FrancophonIA/ELRC3.0 huggingface dataset:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Eculizumab is a humanised monoclonal (IgG2/4κ) antibody produced in NS0 cell line by recombinant DNA technology.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Eculizumab er et humaniseret monoklonalt IgG2/4κ-antistof, der er produceret i en NS0-cellelinje ved rekombinant dna-teknologi.
English: Within 60 minutes after each plasmapheresis or plasma exchange
Danish: Inden for 60 minutter efter hver plasmaferese /plasmaudskiftning
English: In study C04-001 (TRIUMPH) PNH patients with at least 4 transfusions in the prior 12 months, flow cytometric confirmation of at least 10% PNH cells and platelet counts of at least 100,000/microliter were randomized to either Soliris (n = 43) or placebo (n = 44).
Danish: I studiet C04-001 (TRIUMPH) blev PNH-patienter, der havde fået mindst fire transfusioner de foregående 12 måneder, og som havde et flowcytometrisk verificeret indhold af PNH-celler på mindst 10 % og et trombocyttal på mindst 100 000/μl, randomiseret til enten Soliris (n = 43) eller placebo (n = 44).
English: Your doctor will administer a vaccine to your child aged less than 18 years against Haemophilus influenzae and pneumococcal infections according to the national vaccination recommendations for each age group.
Danish: Hvis dit barn er under 18 år, vil lægen vaccinere det mod Haemophilus influenzae og pneumokokinfektioner i henhold til de nationale vaccinationsanbefalinger for de respektive aldersgrupper.
English: • low white blood cell count (leukopenia), reduction in red blood cells which can make the skin pale and cause weakness or breathlessness
Danish: • nedsat antal blodplader, nedsat antal røde blodlegemer, hvilket kan forårsage bleg hud og svaghed eller stakåndethed
English: Soliris was administered as an intravenous infusion over 25 - 45 minutes.
Danish: Soliris blev indgivet som en intravenøs infusion af 25-45 minutters varighed.
English: • The need for children to be vaccinated against pneumococcus and Haemophilus influenzae before eculizumab treatment.
Danish: • behovet for at børn vaccineres mod pneumokokinfektioner og Haemophilus influenzae før behandling med eculizumab.
English: Hepatic impairment The safety and efficacy of Soliris have not been studied in patients with hepatic impairment.
Danish: Nedsat leverfunktion Soliris' sikkerhed og virkning er ikke undersøgt hos patienter med nedsat leverfunktion.
English: Renal impairment No dose adjustment is required for patients with renal impairment (see section 5.1).
Danish: Nedsat nyrefunktion Dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion (se pkt.
English: Population PK analysis on data collected across studies in PNH, aHUS, gMG and NMOSD patients showed gender, race, age (geriatric), or the presence of renal or hepatic impairment.function do not influence the PK of eculizumab.
Danish: En populationsfarmakokinetisk analyse af data indsamlet i studier af patienter med PNH, aHUS, gMG og NMOSD viste, at køn, race, alder (geriatrisk) eller tilstedeværelsen af nedsat nyre-eller leverfunktion ikke påvirker farmakokinetikken af eculizumab.
English: LDH level at 6 months (median, U/L)
Danish: LDH-niveau efter 6 måneder (median, E/l)
English: Eculizumab can block the body's inflammatory response, and its ability to attack and destroy its own vulnerable PNH blood cells.
Danish: Eculizumab er i stand til at blokere for kroppens betændelsesreaktion og dens evne til at angribe og ødelægge sine egne sårbare PNHblodlegemer.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 30 ml (10 mg/ml)
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 30 ml (10 mg/ml)
English: Each infusion will consist of a dose of 900 mg (3 vials of 30 ml) and will take 25 - 45 minutes.
Danish: Hver infusion vil bestå af en dosis på 900 mg (3 hætteglas a 30 ml) og varer 25-45 minutter).
English: In patients with aHUS, their kidney and blood cells, including platelets, can be inflamed which can lead to low blood counts (thrombocytopenia and anaemia), reduced or lost kidney function, blood clots, tiredness and difficulty in functioning.
