SITAGLIPTIN SANDOZ sitagliptin (as hydrochloride monohydrate) 100 mg film-coated tablet blister pack

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

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公众评估报告 公众评估报告 (PAR)
12-01-2021

有效成分:

sitagliptin hydrochloride monohydrate, Quantity: 113.37 mg

可用日期:

Sandoz Pty Ltd

药物剂型:

Tablet, film coated

组成:

Excipient Ingredients: iron oxide black; calcium hydrogen phosphate; purified talc; hyprolose; microcrystalline cellulose; titanium dioxide; macrogol 6000; sodium stearylfumarate; croscarmellose sodium; hypromellose; iron oxide red; iron oxide yellow; magnesium stearate

给药途径:

Oral

每包单位数:

28

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

SITAGLIPTIN SANDOZ 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).

產品總結:

Visual Identification: Light brown, round, biconvex film coated tablet debossed with ST 100 on one side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

授权状态:

Registered

授权日期:

2020-11-10