Summary of medicine characteristics - Virbagen Omega
SUMMARY OF PRODUCT CHARACTERISTICS
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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*
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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
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 PARTICULARS4.1 Target species
Dogs.
Cats.
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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:
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– a reduction of clinical signs during the symptomatic phase (4 months)
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– 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.
4.3 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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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 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.
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4.5 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.
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.
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4.6 Adverse reactions (frequency and seriousness)
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)
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4.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
4.8 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.
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4.9 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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
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.
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4.11 Withdrawal period(s)
Not applicable.
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5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Interferons
ATCvet code : QL03AB
5.1 Pharmacodynamic properties
Omega interferon of feline origin, produced by genetic engineering, is a type I interferon closely related to alpha interferon.
The exact mechanism of action of interferon omega is not perfectly known, but may involve enhancement of the non-specific defence of the body, in particular in the dog against canine parvovirosis and in the cat against feline retrovirosis (FeLV, FIV). Interferon does not act directly and specifically on the pathogenic virus, but exerts its effect by inhibition of the internal synthesis mechanisms of the infected cells.
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5.2 Pharmacokinetic particulars
After injection it is quickly bound to specific receptors of a large variety of cells. It is mainly in cells infected by virus that the mechanism of replication is stopped both by destruction of mRNA and by inactivation of translation proteins (2'5' oligo-adenylate synthetase activation).
6. PHARMACEUTICAL PARTICULARS6.1 List of excipients
Lyophilisate:
Sodium hydroxide 0.2 M
Sodium chloride
D-Sorbitol
Purified gelatin of porcine origin
Solvent:
Sodium chloride
Water for injections
6.2 Major incompatibilities
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the product.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after reconstitution according to directions: use immediately.
6.4. Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Store in the original carton.
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6.5 Nature and composition of immediate packaging
Lyophilisate:
Type I glass vial closed with stopper made with butyl rubber polymer coated with a fluorocarbon polymer resin.
Solvent:
Type I glass vial of 1 ml of solvent closed with butyl elastomer rubber stopper.
For the 5MU presentation:
Cardboard box containing 5 vials of lyophilisate and 5 vials with 1 ml of solvent
For the 10MU presentation:
Cardboard box containing 1 vial of lyophilisate and 1 vial with 1 ml of solvent
Cardboard box containing 2 vials of lyophilisate and 2 vials with 1 ml of solvent
Cardboard box containing 5 vials of lyophilisate and 5 vials with 1 ml of solvent
Not all pack sizes may be marketed.
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6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
7. MARKETING AUTHORISATION HOLDER
VIRBAC
Pre Avenue – 2065m – L.I.D.
06516 CARROS
France
8. MARKETING AUTHORISATION NUMBERS
EU/2/01/030/001
EU/2/01/030/002
EU/2/01/030/003
EU/2/01/030/004
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first autorisation: 06.11.2001 / Date of last renewal: 21.11.2006