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

Vaccination during and after Virbagen Omega treatment is contra-indicated until the dog appears to have recovered.

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.

• 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.

In some cases during treatment the following transient clinical signs may be onserved:

Hyperthermia (3-6 hours after injection)

Vomiting

Soft faeces to mild diarrhoea, in cats only.

In addition, a slight decrease in white blood cells, platelets and red blood cells, and rise in the concentration of alanine aminotransferase may be observed. These parameters return to normal in the week following the last injection.

Transient fatigue during the treatment, in cats only.

Dogs and cats: it was shown that strict compliance with the recommended posology is compulsory to achieve clinical benefit.

Cats: In case of repeated treatments of chronic diseases associated with hepatic, cardiac and renal failure, the corresponding disease has to be monitored prior to administration of VIRBAGEN OMEGA. Fluid therapy and other supplementary supportive treatment are necessary to improve prognosis.

The product should be used with the accompanying solvent only.

The safety of Virbagen Omega has not been established during pregnancy and lactation.

The use of supplementary supportive treatments improves prognosis. No interaction has been observed during the treatment with VIRBAGEN OMEGA together with antibiotics, solution for rehydration, vitamins and non steroidal anti-inflammatory agents. However, as specific information on possible interactions of interferon with other products are missing, supplementary supportive treatments should be used cautiously and after a thorough risk/benefit analysis.

No information is available on the safety and efficacy from the concurrent use of this product with any other vaccine. For dogs, it is recommended that no vaccines should be administered until the animal appears to have recovered. Cat vaccination during and after VIRBAGEN OMEGA treatment is contraindicated as both FeLV and FIV infections are known to be immunosuppressive.

The freeze-dried fraction must be reconstituted with 1 ml of the specific diluent to obtain a solution containing 10 MU of recombinant interferon.

The reconstituted product should be injected intravenously once daily for 3 consecutive days. The dose is 2.5 MU/kg bodyweight.

The reconstituted product should be injected subcutaneously once daily for 5 consecutive days. The dose is 1 MU/kg bodyweight. Three separate 5-day treatments must be performed at day 0, day 14 and day 60.

After a tenfold overdose in both dog and cat the following clinical signs have been observed :

• mild lethargy and drowsiness

• slight increase of body temperature.

• slight increase of respiratory rate

• slight sinus tachycardia.

These clinical signs disappear within 7 days without any particular treatment.

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 described after multiple and long-term administration of type I interferon in man. The possibility of occurrence of autoimmune disorders in treated animals cannot therefore be ruled out and has to be balanced with the risk associated with FeLV/FIV infections.

Efficacy of the product on cats with a tumorous form of the infection by FeLV, or cats infected by FeLV or coinfected by FIV in terminal stages was not tested.

In the case of intravenous administration in cats, increased adverse reactions may be seen, e.g. hyperthermia, soft faeces, anorexia, decreased drinking or collapse.

not applicable.

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