FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro data indicate that this is predominantly mediated by the cytochrome P450 3A4 isoform (CYP3A4).
Danish: In vitro-data indicerer, at dette fortrinsvis medieres af cytokrom P450 3A4-isoform (CYP3A4).
English: Experience with Esmya when several doses are taken at once is limited.
Danish: Der er begrænset erfaring med Esmya, når der tages flere doser på én gang.
English: Thus administration of ulipristal acetate is unlikely to alter the clearance of medicinal products that are metabolised by these enzymes.
Danish: Derfor er det usandsynligt, at administration af ulipristalacetat vil ændre clearance af lægemidler, der metaboliseres af disse enzymer.
English: It is used either before an operation of your fibroids or for long term treatment of your fibroids to reduce their size, to stop or reduce bleeding and to increase your red blood cell count.
Danish: Esmya anvendes enten før operation af dine fibromer eller til langvarig behandling af dine fibromer for at reducere deres størrelse, for at stoppe eller reducere blødning og for at øge antallet af røde blodlegemer.
English: In case of hyperplasia (without atypia), monitoring as per usual clinical practice (e.g. a follow-up control 3 months later) would be recommended.
Danish: I tilfælde af hyperplasi (uden atypi) anbefales overvågning i henhold til normal klinisk praksis (f.eks. opfølgende kontrol 3 månender senere).
English: Pack of 28, 30 and 84 tablets.
Danish: Pakke med 28, 30 og 84 tabletter.
English: • treatment must be stopped if the patient develops ALT or AST > 3 x ULN.
Danish: • behandlingen skal afbrydes, hvis patienten udvikler ALAT eller ASAT > 3 x ULN.
English: Esmya passes into the breast milk.
Danish: Esmya går over i mælken.
English: This card provides information on blood tests you will need throughout treatment and on what you should do if liver side effects occur.
Danish: Dette kort indeholder oplysninger om blodprøver, du skal have taget under hele behandlingen, og hvad du skal gøre, hvis der opstår leverbivirkninger.
English: Educational material for pathologists
Danish: Informationsmateriale til patologer
English: Study 2 contained the active comparator, leuprorelin 3.75 mg given once per month by intramuscular injection.
Danish: Studie 2 indeholdt den aktive komparator, leuprorelin 3,75 mg, der blev givet én gang dagligt som intramuskulær injektion.
English: These symptoms may be signs of liver injury (frequency not known).
Danish: Disse symptomer kan være tegn på leverskade (hyppighed ikke kendt).
English: The treating physician should explain to the patient the requirement for treatment free intervals.
Danish: Den behandlende læge bør forklare patienten nødvendigheden af behandlingsfrie perioder.
English: These are possible symptoms of angioedema (frequency not known).
Danish: Disse er mulige symptomer på angioødem (hyppighed ikke kendt).
English: If you do become pregnant during Esmya treatment, you should stop taking Esmya immediately and contact your doctor or pharmacist.
Danish: Hvis du bliver gravid, mens du er i behandling med Esmya, skal du straks holde op med at tage Esmya og kontakte din læge eller apoteket.
English: Esmya with food and drink You should avoid drinking grapefruit juice while on treatment with Esmya.
Danish: Brug af Esmya sammen med mad og drikke Du skal undgå at drikke grapefrugtjuice, når du tager Esmya.
English: Stop using Esmya and immediately contact a doctor if you experience any of the following symptoms:
Danish: Stop med at bruge Esmya, og kontakt straks en læge, hvis du oplever et eller flere af følgende symptomer:
English: These blood tests will inform the doctor of the functioning of your liver and are vital when monitoring your treatment.
Danish: Disse blodprøver fortæller lægen, hvordan din lever fungerer, og de er meget vigtige i forbindelse med overvågning af din behandling.
English: Esmya can cause side effects although not everybody gets them.
Danish: Esmya kan give bivirkninger, men ikke alle får bivirkninger.
