FrancophonIA/ELRC3.0 huggingface dataset:
English: Plasma protein binding of letrozole is approximately 60%, mainly to albumin (55%).
Danish: Plasmaproteinbindingsgraden for letrozol er ca. 60%, og det bindes hovedsageligt til albumin (55%).
English: Treatment or prophylaxis for osteoporosis should be initiated as appropriate and carefully monitored.
Danish: Behandling eller forebyggelse af osteoporose bør initieres på passende vis og monitoreres omhyggeligt.
English: An increased incidence of foetal malformations was not seen in the rabbit.
Danish: En øget incidens af føtale misdannelser blev ikke set hos kaniner.
English: The frequency category for these adverse reactions is described in Table 1.
Danish: Frekvensen for disse bivirkninger er beskrevet i Tabel 1.
English: It is unknown whether letrozole and its metabolites are excreted in human milk.
Danish: Det er ukendt, om letrozol/metabolitter udskilles i human mælk.
English: Growth of breast cancer is frequently stimulated by oestrogens which are female sex hormones.
Danish: Vækst af brystkræft stimuleres ofte af østrogener, som er kvindelige kønshormoner.
English: The safety and efficacy of {Invented Name} in children and adolescents aged up to 17 years have not been established.
Danish: {Xs} sikkerhed og virkning hos børn i alderen op til 17 år er ikke klarlagt.
English: Taking {Invented Name} at the same time each day will help you remember when to take your tablet.
Danish: Tag {X} på samme tidspunkt hver dag, da det kan hjælpe dig med at huske at tage tabletten.
English: It belongs to a group of medicines called aromatase inhibitors.
Danish: Det tilhører gruppen af lægemidler, som kaldes aromatasehæmmere.
English: Follow all the doctor's instructions carefully.
Danish: Følg altid lægens anvisning.
English: Letrozole is rapidly and extensively distributed to tissues.
Danish: Letrozol fordeles hurtigt og ekstensivt i væv.
English: Median total cholesterol levels in the tamoxifen arm were decreased by 16% after 6 months compared to baseline and this decrease was maintained at subsequent visits up to 24 months.
Danish: Den mediane total-kolesterolværdi i tamoxifen-armen blev nedsat med 16% efter 6 måneder sammenlignet med baseline, og dette fald blev opretholdt ved de efterfølgende besøg indtil 24 måneder.
English: However, your doctor should discuss with you about using effective contraceptive, as you may still have the potential to become pregnant during treatment with {Invented Name}.
Danish: Din læge bør dog diskutere brug af effektiv prævention med dig, da der kan være en risiko for, at du kan blive gravid under behandling med {X}.
English: In a variety of preclinical safety studies conducted in standard animal species, there was no evidence of systemic or target organ toxicity.
Danish: I forskellige prækliniske sikkerhedsstudier udført på standard-dyrearter fandtes ikke evidens for toksicitet, hverken systemisk eller på målorganer.
English: The minor effect on the absorption rate is not considered to be of clinical relevance, and therefore letrozole may be taken without regard to mealtimes.
Danish: Den lille effekt på absorptionshastigheden anses ikke at have klinisk relevans, og letrozol kan derfor tages uden hensyn til måltider.
English: Such patients should therefore be kept under close supervision (see section 5.2).
Danish: Disse patienter bør derfor følges tæt (se pkt.
English: The no-adverse-effect level was 0.3 mg/kg in both species.
Danish: Dosisniveauet uden bivirkninger var 0,3 mg/kg hos begge arter.
English: Metabolism of letrozole is partly mediated via CYP2A6 and CYP3A4.
Danish: Letrozols metabolisme er delvist medieret via CYP2A6 og CYP3A4.
English: Method of administration {Invented Name} should be taken orally and can be taken with or without food.
Danish: Administration {X} skal tages oralt og kan tages sammen med eller uden mad.
English: If you stop taking {Invented Name}
Danish: Hvis du holder op med at tage {X}
English: Letrozole is rapidly and completely absorbed from the gastrointestinal tract (mean absolute bioavailability: 99.9%).
