ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
VIRBAGEN OMEGA 5 MU for dogs and cats
VIRBAGEN OMEGA 10 MU for dogs and cats
2.
Vial containing lyophilisate:
Active substance:
5 MU presentation :
Recombinant Omega interferon of feline origin 5 MU*/ vial
10 MU presentation :
Recombinant Omega interferon of feline origin 10 MU*/ vial
*MU : Million Units
Vial containing solvent:
Isotonic sodium chloride solution
1 ml
Excipients:
For a full list of excipients, see section 6.1.
3.
Lyophilisate and solvent for suspension for injection.
4.
4.1
Dogs.
Cats.
4.2
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.
2
4.3
Dogs
: Vaccination during and after V
IRBAGEN
O
MEGA
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
V
IRBAGEN
O
MEGA
on cat vaccination has not been evaluated.
4.4
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.
4.5
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 V
IRBAGEN
O
MEGA
.
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.
In some cases, during treatment, the following transitory clinical signs may be observed in dogs and
cats:
• 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.
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 V
IRBAGEN
O
MEGA
together with antibiotics, solution for rehydration,
3
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 V
IRBAGEN
O
MEGA
treatment is contra-indicated as
both FeLV and FIV infections are known to be immunosuppressive.
4.9
The freeze-dried fraction must be reconstituted with 1 ml of the specific diluent to obtain, depending
on the presentation, a 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.
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.
Not applicable.
5.
Pharmacotherapeutic group : Interferons
ATCvet code : QL03 AB
5.1
Pharmacodynamic properties
Omega interferon of feline origin, produced by genetic engineering, is a type Ι 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.
4
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.
6.1 List of excipients
Sodium hydroxide 0.2 M, sodium chloride, D-Sorbitol, purified gelatin of porcine origin.
6.2 Incompatibilities
Do not mix with any other vaccine/immunological product, except the solvent supplied for use with
the product.
6.3 Shelf life
2 years.
The product should be used immediately after reconstitution.
6.4. Special precautions for storage
Store and transport at 4°C ± 2°C.
Do not freeze.
Store in the original carton.
6.5 Nature and composition of immediate packaging
For the 5MU presentation:
Box containing 5 vials (glass with stoppers made with butyl rubber polymer coated with a
fluorocarbon polymer resin ) of powder fraction and 5 vials (glass with butyl elastomer rubber stopper)
with 1 ml of solvent.
For the 10MU presentation:
Box containing 1 vial (glass with stoppers made with butyl rubber polymer coated with a fluorocarbon
polymer resin ) of powder fraction and 1 vial (glass with butyl elastomer rubber stopper) with 1 ml of
solvent.
Box containing 2 vials (glass with stoppers made with butyl rubber polymer coated with a
fluorocarbon polymer resin ) of powder fraction and 2 vials (glass with butyl elastomer rubber stopper)
with 1 ml of solvent.
Box containing 5 vials (glass with stoppers made with butyl rubber polymer coated with a
fluorocarbon polymer resin ) of powder fraction and 5 vials (glass with butyl elastomer rubber stopper)
with 1 ml of solvent.
6.6
Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
5
7.
VIRBAC SA
L.I.D. 1
ère
Avenue - 2065 m
06516 CARROS
France
8.
EU/2/01/030/001
EU/2/01/030/002
EU/2/01/030/003
EU/2/01/030/004
9.
06.11.2001 / 21.11.2006
10.
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency (EMA)
http://www.ema.europa.eu
.
PROHIBITION OF SALE, SUPPLY AND/OR USE
The import, sale, supply and/or use of V
IRBAGEN
O
MEGA
is or may be prohibited in certain Member
States on the whole or part of their territory pursuant to national animal health policy. Any person
intending to import, sell, supply and/or use V
IRBAGEN
O
MEGA
must consult the relevant Member
State’s competent authority on the current vaccination policies prior to the import, sale, supply and/or
use.
6
ANNEX II
A.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
BATCH RELEASE
B.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION REGARDING SUPPLY OR USE
C.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
D.
STATEMENT OF THE MRLs
7
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer of the biological active substance
Toray industries, Inc.
EhimePlant
1515 Tsutsui, Masaki-Cho, Iyogun
791-3193
Japan
Name and address of the manufacturer responsible for batch release
VIRBAC SA
L.I.D. 1ère Avenue - 2065 m
06516 Carros, France
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as
amended, Member States prohibit or may prohibit the import, sale, supply and/or use of the veterinary
medicinal product on the whole or part of their territory if it is established that:
a) the administration of the veterinary medicinal product to animals will interfere with the
implementation of national programmes for the diagnosis, control and eradication of animal
diseases, or will cause difficulties in certifying the absence of contamination in live animals or
in foodstuffs or other products obtained from treated animals.
b) the disease to which the veterinary medicinal product is intended to confer immunity is largely
absent from the territory.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable.
