FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not take Esmya if you have liver problems.Tell your doctor if you know that you have problems with your liver or if you have any doubts about the condition of your liver.
Danish: Fortæl det til din læge, hvis du ved, at du har problemer med leveren, eller hvis du er i tvivl om, hvordan din lever har det.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Esmya in all subsets of the paediatric population in leiomyoma of uterus (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Esmya i alle undergrupper af den pædiatriske population med uterusfibromer (se pkt.
English: • if a patient during treatment shows signs or symptoms compatible with liver injury, treatment should be stopped, and the patient should be investigated immediately, and liver function tests performed.
Danish: • hvis en patient under behandlingen viser tegn eller symptomer, som tyder på leverskade, skal behandlingen afbrydes, patienten skal undersøges med det samme, og der skal udføres leverfunktionstest.
English: If hysterectomy or endometrial biopsy specimens are sent for histology, then the pathologist should be informed that the patient has taken ulipristal acetate (see sections 4.4 and 5.1).
Danish: Hvis præparater efter hysterektomi eller endometriebiopsi sendes til histologi, skal patologen informeres om, at patienten har taget ulipristalacetat (se pkt.
English: Study 3 was on open-label study assessing ulipristal acetate 10 mg, where each of the 3-month treatment was followed by 10 days of double-blind treatment with progestin or placebo.
Danish: Studie 3 var et åbent studie, der vurderede ulipristalacetat 10 mg, hvor hvert 3-måneders behandlingsforløb blev efterfulgt af 10 dages dobbeltblindet behandling med gestagen eller placebo.
English: A majority of women taking a therapeutic dose of ulipristal acetate have anovulation, however, the level of fertility while taking multiple doses of ulipristal acetate has not been studied.
Danish: De fleste kvinder, som tager en terapeutisk dosis ulipristalacetat, har anovulation, men fertilitetsniveauet er ikke undersøgt i forbindelse med indtagelse af flere doser ulipristalacetat.
English: - Certain medicines to treat fungal infections (e.g. ketoconazole (except shampoo), itraconazole).
Danish: - Visse lægemidler mod svampeinfektioner (f.eks. ketoconazol (undtagen shampoo), itraconazol).
English: • baseline liver function tests are required before treatment initiation, and before each new treatment course.
Danish: • baselineleverfunktionstest kræves, før behandling påbegyndes, og før hvert nyt behandlingsforløb.
English: • patients with alanine transaminase (ALT) or aspartate aminotransferase (AST) > 2 x ULN (isolated or in combination with bilirubin >2 x ULN) must not be treated.
Danish: • patienter med alaninaminotransferase (ALAT) eller aspartataminotransferase (ASAT) > 2 x den øvre normale grænseværdi (ULN) (alene eller i kombination med bilirubin >2 x ULN) må ikke behandles.
English: This includes annual ultrasound to be performed after resumption of menstruation during off-treatment period.
Danish: Dette inkluderer årlig ultralydsundersøgelse, der skal udføres efter tilbagevenden af menstruation i behandlingsfri periode).
English: This thickening disappears after treatment is withdrawn and menstruation occurs.
Danish: Denne fortykkelse forsvinder, når behandlingen er seponeret, og menstruation finder sted.
English: Ulipristal acetate exerts a direct action on fibroids reducing their size through inhibition of cell proliferation and induction of apoptosis.
Danish: Ulipristalacetat virker direkte på fibromer og reducerer deres størrelse via hæmning af celledeling og induktion af apoptose.
English: For further treatment courses, liver function must be tested once before each new treatment course and when clinically indicated.
Danish: Ved efterfølgende behandlingsforløb skal leverfunktionen testes én gang før hvert nyt behandlingsforløb, og når der er klinisk indikation herfor.
English: • pain in the upper right stomach
Danish: • smerter øverst til højre i maveregionen
English: carbamazepine, oxcarbazepine, primidone).
Danish: oxcarbazepin, primidon).
English: Keep the blister in the outer carton in order to protect from light.
Danish: Opbevar blisteret i den ydre karton for at beskytte mod lys.