Danish: Letrozol absorberes hurtigt og fuldstændigt fra mave-tarmkanalen (gennemsnitlig absolut biotilgængelighed er 99,9%).
English: In the letrozole arm, total cholesterol levels were relatively stable over time, giving a statistically significant difference in favor of tamoxifen at each time point.
Danish: I letrozol-armen var total-kolesterolværdien relativt stabil over tid, hvilket giver en statistisk signifikant forskel til fordel for tamoxifen på ethvert tidspunkt.
English: Median follow-up was 73 months.
Danish: Median opfølgningstid var 73 måneder.
English: Note: This SPC, labelling and packages leaflet is the version valid at the time of Commission decision.
Danish: NB: Følgende produktresumé, etikettering og indlægsseddel er den gyldige version på det tidspunkt, hvor Kommissionen traf beslutningen.
English: If the response is not adequate, treatment with {Invented Name} should be discontinued and surgery scheduled and/or further treatment options discussed with the patient.
Danish: Hvis responset ikke er tilstrækkeligt, bør {X} seponeres og operation planlægges og/eller andre behandlingsmuligheder diskuteres med patienten.
English: Each film-coated tablet contains 2.5 mg letrozole.
Danish: Hver tablet indeholder 2,5 mg letrozol.
English: Overall survival Deaths
Danish: Total overlevelse Dødsfald
English: In patients with severe hepatic impairment (Child-Pugh C), systemic exposure and terminal half-life were approximately doubled compared to healthy volunteers.
Danish: Hos patienter med svært nedsat leverfunktion (Child-Pugh C) var systemisk eksponering og terminal halveringstid næsten fordoblet sammenlignet med raske frivillige.
English: You should only take {Invented Name} when you have gone through the menopause.
Danish: - Du må kun tage {X}, når du har passeret menopausen.
English: There was no significant difference between treatments in the rate of fractures - 15% in the letrozole arm, 17% in the tamoxifen arm.
Danish: Der var ingen signifikant forskel på frakturraten mellem behandlingerne - 15% i letrozol-armen og 17% i tamoxifen-armen.
English: After daily administration of 2.5 mg steady-state levels are reached within 2 to 6 weeks.
Danish: Efter administration af 2,5 mg dagligt opnås steady state i løbet af 2-6 uger.
English: As there are reports of women regaining ovarian function during treatment with {Invented Name} despite a clear postmenopausal status at start of therapy, the physician needs to discuss adequate contraception when necessary.
Danish: Da der er rapporter om kvinder, der har generhvervet ovariefunktionen under behandling med {X} på trods af en klar postmenopausal status ved behandlingsstart, skal lægen omtale passende kontraception, hvis det er nødvendigt.
English: Formation of minor unidentified metabolites and direct renal and faecal excretion play only a minor role in the overall elimination of letrozole.
Danish: Dannelsen af mindre vigtige, uidentificerede metabolitter og direkte renal samt fækal ekskretion spiller kun en mindre rolle i den totale elimination af letrozol.
English: You should only take this medicine under strict medical supervision.
Danish: Du skal tage dette lægemiddel under nøje kontrol af en læge.
English: {Invented Name} is also used to prevent breast tumour spreading to other parts of the body in patients with advanced breast cancer.
Danish: {X} bruges også til at forebygge spredning af tumorer til andre dele af kroppen hos patienter med fremskreden brystkræft.
English: What {Invented Name} is and how it works {Invented Name} contains an active substance called letrozole.
Danish: Hvad {X} er, og hvordan det virker {X} indeholder et aktivt stof, som hedder letrozol.
English: Table 9 Results at a median follow-up of 32 months
Danish: Table 9 Resultater ved median-opfølgningstid på 32 måneder
English: The majority of the adverse reactions occurred during the first few weeks of treatment.
Danish: Hovedparten af bivirkningerne forekom i de første få behandlingsuger.
English: How long to take {Invented Name}
Danish: Hvor længe skal du tage {X}
English: In repeated-dose toxicity studies in rats and dogs up to 12 months, the main findings observed can be attributed to the pharmacological action of the compound.
