FrancophonIA/ELRC3.0 huggingface dataset:
English: The final analysis conducted at a median follow-up of 62 months confirmed the significant reduction in the risk of breast cancer recurrence with {Invented Name}.
Danish: Den endelige analyse, der blev udført ved en median opfølgningsperiode på 62 måneder, bekræftede, at {X} reducerer risikoen for tilbagefald af brystcancer signifikant.
English: In a study involving 19 volunteers with varying degrees of renal function (24-hour creatinine clearance 9116 ml/min) no effect on the pharmacokinetics of letrozole was found after a single dose of 2.5 mg.
Danish: I et studie med 19 frivillige med varierende grader af nyrefunktion (24-timers kreatininclearance 9-116 ml/min) fandtes ingen påvirkning af letrozols farmakokinetik efter administration af 2,5 mg som enkeltdosis.
English: • Advanced breast cancer after relapse or disease progression, in women with natural or artificially induced postmenopausal endocrine status, who have previously been treated with anti-oestrogens.
Danish: • Fremskreden brystcancer efter relaps eller progression hos kvinder i naturlig eller kunstigt induceret postmenopausal endokrin status, som tidligere har været i behandling med antiøstrogener.
English: Protocol definition, including second non-breast primary malignancies, after switch / beyond two years
Danish: 1 Protokol-definition, inklusive anden (ikke-brystcancer) primær tumor, efter skift/ud over 2 år 2 Justeret for brug af kemoterapi
English: No patient with a normal BMD at baseline became osteoporotic during 2 years of treatment and only 1 patient with osteopenia at baseline (T score of -1.9) developed osteoporosis during the treatment period (assessment by central review).
Danish: Ingen patienter med normal BMD ved studiestart blev osteoporotiske under de 2 års behandling, og kun 1 patient med osteopeni ved studiestart (T-score på -1,9) udviklede osteoporose i behandlingsperioden (bedømt ved central gennemgang).
English: There is no clinical experience to date on the use of {Invented Name} in combination with oestrogens or other anticancer agents, other than tamoxifen.
Danish: Der er ingen klinisk erfaring vedrørende anvendelse af {X} i kombination med østrogener eller andre anticancermidler end tamoxifen.
English: Primary Core Analysis Median follow-up 26 months
Danish: Primær analyse Median opfølgning 26 måneder
English: Pharmacotherapeutic group: Endocrine therapy.
Danish: Farmakoterapeutisk klassifikation: Endokrin behandling.
English: In the MA-17 bone substudy in which concomitant calcium and vitamin D were given, greater decreases in BMD compared to baseline occurred with {Invented Name} compared with placebo.
Danish: I knogle-substudiet til MA-17, hvor samtidig calcium og vitamin D blev indgivet, opstod større fald i BMD i forhold til baseline for {X} sammenlignet med placebo.
English: 3 Observations in the tamoxifen arm censored at the date of selectively switching to letrozole
Danish: 3 Observationerne i tamoxifen-armen er vurderet på tidpunktet for selektivt skift til letrozol.
English: Cimetidine, a weak, unspecific inhibitor of CYP450 enzymes, did not affect the plasma concentrations of letrozole.
Danish: Cimetidin, en svag, uspecifik CYP-hæmmer, påvirkede ikke plasmakoncentrationen af letrozol.
English: Food slightly decreases the rate of absorption (median tmax 1 hour fasted versus 2 hours fed; and mean Cmax 129 ± 20.3 nmol/litre fasted versus 98.7 ± 18.6 nmol/litre fed) but the extent of absorption (AUC) is not changed.
Danish: Fødeindtagelse nedsætter absorptionshastigheden en smule (median tmax fastende er 1 time versus 2 timer ved fødeindtagelse, og middel-Cmax 129 ± 20,3 nmol/l fastende versus 98,7 ± 18,6 nmol/l ved fødeindtagelse), medens absorptionsfraktionen (AUC) er uforandret.
English: Based on clinical assessment there were 55% objective responses in the {Invented Name} arm versus 36% for the tamoxifen arm (P<0.001).
Danish: Baseret på den kliniske vurdering var der 55% objektive respons i {X}-armen versus 36% i tamoxifen-armen (p<0,001).
