FrancophonIA/ELRC3.0 huggingface dataset:
English: Your child's doctor may prescribe an initial dose of 40 mg which may be administered one week prior to the start of the usual dose.
Danish: Dit barns læge kan ordinere en startdosis på 40 mg, som skal tages en uge før starten på den sædvanlige dosis.
English: How to use Kromeya
Danish: Sådan skal du tage Kromeya
English: Consequently, Kromeya can be used during breast-feeding.
Danish: Kromeya kan som konsekvens heraf anvendes ved amning.
English: Children and adolescents from 2 years of age weighing at least 30 kg
Danish: Børn og unge fra 2 år, som vejer mindst 30 kg.
English: c p = 0.031
Danish: < 0,001c
English: If this dose does not work well enough, your doctor may increase the dose frequency to 40 mg every week or 80 mg every other week.
Danish: Hvis denne dosis ikke virker godt nok, kan din læge øge dosisfrekvensen til 40 mg hver uge eller 80 mg hver anden uge.
English: Children and adolescents from 2 years of age weighing less than 30 kg
Danish: Børn og unge fra 2 år, som vejer mindre end 30 kg.
English: • If needed, for example when traveling, a single pre-filled syringe can be stored at room temperature for up to 14 days.
Danish: • En enkelt fyldt injektionssprøjte kan om nødvendigt opbevares ved stuetemperatur i op til 14 dage, f.eks. i forbindelse med rejser.
English: If these medicines do not work well enough, you will be given Kromeya to reduce the signs and symptoms of your disease.
Danish: Hvis denne medicin ikke virker godt nok, kan du få Kromeya for at mindske symptomerne på din sygdom.
English: 2.6 Peel off the paper from the vial adapter packaging without taking the vial adaptor out of its packaging.
Danish: Advarsel: Du må ikke røre ved toppen af hætteglasset, når du har renset den. 2.6 Fjern papiret fra hætteglasadapterens emballage uden at tage adapteren ud af emballagen.
English: Read carefully these entire instructions before using your Kromeya pre-filled syringe.
Danish: Læs hele brugsanvisningen grundigt, inden du begynder at bruge Kromeya fyldt injektionssprøjte.
English: Plunger Rod
Danish: Spids Rør
English: Syringe
Danish: Nykturi
English: Children, adolescents and adults from 2 years of age weighing 30 kg or more
Danish: Børn, unge og voksne fra 2 år, som vejer 30 kg eller mere.
English: Your child's doctor may prescribe an initial dose of 80 mg which may be administered one week prior to the start of the usual dose.
Danish: Din barns læge kan ordinere en startdosis på 80 mg, som skal tages en uge før starten på den sædvanlige dosis.
English: • Use your thumb to gently push plunger all the way down (Figure Q).
Danish: 6.4 Injicér • Med tommelfingeren skal du forsigtigt trykke stemplet helt i bund (figur Q).
English: Kromeya 40 mg solution for injection (injection) in pre-filled pen is supplied as a sterile 0.8 mL clear, colourless solution of 40 mg adalimumab.
Danish: Kromeya 40 mg injektionsvæske, opløsning i fyldt pen leveres som en steril 0,8 ml klar, farveløs opløsning af 40 mg adalumumab.
English: Children, adolescents and adults from 6 years of age weighing 30 kg or more
Danish: Børn, unge og voksne fra 6 år, der vejer 30 kg eller mere.
English: Warning: Do not throw away the syringe in your household trash.
Danish: Advarsel: Du må ikke smide injektionssprøjten i skraldespanden.
English: Note: P = Placebo (number at risk); A = Adalimumab (number at risk).
Danish: Note: P = Placebo (antal med risiko); H = Adalimumab (antal med risiko).
English: Kromeya 40 mg solution for injection in pre-filled syringe adalimumab
Danish: Kromeya 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte adalimumab
English: Time to treatment failure at or after week 6 in study UV I Primary analysis (ITT)
Danish: Tid til behandlingssvigt i eller efter uge 6 i Studie UV I Primær analyse (ITT) Placebo Adalimumab 110
English: Each pre-filled syringe contains 40 mg of adalimumab in 0.8 ml of solution.
