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. - 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.

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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - temozolomid - glioma; glioblastoma - antineoplastična sredstva - za zdravljenje odraslih bolnikov z novo diagnosticiranim multiformnim glioblastomom ob sočasnem radioterapiji (rt) in kasneje kot samostojno zdravljenje. za zdravljenje otroke, starejše od treh let, mladostniki in odrasli bolniki s malignega glioma, na primer glioblastomom multiforme anaplastični astrocitomi, ki prikazujejo, ponovitev ali napredovanje po standardni terapiji,.

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - pregabalin - anxiety disorders; epilepsy - antiepileptics, - epilepsypregabalin soglasju je označeno kot adjunctive terapija pri odraslih z delni epileptični napadi z ali brez sekundarne posplošitev. splošne anksioznosti disorderpregabalin soglasju je primerna za zdravljenje splošne anksiozne motnje (gad) pri odraslih.

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. - 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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - cinakalcet hidroklorid - hyperparathyroidism - kalcij homeostaza - sekundarni hyperparathyroidismadultstreatment sekundarne hyperparathyroidism (hpt) pri odraslih bolnikih z končne ledvične bolezni (esrd) na vzdrževanje dializo (zdravljenje. pediatrični populationtreatment sekundarne hyperparathyroidism (hpt) pri otrocih, starih 3 leta in več, z končne ledvične bolezni (esrd) na vzdrževanje dializo (zdravljenje, v katerega sekundarne hpt ni ustrezno nadzorovana z običajnimi oskrbe, terapije (glejte poglavje 4. cinacalcet accordpharma se lahko uporablja kot del terapevtski režim, vključno z fosfat veziv in/ali vitamina d sterolov, kot je primerno (glej poglavje 5. parathyroid karcinom in primarni hyperparathyroidism v adultsreduction od hypercalcaemia pri odraslih bolnikih z:parathyroid karcinom. primarni hpt, za katere parathyroidectomy bi se kazalo na osnovi seruma ravni kalcija (kot je opredeljeno z ustreznimi smernicami za zdravljenje), ampak v katero parathyroidectomy ni klinično primerno ali je kontraindicirana.

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - sorafenib tosilate - carcinoma, hepatocellular; carcinoma, renal cell - antineoplastična sredstva - hepatocellular carcinomasorafenib accord is indicated for the treatment of hepatocellular carcinoma (see section 5. renal cell carcinomasorafenib accord is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.

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.