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

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

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

Tilgængelig fra:

Cipla Australia Pty Ltd

Lægemiddelform:

Tablet, film coated

Sammensætning:

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

Indgivelsesvej:

Oral

Enheder i pakken:

28s

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

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)

Produkt oversigt:

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

Autorisation status:

Registered

Autorisation dato:

2022-03-30