FrancophonIA/ELRC3.0 huggingface dataset:
English: Anxiety (including nervousness), irritability Nervous system disorders Common:
Danish: Ikke almindelig Angst (inklusive nervøsitet), irritabilitet Nervesystemet
English: As the tablets contain lactose, {Invented Name} is not recommended for patients with rare hereditary problems of galactose intolerance, of severe lactase deficiency or of glucose-galactose malabsorption.
Danish: Tabletterne indeholder lactose, og {X} bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for arvelig lactasemangel (Lapp Lactase defiency) eller glucose/galactose malabsorption.
English: Adjusted by chemotherapy use
Danish: 1 Justeret for brug af kemoterapi
English: Weight loss 1 Adverse drug reactions reported only in the metastatic setting
Danish: Ikke almindelig Vægttab 1 Bivirkninger rapporteret alene ved metastaser.
English: The primary endpoint was disease-free survival (DFS); secondary efficacy endpoints were time to distant metastasis (TDM), distant disease-free survival (DDFS), overall survival (OS), systemic disease-free survival (SDFS), invasive contralateral breast cancer and time to breast cancer recurrence.
Danish: Det primære endepunkt var sygdomsfri overlevelse (DFS); sekundært endepunkt var tid til fjernmetastase (TDM), fjernmetastasefri overlevelse (DDFS), total overlevelse (OS), systemisk sygdomsfri overlevelse (SDFS), invasiv kontralateral brystcancer og tid til tilbagefald af brystcancer.
English: The following tables provide information on significant differences in {Invented Name} versus tamoxifen monotherapy and in the {Invented Name}-tamoxifen sequential treatment therapy:
Danish: Følgende tabeller giver information om signifikante forskelle mellem {X} versus tamoxifen ved monoterapi og i {X}-tamoxifen sekventielt behandlingsprogram:
English: Thrombophlebitis (including superficial and deep vein thrombophlebitis)
Danish: Ikke almindelig Tromboflebitis (inklusive overfladisk og dyb venetrombose), Sjælden
English: No clinically relevant changes were found in the plasma concentrations of cortisol, aldosterone, 11-deoxycortisol, 17-hydroxyprogesterone, and ACTH or in plasma renin activity among postmenopausal patients treated with a daily dose of letrozole 0.1 to 5 mg.
Danish: Der blev ikke fundet klinisk relevante ændringer i plasmakoncentrationerne for cortisol, aldosteron, 11-deoxycortisol, 17-hydroxyprogesteron eller ACTH eller i plasmareninaktiviteten hos postmenopausale kvinder, der blev behandlet med en daglig dosis på 0,1-5 mg letrozol.
English: • Extended adjuvant treatment of hormone-dependent invasive breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 years.
Danish: • Forlænget adjuverende behandling af hormonafhængig invasiv tidlig brystcancer hos postmenopausale kvinder, som forud har fået adjuverende standardbehandling med tamoxifen i 5 år.
English: In healthy postmenopausal women, single doses of 0.1 mg, 0.5 mg, and 2.5 mg letrozole suppress serum oestrone and oestradiol by 75%, 78% and 78% from baseline, respectively.
Danish: Hos raske postmenopausale kvinder nedsætter enkeltdoser af letrozol på 0,1 mg, 0,5 mg og 2,5 mg serum-estron og serum-estradiol med henholdsvis 75%, 78% og 78% fra baseline.
English: Yellow skin and eyes, nausea, loss of appetite, dark-coloured urine (signs of hepatitis).
Danish: - Gul hud og øjne, kvalme, appetitløshed, mørkfarvet urin (tegn på leverbetændelse).
English: • First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer.
Danish: • Førstevalgsbehandling til postmenopausale kvinder med hormonafhængig fremskreden brystcancer.
English: Renal impairment {Invented Name} has not been investigated in a sufficient number of patients with a creatinine clearance lower than 10 ml/min.
Danish: Nedsat nyrefunktion {X} er ikke undersøgt hos et tilstrækkeligt antal patienter med kreatininclearance < 10 ml/min.
English: Deaths4
Danish: Dødsfald4
English: In the second study, the response rate was not significantly different between letrozole 2.5 mg and aminoglutethimide (P=0.06).