English: Study D2407 is an open-label, randomised, multicentre post approval safety study designed to compare the effects of adjuvant treatment with letrozole and tamoxifen on bone mineral density (BMD) and serum lipid profiles.
Danish: Studie D2407 er et åbent, randomiseret multicenter-studie designet som et fase 4-sikkerhedsstudie med henblik på at sammenligne effekten af adjuverende behandling med letrozol og tamoxifen på knoglemineraltæthed (BMD) og serumlipidprofil.
English: In the MENQOL scale, significantly more women in the {Invented Name} arm than in the placebo arm were most bothered (generally in the first year of treatment) by those symptoms deriving from oestrogen deprivation - hot flushes and vaginal dryness.
Danish: På MENQOL-skalaen var der signifikant flere kvinder i {X}-armen end i placebo-armen, der var generet (normalt i det første år af behandlingen) af de symptomer, som opstår ved østrogenmangel - hedeture og vaginal tørhed.
English: Significantly less than with {Invented Name} monotherapy ** Significantly more than with {Invented Name} monotherapy Note : Reporting period is during treatment or within 30 days of stopping treatment
Danish: Vaginalblødning * Signifikant mindre end med {X} monoterapi ** Signifikant større end med {X} monoterapi Bemærk: Rapporteringsperiode er under behandlingen eller inden for 30 dage efter behandlingsophør
English: Your doctor may decide to measure your bone density (a way of monitoring for osteoporosis) before, during and after treatment.
Danish: Dette betyder, at din læge kan beslutte at måle mineralindholdet i dine knogler (knoglemineraltætheden en metode til at kontrollere osteoporose) før, under og efter behandlingen.
English: Over 60% of eligible patients (disease-free at unblinding) opted to switch to {Invented Name}.
Danish: Over 60% af de kvalificerede patienter (forudsat at de var sygdomsfri på tidpunktet for afblinding) valgte at skifte til {X}.
English: The first planned interim analysis at a median follow-up of around 28 months (25% of patients being followed up for at least 38 months), showed that {Invented Name} significantly reduced the risk of breast cancer recurrence by 42% compared with placebo (HR 0.58; 95% CI 0.45, 0.76; P=0.00003).
Danish: Den første planlagte interimanalyse, udført ved en median opfølgningstid på ca. 28 måneder (25% af patienterne blev fulgt mindst 38 måneder) viste, at {X} reducerede risikoen for tilbagefald af brystcancer signifikant med 42% sammenlignet med placebo (relativ risiko 0,58; 95% KI 0,45-0,76; p=0,00003).
English: The effect of potent CYP450 inhibitors is unknown.
Danish: Effekten af potente CYP-hæmmere er ukendt.
English: There were no significant differences in DFS, OS, SDFS or DDFS in any of the STA from randomisation pairwise comparisons (Table 7).
Danish: Der var ingen signifikante forskelle i DFS, OS, SDFS eller DDFS i nogle STA fra randomiseringens parvise sammenligning (Tabel 7).
English: Median follow-up 60 months
Danish: Median opfølgning 60 måneder
English: What {Invented Name} is used for {Invented Name} is used to treat breast cancer in women who have gone through menopause i.e cessation of periods.
Danish: Hvad {X} bruges til {X} bruges til at behandle brystkræft hos kvinder, der har passeret menopausen, dvs. efter ophør af menstruationer.
English: The most frequently reported adverse reactions in clinical studies were hot flushes, hypercholesterolaemia, arthralgia, fatigue, increased sweating and nausea.
Danish: De hyppigst rapporterede bivirkninger i de kliniske studier var hedeture, hyperkolesterolæmi, artralgi, træthed, øget svedtendens og kvalme.
English: {Invented Name} treatment in the first-line therapy of advanced breast cancer resulted in a median overall survival of 34 months compared with 30 months for tamoxifen (logrank test P=0.53, not significant).
Danish: {X}-behandling som første-linje-behandling af fremskreden brystcancer resulterede i en gennemsnitlig total overlevelse på 34 måneder sammenlignet med 30 måneder for tamoxifen (log-rank-test p=0,53; ikke signifikant).
