Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozin propanedjol monohydrate, metformin hydrochloride - diabetes mellitus, tip 2 - drogi użati fid-dijabete - dijabete tat-tip 2 mellitusfor-trattament ta mhumiex ikkontrollati biżżejjed b'dijabete mellitus tip 2 bħala żieda mad-dieta u l-eżerċizzju. bħala monoterapija meta metformin huwa meqjus bħala mhux xierqa minħabba l-intolleranza. barra minn hekk għall-prodotti mediċinali oħra għat-trattament tad-dijabete tat-tip 2. għall-riżultati tal-istudju fir-rigward tal-kombinazzjoni ta ' terapiji, l-effetti fuq il-kontroll gliċemiku u episodji kardjovaskulari, u l-popolazzjonijiet studjati, ara sezzjonijiet 4. 4, 4. 5 u 5. dijabete tat-tip 1 mellitusedistride huwa indikat fl-adulti għall-kura ta mhumiex ikkontrollati biżżejjed dijabete mellitus tip 1 bħala kura aġġuntiva għall-insulina f'pazjenti b'bmi ≥ 27 kg/m2, meta l-insulina waħdu ma jipprovdux kontroll gliċemiku adegwat minkejja l-aħjar terapija ta'l-insulina.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astrazeneca ab - metformin hydrochloride, dapagliflozin propanedjol monohydrate - diabetes mellitus, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - xigduo huwa indikat fl-adulti għall-kura ta 'dijabete mellitus tip 2 bħala żieda mad-dieta u l-eżerċizzju:• f'pazjenti li mhumiex ikkontrollati biżżejjed dwar l-ogħla doża ttollerata ta' metformin waħdu • f'kombinazzjoni ma ' prodotti mediċinali oħra għall-kura tad-dijabete f'pazjenti li mhumiex ikkontrollati biżżejjed b'metformin u dawn il-prodotti mediċinali• fil-pazjenti li diġà qegħdin jiġu kkurati b'kumbinazzjoni ta dapagliflozin u metformin bħala pilloli separati. għall-riżultati tal-istudju fir-rigward tal-kombinazzjoni ta ' terapiji, l-effetti fuq il-kontroll gliċemiku u episodji kardjovaskulari, u l-popolazzjonijiet studjati, ara sezzjonijiet 4. 4, 4. 5 u 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astrazeneca ab - metformin hydrochloride, saxagliptin, dapagliflozin - diabetes mellitus, tip 2 - drogi użati fid-dijabete - qtrilmet huwa indikat f'adulti ta ' 18-il sena u akbar b'dijabete mellitus tip 2:biex ittejjeb il-kontroll gliċemiku meta l-metformina flimkien jew mingħajr sulfonilurea (su) u jew saxagliptin jew dapagliflozin ma jipprovdux kontroll gliċemiku adegwat. meta diġà qed jiġu kkurati b'metformin u saxagliptin u dapagliflozin.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozin propanediol monohydrate - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - drogi użati fid-dijabete - type 2 diabetes mellitusedistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance. barra minn hekk għall-prodotti mediċinali oħra għat-trattament tad-dijabete tat-tip 2. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 u 5. heart failureedistride is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseedistride is indicated in adults for the treatment of chronic kidney disease.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozin propanediol monohydrate - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - drogi użati fid-dijabete - type 2 diabetes mellitusforxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance. barra minn hekk għall-prodotti mediċinali oħra għat-trattament tad-dijabete tat-tip 2. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 u 5. heart failureforxiga is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseforxiga is indicated in adults for the treatment of chronic kidney disease.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astra zeneca ab - saxagliptin, dapagliflozin propanedjol monohydrate - diabetes mellitus, type 2; diabetes mellitus; nutritional and metabolic diseases; metabolic diseases; glucose metabolism disorders - drogi użati fid-dijabete - qtern, taħlita fissa tad-doża ta saxagliptin u dapagliflozin, huwa indikat f'adulti ta ' 18-il sena u akbar b'dijabete mellitus tip 2:biex ittejjeb il-kontroll gliċemiku meta metformin u/jew mediċina tat-tip sulphonylurea (su) u waħda mill-monokomponenti tal-qtern ma jipprovdux kontroll gliċemiku adegwat,meta diġà qegħdin jiġu ttrattati bil-kombinazzjoni ħielsa ta dapagliflozin u saxagliptin. (ara sezzjonijiet 4. 2, 4. 4, 4. 5 u 5. 1 għall-dejta disponibbli dwar il-kombinazzjonijiet studjat.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, sitagliptin hydrochloride monohydrate - diabetes mellitus, tip 2 - drogi użati fid-dijabete - for adult patients with type 2 diabetes mellitus:it is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. it is indicated in combination with a sulphonylurea (i. , terapija ta 'kumbinazzjoni tripla) bħala żieda mad-dieta u l-eżerċizzju f'pazjenti mhux ikkontrollati adegwatament fuq id-doża massima ttollerata ta' metformin u sulphonylurea. it is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparγ agonist. it is also indicated as add-on to insulin (i. , triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, vildagliptin - diabetes mellitus, tip 2 - drogi użati fid-dijabete - vildagliptin/metformin hydrochloride accord is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:- in patients who are inadequately controlled with metformin hydrochloride alone. - in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. - in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 u 5. 1 għad-data disponibbli dwar kombinazzjonijiet differenti).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan ireland limited - sitagliptin hydrochloride monohydrate, metformin hydrochloride - diabetes mellitus, tip 2 - drogi użati fid-dijabete - for adult patients with type 2 diabetes mellitus:sitagliptin/metformin hydrochloride mylan is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. sitagliptin/metformin hydrochloride mylan is indicated in combination with a sulphonylurea (i. , terapija ta 'kumbinazzjoni tripla) bħala żieda mad-dieta u l-eżerċizzju f'pazjenti mhux ikkontrollati adegwatament fuq id-doża massima ttollerata ta' metformin u sulphonylurea. sitagliptin/metformin hydrochloride mylan is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparg) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparg agonist. sitagliptin/metformin hydrochloride mylan is also indicated as add-on to insulin (i. , triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sitagliptin fumarate, metformin hydrochloride - diabetes mellitus, tip 2 - drogi użati fid-dijabete - for adult patients with type 2 diabetes mellitus:sitagliptin/metformin hydrochloride sun is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. sitagliptin/metformin hydrochloride sun is indicated in combination with a sulphonylurea (i. , terapija ta 'kumbinazzjoni tripla) bħala żieda mad-dieta u l-eżerċizzju f'pazjenti mhux ikkontrollati adegwatament fuq id-doża massima ttollerata ta' metformin u sulphonylurea. sitagliptin/metformin hydrochloride sun is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparγ agonist. sitagliptin/metformin hydrochloride sun is also indicated as add-on to insulin (i. , triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.