English: In some women, uterine fibroids may cause heavy menstrual bleeding (your ‘period'), pelvic pain (discomfort in the belly) and create pressure on other organs.
Danish: Uterusfibromer kan hos nogle kvinder give kraftig menstruationsblødning, bækkensmerter (mavegener) og trykke på andre organer.
English: NA N=199 N=191
Danish: I/T N=199 N=191
English: investigation of the endometrium including endometrial biopsy should be performed in order to exclude other underlying conditions, including endometrial malignancy.
Danish: endometriebiopsi, være påkrævet for at udelukke andre underliggende sygdomme, herunder endometriemalignitet.
English: It is used to treat moderate to severe symptoms of uterine fibroids (commonly known as myomas), which are non-cancerous tumours of the uterus (womb).
Danish: Det bruges til at behandle moderate til svære symptomer på fibromer i uterus (kaldes også muskelknuder i livmoderen eller myomer), der er godartede tumorer i uterus (livmoderen).
English: In 10-15% of patients, thickening of the endometrium (> 16 mm by ultrasound or MRI at end of treatment) was observed with ulipristal acetate by the end of the first 3-month treatment course.
Danish: Hos 10-15 % af patienterne blev der observeret fortykket endometrium (>16 mm ved ultralyd eller MR-scanning ved behandlingens afslutning) ved udløbet af det første 3-måneders behandlingsforløb med ulipristalacetat.
English: At the end of treatment course 4, 158 (69.6%) subjects and 164 (74.5%) subjects were assessed as being in amenorrhea, in the 5 mg dose and 10 mg dose respectively (p=0.290).
Danish: Ved udgangen af behandlingforløb 4 blev 158 (69,6 %) patienter og 164 (74,5 %) vurderet som værende i amenorré ved doser på hhv. 5 mg og 10 mg (p=0,290).
English: Weight increased Blood cholesterol increased
Danish: Vægtøgning Forhøjet blodkolesterol Forhøjede triglycerider
English: Ulipristal acetate is an orally-active synthetic selective progesterone receptor modulator characterised by a tissue-specific partial progesterone antagonist effect.
Danish: Ulipristalacetat er en oralt aktiv syntetisk selektiv progesteron-receptormodulator, der kendetegnes ved en vævsspecifik delvis progesteronantagonistisk virkning.
English: No pharmacokinetic studies with ulipristal acetate have been performed in women with impaired renal or hepatic function.
Danish: Der er ikke foretaget farmakokinetiske undersøgelser af ulipristalacetat hos kvinder med nedsat nyreeller leverfunktion.
English: Ulipristal acetate may interfere with the action of hormonal contraceptive medicinal products (progestagen only, progestagen releasing devices or combined oral contraceptive pills) and progestagen administered for other reasons.
Danish: Ulipristalacetat kan påvirke virkningen af medicinske hormonale kontraceptiva (gestagen alene, gestagenspiral eller kombinerede p-piller) og gestagen, der administreres af andre årsager.
English: In case of repeated treatment courses, endometrial thickening was less frequently observed (4.9% of patients after second treatment course and 3.5% after fourth treatment course).
Danish: Ved gentagne behandlingsforløb sås fortykkelse af endometriet mindre hyppigt (4,9 % af patienterne efter andet behandlingsforløb og 3,5 % efter fjerde behandlingsforløb).
English: Other medicines and Esmya
Danish: Brug af anden medicin sammen med Esmya
English: In study 4, 61.9% and 72.7% of patients were in amenorrhea at the end of both treatment course 1 and 2 combined (5 mg dose and 10 mg dose, respectively, p=0.032); 48.7 % and 60.5 % were in amenorrhea at the end of all four treatment courses combined (5 mg dose and 10 mg dose, respectively, p=0.027).
Danish: I studie 4 var 61,9 % og 72,7 % af patienterne i amenorré ved udløb af både behandlingsforløb 1 og 2 kombineret (doser på hhv. 5 mg og 10 mg, p=0,032), 48,7 % og 60,5 % var i amenorré ved udløb af alle 4 behandlingsforløb kombineret (henholdsvis 5 mg dosis og 10 mg dosis, p=0,027).
English: Microcrystalline cellulose Mannitol
Danish: Mikrokrystallinsk cellulose Mannitol
English: Ulipristal acetate is rapidly transformed into a pharmacologically active metabolite with a Cmax of 9.0 ± 4.4 ng/ml and 20.6 ± 10.9 ng/ml also occurring approximately 1 h after ingestion, and with an AUC0-∞ of 26.0 ± 12.0 ng.h/ml and 63.6 ± 30.1 ng.h/ml respectively.
Danish: Ulipristalacetat transformeres hurtigt til en farmakologisk aktiv metabolit med en Cmax på 9,0 ± 4,4 ng/ml og 20,6 ± 10,9 ng/ml, der også indtraf ca. 1 t efter indtagelse, og med en AUC0-∞ på henholdsvis 26,0 ± 12,0 ng.t/ml og 63,6 ± 30,1 ng.t/ml.
English: breast discomfort - swelling due to fluid retention (oedema) - extreme tiredness (asthenia) - increase in blood cholesterol seen in blood tests, increase in blood fats (triglycerides) seen in blood tests.
Danish: - Forhøjet kolesterol i blodet (ses i blodprøver), forhøjede triglycerider (fedt i blodet - ses i blodprøver).
English: if you have an underlying hepatic disorder.
Danish: - hvis du har en leversygdom.
English: However, if you continue to experience excessive bleeding tell your doctor.
Danish: Hvis den kraftige blødning fortsætter, skal du informere deres læge.
English: These histological changes are denoted as “Progesterone Receptor Modulator Associated Endometrial Changes” (PAEC) and should not be mistaken for endometrial hyperplasia (see sections 4.8 and 5.1).
Danish: Disse histologiske ændringer kaldes PAEC (progesteron-receptormodulator-associerede endometriske ændringer) og bør ikke forveksles med endometriehyperplasi (se pkt.
English: Although a majority of women taking a therapeutic dose of ulipristal acetate have anovulation, a non hormonal contraceptive method is recommended during treatment.
Danish: Selvom de fleste kvinder, som tager en terapeutisk dosis ulipristalacetat, har anovulation, anbefales en kontraceptionsmetode uden hormoner i forbindelse med behandlingen.
English: Abdominal pain Nausea
Danish: Abdominale smerter Kvalme
English: Tablets may be taken with or without food.
Danish: Tabletterne kan tages sammen med et måltid eller mellem måltiderne.
English: Amenorrhea Endometrial thickening*
Danish: Amenorré Fortykket endometrium*
English: Administration of ulipristal acetate (30 mg tablet) together with a high-fat breakfast resulted in approximately 45% lower mean Cmax, a delayed tmax (from a median of 0.75 hours to 3 hours) and 25% higher mean AUC0-∞ compared with administration in the fasted state.
Danish: Administration af ulipristalacetat (30 mg tablet) sammen med morgenmad med højt fedtindhold medførte en cirka 45 % mindre gennemsnitlig Cmax, en forsinket Tmax (fra en median på 0,75 t til 3 t) og en 25 % højere gennemsnitlig AUC0-∞ sammenlignet med administration i fastende tilstand.
English: Ulipristal acetate is indicated for one treatment course of pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Danish: Ulipristalacetat er indiceret til ét præoperativt behandlingsforløb af moderate til svære symptomer på uterusfibromer hos voksne kvinder i den fertile alder.
English: If a patient during treatment shows signs or symptoms compatible with liver injury (fatigue, asthenia, nausea, vomiting, right hypochondrial pain, anorexia, jaundice), treatment should be stopped and the patient should be investigated immediately, and liver function tests performed.
Danish: Hvis en patient under behandlingen viser tegn eller symptomer, som tyder på leverskader (træthed, asteni, kvalme, opkastning, smerter i højre hypokondrium, anoreksi, gulsot), skal behandlingen afbrydes, patienten skal undersøges med det samme, og der skal udføres leverfunktionstest.
English: Available toxicological data in animals have shown excretion of ulipristal acetate in milk (for details see section 5.3).
Danish: De tilgængelige toksikologiske data fra dyreforsøg viser, at ulipristalacetat udskilles i mælk (se pkt.