English: The frequencies of adverse reactions for {Invented Name} are mainly based on data collected from clinical trials.
Danish: Tabel over bivirkninger Bivirkningsfrekvenserne for {X} er hovedsagelig baseret på data indsamlet fra kliniske studier.
English: Median time to progression was 12.1 months for {Invented Name} and 6.4 months for tamoxifen in patients with soft tissue disease only and median 8.3 months for {Invented Name} and 4.6 months for tamoxifen in patients with visceral metastases.
Danish: Mediantid til progression var 12,1 måneder for {X} og 6,4 måneder for tamoxifen hos patienter med sygdom udelukkende i bløddele og 8,3 måneder for {X} og 4,6 måneder for tamoxifen hos patienter med viscerale metastaser.
English: Isolated cases of overdose with {Invented Name} have been reported.
Danish: Der er rapporteret om isolerede tilfælde af overdosering med {X}.
English: Plasma levels of LH and FSH are not affected by letrozole in patients, nor is thyroid function as evaluated by TSH, T4, and T3 uptake test.
Danish: Plasmakoncentrationen af LH eller FSH påvirkes ikke af behandling med letrozol, det samme gælder thyreoideafunktionen bedømt ved TSH, T4 og T3.
English: Male breast cancer Use of {Invented Name} in men with breast cancer has not been studied.
Danish: Brystcancer hos mænd Anvendelse af {X} til mænd med brystcancer er ikke blevet undersøgt.
English: Thus, {Invented Name} should be administered with caution to patients with severe hepatic impairment and after consideration of the risk/benefit in the individual patient.
Danish: {X} bør derfor gives med forsigtighed til patienter med svært nedsat leverfunktion og under opvejning af risici og fordele for den enkelte patient.
English: In a similar study involving subjects with varying degrees of hepatic function, the mean AUC values of the volunteers with moderate hepatic impairment (Child-Pugh B) was 37% higher than in normal subjects, but still within the range seen in subjects without impaired function.
Danish: I et tilsvarende studie, hvori personer med varierende grader af leverfunktion indgik, var AUC hos frivillige med moderat nedsat leverfunktion (Child-Pugh B) 37% højere end hos personer med normal leverfunktion, men var dog stadig inden for det interval, der sås hos personer uden nedsat leverfunktion.
English: Some of these side effects, such as hot flushes, hair loss or vaginal bleeding, may be due to the lack of oestrogens in your body.
Danish: Nogle af disse bivirkninger, som fx hedeture, hårtab og menstruationslignende blødning, kan skyldes østrogenmangel i kroppen.
English: Coadministration of letrozole with tamoxifen, other anti-oestrogens or oestrogens should be avoided.
Danish: Samtidig administration af letrozol og tamoxifen, andre antiøstrogener eller østrogener bør undgås.
English: What {Invented Name} is and what it is used for What you need to know before you take {Invented Name} How to take {Invented Name} Possible side effects
Danish: Virkning og anvendelse Det skal du vide, før du begynder at tage {X} Sådan skal du tage {X} Bivirkninger
English: (95% CI for rate) Odds ratio (95% CI for odds ratio) P
Danish: (95% KI for rate) Odds ratio (95% KI for oddsratio) p
English: Up to approximately one third of the patients treated with {Invented Name} in the metastatic setting and approximately 80% of the patients in the adjuvant setting as well as in the extended adjuvant setting experienced adverse reactions.
Danish: Op til omkring en tredjedel af patienterne behandlet med {X} ved metastasebehandling og omkring 80% af patienterne i adjuverende behandling eller forlænget adjuverende behandling oplevede bivirkninger.
English: No specific treatment for overdose is known; treatment should be symptomatic and supportive.
Danish: Behandlingen bør være symptomatisk og understøttende.
English: In addition, co-administration of tamoxifen with letrozole has been shown to substantially decrease plasma concentrations of letrozole.
Danish: Desuden har samtidig behandling med tamoxifen og letrozol vist at nedsætte plasmakoncentrationen af letrozol betydeligt.
English: Caution is therefore indicated when giving letrozole contomitantly with medicinal products whose elimination is mainly dependent on these isoenzymes and whose therapeutic index is narrow (e.g. phenytoin, clopidrogel).
