FrancophonIA/ELRC3.0 huggingface dataset:
English: ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I LISTE OVER NAVNENE, LÆGEMIDDELFORMERNE, STYRKERNE PÅ LÆGEMIDLERNE, INDGIVELSESVEJE OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSLANDENE SAMT NORGE OG ISLAND
English: Novartis Hungária Kft. 1114 Budapest Bartók Béla út 43-47 Hungary
Danish: Novartis Hungária Kft. 1114 Budapest Bartók Béla út 43-47 Ungarn
English: Novartis Healthcare A/S, Lyngbyvej 172, DK-2100 København Ø Denmark
Danish: Danmark Novartis Healthcare A/S, Lyngbyvej 172, DK-2100 København Ø
English: Novartis Pharma GmbH, Roonstrasse 25, 90429 Nürnberg Germany
Danish: Novartis Pharma GmbH, Roonstrasse 25, 90429 Nürnberg Tyskland
English: Novartis Pharmaceuticals UK Ltd. Frimley Business Park, Frimley, Camberly, GU16 7SR Surrey UK
Danish: Novartis Pharmaceuticals UK Ltd. Frimley Business Park, Frimley, Camberly, GU16 7SR Surrey Storbritannien
English: Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU-167-SR UK
Danish: Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU-167-SR Cypern
English: Belgium Novartis Pharma NV Medialaan 40 bus 1
Danish: Novartis Pharma NV Medialaan 40 bus 1 B-1800 Vilvoorde Belgien
English: Nederlands
Danish: Holland
English: Member State Marketing Authorisation Holder (Invented) name
Danish: Medlemsland Indehaver af markedsføringstilladelsen Særnavn Styrke Lægemiddelform Indgivelsesvej Østrig
English: 90429 Nürnberg Germany
Danish: 90429 Nürnberg Tyskland
English: D-90429 Nurnberg Germany
Danish: D-90429 Nurnberg Tyskland
English: D-90429 Nuernberg Germany
Danish: D-90429 Nuernberg Tyskland
English: Strength Pharmaceutical form Route of administration Packaging Content (concentration)
Danish: EU- nummer Særnavn Styrke Lægemiddelform Indgivelsesvej
English: Number (%) of patients who had died.
Danish: Antal (%) patienter, der døde.
English: - Try to take your tablet at the same time each day.
Danish: - Prøv at tage din tablet på samme tidspunkt hver dag.
English: An effect in man cannot be excluded.
Danish: En virkning hos mennesker kan ikke udelukkes.
English: It is a long-term treatment and you may need to take it for several years.
Danish: Det er en langvarig behandling, og du skal muligvis tage det i flere år.
English: If bleeding persists, further evaluation should be considered.
Danish: Hvis blødningen fortsætter, bør yderligere evaluering overvejes.
English: After the Commission Decision the Member State Competent Authorities, in liaison with the Reference Member State, will update the product information as required.
Danish: Efter Kommissionens beslutning vil medlemslandenes kompetente myndigheder, i overensstemmelse med referencelandet, opdatere produktinformationen som påkrævet.
English: - Swallow the tablet whole with a drink of water.
Danish: - Slug tabletten hel med et glas vand.
English: This would be seen in a blood test.
Danish: Dette ville fremgå af en blodprøve.
English: If you forget to take a dose, just take your next dose as normal.
Danish: Hvis du har glemt at tage en dosis, skal du bare tage den næste dosis som normalt.
English: Treatment should be based on a benefit-risk evaluation for the individual patient.
Danish: Behandlingen bør baseres på en benefit-risk vurdering hos den enkelte patient.
English: 51689 Reims Cedex France
Danish: 51689 Reims Cedex Frankrig
English: The number of children treated was too limited to draw any reliable conclusions on safety.
Danish: Antallet af behandlede børn var for begrænset til at drage nogen pålidelige konklusioner om sikkerheden.
English: White, round, biconvex tablet with logo on one side and strength on the other.
Danish: Hvid, rund, bikonveks tablet med logo på den ene side og styrke på den anden.
English: The primary objective was to assess the efficacy and safety of this combination regimen over 12 months.
Danish: Det primære formål var at vurdere effekten og sikkerheden af dette kombinationsregime over 12 måneder.
English: Your tablets could harm them.
Danish: Dine tabletter kan skade børn.
English: This may lower the mineral content of your bones.
Danish: Dette kan sænke indholdet af mineraler i dine knogler.
English: General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.
Danish: Generel støttebehandling, herunder hyppig monitorering af vitale tegn og nøje observation af patienten, er indiceret.
English: Thirteen out of the 14 patients enrolled completed 12 months of combination treatment (one patient was lost to follow-up).
Danish: 13 ud af de 14 indrullerede patienter fuldførte 12 måneders kombinationsbehandling (en patient var tabt for opfølgning).
English: All patients received treatment with vitamin D and calcium.
Danish: Alle patienter fik vitamin D og calcium.
English: Results from the secondary endpoints were supportive of the results of the primary efficacy endpoints.
Danish: Resultater fra de sekundære endepunkter understøttede resultaterne af de primære effekt-endepunkter.
English: Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
Danish: Du må ikke tage en dobbeltdosis (to doser på samme tid) som erstatning for den glemte dosis.
English: The rate of prolonged (more than 24 weeks) stable disease, the rate of progression, and survival were also calculated.
Danish: Hyppigheden af længerevarende (mere end 24 uger) stabil sygdom, progressionsrate og overlevelse blev også beregnet.
English: However, the majority of these events occurred in patients with identifiable risk factors for the development of the condition.
Danish: De fleste af disse hændelser forekom hos patienter med identificerbare risikofaktorer for udvikling af tilstanden.
English: Time to progression and objective response rates were the primary efficacy variables.
Danish: Tid til progression og objektive responsrater var de primære effektvariabler.
English: It does this by blocking a natural substance (an enzyme) in your body called ‘aromatase'.
Danish: Det sker ved at blokere et naturligt stof (et enzym) i din krop, som hedder ”aromatase”.
English: • Changes in blood tests that show how well your liver is working.
Danish: • Ændringer i blodprøver, der viser, hvor godt din lever fungerer.
English: Cutaneous vasculitis (including some reports of Henoch-Schönlein purpura)**
Danish: Kutan vaskulitis (inklusive enkelte rapporteringer om Schönlein-Henoch purpura)**
English: There is no specific antidote to overdose and treatment must be symptomatic.
Danish: Der findes ingen specifik antidot ved overdosering, og behandlingen skal være symptomatisk.
English: Anastrozole is only 40% bound to plasma proteins.
Danish: Anastrozol er kun 40 % bundet til plasmaproteiner.
English: Only 14 subjects on Arimidex completed 36 months.
Danish: Kun 14 forsøgspersoner på Arimidex fuldførte 36 måneder.
English: - The usual dose is one tablet once a day.
Danish: - Den sædvanlige dosis er en tablet dagligt.
English: You should talk to your doctor about the risks and treatment options.
Danish: Det anbefales, at du taler med din læge om risici og behandlingsmuligheder.
English: • Changes in special blood tests that show how your liver is working (gamma-GT and bilirubin).
Danish: • Ændringer i særlige blodprøver, der viser, hvordan din lever fungerer (gamma-GT og bilirubin).
English: - if you have problems with your liver or kidneys.
Danish: - hvis du har problemer med leveren eller nyrerne.
English: Food slightly decreases the rate but not the extent of absorption.
Danish: Fødeindtagelse sænker absorptionshastigheden en smule, men ikke absorptionsfraktionen.
English: However, some people may occasionally feel weak or sleepy while taking Arimidex.
Danish: Nogle mennesker vil dog af og til føle sig matte eller søvnige, når de tager Arimidex.
English: • Bleeding from the vagina (usually in the first few weeks of treatment - if the bleeding continues, talk to your doctor).
