Imatinib Actavis Evropska unija - slovenščina - EMA (European Medicines Agency)

imatinib actavis

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. učinek imatinib na izid presaditev kostnega mozga, ni bilo določeno. 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. izkušnje z imatinib pri bolnikih z mds/mpd, povezanih z pdgfr gena ponovno ureditev je zelo omejena. ni kontroliranih preskušanjih, dokazujejo kliničnih koristi ali poveča preživetje pri teh bolezni.

Bexsero Evropska unija - slovenščina - EMA (European Medicines Agency)

bexsero

gsk vaccines s.r.l. - zunanjo membrano semenskih mešičkov iz neisseria meningitidis skupina b (sev nz 98/254), rekombinantne neisseria meningitidis skupina b fhbp fuzijski protein, rekombinantne neisseria meningitidis skupina b nada beljakovin, rekombinantne neisseria meningitidis skupina b nhba fuzijski protein - meningitis, meningokokni - meningococcal cepiva - aktivna imunizacija proti invazivni bolezni, ki jo povzročajo sevi neisseria meningitidis serogroup-b.

Glivec Evropska unija - slovenščina - EMA (European Medicines Agency)

glivec

novartis europharm limited - imatinib - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - antineoplastična sredstva - glivec 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-pdgfra rearrangement. učinek glivec na izid kostnega mozga presaditev ni bilo določeno. glivec is indicated for: , 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. bolniki, ki imajo nizko ali zelo nizko tveganje za ponovitev, ne bi smel imeti adjuvant treatment;, zdravljenje odraslih bolnikov z unresectable dermatofibrosarcoma protuberans (dfsp) in odraslih bolnikih s ponavljajočimi in / ali metastatskim dfsp, ki niso primerni za operacijo. v izobraževanju odraslih in pediatričnih bolnikov, učinkovitost glivec je na podlagi splošno hematoloških in postopek citogenetske stopnjo odziva in napredovanje-free survival v cml, na hematoloških in postopek citogenetske stopnjo odziva, v ph+ all, mds / mpd, na hematoloških stopnjo odziva, v hes / cel in na cilj stopnjo odziva pri odraslih bolnikih z unresectable in / ali metastatskim bistvo in dfsp in na ponovitev-free survival v adjuvant bistvo. izkušnje z glivec pri bolnikih z mds / mpd, povezanih z pdgfr gena ponovno ureditev je zelo omejeno (glej poglavje 5. razen v novo diagnozo kronične faze cml, ni kontroliranih preskušanjih, dokazujejo kliničnih koristi ali poveča preživetje pri teh bolezni.

Improvac Evropska unija - slovenščina - EMA (European Medicines Agency)

improvac

zoetis belgium sa - synthetic peptide analogue of gnrf conjugated to diptheria toxoid - imunologija za suidae - male pigs (from 8 weeks of age); female pigs (from 14 weeks of age) - male pigs:induction of antibodies against gnrf to produce a temporary immunological suppression of testicular function. for use as an alternative to physical castration for the reduction of boar taint caused by the key boar taint compound androstenone, in entire male pigs following the onset of puberty. drugi ključni dejavnik merjasca taint, skatole, se lahko tudi zmanjša kot posredni učinek. agresiven in spolne (montaža) vedenje so zmanjšane tudi. female pigs:induction of antibodies against gnrf to produce a temporary immunological suppression of ovarian function (suppression of oestrus) in order to reduce the incidence of unwanted pregnancies in gilts intended for slaughter, and to reduce the associated sexual behaviour (standing oestrus).

Masivet Evropska unija - slovenščina - EMA (European Medicines Agency)

masivet

ab science s.a. - masitinib mesilate - antineoplastična sredstva - psi - zdravljenje neresetabilnih tumorjev mastocitov (razred 2 ali 3) s potrjenim mutiranim c-kit tirozin-kinaznim receptorjem.

Purevax Rabies Evropska unija - slovenščina - EMA (European Medicines Agency)

purevax rabies

boehringer ingelheim vetmedica gmbh - virus vcp65 - imunologija - mačke - aktivna imunizacija mačk, starih 12 tednov ali več, za preprečevanje smrtnosti zaradi okužbe z steklino. začetek imunosti: 4 tedne po osnovnem cepljenju. trajanje imunitete po primarnem cepljenju: 1 leto. trajanje imunosti po ponovnem cepljenju: 3 leta.

Vectormune ND Evropska unija - slovenščina - EMA (European Medicines Agency)

vectormune nd

ceva-phylaxia co. ltd. - celični rekombinantni herpesvirus rekombinantnega herpesa (rhvt / nd), ki eksprimira fuzijski protein virusa bolezni atipične kokošje d-26 lentogeni sev - immunologicals za aves, Živo virusna cepiva - chicken; embryonated eggs - za aktivno imunizacijo dne 18. dan-stare embryonated kokošja jajca ali en dan starih piščancev za zmanjšanje umrljivosti in kliničnih znakov, ki jih povzroča virus atipične kokošje in zmanjšanje umrljivosti, klinični znaki in poškodb, ki jih povzročajo marek je bolezen, virus z fenotip "sovražno".

Ioa Evropska unija - slovenščina - EMA (European Medicines Agency)

ioa

n.v. organon - nomegestrol acetat, estradiol - kontracepcija - spolni hormoni in zdravila genitalni sistem, - peroralna kontracepcija.

Tagrisso Evropska unija - slovenščina - EMA (European Medicines Agency)

tagrisso

astrazeneca ab - osimertinib mesilate - karcinom, pljučni pljuč - druga zdravila z delovanjem na novotvorbe agenti, protein kinaza inhibitorji - tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations- the first-line treatment of adult patients nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc. tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations. - the first-line treatment of adult patients with locally advanced or metastatic nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc.