natgillin/translations-raw huggingface dataset:
Resultaterne af studierne af lægemiddelanvendelse viste, at ca. 9 % af de patienter, der blev udsat for HES-infusionsvæske, opløsning, var kritisk syge, ca. 5-8 % havde nedsat nyrefunktion, og ca. 3-4 % havde sepsis. 
Amendments to be included in the product information The DUSs results showed that approximately 9% of patients exposed to HES solutions for infusion were critically ill, approximately 5-8% of patients had renal impairment and approximately 3-4% of patients had sepsis.
• Desuden overvejede PRAC andre mulige foranstaltninger til yderligere minimering af disse risici, herunder ændringer i produktinformationen, direkte breve til sundhedspersoner, oplysningsmateriale, advarsel på den primære produktemballage, udfyldelse af medicinblanketter og receptlister/checklister og begrænsning af adgangs- og distributionssystemet til akkrediterede hospitaler/læger. 
• Furthermore, the PRAC considered options for measures to further mitigate these risks, including changes to the product information, direct health care professional communication, educational materials, warning on the primary container of the products, sign-in for medication form, prescription sheet/checklists, restricted access and distribution system to accredited hospitals/physicians.
CMDh tog stilling til PRAC's reviderede anbefaling om at suspendere markedsføringstilladelserne for infusionsvæsker, opløsninger, der blev vedtaget på PRAC's plenarmøde i maj. CMDh tog desuden hensyn til besvarelserne af Europa-Kommissionens spørgsmål og de elementer, der var indsamlet af PRAC, samt oplysningerne fremlagt af indehaveren af markedsføringstilladelse ved de mundtlige redegørelser den 28. maj 2018 og 25. juni 2018. 
The CMDh took also into consideration the responses to the questions raised by the European Commission and the elements collected by the PRAC, as well as the information provided by the MAH during the oral explanations held on 28 May 2018 and 25 June 2018.
Fordelen ved HES-infusionsvæske, opløsning, er påvist som volumenbesparende effekt, og der er i nogen grad holdepunkt for kortvarige hæmodynamiske virkninger, dog med nogen usikkerhed om, hvordan dette omsættes til mere patientrelevante udfald. 
The benefit of HES solutions for infusion has been demonstrated in terms of volume-sparing effect, and there is some support for effects on short-term hemodynamic effects, although there is some uncertainty to what extent this translates into more patient-relevant outcomes.
Resultaterne af to studier af lægemiddelanvendelse vedrørende effektiviteten af de gennemførte risikominimerende foranstaltninger, blev tilgængelige 5. juli 2017 og 9. oktober 2017. 
On 5th July 2017 and 9th October 2017, results from two DUSs on the effectiveness of the implemented risk minimisation measures have become available.
Som resultat af henvisningen i 2013 blev indehaveren af markedsføringstilladelsen pålagt at udføre studier efter markedsføring under disse kliniske betingelser som et vilkår for markedsføringstilladelserne for HESinfusionsvæske, opløsning. 
As an outcome of the 2013 referral, post-authorisation studies were imposed to the MAHs in these clinical settings and are a condition to the terms of the MAs for HES solutions for infusion.
CHMP henstiller derfor ændring af betingelserne for markedsføringstilladelserne for HESinfusionsvæske, opløsninger. 
Therefore the CMDh recommends the variation to the terms of the marketing authorisations for HES solutions for infusion.
• Det vedgås, at der er vanskeligheder ved efteruddannelse, men de vil kunne imødegås ved centraliseret tilrettelæggelse og overvågning fra indehaveren af markedsføringstilladelsen. 
• Whilst acknowledging the difficulties of continuous training, centralising such organisation and monitoring by the MAH will address the challenges raised.
- Indehaveren af markedsføringstilladelsen afholder regelmæssigt oplæring i korrekt brug af HES-infusionsvæske, opløsning, for relevante sundhedspersoner efter aftale med de nationale kompetente myndigheder. 
- The MAH should deliver the training on the appropriate use of HES solutions for infusion to relevant HCPs on a regular basis, as agreed with the national competent authorities.
PRAC konkluderede, at det ikke vil være effektivt eller realistisk at indføre yderligere risikominimerende foranstaltninger til opnåelse af sikker og effektiv anvendelse af HES-opløsninger til infusion inden for en rimelig tid, og at et stort antal højrisikopatienter stadig ville blive eksponeret. 
The PRAC concluded that no additional risk minimisation measures to ensure safe and effective use of HES solutions for infusion would be effective or feasible in a reasonable timeframe, where important number of patients at high risk would continue to be exposed.
