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 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 - 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 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 - fingolimod hidroklorid - multiplo sklerozo, recidivno-nakazila - imunosupresivi - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older:patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 in 5. 1)orpatients s hitro razvijajočimi se hudo recidivno nakazila multiplo sklerozo, opredeljeno z 2 ali več onemogočanje zagonov v enem letu, in z 1 ali več gadolinium krepitev poškodbe na možganih, mri ali znatno povečanje t2 lezije obremenitvi, kot je v primerjavi s predhodnim zadnjih mri.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan ireland limited - rivaroksaban - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - antitrombotična sredstva - rivaroxaban mylan co-administered with acetylsalicylic acid (asa) alone or with asa plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers.  rivaroxaban mylan co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events.  ------prevention of venous thromboembolism (vte) in adult patients undergoing elective hip or knee replacement surgery.  treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults. -------adults prevention of stroke and systemic embolism in adult   patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan ireland limited - sugammadex sodium - neuromuskularna blokada - vsi drugi terapevtski izdelki - reversal of neuromuscular blockade induced by   rocuronium or vecuronium in adults. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hidroklorid - multiplo sklerozo, recidivno-nakazila - imunosupresivi - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 in 5. 1) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

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.