natgillin/translations-raw huggingface dataset:
Tabel over bivirkninger Bivirkningsfrekvenserne for {X} er hovedsagelig baseret på data indsamlet fra kliniske studier. 
The frequencies of adverse reactions for {Invented Name} are mainly based on data collected from clinical trials.
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. 
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.
Der er rapporteret om isolerede tilfælde af overdosering med {X}. 
Isolated cases of overdose with {Invented Name} have been reported.
Plasmakoncentrationen af LH eller FSH påvirkes ikke af behandling med letrozol, det samme gælder thyreoideafunktionen bedømt ved TSH, T4 og T3. 
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.
Brystcancer hos mænd Anvendelse af {X} til mænd med brystcancer er ikke blevet undersøgt. 
Male breast cancer Use of {Invented Name} in men with breast cancer has not been studied.
{X} bør derfor gives med forsigtighed til patienter med svært nedsat leverfunktion og under opvejning af risici og fordele for den enkelte patient. 
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.
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. 
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.
Nogle af disse bivirkninger, som fx hedeture, hårtab og menstruationslignende blødning, kan skyldes østrogenmangel i kroppen. 
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.
Samtidig administration af letrozol og tamoxifen, andre antiøstrogener eller østrogener bør undgås. 
Coadministration of letrozole with tamoxifen, other anti-oestrogens or oestrogens should be avoided.
Virkning og anvendelse Det skal du vide, før du begynder at tage {X} Sådan skal du tage {X} Bivirkninger 
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
(95% KI for rate) Odds ratio (95% KI for oddsratio) p 
(95% CI for rate) Odds ratio (95% CI for odds ratio) P
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. 
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.
Behandlingen bør være symptomatisk og understøttende. 
No specific treatment for overdose is known; treatment should be symptomatic and supportive.
Desuden har samtidig behandling med tamoxifen og letrozol vist at nedsætte plasmakoncentrationen af letrozol betydeligt. 
In addition, co-administration of tamoxifen with letrozole has been shown to substantially decrease plasma concentrations of letrozole.
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). 
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).
I lipid-substudiet til MA-17 var der ingen signifikant forskel mellem {X}- og placebo-armene i totalkolesterol eller i nogen lipidfraktion. 
In the MA-17 lipid substudy there were no significant differences between letrozole and placebo in total cholesterol or in any lipid fraction.
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. 
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.
1 Log-rank-test, stratificeret i forhold til strata ved randomisering og brug af kemoterapi (ja/nej). 
Log rank test, stratified by randomisation option and use of chemotherapy (yes/no)
Ikke almindelig Palpitationer1, takykardi, iskæmiske hjertetilfælde (inklusive ny eller forværret angina, operationskrævende angina, myokardieinfarkt og myokardieiskæmi) 
Palpitations1, tachycardia, ischaemic cardiac events(including new or worsening angina, angina requiring surgery, myocardial infarction and myocardial ischaemia)
Tabel 6 Analyse af sekvensbehandling med hensyn til sygdomsfri overlevelse med letrozol som initial endokrin behandling (STA-skift population) 
Table 6 Sequential treatments analysis of disease-free survival with letrozole as initial endocrine agent (STA switch population)
Analysen af sekvensbehandling (STA) undersøger BIG 1-98-studiets andet primære spørgsmål, dvs. om sekvensbehandling med tamoxifen og letrozol er bedre end monoterapi. 
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.
• Neo-adjuverende behandling af postmenopausale kvinder med hormonreceptor-positiv, HER-2negativ brystcancer, hvor kemoterapi ikke er egnet og operation ikke aktuel. 
• 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.
Suppression af østrogensyntesen i perifere væv og i cancervævet kan derfor opnås ved specifik hæmning af aromataseenzymet. 
The suppression of oestrogen biosynthesis in peripheral tissues and the cancer tissue itself can therefore be achieved by specifically inhibiting the aromatase enzyme.
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. 
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.
Hos præmenopausale kvinder fører hæmning af østrogensyntesen til feedback-mekanisme og stigning i gonadotropin (LH, FSH)-niveauer. 
In premenopausal women, the inhibition of oestrogen synthesis leads to feedback increases in gonadotropin (LH, FSH) levels.
Der var ingen signifikant forskel i total overlevelse: {X} 51 døde; placebo 62 (relativ risiko 0,82; 95% KI 0,56-1,19). 
There was no significant difference in overall survival: ({Invented Name} 51 deaths; placebo 62; HR 0.82; 95% CI 0.56, 1.19).
