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: 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].

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - metformin hydrochloride; sitagliptin as monohydrate phosphate - tablets - sitagliptin as monohydrate phosphate 50 mg; metformin hydrochloride 1000 mg - metformin - januet is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus. important limitations of use:januet 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.januet 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 januet.

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - metformin hydrochloride; sitagliptin as monohydrate phosphate - tablets - sitagliptin as monohydrate phosphate 50 mg; metformin hydrochloride 500 mg - metformin - januet is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus. important limitations of use:januet 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.januet 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 januet.

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - metformin hydrochloride; sitagliptin as monohydrate phosphate - tablets - sitagliptin as monohydrate phosphate 50 mg; metformin hydrochloride 850 mg - metformin - januet is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus. important limitations of use:januet 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.januet 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 januet.

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; magnesium stearate; croscarmellose sodium; microcrystalline cellulose; sodium stearylfumarate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - xelevia (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; calcium hydrogen phosphate; croscarmellose sodium; sodium stearylfumarate; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - xelevia (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: calcium hydrogen phosphate; magnesium stearate; croscarmellose sodium; microcrystalline cellulose; sodium stearylfumarate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - xelevia (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)

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.)

Australia - English - 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.)

Australia - English - 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.)