FOCIPRA dapagliflozin (as propanediol monohydrate) 10 mg film-coated tablet bottle

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

dapagliflozin propanediol monohydrate, Quantity: 12.3 mg (Equivalent: dapagliflozin, Qty 10 mg)

から入手可能:

Cipla Australia Pty Ltd

医薬品形態:

Tablet, film coated

構図:

Excipient Ingredients: microcrystalline cellulose; copovidone; silicon dioxide; magnesium stearate; lactose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350

投与経路:

Oral

パッケージ内のユニット:

28s

処方タイプ:

(S4) Prescription Only Medicine

適応症:

Type 2 diabetes mellitus Glycaemic control,CIPLA DAPAGLIFLOZIN is indicated in adults with type 2 diabetes mellitus:,?as monotherapy as an adjunct to diet and exercise in patients for whom metformin is otherwiseindicated but was not tolerated. ?as initial combination therapy with metformin, as an adjunct to diet and exercise, to improveglycaemic control when diet and exercise have failed to provide adequate glycaemic control andthere are poor prospects for response to metformin monotherapy (for example, high initialhaemoglobin A1c [HbA1c] levels). ?in combination with other anti-hyperglycaemic agents to improve glycaemic control, when thesetogether with diet and exercise, do not provide adequate glycaemic control (see section 5.1Pharmacodynamic properties ? Clinical trials and section 4.4 Special warnings and precautions foruse for available data on different add-on combination therapies).,Prevention of hospitalisation for heart failure DAPAGLICIP is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalization for heart failure (see section 5.1 Pharmacodynamic properties ? Clinical trials).,Heart failure,DAPAGLICIP is indicated in adults for the treatment of symptomatic heart failure with reduced ejection fraction, as an adjunct to standard of care therapy (see section 5.1 Pharmacodynamic properties).,Chronic kidney disease,DAPAGLICIP is indicated to reduce the risk of progressive decline in kidney function in adults with proteinuric chronic kidney disease (CKD Stage 2, 3 or 4 and urine ACR greater than or equal 30 mg/g)

製品概要:

Visual Identification: Tablets are pink, biconvex, diamond-shaped, film-coated tablets with "C389" engraved on one side and plain on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

認証ステータス:

Registered

承認日:

2022-03-30