FrancophonIA/ELRC3.0 huggingface dataset:
English: • Changes in the levels of different enzymes in the blood (may show in your blood tests)
Danish: • Forandringer i mængden af forskellige enzymer i blodet (kan fremgå af dine blodprøver)
English: • Your doctor may lower your dose based on your response to treatment.
Danish: • Lægen vil muligvis nedsætte din dosis ud fra virkningen af din behandling.
English: Abbreviations: N=number of patients; PT=preferred term.
Danish: Forkortelser: N = antal patienter, FT = Foretrukken term.
English: See also section 6.3 for dilution, storage, and infusion information.
Danish: 6.3 vedrørende fortynding, opbevaring og infusion.
English: b. Estimated from Kaplan-Meier curve.
Danish: Estimeret ud fra Kaplan-Meier kurven.
English: MYLOTARG must not to be used in children and adolescents under 15 years of age because limited data are available in this population.
Danish: MYLOTARG må ikke anvendes til børn og unge under 15 år, da der kun er begrænset viden om anvendelse til denne aldersgruppe.
English: Consolidation
Danish: Konsolidering
English: Nervous system alterations were identified in rats with other antibody-calicheamicin conjugates.
Danish: Der blev set forandringer i nervesystemet hos rotter med andre antistof-calicheamicin konjugater.
English: The relevance of the irreversible animal findings to humans is uncertain.
Danish: Betydning for mennesker af de irreversible fund hos dyr er uvis.
English: Eligible patients were between 50 and 70 years of age with previously untreated de novo AML (Study ALFA-0701).
Danish: Egnede patienter var i alderen 50 til 70 år med tidligere ubehandlet de novo AML (Studiet ALFA-0701).
English: Proportions were transformed using Freeman-Tukey double arcsine transformation prior to combining studies, and the estimated combined rate was back-transformed using the harmonic mean of study sample sizes.
Danish: Andele blev transformeret ved brug af dobbelt arcsin-transformation med Freeman-Tukeys metode inden sammenlægning af studierne, og den estimerede totale rate blev tilbage-transformeret ved brug af den harmoniske middelværdi af studiernes polulationsstørrelser.
English: Overall, the median age of patients was 62 years (range 50 to 70 years) and most patients (87.8%) had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1 at baseline.
Danish: Patienternes gennemsnitsalder var 62 år (mellem 50 og 70 år), og de fleste patienter (87,8 %) havde Eastern Cooperative Oncology Group præstationsstatus (ECOG PS) på 0 til 1 ved baseline.
English: MYLOTARG has moderate influence on the ability to drive and use machines.
Danish: MYLOTARG påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: MYLOTARG should not be administered during second induction.
Danish: MYLOTARG bør ikke administreres under den anden induktion.
English: MYLOTARG is intended for the treatment of AML for patients age 15 years and above who have not tried other treatments.
Danish: MYLOTARG er beregnet til behandling af patienter fra 15 år og derover, som ikke har prøvet andre behandlinger.
English: Five (3.8%) of these VOD reactions occurred within 28 days of any dose of gemtuzumab ozogamicin.
Danish: 5 (3,8 %) af disse VOD-reaktioner forekom inden for 28 dage efter dosering med gemtuzumab ozogamicin.
English: MYLOTARG should not be administered as an intravenous push or bolus (see section 6.6).
Danish: MYLOTARG bør ikke administreres som intravenøst push eller bolus (se pkt.
English: CD33 expression on AML blasts by flow cytometry harmonised from local laboratory results was determined in 194/271 (71.6%) patients overall.
Danish: CD33-ekspression på AML-blaster med flowcytometri harmoniseret ud fra lokale laboratorieresultater blev bestemt hos i alt 194/271 (71,6 %) patienter.
English: No dose adjustment is required in elderly patients (≥ 65 years) (see section 5.2).
Danish: Ældre Ingen dosisjustering er nødvendig hos ældre patienter (≥ 65 år) (se pkt.
English: Infections and bleeding/haemorrhagic reactions were reported, some of which were life-threatening or fatal.