Danish: Forsigtighed bør således udvises ved samtidig indgift af letrozol og lægemidler, som hovedsageligt metaboliseres af disse isoenzymer, og som har et smalt terapeutisk indeks (fx phenytoin, clopidrogel).
English: In the MA-17 lipid substudy there were no significant differences between letrozole and placebo in total cholesterol or in any lipid fraction.
Danish: I lipid-substudiet til MA-17 var der ingen signifikant forskel mellem {X}- og placebo-armene i totalkolesterol eller i nogen lipidfraktion.
English: If it is almost time for your next dose (e.g. within 2 or 3 hours), skip the dose you missed and take your next dose when you are meant to.
Danish: Hvis du har glemt at tage {X} - Hvis du snart skal tage den næste tablet (fx inden for 2 til 3 timer), så spring den glemte dosis over og tag den næste dosis til sædvanlig tid.
English: Log rank test, stratified by randomisation option and use of chemotherapy (yes/no)
Danish: 1 Log-rank-test, stratificeret i forhold til strata ved randomisering og brug af kemoterapi (ja/nej).
English: Palpitations1, tachycardia, ischaemic cardiac events(including new or worsening angina, angina requiring surgery, myocardial infarction and myocardial ischaemia)
Danish: Ikke almindelig Palpitationer1, takykardi, iskæmiske hjertetilfælde (inklusive ny eller forværret angina, operationskrævende angina, myokardieinfarkt og myokardieiskæmi)
English: Table 6 Sequential treatments analysis of disease-free survival with letrozole as initial endocrine agent (STA switch population)
Danish: Tabel 6 Analyse af sekvensbehandling med hensyn til sygdomsfri overlevelse med letrozol som initial endokrin behandling (STA-skift population)
English: The Sequential Treatments Analysis (STA) addresses the second primary question of BIG 1-98, namely whether sequencing of tamoxifen and letrozole would be superior to monotherapy.
Danish: Analysen af sekvensbehandling (STA) undersøger BIG 1-98-studiets andet primære spørgsmål, dvs. om sekvensbehandling med tamoxifen og letrozol er bedre end monoterapi.
English: • Neo-adjuvant treatment of postmenopausal women with hormone receptor positive, HER-2 negative breast cancer where chemotherapy is not suitable and immediate surgery not indicated.
Danish: • Neo-adjuverende behandling af postmenopausale kvinder med hormonreceptor-positiv, HER-2negativ brystcancer, hvor kemoterapi ikke er egnet og operation ikke aktuel.
English: The suppression of oestrogen biosynthesis in peripheral tissues and the cancer tissue itself can therefore be achieved by specifically inhibiting the aromatase enzyme.
Danish: Suppression af østrogensyntesen i perifere væv og i cancervævet kan derfor opnås ved specifik hæmning af aromataseenzymet.
English: The ACTH stimulation test performed after 6 and 12 weeks of treatment with daily doses of 0.1 mg, 0.25 mg, 0.5 mg, 1 mg, 2.5 mg, and 5 mg did not indicate any attenuation of aldosterone or cortisol production.
Danish: ACTHstimulationstest udført efter 6 og 12 ugers behandling med daglige doser på 0,1 mg, 0,25 mg, 0,5 mg, 1 mg, 2,5 mg og 5 mg antydede ingen nedsættelse i aldosteron- eller cortisolproduktionen.
English: In premenopausal women, the inhibition of oestrogen synthesis leads to feedback increases in gonadotropin (LH, FSH) levels.
Danish: Hos præmenopausale kvinder fører hæmning af østrogensyntesen til feedback-mekanisme og stigning i gonadotropin (LH, FSH)-niveauer.
English: There was no significant difference in overall survival: ({Invented Name} 51 deaths; placebo 62; HR 0.82; 95% CI 0.56, 1.19).
Danish: Der var ingen signifikant forskel i total overlevelse: {X} 51 døde; placebo 62 (relativ risiko 0,82; 95% KI 0,56-1,19).
English: In the updated quality of life substudy there were no significant differences between treatments in physical component summary score or mental component summary score, or in any domain score in the SF-36 scale.
