ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

Transcription

1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1

2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Eurifel RCPFeLV Powder and solvent for emulsion for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance(s) Per 1-ml dose: Freeze-dried pellet: FeLV recombinant canarypox virus (vcp97) CCID 50 1 Attenuated feline panleucopenia virus (PLI IV) CCID 50 1 Solvent: Type 1 feline herpesvirus antigen (C27) IFA U. 2 Feline calicivirus antigen (FCV255) IFA U. 2 1 : cell culture infective dose 50% 2 : Immunofluorescence antibody titres in mice (log10) List of excipients Traces of gentamicin sulphate Light paraffin oil (as adjuvant) to mg 3. PHARMACEUTICAL FORM Powder and solvent for emulsion for injection 4. IMMUNOLOGICAL PROPERTIES Vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline leukaemia. Stimulates active immunity against feline rhinotracheitis virus, feline calicivirus, feline panleucopenia virus and feline leukaemia virus. The feline leukaemia vaccine strain is a recombinant canarypox virus expressing the env and gag genes of FeLV-A. Under field conditions, only sub-group A is infective and immunisation against subgroup A provides full protection against A, B and C. After inoculation, the virus expresses the protective proteins, but does not replicate in the cat. As a consequence, the vaccine induces an immune status against feline leukaemia virus. 5. CLINICAL PARTICULARS 5.0 Target species Cats 5.1 Indications for use Active immunisation of cats of 8 weeks of age or older against feline infectious rhinotracheitis and calicivirus infection to reduce clinical signs and viral excretion; against feline panleucopenia to prevent mortality and reduce clinical signs; and against feline leukaemia to prevent persistent viraemia and reduce clinical signs of the disease. Eurifel RCPFeLV-powder and solvent for emulsion for injection - EN 2

3 5.2 Contraindications The vaccine is contraindicated in pregnant and lactating animals. 5.3 Undesirable effects. In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.. A temporary small (< 2 cm) nodule may appear at the site of injection, which regresses within 1 to 4 weeks. Transient lethargy and hyperthermia may occur (lasting for 1 day, exceptionally 2 days) as well as transient pain at the injection site. 5.4 Special precaution(s) for use. Vaccinate only healthy animals.. It is recommended that a test for FeLV antigenaemia be carried out prior to vaccination.. Vaccination of FeLV positive cats is of no benefit. 5.5 Pregnancy and lactation See Interaction with other veterinary medicinal products and other forms of interaction No information is available on the safety and efficacy from the concurrent use of this vaccine with any other except Merial inactivated vaccines against rabies (but via a separate site). It is therefore recommended that no other vaccines should be administered within 14 days before or after vaccination with the product. 5.7 Posology and method of administration Inject by subcutaneous route one 1 ml dose of vaccine after reconstitution of the freeze dried components with the oily solvent containing the inactivated antigens according to the following schedule: Basic vaccination: Revaccination: first injection: from 8 weeks of age, second injection: 3 to 4 weeks later. annual In the presence of high levels of maternally derived specific antibodies, the basic vaccination scheme should be delayed until 12 weeks of age. 5.8 Overdose Transient, and occasionally high, fever occurs 4-16 hours after injection and has been shown to last hours in 20% of cats; pain, transient itching and oedema were observed from 4 24 hours after injection. Oedema was observed at 21 days post injection in 20% of cats. Apathy may be observed within three weeks following injection. 5.9 Special warnings for each target species None 5.10 Withdrawal period Not applicable Eurifel RCPFeLV-powder and solvent for emulsion for injection - EN 3

