Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan ireland limited - lenalidomid - multiple myeloma - imunosupresivi - multiple myelomalenalidomide mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide mylan as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. lenalidomide mylan in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide mylan in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1-3a).

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan ireland limited - azacitidin - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastična sredstva - azacitidine mylan is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with:intermediate 2 and high risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29% marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30% blasts and multi lineage dysplasia, according to world health organisation (who) classification,aml with > 30% marrow blasts according to the who classification.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan pharmaceuticals limited - atazanavir (as sulfate) - okužbe z virusom hiv - antivirusi za sistemsko uporabo - atazanavir mylan, co-daje z nizkim odmerkom ritonavir, je indicirano za zdravljenje okužbe z virusom hiv 1 okuženih odraslih in pediatričnih bolnikih 6 let starosti in starejših v kombinaciji z drugimi protiretrovirusnimi zdravili. na podlagi razpoložljivih virological in kliničnih podatkov odraslih bolnikih, nobene koristi ni pričakovati pri bolnikih s sevi, odporni na več protease inhibitorji (≥ 4 pi mutacije). otroci, stari od 6 let do manj kot 18 let, so na voljo zelo omejeni podatki. izbira atazanavir mylan v zdravljenje izkušenih odraslih in pediatričnih bolnikih mora temeljiti na posameznih virusnih odpornost testiranje in bolnika v zdravljenje zgodovina.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan pharmaceuticals limited - deferasiroks - iron overload; beta-thalassemia - kelator železa - deferasirox mylan je označena forthe zdravljenje kronične železa preobremenitve zaradi pogoste transfuzije krvi (≥7 ml/kg/mesec pakirani rdečih krvničk) pri bolnikih z beta talasemija major, starih 6 let in olderthe zdravljenje kronične železa preobremenitve zaradi transfuzije krvi, če deferoxamine zdravljenje je kontraindicirano ali neustrezni v naslednjih bolnik skupine:v pediatričnih bolnikih z beta talasemija major preobremenitve z železom zaradi pogoste transfuzije krvi (≥7 ml/kg/mesec pakirani rdečih krvnih celic), starih od 2 do 5 let,pri odraslih in pediatričnih bolnikih z beta talasemija major preobremenitve z železom zaradi redke transfuzije krvi (.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan ireland limited - arzenov trioksid - levkemija, promyelocytic, akutna - antineoplastična sredstva - arzenov trioksid mylan je primerna za indukcijo remisije, in konsolidacije pri odraslih bolnikih z:- na novo diagnosticirana nizko ali srednje tveganje akutna promyelocytic levkemijo (apl) (belih krvnih telesc, ≤ 10 x 103/µl) v kombinaciji z vsemi trans retinojske kisline (atra)- relapsed/ognjevzdržni akutna promyelocytic levkemijo (apl) (prejšnje zdravljenje mora imeti vključen retinoid in kemoterapijo)značilna prisotnost t(15;17) translokacija in/ali prisotnosti promyelocytic levkemijo/retinojske kisline receptorjev alfa (pml/rar alfa) gena. odgovor stopnja drugih akutnih myelogenous levkemijo podtipov, da arzenov trioksid ni beenexamined.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan ireland limited - abirateron acetat - prostatične neoplazme - endocrine therapy, other hormone antagonists and related agents - abiraterone mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt). the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Evropska unija - slovenščina - EMA (European Medicines Agency)

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

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan ireland limited - dimetil fumarat - multiplo sklerozo, recidivno-nakazila - imunosupresivi - dimethyl fumarate mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan pharmaceuticals limited - razagilinijev tartrat - parkinsonova bolezen - anti-parkinsonska zdravila - rasagilin mylan je indiciran za zdravljenje idiopatske parkinsonove bolezni (pd) kot monoterapijo (brez levodope) ali kot dodatno zdravljenje (z levodopo) pri bolnikih s končno nihanjem odmerka.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan pharmaceuticals limited - amlodipine besilate, valsartan - hipertenzija - sredstva, ki delujejo na sistem renin-angiotenzin - zdravljenje esencialne hipertenzije. amlodipine/valsartan mylan je navedeno pri odraslih, katerih krvni tlak ni ustrezno nadzorovan na amlodipine ali valsartan monotherapy.