FrancophonIA/ELRC3.0 huggingface dataset:
English: A sensitivity analysis of PFS was conducted by a Blinded Independent Central Review (BICR) and showed a median PFS of 11.0 months with TAGRISSO compared with 4.2 months with chemotherapy.
Danish: Der blev udført en sensitivitetsanalyse af PFS ved en blindet uafhængig central gennemgang (BICR), som viste en median PFS på 11,0 måneder med TAGRISSO sammenlignet med 4,2 måneder med kemoterapi.
English: Patient Reported Outcomes (PRO)
Danish: Patientrapporterede resultater (PRO)
English: In a modified embryofoetal development study in the rat, osimertinib caused embryolethality when administered to pregnant rats prior to embryonic implantation.
Danish: I et modificeret embryoføtalt udviklingsstudie hos rotter forårsagede osimertinib embryoletalitet, når det blev administreret til drægtige rotter inden embryo-implantation.
English: Following a single oral dose of 20 mg, 67.8% of the dose was recovered in faeces (1.2% as parent) while 14.2% of the administered dose (0.8% as parent) was found in urine by 84 days of sample collection.
Danish: Efter en enkelt dosis på 20 mg blev 67,8 % af dosen genfundet i fæces (1,2 % som uomdannet stof), mens 14,2 % af den administrerede dosis (0,8 % som uomdannet stof) blev genfundet i urinen efter 84 dages prøveindsamling.
English: There is insufficient information on the excretion of osimertinib or its metabolites in animal milk.
Danish: Der er utilstrækkelig information om udskillelse af osimertinib eller dets metabolitter i mælken hos dyr.
English: In patients who develop relevant cardiac signs/symptoms during treatment, cardiac monitoring including LVEF assessment should be considered.
Danish: Hos patienter, der udvikler relevante kardielle symptomer under behandlingen, bør kardiel monitorering, herunder LVEF-vurdering, overvejes.
English: This is because TAGRISSO can affect the way some other medicines work.
Danish: Dette skyldes, at TAGRISSO kan påvirke den måde, hvorpå anden medicin virker, og nogle andre lægemidler kan påvirke den måde, hvorpå TAGRISSO virker.
English: Yellow iron oxide (E 172) Red iron oxide (E 172) Black iron oxide (E 172)
Danish: Gul jernoxid (E 172) Rød jernoxid (E 172) Sort jernoxid (E 172)
English: This leads to inhibition of cell growth, while showing significantly less activity against EGFR in wild-type cell lines (apparent IC50s from 480 nM to 1.8 μM against phospho-EGFR).
Danish: Dette medfører hæmning af cellevækst, mens der er vist signifikant lavere aktivitet mod EGFR i vildtype-cellelinjer (tilsyneladende IC50'er fra 480 nM til 1,8 μM mod phosphoEGFR).
English: Osimertinib penetrated the intact blood-brain barrier of the cynomolgus monkey (i.v.
Danish: Osimertinib penetrerede i den intakte blodhjernebarriere hos cynomolgusaben (i.v.
English: Patients whose disease has not progressed after four cycles of platinum-based chemotherapy may receive pemetrexed maintenance therapy (pemetrexed 500 mg/m2 on Day 1 of every 21-day cycle).
Danish: Patienter, hvis sygdom ikke var progredieret efter fire cyklusser platinbaseret kemoterapi, kunne få vedligeholdelsesbehandling med pemetrexed (pemetrexed 500 mg/m2 på dag 1 i hver 21-dages cyklus).
English: The AUC and Cmax increased dose proportionally over 20 to 240 mg dose range.
Danish: AUC og Cmax steg dosisproportionalt i intervallet 20-240 mg.
English: Taking the extremes of body weight into consideration, from <43 kg to >88 kg, AZ5104 metabolite ratios ranged from 11.8% to 9.6% while for AZ7550 it ranged from 12.8% to 8.1%, respectively.
Danish: Når der tages hensyn til yderpunkterne i legemsvægt, fra <43 kg til >88 kg, varierede ratioerne for AZ5104-metabolitten fra 11,8 % til 9,6 %, mens ratioerne for AZ7550 varierede fra henholdsvis 12,8 % til 8,1 %.
