natgillin/translations-raw huggingface dataset:
Der er indberettet tre tilfælde af alvorlig, transplantationskrævende leverskade i tidsrummet mellem udfærdigelsen af markedsføringstilladelsen for Esmya (ulipristalacetat) og november 2017.
Three cases of serious liver injury leading to a hepatic transplantation were reported between the marketing authorisation of Esmya (ulipristal acetate) and November 2017.
Behandlingen bør seponeres hos patienter, der viser tegn eller symptomer svarende til leverskade, og patienten bør straks undersøges.
Treatment should be stopped in patients showing signs or symptoms compatible with liver injury and the patient should be investigated immediately.
Særligt var hepatologerne enige om, at der i mindst 2 af de indberettede tilfælde kunne iagttages en sammenhæng med anvendelse af Esmya.
In particular, there was a consensus among hepatologists that in at least 2 cases reported, a relation with the use of Esmya could be observed.
Da den skønnede eksponering for Esmya modsvarer ca. 200 000 til 275 000 patientår, forekommer antallet af alvorlige transplantationskrævende leverskader højere end forventet, skønt baggrundsincidensen for medikamentel leverskade er usikker.
Given the estimated exposure to Esmya of approximately 200,000 to 275,000 patient-years, the number of cases of serious liver injury leading to liver transplantation appears higher than expected, although background incidence on drug induced liver injury is uncertain.
• PRAC konkluderede, at Esmya (ulipristalacetat) måske medfører risiko for alvorlig leverskade.
• The PRAC concluded that Esmya (ulipristal acetate) may carry a risk for serious liver injury.
I betragtning af de tilbageværende usikkerheder er det PRAC's opfattelse, at der bør indsamles yderligere data om Esmya og leverskade.
In the view of the remaining uncertainties, the PRAC is of the view that further data on Esmya and liver injury should be collected.
Da der ikke kunne udelukkes en mulig kausal sammenhæng mellem Esmya og akut leversvigt, har disse tilfælde foranlediget en tilbundsgående undersøgelse af denne risiko og dens indvirkning på benefit/risk-forholdet for Esmya.
Since a possible causal relationship between Esmya and acute liver failure could not be ruled out, these cases prompted an in-depth investigation of this risk and its impact on the benefit risk balance of Esmya.
PRAC var endvidere af den opfattelse, at de indberettede tilfælde af leverskader bør overvåges tæt; til dette formål indeholder den reviderede risikostyringsplan et spørgeskema med henblik på målrettet opfølgning.
The PRAC was also of the view that the reported cases of liver injury should be closely monitored; to this effect a targeted follow up questionnaire has been included in a revised risk management plan (RMP).
• PRAC var desuden af den opfattelse, at der burde udføres mekanistiske studier med henblik på yderligere undersøgelse af en mulig virkningsmekanisme for levertoksicitet.
• The PRAC was also of the opinion that mechanistic studies should be conducted, to further investigate a possible mechanism for hepatic toxicity.
De foreliggende data giver anledning til alvorlige betænkeligheder og kræver, at der træffes foranstaltninger til risikominimering.
The available data raise serious concerns, and warrant risk minimisation measures to be taken.
Det bør bemærkes, at medikamentelt induceret leverskade sædvanligvis er gradvist indsættende og opstår i løbet af 1-4 uger.
Of note, the development of drug induced liver injury generally tends to be a gradual phenomenon, developing over 1-4 weeks.
Desuden finder PRAC, at der bør implementeres advarsler vedrørende overvågnings- og stopkriterier for at identificere en leverskade uanset oprindelse, inden patienten oplever symptomer, hvorved risikoen for alvorlig skade kan mindskes.
In addition, the PRAC considers that warnings regarding monitoring and stopping criteria should be implemented, in order to identify a hepatic injury of any origin before the patient experiences symptoms, which could reduce the risk of developing serious injury.
Patienterne bør oplyse lægen om eventuelle leverproblemer, de måtte have, og bør desuden være opmærksomme på, at der skal tages leverfunktionsprøver før behandlingen, under behandlingen og efter seponering.
Patients should inform physicians on any liver problems they may have, and be also aware of the liver function monitoring tests to be performed before the treatment, during the treatment and after its discontinuation.
Disse anbefalinger bør ligeledes indgå i det eksisterende oplysningsmateriale (lægevejledningen), og der bør udsendes en direkte meddelelse til fagfolk i sundhedssektoren (DHPC), hvor de oplyses om anbefalingerne i nærværende gennemgang.