Danish: I toksicitetsstudier med gentagne doser til rotter og hunde i indtil 12 måneder kan de fleste observerede fund henføres til letrozols farmakologiske virkning.
English: Note: Median duration of treatment 60 months.
Danish: Bemærk: Median varighed af behandlingen var 60 måneder.
English: 4 Exploratory analysis, censoring follow-up times at the date of switch (if it occurred) in the placebo arm.
Danish: 4 Eksplorativ analyse med censur af opfølgningstider på datoen for behandlingsskift (hvis det opstod) i placebo-armen.
English: Letrozole was embryotoxic and foetotoxic in pregnant rats and rabbits following oral administration at clinically relevant doses.
Danish: Letrozol var embryotoksisk og føtotoksisk hos gravide rotter og kaniner efter oral administration af klinisk relevante doser.
English: It is a hormonal (or “endocrine”) breast cancer treatment.
Danish: Det er en hormonel (endokrin) behandling af brystkræft.
English: The results for total hip BMD were similar to those for lumbar spine but less pronounced.
Danish: Resultaterne for total hofte-BMD var sammenlignelige med BMD for lændehvirvlerne, men mindre udtalte.
English: In rats that had live foetuses, there was an increase in the incidence of foetal malformations including domed head and cervical/centrum vertebral fusion.
Danish: Hos rotter, der havde levende fostre, sås en øget incidens af føtale misdannelser, inklusive hvælvet hoved og cervical/centrum vertebral fusion.
English: Paediatric population {Invented Name} is not recommended for use in children and adolescents.
Danish: Pædiatrisk population {X} bør ikke anvendes til børn og unge.
English: 6 Median follow-up until switch (if it occurred) 37 months.
Danish: 6 Median opfølgningstid til skift (hvis det forekom) 37 måneder.
English: Age had no effect on the pharmacokinetics of letrozole.
Danish: Alder havde ingen indflydelse på letrozols farmakokinetik.
English: The potential risk/benefit to such patients should be carefully considered before administration of {Invented Name}.
Danish: Risk/benefit hos disse patienter skal overvejes nøje inden behandling med {X}.
English: In the neoadjuvant setting, treatment with {Invented Name} could be continued for 4 to 8 months in order to establish optimal tumour reduction.
Danish: Ved neo-adjuverende behandling kan behandling med {X} fortsættes i 4 til 8 måneder for at opnå optimal tumorreduktion.
English: Cox model Pvalue
Danish: Cox-model P-værdi
English: Women of perimenopausal status or child-bearing potential {Invented Name} should only be used in women with a clearly established postmenopausal status (see section 4.4).
Danish: Kvinder i perimenopausal status eller fertil alder {X} bør kun anvendes af kvinder med klart fastslået postmenopausal status (se pkt.
English: Letrozole is a non-steroidal aromatase inhibitor.
Danish: Letrozol er en non-steroid aromatasehæmmer.
English: Some adverse reactions have been reported with notably different frequencies in the adjuvant treatment setting.
Danish: Nogle bivirkninger er rapporteret med markant forskellige frekvenser ved adjuverende behandling.
English: In dogs letrozole caused signs of moderate toxicity at 100 mg/kg.
Danish: Hos hunde viste letrozol tegn på moderat toksicitet ved 100 mg/kg.
English: Number of patients with DFS events (protocol definition) Hazard ratio1 (99% CI)
Danish: Antal patienter med DFS-hændelser (protokol-definition) Relativ risiko1 (99% KI)
English: Efficacy has not been demonstrated in patients with hormone receptor negative breast cancer.
Danish: Effekten er ikke blevet påvist hos patienter med hormonreceptor-negativ brystcancer.
English: In a 104-week rat carcinogenicity study, no treatment-related tumours were noted in male rats.
Danish: I et 104 uger karcinogenicitetsstudie på rotter blev der ikke observeret behandlingsrelaterede tumorer hos hanrotter.
