FrancophonIA/ELRC3.0 huggingface dataset:
English: Alternative medicinal products that do not strongly inhibit CYP3A and/or P-gp activity should be considered.
Danish: Alternative lægemidler, der ikke hæmmer CYP3A og/eller P-gp-aktivitet kraftigt, bør overvejes.
English: • Please ensure you show this card to any doctor, pharmacist or nurse for any medical treatment or at any visits to the hospital or clinic.
Danish: • Sørg for at vise dette kort til alle læger, apotekspersonale eller sygeplejersker, uanset hvilken medicinsk behandling du får, samt ved alle besøg på hospitalet eller klinikken.
English: Treatment with Xospata should be initiated and supervised by a physician experienced in the use of anti-cancer therapies.
Danish: Behandling med Xospata skal initieres og overvåges af en læge med erfaring inden for cancerbehandlinger.
English: The safety and efficacy of Xospata in children aged below 18 years has not yet been established.
Danish: Xospatas sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: Hypokalaemia or hypomagnesaemia should therefore be corrected prior to and during Xospata treatment.
Danish: Hypokaliæmi eller hypomagnesiæmi skal derfor korrigeres inden og under behandling med Xospata.
English: Gilteritinib can cause foetal harm when administered to pregnant women.
Danish: Gilteritinib kan forårsage fosterskade, når det administreres til gravide kvinder.
English: It is unknown whether gilteritinib may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method of contraception.
Danish: Det vides ikke, om gilteritinib kan reducere effekten af hormonel prævention, og derfor skal kvinder, som bruger hormonel prævention, supplere med en barriere præventionsmetode.
English: The primary efficacy endpoint for the final analysis was OS in the intent-to-treat (ITT) population, measured from the date of randomisation until death by any cause (number of events analysed was 261).
Danish: Det primære endepunkt for den endelige analyse var OS (samlet overlevelse) i intent-to-treatpopulationen (ITT-populationen) målt fra randomiseringsdatoen til død af enhver årsag (antal analyserede hændelser var 261).
English: In AML, patients develop large numbers of abnormal white blood cells.
Danish: Ved AML danner patienterne et stort antal unormale hvide blodlegemer.
English: In situations where satisfactory therapeutic alternatives do not exist, patients should be closely monitored for toxicities during administration of gilteritinib (see section 4.5).
Danish: I situationer, hvor tilfredsstillende behandlingsalternativer ikke findes, skal patienterne monitoreres tæt for toksicitet under administration af gilteritinib (se pkt.
English: CHRYSALIS study (2215-CL-0101)
Danish: CHRYSALIS studiet (2215-CL-0101)
English: Your doctor may do a test to check if you have developed PRES and will stop Xospata treatment if it is confirmed that you have PRES.
Danish: Din læge vil foretage en test for at undersøge, om du har udviklet PRES, og vil stoppe behandlingen med Xospata, hvis det bekræftes, at du har PRES.
English: Of the patients who were pre-selected to receive salvage chemotherapy, 60.5% were randomised to high intensity and 39.5% to low intensity.
Danish: Af de patienter, som på forhånd var blevet udvalgt til at modtage salvage-kemoterapi, blev 60,5 % randomiseret til høj intensitet og 39,5 % til lav intensitet.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Xospata in one or more subsets of the paediatric population in the treatment of acute myeloid leukaemia.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Xospata i en eller flere undergrupper af den pædiatriske population ved behandling af akut myeloid leukæmi.
English: If you normally take any of these medicines, your doctor might change it and prescribe a different medicine for you during your treatment with Xospata.
Danish: Hvis du normalt tager nogle af disse lægemidler, vil din læge måske ændre det og ordinere et andet lægemiddel til dig, mens du er i behandling med Xospata.
English: Film-coating Hypromellose Talc
Danish: Filmovertræk Hypromellose Talcum
English: The primary metabolites in humans include M17 (formed via N-dealkylation and oxidation), M16 and M10 (both formed via N-dealkylation) and were observed in animals.
Danish: De primære metabolitter hos mennesker inkluderer M17 (dannes via N-dealkylering og oxidering), M16 og M10 (begge dannes via N-dealkylering), og de blev set i dyr.
English: The effect of mild or moderate renal impairment was evaluated using a population pharmacokinetic model.
Danish: Effekten af let eller moderat nyreinsufficiens blev evalueret under anvendelse af en populations-farmakokinetisk model.
English: - Continue taking Xospata for as long as your doctor tells you.
Danish: - Fortsæt med at tage Xospata, så længe som din læge har anvist.
English: In vivo plasma protein binding in humans is approximately 90% and gilteritinib is primarily bound to albumin.
Danish: Bindingen af plasmaproteiner in vivo hos mennesker er cirka 90 %, og gilteritinib binder sig primært til albumin.
English: QTc interval increased by >30 msec on ECG on day 8 of cycle 1
Danish: Øget QTc-interval med >30 ms på EKG på dag 8 af cyklus 1
English: Efficacy was further supported by the rate of complete remission (CR)/complete remission with partial haematologic recovery (CRh) (Table 3, Figure 1).
Danish: Effekten blev yderligere understøttet af antallet af komplet remission (CR)/komplet remission med delvis hæmatologisk bedring (CRh) (tabel 3, figur 1).
English: Juvenile animal toxicity study
Danish: Toksicitetsstudie med juvenile dyr
English: If you use a hormonal contraceptive, you must also use a barrier method, such as a condom or a diaphragm.
Danish: Hvis du bruger hormonel prævention, skal du også bruge en barrieremetode som f.eks. kondom eller pessar.
English: Adverse reactions not observed in clinical studies, but seen in animals (safety pharmacology/repeat dose toxicity) at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:
Danish: Følgende bivirkninger er ikke observeret i kliniske studier, men er set i dyreforsøg (sikkerhedsfarmakologi/toksicitet ved gentaget dosis) efter eksponeringsniveauer, der svarer til kliniske eksponeringsniveauer, og kan muligvis være klinisk relevante:
English: Xospata may cause a heart problem called QT prolongation (may affect up to 1 in 10 people).
Danish: Xospata kan forårsage et hjerteproblem, der hedder QT-forlængelse (kan forekomme hos op til 1 ud af 10 personer).
English: • Swelling of your arms or legs
Danish: • Hævelser af arme eller ben
English: Gilteritinib blocks the action of certain enzymes (kinases) needed for the abnormal cells to multiply and grow, thus preventing the growth of the cancer.
Danish: Gilteritinib blokerer virkningen af nogle enzymer (kinaser), der er nødvendige for, at de unormale celler kan formere sig og vokse, og forhindrer dermed, at kræften vokser.
English: Median tmax was delayed 2 hours when gilteritinib was administered with a high-fat meal.
Danish: Medianen for tmax var forsinket 2 timer, når gilteritinib blev administreret sammen med et måltid med højt fedtindhold.
English: The estimated apparent clearance (CL/F) based on the population PK model is 14.85 L/h.
Danish: Den estimerede angivelige clearance (CL/F) baseret på den populationsfarmakokinetiske model er 14,85 l/t.
English: She or he may also pause Xospata treatment until symptoms are reduced.
Danish: Hun eller han vil muligvis også standse behandlingen med Xospata midlertidigt, indtil symptomerne er aftaget.
English: - if you have a history of low levels of the salts potassium or magnesium in your blood, as this may increase the risk of an abnormal heart rhythm.
Danish: - hvis du tidligere har haft lavt indhold af mineralerne kalium eller magnesium i blodet, da dette kan øge risikoen for unormal hjerterytme.
English: Most patients in the study were Caucasian (59.3%); 27.5% Asian, 5.7% Black, 4% other races and 3.5% unknown.
Danish: De fleste patienter i studiet var kaukasiere (59,3 %); 27,5 % asiatere, 5,7 % sorte, 4 % andre racer og 3,5 % ikke kendte.
English: Xospata is not recommended for use in patients with severe (Child-Pugh Class C) hepatic impairment, as safety and efficacy have not been evaluated in this population (see section 5.2).
Danish: Xospata anbefales ikke til brug hos patienter med svær (Child-Pugh-klasse C) leverinsufficiens, da sikkerhed og virkning ikke er evalueret i denne population (se pkt.
English: If you take more tablets than you should, contact your doctor.
Danish: Hvis du har taget for meget Xospata Hvis du har taget flere tabletter, end du skulle, skal du kontakte din læge.
English: CYP3A/P-gp Inducers
Danish: CYP3A/P-gp-induktorer
English: Patients had the following confirmed mutations: FLT3-ITD alone (88.4%), FLT3-TKD alone (8.4%) or both FLT3-ITD and FLT3-TKD (1.9%).
Danish: Patienterne havde følgende bekræftede mutationer: FLT3-ITD alene (88,4 %), FLT3-TKD alene (8,4 %) eller begge FLT3-ITD og FLT3-TKD (1,9 %).
English: Differentiation syndrome occurred as early as two days and up to 75 days after Xospata initiation and has been observed with or without concomitant leukocytosis.
Danish: Der opstod differentieringssyndrom så tidligt som to dage og op til 75 dage efter initiering af Xospata, og det er set med og uden samtidig leukocytose.
English: Chemotherapy (N=124)
Danish: Kemoterapi (N=124)
English: Xospata is used if AML is linked to an alteration of a gene called FLT3, and is given to patients whose disease has come back or has not improved after previous treatment.
Danish: Xospata bruges, hvis AML er forbundet med en ændring i et gen, der hedder FLT3, og gives til patienter, hvis sygdom er vendt tilbage eller de ikke er i bedring efter tidligere behandling.
English: The median OS was 7.2 months and 7.1 months for the 120 mg dose and the combined dose levels, respectively.
Danish: Median OS var 7,2 måneder og 7,1 måneder for henholdsvis 120 mg dosis og de kombinerede dosisniveauer.
English: These may be signs of an inflammation of the pancreas (pancreatitis).
Danish: Dette kan være tegn på en betændelsestilstand i bugspytkirtlen (pancreatitis).
English: In the absence of a response (patient did not achieve a CRc) after 4 weeks of treatment, the dose can be increased to 200 mg (five 40 mg tablets) once daily, if tolerated or clinically warranted.
Danish: Ved udeblivende respons (patienten opnåede ikke CRc) efter 4 ugers behandling, kan dosis øges til 200 mg (fem 40 mg tabletter) én gang dagligt, hvis tolereret eller klinisk berettiget.
English: The recommended dose is 120 mg (three tablets) once a day.
Danish: Den anbefalede dosis er 120 mg (tre tabletter) én gang dagligt.
English: In the juvenile toxicity study in rats, the minimum lethal dose level (2.5 mg/kg/day) was much lower than that of adult rats (20 mg/kg/day).
Danish: I toksicitetsstudiet med juvenile rotter, var det laveste letale dosisniveau (2,5 mg/kg dagligt) meget lavere end den hos voksne rotter (20 mg/kg dagligt).
English: Sixteen patients were randomised but not treated in the study (1 patient in the gilteritinib arm and 15 patients in the chemotherapy arm).
Danish: 16 patienter blev randomiseret, men ikke behandlet i studiet (1 patient i gilteritinibgruppen og 15 patienter i kemoterapigruppen).
English: The median OS was 9.3 months for patients receiving gilteritinib and 5.6 months for those receiving chemotherapy.
Danish: Medianen for OS var 9,3 måneder for de patienter, der fik gilteritinib, og 5,6 måneder for dem, der fik kemoterapi.
English: • Patient alert card o Patient alert card: - Information for patients that Xospata treatment may cause differentiation syndrome.
Danish: • Patientinformationskort o Patientinformationskort: - Information til patienter om, at Xospata-behandling kan forårsage differentieringssyndrom.
English: - Take Xospata once a day at the same time each day.
Danish: Sådan tager du Xospata - Tag Xospata én gang om dagen, på samme tidspunkt hver dag.
English: Hydroxypropylcellulose Hydroxypropylcellulose, low-substituted
Danish: Hydroxypropylcellulose Hydroxypropylcellulose, lavsubstitueret Magnesiumstearat
English: If you forget to take Xospata
Danish: Hvis du har glemt at tage Xospata
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors, ATC code: L01XE54
Danish: Farmakoterapeutisk klassifikation: antineoplastiske midler, proteinkinaseinhibitorer, ATC-kode: L01XE54
English: Gilteritinib has minor influence on the ability to drive and use machines.
Danish: Gilteritinib påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: In clinical studies, 12 patients had QTcF >500 msec. Three patients interrupted and reinitiated treatment without recurrence of QT prolongation.
Danish: I kliniske studier havde 12 patienter en QTcF >500 ms. Tre patienter afbrød og genoptog behandlingen uden tilbagevenden af QT-forlængelse.
English: Based on in vitro data, gilteritinib is primarily metabolised via CYP3A4.
Danish: Baseret på in vitro-data metaboliseres gilteritinib primært via CYP3A4.
English: Xospata belongs to a class of cancer medicines called protein kinase inihibitors.
Danish: Xospata tilhører en kategori af lægemidler mod kræft, der kaldes proteinkinasehæmmere.
English: Covariate analysis indicated that age (20 years to 90 years), and body weight (36 kg to 157 kg) were statistically significant; however predicted change in gilteritinib exposure was less than 2-fold.
Danish: Kovariat-analysen indikerede, at alder (20 år til 90 år) og legemsvægt (36 kg til 157 kg) var statistisk signifikant, men den forventede ændring i eksponering for gilteritinib var mindre end 2 gange.
English: If you forget to take Xospata at the usual time, take your usual dose as soon as you remember on the same day and take your next dose at the usual time on the following day.
Danish: Hvis du glemmer at tage Xospata på det sædvanlige tidspunkt, skal du tage din sædvanlige dosis, så snart du husker det samme dag, og tage din næste dosis på det sædvanlige tidspunkt dagen efter.
English: No dose adjustment is required in patients ≥65 years of age (see section 5.2).
Danish: Ældre Dosisjustering er ikke påkrævet hos patienter i alderen ≥65 år (se pkt.
English: The pharmacological activity of the metabolites against FLT3 and AXL receptors is unknown.
Danish: Metabolitternes farmakologiske aktivitet mod FLT3- og AXLreceptorerne er ikke kendt.
English: Of the 11 patients who experienced differentiation syndrome, 9 (82%) recovered after treatment or after dose interruption of Xospata.
Danish: Af de 11 patienter, der fik differentieringssyndrom, kom 9 (82 %) sig efter behandling eller efter afbrydelse af behandling med Xospata.
English: The gastrointestinal tract was identified as one of the target organs similar as in adult rats.
Danish: Mave-tarm-kanalen blev identificeret som et af målorganerne ligesom hos voksne rotter.
English: Table 3: ADMIRAL study overall survival and complete remission in patients with relapsed or refractory AML
Danish: Tabel 3: ADMIRAL-studiet - samlet overlevelse og komplet remission hos patienter med recidiverende eller refraktær AML
English: There are no or limited amount of data from the use of gilteritinib in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af gilteritinib til gravide kvinder.
English: LoDAC and azacitidine were given in continuous 4-week cycles until unacceptable toxicity or lack of clinical benefit.
Danish: LoDAC og azacitidin blev givet i kontinuerlige 4 ugers cyklusser, indtil uacceptabel toksicitet eller der ikke var en klinisk fordel.
English: The safety of Xospata was evaluated in 319 patients with relapsed or refractory AML who have received at least one dose of 120 mg gilteritinib.
Danish: Xospatas sikkerhed blev evalueret hos 319 patienter med recidiverende eller refraktær AML, der har fået mindst én dosis gilteritinib på 120 mg.
English: The tablets are provided in blisters and are available in packs containing 84 film-coated tablets (4-blisters of 21 film-coated tablets).
Danish: Tabletterne leveres i blisterkort og fås i pakninger, der indeholder 84 filmovertrukne tabletter (4 blisterkort med 21 filmovertrukne tabletter).
English: Please contact the patient's Haematologist/Oncologist for more information and consult the Product Information for gilteritinib available at https://www.ema.europa.eu/.
Danish: Kontakt patientens hæmatolog/onkolog for yderligere oplysninger, og se produktinformationen for gilteritinib, som er tilgængelig på https://www.ema.europa.eu/.
English: Dose reductions were allowed, to manage adverse reactions, and dose increases were allowed, for those patients who did not respond at the starting dose of 120 mg.
Danish: Doserne kunne reduceres for at håndtere bivirkninger, og doserne kunne øges til de patienter, der ikke responderede på startdosis på 120 mg.
English: 5HT2B receptor or sigma nonspecific receptor
Danish: 5HT2B-receptor eller uspecifikke sigmareceptorer
English: Xospata should be interrupted and can be resumed at a reduced dose when the signs and symptoms of pancreatitis have resolved (see section 4.2).
Danish: Xospata skal afbrydes og kan genoptages med nedsat dosis, når tegnene og symptomerne på pancreatitis er ophørt (se pkt.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene for fremsendelse af PSUR´er for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside.
English: Prior to the launch of Xospata in each Member State the MAH must agree about the content and format of the physician educational material, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Inden lancering af Xospata i hvert medlemsland skal indehaveren af markedsføringstilladelsen opnå enighed med de nationale myndigheder omkring indholdet og formatet af uddannelsesmaterialet til læger, inklusive kommunikationsmedie, distributionsmetode og andre aspekter af programmet.
English: Each pack contains 84 film-coated tablets.
Danish: Hver pakning indeholder 84 filmovertrukne tabletter.
English: - if you have severe pain in the upper abdomen and back, nausea and vomiting.
Danish: - hvis du har stærke smerter i øverste del af maven og ryggen, kvalme og opkastning.
English: • Interrupt gilteritinib if severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids.
Danish: • Afbryd gilteritinib, hvis alvorlige tegn og/eller symptomer fortsætter i mere end 48 timer efter initiering af kortikosteroider.
English: Xospata is used to treat adults with acute myeloid leukaemia (AML), a cancer of certain white blood cells.
