FrancophonIA/ELRC3.0 huggingface dataset:
English: A single dose of Arimidex that results in life-threatening symptoms has not been established.
Danish: Der er ikke fundet en enkeltdosis Arimidex, der har resulteret i livstruende symptomer.
English: Clinical trials have been conducted with various dosages of Arimidex, up to 60 mg in a single dose given to healthy male volunteers and up to 10 mg daily given to postmenopausal women with advanced breast cancer; these dosages were well tolerated.
Danish: Der er blevet udført kliniske forsøg med forskellige doser af Arimidex, hvor op til 60 mg i en enkelt dosis blev givet til raske frivillige mænd, og op til 10 mg dagligt blev givet til postmenopausale kvinder med fremskreden brystkræft.
English: A two-year mouse oncogenicity study resulted in the induction of benign ovarian tumours and a disturbance in the incidence of lymphoreticular neoplasms (fewer histiocytic sarcomas in females and more deaths as a result of lymphomas).
Danish: Et toårigt onkogenicitetsforsøg med mus resulterede i induktion af benigne ovarietumorer og en ændring i forekomsten af lymforetikulære neoplasmer (færre histiocytiske sarkomer hos hundyr og flere dødsfald som følge af lymfomer).
English: • Inflammation of the small blood vessels causing red or purple colouring of the skin.
Danish: • Vævsirritation i de små blodårer, som fremkalder rødt eller rødviolet udslæt på huden.
English: No statistically significant change in the frequency of vaginal bleeding days on treatment was observed.
Danish: Der blev ikke observeret nogen statistisk signifikant ændring i frekvensen af dage med vaginalblødning.
English: This study provides evidence that the use of bisphosphonates could be considered in the management of possible bone mineral loss in postmenopausal women with early breast cancer scheduled to be treated with Arimidex.
Danish: Dette studie påviste, at bisfosfonater kan overvejes til behandling af et muligt knoglemineraltab hos postmenopausale kvinder med tidlig brystkræft, som planlægges behandlet med Arimidex.
English: The survival of litters born to rats given anastrozole at 0.02 mg/kg/day and above (from Day 17 of pregnancy to Day 22 post-partum) was compromised.
Danish: Hos kuld født til rotter, som fik anastrozol 0,02 mg/kg/dag og derover (fra dag 17 i graviditeten til dag 22 postpartum), sås nedsat overlevelse.
English: Effects on your bones
Danish: Indvirkning på dine knogler knogleskørhed
English: The primary efficacy parameter was the analysis of lumbar spine bone mass density using DEXA scanning.
Danish: Den primære effektparameter var analyse af knogledensiteten i columna lumbalis ved hjælp af DXA-scanning.
English: The observed fracture rate for Arimidex is similar to the range reported in age-matched postmenopausal populations.
Danish: Den observerede frakturhyppighed for Arimidex ligger i det interval, der er rapporteret i aldersmatchede postmenopausale populationer.
English: The apparent clearance (CL/F) of anastrozole, following oral administration, was not altered in volunteers with severe renal impairment (GFR <30ml/min) in Study 1033IL/0018, consistent with the fact that anastrozole is eliminated primarily by metabolism.
Danish: Den tilsyneladende clearance (CL/F) af anastrozol efter oral indgift blev ikke ændret hos frivillige med svært nedsat nyrefunktion (GFR <30 ml/min) i forsøg 1033IL/0018, hvilket stemmer overens med, at anastrozol primært elimineres via metabolisering.
English: If you take more Arimidex than you should If you take more Arimidex than you should, talk to a doctor straight away.
Danish: Hvis du har taget for meget Arimidex Hvis du har taget for mange Arimidex, skal du straks kontakte læge.
English: Arimidex is indicated for the:
Danish: Arimidex er indiceret til:
English: Distant disease-free survival is defined as the first occurrence of distant recurrence or death (for any reason).
