Virbagen Omega

recombinant omega interferon of feline origin

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This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

What is Virbagen Omega?

Virbagen Omega is a lyophilisate (freeze-dried pellet) and solvent that are made into a suspension for injection. Virbagen Omega contains the active substance recombinant omega interferon of feline origin (from cats) at 5 MU/vial or 10 MU/vial. It is used for dogs and cats.

What is Virbagen Omega used for?

Virbagen Omega is used to reduce mortality and clinical signs of parvovirosis (a highly contagious viral infection of dogs) in dogs from one month of age.

Virbagen Omega is also used to treat cats infected with feline leukaemia virus (FeLV) or feline immunodeficiency virus (FIV), in non-terminal cats from the age of nine weeks.

Dogs: The suspension should be injected intravenously (into a vein) once daily for three consecutive days. The dose is 2.5 MU/kg bodyweight.

Cats: The suspension should be injected subcutaneously (under the skin) once daily for five consecutive days. The dose is 1 MU/kg bodyweight. Two further five-day treatments must be carried out at 14 days and at 60 days after the first five-day course.

How does Virbagen Omega work?

Virbagen Omega contains the active substance recombinant omega interferon. Interferons are a family of naturally occurring proteins that are produced in response to viral infections. Virbagen Omega works by stimulating the immune system to attack the virus. The active substance of Virbagen Omega, omega interferon, is produced by a method known as ‘recombinant technology’. The omega interferon is made by a cell that has received a gene (DNA), which makes it able to produce omega interferon. The replacement omega interferon acts in the same way as naturally produced omega interferon.

How has the effectiveness of Virbagen Omega been studied?

Virbagen Omega has been studied in dogs (males and females) of at least five weeks old that were infected with parvovirosis. Virbagen Omega 2.5 MU/kg was given intravenously for 3 days. The main measure of effectiveness was the mortality rate compared with dogs that had not been treated. Virbagen Omega has also been studied in the treatment of anaemic or non-anaemic cats infected with FeLV or FIV from the age of nine weeks. The main measure of effectiveness was the mortality rate compared with cats that had not been treated and clinical signs after treatment.

What benefit has Virbagen Omega shown during the studies?

The mortality rate for dogs treated with Virbagen Omega was 4.4-6.4 times lower than that of the untreated animals.

In the treatment of cats with FeLV, there was a reduction of clinical signs over four months and a reduction in the mortality rate. In anaemic cats, the mortality rate in cats infected by FeLV (about 60%) was reduced by about 30%. In non-anaemic cats, the mortality rate (50 %) was reduced by 20%. In cats infected by FIV, the mortality rate was low (5%) and was not changed by the treatment. In the population of cats (whether they were FeLV-positive, FIV-positive or co-infected by both viruses) there was a reduction of clinical signs over time, improving the quality of life of the cats.

What is the risk associated with Virbagen Omega?

The injection of Virbagen Omega may cause the following temporary symptoms in dogs and cats:

  • hyperthermia (increased temperature, three to six hours after injection);
  • transitory vomiting;
  • soft faeces to mild diarrhoea, in cats only;
  • fatigue during the treatment, in cats only.

There may be a slight decrease in white blood cells, platelets and red blood cells, and a rise in the concentration of alanine aminotransferase (a liver enzyme). These symptoms return to normal in the week after the last injection.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the doctor.

Why has Virbagen Omega been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Virbagen Omega are greater than any risks to reduce mortality and clinical signs of parvovirosis in dogs from one month of age, and to treat cats infected with FeLV (feline leukaemia virus) or FIV in non-terminal cats from the age of nine weeks. They recommended that Virbagen Omega should be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Other information about Virbagen Omega

The European Commission granted a marketing authorisation valid throughout the European Union for Virbagen Omega to Virbac SA on 6 November 2001. Information on the prescription status of this product may be found on the labelling.

Name Language First published Last updated
Virbagen Omega : EPAR - Summary for the public BG = bălgarski 2007-03-07  
Virbagen Omega : EPAR - Summary for the public ES = español 2007-03-07  
Virbagen Omega : EPAR - Summary for the public CS = čeština 2007-03-07  
Virbagen Omega : EPAR - Summary for the public DA = dansk 2007-03-07  
Virbagen Omega : EPAR - Summary for the public DE = Deutsch 2007-03-07  
Virbagen Omega : EPAR - Summary for the public ET = eesti keel 2007-03-07  
Virbagen Omega : EPAR - Summary for the public EL = elliniká 2007-03-07  
Virbagen Omega : EPAR - Summary for the public EN = English 2007-03-07  
Virbagen Omega : EPAR - Summary for the public FR = français 2007-03-07  
Virbagen Omega : EPAR - Summary for the public IT = italiano 2007-03-07  
Virbagen Omega : EPAR - Summary for the public LV = latviešu valoda 2007-03-07  
Virbagen Omega : EPAR - Summary for the public LT = lietuvių kalba 2007-03-07  
Virbagen Omega : EPAR - Summary for the public HU = magyar 2007-03-07  
Virbagen Omega : EPAR - Summary for the public NL = Nederlands 2007-03-07  
Virbagen Omega : EPAR - Summary for the public PL = polski 2007-03-07  
Virbagen Omega : EPAR - Summary for the public PT = português 2007-03-07  
Virbagen Omega : EPAR - Summary for the public RO = română 2007-03-07  
Virbagen Omega : EPAR - Summary for the public SK = slovenčina 2007-03-07  
Virbagen Omega : EPAR - Summary for the public SL = slovenščina 2007-03-07  
Virbagen Omega : EPAR - Summary for the public FI = suomi 2007-03-07  
Virbagen Omega : EPAR - Summary for the public SV = svenska 2007-03-07  

This EPAR was last updated on 01/06/2011 .