The existing educational material (physician's guide) should also be updated with these recommendations, and the issuing of a Direct Healthcare Professional Communication (DHPC) is also considered appropriate, to inform healthcare professionals of the recommendations of the present review.
• PRAC fandt det desuden nødvendigt at indføre et patientkort, der skal være indeholdt i hver pakning med Esmya, for at sikre, at patienterne informeres tilstrækkeligt om de mulige risici for leverskader og de indførte risikominimeringsforanstaltninger.
• The PRAC also found it necessary to introduce a patient card to be provided in each package of Esmya, to ensure that patients are adequately informed on the possible risks of liver injury and the implemented risk minimisation measures.
• PRAC gennemgik samtlige data vedrørende risikoen for leverskade med Esmya, som var fremlagt af indehaveren af markedsføringstilladelsen og de nationale kompetente myndigheder vedrørende tilfælde af leverskade og levertransplantation, der var indberettet siden den oprindelige markedsføringstilladelse for produktet.
• The PRAC reviewed the totality of the data regarding the risk for liver injury with Esmya provided by the marketing authorisation holder and National Competent Authorities on cases of liver injury and liver transplantation reported since the initial marketing authorisation of the product.
Uterusfibromer er den hyppigste pelvistumor hos kvinder.
Uterine fibroids are the most common female pelvic tumour.
Trods usikkerheden vedrørende baggrundsincidens og oplysningerne om de indberettede tilfælde giver de indberettede tilfældes alvorlige karakter anledning til betænkelighed.
Acknowledging the uncertainty regarding background incidence and the information in the reported cases, the seriousness of the reported cases raises concern.
Det vedgås dog, at operativ behandling ikke er velegnet til alle kvinder, enten som følge af anamnesen, komorbiditet eller patientens ønske om at bevare fertiliteten.
However, it is recognised that a surgical treatment is not suitable for all women, due to their medical history, co-morbidities or willingness to preserve fertility.
PRAC tog hensyn til alle data indgivet af indehaveren af markedsføringstilladelsen samt data fra de nationale kompetente myndigheder, herunder opfølgende oplysninger om tilfælde af levertransplantation.
PRAC considered all the data submitted by the MAH, as well as data provided by the National Competent Authorities including follow-up information on cases of liver transplantation.
På baggrund af sikkerhedsresultaterne og den mulige virkningsmekanisme var eksperterne i ad hocekspertgruppen af den opfattelse, at der er sandsynlighed for en årsagssammenhæng mellem Esmya og svær leverskade.
Based on the safety findings and possible mechanism of action, the experts of the ad hoc experts group were of the view that a causal association between Esmya and severe liver injury is plausible.
Derudover bør der udføres observationsundersøgelser til nærmere karakterisering af den hepatiske risiko og evaluering af effektiviteten af de indførte risikominimeringsforanstaltninger.
In addition, observational studies should be performed to further characterise the hepatic risk and to evaluate the effectiveness of implemented risk minimisation measures.
Udvalget anbefaler derfor ændring af betingelserne for markedsføringstilladelsen for produkter indeholdende Esmya (ulipristalacetat).
The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for Esmya (ulipristal acetate).
Esmyas udtalte reduktion af blødning og reduktion af anæmi og relaterede symptomer er påvist hurtigt at medvirke til forbedret livskvalitet hos patienter, som ikke har fået operativ behandling.
Through a pronounced reduction of bleeding, reducing anaemia and related symptoms, Esmya has been demonstrated to rapidly contribute to the improvement of the quality of life in patients who did not undertake a surgical treatment.
På ovenstående baggrund finder udvalget, at benefit/risk-forholdet for Esmya (ulipristalacetat) fortsat er positivt under forudsætning af, at der foretages de vedtagne ændringer af produktinformationen og træffes de supplerende risikominimeringsforanstaltninger.
In view of the above, the Committee considers that the benefit-risk balance of Esmya (ulipristal acetate) remains favourable subject to the agreed amendments to the product information and the additional risk minimisation measures.
• PRAC konkluderede yderligere, at Esmya bør være kontraindiceret hos patienter med underliggende leversygdom.
• The PRAC further concluded that Esmya should be contraindicated in patients with underlying hepatic disorder.