English: {Invented Name} reduces the amount of oestrogen by blocking an enzyme (“aromatase”) involved in the production of oestrogens and therefore may block the growth of breast cancer that needs oestrogens to grow.
Danish: {X} nedsætter mængden af østrogen ved at hæmme et enzym (aromatase), som medvirker ved produktionen af østrogener, og kan derfor blokere væksten af brystkræft, som behøver østrogen for at vokse.
English: Events
Danish: Hændelser
English: Stratified by receptor status, nodal status and prior adjuvant chemotherapy.
Danish: 2 Stratificeret for receptorstatus, nodal status og tidligere adjuverende kemoterapi.
English: After administration of 2.5 mg 14C-labelled letrozole, approximately 82% of the radioactivity in plasma was unchanged compound.
Danish: Efter administration af 2,5 mg 14C-mærket letrozol var ca. 82% af radioaktiviteten i plasma uomdannet stof.
English: Increased FSH levels in turn stimulate follicular growth, and can induce ovulation.
Danish: Stigning i FSH-niveau stimulerer follikelvækst og kan inducere ægløsning.
English: The benefit in favour of letrozole was observed regardless of nodal status.
Danish: Den statistisk signifikante gavnlige effekt til fordel for letrozol blev observeret uagtet nodal status.
English: At baseline all patients had tumours stage T2-T4c, N0-2, M0, ER and/or PgR positive and none of the patients would have qualified for breast-conserving surgery.
Danish: Ved baseline havde alle patienter tumorstadie T2-T4c, N0-2, M0, var ER- og/eller PgR-positive, og ingen af patienterne ville have været egnet til brystbevarende kirurgi.
English: Impairment of adrenal steroidogenesis has not been observed.
Danish: Der er ikke observeret nedsat adrenal steroidsyntese.
English: The concentration of letrozole in erythrocytes is about 80% of that in plasma.
Danish: Koncentrationen af letrozol i erytrocytter er ca. 80% af plasmakoncentrationen.
English: Disease-free survival (primary) - events (protocol definition2)
Danish: Sygdomsfri overlevelse (primær) - hændelser (protokol-defineret2)
English: Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: very common 10%, common 1% to 10%, uncommon 0.1% to 1%, rare 0.01% to 0.1%, very rare 0.01%, not known (cannot be estimated from the available data).
Danish: Bivirkninger er opdelt under overskrifter efter organsystem og hyppighed med den hyppigste først efter følgende konvention: Meget almindelig ≥10%; almindelig ≥ 1% til <10%; ikke almindelig ≥0,1% til <1%; sjælden ≥0,01% til <0,1%; meget sjælden <0,01%; ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: With doses of 0.5 mg and higher, many values of oestrone and oestrone sulphate were below the limit of detection in the assays, indicating that higher oestrogen suppression is achieved with these doses.
Danish: Ved doser på 0,5 mg og højere var mange af værdierne af estron og estronsulfat under detektionsgrænsen, hvilket indikerer, at der opnås større østrogensuppression med disse doser.
English: The recommended dose of {Invented Name} is 2.5 mg once daily.
Danish: Den anbefalede dosis af {X} er 2,5 mg én gang daglig.
English: It can be used as first treatment before breast cancer surgery in case immediate surgery is not suitable or it can be used as first treatment after breast cancer surgery or following five years treatment with tamixofen.
Danish: Det kan anvendes som førstebehandling før operation for brystkræft, hvis operation ikke er aktuelt, eller det kan anvendes som førstevalgsbehandling efter brystkræft-operation eller efter 5 års behandling med tamoxifen.
English: The following adverse drug reactions, listed in Table 1, were reported from clinical studies and from postmarketing experience with {Invented Name}:
Danish: Bivirkningerne, vist i Tabel 1, er blevet rapporteret fra kliniske studier og post marketing erfaring med {X}:
English: Based on human experience in which there have been isolated cases of birth defects (labial fusion, ambiguous genitalia), {Invented Name} may cause congenital malformations when administered during pregnancy.