English: In all Phase III studies including repeated intermittent treatment studies, a total of 7 cases of hyperplasia were observed out of 789 patients with adequate biopsies (0.89%).
Danish: I alle fase III-studier, herunder studier med gentaget intermitterende behandling, blev der observeres i alt 7 tilfælde af hyperplasi hos 789 patienter med egnede biopsier (0,89 %).
English: One possible side effect is serious damage to your liver.
Danish: En mulig bivirkning er alvorlig leverskade.
English: Hot flushes were reported by 8.1% of patients but the rates varied across trials.
Danish: Hedestigninger blev indberettet af 8,1 % af patienterne, men forekomsten var forskellig i de forskellige studier.
English: In Study 2, change in the volume of the three largest myomas was measured by ultrasound.
Danish: I studie 2 blev ændringen af volumen af de tre største myomer målt med ultralyd.
English: Study 1 was double-blind placebo controlled.
Danish: Studie 1 var dobbeltblindt og placebokontrolleret.
English: Table 1: Results of primary and selected secondary efficacy assessments in Phase III studies
Danish: Tabel 1: Resultater af vurderinger af primære og udvalgte sekundære virkninger i fase III-studier
English: Do not take Esmya if you are pregnant.
Danish: Du må ikke tage Esmya, hvis du er gravid.
English: Studies 3 and 4 showed efficacy in controlling uterine fibroid symptoms (e.g. uterine bleeding) and reducing fibroid size after 2 and 4 courses.
Danish: Studie 3 og 4 viste virkning til kontrol af symptomer på uterusfibromer (f.eks. uterinblødning) og til reduktion af fibromstørrelse efter hhv. 2 og 4 forløb.
English: Ulipristal acetate should only be prescribed after careful diagnosis.
Danish: Ulipristalacetat bør kun ordineres efter en omhyggelig diagnose.
English: In both studies menstrual blood loss was assessed using the Pictorial Bleeding Assessment Chart (PBAC).
Danish: I begge studier blev blodtabet under menstruationen vurderet ved hjælp af PBAC (Pictorial Bleeding Assessment Chart).
English: When ulipristal acetate treatment is stopped, menstrual cycles generally resume within 4 weeks.
Danish: Når ulipristalacetat-behandlingen afbrydes, genoptages menstruationscyklussen normalt i løbet af 4 uger.
English: If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: The treatment courses should each not exceed 3 months as the risk of adverse impact on the endometrium is unknown if treatment is continued without interruption.
Danish: Behandlingsforløbene bør hver især ikke strække sig over mere end 3 måneder, da risikoen for uønskede virkninger på endometriet, hvis behandlingen fortsættes uden afbrydelse, ikke er kendt.
English: • inform the patients not to take Esmya in case of liver problems.
Danish: • informer patienterne om ikke at tage Esmya i tilfælde af leverproblemer.
English: Medicinal products affecting gastric pH
Danish: Lægemidler, der påvirker den gastrisk pH
English: If a patient misses a dose, the patient should take ulipristal acetate as soon as possible.
Danish: Hvis en patient glemmer en dosis, skal hun tage ulipristalacetat snarest muligt.
English: The size of the three largest myomas was assessed by ultrasound at the end of treatment (Week 13) and for another 25 weeks without treatment in patients who did not have hysterectomy or myomectomy performed.
Danish: Størrelsen af de tre største myomer blev vurderet med ultralyd ved behandlingens afslutning (Uge 13) og i yderligere 25 uger uden behandling hos patienter, som ikke havde fået foretaget hysterektomi eller myomektomi.
English: Patients in this study were required to be anaemic at Study entry (Hb < 10.2 g/dl) and all patients were to receive oral iron 80 mg Fe++ in addition to study medicinal product.
Danish: Patienter i dette studie skulle være anæmiske ved inklusion i studiet (Hb < 10,2 g/dl), og alle patienter skulle have oralt jern ved 80 mg Fe++ i tillæg til studielægemidlet.