Danish: I substudiet for livskvalitet var der ingen signifikant forskel mellem behandlingerne med hensyn til fysisk eller mental livskvalitet eller i scoren for andet domæne i SF-36-skalaen.
English: No dose adjustment of {Invented Name} is required for patients with mild to moderate hepatic insufficiency (Child-Pugh A or B).
Danish: Dosisjustering af {X} er ikke nødvendig hos patienter med let til moderat nedsat leverfunktion (ChildPugh A eller B).
English: In total 45% of patients in the {Invented Name} group versus 35% of patients in the tamoxifen group (P=0.02) underwent breast-conserving therapy).
Danish: Samlet gennemgik 45% af patienterne i {X}-gruppen versus 35% af patienterne i tamoxifen-gruppen (p=0,02) brystbevarende behandling.
English: There were no significant differences in DFS, OS, SDFS, or DDFS from switch with respect to monotherapy (Table 6).
Danish: Der var ingen signifikante forskelle i DFS, OS, SDFS eller DDFS af skift i forhold til monoterapi (Tabel 6).
English: If any of these conditions apply to you, do not take this medicine and talk to your doctor.
Danish: Hvis noget af dette passer på dig, må du ikke tage denne medicin, men skal fortælle det til din læge.
English: In a study comparing the pharmacokinetics of letrozole after a single oral dose in eight male subjects with liver cirrhosis and severe hepatic impairment (Child-Pugh C) to those in healthy volunteers (N=8), AUC and t½ increased by 95 and 187%, respectively.
Danish: I en studie, som sammenlignede letrozols farmakokinetik efter en enkelt oral dosis hos otte mandlige forsøgspersoner med levercirrose og alvorligt nedsat leverfunktion (Child-Pugh C) og otte raske frivillige, steg AUC og t½ med henholdsvis 95% og 187%.
English: In patients whose menopausal status is unclear, luteinising hormone (LH), follicle-stimulating hormone (FSH) and/or oestradiol levels should be measured before initiating treatment with {Invented Name}.
Danish: Hos patienter, hvor menopausal status er uklar, skal serumkoncentrationen af luteiniserende hormon (LH), follikelstimulerende hormon (FSH) og/eller østradiol måles inden behandlingsstart.
English: Table 8 Disease-free and overall survival (Modified ITT population) Median follow-up 28 months
Danish: Tabel 8 Sygdomsfri og total overlevelse (modificeret ITT-population) 28 måneder median opfølgning
English: In female rats, a reduced incidence of benign and malignant mammary tumours at all the doses of letrozole was found.
Danish: Hos hunrotter fandtes reduceret incidens af benigne og maligne mammatumorer ved alle doser letrozol.
English: Median duration for {Invented Name} after switch was 40 months.
Danish: Median varighed af {X} efter skift var 40 måneder.
English: It is not known whether this was an indirect consequence of the pharmacological properties (inhibition of oestrogen biosynthesis) or a direct drug effect (see sections 4.3 and 4.6).
Danish: Det vides ikke, om det indirekte skyldes de farmakologiske egenskaber (hæmning af østrogensyntesen) eller direkte skyldes lægemidlets effekt (se pkt.
English: Table 7 Sequential Treatments Analyses from randomisation (STA-R) of disease-free survival (ITT STA-R population)
Danish: Tabel 7 Analyse af sekvensbehandling efter randomisering (STA-R) for sygdomsfri overlevelse (ITT-STA-R-population)
English: Rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever (signs of skin disorder).
Danish: - Udslæt, rød hud, vabler på læber, øjne eller mund, afskalning af huden, feber (tegn på hudsygdom).
English: This finding was consistently confirmed by ultrasound ({Invented Name} 35% vs tamoxifen 25%, P=0.04) and mammography ({Invented Name} 34% vs tamoxifen 16%, P<0.001).
Danish: Dette fund blev regelmæssigt bekræftet ved ultralyd ({X} 35% vs. tamoxifen 25%, p=0,04) og mammografi ({X} 34% vs. tamoxifen 16%, p<0,001).
English: A double blind trial (P024) was conducted in 337 postmenopausal breast cancer patients randomly allocated either {Invented Name} 2.5 mg for 4 months or tamoxifen for 4 months.
