FrancophonIA/ELRC3.0 huggingface dataset:
English: In view of the seriousness of the cases, the PRAC considered that provisional measures are now needed to minimise this risk and protect patients, while the review is ongoing and a thorough assessment of all available data related to the benefit-risk of Esmya is performed.
Danish: På baggrund af tilfældenes alvorlighed vurderer PRAC, at det er nødvendigt at indføre midlertidige foranstaltninger for at minimere denne risiko og beskytte patienterne, mens gennemgangen udføres, og mens der foretages en grundig evaluering af alle tilgængelige data vedrørende benefit/risk-forholdet for Esmya.
English: The provisional measures proposed by PRAC also include the limitation of use of the medicinal product in patients that are currently under therapeutic treatment.
Danish: De midlertidige foranstaltninger, som PRAC foreslår, omfatter også en begrænsning af anvendelsen af lægemidlet hos patienter, der aktuelt er i behandling.
English: No information on hepatic events is currently included in the Product Information of Esmya.
Danish: Der er aktuelt ingen oplysninger om leverhændelser i produktinformationen for Esmya.
English: With regards to patients under intermittent treatment, the use of the medicinal product should not be repeated in patients who have finalised a previous treatment course.
Danish: Hvad angår patienter i intermitterende behandling, bør anvendelsen af lægemidlet ikke gentages hos patienter, der har afsluttet et tidligere behandlingsforløb.
English: In addition, several cases of hepatic injury in patients using Esmya were reported.
Danish: Desuden er der rapporteret om flere tilfælde af leverskade hos patienter, der er blevet behandlet med Esmya.
English: The therapeutic indication for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age was based on results from another study providing data for up to 4 intermittent treatment courses of 3 months each with ulipristal acetate along with data for repeated treatment courses from the previous studies.
Danish: Den terapeutiske indikation for intermitterende behandling af moderate til svære symptomer på uterusfibrom hos voksne kvinder i den fødedygtige alder blev vurderet ud fra resultater af en anden undersøgelse med data for op til 4 intermitterende behandlingsforløb på hver 3 måneder med ulipristalacetat samt data for gentagne behandlingsforløb fra de tidligere undersøgelser.
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for Esmya (Ulipristal acetate), in particular the need for provisional measures in accordance with Article 20(3) of Regulation (EC) N0 726/2004.
Danish: • På baggrund af lægemiddelovervågningsdata for Esmya (ulipristalacetat) gennemførte PRAC en procedure i henhold til artikel 20 i forordning (EF) nr. 726/2004, navnlig med hensyn til behovet for midlertidige foranstaltninger, jf. artikel 20, stk. 3.
English: The PRAC considered the potential risk of hepatotoxicity of the product, together with the fact that Esmya is a symptomatic treatment and not curative, that has the potential to reduce the need for surgical intervention.
Danish: I sin vurdering tager PRAC hensyn til den potentielle risiko for levertoksicitet ved brug af Esmya samt det faktum, at der er tale om en symptomatisk og ikke en kurativ behandling, der kan mindske behovet for operative indgreb.
English: Given the estimated exposure to Esmya of approximately 175,000 patient years, the number of cases of subacute severe liver impairment leading to liver transplantation with Esmya is higher than expected (4 transplantation cases among 175,000 patient years - a total of 7 cases with severe liver impairment among 175,000 patient years; although causality is uncertain for some of these cases).
Danish: Med den skønnede eksponering for Esmya (ca. 175.000 patientår) er antallet af tilfælde af subakut svært nedsat leverfunktion, der fører til levertransplantation, større end forventet (4 transplantationstilfælde pr. 175.000 patientår og i alt 7 tilfælde med svært nedsat leverfunktion pr. 175.000 patientår, idet årsagssammenhængen dog er usikker for nogle af disse tilfælde).
English: The above provisional measures should be reflected in the terms of the marketing authorisation, including the product information of Esmya, and communicated to HCPs via a DHPC.
Danish: Ovenstående midlertidige foranstaltninger bør afspejles i betingelserne for markedsføringstilladelse, herunder produktinformationen for Esmya, og formidles pr. brev til sundhedspersoner.
English: With regards to patients under intermittent treatment, the use of the medicinal product should be discontinued in patients who have finalised a previous treatment course.
Danish: Hvad angår patienter i intermitterende behandling, bør anvendelsen af lægemidlet ophøre hos patienter, der har afsluttet et tidligere behandlingsforløb.
English: 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.
Danish: Ulipristalacetats kliniske effekt ved præoperativ behandling af moderate til svære symptomer på uterusfibrom hos voksne kvinder i den fødedygtige alder blev vurderet ud fra kortvarige undersøgelser, der påviste det aktive stofs evne til at reducere fibrom-relateret blødning, anæmi og fibromstørrelse, når det administreres i en daglig dosis på 5 mg i op til tre måneder.
English: Patients who develop transaminase levels > 2 times the upper level of normal during Esmya treatment should stop treatment and be closely monitored.
Danish: Patienter, der under behandling med Esmya har transaminaseværdier > 2 gange den øvre normalgrænse, bør have behandlingen seponeret, og de bør overvåges tæt.
English: • During the ongoing review of safety and efficacy data in relation to the overall risk of liver injury with Esmya, the PRAC reviewed all data currently available from post-marketing settings and from clinical trials as well as the responses provided by the marketing authorisation holder on cases of serious liver injury reported with Esmya.
Danish: • Under den igangværende gennemgang af sikkerheds- og effektdata i relation til den samlede risiko for leverskade ved brug af Esmya så PRAC nærmere på alle aktuelt tilgængelige data fra efter markedsføring og kliniske undersøgelser samt svar fra indehaveren af markedsføringstilladelse vedrørende indberettede tilfælde af alvorlig leverskade ved brug af Esmya.
English: In view of the above, the Committee considers that the benefit-risk balance of Esmya remains favourable subject to the agreed provisional measures.
Danish: På grundlag af ovenstående vurderer PRAC, at benefit/risk-forholdet for Esmya fortsat er positivt under forudsætning af, at de midlertidige foranstaltninger gennemføres.
English: • Furthermore, PRAC recommended that a healthcare professional communication should be disseminated to inform healthcare professionals about the precautionary measures, awaiting the outcome of the full review of Esmya.
Danish: • Derudover anbefaler PRAC, at der udsendes breve til sundhedspersoner med en beskrivelse af de midlertidige forholdsregler, mens resultatet af Esmya-gennemgangen afventes.
English: No signal of hepatic toxicity was identified during the review of non-clinical or clinical trials of Esmya inducing hepatic toxicity.
Danish: Der blev ikke fundet tegn på levertoksicitet under gennemgangen af prækliniske og kliniske undersøgelser til vurdering af, om Esmya inducerer levertoksicitet.
English: PRAC reviewed all data currently available from post-marketing settings and from clinical trials as well as the responses provided by the marketing authorisation holder on cases of serious liver injury reported with Esmya.
Danish: PRAC gennemgik alle aktuelt tilgængelige data fra efter markedsføring og kliniske undersøgelser samt svar fra indehaveren af markedsføringstilladelse vedrørende indberettede tilfælde af alvorlig leverskade ved brug af Esmya.
English: In addition, several other cases of hepatic impairment associated with the use of the product were reported.
Danish: Derudover er der rapporteret om flere andre tilfælde af nedsat leverfunktion ved brug af dette lægemiddel.
English: These provisional measures are without prejudice to the outcome of the ongoing review under Article 20 procedure.
Danish: Disse midlertidige foranstaltninger gennemføres med forbehold for udfaldet af den igangværende gennemgangsprocedure i henhold til artikel 20, jf. ovenfor.
English: Considering all these factors, in order to recommend the measure that would be the most proportionate, the PRAC concluded to provisionally limit the use of the medicinal product to patients that are currently under therapeutic treatment.
Danish: For at anbefale så forholdsmæssige foranstaltninger som muligt vurderer PRAC ud fra alle disse faktorer, at anvendelsen af lægemidlet midlertidigt bør begrænses til patienter, der aktuelt er i behandling.
English: Given the estimated exposure to Esmya of approximately 175,000 patient years, the number of cases of subacute severe liver impairment leading to liver transplantation with Esmya appears higher than expected, although background incidence on drug induced liver injury is uncertain.
Danish: Med den skønnede eksponering for Esmya (ca. 175.000 patientår) er antallet af tilfælde af subakut svært nedsat leverfunktion, der fører til levertransplantation, større end forventet, selvom baggrundsincidensen for lægemiddelinduceret leverskade er usikker.
English: Follow-up information on this case was also reviewed by the PRAC, as well as additional information provided by the Marketing Authorisation Holder while the review was ongoing.
Danish: PRAC gennemgik også opfølgningsdataene for dette tilfælde samt yderligere oplysninger, som indehaveren af markedsføringstilladelse fremskaffede under gennemgangen.
English: In post-marketing settings, a total of four cases of acute liver failure leading to liver transplantation including one with fatal outcome have been reported in patients exposed to Esmya.
Danish: Efter markedsføring er der rapporteret om i alt fire tilfælde af akut leversvigt, der har ført til levertransplantation, herunder ét med dødelig udgang, hos patienter, der er blevet behandlet med Esmya.
English: • The PRAC noted that four cases of acute liver failure leading to liver transplantation including one with fatal outcome have been reported with Esmya.
Danish: • PRAC bemærker, at der er rapporteret om fire tilfælde af akut leversvigt ved brug af Esmya, der har ført til levertransplantation, herunder ét med dødelig udgang.
English: The threshold of transaminases elevation for patients not included in clinical trials, which is two times the upper limit of normal, should be considered as the threshold in which the discontinuation of treatment is recommended.
Danish: Eksklusionskriteriet vedrørende forhøjede transaminaser (to gange over den øvre normalgrænse) i kliniske undersøgelser bør også være den grænseværdi, hvor seponering anbefales.
English: Healthcare Professionals (HCPs) should be informed of the cases of liver injury and hepatic failure reported with the use of Esmya in post-marketing experience.
Danish: Sundhedspersoner skal underrettes om indberettede tilfælde af leverskade og leversvigt efter markedsføring ved brug af Esmya.
English: While the magnitude and nature (e.g. pattern of hepatotoxicity and possible mechanism of action) of the risk are being reviewed in depth, having considered the seriousness of the risk, the PRAC considered that the above raised a reasonable doubt that justifies adopting provisional measures in the meantime.
Danish: I betragtning af risikoens alvorlighed vurderer PRAC, at den rimelige tvivl berettiger, at der iværksættes midlertidige foranstaltninger, mens risikoens omfang og art (f.eks. levertoksicitetsmønster og mulig virkningsmekanisme) gennemgås grundigt.
English: Four cases of serious liver injury leading to a hepatic transplantation were reported since the marketing authorisation of Esmya.
Danish: Siden udstedelsen af markedsføringstilladelse for Esmya er der rapporteret om fire tilfælde af alvorlig leverskade, der har ført til levertransplantation.
English: In some cases you may have to stop taking one of the medicines.
Danish: I nogle tilfælde kan du være nødt til at stoppe med at tage et af lægemidlerne.
English: • A heart attack within the last four weeks.
Danish: • Har haft et hjerteanfald inden for de sidste fire uger.
English: • if you are more than 3 months pregnant.
Danish: • hvis du er gravid og er mere end 3 måneder henne.
English: You may notice this as dizziness when standing up.
Danish: Du kan opleve dette som svimmelhed, når du rejser dig op.
English: It is important that you take Onduarp every day until your doctor tells you otherwise.
Danish: Det er vigtigt, at du tager Onduarp hver dag, indtil din læge siger noget andet.
English: Treatment of essential hypertension in adults:
Danish: Behandling af essentiel hypertension hos voksne:
English: Supportive treatment should be instituted.
Danish: Der skal iværksættes understøttende behandling.
English: Thus it is important to regularly measure blood pressure to verify if it is within the normal range.
Danish: Derfor er det vigtigt jævnligt at få sit blodtryk målt for at kontrollere, om det ligger inden for normalområdet.
English: However, there may be a risk of prolonged delivery.
Danish: Der kan dog være risiko for forlænget fødsel.
English: Cumulative urinary excretion is <1 % of dose.
Danish: Kumulativ urinudskillelse er <1% af dosis.
English: See section 3.
Danish: Se punkt 3.
English: Therefore, the combination should be administered with caution, especially in the elderly.
Danish: Ved administrering af kombinationen skal derfor udvises forsigtighed, særligt hos ældre.
English: Grapefruit and grapefruit juice
Danish: Grapefrugt og grapefrugtjuice
English: You can take Onduarp with or without food.
Danish: Du kan tage Onduarp med eller uden mad.
English: The tablets should be swallowed with some water or other non-alcoholic drink.
Danish: Tabletterne skal synkes sammen med vand eller andre alkoholfrie drikkevarer.
English: There are usually no symptoms of high blood pressure before damage occurs.
