FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, it is important that men also use effective contraception.
Danish: Derfor er det vigtigt, at mænd også bruger effektiv prævention.
English: Because of this defect, other protein kinase medicines may no longer work.
Danish: På grund af denne defekt vil andre proteinkinaselægemidler muligvis ikke længere virke.
English: • you have ever had heart problems - your doctor may want to keep a close eye on you.
Danish: • du nogensinde har haft hjerteproblemer - lægen vil måske overvåge dig mere omhyggeligt.
English: Most cases improved or resolved with interruption of treatment.
Danish: De fleste tilfælde blev bedre eller gik over ved afbrydelse af behandlingen.
English: TAGRISSO can be taken with or without food at the same time each day.
Danish: TAGRISSO kan tages med eller uden mad på samme tidspunkt hver dag.
English: However, with current available data, alternative metabolic pathways cannot be fully ruled out.
Danish: Med de nuværende tilgængelige data kan alternative metaboliseringsveje imidlertid ikke helt udelukkes.
English: It may also help to reduce the size of the tumour.
Danish: Det kan også være med til at nedsætte tumorens størrelse.
English: This is because some medicine may remain in your body, (see advice on contraception below).
Danish: Dette skyldes, at medicinen fortsat kan være i din krop (se rådene om prævention nedenfor).
English: Dosing interruption and/or dose reduction may be required based on individual safety and tolerability.
Danish: Doseringsafbrydelse og/eller dosisreduktion kan være nødvendig på baggrund af individuel sikkerhed og tolerance.
English: • Take TAGRISSO every day at the same time.
Danish: • Tag TAGRISSO hver dag på samme tidspunkt.
English: • Do not use any pack that is damaged or shows signs of tampering.
Danish: • Brug ikke en pakning, der er beskadiget eller viser tegn på at have været åbnet.
English: It is important to take this medicine every day, for as long as your doctor prescribes it for you.
Danish: Det er vigtigt at tage denne medicin hver dag lige så længe, lægen ordinerer den til dig.
English: Interactions with transport proteins
Danish: Interaktion med transportproteiner
English: These changes are small and not likely to be of clinical significance.
Danish: Disse ændringer er små, og det er ikke sandsynligt, at de er klinisk relevante.
English: See ‘Serious side effects' in section 4 for more information.
Danish: Se "alvorlige bivirkninger" i punkt 4 for yderligere information.
English: Reintroduction of TAGRISSO should be considered only after careful consideration of the individual patient's benefits and risk.
Danish: Genoptagelse af TAGRISSO bør kun overvejes efter nøje overvejelse af fordele og risici for den enkelte patient.
English: Take your next normal dose at its scheduled time.
Danish: Tag din næste dosis på det sædvanlige tidspunkt.
English: Of 556 patients, 200 patients had available baseline brain scans.
Danish: Af 556 patienter havde 200 patienter tilgængelige baseline-hjernescanninger.
English: If you forget a dose, take it as soon as you remember it.
Danish: Hvis du glemmer en dosis, skal du tage den så snart, du kommer i tanke om det.
English: Date of first authorisation: 2 February 2016 Date of latest renewal: 12 December 2016
Danish: Dato for første markedsføringstilladelse: 2. februar 2016 Fornyelse af markedsføringstilladelsen 12. december 2016
English: Compliance over the first 9 months was generally high (≥70%) and similar in both arms.
Danish: Compliance over de første 9 måneder var generelt høj (≥70 %) og ens i begge arme.
English: • Stir thewater until the tablet breaks up into very small pieces -the tablet will not completely dissolve.
Danish: • Omrør vandet, indtil tabletten har delt sig i meget små stykker - tabletten vil ikke blive helt opløst.
English: The median duration of follow up for PFS was 12.6 months.
Danish: Den gennemsnitlige opfølgningsvarighed for PFS var 12,6 måneder.
English: Overall survival data were not mature at the time of this initial OS analysis.
Danish: De samlede overlevelsesdata var ikke modne på tidspunktet for denne indledende OS-analyse.