English: The following medicines may reduce how well TAGRISSO works:
Danish: Nedenstående medicin kan nedsætte TAGRISSOs virkning:
English: Degenerative changes were present in the testes in rats and dogs exposed to osimertinib for ≥1 month and there was a reduction in male fertility in rats following exposure to osimertinib for 3 months.
Danish: Degenerative forandringer var til stede i testiklerne hos rotter og hunde, som var blevet eksponeret for osimertinib i ≥1 måned, og der var nedsat fertilitet hos hanrotter efter eksponering for osimertinib i 3 måneder.
English: Studies in animals have shown reproductive toxicity (embryolethality, reduced foetal growth, and neonatal death, see section 5.3).
Danish: Dyrestudier har vist reproduktionstoksicitet (embryoletalitet, nedsat fostervækst og neonatal død, se pkt.
English: In TAGRISSO clinical trials a limited number of patients were treated with daily doses of up to 240 mg without dose limiting toxicities.
Danish: I kliniske studier med TAGRISSO blev et begrænset antal patienter behandlet med daglige doser TAGRISSO på op til 240 mg uden dosisbegrænsende toksicitet.
English: These patients received TAGRISSO at a dose of 80 mg daily in two randomised Phase 3 studies (FLAURA, first line and AURA3, second line only), two single-arm studies (AURAex and AURA2, second line or greater) and one Phase 1 study (AURA1, first-line or greater) (see section 5.1).
Danish: Disse patienter fik TAGRISSO i en dosis på 80 mg dagligt i to randomiserede fase 3-studier (FLAURA, første linje og AURA3 kun som anden linje), to enkeltarmede studier (AURAex og AURA2, anden linje eller højere) og et fase 1-studie (AURA1, første linje eller højere) (se pkt.
English: The incidence of ILD was 10.4% in patients of Japanese ethnicity, 1.8% in patients of Asian ethnicity and 2.8% in non-Asian patients (see section 4.8).
Danish: Forekomsten af ILD var 10,4 % hos patienter af japansk etnicitet, 1,8 % hos patienter af asiatisk etnicitet og 2,8 % hos ikke-asiatiske patienter (se pkt.
English: It is recommended that concomitant use of strong CYP3A inducers (e.g. Phenytoin, rifampicin and carbamazepine) with TAGRISSO should be avoided.
Danish: Det anbefales at undgå samtidig brug af potente CYP3A-induktorer (fx phenytoin, rifampicin og carbamazepin) og TAGRISSO.
English: In case of suspected overdose, TAGRISSO should be withheld and symptomatic treatment initiated.
Danish: Ved mistanke om overdosering bør TAGRISSO seponeres og symptomatisk behandling indledes.
English: In the FLAURA and AURA studies, diarrhoea was reported in 49% of patients of which 39% were Grade 1 events, 8.0% Grade 2 and 1.2% were Grade 3; no Grade 4 or 5 events were reported.
Danish: I FLAURA- og AURA-studierne blev diarré rapporteret hos 49 % af patienterne, hvoraf 39 % var grad 1-tilfælde, 8,0 % grad 2 og 1,2 % grad 3; der blev ikke rapporteret grad 4 eller 5 tilfælde.
English: Based on population pharmacokinetic analysis, osimertinib apparent plasma clearance is 14.3 L/h, apparent volume of distribution is 918 L and terminal half-life of approximately 44 hours.
Danish: Baseret på farmakokinetisk populationsanalyse er osimertinibs tilsyneladende clearance 14,3 l/t, det tilsyneladende distributionsvolumen er 918 l, og den terminale halveringstid ca. 44 timer.
English: Periodic monitoring with electrocardiograms (ECGs) and electrolytes should be considered in patients with congestive heart failure, electrolyte abnormalities, or those who are taking medicinal products that are known to prolong the QTc interval.
Danish: Regelmæssig monitorering med elektrokardiogram (EKG) og elektrolytter bør overvejes hos patienter med kongestivt hjertesvigt eller elektrolytforstyrrelser og hos patienter, som tager lægemidler, der er kendt for at forlænge QTc-intervallet.
