FrancophonIA/ELRC3.0 huggingface dataset:
English: Reducing circulating estradiol levels has been shown to produce a beneficial effect in women with breast cancer.
Danish: Det er påvist, at nedsat koncentration af cirkulerende estradiol har en gavnlig virkning hos kvinder med brystkræft.
English: Treatment or prophylaxis for osteoporosis should be initiated as appropriate and carefully monitored.
Danish: Hvis relevant, skal behandling af eller profylakse mod osteoporose påbegyndes og monitoreres nøje.
English: In the pivotal clinical trial, efficacy was not demonstrated and safety was not established (see section 5.1).
Danish: I det kliniske hovedforsøg blev der ikke påvist virkning, og sikkerheden blev ikke fastlagt (se pkt.
English: Pharmacotherapeutic group: Enzyme inhibitors, ATC code: L02B G03
Danish: Farmakoterapeutisk klassifikation: Enzymhæmmere, ATC-kode: L02B G03
English: The small change in the rate of absorption is not expected to result in a clinically significant effect on steady-state plasma concentrations during once daily dosing of Arimidex tablets.
Danish: Den lille ændring i absorbtionshastigheden forventes ikke at resultere i en klinisk signifikant virkning på steady-state-plasmakoncentrationen ved dosering af Arimidex-tabletter én gang dagligt.
English: The effects of Arimidex on fertility in humans have not been studied.
Danish: Arimidex' indvirkning på fertiliteten hos mennesker er ikke blevet undersøgt.
English: • Pain or stiffness in your joints.
Danish: • Smerte eller stivhed i leddene.
English: Those effects that were seen (placental enlargement in rats and pregnancy failure in rabbits) were related to the pharmacology of the compound.
Danish: De virkninger, der sås (forstørret placenta hos rotter og spontane aborter hos kaniner), var relateret til stoffets farmakologi.
English: These medicines are used to treat breast cancer, certain female health (gynaecological) conditions, and infertility.
Danish: Disse lægemidler anvendes til at behandle brystkræft, visse gynækologiske sygdomme og infertilitet.
English: This is because these medicines may stop Arimidex from working properly.
Danish: Det skyldes, at disse lægemidler kan forhindre Arimidex i at virke optimalt.
English: If you go into the hospital, let the medical staff know you are taking Arimidex.
Danish: Hvis du skal på hospitalet, skal du fortælle sundhedspersonalet, at du tager Arimidex.
English: • Skin rash caused by hypersensitivity (this can be from allergic or anaphylactoid reaction).
Danish: • Hududslæt forårsaget af overfølsomhed (som kan skyldes en allergisk eller allergilignende reaktion).
English: Ischaemic cardiovascular disease Angina pectoris
Danish: Iskæmisk hjerte-karsygdom Angina pectoris
English: While the number of children treated was too limited to draw any reliable conclusions on safety, there was an increased fracture rate and a trend towards reduced bone mineral density in the Arimidex arm compared to placebo.
Danish: Det behandlede antal børn var for lavt til at drage nogen pålidelige konklusioner om sikkerheden, men der var en øget forekomst af frakturer og en tendens til reduceret knoglemineraltæthed i Arimidex-armen sammenlignet med placebo-armen.
English: However, asthenia and somnolence have been reported with the use of Arimidex and caution should be observed when driving or operating machinery while such symptoms persist.
Danish: Der er imidlertid rapporteret asteni og søvnighed i forbindelse med brug af Arimidex, og der skal udvises forsigtighed, når man skal føre motorkøretøjer eller betjene maskiner, så længe sådanne symptomer forekommer.
English: p-value Time to distant recurrenced
Danish: p-værdi Tid til fjernt recidivd
English: These changes occurred at a dose which represents 100-fold greater exposure than occurs at human therapeutic doses, and are considered not to be clinically relevant to the treatment of patients with anastrozole.
Danish: Disse ændringer skete ved en dosis, der repræsenterer en 100 gange større eksponering, end der forekommer ved terapeutiske doser hos mennesker, og anses ikke for at være klinisk relevante ved behandling af patienter med anastrozol.
English: Women with osteoporosis or at risk of osteoporosis, should have their bone mineral density formally assessed at the commencement of treatment and at regular intervals thereafter.
Danish: Kvinder med osteoporose eller risiko for osteoporose bør få foretaget en formel vurdering af deres knoglemineraltæthed ved behandlingens start og derefter med regelmæssige mellemrum.
English: The primary endpoints for both trials were time to tumour progression, objective tumour response rate, and safety.
Danish: De primære endepunkter i begge studier var tid til tumorprogression, objektiv tumorresponsrate og sikkerhed.
English: Dialysis may be helpful because Arimidex is not highly protein bound.
Danish: Dialyse kan være hensigtsmæssig, fordi Arimidex ikke er proteinbundet i udtalt grad.
English: In animal studies, anastrozole demonstrated low acute toxicity.
Danish: I dyreforsøg udviste anastrozol lav akut toksicitet.
English: • Pregnant or breast-feeding women.
Danish: • Gravide eller ammende kvinder.
English: The efficacy of study treatment was based on the proportion of patients fulfilling defined criteria relating to vaginal bleeding, bone age, and growth velocity.
Danish: Virkningen af forsøgsbehandlingen var baseret på den andel af patienter, som opfyldte de fastlagte kriterier vedrørende vaginalblødning, knoglealder og væksthastighed.
English: Table 1 Adverse reactions by System Organ Class and frequency Adverse reactions by SOC and frequency Metabolism and nutrition disorders Common
Danish: Tabel 1 Bivirkninger efter systemorganklasse og frekvens Bivirkninger efter SOC og frekvens Metabolisme og ernæring
English: • Trigger finger (a condition in which your finger or thumb catches in a bent position).
Danish: • Springfinger (en lidelse, hvor din finger fastlåses i en bøjet position).
English: In boys with pubertal gynaecomastia (10-17 years), anastrozole was rapidly absorbed, was widely distributed, and was eliminated slowly with a half-life of approximately 2 days.
Danish: Hos drenge (10-17 år) med pubertal gynækomasti blev anastrozol absorberet hurtigt, fordelt i vid udstrækning og elimineret langsomt med en halveringstid på ca. 2 dage.
English: These effects were related to the pharmacology of the compound and were completely reversed after a 5-week compound withdrawal period.
Danish: Disse virkninger var relateret til stoffets farmakologi og var helt ophævet efter en 5-ugers behandlingsfri periode.
English: Stop Arimidex if you become pregnant and talk to your doctor.
Danish: Stop med at tage Arimidex, hvis du bliver gravid, og tal med din læge.
English: Your doctor will manage these risks according to treatment guidelines for managing bone health in women who have gone through the menopause.
Danish: Din læge vil afveje disse risici i henhold til retningslinjerne for behandling af knogleskørhed hos kvinder, der har passeret overgangsalderen.
English: • Allergic (hypersensitivity) reactions with swelling of the throat that may cause difficulty in swallowing or breathing.
Danish: • Allergiske reaktioner (overfølsomhed) med hævelse i halsen, der kan gøre det svært at sluge eller trække vejret.
English: A review of the clinical trial safety database did not reveal evidence of clinically significant interaction in patients treated with Arimidex who also received other commonly prescribed medicinal products.
Danish: En gennemgang af sikkerhedsdatabasen fra de kliniske forsøg viste ikke nogen tegn på klinisk signifikant interaktion hos patienter behandlet med Arimidex, der også fik andre almindeligt ordinerede lægemidler.
English: The enzymes mediating metabolism of anastrozole have not been identified.
Danish: Enzymerne, som medierer metaboliseringen af anastrozol, er ikke blevet identificeret.
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Arimidex.
Danish: Hvis du ikke er sikker på, om noget af ovenstående gælder for dig, skal du tale med din læge eller spørge på apoteket, før du tager Arimidex.
English: This includes medicines that you buy without a prescription and herbal medicines.
Danish: Dette gælder også medicin, som ikke er købt på recept samt naturlægemidler.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendte lægemidler samt affald herfra bør destrueres i henhold til lokale retningslinier.
English: Table 2 ATAC study pre-specified adverse events Adverse events
Danish: Tabel 2 Forudspecificerede utilsigtede hændelser i ATAC-forsøget Utilsigtede hændelser
English: In addition, a decrease in BMD which was not statistically significant was seen in the low risk group treated with Arimidex 1 mg/day alone.
Danish: Et fald i BMD, som ikke var statistisk signifikant, blev desuden konstateret i lavrisikogruppen, som blev behandlet med Arimidex 1 mg/dag alene.
English: Use in children Arimidex should not be given to children and adolescents.
Danish: Brug til børn Arimidex må ikke gives til børn og unge.
English: • Allergic (hypersensitivity) reactions including face, lips, or tongue.
Danish: • Allergiske reaktioner (overfølsomhed), bl.a. i ansigtet, på læberne eller tungen.
English: Arimidex contains a substance called anastrozole.
Danish: Arimidex indeholder et stof, der hedder anastrozol.
English: No significant difference in the number of patients who had a 50% or greater reduction in total breast volume after 6 months of treatment was observed between the Arimidex 1 mg treated group and the placebo group.
Danish: Der blev ikke observeret nogen signifikant forskel i antal patienter, der havde en 50 % eller større reduktion i total brystvolumen efter 6 måneders behandling, mellem gruppen behandlet med Arimidex 1 mg og placebogruppen.
English: The secondary objectives were to evaluate the proportion of patients with reductions from baseline in the calculated volume of gynaecomastia of both breasts combined of at least 50% between day 1 and after 6 months of study treatment, and patient tolerability and safety.
Danish: Det sekundære formål var at evaluere den andel af patienter, som havde reduktion i forhold til baseline i det beregnede volumen, som skyldtes gynækomasti i begge bryster, kombineret med mindst 50 % reduktion mellem dag 1 og efter 6 måneders forsøgsbehandling, samt patienttolerabilitet og -sikkerhed.
English: In an oral acute toxicity study in the dog, the median lethal dose was greater than 45 mg/kg/day.
Danish: I et oralt akut toksicitetsforsøg hos hunde var den gennemsnitlige letale dosis større end 45 mg/kg/dag.
English: In both studies there were no significant differences between treatment arms with respect to any of the efficacy parameters.
Danish: Der var ingen signifikant forskel mellem behandlingsarmene i de to forsøg, hvad angår nogen af effektparametrene.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction for the indicated population.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet og reproduktionstoksicitet.
English: McCune-Albright Syndrome study
Danish: McCune-Albright syndrom
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Spørg lægen eller på apoteket, før du tager nogen form for medicin.
English: The most frequently reported adverse reactions were headache, hot flushes, nausea, rash, arthralgia, joint stiffness, arthritis, and asthenia.
Danish: De hyppigst rapporterede bivirkninger var hovedpine, hedeture, kvalme, udslæt, ledsmerter, stivhed, artrit og asteni.
English: Vaginal dryness Vaginal bleeding ***
Danish: Vaginal tørhed Vaginalblødning***
English: The Arimidex safety profile in these 3 studies was consistent with the known safety profile established in postmenopausal women with hormone receptor-positive early breast cancer.
Danish: Arimidex' sikkerhedsprofil i disse 3 forsøg stemte overens med den kendte sikkerhedsprofil, som var fastslået hos postmenopausale kvinder med hormonreceptor-positiv tidlig brystkræft.
English: Before treatment with Arimidex check with your doctor or pharmacist - if you still have menstrual periods and have not yet gone through the menopause.
Danish: Inden du tager Arimidex, skal du spørge din læge eller på apoteket - hvis du har menstruation og ikke har overstået overgangsalderen.
English: p-value Time to recurrencec
Danish: p-værdi Tid til recidivc
English: Patients in the low risk group received Arimidex alone (N=42), those in the moderate group were randomised to Arimidex plus risedronate 35 mg once a week (N=77) or Arimidex plus placebo (N=77) and those in the high risk group received Arimidex plus risedronate 35 mg once a week (N=38).
Danish: Patienter i lavrisikogruppen fik Arimidex alene (N=42), patienter med moderat risiko blev randomiseret til Arimidex plus risedronat 35 mg en gang om ugen (N=77) eller Arimidex plus placebo (N=77), og patienter i højrisikogruppen fik Arimidex plus risedronat 35 mg en gang om ugen (N=38).
English: There are no data to support the use of Arimidex with LHRH analogues.
Danish: Der er ingen data, som understøtter brug af Arimidex med LHRH-analoger.
English: A total of 1,021 patients were randomised to receive 1 mg of Arimidex once daily or 20 mg of tamoxifen once daily.
Danish: I alt 1.021 patienter blev randomiseret til at få 1 mg Arimidex en gang dagligt eller 20 mg tamoxifen en gang dagligt.
English: No no-effect levels were established for anastrozole in the toxicity studies, but those effects that were observed at the low doses (1 mg/kg/day) and mid doses (dog 3 mg/kg/day; rat 5 mg/kg/day) were related to either the pharmacological or enzyme inducing properties of anastrozole and were unaccompanied by significant toxic or degenerative changes.
Danish: Der blev ikke fastlagt et ingen-virkningsniveau for anastrozol i toksicitetsforsøgene, men de virkninger, der blev observeret ved lave doser (1 mg/kg/dag) og middeldoser (hund 3 mg/kg/dag; rotte 5 mg/kg/dag), var enten relateret til anastrozols farmakologiske eller enzym-inducerende egenskaber og var ikke ledsaget af signifikante toksiske eller degenerative ændringer.
English: Fractures of the spine, hip, or wrist/Colles Wrist/Colles fractures
Danish: Frakturer i rygrad, hofte eller håndled/Colles Frakturer i håndled/Colles Frakturer i rygraden
English: Arimidex should be taken orally.
Danish: Arimidex skal indtages oralt.
English: Since anastrozole reduces estradiol levels, Arimidex must not be used in girls with growth hormone deficiency in addition to growth hormone treatment.
Danish: Da anastrozol reducerer estradiolniveauet, må Arimidex ikke bruges hos piger med væksthormonmangel som supplement til behandling med væksthormon.
English: No statistically significant change in the rate of increase in bone age on treatment compared to the rate during baseline was observed.
Danish: Der blev ikke observeret nogen statistisk signifikant ændring i stigningsraten i knoglealder ved behandling sammenlignet med raten ved baseline.
English: Oral administration of anastrozole to pregnant rats and rabbits caused no teratogenic effects at doses up to 1.0 and 0.2 mg/kg/day respectively.
Danish: Oral indgift af anastrozol til gravide rotter og kaniner forårsagede ingen teratogene virkninger ved doser op til henholdsvis 1,0 og 0,2 mg/kg/dag.
English: ‘Stevens-Johnson syndrome'.
Danish: Dette kaldes ‘Stevens-Johnsons syndrom'.
English: Anastrozole is extensively metabolised by postmenopausal women with less than 10% of the dose excreted in the urine unchanged within 72 hours of dosing.
Danish: Postmenopausale kvinder metaboliserer anastrozol i udpræget grad, idet mindre end 10 % udskilles uomdannet i urinen inden for 72 timer efter doseringen.
English: Do not take Arimidex if you are pregnant or breast-feeding.
Danish: Tag ikke Arimidex, hvis du er gravid eller ammer.
English: Keep taking Arimidex for as long as your doctor tells you to.
Danish: Fortsæt med at tage Arimidex, så længe din læge siger det.