English: Represents the incidence of laboratory findings, not of reported adverse events.
Danish: Repræsenterer forekomsten af laboratoriefund, ikke af rapporterede bivirkninger.
English: dosing), rat and mouse (oral administration).
Danish: dosering), rotte og mus (oral administration).
English: Do not stop taking this medicine - talk to your doctor first.
Danish: Du må ikke holde op med at tage denne medicin - tal først med lægen.
English: No other liquids should be added.
Danish: Der må ikke tilsættes andre væsker.
English: • asthe first medicine you receive for your cancer or
Danish: • som den første medicin, du får for din kræftsygdom eller
English: Randomisation was stratified by ethnicity (Asian and non-Asian).
Danish: Randomisering blev stratificeret efter etnicitet (asiatisk og ikke-asiatisk).
English: If you are able to become pregnant, you must use effective contraception.
Danish: Hvis du kan blive gravid, skal du bruge effektiv prævention.
English: Patients should be advised to use effective contraception for the following periods after completion of treatment with this medicinal product: at least 2 months for females and 4 months for males.
Danish: Patienterne skal informeres om at anvende effektiv antikonception i følgende tidsum efter afsluttet behandling med dette lægemiddel: mindst 2 måneder for kvinder og mindst 4 måneder for mænd.
English: Do not take TAGRISSO if:
Danish: Tag ikke TAGRISSO hvis:
English: • Do not usethis medicine after the expiry date (EXP) which is stated on the blister foil and carton.
Danish: • Brug ikke lægemidlet efter den udløbsdato (EXP), der står på blisterfolien og æsken.
English: A consistent pattern in safety and efficacy results was observed in the analysis of AURA Phase 2 studies.
Danish: Der blev observeret et konsistent mønster i sikkerheds- og virkningsresultater i analysen af fase 2-AURA-studierne.
English: Swallow the tablet whole with water.
Danish: Synk tabletten hel med vand.
English: See ‘Contraception - information for women and men' below.
Danish: Se "Prævention - information til kvinder og mænd" nedenfor.
English: Duration of Response (DoR)
Danish: Responsvarighed (DoR)
English: • TAGRISSO is taken by mouth.
Danish: • TAGRISSO indtages gennem munden.
English: Severe renal impairment may influence the elimination of hepatically eliminated medicinal products.
Danish: Svært nedsat nyrefunktion kan påvirke eliminationen af hepatisk eliminerede lægemidler.
English: Tell your doctor if your diarrhoea does not go away or becomes severe.
Danish: Fortæl det til lægen, hvis diarréen ikke går væk eller bliver voldsom.
English: No overall differences in efficacy were observed between these subjects and younger subjects.
Danish: Der blev ikke observeret nogen overordnet forskel i virkning mellem disse forsøgspersoner og yngre forsøgspersoner.
English: TAGRISSO can be prescribed for you:
Danish: TAGRISSO kan ordineres til dig:
English: Tell your doctor if your skin or nail problems get worse.
Danish: Fortæl det til lægen, hvis problemerne med hud og negle bliver værre.
English: Further catalyzing enzymes have not been identified.
Danish: Der er ikke identificeret andre katalyserende enzymer.
English: Represents the incidence of patients who had a QTcF prolongation >500msec.
Danish: Repræsenterer forekomsten af patienter, som havde QTcF-forlængelse >500 msek.
English: Tablet coating Polyvinyl alcohol Titanium dioxide (E 171) Macrogol 3350
Danish: Tabletovertræk Polyvinylalkohol Titandioxid (E 171) Macrogol 3350
English: TAGRISSO works by blocking EGFR and may help to slow or stop your lung cancer from growing.
Danish: TAGRISSO virker ved at blokere for EGFR og kan hjælpe med at bremse eller standse din lungekræft fra at vokse.
English: These findings were seen at clinically relevant plasma concentrations.
Danish: Disse fund blev set ved klinisk relevante plasmakoncentrationer.
