Eiropas Savienība - latviešu - EMA (European Medicines Agency)

novartis europharm limited - asciminib hydrochloride - leikēmija, mielogēns, hronisks, bcr-abl pozitīvs - antineoplastiski līdzekļi - scemblix is indicated for the treatment of adult patients with philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (ph+ cml cp) previously treated with two or more tyrosine kinase inhibitors (see section 5.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

csl behring gmbh - etranacogene dezaparvovec - hemophilia b - other hematological agents - treatment of severe and moderately severe haemophilia b (congenital factor ix deficiency) in adult patients without a history of factor ix inhibitors.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

sandoz gmbh - natalizumab - multiple sclerosis, relapsing-remitting; multiple sclerosis - imūnsupresanti - tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (rrms) for the following patient groups: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 un 5. 1), or, patients with rapidly evolving severe rrms defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain magnetic resonance imaging (mri) or a significant increase in t2 lesion load as compared to a previous recent mri.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

sanofi winthrop industrie - teriflunomīds - multiplā skleroze - selective immunosuppressants - aubagio 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).

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

bayer ag - aflibercept - wet macular degeneration; macular edema; diabetes complications - oftalmoloģiskie līdzekļi - eylea ir norādīts ārstēšanai pieaugušajiem:neovascular (wet) vecuma saistīto makulas deģenerāciju (amd);redzes traucējumiem, jo makulas tūska vidusskolas tīklenes vēnu oklūzija (filiāle rvo vai centrālās rvo);redzes traucējumiem, jo diabētiskā makulas tūska (dme);redzes traucējumiem, jo tuvredzīgs choroidal neovascularisation (tuvredzīgs cnv).

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

csl behring gmbh - cilvēka normālais imūnglobulīns (scig) - imūndeficīta sindromi - un imūnglobulīni, - replacement therapy in adults, children and adolescents (0-18 years) in:- primary immunodeficiency syndromes with impaired antibody production (see section 4. - secondary immunodeficiencies (sid) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (psaf)* or serum igg level of.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

actavis group ptc ehf - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis is indicated for the treatment of: , 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;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult 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-pdgfr rearrangement;, 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. spēkā imatinib par rezultātiem, kaulu smadzeņu transplantācija nav noteikta. imatinib actavis is indicated for: , 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. pieredze ar imatinib pacientiem ar mds/mpd, kas saistīti ar pdgfr gēnu re-kārtība ir ļoti ierobežota. nav kontrolētos pētījumos, kas liecina par klīnisko ieguvumu vai palielina izdzīvošanas šo slimību.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

takeda pharma a/s - alogliptin, pioglitazone - cukura diabēts, 2. tips - drugs used in diabetes, combinations of oral blood glucose lowering drugs - incresync is indicated as a second- or third-line treatment in adult patients aged 18 years and older with type-2 diabetes mellitus: , as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on pioglitazone alone, and for whom metformin is inappropriate due to contraindications or intolerance;, in combination with metformin (i. trīskāršās kombinācijas terapija), kā palīglīdzekli, lai diētu un vingrinājumiem, lai uzlabotu glycaemic kontroles pieaugušiem pacientiem (īpaši lieko svaru, pacientiem) nepietiekami kontrolē par to maksimālā pieļaujama devu metformīns un pioglitazone. turklāt incresync var izmantot, lai aizstātu atsevišķas tabletes alogliptin un pioglitazone šajos pieaugušo pacientiem, kuri ir 18 gadus veci un vecāki ar 2. tipa cukura diabētu, kas jau tiek ārstēti ar šo kombināciju. pēc tam, kad sākta terapija ar incresync, pacientiem būtu jāpārskata pēc trīs līdz seši mēneši, lai novērtētu atbilstību ārstēšanas e. samazinājums hba1c). pacientiem, kas nespēj izrādīt pienācīgu atbildi, incresync būtu jāpārtrauc. Ņemot vērā potenciālos riskus, ar ilgstošu pioglitazone terapija, prescribers jāapstiprina turpmāk kārtējās atsauksmes, ka labā incresync ir saglabāta (skatīt 4. iedaļu.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

takeda pharma a/s - fentanila citrāts - pain; cancer - pretsāpju līdzekļi - instanyl ir indicēts sāpju novēršanai pieaugušajiem, kas jau saņem ārstēšanas opioīdu terapiju hronisku vēža sāpju ārstēšanai. izrāvienu sāpes ir pārejoša sāpju saasināšanās, kas rodas, kontrolējot pastāvīgas sāpes.  patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

intervet international bv - tildipirozīns - antiinfectives līdzekļi sistēmiskai lietošanai - pigs; cattle - 40 mg/ml šķīdums injekcijām pigstreatment un metaphylaxis cūku elpošanas ceļu slimības (srd), kas saistīti ar actinobacillus pleuropneumoniae, pasteurella multocida, bordetella bronchiseptica un haemophilus parasuis jutīgas pret tildipirosin. slimības klātbūtne ganāmpulkā jāapstiprina pirms metafilakses ieviešanas. 180 mg/ml šķīdums injekcijām cattlefor ārstēšanai un profilaksei liellopu elpošanas ceļu slimības (brd), kas saistīti ar mannheimia haemolytica, pasteurella multocida un histophilus somni jutīgas pret tildipirosin. slimības klātbūtne ganāmpulkā jāapstiprina pirms profilaktiskas ārstēšanas.