Authorisation details

Product details

Product details for Virbagen Omega
NameVirbagen Omega
Agency product numberEMEA/V/C/000061
Active substance

recombinant omega interferon of feline origin

International non-proprietary name (INN) or common name

interferon (omega)

Species DogsCats
Anatomical therapeutic chemical veterinary (ATCvet) codeQL03AB

Publication details

Publication details for Virbagen Omega
Marketing-authorisation holder

Virbac S.A.

Revision9
Date of issue of marketing authorisation valid throughout the European Union06/11/2001

Contact address:

Virbac S.A.
1ère Avenue 2065 M
06516 Carros
France

Product information

Product information

19/05/2011  Virbagen Omega -EMEA/V/C/000061 -IA/0006

Name Language First published Last updated
Virbagen Omega : EPAR - Product Information SV = svenska 2008-06-03 2011-06-01
Virbagen Omega : EPAR - Product Information SV = svenska 2008-06-03 2011-06-01
Virbagen Omega : EPAR - Product Information SV = svenska 2008-06-03 2011-06-01
Virbagen Omega : EPAR - Product Information SV = svenska 2008-06-03 2011-06-01
Virbagen Omega : EPAR - Product Information SV = svenska 2008-06-03 2011-06-01
Virbagen Omega : EPAR - Product Information SV = svenska 2008-06-03 2011-06-01
Virbagen Omega : EPAR - Product Information SV = svenska 2008-06-03 2011-06-01
Virbagen Omega : EPAR - Product Information SV = svenska 2008-06-03 2011-06-01
Virbagen Omega : EPAR - Product Information SV = svenska 2008-06-03 2011-06-01
Virbagen Omega : EPAR - Product Information SV = svenska 2008-06-03 2011-06-01
Virbagen Omega : EPAR - Product Information SV = svenska 2008-06-03 2011-06-01
Virbagen Omega : EPAR - Product Information SV = svenska 2008-06-03 2011-06-01
Virbagen Omega : EPAR - Product Information SV = svenska 2008-06-03 2011-06-01
Virbagen Omega : EPAR - Product Information SV = svenska 2008-06-03 2011-06-01
Virbagen Omega : EPAR - Product Information SV = svenska 2008-06-03 2011-06-01
Virbagen Omega : EPAR - Product Information SV = svenska 2008-06-03 2011-06-01
Virbagen Omega : EPAR - Product Information SV = svenska 2008-06-03 2011-06-01
Virbagen Omega : EPAR - Product Information SV = svenska 2008-06-03 2011-06-01
Virbagen Omega : EPAR - Product Information SV = svenska 2008-06-03 2011-06-01
Virbagen Omega : EPAR - Product Information SV = svenska 2008-06-03 2011-06-01
Virbagen Omega : EPAR - Product Information SV = svenska 2008-06-03 2011-06-01
Virbagen Omega : EPAR - Product Information SV = svenska 2008-06-03 2011-06-01
Virbagen Omega : EPAR - Product Information SV = svenska 2008-06-03 2011-06-01
Virbagen Omega : EPAR - Product Information SV = svenska 2008-06-03 2011-06-01

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Virbagen Omega : EPAR - All Authorised presentations SV = svenska 2006-08-29  
Virbagen Omega : EPAR - All Authorised presentations SV = svenska 2006-08-29  
Virbagen Omega : EPAR - All Authorised presentations SV = svenska 2006-08-29  
Virbagen Omega : EPAR - All Authorised presentations SV = svenska 2006-08-29  
Virbagen Omega : EPAR - All Authorised presentations SV = svenska 2006-08-29  
Virbagen Omega : EPAR - All Authorised presentations SV = svenska 2006-08-29  
Virbagen Omega : EPAR - All Authorised presentations SV = svenska 2006-08-29  
Virbagen Omega : EPAR - All Authorised presentations SV = svenska 2006-08-29  
Virbagen Omega : EPAR - All Authorised presentations SV = svenska 2006-08-29  
Virbagen Omega : EPAR - All Authorised presentations SV = svenska 2006-08-29  
Virbagen Omega : EPAR - All Authorised presentations SV = svenska 2006-08-29  
Virbagen Omega : EPAR - All Authorised presentations SV = svenska 2006-08-29  
Virbagen Omega : EPAR - All Authorised presentations SV = svenska 2006-08-29  
Virbagen Omega : EPAR - All Authorised presentations SV = svenska 2006-08-29  
Virbagen Omega : EPAR - All Authorised presentations SV = svenska 2006-08-29  
Virbagen Omega : EPAR - All Authorised presentations SV = svenska 2006-08-29  
Virbagen Omega : EPAR - All Authorised presentations SV = svenska 2006-08-29  
Virbagen Omega : EPAR - All Authorised presentations SV = svenska 2006-08-29  
Virbagen Omega : EPAR - All Authorised presentations SV = svenska 2006-08-29  

Pharmacotherapeutic group

Immunostimulants

Therapeutic indication

Dogs

Reduction of mortality and clinical signs of parvovirosis (enteric form) in dogs from one month of age.

Cats

Treatment 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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Virbagen Omega : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2006-11-28 2011-06-01

Initial marketing-authorisation documents

Name Language First published Last updated
Virbagen Omega : EPAR - Procedural steps taken before authorisation SV = svenska 2006-08-29  
Virbagen Omega : EPAR - Scientific Discussion SV = svenska 2006-08-29