ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS VIRBAGEN OMEGA - EN 1

Transcription

1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS VIRBAGEN OMEGA - EN 1

2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Virbagen Omega 5 MU for dogs Virbagen Omega 10 MU for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION VIAL CONTAINING LYOPHYLISATE Active substance 5 MU presentation: Recombinant Omega interferon of feline origin 10 MU presentation: Recombinant Omega interferon of feline origin 5 MU*/vial 10 MU*/vial *MU: Million Units List of excipients Sodium Chloride, D-sorbitol, gelatin VIAL CONTAINING SOLVENT: Isotonic sodium chloride solution... 1 ml 3. PHARMACEUTICAL FORM Powder and solvent for suspension for injection 4. IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: ATCvet-Code: QL03 AB 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. 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. Omega interferon of feline origin, produced by genetic engineering, is a type I interferon related to alpha interferon. After injection it is quickly bound to specific receptors of a large variety of cells. It is mainly in cells infected by the 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). VIRBAGEN OMEGA - EN 2

3 5. CLINICAL PARTICULARS 5.0 Target species Dogs 5.1 Indications for use Reduction of mortality and clinical signs of parvovirosis (enteric form) in dogs from one month of age. 5.2 Contraindications Vaccination during and after Virbagen Omega treatment is contra-indicated, until the dog appears to have recovered. 5.3 Undesirable effects In some cases, during treatment, the followings transitory clinical signs may be observed: hyperthermia (3-6 hours after injection) vomiting slight decrease in white blood cells, platelets and red blood cells; parameters are restored within 1 week. 5.4 Special precautions for use Fluid therapy and other supplementary supportive treatments, are necessary to improve prognosis. The product should be used with the accompanying solvent only. 5.5 Pregnancy and lactation The safety of the veterinary medicinal product has not been established during pregnancy and lactation. 5.6 Interactions with other medicaments and other form of interaction No information is available on the safety and efficacy from the concurrent use of this product with vaccines. It is therefore recommended that no vaccines should be administered until the dog appears to have recovered. 5.7 Posology and method of administration The freeze-dried fraction must be reconstituted with 1 ml of the specific solvent to obtain, depending on the presentation, a solution containing 5 MU or 10 MU of recombinant interferon. The reconstituted product should be injected intravenously once daily for 3 consecutive days. The dose is 2.5 MU/kg bodyweight. VIRBAGEN OMEGA - EN 3

4 5.8 Overdose After a tenfold overdose of 25 MU/kg/body weight the following transient clinical signs of disease 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. 5.9 Special warnings No information on the induction of long-term side effects is available in dogs, especially for auto-immune disorders. Such side-effects have been described after multiple and long-term administration of type I interferon in man. The possibility of occurrence of auto immune disorders in dogs cannot therefore be ruled out Withdrawal period Not applicable Special precautions to be taken by the person administering the product to animals In case of accidental self-injection, seek medical advice immediately and show the package insert or the label to the physician. 6. PHARMACEUTICAL PARTICULARS 6.1 Incompatibilities Do not mix with any other vaccine/immunological product, except the solvent supplied for use with the product. 6.2 Shelf life 2 years The product should be used immediately after reconstitution due to the absence of preservative. 6.3 Special precautions for storage Store and transport at 4 C ± 2 C. Do not freeze. Store in the original carton. VIRBAGEN OMEGA - EN 4

5 6.4 Nature and contents of container For each presentation of 5 MU and 10 MU: Box containing 5 vials (glass with stopper) of powder fraction and 5 vials (glass with stopper) with 1 ml of solvent. 6.5 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from such veterinary medicinal products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. 7. PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable. 8. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER VIRBAC SA L.I.D. 1ère Avenue m F CARROS FRANCE 9. NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS 10. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 11. DATE OF REVISION OF THE TEXT VIRBAGEN OMEGA - EN 5

6 ANNEX II A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OF THE MARKETING AUTHORISATION INCLUDING RESTRICTIONS REGARDING SUPPLY AND USE C. PROHIBITION OF SALE, SUPPLY AND/OR USE D. STATEMENT OF THE MRLs VIRBAGEN OMEGA - EN 6

7 A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturers of the biological active substance(s) TORAY Industries, Inc. 2-1 Nihonbashi -muromachi 2-chome Chuo-ku, Tokyo 103, Japan Name and address of the manufacturer(s) responsible for batch release VIRBAC SA L.I.D. 1 ère Avenue m Carros, France B. CONDITIONS OF THE MARKETING AUTHORISATION INCLUDING RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription. The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision. C. PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable D. STATEMENT OF THE MRLs Not applicable VIRBAGEN OMEGA - EN 7

