomatic phase of
FeLV/FIV infections, the effect of
V
IRBAGEN
O
MEGA
on cat vaccination has not been evaluated.
6.
ADVERSE REACTIONS
In some cases, during treatment, the fol

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
VIRBAGEN OMEGA 5 MU for dogs and cats
VIRBAGEN OMEGA 10 MU for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCE:
Lyophilisate:
5 MU presentation:
Recombinant Omega interferon of feline origin
5 MU*
10 MU presentation:
Recombinant Omega interferon of feline origin
10 MU*
*MU : Million Units
SOLVENT:
Isotonic sodium chloride solution
1 ml
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: white pellet.
Solvent: colourless liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dogs:
Reduction of mortality and clinical signs of parvovirosis (enteric
form) in dogs from one month of age.
Cats:
Treatment of cats infected with FeLV and/or FIV, in non-terminal
clinical stages, from the age of 9
weeks. In a field study conducted, it was observed that there was:
- a reduction of clinical signs during the symptomatic phase (4
months)
- a reduction of mortality:
•
in anaemic cats, mortality rate of about 60% at 4, 6, 9 and 12 months
was reduced by
approximately 30% following treatment with interferon.
3
•
in non-anaemic cats, mortality rate of 50 % in cats infected by FeLV
was reduced by 20%
following treatment with interferon. In cats infected by FIV,
mortality was low (5%) and
was not influenced by the treatment.
4.3
CONTRAINDICATIONS
Dogs: Vaccination during and after V
IRBAGEN
O
MEGA
treatment is contra-indicated, until the dog
appears to have recovered.
Cats: as vaccination is contra-indicated in the symptomatic phase of
FeLV/FIV infections, the effect of
V
IRBAGEN
O
MEGA
on cat vaccination has not been evaluated.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
No information on the induction of long-term side effects is available
in dog and cat, especially for
autoimmune disorders. Such side effects have been desc