オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - dapagliflozin propanediol monohydrate, quantity: 12.3 mg (equivalent: dapagliflozin, qty 10 mg) - tablet, film coated - excipient ingredients: silicon dioxide; microcrystalline cellulose; magnesium stearate; crospovidone; purified water; lactose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - type 2 diabetes mellitus,glycaemic control,forxiga is indicated in adults with type 2 diabetes mellitus:,? as monotherapy as an adjunct to diet and exercise in patients for whom metformin is otherwise indicated but was not tolerated.,? as initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycaemic control when diet and exercise have failed to provide adequate glycaemic control and there are poor prospects for response to metformin monotherapy (for example, high initial haemoglobin a1c [hba1c] levels).,? in combination with other anti-hyperglycaemic agents to improve glycaemic control, when these together with diet and exercise, do not provide adequate glycaemic control (see section 5.1 pharmacodynamic properties ? clinical trials and section 4.4 special warnings and precautions for use for available data on different add-on combination therapies).,prevention of hospitalisation for heart failure,forxiga 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,forxiga is indicated in adults for the treatment of symptomatic heart failure independent of left ventricular ejection fraction, as an adjunct to standard of care therapy (see section 5.1 pharmacodynamic properties). chronic kidney disease,forxiga 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 ? 30 mg/g)

ケニア - 英語 - Pharmacy and Poisons Board

m/s. innocia lifesciences pvt. ltd. block a, no.12, balaji nagar, ambattur, chennai – - dapagliflozin propanediol monohydrate & metformin… - tablet - dapagliflozin propanediol monohydrate equivalent… - metformin and dapagliflozin

欧州連合 - 英語 - myHealthbox

astrazeneca ab - metformin hydrochloride, dapagliflozin propanediol monohydrate - film-coated tablet (tablet) - 5 mg/850 mg - diabetes mellitus, type 2 - drugs used in diabetes, combinations of oral blood glucose-lowering drugs - indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control - in patients inadequately controlled on their maximally tolerated dose of metformin alone - in combination with other glucose-lowering medicinal products, including insulin, in patients inadequately controlled with metformin and these medicinal products - in patients already being treated with the combination of dapagliflozin and metformin as separate tablets

欧州連合 - 英語 - myHealthbox

astrazeneca ab - metformin hydrochloride, dapagliflozin propanediol monohydrate - film-coated tablet (tablet) - 5 mg/1,000 mg - diabetes mellitus, type 2 - drugs used in diabetes, combinations of oral blood glucose-lowering drugs - indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control - in patients inadequately controlled on their maximally tolerated dose of metformin alone - in combination with other glucose-lowering medicinal products, including insulin, in patients inadequately controlled with metformin and these medicinal products - in patients already being treated with the combination of dapagliflozin and metformin as separate tablets

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - dapagliflozin (unii: 1ull0qj8uc) (dapagliflozin - unii:1ull0qj8uc), saxagliptin hydrochloride (unii: z8j84yix6l) (saxagliptin anhydrous - unii:8i7io46ivq), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - qternmet xr (dapagliflozin, saxagliptin, and metformin hydrochloride) extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use qternmet xr is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. qternmet xr initiation is intended only for patients currently taking metformin. qternmet xr is contraindicated in patients with: risk summary based on animal data showing adverse renal effects, from dapagliflozin, qternmet xr is not recommended during the second and third trimesters of pregnancy. the limited available data with qternmet xr or components (dapagliflozin and saxagliptin) in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk (see data ). there are risks to the moth

ニュージーランド - 英語 - Medsafe (Medicines Safety Authority)

astrazeneca limited - dapagliflozin propanediol monohydrate 12.3mg equivalent to dapagliflozin 10 mg;  ; metformin hydrochloride 1000mg (with 0.5% magnesium stearate);   - modified release tablet - 10mg/1000mg - active: dapagliflozin propanediol monohydrate 12.3mg equivalent to dapagliflozin 10 mg   metformin hydrochloride 1000mg (with 0.5% magnesium stearate)   excipient: carmellose sodium colloidal silicon dioxide crospovidone hypromellose lactose magnesium stearate microcrystalline cellulose opadry yellow 85f12372 - glycaemic control xigduo xr is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control when treatment with both dapagliflozin and metformin is appropriate (see sections 5.1 and 4.4 for available data on the combination therapy). prevention of hospitalisation for heart failure dapagliflozin is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalisation for heart failure (see section 5.1 pharmacodynamic properties – clinical efficacy and safety). prevention of new or worsening nephropathy dapagliflozin is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease for the prevention of new or worsening nephropathy (see section 5.1 pharmacodynamic properties – clinical efficacy and safety).

ニュージーランド - 英語 - Medsafe (Medicines Safety Authority)

astrazeneca limited - dapagliflozin propanediol monohydrate 12.3mg equivalent to dapagliflozin 10 mg;  ; metformin hydrochloride 500mg (with 0.5% magnesium stearate);   - modified release tablet - 10mg/500mg - active: dapagliflozin propanediol monohydrate 12.3mg equivalent to dapagliflozin 10 mg   metformin hydrochloride 500mg (with 0.5% magnesium stearate)   excipient: carmellose sodium colloidal silicon dioxide crospovidone hypromellose microcrystalline cellulose (ph302) hypromellose (2910) lactose magnesium stearate microcrystalline cellulose opadry pink 85f94333 - glycaemic control xigduo xr is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control when treatment with both dapagliflozin and metformin is appropriate (see sections 5.1 and 4.4 for available data on the combination therapy). prevention of hospitalisation for heart failure dapagliflozin is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalisation for heart failure (see section 5.1 pharmacodynamic properties – clinical efficacy and safety). prevention of new or worsening nephropathy dapagliflozin is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease for the prevention of new or worsening nephropathy (see section 5.1 pharmacodynamic properties – clinical efficacy and safety).

ニュージーランド - 英語 - Medsafe (Medicines Safety Authority)

astrazeneca limited - dapagliflozin propanediol monohydrate 6.15mg equivalent to dapagliflozin 5 mg;  ; metformin hydrochloride 1000mg (with 0.5% magnesium stearate);   - modified release tablet - 5mg/1000mg - active: dapagliflozin propanediol monohydrate 6.15mg equivalent to dapagliflozin 5 mg   metformin hydrochloride 1000mg (with 0.5% magnesium stearate)   excipient: carmellose calcium colloidal silicon dioxide crospovidone hypromellose lactose magnesium stearate microcrystalline cellulose opadry pink 85f94592 - glycaemic control xigduo xr is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control when treatment with both dapagliflozin and metformin is appropriate (see sections 5.1 and 4.4 for available data on the combination therapy). prevention of hospitalisation for heart failure dapagliflozin is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalisation for heart failure (see section 5.1 pharmacodynamic properties – clinical efficacy and safety). prevention of new or worsening nephropathy dapagliflozin is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease for the prevention of new or worsening nephropathy (see section 5.1 pharmacodynamic properties – clinical efficacy and safety).

マレーシア - 英語 - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

astrazeneca sdn. bhd. - metformin hydrochloride; dapagliflozin propanediol -

マレーシア - 英語 - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

astrazeneca sdn. bhd. - metformin hydrochloride; dapagliflozin propanediol -