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. 
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.
Dosisjustering af {X} er ikke nødvendig hos patienter med let til moderat nedsat leverfunktion (ChildPugh A eller B). 
No dose adjustment of {Invented Name} is required for patients with mild to moderate hepatic insufficiency (Child-Pugh A or B).
Samlet gennemgik 45% af patienterne i {X}-gruppen versus 35% af patienterne i tamoxifen-gruppen (p=0,02) brystbevarende behandling. 
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).
Der var ingen signifikante forskelle i DFS, OS, SDFS eller DDFS af skift i forhold til monoterapi (Tabel 6). 
There were no significant differences in DFS, OS, SDFS, or DDFS from switch with respect to monotherapy (Table 6).
Hvis noget af dette passer på dig, må du ikke tage denne medicin, men skal fortælle det til din læge. 
If any of these conditions apply to you, do not take this medicine and talk to your doctor.
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%. 
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.
Hos patienter, hvor menopausal status er uklar, skal serumkoncentrationen af luteiniserende hormon (LH), follikelstimulerende hormon (FSH) og/eller østradiol måles inden behandlingsstart. 
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}.
Tabel 8 Sygdomsfri og total overlevelse (modificeret ITT-population) 28 måneder median opfølgning 
Table 8 Disease-free and overall survival (Modified ITT population) Median follow-up 28 months
Hos hunrotter fandtes reduceret incidens af benigne og maligne mammatumorer ved alle doser letrozol. 
In female rats, a reduced incidence of benign and malignant mammary tumours at all the doses of letrozole was found.
Median varighed af {X} efter skift var 40 måneder. 
Median duration for {Invented Name} after switch was 40 months.
Det vides ikke, om det indirekte skyldes de farmakologiske egenskaber (hæmning af østrogensyntesen) eller direkte skyldes lægemidlets effekt (se pkt. 
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).
Tabel 7 Analyse af sekvensbehandling efter randomisering (STA-R) for sygdomsfri overlevelse (ITT-STA-R-population) 
Table 7 Sequential Treatments Analyses from randomisation (STA-R) of disease-free survival (ITT STA-R population)
- Udslæt, rød hud, vabler på læber, øjne eller mund, afskalning af huden, feber (tegn på hudsygdom). 
Rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever (signs of skin disorder).
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). 
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).
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. 
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.
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). 
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).
In vitro hæmmer letrozol CYP-isoenzymet 2A6 og - i moderat grad - 2C19, men den kliniske relevans er ukendt. 
In vitro, letrozole inhibits the cytochrome P450 isoenzymes 2A6 and, moderately, 2C19, but the clinical relevance is unkown.
Endometriehyperplasi / endometriecancer 
Endometrial hyperplasia / endometrial cancer
Median behandlingstid var 5 år for {X} og 3 år for placebo. 
Median duration of treatment was 5 years for {Invented Name}, compared with 3 years for placebo.
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. 
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.
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. 
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.
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). 
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%).
Nogle bivirkninger er meget almindelige. 
Some side effects are very common.
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. 
In the adjuvant and extended adjuvant setting, treatment with {Invented Name} should continue for 5 years or until tumour relapse occurs, whichever is first.
Det hæmmer aromataseenzymet ved kompetitiv binding til hæmgruppen i CYP-enzymet, hvilket resulterer i reduktion af østrogensyntesen i alle væv, hvor det forekommer. 
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.
Tamoxifen, andre antiøstrogener eller østrogener kan nedsætte den farmakologiske virkning af letrozol. 
Tamoxifen, other anti-oestrogens or oestrogen-containing therapies may diminish the pharmacological action of letrozole.
Der var ikke signifikant forskel i total overlevelse mellem de to behandlinger (p=0,2). 
Overall survival was not significantly different between the 2 arms (P=0.2).
Tromboembolisk hændelse 
Thromboembolic events
Ikke almindelig Angst (inklusive nervøsitet), irritabilitet Nervesystemet 
Anxiety (including nervousness), irritability Nervous system disorders Common:
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. 
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.
1 Justeret for brug af kemoterapi 
Adjusted by chemotherapy use
Ikke almindelig Vægttab 1 Bivirkninger rapporteret alene ved metastaser. 
Weight loss 1 Adverse drug reactions reported only in the metastatic setting
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. 
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.