Danish: Fjern sygdomsfri overlevelse defineres som den første forekomst af fjernt recidiv eller død (uanset årsag).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Arimidex in one or several subsets of the paediatric population in short stature due to growth hormone deficiency (GHD), testotoxicosis, gynaecomastia, and McCune-Albright syndrome (see section 4.2).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne af studier med Arimidex hos alle undergrupper af den pædiatriske population, som er små af vækst på grund af væksthormonmangel (GHD), testotoksikose, gynækomasti og McCune-Albright-syndromet (se pkt.
English: Genetic toxicology studies with anastrozole show that it is not a mutagen or a clastogen.
Danish: Genotoksicitetsstudier med anastrozol har vist, at det ikke har nogen mutagen eller klastogen aktivitet.
English: • An extremely severe skin reaction with ulcers or blisters on the skin.
Danish: • En meget svær hudreaktion med sår eller blærer på huden.
English: • Inflammation of the liver (hepatitis).
Danish: • Leverbetændelse (hepatitis)
English: anastrozole
Danish: anastrozol
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet.
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Filmovertrukne tabletter.
English: * Events of Carpal Tunnel Syndrome have been reported in patients receiving Arimidex treatment in clinical trials in greater numbers than those receiving treatment with tamoxifen.
Danish: * Karpaltunnelsyndrom er rapporteret hos flere patienter, som fik behandling med Arimidex i kliniske forsøg, end hos patienter, som blev behandlet med tamoxifen.
English: As Arimidex lowers circulating estrogen levels it may cause a reduction in bone mineral density with a possible consequent increased risk of fracture (see section 4.8).
Danish: Da Arimidex sænker cirkulerende østrogenniveauer, kan det medføre en reduktion i knoglemineraltæthed med deraf følgende øget risiko for fraktur (se pkt.
English: In postmenopausal women, Arimidex at a daily dose of 1 mg produced estradiol suppression of greater than 80% using a highly sensitive assay.
Danish: Hos postmenopausale kvinder resulterede en daglig dosis på 1 mg Arimidex i estradiolsuppression på mere end 80 %, målt ved en meget følsom analyse.
English: The primary endpoint was change from baseline in lumbar spine bone mass density at 12 months.
Danish: Det primære endepunkt var ændring fra baseline i knogledensitet i columna lumbalis efter 12 måneder.
English: Keep your tablets in a safe place where children cannot see or reach them.
Danish: Tabletterne skal opbevares på et sikkert sted uden for børns rækkevidde.
English: In a large phase III study conducted in 9,366 postmenopausal women with operable breast cancer treated for 5 years (see below), Arimidex was shown to be statistically superior to tamoxifen in disease-free survival.
Danish: I et stort fase III-studie med 9.366 postmenopausale kvinder med operabel brystkræft behandlet i 5 år (se nedenfor) var Arimidex statistisk overlegent i forhold til tamoxifen med hensyn til sygdomsfri overlevelse.
English: AstraZeneca UK Ltd, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, United Kingdom
Danish: AstraZeneca UK Ltd, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, Storbritannien
English: Sodium starch glycollate
Danish: Natriumstivelsesglycolat
English: For postmenopausal women with hormone receptor-positive early invasive breast cancer, the recommended duration of adjuvant endocrine treatment is 5 years.
Danish: For postmenopausale kvinder med hormonreceptor-positiv tidlig invasiv brystkræft er den anbefalede behandlingsvarighed 5 år.
English: Very common Hot flushes Very common Nausea
Danish: Meget almindelig Hedeture Meget almindelig Kvalme
English: Trial 0046 was an international, multi-centre, open-label exploratory trial of Arimidex in 28 girls (aged 2 to ≤ 10 years) with McCune-Albright Syndrome (MAS).
Danish: Forsøg 0046 var et internationalt, multicenter, open-label, eksploratorisk forsøg med Arimidex hos 28 piger (i alderen 2 til ≤ 10 år) med McCune-Albright syndrom (MAS).
English: Arimidex works by cutting down the amount of the hormone called estrogen that your body makes.
Danish: Arimidex fungerer ved at nedsætte mængden af hormonet østrogen, som din krop producerer.
English: • Inflammation of the joints (arthritis).
