FrancophonIA/ELRC3.0 huggingface dataset:
English: Mechanism of action Ulipristal acetate exerts a direct effect on the endometrium.
Danish: Virkningsmekanisme Ulipristalacetat virker direkte på endometriet.
English: - If you suffer from severe asthma, treatment with Esmya may not be suitable for you.
Danish: - Hvis du lider af svær astma, er behandling med Esmya måske ikke egnet til dig.
English: Drug hypersensitivity*
Danish: Medicinoverfølsomhed*
English: The incidence of hyperplasia did not increase with repeated treatment courses, including data on 340 women who received up to 4 courses of ulipristal acetate 5 or 10 mg and limited data of 43 women who received up to 8 courses of ulipristal acetate 10 mg.
Danish: data for 340 kvinder, som fik op til 4 forløb med ulipristalacetat 5 eller 10 mg, og begrænsede data for 43 kvinder, som fik op til 8 forløb med ulipristalacetat 10 mg.
English: What Esmya contains - The active substance is ulipristal acetate.
Danish: Esmya indeholder: - Aktivt stof: Ulipristalacetat.
English: The endometrial thickening reverses when treatment is stopped and menstrual periods resume.
Danish: Fortykkelse af endometriet forsvinder, når behandlingen afbrydes, og menstruationen starter igen.
English: One tablet contains 5 mg of ulipristal acetate.
Danish: En tablet indeholder 5 mg ulipristalacetat.
English: Patients whose menstrual bleeding became normal (PBAC < 75) at week 13 Median change in myoma volume from baseline to week 13
Danish: Patienter med amenorré i uge 13 Patienter, hvis menstruationsblødning blev normal (PBAC < 75) i uge 13
English: Uterine haemorrhage* Metrorrhagia Genital discharge Breast discomfort
Danish: Uterinblødning* Metrorragi Genitalt udflåd Brystgener
English: These changes return to normal after treatment is stopped and your periods restart.
Danish: Disse ændringer forsvinder, efter at behandlingen er stoppet, og din menstruation starter igen.
English: You should nonetheless ask your doctor or pharmacist for advice if you take more Esmya than you should.
Danish: Ikke desto mindre skal du spørge lægen eller apoteket til råds, hvis du tager for meget Esmya.
English: • the posology: 5 mg tablet once daily for treatment courses of up to 3 months each.
Danish: • dosering: 5 mg tablet 1 gang dagligt i behandlingsforløb på op til 3 måneder.
English: At doses which were low enough to maintain gestation in the animal species, no teratogenic potential was observed.
Danish: Der blev ikke observeret noget teratogent potentiale ved doser, der var lave nok til at fastholde drægtighed hos dyr.
English: Therefore concomitant administration of medicinal products containing progestagen is not recommended (see section 4.4 and 4.6).
Danish: Derfor anbefales samtidig administration af lægemidler med gestagen ikke (se pkt.
English: Uterine, cervical, ovarian or breast cancer.
Danish: Livmoder-, livmoderhals-, brystkræft og kræft i æggestokkene.
English: If endometrial thickening is noted, which persists after return of menstruations during off-treatment periods or beyond 3 months following the end of treatment courses, and/or an altered bleeding pattern is noted (see section "Bleeding pattern" below), investigation including endometrial biopsy should be performed in order to exclude other underlying conditions, including endometrial malignancy.
Danish: Hvis der observeres fortykkelse af endometriet, der varer ved, efter at menstruationerne er vendt tilbage i behandlingsfrie perioder eller 3 måneder efter afslutningen af behandlingsforløb, og/eller der observeres et ændret blødningsmønster (se punktet ”Blødningsmønster” nedenfor), bør der udføres en undersøgelse, herunder endometriebiopsi, for at udelukke andre underliggende sygdomme, herunder endometriemalignitet.
English: swelling of face, tongue or throat; difficulty swallowing; hives and breathing difficulties.
Danish: - hævelse af ansigt, tunge eller svælg, synkebesvær, nældefeber og vejrtrækningsbesvær.
English: These changes should not be confused with endometrial hyperplasia.