English: One event (0.1%) led to discontinuation.
Danish: Ét tilfælde (0,1 %) medførte seponering.
English: • TAGRISSO may pass into semen.
Danish: • TAGRISSO kan passere over i sæd.
English: TAGRISSO may affect how well the following medicines work and/or increase side effects of these medicines:
Danish: TAGRISSO kan påvirke, hvor godt følgende medicin virker og/eller øge bivirkningerne af disse lægemidler:
English: A risk for decreased exposure of hormonal contraceptives cannot be excluded.
Danish: Det kan ikke udelukkes, at der er en risiko for nedsat eksponering for hormonelle kontraceptiva.
English: Frequency of CTCAE grade 3 or higher
Danish: Frekvens af CTCAE-grad 3 eller højere
English: In vitro plasma protein binding of osimertinib is 94.7% (5.3% free).
Danish: In vitro plasmaproteinbinding af osimertinib er 94,7% (5,3% fri).
English: • Reduction in the number of platelets in the blood.
Danish: • Nedsat antal blodplader.
English: Osimertinib is eliminated mainly via the liver.
Danish: Osimertinib elimineres hovedsageligt via leveren.
English: 5 CTCAE grade 5 events (fatal) were reported.
Danish: Der blev indberettet 5 tilfælde af CTCAE-grad 5 (dødelige).
English: There is limited experience with accidental overdoses in humans.
Danish: Der er begrænset erfaring med utilsigtet overdosering hos mennesker.
English: Before initiating treatment, patients should be advised of signs and symptoms of SJS.
Danish: Før behandlingen indledes, skal patienterne informeres om tegn og symptomer på SJS.
English: Your doctor will discuss appropriate treatment options with you.
Danish: Lægen vil tale med dig om passende behandlingsmuligheder.
English: Adverse reactions are listed according to system organ class (SOC) in MedDRA.
Danish: Bivirkningerne er opstillet i henhold til systemorganklasse (SOC) i MedDRA.
English: If the patient is unable to swallow the tablet, the tablet may first be dispersed in 50 mL of non-carbonated water.
Danish: Hvis patienten ikke er i stand til at synke tabletten, kan tabletten først opslæmmes i 50 ml vand uden kulsyre.
English: • you have a history of eye problems.
Danish: • du tidligere har haft problemer med øjnene.
English: TAGRISSO may be restarted at the same dose (80 mg) or a lower dose (40 mg)
Danish: TAGRISSO kan genstartes ved samme dosis (80 mg) eller ved en lavere dosis (40 mg)
English: An additional half a glass of water should be added to ensure that no residue remains and then immediately swallowed.
Danish: Derefter skal yderligere et halvt glas vand hældes op for at sikre, at der ikke er nogen tabletrester tilbage, og dette skal straks synkes.
English: • you have sudden difficulty in breathing together with a cough or fever.
Danish: • du pludseligt har besvær med at trække vejret og samtidig får hoste eller feber.
English: Do not crush, split or chew the tablet.
Danish: Du må ikke knuse, dele eller tygge tabletten.
English: These exposure changes due to body weight or baseline albumin differences are not considered clinically relevant.
Danish: Disse eksponeringsændringer, der skyldes forskelle i legemsvægt eller baseline-albumin, anses ikke for klinisk relevante.
English: Treatment with this medicinal product should be interrupted pending investigation of these symptoms.
Danish: Behandlingen med dette lægemiddel skal afbrydes, mens symptomerne undersøges.
English: Patients were evaluated for LVEF at screening and every 12 weeks thereafter.
Danish: Patienternes LVEF blev evalueret ved screening og derefter hver 12. uge.
English: • Rosuvastatin - used to lower cholesterol.
Danish: • Rosuvastatin - bruges til at sænke kolesterol.
English: • Digoxin - used for irregular heart beat or other heart problems.
