natgillin/translations-raw huggingface dataset:
• Allergiske reaktioner (overfølsomhed), bl.a. i ansigtet, på læberne eller tungen.
• Allergic (hypersensitivity) reactions including face, lips, or tongue.
Arimidex indeholder et stof, der hedder anastrozol.
Arimidex contains a substance called anastrozole.
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.
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.
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.
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.
I et oralt akut toksicitetsforsøg hos hunde var den gennemsnitlige letale dosis større end 45 mg/kg/dag.
In an oral acute toxicity study in the dog, the median lethal dose was greater than 45 mg/kg/day.
Der var ingen signifikant forskel mellem behandlingsarmene i de to forsøg, hvad angår nogen af effektparametrene.
In both studies there were no significant differences between treatment arms with respect to any of the efficacy parameters.
De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet og reproduktionstoksicitet.
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.
McCune-Albright syndrom
McCune-Albright Syndrome study
Spørg lægen eller på apoteket, før du tager nogen form for medicin.
Ask your doctor or pharmacist for advice before taking any medicine.
De hyppigst rapporterede bivirkninger var hovedpine, hedeture, kvalme, udslæt, ledsmerter, stivhed, artrit og asteni.
The most frequently reported adverse reactions were headache, hot flushes, nausea, rash, arthralgia, joint stiffness, arthritis, and asthenia.
Vaginal tørhed Vaginalblødning***
Vaginal dryness Vaginal bleeding ***
Arimidex' sikkerhedsprofil i disse 3 forsøg stemte overens med den kendte sikkerhedsprofil, som var fastslået hos postmenopausale kvinder med hormonreceptor-positiv tidlig brystkræft.
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.
Inden du tager Arimidex, skal du spørge din læge eller på apoteket - hvis du har menstruation og ikke har overstået overgangsalderen.
Before treatment with Arimidex check with your doctor or pharmacist - if you still have menstrual periods and have not yet gone through the menopause.
p-værdi Tid til recidivc
p-value Time to recurrencec
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).
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).
Der er ingen data, som understøtter brug af Arimidex med LHRH-analoger.
There are no data to support the use of Arimidex with LHRH analogues.
I alt 1.021 patienter blev randomiseret til at få 1 mg Arimidex en gang dagligt eller 20 mg tamoxifen en gang dagligt.
A total of 1,021 patients were randomised to receive 1 mg of Arimidex once daily or 20 mg of tamoxifen once daily.
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.
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.
Frakturer i rygrad, hofte eller håndled/Colles Frakturer i håndled/Colles Frakturer i rygraden
Fractures of the spine, hip, or wrist/Colles Wrist/Colles fractures
Arimidex skal indtages oralt.
Arimidex should be taken orally.
Da anastrozol reducerer estradiolniveauet, må Arimidex ikke bruges hos piger med væksthormonmangel som supplement til behandling med væksthormon.
Since anastrozole reduces estradiol levels, Arimidex must not be used in girls with growth hormone deficiency in addition to growth hormone treatment.
Der blev ikke observeret nogen statistisk signifikant ændring i stigningsraten i knoglealder ved behandling sammenlignet med raten ved baseline.
No statistically significant change in the rate of increase in bone age on treatment compared to the rate during baseline was observed.
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.
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.
Dette kaldes ‘Stevens-Johnsons syndrom'.
‘Stevens-Johnson syndrome'.
Postmenopausale kvinder metaboliserer anastrozol i udpræget grad, idet mindre end 10 % udskilles uomdannet i urinen inden for 72 timer efter doseringen.
Anastrozole is extensively metabolised by postmenopausal women with less than 10% of the dose excreted in the urine unchanged within 72 hours of dosing.
Tag ikke Arimidex, hvis du er gravid eller ammer.
Do not take Arimidex if you are pregnant or breast-feeding.
Fortsæt med at tage Arimidex, så længe din læge siger det.
Keep taking Arimidex for as long as your doctor tells you to.
Den største fordel blev observeret for sygdomsfri overlevelse til fordel for Arimidex versus tamoxifen i den prospektivt definerede hormonreceptor-positive population.
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.
Anastrozol metaboliseres ved N-dealkylering, hydroxylering og glukuronidering.
Metabolism of anastrozole occurs by N-dealkylation, hydroxylation and glucuronidation.
