natgillin/translations-raw huggingface dataset:
Esmya indeholder: - Aktivt stof: Ulipristalacetat.
What Esmya contains - The active substance is ulipristal acetate.
Fortykkelse af endometriet forsvinder, når behandlingen afbrydes, og menstruationen starter igen.
The endometrial thickening reverses when treatment is stopped and menstrual periods resume.
En tablet indeholder 5 mg ulipristalacetat.
One tablet contains 5 mg of ulipristal acetate.
Patienter med amenorré i uge 13 Patienter, hvis menstruationsblødning blev normal (PBAC < 75) i uge 13
Patients whose menstrual bleeding became normal (PBAC < 75) at week 13 Median change in myoma volume from baseline to week 13
Uterinblødning* Metrorragi Genitalt udflåd Brystgener
Uterine haemorrhage* Metrorrhagia Genital discharge Breast discomfort
Disse ændringer forsvinder, efter at behandlingen er stoppet, og din menstruation starter igen.
These changes return to normal after treatment is stopped and your periods restart.
Ikke desto mindre skal du spørge lægen eller apoteket til råds, hvis du tager for meget Esmya.
You should nonetheless ask your doctor or pharmacist for advice if you take more Esmya than you should.
• dosering: 5 mg tablet 1 gang dagligt i behandlingsforløb på op til 3 måneder.
• the posology: 5 mg tablet once daily for treatment courses of up to 3 months each.
Der blev ikke observeret noget teratogent potentiale ved doser, der var lave nok til at fastholde drægtighed hos dyr.
At doses which were low enough to maintain gestation in the animal species, no teratogenic potential was observed.
Derfor anbefales samtidig administration af lægemidler med gestagen ikke (se pkt.
Therefore concomitant administration of medicinal products containing progestagen is not recommended (see section 4.4 and 4.6).
Livmoder-, livmoderhals-, brystkræft og kræft i æggestokkene.
Uterine, cervical, ovarian or breast cancer.
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.
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.
- hævelse af ansigt, tunge eller svælg, synkebesvær, nældefeber og vejrtrækningsbesvær.
swelling of face, tongue or throat; difficulty swallowing; hives and breathing difficulties.
Disse ændringer forsvinder efter seponering af behandlingen og må ikke forveksles med endometriehyperplasi.
These changes should not be confused with endometrial hyperplasia.
- Lægemidler mod visse bakterieinfektioner (f.eks. rifampicin, telithromycin, clarithromycin,
- Medicines used to treat certain bacterial infections (e.g. rifampicin, telithromycin,
Du må derfor ikke amme dit barn, når du tager Esmya.
Therefore, do not breast-feed your baby while taking Esmya.
Navn og adresse på fremstilleren (fremstillerne) ansvarlig(e) for batchfrigivelse
Name and address of the manufacturers responsible for batch release
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE ESMYA
What you need to know before you take Esmya
Ruptur af ovariecyste* Hævelse af bryst
Ovarian cyst ruptured* Breast swelling
• mørkfarvet urin
• darkening of the urine
• der skal desuden udføres levertest 2-4 uger efter afbrydelse af behandlingen.
• in addition, liver testing should be performed within 2-4 weeks after treatment has stopped.
Selvom de fleste kvinder, som tager en terapeutisk dosis ulipristalacetat, har anovulation, anbefales en kontraceptionsmetode uden hormoner i forbindelse med behandlingen (se pkt.
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).
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.
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.
Der skal desuden udføres levertest 2- 4 uger efter ophør af behandlingen.
In addition liver testing should be performed 2- 4 weeks after treatment has stopped.
Medicinoverfølsomhed
Drug hypersensitivity
Den sædvanlige dosis er én 5 mg tablet om dagen i behandlingsforløb på op til 3 måneder.
The recommended dose is one 5 mg tablet per day, for treatment courses of up to 3 months each..
• Informationsmateriale til ordinerende læger (gynækologer), der indeholder: o Følgeskrivelse o Produktresumé o Lægevejledning vedr.