Danish: • Digoxin - bruges mod uregelmæssige hjerteslag eller andre hjerteproblemer
English: Name and address of the manufacturer responsible for batch release AstraZeneca AB
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse AstraZeneca AB
English: Age and body weight
Danish: Alder og legemsvægt
English: The recommended dose is 80 mg osimertinib once a day until disease progression or unacceptable toxicity.
Danish: Den anbefalede dosis er 80 mg osimertinib én gang dagligt indtil sygdomsprogression eller uacceptabel toksicitet.
English: • You should not become pregnant while taking this medicine.
Danish: • Du må ikke blive gravid, mens du tager denne medicin.
English: If you take more TAGRISSO than you should If you take more than your normal dose, contact your doctor or nearest hospital straight away.
Danish: Hvis du har taget for mange TAGRISSO Hvis du har taget mere end din normale dosis, skal du straks kontakte lægen eller nærmeste skadestue.
English: TAGRISSO should not be used during pregnancy unless the clinical condition of the woman requires treatment with osimertinib.
Danish: TAGRISSO må ikke anvendes under graviditet, medmindre kvindens kliniske tilstand kræver behandling med osimertinib.
English: Dose reduction was required in 0.2% of patients and dose interruption in 1.4%.
Danish: Dosisreduktion var nødvendig hos 0,2 % af patienterne og doseringsafbrydelse hos 1,4 %.
English: All patients received at least one prior line of therapy.
Danish: Alle patienter havde fået mindst én type behandling tidligere.
English: Your doctor will decide with you whether you should carry on taking TAGRISSO.
Danish: Lægen vil sammen med dig beslutte, om du skal fortsætte med at tage TAGRISSO.
English: Patients with CLcr less than 15 mL/min were not included in the clinical trials.
Danish: Patienter med CLcr under 15 ml/min blev ikke inkluderet i de kliniske studier.
English: Discuss with your doctor the most appropriate methods of contraception.
Danish: Tal med lægen om de bedst egnede præventionsmetoder.
English: If a test has shown that your cancer has certain changes (mutations) in a gene called ‘EGFR' (epidermal growth factor receptor) and has spread to your other lung or other organs, your cancer is likely to respond to treatment with TAGRISSO.
Danish: Hvis en prøve har vist, at din kræftsygdom har visse ændringer (mutationer) i et gen kaldet ”EGFR” (epidermal vækstfaktorreceptor) og har spredt sig til din anden lunge eller andre organer, vil din kræft sandsynligvis reagere på behandling med TAGRISSO.
English: • Men - keep using contraception for 4 months after.
Danish: • Mænd - brug prævention i 4 måneder efter.
English: There are no data on the effect of TAGRISSO on human fertility.
Danish: Der er ingen data om TAGRISSOs indvirkning på fertiliteten hos mennesker.
English: • If necessary, your doctor may reduce your dose to one 40 mg tablet each day.
Danish: • Om nødvendigt kan lægen nedsætte din dosis til én 40 mg tablet hver dag.
English: • in certain circumstances if you have beentreated for your cancer before with other protein kinase inhibitor medicines.
Danish: • under visse omstændigheder, hvis du tidligere har været behandlet for kræft med andre proteinkinasehæmmende lægemidler.
English: Treatment with TAGRISSO should be initiated by a physician experienced in the use of anticancer therapies.
Danish: Behandling med TAGRISSO skal igangsættes af en læge med erfaring i anvendelse af anticancerbehandling.
English: Elderly patients (>65 years) or patients with low body weight (<50 kg) may be at increased risk of developing adverse events of Grade 3 or higher.
Danish: Ældre patienter (>65 år) eller patienter med en lav legemsvægt (<50 kg) kan have øget risiko for at udvikle bivirkninger af grad 3 eller højere.
English: One event was reported in a post-marketing study, and the frequency has been derived from the FLAURA and AURA studies and the post-marketing study (N=4720).
Danish: Et tilfælde blev rapporteret i et postmarketingstudie, og hyppigheden er afledt af FLAURA- og AURA-studiet og postmarketingstudiet (N=4720).