Stevens-Johnsons syndrom Angioødem
Stevens-Johnson syndrome Angioedema
Hyperkolesterolæmi Meget almindelig Hovedpine
Hypercholesterolaemia Very common Headache
[Se bilag I - Udfyldes nationalt] Denne indlægsseddel blev senest godkendt {MM/YYYY}.
[See Annex I - To be completed nationally] This leaflet was last approved in {MM/YYYY}.
Der sås ingen indvirkning på adfærd eller reproduktion, som kunne tilskrives behandling af moderen med anastrozol, hos den første generation.
There were no adverse effects on behaviour or reproductive performance of the first generation offspring attributable to maternal treatment with anastrozole.
Kombination af Arimidex og tamoxifen udviste ikke nogen effektfordele sammenlignet med tamoxifen hverken hos den totale population eller hos hormonreceptor-positiv-populationen.
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.
Der blev ikke observeret nogen statistisk signifikant forskel versus placebo for de vækstrelaterede parametre forventet voksenhøjde, højde, højde-standardafvigelse og væksthastighed.
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.
Disse virkninger var relateret til stoffets farmakologiske virkning på fødslen.
These effects were related to the pharmacological effects of the compound on parturition.
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).
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).
Disse fund afspejledes i den sekundære effektvariabel med ændring i total hofte-BMD i forhold til baseline efter 12 måneder.
These findings were mirrored in the secondary efficacy variable of change from baseline in total hip BMD at 12 months.
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.
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.
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.
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.
I dyreforsøg blev der kun set toksicitet ved høje doser.
In animal studies toxicity was only seen at high doses.
Arimidex anbefales ikke til børn og unge, da sikkerhed og virkning ikke er blevet fastlagt for denne patientgruppe (se pkt.
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).
Arimidex anvendes til at behandle brystkræft hos kvinder, der har passeret overgangsalderen.
Arimidex is used to treat breast cancer in women who have gone through the menopause.
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).
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).
• Appetitløshed.
• Loss of appetite.
Cimetidin, en svag, uspecifik CYP-hæmmer, påvirkede ikke plasmakoncentrationen af anastrozol.
Cimetidine, a weak, unspecific inhibitor of CYP enzymes, did not affect the plasma concentrations of anastrozole.
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).
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.
p-værdi Samlet overlevelsee
p-value Overall survival e
Disse ændringer anses for at være musespecifikke virkninger på grund af aromatasehæmning og ikke klinisk relevante ved behandling af patienter med anastrozol.
These changes are considered to be mouse-specific effects of aromatase inhibition and not clinically relevant to the treatment of patients with anastrozole.
Arimidex er ikke indiceret til brug hos børn og unge.
Arimidex is not indicated for use in children and adolescents.
Antal hændelser (frekvens) Arimidex (N=1.297)
Number of events (frequency) Arimidex (N=1,297)
Specifikke behandlinger f.eks. med bisfosfonater kan standse yderligere knoglemineraltab forårsaget af Arimidex hos postmenopausale kvinder og kan overvejes (se pkt.
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).
Arimidex må ikke anvendes til drenge med væksthormonmangel som supplement til behandling med væksthormon.
Arimidex should not be used in boys with growth hormone deficiency in addition to growth hormone treatment.
Meget almindelig Ledsmerter/stivhed Artrit
Very common Arthralgia/joint stiffness Arthritis
• Knogleskørhed (osteoporose).
• Bone loss (osteoporosis).
Hver filmovertrukken tablet indeholder 93 mg lactosemonohydrat (se pkt.
Each film-coated tablet contains 93 mg of lactose monohydrate (see section 4.4).
Der er ikke fundet en enkeltdosis Arimidex, der har resulteret i livstruende symptomer.
A single dose of Arimidex that results in life-threatening symptoms has not been established.
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.
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.
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).
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).
• Vævsirritation i de små blodårer, som fremkalder rødt eller rødviolet udslæt på huden.
• Inflammation of the small blood vessels causing red or purple colouring of the skin.
Der blev ikke observeret nogen statistisk signifikant ændring i frekvensen af dage med vaginalblødning.
No statistically significant change in the frequency of vaginal bleeding days on treatment was observed.
Dette studie påviste, at bisfosfonater kan overvejes til behandling af et muligt knoglemineraltab hos postmenopausale kvinder med tidlig brystkræft, som planlægges behandlet med Arimidex.