Danish: Sædvanligvis er der ingen symptomer på højt blodtryk, før skader er indtruffet.
English: Values are adjusted for baseline and country.
Danish: Værdierne er justeret for baseline og ophavsland.
English: Your doctor may need to change the dose of these other medicines or take other precautions.
Danish: Det er muligt, at lægen er nødt til at ændre din dosis af den anden medicin eller træffer andre forholdsregler.
English: The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Danish: Patienten skal monitoreres nøje, og behandlingen skal være symptomatisk og understøttende.
English: • Shock (including cardiogenic shock)
Danish: • Shock (herunder kardiogent shock)
English: (It is also better to avoid Onduarp in early pregnancysee Warnings and precautions and Pregnancy section.)
Danish: (Det foretrækkes også at undgå Onduarp tidligt i graviditeten - se punktet Advarsler og forsigtighedsregler og punktet Graviditet.)
English: There are no adequate data from the use of Onduarp in pregnant women.
Danish: Der er ikke tilstrækkelige data fra brug af Onduarp hos gravide kvinder.
English: The mean steady state apparent volume of distribution (Vdss) is approximately 500 l.
Danish: Det tilsyneladende steady state-fordelingsvolumen (Vdss) er ca. 500 l.
English: Steady-state plasma levels are reached after continuous administration for 7-8 days.
Danish: Steady-state koncentration nås efter 7-8 dage.
English: Influenza-like illness
Danish: Influenza-lignende sygdom
English: It is recommended to take Onduarp with some liquid.
Danish: Det anbefales at tage Onduarp med væske.
English: Absorption of telmisartan is rapid although the amount absorbed varies.
Danish: Telmisartan absorberes hurtigt, selvom den absorberede mængde varierer.
English: No new or more severe adverse reactions were observed.
Danish: Ingen nye eller sværere bivirkninger blev observeret.
English: In vitro studies have shown that approximately 97.5 % of circulating amlodipine is bound to plasma proteins in hypertensive patients.
Danish: In vitro-undersøgelser har vist, at ca. 97,5% af det cirkulerende amlodipin er bundet til plasmaproteiner hos hypertensive patienter.
English: If you forget to take a dose, take it as soon as you remember and then carry on as before.
Danish: Hvis du har glemt at tage en dosis, skal du tage den, så snart du kommer i tanke om det, og fortsætte behandlingen som hidtil.
English: Onduarp is indicated for long term treatment.
Danish: Onduarp er indiceret til langtidsbehandling.
English: Paediatric population (age below 18 years) No pharmacokinetic data are available in the paediatric population.
Danish: Pædiatrisk population (under 18 år) Der er ingen farmakokinetiske data for den pædiatriske population.
English: You might experience low blood pressure and rapid heart beat.
Danish: Du kan få lavt blodtryk og hurtig hjerterytme.
English: Your doctor will normally advise you to stop taking Onduarp before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Onduarp.
Danish: Lægen vil normalt råde dig til at stoppe med at tage Onduarp, før du bliver gravid, eller så snart du ved, du er gravid, og vil råde dig til at tage en anden medicin end Onduarp.
English: The small reduction in AUC for telmisartan is not expected to cause a reduction in the therapeutic efficacy.
Danish: Den lille reduktion i AUC for telmisartan forventes ikke at påvirke den terapeutiske virkning.
English: Plasma aldosterone levels are decreased by telmisartan.
Danish: Plasmaaldosteron-niveauerne sænkes af telmisartan.
English: This applies especially to the medicines listed below taken at the same time with Onduarp:
Danish: Det gælder især for de nedenfor anførte lægemidler, når de tages sammen med Onduarp:
English: However, no adverse events attributable to such interaction have been reported.
Danish: Der er dog ikke rapporteret om uønskede hændelser, der relateres til sådanne interaktioner.
English: If you do not take your tablet on one day, take your normal dose on the next day.
Danish: Hvis du en hel dag glemmer at tage din tablet, skal du nøjes med at tage den normale dosis den næste dag.
English: Onduarp is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Danish: Onduarp frarådes tidligt i graviditeten og må ikke tages efter graviditetens tredje måned, da det kan forårsage alvorlig skade på din baby, hvis det anvendes efter graviditetens tredje måned.
English: Talk to your doctor before taking Onduarp:
Danish: Kontakt lægen, før du tager Onduarp:
English: Interactions linked to telmisartan
Danish: Interaktioner associeret til telmisartan
English: System Organ Class
Danish: SystemorganKlasse
English: Onduarp contains sorbitol.