Danish: Infektioner og blødning/hæmoragiske reaktioner blev indberettet, og nogle af dem var livstruende eller dødelige.
English: Dose modification of MYLOTARG is recommended based on individual safety and tolerability (see section 4.4).
Danish: Det anbefales at justere dosis af MYLOTARG baseret på individuel sikkerhed og tolerabilitet (se pkt.
English: Both men and women should seek advice on fertility preservation before treatment.
Danish: Både mænd og kvinder bør inden behandling søge rådgivning omkring bevarelse af fertiliteten.
English: This substance is delivered to cancer cells by the monoclonal antibody.
Danish: Dette stof bliver overført til kræftcellerne af det monoklonale antistof.
English: Saturation of a high percentage of CD33 antigenic sites is presumed to be required for maximum delivery of calicheamicin to leukaemic blast cells.
Danish: Det antages at høj mætningsprocent af CD33 antigen-sites er nødvendig for maksimal overførsel af calicheamicin til leukæmiske blasterceller.
English: Relapsed or refractory AML
Danish: Recidiverende eller refraktær AML
English: Do not use this medicine if you notice any particulate matter or discolouration prior to administration.
Danish: Brug ikke lægemidlet, hvis du bemærker et partikelagtigt stof eller misfarvning før indgivelsen.
English: Symptoms may also include feeling sick (nausea) and/or vomiting.
Danish: Symptomerne kan være at man føler sig syg (kvalme) og/eller kaster op.
English: • Infections (signs of a low number of white blood cells known as neutrophils) Some infections may be serious and can be due to viruses, bacteria, or other causes that may be life-threatening.
Danish: • Infektioner (tegn på lavt antal hvide blodlegemer kaldet neutrofile leukocytter) Visse infektioner kan være alvorlige og kan være forårsaget af virus, bakterier eller andre årsager, som kan være livstruende.
English: In patients, the total volume of distribution of hP67.6 antibody (sum of V1 [10 L] and V2 [15 L]) was found to be approximately 25 L.
Danish: Hos patienter med den samlede fordelingsvolumen af hP67.6 antistof (summen af V1 (10 l) og V2 (15 l)) viste sig at være ca. 25 l.
English: Pregnant women, or patients becoming pregnant whilst receiving gemtuzumab ozogamicin, or treated male patients as partners of pregnant women, must be apprised of the potential hazard to the foetus.
Danish: Gravide kvinder eller patienter, der bliver gravide, mens de får gemtuzumab ozogamicin, eller behandlede mandlige patienter med en gravid partner, skal informeres om den mulige risiko for fosteret.
English: EFS and OS analysed by cytogenetic risk classification and cytogenetic/molecular risk classification are presented in Table 9 and Table 10 below.
Danish: EFS og OS analyseret i forhold til cytogenetisk risiko-klassifikation og cytogenetisk/molekylær risiko-klassifikation ses i skema 9 og skema 10.
English: An in-line, low protein-binding 0.2 micron polyethersulphone (PES) filter must be used for infusion of MYLOTARG.
Danish: Der skal anvendes et in-line, lavt protein-bindende 0,2 mikron polyethersulfon (PES)-filter til infusion med MYLOTARG.
English: Hepatotoxicity, including hepatic VOD/SOS
Danish: Levertoksicitet, herunder hepatisk VOD/SOS
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC05
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, monoklonale antistoffer, ATC-kode: L01XC05
English: Patients should be monitored until signs and symptoms completely resolve.
Danish: Patienten bør overvåges, indtil symptomerne er fuldstændigt afklaret.
English: Patients with CR or CRp received consolidation therapy with 2 courses of treatment including DNR and AraC with or without MYLOTARG according to their initial randomisation.
Danish: Patienter med CR eller CRp fik konsolideringsterapi med 2 behandlingsforløb, herunder DNR og AraC med eller uden MYLOTARG i henhold til deres oprindelige randomisering.
English: Interrupt the infusion and institute appropriate medical management based on the severity of symptoms.
Danish: Infusionsrelaterede reaktioner Afbryd infusionen, og iværksæt passende medicinsk behandling på grundlag af symptomernes sværhedsgrad.