• Educational material for prescribers (gynaecologists) which contains: o Cover letter o SmPC o Physician's guide to prescribing Esmya
5 mg/dag N=213
5 mg/day N=213
Esmya kan forårsage let svimmelhed (se pkt.
Esmya may cause mild dizziness (see section 4 “Possible side effects”).
• ekstrem træthed
• fatigue, severe tiredness
Esmya 5 mg tabletter Ulipristalacetat
Esmya 5 mg tablets Ulipristal acetate
5 mg/dag N=178
5 mg/day N=178
Muskuloskelet ale smerter
Musculoskeletal pain
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.
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.
- Visse lægemidler mod for højt blodtryk (f.eks. verapamil).
- Certain medicines used to treat hypertension (e.g. verapamil).
10 mg/dag N=176
10 mg/day N=176
10 mg/dag N=132
10 mg/day N=132
Sådan skal du tage Esmya
How to take Esmya
Desuden bør leverfunktionen kontrolleres 2-4 uger efter, at behandlingen er ophørt.
In addition, an additional check of your liver 2-4 weeks after your treatment has stopped should be done.
Ovariecyste* Brystømhed/smerter
Hot flush* Pelvic pain Ovarian cyst* Breast tenderness/pain
Ulipristalacetat 10 mg/dag N=94
Ulipristal acetate 10 mg/day N=94
Følelsesmæssig forstyrrelse
Anxiety Emotional disorder
BLODPRØVE (12 uger efter behandlingsstart) 5.
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)
10 mg/dag N=207
10 mg/day N=207
10 mg/dag N=107
10 mg/day N=107
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.
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).
Ulipristalacetat 5 mg/dag N=93
Ulipristal acetate 5 mg/day N=93
Hovedpine* Svimmelhed
• nausea (feeling sick)
Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer): - Næseblødning.
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.
Ulipristalacetat er kontraindiceret under amning (se pkt.
Ulipristal acetate is contraindicated during breastfeeding (see sections 4.3 and 5.2).
Dosering
Pituitary
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.
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).
Median ændring i myomvolumen fra baseline til uge 13
Patients in amenorrhea at week 13
Nyrer og urinveje
Uterine haemorrhage
- Humørsvingninger.
Underlying hepatic disorder.
Menstruationsblødning
Menstrual bleeding
Ulipristalacetat 5 mg/dag N=95
Ulipristal acetate 5 mg/day N=95
Fortykket endometrium
Endometrial thickening
Ændringer i endometriets histologi kan ses hos patienter, som behandles med ulipristalacetat.
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.
- Visse lægemidler, der bruges for at forebygge slagtilfælde og blodpropper (f.eks.
- Certain medicines used to prevent strokes and blood clots (e.g. dabigatran etexilate).
Ulipristalacetat 10 mg/dag N=95
Ulipristal acetate 10 mg/day N=95
Det skal du vide, før du begynder at tage Esmya Sådan skal du tage Esmya Bivirkninger
What Esmya is and what it is used for What you need to know before you take Esmya How to take Esmya
Opbevar dette lægemiddel utilgængeligt for børn
Keep this medicine out of the sight and reach of children.
ordinering af Esmya
How to store Esmya
Leversygdom.
Hepatic injury
Væskefyldt blære på æggestokkene (ovariecyste), brystømhed/-smerter, bækkensmerter, hedeture.
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)
Træthed Ødem Asteni
Renal impairment
ordinering
Posology
Tal med din læge.
Talk to your doctor.
Resultater ved 208 uger
Results at 208 weeks
Pas på, du ikke smitter andre mennesker
Take care not to infect other people
Virkning af mad på oral absorption
Effect of food on oral absorption
<30 (kræver ikke dialyse)
< 30 (not requiring dialysis)
Den næste dosis skal tages til sædvanlig tid.
The next dose should be taken at the usual time.
Denne medicin er beregnet til langtidsbehandling, muligvis varende i måneder eller år.
