Target species
Dogs and Cats
Indications for use, specifying the target species
Dogs:
For the reduction in mortality and clinical signs of parvovirus (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.
• 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.
Contraindications
Dogs:
Vaccination during and after VIRBAGEN OMEGA 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 VIRBAGEN OMEGA on cat vaccination has not been evaluated.
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 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.
Special precautions for use
Special precautions for use in animals
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.
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.
Adverse reactions
In some cases, during treatment, the following transitory clinical signs may be observed in dogs and cats: A slight decrease in white blood cells, platelets and red blood cells, and rise in the concentration of alanine aminotransferase were observed very commonly in safety studies. These parameters return to normal in the week following the last injection. Slight and transient clinical signs such as hyperthermia (3-6 hours after injection) lethargy and digestive signs (vomiting and soft faeces to mild diarrhoea, in cats only.) were commonly observed in safety studies.
Pregnancy and lactation
The safety of Virbagen Omega has not been established during pregnancy and lactation.
Interactions with other medicaments and other forms of interaction
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.
Amounts to be administered and administration route
The freeze-dried fraction must be reconstituted with 1 ml of the specific diluent to obtain, depending on the presentation, a limpid and colourless suspension containing 5 MU or 10 MU of recombinant interferon.
Dogs:
The reconstituted product should be injected intravenously once daily for 3 consecutive days. The dose is 2.5 MU/kg bodyweight.
Cats:
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.
The product should be used with the accompanying solvent only.
Overdose
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.