English: Signs and symptoms of infusion related reactions may include fever and chills, and less frequently hypotension, tachycardia, and respiratory symptoms that may occur during the first 24 hours after administration.
Danish: Symptomer på infusionsrelaterede reaktioner kan omfatte feber og kuldegysninger, og mindre hyppigt hypotension, takykardi og respiratoriske symptomer, der kan forekomme i de første 24 timer efter indgift.
English: The adverse reactions are presented by system organ class (SOC) and frequency categories, defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Bivirkninger er ordnet efter organklasse og hyppighed i følgende grupperinger: meget almindelig (1/10), almindelig (1/100 til <1/10), ikke almindelig (1/1.000 til <1/100), sjælden (1/10.000 til <1/1.000), meget sjælden (<1/10.000), ukendt (kan ikke estimeres ud fra forhåndenværende data).
English: Use appropriate aseptic technique for the reconstitution and dilution procedures.
Danish: Brug passende aseptisk teknik under rekonstitution og fortynding.
English: Both of these patients experienced VOD more than 28 days after the last dose of gemtuzumab ozogamicin.
Danish: Begge disse patienter oplevede VOD mere end 28 dage efter den sidste dosis med gemtuzumab ozogamicin.
English: Patients in the Phase 2 trials did not develop antidrug antibodies (ADAs) and only 2 patients in a Phase 1 trial developed antibodies against the calicheamicin-linker complex, 1 of whom had reduced hP67.6 plasma concentrations.
Danish: Patienterne i fase 2-studierne udviklede ikke antistoffer mod lægemidlet (ADA'er), og kun 2 patienter i fase 1 studiet udviklede antistoffer mod calicheamicin-koblet komplekset, hvor den ene havde nedsat hP67.6 plasmakoncentration.
English: If you need treatment with MYLOTARG, you must stop breast-feeding during treatment and for at least 1 month after treatment.
Danish: Hvis du skal i behandling med MYLOTARG, skal du stoppe med at amme under behandlingen og i mindst 1 måned efter behandlingen.
English: The secondary endpoints included CR and CRp rates, relapse-free survival (RFS), overall survival (OS), and safety of the combination DA with or without MYLOTARG.
Danish: De sekundære endepunkter omfattede CR- og CRp-rater, relapsfri overlevelse (RFS), samlet overlevelse (OS) og sikkerhed ved kombinationen DA med eller uden MYLOTARG.
English: Patients in either arm who did not receive the second course of induction therapy and did not achieve a CR after induction could receive a salvage course comprised of idarubicin, AraC, and granulocyte colonystimulating factor (G-CSF).
Danish: Patienter fra begge arme, der ikke var i det andet forløb af induktionsbehandlingen og ikke opnåede et CR efter induktion, kunne modtage en salvage-behandling bestående af idarubicin, AraC og granulocytkolonistimulerende faktor (G-CSF).
English: Seek advice regarding fertility preservation before treatment.
Danish: Søg rådgivning om bevarelse af frugtbarheden, inden du får behandling.
English: The ALFA-0701 trial was not designed to prospectively evaluate the benefit of MYLOTARG in subgroups; analysis are presented for descriptive purposes only.
Danish: ALFA-0701 studiet var ikke designet til fremadrettet at evaluere fordelen af Mylotarg i undergrupper, analysen er kun vist her af beskrivelsesmæssige årsager.
English: No definitive relationship was found between VOD and time of HSCT relative to higher MYLOTARG monotherapy doses, however, the ALFA-0701 study recommended an interval of 2 months between the last dose of MYLOTARG and HSCT.
Danish: Der blev ikke fundet en klar sammenhæng mellem VOD og tidspunkt for HSCT i relation til højere MYLOTARG monoterapi-doser, men ALFA-0701 studiet anbefaler et interval på 2 måneder mellem sidste dosis af Mylotarg og HSCT.
English: This is consistent with the known induction of DNA breaks by calicheamicin and other enediyne antitumour antibiotics.