8 ANNEX III LABELLING AND PACKAGE INSERT VIRBAGEN OMEGA - EN 8

9 A. LABELLING VIRBAGEN OMEGA - EN 9

10 PARTICULARS TO APPEAR ON THE OUTER PACKAGE OR, WHERE THERE IS NO OUTER PACKAGE, ON THE IMMEDIATE PACKAGE 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Virbagen Omega 5 MU for dogs 2. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S) Vial containing lyophilisate: Active substance Recombinant Omega interferon of feline origin...5 MU* *MU: Million Units Excipients Sodium Chloride, D-sorbitol, gelatin Vial containing solvent: Isotonic sodium chloride solution... 1 ml 3. PHARMACEUTICAL FORM Powder and solvent for suspension for injection 4. PACKAGE SIZE Box containing 5 vials of lyophylisate fraction and 5 vials with 1 ml of solvent. 5. TARGET SPECIES Dogs 6. INDICATIONS Reduction of mortality and clinical signs of parvovirosis (enteric form) in dogs from one month of age. 7. METHOD AND ROUTE(S) OF ADMINISTRATION The freeze-dried fraction must be reconstituted with 1 ml of the specific solvent to obtain a solution containing 5 MU of recombinant interferon. The reconstituted product should be injected intravenously once daily for 3 consecutive days. VIRBAGEN OMEGA - EN 10

11 8. WITHDRAWAL PERIOD Not applicable 9. SPECIAL WARNINGS Vaccination during and after Virbagen Omega treatment is contra-indicated, until the dog appears to have recovered. Fluid therapy and other supplementary supportive treatments are necessary to improve prognosis. The product should be used with the accompanying solvent only. No information on the induction of long-term side effects is available in dogs, especially for auto-immune disorders. Such side-effects have been described after multiple and long-term administration of type I interferon in human. The possibility of occurrence of auto immune disorders in dogs cannot therefore be ruled out. 10. EXPIRY DATE EXP: month / year The product should be used immediately after reconstitution due to the absence of preservative. 11. SPECIAL STORAGE PRECAUTIONS Store and transport at 4 C ± 2 C. Do not freeze. Store in the original carton. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH VETERINARY MEDICINAL PRODUCTS 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 For animal treatment only. 14. THE WORDS KEEP OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children. 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT VIRBAC SA L.I.D. 1ère Avenue m VIRBAGEN OMEGA - EN 11

12 F CARROS FRANCE 16. NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/0/00/000/ MANUFACTURER S BATCH NUMBER Batch number 18. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription. VIRBAGEN OMEGA - EN 12

13 PARTICULARS TO APPEAR ON THE OUTER PACKAGE OR, WHERE THERE IS NO OUTER PACKAGE, ON THE IMMEDIATE PACKAGE 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Virbagen Omega 10 MU for dogs 2. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S) Vial containing lyophilisate: Active substance Recombinant Omega interferon of feline origin...10 MU* *MU: Million Units Excipients Sodium Chloride, D-sorbitol, gelatin Vial containing solvent: Isotonic sodium chloride solution... 1 ml 3. PHARMACEUTICAL FORM Powder and solvent for suspension for injection 4. PACKAGE SIZE Box containing 5 vials of lyophylisate fraction and 5 vials with 1 ml of solvent. 5. TARGET SPECIES Dogs 6. INDICATIONS Reduction of mortality and clinical signs of parvovirosis (enteric form) in dogs from one month of age. 7. METHOD AND ROUTE(S) OF ADMINISTRATION VIRBAGEN OMEGA - EN 13

14 The freeze-dried fraction must be reconstituted with 1 ml of the specific solvent to obtain a solution containing 10 MU of recombinant interferon. The reconstituted product should be injected intravenously once daily for 3 consecutive days. 8. WITHDRAWAL PERIOD Not applicable 9. SPECIAL WARNINGS Vaccination during and after Virbagen Omega treatment is contra-indicated, until the dog appears to have recovered. Fluid therapy and other supplementary supportive treatments, are necessary to improve prognosis. The product should be used with the accompanying solvent only. No information on the induction of long-term side effects is available in dogs, especially for auto-immune disorders. Such side-effects have been described after multiple and long-term administration of type I interferon in human. The possibility of occurrence of auto immune disorders in dogs cannot therefore be ruled out. 10. EXPIRY DATE EXP: month / year The product should be used immediately after reconstitution due to the absence of preservative. 11. SPECIAL STORAGE PRECAUTIONS Store and transport at 4 C ± 2 C. Do not freeze. Store in the original carton. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH VETERINARY MEDICINAL PRODUCTS 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 For animal treatment only. 14. THE WORDS KEEP OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children. VIRBAGEN OMEGA - EN 14