Danish: Onduarp indeholder sorbitol
English: Japanese patients are more likely to experience this side effect.
Danish: Japanske patienter har større sandsynlighed for at få denne bivirkning.
English: Telmisartan has been studied in a large outcome study in 25,620 patients with high cardiovascular risk (ONTARGET).
Danish: Telmisartan er blevet undersøgt i et stort resultatstudie hos 25.620 patienter med høj risiko for hjerte-kar-sygdom (ONTARGET).
English: Adverse reactions have been ranked under headings of 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).
Danish: Bivirkningerne er opstillet efter hyppighed ved anvendelse af følgende definition: 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).
English: In two corresponding open-label long-term follow up studies performed over a further 6 months the effect of Onduarp was maintained over the trial period.
Danish: I to identiske åbne, langtids, follow-up studier gennemført over yderligere 6 måneder, blev virkningen af Onduarp fastholdt i hele studieperioden.
English: By 3 hours after administration, plasma concentrations are similar whether telmisartan is taken fasting or with food.
Danish: 3 timer efter administration er plasmakoncentrationerne ens, uanset om telmisartan tages fastende eller sammen med føde.
English: There is no linear relationship between doses and plasma levels.
Danish: Der er ikke noget lineært forhold mellem doser og plasmaniveauer.
English: The antihypertensive effect of Onduarp was similar irrespective of age and gender, and was similar in patients with and without diabetes.
Danish: Den antihypertensive virkning af Onduarp var den samme uanset alder og køn, og den var ens hos patienter med og uden diabetes.
English: Corticosteroids (systemic route) Reduction of the antihypertensive effect.
Danish: Kortikosteroider (systemisk administrationsvej) Reduktion af den antihypertensive virkning.
English: After the first dose of telmisartan, the antihypertensive activity gradually becomes evident within 3 hours.
Danish: Efter den første dosis telmisartan indtræder den antihypertensive aktivitet gradvist inden for 3 timer.
English: Onduarp has moderate influence on the ability to drive and use machines.
Danish: Onduarp har moderat indflydelse på evnen til at føre motorkøretøj eller betjene maskiner.
English: Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome have been reported.
Danish: Udtalt og sandsynligvis forlænget systemisk hypotension til og med shock med dødelig udgang er set.
English: Furthermore, orthostatic hypotension may be aggravated by alcohol.
Danish: Desuden kan ortostatisk hypotension forværres ved indtagelse af alkohol.
English: In this respect data concerning diastolic blood pressure (DBP) are inconsistent.
Danish: Data for diastolisk blodtryk (DBP) er her inkonsistente.
English: Telmisartan is largely bound to plasma protein (>99.5 %), mainly albumin and alpha-1 acid glycoprotein.
Danish: Telmisartan er i høj grad bundet til plasmaprotein (>99,5%), hovedsagelig albumin og alfa-1-syreglykoprotein.
English: Plasma concentrations were higher in females than in males, without relevant influence on efficacy.
Danish: Plasmakoncentrationerne var højere hos kvinder end hos mænd uden relevant påvirkning af effekten.
English: The safety and tolerability of Onduarp has been evaluated in five controlled clinical studies with over 3500 patients, over 2500 of whom received telmisartan in combination with amlodipine.
Danish: Sikkerheden og tolerabiliteten ved brug af Onduarp er blevet evalueret i fem kontrollerede kliniske studier med over 3.500 patienter, hvoraf over 2.500 modtog telmisartan i kombination med amlodipin.
English: • Diltiazem (cardiac medicine).
Danish: • Diltiazem (hjertemedicin).
English: • Erythromycin (antibiotic).
Danish: • Erythromycin (antibotikum).
English: There is no evidence of clinically relevant accumulation of telmisartan taken at the recommended dose.
Danish: Der er ingen tegn på klinisk relevant akkumulering af telmisartan, når det tages i den anbefalede dosis.
English: Such conditions should be corrected before the administration of telmisartan.
Danish: De nævnte tilstande bør afhjælpes før indgivelse af telmisartan.
English: Therefore, the use of telmisartan is not recommended.
Danish: Brug af telmisartan frarådes derfor.
English: Therefore it is not expected to potentiate bradykinin-mediated adverse reactions.
Danish: Det forventes derfor ikke, at bradykinin-medierede bivirkninger potenseres.