Australië - Engels - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - sitagliptin phosphate monohydrate, quantity: 64.25 mg (equivalent: sitagliptin, qty 50 mg); metformin hydrochloride, quantity: 500 mg - tablet, film coated - excipient ingredients: povidone; microcrystalline cellulose; sodium stearylfumarate; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - velmetia (sitagliptin phosphate monohydrate and metformin hydrochloride) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.,[see sections 5.1 pharmacodynamic properties, clinical trials and 4.2 dose and method of administration].

Australië - Engels - 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].

Australië - Engels - 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].

Australië - Engels - 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].

Europese Unie - Engels - 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.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - sitagliptin hydrochloride monohydrate, quantity: 113.373 mg (equivalent: sitagliptin, qty 100 mg) - tablet, film coated - excipient ingredients: magnesium stearate; croscarmellose sodium; calcium hydrogen phosphate; hyprolose; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - sitagliptin lupin 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 antihyperglycaemic agents, including insulin.,(see section 5.1 pharmacodynamic properties - clinical trials and section 4.5 interactions with other medicines and other forms of interactions for available data on different add-on combination therapies.)

Australië - Engels - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - sitagliptin hydrochloride monohydrate, quantity: 56.686 mg (equivalent: sitagliptin, qty 50 mg) - tablet, film coated - excipient ingredients: magnesium stearate; croscarmellose sodium; calcium hydrogen phosphate; microcrystalline cellulose; hyprolose; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - sitagliptin lupin 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 antihyperglycaemic agents, including insulin.,(see section 5.1 pharmacodynamic properties - clinical trials and section 4.5 interactions with other medicines and other forms of interactions for available data on different add-on combination therapies.)

Australië - Engels - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - sitagliptin hydrochloride monohydrate, quantity: 28.343 mg (equivalent: sitagliptin, qty 25 mg) - tablet, film coated - excipient ingredients: hyprolose; calcium hydrogen phosphate; croscarmellose sodium; microcrystalline cellulose; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - sitagliptin lupin 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 antihyperglycaemic agents, including insulin,(see section 5.1 pharmacodynamic properties - clinical trials and section 4.5 interactions with other medicines and other forms of interactions for available data on different add-on combination therapies.)

Canada - Engels - Health Canada

apotex inc - sitagliptin (sitagliptin phosphate monohydrate) - tablet - 25mg - sitagliptin (sitagliptin phosphate monohydrate) 25mg

Canada - Engels - Health Canada

apotex inc - sitagliptin (sitagliptin phosphate monohydrate) - tablet - 50mg - sitagliptin (sitagliptin phosphate monohydrate) 50mg