Danish: Hver fyldt injektionssprøjte indeholder 40 mg adalimumab i 0,8 ml opløsning.
English: Your doctor may prescribe an initial dose of 40 mg which may be administered one week prior to the start of the usual dose.
Danish: Din læge kan ordinere en startdosis på 40 mg, som skal tages en uge før starten på den sædvanlige dosis.
English: Alcohol pads
Danish: Spritservietter
English: 3.3 Check the label to make sure that:
Danish: Figur J 3.3 Tjek etiketten for at sikre dig:
English: Kromeya 40 mg solution for injection (injection) in pre-filled syringe is supplied as a sterile 0.8 mL clear, colourless solution of 40 mg adalimumab.
Danish: Kromeya 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte leveres som en steril 0,8 ml klar, farveløs opløsning af 40 mg adalumumab.
English: Discontinuation of Kromeya therapy should be considered in patients with confirmed significant haematologic abnormalities.
Danish: Hos patienter med bekræftede signifikante hæmatologiske abnormiteter bør det overvejes at afbryde behandlingen med Kromeya.
English: Children, adolescents and adults from 6 years of age weighing 40 kg or more
Danish: Børn, unge og voksne fra 6 år, som vejer 40 kg eller mere.
English: Table 24 Paediatric CD study PCDAI clinical remission and response
Danish: Tabel 24 Pædiatrisk CD-studie PCDAI klinisk remission og respons Standard-dosis 40/20 mg hver anden uge N = 93
English: There is no relevant use of adalimumab in the paediatric population for the indications of ankylosing spondylitis and psoriatic arthritis.
Danish: Det er ikke relevant at bruge adalimumab hos børn under 4 år til denne indikation Psoriasisartrit og aksial spondyloartritis inklusive ankyloserende spondylitis Det er ikke relevant at bruge adalimumab til den pædiatriske population til indikationerne ankyloserende spondylitis og psoriatrisartrit.
English: Single use pre-filled syringe (adalimumab) for subcutaneous injection 40mg
Danish: Fyldt injektionssprøjte (adalimumab) til subkutan injektion 40 mg. Til engangsbrug.
English: RA Study III a**
Danish: RA-studie IIa**
English: Headache
Danish: Hætte
English: Renal impairment, haematuria
Danish: Nyreinsufficiens, hæmaturi
English: Needle covered
Danish: Beskyttet kanyle
English: 3.1 Check the syringe to make sure that: • The syringe, the clear needle guard, and the needle cap are not cracked or damaged (Figure G).
Danish: • at injektionssprøjten, den gennemsigtige kanylebeskyttelse og kanylehætten ikke er revnet eller beskadiget (figur G).
English: Bath Ankylosing Spondylitis Disease Activity Index
Danish: ASDASc inaktiv sygdom
English: It is important to tell your doctor if your child gets symptoms such as fever, wounds, feeling tired or dental problems.
Danish: Det er vigtigt at informere din læge, hvis dit barn får symptomer som feber, sår, træthedsfornemmelse eller tandproblemer.
English: • Do not use the Kromeya pre-filled syringe if it has been dropped or crushed, as the pre-filled syringe may be broken even if you cannot see the break.
Danish: • Du må ikke bruge Kromeya fyldt injektionssprøjte, hvis du er kommet til at tabe eller klemme
English: Kromeya dose for paediatric patients with uveitis
Danish: Kromeya-dosis til patienter med uveitis Patient vægt
English: Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis Age or body weight
Danish: De anbefalede doser af Kromeya, til hver af de godkendte anvendelser, er vist i følgende tabel: Rheumatoid artrit, psoriasisartrit, ankyloserende spondylitis eller aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis Alder eller vægt
English: • psoriatic arthritis,
Danish: • Psoriasisartrit,
English: Skin and subcutaneous tissue disorders
Danish: Pankreatit, dysfagi ansigtsødem
English: Syringe plunger
Danish: Nyrer og urinveje
English: b p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test c p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Danish: JSN score 2,0 (1,2-2,8) 1,3 (0,5-2,1) 0,5 (0-1,0) < 0,001 0,0037 0,151 ap-værdien for den parvise sammenligning af methotrexat-monoterapi og adalimumab/methotrexat-kombinationsbehandling ved anvendelse af Mann-Whitney U test. bp-værdien for den parvise sammenligning af adalimumab monoterapi og adalimumab/methotrexat-kombinationsbehandling ved anvendelse af Mann-Whitney U test cp-værdien for den parvise sammenligning af adalimumab monoterapi og methotrexat- monoterapi ved anvendelse af Mann-Whitney U test
English: 0.8 mL
Danish: 26,0a
English: Each vial contains 40 mg of adalimumab in 0.8 ml of solution.