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.
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.
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.
Indvirkning på dine knogler knogleskørhed
Effects on your bones
Den primære effektparameter var analyse af knogledensiteten i columna lumbalis ved hjælp af DXA-scanning.
The primary efficacy parameter was the analysis of lumbar spine bone mass density using DEXA scanning.
Den observerede frakturhyppighed for Arimidex ligger i det interval, der er rapporteret i aldersmatchede postmenopausale populationer.
The observed fracture rate for Arimidex is similar to the range reported in age-matched postmenopausal populations.
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.
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.
Hvis du har taget for meget Arimidex Hvis du har taget for mange Arimidex, skal du straks kontakte læge.
If you take more Arimidex than you should If you take more Arimidex than you should, talk to a doctor straight away.
Arimidex er indiceret til:
Arimidex is indicated for the:
Fjern sygdomsfri overlevelse defineres som den første forekomst af fjernt recidiv eller død (uanset årsag).
Distant disease-free survival is defined as the first occurrence of distant recurrence or death (for any reason).
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.
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).
Genotoksicitetsstudier med anastrozol har vist, at det ikke har nogen mutagen eller klastogen aktivitet.
Genetic toxicology studies with anastrozole show that it is not a mutagen or a clastogen.
• En meget svær hudreaktion med sår eller blærer på huden.
• An extremely severe skin reaction with ulcers or blisters on the skin.
• Leverbetændelse (hepatitis)
• Inflammation of the liver (hepatitis).
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Filmovertrukne tabletter.
PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet.
* Karpaltunnelsyndrom er rapporteret hos flere patienter, som fik behandling med Arimidex i kliniske forsøg, end hos patienter, som blev behandlet med tamoxifen.
* 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.
Da Arimidex sænker cirkulerende østrogenniveauer, kan det medføre en reduktion i knoglemineraltæthed med deraf følgende øget risiko for fraktur (se pkt.
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).
Hos postmenopausale kvinder resulterede en daglig dosis på 1 mg Arimidex i estradiolsuppression på mere end 80 %, målt ved en meget følsom analyse.
In postmenopausal women, Arimidex at a daily dose of 1 mg produced estradiol suppression of greater than 80% using a highly sensitive assay.
Det primære endepunkt var ændring fra baseline i knogledensitet i columna lumbalis efter 12 måneder.
The primary endpoint was change from baseline in lumbar spine bone mass density at 12 months.
Tabletterne skal opbevares på et sikkert sted uden for børns rækkevidde.
Keep your tablets in a safe place where children cannot see or reach them.
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.
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.
AstraZeneca UK Ltd, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, Storbritannien
AstraZeneca UK Ltd, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, United Kingdom
Natriumstivelsesglycolat
Sodium starch glycollate
For postmenopausale kvinder med hormonreceptor-positiv tidlig invasiv brystkræft er den anbefalede behandlingsvarighed 5 år.
For postmenopausal women with hormone receptor-positive early invasive breast cancer, the recommended duration of adjuvant endocrine treatment is 5 years.
Meget almindelig Hedeture Meget almindelig Kvalme
Very common Hot flushes Very common Nausea
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).
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).
Arimidex fungerer ved at nedsætte mængden af hormonet østrogen, som din krop producerer.
Arimidex works by cutting down the amount of the hormone called estrogen that your body makes.
• Betændelse i leddene (artrit).
• Inflammation of the joints (arthritis).
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.
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.
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.
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.
Tid til fjernt recidiv defineres som den første forekomst af fjernt recidiv eller død på grund af brystkræft.
Time to distant recurrence is defined as the first occurrence of distant recurrence or death due to breast cancer.
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.
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.
Hvis du har glemt at tage Arimidex
If you forget to take Arimidex
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.
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.
I dyreforsøg forekom der kun bivirkninger ved høje doser.
In animal studies adverse effects were only seen at high doses.
Der blev ikke observeret nogen klinisk signifikante ændringer i Tanner-stadieinddeling, middel ovarievolumen eller middel uterusvolumen.
There were no clinically significant changes in Tanner staging, mean ovarian volume, or mean uterine volume.
Arimidex udviser ikke nogen gestagen, androgen eller østrogen aktivitet.
Arimidex does not possess any progestogenic, androgenic, or estrogenic activity.