natgillin/translations-raw huggingface dataset:
Nedsat nyrefunktion forventes ikke at ændre eliminationen af ulipristalacetat i væsentlig grad. 
Renal impairment is not expected to significantly alter the elimination of ulipristal acetate.
Denne kinetiske virkning af mad forventes ikke at være af klinisk relevans for den daglige administration af ulipristalacetat tabletter. 
This kinetic effect of food is not expected to be of clinical relevance for daily administration of ulipristal acetate tablets.
Median ændring i myomvolumen i forhold til baseline a Behandlingsforløb 2 vurderet efter behandlingsforløb 2 plus 1 menstruation. 
Median change in myoma volume from baseline a Treatment course 2 assessment corresponds to Treatment course 2 plus one menstrual bleeding.
a a I studie 1 blev ændringen fra baseline i den samlede myomvolumen målt med MR-scanning. 
a a In Study 1, change from baseline in total myoma volume was measured by MRI.
Selvom der ikke blev observeret noget teratogent potentiale, er dataene fra dyreforsøg utilstrækkelige, for så vidt angår reproduktionstoksicitet (se pkt. 
Although no teratogenic potential was observed, animal data are insufficient with regard to reproduction toxicity (see section 5.3).
Tabletten skal synkes med vand og kan tages sammen med et måltid eller mellem måltiderne. 
The tablet should be swallowed with water and may be taken with or without food.
Desuden vil hormonelle præventionsmidler (f.eks. norethindron eller levonorgestrel) også sandsynligvis nedsætte virkningen af Esmya. 
In addition, hormonal contraceptives and progestagens (e.g. norethindrone or levonorgestrel) are also likely to make Esmya less effective.
• informer patienterne om potentielle bivirkninger vedrørende leveren, som kan skyldes Esmya. 
• inform the patients about potential adverse reactions related to liver that could be caused by the use of Esmya.
Under behandlingen med Esmya tager din læge jævnligt blodprøver for at kontrollere din leverfunktion. 
During treatment with Esmya, your doctor will carry out regular blood tests to check your liver function.
Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen. 
Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP.
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. 
If you miss a dose by more than 12 hours, skip the missed tablet and take only a single tablet as usual.
Desuden betegnes reversible ændringer af endometriet PAEC og adskiller sig fra endometriehyperplasi. 
In addition, reversible changes to the endometrium are denoted PAEC and are different from endometrial hyperplasia.
Hormonale kontraceptiva og gestagener vil således sandsynligvis reducere virkningen af ulipristalacetat ved en kompetitiv virkning på progesteronreceptoren. 
Thus hormonal contraceptives and progestagens are likely to reduce ulipristal acetate efficacy by competitive action on the progesterone receptor.
Det anses ikke for nødvendigt at justere dosis i forbindelse med administration af ulipristalacetat til patienter, som samtidig får svage CYP3A4-hæmmere. 
No dose adjustment is considered necessary for administration of ulipristal acetate to patients receiving concomitant mild CYP3A4 inhibitors.
A. FREMSTILLER (E) ANSVARLIG(E) FOR BATCHFRIGIVELSE 
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Ulipristalacetat udskilles i human mælk. 
Ulipristal acetate is excreted in human milk.
Livmoderslimhinden kan blive tykkere eller ændre sig, når du tager Esmya. 
The lining of the uterus may thicken or change as a result of taking Esmya.
• Esmyas vigtigste virkninger på PAEC (progesteron-receptor-modulator-associerede endometriske ændringer), og hvordan de adskiller sig fra virkningerne af østrogen alene. 
• key effects of Esmya on Progesterone Receptor Modulator Associated Endometrial Changes (PAEC) and how they differ from those of unopposed oestrogen.
- 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. 
- 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.
6.5 Emballagetype og pakningsstørrelser alu/PVC/PE/PVDC eller alu/PVC/PVDC blister. 
Alu/PVC/PE/PVDC or Alu/PVC/PVDC blister.
