FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for methotrexate-containing medicinal products.
Danish: CHMP anbefaler derfor, at betingelserne for markedsføringstilladelse for methotrexat-holdige lægemidler ændres.
English: This card was considered a necessary tool to remind patients to take the product only once weekly, inform on serious adverse effects that may be fatal, on the symptoms of overdose and steps to be taken should symptoms arise, and recommend patients to show the card and alert any healthcare professionals not familiar with their methotrexate treatment about their once weekly dosing schedule (e.g. on hospital admission, change of care).
Danish: Patientkortet vurderes at være et nødvendigt værktøj, der kan minde patienterne om, at de kun skal tage lægemidlet én gang om ugen, oplyse om alvorlige bivirkninger, der kan have dødelig udgang, om symptomerne på overdosering og håndtering af eventuelle symptomer, og minde patienterne om, at de skal vise kortet til sundhedspersoner, der ikke kender til deres methotrexatbehandling, og fortælle dem, at de får lægemidlet én gang om ugen (f.eks. ved indlæggelse på hospital eller ændring af behandling).
English: • Considering the number of reported inadvertent daily administration of methotrexate oral formulations, the PRAC concluded that for these products educational materials for healthcare professionals should be developed or updated, if already in place, in accordance with the key elements agreed, as well as a patient card to be provided with the medicinal product, to further increase awareness.
Danish: • I betragtning af de mange indberettede tilfælde af fejlagtig daglig dosering af orale methotrexat-formuleringer vurderer PRAC, at informationsmateriale til sundhedspersoner vedrørende disse lægemidler bør udarbejdes eller opdateres (alt efter hvad der er relevant), ligesom et patientkort bør følge med lægemidlet for at øge bevidstheden yderligere, jf. de vedtagne hovedpunkter.
English: Overall, it was considered that such practice may generate more confusion and lead to more medication errors and should therefore not be recommended.
Danish: En sådan praksis anbefales ikke, da det samlet set vurderes, at den kan give mere forvirring og føre til flere medicineringsfejl.
English: To address this issue, the PRAC recommended that for all tablet formulations of methotrexate, bulk packaging such as bottles or tubes should be replaced by blisters.
Danish: For at løse dette problem anbefaler PRAC, at bulkpakninger som f.eks. beholdere og rør bør udskiftes med blisterkort for alle tabletformuleringer af methotrexat.
English: Extensive assessment of spontaneously reported post-marketing cases has been performed by the PRAC and although some relevant data might not have been provided in all spontaneously reported post-marketing cases, the root cause analysis was further substantiated by the assessment of literature data, which provided more detailed description of methotrexate medication error cases.
Danish: Nogle relevante data er måske ikke blevet oplyst i alle spontant rapporterede tilfælde efter markedsføring, men kerneårsagsanalysen er blevet yderligere underbygget af data fra litteraturen, der giver en mere detaljeret beskrivelse af tilfælde af medicineringsfejl med methotrexat.
English: The CHMP, as a consequence, considers that the benefit-risk balance of methotrexate-containing medicinal products remains favourable subject to the amendments to the product information and to the conditions described above.
Danish: På baggrund af ovenstående vurderer CHMP, at benefit/risk-forholdet for methotrexat-holdige lægemidler fortsat er positivt under forudsætning af, at de nævnte ændringer indføres i produktinformationen, og i henhold til ovennævnte betingelser.
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for methotrexate-containing medicinal products.
Danish: Udvalget anbefaler derfor, at betingelserne for markedsføringstilladelse for methotrexat-holdige lægemidler ændres.
English: In addition, as understanding of the once weekly dosing schedule of methotrexate is essential to avoid dosing errors by the patients or their carer and for the adherence to this special treatment schedule, an update of the product information of methotrexate products with at least one indication requiring a once weekly dosing schedule was considered necessary to alert healthcare professionals to restrict the use of oral methotrexate to patients/carers who are able to comply with the once weekly dosing schedule.
Danish: Da det desuden er vigtigt at forstå doseringsregimet med indgivelse af methotrexat én gang ugentligt for at undgå, at patienterne eller deres omsorgspersoner doserer forkert, og for at sikre, at dette særlige behandlingsregime følges, vurderes det nødvendigt at opdatere produktinformationen for methotrexat-produkter, som har mindst én indikation, der kræver indgivelse én gang ugentligt, for at advare sundhedspersoner om, at de skal begrænse anvendelsen af oralt methotrexat til patienter/omsorgspersoner, der er i stand til følge doseringsregimet med indgivelse én gang ugentligt.