For at sikre, at beslutninger om initiering og fortsættelse af behandlingen træffes af læger, der er fortrolige med diagnosticering af uterusfibrom, anbefaler PRAC desuden, at initiering af og tilsyn med behandlingen med Esmya begrænses til læger med erfaring i diagnose og behandling af uterusfibrom.
In order to ensure that decisions on the initiation and continuation of the treatment are made by physicians who are familiar with diagnosis of uterine fibrosis, the PRAC also recommends that the initiation and supervision of treatment with Esmya should be restricted to physicians experienced in the diagnosis and treatment of uterine fibroids.
Der bør derfor udføres leverfunktionstests inden behandling med Esmya en gang om måneden under de to første behandlingsforløb samt to til fire uger efter seponering af behandlingen.
Therefore, liver function tests should be performed before starting treatment with Esmya, monthly during the first two courses of treatment as well as two to four weeks after the discontinuation of the treatment.
Idet der tages hensyn til den kliniske værdi af Esmya til den intermitterende behandlingsindikation, hvor der ikke er godkendt noget andet farmakologisk langtidsdækkende alternativ, bør denne indikation begrænses til voksne kvinder, som er i den reproduktive alder og ikke er egnede til operation.
Taking into account the clinical utility of Esmya in the intermittent treatment indication, where no other long-term pharmacological alternative is authorised, this indication should be limited to adult women of reproductive age who are not eligible for surgery.
PRAC fandt, at det i ordlyden af indikationen bør præciseres, at Esmya er beregnet til anvendelse i ét enkelt præoperativt behandlingsforløb i overensstemmelse med den nuværende dosering.
PRAC considered that it should be clarified in in the wording of the indication that in line with the current posology Esmya is to be used for a single treatment course in pre-operative setting.
I lyset af de eksisterende betænkeligheder ved nyligt indberettede tilfælde af alvorlig leverskade og i erkendelse af, at fordelen afhænger af den kliniske situation, fandt PRAC, at anvendelsen af Esmya bør begrænses.
In view of the existing concerns on recently reported cases of serious liver injury and acknowledging that the magnitude of the benefit differs for different clinical situations, the PRAC considered that the use of Esmya should be limited.
Baseret på de indberettede tilfælde af potentiel leverskade med Esmya - og forud at alle sådanne tilfælde er forårsaget af Esmya uanset årsagssammenhæng - er tiden til maksimal indsætten af leverskade ca. 140 dage, og langt størstedelen af de indberettede potentielt medikamentelt inducerede leverskader indtræder ved mellem 1 og 8 måneder (2 behandlingscyklusser inkl.
and assuming that all such cases are due to Esmya, regardless of causality, the peak time to onset of liver injury is around 140 days and the vast majority of the reported potential drug induced liver injuries occurring between 1 and 8 months (2 treatment cycles including 2 months pause).
I alle tilfælde, der er indberettet efter markedsføring, mangler der oplysninger, hvilket vanskeliggør vurdering af kausalitet, og der har derfor ikke med sikkerhed kunnet fastslås en kausal sammenhæng mellem Esmya og alvorlig leverskade.
In post marketing settings, all of the reported cases lack information hampering causality assessment, and causal relationship with Esmya and serious hepatic injury is therefore not firmly established.
Patienterne bør informeres om potentielle leverrelaterede bivirkninger, som Esmya måske kan forårsage, og om nødvendigheden af at underrette lægen om eventuelle leverproblemer, de måtte have.
Patients should be informed of potential adverse reactions related to liver that could be caused by the use of Esmya, as well as on the need to warn their physicians on any liver problems they may have.
Disse nye henstillinger erstatter den midlertidige foranstaltning, der er indebar at undlade at behandle nye patienter, som PRAC anbefalede i februar 2018.
The temporary measure recommended by the PRAC in February 2018, to not treat any new patients is superseded by these new recommendations.
Som afvejning heraf i forhold til fordelene ved Esmya til behandling af moderate til svære symptomer på uterusfibromer konkluderede PRAC, at den indicerede population bør begrænses af sikkerhedshensyn.
Balancing this to the benefits of Esmya treatment of moderate to severe symptoms of uterine fibroids, the PRAC concluded that the indicated population should be restricted for safety reasons.
Sammenfattende fandt PRAC, at benefit/risk-forholdet for Esmya fortsat var positivt, forudsat at der foretages ændringer i betingelserne for markedsføringstilladelserne.
In conclusion, the PRAC considered that the benefit-risk balance of Esmya remained favourable subject to the amendments of the terms of the marketing authorisations.
