FrancophonIA/ELRC3.0 huggingface dataset:
English: SIGNS AND SYMPTOMS OF POSSIBLE LIVER PROBLEMS Stop treatment and contact a doctor right away if you observe any of the following signs or symptoms:
Danish: TEGN OG SYMPTOMER PÅ MULIGE LEVERPROBLEMER Afbryd behandlingen, og søg straks læge, hvis du observerer et eller flere af følgende tegn eller symptomer:
English: Menstrual periods generally return within 4 weeks after the end of each treatment course.
Danish: Menstruationen vender normalt tilbage i løbet af 4 uger efter afslutning af hvert behandlingsforløb.
English: About 5% of patients of reproductive age experiencing heavy menstrual bleeding have an endometrial thickness of greater than 16 mm.
Danish: Ca. 5 % af patienter i den fertile alder med kraftig menstruationsblødning har en endometrietykkelse på mere end 16 mm.
English: For further treatment courses, your liver will be checked once before each new treatment course and if you experience any of the symptoms described below.
Danish: Ved efterfølgende behandlingsforløb bliver din lever kontrolleret én gang før hvert nye behandlingsforløb, og hvis du oplever et eller flere af de symptomer, som er beskrevet nedenfor.
English: In the first 3-month treament course of the two long term Phase III trials, the frequency was 5.3% and 5.8% for ulipristal acetate, respectively.
Danish: I det første 3-måneders behandlingsforløb i de to langvarige fase III-studier var hyppigheden hhv. 5,3 % og 5,8 % for ulipristalacetat.
English: • inform the patients about the need for monitoring of liver function before starting each treatment course, monthly during treatment and within a few weeks after the treatment has stopped.
Danish: • informer patienterne om, at leverfunktionen skal overvåges, før hvert behandlingsforløb påbegyndes, hver måned under behandlingen og få uger efter, at behandlingen er ophørt.
English: When daily administration of a 5 mg dose is commenced during a menstrual cycle most subjects (including patients with myoma) will complete their first menstruation but will not menstruate again until after treatment is stopped.
Danish: Når daglig administration af en 5 mg dosis påbegyndes under en menstruationscyklus, afslutter de fleste personer (herunder patienter med fibromer) deres første menstruation, men de menstruerer først igen, når behandlingen er blevet afbrudt.
English: In the active comparator controlled study the rates were 24% (10.5% moderate or severe) for ulipristal acetate and 60.4% (39.6% moderate or severe) for leuprorelin-treated patients.
Danish: I det aktive komparator-kontrollerede studie var forekomsten 24 % (10,5 % moderate eller svære) for ulipristalacetat og 60,4 % (39,6 % moderat eller svær) for patienter, som blev behandlet med leuprorelin.
English: No dose adjustment is recommended in patients with mild or moderate renal impairment.
Danish: Der anbefales ingen dosisjustering til patienter med let eller moderat nedsat nyrefunktion.
English: After treatment course 2 (two times 3 months of treatment)
Danish: Efter behandlingsforløb 2 (2 gange 3-måneders behandling)
English: Single doses up to 200 mg and daily doses of 50 mg for 10 consecutive days were administered to a limited number of subjects, and no severe or serious adverse reactions were reported.
Danish: Enkeltdoser på op til 200 mg og daglige doser på 50 mg i 10 på hinanden følgende dage blev indgivet hos et begrænset antal forsøgspersoner, og der blev ikke rapporteret om svære eller alvorlige bivirkninger.
English: Study 4 was a randomized, double-blind clinical study assessing ulipristal acetate 5 or 10 mg.
Danish: Studie 4 var et randomiseret, dobbeltblindet klinisk studie, der vurderede ulipristalacetat 5 eller 10 mg.
English: Renal impairment is not expected to significantly alter the elimination of ulipristal acetate.
Danish: Nedsat nyrefunktion forventes ikke at ændre eliminationen af ulipristalacetat i væsentlig grad.
English: This kinetic effect of food is not expected to be of clinical relevance for daily administration of ulipristal acetate tablets.
Danish: Denne kinetiske virkning af mad forventes ikke at være af klinisk relevans for den daglige administration af ulipristalacetat tabletter.
English: Median change in myoma volume from baseline a Treatment course 2 assessment corresponds to Treatment course 2 plus one menstrual bleeding.
Danish: Median ændring i myomvolumen i forhold til baseline a Behandlingsforløb 2 vurderet efter behandlingsforløb 2 plus 1 menstruation.
English: a a In Study 1, change from baseline in total myoma volume was measured by MRI.
Danish: a a I studie 1 blev ændringen fra baseline i den samlede myomvolumen målt med MR-scanning.
English: Although no teratogenic potential was observed, animal data are insufficient with regard to reproduction toxicity (see section 5.3).
Danish: Selvom der ikke blev observeret noget teratogent potentiale, er dataene fra dyreforsøg utilstrækkelige, for så vidt angår reproduktionstoksicitet (se pkt.
English: The tablet should be swallowed with water and may be taken with or without food.
Danish: Tabletten skal synkes med vand og kan tages sammen med et måltid eller mellem måltiderne.
English: In addition, hormonal contraceptives and progestagens (e.g. norethindrone or levonorgestrel) are also likely to make Esmya less effective.
Danish: Desuden vil hormonelle præventionsmidler (f.eks. norethindron eller levonorgestrel) også sandsynligvis nedsætte virkningen af Esmya.
English: • inform the patients about potential adverse reactions related to liver that could be caused by the use of Esmya.
Danish: • informer patienterne om potentielle bivirkninger vedrørende leveren, som kan skyldes Esmya.
English: During treatment with Esmya, your doctor will carry out regular blood tests to check your liver function.
Danish: Under behandlingen med Esmya tager din læge jævnligt blodprøver for at kontrollere din leverfunktion.
English: Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen.
English: If you miss a dose by more than 12 hours, skip the missed tablet and take only a single tablet as usual.
Danish: Hvis du glemmer en dosis i mere end 12 timer, skal du springe den glemte tablet over og kun tage en enkelt tablet som normalt.
English: In addition, reversible changes to the endometrium are denoted PAEC and are different from endometrial hyperplasia.
Danish: Desuden betegnes reversible ændringer af endometriet PAEC og adskiller sig fra endometriehyperplasi.
English: Thus hormonal contraceptives and progestagens are likely to reduce ulipristal acetate efficacy by competitive action on the progesterone receptor.
Danish: Hormonale kontraceptiva og gestagener vil således sandsynligvis reducere virkningen af ulipristalacetat ved en kompetitiv virkning på progesteronreceptoren.
English: No dose adjustment is considered necessary for administration of ulipristal acetate to patients receiving concomitant mild CYP3A4 inhibitors.
Danish: Det anses ikke for nødvendigt at justere dosis i forbindelse med administration af ulipristalacetat til patienter, som samtidig får svage CYP3A4-hæmmere.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER (E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: Ulipristal acetate is excreted in human milk.
Danish: Ulipristalacetat udskilles i human mælk.
English: The lining of the uterus may thicken or change as a result of taking Esmya.
Danish: Livmoderslimhinden kan blive tykkere eller ændre sig, når du tager Esmya.
English: • key effects of Esmya on Progesterone Receptor Modulator Associated Endometrial Changes (PAEC) and how they differ from those of unopposed oestrogen.
Danish: • Esmyas vigtigste virkninger på PAEC (progesteron-receptor-modulator-associerede endometriske ændringer), og hvordan de adskiller sig fra virkningerne af østrogen alene.
English: - If you are currently taking hormonal contraception (for example birth control pills) (see “Other medicines and Esmya”) you should use an alternative reliable barrier contraceptive method (such as a condom) while taking Esmya.
Danish: - Hvis du i øjeblikket anvender hormonprævention (f.eks. p-piller) (se ”Brug af anden medicin sammen med Esmya), bør du også bruge en anden pålidelig barriere-prævention (f.eks. et kondom), mens du tager Esmya.
English: Alu/PVC/PE/PVDC or Alu/PVC/PVDC blister.
Danish: 6.5 Emballagetype og pakningsstørrelser alu/PVC/PE/PVDC eller alu/PVC/PVDC blister.
English: In about 10-15% of patients treated with ulipristal acetate the endometrium may thicken (> 16 mm) during the first 3-month treatment course.
Danish: Hos ca. 10-15 % af de patienter, som behandles med ulipristalacetat, kan endometriet fortykkes (>16 mm) under det første 3-måneders behandlingsforløb.
English: After treatment course 4 (four times 3 months of treatment)
Danish: Efter behandlingsforløb 4 (4 gange 3 måneders behandling)
English: • the contraindications of pregnancy and breastfeeding, genital bleeding of unknown aetiology or for reasons other than uterine fibroids, and uterine, cervical, ovarian or breast cancer as well as underlying hepatic disorder.
Danish: • kontraindikationer: graviditet og amning, genitalblødning af ukendt ætiologi eller af andre årsager end uterusfibromer samt livmoder-, livmoderhals-, brystkræft og kræft i æggestokkene samt leversygdom.
English: If you have been prescribed several courses of Esmya 3-month treatment, you should start each course at the earliest during the second menstrual period following the previous treatment completion.
Danish: Hvis du har fået ordineret flere 3-måneders behandlingsforløb med Esmya, må du tidligst starte hvert forløb i den anden menstruationsperiode efter afslutning af det foregående behandlingsforløb.
English: - If you have liver or kidney disease tell your doctor or pharmacist before taking Esmya.
Danish: - Hvis du har en lever- eller nyresygdom, skal du fortælle det til lægen eller på apoteket, før du tager Esmya.
English: If you miss a dose by less than 12 hours, take it as soon as you remember.
Danish: Hvis du glemmer at tage en dosis i mindre end 12 timer, skal du tage den hurtigst muligt.
English: Ulipristal acetate is readily converted to its mono-N-demethylated and subsequently to its di-N-demethylated metabolites.
Danish: Ulipristalacetat konverteres nemt til sine mono-N-demethylerede og derefter til sine di-Ndemethylerede metabolitter.
English: Esmya is to be taken daily during treatment courses of up to 3 months continuously.
Danish: Esmya skal tages dagligt i behandlingsforløb på op til 3 måneder uden afbrydelse.
English: Likewise, patients treated with ulipristal acetate had a greater reduction in myoma size, as assessed by MRI.
Danish: Patienter, som blev behandlet med ulipristalacetat, havde ligeledes en større reduktion i myomstørrelsen, der blev vurderet ved MR-scanning.
English: c N and % include withdrawn patients d Controlled bleeding was defined as no episodes of heavy bleeding and a maximum of 8 days of bleeding (not including days of spotting) during the last 2 months of a treatment course.
Danish: d Kontrolleret blødning blev defineret som ingen episoder med kraftig blødning og maksimalt 8 dages blødning (dage med pletblødning er ikke inkluderet) i de sidste 2 måneder af et behandlingsforløb.
English: • detailed recommendations for management of endometrial thickening.
Danish: • detaljerede anbefalinger til behandling af fortykket endometrium.
English: Treatment with Esmya usually leads to a significant reduction or may even stop your menstrual bleeding (your ‘period') within the first 10 days of treatment.
Danish: Behandling med Esmya medfører normalt en væsentlig reduktion eller stopper måske også din menstruation i løbet af de første 10 dages behandling.
English: Prior to launch of the medicinal product in each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority.
Danish: • Yderligere risikominimeringsforanstaltninger Før lægemiddelproduktet lanceres i hvert medlemsland, skal indehaveren af markedsføringstilladelsen aftale informationsmaterialets indhold og format med medlemsstatens kompetente myndighed.
English: • the need to investigate as per usual clinical practice persistence of endometrial thickening following treatment discontinuation and return of menstruation to exclude other underlying conditions.
Danish: • behovet for i henhold til normal klinisk praksis at undersøge fortykkelse af endometriet efter seponering af behandlingen og menstruationens tilbagevenden for at udelukke andre underliggende sygdomme.
English: This effect of medicinal products that increase gastric pH is not expected to be of clinical relevance for daily administration of ulipristal acetate tablets.
Danish: Denne virkning af lægemidler, der øger den gastrisk pH, forventes ikke at være af klinisk relevans for den daglige administration af ulipristalacetat-tabletter.
English: Before you start treatment with Esmya blood tests will be undertaken to find out how well your liver is working.
Danish: Før du påbegynder behandling med Esmya, bliver der taget blodprøver for at finde ud af, hvor godt din lever fungerer.
English: In study 3, treatment efficacy has been shown over > 18 months of repeated intermittent treatment (4 courses of 10 mg once daily), 89.7% of patients were in amenorrhea at the end of the treatment course 4.
Danish: I studie 3 blev der påvist virkning af gentaget intermitterende behandling i mere end 18 måneder (4 forløb med 10 mg en gang dagligt), og 89,7 % af patienterne var i amenorré ved udløb af behandlingsforløb 4.
English: Co-administration of moderate or potent CYP3A4 inhibitors and ulipristal acetate is not recommended (see section 4.4).
Danish: Samtidig administration af moderate eller potente CYP3A4-hæmmere og ulipristalacetat anbefales ikke (se pkt.
English: White to off-white, round biconvex tablet of 7 mm engraved with “ES5” on one face.
Danish: Hvid til næsten hvid, rund, bikonveks tablet på 7 mm præget med ”ES5” på den ene side.
English: In study 2, the reduction in menstrual blood loss was comparable for the patients treated with ulipristal acetate and the gonadotrophin releasing hormone-agonist (leuprorelin).
Danish: I studie 2 var reduktionen af blodtabet under menstruation sammenlignelig for de patienter, som blev behandlet med ulipristalacetat og GnRh-agonist (gonadotropin-releasing hormon) (leuprorelin).
English: • recommendation of a periodic monitoring of the endometrium in case of repeated intermittent treatment.
Danish: • anbefaling af periodisk overvågning af endometriet ved gentaget intermitterende behandling.
English: Patients in amenorrhea b,c
Danish: Patienter i amenorré b,c
English: Typically, the histological appearance is an inactive and weakly proliferating epithelium associated with asymmetry of stromal and epithelial growth resulting in prominent cystically dilated glands with admixed oestrogen (mitotic) and progestin (secretory) epithelial effects.
Danish: Det histologiske udseende er et inaktivt epitel med svag celledeling associeret med asymmetrisk stromal og epitelial vækst med deraf følgende prominente cystisk dilaterede kirtler med iblandet østrogen (mitose) og progestin (sekretorisk) epitelial virkning.
English: Repeated intermittent treatment has been studied up to 4 intermittent treatment courses.
Danish: Gentaget intermitterende behandling er undersøgt for op til 4 intermitterende behandlingsforløb.
English: The terminal half-life of ulipristal acetate in plasma following a single dose of 5 or 10 mg is estimated to be about 38 hours, with a mean oral clearance (CL/F) of about 100 l/h.
Danish: Ulipristalacetats terminale halveringstid i plasma efter en enkelt dosis på 5 eller 10 mg skønnes at være ca. 38 timer med en gennemsnitlig oral clearance (CL/F) på 100 l/t.
English: The vast majority spontaneously reversed to normal endometrium after resumption of menstruation during the off-treatment period.
Danish: De fleste af disse tilfælde reverserede spontant til normalt endometrium, efter menstruationen var vendt tilbage i den behandlingsfri periode.
English: It is therefore recommended that co-administration of ulipristal acetate and P-gp substrates (e.g. dabigatran etexilate, digoxin, fexofenadine) should be separated in time by at least 1.5 hours.
Danish: Det anbefales derfor, at ulipristalacetat og P-gp-substrater (f.eks. dabigatranetexilat, digoxin, fexofenadin) administreres med mindst 1,5 times mellemrum.
English: Treatments should only be initiated when menstruation has occurred: - The first treatment course should start during the first week of menstruation.
Danish: Behandlinger bør kun påbegyndes, når der har været menstruation: - Det første behandlingsforløb bør starte i den første menstruationsuge.
English: Esmya is likely to make some hormonal contraceptives less effective (see “Other medicines and Esmya”).
Danish: Esmya vil sandsynligvis nedsætte virkningen af visse hormonelle præventionsmidler (se ”Brug af anden medicin sammen med Esmya).
English: During the post-marketing experience, cases of liver injury and hepatic failure were reported (see section 4.3).
Danish: Efter markedsføring er der indberettet tilfælde af leverskader og leversvigt (se pkt.
English: In the absence of specific studies, ulipristal acetate is not recommended for patients with severe renal impairment unless the patient is closely monitored (see section 4.2).
Danish: Da der ikke foreligger specifikke studier, anbefales ulipristalacetat ikke til patienter med svært nedsat nyrefunktion, medmindre patienten monitoreres nøje (se pkt.
English: Esmya contains the active substance ulipristal acetate.
Danish: Esmya indeholder det aktive stof ulipristalacetat.
English: Ulipristal acetate and its active mono-N-demethylated metabolite are excreted in breast milk with a mean AUCt milk/plasma ratio of 0.74 ± 0.32 for ulipristal acetate.
Danish: Ulipristalacetat og dets aktive mono-N-demetylerede metabolit udskilles i human mælk med et gennemsnitligt AUCt-forhold mellem mælk og plasma på 0,74 ± 0,32 for ulipristalacetat.
English: These tests will be repeated monthly for the first 2 treatment courses.
Danish: Prøverne gentages hver måned under de 2 første behandlingsforløb.
English: • liver function must be monitored monthly during the first 2 treatment courses, and thereafter when clinically indicated.
Danish: • leverfunktionen skal overvåges hver måned under de 2 første behandlingsforløb og derefter, når der er klinisk indikation herfor.
English: Esmya is likely to make some hormonal contraceptives less effective.
Danish: Esmya vil sandsynligvis nedsætte virkningen af visse hormonelle præventionsmidler.
English: A daily dose of ulipristal acetate 5 mg partially suppresses FSH levels but serum oestradiol levels are maintained in the mid-follicular range in the majority of patients and are similar to levels in patients who received placebo.
Danish: En daglig dosis ulipristalacetat på 5 mg undertrykker delvist FSH-niveauer, men serumøstradiolniveauer opretholdes i middelfollikelområdet hos de fleste patienter og er på samme niveau som hos de patienter, som fik placebo.
English: Ulipristal acetate is highly bound (>98%) to plasma proteins, including albumin, alpha-l-acid glycoprotein, high density lipoprotein and low density lipoprotein.
Danish: Ulipristalacetat binder i høj grad (> 98 %) til plasmaproteiner, herunder albumin, alpha-1-syreglykoprotein, højdensitetslipoprotein (HDL) og lavdensitetslipoprotein (LDL).
English: The MAH shall ensure that, at launch and thereafter, all prescribers of Esmya and pathologists who review samples from Esmya-treated patients, as well as patients treated with Esmya, are provided with educational material.
Danish: Indehaveren af markedsføringstilladelsen skal i forbindelse med lanceringen og derefter sikre, at alle ordinerende læger og patologer, der ser på prøver fra patienter, som behandles med Esmya, og alle patienter som behandles med Esmya, får udleveret informationsmaterialet.
English: • reminder of the effect of ulipristal acetate on the endometrium.
Danish: • påmindelse om ulipristalacetats virkning på endometriet.
English: Ulipristal acetate may have minor influence on the ability to drive or use machines as mild dizziness has been observed after ulipristal acetate intake.
Danish: Ulipristalacetat kan i mindre grad påvirke evnen til at føre motorkøretøj eller betjene maskiner, eftersom der er observeret let svimmelhed efter indtagelse af ulipristalacetat.
English: Due to its mechanism of action, ulipristal acetate has an embryolethal effect in rats, rabbits (at repeated doses above 1 mg/kg), guinea pigs and in monkeys.
Danish: Ulipristalacetat har en embryoletal virkning hos rotter, kaniner (ved gentagne doser over 1 mg/kg), marsvin og aber på grund af dets virkningsmekanisme.
English: Table 2: Results of primary and selected secondary efficacy assessments in long term Phase III studies Parameter
Danish: Tabel 2: Resultater af vurdering af primære og udvalgte sekundære virkninger i langvarige fase IIIstudier
English: Potential for other medicinal products to affect ulipristal acetate:
Danish: Potentiel risiko for, at andre lægemidler kan påvirke ulipristalacetat:
English: Therefore, hormonal contraceptives are not recommended and you should use an alternative reliable barrier contraceptive method, such as a condom, during Esmya treatment.
Danish: Derfor frarådes brug af hormonelle præventionsmidler, og du bør bruge en anden pålidelig barriere-prævention (f.eks. et kondom), når du er i behandling med Esmya.
English: Liver function tests must be performed before starting treatment.
Danish: Der skal udføres leverfunktionstest, før behandling påbegyndes.
English: Potential for ulipristal acetate to affect other medicinal products:
Danish: Potentiel risiko for, at ulipristalacetat kan påvirke andre lægemidler:
English: Ulipristal acetate has a steroid structure and acts as a selective progesterone receptor modulator with predominantly inhibitory effects on the progesterone receptor.
Danish: Ulipristalacetat har en steroid struktur og virker som en selektiv progesteron-receptormodulator med fortrinsvis hæmmende virkninger på progesteronreceptoren.
English: Depending on the result of these tests your doctor will decide if treatment with Esmya is suitable for you.
Danish: Alt efter resultatet af disse prøver beslutter din læge, om behandling med Esmya er egnet til dig.
English: The safety of ulipristal acetate has been evaluated in 1,053 women with uterine fibroids treated with 5 mg or 10 mg ulipristal acetate during Phase III studies.
Danish: Sikkerheden af ulipristalacetat er blevet evalueret hos 1.053 kvinder med uterusfibromer, som behandles med 5 mg eller 10 mg ulipristalacetat i fase III-studier.
English: - Re-treatment courses should start at the earliest during the first week of the second menstruation following the previous treatment course completion.
Danish: - Genbehandlingsforløb bør tidligst starte i den første uge af den anden menstruation efter afslutning af det foregående behandlingsforløb.
English: In case of repeated intermittent treatment, periodic monitoring of the endometrium is recommended.
Danish: Ved gentagen intermitterende behandling anbefales periodisk overvågning af endometriet, inkl.
English: • the differential diagnosis between PAEC, unopposed oestrogen and endometrial hyperplasia.
Danish: • differentialdiagnosen mellem PAEC, østrogen alene og endometriehyperplasi.
English: Treatment must not be initiated if transaminases (alanine transaminase (ALT) or aspartate aminotransferase (AST)) exceed 2 x ULN (isolated or in combination with bilirubin >2 x ULN).
Danish: Desuden må behandling ikke igangsættes, hvis transaminaser (alaninaminotransferase (ALAT) eller aspartataminotransferase (ASAT)) overstiger 2 x den øvre normale grænseværdi (ULN) (alene eller i kombination med bilirubin >2 x ULN).
English: In case of atypical hyperplasia, investigation and management as per usual clinical practice should be performed.
Danish: Atypisk hyperplasi bør undersøges og behandles i henhold til normal klinisk praksis.
English: DATE
Danish: DATO
English: OUTER CARTON
Danish: YDERKARTON