Begrundelse for afvigelserne fra PRAC's anbefaling 
Grounds for differences with the PRAC recommendation
Det kan også være problematisk at skulle udfylde medicinblanketter/checklister i nødsituationer. 
The medication form/checklists would also raise feasibility issues in an emergency setting.
PRAC vurderede også, at anvendelsen af HES-infusionsvæske, opløsning, hos patienter med sepsis eller kritisk sygdom er kontraindiceret. 
The PRAC also contraindicated the use of HES solutions for infusion in patients with sepsis or who are critically ill.
PRAC var navnlig bekymret over, at ca. 9 % af de patienter, der blev eksponeret for HES-opløsninger til infusion, havde kritisk sygdom, ca. 5-8 % havde nedsat nyrefunktion, og ca. 3-4 % havde sepsis. 
Overall non-adherence to the revised product information was reported to be high, and PRAC was particularly concerned that approximately 9% of patients exposed to HES solutions for infusion were critically ill, approximately 5-8% of patients had renal impairment and approximately 3-4% of patients had sepsis.
Disse studier såvel som igangværende frivillige kliniske studier (f.eks. FLASH-studiet) ville nærmere karakterisere virknings- og sikkerhedsprofilen ved elektiv kirurgi og for traumepatienter. 
FLASH study) would further characterise the efficacy and safety profile in elective surgery and trauma patients.
PRAC henstillede også til, at anvendelsen af disse lægemidler bør undersøges med henblik på at vurdere effektiviteten af de risikominimerende foranstaltninger. 
The PRAC also required that drug utilisation should be studied to evaluate the effectiveness of the risk minimisation measures.
CMDh noterede sig navnlig resultaterne af en høring af medlemsstaterne, hvor suspenderingen af markedsføringstilladelsen for HES-infusionsvæske, opløsning, ville få indflydelse på klinisk praksis, hvor HES beskrives som en egnet behandlingsmulighed. 
• In particular, the CMDh noted the results of a consultation of Member States where the suspension of the marketing authorisation for HES solutions for infusion would have an impact on the clinical practice and concerns raised by those EU Member States about a potential medical need.
PRAC overvejede yderligere risikominimerende foranstaltninger for at opnå tilstrækkelig minimering af eksponeringen, herunder ændringer i produktinformationen, et brev direkte til sundhedspersoner, oplysningsmateriale, advarsel på den primære produktemballage, udfyldelse af medicinblanketter, receptlister/checklister. 
The PRAC considered other further risk minimisation measures to sufficiently minimise this exposure, including changes to the product information, direct health care professional communication, educational materials, warning on the primary container of the products, sign-in for medication form, prescription sheet/checklists.
fortsat er gunstigt, forudsat at de vedtagne ændringer af produktinformationen og betingelser for markedsføringstilladelsen gennemføres. 
As a consequence, the CMDh is of the position that the benefit-risk balance of HES solutions for infusion remains favourable subject to the agreed amendments to the product information and the conditions to the marketing authorisation.
- Indehaveren af markedsføringstilladelsen udarbejder uddannelsesmaterialet til de pågældende sundhedspersoner, der forventes at ordinere/administrere HES-infusionsvæske, opløsning, og aftaler dette materiales nøjagtige indhold og format med de pågældende nationale kompetente myndigheder. 
Therefore, the CMDh is of the position that each MAH shall be responsible for the implementation and the supervision of the access controlled program as follows: - The MAH should develop the training materials for relevant HCPs expected to prescribe / administer HES solutions for infusion and agree the exact content and format of these materials with the relevant national competent authorities.
CMDh anmodede om, at programmet for kontrolleret adgang var faktisk implementeret senest 9 måneder efter Kommissionens afgørelse, idet CMDh tog hensyn til forskellighederne mellem de nationale systemer foruden nødvendigheden af en aftale med de nationale kompetente myndigheder om de nærmere enkeltheder ved gennemførelsen af den kontrollerede adgang, og den tid, det tager at gennemføre tilstrækkelig oplæring af alle sundhedspersoner, der er bestemt til at anvende HESprodukter, samt akkrediteringen af hospitaler/centre. 
Having considered the specificities of the national systems and the need for agreement with the national competent authorities on the details on the implementation of the controlled access and the time required to complete the adequate training to all HCPs intended to use HES products and the accreditation of the hospitals/ centres, the CMDh requested that the controlled access program should be effectively implemented at the latest 9 months after Commission Decision.
Den tilgængelige evidens viser imidlertid, at den manglende overholdelse ikke kun skyldes de ordinerende lægers manglende bevidsthed om begrænsningerne, men også i nogle tilfælde kan tilskrives bevidste valg. 
However, the available evidence shows that the non-adherence is not only due to a lack of awareness of the restrictions by prescribers but also due in some cases to deliberate choice, rendering further communication and education unlikely to be sufficiently effective to address the risks identified.
Forslagene om at ændre indikationerne og kontraindikationerne vurderes ikke at kunne påvirke de ordinerende lægers adfærd i tilstrækkelig grad. PRAC bemærkede også, at aktuel klinisk erfaring viser, at det er vanskeligt at foretage en klar sondring mellem de patientpopulationer, hvor der i randomiserede kliniske studier er set alvorlig skade, og de populationer, der er omfattet af den godkendte indikation. 
The PRAC also noted that the current clinical experience suggests that it is difficult to clearly separate patient populations where randomised clinical trials have shown serious harm from populations targeted by the approved indication.
Den tilgængelige evidens viser imidlertid, at den manglende overholdelse ikke kun skyldes de ordinerende lægers manglende bevidsthed om begrænsningerne. 
However, the available evidence shows that the non-adherence is not only due to a lack of awareness of the restrictions by prescribers, rendering further communication and education unlikely to be sufficiently effective.
• CMDh hæftede sig navnlig ved resultaterne af en høring af medlemsstaterne, hvor suspenderingen af markedsføringstilladelsen for HES-infusionsvæske, opløsning. 
In particular, the CMDh noted the results of a consultation of Member States where the suspension of the
På baggrund af CMDh's indblik i de nationale sundhedssystemer fandt det, at følgende supplerende risikominimeringsforanstaltninger er gennemførlige og må forventes effektivt at ville minimere risikoen for, at HES-infusionsvæske, opløsning. 
In view of the insight that the CMDh has on the national healthcare systems, it agreed that the following additional risk minimisation measures are feasible and likely to be effective to minimise the risk of using HES solutions for infusion in contraindicated populations: the inclusion of an emphasised warning on the SmPC, PL, primary and secondary packaging, the circulation of a targeted DHPC and the implementation of a controlled access program.
Der anføres en advarsel om ikke at anvende HES-infusionsvæske, opløsning, hos patienter med sepsis, nedsat nyrefunktion eller kritisk sygdom, øverst i produktresuméet og indlægssedlen for at henlede opmærksomheden hos modtagerne af produktinformationen på de ovenfor beskrevne kliniske situationer. 
In order to prompt the attention of the recipients of the product information on the clinical situations above described, a warning to not use HES solutions for infusion in septic, renal impaired and critically ill patients should be mentioned at the top of the SmPC and PL.
- en påmindelse om indikation, dosis, behandlingsvarighed, kontraindikationer og nødvendigheden af at overholde produktinformationen, 
The above training materials should be based on the following key elements: - the risks related to the use of HES solutions for infusion outside the terms of the MA, - a reminder of the indication, dose, duration of treatment and contraindications and the need to comply with the product information, - the new additional risk minimisation measures, - the results from the DUSs.
Fokus for studierne af lægemiddelanvendelsen har været at vurdere, om man overholder de begrænsninger af anvendelsen,der er anført i 
The focus for the drug utilisation studies (DUSs) has been to evaluate the adherence to the restrictions in use, implemented in the product information, concerning the indication, posology, and contraindication for HES solutions for infusion.
Indgivelsesvej Emballage Pakningsstørrelse 
Packaging Package size
- er mere end 3 måneder henne i graviditeten. 
- are more than 3 months pregnant.
Ældre (65 år og derover) 
Elderly (65 years and over)
Du kan tage dette lægemiddel med eller uden mad. 
You can take this medicine with or without food.
Du skal blot tage den næste dosis til sædvanlig tid. 
Just take the next dose at the usual time.
Dato for første markedsføringstilladelse: 7. december 2011 Dato for seneste fornyelse: 
Date of first authorisation: 7 December 2011 Date of latest renewal:
Det er vigtigt, at fortsætte med at tage Edarbi på samme tidspunkt hver dag. 
It is important to keep taking Edarbi every day at the same time.
Elimination Efter en oral dosis på 
Elimination Following an oral dose of
- har hjerteproblemer (herunder dårligt hjerte, nyligt hjerteanfald) 
- have heart problems (including heart failure, recent heart attack).