English: A greater magnitude of benefit was observed for disease free survival in favour of Arimidex versus tamoxifen for the prospectively defined hormone receptor-positive population.
Danish: Den største fordel blev observeret for sygdomsfri overlevelse til fordel for Arimidex versus tamoxifen i den prospektivt definerede hormonreceptor-positive population.
English: Metabolism of anastrozole occurs by N-dealkylation, hydroxylation and glucuronidation.
Danish: Anastrozol metaboliseres ved N-dealkylering, hydroxylering og glukuronidering.
English: Stevens-Johnson syndrome Angioedema
Danish: Stevens-Johnsons syndrom Angioødem
English: Hypercholesterolaemia Very common Headache
Danish: Hyperkolesterolæmi Meget almindelig Hovedpine
English: [See Annex I - To be completed nationally] This leaflet was last approved in {MM/YYYY}.
Danish: [Se bilag I - Udfyldes nationalt] Denne indlægsseddel blev senest godkendt {MM/YYYY}.
English: There were no adverse effects on behaviour or reproductive performance of the first generation offspring attributable to maternal treatment with anastrozole.
Danish: Der sås ingen indvirkning på adfærd eller reproduktion, som kunne tilskrives behandling af moderen med anastrozol, hos den første generation.
English: The combination of Arimidex and tamoxifen did not demonstrate any efficacy benefits in comparison with tamoxifen in all patients as well as in the hormone receptor-positive population.
Danish: Kombination af Arimidex og tamoxifen udviste ikke nogen effektfordele sammenlignet med tamoxifen hverken hos den totale population eller hos hormonreceptor-positiv-populationen.
English: No statistically significant difference from placebo was observed for the growth related parameters of predicted adult height, height, height SDS (standard deviation score), and height velocity.
Danish: Der blev ikke observeret nogen statistisk signifikant forskel versus placebo for de vækstrelaterede parametre forventet voksenhøjde, højde, højde-standardafvigelse og væksthastighed.
English: These effects were related to the pharmacological effects of the compound on parturition.
Danish: Disse virkninger var relateret til stoffets farmakologiske virkning på fødslen.
English: The apparent clearance (CL/F) of anastrozole, following oral administration, was approximately 30% lower in volunteers with stable hepatic cirrhosis than in matched controls (Study 1033IL/0014).
Danish: Den tilsyneladende clearance (CL/F) af anastrozol efter oral indgift var ca. 30 % lavere hos frivillige med stabil levercirrose end hos tilsvarende kontrolpersoner (forsøg 1033IL/0014).
English: These findings were mirrored in the secondary efficacy variable of change from baseline in total hip BMD at 12 months.
Danish: Disse fund afspejledes i den sekundære effektvariabel med ændring i total hofte-BMD i forhold til baseline efter 12 måneder.
English: Clinical studies with antipyrine and warfarin showed that anastrozole at a 1 mg dose did not significantly inhibit the metabolism of antipyrine and R- and S-warfarin indicating the co-administration of Arimidex with other medicinal products is unlikely to result in clinically significant medicinal product interactions mediated by CYP enzymes.
Danish: Kliniske studier med phenazon og warfarin viste, at anastrozol ved en dosis på 1 mg ikke signifikant hæmmede metaboliseringen af phenazon og R- og S-warfarin, hvilket indicerer, at indgivelse af Arimidex sammen med andre lægemidler sandsynligvis ikke resulterer i klinisk signifikante lægemiddelinteraktioner medieret af CYP-enzymer.
English: The table below presents the frequency of pre-specified adverse events in the ATAC study after a median follow-up of 68 months, irrespective of causality, reported in patients receiving trial therapy and up to 14 days after cessation of trial therapy.
Danish: Nedenstående tabel viser frekvensen uanset kausalitet af forudspecificerede utilsigtede hændelser i ATAC-forsøget efter en median opfølgning på 68 måneder, rapporteret hos patienter, som får forsøgsbehandling, og op til 14 dage efter ophør af forsøgsbehandling.