Hos ca. 10-15 % af de patienter, som behandles med ulipristalacetat, kan endometriet fortykkes (>16 mm) under det første 3-måneders behandlingsforløb. 
In about 10-15% of patients treated with ulipristal acetate the endometrium may thicken (> 16 mm) during the first 3-month treatment course.
Efter behandlingsforløb 4 (4 gange 3 måneders behandling) 
After treatment course 4 (four times 3 months of treatment)
• kontraindikationer: graviditet og amning, genitalblødning af ukendt ætiologi eller af andre årsager end uterusfibromer samt livmoder-, livmoderhals-, brystkræft og kræft i æggestokkene samt leversygdom. 
• 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.
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. 
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.
- Hvis du har en lever- eller nyresygdom, skal du fortælle det til lægen eller på apoteket, før du tager Esmya. 
- If you have liver or kidney disease tell your doctor or pharmacist before taking Esmya.
Hvis du glemmer at tage en dosis i mindre end 12 timer, skal du tage den hurtigst muligt. 
If you miss a dose by less than 12 hours, take it as soon as you remember.
Ulipristalacetat konverteres nemt til sine mono-N-demethylerede og derefter til sine di-Ndemethylerede metabolitter. 
Ulipristal acetate is readily converted to its mono-N-demethylated and subsequently to its di-N-demethylated metabolites.
Esmya skal tages dagligt i behandlingsforløb på op til 3 måneder uden afbrydelse. 
Esmya is to be taken daily during treatment courses of up to 3 months continuously.
Patienter, som blev behandlet med ulipristalacetat, havde ligeledes en større reduktion i myomstørrelsen, der blev vurderet ved MR-scanning. 
Likewise, patients treated with ulipristal acetate had a greater reduction in myoma size, as assessed by MRI.
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. 
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.
• detaljerede anbefalinger til behandling af fortykket endometrium. 
• detailed recommendations for management of endometrial thickening.
Behandling med Esmya medfører normalt en væsentlig reduktion eller stopper måske også din menstruation i løbet af de første 10 dages behandling. 
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.
• Yderligere risikominimeringsforanstaltninger Før lægemiddelproduktet lanceres i hvert medlemsland, skal indehaveren af markedsføringstilladelsen aftale informationsmaterialets indhold og format med medlemsstatens kompetente myndighed. 
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.
• 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. 
• 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.
Denne virkning af lægemidler, der øger den gastrisk pH, forventes ikke at være af klinisk relevans for den daglige administration af ulipristalacetat-tabletter. 
This effect of medicinal products that increase gastric pH is not expected to be of clinical relevance for daily administration of ulipristal acetate tablets.
Før du påbegynder behandling med Esmya, bliver der taget blodprøver for at finde ud af, hvor godt din lever fungerer. 
Before you start treatment with Esmya blood tests will be undertaken to find out how well your liver is working.
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. 
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.
Samtidig administration af moderate eller potente CYP3A4-hæmmere og ulipristalacetat anbefales ikke (se pkt. 
Co-administration of moderate or potent CYP3A4 inhibitors and ulipristal acetate is not recommended (see section 4.4).
Hvid til næsten hvid, rund, bikonveks tablet på 7 mm præget med ”ES5” på den ene side. 
White to off-white, round biconvex tablet of 7 mm engraved with “ES5” on one face.
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). 
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).
• anbefaling af periodisk overvågning af endometriet ved gentaget intermitterende behandling. 
• recommendation of a periodic monitoring of the endometrium in case of repeated intermittent treatment.
Patienter i amenorré b,c 
Patients in amenorrhea b,c
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. 
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.
Gentaget intermitterende behandling er undersøgt for op til 4 intermitterende behandlingsforløb. 
Repeated intermittent treatment has been studied up to 4 intermittent treatment courses.
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. 
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.
De fleste af disse tilfælde reverserede spontant til normalt endometrium, efter menstruationen var vendt tilbage i den behandlingsfri periode. 