This medicine is intended for long-term treatment, possibly lasting for months or years.
• Risikostyringsplan (RMP)
• Risk Management plan (RMP)
Disse mutationer er sandsynligvis kompensatoriske mutationer.
These mutations most likely are compensatory mutations.
Dato for første markedsføringstilladelse: 24. april 2007 Dato for seneste fornyelse: 16. december 2016
Date of first authorisation: 24 April 2007 Date of latest renewal: 16 December 2016
- hvis du har fået en levertransplantation.
- if you have had a liver transplant.
Den primære dataanalyse blev udført, efter at alle patienter havde nået uge 52.
The primary data analysis was conducted after all patients had reached week 52.
Sebivo kan også give følgende andre bivirkninger:
Sebivo may also cause other side effects:
Din læge vil bestemme hvilken behandling, der er bedst for dig.
Your doctor will decide which treatment is most appropriate for you.
Den kliniske betydning af disse reduktioner er ikke bestemt.
The clinical significance of these reductions has not been determined.
Læs disse instruktioner omhyggeligt, så du ved, hvordan du bruger opløsningen korrekt.
Please read these instructions carefully so that you know how to use the solution correctly.
Andre bivirkninger af denne type medicin
Other side effects of this type of medicine
Ingen nye mutationer blev rapporteret.
No novel mutation was reported.
Uge 52 Uge 104 Uge 156 Uge 208
Week 52 Week 104 Week 156 Week 208
Hvis nogle af disse symptomer er rapporteret, skal der udføres en grundig muskelundersøgelse for at vurdere muskelfunktionen.
If any of these symptoms are reported, a detailed muscle examination should be performed in order to evaluate muscle function.
En kombination af telbivudin og disse lægemidler bør anvendes med forsigtighed.
The combination of telbivudine with these medicinal products should be used with caution.
Denne virkning blev anset for at være sekundær til maternel toksicitet.
This effect was considered to be secondary to maternal toxicity.
Ikke desto mindre er der også indberettet svære - og undertiden fatale - sygdoms-eksacerbationer efter behandlingen.
Nonetheless, there have also been reports of severe - and sometimes fatal - post-treatment disease exacerbations.
Del aldrig kanyler.
Never share needles.
Telbivudin viste intet karcinogent potentiale.
Telbivudine did not show any carcinogenic potential.
De mest almindelige HBV-genotyper var b (26 %) og c (51 %).
The most common HBV genotypes were B (26%) and C (51%).
5.1 for detaljer om den kliniske undersøgelse og de specifikke patientkarakteristika, som denne indikation er baseret på.
See section 5.1 for details of the study and specific patient characteristics on which this indication is based.
Bliv ved med at tage Sebivo hver dag så længe din læge siger det.
Continue taking Sebivo every day for as long as your doctor tells you.
Behandlingsophør skal overvejes i følgende situationer:
Treatment discontinuation should be considered as follows:
Nogle mennesker kan få meget alvorlige hepatitis-symptomer, når de stopper med at tage medicin som Sebivo.
Some people may get very serious hepatitis symptoms when they stop taking medicines like Sebivo.
Den gennemsnitlige behandlingsvarighd var 104 uger.
The median treatment duration was 104 weeks.
Skal anvendes inden 2 måneder efter, at flasken er åbnet.
Use within 2 months of opening the bottle.
Et lille antal (totalt 98) kaukasiske patienter blev behandlet med telbivudin.
A small number (total of 98) of Caucasian patients were treated with telbivudine.
Patienterne bør følges nøje.
Patients should be followed closely.
Den totale sikkerhedsprofil fra den samlede analyse op til 104 og 208 uger var ens.
The overall safety profile from the pooled analysis up to 104 and 208 weeks was similar.
Metabolisme og ernæring Sjælden*
Metabolism and nutrition disorders Rare*
Behandlingsvarighed Den optimale behandlingsvarighed er ikke kendt.