English: To gain further knowledge on the reasons leading to medication errors and prevent them adequately, as well as in support of the measurement of the effectiveness of the agreed risk minimisation measures, all MAHs are requested to implement and use a targeted follow-up questionnaire, as agreed by PRAC, for all medication errors reported with methotrexate and resulting in overdose.
Danish: For at få mere viden om årsagerne til medicineringsfejl, så disse kan forebygges hensigtsmæssigt, og for at måle effektiviteten af de vedtagne risikominimerende foranstaltninger skal alle indehavere af markedsføringstilladelse indføre og anvende et målrettet opfølgningsspørgeskema for alle indberettede methotrexat-relaterede medicineringsfejl og deraf følgende overdosering, jf. PRAC's anbefalinger.
English: To increase awareness of HCPs on the risk of medication errors and their possible consequences, it was considered that for methotrexate oral formulations, educational materials for healthcare professionals should be developed or updated, if already in place, to inform them on the potential for fatal overdose due to medication errors (ME), including daily instead of once weekly use, highlight the need to inform patients and relatives/carers about the once weekly dosing, and provide information on the importance to fill in prescriptions with clear instructions about once weekly dosing, defined day of intake, and to not use abbreviations.
Danish: For at øge sundhedspersoners bevidsthed om risikoen for medicineringsfejl og de mulige konsekvenser heraf vurderes det, at informationsmateriale til sundhedspersoner om orale methotrexat-formuleringer bør udarbejdes eller opdateres (alt efter hvad der er relevant) for at oplyse dem om, at der er risiko for dødelig overdosering ved medicineringsfejl, herunder daglig indgivelse i stedet for ugentlig indgivelse, at patienter og pårørende/omsorgspersoner skal oplyses specifikt om doseringsregimet med indgivelse én gang ugentligt, og at det er meget vigtigt at skrive recepterne uden brug af forkortelser og med tydelig instruktion om indgivelse én gang ugentligt samt angivelse af den pågældende indgivelsesdag.
English: In order to assess the root causes and the impact of the risk of medication errors due to inadvertent daily dosing instead of weekly dosing, the PRAC considered the analyses of cases report of inadvertent daily instead of weekly usage of methotrexate-containing products, including reports without adverse events, for the period 1 January 2013 until 31 March 2018 from the EudraVigilance database as well as from the data provided by the MAHs of methotrexate-containing products which included analyses of the medication error case reports from the companies' pharmacovigilance databases and in the literature.
Danish: For at vurdere kerneårsagerne til og betydningen af risikoen for medicineringsfejl ved fejlagtig daglig dosering i stedet for ugentlig dosering har PRAC gennemgået analyser af hændelsesrapporter om fejlagtig daglig brug i stedet for ugentlig brug af methotrexat-holdige lægemidler, herunder rapporter uden uønskede hændelser, for perioden 1. januar 2013 til 31. marts 2018.
English: Since early 1996, harmful or fatal errors with low dose oral methotrexate have been reported to the Institute for Safe Medication Practices (ISMP) and published in more than 50 of its newsletters, but in spite of this and numerous risk minimization measures, methotrexate continues to be subject in documented serious medication errors (Grissinger, 20182).
Danish: Siden starten af 1996 er medicineringsfejl med oralt lavdosis-methotrexat, som har medført skade eller dødsfald, blevet indberettet til Institute for Safe Medication Practices (ISMP) og omtalt i mere end 50 af instituttets nyhedsbreve, men på trods af dette og en lang række risikominimerende foranstaltninger bliver
English: To increase awareness and remind healthcare professionals and patients of the weekly dosing schedule required for the treatment of some conditions, the MAHs for oral methotrexate-containing products with at least an indication requiring dosing once a week had been requested, as outcome of the PSUSA (EMEA/H/C/PSUSA/00002014/201706), to implement a visual reminder on the outer and immediate packaging to warn patients to take the product once a week for those indications requiring dosing once a week.
