Unjoni Ewropea - Finlandiż - EMA (European Medicines Agency)

accord healthcare s.l.u. - lakosamidi - epilepsia - epilepsialääkkeet, - 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.

Unjoni Ewropea - Finlandiż - EMA (European Medicines Agency)

accord healthcare s.l.u. - eptifibatidin - sydäninfarkti - antitromboottiset aineet - eptifibatide accord on tarkoitettu käytettäväksi asetyylisalisyylihapon ja fraktioimattoman hepariinin kanssa. eptifibatidi accord on tarkoitettu käytettäväksi estämään varhaista sydäninfarktia aikuisilla esittelee joilla oli epästabiili angina pectoris tai non-q-aaltoinfarkti, kun viimeinen episodi rintakipua esiintyy 24 tunnin sisällä ja sydänfilmi (ekg) muutoksia ja/tai sydänentsyymien kohoaminen. potilaat todennäköisesti hyötyvät eniten eptifibatidi accord-hoito on niille, joilla on suuri riski sairastua sydäninfarktiin ensimmäisten 3-4 päivää alkamisen jälkeen akuutin angina pectoris-oireita, kuten esimerkiksi ne, jotka ovat todennäköisesti tehdään varhaisessa ptca (pallolaajennus).

Unjoni Ewropea - Finlandiż - EMA (European Medicines Agency)

accord healthcare s.l.u. - vorikonatsoli - aspergillosis; candidiasis; mycoses - systeemiset sienilääkkeet, triatsolijohdokset - vorikonatsoli on laajakirjoinen, triatsoli sienilääkettä ja on tarkoitettu aikuisille ja lapsille kaksi vuotta ja yli seuraavasti:invasiivisen aspergilloosin hoito;hoito kandidemia kun potilaalla ei ole neutropeniaa;hoitoon flukonatsolille resistentti, vakavien, invasiivisten candida-infektiot (mukaan lukien c. krusei);hoito vakavien sieni-infektioiden aiheuttamia scedosporium. ja fusarium spp. voriconazole accord tulee annostella pääasiallisesti potilaille, joilla on progressiivisia, mahdollisesti henkeä uhkaavia infektioita.

Unjoni Ewropea - Finlandiż - EMA (European Medicines Agency)

accord healthcare s.l.u. - pramipeksoli-dihydrokloridimonohydraatti - parkinson disease; restless legs syndrome - parkinson-lääkkeet - pramipexole accord on tarkoitettu aikuisille idiopaattisen parkinsonin taudin oireiden, yksinään (ilman levodopaa) tai yhdessä levodopan, i. taudin kulun kautta myöhäisiin vaiheisiin, jolloin levodopan vaikutus heikkenee tai tulee epäjohdonmukaisiksi ja terapeuttisen vaikutuksen vaihtelut ilmenevät (annoksen lopettaminen tai "on-off" -vaihtelut).

Unjoni Ewropea - Finlandiż - EMA (European Medicines Agency)

accord healthcare s.l.u. - degarelix acetate - prostatiset kasvaimet - 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.

Unjoni Ewropea - Finlandiż - EMA (European Medicines Agency)

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

Unjoni Ewropea - Finlandiż - EMA (European Medicines Agency)

accord healthcare s.l.u. - ibandronihappo - wounds and injuries; breast diseases; neoplastic processes; calcium metabolism disorders; water-electrolyte imbalance - lääkkeet luusairauksien hoitoon - ibandronihappo on tarkoitettu aikuisille forprevention luustoon liittyvien tapahtumien (patologiset murtumat tai luustoon liittyvät komplikaatiot, jotka vaativat sädehoitoa tai leikkausta) estoon potilailla, joilla on rintasyöpä ja luustometastaaseja. kasvainten aiheuttaman hyperkalsemian hoito kanssa tai ilman etäpesäkkeitä. osteoporoosin hoito postmenopausaalisilla naisilla joilla on suurentunut murtumien riski (ks. kohta 5. vähentää nikamamurtumien riskiä on osoitettu, tehoa on reisiluun kaulan murtumia ei ole osoitettu.

Unjoni Ewropea - Finlandiż - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinibi - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinibi - 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. paitsi äskettäin diagnosoitu kroonisen vaiheen kml, ei ole kontrolloituja tutkimuksia, jotka osoittaisivat kliinistä tehoa tai eloonjäämisetua näissä sairauksia. .

Unjoni Ewropea - Finlandiż - EMA (European Medicines Agency)

accord healthcare s.l.u. - rivaroksabaani - acute coronary syndrome; coronary artery disease; peripheral arterial disease; venous thromboembolism; stroke; atrial fibrillation; pulmonary embolism - antitromboottiset aineet - laskimotromboembolian (vte) ehkäisy aikuisilla potilailla, jotka saavat elektiivisen lonkan tai polven korvaavan leikkauksen. hoito syvä laskimotukos (dvt) ja keuhkoembolian (pe), ja toistuvien dvt ja pe aikuisilla. (see section 4. 4 for haemodynamically unstable pe patients. hoito syvä laskimotukos (dvt) ja keuhkoembolian (pe), ja toistuvien dvt ja pe aikuisilla. (see section 4. 4 hemodynaamisesti epävakaa pe potilaat). 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. hoito syvä laskimotukos (dvt) ja keuhkoembolian (pe), ja toistuvien dvt ja pe aikuisilla. (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. hoito syvä laskimotukos (dvt) ja keuhkoembolian (pe), ja toistuvien dvt ja pe aikuisilla. (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.

Unjoni Ewropea - Finlandiż - EMA (European Medicines Agency)

accord healthcare s.l.u. - teriflunomidi - multippeliskleroosi, relapsoiva-remittoiva - immunosuppressantit, selektiiviset immunosuppressantit - 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).