Danish: Baseret på humane data, hvor der har været isolerede tilfælde af misdannelser (labial fusion, tvetydige genitalier), er det vist, at {X} kan forårsage medfødte misdannelser, når det anvendes under graviditeten.
English: Metabolic clearance to a pharmacologically inactive carbinol metabolite is the major elimination pathway of letrozole (CLm = 2.1 l/h) but is relatively slow when compared to hepatic blood flow (about 90 l/h).
Danish: Metabolisering til den farmakologisk inaktive carbinolmetabolit (Clm = 2,1 l/t) er den primære eliminationsvej for letrozol, men eliminationen er relativt langsom sammenlignet med den hepatiske blodgennemstrømning (ca. 90 l/t).
English: Endometrial proliferative disorders
Danish: Endometrielle proliferative sygdomme
English: Letrozole showed a low degree of acute toxicity in rodents exposed up to 2000 mg/kg.
Danish: Letrozol viste lav grad af akut toksicitet hos gnavere, der blev eksponeret for op til 2.000 mg/kg.
English: 5 Median follow-up 62 months.
Danish: 5 Median opfølgningstid 62 måneder.
English: Disease-free survival events (primary)2
Danish: Hændelser ved sygdomsfri overlevelse (primær)2
English: • Premenopausal endocrine status
Danish: • Præmenopausal endokrin status.
English: {Invented Name} has minor influence on the ability to drive and use machines.
Danish: {X} påvirker i mindre grad evnen til at føre motorkøretøj eller betjene maskiner.
English: In postmenopausal women, oestrogens are mainly derived from the action of the aromatase enzyme, which converts adrenal androgens - primarily androstenedione and testosterone - to oestrone and oestradiol.
Danish: Hos postmenopausale kvinder dannes østrogener hovedsageligt ved hjælp af aromataseenzymet, som omdanner adrenale androgener (primært androstendion og testosteron) til estron og estradiol.
English: The 5-year DFS rates were 84% for {Invented Name} and 81.4% for tamoxifen.
Danish: 5 års DFS-rater var 84% for {X} og 81,4% for tamoxifen.
English: In 907 women, letrozole was superior to tamoxifen in time to progression (primary endpoint) and in overall objective response, time to treatment failure and clinical benefit.
Danish: Hos 907 kvinder var letrozol mere effektivt end tamoxifen med hensyn til tid til progression (primært endepunkt) og i det totale objektive respons, tid indtil behandlingssvigt og klinisk bedring.
English: A total of 262 patients were assigned either letrozole for 5 years or tamoxifen for 2 years followed by letrozole for 3 years.
Danish: Totalt 262 patienter fik enten letrozol i 5 år eller tamoxifen i 2 år efterfulgt af letrozol i 3 år.
English: Skeletal adverse reactions For skeletal safety data from the adjuvant setting, please refer to Table 2.
Danish: Knoglerelaterede bivirkninger For sikkerhedsdata for knogler fra den adjuverende behandling henvises til Tabel 2.
English: Approximately 50% of patients crossed over to the opposite treatment arm and crossover was virtually completed by 36 months.
Danish: Ca. 50% af patienterne overgik til den anden behandlingsarm, og cross-over var praktisk talt overstået efter 36 måneder.
English: At least 75% of the radioactivity recovered in urine up to 216 hours (84.7 ± 7.8% of the dose) was attributed to the glucuronide of the carbinol metabolite, about 9% to two unidentified metabolites, and 6% to unchanged letrozole.
Danish: Mindst 75% af den radioaktivitet, der blev genfundet i urinen i løbet af 216 timer (84,7 ± 7,8% af dosis), kunne tilskrives et glukuronid af carbinolmetabolitten, ca. 9% kunne tilskrives to uidentificerede metabolitter, og 6% kunne tilskrives uomdannet letrozol.
English: During the 4-month pre-operative treatment period, 12% of patients treated with {Invented Name} and 17% of patients treated with tamoxifen had disease progression on clinical assessment.