Danish: • Betændelse i leddene (artrit).
English: In acute toxicity studies in rodents, the median lethal dose of anastrozole was greater than 100 mg/kg/day by the oral route and greater than 50 mg/kg/day by the intraperitoneal route.
Danish: I akutte toksicitetsforsøg med gnavere var den gennemsnitlige letale dosis af anastrozol større end 100 mg/kg/dag oralt og større end 50 mg/kg/dag intraperitonealt.
English: In the phase III/IV study (Study of Anastrozole with the Bisphosphonate Risedronate [SABRE]), 234 postmenopausal women with hormone receptor-positive early breast cancer scheduled for treatment with Arimidex 1 mg/day were stratified to low, moderate and high risk groups according to their existing risk of fragility fracture.
Danish: I et fase III/IV-studie (Study of Anastrozole with the Bisphosphonate Risedronate [SABRE]) blev 234 postmenopausale kvinder med hormonreceptor-positiv tidlig brystkræft, planlagt til behandling med Arimidex 1 mg/dag, stratificeret til lav, moderat og høj risikogruppe i henhold til deres eksisterende risiko for fraktur på grund af øget knogleskørhed.
English: Time to distant recurrence is defined as the first occurrence of distant recurrence or death due to breast cancer.
Danish: Tid til fjernt recidiv defineres som den første forekomst af fjernt recidiv eller død på grund af brystkræft.
English: A total of 764 patients were randomised to receive either a single daily dose of 1 mg or 10 mg of Arimidex or megestrol acetate 40 mg four times a day.
Danish: I alt 764 patienter blev randomiseret til at få enten 1 mg eller 10 mg Arimidex en gang dagligt eller megestrolacetat 40 mg fire gange dagligt.
English: If you forget to take Arimidex
Danish: Hvis du har glemt at tage Arimidex
English: Oral administration of anastrozole to female rats produced a high incidence of infertility at 1 mg/kg/day and increased pre-implantation loss at 0.02 mg/kg/day.
Danish: Oral indgift af anastrozol til hunrotter gav en høj forekomst af infertilitet ved 1 mg/kg/dag og øgede præimplantationstabet ved 0,02 mg/kg/dag.
English: In animal studies adverse effects were only seen at high doses.
Danish: I dyreforsøg forekom der kun bivirkninger ved høje doser.
English: There were no clinically significant changes in Tanner staging, mean ovarian volume, or mean uterine volume.
Danish: Der blev ikke observeret nogen klinisk signifikante ændringer i Tanner-stadieinddeling, middel ovarievolumen eller middel uterusvolumen.
English: Arimidex does not possess any progestogenic, androgenic, or estrogenic activity.
Danish: Arimidex udviser ikke nogen gestagen, androgen eller østrogen aktivitet.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 1 mg anastrozole.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 1 mg anastrozol.
English: Daily doses of Arimidex up to 10 mg do not have any effect on cortisol or aldosterone secretion, measured before or after standard adrenocorticotrophic hormone (ACTH) challenge testing.
Danish: Arimidexdoser på op til 10 mg dagligt har ingen indvirkning på udskillelsen af cortisol eller aldosteron, målt før eller efter standard ACTH-test. Der er derfor ikke behov for kortikoid-tilskud.
English: Always take Arimidex exactly as your doctor has told you.
Danish: Tag altid Arimidex nøjagtigt efter lægens anvisning.
English: Arimidex is not recommended for use in children and adolescents due to insufficient data on safety and efficacy (see sections 4.4 and 5.1).
Danish: Arimidex bør ikke anvendes til børn og unge på grund af utilstrækkelige data vedrørende sikkerhed og virkning (se pkt.
English: Trial 0001 was an open-label, multiple-dose pharmacokinetic study of Arimidex 1 mg/day in 36 pubertal boys with gynaecomastia of less than 12 months duration.
Danish: Forsøg 0001 var et open-label, farmakokinetisk studie med Arimidex 1 mg/dag hos 36 drenge i puberteten med gynækomasti af mindre end 12 måneders varighed.