D.
STATEMENT OF THE MRLs
Not applicable.
8
ANNEX III
LABELLING AND PACKAGE LEAFLET
9
A. LABELLING
10
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
1.
VIRBAGEN OMEGA 5 MU for dogs and cats
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Vial containing lyophilisate:
Active substance
Recombinant Omega interferon of feline origin 5 MU*/ vial
*MU : Million Units
Vial containing solvent:
Isotonic sodium chloride solution
1 ml
3.
Lyophilisate and solvent for suspension for injection.
4.
PACKAGE SIZE
Box containing 5 vials of powder fraction and 5 vials with 1 ml of solvent.
5.
Dogs and cats.
6.
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.
11
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
The freeze-dried fraction must be reconstituted with 1 ml of the specific diluent to obtain a solution
containing 5 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.
Read the package leaflet before use.
8.
Not applicable.
9.
SPECIAL WARNING(S), IF NECESSARY
Dog
: Vaccination during and after V
IRBAGEN
O
MEGA
treatment is contra-indicated, until the dog
appears to have recovered.
Cat
: as vaccination is contra-indicated in symptomatic phase of FeLV/FIV infections, effect of
V
IRBAGEN
O
MEGA
on cat vaccination has not been evaluated.
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 V
IRBAGEN
O
MEGA
.
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.
10. EXPIRY DATE
EXP {month/year}
The product should be used immediately after reconstitution.
11. SPECIAL STORAGE CONDITIONS
Store and transport at 4°C ± 2°C.
Do not freeze.
Store in the original carton.
12
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS 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.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only.
To be supplied only on veterinary prescription.
The import, sale, supply and/or use of this veterinary medicinal product is or may be prohibited in
certain Member States on the whole or part of their territory, see package leaflet for further
information.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
VIRBAC SA
L.I.D. 1ère Avenue - 2065 m
06516 CARROS
France
EU/2/01/030/001
17. MANUFACTURER’S BATCH NUMBER
Batch number
13
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
1.
VIRBAGEN OMEGA 10 MU for dogs and cats
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Vial containing lyophilisate:
Active substance
Recombinant Omega interferon of feline origin 10 MU*/ vial
*MU : Million Units
Vial containing solvent:
Isotonic sodium chloride solution
1 ml
3.
Lyophilisate and solvent for suspension for injection.
4.
PACKAGE SIZE
Box containing 5 vials of powder fraction and 5 vials with 1 ml of solvent.
5.
Dogs and cats.
6.
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.
14
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
The freeze-dried fraction must be reconstituted with 1 ml of the specific diluent to obtain a solution
containing 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.
Read the package leaflet before use.
8.
Not applicable.
9.
SPECIAL WARNING(S), IF NECESSARY
Dog
: Vaccination during and after V
IRBAGEN
O
MEGA
treatment is contra-indicated, until the dog
appears to have recovered.
Cat
: as vaccination is contra-indicated in symptomatic phase of FeLV/FIV infections, effect of
V
IRBAGEN
O
MEGA
on cat vaccination has not been evaluated.
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 V
IRBAGEN
O
MEGA
.
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.
10. EXPIRY DATE
EXP {month/year}
The product should be used immediately after reconstitution.
11. SPECIAL STORAGE CONDITIONS
Store and transport at 4°C ± 2°C.
Do not freeze.
Store in the original carton.
15
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS 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.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only.
To be supplied only on veterinary prescription.
The import, sale, supply and/or use of this veterinary medicinal product is or may be prohibited in
certain Member States on the whole or part of their territory, see package leaflet for further
information.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
VIRBAC SA
L.I.D. 1ère Avenue - 2065 m
06516 CARROS
France
EU/2/01/030/002
17. MANUFACTURER’S BATCH NUMBER
Batch number
16
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
1.
VIRBAGEN OMEGA 10 MU for dogs and cats
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Vial containing lyophilisate:
Active substance
Recombinant Omega interferon of feline origin 10 MU*/ vial
*MU : Million Units
Vial containing solvent:
Isotonic sodium chloride solution
1 ml
3.
Lyophilisate and solvent for suspension for injection.
4.
PACKAGE SIZE
Box containing 2 vials of powder fraction and 2 vials with 1 ml of solvent.
5.
Dogs and cats.
6.
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.