Danish: I løbet af den 4-måneders præ-operative behandlingsperiode havde 12% af de patienter, der blev behandlet med {X}, og 17% af de patienter, der blev behandlet med tamoxifen, sygdomsprogression ved kliniske vurdering.
English: The elimination of oestrogen-mediated growth stimulation is a prerequisite for tumour response in cases where the growth of tumour tissue depends on the presence of oestrogens and endocrine therapy is used.
Danish: Elimination af den østrogenmedierede væktstimulation er forudsætningen for tumorrespons i tilfælde, hvor tumorvækst afhænger af tilstedeværelsen af østrogener, og endokrin behandling anvendes.
English: Important additional adverse reactions that may occur with {Invented Name} are: skeletal events such as osteoporosis and/or bone fractures and cardiovascular events (including cerebrovascular and thromboembolic events).
Danish: Yderligere væsentlige bivirkninger, som kan optræde ved behandling med {X}, er knoglerelaterede hændelser såsom osteoporose og/eller knoglebrud og kardiovaskulære hændelser (inklusive cerebrovaskulære og tromboemboliske hændelser).
English: Only women of postmenopausal endocrine status should receive {Invented Name}.
Danish: Kun kvinder i postmenopausal endokrin status må behandles med {X}.
English: Overall survival (secondary) - deaths
Danish: Total overlevelse (sekundær) - antal døde
English: Efficacy results at a median follow-up of 26 and 60 months Data in Table 4 reflect the results of the Primary Core Analysis (PCA) based on data from the monotherapy arms (A and B) and from the two switching arms (C and D) at a median treatment duration of 24 months and a median follow-up of 26 months and at a median treatment duration of 32 months and a median follow-up of 60 months.
Danish: Effektresultater ved median opfølgningstid på 26 og 60 måneder Data i Tabel 4 viser resultater fra den primære analyse (PCA) baseret på data fra de 2 monoterapi-arme (A og B) og fra de 2 overkrydsende arme (C og D) efter en median behandlingsvarighed på 24 måneder og en median opfølgningstid på 26 måneder og ved en median behandlingsvarighed på 32 måneder og en median opfølgningstid på 60 måneder.
English: The final analysis included 1,551 women who switched from placebo to {Invented Name} at a median of 31 months (range 12 to 106 months) after completion of tamoxifen adjuvant therapy.
Danish: Den endelige analyse inkluderede 1.551 kvinder, som skiftede fra placebo til {X} med en medianperiode på 31 måneder (fra 12 til 106 måneder) efter afsluttet adjuverende tamoxifen-behandling.
English: if you are pregnant, if you are breast-feeding.
Danish: - hvis du er gravid, - hvis du ammer.
English: 3, including deaths from any cause
Danish: Sygdomsfri overlevelse, inklusive dødsfald uanset årsag
English: Both in vitro and in vivo investigations of letrozole's mutagenic potential revealed no indications of any genotoxicity.
Danish: Hverken in vitro eller in vivo studier af letrozols mutagenicitet tydede på genotoksicitet.
English: Therefore, this SPC, labelling and package leaflet may not necessarily represent the current text.
Danish: Følgende produktresumé, etikettering og indlægsseddel repæsenterer derfor ikke nødvendigvis den gældende tekst
English: Consequently, after the the first interim analysis the study was unblinded and continued in an open-label fashion and patients in the placebo arm were allowed to switch to {Invented Name} for up to 5 years.
Danish: Efter den første interimanalyse blev studiet derfor ublindet og fortsatte åbent, og patienter i placeboarmen kunne skifte til {X} i op til 5 år.
English: In patients with advanced or metastatic breast cancer, treatment with {Invented Name} should continue until tumour progression is evident.
Danish: Hos patienter med fremskreden eller metastaserende brystcancer bør behandling med {X} fortsætte, indtil tumorprogression er evident.
English: The median time to crossover was 17 months ({Invented Name} to tamoxifen) and 13 months (tamoxifen to {Invented Name}).
Danish: Mediantid til cross-over var henholdsvis 17 måneder ({X} til tamoxifen) og 13 måneder (tamoxifen til {X}).