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. - vorikonazol - aspergillosis; candidiasis; mycoses - antimycotics za sistemsko uporabo, triazol derivati - voriconazole je v širokem spektru, triazol protiglivično sredstvo, ter je označena pri odraslih in otrocih, starih dve leti ali več, kot sledi:zdravljenje invazivne aspergillosis;zdravljenje candidaemia v ne-neutropenic bolnikov;zdravljenje fluconazole-odporne resno invazivne candida okužbe (vključno c. krusei);zdravljenje hude glivične okužbe, ki jih povzročajo scedosporium spp. in oxysporum spp. voriconazole soglasju mora biti urejen, predvsem pri bolnikih z napredujočo, morda celo smrtno nevarne okužbe.

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. - 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. - dexmedetomidine - premedication - psiholeptiki - za sedacijo odraslih icu (enoti za intenzivno nego) bolnikov, ki potrebujejo sedacijo ravni ne globlje, kot je vzburjenje v odgovor na verbalne dražljaje (ustrezno richmond vznemirjenost-sedacija lestvici (rass) 0 -3). za sedacijo non-intubated odraslih bolnikov pred in/ali v diagnostične ali kirurški postopki, ki zahtevajo sedacijo, i. postopkovna/buden sedacijo.

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - kaspofungin acetat - candidiasis; aspergillosis - antimikotiki za sistemsko uporabo - zdravljenje invazivne kandidoze pri odraslih ali pediatričnih bolnikih. zdravljenje invazivne aspergillosis pri odraslih ali pediatričnih bolnikih, ki so utrjene ali nestrpne amphotericin b, lipidov formulacije amphotericin b in/ali itraconazole. refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. empirično terapijo za domnevnih glivičnih okužb (kot so candida ali gillus) v febrile, neutropaenic odraslih ali pediatričnih bolnikih.

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

accord healthcare - letrozol - filmsko obložena tableta - letrozol 2,5 mg / 1 tableta - letrozol

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

accord healthcare - letrozol - filmsko obložena tableta - letrozol 2,5 mg / 1 tableta - letrozol

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

accord healthcare - letrozol - filmsko obložena tableta - letrozol 2,5 mg / 1 tableta - letrozol

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

accord healthcare - letrozol - filmsko obložena tableta - letrozol 2,5 mg / 1 tableta - letrozol