Danish: Dette stemmer overens med den kendte induktion af DNA-brud, som calicheamicin og andre tumorhæmmende enediyn-antibiotika medfører.
English: Information about adverse drug reactions from monotherapy studies and post-marketing experience is presented Table 6 in order to provide full characterisation of adverse reactions.
Danish: Oplysninger om bivirkninger fra monobehandlingsstudier og erfaringer efter markedsføring er præsenteret i skema 6 for at give en fuldstændig karakterisering af bivirkningerne.
English: • Calculate the dose (mg) of MYLOTARG required.
Danish: • Beregn den nødvendige dosis (mg) MYLOTARG.
English: A second course of induction therapy with DA but without MYLOTARG, regardless of the randomisation arm, was allowed.
Danish: Der blev tilladt et andet forløb med induktionsbehandling med DA, men uden MYLOTARG, uanset hvilken randomiseringsarm.
English: The number of patients with persistent thrombocytopenia remained similar across treatment courses (8 [7.4%] patients at the induction phase and 8 [8.5%] patients at the consolidation 1 phase and 10 [13.2%] patients at the consolidation 2 phase).
Danish: Antallet af patienter med vedvarende trombocytopeni forblev det samme på tværs af behandlingsforløb (8 (7,4 %) patienter ved induktionsfasen, 8 (8,5 %) patienter ved konsolideringsfase 1 og 10 (13,2 %) patienter ved konsolideringsfase 2).
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelig (kan påvirke flere end 1 ud af 10 personer):
English: When male rats were mated again after a 9-week non-dosing period, effects on sperm and fertility were worse but there was partial recovery of the lower spermatogonia and spermatocytes in the testes.
Danish: Når hanrotter parrede sig igen efter en 9-ugers periode uden dosering, var påvirkningen af sædceller og fertiliteten forværret, mens der var delvis bedring af spermatogonier og spermatocytter i testiklerne.
English: • Reduced number of blood platelets (cells that help blood to clot)
Danish: • Nedsat antal blodplader (celler, der hjælper blodet med at størkne)
English: Across all studies, near maximal peripheral CD33 saturation was observed post-MYLOTARG dose at all dose levels of 2 mg/m² and above, suggesting that a low dose of gemtuzumab ozogamicin is sufficient to bind all available CD33 sites.
Danish: På tværs af alle studier blev der observeret næsten maksimal mætning af perifert CD33 efter MYLOTARG dosering på alle dosisniveauer på 2 mg/m² og derover, hvilket antyder, at en lav dosis gemtuzumab ozogamicin er tilstrækkelig til at binde alle tilgængelige CD33-steder.
English: **Including fatal adverse reactions in the post-marketing setting.
Danish: **Herunder dødsfald efter markedsføring.
English: Combinationa
Danish: Kombination
English: MYLOTARG should be used only in patients eligible to receive intensive induction chemotherapy.
Danish: MYLOTARG bør kun anvendes til patienter, der er egnet til at modtage intensiv induktionskemoterapi.
English: Consider permanent discontinuation of treatment for severe or life-threatening infusion reactions (see section 4.4).
Danish: Overvej permanent seponering af behandlingen ved alvorlige eller livstruende infusionsrelaterede reaktioner (se pkt.
English: Delay treatment with MYLOTARG until recovery to a severity of no more than mild.
Danish: Udskyd behandling med MYLOTARG indtil restitution til mild sværhedsgrad.
English: • infection: have or think you have, an infection, develop chills or shivering, or feel warm, or have fever.
Danish: • infektion: har eller mener, du har en infektion, får kuldegysninger eller skælven, føler dig varm eller har feber.
English: During treatment, patients should be monitored for signs and symptoms of infection, bleeding/haemorrhage, or other effects of myelosuppression.
Danish: Under behandlingen bør patienten overvåges for symptomer på infektion, blødning/hæmoragi eller andre virkninger af knoglemarvs-suppression.
English: No dose adjustment is required in patients with mild to moderate renal impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let til moderat nedsat nyrefunktion.
English: Do not mix MYLOTARG with, or administer as an infusion with, other medicinal products.