4 5.11 Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of accidental self-injection with this oil-adjuvanted vaccine, 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 veterinary medicinal product except the solvent supplied. 6.2 Shelf life 1 year Use immediately after reconstitution. 6.3 Special precautions for storage Store at 2 C 8 C, protected from light. Do not freeze. Transportation must be carried out at 2 C-8 C 6.4 Nature and contents of container Type I glass bottle containing 1 dose of powder and type I glass bottle containing1 ml solvent, closed with a butyl elastomer closure and sealed with an aluminium cap. 10 bottles of 1 dose (powder ) and 10 bottles of 1 ml (solvent) 50 bottles of 1 dose (powder ) and 50 bottles of 1 ml (solvent) 6.5 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from such veterinary medicinal products Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant or by appropriate channels approved for use by the competent authorities. 7. PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable. 8. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER MERIAL 17, rue Bourgelat F LYON 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 Eurifel RCPFeLV-powder and solvent for emulsion for injection - EN 4

5 ANNEX II A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) 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 Eurifel RCPFeLV-powder and solvent for emulsion for injection - EN 5

6 A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer of the biological active substance(s) MERIAL Laboratory of Lyon Gerland, 254 rue Marcel Mérieux, Lyon, France Manufacturing authorisation holder responsible for batch release MERIAL 17 rue Bourgelat Lyon France Site of Batch release MERIAL 1 chemin de Cruzols Lentilly France Manufacturing Authorisation granted by French Ministerial Decree No. V 3472/79/2 has been presented. GMP status was confirmed by the French Authorities during an inspection on 1 and 2 September 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. Eurifel RCPFeLV-powder and solvent for emulsion for injection - EN 6

7 ANNEX III LABELLING AND PACKAGE INSERT Eurifel RCPFeLV-powder and solvent for emulsion for injection - EN 7

8 A. LABELLING Eurifel RCPFeLV-powder and solvent for emulsion for injection - EN 8

9 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 Eurifel RCPFeLV powder and solvent for emulsion for injection 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Per 1-ml dose: FeLV rec CCID50 FPV CCID50 FHV IFA U. FCV IFA U. Light paraffin oil (as adjuvant) to mg 3. PHARMACEUTICAL FORM Powder and solvent for emulsion for injection 4. PACKAGE SIZE Powder (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) 5. TARGET SPECIES Cats 6. INDICATION(S) See METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use. Read the package insert before use 8. WITHDRAWAL PERIOD Not applicable 9. SPECIAL WARNING(S), IF NECESSARY In case of accidental self-injection with this oil-adjuvanted vaccine, seek medical advice immediately and show the package insert or the label to the physician. Eurifel RCPFeLV-powder and solvent for emulsion for injection - EN 9

10 10. EXPIRY DATE EXP (mm/yy) Use immediately after reconstitution 11. SPECIAL STORAGE CONDITIONS Store at 2 C 8 C (in a refrigerator), protected from light. Do not freeze. Transportation must be carried out at 2 C-8 C. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH VETERINARY MEDICINAL PRODUCTS, IF APPROPRIATE See 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 Marketing authorisation holder MERIAL 17, rue Bourgelat F LYON FRANCE 16. NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS 17. MANUFACTURER S BATCH NUMBER Batch 18. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription. Eurifel RCPFeLV-powder and solvent for emulsion for injection - EN 10

11 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 Eurifel RCPFeLV powder and solvent for emulsion for injection 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Per 1-ml dose: FeLV rec CCID50 FPV CCID50 FHV IFA U. FCV IFA U. Light paraffin oil (as adjuvant) to mg 3. PHARMACEUTICAL FORM Powder and solvent for emulsion for injection 4. PACKAGE SIZE Powder (50 bottles of 1 dose) + solvent (50 bottles of 1 ml) 5. TARGET SPECIES Cats 6. INDICATION(S) See METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use. Read the package insert before use 8. WITHDRAWAL PERIOD Not applicable 9. SPECIAL WARNING(S), IF NECESSARY In case of accidental self-injection with this oil-adjuvanted vaccine, seek medical advice immediately and show the package insert or the label to the physician. Eurifel RCPFeLV-powder and solvent for emulsion for injection - EN 11