Danish: I det andet studie var responsraten mellem letrozol 2,5 mg og aminoglutethimid ikke signifikant forskellig (p=0,06).
English: Events marked * were statistically significantly different in the two treatment arms.
Danish: Der var statistisk signifikant forskel mellem de to behandlingsarme for hændelser markeret med *.
English: Some side effects are common.
Danish: Nogle bivirkninger er almindelige.
English: Table 4 Primary Core Analysis: Disease-free and overall survival,at a median follow-up of 26 months and at median follow-up of 60 months (ITT population)
Danish: Tabel 4 Primær analyse: Sygdomsfri og total overlevelse ved en median opfølgningtid på 26 måneder og en median opfølgningstid på 60 måneder (ITT-population)
English: Time to progression was not significantly different between letrozole 2.5 mg and megestrol acetate (P=0.07).
Danish: Perioden indtil progression var ikke signifikant forskellig mellem letrozol 2,5 mg og megestrolacetat (p=0,07).
English: Neoadjuvant treatment
Danish: Neo-adjuverende behandling
English: The pharmacological action of letrozole is to reduce oestrogen production by aromatase inhibition.
Danish: Farmakologisk virker letrozol ved at reducere østrogenproduktionen ved aromatasehæmning.
English: Plasma concentrations at steady state are approximately 7 times higher than concentrations measured after a single dose of 2.5 mg, while they are 1.5 to 2 times higher than the steady-state values predicted from the concentrations measured after a single dose, indicating a slight non-linearity in the pharmacokinetics of letrozole upon daily administration of 2.5 mg.
Danish: Plasmakoncentrationen i steady state er ca. 7 gange højere end koncentrationen målt efter en enkeltdosis på 2,5 mg, medens den er 1,5-2 gange højere end steady state-værdier skønnet ud fra koncentrationsmåling efter en enkelt dosis.
English: In the extended adjuvant setting, significantly more patients treated with {Invented Name} experienced bone fractures or osteoporosis (bone fractures, 10.4% and osteoporosis, 12.2%) than patients in the placebo arm (5.8% and 6.4%, respectively).
Danish: Ved forlænget adjuverende behandling opstod der knoglebrud og osteporose hos signifikant flere patienter behandlet med {X} (knoglebrud 10,4% og osteoporose 12,2%) sammenlignet med placebo (henholdsvis 5,8% og 6,4%).
English: Increased urinary frequency Reproductive system and breast disorders Common:
Danish: Ikke almindelig Øget urineringsfrekvens Det reproduktive system og mammae Almindelig
English: • Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer.
Danish: • Adjuverende behandling af postmenopausale kvinder med hormonreceptor-positiv invasiv tidlig brystcancer.
English: {Invented Name} may cause thinning or wasting of your bones (osteoporosis) due to the reduction of oestrogens in your body.
Danish: {X} kan give anledning til tab af knoglemasse (osteoporose), da det nedsætter mængden af østrogen i din krop.
English: Preclinical observations were confined to those associated with the recognised pharmacological action, which is the only safety concern for human use derived from animal studies.
Danish: hvilket er den eneste problemstilling vedrørende sikkerheden ved human anvendelse, som kan uddrages fra dyrestudierne.
English: Somnolence, insomnia, memory impairment, dysaesthesia (including paraesthesia, hypoaesthesia), taste disturbance, cerebrovascular accident
Danish: Ikke almindelig Døsighed, søvnløshed, hukommelsessvækkelse, dysæstesi (inklusive paræstesi, hypæstesi), smagsforstyrrelser, cerebrovaskulær hændelse
English: Table 2 Adjuvant {Invented Name} monotherapy versus tamoxifen monotherapy - adverse events with significant differences
Danish: Tabel 2 Adjuverende {X} monoterapi versus tamoxifen monoterapi - bivirkninger med signifikante forskelle
English: Anorexia, appetite increase
Danish: Anoreksi, øget appetit Psykiske forstyrrelser Almindelig
English: Time to progression was significantly longer, and response rate significantly higher for letrozole irrespective of whether adjuvant anti-oestrogen therapy had been given or not.
