Evrópusambandið - eistneska - EMA (European Medicines Agency)

accord healthcare s.l.u. - posakonasool - mycoses - antimükoosid süsteemseks kasutamiseks - 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. refractoriness defineeritakse kui infektsiooni progresseerumise või suutmatus parandada pärast vähemalt 7 päeva enne ravi annuste efektiivne seenhaiguste ravi. posaconazole kokkuleppel on näidatud ka profülaktika invasiivsete seeninfektsioonide järgmistel patsientidel: saavate patsientide vähendamine-induktsioon kemoteraapia ägeda müeloidse leukeemia (aml) või müelodüsplastiline sündroom (mds) oodatav tulemus on pikaajaline neutropenia ja kellel on suur risk haigestuda invasiivsete seeninfektsioonide;vereloome tüvirakkude siirdamist (hsct) saajad, kes saavad suures annuses immunosupressiivsed ravi hülgamisreaktsioon ja kellel on suur risk haigestuda invasiivsete seeninfektsioonide.

Evrópusambandið - eistneska - EMA (European Medicines Agency)

accord healthcare s.l.u. - tigecycline - soft tissue infections; intraabdominal infections; bacterial infections; skin diseases, infectious - antibacterials süsteemseks kasutamiseks, - tygecycline kokkuleppel on näidustatud täiskasvanutel ja lastel alates vanusest kaheksa aastat ravi järgmiste infektsioonide raviks (vt lõigud 4. 4 ja 5. 1):keeruline naha ja pehmete kudede infektsioonid (cssti), välja arvatud diabeetiline jalg infektsioonid (vt lõik 4. 4)keeruline intra-kõhuõõne infektsioonid (ciai)tygecycline accord tuleks kasutada ainult olukordades, kus alternatiivseid antibiootikumid ei sobi (vt lõigud 4. 4, 4. 8 ja 5. tuleks arvesse võtta ametlikke juhiseid sobiva kasutada antibakteriaalseid aineid.

Evrópusambandið - eistneska - EMA (European Medicines Agency)

accord healthcare s.l.u. - rivaroksabaan - acute coronary syndrome; coronary artery disease; peripheral arterial disease; venous thromboembolism; stroke; atrial fibrillation; pulmonary embolism - antitrombootilised ained - täiskasvanud patsientidel, kellele tehti plaaniline puusa- või põlveliigese asendamise operatsiooni venoosse trombemboolia (vte) ennetamine. ravi süvaveenide tromboos (dvt) ja kopsuarteri emboolia (pe), ning ennetamine korduvate digi-tv ja pe täiskasvanutel. (see section 4. 4 for haemodynamically unstable pe patients. ravi süvaveenide tromboos (dvt) ja kopsuarteri emboolia (pe), ning ennetamine korduvate digi-tv ja pe täiskasvanutel. (see section 4. 4 haemodynamically ebastabiilne pe patsientidel). 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. ravi süvaveenide tromboos (dvt) ja kopsuarteri emboolia (pe), ning ennetamine korduvate digi-tv ja pe täiskasvanutel. (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 ja 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. ravi süvaveenide tromboos (dvt) ja kopsuarteri emboolia (pe), ning ennetamine korduvate digi-tv ja pe täiskasvanutel. (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.

Evrópusambandið - eistneska - EMA (European Medicines Agency)

accord healthcare s.l.u. - sunitiniib - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - antineoplastilised ained - 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.

Evrópusambandið - eistneska - EMA (European Medicines Agency)

accord healthcare s.l.u. - icatibant acetate - angioödeem, pärilik - 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.

Evrópusambandið - eistneska - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - suhkurtõbi, tüüp 2 - diabeetis kasutatavad ravimid - 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.

Evrópusambandið - eistneska - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, vildagliptin - suhkurtõbi, tüüp 2 - diabeetis kasutatavad ravimid - vildagliptin/metformin hydrochloride accord is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:- in patients who are inadequately controlled with metformin hydrochloride alone. - in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. - in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 ja 5. 1 erinevate kombinatsioonide kohta kättesaadavate andmete osas).

Evrópusambandið - eistneska - EMA (European Medicines Agency)

accord healthcare s.l.u. - sorafenib tosilate - carcinoma, hepatocellular; carcinoma, renal cell - antineoplastilised ained - 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.

Evrópusambandið - eistneska - EMA (European Medicines Agency)

accord healthcare s.l.u. - teriflunomide - sclerosis multiplex, relapsing-remitting - immunosuppressants, valikuline immunosuppressants - 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).

Evrópusambandið - eistneska - 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.