Danish: For at øge bevidstheden og minde sundhedspersoner og patienter om, at der skal anvendes et doseringsregime med indgivelse én gang ugentligt ved behandling af visse tilstande, skal indehaverne af markedsføringstilladelse til orale methotrexat-holdige lægemidler med mindst én indikation, der kræver indgivelse én gang ugentligt, forsyne den ydre og indre emballage med en visuel påmindelse
English: The use of more than one of these products concomitantly should be avoided.
Danish: Brugen af flere end et af disse produkter samtidig bør undgås.
English: This risk persists until significant remission occurs.
Danish: Risikoen forbliver, indtil der er signifikant remission.
English: Date of first authorisation: 11 August 2004 Date of latest renewal: 24 June 2009
Danish: Dato for første markedsføringstilladelse: 11. august 2004 Dato for seneste fornyelse: 24. juni 2009
English: 8 Falls were more common in the elderly (≥65 years old).
Danish: 8 Fald var hyppigst hos ældre (≥65 år).
English: You should swallow your capsule whole with a drink of water.
Danish: De skal synke kapslen hel sammen med et glas vand.
English: Frequency estimate: 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).
Danish: Estimeret hyppighed: Meget almindelig (≥1/10), almindelig (≥1/100 ti, <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000).
English: YENTREVE is indicated in adults.
Danish: YENTREVE er indiceret til voksne.
English: To help you remember to take YENTREVE, you may find it easier to take it at the same times every day.
Danish: Det kan være lettere at huske at tage YENTREVE, hvis De tager det på samme tidspunkter hver dag.
English: Some patients, who suddenly stop taking YENTREVE after more than 1 week of therapy, have had symptoms such as:
Danish: Nogle patienter, som pludselig holdt op med at tage YENTREVE efter mere end 1 uges behandling, fik symptomer såsom:
English: The benefit of treatment should be re-assessed at regular intervals.
Danish: Fordelene ved behandling bør undersøges regelmæssigt.
English: You should also tell your doctor if you are taking any of the following:
Danish: De skal også kontakte Deres læge, hvis De tager noget af følgende:
English: If it is not treated, your condition may not go away and may become more serious and difficult to treat.
Danish: Hvis den ikke behandles, vil De måske ikke få det bedre, og Deres tilstand kan forværres og blive sværere at behandle.
English: If your doctor thinks that you no longer need YENTREVE he or she will ask you to reduce your dose over 2 weeks.
Danish: Hvis lægen mener, at De ikke længere behøver at tage YENTREVE, vil denne bede Dem reducere dosis over 2 uger.
English: Do not drive or use any tools or machines until you know how YENTREVE affects you.
Danish: De må ikke køre bil eller arbejde med værktøj eller maskiner, før De ved, hvordan YENTREVE påvirker Dem.
English: The relevance of this mouse data to humans is unknown.
Danish: Relevansen af disse data for mus i forhold til mennesker kendes ikke.
English: Most of them occurred during the first months of treatment.
Danish: De fleste skete inden for de første måneder af behandlingen.
English: The requirements for submission of periodic safety update reports for this medicinal product are in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Your doctor or midwife should be aware that you are taking duloxetine so they can advise you.
Danish: Deres læge eller jordemoder skal gøres opmærksom på, at De tager duloxetin, så de kan rådgive Dem.
English: You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Danish: De kan bede dem om at fortælle det til Dem, hvis de synes, at Deres depression eller angstsygdom bliver værre, eller hvis de er bekymrede over ændringer i Deres adfærd.
English: DO NOT stop taking your capsules without the advice of your doctor even if you feel better.
Danish: De må IKKE holde op med at tage kapslerne uden at have konsulteret Deres læge, heller ikke selv om De har fået det bedre.
English: If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms.
Danish: Hvis der alligevel tages en beslutning om at behandle på baggrund af kliniske behov, skal patienten nøje overvåges for opdukken af selvmordssymptomer.
English: Distribution: Duloxetine is approximately 96% bound to human plasma proteins.
Danish: Fordeling: Duloxetin har en cirka 96% binding til humane plasmaproteiner.
English: Elderly Caution should be exercised when treating the elderly.
Danish: Ældre Forsigtighed bør udvises ved behandling af ældre patienter.
English: Depression, suicidal ideation and behaviour
Danish: Depression, selvmordstanker og -adfærd
English: Food delays the time to reach the peak concentration from 6 to 10 hours and it marginally decreases the extent of absorption (approximately 11 %).