15 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT VIRBAC SA L.I.D. 1ère Avenue m F CARROS FRANCE 16. NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/0/00/000/ MANUFACTURER S BATCH NUMBER Batch number 18. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription. VIRBAGEN OMEGA - EN 15

16 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Virbagen Omega 5 MU for dogs Powder for suspension for injection 2. QUANTITY OF THE ACTIVE AND OTHER SUBSTANCE(S) Recombinant Omega interferon of feline origin...5 MU* *MU: Million Units 3. CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 5 MU 4. ROUTE OF ADMINISTRATION Intravenous use 5. BATCH NUMBER Batch number 6. EXPIRY DATE EXP: month / year 7. THE WORDS FOR ANIMAL TREATMENT ONLY For animal treatment only. VIRBAGEN OMEGA - EN 16

17 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 3. NAME OF THE VETERINARY MEDICINAL PRODUCT Virbagen Omega 10 MU for dogs Powder for suspension for injection 4. QUANTITY OF THE ACTIVE AND OTHER SUBSTANCE(S) Recombinant Omega interferon of feline origin...10 MU* *MU: Million Units 5. CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 10 MU 6. ROUTE OF ADMINISTRATION Intravenous use 7. BATCH NUMBER Batch number 8. EXPIRY DATE EXP: month / year 9. THE WORDS FOR ANIMAL TREATMENT ONLY For animal treatment only. VIRBAGEN OMEGA - EN 17

18 VIRBAGEN OMEGA - EN 18

19 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Virbagen Omega Solvent for suspension for injection 2. QUANTITY OF THE ACTIVE AND OTHER SUBSTANCE(S) Isotonic sodium chloride solution... 1 ml 3. CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 1 ml 4. ROUTE OF ADMINISTRATION Intravenous use 5. BATCH NUMBER Batch number 6. EXPIRY DATE EXP: month / year 7. THE WORDS FOR ANIMAL TREATMENT ONLY For animal treatment only. VIRBAGEN OMEGA - EN 19

20 B. PACKAGE INSERT VIRBAGEN OMEGA - EN 20

21 PACKAGE INSERT 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Virbagen Omega 5 MU for dogs Virbagen Omega 10 MU for dogs 2. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S) VIAL CONTAINING LYOPHYLISATE Active substance 5 MU presentation: Recombinant Omega interferon of feline origin 10 MU presentation: Recombinant Omega interferon of feline origin 5 MU*/vial 10 MU*/vial *MU: Million Units List of excipients Sodium Chloride, D-sorbitol, gelatin VIAL CONTAINING SOLVENT: Isotonic sodium chloride solution... 1 ml 3. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT VIRBAC SA L.I.D. 1ère Avenue m F CARROS FRANCE 4. TARGET SPECIES Dogs 5. INDICATIONS Reduction of mortality and clinical signs of parvovirosis (enteric form) in dogs from one month of age. 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 parvovirosis. VIRBAGEN OMEGA - EN 21

22 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. 6. DOSAGE FOR EACH SPECIES The dose is 2.5 MU/kg bodyweight. 7. METHOD AND ROUTE(S) OF ADMINISTRATION The freeze-dried fraction must be reconstituted with 1 ml of the specific solvent to obtain, depending on the presentation, a solution containing 5 MU or 10 MU of recombinant interferon. The reconstituted product should be injected intravenously once daily for 3 consecutive days. The product should be used immediately after reconstitution due to the absence of preservative. 8. ADVICE ON CORRECT ADMINISTRATION Fluid therapy and other supplementary supportive treatments, are necessary to improve prognosis. The product should be used with the accompanying solvent only. 9. CONTRAINDICATIONS Vaccination during and after VIRBAGEN OMEGA treatment is contra-indicated, until the dog appears to have recovered. 10. UNDESIRABLE EFFECTS In some cases, during treatment, the followings transitory clinical signs may be observed: hyperthermia (3-6 hours after injection) vomiting slight decrease in white blood cells, platelets and red blood cells; parameters are restored within 1 week. 11. WITHDRAWAL PERIOD Not applicable 12. 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. VIRBAGEN OMEGA - EN 22

23 13. SPECIAL WARNINGS 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 dogs, especially for auto-immune disorders. Such side-effects have been described after multiple and long-term administration of type I interferon in human. The possibility of occurrence of auto immune disorders in dogs cannot therefore be ruled out. In case of accidental self-injection, seek medical advice immediately and show this package insert or the label to the physician. 14. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH VETERINARY MEDICINAL PRODUCTS Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. 15. DATE ON WHICH THE PACKAGE INSERT WAS LAST REVISED 16. OTHER INFORMATION Not applicable VIRBAGEN OMEGA - EN 23