The vast majority spontaneously reversed to normal endometrium after resumption of menstruation during the off-treatment period.
Det anbefales derfor, at ulipristalacetat og P-gp-substrater (f.eks. dabigatranetexilat, digoxin, fexofenadin) administreres med mindst 1,5 times mellemrum. 
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.
Behandlinger bør kun påbegyndes, når der har været menstruation: - Det første behandlingsforløb bør starte i den første menstruationsuge. 
Treatments should only be initiated when menstruation has occurred: - The first treatment course should start during the first week of menstruation.
Esmya vil sandsynligvis nedsætte virkningen af visse hormonelle præventionsmidler (se ”Brug af anden medicin sammen med Esmya). 
Esmya is likely to make some hormonal contraceptives less effective (see “Other medicines and Esmya”).
Efter markedsføring er der indberettet tilfælde af leverskader og leversvigt (se pkt. 
During the post-marketing experience, cases of liver injury and hepatic failure were reported (see section 4.3).
Da der ikke foreligger specifikke studier, anbefales ulipristalacetat ikke til patienter med svært nedsat nyrefunktion, medmindre patienten monitoreres nøje (se pkt. 
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).
Esmya indeholder det aktive stof ulipristalacetat. 
Esmya contains the active substance ulipristal acetate.
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. 
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.
Prøverne gentages hver måned under de 2 første behandlingsforløb. 
These tests will be repeated monthly for the first 2 treatment courses.
• leverfunktionen skal overvåges hver måned under de 2 første behandlingsforløb og derefter, når der er klinisk indikation herfor. 
• liver function must be monitored monthly during the first 2 treatment courses, and thereafter when clinically indicated.
Esmya vil sandsynligvis nedsætte virkningen af visse hormonelle præventionsmidler. 
Esmya is likely to make some hormonal contraceptives less effective.
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. 
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.
Ulipristalacetat binder i høj grad (> 98 %) til plasmaproteiner, herunder albumin, alpha-1-syreglykoprotein, højdensitetslipoprotein (HDL) og lavdensitetslipoprotein (LDL). 
Ulipristal acetate is highly bound (>98%) to plasma proteins, including albumin, alpha-l-acid glycoprotein, high density lipoprotein and low density lipoprotein.
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. 
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.
• påmindelse om ulipristalacetats virkning på endometriet. 
• reminder of the effect of ulipristal acetate on the endometrium.
Ulipristalacetat kan i mindre grad påvirke evnen til at føre motorkøretøj eller betjene maskiner, eftersom der er observeret let svimmelhed efter indtagelse af ulipristalacetat. 
Ulipristal acetate may have minor influence on the ability to drive or use machines as mild dizziness has been observed after ulipristal acetate intake.
Ulipristalacetat har en embryoletal virkning hos rotter, kaniner (ved gentagne doser over 1 mg/kg), marsvin og aber på grund af dets virkningsmekanisme. 
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.
Tabel 2: Resultater af vurdering af primære og udvalgte sekundære virkninger i langvarige fase IIIstudier 
Table 2: Results of primary and selected secondary efficacy assessments in long term Phase III studies Parameter
Potentiel risiko for, at andre lægemidler kan påvirke ulipristalacetat: 
Potential for other medicinal products to affect ulipristal acetate:
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. 
Therefore, hormonal contraceptives are not recommended and you should use an alternative reliable barrier contraceptive method, such as a condom, during Esmya treatment.
Der skal udføres leverfunktionstest, før behandling påbegyndes. 
Liver function tests must be performed before starting treatment.
Potentiel risiko for, at ulipristalacetat kan påvirke andre lægemidler: 
Potential for ulipristal acetate to affect other medicinal products:
Ulipristalacetat har en steroid struktur og virker som en selektiv progesteron-receptormodulator med fortrinsvis hæmmende virkninger på progesteronreceptoren. 