17
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
The freeze-dried fraction must be reconstituted with 1 ml of the specific diluent to obtain a solution
containing 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.
Read the package leaflet before use.
8.
Not applicable.
9.
SPECIAL WARNING(S), IF NECESSARY
Dog
: Vaccination during and after V
IRBAGEN
O
MEGA
treatment is contra-indicated, until the dog
appears to have recovered.
Cat
: as vaccination is contra-indicated in symptomatic phase of FeLV/FIV infections, effect of
V
IRBAGEN
O
MEGA
on cat vaccination has not been evaluated.
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 V
IRBAGEN
O
MEGA
.
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.
10. EXPIRY DATE
EXP {month/year}
The product should be used immediately after reconstitution.
11. SPECIAL STORAGE CONDITIONS
Store and transport at 4°C ± 2°C.
Do not freeze.
Store in the original carton.
18
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS 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.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only.
To be supplied only on veterinary prescription.
The import, sale, supply and/or use of this veterinary medicinal product is or may be prohibited in
certain Member States on the whole or part of their territory, see package leaflet for further
information.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
VIRBAC SA
L.I.D. 1ère Avenue - 2065 m
06516 CARROS
France
EU/2/01/030/003
17. MANUFACTURER’S BATCH NUMBER
Batch number
19
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
1.
VIRBAGEN OMEGA 10 MU for dogs and cats
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Vial containing lyophilisate:
Active substance
Recombinant Omega interferon of feline origin 10 MU*/ vial
*MU : Million Units
Vial containing solvent:
Isotonic sodium chloride solution
1 ml
3.
Lyophilisate and solvent for suspension for injection.
4.
PACKAGE SIZE
Box containing 1 vial of powder fraction and 1 vial with 1 ml of solvent.
5.
Dogs and cats.
6.
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.
20
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
The freeze-dried fraction must be reconstituted with 1 ml of the specific diluent to obtain a solution
containing 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.
Read the package leaflet before use.
8.
Not applicable.
9.
SPECIAL WARNING(S), IF NECESSARY
Dog
: Vaccination during and after V
IRBAGEN
O
MEGA
treatment is contra-indicated, until the dog
appears to have recovered.
Cat
: as vaccination is contra-indicated in symptomatic phase of FeLV/FIV infections, effect of
V
IRBAGEN
O
MEGA
on cat vaccination has not been evaluated.
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 V
IRBAGEN
O
MEGA
.
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.
10. EXPIRY DATE
EXP {month/year}
The product should be used immediately after reconstitution.
11. SPECIAL STORAGE CONDITIONS
Store and transport at 4°C ± 2°C.
Do not freeze.
Store in the original carton.
21
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS 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.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only.
To be supplied only on veterinary prescription.
The import, sale, supply and/or use of this veterinary medicinal product is or may be prohibited in
certain Member States on the whole or part of their territory, see package leaflet for further
information.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
VIRBAC SA
L.I.D. 1ère Avenue - 2065 m
06516 CARROS
France
EU/2/01/030/004
17. MANUFACTURER’S BATCH NUMBER
Batch number
22
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
1.
VIRBAGEN OMEGA 5 MU for dogs and cats
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Recombinant Omega interferon of feline origin 5 MU*/ vial
* MU: Million Units
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
5 MU
4.
ROUTE(S) OF ADMINISTRATION
Dogs: Intravenous route
Cats: Subcutaneous route
5.
Not applicable.
6.
BATCH NUMBER
Batch number
7.
EXPIRY DATE
EXP: month/year
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
23
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
1.
VIRBAGEN OMEGA 10 MU for dogs and cats
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Recombinant Omega interferon of feline origin 10 MU*/ vial
* MU: Million Units
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
10 MU
4.
ROUTE(S) OF ADMINISTRATION
Dogs: Intravenous route
Cats: Subcutaneous route
5.
Not applicable.
6.
BATCH NUMBER
Batch number
7.
EXPIRY DATE
EXP: month/year
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
24
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
1.
VIRBAGEN OMEGA
Solvent for suspension for injection
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Isotonic sodium chloride solution
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
1 ml
4.
ROUTE(S) OF ADMINISTRATION
Dogs: Intravenous route
Cats: Subcutaneous route
5.
Not applicable.
6.
BATCH NUMBER
Batch number
7.
EXPIRY DATE
EXP: month/year
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET
VIRBAGEN OMEGA 5 MU for dogs and cats
VIRBAGEN OMEGA 10 MU for dogs and cats
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
VIRBAC SA
L.I.D. 1ère Avenue - 2065 m
06516 CARROS
France
2.