Danish: Hvert hætteglas indeholder 40 mg adalimumab i 0,8 ml opløsning.
English: Each 0.8 ml single dose pre-filled pen contains 40 mg of adalimumab.
Danish: ANGIVELSE AF AKTIVT STOF En 0,8 ml fyldt pen indeholder 40 mg adalimumab.
English: ≥ 40 kg
Danish: ≥ 40 kg 20 mg
English: Your doctor may also prescribe an initial dose of 80 mg which may be administered one week prior to the start of the usual dose.
Danish: Din læge kan ordinere en startdosis på 80 mg, som skal tages en uge før starten på den sædvanlige dosis.
English: (up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at week 24) serum adalimumab concentrations were 8.8 ± 6.6 μg/mL for adalimumab without concomitant methotrexate and 11.8 ± 4.3 μg/mL with concomitant methotrexate.
Danish: Efter administration af 24 mg/m2 (op til maksimalt 40 mg) subkutant hver anden uge til patienter med entesopatirelateret artrit i alderen 6 til 17 år var den gennemsnitlige dal-serumkoncentration ved steady state af adalimumab (målt i uge 24) 8,8 ± 6,6 µg/ml for adalimumab uden samtidig methotrexat og 11,8 ± 4,3 µg/ml med samtidig methotrexat.
English: SPARCC
Danish: Score
English: Kromeya 40 mg/0.8 mL solution for injection for paediatric use
Danish: Kromeya 40 mg/0,8 ml injektionsvæske, opløsning til pædiatrisk brug.
English: Not applicable
Danish: UTILGÆNGELIGT FOR BØRN
English: one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later.
Danish: dage) efterfulgt af en dosis på 80 mg (som to 40 mg injektioner på samme dag) to uger senere.
English: Subcutaneous use Each item for single use only
Danish: Hver del kun til engangsbrug.
English: pen containing a pre-filled syringe (type I glass) with a 29G Thin-Wall, ½ inch needle with latex-free needle cap and a plunger stopper (synthetic rubber).
Danish: Kromeya, 40 mg injektionsvæske, opløsning i fyldt pen 0,8 ml opløsning i fyldt PhysiojectTM pen indeholdende en fyldt injektionssprøjte (type 1 glas) med en 29G-Thin-Wall, ½ inch kanyle med en latexfri kanylehætte og en stempelprop (syntetisk gummi).
English: Placebo/MTXAdalimumab/MTX (95% confidence interval b)
Danish: Placebo/MTXAdalimumab/MTX
English: It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.
Danish: Det er vigtigt, at du fortæller din læge, hvis du får symptomer på infektion såsom feber, sår, træthedsfornemmelse eller problemer med tænderne.
English: • 40 mg at week 0 and 20 mg at week 2
Danish: < 40 kg • 40 mg i uge 0 og 20 mg i uge 2
English: Instructions for use
Danish: Brugsvejledning
English: Non-serious allergic reactions associated with adalimumab were uncommon during clinical trials.Reports of serious allergic reactions including anaphylaxis have been received following adalimumab administration.
Danish: Der er modtaget rapporter om alvorlige allergiske reaktioner, inklusive anafylaksi, efter administration af adalimumab.
English: diverticulitis
Danish: • udslæt
English: Needle cap Liquid-filled syringe Barrel (inside)
Danish: Væskefyldt sprøjte Rør (indeni)
English: It is important to tell your doctor if you get symptoms such as fever, wounds, feeling tired or dental problems.
