natgillin/translations-raw huggingface dataset:
Der er hovedsagelig rapporteret om fejlagtig daglig brug i stedet for ugentlig brug af methotrexat ved orale formuleringer i ikke-onkologiske indikationer, primært reumatoid artritis og psoriasis, men dette ses også ved brug af parenterale formuleringer, ligesom der er mange rapporter, hvor indgivelsesvejen ikke er angivet. 
While daily instead of once weekly use of methotrexate was mainly reported with oral dosage forms in non-oncologic indications, predominantly rheumatoid arthritis and psoriasis, there were also cases with the use of parenteral formulations, as well as many reports which did not specify the route of administration.
På trods af de risikominimerende foranstaltninger sker der stadig medicineringsfejl i EU/EØS. 
In EU/EEA, despite the risk minimisation measures in place, cases of medication errors are still occurring.
Derfor vurderer PRAC, at den visuelle påmindelse, der skal anføres på den ydre emballage for orale formuleringer af methotrexat, også bør anføres på den ydre emballage for parenterale formuleringer af methotrexat, hvor der er mindst én indikation, der kræver indgivelse én gang ugentligt, og at den korte advarsel, der skal anføres på den indre emballage for orale formuleringer, også bør anføres på den mellemliggende (hvis relevant) og indre emballage for parenterale formuleringer. 
For this reason, the PRAC was of the view that the visual reminder agreed for the outer packaging of the oral formulations of methotrexate should also be implemented on the outer packaging of the parenteral formulations of methotrexate with at least one indication requiring once weekly dosing, and that the shorter warning agreed for the immediate packaging of the oral formulations should be implemented on the intermediate (where applicable) and immediate packaging of the parenteral formulations.
Hvad angår alle tabletformuleringer af methotrexat, er det også blevet vedtaget, at de beholdere og rør, der aktuelt anvendes som indre emballage, bør udskiftes med blisterkort. 
It was also agreed that for all tablet formulations of methotrexate, bottles and tubes currently used as immediate packaging should be replaced by blisters.
• PRAC vurderer, at der er behov for at skærpe de nuværende risikominimerende foranstaltninger ved at tilføje advarsler i produktinformationen og anføre visuelle påmindelser på den ydre, mellemliggende og indre emballage for methotrexat-holdige lægemidler med mindst én indikation, der kræver indgivelse én gang ugentligt (for både oral og parenteral anvendelse). 
• The PRAC concluded that there is a need to further strengthen the current risk minimisation measures by adding warnings in the product information and visual reminders on the outer, intermediate and immediate packaging of methotrexate-containing medicinal products with at least one indication requiring a once weekly dosing, for both oral and parenteral use;
For at minimere risikoen for ordineringsfejl, som skyldes manglende viden hos den læge, der ordinerer methotrexat til indgivelse én gang ugentligt ved behandling af autoimmune sygdomme, vurderer PRAC, at methotrexat udelukkende bør ordineres af læger med ekspertise i anvendelse af methotrexat og fuld forståelse af risiciene ved methotrexat-behandling. 
To minimise the risk of prescribing errors due to lack of knowledge by the prescriber of the weekly dosing schedule of methotrexate for the treatment of auto-immune diseases, the PRAC was of the view that methotrexate should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy.
Ud fra de tilgængelige data har PRAC bemærket, at ovenfor omtalte risiko for medicineringsfejl kan ses i alle stadier af medicineringsprocessen fra ordinering til indgivelse. 
Based on the available data, the PRAC noted that the abovementioned risk of medication errors can occur at all stages of the medication process, from prescription to administration.
I lyset af ovenstående vurderer udvalget, at benefit/risk-forholdet for methotrexat-holdige lægemidler fortsat er positivt under forudsætning af, at de vedtagne betingelser for markedsføringstilladelserne og de vedtagne ændringer af produktinformationen og øvrige risikominimerende foranstaltninger gennemføres. 
In view of the above, the Committee considers that the benefit-risk balance of methotrexatecontaining medicinal products remains favourable subject to the agreed conditions to the marketing authorisations, and taking into account the agreed amendments to the product information and other risk minimisation measures.
