Patient leaflet - Virbagen Omega
B. PACKAGE LEAFLET
PACKAGE LEAFLET
VIRBAGEN OMEGA 5 MU for dogs and cats
VIRBAGEN OMEGA 10 MU for dogs and cats
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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
1ere Avenue – 2065 m – L.I.D.
06516 CARROS
France
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
VIRBAGEN OMEGA 5 MU for dogs and cats
VIRBAGEN OMEGA 10 MU for dogs and cats
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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*
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*MU : Million Units
Solvent:
Isotonic sodium chloride solution 1 ml
Lyophilisate: white pellet
Solvent: colourless liquid
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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.
- 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.
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5. 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.
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6. 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.
The frequency of adverse reactions is defined using the following convention:
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– very common (more than 1 in 10 animals treated displaying adverse reaction(s))
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
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7. TARGET SPECIES
Dogs and cats.
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Dogs: The dose is 2.5 MU/kg bodyweight.
Cats: The dose is 1 MU/kg bodyweight.
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.
Cats: The reconstituted product should be injected subcutaneously once daily for 5 consecutive days.
Three separate 5-day treatments must be performed at day 0, day 14 and day 60.
The product should be used immediately after reconstitution.
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9. ADVICE ON CORRECT ADMINISTRATION
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 The use of supplementary supportive treatments improves prognosis.
The product should be used with the accompanying solvent only.
WITHDRAWAL PERIOD(S)
Not applicable.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Store in the original carton.
Do not use after the expiry date stated on the label.
Shelf life after reconstitution according to directions: use immediately.
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12. SPECIAL WARNING(S)
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 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.
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 insert or the label to the physician.
Pregnancy and lactation
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Interaction with other medicinal products 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 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 contra-indicated as both FeLV and FIV infections are known to be immunosuppressive.
Overdose (symptoms, emergency procedures, antidotes)
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.
Incompatibilities
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the product.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED