FrancophonIA/ELRC3.0 huggingface dataset:
English: Two single-arm, open-label clinical studies, AURAex (Phase 2 Extension cohort, (n=201)) and AURA2 (n=210) were conducted in patients with EGFR T790M mutation-positive lung cancer who have progressed on one or more prior systemic therapies, including an EGFR TKI.
Danish: Tidligere behandlede T790M-positive NSCLC-patienter - AURAex og AURA2 Der blev udført to åbne, enkeltarmede kliniske studier, AURAex (fase 2-forlængelses kohorte (n=201)) og AURA2 (n=210) med patienter med EGFR T790M-mutationspositiv lungecancer, som havde progredieret på en eller flere tidligere systemiske behandlinger, herunder en EGFR TKI.
English: Patients with clinically important abnormalities in rhythm and conduction as measured by resting electrocardiogram (ECG) (e.g. QTc interval greater than 470 ms) were excluded from these studies (see section 4.8).
Danish: Patienter med klinisk betydningsfulde anormaliteter i rytme og ledning målt ved hvilende elektrokardiogram (EKG) (fx QTc-interval over 470 ms) blev udelukket fra disse studier (se pkt.
English: Serious side effects Tell your doctor straight away if you notice the following serious side effects:
Danish: Fortæl det straks til lægen, hvis du bemærker denne alvorlige bivirkning:
English: In a clinical PK study, co-administration of TAGRISSO with simvastatin (sensitive CYP3A4 substrate) decreased the AUC and Cmax of simvastatin by 9% and 23% respectively.
Danish: I et klinisk farmakokinetisk studie reducerede samtidig administration af TAGRISSO og simvastatin (sensitivt CYP3A4-substrat) AUC og Cmax af simvastatin med henholdsvis 9 % og 23 %.
English: Overall PFS by investigator assessment by CNS metastases status at study entry, Kaplan-Meier plot (full analysis set) in AURA3
Danish: Samlet PFS efter investigators vurdering efter status for CNS-metastaser ved studiets start, Kaplan-Meier-plot (fuldt analysesæt) i AURA3
English: Beige, 7.25 x 14.5 mm, oval, biconvex tablet, debossed with “AZ” and “80” on one side and plain on the reverse.
Danish: Beige, 7,25 x 14,5 mm oval, bikonveks tablet, præget med “AZ” og “80” på den ene side og uden prægning på den anden side.
English: Fifty-four percent (54%) of patients had extra-thoracic visceral metastases, including 34% with CNS metastases (identified by CNS lesion site at baseline, medical history, and/or prior surgery, and/or prior radiotherapy to CNS metastases) and 23% with liver metastases.
Danish: 54 % af patienterne havde ekstra-torakale viscerale metastaser, herunder 34 % med CNS-metastaser (identificeret som CNS-læsion ved baseline, anamnese og/eller tidligere kirurgi og/eller tidligere strålebehandling for CNS-metastaser) og 23 % med levermetastaser.
English: Population PK analysis indicated that body weight was a significant covariate with a less than 20% change in osimertinib AUCss expected across a body weight range of 88 kg to 43 kg respectively (95% to 5% quantiles) when compared to the AUCss for the median body weight of 61 kg.
Danish: En populationsfarmakokinetisk analyse indikerede, at legemsvægt var en signifikant kovariat med en forventet ændring på < 20 % i osimertinib-AUCss over et interval på henholdsvis 88 kg til 43 kg (95 % til 5 % fraktiler) i sammenligning med AUCss for den mediane legemsvægt på 61 kg.
English: Interstitial lung disease (ILD)
Danish: Interstitiel lungesygdom (ILD)
English: Includes cases reported within the clustered terms: Keratitis, punctate keratitis, corneal erosion, corneal epithelium defect.
Danish: Inkluderer tilfælde rapporteret inden for termgruppen: Keratitis, punktat keratitis, corneaerosion, defekt i corneaepitelet.
English: Very common (47%) 0.9%
Danish: Meget almindelig (47 %) 0,9 %
English: All patients were required to have EGFR T790M mutation-positive NSCLC identified by the cobas EGFR mutation test performed in a central laboratory prior to randomisation.
Danish: Det var et krav, at alle patienter skulle have EGFR-T790M-mutationspositiv NSCLC, identificeret ved hjælp af cobas EGFR-mutationstest udført af et centralt laboratorium inden randomisering.
English: Fifty-nine percent (59%) of patients had extra-thoracic visceral metastasis including 39% with CNS metastases (identified by CNS lesion site at baseline, medical history, and/or prior surgery and/or prior radiotherapy to CNS metastases) and 29% with liver metastases.
Danish: 59 % af patienterne havde ekstra-torakale viscerale metastaser, herunder 39 % med CNS-metastaser (defineret som CNS-læsion ved baseline, anamnese og/eller tidligere operation og/eller tidligere strålingsbehandling af CNS-metastaser) og 29 % med levermetastaser.
English: Number of Deaths (% maturity)
Danish: Antal døde (% modenhed)
English: CNS metastases efficacy data in FLAURA study
Danish: CNS-metastase-effektdata fra FLAURA-studiet
English: Gärtunavägen SE-151 85 Södertälje Sweden
Danish: AstraZeneca AB Gärtunavägen SE-151 85 Södertälje Sverige
English: Appetite Loss
Danish: Appetitløshed
English: Adverse reactions reported in FLAURA and AURA studies
Danish: Bivirkninger indberettet i FLAURA- og AURA-studierne
English: TAGRISSO 80 mg is supplied as beige, film-coated, oval and biconvex tablets, marked with “AZ” and “80” on one side, and plain on the other.
Danish: TAGRISSO 80 mg leveres som beige, filmovertrukne, ovale og bikonvekse tabletter, præget med “AZ” og “80” på den ene side og uden prægning på den anden side.
English: Very common (54%) 1.6%
Danish: Meget almindelig (54 %) 1,6 %
English: The baseline demographic and disease characteristics of the overall study population were: median age 62, ≥75 years old (15%), female (64%), white (32%), Asian (65%), never smoker (68%), WHO performance status 0 or 1 (100%).
Danish: Demografiske data og sygdomskarakteristika ved baseline i den samlede studiepopulation var: medianalder 62, ≥75 år (15 %), kvinder (64 %), hvide (32 %), asiatere (65 %), aldrig-rygere (68 %), WHO performance-status 0 eller 1 (100 %).
English: No arrhythmic events were reported in FLAURA or AURA studies (see section 4.8).
Danish: Der blev ikke rapporteret tilfælde af arytmi i FLAURA- eller AURA-studierne (se pkt.
English: Difference (95%CI) p-value p <0.001
Danish: Justeret middelværdi Estimeret forskel (95 %CI) p-værdi p <0,001
English: Number of Events (% maturity)
Danish: Antal hændelser (% modenhed)
English: Discontinue TAGRISSO (see Section 4.4)
Danish: Seponering af TAGRISSO (se pkt.
English: CIOMS descriptor/ overall frequency (all CTCAE grades)
Danish: MedDRA SOC MedDRA-term CIOMS-beskrivelse/ samlet frekvens (alle
English: Paronychia
Danish: Paronychion
English: Very common (35%) 4.1%
Danish: Meget almindelig (35 %) 4,1 %
English: Early reductions in the median laboratory counts of leukocytes, lymphocytes, neutrophils and platelets have been observed in patients treated with TAGRISSO, which stabilised over time and then remained above the lower limit of normal.
Danish: Tidlige reduktioner i medianlaborietorietællinger af leukocytter, lymfocytter, neutrofilocytter og blodplader er observeret hos patienter behandlet med TAGRISSO.
English: CNS efficacy by BICR in patients with CNS metastases on a baseline brain scan in FLAURA
Danish: BICR hos patienter med CNS-metastaser ved en baselinehjernescanning i FLAURA
English: Number of responses (n), Response Rate (95% CI)
Danish: Antal med respons (n), responsrate (95 % CI)
English: Haematological events
Danish: Hæmatologiske tilfælde
English: Number of responses, Response Rate (95% CI)
Danish: Antal med respons, responsrate (95 % CI)
English: • Modafinil -used for sleep disorders.
Danish: • Modafinil - bruges mod overdreven søvntrang (narkolepsi)
English: The geometric mean ratio (90% CI) of osimertinib AUC and Cmax was 63.3% (47.3, 84.5) and 51.4% (36.6, 72.3) in patients with mild hepatic impairment and 68.4% (49.6, 94.2) and 60.7% (41.6, 88.6) in patients with moderate hepatic impairment; for the metabolite AZ5104 the AUC and Cmax were 66.5% (43.4, 101.9) and 66.3% (45.3, 96.9) in patients with mild hepatic impairment and 50.9% (31.7, 81.6) and 44.0% (28.9, 67.1) in patients with moderate hepatic impairment, compared to the exposure in patients with normal hepatic function.
Danish: Den geometriske middelværdi (90% CI) for osimertinib AUC og Cmax var 63,3% (47,3; 84,5) og 51,4% (36,6; 72,3) hos patienter med let nedsat leverfunktionog 68,4% (49,6; 94,2) og 60,7% (41,6; 88,6) hos patienter med moderat nedsat leverfunktion.
English: Concomitant use of St. John's Wort is contraindicated (see section 4.3).
Danish: Samtidig anvendelse af perikon er kontraindiceret (se pkt.
English: Each 40mg film-coated tablet contains 40mg of osimertinib.
Danish: Hver 40 mg filmovertrukket tablet indeholder 40 mg osimertinib.
English: Each 80 mg film-coated tablet contains 80 mg of osimertinib.
Danish: Hver 80 mg filmovertrukket tablet indeholder 80 mg osimertinib.
English: Beige, 9 mm, round, biconvex tablet, debossed with “AZ” and “40” on one side and plain on the reverse.
Danish: Beige, 9 mm rund, bikonveks tablet, præget med “AZ” og “40” på den ene side og uden prægning på den anden side.
English: Very common (17%) 0.1%
Danish: Meget almindelig (17 %) 0,1 %
English: Very common (31%) 0.3%
Danish: Meget almindelig (31 %) 0,3 %
English: How to take TAGRISSO
Danish: Sådan skal du tage TAGRISSO
English: • Oral hormonal contraceptive pill- used to prevent pregnancy.
Danish: • Orale (taget gennem munden) hormonelle svangerskabsforebyggende tabletter (f.eks. P-piller).
English: Includes cases reported within the clustered terms for rash AEs: Rash, rash generalised, rash erythematous, rash macular, rash maculo-papular, rash papular, rash pustular, rash pruritic, rash vesicular, rash follicular, erythema, folliculitis, acne, dermatitis, dermatitis acneiform, drug eruption, skin erosion.
Danish: Inkluderer tilfælde rapporteret inden for termgruppen udslæt: Udslæt, generaliseret udslæt, erytematøst udslæt, makuløst udslæt, makulopapuløst udslæt, papuløst udslæt, pustuløst udslæt, pruritisk udslæt, vesikulært udslæt, follikulært udslæt, erytem, folliculitis, akne, dermatitis, acneiform dermatitis, medikamentelt udslæt, huderosion.
English: TAGRISSO 40 mg tablets Each tablet contains 40 mg osimertinib (as mesylate).
Danish: TAGRISSO 40 mg tabletter Hver tablet indeholder 40 mg osimertinib (som mesylat).
English: TAGRISSO 40 mg tablets
Danish: TAGRISSO 40 mg tabletter
English: Following oral administration of TAGRISSO, peak plasma concentrations of osimertinib were achieved with a median (min-max) tmax of 6 (3-24) hours, with several peaks observed over the first 24 hours in some patients.
Danish: Efter oral administration af TAGRISSO blev peak plasma-koncentration af osimertinib nået med en median tmax på 6 (min.-maks.
English: Patient Reported Outcomes
Danish: Patientrapporterede resultater
English: TAGRISSO 80 mg tablets Each tablet contains 80 mg osimertinib (as mesylate).
Danish: TAGRISSO 80 mg tabletter Hver tablet indeholder 80 mg osimertinib (som mesylat).
English: What TAGRISSO contains
Danish: TAGRISSO indeholder:
English: Very common (33%) 0.1%
Danish: Meget almindelig (33 %) 0,1 %
English: TAGRISSO 80 mg tablets
Danish: TAGRISSO 80 mg tabletter
English: Odds ratio (95% CI); P-value
Danish: Odds ratio (95 % CI); p-værdi
English: CNS Duration of Response
Danish: CNS-responsvarighed
English: CNS Objective Response Rate and Duration of Response determined by RECIST v1.1 by CNS BICR in the evaluable for response population (CNS measurable lesions at baseline by BICR) n=30 for TAGRISSO and n=16 for Chemotherapy
Danish: CNS-progressionsfri overlevelse bestemt ved RECIST v1.1 af CNS-BICR i ITT-populationen (fuldt analysesæt) (målbare og ikke-målbare CNS-læsioner ved baseline i henhold til BICR), n=75 for TAGRISSO og n=41 for kemoterapi
English: Each tablet contains 40 mg osimertinib (as mesylate).
Danish: Hver tablet indeholder 40 mg osimertinib (som mesylat).