Risikoen for medicineringsfejl, der skyldes fejlagtig daglig dosering i stedet for ugentlig dosering, er en væsentlig identificeret risiko, og for alle methotrexat-holdige lægemidler, hvor der kræves yderligere risikominimerende foranstaltninger for at imødegå denne risiko (dvs. udskiftning af beholdere/rør med blisterkort, anvendelse af informationsmateriale og patientkort), bør der udarbejdes en risikostyringsplan (RMP) med angivelse af alle vedtagne lægemiddelovervågningsaktiviteter og risikominimerende foranstaltninger. 
The risk of medication errors due to inadvertent daily instead of once weekly dosing is an important identified risk and all methotrexate-containing products for which additional risk minimisation measures are required to address this risk (i.e. replacement of bottles/tubes by blisters, implementation of educational material and patient card), should have a risk management plan (RMP) in place listing all pharmacovigilance activities and risk minimisation measures agreed.
CHMP anbefaler derfor, at betingelserne for markedsføringstilladelse for methotrexat-holdige lægemidler ændres. 
Therefore the CHMP recommends the variation to the terms of the marketing authorisations for methotrexate-containing medicinal products.
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). 
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).
• 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. 
• 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.
En sådan praksis anbefales ikke, da det samlet set vurderes, at den kan give mere forvirring og føre til flere medicineringsfejl. 
Overall, it was considered that such practice may generate more confusion and lead to more medication errors and should therefore not be recommended.
For at løse dette problem anbefaler PRAC, at bulkpakninger som f.eks. beholdere og rør bør udskiftes med blisterkort for alle tabletformuleringer af methotrexat. 
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.
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. 
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.
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. 
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.
Udvalget anbefaler derfor, at betingelserne for markedsføringstilladelse for methotrexat-holdige lægemidler ændres. 
The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for methotrexate-containing medicinal products.
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. 
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.
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. 
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.
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. 
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.
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. 
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.
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 
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).
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 
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.
Brugen af flere end et af disse produkter samtidig bør undgås. 
The use of more than one of these products concomitantly should be avoided.
Risikoen forbliver, indtil der er signifikant remission. 
This risk persists until significant remission occurs.
Dato for første markedsføringstilladelse: 11. august 2004 Dato for seneste fornyelse: 24. juni 2009 
Date of first authorisation: 11 August 2004 Date of latest renewal: 24 June 2009
8 Fald var hyppigst hos ældre (≥65 år). 
8 Falls were more common in the elderly (≥65 years old).
De skal synke kapslen hel sammen med et glas vand. 
You should swallow your capsule whole with a drink of water.
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). 
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).
YENTREVE er indiceret til voksne. 
YENTREVE is indicated in adults.
Det kan være lettere at huske at tage YENTREVE, hvis De tager det på samme tidspunkter hver dag. 
To help you remember to take YENTREVE, you may find it easier to take it at the same times every day.
Nogle patienter, som pludselig holdt op med at tage YENTREVE efter mere end 1 uges behandling, fik symptomer såsom: 
Some patients, who suddenly stop taking YENTREVE after more than 1 week of therapy, have had symptoms such as:
Fordelene ved behandling bør undersøges regelmæssigt. 
The benefit of treatment should be re-assessed at regular intervals.
De skal også kontakte Deres læge, hvis De tager noget af følgende: 
You should also tell your doctor if you are taking any of the following:
Hvis den ikke behandles, vil De måske ikke få det bedre, og Deres tilstand kan forværres og blive sværere at behandle. 
If it is not treated, your condition may not go away and may become more serious and difficult to treat.
Hvis lægen mener, at De ikke længere behøver at tage YENTREVE, vil denne bede Dem reducere dosis over 2 uger. 
If your doctor thinks that you no longer need YENTREVE he or she will ask you to reduce your dose over 2 weeks.
De må ikke køre bil eller arbejde med værktøj eller maskiner, før De ved, hvordan YENTREVE påvirker Dem. 
Do not drive or use any tools or machines until you know how YENTREVE affects you.
Relevansen af disse data for mus i forhold til mennesker kendes ikke. 
The relevance of this mouse data to humans is unknown.
De fleste skete inden for de første måneder af behandlingen. 
Most of them occurred during the first months of treatment.
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. 
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.
Deres læge eller jordemoder skal gøres opmærksom på, at De tager duloxetin, så de kan rådgive Dem. 
Your doctor or midwife should be aware that you are taking duloxetine so they can advise you.