12 10. EXPIRY DATE EXP (dd/mm/yy) Use immediately after reconstitution 11. SPECIAL STORAGE CONDITIONS Store at 2 C 8 C (in a refrigerator), protected from light. Do not freeze. Transportation must be carried out at 2 C-8 C. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH VETERINARY MEDICINAL PRODUCTS, IF APPROPRIATE See 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 Marketing authorisation holder MERIAL 17, rue Bourgelat F LYON FRANCE 16. NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS 17. MANUFACTURER S BATCH NUMBER Batch 18. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription. Eurifel RCPFeLV-powder and solvent for emulsion for injection - EN 12

13 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Eurifel RCPFeLV powder for injection 2. QUANTITY OF THE ACTIVE SUBSTANCE(S) Read package insert before use 3. CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 1 dose 4. ROUTE(S) OF ADMINISTRATION Subcutaneous use 5. BATCH NUMBER Batch 6. EXPIRY DATE EXP 7. THE WORDS FOR ANIMAL TREATMENT ONLY For animal treatment only Eurifel RCPFeLV-powder and solvent for emulsion for injection - EN 13

14 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Eurifel RCPFeLV solvent 2. QUANTITY OF THE ACTIVE SUBSTANCE(S) Read package insert before use 3. CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 1 dose 4. ROUTE(S) OF ADMINISTRATION Subcutaneous use 5. BATCH NUMBER Batch 6. EXPIRY DATE EXP 7. THE WORDS FOR ANIMAL TREATMENT ONLY For animal treatment only Eurifel RCPFeLV-powder and solvent for emulsion for injection - EN 14

15 B. PACKAGE INSERT Eurifel RCPFeLV-powder and solvent for emulsion for injection - EN 15

16 PACKAGE INSERT 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Eurifel RCPFeLV powder and solvent for emulsion for injection 2. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S) Per 1-ml dose: Freeze-dried pellet: FeLV recombinant Canarypox virus (vcp97) CCID50 1 Attenuated feline panleucopenia virus (PLI IV) CCID50 1 Diluent: Type 1 feline herpesvirus antigen (C27) IFA U. 2 Feline calicivirus antigen (FCV255) IFA U. 2 1 : cell culture infective dose 50% 2 : Immunofluorescence antibody titres in mice (log10). Traces of gentamicin sulphate Light paraffin oil (as adjuvant) to mg 3. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT Marketing authorisation holder MERIAL 17, rue Bourgelat Lyon France Manufacturing authorisation holder responsible for batch release MERIAL 1 chemin de Cruzols Lentilly France 4. TARGET SPECIES Cats 5. INDICATION(S) Active immunisation of cats of 8 weeks of age or older against feline infectious rhinotracheitis and calicivirus infection to reduce clinical signs and viral excretion; against feline panleucopenia to prevent mortality and reduce clinical signs; and against feline leukaemia to prevent persistent viraemia and reduce clinical signs of the disease. Eurifel RCPFeLV-powder and solvent for emulsion for injection - EN 16

17 6. DOSAGE Inject by subcutaneous route one 1-ml dose of vaccine after reconstitution of the freeze-dried components with the oily solvent containing the inactivated antigens according to the following schedule Basic vaccination: first injection: from 8 weeks of age, second injection: 3 to 4 weeks later. Revaccination: annual In the presence of high levels of maternally derived specific antibodies, the basic vaccination scheme should be delayed until 12 weeks of age. 7. METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use 8. ADVICE ON CORRECT ADMINISTRATION. Shake well after reconstitution.. No information is available on the safety and efficacy from the concurrent use of this vaccine with any other except Merial inactivated vaccines against rabies (but via a separate site). It is therefore recommended that no other vaccines should be administered within 14 days before or after vaccination with the product. Additional information: The feline leukaemia vaccine strain is a recombinant canarypox virus expressing the env and gag genes of FeLV-A. Under field conditions, only sub-group A is infective and immunisation against subgroup A provides full protection against A, B and C. After inoculation, the virus expresses the protective proteins, but does not replicate in the cat. As a consequence, the vaccine induces an immune status against feline leukaemia virus. 9. CONTRAINDICATIONS The vaccine is contraindicated in pregnant and lactating animals. 10. UNDESIRABLE EFFECTS. In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.. A temporary small (< 2 cm) nodule may appear at the site of injection, which regresses within 1 to 4 weeks. Transient lethargy and hyperthermia may occur (lasting for 1 day, exceptionally 2 days) as well as transient pain at the injection site.. If you notice any other side effects, please inform your veterinary surgeon. Following an overdose, transient, and occasionally high, fever occurs 4-16 hours after injection and has been shown to last hours in 20% of cats; pain, transient itching and oedema were observed from 4 24 hours after injection. Oedema was observed at 21 days post injection in 20% of cats. Apathy may be observed within three weeks following injection. Eurifel RCPFeLV-powder and solvent for emulsion for injection - EN 17