Derudover anbefalede PRAC, at der foretages leverfunktionstests før initiering af hvert behandlingsforløb med Esmya, under behandlingen samt to til fire uger efter ophør af behandlingen.
In addition, the PRAC recommended the performance of liver function tests before starting each treatment course with Esmya, during treatment as well as two to four weeks after the discontinuation of treatment.
Skønt Esmyas generelle egenskaber ikke svarer til et typisk leverskadeligt lægemiddel, konkluderede PRAC på grundlag af den aktuelle gennemgang og under hensyn til eksperternes synspunkter, at Esmya (ulipristalacetat) kan indebære risiko for alvorlig leverskade.
Although the general characteristics of Esmya do not support it to be a typical DILI causing agent, based on the current review, and taking experts views into consideration, the PRAC concluded that Esmya (ulipristal acetate) may carry a risk for serious liver injury.
Produktinformationen for Esmya indeholdt på daværende tidspunkt ingen oplysninger om hepatiske hændelser.
No information on hepatic events was at that time included in the Product Information of Esmya.
Ligesom ved vurderingen i den oprindelige markedsføringstilladelse for Esmya var den kliniske virkning af ulipristalacetat ved præoperativ behandling af moderate til svære symptomer på uterusfibromer hos voksne kvinder i den reproduktive alder baseret på kortvarige undersøgelser, der viste det aktive stofs evne til at reducere fibromrelateret blødning, anæmi og fibromstørrelse gennem administration af 5 mg dagligt i op til tre måneder.
As assessed in the initial marketing authorisation of Esmya, the clinical efficacy of ulipristal acetate in the pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age was based on short-term studies demonstrating the ability of the active substance to reduce fibroid-related bleeding, anaemia and fibroid size if administered in a daily dose of 5 mg for up to three months.
Skønt der tilbagestår usikkerheder omkring årsagssammenhængen, hæftede PRAC sig ved det meget alvorlige udfald af de indberettede tilfælde af leverskade.
While uncertainties around causality remain, PRAC recognised the very serious outcome of the reported cases of liver injury.
Derudover er der indberettet andre tilfælde af leverskader med Esmya efter markedsføring.
In addition, other cases of hepatic injury were also reported post marketing for Esmya.
Esmya (ulipristalacetat, 5 mg) er et centralt godkendt lægemiddel, der er indiceret til præoperativ behandling og intermitterende behandling af moderate til svære symptomer på uterusfibromer hos voksne kvinder i den reproduktive alder.
Esmya (ulipristal acetate, 5 mg) is a centrally authorised medicinal product indicated for pre-operative treatment, as well as intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Markedsføringstilladelsen for Esmya blev udvidet til at omfatte den terapeutiske indikation intermitterende behandling af moderate til svære symptomer på uterusfibromer hos voksne kvinder i den reproduktive alder.
The marketing authorisation of Esmya was extended to include the therapeutic indication for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
• PRAC henstillede, at intermitterende behandling med Esmya af moderate til svære symptomer på uterusfibromer begrænses til voksne kvinder i den reproduktive alder, som ikke er egnede til operation.
• The PRAC recommended that intermittent treatment of moderate to severe symptoms of uterine fibroids with Esmya should be restricted to adult women of reproductive age who are not eligible for surgery.
PRAC finder, at indehaveren af markedsføringstilladelsen bør udføre in vitro-undersøgelser til bedre karakterisering af virkningsprofilen for lægemiddelinduceret leverskade forbundet med Esmya.
The PRAC considers that in vitro studies should be performed by the MAH, in order to better characterize the mechanistic profile of DILI as associated with Esmya.
AST> 2 x ULN (alene eller i kombination med bilirubin > 2 x ULN) bør behandlingen ikke initieres, hvilket er i overensstemmelse med eksklusionskriterierne i de kliniske undersøgelser med Esmya.
In line with the exclusion criteria in the clinical studies of Esmya, patients with ALT or AST> 2 x ULN (isolated or in combination with bilirubin >2 x ULN) should not initiate treatment.
Derudover bør der udføres observationsundersøgelser med henblik på at analysere data om risikoen for leverskader med sammenhæng med Esmya og om effektiviteten af risikominimeringsforanstaltningerne.
In addition, in order to analyse data on risk of liver injury related with Esmya and on effectiveness of risk minimisation measures, observational studies should be performed.