Danish: Progressionstiden var signifikant længere og responsrater signifikant højere for letrozol uafhængigt af, om der var givet adjuverende antiøstrogen-behandling eller ej. Progressionstiden var signifikant længere for letrozol uafhængigt af det dominerende sygdomssted.
English: Myalgia, bone pain1, osteoporosis, bone fractures
Danish: Myalgi, knoglesmerter1, osteoporose, knoglebrud.
English: Percentages in parentheses indicate event frequencies any time after randomisation, including post study treatment period.
Danish: Rapporteringsperioden inkluderer behandlingsperioden plus 30 dage efter behandlingsophør Procenter i parentes indikerer hændelsesfrekvenser på enhvert tidspunkt efter randomisering, inklusive behandlingsperiode efter studiet.
English: Warnings and precautions Talk to your doctor or pharmacist before taking {Invented Name} if you have a severe kidney disease, if you have a severe liver disease, if you have a history of osteoporosis or bone fractures (see also “Follow-up during {Invented Name} treatment” in section 3).
Danish: Kontakt lægen eller apoteket, før du tager {X} - hvis du lider af en alvorlig nyresygdom - hvis du lider af en alvorlig leversygdom - hvis du lider af knogleskørhed (osteoporose) eller tidligere har haft knoglebrud (se også
English: The primary endpoint was disease-free survival, defined as the interval between randomisation and the earliest occurrence of loco-regional recurrence, distant metastasis, or contralateral breast cancer.
Danish: Det primære endepunkt var sygdomsfri overlevelse defineret som intervallet mellem randomisering og første forekomst af lokoregionalt tilbagefald, fjernmetastase eller kontralateral brystcancer.
English: Co-administration of {Invented Name} with tamoxifen, other anti-oestrogens or oestrogen-containing therapies should be avoided as these substances may diminish the pharmacological action of letrozole (see section 4.5).
Danish: Samtidig administration af tamoxifen, andre antiøstrogener eller østrogener skal undgås, da disse stoffer kan nedsætte den farmakologiske virkning af letrozol (se pkt.
English: Since fatigue and dizziness have been observed with the use of {Invented Name} and somnolence has been reported uncommonly, caution is advised when driving or using machines.
Danish: Da træthed og svimmelhed kan forekomme hos patienter i behandling med {X}, og døsighed er rapporteret som en ikke almindelig bivirkning, bør der udvises forsigtighed ved bilkørsel og betjening af maskiner.
English: Bone effects {Invented Name} is a potent oestrogen-lowering agent.
Danish: Effekter på knoglerne {X} er et potent østrogen-supprimerende stof.
English: labelled letrozole to healthy postmenopausal volunteers, 88.2 ± 7.6% of the radioactivity was recovered in urine and 3.8 ± 0.9% in faeces.
Danish: 88,2 ± 7,6% af radioaktiviteten genfundet i urin og 3,8 ± 0,9% i fæces.
English: Angioedema, toxic epidermal necrolysis, erythema multiforme Musculoskeletal and connective tissue disorders Very common:
Danish: Angioødem, toksisk epidermal nekrolyse, erythema multiforme Knogler, led, muskler og bindevæv Meget almindelig Artralgi
English: Letrozole is highly specific in inhibiting aromatase activity.
Danish: Letrozol er en meget specifik aromatasehæmmer.
English: Letrozole N=2582
Danish: Letrozol N=2.582
English: In the adjuvant setting, in addition to the date presented in Table 2, the following adverse events were reported for {Invented Name} and tamoxifen, respectively (at median treatment duration of 60 months plus 30 days): angina requiring surgery (1.0% vs. 1.0%); cardiac failure (1.1% vs. 0.6%); hypertension (5.6% vs. 5.7%); cerebrovascular accident/transient ischaemic attack (2.1% vs. 1.9%).
Danish: Ved adjuverende behandling blev der udover de bivirkninger, der er præsenteret i Tabel 2, rapporteret følgende bivirkninger for henholdsvis {X} og tamoxifen (ved median behandlingsvarighed på 60 måneder plus 30 dage): operationskrævende angina (1,0% vs. 1,0%); hjertesvigt (1,1% vs. 0,6%); hypertension (5,6% vs. 5,7%); cerebrovaskulær hændelse/transitorisk cerebral iskæmi (2,1% vs.
