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

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

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

Saatavilla:

Cipla Australia Pty Ltd

Lääkemuoto:

Tablet, film coated

Koostumus:

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

Antoreitti:

Oral

Kpl paketissa:

28s

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

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)

Tuoteyhteenveto:

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

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2022-03-30