Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
sitagliptin, metformin hydrochloride
Merck Sharp & Dohme B.V.
A10BD07
sitagliptin, metformin hydrochloride
Drugs used in diabetes
Diabetes Mellitus, Type 2
For patients with type-2 diabetes mellitus:Ristfor is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.Ristfor is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.Ristfor is indicated as triple combination therapy with a peroxisome proliferator-activated-receptor-gamma (PPARγ) agonist (i.e. a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARγ agonist.Ristfor is also indicated as add-on to insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.
Revision: 27
Authorised
2010-03-15
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDIC INAL PRODUCT Ristfor 50 mg/850 mg film- coated tablets Ristfor 50 mg/1,000 mg film- coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ristfor 50 mg/850 mg film-coated tablets Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metf ormin hydrochloride. Ristfor 50 mg/1,000 mg film-coated tablets Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg of metf ormin hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film- coated tablet (tablet). Ristfor 50 mg/850 mg film-coated tablets Capsule-sh aped, pink film -coated tablet wi th “515” debossed on one side. Ristfor 50 mg/1,000 mg film-coated tablets Capsule-shaped, red film- coated tablet with “ 577 ” debossed on one side . 4. CLINICA L PARTICULARS 4.1 THERAPEUTIC INDICATIONS For adult patients with type 2 diabetes mellitus: Ristfor is indicated as an adjunct to diet and exercise to improve glycaemic contro l in patients inadequately controlled on their maximal tolerated dose of met fo rmin alone or those already being treated with the combination of sitagliptin and metformin. Ris tfor is indicated in combination with a sulphonylurea (i.e., triple combination t herapy) as an adjunct to diet and exercise in patients inadequately controll ed on their maximal tolerated dose of metformin and a sulphonylurea. Ristfor is indicated as trip l e combination therapy with a peroxisome proliferator - activated receptor gamma (PPAR ) ag onist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist. Ristfor is also indicated as add - on to insulin (i.e., triple combination the rapy) a s an adjunct to diet and exercise to improve glycaemic control in pat ie nts when stable dose of insulin and metformin alone do not provide adequate glycaemic contro Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDIC INAL PRODUCT Ristfor 50 mg/850 mg film- coated tablets Ristfor 50 mg/1,000 mg film- coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ristfor 50 mg/850 mg film-coated tablets Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metf ormin hydrochloride. Ristfor 50 mg/1,000 mg film-coated tablets Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg of metf ormin hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film- coated tablet (tablet). Ristfor 50 mg/850 mg film-coated tablets Capsule-sh aped, pink film -coated tablet wi th “515” debossed on one side. Ristfor 50 mg/1,000 mg film-coated tablets Capsule-shaped, red film- coated tablet with “ 577 ” debossed on one side . 4. CLINICA L PARTICULARS 4.1 THERAPEUTIC INDICATIONS For adult patients with type 2 diabetes mellitus: Ristfor is indicated as an adjunct to diet and exercise to improve glycaemic contro l in patients inadequately controlled on their maximal tolerated dose of met fo rmin alone or those already being treated with the combination of sitagliptin and metformin. Ris tfor is indicated in combination with a sulphonylurea (i.e., triple combination t herapy) as an adjunct to diet and exercise in patients inadequately controll ed on their maximal tolerated dose of metformin and a sulphonylurea. Ristfor is indicated as trip l e combination therapy with a peroxisome proliferator - activated receptor gamma (PPAR ) ag onist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist. Ristfor is also indicated as add - on to insulin (i.e., triple combination the rapy) a s an adjunct to diet and exercise to improve glycaemic control in pat ie nts when stable dose of insulin and metformin alone do not provide adequate glycaemic contro Aqra d-dokument sħiħ