Man skal dog være opmærksom på, at der kan forekomme lejlighedsvis svimmelhed eller træthed. 
However it should be taken into account that occasionally dizziness or tiredness may occur.
Se også information under overskriften ”Tag ikke Edarbi” 
See also information under the heading “Do not take Edarbi”.
Dette lægemiddel må derfor ikke bruges til børn eller unge. 
Therefore, this medicine should not be given to children or adolescents.
Mange af disse forhøjelser var forbigående eller ikke-progressive, mens patienterne fortsat modtog behandling. 
Many of these elevations were transient or nonprogressive while subjects continued to receive treatment.
51 % af patienterne var mænd og 26 % var 65 år eller ældre (5 % ≥ 75 år); 67 % var hvide og 19 % var negroide. 
Overall, 51% of patients were male and 26% were 65 years or older (5% ≥ 75 years); 67% were white and 19% were black.
Hyppigheden for denne virkning er størst, når amlodipin tages alene. 
The frequency of this effect is highest when amlodipine is taken alone.
Incidensen af bivirkninger med denne behandling var ikke påvirket af køn, alder eller race. 
The incidence of adverse reactions with this treatment was not affected by gender, age, or race.
(Du skal desuden helst undgå at tage dette lægemiddel tidligt i graviditeten - se afsnittet om graviditet.) 
(It is also better to avoid this medicine in early pregnancy - see pregnancy section).
Tabletten skal synkes med rigeligt vand. 
Take the tablet with plenty of water.
Denne medicin anvendes til behandling af forhøjet blodtryk (essentiel hypertension) hos voksne patienter (over 18 år). 
This medicine is used for treating high blood pressure (essential hypertension) in adult patients (over 18 years of age).
Essentiel hypertension 
Essential hypertension
Hvis der skulle opstå symptomatisk hypotension, skal der iværksættes understøttende behandling, og de vitale tegn skal monitoreres. 
If symptomatic hypotension should occur, supportive treatment should be instituted and vital signs monitored.
Risikoen for tilsvarende virkninger med Edarbi kan ikke udelukkes. 
The possibility of similar effects cannot be excluded with Edarbi.
Den placebokorrigerede trough-to-peak ratio for SBP og DBP var ca. 80 % eller højere. 
The placebo-corrected trough-to-peak ratios for SBP and DBP were approximately 80% or higher.
Edarbi er indiceret til behandling af essentiel hypertension hos voksne. 
Edarbi is indicated for the treatment of essential hypertension in adults.
Azilsartan metaboliseres til to primære metabolitter. 
Azilsartan is metabolised to two primary metabolites.
Du må derfor ikke stoppe med at tage Edarbi uden først at talt med din læge om andre behandlingsmuligheder. 
Therefore do not stop taking Edarbi without first talking to your doctor about alternative treatment options.
Supplerende oplysninger 
Additional information
Denne indlægsseddel blev senest godkendt den {MM/YYYY} 
This leaflet was last approved in {MM/YYYY}.
Dosis kan øges til maksimalt 80 mg én gang dagligt til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret ved den lavere dosis. 
The dose may be increased to a maximum of 80 mg once daily for patients whose blood pressure is not adequately controlled at the lower dose.
Der er begrænsede data vedrørende brug af Edarbi til børn eller unge under 18 år. 
There is limited data on the use of Edarbi in children or adolescents under 18 years of age.
Hvis du holder op med at tage Edarbi, kan dit blodtryk stige igen. 
If you stop taking Edarbi, your blood pressure may increase again.
In vitro-studier indikerede, at interaktioner baseret på hæmning af esterase er usandsynlige. 
In vitro studies indicated that interactions based on esterase inhibition are unlikely.
Centralt sekundært endepunkt: 
Key Secondary End Point:
Bivirkningerne er opdelt efter frekvens ud fra følgende konvention: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), herunder isolerede indberetninger. 
These are ranked by 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), including isolated reports.
Hos patienter med mild, moderat og svært nedsat nyrefunktion var den totale azilsartaneksponering (AUC) forøget med +30 %, +25 % og +95 %. 
In patients with mild, moderate, and severe renal impairment azilsartan total exposure (AUC) was +30%, +25% and +95% increased.
Ældre 
Older people
Azilsartans farmakokinetik adskiller sig ikke signifikant mellem yngre (aldersinterval 18-45 år) og ældre (aldersinterval 65-85 år) patienter. 
Pharmacokinetics of azilsartan do not differ significantly between young (age range 18-45 years) and elderly (age range 65-85 years) patients.
