Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - for adult patients with type 2 diabetes mellitus, sitagliptin accord 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 (ppary) agonist (i. a thiazolidinedione) when use of a ppary agonist is appropriate and when diet and exercise plus the ppary 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 ppary agonist and metformin when use of a ppary agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin accord 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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - plerixafor - multiple myeloma; hematopoietic stem cell transplantation - immunostimulants, - adult patientsplerixafor accord is indicated in combination with granulocyte-colony stimulating factor (g-csf) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4. paediatric patients (1 to less than 18 years)plerixafor accord is indicated in combination with g-csf to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with g-csf (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or- who previously failed to collect sufficient haematopoietic stem cells (see section 4.

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - degarelix acetate - prostatične neoplazme - other hormone antagonists and related agents - degarelix accord is a gonadotrophin releasing hormone (gnrh) antagonist indicated:for treatment of adult male patients with advanced hormone-dependent prostate cancer. for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

accord healthcare - solifenacin - filmsko obložena tableta - solifenacin 7,5 mg / 1 tableta - solifenacin

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. - 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. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord is indicated for the treatment of- adult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. - adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. - adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. - adult patients with relapsed or refractory ph+ all as monotherapy. - adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. - adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). - the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. razen v novo diagnozo kronične faze cml, ni kontroliranih preskušanjih, dokazujejo kliničnih koristi ali poveča preživetje pri teh bolezni. .

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. - 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. - lakosamid - epilepsija - antiepileptics, - 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.