Danish: Et dobbeltblindet studie (P024) blev udført hos 337 postmenopausale brystcancerpatienter tilfældigt allokeret til enten {X} 2,5 mg i 4 måneder eller tamoxifen i 4 måneder.
English: Letrozole 2.5 mg was statistically superior to aminoglutethimide for time to progression (P=0.008), time to treatment failure (P=0.003) and overall survival (P=0.002).
Danish: Letrozol 2,5 mg var aminoglutethimid statistisk overlegen i perioden indtil progression (p=0,008), i perioden indtil behandlingssvigt (p=0,003) og i total overlevelse (p=0,002).
English: In vitro, letrozole inhibits the cytochrome P450 isoenzymes 2A6 and, moderately, 2C19, but the clinical relevance is unkown.
Danish: In vitro hæmmer letrozol CYP-isoenzymet 2A6 og - i moderat grad - 2C19, men den kliniske relevans er ukendt.
English: Endometrial hyperplasia / endometrial cancer
Danish: Endometriehyperplasi / endometriecancer
English: Median duration of treatment was 5 years for {Invented Name}, compared with 3 years for placebo.
Danish: Median behandlingstid var 5 år for {X} og 3 år for placebo.
English: Women with a history of osteoporosis and/or fractures, or who are at increased risk of osteoporosis, should have their bone mineral density formally assessed prior to the commencement of adjuvant and extended adjuvant treatment and monitored during and following treatment with letrozole.
Danish: Kvinder med osteoporose og/eller knoglebrud i anamnesen, eller som har en øget risiko for osteoporose, skal have målt knoglemineraldensiteten før påbegyndelse af adjuverende og forlænget adjuverende behandling og skal monitoreres for udvikling af osteoporose under og efter behandling med letrozol.
English: Results at a median follow-up of 73 months (monotherapy arms only) The Monotherapy Arms Analysis (MAA) long-term update of the efficacy of {Invented Name} monotherapy compared to tamoxifen monotherapy (median duration of adjuvant treatment: 5 years) is presented in Table 5.
Danish: Effektresultater ved median opfølgning på 73 måneder (kun monoterapi-arme) Monoterapi-arm-analysen (MAA) langtidsopdatering af effekten af {X} monoterapi sammenlignet med tamoxifen-monoterapi (median varighed af adjuverende behandling: 5 år) vises i Tabel 5.
English: The only statistically significant difference occurred at 2 years and was in total hip BMD (letrozole median decrease of 3.8% vs placebo median decrease of 2.0%).
Danish: Den eneste statistisk signifikante forskel opstod efter 2 år og var et større fald i BMD af hele hoften (median nedsættelse på 3,8% i letrozol-gruppen sammenlignet med 2,0% i placebogruppen).
English: Some side effects are very common.
Danish: Nogle bivirkninger er meget almindelige.
English: Letrozole → Tamoxifen
Danish: Letrozol → Tamoxifen
English: In the adjuvant and extended adjuvant setting, treatment with {Invented Name} should continue for 5 years or until tumour relapse occurs, whichever is first.
Danish: Ved adjuverende behandling og forlænget adjuverende behandling bør behandling med {X} fortsætte i 5 år, eller indtil tumor recidiverer, afhængigt af hvad der indtræffer først.
English: It inhibits the aromatase enzyme by competitively binding to the haem of the aromatase cytochrome P450, resulting in a reduction of oestrogen biosynthesis in all tissues where present.
Danish: Det hæmmer aromataseenzymet ved kompetitiv binding til hæmgruppen i CYP-enzymet, hvilket resulterer i reduktion af østrogensyntesen i alle væv, hvor det forekommer.
English: Tamoxifen, other anti-oestrogens or oestrogen-containing therapies may diminish the pharmacological action of letrozole.
Danish: Tamoxifen, andre antiøstrogener eller østrogener kan nedsætte den farmakologiske virkning af letrozol.
English: Overall survival was not significantly different between the 2 arms (P=0.2).
Danish: Der var ikke signifikant forskel i total overlevelse mellem de to behandlinger (p=0,2).
English: Thromboembolic events
Danish: Tromboembolisk hændelse