FrancophonIA/ELRC3.0 huggingface dataset:
English: The in vivo micronucleus test showed that gilteritinib has a potential to induce micronuclei in mice.
Danish: Mikronukleusanalysen in vivo viste, at gilteritinib har et potentiale for at inducere mikronukleus i mus.
English: - The other ingredients are: mannitol (E421), hydroxypropylcellulose, low-substituted hydroxypropylcellulose, magnesium stearate, hypromellose, talc, macrogol, titanium dioxide, iron oxide yellow (E172).
Danish: - Øvrige indholdsstoffer: mannitol (E421), hydroxypropylcellulose, lav-substitueret hydroxypropylcellulose, magnesiumstearat, hypromellose, talcum, macrogol, titandioxid, jernoxid, gul (E172).
English: Women of childbearing potential are recommended to use effective contraception (methods that result in less than 1% pregnancy rates) during and up to 6 months after treatment.
Danish: Kvinder i den fertile alder anbefales at bruge sikker prævention (metoder, der resulterer i graviditetsrater på mindre end 1 %) under og i op til 6 måneder efter behandlingen.
English: A majority of patients had AML with intermediate risk cytogenetics (73%), 10% had unfavourable, 1.3% had favourable and 15.6% had unclassified cytogenetics.
Danish: Størstedelen af patienterne havde AML med intermediær cytogenetisk risiko (73 %), 10 % havde høj risiko, 1,3 % havde favorabel og 15,6 % havde uklassificeret cytogenetik.
English: Patients randomised to the gilteritinib arm had significantly longer survival compared to the chemotherapy arm (HR 0.637; 95% CI 0.490 - 0.830; 1 sided p-value: 0.0004).
Danish: De patienter, der blev randomiseret til gilteritinib-gruppen havde signifikant længere overlevelse sammenlignet med kemoterapigruppen (HR 0,637; 95 % CI 0,490 - 0,830; 1-sidet p-værdi: 0,0004).
English: Each film-coated tablet contains 40 mg gilteritinib (as fumarate).
Danish: Hver filmovertrukket tablet indeholder 40 mg gilteritinib (som fumarat).
English: Caution is warranted in patients with relevant cardiac history.
Danish: Der bør udvises forsigtighed hos patienter med relevant hjerteanamnese.
English: Co-administration of CYP3A/P-gp inducers may lead to decreased gilteritinib exposure and consequently a risk for lack of efficacy.
Danish: Samtidig administration af CYP3A/P-gp-induktorer kan føre til lavere eksponering for gilteritinib og dermed en risiko for manglende virkning.
English: Gilteritinib is primarily metabolised by CYP3A enzymes, which can be induced or inhibited by a number of concomitant medicinal products.
Danish: Gilteritinib metaboliseres primært af CYP3A-enzymer, som kan induceres eller hæmmes af en række samtidigt administrerede lægemidler.
English: If it occurs, your doctor will monitor you and may give you a medicine to treat your condition.
Danish: Hvis det opstår, vil lægen følge dig og måske give dig medicin til behandling af denne tilstand.
English: Your doctor will monitor you, may pause your treatment and/or may give you a medicine to treat your condition.
Danish: Lægen vil holde øje med dig og kan sætte behandlingen på pause og/eller kan give dig medicin til behandling af tilstanden.
English: Gilteritinib undergoes first-order absorption with an estimated absorption rate (ka) of 0.43 h-1 with a lag time of 0.34 hours based on population PK modelling.
Danish: Gilteritinib gennemgår førsteordens-absorption med en estimeret absorptionsrate (ka) på 0,43 t med en tidsforsinkelse på 0,34 timer baseret på en populations-farmakokinetisk model.
English: Gilteritinib plasma concentrations declined in a bi-exponential manner with a population mean estimated half-life of 113 hours.
Danish: Plasmakoncentrationerne af gilteritinib faldt bieksponentielt med en estimeret gennemsnitlig halveringstid for populationen på 113 timer.
English: Nervous system disorders
Danish: Nervesystemet Svimmelhed
English: Dizziness has been reported in patients taking Xospata and should be considered when assessing a patient's ability to drive or use machines (see section 4.8).
Danish: Der er rapporteret svimmelhed hos patienter, der tager Xospata, og dette skal tages med i overvejelserne ved vurdering af en patients evne til at føre motorkøretøj og betjene maskiner (se pkt.
English: Gilteritinib is not an inhibitor or inducer of CYP3A4 or and inhibitor of MATE1 in vivo.
Danish: Gilteritinib er ikke en hæmmer eller induktor af CYP3A4 eller en hæmmer af MATE1 in vivo.
English: Therefore, concomitant use of gilteritinib with strong CYP3A4/P-gp inducers should be avoided (see section 4.5).
Danish: Derfor skal samtidig brug af gilteritinib og stærke CYP3A4/P-gp-induktorer undgås (se pkt.
English: Gilteritinib inhibits FLT3 receptor signalling and proliferation in cells exogenously expressing FLT3 including FLT3-ITD, FLT3-D835Y, and FLT3-ITD-D835Y, and it induced apoptosis in leukemic cells expressing FLT3-ITD.
Danish: Gilteritinib hæmmer FLT3-receptorsignalering og -proliferation i celler, der udtrykker FLT3mutationer eksogent, herunder FLT3-ITD, FLT3-D835Y og FLT3-ITD-D835Y, og det inducerer apoptose i leukæmiceller, der udtrykker FLT3-ITD.
English: • Educational tool targeting prescribers o Educational tool targeting prescribers: - Information on Xospata, including the approved indication according to the SmPC.
Danish: • Uddannelsesredskab rettet mod ordinerende læger o Uddannelsesredskab rettet mod ordinerende læger: - Information omkring Xospata, inklusive den godkendte indikation i forhold til produktresuméet.
English: While the study included patients with various AML-related cytogenetic abnormalities, patients with acute promyelocytic leukaemia (APL) or therapy-related AML were excluded.
Danish: Studiet inkluderede patienter med forskellige AML-relaterede cytogenetiske anormaliteter, mens patienter med akut promyelocytisk leukæmi (APL) eller behandlings-relateret AML var ekskluderet.
English: Talk to your doctor, pharmacist or nurse before taking Xospata: - if you have a heart rhythm disorder, such as an irregular heartbeat or a condition called QT prolongation (see section 4.
Danish: Kontakt lægen, apotekspersonalet eller sygeplejersken, før du tager Xospata: - hvis du får en forstyrrelse i hjerterytmen, såsom uregelmæssigt hjerteslag eller en tilstand, der kaldes QT-forlængelse (se afsnit 4 - Bivirkninger).
English: Median in months (95% CI) Hazard Ratio (95% CI) p-value (1-sided) 1 year survival rate, % (95% CI)
Danish: Median i måneder (95 % CI) Hazard ratio (95 % CI) p-værdi (1-sidet)
English: Fertility There are no data on the effect of gilterinitib on human fertility.
Danish: Fertilitet Der er ingen data om virkningen af gilteritinib på fertiliteten hos mennesker.
English: In dogs, positive faecal occult blood at 10 mg/kg and higher, a decrease in the blood calcium concentration at 30 mg/kg, and salivation and an increase followed by a decrease in the blood calcium concentration at 100 mg/kg were observed.
Danish: I hunde sås positivt fækalt okkult blod ved 10 mg/kg og derover, et fald i calciumkoncentrationen i blodet ved 30 mg/kg samt spytsekretion og en stigning efterfulgt af et fald i calciumkoncentrationen i blodet ved 100 mg/kg.
English: Xospata should be interrupted in patients who have a QTcF >500 msec (see section 4.2).
Danish: Xospata skal afbrydes hos patienter, der har en QTcF >500 ms (se pkt.
English: These may be signs of a condition called differentiation syndrome (may affect up to 1 in 10 people).
Danish: Dette kan være tegn på en tilstand, der kaldes differentieringssyndrom (kan forekomme hos op til 1 ud af 10 personer).
English: - Heart rhythm problems (QT prolongation).
Danish: - Problemer med hjerterytmen (QT-forlængelse).
English: Gilteritinib as an inhibitor or inducer
Danish: Gilteritinib som en hæmmer eller induktor
English: - Description of the signs and symptoms of differentiation syndrome.
Danish: - Beskrivelse af tegn og symptomer på differentieringssyndrom.
English: Of the 319 patients treated with Xospata in the clinical studies, 0.6% experienced posterior reversible encephalopathy syndrome (PRES).
Danish: Af de 319 patienter, der blev behandlet med Xospata i kliniske studier, fik 0,6 % posterior reversibelt encefalopati-syndrom (PRES).
English: The most frequent adverse reactions with gilteritinib were blood creatine phosphokinase increased (93.4%), alanine aminotransferase (ALT) increased (82.1%), aspartate aminotransferase (AST) increased (80.6%), blood alkaline phosphatase increased (68.7%), diarrhoea (35.1%), fatigue (30.4%), nausea (29.8%), constipation (28.2%), cough (28.2%), peripheral oedema (24.1%), dyspnea (24.1%), dizziness (20.4%), hypotension (17.2%), pain in extremity (14.7%), asthenia (13.8%), arthralgia (12.5%) and myalgia (12.5%).
Danish: De hyppigste bivirkninger med gilteritinib var forhøjet kreatinphosphokinase i blodet (93,4 %), forhøjet alaninaminotransferase (ALAT) (82,1 %), forhøjet aspartataminotransferase (ASAT) (80,6 %), forhøjet alkalisk phosphatase i blodet (68,7 %), diarré (35,1 %), træthed (30,4 %), kvalme (29,8 %), konstipation (28,2 %), hoste (28,2 %), perifert ødem (24,1 %), dyspnø (24,1 %), svimmelhed (20,4 %), hypotension (17,2 %), smerter i ekstremiteterne (14,7 %), asteni (13,8 %), artralgi (12,5 %) og myalgi (12,5 %).
English: • Interrupt gilteritinib until toxicity resolves or improves to Grade 1a.
Danish: • Afbryd gilteritinib, indtil toksiciteten er forsvundet eller forbedret til grad 1
English: • Interrupt gilteritinib until pancreatitis is resolved.
Danish: • Afbryd gilteritinib, indtil pancreatitis-sygdommen er ophørt.
English: If a dose is missed or not taken at the usual time, the dose should be administered as soon as possible on the same day, and patients should return to the normal schedule the following day.
Danish: Hvis en dosis bliver glemt eller ikke bliver taget på det sædvanlige tidspunkt, skal dosis tages så hurtigt som muligt den samme dag, og patienterne skal vende tilbage til det normale doseringstidspunkt dagen efter.
English: Therefore, concomitant use of gilteritinib with these products should be avoided unless use is considered essential for the care of the patient (see section 4.5).
Danish: Derfor skal samtidig anvendelse af gilteritinib og disse midler undgås, medmindre anvendelsen anses for afgørende for behandlingen af patienten (se pkt.
English: In vitro experiments demonstrated that gilteritinib is a P-gp substrate and may potentially inhibit BCRP and P-gp in the small intestine, OCT1 in the liver at clinically relevant concentrations (see section 4.5).
Danish: In vitro-eksperimenter har påvist, at gilteritinib er et P-gp-substrat og kan potentielt hæmme BCRP og P-gp i tyndtarmen og OCT1 i leveren i klinisk relevante koncentrationer (se pkt.
English: In this study, 371 patients were randomised in a 2:1 ratio to receive gilteritinib or one of the following salvage chemotherapies (247 in the gilteritinib arm and 124 in the salvage chemotherapy arm):
Danish: I dette studie blev 371 patienter randomiseret i forholdet 2:1 til at få gilteritinib eller en af følgende salvage-kemoterapier (247 i gilteritinib-gruppen og 124 i gruppen, der fik salvage-kemoterapi):
English: Patients included were relapsed or refractory after first line AML therapy and were stratified by response to prior AML treatment and preselected chemotherapy i.e. high or low intensity.
Danish: Inkluderede patienter var recidiverende eller refraktær efter første linje AML-behandling, og var inddelt efter respons på tidligere AML-behandling og forudvalgt kemoterapi dvs. høj eller lav intensitet.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkninger opstillet efter sværhedsgrad.
English: Prior to treatment with gilteritinib, 39.4% of patients had primary refractory AML and the majority of these patients were classified as refractory after 1 cycle of chemotherapy induction treatment, 19.7% had relapsed AML after an allogeneic haematopoietic stem cell transplant (HSCT) and 41% had relapsed AML with no allogeneic HSCT.
Danish: Inden behandling med gilteritinib havde 39,4 % af patienterne primær refraktær AML og størstedelen af disse patienter var klassificeret som refraktær efter første cyklus af induktionskemoterapibehandling, 19,7 % havde recidiverende AML efter en allogen hæmatopoietisk stamcelletransplantation (HSCT), og 41 % havde recidiverende AML uden allogen HSCT.
English: Κύπρος Ελλάδα
Danish: Κύπρος
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen, apotekspersonalet eller sygeplejersken, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
English: IMPORTANT SAFETY INFORMATION FOR PATIENTS Xospata may cause serious side effects, including differentiation syndrome.
Danish: Xospata kan forårsage alvorlige bivirkninger, herunder differentieringssyndrom.
English: If Xospata is re-introduced at a reduced dose, ECG should be performed after 15 days of dosing, and prior to the start of the next three subsequent months of treatment.
Danish: Hvis Xospata genoptages med nedsat dosis, skal der tages et EKG efter 15 dages dosering og inden starten på de tre efterfølgende måneder i behandlingen.
English: Physician educational material:
Danish: Uddannelsesmateriale til læger:
English: Xospata may be re-initiated in patients following haematopoietic stem cell transplantation (HSCT) (see Table 1).
Danish: Xospata kan genoptages hos patienter efter hæmatopoietisk stamcelletransplantation (HSCT) (se tabel
English: A population pharmacokinetic analysis was performed to evaluate the impact of intrinsic and extrinsic covariates on the predicted exposure of gilteritinib in patients with relapsed or refractory AML.
Danish: Der blev udført en farmakokinetisk populationsanalyse for at evaluere indvirkningen af interne og eksterne kovariater på den forventede eksponering af gilteritinib hos patienter med recidiverende eller refraktær AML.
English: Titanium dioxide Iron oxide yellow (E172)
Danish: Titandioxid Jernoxid, gul (E172)
English: - Posterior reversible encephalopathy syndrome (PRES).
Danish: - Posterior reversibelt encefalopati-syndrom (PRES).
English: Gilteritinib has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Danish: Gilteritinib er ikke undersøgt hos patienter med svær leverinsufficiens (Child-Pugh-klasse C).
English: Xospata 40 mg film-coated tablets are round, light yellow film-coated tablets with the company logo and ‘235' debossed on one side of the tablet.
Danish: Xospata 40 mg filmovertrukne tabletter er runde, lysegule filmovertrukne tabletter med firmalogo og '235' præget på den ene side af tabletten.
English: If vomiting occurs after dosing, patients should not take another dose but should return to the normal schedule the following day.
Danish: Hvis der er opkastning, efter at dosis er taget, må patienterne ikke tage endnu en dosis, men skal vende tilbage til det normale doseringstidspunkt dagen efter.
English: Gilteritinib showed suppressed foetal growth, and induced embryo-foetal deaths and teratogenicity in the embryo-foetal development studies in rats at exposure levels similar to clinical exposure levels.
Danish: Gilteritinib udviste nedsat føtal vækst og inducerede embryo-føtale dødsfald og teratogenicitet i studier af den embryo-føtale udvikling i rotter ved eksponeringsniveauer, der svarer til de kliniske eksponeringsniveauer.
English: The recommended starting dose is 120 mg gilteritinib (three 40 mg tablets) once daily.
Danish: Den anbefalede startdosis er 120 mg gilteritinib (tre 40 mg tabletter) én gang dagligt.
English: Alanine aminotransferase increased*
Danish: Lever og galdeveje Forhøjet alaninaminotransferase*
English: Round, light yellow film-coated tablet, debossed with the company logo and ‘235' on the same side.
Danish: Rund, lysegul filmovertrukket tablet, præget med firmalogo og ”235” på samme side.
English: It contains the active substance gilteritinib.
Danish: Det indeholder det aktive stof gilteritinib.
English: There have been reports of posterior reversible encephalopathy syndrome (PRES) in patients receiving Xospata (see section 4.8).
Danish: Der har været rapporter om posterior reversibelt encefalopati-syndrom (PRES) hos patienter, der fik Xospata (se pkt.
English: Gilteritinib was distributed through the breast milk to different tissues, except for the brain, of suckling rats.
Danish: Gilteritinib vidergives fra modermælken til forskellige væv, undtagen hjernen, hos diende rotter.
English: Xospata dose interruption, reduction and discontinuation recommendations in patients with relapsed or refractory AML
Danish: Anbefalinger til afbrydelse, reducering og seponering af Xospata hos patienter med recidiverende eller refraktær AML
English: Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal if not treated.
Danish: Differentieringssyndrom er forbundet med hurtig proliferation og differentiering af myeloide celler og kan være livstruende eller letalt, hvis det ikke behandles.
English: Of 319 patients treated with Xospata in the clinical studies, 11 (3%) experienced differentiation syndrome.
Danish: Ud af 319 patienter, der blev behandlet med Xospata i kliniske studier, fik 11 (3 %) differentieringssyndrom.
English: The response rate (CR/CRh) observed in Study 2215-CL-0101 in the patients who received more than 1 line of prior therapy was 21.4% and 15.7% for the 120 mg dose and the combined dose levels, respectively.
Danish: Responseraten (CR/CRh) der blev observeret i studie 2215-CL-0101 hos patienter der modtog mere end 1 tidligere linjebehandling var 21,4 % og 15,7 % for henholdsvis 120 mg dosis og de kombinerede dosisniveauer.
English: Available animal data have shown excretion of gilteritinib and its metabolites in the animal milk of lactating rats and distribution to the tissues in infant rats via the milk (see section 5.3).
Danish: Tilgængelige data fra dyr har vist, at gilteritinib og dets metabolitter bliver udskilt i dyrenes mælk hos diegivende rotter og spredes til deres afkoms væv via mælken (se pkt.
English: The supportive Phase 1/2 dose-escalation study 2215-CL-0101 included 157 patients with FLT3 mutated AML treated with either 1 or >1 prior lines of treatment in the combined dose group (i.e. 80 mg, 120 mg or 200 mg); 31.2% received 1 prior line of treatment and 68.8% received >1 prior lines of treatment.
Danish: Det understøttende fase 1/2 dosiseskalerings-studie 2215-CL-0101 inkluderede 157 patienter med FLT3-muteret AML behandlet med enten 1 eller >1 tidligere linjebehandlinger i den kombinerede dosisgruppe (dvs. 80 mg, 120 mg eller 200 mg); 31,2 % modtog 1 tidligere linjebehandling og 68,8 % modtog >1 tidligere linjebehandlinger.
English: • Resume gilteritinib at the same dose when signs and symptoms improve to Grade 2a or lower.
Danish: • Genoptag gilteritinib med samme dosis, når tegn og symptomer forbedres til grad 2
English: Differentiation syndrome can happen any time during the first 3 months of treatment from as early as 2 days after starting treatment.
Danish: Differentieringssyndrom kan opstå når som helst i løbet af de første 3 måneders behandling, så tidligt som 2 dage efter behandlingens start.
English: Gilteritinib may reduce the effects of medicinal products that target 5HT2B receptor or sigma nonspecific receptors.
Danish: Gilteritinib kan nedsætte virkningen af lægemidler, der er rettet mod 5HT2B-receptoren eller uspecifikke sigmareceptorer.
English: The effect of severe renal impairment on gilteritinib exposure has not been investigated (see section 4.2).
Danish: Effekten af svær nyreinsufficiens på eksponeringen for gilteritinib er ikke undersøgt (se pkt.
English: • Rapid weight gain
Danish: • Hurtig vægtøgning
English: • Resume treatment with gilteritinib at a reduced dose (80 mg or 120 mgb).
Danish: • Genoptag behandlingen med gilteritinib med nedsat dosis (80 mg eller 120 mg b).
English: These may be signs of a condition called differentiation syndrome (see section 4 - Possible side effects).
Danish: Dette kan være tegn på en tilstand, der kaldes differentieringssyndrom (se afsnit 4 - Bivirkninger).
English: The effect of mild hepatic impairment [as defined by NCI-ODWG] on gilteritinib exposure was also assessed using the population PK model and the results demonstrate little difference in predicted steady-state gilteritinib exposure relative to a typical patient with relapsed or refractory AML and normal liver function.
Danish: Virkningen af let leverinsufficiens [som defineret af NCI-ODWG] på eksponeringen for gilteritinib blev også vurderet ved hjælp af den populations-farmakokinetiske model, og resultaterne påviser, at der er en lille forskel i forventet gilteritinib-eksponering ved steady-state i forhold til en typisk patient med recidiverende eller refraktær AML og normal leverfunktion.
English: x 109/L and platelets ≥50 x 109/L, no evidence of extramedullary leukemia and could not have been classified as CR.
Danish: 9/l, ingen evidens for ekstramedullær leukæmi og kunne ikke være blevet klassificeret som CR.
English: Do not stop taking this medicine unless your doctor tells you to.
Danish: Hvis du holder op med at tage Xospata Du må ikke holde op med at tage dette lægemiddel, med mindre din læge siger det.
English: A dedicated renal impairment study has not been conducted to assess of the effect of renal impairment on gilteritinib pharmacokinetics.
Danish: Der er ikke blevet udført et dedikeret studie af nyreinsufficens for at vurdere nyreinsufficiensens indvirkning på gilteritinibs farmakokinetik.
English: There is no clinical experience in patients with severe renal impairment (see section 5.2).
Danish: Der er ingen klinisk erfaring med patienter med svær nyreinsufficiens (se pkt.
English: In patients with relapsed or refractory AML receiving gilteritinib 120 mg, substantial (> 90%) inhibition of FLT3 phosphorylation was rapid (within 24 hours after first dose) and sustained, as characterised by an ex vivo plasma inhibitory activity (PIA) assay.
Danish: Hos patienter med recidiverende eller refraktær AML, der fik 120 mg gilteritinib, sås en betydelig (> 90 %) hæmning af phosphoryleringen af FLT3, som både var hurtig (inden for 24 timer efter den første dosis) og vedholdende, karakteriseret ved ex vivo PIA-test (plasma inhibitory activity assay).
English: Following oral administration of gilteritinib, peak plasma concentrations are observed at a median tmax approximately between 4 and 6 hours in healthy volunteers and patients with relapsed or refractory AML.
Danish: Efter oral administration af gilteritinib ses højeste plasmakoncentration ved medianen for tmax cirka mellem 4 og 6 timer hos raske frivillige og patienter med recidiverende eller refraktær AML.
English: • Interrupt gilteritinib.
Danish: • Afbryd gilteritinib.
English: Symptoms of differentiation syndrome may recur with premature discontinuation of corticosteroid treatment.
Danish: Symptomer på differentieringssyndrom kan vende tilbage, hvis kortikosteroidbehandlingen seponeres for tidligt.
English: Effects of other medicinal products on Xospata
Danish: Virkning af andre lægemider på Xospata
English: Gilteritinib has been associated with prolonged cardiac ventricular repolarisation (QT Interval) (see sections 4.8 and 5.1).
Danish: Gilteritinib er blevet forbundet med forlænget kardiel ventrikelrepolarisering (QT-interval) (se pkt.
English: Reproductive studies in rats have shown that gilteritinib caused suppressed foetal growth, embryo-foetal deaths and teratogenicity (see section 5.3).
Danish: Reproduktionsstudier med rotter har vist, at gilteritinib forårsagede nedsat føtal vækst, embryo-føtale dødsfald og teratogenicitet (se pkt.
English: Effects of Xospata on other medicinal products
Danish: Virkning af Xospata på andre lægemider
English: • Dizziness or lightheadedness
Danish: • Svimmelhed eller ørhed
English: The median age at randomisation was 62 years (range 20 to 84 years) in the gilteritinib arm and 62 years (range 19 to 85 years) in the salvage chemotherapy arm.
Danish: Medianalderen ved randomisering var 62 år (interval 20 til 84 år) i gilteritinibgruppen og 62 år (interval 19 til 85 år) i gruppen, der fik salvage-kemoterapi.