European Union - Icelandic - 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. nema í nýlega greind langvarandi áfanga cml, það eru ekki stjórnað rannsóknir sýna klínískum gagnast eða jókst að lifa fyrir þessum sjúkdómum. .

European Union - Icelandic - EMA (European Medicines Agency)

accord healthcare s.l.u. - pramipexól tvíhýdróklóríð einhýdrat - parkinson disease; restless legs syndrome - anti-parkinsonslyf - pramipexole accord er ætlað fullorðnum til meðferðar á einkennum parkinsonsveiki, einkennalaus (án levodopa) eða í samsettri meðferð með levodopa, ég. á meðan á sjúkdómnum stendur, í gegnum seint stig þegar áhrif levódópa berast eða verða ósamræmi og sveiflur á meðferðaráhrifum eiga sér stað (lokaskammtur eða "á-burt" sveiflur).

European Union - Icelandic - EMA (European Medicines Agency)

accord healthcare s.l.u. - lacosamíð - flogaveiki - 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.

European Union - Icelandic - EMA (European Medicines Agency)

accord healthcare s.l.u. - lenalídómíð - mergæxli - Ónæmisbælandi lyf - 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) er ætlað fyrir meðferð fullorðinn sjúklinga með áður ómeðhöndlað margar forráðamenn sem eru ekki rétt fyrir ígræðslu. lenalídómíði hvötum ásamt leiðbeina er ætlað fyrir meðferð margar forráðamenn í fullorðinn sjúklingar sem hafa fengið að minnsta kosti einn áður en meðferð. 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).

European Union - Icelandic - EMA (European Medicines Agency)

accord healthcare s.l.u. - posakónazól - mycoses - sveppalyf fyrir almenn nota - 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. svara ekki meðferð er skilgreint eins og framgangi sýkingu eða bilun til að bæta eftir að minnsta kosti 7 daga áður en lækninga skammta af árangri mikla meðferð. posaconazole hvötum er einnig ætlað til að fyrirbyggja innrásar sveppasýkingu í eftirfarandi sjúklingar: sjúklingar fá fyrirgefningu-framkalla lyfjameðferð fyrir bráð kyrningahvítblæði (aml) eða myelodysplastic heilkennum (stýrð útgjöld) gert ráð fyrir að leiða í langvarandi mæði í tengslum og hver ert í mikilli hættu að fá innrásar sveppasýkingu;blóðmyndandi stafa klefi grætt (hsct) viðtakendur sem eru að verða hár-skammt ónæmisbælandi meðferð fyrir ígræðslu móti gestgjafi sjúkdómur og hver ert í mikilli hættu að fá innrásar sveppasýkingu.

European Union - Icelandic - EMA (European Medicines Agency)

accord healthcare s.l.u. - fampridine - margvísleg sclerosis - Önnur lyf í taugakerfinu - fampridine accord is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (edss 4-7).

European Union - Icelandic - EMA (European Medicines Agency)

accord healthcare s.l.u. - rivaroxaban - acute coronary syndrome; coronary artery disease; peripheral arterial disease; venous thromboembolism; stroke; atrial fibrillation; pulmonary embolism - blóðþurrðandi lyf - til að koma í veg fyrir segareki í bláæðum (vte) hjá fullorðnum sjúklingum sem gangast undir valhimnubólgu eða meðhöndlun á hné. meðferð djúpt æð blóðtappa (hjá sjúklingum sem fengu) og í lungum stíflu (pe), og koma í veg fyrir endurteknum hjá sjúklingum sem fengu pe í fullorðnir. (see section 4. 4 for haemodynamically unstable pe patients. meðferð djúpt æð blóðtappa (hjá sjúklingum sem fengu) og í lungum stíflu (pe), og koma í veg fyrir endurteknum hjá sjúklingum sem fengu pe í fullorðnir. (see section 4. 4 fyrir haemodynamically óstöðug pe sjúklingar). adultsprevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. meðferð djúpt æð blóðtappa (hjá sjúklingum sem fengu) og í lungum stíflu (pe), og koma í veg fyrir endurteknum hjá sjúklingum sem fengu pe í fullorðnir. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. rivaroxaban accord, co administered with acetylsalicylic acid (asa) alone or with asa plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers (see sections 4. 3, 4. 4 og 5. rivaroxaban accord, co administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. adultsprevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. meðferð djúpt æð blóðtappa (hjá sjúklingum sem fengu) og í lungum stíflu (pe), og koma í veg fyrir endurteknum hjá sjúklingum sem fengu pe í fullorðnir. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

European Union - Icelandic - EMA (European Medicines Agency)

accord healthcare s.l.u. - abirateron asetat - blöðruhálskirtli - innkirtla meðferð - 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.

European Union - Icelandic - EMA (European Medicines Agency)

accord healthcare s.l.u. - sunitinib - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - Æxlishemjandi lyf - 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.

European Union - Icelandic - EMA (European Medicines Agency)

accord healthcare s.l.u. - icatibant acetate - ofsabjúgur, arfgengur - other hematological agents - icatibant accord is indicated for symptomatic treatment of acute attacks of hereditary angioedema (hae) in adults, adolescents and children aged 2 years and older, with c1 esterase inhibitor deficiency.