18 11. WITHDRAWAL PERIOD Not applicable 12. SPECIAL STORAGE PRECAUTIONS. Keep out of the reach and sight of children. Store at 2 C 8 C (in a refrigerator), protected from light. Do not freeze.. Transportation must be carried out at 2 C-8 C.. Use immediately after reconstitution.. Do not use after the expiry date stated on the label. 13. SPECIAL WARNING(S). It is recommended that a test for FeLV antigenaemia be carried out prior to vaccination.. Vaccination of FeLV positive cats is of no benefit.. Vaccinate only healthy animals.. Do not mix with any veterinary medicinal product except the solvent supplied.. In case of accidental self-injection with this oil-adjuvanted vaccine, 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 Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant or by appropriate channels approved for use by the competent authorities. 15. DATE ON WHICH THE PACKAGE INSERT WAS LAST REVISED 16. OTHER INFORMATION Veterinary medicinal product subject to prescription. Eurifel RCPFeLV-powder and solvent for emulsion for injection - EN 18

19 For any information about this veterinary medicinal product, please contact the local representative of the Marketing Authorisation Holder. België/Belgique/Belgien MERIAL BELGIUM S.A./N.V. Bd Sylvain Dupuislaan 243 B-1070 Brussel - Bruxelles - Brüssel Tél/Tel: + 32-(0) Danmark MERIAL NORDEN A/S Gladsaxevej 378 DK-2860 Søborg Tlf: Deutschland MERIAL GmbH Am Söldnermoos 6 D Hallbergmoos Tel: + 49-(0) Luxembourg/Luxemburg MERIAL BELGIUM S.A./N.V. Bd Sylvain Dupuislaan 243 B-1070 Bruxelles - Brüssel Belgique - Belgien Tél: Nederland MERIAL B.V. Bovenkerkerweg 6-8, NL-1185 XE Amstelveen Tel: + 31-(0) Österreich Richter Pharma AG Feldgasse 19 A-4600 Wels Tel.: Ελλάδα Π.Ν. ΓΕΡΟΛΥΜΑΤΟΣ ΑΕΒΕ Ασκληπιού 13 GR Κρυονέρι Αττικής Τηλ. : + 30 (0) España MERIAL Laboratorios SA C/Tarragona n 161 E Barcelona Tel: France MERIAL 29 avenue Tony Garnier F Lyon Tél: + 33-(0) Ireland MERIAL ANIMAL HEALTH Limited PO Box 327, Sandringham House, Sandringham Avenue Harlow Business Park Harlow, CM 19 5TG - UK Tel: Portugal MERIAL PORTUGUESA Saùde Animal, Lda. Av. Maria Lamas, Lote 19 BL.A Piso 2 Serra das Minas P Rio de Mouro Tel: Suomi/Finland VETER AB Klockarvägen 114 S Södertälje Ruotsi/Sverige Puh/Tln: Sverige VETER AB Klockarvägen 114 S Södertälje Tln: + 46-(0) United Kingdom MERIAL ANIMAL HEALTH Limited PO Box 327, Sandringham House, Sandringham Avenue Harlow Business Park Harlow, CM 19 5TG - UK Tel: + 44-(0) Italia MERIAL ITALIA S.p.A Piazza Pio XI-1 I Milano Tel: Eurifel RCPFeLV-powder and solvent for emulsion for injection - EN 19