English: Keep the blisters in the outer carton in order to protect from light.
Danish: Opbevar blisterne i den ydre karton for at beskytte mod lys.
English: Croscarmellose sodium Talc
Danish: Croscarmellosenatrium Talcum
English: - Certain medicines used to treat depression (e.g. nefazodone).
Danish: - Visse lægemidler mod depression (f.eks. nefazodon).
English: Treatments should only be initiated when menstruation has occurred: the first treatment course should start during the first week of menstruation, re-treatment courses should start at the earliest during the first week of the second menstruation following the previous treatment course completion.
Danish: Behandlinger bør kun påbegyndes, når der var været menstruation: det første behandlingsforløb bør starte i den første menstruationsuge, genbehandlingsforløb bør tidligst starte i den første uge af den anden menstruation efter afslutning af det foregående behandlingsforløb.
English: Ulipristal acetate is contraindicated during pregnancy (see section 4.3).
Danish: Ulipristalacetat er kontraindiceret under graviditet (se pkt.
English: Following oral administration of a single dose of 5 or 10 mg, ulipristal acetate is rapidly absorbed, with a Cmax of 23.5 ± 14.2 ng/ml and 50.0 ± 34.4 ng/ml occurring approximately 1 h after ingestion, and with an AUC0-∞ of 61.3 ± 31.7 ng.h/ml and 134.0 ± 83.8 ng.h/ml, respectively.
Danish: Efter oral administration af en enkelt dosis på 5 eller 10 mg absorberes ulipristalacetat hurtigt med en Cmax på 23,5 ± 14,2 ng/ml og 50,0 ± 34,4 ng/ml, der indtræffer ca. 1 t efter indtagelse, og med en AUC0-∞ på henholdsvis 61,3 ± 31,7 ng.t/ml og 134,0 ± 83,8 ng.t/ml.
English: Co-administration of moderate (e.g. erythromycin, grapefruit juice, verapamil) or potent (e.g. ketoconazole, ritonavir, nefazodone, itraconazole, telithromycin, clarithromycin) CYP3A4 inhibitors and ulipristal acetate is not recommended (see section 4.5).
Danish: Samtidig administration af moderate (f.eks. erythromycin, grapefrugtjuice, verapamil) eller potente (f.eks. ketoconazol, ritonavir, nefazodon, itraconazol, telithromycin, clarithromycin) CYP3A4hæmmere og ulipristalacetat anbefales ikke (se pkt.
English: - Herbal remedies containing St John's wort (Hypericum perforatum) used for depression or anxiety.
Danish: - Naturlægemidler med perikon (Hypericum perforatum), der anvendes mod depression eller angst.
English: If during the treatment you experience any liver related signs such as feeling of being sick (nausea or vomiting), fatigue, severe tiredness, jaundice (yellowing of the eyes or skin), dark urine, itching or upper stomach ache, you should stop treatment and immediately contact a doctor, who will check the functioning of your liver and decide if you can continue the treatment.
Danish: Hvis du under behandlingen oplever nogen tegn, der har forbindelse til leveren, f.eks. kvalme, opkastning, træthed, ekstrem træthed, gulsot (gulfarvning af øjne eller hud), mørkfarvet urin, kløe eller smerter øverst i maveregionen, skal du afbryde behandlingen og straks søge læge, som kontrollerer leverfunktionen og beslutter, om du kan fortsætte med behandlingen.
English: Very common (may affect more than 1 in 10 people) side effects: - reduction or absence of menstrual bleeding (amenorrhea) - thickening of the lining of the womb (endometrial thickening).
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer) - Reduktion eller udeblivelse af menstruation (amenorré).
English: A daily dose of ulipristal acetate 5 mg inhibits ovulation in the majority of patients as indicated by progesterone levels maintained at around 0.3 ng/ml.
Danish: En daglig dosis ulipristalacetat på 5 mg hæmmer ovulation hos de fleste patienter indiceret ved progesteronniveauer, der opretholdes ved ca. 0,3 ng/ml.
English: If endometrial thickness persists after return of menstruations during off-treatment periods or beyond 3 months following the end of treatment courses, it may need to be investigated as per usual clinical practice to exclude other underlying conditions.
