Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
sitagliptin
Merck Sharp & Dohme B.V.
A10BH01
sitagliptin
Drugs used in diabetes
Diabetes Mellitus, Type 2
For adult patients with type-2 diabetes mellitus, Xelevia is indicated to improve glycaemic control:as monotherapy:in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;as dual oral therapy in combination with:metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control;a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance;a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control;as triple oral therapy in combination with:a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control;a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.Xelevia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Revision: 39
Authorised
2007-03-21
23 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 1. NAME OF THE MEDICINAL PRODUCT Xelevia 25 mg film- coated tablets sitagliptin 2. STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains sitagliptin phosphate monohydrate equivalent to 25 mg of sitagliptin. 3. LIST OF EXCIPIENTS 4. PHARMACEU TICAL FORM AND CONTENT S 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 84 film- coated tablets 90 film- coated tablets 98 film- coated tablets 50 x 1 film-coated tablets 5. METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaf let before use. Oral use. 6. SPECIAL WARNING THAT THE MEDI CINAL PRODUCT MUST BE STORED O UT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of childr en. 7. OTHER SPECIAL WARNING(S), IF NECESSARY 8. EXPIRY DATE EXP 9. SPECIAL STO RAGE CONDITIONS Store below 25 °C. 24 10. SPECIAL PREC AUTION S FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WAS TE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HO LDER Merck Sharp & Dohme B.V. Waarderweg 3 9 2031 BN Haarlem The Netherlands 12. M ARKETING AUTHORISATION NUMBER(S) EU/1/07/382/001 14 film- coated tablets EU/1/07/382/002 28 film - coated tablets EU/1/07/382/019 30 film-c oated tablets EU/1/07/382/003 56 film-c oated tablets EU/1/07/382/004 84 film - coated tablets EU/1/07 /382/020 90 film-c oated tablets EU/1/07/382/005 98 film -coated tablets EU/1/07/382/006 50 x 1 film - coated tablets 13. BATCH NUMBER Lot 14. GENERAL CLASS IFICATION FOR SUPPLY 15. INSTRUCTIONS ON USE 16. INFORMATION IN BRAILLE Xelevia 25 mg 17. UN IQUE IDENTIF IER – 2D BARCODE 2D barcode carrying the unique identif ier included. 18. UNIQUE IDENTIFIER - HUMAN READABLE DATA PC SN NN 25 MINIMUM PARTIC ULARS TO APPEAR ON BLISTERS OR ST RIPS BLISTERS 1. NAME OF THE MEDICINAL P RODUCT Xelevia 25 mg tablets sitagliptin 2. NAME OF THE MARKETING AUTHORISATION HOLD ER MSD 3. EXPIRY DATE EXP 4. BATCH NUMBER Lot 5. OTHER 26 PARTICULARS TO A PPEAR ON THE O Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Xelevia 25 mg film- coated tablets Xelevia 50 mg film- coated tablets Xelevia 100 mg film- coated tablets 2. QUALITATIV E AND QUANTITATIVE COMPOSITION Xelevia 25 mg film- coated tablets Each tablet contains sitagliptin phosphate monohydrate, equivalent to 25 mg sitagliptin. Xelevia 50 mg film-coated tablets Each tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin . Xelevia 100 mg film- coated tablets Each tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin . For the full list of excipients, s ee section 6.1. 3. PHARMACEUTICAL FORM Film- coated tablet (tablet). Xelevia 25 mg film- coated tablets Rou nd, pink film - coated tablet with “221” on one side. Xelevia 50 mg film- coated tablets Round, light beige film - coated table t with “112” on one side . Xelevia 100 mg film- coated tablets Round, beige f ilm- coated tablet wi th “277” on one side. 4. CLINICAL P ARTICULARS 4.1 THERAPEUTIC INDICATIONS For adult patients w ith type 2 diabetes mellitus, Xelevia is indicated to improve glycaemic control: as monotherapy: • in patients inadequately controlled by diet and exercise al one and for whom metform in is inappro priate due to contraindications or intolerance. as dual oral t herapy in combination with : • metformin when diet and exercise plus metformin alone d o not provide adequate glycaemic control. • a sulphonylurea when diet and exercise plus maximal t olerated dose of a sulphonylurea alone do not provide adequate glycaemic co nt rol and when metformin is inappropriate due to contraindications or intolerance. 3 • a peroxisome proliferator - activated receptor gamma (PPAR ) agonist (i.e. a thiazolidinedione) when use of a PPAR agonist is appropriate and when diet and exercise plus the PPAR agonist alone do not provide adequate glycaemic control. as triple oral thera py in combination with : • a sulphonylurea and metformin when diet and exe Przeczytaj cały dokument