Evropska unija - slovenščina - EMA (European Medicines Agency)

teva b.v. - pioglitazon hidroklorid - diabetes mellitus, tip 2 - prehrambeni trakt in metabolizem - pioglitazone je navedeno v zdravljenju diabetesa tipa 2 bolezni:kot monotherapy - pri odraslih bolnikih (zlasti prekomerno telesno težo bolnikov) neustrezno nadzorovane z dieto in telesno vadbo, za katere metformin ni primeren, ker kontraindikacije ali intoleranceas dvojno oralna terapija v kombinaciji z metforminom, pri odraslih bolnikih (zlasti prekomerno telesno težo bolnikov) z nezadostno glycaemic nadzor kljub maksimalne dopustne odmerek monotherapy z metforminom - sulfonil sečnine, le pri odraslih bolnikih, ki pokažejo nestrpnost do metforminom ali za katere metformin je kontraindiciran, z nezadostno glycaemic nadzor kljub maksimalne dopustne odmerek monotherapy z sulphonylureaas trojno oralna terapija v kombinaciji z metforminom in sulfonil sečnine, pri odraslih bolnikih (zlasti prekomerno telesno težo bolnikov) z nezadostno glycaemic nadzor kljub dvojno oralna terapija. pioglitazone je prikazano tudi za kombinacijo z insulina v vrsto 2 sladkorna bolezen odraslih bolnikih z nezadostno glycaemic nadzor na insulin, za katere metformin ni primeren, ker kontraindikacije ali nestrpnosti. po začetku terapije z pioglitazone, bolnike je treba pregledati in po 3 do 6 mesecev, da oceni ustreznost odziva na zdravljenje (e. zmanjšanje hba1c). pri bolnikih, ki ne kažejo ustrezen odgovor, pioglitazone, je treba prekiniti,. v luči možnih tveganj z dolgotrajna terapija, predpisovalce morajo potrditi na kasnejše redne preglede, da je korist pioglitazone je ohranjena.

Evropska unija - slovenščina - EMA (European Medicines Agency)

actavis group ptc ehf   - pioglitazon hidroklorid - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below:as monotherapyin adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. as dual oral therapy in combination withmetformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin. a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea. as triple oral therapy in combination withmetformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4. po začetku terapije z pioglitazone, bolnike je treba pregledati in po 3 do 6 mesecev, da oceni ustreznost odziva na zdravljenje (e. zmanjšanje hba1c). pri bolnikih, ki ne kažejo ustrezen odgovor, pioglitazone, je treba prekiniti,. v luči možnih tveganj z dolgotrajna terapija, predpisovalce morajo potrditi na kasnejše redne preglede, da je korist pioglitazone je ohranjena (glej poglavje 4.

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, sitagliptin hydrochloride monohydrate - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - 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. , trojna kombinacija terapija), kot dodatek k prehrani in vadbi pri bolnikih neustrezno nadzorovano na maksimalno dopustne odmerek metforminom in sulfonil sečnine. 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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sitagliptin fumarate, metformin hydrochloride - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - 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. , trojna kombinacija terapija), kot dodatek k prehrani in vadbi pri bolnikih neustrezno nadzorovano na maksimalno dopustne odmerek metforminom in sulfonil sečnine. 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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

amryt pharmaceuticals dac - metreleptin - lipodystrophy, družinsko delno - drugi zdravljene bolezni prebavil in presnove izdelki, - myalepta je indicirano kot dodatek k dieti kot nadomestno zdravljenje za zdravljenje zapletov leptin pomanjkljivost v lipodystrophy (ld) bolnikov:s potrjeno prirojene splošnih ld (berardinelli-seip sindrom) ali pridobljenih splošnih ld (lawrence sindrom) pri odraslih in otrok do 2 let starosti in abovewith potrdili družinsko delno ld ali pridobljeno delno ld (barraquer-simons sindrom), pri odraslih in otrok 12 let in zgoraj za katere standardno zdravljenje ni uspelo doseči ustrezno presnovno nadzor.

Evropska unija - slovenščina - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozin propanediol monohidrat, metformin hidroklorid - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - diabetes tipa 2 mellitusfor zdravljenje ni dovolj nadzorovano tipa 2 sladkorna bolezen kot dodatek k dieti in telesni. kot monotherapy ko metformin je neprimerno zaradi nestrpnosti. poleg drugimi zdravili za zdravljenje diabetesa tipa 2. za študijski rezultati glede kombinacija terapij, vplivi na glycaemic nadzor in srčno-žilne dogodke, in populacije, ki je študiral glej poglavji 4. 4, 4. 5 in 5. sladkorna bolezen tipa 1 mellitusedistride je navedeno pri odraslih za zdravljenje premalo nadzorovana sladkorna bolezen tipa 1 kot dodatek k insulina pri bolnikih z itm ≥ 27 kg/m2, če insulin sam ne zagotavljajo ustrezne glycaemic nadzor kljub optimalno insulina terapija.

Evropska unija - slovenščina - EMA (European Medicines Agency)

astra zeneca ab - saxagliptin, dapagliflozin propanediol monohidrat - diabetes mellitus, type 2; diabetes mellitus; nutritional and metabolic diseases; metabolic diseases; glucose metabolism disorders - zdravila, ki se uporabljajo pri diabetesu - qtern, fiksni odmerek kombinacija saxagliptin in dapagliflozin, je navedeno pri odraslih, starih 18 let in več, z vrsto 2 sladkorna bolezen:za izboljšanje glycaemic nadzor, ko metforminom in/ali sulfonil sečnine (su) in eden od monocomponents od qtern ne zagotavljajo ustrezne glycaemic nadzor,ko se že zdravijo z brezplačno kombinacija dapagliflozin in saxagliptin. (glej točki 4. 2, 4. 4, 4. 5 in 5. 1, če so na voljo podatki o kombinacije študiral.

Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm ltd. - nateglinid - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - nateglinid je indiciran za kombinirano terapijo z metforminom pri bolnikih z diabetesom tipa 2, ki so bili neustrezno nadzorovani kljub največjemu dovoljenemu odmerku samo metformina.

Evropska unija - slovenščina - EMA (European Medicines Agency)

atnahs pharma netherlands b.v. - macimorelin acetat - diagnostične tehnike, endokrine - macimorelin - to zdravilo je samo za diagnostično uporabo.  ghryvelin is indicated for the diagnosis of growth hormone deficiency (ghd) in adults.

Evropska unija - slovenščina - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sitagliptin fumarate - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - for adult patients with type 2 diabetes mellitus, sitagliptin sun is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i. a thiazolidinedione) when use of a pparγ agonist is appropriate and when diet and exercise plus the pparγ agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a pparγ agonist and metformin when use of a pparγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin sun is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.