Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - pramipeksol dihidroklorid monohidrat - parkinson disease; restless legs syndrome - anti-parkinsonska zdravila - zdravilo pramipeksol accord je indicirano pri odraslih za zdravljenje znakov in simptomov idiopatske parkinsonove bolezni, samega (brez levodope) ali v kombinaciji z levodopo, i. v času bolezni, do poznih stopenj, ko se učinek levodope izčrpa ali postane neskladen, pojavijo pa se tudi nihanja terapevtskega učinka (nihanja na koncu odmerka ali "on-off" nihanja).

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - lenalidomid - multiple myeloma - 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) je indiciran za zdravljenje odraslih bolnikov s predhodno nezdravljenih več plazmocitom, ki niso primerni za presaditev. lenalidomide sebe v kombinaciji z dexamethasone je primerna za zdravljenje več plazmocitom pri odraslih bolnikih, ki so prejeli vsaj en pred terapijo. 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).

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, vildagliptin - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - 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 in 5. 1 za razpoložljive podatke o različnih kombinacijah).

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - kapecitabin - colonic neoplasms; breast neoplasms; colorectal neoplasms; stomach neoplasms - antineoplastična sredstva - capecitabine accord je indiciran za adjuvantno zdravljenje bolnikov po operaciji stopnje iii (dukes 'stadij c) raka debelega črevesa. capecitabine soglasju je primerna za zdravljenje metastatskega raka debelega črevesa in danke. capecitabine soglasju je določen za prvo linijo zdravljenja naprednih raka želodca v kombinaciji z platinum, ki temelji režim. capecitabine sebe v kombinaciji z docetaxel je indiciran za zdravljenje bolnikov z lokalno napredno ali metastatskega raka dojke po okvari citotoksična kemoterapija. predhodno zdravljenje bi moralo vključiti antraciklin. capecitabine soglasju navede tudi kot monotherapy za zdravljenje bolnikov z lokalno napredno ali metastatskega raka dojke po okvari taxanes in anthracycline, ki vsebujejo kemoterapijo režim ali za koga še anthracycline zdravljenje ni navedeno.

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - abirateron acetat - prostatične neoplazme - endokrini 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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - tolvaptan - neprimeren adh sindrom - diuretiki, - tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (siadh).

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - eptifibatid - miokardni infarkt - antitrombotična sredstva - zdravilo eptifibatide accord je namenjeno uporabi z acetilsalicilno kislino in nefrakcioniranim heparinom. eptifibatide soglasju je navedena za preprečevanje zgodnje miokardni infarkt pri odraslih, ki predstavljajo z nestabilno angino pektoris ali ne-q-val, miokardni infarkt, z zadnjo epizodo bolečine v prsih, ki se pojavljajo v 24 urah in z elektrokardiograma (ekg), ki se s spremembami in/ali zvišan srčni encimi. bolniki najbolj verjetno, da koristi od eptifibatide soglasju zdravljenje, so tiste z visokim tveganjem za razvoj miokardnega infarkta v prvih 3-4 dni po nastopu akutne angina simptomov, vključno z, na primer tiste, ki jih je verjetno, da opravijo zgodnji ptca (perkutana transluminal koronarno angioplastiko).

Evropska unija - slovenščina - EMA (European Medicines Agency)

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).

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - entecavir - hepatitis b, kronični - antivirusi za sistemsko uporabo - 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. , decompensated bolezen jeter. tako za odškodnino in decompensated bolezni jeter, ta navedba temelji na kliničnem preskušanju podatkov v nucleoside naivnih bolnikov z hbeag pozitivnih in hbeag negativnih hbv okužbe. glede bolnikov z lamivudinom neodzivnega hepatitisa b. entecavir soglasju navede tudi za zdravljenje kronične hbv okužbe v nucleoside naivno pediatričnih bolnikih od 2 do.

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastična sredstva - dasatinib accordpharma is indicated for the treatment of adult patients with: newly diagnosed philadelphia chromosome positive (ph+) chronic myelogenous leukaemia (cml) in the chronic phase.  chronic, accelerated or blast phase cml with resistance or intolerance to prior therapy including imatinib.  ph+ acute lymphoblastic leukaemia (all) and lymphoid blast cml with resistance or intolerance to prior therapy. dasatinib accordpharma is indicated for the treatment of paediatric patients with: newly diagnosed ph+ cml in chronic phase (ph+ cml-cp) or ph+ cml-cp resistant or intolerant to prior therapy including imatinib.  newly diagnosed ph+ all in combination with chemotherapy.