Danish: Disse ændringer forsvinder efter seponering af behandlingen og må ikke forveksles med endometriehyperplasi.
English: - Medicines used to treat certain bacterial infections (e.g. rifampicin, telithromycin,
Danish: - Lægemidler mod visse bakterieinfektioner (f.eks. rifampicin, telithromycin, clarithromycin,
English: Therefore, do not breast-feed your baby while taking Esmya.
Danish: Du må derfor ikke amme dit barn, når du tager Esmya.
English: Name and address of the manufacturers responsible for batch release
Danish: Navn og adresse på fremstilleren (fremstillerne) ansvarlig(e) for batchfrigivelse
English: What you need to know before you take Esmya
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE ESMYA
English: Ovarian cyst ruptured* Breast swelling
Danish: Ruptur af ovariecyste* Hævelse af bryst
English: • darkening of the urine
Danish: • mørkfarvet urin
English: • in addition, liver testing should be performed within 2-4 weeks after treatment has stopped.
Danish: • der skal desuden udføres levertest 2-4 uger efter afbrydelse af behandlingen.
English: Although a majority of women taking a therapeutic dose of ulipristal acetate have anovulation, a non hormonal contraceptive method is recommended during treatment (see sections 4.4 and 4.5).
Danish: Selvom de fleste kvinder, som tager en terapeutisk dosis ulipristalacetat, har anovulation, anbefales en kontraceptionsmetode uden hormoner i forbindelse med behandlingen (se pkt.
English: If endometrial thickening is noted, which persists after return of menstruations during off-treatment periods or beyond 3 months following the end of treatment courses, and/or an altered bleeding pattern is noted, investigation including endometrial biopsy should be performed in order to exclude other underlying conditions, including endometrial malignancy.
Danish: Hvis der oberveres fortykkelse af endometriet, der varer ved, efter at menstruationerne er vendt tilbage i behandlingsfrie perioder eller 3 måneder efter afslutningen af behandlingsforløb, og/eller der observeres et ændret blødningsmønster, skal der foretages en undersøgelse, herunder endometriebiopsi, for at udelukke andre underliggende sygdomme, herunder endometriemalignitet.
English: In addition liver testing should be performed 2- 4 weeks after treatment has stopped.
Danish: Der skal desuden udføres levertest 2- 4 uger efter ophør af behandlingen.
English: Drug hypersensitivity
Danish: Medicinoverfølsomhed
English: The recommended dose is one 5 mg tablet per day, for treatment courses of up to 3 months each..
Danish: Den sædvanlige dosis er én 5 mg tablet om dagen i behandlingsforløb på op til 3 måneder.
English: • Educational material for prescribers (gynaecologists) which contains: o Cover letter o SmPC o Physician's guide to prescribing Esmya
Danish: • Informationsmateriale til ordinerende læger (gynækologer), der indeholder: o Følgeskrivelse o Produktresumé o Lægevejledning vedr.
English: 5 mg/day N=213
Danish: 5 mg/dag N=213
English: Esmya may cause mild dizziness (see section 4 “Possible side effects”).
Danish: Esmya kan forårsage let svimmelhed (se pkt.
English: • fatigue, severe tiredness
Danish: • ekstrem træthed
English: Esmya 5 mg tablets Ulipristal acetate
Danish: Esmya 5 mg tabletter Ulipristalacetat
English: 5 mg/day N=178
Danish: 5 mg/dag N=178
English: Musculoskeletal pain
Danish: Muskuloskelet ale smerter
English: Among these 1,053 women, the safety of repeated intermittent treatment courses (each limited to 3 months) has been evaluated in 551 women with uterine fibroids treated with 5 or 10 mg ulipristal acetate in two phase III studies (including 446 women exposed to four intermittent treatment courses of whom 53 were exposed to eight intermittent treatment courses) and demonstrated a similar safety profile to that observed for one treatment course.
Danish: Blandt disse 1.053 kvinder blev sikkerheden af gentagne intermitterende behandlingsforløb (hver især begrænset til 3 måneder) evalueret hos 551 kvinder med uterusfibromer i to fase III-studier (inkl.
English: - Certain medicines used to treat hypertension (e.g. verapamil).
Danish: - Visse lægemidler mod for højt blodtryk (f.eks. verapamil).
English: 10 mg/day N=176
Danish: 10 mg/dag N=176
English: 10 mg/day N=132
Danish: 10 mg/dag N=132
English: How to take Esmya
Danish: Sådan skal du tage Esmya
English: In addition, an additional check of your liver 2-4 weeks after your treatment has stopped should be done.
Danish: Desuden bør leverfunktionen kontrolleres 2-4 uger efter, at behandlingen er ophørt.
English: Hot flush* Pelvic pain Ovarian cyst* Breast tenderness/pain
Danish: Ovariecyste* Brystømhed/smerter
English: Ulipristal acetate 10 mg/day N=94
Danish: Ulipristalacetat 10 mg/dag N=94
English: Anxiety Emotional disorder
Danish: Følelsesmæssig forstyrrelse
English: 2nd TEST (4 weeks after starting treatment) 3rd TEST (8 weeks after starting treatment) 4th TEST (12 weeks after starting treatment) 5th TEST (2- 4 weeks after stopping Esmya treatment)
Danish: BLODPRØVE (12 uger efter behandlingsstart) 5.
English: 10 mg/day N=207
Danish: 10 mg/dag N=207
English: 10 mg/day N=107
Danish: 10 mg/dag N=107
English: Following administration of the moderate CYP3A4 inhibitor erythromycin propionate (500 mg twice daily for 9 days) to healthy female volunteers, Cmax and AUC of ulipristal acetate increased 1.2 and 2.9 fold, respectively; the AUC of the active metabolite of ulipristal acetate increased 1.5 fold while the Cmax of the active metabolite decreased (0.52 fold change).
Danish: Efter administration af den moderate CYP3A4-hæmmer erythromycinpropionat (500 mg to gange dagligt i 9 dage) til raske kvindelige forsøgspersoner steg Cmax og AUC for ulipristalacetat henholdsvis 1,2 og 2,9 gange.
English: Ulipristal acetate 5 mg/day N=93
Danish: Ulipristalacetat 5 mg/dag N=93
English: • nausea (feeling sick)
Danish: Hovedpine* Svimmelhed
English: Rare (may affect up to 1 in 1,000 people) side effects: - nosebleed - indigestion, bloating - break of sac of fluid within the ovaries (ovarian cyst ruptured) - breast swelling.
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer): - Næseblødning.
English: Ulipristal acetate is contraindicated during breastfeeding (see sections 4.3 and 5.2).
Danish: Ulipristalacetat er kontraindiceret under amning (se pkt.
English: Pituitary
Danish: Dosering
English: Following administration of the potent CYP3A4 inhibitor ketoconazole (400 mg once daily for 7 days) to healthy female volunteers, Cmax and AUC of ulipristal acetate increased 2 and 5.9 fold, respectively; the AUC of the active metabolite of ulipristal acetate increased 2.4 fold while the Cmax of the active metabolite decreased (0.53 fold change).
Danish: Efter administration af den potente CYP3A4-hæmmer ketoconazol (400 mg en gang dagligt i 7 dage) til raske kvindelige forsøgspersoner steg Cmax og AUC for ulipristalacetat henholdsvis 2 og 5,9 gange.
English: Patients in amenorrhea at week 13
Danish: Median ændring i myomvolumen fra baseline til uge 13
English: Uterine haemorrhage
Danish: Nyrer og urinveje
English: Underlying hepatic disorder.
Danish: - Humørsvingninger.
English: Menstrual bleeding
Danish: Menstruationsblødning
English: Ulipristal acetate 5 mg/day N=95
Danish: Ulipristalacetat 5 mg/dag N=95
English: Endometrial thickening
Danish: Fortykket endometrium
English: Ulipristal acetate has a specific pharmacodynamic action on the endometrium: Changes in the histology of the endometrium may be observed in patients treated with ulipristal acetate.
Danish: Ændringer i endometriets histologi kan ses hos patienter, som behandles med ulipristalacetat.
English: - Certain medicines used to prevent strokes and blood clots (e.g. dabigatran etexilate).
