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

arrotex pharmaceuticals pty ltd - sitagliptin phosphate monohydrate, quantity: 128.5 mg (equivalent: sitagliptin, qty 100 mg) - tablet - excipient ingredients: hypromellose; croscarmellose sodium; hyprolose; purified talc; calcium hydrogen phosphate; titanium dioxide; microcrystalline cellulose; magnesium stearate; macrogol 8000; iron oxide red; 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).

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

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - ertugliflozin (l-pga); sitagliptin as monohydrate phosphate - film coated tablets - sitagliptin as monohydrate phosphate 100 mg; ertugliflozin (l-pga) 15 mg - sitagliptin and ertugliflozin - steglujan is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:• when metformin and/or a sulphonylurea (su) and one of the monocomponents of steglujan do not provide adequate glycaemic control• in patients already being treated with the combination of ertugliflozin and sitagliptin as separate tablets.

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - ertugliflozin (l-pga); sitagliptin as monohydrate phosphate - film coated tablets - sitagliptin as monohydrate phosphate 100 mg; ertugliflozin (l-pga) 5 mg - sitagliptin and ertugliflozin - steglujan is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:• when metformin and/or a sulphonylurea (su) and one of the monocomponents of steglujan do not provide adequate glycaemic control• in patients already being treated with the combination of ertugliflozin and sitagliptin as separate tablets.

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

merck sharp & dohme (australia) pty ltd - metformin hydrochloride, quantity: 850 mg; sitagliptin phosphate monohydrate, quantity: 64.25 mg - tablet - excipient ingredients: microcrystalline cellulose; sodium stearylfumarate; povidone; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - 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)

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].

Australia - English - 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].

Australia - English - 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].

Australia - English - 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].