Europäische Union - Isländisch - 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.

Europäische Union - Isländisch - 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.

Europäische Union - Isländisch - 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.

Europäische Union - Isländisch - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - Æxlishemjandi lyf - dasatinib accord is indicated for the treatment of adult patients with:• ph+ acute lymphoblastic leukaemia (all) with resistance or intolerance to prior therapy. dasatinib accord is indicated for the treatment of paediatric patients with:• newly diagnosed ph+ all in combination with chemotherapy.

Europäische Union - Isländisch - EMA (European Medicines Agency)

accord healthcare s.l.u. - sorafenib tosilate - carcinoma, hepatocellular; carcinoma, renal cell - Æxlishemjandi lyf - 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.

Europäische Union - Isländisch - EMA (European Medicines Agency)

accord healthcare s.l.u. - plerixafor - multiple myeloma; hematopoietic stem cell transplantation - Ónæmisörvandi, - 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.

Europäische Union - Isländisch - EMA (European Medicines Agency)

accord healthcare s.l.u. - dímetýl fúmarat - multiple sclerosis, relapsing-remitting; multiple sclerosis - Ónæmisbælandi lyf - dimethyl fumarate accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).

Europäische Union - Isländisch - EMA (European Medicines Agency)

accord healthcare s.l.u. - degarelix acetate - blöðruhálskirtli - 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.

Europäische Union - Isländisch - EMA (European Medicines Agency)

accord healthcare s.l.u. - bortezomib - mergæxli - Æxlishemjandi lyf - bortezomib hvötum eitt og sér eða saman með mjög liposomal doxórúbicíns eða leiðbeina er ætlað fyrir meðferð fullorðinn sjúklinga með versnandi margar forráðamenn sem hafa fengið að minnsta kosti áður en 1 meðferð og hver hefur þegar tekið eða eru ekki við hæfi fyrir skurðaðgerðir stafa klefi ígræðslu. bortezomib hvötum ásamt melfalan og prednisone er ætlað fyrir meðferð fullorðinn sjúklinga með áður ómeðhöndlað margar forráðamenn sem eru ekki hæf til hár‑skammt lyfjameðferð með skurðaðgerðir stafa klefi ígræðslu. bortezomib hvötum ásamt leiðbeina, eða með leiðbeina og dauða, er ætlað til að framkalla meðferð fullorðinn sjúklinga með áður ómeðhöndlað margar forráðamenn sem eru rétt fyrir hár‑skammt lyfjameðferð með skurðaðgerðir stafa klefi ígræðslu. bortezomib hvötum ásamt rítúxímab, cýklófosfamíði, doxórúbicíns og prednisone er ætlað fyrir meðferð fullorðinn sjúklinga með áður ómeðhöndlað skikkju eitlaæxli sem eru ekki við hæfi fyrir skurðaðgerðir stafa klefi ígræðslu.

Europäische Union - Isländisch - EMA (European Medicines Agency)

accord healthcare s.l.u. - azasitidín - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - Æxlishemjandi lyf - azacitidine hvötum er ætlað fyrir meðferð fullorðinn sjúklingum sem eru ekki hæf til skurðaðgerðir stafa klefi ígræðslu (hsct) með:- millistig-2 og hár-hættu myelodysplastic heilkennum (stýrð útgjöld) í samræmi við alþjóða bata skora kerfi (ipss),- langvarandi myelomonocytic hvítblæði (cmml) með 10-29 % marrow blastfrumur án mergfrumnafjölgun röskun,- bráð merg hvítblæði (aml) með 20-30 % blastfrumur og margar-ætt dysplasia, samkvæmt heiminum heilsu fyrirtækisins (sem) flokkun,- aml með >30% marrow blastfrumur samkvæmt sem flokkun.