Danish: - Visse lægemidler, der bruges for at forebygge slagtilfælde og blodpropper (f.eks.
English: Ulipristal acetate 10 mg/day N=95
Danish: Ulipristalacetat 10 mg/dag N=95
English: What Esmya is and what it is used for What you need to know before you take Esmya How to take Esmya
Danish: Det skal du vide, før du begynder at tage Esmya Sådan skal du tage Esmya Bivirkninger
English: Keep this medicine out of the sight and reach of children.
Danish: Opbevar dette lægemiddel utilgængeligt for børn
English: How to store Esmya
Danish: ordinering af Esmya
English: Hepatic injury
Danish: Leversygdom.
English: Common (may affect up to 1 in 10 people) side effects: - headache - spinning sensation (vertigo) - stomach ache, feeling sick (nausea) - acne - muscle and bone (musculoskeletal) pain - sac of fluid within the ovaries (ovarian cyst), breast tenderness/pain, lower abdominal (pelvic)
Danish: Væskefyldt blære på æggestokkene (ovariecyste), brystømhed/-smerter, bækkensmerter, hedeture.
English: Renal impairment
Danish: Træthed Ødem Asteni
English: Posology
Danish: ordinering
English: Talk to your doctor.
Danish: Tal med din læge.
English: Results at 208 weeks
Danish: Resultater ved 208 uger
English: Take care not to infect other people
Danish: Pas på, du ikke smitter andre mennesker
English: Effect of food on oral absorption
Danish: Virkning af mad på oral absorption
English: < 30 (not requiring dialysis)
Danish: <30 (kræver ikke dialyse)
English: The next dose should be taken at the usual time.
Danish: Den næste dosis skal tages til sædvanlig tid.
English: This medicine is intended for long-term treatment, possibly lasting for months or years.
Danish: Denne medicin er beregnet til langtidsbehandling, muligvis varende i måneder eller år.
English: • Risk Management plan (RMP)
Danish: • Risikostyringsplan (RMP)
English: These mutations most likely are compensatory mutations.
Danish: Disse mutationer er sandsynligvis kompensatoriske mutationer.
English: Date of first authorisation: 24 April 2007 Date of latest renewal: 16 December 2016
Danish: Dato for første markedsføringstilladelse: 24. april 2007 Dato for seneste fornyelse: 16. december 2016
English: - if you have had a liver transplant.
Danish: - hvis du har fået en levertransplantation.
English: The primary data analysis was conducted after all patients had reached week 52.
Danish: Den primære dataanalyse blev udført, efter at alle patienter havde nået uge 52.
English: Sebivo may also cause other side effects:
Danish: Sebivo kan også give følgende andre bivirkninger:
English: Your doctor will decide which treatment is most appropriate for you.
Danish: Din læge vil bestemme hvilken behandling, der er bedst for dig.
English: The clinical significance of these reductions has not been determined.
Danish: Den kliniske betydning af disse reduktioner er ikke bestemt.
English: Please read these instructions carefully so that you know how to use the solution correctly.
Danish: Læs disse instruktioner omhyggeligt, så du ved, hvordan du bruger opløsningen korrekt.
English: Other side effects of this type of medicine
Danish: Andre bivirkninger af denne type medicin
English: No novel mutation was reported.
Danish: Ingen nye mutationer blev rapporteret.
English: Week 52 Week 104 Week 156 Week 208
Danish: Uge 52 Uge 104 Uge 156 Uge 208
English: If any of these symptoms are reported, a detailed muscle examination should be performed in order to evaluate muscle function.
Danish: Hvis nogle af disse symptomer er rapporteret, skal der udføres en grundig muskelundersøgelse for at vurdere muskelfunktionen.
English: The combination of telbivudine with these medicinal products should be used with caution.
Danish: En kombination af telbivudin og disse lægemidler bør anvendes med forsigtighed.
English: This effect was considered to be secondary to maternal toxicity.
Danish: Denne virkning blev anset for at være sekundær til maternel toksicitet.
English: Nonetheless, there have also been reports of severe - and sometimes fatal - post-treatment disease exacerbations.
Danish: Ikke desto mindre er der også indberettet svære - og undertiden fatale - sygdoms-eksacerbationer efter behandlingen.
English: Never share needles.
Danish: Del aldrig kanyler.
English: Telbivudine did not show any carcinogenic potential.
Danish: Telbivudin viste intet karcinogent potentiale.
English: The most common HBV genotypes were B (26%) and C (51%).
Danish: De mest almindelige HBV-genotyper var b (26 %) og c (51 %).
English: See section 5.1 for details of the study and specific patient characteristics on which this indication is based.
Danish: 5.1 for detaljer om den kliniske undersøgelse og de specifikke patientkarakteristika, som denne indikation er baseret på.
English: Continue taking Sebivo every day for as long as your doctor tells you.
Danish: Bliv ved med at tage Sebivo hver dag så længe din læge siger det.
English: Treatment discontinuation should be considered as follows:
Danish: Behandlingsophør skal overvejes i følgende situationer:
English: Some people may get very serious hepatitis symptoms when they stop taking medicines like Sebivo.
Danish: Nogle mennesker kan få meget alvorlige hepatitis-symptomer, når de stopper med at tage medicin som Sebivo.
English: The median treatment duration was 104 weeks.
Danish: Den gennemsnitlige behandlingsvarighd var 104 uger.
English: Use within 2 months of opening the bottle.
Danish: Skal anvendes inden 2 måneder efter, at flasken er åbnet.
English: A small number (total of 98) of Caucasian patients were treated with telbivudine.
Danish: Et lille antal (totalt 98) kaukasiske patienter blev behandlet med telbivudin.
English: Patients should be followed closely.
Danish: Patienterne bør følges nøje.
English: The overall safety profile from the pooled analysis up to 104 and 208 weeks was similar.
Danish: Den totale sikkerhedsprofil fra den samlede analyse op til 104 og 208 uger var ens.
English: Metabolism and nutrition disorders Rare*
Danish: Metabolisme og ernæring Sjælden*
English: Duration of therapy The optimal treatment duration is unknown.
Danish: Behandlingsvarighed Den optimale behandlingsvarighed er ikke kendt.
English: In vitro binding of telbivudine to human plasma proteins is low (3.3%).
Danish: In vitro-bindingen af telbivudin til humane plasmaproteiner er lav (3,3 %).
English: - If you have hepatitis B and become pregnant, talk to your doctor about how you can best protect your baby.
Danish: - Hvis du har haft hepatitis B og bliver gravid, skal du tale med lægen om, hvordan du bedst beskytter barnet.
English: Predictability at week 24
Danish: Forudsigelighed ved uge 24
English: Take the tablet at about the same time each day.
Danish: Tag tabletten på nogenlunde samme tid hver dag.
English: If you feel dizzy while taking this medicine, do not drive a vehicle or use any tools or machines.
Danish: Hvis du føler dig svimmel, når du tager dette lægemiddel, skal du ikke køre bil eller bruge værktøj eller maskiner.
English: Such patients should, therefore, be closely monitored.
Danish: Sådanne patienter skal derfor monitoreres tæt.
English: Do not change your dose or stop taking Sebivo without talking to your doctor.
Danish: Lad være med at ændre dosis eller at holde op med at tage Sebivo uden at tale med din læge.
English: HBV DNA should be monitored every 6 months to assure continued response.
Danish: HBV-DNA bør monitoreres hver 6. måned for at sikre vedvarende respons.
English: Therefore, the potential for CYP450-mediated drug interactions involving Sebivo is low.
Danish: Potentialet for CYP450-medierede lægemiddelinteraktioner, der involverer Sebivo, er derfor lille.
English: Also contains sodium.
Danish: Indeholder også natrium.
English: No metabolites of telbivudine were detected following administration of
Danish: Der blev ikke detekteret metabolitter af telbivudin efter administration af
English: The proposed dose modifications are based on extrapolation and may not be optimal.
Danish: De foreslåede dosismodifikationer er baseret på ekstrapolation, og det er derfor ikke sikkert, de er optimale.
English: In the event of an overdose, Sebivo should be discontinued and appropriate general supportive treatment applied as necessary.
Danish: I tilfælde af en overdosering skal Sebivo seponeres, og der skal gives passende generel støttebehandling efter behov.
English: Your doctor will discuss with you the potential risks of taking Sebivo during pregnancy.
Danish: Din læge vil drøfte de mulige risici ved at tage Sebivo under graviditet med dig.
English: Tested doses up to 1,800 mg/day, three times greater than the recommended daily dose, have been well tolerated.
Danish: Testede doser op til 1.800 mg/dag, 3 gange højere end den anbefalede daglige dosis, er blevet tålt godt.
English: Do not pour it back into the bottle.
Danish: Du må ikke hælde det tilbage i flasken.
English: If patients test positive for HBV DNA at any time after their initial response, treatment modification should be considered.
Danish: Hvis patienter testes positive for HBV-DNA til enhver tid efter den initiale respons, bør ændring af behandling overvejes.
English: Monitoring during treatment
Danish: Monitorering under behandling
English: It is efficiently phosphorylated by cellular kinases to the active triphosphate form, which has an intracellular half-life of 14 hours.
Danish: Det fosforyleres effektivt af cellulære kinaser til den aktive trifosfatform, som har en intracellulær halveringstid på 14 timer.
English: A vaccine is available to prevent infection with HBV.
Danish: Der kan fås en vaccine til forebyggelse af infektion med HBV.
English: Due to the limited data available (about 3% of patients enrolled had cirrhosis), telbivudine should be used with particular caution in cirrhotic patients.
Danish: Da der kun er begrænsede data tilgængelige (ca. 3 % af de inkluderede patienter havde cirrose), skal telbivudin anvendes med særlig forsigtighed hos patienter med cirrose.
English: Take Sebivo at about the same time each day.
Danish: Tag Sebivo på nogenlunde samme tid hver dag.
English: Missed doses
Danish: Glemt dosis
English: Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Danish: Din læge vil undersøge din tilstand regelmæssigt for at kontrollere at behandlingen har den ønskede virkning.
English: There are currently no efficacy and safety data for other antiviral combinations with telbivudine.
Danish: Der er på nuværende tidspunkt ingen effekt- og sikkerhedsdata for andre antivirale kombinationer med telbivudin.
English: Fertility was assessed in conventional studies performed in adult rats, and as part of a juvenile toxicology study.
Danish: Fertilitet blev vurderet i konventionelle undersøgelser udført på voksne rotter og som en del af en toksikologiundersøgelse i unge dyr.
English: Tell your doctor or pharmacist if you are being treated with interferon.
Danish: Fortæl det til din læge eller på apoteket, hvis du bliver behandlet med interferon.
English: The frequency category was estimated from a statistical calculation based on the total number of patients exposed to telbivudine in clinical trials (n = 8,914).
Danish: Frekvenskategorien blev estimeret ud fra en statistisk beregning baseret på det totale antal patienter eksponeret over for telbivudin i kliniske studier (n=8.914).
English: With prolonged treatment for more than 2 years, regular reassessment is recommended to confirm that continuation of the selected therapy remains appropriate for the patient.
Danish: Hvis behandlingen forlænges i mere end 2 år, anbefales det at udføre regelmæssige revurderinger for at få bekræftet, at det er hensigtsmæssigt at fortsætte den valgte behandling for patienten.
English: Studies in pregnant rats and rabbits showed that telbivudine crosses the placenta.
Danish: Studier med drægtige rotter og kaniner viste, at telbivudin passerer placenta.
English: Sebivo should be used during pregnancy only if the benefit to the mother outweighs the potential risk to the foetus.
Danish: Sebivo bør kun anvendes under graviditet, hvis fordelen for moderen opvejer den potentielle risiko for fostret.
English: Titanium dioxide (E171) Macrogol
Danish: Titandioxid (E171) Macrogol Talcum
English: Drink the solution or administer it to the patient immediately.
Danish: Drik opløsningen eller giv den straks til patienten.
English: Clinical results at week 104
Danish: Kliniske resultater ved uge 104
English: Sebivo oral solution may be considered for patients who have difficulties swallowing tablets.
Danish: Sebivo oral opløsning kan overvejes til patienter, der har svært ved at sluge tabletter.