Produktet bør være kontraindiceret hos patienter med underliggende leversygdom for at udelukke patienter med potentielt større følsomhed for leverpåvirkning af behandling med Esmya.
In order to exclude patients that would be potentially more susceptible to hepatic insult from the treatment with Esmya, the product should be contraindicated in patients with underlying hepatic disorder.
Der bør udleveres et patientkort for at sikre, at patienterne er tilstrækkeligt informeret om de mulige risici for leverskade og de implementerede risikominimeringsforanstaltninger.
In order to ensure that patients are adequately informed on the possible risks of liver injury and the implemented risk minimisation measures, a patient card should be issued.
Dette sammendrag blev sidst ajourført 11-2016.
This summary was last updated in 11-2016.
Resultaterne af tre hovedundersøgelser er følgende:
The results from three main studies are as follows:
Emtriva emtricitabin
Emtriva emtricitabine
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Emtriva den 24. oktober 2003.
The European Commission granted a marketing authorisation valid throughout the European Union for Emtriva on 24 October 2003.
Denne forskel holdt sig efter 48 ugers behandling (73 % og 56 %).
This difference was maintained after 48 weeks of treatment (73% and 56%).
Den fuldstændige EPAR for Emtriva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Emtriva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Andre oplysninger om Emtriva:
Other information about Emtriva:
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Emtriva.
This is a summary of the European public assessment report (EPAR) for Emtriva.
Udvalget anbefalede og anbefalede udstedelse af en markedsføringstilladelse.
The Committee recommended that it be given marketing authorisation.
Misfarvning af huden forekom meget ofte hos børn.
Skin discoloration was very common in children.
Den orale opløsning er til patienter, som vejer mindre end 33 kg, og dem, der ikke kan sluge kapslerne.
The oral solution is for patients who weigh less than 33 kg, and those who cannot swallow the capsules.
Det blokerer aktiviteten af reverse transcriptase, et enzym, som virussen producerer, så det kan formere sig i de celler, det har inficeret.
It blocks the activity of reverse transcriptase, an enzyme made by the virus that allows it to reproduce itself in the cells it has infected.
Den normale dosis af Emtriva er en kapsel en gang om dagen til patienter, der vejer 33 kg eller mere.
The usual dose of Emtriva is one capsule once a day for patients who weigh 33 kg or more.
Den normale dosis er 6 mg pr. kilogram kropsvægt en gang om dagen til en maksimal dosis på 240 mg (24 ml).
The usual dose of oral solution is 6 mg per kilogram body weight once a day, up to a maximum of 240 mg (24 ml).
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Emtriva?
What measures are being taken to ensure the safe and effective use of Emtriva?
Hvad er Emtriva, og hvad anvendes det til?
What is Emtriva and what is it used for?
Det kan være nødvendigt at tilpasse dosen hos patienter med nyreproblemer.
The dose may need to be adjusted in patients who have problems with their kidneys.
Hvorfor blev Emtriva godkendt?
Why is Emtriva approved?
Emtriva fås som kapsler (200 mg) og som en opløsning (10 mg/ml) til indtagelse gennem munden.
Emtriva is available as capsules (200 mg) and as a solution (10 mg/ml) to be taken by mouth.
Det er ikke en praktisk vejledning i, hvordan Emtriva bør anvendes.
It is not intended to provide practical advice on how to use Emtriva.
Emtriva kurerer ikke hivinfektion eller aids, men det kan udsætte beskadigelsen af immunsystemet og hindre udvikling af infektioner og sygdomme, der er forbundet med aids.
Emtriva does not cure HIV infection or AIDS, but it can hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Hvilken risiko er der forbundet med Emtriva?
What is the risk associated with Emtriva?
De hyppigste bivirkninger ved Emtriva (som ses hos flere end 1 ud af 10 patienter) er hovedpine, diarré, kvalme og forhøjet indhold i blodet af kreatinkinase (et enzym, der findes i musklerne).
The most common side effects with Emtriva (seen in more than 1 patient in 10) are headache, diarrhoea, nausea (feeling sick), and elevated creatine kinase levels in the blood (an enzyme found in muscles).
• I en anden undersøgelse af 468 tidligere ubehandlede patienter var Emtriva ligeså effektiv som lamivudin (begge taget i kombination med stavudin og eller efavirenz eller nevirapin).
• In another study in 468 previously untreated patients, Emtriva was as effective as lamivudine (both taken in combination with stavudine and either efavirenz or nevirapine).