Danish: Det er vigtigt at informere din læge, hvis du får symptomer som feber, sår, træthedsfornemmelse eller tandproblemer.
English: Vial adapter
Danish: Mave-tarm-kanalen
English: Week 24 ***,** Statistically significant at p < 0.001, < 0.01 for all comparisons between adalimumab and placebo at weeks 2, 12 and 24
Danish: ***,** Statistisk signifikant på<0,001, <0,01 for alle sammenligning mellem adalimumab og placebo ved uge 2, 12 og 24 a Assessment in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
English: Cardiac disorders*
Danish: Nervesystemet *
English: Do not try to reinsert it and use a new kit.
Danish: Start forfra med et nyt sæt.
English: Adalimumab b n=113
Danish: Adalimumabb n=113
English: ASAS
Danish: Stempelstang
English: • paediatric uveitis
Danish: • Pædiatrisk uveitis.
English: Each 0.8 ml single dose vial contains 40 mg of adalimumab.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert 0,8 ml enkeltdosishætteglas indeholder 40 mg adalimumab.
English: • Top of the thighs.
Danish: • fortil på låret.
English: every week or 80 mg every other week.
Danish: 20 mg hver anden uge.
English: Warning: Gloves do not replace the need for washing hands.
Danish: Advarsel: Du skal også vaske hænder, selvom du bruger handsker.
English: Vial Kit
Danish: Se pkt.
English: Kromeya 40 mg/0.8 mL injection adalimumab
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ Kromeya 40 mg/0,8 ml injektionsvæske adalimumab s.c.
English: Note: P = Placebo (Number at Risk); A = Adalimumab (Number at Risk).
Danish: Adalimumab Bemærk: P = Placebo (antal med risiko); H = Adalimumab (antal med risiko).
English: c n=207
Danish: Adalimumabb/ MTXc n=207
English: - This medicine has been prescribed for your child only.
Danish: - Lægen har ordineret Kromeya til dit barn personligt.
English: Adalimumab 0.8 mg/kg eow N=38
Danish: Adalimumab 0,8mg/kg hver anden uge N=38
English: • pull the syringe straight up and out of the packaging (Figure C).
Danish: • tag fat om injektionssprøjten med to fingre midt på den gennemsigtige kanylebeskyttelse løft injektionssprøjten lige op og ud af æsken (figur C).
English: PASI 75
Danish: PASI 75b
English: • increased lipids in the blood; • raised liver enzymes.
Danish: • forhøjede bilirubinmålinger (leverblodtest)
English: Warning: Do not use the vial if the liquid is cloudy, colored or has particles or flakes in it. 2.4 Gently remove the yellow cap from the vial.
Danish: Advarsel: Du må ikke bruge hætteglasset, hvis væsken er uklar eller misfarvet eller indeholder partikler eller flager.
English: > 32 weeks 14 weeks a
Danish: -44,2 a
English: This includes any possible side effects not listed in this leaflet (see section 4).
Danish: - Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her (se punkt 4).
English: Note: P = Placebo (number at risk (flared)); A = Adalimumab (number at risk (flared)).
Danish: Bemærk: P = Placebo (antal med risiko (opblussen af sygdom)); A = Adalimumab (antal med risiko (opblussen af sygdom)).
English: Back view
Danish: Bagfra
English: Placebo Adalimumab 40 mg eow
Danish: Placebo Adalimumab 40 mg hver anden uge
English: • pain in the muscles.
Danish: • blødning i mave-tarm kanalen
English: Adalimumab 40 mg eow N=80
Danish: Adalimumab 40 mg hver anden uge N=80
English: Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab.
Danish: ANGIVELSE AF AKTIVT STOF En 0,8 ml fyldt injektionssprøjte indeholder 40 mg adalimumab.
English: 6 months 6.7% 12 months NA
Danish: 6 måneder 6,7% 52,4% 8,2% 22,1% 9,5% 39,1% 12 måneder NA
English: What you need to know before you use Kromeya 3.
Danish: Det skal du vide, før du begynder at tage Kromeya Sådan skal du tage Kromeya Bivirkninger
English: Needle
Danish: Kanyle
English: Patients remained on stable doses of NSAIDs and or prednisone (≤ 0.2 mg /kg/day or 10 mg/day maximum).
Danish: Patienterne fortsatte på faste doser NSAID og/eller prednison (≤ 0,2 mg/kg/dag eller maksimalt 10 mg/dag) I den åbne indkøringsfase fik alle patienter 24 mg/m2 op til maksimalt på 40 mg adalimumab hver anden uge i 16 uger.
English: • Leak-resistant and
Danish: • der ikke lækker, og
English: HR
Danish: • ar
English: • The needle guard spring is not extended (Figure I).
Danish: Figur H • at kanylebeskyttelsesfjederen ikke er udløst (figur I).
English: Adverse reaction skin and soft tissue infections (including paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zoster),
Danish: Systemiske infektioner (inklusive sepsis, candidiasis og influenza), intestinale infektioner (inklusive viral gastroenteritis), hud- og bløddelssinfektioner (inklusive paronychia, cellulitis, impetigo, nekrotiserende fasciitis og herpes zoster), øreinfektioner, orale infektioner (inklusive herpes simplex, oral herpes og tandinfektioner), infektioner i reproduktionsvejene (inklusive vulvovaginal svampeinfektion), urinvejsinfektioner (inklusive pylonephritis), svampeinfektioner
English: Cap
Danish: HRa
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Danish: Særnavn Styrke Lægemiddelform
English: Package size
Danish: Indhold Paknings-størrelse
English: The effectiveness of this measure should be considered in combination with other measures.
Danish: Effektiviteten af denne foranstaltning bør vurderes i kombination med andre foranstaltninger.
English: The protocol should also include a measure of the primary outcomes at baseline.
Danish: Protokollen bør desuden indeholde et mål for de primære udfald ved baseline.
English: The CMDh emphasised the importance of having meaningful results from these studies as soon as possible.
Danish: CMDh understregede vigtigheden af at få meningsfulde resultater fra disse studier hurtigst muligt.
English: This complicates effective risk minimisation in these patients.
Danish: Dette vanskeliggør effektiv risikominimering hos disse patienter.
English: These views often reflected the current national medical practice and the debate in the medical community.
Danish: Disse synspunkter afspejlede ofte den aktuelle nationale lægepraksis og debatten i det medicinske samfund.
English: Protocols should include a representative sample of EU Member States.
Danish: Protokollerne bør omfatte en repræsentativ stikprøve af EU-medlemsstater.
English: However, this measure should be seen as part of the complete program of risk minimisation measures.
Danish: Denne foranstaltning bør imidlertid ses som en del af det fuldstændige program for risikominimeringsforanstaltninger.
English: The PRAC discussed the above two points at its May meeting, taking into consideration information provided by the Member States.
Danish: PRAC drøftede ovennævnte to punkter på sit møde i maj under hensyntagen til oplysninger fra medlemsstaterne.
English: The frequency of the training / reminders should be discussed at national level taking consideration particularities of each national healthcare system.
Danish: Hyppigheden af oplæring/påmindelser bør drøftes på nationalt plan under hensyntagen til særlige forhold i de forskellige nationale sundhedssystemer.
English: The primary outcomes should be common to all studied EU Member States.
Danish: De primære udfald skal være fælles for alle EU-medlemsstater omfattet af studiet.
English: Hence:
Danish: Det fremgår heraf:
English: • This measure will act as a reminder at time of administration, which is important in an emergency setting.
Danish: • Denne foranstaltning ville fungere som en påmindelse på administrationstidspunktet, hvilket er vigtigt i en akut situation.
English: These include drug utilisation data from 11 EU Member States.
Danish: Resultaterne omfatter data for lægemiddelanvendelsen i 11 EU-medlemsstater.
English: These views are based on PRAC members' routine review processes and preparation.
Danish: Disse synspunkter er baseret på PRAC-medlemmernes rutinemæssige procedurer og forberedelser.