English: The main metabolic pathway of osimertinib was oxidation and dealkylation.
Danish: Den vigtigste metaboliseringsvej for osimertinib var oxidation og dealkylering.
English: The dispersion and residues should be administered within 30 minutes of the addition of the tablets to water.
Danish: Suspensionen og efterskylningerne bør administreres inden for 30 minutter efter, tabletten er lagt i vandet.
English: • you have severe peeling of your skin.
Danish: • din hud skaller i alvorlig grad.
English: A HR<1 favours TAGRISSO
Danish: En HR<1 favoriserer TAGRISSO
English: • Reduction in the number of white blood cells (leukocytes, lymphocytesor neutrophils).
Danish: • Nedsat antal hvide blodlegemer (leukocytter, lymfocytter eller neutrofile granulocytter).
English: • If TAGRISSO is the first protein kinase inhibitor medicine you are receiving, it means that your cancer contains defects in the EGFR gene, for example ‘exon 19 deletions' or ‘exon 21 substitution mutations'.
Danish: • Hvis TAGRISSO er den første proteinkinasehæmmende medicin, du får, betyder det, at din kræftsygdom indeholder defekter i EGFR-genet, for eksempel ”exon 19-deletioner” eller ”exon 21-substitutionsmutationer”.
English: (Findings based on test results presented as CTCAE grade shifts)
Danish: (Fund baseret på testresultater præsenteret som skift af
English: The model included patient, treatment, visit, treatment-by-visit interaction, baseline symptom score, and baseline symptom score-by-visit interaction and used an unstructured covariance matrix.
Danish: Modellen omfattede patient, behandling, besøg, treatment-by-visit interaction, baselinesymptomscore og baseline symptom score-by-visit interaction og anvendte en ustruktureret kovariansmatrix.
English: TAGRISSO as monotherapy is indicated for:
Danish: TAGRISSO som monoterapi er indikeret til:
English: • The recommended dose is one 80 mg tablet each day.
Danish: • Den anbefalede dosis er én 80 mg tablet hver dag.
English: Analysis of post-progression end-points demonstrated that the PFS benefit was preserved through subsequent lines of therapy.
Danish: Analyse af postprogressionsendepunkter viste, at PFS-fordelen var bevaret gennem efterfølgende behandlingsforløb.
English: These findings occurred at plasma concentrations that were below those seen in patients at the 80 mg therapeutic dose.
Danish: Disse fund forekom ved plasmakoncentrationer, der var lavere end dem, der ses hos patienter ved den terapeutiske dosis på 80 mg.
English: Administration of osimertinib once daily results in approximately 3 fold accumulation with steady-state exposures achieved by 15 days of dosing.
Danish: Administration af osimertinib én gang dagligt resulterer i ca. 3 gange akkumulering med steady state-eksponering nået efter 15 dages dosering.
English: You must also do this after completing treatment with TAGRISSO:
Danish: Dette skal du gøre efter afslutning af behandling med TAGRISSO:
English: There is no specific treatment in the event of TAGRISSO overdose.
Danish: Der er ingen specifik behandling i tilfælde af overdosering med TAGRISSO.
English: HRQL and physical functioning improvement analysis Both groups reported similar improvements in most functioning domains and global health status/HRQL, indicating that patients' overall health status improved.
Danish: Analyse af HRQL og af forbedring af fysiske funktioner Begge grupper rapporterede lignende forbedringer i de fleste fungerende domæner og almen helbredstilstand/HRQL, hvilket tyder på, at patienternes generelle helbredstilstand blev forbedret.
English: • you are allergic (hypersensitive) to osimertinib or any of the other ingredients of this medicine
Danish: • du er allergisk over for osimertinib eller et af de øvrige indholdsstoffer i dette lægemiddel
English: Seventy-two percent (72%) of patients were never smokers, 100% of patients had a World Health Organization (WHO) performance status of 0 or 1.
Danish: 72 % af patienterne havde aldrig røget, 100 % af patienterne havde World Health Organization (WHO)-funktionsstatus 0 eller 1.