English: There are no or limited amount of data from the use of ulipristal acetate in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af ulipristalacetat til gravide kvinder.
English: In the placebo-controlled study, the rate of hot flushes was 1.0% for ulipristal acetate and 0% for placebo.
Danish: I det placebokontrollerede studie var forekomsten af hedestigninger 1,0 % for ulipristalacetat og 0 % for placebo.
English: The vast majority of adverse reactions were mild and moderate (95.0%), did not lead to discontinuation of the medicinal product (98.0%) and resolved spontaneously.
Danish: Langt størstedelen af bivirkningerne var milde til moderate (95,0 %), medførte ikke seponering af lægemidlet (98,0 %) og forsvandt spontant.
English: Patients who develop transaminase levels (ALT or AST) > 3 times the upper limit of normal during treatment should stop treatment and be closely monitored.
Danish: Patienter, som udvikler transaminaseniveauer (ALAT eller ASAT) > 3 gange den øvre normalgrænse under behandling, skal afbryde behandlingen og monitoreres tæt.
English: In vitro data indicate that ulipristal acetate and its active metabolite are not P-gp (ABCB1) substrates.
Danish: In vitro-data indikerer, at ulipristalacetat og dets aktive metabolit ikke er P gp (ABCB1)-substrater.
English: • the need to inform the pathologist that patients were treated with Esmya if biopsy/surgical samples are to be sent for analysis.
Danish: • behovet for at informere patologen om, at patienter er behandlet med Esmya, hvis biopsier/kirurgiske prøver sendes til analyse.
English: Tell your doctor or pharmacist if you are taking any of the medicines listed below, as these medicines can affect Esmya or be affected by Esmya: - Certain medicines which are used to treat the heart (e.g. digoxin).
Danish: Fortæl det til lægen eller på apoteket, hvis du tager nogen af de lægemidler, der er nævnt herunder, eftersom disse lægemidler kan påvirke Esmya eller blive påvirket af Esmya: - Visse lægemidler mod hjertesygdomme (f.eks. digoxin).
English: You need blood tests before starting each treatment course to find out how your liver is working.
Danish: Du skal have taget blodprøver, inden du påbegynder hvert behandlingsforløb, for at finde ud af, hvordan din lever fungerer.
English: 1st TEST (before treatment start) Start of treatment
Danish: BLODPRØVE (før behandlingsstart) Behandlingsstart
English: Your period should generally return within 4 weeks after treatment with Esmya is stopped.
Danish: Din menstruation bør normalt vende tilbage i løbet af 4 uger, efter behandling med Esmya er stoppet.
English: In a 39-week study in cynomolgus monkeys, histological changes resembling PAEC were noted at low doses.
Danish: I et 39-ugers studie med cynomolgus aber blev der ved lave doser set histologiske ændringer, der ligner PAEC.
English: Adverse reactions during treatment course 1 Very common Common
Danish: Bivirkninger under første behandlingsforløb Meget almindelig
English: Most patients treated with ulipristal acetate stopped bleeding within the first week of treatment (amenorrhea).
Danish: De fleste patienter, som blev behandlet med ulipristalacetat, holdt op med at bløde i løbet af den første uge af behandlingen (amenorré).
English: Patients with heavy menstrual bleeding due to uterine fibroids are at risk of excessive bleeding, which may require surgical intervention.
Danish: Patienter med kraftig menstruationsblødning på grund af uterinfibromer har en risiko for kraftig blødning, der kan kræve kirurgisk indgreb.
English: It is available in Alu/PVC/PE/PVDC blisters in cartons containing 28, 30 and 84 tablets or Alu/PVC/PVDC blisters in cartons containing 28 and 84 tablets.
Danish: Det fås i alu/PVC/PE/PVDC blister i kartoner a 28, 30 og 84 tabletter eller alu/PVC/PVDC blister i kartoner a 28 og 84 tabletter.