Danish: Hos patienter med aHUS kan der opstå betændelse i nyreceller og blodlegemer, herunder blodplader, hvilket kan føre til lave blodtal (trombocytopeni og anæmi), nedsat eller ophørt nyrefunktion, blodpropper, træthed og nedsat funktionsevne.
English: All patients should be monitored for early signs of meningococcal infection, evaluated immediately if infection is suspected, and treated with appropriate antibiotics if necessary.
Danish: Ved mistanke om infektion bør patienten straks vurderes og passende antibiotikabehandling om nødvendigt indledes.
English: • Discard any unused portion left in a vial as the medicinal product contains no preservatives.
Danish: • Eventuelt restindhold i hætteglasset skal kasseres, da lægemidlet er uden konserveringsstof.
English: Table 6: Efficacy Outcomes in Prospective aHUS Studies C08-002A/B and C08-003A/B C08-002A/B
Danish: Tabel 6: Effektresultater i de prospektive aHUS-studier C08-002A/B og C08-003A/B C08-002A/B N = 17
English: Total number of relapses
Danish: Antal recidiver i alt
English: Fresh frozen plasma infusion
Danish: Infusion af frisk frosset plasma
English: • destruction of red blood cells (haemolysis), clumping of cells, abnormal clotting factor, abnormal blood clotting,
Danish: • nedbrydning af røde blodlegemer (hæmolyse), sammenklumpning af blodlegemer, unormal koagulationsfaktor, unormal blodstørkning
English: Soliris 300 mg concentrate for solution for infusion Eculizumab
Danish: Soliris 300 mg koncentrat til infusionsvæske, opløsning Eculizumab
English: Pneumonia, Upper respiratory tract infection, Bronchitis, Nasopharyngitis, Urinary tract infection, Oral Herpes
Danish: Pneumoni, infektion i øvre luftveje, bronkitis, nasofaryngitis, urinvejsinfektion, oral herpes
English: • infection, fungal infection, collection of pus (abscess), type of infection of the skin (cellulitis),
Danish: • infektion, svampeinfektion, ansamling af betændelse (byld), en type hudinfektion (cellulitis),
English: Mean Age (SD)
Danish: Gennemsnit (SD)
English: • infection by fungi (Aspergillus infection), infection of the joint (arthritis bacterial), Haemophilus influenzae infection, gum infection, impetigo, bacterial sexual transmitted disease (gonorrhea)
Danish: • svampeinfektion (Aspergillus-infektion), infektion i leddene (bakteriel artritis), Haemophilus influenzae-infektion, infektion i tandkødet, børnesår, seksuelt overført bakteriesygdom (gonorré)
English: Neuromyelitis Optica Spectrum Disorders
Danish: Neuromyelitis optica spektrumsygdomme
English: Your doctor will discuss the possible side effects with you and explain the risks and benefits of Soliris with you prior to treatment.
Danish: Lægen vil inden behandlingen tale med dig om de mulige bivirkninger og forklare risici og fordele ved Soliris.
English: • Treatment with eculizumab increases the risk of severe infection and sepsis, especially of Neisseria meningitidis and other Neisseria species, including disseminated gonorrhoeae.
Danish: • behandling med eculizumab øger risikoen for svær infektion og sepsis, specielt infektion med Neisseria meningitidis og andre Neisseria-arter, herunder dissemineret gonorré.
English: PNH Laboratory Monitoring
Danish: Løbende kontrol af PNH-laboratorieprøver
English: One vial of 30 ml contains 300 mg of eculizumab (10 mg/ml).
Danish: Ét hætteglas a 30 ml indeholder 300 mg eculizumab (10 mg/ml).
English: 300 mg per infusion of fresh frozen plasma
Danish: ≥300 mg 300 mg for hver infusion af frisk frosset plasma
English: In patients with gMG, their muscles can be attacked and damaged by the immune system which can lead to profound muscle weakness, impaired mobility, shortness of breath, extreme fatigue, risk for aspiration, and markedly impaired activities of daily living.
Danish: Hos patienter med gMG kan musklerne angribes og beskadiges af immunsystemet, hvilket kan føre til udpræget muskelsvaghed, nedsat førlighed, stakåndethed, ekstrem træthed, risiko for fejlsynkning til luftvejene (aspiration) og markant begrænsning af dagligdags aktiviteter.