English: The 12-month main analysis has shown that patients already at moderate to high risk of fragility fracture showed no decrease in their bone mass density (assessed by lumbar spine bone mineral density using DEXA scanning) when managed by using Arimidex 1 mg/day in combination with risedronate 35 mg once a week.
Danish: 12-måneders hovedanalyse viste, at patienter med eksisterende moderat til høj risiko for fraktur ikke havde et fald i knogledensitet (vurderet ud fra knogledensitet i columna lumbalis ved hjælp af DXAscanning), når de blev behandlet med Arimidex 1 mg/dag i kombination med risedronat 35 mg en gang om ugen.
English: Disease-free survival includes all recurrence events and is defined as the first occurrence of loco-regional recurrence, contralateral new breast cancer, distant recurrence or death (for any reason).
Danish: Sygdomsfri overlevelse inkluderer alle recidiverende hændelser og defineres som den første forekomst af loko-regionalt recidiv, kontralateral ny brystkræft, fjernt recidiv eller død (uanset årsag).
English: Hair thinning (alopecia) Allergic reactions
Danish: Hårudtynding (alopeci) Allergiske reaktioner Ikke almindelig Urticaria Sjælden
English: Study 1033IL/0027 showed that Arimidex and tamoxifen had similar objective tumour response rates and time to tumour progression.
Danish: Studie 1033IL/0027 viste, at objektive tumorresponsrater og tid til tumorprogression var sammenlignelige for Arimidex og tamoxifen.
English: An open-label, non-comparative, multi-centre study evaluated 14 male patients (aged 2 to 9 years) with familial male-limited precocious puberty, also known as testotoxicosis, treated with combination of Arimidex and bicalutamide.
Danish: I et open-label, ikke-komparativt, multicenter-studie evalueredes 14 drenge (i alderen 2-9 år) med familiær mandlig pubertas praecox, også kendt som testotoksikose, behandlet med Arimidex og bicalutamid i kombination.
English: Time to recurrence is defined as the first occurrence of loco-regional recurrence, contralateral new breast cancer, distant recurrence or death due to breast cancer.
Danish: Tid til recidiv defineres som den første forekomst af loko-regionalt recidiv, kontralateral ny brystkræft, fjernt recidiv eller død på grund af brystkræft.
English: In a fertility study weanling male rats were dosed orally with 50 or 400 mg/l anastrozole via their drinking water for 10 weeks.
Danish: I et fertilitetsforsøg blev afvænnede hanrotter doseret i 10 uger med 50 eller 400 mg anastrozol per liter gennem drikkevandet.
English: 2-sided 95% CI
Danish: 2-sidet 95 % CI
English: Second-line therapy in postmenopausal women with advanced breast cancer Arimidex was studied in two controlled clinical trials (Study 0004 and Study 0005) in postmenopausal women with advanced breast cancer who had disease progression following tamoxifen therapy for either advanced or early breast cancer.
Danish: Andenlinjebehandling hos postmenopausale kvinder med fremskreden brystkræft Arimidex blev undersøgt i to kontrollerede kliniske forsøg (studie 0004 og studie 0005) hos postmenopausale kvinder med fremskreden brystkræft, der havde sygdomsprogression efter tamoxifenbehandling for enten fremskreden eller tidlig brystkræft.
English: Detailed information on this medicine is available on the web site of {MA/Agency}
Danish: Yderligere information om Arimidex er tilgængelig på Lægemiddelstyrelsens hjemmeside.
English: AstraZeneca UK Ltd Silk Road Business Park Macclesfield Cheshire SK10 2NA United Kingdom
Danish: AstraZeneca UK Ltd Silk Road Business Park Macclesfield Cheshire SK10 2NA Storbritannien
English: Each film-coated tablet contains 1 mg of anastrozole.
Danish: Hver filmovertrukken tablet indeholder 1 mg anastrozol.
English: Mood disturbances
Danish: Humørsvingninger
English: Do not take Arimidex - if you are allergic (hypersensitive) to anastrozole or any of the other ingredients of Arimidex (see section 6: Further information).