Følgende tabeller giver information om signifikante forskelle mellem {X} versus tamoxifen ved monoterapi og i {X}-tamoxifen sekventielt behandlingsprogram: 
The following tables provide information on significant differences in {Invented Name} versus tamoxifen monotherapy and in the {Invented Name}-tamoxifen sequential treatment therapy:
Ikke almindelig Tromboflebitis (inklusive overfladisk og dyb venetrombose), Sjælden 
Thrombophlebitis (including superficial and deep vein thrombophlebitis)
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. 
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.
• Forlænget adjuverende behandling af hormonafhængig invasiv tidlig brystcancer hos postmenopausale kvinder, som forud har fået adjuverende standardbehandling med tamoxifen i 5 år. 
• Extended adjuvant treatment of hormone-dependent invasive breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 years.
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. 
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.
- Gul hud og øjne, kvalme, appetitløshed, mørkfarvet urin (tegn på leverbetændelse). 
Yellow skin and eyes, nausea, loss of appetite, dark-coloured urine (signs of hepatitis).
• Førstevalgsbehandling til postmenopausale kvinder med hormonafhængig fremskreden brystcancer. 
• First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer.
Nedsat nyrefunktion {X} er ikke undersøgt hos et tilstrækkeligt antal patienter med kreatininclearance < 10 ml/min. 
Renal impairment {Invented Name} has not been investigated in a sufficient number of patients with a creatinine clearance lower than 10 ml/min.
Dødsfald4 
Deaths4
I det andet studie var responsraten mellem letrozol 2,5 mg og aminoglutethimid ikke signifikant forskellig (p=0,06). 
In the second study, the response rate was not significantly different between letrozole 2.5 mg and aminoglutethimide (P=0.06).
Der var statistisk signifikant forskel mellem de to behandlingsarme for hændelser markeret med *. 
Events marked * were statistically significantly different in the two treatment arms.
Nogle bivirkninger er almindelige. 
Some side effects are common.
Tabel 4 Primær analyse: Sygdomsfri og total overlevelse ved en median opfølgningtid på 26 måneder og en median opfølgningstid på 60 måneder (ITT-population) 
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)
Perioden indtil progression var ikke signifikant forskellig mellem letrozol 2,5 mg og megestrolacetat (p=0,07). 
Time to progression was not significantly different between letrozole 2.5 mg and megestrol acetate (P=0.07).
Neo-adjuverende behandling 
Neoadjuvant treatment
Farmakologisk virker letrozol ved at reducere østrogenproduktionen ved aromatasehæmning. 
The pharmacological action of letrozole is to reduce oestrogen production by aromatase inhibition.
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. 
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.
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%). 
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).
Ikke almindelig Øget urineringsfrekvens Det reproduktive system og mammae Almindelig 
Increased urinary frequency Reproductive system and breast disorders Common:
• Adjuverende behandling af postmenopausale kvinder med hormonreceptor-positiv invasiv tidlig brystcancer. 
• Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer.
{X} kan give anledning til tab af knoglemasse (osteoporose), da det nedsætter mængden af østrogen i din krop. 
{Invented Name} may cause thinning or wasting of your bones (osteoporosis) due to the reduction of oestrogens in your body.
hvilket er den eneste problemstilling vedrørende sikkerheden ved human anvendelse, som kan uddrages fra dyrestudierne. 
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.
Ikke almindelig Døsighed, søvnløshed, hukommelsessvækkelse, dysæstesi (inklusive paræstesi, hypæstesi), smagsforstyrrelser, cerebrovaskulær hændelse 
Somnolence, insomnia, memory impairment, dysaesthesia (including paraesthesia, hypoaesthesia), taste disturbance, cerebrovascular accident
Tabel 2 Adjuverende {X} monoterapi versus tamoxifen monoterapi - bivirkninger med signifikante forskelle 
Table 2 Adjuvant {Invented Name} monotherapy versus tamoxifen monotherapy - adverse events with significant differences
Anoreksi, øget appetit Psykiske forstyrrelser Almindelig 
Anorexia, appetite increase
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. 
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.
Myalgi, knoglesmerter1, osteoporose, knoglebrud. 
Myalgia, bone pain1, osteoporosis, bone fractures
Rapporteringsperioden inkluderer behandlingsperioden plus 30 dage efter behandlingsophør Procenter i parentes indikerer hændelsesfrekvenser på enhvert tidspunkt efter randomisering, inklusive behandlingsperiode efter studiet. 
Percentages in parentheses indicate event frequencies any time after randomisation, including post study treatment period.
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 
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).