English: Infusion Reactions
Danish: Infusionsreaktioner
English: In aHUS Study C08-002A/B, the median duration of Soliris therapy was approximately100 weeks (range: 2 weeks to 145 weeks).
Danish: I aHUS-studiet C08-002A/B var den mediane varighed af Soliris-behandlingen ca. 100 uger (interval: 2 uger til 145 uger).
English: No paediatric patient required new dialysis during treatment with Soliris.
Danish: Ingen af de pædiatriske patienter havde behov for ny dialyse under behandlingen med Soliris.
English: • depression, anxiety, mood swings
Danish: • depression, angst, humørsvingninger
English: FACIT-Fatigue is measured on a scale of 0-52, with higher values indicating less fatigue Atypical Haemolytic Uremic Syndrome
Danish: FACIT-træthed måles på en skala fra 0 til 52, hvor den højeste værdi er lig med mindst træthed.
English: Supportive safety data were obtained in 12 completed clinical studies that included 934 patients exposed to eculizumab in other disease populations other than PNH, aHUS, refractory gMG or NMOSD.
Danish: Der blev uddraget støttende sikkerhedsdata fra 12 afsluttede kliniske studier med 934 patienter, som var blevet eksponeret for eculizumab i andre sygdomspopulationer end PNH, aHUS, refraktær gMG eller NMOSD.
English: Soliris is also used to treat adult patients with a certain type of disease affecting the muscles and called generalized Myasthenia Gravis (gMG).
Danish: Soliris anvendes også til behandling af voksne patienter med en særlig sygdom, der påvirker musklerne, kaldet generaliseret myasthenia gravis (gMG).
English: In Study ECU-NMO-301, patients with NMOSD with a positive serologic test for anti-AQP4 antibodies, a history of at least 2 relapses in last 12 months or 3 relapses in the last 24 months with at least 1 relapse in the 12 months prior to screening and an Expanded Disability Status Scale (EDSS) score ≤ 7, were randomized 2:1 to either Soliris (n = 96) or placebo (n = 47).
Danish: I studie ECU-NMO-301 blev patienter med NMOSD med en positiv serologisk test for anti-AQP4antistoffer, mindst 2 tidligere recidiver i løbet af de sidste 12 måneder eller 3 recidiver i løbet af de sidste 24 måneder med mindst 1 recidiv i løbet af de 12 måneder før screeningen og en udvidet skala for handicapstatus (Expanded Disability Status Scale, EDSS)-score på ≤ 7 randomiseret i forholdet 2:1 til enten Soliris (n = 96) eller placebo (n = 47).Det var tilladt, at patienterne fik immunsuppressiv baggrundsbehandling med en stabil dosis i løbet af studiet, med undtagelse af rituximab og mitoxantron.
English: • upper respiratory tract infection, cough, throat pain (oropharyngeal pain), bronchitis, cold sores (herpes simplex)
Danish: • infektion i øvre luftveje, hoste, smerter i svælget, bronkitis, forkølelsessår (herpes simplex)
English: • skin tumor (melanoma), bone marrow disorder
Danish: • hudkræft (melanom), knoglemarvssygdom
English: Soliris can block the body's inflammatory response, and its ability to attack and destroy its own muscles to improve muscle contraction, thereby reducing symptoms of the disease and impact of the disease on the activities of daily living.
Danish: Soliris kan blokere kroppens reaktion på betændelsestilstande og dens evne til at angribe og ødelægge sine egne muskler, så muskelsammentrækningerne forbedres, hvorved sygdomssymptomerne og påvirkning af de dagligdags aktiviteter nedsættes.
English: Table 11: Clinical deterioration and rescue therapy in ECU-MG-301 Variable
Danish: Tabel 11: Klinisk forværring og nødbehandling i ECU-MG-301
English: Cases of haemolysis have been reported in the setting of missed or delayed Soliris dose in PNH clinical trials (see also Section 4.4).
Danish: Tilfælde af hæmolyse er rapporteret ved glemt eller forsinket Soliris-dosis i kliniske PNH-studier (se også pkt.
English: Discard any unused portion left in a vial, as the product contains no preservatives.
Danish: Eventuelt restindhold i hætteglasset skal kasseres, da produktet er uden konserveringsstof.
English: Table 18 summarizes the efficacy results for aHUS C10-003.
Danish: Tabel 18 opsummerer effektresultaterne for aHUS C10-003.
English: • Treatment with eculizumab increases the risk of severe infection, especially Neisseria meningitidis and other Neisseria species, including disseminated gonorrhoeae.
Danish: • behandling med eculizumab øger risikoen for svær infektion, specielt infektion med Neisseria meningitidis og andre Neisseria-arter, herunder dissemineret gonorré.
English: • After the fifth week, your doctor will administer 900 mg of diluted Soliris every two weeks as a long-term treatment.
Danish: • Efter den femte uge vil lægen give dig 900 mg fortyndet Soliris hver anden uge som langtidsbehandling.
English: Table 1: Adverse Reactions reported in eculizumab clinical trials, including patients with PNH, aHUS, refractory gMG and NMOSD as well as from postmarketing experience MedDRA System Organ Class
Danish: Tabel 1: Bivirkninger rapporteret fra kliniske studier af eculizumab, inklusive patienter med PNH, aHUS, refraktær gMG og NMOSD, og ved erfaring efter markedsføring
English: • Risk of severe thrombotic microangiopathic complications following eculizumab discontinuation and postponement of administration, its signs, symptoms, monitoring and management (aHUS only).
Danish: • risikoen for alvorlige komplikationer som følge af trombotisk mikroangiopati efter behandlingsafbrydelse og udsættelse af administration af eculizumab, tegn, symptomer, monitorering og håndtering (kun aHUS).
English: Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret FRANCE
Danish: Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret FRANKRIG
English: Each infusion will consist of a dose of 600 mg (2 vials of 30 ml) and will take 25 - 45 minutes.
Danish: Hver infusion består af en dosis på 600 mg (2 hætteglas a 30 ml) og varer ca. 25-45 minutter.
English: Table 15: Efficacy Results in Paediatric Patients Enrolled in aHUS C09-001r
Danish: Tabel 15: Effektresultater hos pædiatriske patienter, som deltog i aHUS studiet C09-001r
English: Pyrexia, Fatigue, Influenza like illness
Danish: Pyreksi, træthed, asteni, influenzalignende sygdom
English: Prior to administration, the Soliris solution should be visually inspected for particulate matter and discolouration.
Danish: Inden indgift inspiceres den fortyndede opløsning af Soliris visuelt for partikler og misfarvning.
English: Immunization
Danish: Vaccination
English: Soliris is also used to treat adult patients with a certain type of disease that predominantly affects the eye nerves and the spinal cord called Neuromyelitis Optica Spectrum Disorder (NMOSD).
Danish: Soliris anvendes også til at behandle voksne patienter med en bestemt type sygdom, der primært påvirker øjennerverne og rygmarven, som kaldes neuromyelitis optica spektrumsygdom (NMOSD).
English: • Risk of serious haemolysis following eculizumab discontinuation and postponement of administration, its criteria, the required post-treatment monitoring and its proposed management (PNH only).
Danish: • risikoen for alvorlig hæmolyse efter behandlingsafbrydelse og udsættelse af administration af eculizumab, kriterier forbundet hermed, den påkrævede post-behandlings monitorering og den foreslåede håndtering heraf (kun PNH).
English: Patients who entered NMOSD clinical trials while receiving background immunosuppressant therapy continued treatment with immunosuppressant therapy while on Soliris treatment (See section 5.3).
Danish: Patienterne, der indgik i kliniske studier med NMOSD, mens de fik immunsuppressiv baggrundsbehandling, fortsatte den immunsuppressive behandling, mens de fik Soliris (se pkt.
English: - Atypical haemolytic uremic syndrome (aHUS) (see section 5.1).
Danish: Atypisk hæmolytisk uræmisk syndrom (aHUS) (se pkt.