Danish: Fødeindtagelse udsætter tidspunktet for opnåelse af den maksimale serumkoncentration fra 6 til 10 timer og mindsker omfanget af absorptionen marginalt (omtrent 11%).
English: However, if it is time for your next dose, skip the missed dose and take only a single dose as usual.
Danish: Hvis det allerede er blevet tid til Deres næste dosis, skal De springe den glemte dosis over og blot tage en enkelt dosis, som De plejer.
English: Orgasm abnormal Abnormal dreams
Danish: Abnorm orgasme Abnorme drømme
English: • Tell your doctor if you become pregnant, or you are trying to become pregnant, while you are taking YENTREVE.
Danish: • Fortæl Deres læge, hvis De bliver gravid, eller hvis De prøver at blive gravid, mens De tager YENTREVE.
English: These effects are normally mild to moderate and often disappear after a short time.
Danish: Bivirkningerne er normalt milde til moderate og forsvinder ofte efter en kort periode.
English: These symptoms usually begin during the first 24 hours after the baby is born.
Danish: Symptomerne opstår som regel inden for de første 24 timer efter at barnet er født.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit risk profile or as the result of an important (pharmacovililance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk -forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: YENTREVE is for oral use.
Danish: YENTREVE er til oral brug.
English: After 2-4 weeks of treatment, patients should be re-assessed in order to evaluate the benefit and tolerability of the therapy.
Danish: Efter 2-4 ugers behandling bør patienten evalueres med henblik på vurdering af virkning og bivirkninger af behandlingen.
English: If you miss a dose, take it as soon as you remember.
Danish: Glemmer De at tage en dosis, skal De tage den, så snart De kommer i tanke om det.
English: These symptoms are usually not serious and disappear within a few days, but if you have symptoms that are troublesome you should ask your doctor for advice.
Danish: Disse symptomer er normalt ikke alvorlige og forsvinder inden for få dage, men hvis De oplever meget generende symptomer, skal De rådføre Dem med lægen.
English: • tinnitus (hearing sound in the ear when there is no external sound), ear pain
Danish: • tinnitus (opfattelse af lyd i øret, når der ingen lyd er), ørepine
English: The recommended dose of YENTREVE is 40 mg twice a day (in the morning and late afternoon/evening).
Danish: Den anbefalede dosis af YENTREVE er 40 mg to gange dagligt (om morgenen og sent eftermiddag/aften).
English: • falls (mostly in elderly people), abnormal gait
Danish: • fald (oftest hos ældre), unormal gangart
English: However, limited data are available to support the efficacy of YENTREVE 20 mg twice daily.
Danish: Der er dog begrænset data tilgængelig til at understøtte effekten af YENTREVE 20 mg to gange dagligt.
English: Check with your doctor if you are already taking other medicines containing duloxetine.
Danish: Spørg Deres læge, om De allerede tager andre lægemidler indeholdende duloxetin.
English: • If you take YENTREVE near the end of your pregnancy, your baby might have some symptoms when it is born.
Danish: • Hvis De tager YENTREVE i slutningen af graviditeten, kan Deres barn udvise visse symptomer når det bliver født.
English: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
Danish: Depression er forbundet med en øget risiko for selvmordstanker, at forvolde skade på sig selv og selvmord (selvmordsrelaterede handlinger).
English: Patients should be instructed that if they experience sedation or dizziness they should avoid potentially hazardous tasks such as driving or operating machinery.
Danish: Patienter bør informeres om, at hvis de oplever sedation eller svimmelhed, bør de undgå mulige farlige aktiviteter såsom bilkørsel og betjening af maskiner.
English: Suicidal behaviour5,6
Danish: Selvmords relateret adfærd5,6
English: • Make sure your midwife and/or doctor knows you are on YENTREVE.
Danish: • De skal sikre Dem, at Deres jordemoder og/eller læge ved, at De tager YENTREVE.
English: YENTREVE increases the levels of serotonin and noradrenaline in the nervous system.
Danish: YENTREVE øger indholdet af serotonin og noradrenalin i nervesystemet.
English: Your doctor will tell you if you should be taking YENTREVE.
Danish: Deres læge vil fortælle Dem, om De skal tage YENTREVE.