English: If pregnancy is suspected prior to initiation of a new treatment course, a pregnancy test should be performed.
Danish: Ved mistanke om graviditet før iværksættelse af et nyt behandlingsforløb skal der foretages en graviditetstest.
English: THE TABLE BELOW HELPS YOU TO TRACK YOUR BLOOD TESTS:
Danish: I NEDENSTÅENDE SKEMA KAN DU HOLDE ØJE MED DINE BLODPRØVER:
English: Marketing Authorisation Holder Gedeon Richter Plc.
Danish: Indehaver af markedsføringstilladelsen Gedeon Richter Plc.
English: Use in women with severe asthma insufficiently controlled by oral glucocorticoids is not recommended.
Danish: Astmapatienter Brug til kvinder med svær astma, der er utilstrækkeligt kontrolleret af orale glukokortikoider, frarådes.
English: Alopecia** Dry skin Hyperhidrosis
Danish: Alopeci** Hudtørhed Hyperhidrose
English: DD/MM/YYYY
Danish: DD/MM/ÅÅÅÅ
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede lægemiddelovervågningsaktiviteter og foranstaltninger, som er beskrevet i den godkendte RMP der fremgår af, modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Myoma size reduction was generally maintained during this follow-up period in patients originally treated with ulipristal acetate but some re-growth occurred in patients treated with leuprorelin.
Danish: Reduktionen af myomstørrelsen blev generelt oprethold i denne opfølgningsperiode hos patienter, som oprindeligt blev behandlet med ulipristalacetat, men der skete nogen genvækst hos patienter, som blev behandlet med leuprorelin.
English: Patients should be informed that treatment with ulipristal acetate usually leads to a significant reduction in menstrual blood loss or amenorrhea within the first 10 days of treatment.
Danish: Patienterne skal informeres om, at behandling med ulipristalacetat normalt giver et væsentlig mindre blodtab under menstruationen eller amenorré inden for de første 10 dages behandling.
English: Bold values in shaded squares indicate that there was a significant difference in the comparisons between ulipristal acetate and the control.
Danish: Værdier angivet med fed skrift i skraverede felter angiver, at der var en signifikant forskel i sammenligningerne mellem ulipristalacetat og kontrolpræparatet.
English: In addition, reversible increase of the endometrium thickness may occur under treatment.
Danish: Endvidere kan reversibel forøgelse af endometriets tykkelse forekomme under behandling.
English: In vitro data indicate that ulipristal acetate and its active metabolite do not inhibit CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4, or induce CYP1A2 at clinically relevant concentrations.
Danish: In vitro-data indikerer, at ulipristalacetat og dets aktive metabolit ikke hæmmer CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1 og 3A4 og ikke induktorer CYP1A2 ved klinisk relevante koncentrationer.
English: Based on pooled data from four phase III studies in patients with uterine fibroids treated for 3 months, the following adverse reactions have been reported.
Danish: Baseret på sammenlagte data fra fire fase III-studier med patienter med uterusfibromer, som blev behandlet i 3 måneder, er der indberettet følgende bivirkninger.
English: EU/1/12/750/001 28 tablets EU/1/12/750/002 84 tablets EU/1/12/750/003 30 tablets EU/1/12/750/004 28 tablets EU/1/12/750/005 84 tablets
Danish: EU/1/12/750/001 28 tabletter EU/1/12/750/002 84 tabletter EU/1/12/750/003 30 tabletter EU/1/12/750/004 28 tabletter EU/1/12/750/005 84 tabletter
English: Endometrial changes
Danish: Endometriske ændringer
English: Genital bleeding of unknown aetiology or for reasons other than uterine fibroids.
Danish: Genitalblødning af ukendt ætiologi eller af andre årsager end uterusfibromer.
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, progesterone receptor modulators.
Danish: Farmakoterapeutisk klassifikation: Kønshormoner og modulatorer af genitalsystemet, progesteronreceptormodulatorer.