VIRBAGEN OMEGA 5 MU for dogs and cats
VIRBAGEN OMEGA 10 MU for dogs and cats
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Vial containing lyophilisate:
Active substance
5 MU presentation :
Recombinant Omega interferon of feline origin 5 MU*/ vial
10 MU presentation :
Recombinant Omega interferon of feline origin 10 MU*/ vial
*MU : Million Units
Vial containing solvent :
Isotonic sodium chloride solution
1 ml
4.
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.
27
5.
Dogs
: Vaccination during and after V
IRBAGEN
O
MEGA
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
V
IRBAGEN
O
MEGA
on cat vaccination has not been evaluated.
6.
In some cases, during treatment, the following transitory clinical signs may be observed in dogs and
cats:
• 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.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Dogs and cats.
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 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.
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 V
IRBAGEN
O
MEGA
The use of supplementary supportive treatments improves prognosis.
The product should be used with the accompanying solvent only.
10. WITHDRAWAL PERIOD
Not applicable.
28
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Store and transport at 4° C ± 2° C.
Do not freeze.
Store in the original carton.
Do not use after the expiry date stated on the label.
12. SPECIAL WARNING(S)
The safety of the veterinary medicinal product has not been established during pregnancy and
lactation.
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.
If you are accidentally injected with this product, seek prompt medical advice even if only a very small
amount is injected and take the package insert with you.
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.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this product is available on the website of the European Medicines Agency
(EMA)
http://ema.europa.eu
.
15. OTHER INFORMATION
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.
België/Belgique/Belgien
VIRBAC BELGIUM S.A.
Rue de la station 17
B-1300 WAVRE
Tel. : 32 (0) 10 47 06 35
Luxembourg/Luxemburg
VIRBAC BELGIUM S.A.
Rue de la station 17
B-1300 WAVRE
Tel. : 32 (0) 10 47 06 35
Česká republika
VIRBAC S.A.
Magyarország
VIRBAC S.A.
29
1ère avenue 2065m – L.I.D.
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
1ère avenue 2065m – L.I.D.
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Danmark
VIRBAC S.A.
1ère avenue 2065m – L.I.D.
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Malta
VIRBAC S.A.
1ère avenue 2065m – L.I.D.
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Deutschland
VIRBAC Tierarzneimittel GmbH
West Rögen 20
D-23843 Bad Oldesloe
Tel: 49 (4531) 805 555
Nederland
VIRBAC NEDERLAND BV
Hermesweg 15
NL-3771 ND - BARNEVELD
Tel: 31 (0) 342 427 100
Eesti
VIRBAC S.A.
1ère avenue 2065m – L.I.D.
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Norge
VIRBAC S.A.
1ère avenue 2065m – L.I.D.
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
España
VIRBAC ESPAÑA S.A.
ES-8950 Esplugues de Llobregat (Barcelona).
Tél. : + 34 93 470 79 40
Polska
VIRBAC S.A.
1ère avenue 2065m – L.I.D.
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Ireland
C&M Veterinary Distributors Limited
IE- Limerick
Tel.: 353 61 314 933
Portugal
VIRBAC DE PORTUGAL
LABORATÓRIOS LDA
P-2080-Almeirim
Tél. : (351) 243.570 500
Ísland
VIRBAC S.A.
1ère avenue 2065m – L.I.D.
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Slovenská republika
VIRBAC S.A.
1ère avenue 2065m – L.I.D.
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Italia
VIRBAC SRL
Via dei Gracchi 30
I-20146 Milano
Tel: 39 02 48 53 451
Suomi/Finland
VIRBAC S.A.
1ère avenue 2065m – L.I.D.
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Κύπρος
VIRBAC S.A.
1ère avenue 2065m – L.I.D.
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Sverige
VIRBAC S.A.
1ère avenue 2065m – L.I.D.
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Latvija
VIRBAC S.A.
United Kingdom
VIRBAC Ltd
30
Ελλάδα
VIRBAC S.A.
1ère avenue 2065m – L.I.D.
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Österreich
VIRBAC Österreich GmbH
A-1180 Wien
Tel : 43 (0) 1 2183426 0
France
VIRBAC S.A.
1ère avenue 2065m – L.I.D.
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Slovenija
VIRBAC S.A.
1ère avenue 2065m – L.I.D.
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
1ère avenue 2065m – L.I.D.
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
UK-Suffolk IP30 9UP
Tel: 44 (0) 1359 243243
Lietuva
VIRBAC S.A.
1ère avenue 2065m – L.I.D.
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Република България
VIRBAC S.A.
1ère avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
România
VIRBAC S.A.
1ère avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
31
Source: European Medicines Agency
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