Danish: Tag ikke Arimidex - hvis du er overfølsom (allergisk) over for anastrozol eller et af de øvrige indholdsstoffer
English: A randomised, double-blind, multi-centre study evaluated 52 pubertal boys (aged 11 to 16 years inclusive) with GHD treated for 12 to 36 months with Arimidex 1 mg/day or placebo in combination with growth hormone.
Danish: I et randomiseret, dobbeltblindet, multicenter-studie blev 52 drenge i puberteten (i alderen 11 til og med 16 år) med GHD behandlet i 12 til 36 måneder med Arimidex 1 mg/dag eller placebo i kombination med væksthormon.
English: A two-year rat oncogenicity study resulted in an increase in incidence of hepatic neoplasms and uterine stromal polyps in females and thyroid adenomas in males at the high dose (25 mg/kg/day) only.
Danish: I et toårigt onkogenicitetsforsøg med rotter blev der kun set en stigning i forekomsten af hepatiske neoplasmer og uterine stromale polypper hos hundyr og tyroide adenomer hos handyr ved den høje dosis (25 mg/kg/dag).
English: Somnolence Carpal Tunnel Syndrome*
Danish: Søvnighed Karpaltunnelsyndrom*
English: [See Annex I - To be completed nationally] anastrozole
Danish: [Se bilag I - Udfyldes nationalt] anastrozol
English: Arimidex has not been investigated in breast cancer patients with moderate or severe hepatic impairment.
Danish: Arimidex er ikke blevet undersøgt hos brystkræftpatienter med moderat eller svært nedsat leverfunktion.
English: Arimidex lowers the amount of the hormone called estrogen that is in your body.
Danish: Arimidex sænker mængden af hormonet østrogen i din krop.
English: Myocardial infarct
Danish: Myokardieinfarkt
English: First-line therapy in postmenopausal women with advanced breast cancer Two double-blind, controlled clinical studies of similar design (Study 1033IL/0030 and Study 1033IL/0027) were conducted to assess the efficacy of Arimidex compared with tamoxifen as first-line therapy for hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer in postmenopausal women.
Danish: Førstelinjebehandling hos postmenopausale kvinder med fremskreden brystkræft To dobbeltblindede, kontrollerede kliniske studier (studie 1033IL/0030 og studie 1033IL/0027) blev udført for at vurdere effekten af Arimidex sammenlignet med tamoxifen som førstelinjebehandling af lokalt fremskreden eller metastatisk brystkræft hos postmenopausale kvinder, enten hormonreceptorpositiv eller med ukendt hormonreceptor-status.
English: Arimidex is not likely to affect your ability to drive or use any tools or machines.
Danish: Det er usandsynligt, at Arimidex vil påvirke evnen til at føre motorkøretøjer, arbejde med værktøj eller betjene maskiner.
English: Adjuvant treatment of early invasive breast cancer for hormone receptor-positive patients
Danish: Adjuverende behandling af tidlig invasiv brystkræft hos hormonreceptor-positive patienter
English: Time to distant recurrence Hazard ratio
Danish: Tid til et vilkårligt recidiv Hazard ratio
English: 0.70 to 1.00
Danish: 0,70 til 1,00
English: • Rare inflammation of your skin that may include red patches or blisters.
Danish: • Betændelse i huden, der kan vise sig ved røde pletter eller blærer.
English: Adjuvant treatment of early invasive breast cancer for hormone receptor-positive patients being treated with adjuvant tamoxifen
Danish: Adjuverende behandling af tidlig invasiv brystkræft hos hormonreceptor-positive patienter, som behandles med adjuverende tamoxifen
English: General disorders and administration site conditions
Danish: Almene symptomer og reaktioner på administrationsstedet.
English: • Patients with known hypersensitivity to anastrozole or to any of the excipients as referenced in section 6.1.
Danish: • Patienter med overfølsomhed over for anastrozol eller over for et eller flere af hjælpestofferne,
English: Co-administration of tamoxifen or estrogen-containing therapies with Arimidex should be avoided as this may diminish its pharmacological action (see section 4.5 and 5.1).