English: • inform the patients about the symptoms and signs of possible liver injury so that they are aware of situations in which they should stop treatment and contact a physician in a timely manner.
Danish: • informer patienterne om tegn og symptomer på mulig leverskade, så de er bekendt med situationer, hvor de skal afbryde behandlingen og kontakte en læge i rette tid.
English: Medicinal products containing progestagen should not be taken within 12 days after cessation of ulipristal acetate treatment.
Danish: Lægemidler med gestagen bør ikke tages inden for 12 dage efter afslutning af ulipristalacetat-behandlingen.
English: Esmya treatment is to be initiated and supervised by physicians experienced in the diagnosis and treatment of uterine fibroids.
Danish: Behandling med Esmya skal iværksættes og overvåges af læger med erfaring i diagnosticering og behandling af uterusfibromer.
English: There is no relevant use of ulipristal acetate in the paediatric population.
Danish: Der er ingen relevante indikationer for ulipristalacetat i den pædiatriske population.
English: In study 1, a statistically significant difference was observed in reduction in menstrual blood loss in favour of the patients treated with ulipristal acetate compared to placebo (see Table 1 below), resulting in faster and more efficient correction of anaemia than iron alone.
Danish: I studie 1 blev der observeret en statistisk signifikant forskel i reduktionen af blodtabet under menstruation hos patienter, som blev behandlet med ulipristalacetat, sammenlignet med placebo (se tabel 1 herunder), hvilket gav en hurtigere og mere effektiv korrektion af anæmi end jern alene.
English: - if you have vaginal bleeding not caused by uterine fibroids.
Danish: - hvis du har blødning fra skeden, der ikke skyldes uterusfibromer.
English: In vitro data indicate that ulipristal acetate may be an inhibitor of P-gp at clinically relevant concentrations in the gastrointestinal wall during absorption.
Danish: In vitro-data indikerer, at ulipristalacetat kan være en hæmmer af P-gp i klinisk relevante koncentrationer i den gastrointestinale væg under absorption.
English: - The other ingredients are microcrystalline cellulose, mannitol, croscarmellose sodium, talc and magnesium stearate.
Danish: - Øvrige indholdsstoffer: Mikrokrystallinsk cellulose, mannitol, croscarmellosenatrium, talcum og magnesiumstearat.
English: clarithromycin, erythromycin, rifabutin).
Danish: erythromycin, rifabutin).
English: 17, Rue de Pontoise FR-95520 Osny France
Danish: 17 Rue de Pontoise FR-95520 Osny Frankrig
English: When comparing repeated treatment courses, overall adverse reactions rate was less frequent in subsequent treatment courses than during the first one and each adverse reaction was less frequent or remained in the same frequency category (except for dyspepsia which was classified as uncommon in treatment course 3 based on one patient occurence).
Danish: Ved sammenligning af gentagne behandlingsforløb var forekomsten af bivirkninger mindre hyppig i efterfølgende behandlingsforløb end i det første, og hver bivirkning var mindre hyppig eller i samme hyppighedskategori (undtagen dyspepsi, der blev grupperet som ”ikke almindelig” i behandlingsforløb 3 baseret på én patientforekomst).
English: In vivo results show that ulipristal acetate (administered as a single 10 mg tablet) 1.5 hour before administration of the P-gP substrate fexofenadine (60 mg) has no clinically relevant effects on the pharmacokinetic of fexofenadine.
Danish: In vivo-resultater viser, at ulipristalacetat (administreret som en enkelt 10 mg tablet) 1,5 time før administration af P-gp-substratet fexofenadin (60 mg) ikke har nogen klinisk relevant virkning på fexofenadins farmakokinetik.
English: Contraception in females
Danish: Kontraception til kvinder
English: If the dose was missed by more than 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Danish: Hvis dosis blev glemt i mere end 12 timer, skal patienten ikke tage den glemte dosis og blot fortsætte med den sædvanlige doseringsplan.