English: Alopecia, rash (including erythematous, maculopapular, psoriaform, and vesicular rash), dry skin
Danish: Alopeci, udslæt (inklusive erytematøst, makulopapuløst og psoriasislignende udslæt samt udslæt med blærer), tør hud.
English: Protocol definition of disease-free survival events: loco-regional recurrence, distant metastasis or contralateral breast cancer.
Danish: 3 Protokol-definition af hændelser ved sygdomsfri overlevelse: lokoregionalt tilbagefald, fjernmetastaser eller kontralateral brystcancer.
English: Two well-controlled clinical trials were conducted comparing two letrozole doses (0.5 mg and 2.5 mg) to megestrol acetate and to aminoglutethimide, respectively, in postmenopausal women with advanced breast cancer previously treated with anti-oestrogens.
Danish: To velkontrollerede kliniske studier blev udført, hvor to doser letrozol (0,5 mg og 2,5 mg) blev sammenlignet med henholdsvis megestrolacetat og aminoglutethimid hos postmenopausale kvinder med fremskreden brystcancer, som tidligere havde været i behandling med antiøstrogener.
English: In the extended adjuvant setting for {Invented Name} (median duration of treatment 5 years) and placebo (median duration of treatment 3 years), respectively: angina requiring surgery (0.8% vs. 0.6%); new or worsening angina (1.4% vs. 1.0%); myocardial infarction (1.0% vs. 0.7%); thromboembolic event* (0.9% vs. 0.3%); stroke/transient ischaemic attack* (1.5% vs. 0.8%) were reported.
Danish: Ved forlænget adjuverende behandling med {X} (median behandlingstid 5 år) henholdsvis placebo (median behandlingstid 3 år) blev der rapporteret operationskrævende angina (0,8% vs. 0,6%), forekomst eller forværring af angina (1,4% vs. 1,0%), myokardieinfarkt (1,0% vs. 0,7%), tromboembolisk hændelse* (0,9% vs. 0,3%), apopleksi/transitorisk cerebral iskæmi* (1,5% vs. 0,8%).
English: One controlled double-blind trial was conducted comparing {Invented Name} (letrozole) 2.5 mg to tamoxifen 20 mg as first-line therapy in postmenopausal women with advanced breast cancer.
Danish: Et kontrolleret dobbeltblindet studie sammenlignede {X} (letrozol) 2,5 mg med tamoxifen 20 mg som første-linje-behandling til postmenopausale kvinder med fremskreden brystcancer.
English: When the study was unblinded in 2003, 1551 patients in the randomised placebo arm (60% of those eligible to switch, i.e. who were disease-free) switched to letrozole at a median 31 months after randomisation.
Danish: RR= Relativ risiko; KI = konfidensinterval 1 Da studiet blev afblindet i 2003, skiftede 1.551 patienter fra placebo-armen (60% af dem, der var egnet til at skifte - dvs. sygdomsfri) til letrozol med en median på 31 måneder efter randomisering.
English: Table 3 Sequential treatment versus {Invented Name} monotherapy - adverse events with significant differences
Danish: Tabel 3 Sekventiel behandling versus {X} monoterapi - bivirkninger med signifikante forskelle
English: As a consequence tumour cells slow or stop growing and/or spreading to other parts of the body.
Danish: Dette medfører, at væksten af kræftceller eller spredningen af kræftceller til andre dele af kroppen stoppes eller hæmmes.
English: {Invented Name} N=453
Danish: { X} N=453
English: This medicine has been prescribed for you only.
Danish: - Lægen har ordineret {X} til dig personligt.
English: Do not take {Invented Name} if you are allergic to letrozole or to any of the other ingredients of this medicine (listed in section 6), if you still have periods, i.e. if you have not yet gone through the menopause,
Danish: Tag ikke {X} - hvis du er allergisk over for letrozol eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: NAME OF THE MEDICINAL PRODUCT {Invented name} and associated names (see Annex I) strength pharmaceutical form [See Annex I - To be completed nationally]
Danish: LÆGEMIDLETS NAVN {Lægemidlets (sær)navn} og relaterede navne (Se bilag I) styrke lægemiddelform [Se bilag I - Udfyldes nationalt]
English: In postmenopausal patients with advanced breast cancer, daily doses of 0.1 mg to 5 mg suppressed plasma concentration of oestradiol, oestrone, and oestrone sulphate by 75-95% from baseline in all patients treated.
