Imatinib Accord 유럽 연합 - 라트비아어 - EMA (European Medicines Agency)

imatinib accord

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - 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. izņemot tikko diagnosticēta cml hroniskā fāzē, nav kontrolētos pētījumos, kas liecina par klīnisko ieguvumu vai palielina izdzīvošanas šo slimību. .

Imatinib Teva 유럽 연합 - 라트비아어 - EMA (European Medicines Agency)

imatinib teva

teva b.v. - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - antineoplastic agents, protein kinase inhibitors - imatinib teva ir indicēts, lai ārstētu ofadult un pediatrijā, pacientiem ar jaunatklātiem filadelfijas hromosoma (bcr‑abl) pozitīva (ph+) hroniska mieloīda leikēmija (cml), par kurām kaulu smadzeņu transplantācijas netiek uzskatīta par pirmo rindu apstrāde. pieaugušajiem un pediatrijas pacientiem ar ph+ cml hroniskā fāzē pēc neveiksmīgas interferona‑alfa terapiju vai paātrināta posmā vai blastu krīzi. pieaugušajiem un pediatrijas pacientiem ar jaunatklātiem filadelfijas hromosoma pozitīva akūtas limfoblastiskas leikēmija (ph+) integrēta ar ķīmijterapiju. pieaugušiem pacientiem ar relapsed vai ugunsizturīgs ph+ visi kā monotherapy. pieaugušiem pacientiem ar mielodisplastiskais/myeloproliferative slimībām (mds/mpd), kas saistīti ar trombocītu-iegūti augšanas faktora receptoru (pdgfr) gēnu atkārtoti kārtība. pieaugušiem pacientiem ar progresējošu hypereosinophilic sindroms (hes) un/vai hronisku eosinophilic leikēmija (cel) ar fip1l1-pdgfra pārkārtošanas. ietekme imatinib par rezultātiem, kaulu smadzeņu transplantācija nav noteikta. imatinib teva 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.

Imbruvica 유럽 연합 - 라트비아어 - EMA (European Medicines Agency)

imbruvica

janssen-cilag international nv - ibrutinibs - lymphoma, mantle-cell; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, protein kinase inhibitors - imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl). imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with cll who have received at least one prior therapy. imbruvica as a single agent is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. imbruvica in combination with rituximab is indicated for the treatment of adult patients with wm.

Imvanex 유럽 연합 - 라트비아어 - EMA (European Medicines Agency)

imvanex

bavarian nordic a/s - modificētu vaccinia vīrusu ankara - bavarian nordic (mva-bn) vīruss - smallpox vaccine; monkeypox virus - citu vīrusu vakcīnas, - active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in adults (see sections 4. 4 un 5. izmantojot šo vakcīnu, kas būtu saskaņā ar oficiālās rekomendācijas.

Invirase 유럽 연합 - 라트비아어 - EMA (European Medicines Agency)

invirase

roche registration gmbh - saquinavir - hiv infekcijas - pretvīrusu līdzekļi sistēmiskai lietošanai - invirase indicēts hiv-1 inficētiem pieaugušiem pacientiem. invirase drīkst lietot tikai kopā ar ritonavīru un citiem pretretrovīrusu līdzekļiem.

Invokana 유럽 연합 - 라트비아어 - EMA (European Medicines Agency)

invokana

janssen-cilag international nv - canagliflozin - cukura diabēts, 2. tips - cukura diabēts - invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 un 5.

Jakavi 유럽 연합 - 라트비아어 - EMA (European Medicines Agency)

jakavi

novartis europharm limited - ruksolitinibs (fosfāts) - myeloproliferative disorders; polycythemia vera; graft vs host disease - antineoplastiski līdzekļi - myelofibrosis (mf)jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. polycythaemia vera (pv)jakavi ir norādīts ārstēšanai pieaugušiem pacientiem ar polycythaemia vera, kas ir izturīgas pret vai nepanes hydroxyurea. graft versus host disease (gvhd)jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.

Jalra 유럽 연합 - 라트비아어 - EMA (European Medicines Agency)

jalra

novartis europharm limited - vildagliptin - cukura diabēts, 2. tips - dipeptidyl peptidase 4 (dpp-4) inhibitors, drugs used in diabetes - vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. 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 un 5. 1 pieejamo datu par dažādām kombinācijām).

Jardiance 유럽 연합 - 라트비아어 - EMA (European Medicines Agency)

jardiance

boehringer ingelheim international gmbh - empagliflozin - diabetes mellitus, type 2; heart failure; renal insufficiency, chronic - cukura diabēts - type 2 diabetes mellitusjardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesfor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 un 5. of the annex. heart failurejardiance is indicated in adults for the treatment of symptomatic chronic heart failure.  chronic kidney diseasejardiance is indicated in adults for the treatment of chronic kidney disease.

Kadcyla 유럽 연합 - 라트비아어 - EMA (European Medicines Agency)

kadcyla

roche registration gmbh - trastuzumab emtansine - krūts audzējs - antineoplastiski līdzekļi - agrīna krūts vēža (ebc)kadcyla, kā viens pārstāvis, ir norādīts palīgvielu ārstēšanai pieaugušiem pacientiem ar her2 pozitīva agrīna krūts vēža, kas ir atlikusī invazīvās slimības, krūts un/vai limfmezglu, pēc neoadjuvant taxane-pamatā, un her2-mērķtiecīga terapija. metastātiska krūts vēža (mbc)kadcyla, kā viens pārstāvis, norāda ārstēšanai pieaugušiem pacientiem ar her2 pozitīvu, unresectable vietas papildu vai metastātisku krūts vēzi, kas iepriekš saņēmušas trastuzumab un taxane, atsevišķi vai kopā. pacientiem ir jābūt vai nu:kas saņemti pirms terapijas vietas papildu vai metastātiska slimība, ordeveloped slimības atkārtošanās laikā, vai sešu mēnešu laikā pabeigt palīgvielu terapija.