English: Contraception in males and females
Danish: Antikonception hos mænd og kvinder
English: Based on studies in animals, female fertility may be impaired by treatment with osimertinib.
Danish: På baggrund af dyrestudier kan fertiliteten hos hunner være nedsat ved behandling med osimertinib.
English: • If you develop watery eyes, sensitivity to light, eye pain, eye redness, or vision changes.
Danish: • Hvis dine øjne begynder at løbe i vand, bliver følsomme for lys, du får øjensmerter, røde øjne eller synsforandringer.
English: Time from randomisation to second subsequent treatment or death (TSST)
Danish: Tid fra randomisering til anden efterfølgende behandling eller død (TSST)
English: In the 411 pre-treated EGFR T790M mutation-positive patients, the total ORR by Blinded Independent Central Review (BICR) was 66% (95% CI: 61, 71).
Danish: Hos de 411 tidligere behandlede EGFR T790M-mutationspositive patienter var den samlede ORR efter blindet uafhængig central gennemgang (BICR) 66 % (95 % CI: 61; 71).
English: • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: • Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: No clinical studies have been conducted to specifically evaluate the effect of renal impairment on the pharmacokinetics of osimertinib.
Danish: Der er ikke udført kliniske studier for specifikt at evaluere effekten af nedsat nyrefunktion på osimertinibs farmakokinetik.
English: • Stevens-Johnson syndrome, which can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and be preceded by fever and flu-like symptoms.
Danish: • Stevens-Johnsons syndrom, der kan forekomme som rødlige målskivelignende pletter eller runde områder, ofte med blærer centralt på kroppen, afskalning af hud, sår i mund, hals, næse, på kønsorganer og i øjnene, og som kommer efter feber og influenzalignende symptomer.
English: Rare (0.02%)
Danish: Sjælden (0,02 %)
English: Your doctor may wish to stop TAGRISSO if you get this side effect.
Danish: Lægen kan beslutte, at du skal stoppe med at tage TAGRISSO, hvis du får denne bivirkning.
English: Time from randomisation to first subsequent treatment or death (TFST)
Danish: Tid fra randomisering til første efterfølgende behandling eller død (TFST)
English: If you have trouble swallowing the tablet, you can mix it in water:
Danish: Hvis du har svært ved at synke tabletten, kan du blande den op i vand: • Put tabletten i et glas.
English: No dose adjustment is recommended in patients with mild, moderate, or severe renal impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let, moderat eller svært nedsat nyrefunktion.
English: Data is cumulative from FLAURA and AURA (AURA3, AURAex, AURA 2 and AURA1) studies; only events for patients receiving at least one dose of TAGRISSO as their randomised treatment are summarised.
Danish: Data er kumulative fra FLAURA og AURA (AURA3, AURAex, AURA2 og AURA1)-studierne; kun bivirkninger hos patienter, der fik mindst én dosis TAGRISSO som deres randomiserede behandling, er medtaget.
English: The median PFS was 11.0 months 95% CI (9.6, 12.4).
Danish: Median PFS var 11,0 måneder (95 % CI: 9,6; 12,4).
English: Active substances whose plasma concentrations may be altered by TAGRISSO Based on in vitro studies, osimertinib is a competitive inhibitor of BCRP transporters.
Danish: Aktive substanser, hvis plasmakoncentration kan ændres af TAGRISSO Baseret på in vitro-studier er osimertinib en kompetitiv hæmmer af BCRP-transportører.
English: Osimertinib pharmacokinetic parameters have been characterised in healthy subjects and NSCLC patients.
Danish: Osimertinibs farmakokinetiske parametre er undersøgt hos raske forsøgspersoner og NSCLC-patienter.
English: This side effect is common: it may affect up to 1 in 10 people.
Danish: Denne bivirkning er almindelig: kan forekomme hos op til 1 ud af 10 personer.
English: Strong CYP3A4 inducers can decrease the exposure of osimertinib.
Danish: Potente CYP3A4-induktorer kan nedsætte eksponeringen af osimertinib.
English: The LC13 was initially administered once a week for the first 6 weeks, then every 3 weeks before and after progression.
Danish: LC13 blev indledningsvis anvendt en gang ugentligt i de første 6 uger, derefter hver 3. uge før og efter progression.
