Ástralía - enska - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - sitagliptin hydrochloride monohydrate, quantity: 27.25 mg (equivalent: sitagliptin, qty 25 mg) - tablet, film coated - excipient ingredients: sodium stearylfumarate; microcrystalline cellulose; magnesium stearate; croscarmellose sodium; calcium hydrogen phosphate dihydrate; povidone; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - sitagliptin pcor is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:,- monotherapy when metformin is considered inappropriate due to intolerance; or,- in combination with other anti-hyperglycaemic agents, including insulin,[see 5.1 pharmacodynamic properties, clinical trials, 4.5 interactions with other medicines and other forms of interactions for available data on different add-on combination therapies].

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - sitagliptin hydrochloride monohydrate, quantity: 27.25 mg (equivalent: sitagliptin, qty 25 mg) - tablet, film coated - excipient ingredients: magnesium stearate; sodium stearylfumarate; calcium hydrogen phosphate dihydrate; croscarmellose sodium; povidone; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - sitagliptin pcor is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:,- monotherapy when metformin is considered inappropriate due to intolerance; or,- in combination with other anti-hyperglycaemic agents, including insulin,[see 5.1 pharmacodynamic properties, clinical trials, 4.5 interactions with other medicines and other forms of interactions for available data on different add-on combination therapies].

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - sitagliptin hydrochloride monohydrate, quantity: 54.5 mg (equivalent: sitagliptin, qty 50 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; calcium hydrogen phosphate dihydrate; sodium stearylfumarate; povidone; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - sitagliptin pcor is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:,- monotherapy when metformin is considered inappropriate due to intolerance; or,- in combination with other anti-hyperglycaemic agents, including insulin,[see 5.1 pharmacodynamic properties, clinical trials, 4.5 interactions with other medicines and other forms of interactions for available data on different add-on combination therapies].

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - sitagliptin hydrochloride monohydrate, quantity: 109 mg (equivalent: sitagliptin, qty 100 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; povidone; sodium stearylfumarate; magnesium stearate; calcium hydrogen phosphate dihydrate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - sitagliptin pcor is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:,- monotherapy when metformin is considered inappropriate due to intolerance; or,- in combination with other anti-hyperglycaemic agents, including insulin,[see 5.1 pharmacodynamic properties, clinical trials, 4.5 interactions with other medicines and other forms of interactions for available data on different add-on combination therapies].

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - sitagliptin hydrochloride monohydrate, quantity: 109 mg (equivalent: sitagliptin, qty 100 mg) - tablet, film coated - excipient ingredients: povidone; sodium stearylfumarate; magnesium stearate; croscarmellose sodium; calcium hydrogen phosphate dihydrate; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - sitagliptin pcor is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:,- monotherapy when metformin is considered inappropriate due to intolerance; or,- in combination with other anti-hyperglycaemic agents, including insulin,[see 5.1 pharmacodynamic properties, clinical trials, 4.5 interactions with other medicines and other forms of interactions for available data on different add-on combination therapies].

Evrópusambandið - enska - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - for adult patients with type 2 diabetes mellitus, sitagliptin accord 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 (ppary) agonist (i.e. a thiazolidinedione) when use of a ppary agonist is appropriate and when diet and exercise plus the ppary 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 ppary agonist and metformin when use of a ppary agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.sitagliptin accord 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.

Ísrael - enska - Ministry of Health

k.s.kim international (sk- pharma) ltd., israel - sitagliptin as hydrochloride monohydrate - film coated tablets - sitagliptin as hydrochloride monohydrate 100 mg - sitagliptin - sitagliptin s.k. is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes melitus. important limitations of use: sitagliptin s.k. should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis as it would not be effective in these settings. sitagliptin s.k. has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin s.k..

Ísrael - enska - Ministry of Health

k.s.kim international (sk- pharma) ltd., israel - sitagliptin as hydrochloride monohydrate - film coated tablets - sitagliptin as hydrochloride monohydrate 25 mg - sitagliptin - sitagliptin s.k. is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes melitus. important limitations of use: sitagliptin s.k. should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis as it would not be effective in these settings. sitagliptin s.k. has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin s.k..

Ísrael - enska - Ministry of Health

k.s.kim international (sk- pharma) ltd., israel - sitagliptin as hydrochloride monohydrate - film coated tablets - sitagliptin as hydrochloride monohydrate 50 mg - sitagliptin - sitagliptin s.k. is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes melitus. important limitations of use: sitagliptin s.k. should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis as it would not be effective in these settings. sitagliptin s.k. has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin s.k..

Evrópusambandið - enska - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sitagliptin fumarate, metformin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - for adult patients with type 2 diabetes mellitus:sitagliptin/metformin hydrochloride sun 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.sitagliptin/metformin hydrochloride sun 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.sitagliptin/metformin hydrochloride sun 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.sitagliptin/metformin hydrochloride sun 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.