English: Dose escalation may decrease, though not eliminate, the risk of nausea and dizziness.
Danish: Dosiseskalering kan sænke, men ikke udelukke, risikoen for kvalme og svimmelhed.
English: In these women, YENTREVE may provide no benefit beyond that afforded by more conservative behavioural interventions.
Danish: For disse kvinder kan YENTREVE nok ikke yde nogen fordele ud over det som konservativ livsstilsomlægninger kan bidrage med.
English: Differences were observed at each visit after 4 weeks (duloxetine 54% and placebo 22%), 8 weeks (52% and 29%), and 12 weeks (52% and 33%) of medication.
Danish: Forskellene blev observeret ved hvert besøg efter medicinering i 4 uger (duloxetin 54% og placebo 22%), 8 uger (52% og 29%) og 12 uger (52% og 29%).
English: Polyvinylchloride (PVC), polyethylene (PE), and polychlorotrifluoroethylene (PCTFE) blister sealed with an aluminium foil.
Danish: Polyvinylchlorid (PVC), polyethylen (PE) og polychlorotrifluoroethylen (PCTFE) blister forseglet med aluminiumfolie.
English: You should take extra care if you drink alcohol while taking YENTREVE.
Danish: De bør udvise forsigtighed, hvis De drikker alkohol samtidig med, at De er i behandling med YENTREVE.
English: de la Industria Nº 30, 28108 Alcobendas Madrid
Danish: Avenida de la Industria No 30 28108 Alcobendas Madrid
English: YENTREVE should not be used for children and adolescents under 18 years.
Danish: YENTREVE bør ikke bruges til behandling af børn og unge under 18 år.
English: These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
Danish: Særlig i starten af behandlingen med antidepresssiva kan disse tanker blive forstærket, da det tager nogen tid før denne slags medicin virker, sædvanligvis omkring to uger, men af og til længere.
English: It is recommended that consideration be given to concomitant PFMT.
Danish: Det anbefales at overveje samtidig bækkenbundstræning.
English: Your doctor should decide whether you can take YENTREVE with other medicines.
Danish: Deres læge bør afgøre, om YENTREVE kan tages sammen med anden medicin.
English: Limited data suggest that the plasma levels of duloxetine are higher in these patients.
Danish: Begrænsede data tyder på at duloxetin plasmaniveauet hos disse patienter er højere.
English: In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Danish: Derudover mangler der data for langtidssikkerheden hos børn og unge hvad angår vækst, modning, kognitivudvikling og adfærdsudvikling.
English: Physicians should encourage patients to report any distressing thoughts or feelings or depressive symptoms at any time.
Danish: Læger bør opfordre patienterne til at rapportere, hvis de på noget tidspunkt er bekymrede over deres tanker, følelser eller depressive symptomer.
English: You may be more likely to think like this if you: - have previously had thoughts about killing or harming yourself - are a young adult.
Danish: De vil mere sandsynligt tænke på dette, hvis De: - tidligere har haft tanker om at begå selvmord eller at skade Dem selv.
English: Age: Pharmacokinetic differences have been identified between younger and elderly females (≥65 years) (AUC increases by about 25% and half-life is about 25% longer in the elderly), although the magnitude of these changes is not sufficient to justify adjustments to the dose.
Danish: Alder: Der er fundet farmakokinetiske forskelle mellem yngre og ældre kvinder (≥ 65 år) (AUCværdien forøges med ca. 25%, og halveringstiden er ca. 25% længere hos ældre), selv om størrelsesordenen på disse forandringer ikke er tilstrækkelig til at retfærdiggøre dosisjusteringer.
English: The clinical benefit of YENTREVE compared with placebo has not been demonstrated in women with mild SUI, defined in randomised trials as those with IEF < 14 per week.
Danish: Den kliniske fordel ved YENTREVE sammenlignet med placebo er ikke blevet undersøgt hos kvinder med let SUI, defineret i randomiserede studier som kvinder med IEF < 14 om ugen.
English: The pharmacokinetics of duloxetine demonstrate large intersubject variability (generally 50-60%), partly due to gender, age, smoking status and CYP2D6 metaboliser status.
Danish: Duloxetins farmakokinetik viser stor variation mellem patienter (generelt 50-60%), delvist på grund af køn, alder, ryger ikkeryger status og CYP2D6 metaboliseringsstatus.