Danish: Hos postmenopausale kvinder med fremskreden brystcancer nedsætter daglige doser på 0,1-5 mg plasmakoncentrationen af estradiol, estron og estronsulfat med 75-95% fra baseline hos alle behandlede patienter.
English: Adjusted by chemotherapy use (yes/no) 624 (40%) patients selectively crossed to letrozole after tamoxifen arm unblinded in 2005
Danish: 2 624 (40%) patienter, som selektivt blev krydset over til letrozol, efter tamoxifen-armen blev afblindet i 2005.
English: No dosage adjustment of {Invented Name} is required for patients with renal insufficiency with creatinine clearance ≥10 ml/min.
Danish: Dosisjustering af {X} er ikke nødvendig hos patienter med nedsat nyrefunktion, hvis kreatininclearance er ≥ 10 ml/min.
English: 5-year DFS rate Distant metastases Events
Danish: Rate for sygdomsfri overlevelse efter 5 år Fjernmetastase Hændelser
English: Censored analysis of OS3
Danish: Censoreret analyse af total overlevelse3
English: Table 5 Monotherapy Arms Analysis: Disease-free and overall survival at a median follow-up of 73 months (ITT population)
Danish: Monoterapi-arm-analyse: Sygdomsfri og total overlevelse ved median opfølgning på 73 måneder (ITT-population)
English: Anaphylactic reaction Metabolism and nutrition disorders Very common:
Danish: Anafylaktisk reaktion Metabolisme og ernæring Meget almindelig Hyperkolesterolæmi Almindelig
English: The other ingredients are [To be completed nationally] What {Invented Name} looks like and contents of the pack [To be completed nationally]
Danish: - Øvrige indholdsstoffer [Udfyldes nationalt] Udseende og pakningsstørrelser [Udfyldes nationalt]
English: {Invented Name} is contraindicated during pregnancy (see sections 4.3 and 5.3).
Danish: {X} er kontraindiceret under graviditeten (se pkt.
English: At 24 months there was a statistically significant difference in the primary end-point; the lumbar spine BMD (L2-L4) showed a median decrease of 4.1% for letrozole compared to a median increase of 0.3% for tamoxifen.
Danish: BMD i lændehvirvlerne (L2-L4) viste et mediant fald på 4,1% for letrozol sammenlignet med en median øgning på 0,3% for tamoxifen.
English: The usual dose is one tablet of {Invented Name} to be taken once a day.
Danish: Den sædvanlige dosis er 1 tablet daglig.
English: Patients with severe hepatic impairment (Child-Pugh C) require close supervision (see sections 4.4 and 5.2).
Danish: Tæt opfølgning er nødvendig hos patienter med svært nedsat leverfunktion (Child-Pugh C) (se pkt.
English: Disease-free survival Events
Danish: Sygdomsfri overlevelse Hændelser
English: Nausea, dyspepsia1, constipation, abdominal pain, diarrhoea, vomiting
Danish: Kvalme, dyspepsi1, obstipation, abdominalsmerter, diarré, opkastning Ikke almindelig Mundtørhed, stomatitis1
English: The symptom that bothered most patients in both treatment arms was aching muscles, with a statistically significant difference in favour of placebo.
Danish: Det symptom, der generede flest patienter i begge behandlingsarme (men signifikant oftere i {X}armen end i placebo-armen), var muskelsmerter.
English: Median follow-up 62 months
Danish: 62 måneder median opfølgning
English: No changes were noted in plasma concentrations of androgens (androstenedione and testosterone) among healthy postmenopausal women after 0.1 mg, 0.5 mg, and 2.5 mg single doses of letrozole or in plasma concentrations of androstenedione among postmenopausal patients treated with daily doses of 0.1 mg to 5 mg, indicating that the blockade of oestrogen biosynthesis does not lead to accumulation of androgenic precursors.
Danish: Der blev ikke fundet ændringer i plasmakoncentrationen af androgener (androstendion og testosteron) hos raske postmenopausale kvinder efter administration af enkeltdoser på 0,1 mg, 0,5 mg og 2,5 mg letrozol eller i plasmakoncentrationen af androstendion hos postmenopausale patienter i behandling med daglige doser på 0,1-5 mg.