English: All patients enrolled in aHUS Study C10-004 had an ADAMTS-13 level above 5%.
Danish: Alle patienter, der indgik i aHUS-studie C10-004, havde et ADAMTS-13-niveau over 5 %.
English: • The requirement to vaccinate children against pneumococcus and Haemophilus influenzae before eculizumab treatment.
Danish: • kravet om at børn vaccineres mod pneumokokinfektioner og Haemophilus influenzae før behandling med eculizumab.
English: Change from baseline at 12 weeks of PedsQLTM Multidimensional Fatigue (parents)
Danish: Ændring fra baseline efter 12 uger i PedsQLTM Multidimensional Fatigue (parenter)
English: Soliris reduced signs of complement-mediated TMA activity, as shown by an increase in mean platelet counts from baseline to 26
Danish: Soliris reducerede tegn på komplementmedieret TMA-aktivitet, som vist ved en stigning i det gennemsnitlige trombocyttal fra baseline til 26 uger.
English: If aHUS patients discontinue treatment with Soliris, they should be monitored closely for signs and symptoms of severe thrombotic microangiopathy complications.
Danish: Hvis aHUS-patienter afbryder behandlingen med Soliris, bør de monitoreres nøje for tegn og symptomer på svære komplikationer som følge af trombotisk mikroangiopati.
English: Reduction in terminal complement activity was observed in all patients after commencement of Soliris.
Danish: Der blev observeret en reduktion i terminal komplementaktivitet hos alle patienter, efter Soliris blev påbegyndt.
English: - Neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4)
Danish: Neuromyelitis optica spektrumsygdom (NMOSD) hos patienter, som er positive for antiaquaporin-4 (AQP4)-antistoffer med et recidiverende behandlingsforløb (se pkt.
English: What is Soliris used for
Danish: Hvad anvendes Soliris til
English: * Immunosuppressant's included, but are not limited to, corticosteroids, azathioprine, mycophenolate, methotrexate , cyclosporine, tacrolimus, or cyclophosphamide.
Danish: Tidligere intubering siden diagnose (MGFA klasse V), n (%) * Immunsuppressive midler omfattede, men er ikke begrænset til, kortikosteroider, azathioprin, mycophenolat, methotrexat, ciclosporin, tacrolimus eller cyklophosphamid.
English: Double Blind
Danish: Sløret syn
English: Urticaria, Erythema, Petechiae, Hyperhidrosis, Dry skin
Danish: Urticaria, erytem, petekkier, hyperhidrose, tør hud
English: Consult your doctor before you take Soliris to be sure that you receive vaccination against Neisseria meningitidis, an organism that causes meningococcal infection, at least 2 weeks before beginning therapy, or that you take antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated.
Danish: Før du får Soliris, skal du rådføre dig med lægen, så du sikrer dig, at du mindst to uger inden påbegyndelse af behandlingen bliver vaccineret mod Neisseria meningitidis (en bakterie, der forårsager meningokokinfektion), eller at du får forebyggende antibiotika i 2 uger efter, du er blevet vaccineret, for at mindske risikoen for infektion.
English: Infusion related reaction
Danish: Infusionsrelaterede reaktioner
English: Monitor any patient who discontinues Soliris for at least 8 weeks to detect serious haemolysis and other reactions.
Danish: Patienter, der får afbrudt Soliris-behandling, skal monitoreres i mindst 8 uger for tegn og symptomer på alvorlig intravaskulær hæmolyse og andre reaktioner.
English: Daily TMA intervention rate, median (range) Before eculizumab On eculizumab treatment
Danish: Daglig forekomst af TMAinterventioner, median (interval) Før eculizumab Under eculizumab-behandling
English: aHUS Laboratory Monitoring aHUS patients receiving Soliris therapy should be monitored for thrombotic microangiopathy by measuring platelet counts, serum LDH and serum creatinine, and may require dose adjustment within the recommended 14±2 day dosing schedule during the maintenance phase (up to every 12 days).
Danish: Patienter med aHUS, som behandles med Soliris, bør monitoreres for trombotisk mikroangiopati ved at måle trombocyttal, serum-LDH og serum-kreatinin og kan have behov for dosisjustering i vedligeholdelsesfasen inden for de anbefalede 14 ± 2 dage iht.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til intravenøs anvendelse.