Duration of therapy The optimal treatment duration is unknown.
In vitro-bindingen af telbivudin til humane plasmaproteiner er lav (3,3 %).
In vitro binding of telbivudine to human plasma proteins is low (3.3%).
- Hvis du har haft hepatitis B og bliver gravid, skal du tale med lægen om, hvordan du bedst beskytter barnet.
- If you have hepatitis B and become pregnant, talk to your doctor about how you can best protect your baby.
Forudsigelighed ved uge 24
Predictability at week 24
Tag tabletten på nogenlunde samme tid hver dag.
Take the tablet at about the same time each day.
Hvis du føler dig svimmel, når du tager dette lægemiddel, skal du ikke køre bil eller bruge værktøj eller maskiner.
If you feel dizzy while taking this medicine, do not drive a vehicle or use any tools or machines.
Sådanne patienter skal derfor monitoreres tæt.
Such patients should, therefore, be closely monitored.
Lad være med at ændre dosis eller at holde op med at tage Sebivo uden at tale med din læge.
Do not change your dose or stop taking Sebivo without talking to your doctor.
HBV-DNA bør monitoreres hver 6. måned for at sikre vedvarende respons.
HBV DNA should be monitored every 6 months to assure continued response.
Potentialet for CYP450-medierede lægemiddelinteraktioner, der involverer Sebivo, er derfor lille.
Therefore, the potential for CYP450-mediated drug interactions involving Sebivo is low.
Indeholder også natrium.
Also contains sodium.
Der blev ikke detekteret metabolitter af telbivudin efter administration af
No metabolites of telbivudine were detected following administration of
De foreslåede dosismodifikationer er baseret på ekstrapolation, og det er derfor ikke sikkert, de er optimale.
The proposed dose modifications are based on extrapolation and may not be optimal.
I tilfælde af en overdosering skal Sebivo seponeres, og der skal gives passende generel støttebehandling efter behov.
In the event of an overdose, Sebivo should be discontinued and appropriate general supportive treatment applied as necessary.
Din læge vil drøfte de mulige risici ved at tage Sebivo under graviditet med dig.
Your doctor will discuss with you the potential risks of taking Sebivo during pregnancy.
Testede doser op til 1.800 mg/dag, 3 gange højere end den anbefalede daglige dosis, er blevet tålt godt.
Tested doses up to 1,800 mg/day, three times greater than the recommended daily dose, have been well tolerated.
Du må ikke hælde det tilbage i flasken.
Do not pour it back into the bottle.
Hvis patienter testes positive for HBV-DNA til enhver tid efter den initiale respons, bør ændring af behandling overvejes.
If patients test positive for HBV DNA at any time after their initial response, treatment modification should be considered.
Monitorering under behandling
Monitoring during treatment
Det fosforyleres effektivt af cellulære kinaser til den aktive trifosfatform, som har en intracellulær halveringstid på 14 timer.
It is efficiently phosphorylated by cellular kinases to the active triphosphate form, which has an intracellular half-life of 14 hours.
Der kan fås en vaccine til forebyggelse af infektion med HBV.
A vaccine is available to prevent infection with HBV.
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.
Due to the limited data available (about 3% of patients enrolled had cirrhosis), telbivudine should be used with particular caution in cirrhotic patients.
Tag Sebivo på nogenlunde samme tid hver dag.
Take Sebivo at about the same time each day.
Glemt dosis
Missed doses
Din læge vil undersøge din tilstand regelmæssigt for at kontrollere at behandlingen har den ønskede virkning.
Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Der er på nuværende tidspunkt ingen effekt- og sikkerhedsdata for andre antivirale kombinationer med telbivudin.
There are currently no efficacy and safety data for other antiviral combinations with telbivudine.
Fertilitet blev vurderet i konventionelle undersøgelser udført på voksne rotter og som en del af en toksikologiundersøgelse i unge dyr.
Fertility was assessed in conventional studies performed in adult rats, and as part of a juvenile toxicology study.