English: Rare or uncommon side effects (i.e. they may affect between 1 to 100 in every 10,000 patients): Weakness, paralysis or loss of feeling in any part of the body (particularly arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (sign of a brain disorder, e.g. stroke).
Danish: Ikke almindelige eller sjældne bivirkninger (de kan forekomme hos mellem 1 og 100 ud af 10.000 patienter): - Svaghed, lammelse eller følelsesløshed i en hvilken som helst del af kroppen (specielt arm eller ben), manglende koordinationsevne, kvalme, svært ved at tale eller trække vejret (tegn på blodprop i hjernen eller hjerneblødning) - Pludselig, trykkende smerte i brystet (tegn på hjertesygdom) - Besvær med at trække vejret, brystsmerte, besvimelsesanfald, hurtig hjerterytme (puls), blålig misfarvning af huden eller pludselig smerte i arm eller ben (tegn på en blodprop) - Hævelse eller rødme langs en vene, som er ekstremt øm og kan være smertefuld ved berøring - Høj feber, kulderystelser eller sår i munden på grund af infektion (mangel på hvide blodlegemer) - Svære, vedvarende synsforstyrrelser.
English: Pulmonary embolism, arterial thrombosis, cerebrovascular infarction Respiratory, thoracic and mediastinal disorders Uncommon:
Danish: Lungeemboli, arteriel blodprop og cerebrovaskulært infarkt Luftveje, thorax og mediastinum Ikke almindelig Dyspnø, hoste
English: {Invented Name}>tamoxifen
Danish: {X}->tamoxifen
English: Hazard Ratio1 (95% CI)
Danish: Relativ risiko1 (95% KI)
English: {Invented name} and associated names (see Annex I) strength pharmaceutical form [See Annex I - To be completed nationally]
Danish: {Lægemidlets (sær)navn} og relaterede navne (Se bilag I) styrke lægemiddelform [Se bilag I - Udfyldes nationalt]
English: Show them the pack of tablets.
Danish: Tag pakningen med.
English: If you have any questions about how {Invented Name} works or why this medicine has been prescribed for you, ask your doctor.
Danish: Tal med din læge, hvis du har spørgsmål om, hvordan {X} virker, eller er i tvivl om, hvorfor det er ordineret til dig.
English: You should also inform the doctor straight away if you experience any of the following symptoms during treatment with {Invented Name}:
Danish: Du skal også straks fortælle lægen, hvis du får et af følgende symptomer under behandling med {X}: - Hævelse, især af ansigt og hals (tegn på allergisk reaktion).
English: {Invented Name}, incidence rate Tamoxifen, incidence rate
Danish: Tamoxifen, incidensrate
English: The cytochrome P450 isoenzymes 3A4 and 2A6 were found to be capable of converting letrozole to this metabolite.
Danish: CYP3A4 og 2A6 kan metabolisere letrozol til ovenstående metabolit.
English: If any of these affects you severely, tell your doctor.
Danish: Hvis nogen af disse bivirkninger påvirker dig meget, så fortæl det til lægen.
English: {Invented Name} N=4003
Danish: {X} N=4.003
English: In a multicentre, double-blind, randomised, placebo-controlled study (MA-17), over 5,100 postmenopausal women with receptor-positive or unknown primary breast cancer who had completed adjuvant treatment with tamoxifen (4.5 to 6 years) were randomised to either {Invented Name} or placebo for 5 years.
Danish: I et multicenter, dobbelt-blindet, randomiseret, placebokontrolleret studie (MA-17) blev over 5.100 postmenopausale kvinder med receptor-positiv brystcancer eller ukendt primær brystcancer,
English: General oedema, mucosal dryness, thirst, pyrexia
Danish: Ikke almindelig Generaliseret ødem, tørre slimhinder, tørst, pyreksi Undersøgelser
English: Immune system disorders Not known:
Danish: Ikke almindelig Forhøjede leverenzymer Ikke kendt
English: {Invented Name} is contraindicated during breast-feeding (see section 4.3).
Danish: {X} er kontraindiceret under amning (se pkt.