Apo-Sitagliptin

Država: Nova Zelandija

Jezik: angleščina

Source: Medsafe (Medicines Safety Authority)

Aktivna sestavina:

Sitagliptin phosphate monohydrate 32.125mg equivalent to 25 mg sitagliptin

Dostopno od:

Apotex NZ Ltd

INN (mednarodno ime):

Sitagliptin phosphate monohydrate 32.125 mg (equiv to 25 mg sitagliptin)

Odmerek:

25 mg

Farmacevtska oblika:

Film coated tablet

Sestava:

Active: Sitagliptin phosphate monohydrate 32.125mg equivalent to 25 mg sitagliptin Excipient: Calcium hydrogen phosphate Croscarmellose sodium Hyprolose Hypromellose Iron oxide red Iron oxide yellow Macrogol 8000 Magnesium stearate   Microcrystalline cellulose Purified talc Titanium dioxide

Tip zastaranja:

Prescription

Izdeluje:

Apotex Pharmachem Inc

Terapevtske indikacije:

Monotherapy: Sitagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus. Combination with Metformin: Sitagliptin 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: Sitagliptin 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 PPAR-gamma agonist: Sitagliptin is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with a PPAR-gamma 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: Sitagliptin 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 PPAR-gamma agonist: Sitagliptin is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with metformin and a PPAR-gamma agonist (i.e. thiazolidinediones) when dual therapy with these agents, with diet and exercise, does not provide adequate glycaemic control. Combination with Insulin: Sitagliptin 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).

Povzetek izdelek:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC/AL, AL/AL, Closed closure: PVC/PVdC film&Al foil , Al foil & Al foil - 28 dose units - 18 months from date of manufacture stored at or below 25°C

Datum dovoljenje:

2015-11-13