Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - sitagliptin phosphate monohydrate, quantity: 32.13 mg (equivalent: sitagliptin, qty 25 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; microcrystalline cellulose; sodium stearylfumarate; magnesium stearate; croscarmellose sodium; titanium dioxide; iron oxide yellow; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350 - januvia (sitagliptin phosphate monohydrate) 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - sitagliptin phosphate monohydrate, quantity: 64.25 mg (equivalent: sitagliptin, qty 50 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; sodium stearylfumarate; calcium hydrogen phosphate; magnesium stearate; croscarmellose sodium; titanium dioxide; iron oxide yellow; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350 - januvia (sitagliptin phosphate monohydrate) 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - sitagliptin phosphate monohydrate, quantity: 128.5 mg (equivalent: sitagliptin, qty 100 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; calcium hydrogen phosphate; microcrystalline cellulose; sodium stearylfumarate; magnesium stearate; titanium dioxide; iron oxide yellow; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350 - januvia (sitagliptin phosphate monohydrate) 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - sitagliptin phosphate monohydrate, quantity: 64.25 mg; metformin hydrochloride, quantity: 1000 mg - tablet - excipient ingredients: microcrystalline cellulose; sodium lauryl sulfate; sodium stearylfumarate; povidone; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; iron oxide black; macrogol 3350 - janumet (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].

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - sitagliptin phosphate monohydrate, quantity: 64.25 mg; metformin hydrochloride, quantity: 500 mg - tablet - excipient ingredients: povidone; microcrystalline cellulose; sodium stearylfumarate; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; iron oxide black; macrogol 3350 - janumet (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].

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - sitagliptin as monohydrate phosphate - film coated tablets - sitagliptin as monohydrate phosphate 25 mg - sitagliptin - sitagliptin - januvia is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes melitus.important limitations of use:januvia 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.januvia 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 januvia.

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - sitagliptin as monohydrate phosphate - film coated tablets - sitagliptin as monohydrate phosphate 50 mg - sitagliptin - sitagliptin - januvia is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes melitus.important limitations of use:januvia 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.januvia 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 januvia.

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - sitagliptin as monohydrate phosphate - film coated tablets - sitagliptin as monohydrate phosphate 100 mg - sitagliptin - sitagliptin - januvia is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes melitus.important limitations of use:januvia 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.januvia 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 januvia.

Australia - English - 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: iron oxide red; purified talc; titanium dioxide; hyprolose; croscarmellose sodium; hypromellose; macrogol 8000; microcrystalline cellulose; magnesium stearate; iron oxide yellow; calcium hydrogen phosphate - 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).

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - sitagliptin phosphate monohydrate, quantity: 64.25 mg (equivalent: sitagliptin, qty 50 mg) - tablet - excipient ingredients: microcrystalline cellulose; purified talc; croscarmellose sodium; macrogol 8000; calcium hydrogen phosphate; hyprolose; hypromellose; iron oxide red; iron oxide yellow; titanium dioxide; magnesium stearate - 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).