Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
sitagliptin, metformin hydrochloride
Merck Sharp and Dohme B.V
A10BD07
sitagliptin, metformin
Drugs used in diabetes
Diabetes Mellitus, Type 2
For patients with type-2 diabetes mellitus:Efficib 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.Efficib 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.Efficib is indicated as triple combination therapy with a PPAR 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 PPAR agonist.Efficib 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 dosage of insulin and metformin alone do not provide adequate glycaemic control.
Revision: 33
Authorised
2008-07-15
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDI CINAL PRODUCT Efficib 50 mg/850 mg film- coated tablets Efficib 50 mg/1,000 mg film- coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Efficib 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. Efficib 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). Efficib 50 mg/850 mg film-coated tablets Capsule-sh aped, pink film -coated tablet with “515” debossed on one side. Efficib 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: Efficib 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. Efficib 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 s u lphonylurea. Efficib is indicated as tr iple combination therapy with a peroxisome proliferator - activated receptor gamma (PPAR ) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal to l erated dose of metformin and a PPAR agonist. Efficib is also indicated as add - on to insulin (i.e., triple combination ther apy) a s an adjunct to diet and exercise to improve glycaemic control in pati en ts when stable dose of insulin and metformin alone do not provide adequate glycaemic contro Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDI CINAL PRODUCT Efficib 50 mg/850 mg film- coated tablets Efficib 50 mg/1,000 mg film- coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Efficib 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. Efficib 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). Efficib 50 mg/850 mg film-coated tablets Capsule-sh aped, pink film -coated tablet with “515” debossed on one side. Efficib 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: Efficib 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. Efficib 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 s u lphonylurea. Efficib is indicated as tr iple combination therapy with a peroxisome proliferator - activated receptor gamma (PPAR ) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal to l erated dose of metformin and a PPAR agonist. Efficib is also indicated as add - on to insulin (i.e., triple combination ther apy) a s an adjunct to diet and exercise to improve glycaemic control in pati en ts when stable dose of insulin and metformin alone do not provide adequate glycaemic contro Прочетете целия документ