English: Reproduction studies performed in rats at doses giving exposure in the same range as the human dose have revealed no evidence of impaired fertility due to ulipristal acetate in treated animals or the offspring of treated females.
Danish: Reproduktionsstudier udført hos rotter ved doser, der giver eksponering i samme område som den humane dosis, har ikke vist evidens for nedsat fertilitet på grund af ulipristalacetat hos behandlede dyr eller afkommet af behandlede dyr.
English: 17 rue de Pontoise F-95520 Osny France
Danish: 17, rue de Pontoise F-95520 Osny Frankrig
English: Ulipristal acetate does not affect serum levels of TSH, ACTH or prolactin.
Danish: Ulipristalacetat påvirker ikke serumniveauet af TSH, ACTH eller prolaktin.
English: Most findings in general toxicity studies were related to its action on progesterone receptors (and at higher concentrations on glucocorticoid receptors), with antiprogesterone activity observed at exposures similar to therapeutic levels.
Danish: I generelle toksicitetsundersøgelser var de fleste fund relateret til stoffets virkning på progesteronreceptorer (og ved højere koncentrationer på glukokortikoidreceptorer), og der sås antiprogesteronaktivitet ved eksponeringer svarende til terapeutiske niveauer.
English: The most frequent adverse reaction was hot flush.
Danish: Den hyppigste bivirkning var hedestigninger.
English: Due to the CYP-mediated metabolism, hepatic impairment is expected to alter the elimination of ulipristal acetate, resulting in increased exposure.
Danish: På grund af den CYP-medierede metabolisme forventes nedsat leverfunktion at ændre eliminationen af ulipristalacetat med deraf følgende øget eksponering.
English: • inform the patients on the need to warn their physicians on any liver problems they may have.
Danish: • informer patienterne om, at de skal oplyse deres læger om eventuelle leverproblemer, de måtte have.
English: The most common finding in clinical trials was amenorrhea (79.2%), which is considered as a desirable outcome for the patients (see section 4.4).
Danish: Det mest almindelige fund i kliniske studier var amenorré (79,2 %), der anses for at være et ønskeligt resultat for patienterne (se pkt.
English: Do not take Esmya - if you are allergic to ulipristal acetate or any of the other ingredients of Esmya (listed in section 6).
Danish: Tag ikke Esmya - hvis du er allergisk over for ulipristalacetat eller et af de øvrige indholdsstoffer (angivet i pkt.
English: A few cases have been reported during ulipristal acetate treatment or within 2-3 months after ulipristal acetate treatment was stopped.
Danish: Der er indberettet nogle få tilfælde i forbindelse med ulipristalacetat-behandlingen eller i løbet af 2-3 måneder efter afbrydelse af ulipristalacetatbehandlingen.
English: • Educational material for pathologists which contains o Pathologist's guide o USB stick or CD ROM with images of digital specimens (digital library with high resolution images) o SmPC
Danish: • Informationsmateriale til patologer, der indeholder o Patologvejledning o USB-nøgle (eller cd-rom) med billeder af digitale prøver (digitalt bibliotek med højopløste billeder) o Produktresumé
English: • absence of safety data on the endometrium for continuous treatment longer than 3 months.
Danish: • ingen sikkerhedsdata for endometriet for uafbrudte perioder over 3 måneder.
English: The direct action on the endometrium results in class-specific changes in histology termed PAEC.
Danish: Den direkte virkning på endometriet medfører klassespecifikke ændringer i den histologi, der kaldes PAEC.
English: Drug hypersensitivity symptoms such as generalised oedema, pruritus, rash, swelling face or urticaria were reported by 0.4% of patients in Phase III trials.
Danish: Symptomer på medicinoverfølsomhed, såsom generaliseret ødem, pruritus, udslæt, hævet ansigt eller urticaria, blev indberettet af 0,4 % af patienterne i fase III-studier.