Imatinib Koanaa Eiropas Savienība - latviešu - EMA (European Medicines Agency)

imatinib koanaa

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - antineoplastiski līdzekļi - imatinib koanaa is indicated for the treatment ofadult 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. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe 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. pacienti, kuriem ir ar zemu vai ļoti zemu atkārtošanās risku, nevajadzētu saņemt palīgvielu ārstēšana. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. 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 gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. izņemot tikko diagnosticēta cml hroniskā fāzē, nav kontrolētos pētījumos, kas liecina par klīnisko ieguvumu vai palielina izdzīvošanas šo slimību.

Dasatinib Accord Eiropas Savienība - latviešu - EMA (European Medicines Agency)

dasatinib accord

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastiski līdzekļi - 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.

Dasatinib Accordpharma Eiropas Savienība - latviešu - EMA (European Medicines Agency)

dasatinib accordpharma

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastiski līdzekļi - 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.

Enrylaze Eiropas Savienība - latviešu - EMA (European Medicines Agency)

enrylaze

jazz pharmaceuticals ireland limited - crisantaspase - prekursoru šūnu limfoblastiska leikēmija-limfoma - antineoplastiski līdzekļi - enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (all) and lymphoblastic lymphoma (lbl) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to e. coli-derived asparaginase.

Padcev Eiropas Savienība - latviešu - EMA (European Medicines Agency)

padcev

astellas pharma europe b.v. - enfortumab vedotin - carcinoma, transitional cell; urologic neoplasms - antineoplastiski līdzekļi - padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor 1 or programmed death ligand 1 inhibitor.

Adenuric Eiropas Savienība - latviešu - EMA (European Medicines Agency)

adenuric

menarini international operations luxembourg s.a. (miol) - febuxostat - podagra - antigut preparāti - 80 mg spēku:hroniskas hyperuricaemia apstākļos, kad urate uzklāšanas jau ir noticis (tai skaitā vēsturē, vai klātbūtne, tophus un/vai podagras artrīta). adenuric ir norādīts pieaugušie. 120 mg stiprums:adenuric ir indicēts, lai ārstētu hronisku hyperuricaemia apstākļos, kad urate uzklāšanas jau ir noticis (tai skaitā vēsturē, vai klātbūtne, tophus un/vai podagras artrīta). adenuric ir norādīts profilaksei un ārstēšanai hyperuricaemia pieaugušo pacientiem, kam veic ķīmijterapiju haematologic ļaundabīgu audzēju pie vidēja līdz augsta riska par tumora līzes sindromu (tls). adenuric ir norādīts pieaugušie.

Evoltra Eiropas Savienība - latviešu - EMA (European Medicines Agency)

evoltra

sanofi b.v. - clofarabine - prekursoru šūnu limfoblastiska leikēmija-limfoma - antineoplastiski līdzekļi - akūtu limfoblastisku leikēmiju (visi) pediatrijas pacientiem, kuriem ir atkal vai ugunsizturīgu ir saņēmusi vismaz divas iepriekšējas terapiju ārstēšanai un ja nav citas ārstēšanas iespēja paredzēt izraisīt ilgstošu atbildi. drošība un efektivitāte tika novērtēta pētījumos ar pacientiem ≤ 21 gadus veciem pēc sākotnējās diagnostikas.

Hexavac Eiropas Savienība - latviešu - EMA (European Medicines Agency)

hexavac

sanofi pasteur msd, snc - attīrīts difterijas toxoid, attīrīts tetanus toxoid, attīrīts klepus toxoid, attīrīts klepus hemaglutinīna, b hepatīta virsmas antigēnu, inaktivēta tips 1, poliomielīta (mahoney), inaktivēta 2. tipa poliomielīta (mef 1), inaktivēta tips 3, poliomielīta (saukett), haemophilus influenzae b tipa polisaharīds - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - vakcīnas - Šī kombinētā vakcīna ir norādīta primārā un pastiprinātājs bērnu vakcinācijai pret difterija, stingumkrampji, garais klepus, b hepatīts izraisa visu zināmo apakštipu vīrusiem, poliomielīts un invazīvo sēnīšu infekciju, kas izraisa haemophilus influenzae tips b.