Európai Unió - magyar - 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 - antitrombotikus szerek - a vénás tromboembólia (vte) megelőzése felnőtt betegeknél, akik elektív csípő- vagy térdpótló műtéten mennek keresztül. kezelés a mélyvénás trombózis (dvt), mind a pulmonalis embolia (pe), illetve megelőzése, a visszatérő mvt, illetve pe felnőttek. (see section 4. 4 for haemodynamically unstable pe patients. kezelés a mélyvénás trombózis (dvt), mind a pulmonalis embolia (pe), illetve megelőzése, a visszatérő mvt, illetve pe felnőttek. (see section 4. 4 a hemodinamikailag instabil pe beteg). 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. kezelés a mélyvénás trombózis (dvt), mind a pulmonalis embolia (pe), illetve megelőzése, a visszatérő mvt, illetve pe felnőttek. (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 és 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. kezelés a mélyvénás trombózis (dvt), mind a pulmonalis embolia (pe), illetve megelőzése, a visszatérő mvt, illetve pe felnőttek. (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.

Európai Unió - magyar - EMA (European Medicines Agency)

accord healthcare s.l.u. - teriflunomide - a sclerosis multiplex, a relapszáló-remittáló - immunszuppresszánsok, szelektív immunszuppresszánsok - teriflunomide accord is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

Európai Unió - magyar - EMA (European Medicines Agency)

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

Európai Unió - magyar - EMA (European Medicines Agency)

accord healthcare s.l.u. - szunitinibbel - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - daganatellenes szerek - 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.

Európai Unió - magyar - 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.

Európai Unió - magyar - EMA (European Medicines Agency)

accord healthcare s.l.u. - degarelix acetate - prosztatikus daganatok - 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.

Európai Unió - magyar - EMA (European Medicines Agency)

accord healthcare s.l.u. - ivabradin-hidroklorid - angina pectoris; heart failure - cardiac terápia - tüneti kezelés a krónikus stabil angina pectorisivabradine javallt a tüneti kezelés a krónikus stabil angina pectoris, a koszorúér-betegség felnőttek a normál sinus ritmus, valamint a pulzusszám legalább 70 bpm. az ivabradin jelzi :- a felnőttek nem tudja elviselni, vagy egy ellenjavallat, hogy a béta-blokkolók - vagy kombinálva béta-blokkolók, a betegek nem megfelelően ellenőrzött optimális béta-blokkoló adag. a kezelés a krónikus szív failureivabradine jelzi a krónikus szívelégtelenség nyha ii-iv osztály szisztolés diszfunkció, a betegek a sinus ritmus, akinek a szíve arány ≥ 75 bpm, kombinálva a standard terápia beleértve a béta-blokkoló kezelés, vagy ha a béta-blokkoló-kezelés ellenjavallt vagy nem tolerálható. (lásd az 5. részt.

Európai Unió - magyar - EMA (European Medicines Agency)

accord healthcare s.l.u. - az entekavir - hepatitis b, krónikus - vírusellenes szerek szisztémás alkalmazásra - 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. , dekompenzált májbetegségben. mindkét kompenzált, dekompenzált májbetegségben, ez a jelölés alapja a klinikai adat a nukleozid naiv betegek hbeag pozitív, valamint a hbeag negatív, hbv fertőzés. a lamivudin-refrakter hepatitisz b betegek tekintetében. az entekavir accord is jelezte, a kezelés a krónikus hbv fertőzés nukleozid naiv gyermekgyógyászati betegek 2-től.

Európai Unió - magyar - EMA (European Medicines Agency)

accord healthcare s.l.u. - icatibant acetate - angioödéma, örökletes - 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.

Európai Unió - magyar - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - diabetes mellitus, 2. típus - cukorbetegségben szedett gyógyszerek - 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.