English: Population estimated mean volume of distribution at steady-state (Vss/F) of osimertinib is 918 L indicating extensive distribution into tissue.
Danish: Det populationsestimerede gennemsnitlige fordelingsvolumen for osimertinib ved steady state (Vss/F) er 918 l, hvilket indikerer ekstensiv fordeling til væv.
English: Only robust, reliable and sensitive tests with demonstrated utility for the determination of EGFR mutation status of tumour derived DNA (from a tissue or a plasma sample) should be used.
Danish: Der må kun anvendes tests, der er påvist robuste, pålidelige og sensitive til bestemmelse af EGFR-mutationsstatus af tumorafledt DNA (fra en vævs- eller plasmaprøve).
English: • The active substance is osimertinib (as mesylate).
Danish: • Aktivt stof: osimertinib (som mesylat).
English: In patients treated with TAGRISSO 80 mg once daily, dose reductions due to adverse reactions occurred in 2.1% of the patients.
Danish: Hos patienter, der blev behandlet med TAGRISSO 80 mg én gang dagligt, blev dosis reduceret hos 2,1 % af patienterne på grund af bivirkninger.
English: Gastric pH modifying agents can be concomitantly used with TAGRISSO without any restrictions.
Danish: Mavesyremodificerende midler kan anvendes sammen med TAGRISSO uden restriktioner.
English: Data collected from baseline up to month 9 showed similar improvements in TAGRISSO and EGFR TKI comparator groups for the five pre-specified primary PRO symptoms (cough, dyspnoea, chest pain, fatigue, and appetite loss) with improvement in cough reaching the established clinically relevant cutoff.
Danish: Data indsamlet fra baseline til og med 9. måned viste tilsvarende forbedringer i TAGRISSO og EGFR TKI-komparatorgrupperne for de fem præspecificerede primære PRO-symptomer (hoste, dyspnø, brystsmerter, træthed og appetitløshed) med forbedring af hoste, der nåede det etablerede klinisk relevante mål.
English: This medicine contains 0.3 mg sodium per 40 mg tablet and 0.6 mg sodium per 80 mg tablet.
Danish: Denne medicin indeholder 0,3 mg natrium per 40 mg tablet og 0,6 mg natrium per 80 mg tablet.
English: Patient tumour tissue samples were required to have one of the two common EGFR mutations known to be associated with EGFR TKI sensitivity (Ex19del or L858R), as identified by local or central testing.
Danish: Tumorvævsprøver fra patienter skulle have en af de to almindelige EGFR-mutationer, der vides at være associeret med EGFR TKI-sensitivitet (Ex19del eller L858R), identificeret ved lokal eller central testning.
English: These findings showed evidence of reversibility following a 1 month off-dose.
Danish: Disse resultater viste tegn på reversibilitet 1 måned efter seponering.
English: 30 x 1 film-coated tablets 28 x 1 film-coated tablets
Danish: 30 x 1 filmovertrukne tabletter 28 x 1 filmovertrukne tabletter
English: When osimertinib was administered to pregnant female rats throughout gestation and then through early lactation, there was demonstrable exposure to osimertinib and its metabolites in suckling pups plus a reduction in pup survival and poor pup growth (at doses of 20 mg/kg and above).
Danish: Når osimertinib blev administreret til drægtige hunrotter under hele drægtighedsperioden og derefter under den tidlige diegivning, var der påviselig eksponering for osimertinib og dets metabolitter hos diende unger samt en reduktion i afkommets overlevelse og ringe vækst af afkommet (ved doser på 20 mg/kg og derover).
English: When considering the use of TAGRISSO as a treatment for locally advanced or metastatic NSCLC, it is important that the EGFR mutation positive status is determined.
Danish: Når det overvejes at anvende TAGRISSO som behandling til lokalt fremskreden eller metastatisk NSCLC, er det vigtigt at bestemme EGFR-mutationspositiv status.
English: Based on its mechanism of action and preclinical data, osimertinib may cause foetal harm when administered to a pregnant woman.
Danish: Baseret på virkningsmekanismen og prækliniske data kan osimertinib forårsage fosterskader, hvis det gives til en gravid kvinde.
