Australija - engleski - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - sitagliptin phosphate monohydrate, quantity: 32.125 mg (equivalent: sitagliptin, qty 25 mg) - tablet - excipient ingredients: purified talc; titanium dioxide; magnesium stearate; microcrystalline cellulose; hypromellose; iron oxide yellow; croscarmellose sodium; hyprolose; macrogol 8000; calcium hydrogen phosphate; iron oxide red - sitagliptin is indicated for the treatment of diabetes mellitus type 2 in persons 18 years of age and older who have failed dietary measures and exercise:,- as monotherapy, as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus, when metformin cannot be used.,- as dual combination therapy, with metformin, or with a sulfonylurea, or with a thiazolidinedione where the use of a thiazolidinedione is considered appropriate.,- as triple combination therapy with metformin and a sulfonylurea when combination therapy with both agents does not provide adequate glycaemic control.,- as add-on combination therapy with insulin (with or without metformin).

Australija - engleski - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - sitagliptin phosphate monohydrate, quantity: 32.125 mg (equivalent: sitagliptin, qty 25 mg) - tablet - excipient ingredients: hypromellose; magnesium stearate; purified talc; microcrystalline cellulose; iron oxide red; macrogol 8000; hyprolose; croscarmellose sodium; calcium hydrogen phosphate; titanium dioxide; iron oxide yellow - sitagliptin is indicated for the treatment of diabetes mellitus type 2 in persons 18 years of age and older who have failed dietary measures and exercise:,- as monotherapy, as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus, when metformin cannot be used.,- as dual combination therapy, with metformin, or with a sulfonylurea, or with a thiazolidinedione where the use of a thiazolidinedione is considered appropriate.,- as triple combination therapy with metformin and a sulfonylurea when combination therapy with both agents does not provide adequate glycaemic control.,- as add-on combination therapy with insulin (with or without metformin).

Australija - engleski - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - sitagliptin phosphate monohydrate, quantity: 32.125 mg (equivalent: sitagliptin, qty 25 mg) - tablet - excipient ingredients: titanium dioxide; magnesium stearate; macrogol 8000; hypromellose; calcium hydrogen phosphate; iron oxide red; microcrystalline cellulose; hyprolose; purified talc; croscarmellose sodium; iron oxide yellow - sitagliptin is indicated for the treatment of diabetes mellitus type 2 in persons 18 years of age and older who have failed dietary measures and exercise:,- as monotherapy, as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus, when metformin cannot be used.,- as dual combination therapy, with metformin, or with a sulfonylurea, or with a thiazolidinedione where the use of a thiazolidinedione is considered appropriate.,- as triple combination therapy with metformin and a sulfonylurea when combination therapy with both agents does not provide adequate glycaemic control.,- as add-on combination therapy with insulin (with or without metformin).

Australija - engleski - 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].

Australija - engleski - 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].

Novi Zeland - engleski - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - sitagliptin phosphate monohydrate 128.5mg equivalent to 100 mg sitagliptin - film coated tablet - 100 mg - active: sitagliptin phosphate monohydrate 128.5mg equivalent to 100 mg sitagliptin excipient: calcium hydrogen phosphate croscarmellose sodium magnesium stearate microcrystalline cellulose opadry beige 85f17438 sodium stearyl fumarate - · monotherapy: januvia is indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus. · combination with metformin: januvia is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with metformin as initial therapy or when diet and exercise, plus the single agent do not provide adequate glycaemic control. ·combination with a sulfonylurea: januvia is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with a sulfonylurea when treatment with the single agent alone, with diet and exercise, does not provide adequate glycaemic control. ·combination with a ppargamma agonist: januvia is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with a ppargamma agonist (i.e., thiazolidinediones) as initial therapy or when the single agent alone, with diet and exercise, does not provide adequate glycaemic control. ·combination with metformin and a sulfonylurea: januvia is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with metformin and a sulfonylurea when dual therapy with these agents, with diet and exercise, does not provide adequate glycaemic control. · combination with metformin and a ppargamma agonist: januvia is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with metformin and a ppargamma agonist (i.e., thiazolidinediones) when dual therapy with these agents, with diet and exercise, does not provide adequate glycaemic control. ·combination with insulin: januvia is indicated in patients with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control in combination with premixed or long/intermediate acting insulin (with or without metformin).