English: In animal studies toxicity was only seen at high doses.
Danish: I dyreforsøg blev der kun set toksicitet ved høje doser.
English: Arimidex is not recommended for use in children and adolescents as safety and efficacy have not been established in this group of patients (see section 5.1).
Danish: Arimidex anbefales ikke til børn og unge, da sikkerhed og virkning ikke er blevet fastlagt for denne patientgruppe (se pkt.
English: Arimidex is used to treat breast cancer in women who have gone through the menopause.
Danish: Arimidex anvendes til at behandle brystkræft hos kvinder, der har passeret overgangsalderen.
English: Unless specified, the frequency categories were calculated from the number of adverse events reported in a large phase III study conducted in 9,366 postmenopausal women with operable breast cancer given adjuvant treatment for five years (the Arimidex, Tamoxifen, Alone or in Combination [ATAC] study).
Danish: Medmindre andet er angivet, er frekvenskategorierne beregnet ud fra antallet af utilsigtede hændelser, som blev rapporteret i et stort fase III-studie med 9.366 postmenopausale kvinder med operabel brystkræft, som fik adjuverende behandling i fem år (Arimidex, Tamoxifen, Alone or in Combination [ATAC] studiet).
English: • Loss of appetite.
Danish: • Appetitløshed.
English: Cimetidine, a weak, unspecific inhibitor of CYP enzymes, did not affect the plasma concentrations of anastrozole.
Danish: Cimetidin, en svag, uspecifik CYP-hæmmer, påvirkede ikke plasmakoncentrationen af anastrozol.
English: For the primary endpoints, Study 1033IL/0030 showed that Arimidex had a statistically significant advantage over tamoxifen for time to tumour progression (Hazard ratio (HR) 1.42, 95% Confidence Interval (CI) [1.11, 1.82], Median time to progression 11.1 and 5.6 months for Arimidex and tamoxifen respectively, p=0.006); objective tumour response rates were similar for Arimidex and tamoxifen.
Danish: For de primære endepunkter viste studie 1033IL/0030, at Arimidex havde en statistisk signifikant fordel i forhold til tamoxifen for tid til tumorprogression (hazard ratio (HR) 1,42; 95 % konfidensinterval (CI) [1,11-1,82], median tid til progression 11,1 og 5,6 måned for hhv. Arimidex og tamoxifen, p=0,006).
English: p-value Overall survival e
Danish: p-værdi Samlet overlevelsee
English: These changes are considered to be mouse-specific effects of aromatase inhibition and not clinically relevant to the treatment of patients with anastrozole.
Danish: Disse ændringer anses for at være musespecifikke virkninger på grund af aromatasehæmning og ikke klinisk relevante ved behandling af patienter med anastrozol.
English: Arimidex is not indicated for use in children and adolescents.
Danish: Arimidex er ikke indiceret til brug hos børn og unge.
English: Number of events (frequency) Arimidex (N=1,297)
Danish: Antal hændelser (frekvens) Arimidex (N=1.297)
English: The use of specific treatments, e.g., bisphosphonates, may stop further bone mineral loss caused by Arimidex in postmenopausal women and could be considered (see section 4.8).
Danish: Specifikke behandlinger f.eks. med bisfosfonater kan standse yderligere knoglemineraltab forårsaget af Arimidex hos postmenopausale kvinder og kan overvejes (se pkt.
English: Arimidex should not be used in boys with growth hormone deficiency in addition to growth hormone treatment.
Danish: Arimidex må ikke anvendes til drenge med væksthormonmangel som supplement til behandling med væksthormon.
English: Very common Arthralgia/joint stiffness Arthritis
Danish: Meget almindelig Ledsmerter/stivhed Artrit
English: • Bone loss (osteoporosis).
Danish: • Knogleskørhed (osteoporose).
English: Each film-coated tablet contains 93 mg of lactose monohydrate (see section 4.4).
Danish: Hver filmovertrukken tablet indeholder 93 mg lactosemonohydrat (se pkt.