Danish: Indgivelse af tamoxifen eller østrogenholdig behandling sammen med Arimidex bør undgås, da dette kan mindske dets farmakologiske virkning (se pkt.
English: Diarrhoea Vomiting
Danish: Diarré Opkastning
English: Arimidex has not been investigated in breast cancer patients with severe renal impairment.
Danish: Arimidex er ikke blevet undersøgt hos brystkræftpatienter med svært nedsat nyrefunktion.
English: Number of events (frequency) Intention-to-treat population Hormone receptor-positive tumour status
Danish: Antal hændelser (frekvens) Intent-to-treat-population
English: If this happens to you, ask your doctor or pharmacist for advice.
Danish: Hvis det sker for dig, skal du spørge din læge eller apoteket til råds.
English: • Adjuvant treatment of hormone receptor-positive early invasive breast cancer in postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.
Danish: • Adjuverende behandling af hormonreceptor-positiv tidlig invasiv brystkræft hos postmenopausale kvinder, der har fået adjuverende tamoxifen i 2-3 år.
English: 0.19 to 1.13
Danish: 0,19 til 1,13
English: Trial 0006 was a randomised, double-blind, multi-centre study of 82 pubertal boys (aged 11-18 years inclusive) with gynaecomastia of greater than 12 months duration treated with Arimidex 1 mg/day or placebo daily for up to 6 months.
Danish: Forsøg 0006 var et randomiseret, dobbeltblindet, multicenter-studie med 82 drenge i puberteten (i alderen 11 til og med 18 år) med gynækomasti af over 12 måneders varighed behandlet med Arimidex 1 mg/dag eller placebo dagligt i op til 6 måneder.
English: 0.49 to 0.92
Danish: 0,49 til 0,92
English: There are no data on the use of Arimidex during lactation.
Danish: Der er ingen data fra anvendelse af Arimidex under amning.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Dette lægemiddel indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for arvelig lactasemangel (Lapp Lactase deficiency) eller glucosegalactose-malabsorption.
English: However, plasma anastrozole concentrations in the volunteers with hepatic cirrhosis were within the range of concentrations seen in normal subjects in other trials.
Danish: Plasmakoncentrationerne af anastrozol hos frivillige med levercirrose lå inden for det koncentrationsområde, som sås hos normale forsøgspersoner i andre forsøg.
English: • Raised or high levels of a fatty substance known as cholesterol in your blood.
Danish: • For høje niveauer af kolesterol (fedt) i blodet.
English: Caution is advised in patients with moderate to severe hepatic impairment (see section 4.4).
Danish: Der tilrådes, at der udvises forsigtighed hos patienter med moderat til svært nedsat leverfunktion (se pkt.
English: 0.31 to 0.88
Danish: 0,31 til 0,88
English: • Treatment of hormone receptor-positive advanced breast cancer in postmenopausal women.
Danish: • Behandling af hormonreceptor-positiv fremskreden brystkræft hos postmenopausale kvinder.
English: Very rare side effects (affect less than 1 person in 10,000 people)
Danish: Meget sjældne bivirkninger (påvirker færre end 1 person ud af 10.000)
English: What Arimidex is and what it is used for Before you take Arimidex How to take Arimidex Possible side effects
Danish: Det skal du vide, før du begynder at tage Arimidex Sådan skal du tage Arimidex Bivirkninger
English: Any venous thromboembolic event Deep venous thromboembolic events including PE (pulmonary embolism)
Danish: Enhver venøs tromboembolisk hændelse Dyb venetrombose, inklusive lungeemboli Iskæmiske, cerebrovaskulære hændelser Endometriecancer
English: 0.85 to 1.12
Danish: 0,85 til 1,12
English: 0.63 to 1.46
Danish: 0,63 til 1,46
English: - The other ingredients are: lactose monohydrate, povidone, sodium starch glycollate, magnesium stearate, hypromellose, macrogol 300, titanium dioxide.
Danish: - Øvrige indholdsstoffer: lactosemonohydrat, povidon, natriumstivelsesglycolat,