País: União Europeia
Língua: inglês
Origem: EMA (European Medicines Agency)
sitagliptin, metformin hydrochloride
Merck Sharp & Dohme B.V.
A10BD07
sitagliptin, metformin
Drugs used in diabetes
Diabetes Mellitus, Type 2
For patients with type 2 diabetes mellitus:Janumet 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.Janumet 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.Janumet 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.Janumet 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: 30
Authorised
2008-07-16
1 ANNEX I SUM MARY OF PRODUCT CHARACTE RISTICS 2 1. NAME OF T HE MEDICINAL PRODUCT Janumet 50 mg/850 mg film-coated tablets Janumet 50 mg/1,000 mg film-coated tablets 2. QUALITATIVE AND QUANTITAT I VE COMPOSITION Janumet 50 mg/850 mg film-coated tablets Each tab let contains sitagliptin phospha te monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metf ormin hydrochloride. Janumet 50 mg/1,000 mg film-coated tablets Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin a nd 1,000 mg of metformin hydrochloride. For the full list of excipients, see section 6.1. 3. PHAR MACEUTIC AL FORM Film- coated tablet (tablet). Janumet 50 mg/850 mg film-coated tablets Capsule-sh aped, pink film -coated tab let with “515” debossed on one s ide. Janumet 50 mg/1,000 mg film-coated tablets Capsule-shaped, red film- coated tablet with “ 577 ” d ebossed on one side . 4. CLINICA L PARTICULARS 4.1 THERAPEUTIC INDI CATIONS For adult patients with type 2 diabetes mel litus: Janumet is indicated as an a djunct to diet and exercise to i mprove glycaemic co ntrol in patients inadequately controlled on thei r maximal tolerated d ose of metfo rmin alone or those already being treated with the combination of sitagliptin and metformin. Janumet i s indicated in combi nation with a sulphonylurea (i.e ., triple combinati on therapy) as an adjunct to diet and exercise in patients inadequatel y controlled on their maximal tolerated dose of metform in and a sulphonylurea. Janumet is indicate d as triple comb ination therapy with a peroxisome proliferator-activ ated receptor gamma (PPAR ) agonist (i.e., a thiazolidinedione) as a n adjunct to diet and exercise in patients inadequately controlled o n their maximal tolerated dose of metformin and a PP AR agonist. J anumet is also indic ated as add-on to insulin (i.e., triple combination therap y) as an adjunct to diet and exercise to i mprove glycaemic cont rol in patie nts when stable dose of insulin and metformin alone do not provide adequate Leia o documento completo
1 ANNEX I SUM MARY OF PRODUCT CHARACTE RISTICS 2 1. NAME OF T HE MEDICINAL PRODUCT Janumet 50 mg/850 mg film-coated tablets Janumet 50 mg/1,000 mg film-coated tablets 2. QUALITATIVE AND QUANTITAT I VE COMPOSITION Janumet 50 mg/850 mg film-coated tablets Each tab let contains sitagliptin phospha te monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metf ormin hydrochloride. Janumet 50 mg/1,000 mg film-coated tablets Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin a nd 1,000 mg of metformin hydrochloride. For the full list of excipients, see section 6.1. 3. PHAR MACEUTIC AL FORM Film- coated tablet (tablet). Janumet 50 mg/850 mg film-coated tablets Capsule-sh aped, pink film -coated tab let with “515” debossed on one s ide. Janumet 50 mg/1,000 mg film-coated tablets Capsule-shaped, red film- coated tablet with “ 577 ” d ebossed on one side . 4. CLINICA L PARTICULARS 4.1 THERAPEUTIC INDI CATIONS For adult patients with type 2 diabetes mel litus: Janumet is indicated as an a djunct to diet and exercise to i mprove glycaemic co ntrol in patients inadequately controlled on thei r maximal tolerated d ose of metfo rmin alone or those already being treated with the combination of sitagliptin and metformin. Janumet i s indicated in combi nation with a sulphonylurea (i.e ., triple combinati on therapy) as an adjunct to diet and exercise in patients inadequatel y controlled on their maximal tolerated dose of metform in and a sulphonylurea. Janumet is indicate d as triple comb ination therapy with a peroxisome proliferator-activ ated receptor gamma (PPAR ) agonist (i.e., a thiazolidinedione) as a n adjunct to diet and exercise in patients inadequately controlled o n their maximal tolerated dose of metformin and a PP AR agonist. J anumet is also indic ated as add-on to insulin (i.e., triple combination therap y) as an adjunct to diet and exercise to i mprove glycaemic cont rol in patie nts when stable dose of insulin and metformin alone do not provide adequate Leia o documento completo