Imatinib Koanaa Den Europæiske Union - dansk - 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 - antineoplastiske midler - 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. patienter, der har en lav eller meget lav risiko for tilbagefald, bør ikke modtage adjuverende behandling. 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. undtagen i nyligt diagnosticeret kronisk cml-fase, der er ingen kontrollerede undersøgelser, der påviser en klinisk fordel eller øget overlevelse for disse sygdomme.

Ziagen Den Europæiske Union - dansk - EMA (European Medicines Agency)

ziagen

viiv healthcare b.v. - abacavir - hiv infektioner - antivirale midler til systemisk anvendelse - ziagen er indiceret i antiretroviral kombinationsbehandling til behandling af human immundefektvirus (hiv) infektion hos voksne, unge og børn. demonstration til fordel for ziagen er primært baseret på resultaterne af undersøgelser, der udføres med en to gange dagligt, i behandling-naive voksne patienter på en kombination terapi. før du starter behandling med abacavir, screening for transport af hla-b*5701 allel bør være udført i enhver hiv-smittet patient, uanset race. abacavir bør ikke anvendes i patienter, der er kendt for at bære hla-b*5701 allel.

Reconcile Den Europæiske Union - dansk - EMA (European Medicines Agency)

reconcile

forte healthcare limited - fluoxetin - psychoanaleptics - hunde - som hjælp til behandling af separationsrelaterede lidelser hos hunde manifesteret ved ødelæggelse og uhensigtsmæssig adfærd (vokalisering og uhensigtsmæssig afføring og / eller vandladning) og kun i kombination med adfærdsmæssige modifikationsteknikker.

Conbriza Den Europæiske Union - dansk - EMA (European Medicines Agency)

conbriza

pfizer europe ma eeig - bazedoxifen - osteoporose, postmenopausale - køn hormoner og modulatorer af den genitale system, - conbriza er indiceret til behandling af postmenopausal osteoporose hos kvinder med øget risiko for brud. en signifikant reduktion i forekomsten af ​​vertebrale frakturer er blevet påvist; effekt på hoftefrakturer er ikke blevet fastslået. når du bestemme valg af conbriza eller andre behandlingsformer, herunder østrogener, for en individuel postmenopausale kvinde, bør det overvejes, menopausale symptomer, effekter på livmoder og bryst væv, og hjerte-kar-risiko og fordele.

Adrovance Den Europæiske Union - dansk - EMA (European Medicines Agency)

adrovance

n.v. organon - colecalciferol, alendronic acid (as sodium trihydrate) - osteoporose, postmenopausale - narkotika til behandling af knoglesygdomme - behandling af postmenopausal osteoporose hos patienter med risiko for vitamin d-insufficiens. adrovance reducerer risikoen for vertebrale og hoftebrud.

Fosavance Den Europæiske Union - dansk - EMA (European Medicines Agency)

fosavance

n.v. organon - alendronsyre, colecalciferol - osteoporose, postmenopausale - narkotika til behandling af knoglesygdomme - behandling af postmenopausal osteoporose hos patienter med risiko for vitamin d-insufficiens. fosavance reducerer risikoen for vertebrale og hoftebrud.