English: No dosage adjustment is required due to patient age, body weight, gender, ethnicity and smoking status (see section 5.2).
Danish: Dosisjustering er ikke nødvendig på grund af patientens alder, vægt, køn, etnicitet eller rygestatus (se pkt.
English: Mixed Model Repeated Measures - Key lung cancer symptoms - mean change from baseline in TAGRISSO patients compared with chemotherapy
Danish: Blandet model for gentagne målinger (MMRM) - hovedsymptomer på lungecancermiddelændring fra baseline hos TAGRISSO-patienter sammenlignet med kemoterapi
English: The resulting 30 mL of liquid should be administered as per the naso-gastric tube manufacturer's instructions with appropriate water flushes.
Danish: Det resulterende volumen på 30 ml væske skal administreres i henhold til vejledningen fra fremstilleren af den nasogastriske sonde med passende efterskylninger.
English: In FLAURA and AURA3 (N=1142), 43% of patients were 65 years of age and older, and 13% were 75 years of age and older.
Danish: I FLAURA og AURA3 (N=1.142) var 43 % af patienterne ≥ 65 år, og 13 % var ≥ 75 år.
English: Based on in vitro studies, 2 pharmacologically active metabolites (AZ7550 and AZ5104) have subsequently been identified in the plasma of preclinical species and in humans after oral dosing with osimertinib; AZ7550 showed a similar pharmacological profile to TAGRISSO while AZ5104 showed greater potency across both mutant and wild-type EGFR.
Danish: På baggrund af in vitro-studier er 2 farmakologisk aktive metabolitter (AZ7550 og AZ5104) efterfølgende blevet identificeret i plasma fra arter fra prækliniske studier og hos mennesker efter oral dosering med osimertinib; AZ7550 viste en tilsvarende farmakologisk profil som TAGRISSO, mens AZ5104 er mere potent over for både muteret EGFR og vildtype-EGFR.
English: Patient-reported symptoms and health-related quality of life (HRQL) were electronically collected using the EORTC QLQ-C30 and its lung cancer module (EORTC QLQ-LC13).
Danish: Patientrapporterede symptomer og helbredsrelateret livskvalitet (HRQL) blev indsamlet elektronisk under anvendelse af EORTC QLQ-C30 og dets lungecancermodul (EORTC QLQ-LC13).
English: Clinical studies that were conducted excluded patients with AST or ALT >2.5x upper limit of normal (ULN), or if due to underlying malignancy, >5.0x ULN or with total bilirubin >1.5x ULN.
Danish: De kliniske studier, der blev udført, udelukkede patienter med ASAT eller ALAT >2,5x øvre normalgrænse (ULN) eller, hvis det skyldtes underliggende malignitet, >5,0 x ULN eller med total-bilirubin >1,5 x ULN.
English: It is an irreversible inhibitor of Epidermal Growth Factor Receptors (EGFRs) harboring sensitising-mutations (EGFRm) and TKI-resistance mutation T790M.
Danish: Det er en irreversibel hæmmer af epidermal vækstfaktor-receptorer (EGFR'er) med sensibiliseringsmutationer (EGFRm) og TKI-resistensmutation T790M.
English: A CNS ORR of 54% (27/50 patients; 95% CI: 39.3, 68.2) was observed with 12% of these responses being complete responses.
Danish: Der blev observeret en CNS-ORR på 54 % (27/50 patienter; 95 % CI: 39,368,2), og 12 % af disse responser var komplette responser.
English: Keratitis was reported in 0.7% (n=8) of the 1142 patients treated with TAGRISSO in the FLAURA and AURA studies.
Danish: Keratitis blev rapporteret hos 0,7 % (n=8) af de 1.142 patienter, der blev behandlet med TAGRISSO i FLAURA- og AURA-studierne.
English: When considering the use of TAGRISSO, EGFR mutation status in tumour or plasma specimens should be determined using a validated test method (see section 4.4).
Danish: Når det overvejes at anvende TAGRISSO bør EGFR-mutationsstatus i tumor eller plasmaprøver bestemmes under anvendelse af en valideret testmetode (se pkt.
English: Results from animal studies have shown that osimertinib has effects on male and female reproductive organs and could impair fertility (see section 5.3).
