Entecavir Accord Europska Unija - hrvatski - EMA (European Medicines Agency)

entecavir accord

accord healthcare s.l.u. - Энтекавир - hepatitis b, kronični - antivirusni lijekovi za sustavnu uporabu - entecavir accord is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with: , compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis. , dekompenziranom bolesti jetre . kao компенсированные i dekompenziranom bolesti jetre, ovaj pokazatelj temelji se na podacima iz kliničkih istraživanja u naivnih pacijenata nukleozida s pozitivnim rezultatom testa na hbeag i hbeag-negativni hbv-infekcije. Što se tiče bolesnika s refluksom hepatitis b lamivudina. Энтекавир accord je također indiciran za liječenje kronične hbv-infekcije u nukleozida naivan pedijatrijska bolesnika od 2 do.

Lacosamide Accord Europska Unija - hrvatski - EMA (European Medicines Agency)

lacosamide accord

accord healthcare s.l.u. - lakozamida - epilepsija - antiepileptici sredstva, - lacosamide accord is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. lacosamide accord is indicated as adjunctive therapy•         in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. •         in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.

Lenalidomide Accord Europska Unija - hrvatski - EMA (European Medicines Agency)

lenalidomide accord

accord healthcare s.l.u. - lenalidomid - multipli mijelom - imunosupresivi - multiple myelomalenalidomide accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide accord as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) indiciran za liječenje odraslih bolesnika s ranije нелеченной multiplog mijeloma koji se ne oslanja transplantacije. akord леналидомид u kombinaciji s дексаметазоном indiciran za liječenje multiple myeloma kod odraslih pacijenata koji su primili barem jedan tečaj terapija. follicular lymphomalenalidomide accord in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Posaconazole Accord Europska Unija - hrvatski - EMA (European Medicines Agency)

posaconazole accord

accord healthcare s.l.u. - posakonazol - mycosis - antimikotika za sustavnu uporabu - posaconazole accord is indicated for use in the treatment of the following fungal infections in adults:invasive aspergillosis;fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. Позаконазол accord je također indiciran za prevenciju invazivnih gljivičnih infekcija kod sljedećih bolesnika: kod bolesnika remisije-indukcija kemoterapije akutni миелолейкозе (aml) ili миелодиспластические sindroma (mds) očekuje se da će rezultat dugotrajne нейтропенией i visokim rizikom za razvoj invazivnih gljivičnih infekcija;presađivanje гемопоэтических matičnih stanica (ТГСК) primatelja, koji se održavaju высокодозную иммуносупрессивную terapiju reakcija graft protiv domaćina i koji su s visokim rizikom za razvoj invazivnih gljivičnih infekcija.

Abiraterone Accord Europska Unija - hrvatski - EMA (European Medicines Agency)

abiraterone accord

accord healthcare s.l.u. - abirateron acetat - prostatske neoplazme - endokrinska terapija - abiraterone accord 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 indicatedthe treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Sunitinib Accord Europska Unija - hrvatski - EMA (European Medicines Agency)

sunitinib accord

accord healthcare s.l.u. - sunitinib - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - antineoplastična sredstva - gastrointestinal stromal tumour (gist)sunitinib accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib treatment due to resistance or intolerance. metastatic renal cell carcinoma (mrcc)sunitinib accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults. pancreatic neuroendocrine tumours (pnet)sunitinib accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pnet) with disease progression in adults.

Vildagliptin / Metformin hydrochloride Accord Europska Unija - hrvatski - EMA (European Medicines Agency)

vildagliptin / metformin hydrochloride accord

accord healthcare s.l.u. - metformin hydrochloride, vildagliptin - dijabetes mellitus, tip 2 - lijekovi koji se koriste u dijabetesu - 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 i 5. 1 za dostupne podatke o različitim kombinacijama).

Teriflunomide Accord Europska Unija - hrvatski - EMA (European Medicines Agency)

teriflunomide accord

accord healthcare s.l.u. - teriflunomide - multipla skleroza, Рецидивно-Ремиттирующее - imunosupresivima selektivni imunosupresivima - teriflunomide accord is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

Dimethyl fumarate Accord Europska Unija - hrvatski - EMA (European Medicines Agency)

dimethyl fumarate accord

accord healthcare s.l.u. - dimetil fumarat - multiple sclerosis, relapsing-remitting; multiple sclerosis - imunosupresivi - dimethyl fumarate accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).

Ciklofosfamid Accord 2000 mg prašak za otopinu za injekciju/infuziju Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

ciklofosfamid accord 2000 mg prašak za otopinu za injekciju/infuziju

accord healthcare polska sp. z o.o., ul. lutomierska 50, pabianice, poljska - ciklofosfamid hidrat - prašak za otopinu za injekciju / infuziju - urbroj: 1 bočica 2000 mg ciklofosfamida u obliku ciklofosfamid hidrata, 1 ml rekonstituirane otopine sadrži 20 mg ciklofosfamida.