Danish: • Blødning fra skeden (sædvanligvis kun under de første få ugers behandling - hvis blødningen fortsætter, skal du kontakte din læge).
English: The metabolites are excreted primarily via the urine.
Danish: Metabolitterne udskilles primært gennem urinen.
English: This belongs to a group of medicines called ‘aromatase inhibitors'.
Danish: Det tilhører en gruppe lægemidler, som kaldes ”aromatasehæmmere”.
English: Short stature due to Growth Hormone Deficiency
Danish: Lille af vækst på grund af væksthormonmangel
English: Keep your tablets in the container they came in.
Danish: Opbevar tabletterne i den pakning, som de leveres i.
English: Do not use Arimidex after the expiry date which is stated on the carton and <container> [To be completed nationally].
Danish: Brug ikke Arimidex efter den udløbsdato, der står på pakningen og <beholderen> [Udfyldes nationalt].
English: Adverse reactions listed below are classified according to frequency and System Organ Class (SOC).
Danish: De nedenfor angivne bivirkninger er klassificeret efter frekvens og systemorganklasse (SOC).
English: Frequency groupings are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to <1/1,000), and very rare (<1/10,000).
Danish: Frekvensgrupper er defineret i henhold til følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til <1/1.000) og meget sjælden (<1/10.000).
English: Estrone is subsequently converted to estradiol.
Danish: Estron omdannes derefter til estradiol.
English: - It does not matter if you take Arimidex before, with or after food.
Danish: - Det er lige meget, om du tager Arimidex før, under eller efter et måltid.
English: Long-term safety data in children and adolescents are not available.
Danish: Sikkerhedsdata ved langvarig behandling hos børn og unge er ikke tilgængelige.
English: The effect of potent CYP inhibitors is unknown.
Danish: Virkningen af stærke CYP-hæmmere er ukendt.
English: Do not take Arimidex if any of the above apply to you.
Danish: Tag ikke Arimidex, hvis noget af ovenstående gælder for dig.
English: These effects occurred at clinically relevant doses.
Danish: Disse virkninger optrådte ved klinisk relevante doser.
English: New contralateral breast cancer Odds ratio
Danish: Ny kontralateral brystkræft Odds ratio
English: Your bones may be less strong and may be more likely to fracture.
Danish: Dine knogler kan blive svagere, og du kan have større risiko for knoglebrud.
English: - if you are pregnant or breast-feeding (see the section called ‘Pregnancy and breast-feeding').
Danish: - hvis du er gravid eller ammer (se afsnittet ”Graviditet og amning”).
English: Vomiting may be induced if the patient is alert.
Danish: Opkastning kan fremkaldes, hvis patienten er ved bevidsthed.
English: • Thinning of your hair (hair loss).
Danish: • Udtynding af håret (hårtab).
English: The following table presents adverse reactions from clinical trials, post-marketing studies or spontaneous reports.
Danish: Følgende tabel giver en oversigt over bivirkninger fra kliniske forsøg, post-marketingundersøgelser eller spontane rapporter.
English: This includes gonadorelin, buserelin, goserelin, leuprorelin and triptorelin.
Danish: Disse inkluderer gonadorelin, buserelin, goserelin, leuprorelin og triptorelin.
English: Efficacy has not been established in the paediatric populations studied (see below).
Danish: Virkningen er ikke fastslået i de undersøgte pædiatriske populationer (se nedenfor).
English: Do not take Arimidex if you are already taking any of the following medicines: - Certain medicines used to treat breast cancer (selective estrogen receptor modulators), e.g., medicines that contain tamoxifen.
Danish: Tag ikke Arimidex, hvis du allerede tager et af følgende lægemidler: - Visse lægemidler, der anvendes til at behandle brystkræft (selektive østrogenreceptor modulatorer), f.eks. lægemidler, som indeholder tamoxifen.
English: Note: This SPC, labelling and packages leaflet is the version valid at the time of Commission Decision.
Danish: Bemærk: Produktresume, etikettering og indlægsseddel herunder er den gældende version på tidspunktet for Kommissionens beslutning.
English: The primary objective was to evaluate the safety and efficacy of Arimidex 1 mg/day in patients with MAS.
Danish: Det primære formål var at evaluere sikkerheden og virkningen af Arimidex 1 mg/dag hos patienter med MAS.
English: Anastrozole inhibits CYPs 1A2, 2C8/9 and 3A4 in vitro.
Danish: Anastrozol hæmmer CYP1A2, 2C8/9 og 3A4 in vitro.
English: Table 3 ATAC endpoint summary: 5-year treatment completion analysis Efficacy endpoints
Danish: Tabel 3 Sammendrag af ATAC-endepunkter: Analyse af 5-års behandlingsgennemførelse Effekt-endpoints
English: Clearance of anastrozole was lower in girls (3-10 years) than in the older boys and exposure higher.
Danish: Anastrozolclearance var lavere hos piger (3-10 år) end hos de ældre drenge og eksponeringen højere.
English: Tell your doctor or pharmacist if you are taking the following: - A medicine known as an ‘LHRH analogue'.
Danish: Fortæl det til lægen eller på apoteket, hvis du tager følgende: - Medicin, som kaldes ”LHRH-analoger”.
English: The incidence of osteoporosis was 10.5% in patients treated with Arimidex and 7.3% in patients treated with tamoxifen.
Danish: Forekomsten af osteoporose var 10,5 % hos patienter behandlet med Arimidex og 7,3 % hos patienter behandlet med tamoxifen.
English: Measured mean plasma concentrations were 44.4 (±14.7) ng/ml and 165 (±90) ng/ml respectively.
Danish: De målte middelplasmakoncentrationer var henholdsvis 44,4 (±14,7) ng/ml og 165 (±90) ng/ml.
English: - if you have ever had a condition that affects the strength of your bones (osteoporosis).
Danish: - hvis du nogensinde har haft en sygdom, der påvirker styrken af dine knogler (knogleskørhed,
English: This is known as ‘angioedema'.
Danish: Dette kaldes ‘angioødem'.
English: There were too few deaths occurring across treatment groups of both trials to draw conclusions on overall survival differences.
Danish: I begge forsøg var der for få dødsfald på tværs af behandlingsgrupperne til at drage nogen konklusioner om forskelle i den overordnede overlevelse.
English: Multiple dose toxicity studies utilized rats and dogs.
Danish: Der blev udført toksicitetsforsøg med multiple doser hos rotter og hunde.
English: Two further similar trials (GABG/ARNO 95 and ITA), in one of which patients had received surgery and chemotherapy, as well as a combined analysis of ABCSG 8 and GABG/ARNO 95, supported these results.
Danish: To andre tilsvarende forsøg (GABG/ARNO 95 og ITA), hvor patienter i et af dem var blevet opereret og havde fået kemoterapi, samt en kombineret analyse af ABCSG 8 og GABG/ARNO 95 underbyggede disse resultater.
English: Important information about some of the ingredients of Arimidex Arimidex contains lactose which is a type of sugar.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Arimidex Arimidex indeholder lactose, der er en form for sukker.
English: In the management of an overdose, consideration should be given to the possibility that multiple agents may have been taken.
Danish: Ved behandling af en overdosis skal man overveje den mulighed, at patienten kan have taget flere stoffer.
English: • Carpal tunnel syndrome (tingling, pain, coldness, weakness in parts of the hand).
Danish: • Karpaltunnelsyndrom (prikken, smerte, kuldefornemmelse, svaghed i dele af hånden).
English: This is because Arimidex can affect the way some medicines work and some medicines can have an effect on Arimidex.
Danish: Det skyldes, at Arimidex kan påvirke den måde, visse lægemidler virker på, og visse lægemidler kan påvirke Arimidex.
English: Anastrozole in girls was widely distributed and slowly eliminated.
Danish: Anastrozol blev hos piger fordelt i vid udstrækning og elimineret langsomt.
English: Final height data were not available.
Danish: Data om sluthøjde var ikke tilgængelige.
English: - Medicines that contain estrogen, such as hormone replacement therapy (HRT).
Danish: - Medicin, der indeholder østrogen, såsom hormonerstatningsterapi (HRT).
English: Mating indices were adversely affected in both dose groups, whilst a reduction in fertility was evident only at the 400 mg/l dose level.
Danish: Parringsindekset blev påvirket negativt i begge dosisgrupper, men en reduktion i fertilitet var kun tydelig ved dosisniveauet på 400 mg/l.
English: ** Since cutaneous vasculitis and Henoch-Schönlein purpura was not observed in ATAC, the frequency category for these events can be considered as ‘Rare' (≥ 0.01% and < 0.1%) based on the worst value of the point estimate.
Danish: ** Da kutan vaskulitis og Schönlein-Henoch purpura ikke blev observeret i ATAC, kan frekvenskategorien for disse hændelser anses for at være ”Sjælden” (≥ 1/10.000 til < 1/1.000) baseret på den værste værdi i punktestimatet.
English: Triazole, the major metabolite in plasma, does not inhibit aromatase.
Danish: Triazol, hovedmetabolitten i plasma, hæmmer ikke aromatase.
English: There is limited clinical experience of accidental overdose.
Danish: Der er begrænset klinisk erfaring med overdosering.
English: Anastrozole pharmacokinetics are independent of age in postmenopausal women.
Danish: Anastrozol farmakokinetik er uafhængig af alder hos postmenopausale kvinder.
English: The recommended dose of Arimidex for adults including the elderly is one 1 mg tablet once a day.
Danish: Den anbefalede dosis Arimidex til voksne, inklusive ældre, er én 1 mg tablet dagligt.
English: Approximately 90 to 95% of plasma anastrozole steady-state concentrations are attained after 7 daily doses, and accumulation is 3- to 4-fold.
Danish: Ca. 90-95 % af anastrozol steady-state-koncentrationen i plasma nås efter 7 døgndoser, og akkumulationen er 3-4 gange.
English: Increases in alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase
Danish: Stigning i alkalisk fosfatase, alaninaminotransferase og aspartat-aminotransferase
English: A decrease in 50% or more of total breast volume was seen in 56% (20/36) of the boys after 6 months.
Danish: Der sås et fald i det samlede brystvolumen på 50 % eller derover hos 56 % (20/36) af drengene efter 6 måneder.
English: Arimidex is a potent and highly selective non-steroidal aromatase inhibitor.
Danish: Arimidex er en potent og meget selektiv non-steroid aromatasehæmmer.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Hvis din læge har fortalt dig, at du ikke tåler visse sukkerarter, skal du kontakte din læge, før du tager denne medicin.
English: There was no significant difference in growth rate after 12 months of treatment, relative to the growth rate during the 6 months prior to entering the study.
Danish: Der var ingen signifikant forskel i vækstrate efter 12 måneders behandling set i forhold til vækstraten i 6-måneders perioden før indrullering i forsøget.
English: Anastrozole is eliminated slowly with a plasma elimination half-life of 40 to 50 hours.
Danish: Anastrozol elimineres langsomt med en plasmahalveringstid på 40-50 timer.
English: Table 4 ABCSG 8 trial endpoint and results summary Efficacy endpoints
Danish: Tabel 4 ABCSG 8 forsøgsendepunkt og resultatoversigt Effekt-endpoints
English: Fracture rates of 22 per 1,000 patient-years and 15 per 1,000 patient-years were observed for the Arimidex and tamoxifen groups, respectively, after a median follow-up of 68 months.
Danish: Frakturhyppigheder på 22 per 1.000 patient-år og 15 per 1.000 patient-år blev observeret for henholdsvis Arimidex- og tamoxifen-gruppen efter en median opfølgning på 68 måneder.
English: It has not been determined whether the rates of fracture and osteoporosis seen in ATAC in patients on Arimidex treatment reflect a protective effect of tamoxifen, a specific effect of Arimidex, or both.
Danish: Det er ikke fastslået, om hyppigheden af fraktur og osteoporose set i ATAC hos patienter i Arimidexbehandling afspejler en beskyttende virkning af tamoxifen, en specifik virkning af Arimidex eller begge dele.
English: This treatment arm was discontinued from the study.
Danish: Denne behandlingsarm blev ekskluderet fra forsøget.
English: Advanced breast cancer
Danish: Fremskreden brystkræft
English: If any of these happen to you, call an ambulance or see a doctor straight away - you may need urgent medical treatment.
Danish: Hvis du får en af disse bivirkninger, skal du straks tilkalde en ambulance eller søge læge - du skal muligvis behandles med det samme.
English: - if you are taking a medicine that contains tamoxifen or medicines that contain estrogen (see the section called ‘Taking other medicines').
Danish: - hvis du tager et lægemiddel, som indeholder tamoxifen, eller lægemidler, der indeholder østrogen (se afsnittet ‘Brug af anden medicin').
English: *** Vaginal bleeding has been reported commonly, mainly in patients with advanced breast cancer during the first few weeks after changing from existing hormonal therapy to treatment with Arimidex.
Danish: *** Vaginalblødning er almindeligt rapporteret, hovedsagelig hos patienter med fremskreden brystkræft i de første få uger efter at have skiftet fra den eksisterende hormonbehandling til behandling med Arimidex.
English: Like all medicines, Arimidex can cause side effects, although not everybody gets them.
Danish: Arimidex kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: No data on the potential long-term effects of Arimidex treatment in children and adolescents are available (see also section 5.3).
Danish: Der findes ingen data om de potentielle langtidsvirkninger af Arimidex-behandling hos børn og unge (se også pkt.
English: Growth rate (in cm/year) was significantly reduced (p<0.05) from pretreatment through month 0 to month 12, and from pre-treatment to the second 6 months (month 7 to month 12).
Danish: Væksthastigheden (i cm/år) blev reduceret signifikant (p<0,05) fra før behandling til måned 0 og til måned 12, og fra før behandling til de sidste 6 måneder (måned 7 til måned 12).
English: AstraZeneca GmbH Tinsdaler Weg 183 D-22880 Wedel Germany
Danish: AstraZeneca GmbH Tinsdaler Weg 183 D-22880 Wedel Tyskland
English: The menopause should be defined biochemically (luteinizing-hormone [LH], follicle stimulating hormone [FSH], and/or estradiol levels) in any patient where there is doubt about menopausal status.
Danish: Menopausen skal defineres biokemisk (niveauet af luteiniserende hormon [LH], follikelstimulerende hormon [FSH] og/eller estradiol) hos alle patienter, hvor der hersker tvivl om den menopausale status.
English: The reduction was transient as all mating and fertility parameters were similar to control group values following a 9 week treatment-free recovery period.
Danish: Reduktionen var forbigående, da alle parringsog fertilitetsparametre svarede til kontrolgruppeværdierne efter en 9-ugers behandlingsfri periode.
English: With an updated follow-up at a median of 10 years, long term comparison of the treatment effects of Arimidex relative to tamoxifen were shown to be consistent with previous analyses.
Danish: Med en opdateret opfølgning ved en median på 10 år blev det påvist, at langvarig sammenligning af behandlingsvirkningerne af Arimidex i forhold til tamoxifen var i overensstemmelse med tidligere analyser.
English: Absorption of anastrozole is rapid and maximum plasma concentrations typically occur within two hours of dosing (under fasted conditions).
Danish: Absorption af anastrozol sker hurtigt, og maksimale plasmakoncentrationer nås normalt inden for to timer efter dosering (under faste).
English: In postmenopausal women, estradiol is produced primarily from the conversion of androstenedione to estrone through the aromatase enzyme complex in peripheral tissues.
Danish: Hos postmenopausale kvinder produceres estradiol primært fra omdannelse af androstendion til estron ved hjælp af aromatase-enzym-komplekset i perifere væv.