Novi Zeland - engleski - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - sitagliptin phosphate monohydrate 32.13mg equivalent to 25 mg sitagliptin - film coated tablet - 25 mg - active: sitagliptin phosphate monohydrate 32.13mg equivalent to 25 mg sitagliptin excipient: calcium hydrogen phosphate croscarmellose sodium magnesium stearate microcrystalline cellulose opadry pink 85f97191 sodium stearyl fumarate - · monotherapy: januvia is indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus. · combination with metformin: januvia is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with metformin as initial therapy or when diet and exercise, plus the single agent do not provide adequate glycaemic control. ·combination with a sulfonylurea: januvia is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with a sulfonylurea when treatment with the single agent alone, with diet and exercise, does not provide adequate glycaemic control. ·combination with a ppargamma agonist: januvia is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with a ppargamma agonist (i.e., thiazolidinediones) as initial therapy or when the single agent alone, with diet and exercise, does not provide adequate glycaemic control. ·combination with metformin and a sulfonylurea: januvia is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with metformin and a sulfonylurea when dual therapy with these agents, with diet and exercise, does not provide adequate glycaemic control. · combination with metformin and a ppargamma agonist: januvia is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with metformin and a ppargamma agonist (i.e., thiazolidinediones) when dual therapy with these agents, with diet and exercise, does not provide adequate glycaemic control. ·combination with insulin: januvia is indicated in patients with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control in combination with premixed or long/intermediate acting insulin (with or without metformin).

Novi Zeland - engleski - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - sitagliptin phosphate monohydrate 64.25mg equivalent to 50 mg sitagliptin - film coated tablet - 50 mg - active: sitagliptin phosphate monohydrate 64.25mg equivalent to 50 mg sitagliptin excipient: calcium hydrogen phosphate croscarmellose sodium magnesium stearate microcrystalline cellulose opadry beige 85f17498 sodium stearyl fumarate - · monotherapy: januvia is indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus. · combination with metformin: januvia is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with metformin as initial therapy or when diet and exercise, plus the single agent do not provide adequate glycaemic control. ·combination with a sulfonylurea: januvia is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with a sulfonylurea when treatment with the single agent alone, with diet and exercise, does not provide adequate glycaemic control. ·combination with a ppargamma agonist: januvia is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with a ppargamma agonist (i.e., thiazolidinediones) as initial therapy or when the single agent alone, with diet and exercise, does not provide adequate glycaemic control. ·combination with metformin and a sulfonylurea: januvia is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with metformin and a sulfonylurea when dual therapy with these agents, with diet and exercise, does not provide adequate glycaemic control. · combination with metformin and a ppargamma agonist: januvia is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with metformin and a ppargamma agonist (i.e., thiazolidinediones) when dual therapy with these agents, with diet and exercise, does not provide adequate glycaemic control. ·combination with insulin: januvia is indicated in patients with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control in combination with premixed or long/intermediate acting insulin (with or without metformin).

Malta - engleski - Medicines Authority

medochemie limited 1-10 constantinoupleos street, 3011 limassol, cyprus - sitagliptin phosphate, monohydrate - film-coated tablet - sitagliptin phosphate monohydrate 50 mg - drugs used in diabetes

Malta - engleski - Medicines Authority

medochemie limited 1-10 constantinoupleos street, 3011 limassol, cyprus - sitagliptin phosphate, monohydrate - film-coated tablet - sitagliptin phosphate monohydrate 100 mg - drugs used in diabetes