Danish: MYLOTARG må ikke blandes eller indgives som infusion med andre lægemidler.
English: MYLOTARG was given as monotherapy in 47.1%, part of a combination in 23.5%, and in both settings in 29.4% of the studies.
Danish: MYLOTARG blev givet som monoterapi i 47,1 % af studierne, som del af en kombination i 23,5 % af studierne og i begge behandlingsregimer i 29,4 % af studierne.
English: What MYLOTARG contains
Danish: MYLOTARG indeholder
English: The relevance of these animal findings to humans is uncertain.
Danish: Betydning for mennesker af disse fund hos dyr er uvis.
English: In the combination setting, the response rate was 49.0% with non-fractionated MYLOTARG (3 studies) and 38.8% with fractionated MYLOTARG (2 studies).
Danish: Ved kombinationsbehandling var responsraten 49,0 % med ikke-fraktioneret MYLOTARG (3 studier) og 38,8 % med fraktioneret MYLOTARG (2 studier).
English: What you need to know before you are given MYLOTARG 3.
Danish: Det skal du vide, før du får MYLOTARG 3.
English: The terminal plasma half-life (t½) for hP67.6 was predicted to be approximately 160 hours for a typical patient at the recommended dose level (3 mg/m2) of MYLOTARG.
Danish: Halveringstiden (t½) for hP67.6 forventes at være ca.160 timer for en typisk patient ved det anbefalede dosisniveau (3 mg/m2) af MYLOTARG
English: Following reconstitution and dilution, the solution should be protected from light and should be used immediately.
Danish: Efter rekonstitution og fortynding bør opløsningen beskyttes mod lys og anvendes øjeblikkeligt.
English: MYLOTARG is for intravenous use and must be reconstituted and diluted before administration (see section 6.6).
Danish: MYLOTARG er til intravenøs brug og skal rekonstitueres og fortyndes før administration (se pkt.
English: Safety results from a systematic literature review in paediatric patients with relapsed or refractory AML who received MYLOTARG
Danish: Sikkerhedsresultater fra en systematisk litteraturgennemgang hos pædiatriske patienter med recidiverende eller refraktær AML, som fik MYLOTARG
English: Based on non-clinical findings, male and female fertility may be compromised by treatment with gemtuzumab ozogamicin (see section 5.3).
Danish: På grundlag af ikke-kliniske fund kan mænds og kvinders fertilitet blive kompromitteret af behandling med gemtuzumab ozogamicin (se pkt.
English: For patients who develop abnormal liver tests, more frequent monitoring of liver tests and clinical signs and symptoms of hepatotoxicity is recommended.
Danish: Hos patienter, der udvikler abnorme levertal, anbefales hyppigere levertests og monitorering af kliniske symptomer på levertoksicitet.
English: Total dosing of MYLOTARG ranged from 1.8 mg/m2 to 9 mg/m2.
Danish: Den totale dosering af MYLOTARG varierede fra 1,8 mg/m2 til 9 mg/m2.
English: Reconstituted and diluted solution: Following reconstitution and dilution, the solution should be protected from light and should be used immediately.
Danish: Rekonstitueret og fortyndet opløsning: Efter rekonstitution og fortynding bør opløsningen beskyttes mod lys og anvendes øjeblikkeligt.
English: Baseline characteristics were balanced between treatment arms with the exception of gender as a higher percentage of males were enrolled in the MYLOTARG arm (54.8%) than in the DA alone arm (44.1%).
Danish: Baselinekarakteristika var jævn fordelt mellem behandlingsarmene med undtagelse af køn, da en højere procentdel af mænd var inkluderet i MYLOTARG-armen (54,8 %) end i armen, der kun fik DA (44,1 %).
English: One VOD event occurred more than 28 days of last dose of gemtuzumab ozogamicin; with 1 of these events occurring a few days after having started an HSCT conditioning regimen.
Danish: 1 VODhændelse opstod mere end 28 dage fra den sidste dosis gemtuzumab ozogamicin, og 1 hændelse opstod et par dage efter start af en HSCT-konditionerende behandling.