English: • After the fifth week, your doctor will administer 1,200 mg of diluted Soliris every two weeks as a long-term treatment.
Danish: • Efter den 5. uge vil lægen give dig 1.200 mg fortyndet Soliris hver 2. uge som langtidsbehandling.
English: In clinical trials, no PNH, aHUS, refractory gMG or NMOSD patients experienced an infusion reaction which required discontinuation of Soliris.
Danish: I de kliniske studier forekom der ingen infusionsreaktioner blandt PNH-, aHUS-, refraktær gMG- eller NMOSD-patienterne, der gjorde det nødvendigt at afbryde Solirisbehandlingen.
English: In aHUS, chronic administration of Soliris resulted in a rapid and sustained reduction in complementmediated thrombotic microangiopathy.
Danish: Hos aHUS-patienter resulterede kronisk administration af Soliris i hurtig og vedvedvarende reduktion i komplementmedieret trombotiske mikroangiopati.
English: In aHUS C10-003, responses to Soliris were similar in patients with and without identified mutations in genes encoding complement regulatory factor proteins or auto-antibodies to factor H.
Danish: I aHUS C10-003 var responset på Soliris sammenligneligt hos patienter med og uden identificerede mutationer i de gener, der koder for de proteiner, der er regulatorer af komplementsystemet, eller autoantistoffer mod faktor H.
English: The diluted solution should be allowed to warm to room temperature prior to administration by exposure to ambient air.
Danish: Den fortyndede opløsning skal henstå, til den er nået op på rumtemperatur, før den administreres.
English: • Withdraw the required amount of Soliris from the vial(s) using a sterile syringe.
Danish: • Den nødvendige mængde Soliris trækkes op af hætteglasset eller -glassene med en steril sprøjte.
English: Withdrawal of immunosuppressant therapy during Soliris treatment for NMOSD has not been assessed.
Danish: En seponering af immunsuppressiv behandling, mens patienterne får Soliris mod NMOSD, er ikke blevet vurderet.
English: Table 1 gives the adverse reactions observed from spontaneous reporting and in eculizumab completed clinical trials, including PNH, aHUS, refractory gMG and NMOSD studies.
Danish: Tabel 1 viser de bivirkninger, der blev konstateret ved spontane indberetninger og i afsluttede kliniske studier af eculizumab, herunder PNH-, aHUS-, refraktær gMG- og NMOSD-studier.
English: The diluted solution of Soliris should be administered by intravenous infusion over 25 - 45 minutes in adults and 1-4 hours in paediatric patients via gravity feed, a syringe-type pump, or an infusion pump.
Danish: Den fortyndede opløsning af Soliris gives ved intravenøs infusion i løbet af 25-45 minutter hos voksne og 1-4 timer hos pædiatriske patienter enten ved naturligt tilløb, med en pumpe af sprøjtetypen eller med en infusionspumpe.
English: After completion of the initial 26-week treatment period, most patients continued to receive Soliris by enrolling into an extension study.
Danish: Efter den oprindelige 26-ugers periode fortsatte de fleste patienter med at få Soliris, idet de fortsatte i en forlængelse af studiet.
English: influenza, sinusitis, tooth infection (abscess)
Danish: influenza, bihulebetændelse, tandinfektion (byld)
English: In paediatric PNH and aHUS patients with body weight below 40 kg, the Soliris dosing regimen consists of: Patient Body Weight
Danish: Hos pædiatriske PNH- og aHUS-patienter med en kropsvægt under 40 kg er dosisregimet for Soliris følgende:
English: Date:
Danish: inden:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation : 20 June 2007
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: • Gently agitate the infusion bag containing the diluted Soliris solution to ensure thorough mixing of the medicinal product and diluent.
Danish: • Infusionsposen med den fortyndede opløsning omrystes forsigtigt, så lægemidlet bliver grundigt opblandet i fortyndingsmidlet.
English: LDH levels at end of study (median, U/L)
Danish: LDH-værdi ved studiets slutning (median, E/l)