Danish: Resultater fra dyrestudier har vist, at osimertinib har indvirkning på kønsorganer hos hanner og hunner og kan forringe fertiliteten (se pkt.
English: Studies in EGFR mutation-positive NSCLC patients The data described below reflect exposure to TAGRISSO in 1142 patients with EGFR mutationpositive non-small cell lung cancer.
Danish: Studier hos EGFR-mutationspositive NSCLC-patienter De nedenfor beskrevne data viser eksponering for TAGRISSO hos 1.142 patienter med EGFR-mutationspositiv ikke-småcellet lungecancer.
English: In patients with cardiac risk factors and those with conditions that can affect LVEF, cardiac monitoring, including an assessment of LVEF at baseline and during treatment, should be considered.
Danish: Hos patienter med kardielle risikofaktorer eller sygdomme, der kan påvirke LVEF, bør kardiel monitorering, herunder vurdering af LVEF ved baseline og under behandlingen, overvejes.
English: • Bosentan - used for high blood pressure in the lungs.
Danish: • Bosentan - bruges mod forhøjet blodtryk i lungerne
English: Patients were randomised 1:1 to receive either TAGRISSO (n=279, 80 mg orally once daily) or EGFR TKI comparator (n=277; gefitinib 250 mg orally once daily or erlotinib 150 mg orally once daily).
Danish: Patienterne blev randomiseret 1:1 til enten at få TAGRISSO (n=279, 80 mg oralt en gang daglig) eller EGFR TKI-komparator (n=277; gefitinib 250 mg oralt en gang daglig eller erlotinib 150 mg oralt en gang daglig).
English: • If your partner becomes pregnant while you are taking this medicine, tell your doctor straight away.
Danish: • Hvis din partner bliver gravid, mens du tager dette lægemiddel, skal du straks fortælle det til din læge.
English: Active substances that may increase osimertinib plasma concentrations In vitro studies have demonstrated that the Phase I metabolism of osimertinib is predominantly via CYP3A4 and CYP3A5.
Danish: Aktive substanser, der kan øge plasmakoncentrationen af osimertinib In vitro-studier har vist, at fase I-metaboliseringen af osimertinib hovedsageligt sker via CYP3A4 og CYP3A5.
English: Efficacy results from FLAURA by investigator assessment
Danish: Effektresultater fra FLAURA efter investigators vurdering
English: However, osimertinib and its metabolites were detected in the suckling pups and there were adverse effects on pup growth and survival (see section 5.3).
Danish: Osimertinib og dets metabolitter blev imidlertid påvist hos det diende afkom, og der var negativ indvirkning på afkommets vækst og overlevelse (se pkt.
English: The ORR by BICR in AURAex was 62% (95% CI: 55, 68) and 70% (95% CI: 63, 77) in AURA2.
Danish: ORR i henhold til BICR i AURAex var 62 % (95 % CI: 55; 68) og 70 % (95 % CI: 63; 77) i AURA2.
English: Patients with CNS metastases not requiring steroids and with stable neurologic status for at least two weeks after completion of the definitive therapy and steroids were eligible to be randomised in the FLAURA study.
Danish: Patienter med CNS-metastaser, der ikke krævede steroider, og med stabil neurologisk status i mindst to uger efter afsluttet definitiv og steroid-behandling, var kvalificerede til at blive randomiseret til FLAURA-studiet.
English: Based on a pharmacokinetic analysis of 134 patients with mild hepatic impairment, 8 patients with moderate hepatic impairment and 1216 patients with normal hepatic function osimertinib exposures were similar.
Danish: Baseret på en farmakokinetisk analyse af 134 patienter med let nedsat leverfunktion, 8 patienter med moderat nedsat leverfunktion og 1.216 patienter med normal leverfunktion var eksponeringerne for osimertinib sammenlignelige.
English: If you forget to take TAGRISSO
Danish: Hvis du har glemt at tage TAGRISSO
English: • the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
Danish: • førstelinjebehandling af voksne patienter med lokalt fremskreden eller metastatisk ikkesmåcellet lungecancer (NSCLC) med aktiverende epidermal vækstfaktorreceptor (EGFR)-mutationer.