English: Patients with acute promyelocytic leukaemia (APL, AML3) and patients with AML arising from myelodysplastic syndrome (MDS) or secondary AML were excluded from the study.
Danish: Patienter med akut promyelocyt leukæmi (APL, AML3) samt patienter med AML udviklet fra myelodysplastisk syndrom (MDS) eller sekundær AML var ekskluderet fra studiet.
English: Response rate (by Investigator)
Danish: Responsrate (ved investigator)
English: AML with adverse-risk cytogenetics
Danish: AML med negativ risiko-cytogenetik
English: MYLOTARG is light sensitive and should be protected from ultraviolet light during reconstitution, dilution and administration.
Danish: MYLOTARG er lysfølsomt og skal beskyttes mod ultraviolet lys under rekonstitution, fortynding og administration.
English: 22.5 [15.5, NE]
Danish: 22,5 [15,5-ikke estimerbart]
English: • Doses must be mixed to a concentration between 0.075 mg/mL to 0.234 mg/mL according to the following instructions: o Doses less than 3.9 mg must be prepared for administration by syringe.
Danish: • Doser skal blandes til en koncentration på mellem 0,075 mg/ml og 0,234 mg/ml i henhold til efterfølgende instruktion: o Doser mindre end 3,9 mg skal fremstilles til administration med sprøjte.
English: Your doctor may do blood tests and find abnormalities in liver blood tests, which might be signs of a potentially life-threatening condition called venoocclusive liver disease.
Danish: Din læge kan tage blodprøver for at undersøge om din lever fungerer normalt og kan finde tegn på en mulig livstruende tilstand, der kaldes veno-okklusiv leversygdom.
English: MYLOTARG is used to treat a certain type of cancer called acute myeloid leukaemia (AML) in which the bone marrow makes abnormal white blood cells.
Danish: MYLOTARG anvendes til behandling af en særlig type kræft, der kaldes akut myeloid leukæmi (AML), hvor knoglemarven producerer unormale hvide blodlegemer.
English: Adverse reactions in patients who received MYLOTARG in monotherapy*** studies and post-marketing
Danish: Bivirkninger hos patienter, som fik MYLOTARG i monobehandlingsstudier***, og efter markedsføring.
English: Effects on male rat reproductive organs were partially reversible or not reversible (see section 4.6).
Danish: Virkningen på hanrotters reproduktionsorganer var delvist reversibel og delvist ikke-reversibel (se pkt.
English: Ask your doctor how to throw away medicines you no longer use.
Danish: Spørg apotekspersonalet, hvordan du skal bortskaffe medicinrester.
English: In vitro, the binding N-acetyl gamma calicheamicin dimethyl hydrazide to human plasma proteins is approximately 97%.
Danish: Bindingen in vitro af N-acetyl-gamma-calicheamicin dimethylhydrazid til humane plasmaproteiner er ca. 97 %.
English: The reconstituted solution may contain small white to off-white, opaque to translucent, and amorphous to fibre-like particles.
Danish: Den rekonstituerede opløsning kan indeholde små hvide/råhvide, uigennemsigtige til gennemsigtige, ubestemmelige fiberlignende partikler.
English: Infusion should be interrupted immediately for patients who develop evidence of severe reactions, especially dyspnoea, bronchospasm, or clinically significant hypotension.
Danish: Infusionen skal straks afbrydes, hvis patienten viser tegn på alvorlige reaktioner, især dyspnø, bronkospasme eller klinisk signifikant hypotension.
English: Thus, the optimal dose of gemtuzumab ozogamicin for paediatric patients was not established (see section 4.2).
Danish: Derfor blev den optimale dosis gemtuzumab ozogamicin for pædiatriske patienter ikke klarlagt (se pkt.
English: • Infusion reactions
Danish: • Infusionsrelaterede reaktioner
English: Overall, 29 (5.5%) of patients in the MYLOTARG arm and 15 (2.8%) patients in the comparator arm died during remission.
Danish: Samlet døde 29 (5,5%) patienter i MYLOTARG-armen og 15 (2,8%) patienter i komparator-armen under remission.