Danish: Hvis endometriefortykkelsen varer ved efter tilbagevenden af menstruation i behandlingsfrie perioder eller længere end 3 måneder efter behandlingsforløbets afslutning, kan det være nødvendigt at undersøge dette i henhold til normal klinisk praksis for at udelukke andre underliggende sygdomme.
English: Leuprorelin 3.75 mg/ month N=93
Danish: Leuprorelin 3,75 mg/ måned N=93
English: The efficacy of fixed doses of ulipristal acetate 5 mg and 10 mg once daily was evaluated in two Phase 3 randomised, double-blind, 13 week studies recruiting patients with very heavy menstrual bleeding associated with uterine fibroids.
Danish: Virkningen af faste doser ulipristalacetat på 5 mg og 10 mg én gang dagligt blev vurderet i to randomiserede, dobbeltblinde, 13 ugers fase III-studier, der rekrutterede patienter med meget kraftig menstruationsblødning i forbindelse med uterusfibromer.
English: If you forget to take Esmya
Danish: Hvis du har glemt at tage Esmya
English: If you stop taking Esmya
Danish: Hvis du holder op med at tage Esmya
English: ESMYA 5mg TABLETS
Danish: ESMYA 5mg TABLETTER
English: If, during repeated intermittent treatment, after the initial reduction in bleeding or amenorrhea, an altered persistent or unexpected bleeding pattern occurs, such as inter-menstrual bleeding,
Danish: Hvis der under gentaget intermitterende behandling efter den første reduktion i blødning eller amenorré forekommer et ændret vedvarende eller uventet blødningsmønster, f.eks. blødning mellem menstruationer, kan en undersøgelse af endometriet, inkl.
English: Ulipristal acetate is likely to adversely interact with progestagen-only pills, progestagen-releasing devices or combined oral contraceptive pills, therefore, concomitant use is not recommended.
Danish: Ulipristalacetat vil sandsynligvis have en ugunstig interaktion med piller med gestagen alene, gestagenspiraler eller kombinerede p-piller, og derfor anbefales samtidig anvendelse ikke.
English: - Certain medicines used to treat HIV infection (e.g. ritonavir, efavirenz, nevirapine).
Danish: - Visse lægemidler mod hiv-infektion (f.eks. ritonavir, efavirenz, nevirapin).
English: In subsequent treatment courses, endometrial thickening was less frequently observed (4.9% and 3.5% of patients by the end of second and fourth treatment course, respectively).
Danish: I efterfølgende behandlingsforløb sås endometriefortykkelse mindre hyppigt (hhv. 4,9 % og 3,5 % af patienterne ved udløb af andet og fjerde behandlingsforløb).
English: NA N=202 N=192
Danish: I/T N=202 N=192
English: Each tablet contains 5 mg of ulipristal acetate.
Danish: Hver tablet indeholder 5 mg ulipristalacetat.
English: Do not throw away via wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: Pregnancy and breastfeeding.
Danish: Graviditet og amning.
English: Administration of ulipristal acetate (10 mg tablet) together with the proton pump inhibitor esomeprazole (20 mg daily for 6 days) resulted in approximately 65% lower mean Cmax, a delayed tmax (from a median of 0.75 hours to 1.0 hours) and 13% higher mean AUC.
Danish: Administration af ulipristalacetat (10 mg tablet) sammen med protonpumpehæmmeren esomeprazol (20 mg dagligt i 6 dage) medførte en ca. 65 % lavere gennemsnitlig Cmax, en forsinket tmax (fra en median på 0,75 t til 1,0 t) og en 13 % højere gennemsnitlig AUC.
English: Esmya is contraindicated in patients with hepatic disorder (see section 4.3 and 4.4).
Danish: Esmya er kontraindiceret hos patienter med leversygdom (se pkt.
English: The treatment consists of one tablet of 5 mg to be taken once daily for treatment courses of up to 3 months each.
Danish: Behandlingen består af én tablet på 5 mg, der skal tages én gang dagligt, i behandlingsforløb på op til 3 måneder.