Danish: Xospata bruges til at behandle voksne med akut myeloid leukæmi (AML), en kræftform i visse hvide blodlegemer.
English: Talk to your doctor, pharmacist or nurse immediately if you have any of the following symptoms:
Danish: Tal straks med lægen, apotekspersonalet eller sygeplejersken, hvis du har nogen af følgende symptomer:
English: Blood chemistries, including creatine phosphokinase, should be assessed prior to initiation of treatment, on day 15 and monthly for the duration of treatment.
Danish: Blodbilledet, herunder kreatinphosphokinase, skal vurderes inden initiering af behandlingen, på dag 15 og månedligt under hele behandlingsforløbet.
English: Gilteritinib did not induce gene mutation or chromosomal aberrations in vitro.
Danish: Gilteritinib inducerede ikke genmutation eller kromosomafvigelser in vitro.
English: Steady-state plasma levels are reached within 15 days of once-daily dosing with an approximate 10-fold accumulation.
Danish: Plasmaniveauer på steady-state nås inden for 15 dage efter dosering en gang dagligt med cirka 10 ganges akkumulering.
English: Embryofoetal toxicity and contraception
Danish: Embryoføtal toksicitet og prævention
English: Avoid concomitant use of these medicinal products with Xospata unless use is considered essential for the care of the patient.
Danish: Undgå samtidig anvendelse af disse lægemidler og Xospata, med mindre anvendelsen anses for afgørende for behandlingen af patienten.
English: The patient information pack:
Danish: Patientinformationspakken:
English: No dose adjustment is necessary in patients with mild or moderate renal impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let eller moderat nyreinsufficiens.
English: However, the predicted increase on gilteritinib exposure was less than 2-fold.
Danish: Den forventede stigning var imidlertid mindre end 2 gange af eksponeringen for gilteritinib.
English: Women using hormonal contraceptives should add a barrier method of contraception.
Danish: Kvinder, som bruger hormonel prævention, skal supplere med en barrierepræventionsmetode.
English: In rats, decreased urination at 30 mg/kg and higher and decreased defecation at 100 mg/kg were observed.
Danish: I rotter sås nedsat urinering ved 30 mg/kg og derover og nedsat defækation ved 100 mg/kg.
English: Other clinically significant serious adverse reactions included differentiation syndrome (2.2%), electrocardiogram QT prolonged (0.9%) and posterior reversible encephalopathy syndrome (0.6%).
Danish: Andre klinisk signifikante alvorlige bivirkninger var blandt andet differentieringssyndrom (2,2 %), forlænget QT på elektrokardiogram (0,9 %) og posterior reversibelt encefalopati-syndrom (0,6 %).
English: The educational material is aimed at haematologists who treat patients with leukemias including AML, and patients with AML prescribed Xospata to further inform prescribers and patients regarding the important identified risk of differentiation syndrome.
Danish: Uddannelsesmaterialet er rettet mod hæmatologer som behandler patienter med leukæmi inklusive AML, og patienter med AML der får ordineret Xospata, for yderligere at informere ordinerende læger og patienter omkring de vigtige identificerede risici ved differentieringssyndrom.
English: The MAH shall ensure that in each Member State where Xospata is marketed, haematologists who are expected to prescribe Xospata, and patients who are expected to use Xospata are provided with the following educational materials:
Danish: I hvert medlemsland hvor Xospata er markedsført, skal indehaveren af markedsføringstilladelsen sikre, at hæmatologer der forventes at udskrive Xospata, og patienter der forventes at bruge Xospata har følgende uddannelsesmaterialer stillet til rådighed:
English: Differentiation syndrome is a condition that affects your blood cells and may be life-threatening or lead to death if not treated in a timely manner.
Danish: Differentieringssyndrom er en tilstand, der påvirker dine blodlegemer og kan være livstruende eller medføre dødsfald, hvis det ikke behandles i tide.
English: The most frequent serious adverse reactions were diarrhoea (4.7%), ALT increased (4.1%), dyspnea (3.4%), AST increased (3.1%) and hypotension (2.8%).
Danish: De hyppigste alvorlige bivirkninger var diarré (4,7 %), forhøjet ALAT (4,1 %), dyspnø (3,4 %), forhøjet ASAT (3,1 %) og hypotension (2,8 %).
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken og blisterkortet efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Gilteritinib was given orally at a starting dose of 120 mg daily until unacceptable toxicity or lack of clinical benefit.
Danish: Gilteritinib blev givet oralt med en startdosis på 120 mg dagligt indtil uacceptabel toksicitet, eller der ikke var en klinisk fordel.