Virbagen Omega
interferon (omega)
Marketing authorisation holder and manufacturer responsible for batch release
VIRBAC
1ère Avenue - 2065 m - L.I.D. 06516 CARROS
France
VIRBAGEN OMEGA 5 MU for dogs and cats VIRBAGEN OMEGA 10 MU for dogs and cats
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*
*MU : Million Units
Isotonic sodium chloride solution 1 ml
Lyophilisate: white pellet Solvent: colourless liquid
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.
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.
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:
very common (more than 1 in 10 animals treated displaying adverse reaction(s))
common (more than 1 but less than 10 animals in 100 animals treated)
uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
rare (more than 1 but less than 10 animals in 10,000 animals treated)
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.
Dogs and cats.
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.
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.
Not applicable.
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.
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.
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.
In case of accidental self-injection, seek medical advice immediately and show the package insert or the label to the physician.
The safety of the veterinary medicinal product 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 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.
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.
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the product.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
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.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
VIRBAC BELGIUM N.V.
Esperantolaan 4 BE-3001 Leuven
Tel: + 32 (0) 16 38 72 60
VIRBAC BELGIUM N.V.
Esperantolaan 4
BE-3001 Leuven Belgique / Belgien Tel: + 32 (0) 16 38 72 60
VIRBAC
1ère avenue 2065 m – L.I.D FR-06516 Carros Francie
Tel: + 33 (0) 4 92 08 73 00
VIRBAC HUNGARY KFT
Szent Istvàn krt.11.II/21. HU-1055 Budapest
Tel: +36703387177
VIRBAC Danmark A/S
Profilvej 1
DK-6000 Kolding Tel: + 45 7552 1244
VIRBAC
1ère avenue 2065 m – L.I.D FR-06516 Carros Franza
Tel: + 33 (0) 4 92 08 73 00
VIRBAC Tierarzneimittel GmbH
Rögen 20
DE-23843 Bad Oldesloe Tel: + 49 (4531) 805 111
VIRBAC NEDERLAND BV
Hermesweg 15
NL-3771 ND-Barneveld Tel: + 31 (0) 342 427 127
VIRBAC
1ère avenue 2065 m LID
FR-06516 Carros Prantsusmaa Tel: +33-(0)4 92 08 73 00
VIRBAC Danmark A/S Profilvej 1
DK-6000 Kolding Danmark Tel: + 45 75521244
VIRBAC HELLAS A.E.
13o χλμ Ε.Ο. Αθηνών - Λαμίας
EL-14452, Μεταμόρφωση Τηλ: +30 2106219520
VIRBAC Österreich GmbH Hildebrandgasse 27
A-1180 Wien
Tel: + 43 (0) 1 21 834 260
VIRBAC ESPAÑA, S.A.
Angel Guimera 179-181
ES-08950 - Esplugues de Llobregat (Barcelona) Tel: + 34 93 470 79 40
VIRBAC Sp. z o.o.
ul. Puławska 314
PL 02-819 Warszawa
Tel.: + 48 22 855 40 46
VIRBAC France 13ème rue – L.I.D.
FR-06516 Carros Cedex Tél : +33 805 05 55 55
VIRBAC DE PORTUGAL LABORATÓRIOS LDA
R.do Centro Empresarial Ed13-Piso 1- Esc.3
Quinta da Beloura PT-2710-693 Sintra
+ 351 219 245 020
VIRBAC
1ère avenue 2065 m – L.I.D FR-06516 Carros France
Tel: + 33 (0) 4 92 08 73 00
VIRBAC
1ère avenue 2065 m – L.I.D FR-06516 Carros Francija
Tel: + 33 (0) 4 92 08 73 00
VIRBAC
1ère avenue 2065 m – L.I.D FR-06516 Carros Frakkland Simi: + 33 (0) 4 92 08 73 00
VIRBAC
1ère avenue 2065 m – L.I.D FR-06516 Carros Francúzsko Tel: + 33 (0) 4 92 08 73 00
VIRBAC SRL
Via Ettore Bugatti 15 IT-20142 Milano
Tel: + 39 02 40 92 47 1
VIRBAC
1ère avenue 2065 m – L.I.D FR-06516 Carros Ranska Puh/Tel: + 33 (0) 4 92 08 73 00
VIRBAC HELLAS Α.Ε.
13o χλμ Ε.Ο. Αθηνών - Λαμίας EL-14452, Μεταμόρφωση Τηλ.: +30 2106219520
VIRBAC DANMARK A/S FILIAL
SVERIGE,
c/o Incognito AB, Box 1027,
SE-171 21 Solna
Tel: + 45 7552 1244
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros Francjia
Tel: +33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065m LID FR-06516 Carros France
Tel: + 33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065 m LID
FR-06516 Carros Prancūzija
Tel: +33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065 m – L.I.D FR-06516 Carros Francuska
Tel: + 33 (0) 4 92 08 73 00
VIRBAC
1ère avenue 2065 m – L.I.D FR-06516 Carros Franţa
Tel: + 33 (0) 4 92 08 73 00
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros Франция
Teл: +33-(0)4 92 08 73 00