English: Patient card
Danish: Patientkort
English: Manufacturer Cenexi
Danish: Fremstiller Cenexi
English: - Certain medicines used to treat epilepsy (e.g. phenytoin, fosphenytoin, phenobarbital,
Danish: - Visse lægemidler mod epilepsi (f.eks. phenytoin, fosphenytoin, phenobarbital, carbamazepin,
English: The efficacy of repeated treatment courses fixed doses of ulipristal acetate 5 mg or 10 mg once daily was evaluated in two Phase 3 studies assessing up to 4 intermittent 3-month treatment courses in patients with heavy menstrual bleeding associated with uterine fibroids.
Danish: Virkningen af gentagne behandlingsforløb med faste doser ulipristalacetat på 5 mg eller 10 mg en gang dagligt blev evalueret i to fase 3-studier, der vurderede op til 4 intermitterende 3-måneders behandlingsforløb til patienter med kraftig menstruation associeret med uterusfibromer.
English: During treatment, liver function tests must be performed monthly during the first 2 treatment courses.
Danish: Der skal udføres månedlige leverfunktionstest under de 2 første behandlingsforløb.
English: What Esmya looks like and contents of the pack Esmya is white to off-white, round curved tablet of 7 mm engraved with code “ES5” on one face.
Danish: Esmya er en hvid til næsten hvid, rund, buet tablet på 7 mm præget med koden ”ES5” på den ene side.
English: nausea or vomiting, severe tiredness, jaundice (yellowing of the eyes or skin), dark urine, itching or upper stomach ache.
Danish: - Kvalme eller opkastning, ekstrem træthed, gulsot (gulfarvning af øjne eller hud), mørkfarvet urin, kløe eller smerter øverst i maveregionen.
English: Ulipristal acetate is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age who are not eligible for surgery.
Danish: Ulipristalacetat er indiceret til intermitterende behandling af moderate til svære symptomer på uterusfibromer hos voksne kvinder i den fertile alder som ikke kan eller vil opereres.
English: Depending on the result of these tests, the doctor will decide if treatment with Esmya is suitable for you.
Danish: Alt efter resultatet af blodprøverne vil lægen beslutte, om behandling med Esmya er egnet til dig.
English: Esmya 5 mg tablets
Danish: Esmya 5 mg tabletter
English: Concomitant use of ulipristal acetate and potent CYP3A4 inducers (e.g. rifampicin, rifabutin, carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital, primidone, St John´s wort, efavirenz, nevirapine, long term use of ritonavir) is not recommended (see section 4.4).
Danish: Samtidig brug af ulipristalacetat og potente CYP3A4-induktorer (f.eks. rifampicin, rifabutin, carbamazepin, oxcarbazepin, phenytoin, fosphenytoin, phenobarbital, primidon, perikon, efavirenz, nevirapin, langtidsbehandling med ritonavir) anbefales ikke (se pkt.
English: This medicine acts by modifying the activity of progesterone, a naturally occuring hormone in the body.
Danish: Progesteron er et naturligt forekommende hormon i kroppen.
English: Concomitant use of progestagen-only pills, a progestagen-releasing intrauterine device or combined oral contraceptive pills is not recommended (see section 4.5).
Danish: Samtidig brug af piller med gestagen alene, en gestagenspiral eller kombinerede p-piller anbefales ikke (se pkt.
English: Dyspepsia Flatulence
Danish: Dyspepsi Flatulens
English: Administration of the potent CYP3A4 inducer rifampicin (300 mg twice daily for 9 days) to healthy female volunteers markedly decreased Cmax and AUC of ulipristal acetate and its active metabolite by 90% or more and decreased ulipristal acetate half-life by 2.2-fold corresponding to an approximately 10-fold decrease of ulipristal acetate exposure.
Danish: Administration af den potente CYP3A4-induktor rifampicin (300 mg to gange dagligt i 9 dage) til raske kvindelige forsøgspersoner medførte et markant fald i Cmax og AUC for ulipristalacetat og dets aktive metabolit med 90 % eller mere og reducerede ulipristalacetats halveringstid 2,2 gange, svarende til et fald på ca. 10 gange i eksponeringen for ulipristalacetat.