English: This includes recordings of trainings and accreditation.
Danish: Hertil hører registrering af af oplæringssessioner og akkreditering.
English: A follow-up questionnaire to be filled after administration would not be effective in minimising the risk.
Danish: At skulle udfylde et opfølgende spørgeskema efter administrationen ville ikke være effektivt til at minimere risikoen.
English: • Proposals for additional risk minimisation measures and pharmacovigilance activities
Danish: • Forslag til supplerende risikominimeringsforanstaltninger og lægemiddelovervågningsaktiviteter
English: • The continued presence of this warning on the packaging will also contribute to long-term awareness of HPCs.
Danish: • Den fortsatte tilstedeværelse af denne advarsel på emballagen vil desuden bidrage til sundhedspersoners opmærksomhed på lang sigt.
English: These views, along with all substantial data and information crucial for the full understanding of these views have been either shared with all the parties involved or otherwise made available in the course of the procedure.
Danish: Synspunkterne og alle de væsentlige data og oplysninger, der er afgørende for at forstå synspunkterne fuldt ud, er blevet delt med alle relevante parter eller på anden måde gjort tilgængelige for dem under proceduren.
English: The position was afterwards forwarded to the European Commission, the Member States, to Iceland and Norway and to the marketing authorisation holders for the above mentioned medicinal products, together with its annexes and appendices.
Danish: Udtalelsen blev derefter overgivet til Europa-Kommissionen, medlemsstaterne, Island og Norge samt indehaverne af markedsføringstilladelse for ovennævnte lægemidler, sammen med de tilhørende bilag og tillæg.
English: Revised CMDh position
Danish: Revideret udtalelse fra CMDh
English: It is expected that the involvement of the learned societies will have an important role in channelling the messages of the training.
Danish: Inddragelsen af de videnskabelige samfund forventes at spille en vigtig rolle i kanalisering af budskaberne i oplæringen.
English: • This measure will ensure long term effectiveness through reminders sent to the trained HCPs and training of new ones.
Danish: • Denne foranstaltning sikrer effektivitet på lang sigt gennem påmindelser, der sendes til de oplærte sundhedspersoner og ved oplæring af nye.
English: The benefits in the approved indication therefore remain modest.
Danish: Fordelene ved den godkendte indikation er derfor beskedne.
English: Progress on the ongoing DUS shall be reported within the upcoming PSUR.
Danish: Fremskridtene i det igangværende studie af lægemiddelanvendelse skal rapporteres i den kommende PSUR.
English: Overall, the evidence for this indication is based on studies for which the sample size and the duration of follow-up are limited.
Danish: Generelt er evidensen for denne indikation baseret på studier med begrænset stikprøvestørrelse og opfølgningsvarighed.
English: It will complement other measures such as training to HCPs.
Danish: Den vil supplere andre foranstaltninger såsom oplæring af sundhedspersoner.
English: Therefore, the PRAC recommends the suspension of the marketing authorisations for all medicinal products referred to in Annex I.
Danish: Derfor henstiller PRAC, at markedsføringstilladelserne for alle de lægemidler, der er omhandlet i bilag I, suspenderes.
English: The PRAC adopted a recommendation on 11 January 2018 which was then considered by the CMDh, in accordance with Article 107k of Directive 2001/83/EC.
Danish: PRAC har den 11. januar 2018 vedtaget en anbefaling, der efterfølgende er blevet vurderet af CMDh, jf. artikel 107k i direktiv 2001/83/EF.
English: The PRAC also consulted an ad-hoc expert group and considered carefully views expressed during the meeting that took place on 18 December 2017.
Danish: PRAC rådspurgte desuden en ad hoc-ekspertgruppe og overvejede nøje de synspunkter, der blev givet udtryk for på mødet den 18. december 2017.
English: • The PRAC also noted the overall exposure to HES solutions for infusion in the EU, estimated to about 1.5 to 2 million patients per year since 2014.
Danish: • PRAC bemærkede også den samlede eksponering for HES-infusionsvæske, opløsning, i EU, der skønnes at omfatte ca. 1,5-2 millioner patienter om året siden 2014.