Kravene til fremsendelse af PSUR'er for dette lægemiddel er anført på 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 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.
Det største enzym, der er ansvarligt for metabolisme af azilsartan, er CYP2C9. 
The major enzyme responsible for azilsartan metabolism is CYP2C9.
Primært endepunkt: 
Primary end point:
De gavnlige virkninger af Edarbi på mortalitet og kardiovaskulær morbiditet og målorganskade kendes ikke på nuværende tidspunkt. 
Beneficial effects of Edarbi on mortality and cardiovascular morbidity and target organ damage are currently unknown.
Denne virkning er også set med andre inhibitorer af RAAS. 
This effect is also seen with other inhibitors of the RAAS.
Såfrem denne kombination skønnes nødvendig, tilrådes tæt monitorering af serum-lithiumniveauet. 
If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
- har en alvorlig leversygdom 
- have severe liver disease.
Azilsartans steady-stateniveau opnås inden for 5 dage og der forekommer ingen ophobning i plasma ved gentagen dosering 1 gang dagligt. 
Steady-state levels of azilsartan are achieved within 5 days and no accumulation in plasma occurs with repeated once-daily dosing.
Azilsartan er i høj grad bundet til plasmaproteiner (> 99 %), hovedsagelig til serumalbumin. 
Azilsartan is highly bound to plasma proteins (> 99%), mainly serum albumin.
Edarbis sikkerhed og virkning hos børn og unge i alderen 0 til < 18 år er endnu ikke klarlagt. 
The safety and efficacy of Edarbi in children and adolescents aged 0 to < 18 years have not yet been established.
Påvirkning af kardial repolarisering 
Effect on cardiac repolarisation
Negroid population 
Black population
Pædiatrisk population Azilsartans farmakokinetik er ikke undersøgt hos børn under 18 år. 
Paediatric population The pharmacokinetics of azilsartan have not been studied in children under 18 years of age.
Edarbi er til oral brug og kan tages med eller uden mad (se pkt. 
Edarbi is for oral use and may be taken with or without food (see section 5.2).
Ændring fra BL -0,3 
Change from BL -0.3
Der blev ikke observeret en stigning (+5 %) hos patienter med terminal nyresygdom, der havde været i dialyse. 
No increase (+5%) was observed in end-stage renal disease patients who were dialysed.
Der er på nuværende tidspunkt ingen erfaring med anvendelse af Edarbi til patienter, der for nylig har fået foretaget en nyretransplantation. 
There is currently no experience on the use of Edarbi in patients who have recently undergone kidney transplantation.
Disse virkninger, der blev forebygget ved hjælp af oral saltvandstilskud, har ingen klinisk signifikans for behandlingen af hypertension. 
These effects, which were prevented by oral saline supplementation, do not have clinical significance in treatment of hypertension.
Ændring fra BL -1,8 
Change from BL -1.8
Karakteristika hos specifikke patientgrupper 
Characteristics in specific groups of patients
Edarbi i doser à 20, 40 eller 80 mg er blevet undersøgt for sikkerhed i kliniske studier hos patienter behandlet i op til 56 uger. 
Edarbi at doses of 20, 40 or 80 mg has been evaluated for safety in clinical studies in patients treated for up to 56 weeks.
Edarbi leveres i blisterpakninger med enten 14 eller 15 tabletter pakket i æsker, der indeholder 14, 28, 56 eller 98 tabletter, samt blisterpakninger med tørremiddel med enten 14 eller 15 tabletter pakket i æsker, der indeholder 14, 28, 30, 56, 90 eller 98 tabletter. 
Edarbi is provided in blisters with either 14 tablets or 15 tablets in cartons containing 14, 28, 56 or 98 tablets and blisters integrated with desiccant with either 14 tablets or 15 tablets in cartons containing 14, 28, 30, 56, 90 or 98 tablets.
Edarbi kan påvirke den måde andre lægemidler virker på, og andre lægemidler kan påvirke den måde Edarbi virker på. 
Edarbi can affect the way some other medicines work and some medicines can have an effect on Edarbi.
Edarbi blev sammenlignet med placebo og aktive komparatorer i to randomiserede, dobbeltblinde 6-ugers studier. 
Edarbi was compared with placebo and active comparators in two 6 week randomised, double blind studies.
Edarbi blokerer for denne virkning, således at blodkarrene kan slappe af, hvilket bidrager til at sænke dit blodtryk. 
Edarbi blocks this effect so that the blood vessels relax, which helps lower your blood pressure.
(hæmoglobin). 
(haemoglobin).