Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

accord healthcare s.l.u. - kaspofungino acetatas - candidiasis; aspergillosis - antimycotics sisteminiam vartojimui - gydymo invazinių kandidozė suaugusiųjų ar vaikų populiacijos gydymui. gydymo invazinių aspergillosis suaugusiųjų ar vaikų pacientams, kurie yra neatsparūs arba netoleruoja amphotericin b, lipidų sudėtį, amphotericin b ir/arba itraconazole. atsparumą apibrėžiamas kaip progresavimo infekcija ar nesugebėjimo pagerinti po mažiausiai 7 dienas, prieš terapinės dozės efektyvus priešgrybelinis gydymas. empirinė terapija prielaidą, grybelinės infekcijos (pvz., candida ar aspergillus) febrilines, neutropaenic suaugusiųjų ar vaikų populiacijos gydymui.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

accord healthcare s.l.u. - pramipeksolio dihidrochlorido monohidratas - parkinson disease; restless legs syndrome - anti-parkinsono vaistai - pramipexole accord skiriamas suaugusiems žmonėms idiopatinės parkinsono ligos požymių ir simptomų gydymui atskirai (be levodopos) arba kartu su levodopa, i. per liga, per vėlesniuose etapuose, kai levodopos poveikis praeina arba tampa nenuosekli ir svyravimų gydomasis poveikis atsiranda (dozės pabaigos arba "on-off" svyravimų).

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinibas - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antinavikiniai vaistai - 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.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinibas - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antinavikiniai vaistai - 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.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - cukrinis diabetas, 2 tipas - narkotikai, vartojami diabetu - 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.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinibas - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinibas - 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. išskyrus naujai diagnozuota lėtinė fazė lml, nėra kontroliuojamų tyrimų rodo, klinikinės naudos ar padidėjo išgyvenamumas šių ligų. .

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

accord healthcare s.l.u. - deferasiroksas - iron overload; beta-thalassemia - visi kiti gydomieji produktai, geležies chelatinių agentų - deferasirox sutarimu skiriamas gydymas lėtinio geležies pertekliaus dėl dažnų kraujo perpylimų (≥7 ml/kg/mėnesį supakuoti raudonųjų kraujo ląstelių) sergantiems pacientams beta thalassaemia didžiųjų nuo 6 metų ir vyresni. deferasirox sutarimu taip pat nurodė, gydymas lėtinio geležies pertekliaus, dėl kraujo perpylimo, kai deferoksaminu gydymas yra kontraindikuotinas ar netinkamas šios pacientų grupės:vaikų pacientams su beta thalassaemia pagrindinis su geležies pertekliaus dėl dažnų kraujo perpylimų (≥7 ml/kg/mėnesį supakuoti raudonųjų kraujo ląstelių) metų nuo 2 iki 5 metų,suaugusiųjų ir vaikų pacientams su beta thalassaemia pagrindinis su geležies pertekliaus, nes retai kraujo perpylimų (.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

accord healthcare s.l.u. - rivaroksabanas - acute coronary syndrome; coronary artery disease; peripheral arterial disease; venous thromboembolism; stroke; atrial fibrillation; pulmonary embolism - antitromboziniai vaistai - venų tromboembolijos (vte) profilaktika suaugusiems pacientams, kuriems atliekama pasirinktinė klubo ar kelio sąnario pakeitimo operacija. gydant giliųjų venų trombozės (gvt) ir plaučių embolija (pe), prevencijos ir pasikartojančios gvt ir pe suaugusiems. (see section 4. 4 for haemodynamically unstable pe patients. gydant giliųjų venų trombozės (gvt) ir plaučių embolija (pe), prevencijos ir pasikartojančios gvt ir pe suaugusiems. (see section 4. 4 haemodynamically nestabili pe pacientų). 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. gydant giliųjų venų trombozės (gvt) ir plaučių embolija (pe), prevencijos ir pasikartojančios gvt ir pe suaugusiems. (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 ir 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. gydant giliųjų venų trombozės (gvt) ir plaučių embolija (pe), prevencijos ir pasikartojančios gvt ir pe suaugusiems. (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.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

accord healthcare s.l.u. - sorafenib tosilate - carcinoma, hepatocellular; carcinoma, renal cell - antinavikiniai vaistai - 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.

Europos Sąjunga - lietuvių - 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.