Fortæl det til din læge eller på apoteket, hvis du bliver behandlet med interferon.
Tell your doctor or pharmacist if you are being treated with interferon.
Frekvenskategorien blev estimeret ud fra en statistisk beregning baseret på det totale antal patienter eksponeret over for telbivudin i kliniske studier (n=8.914).
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).
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.
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.
Studier med drægtige rotter og kaniner viste, at telbivudin passerer placenta.
Studies in pregnant rats and rabbits showed that telbivudine crosses the placenta.
Sebivo bør kun anvendes under graviditet, hvis fordelen for moderen opvejer den potentielle risiko for fostret.
Sebivo should be used during pregnancy only if the benefit to the mother outweighs the potential risk to the foetus.
Titandioxid (E171) Macrogol Talcum
Titanium dioxide (E171) Macrogol
Drik opløsningen eller giv den straks til patienten.
Drink the solution or administer it to the patient immediately.
Kliniske resultater ved uge 104
Clinical results at week 104
Sebivo oral opløsning kan overvejes til patienter, der har svært ved at sluge tabletter.
Sebivo oral solution may be considered for patients who have difficulties swallowing tablets.
Optimal behandling bør kontrolleres ved test for resistens.
Optimal therapy should be guided by resistance testing.
Den maksimalt tolererede dosis for telbivudin er ikke fastsat.
A maximum tolerated dose of telbivudine has not been determined.
Flaske, der indeholder den orale opløsning.
Bottle containing the oral solution.
Vær ikke fælles om personlige ting, som kunne have blod eller legemsvæsker på sig, såsom tandbørster eller barberblade.
Do not share personal items that could have blood or body fluids on them, such as toothbrushes or razor blades.
Kliniske studier af telbivudin omfattede ikke et tilstrækkeligt antal patienter ≥65 år til at afgøre, om denne patientgruppe responderer anderledes end yngre personer.
Clinical studies of telbivudine did not include sufficient numbers of patients  65 years of age to determine whether they respond differently from younger subjects.
ALAT normaliseringsrater (78 % vs. 70 %) vedblev at være højere i uge 104.
ALT normalisation rates (78% vs 70%) continued to be higher by week 104.
Studier med drægtige kaniner viste tidlig fødsel og/eller abort sekundært til maternel toksicitet.
Studies in pregnant rabbits showed early delivery and/or abortion secondary to maternal toxicity.
Mekanismen bag dette er ikke kendt (se pkt.
The mechanism behind these events is not known (see section 4.4).
Hæmodialyse (op til 4 timer) reducerer systemisk telbivudineksponering med ca. 23 %.
Haemodialysis (up to 4 hours) reduces systemic telbivudine exposure by approximately 23%.
En sådan øget risiko kan ikke udelukkes for andre interferon-alfa (pegyleret eller standard).
Such increased risk cannot be excluded for other interferon alfa (pegylated or standard).
Tabel 2 lister bivirkningerne i henhold til MedDRA organklassesystem og frekvens ved brug af følgende konvention: Meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Table 2 lists the adverse reactions according to MedDRA system organ class and frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Hæld den ikke tilbage i flasken, da dette kan forurene opløsningen.
Do not pour it back into the bottle as this could cause contamination.
Genotypemutationsmønster og krydsresistens
Genotypic mutation pattern and cross-resistance
Risikoen for leverinkompensation - og for en efterfølgende eksacerbation af hepatiten - kan være forhøjet hos patienter med cirrose.
The risk of hepatic decompensation - and of a subsequent exacerbation of hepatitis - may be elevated in patients with cirrhosis.
Patienter med tidligere eksponering for nukleosid/nukleotidanaloger
Patients with previous exposure to nucleoside/nucleotide analogues
Børn og unge Sebivo frarådes til børn og unge.
Children and adolescents Sebivo is not recommended for use in children and adolescents.
Alternativ** dosisjustering med øgede doseringsintervaller
Alternative** dose adjustment with increased dose intervals