English: TAGRISSO is used to treat adults with a type of lung cancer called ‘non-small cell lung cancer.'
Danish: TAGRISSO anvendes til behandling af voksne med en type lungekræft, som kaldes "ikke-småcellet lungecancer".
English: All cases were isolated incidents of patients taking an additional daily dose of TAGRISSO in error, without any resulting clinical consequences.
Danish: Alle tilfælde var isolerede hændelser hos patienter, der ved en fejl har taget en ekstra daglig dosis af TAGRISSO, uden nogen kliniske konsekvenser.
English: However, if a plasma-based ctDNA test is used and the result is negative, it is advisable to follow-up with a tissue test wherever possible due to the potential for false negative results using a plasma-based test.
Danish: Hvis der anvendes en plasmabaseret ctDNA-test, og resultatet er negativt, anbefales det så vidt muligt at følge op med en vævsbaseret test på grund af potentialet for falsk negative resultater ved en plasmabaseret test.
English: Similarly, the exposure to metabolite AZ5104 decreased by 82% for the AUC and 78% for Cmax.
Danish: Ligeledes faldt eksponeringen af metabolit AZ5104 med 82 % for AUC og 78 % for Cmax.
English: Secondary efficacy outcome measures included Duration of Response (DoR) and Progression-Free Survival (PFS).
Danish: De sekundære effektmål omfattede varighed af respons (DoR) og progressionsfri overlevelse (PFS).
English: If dose reduction is necessary, then the dose should be reduced to 40 mg taken once daily.
Danish: Hvis dosisreduktion er nødvendig, skal dosis reduceres til 40 mg én gang dagligt.
English: Grade 3 or higher adverse reaction that does not improve to Grade 0-2 after withholding for up to 3 weeks
Danish: Bivirkning af grad 3 eller højere, som ikke forbedres til grad 0-2 efter afbrydelse i op til 3 uger
English: The safety and efficacy of TAGRISSO in children or adolescents aged less than 18 years have not been established.
Danish: TAGRISSOs sikkerhed og virkning hos børn og unge i alderen under 18 år er ikke klarlagt.
English: Osimertinib may increase the exposure of breast cancer resistant protein (BCRP) and P-glycoprotein (P-gp) substrates.
Danish: Osimertinib kan øge eksponeringen af brystcancerresistent protein (BCRP) og P-glykoprotein (P-gp) substrater.
English: Note: The intensity of clinical adverse events graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Danish: Note: Intensiteten af kliniske bivirkninger klassificeret af National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
English: In the evaluable for response population, 85% (223/262) had documentation of response at the time of the first scan (6 weeks); 94% (247/262) had documentation of response at the time of the second scan (12 weeks).
Danish: I populationen, der var evaluerbar for respons, havde 85 % (223/262) dokumenteret respons på tidspunktet for første scanning (6 uger); 94 % (247/262) havde dokumentation for respons på tidspunktet for anden scanning (12 uger).
English: The primary efficacy outcome measure of these two trials was ORR according to RECIST v1.1 as evaluated by a Blinded Independent Central Review (BICR).
Danish: Det primære effektmål i disse to studier var ORR ifølge RECIST v1.1, evalueret ved en blindet uafhængig central gennemgang (BICR).
English: In addition, the corresponding frequency category for each adverse reaction is based on the CIOMS III convention and is defined as: 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 available data).
Danish: Derudover er den tilhørende frekvenskategori for hver bivirkning anført, baseret på CIOMS III-konventionen og defineret som: 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); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Grade 3 and Grade 4 adverse reactions across both studies were 9.7% and 0.9%, respectively.
Danish: Bivirkninger af grad 3 og grad 4 på tværs af de 2 studier var henholdsvis 9,7 % og 0,9 %.
English: Intestinal inhibition of UGT1A1 is possible but the clinical impact is unknown.
Danish: Intestinal hæmning af UGT1A1 er mulig, men den kliniske relevans er ukendt.