Ulipristal acetate has a steroid structure and acts as a selective progesterone receptor modulator with predominantly inhibitory effects on the progesterone receptor.
Alt efter resultatet af disse prøver beslutter din læge, om behandling med Esmya er egnet til dig. 
Depending on the result of these tests your doctor will decide if treatment with Esmya is suitable for you.
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. 
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.
- Genbehandlingsforløb bør tidligst starte i den første uge af den anden menstruation efter afslutning af det foregående behandlingsforløb. 
- Re-treatment courses should start at the earliest during the first week of the second menstruation following the previous treatment course completion.
Ved gentagen intermitterende behandling anbefales periodisk overvågning af endometriet, inkl. 
In case of repeated intermittent treatment, periodic monitoring of the endometrium is recommended.
• differentialdiagnosen mellem PAEC, østrogen alene og endometriehyperplasi. 
• the differential diagnosis between PAEC, unopposed oestrogen and endometrial hyperplasia.
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). 
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).
Atypisk hyperplasi bør undersøges og behandles i henhold til normal klinisk praksis. 
In case of atypical hyperplasia, investigation and management as per usual clinical practice should be performed.
DATO 
DATE
YDERKARTON 
OUTER CARTON
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. 
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.
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. 
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).
• 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. 
• 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.
Hvis præparater efter hysterektomi eller endometriebiopsi sendes til histologi, skal patologen informeres om, at patienten har taget ulipristalacetat (se pkt. 
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).
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. 
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.
De fleste kvinder, som tager en terapeutisk dosis ulipristalacetat, har anovulation, men fertilitetsniveauet er ikke undersøgt i forbindelse med indtagelse af flere doser ulipristalacetat. 
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.
- Visse lægemidler mod svampeinfektioner (f.eks. ketoconazol (undtagen shampoo), itraconazol). 
- Certain medicines to treat fungal infections (e.g. ketoconazole (except shampoo), itraconazole).
• baselineleverfunktionstest kræves, før behandling påbegyndes, og før hvert nyt behandlingsforløb. 
• baseline liver function tests are required before treatment initiation, and before each new treatment course.
• 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. 
• 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.
Dette inkluderer årlig ultralydsundersøgelse, der skal udføres efter tilbagevenden af menstruation i behandlingsfri periode). 
This includes annual ultrasound to be performed after resumption of menstruation during off-treatment period.
Denne fortykkelse forsvinder, når behandlingen er seponeret, og menstruation finder sted. 
This thickening disappears after treatment is withdrawn and menstruation occurs.
Ulipristalacetat virker direkte på fibromer og reducerer deres størrelse via hæmning af celledeling og induktion af apoptose. 
Ulipristal acetate exerts a direct action on fibroids reducing their size through inhibition of cell proliferation and induction of apoptosis.
Ved efterfølgende behandlingsforløb skal leverfunktionen testes én gang før hvert nyt behandlingsforløb, og når der er klinisk indikation herfor. 
For further treatment courses, liver function must be tested once before each new treatment course and when clinically indicated.
• smerter øverst til højre i maveregionen 
• pain in the upper right stomach
oxcarbazepin, primidon). 
carbamazepine, oxcarbazepine, primidone).
Opbevar blisteret i den ydre karton for at beskytte mod lys. 
Keep the blister in the outer carton in order to protect from light.
Uterusfibromer kan hos nogle kvinder give kraftig menstruationsblødning, bækkensmerter (mavegener) og trykke på andre organer. 
In some women, uterine fibroids may cause heavy menstrual bleeding (your ‘period'), pelvic pain (discomfort in the belly) and create pressure on other organs.
I/T N=199 N=191 
NA N=199 N=191
endometriebiopsi, være påkrævet for at udelukke andre underliggende sygdomme, herunder endometriemalignitet. 
investigation of the endometrium including endometrial biopsy should be performed in order to exclude other underlying conditions, including endometrial malignancy.