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. 
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.
De må IKKE holde op med at tage kapslerne uden at have konsulteret Deres læge, heller ikke selv om De har fået det bedre. 
DO NOT stop taking your capsules without the advice of your doctor even if you feel better.
Hvis der alligevel tages en beslutning om at behandle på baggrund af kliniske behov, skal patienten nøje overvåges for opdukken af selvmordssymptomer. 
If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms.
Fordeling: Duloxetin har en cirka 96% binding til humane plasmaproteiner. 
Distribution: Duloxetine is approximately 96% bound to human plasma proteins.
Ældre Forsigtighed bør udvises ved behandling af ældre patienter. 
Elderly Caution should be exercised when treating the elderly.
Depression, selvmordstanker og -adfærd 
Depression, suicidal ideation and behaviour
Fødeindtagelse udsætter tidspunktet for opnåelse af den maksimale serumkoncentration fra 6 til 10 timer og mindsker omfanget af absorptionen marginalt (omtrent 11%). 
Food delays the time to reach the peak concentration from 6 to 10 hours and it marginally decreases the extent of absorption (approximately 11 %).
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. 
However, if it is time for your next dose, skip the missed dose and take only a single dose as usual.
Abnorm orgasme Abnorme drømme 
Orgasm abnormal Abnormal dreams
• Fortæl Deres læge, hvis De bliver gravid, eller hvis De prøver at blive gravid, mens De tager YENTREVE. 
• Tell your doctor if you become pregnant, or you are trying to become pregnant, while you are taking YENTREVE.
Bivirkningerne er normalt milde til moderate og forsvinder ofte efter en kort periode. 
These effects are normally mild to moderate and often disappear after a short time.
Symptomerne opstår som regel inden for de første 24 timer efter at barnet er født. 
These symptoms usually begin during the first 24 hours after the baby is born.
• 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. 
• 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.
YENTREVE er til oral brug. 
YENTREVE is for oral use.
Efter 2-4 ugers behandling bør patienten evalueres med henblik på vurdering af virkning og bivirkninger af behandlingen. 
After 2-4 weeks of treatment, patients should be re-assessed in order to evaluate the benefit and tolerability of the therapy.
Glemmer De at tage en dosis, skal De tage den, så snart De kommer i tanke om det. 
If you miss a dose, take it as soon as you remember.
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. 
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.
• tinnitus (opfattelse af lyd i øret, når der ingen lyd er), ørepine 
• tinnitus (hearing sound in the ear when there is no external sound), ear pain
Den anbefalede dosis af YENTREVE er 40 mg to gange dagligt (om morgenen og sent eftermiddag/aften). 
The recommended dose of YENTREVE is 40 mg twice a day (in the morning and late afternoon/evening).
• fald (oftest hos ældre), unormal gangart 
• falls (mostly in elderly people), abnormal gait
Der er dog begrænset data tilgængelig til at understøtte effekten af YENTREVE 20 mg to gange dagligt. 
However, limited data are available to support the efficacy of YENTREVE 20 mg twice daily.
Spørg Deres læge, om De allerede tager andre lægemidler indeholdende duloxetin. 
Check with your doctor if you are already taking other medicines containing duloxetine.
• Hvis De tager YENTREVE i slutningen af graviditeten, kan Deres barn udvise visse symptomer når det bliver født. 
• If you take YENTREVE near the end of your pregnancy, your baby might have some symptoms when it is born.
Depression er forbundet med en øget risiko for selvmordstanker, at forvolde skade på sig selv og selvmord (selvmordsrelaterede handlinger). 
Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
Patienter bør informeres om, at hvis de oplever sedation eller svimmelhed, bør de undgå mulige farlige aktiviteter såsom bilkørsel og betjening af maskiner. 
Patients should be instructed that if they experience sedation or dizziness they should avoid potentially hazardous tasks such as driving or operating machinery.
Selvmords relateret adfærd5,6 
Suicidal behaviour5,6
• De skal sikre Dem, at Deres jordemoder og/eller læge ved, at De tager YENTREVE. 
• Make sure your midwife and/or doctor knows you are on YENTREVE.
YENTREVE øger indholdet af serotonin og noradrenalin i nervesystemet. 
YENTREVE increases the levels of serotonin and noradrenaline in the nervous system.