Artesunate/amodiaquine 100/270 mg WHOPAR part 5 03/2009, version 1.0 (Sanofi-Aventis) MA058 LABELING

Transcription

1 LABELING 1

2 PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton box 25 blisters of 3 tablets 1. NAME OF THE MEDICINAL PRODUCT ARTESUNATE AMODIAQUINE WINTHROP 100mg / 270mg Tablets* 2. STATEMENT OF ACTIVE SUBSTANCE(S) Artesunate mg Amodiaquine base mg (in the form of amodiaquine hydrochloride) mg 3. LIST OF EXCIPIENTS 4. PHARMACEUTICAL FORM AND CONTENTS 25 blisters of 3 tablets 5. METHOD AND ROUTE(S) OF ADMINISTRATION Oral route Read the package leaflet before use. 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children. 7. OTHER SPECIAL WARNING(S), IF NECESSARY 8. EXPIRY DATE EXP {MM/YYYY} 9. SPECIAL STORAGE CONDITIONS Store below 30 C * Trade names are not prequalified by WHO. This is under local DRA responsibility. Throughout this WHOPAR the proprietary name is given as an example only. 2

3 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11. NAME AND ADDRESS OF THE SUPPLIER Sanofi-aventis 82 avenue Raspail Gentilly France 12. WHO REFERENCE NUMBER (PREQUALIFICATION PROGRAMME) MA BATCH NUMBER Batch { } 14. (ADVICE ON) GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription 15. INSTRUCTIONS ON USE 3

4 PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton box 25 blisters of 6 tablets 1. NAME OF THE MEDICINAL PRODUCT ARTESUNATE AMODIAQUINE WINTHROP 100mg / 270mg Tablets 2. STATEMENT OF ACTIVE SUBSTANCE(S) Artesunate mg Amodiaquine base mg (in the form of amodiaquine hydrochloride) mg 3. LIST OF EXCIPIENTS 4. PHARMACEUTICAL FORM AND CONTENTS 25 blisters of 6 tablets 5. METHOD AND ROUTE(S) OF ADMINISTRATION Oral route Read the package leaflet before use. 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children. 7. OTHER SPECIAL WARNING(S), IF NECESSARY 8. EXPIRY DATE EXP {MM/YYYY} 9. SPECIAL STORAGE CONDITIONS Store below 30 C 4

5 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11. NAME AND ADDRESS OF THE SUPPLIER Sanofi-aventis 82 avenue Raspail Gentilly France 12. WHO REFERENCE NUMBER (PREQUALIFICATION PROGRAMME) MA BATCH NUMBER Batch { } 14. (ADVICE ON) GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription 15. INSTRUCTIONS ON USE 5

6 PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton box 1 blister of 3 tablets 1. NAME OF THE MEDICINAL PRODUCT ARTESUNATE AMODIAQUINE WINTHROP 100mg / 270 mg Tablets 2. STATEMENT OF ACTIVE SUBSTANCE(S) Artesunate mg Amodiaquine base mg (in the form of amodiaquine hydrochloride) mg 3. LIST OF EXCIPIENTS 4. PHARMACEUTICAL FORM AND CONTENTS 1 blister of 3 tablets 5. METHOD AND ROUTE(S) OF ADMINISTRATION Oral route Read the package leaflet before use. 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children. 7. OTHER SPECIAL WARNING(S), IF NECESSARY 8. EXPIRY DATE EXP {MM/YYYY} 9. SPECIAL STORAGE CONDITIONS Store below 30 C. 6

7 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11. NAME AND ADDRESS OF THE SUPPLIER Sanofi-aventis + 82 avenue Raspail Gentilly France 12. WHO REFERENCE NUMBER (PREQUALIFICATION PROGRAMME) MA BATCH NUMBER Batch { } 14. (ADVICE ON) GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription 15. INSTRUCTIONS ON USE 7

8 PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton box 1 blister of 6 tablets 1. NAME OF THE MEDICINAL PRODUCT ARTESUNATE AMODIAQUINE WINTHROP 100mg / 270 mg Tablets 2. STATEMENT OF ACTIVE SUBSTANCE(S) Artesunate mg Amodiaquine base mg (in the form of amodiaquine hydrochloride) mg 3. LIST OF EXCIPIENTS 4. PHARMACEUTICAL FORM AND CONTENTS 1 blister of 6 tablets 5. METHOD AND ROUTE(S) OF ADMINISTRATION Oral route Read the package leaflet before use. 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children. 7. OTHER SPECIAL WARNING(S), IF NECESSARY 8. EXPIRY DATE EXP {MM/YYYY} 9. SPECIAL STORAGE CONDITIONS Store below 30 C. 8

9 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11. NAME AND ADDRESS OF THE SUPPLIER Sanofi-aventis + 82 avenue Raspail Gentilly France 12. WHO REFERENCE NUMBER (PREQUALIFICATION PROGRAMME) MA BATCH NUMBER Batch { } 14. Advice on GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription 15. INSTRUCTIONS ON USE 9

10 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Aluminium/aluminium blister 1. NAME OF THE MEDICINAL PRODUCT ARTESUNATE AMODIAQUINE WINTHROP 100mg / 270mg Tablets 2. NAME OF THE SUPPLIER Sanofi-Aventis 3. EXPIRY DATE EXP {MM/YYYY} 4. BATCH NUMBER Batch { } 10