English: CNS PFS determined by RECIST v1.1by CNS BICR (CNS measurable and non-measurable lesions at baseline by BICR) n=61 for TAGRISSO and n=67 for EGFR TKI comparator; responses are unconfirmed Nominally statistically significant
Danish: HR=Hazard ratio; CI=Konfidensinterval, NC=Ikke muligt at beregne En HR< 1 favoriserer TAGRISSO, en oddsratio på >1 favoriserer TAGRISSO CNS PFS bestemt ved RECIST v1.1 af CNS BICR (målbare og ikke målbare CNS-læsioner ved baseline ved BICR) n=61 for TAGRISSO og n=67 for EGFR TKI-komparator; ubekræftede responser
English: Median OS in months (95% CI)
Danish: Median OS i måneder (95 % CI)
English: What TAGRISSO looks like and contents of the pack TAGRISSO 40 mg is supplied as beige, film-coated, round and biconvex tablets, marked with “AZ” and “40” on one side, and plain on the other.
Danish: TAGRISSO 40 mg leveres som beige, filmovertrukne, runde og bikonvekse tabletter, præget med “AZ” og “40” på den ene side og uden prægning på den anden side.
English: Based on patients with response only; DoR defined as the time from the date of first documented response (complete response or partial response) until progression or death event; DCR definedas the proportion of patients with response (complete response or partial response), or stable disease ≥ 6 weeks CNS Progression Free Survival determined by RECIST v1.1 by CNS BICR in the full analysis set population (CNS measurable and non-measurable lesions at baseline by BICR) n=75 for TAGRISSO and n=41 for Chemotherapy
Danish: CNS objektiv responsrate og responsvarighed bestemt ved RECIST v1.1 af CNS-BICR i den population, der var evaluerbar for respons (målbare CNS-læsioner ved baseline i henhold til BICR), n=30 for TAGRISSO og n=16 for kemoterapi Baseret kun på patienter med respons; DoR defineret som tiden fra datoen for første dokumenterede respons (komplet respons eller delvist respons) indtil progression eller død; DCR defineret som andelen af patienter med respons (komplet respons eller delvist respons) eller stabil sygdom ≥ 6 uger
English: Safety findings in the single-arm Phase 2 AURAex and AURA2 studies were generally consistent with those observed in the AURA3 TAGRISSO arm. No additional or unexpected toxicity has been observed and adverse events have been aligned in type, severity and frequency.
Danish: Sikkerhedsfund i de enkeltarmede fase 2-studier (AURAex og AURA2) var generelt i overensstemmelse med dem, der blev observeret i TAGRISSO-armen i AURA3.
English: No QTcrelated arrhythmias were reported in the FLAURA or AURA studies (see sections 4.4 and 5.1).
Danish: Der blev ikke indberettet tilfælde af QTc-relateret arytmi i FLAURA- eller AURA-studierne (se pkt.
English: Each tablet contains 80 mg osimertinib (as mesylate).
Danish: Hver tablet indeholder 80 mg osimertinib (som mesylat).
English: • you have suffered from inflammation of your lungs (a condition called ‘interstitial lung disease').
Danish: • du tidligere har haft en betændelseslignende sygdom (inflammation) i dine lunger (en sygdom,
English: Median PFS2, months (95% CI)
Danish: Median PFS2, måneder (95 % CI)
English: Patients with a past medical history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD were excluded from clinical studies (see section 4.8).
Danish: lægemiddelinduceret ILD, steroidkrævende strålingspneumonitis eller anden evidens for klinisk aktiv ILD blev udelukket fra de kliniske studier (se pkt.
English: TAGRISSO 40 mg film-coated tablets TAGRISSO 80 mg film-coated tablets
Danish: TAGRISSO 40 mg filmovertrukne tabletter TAGRISSO 80 mg filmovertrukne tabletter
English: The hepatic impairment marker serum albumin showed an effect on the PK of osimertinib.
Danish: Det er vist, at serumalbumin, der også er en markør for nedsat leverfunktion, påvirker osimertinibs farmakokinetik.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med TAGRISSO Fortæl lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: EGFR TKI comparator (gefitinib or erlotinib) N=67
Danish: EGFR TKI-komparator (gefitinib eller erlotinib)
English: Very common (67%) 7.2%
Danish: Nedsat antal lymfocytter l Meget almindelig (67 %) 7,2 %
English: ORR and DoR results by investigator assessment were consistent with those reported via Blinded Independent Central Review (BICR); ORR by BICR assessment was 64.9% [95% CI: 59.0, 70.5] on osimertinib and 34.3 % [95% CI: 26.5, 42.8] on chemotherapy; DoR by BICR assessment was 11.2 months (95% CI: 8.3, NC) on osimertinib and 3.1 months (95% CI: 2.9, 4.3) on chemotherapy.
Danish: BICR-vurdering var 64,9 % [95 % CI: 59,0; 70,5] ved osimertinib og 34,3 % [95 % CI: 26,5; 42,8] ved kemoterapi; DoR iht.
English: Median, Months (95% CI)
Danish: Median, måneder (95 % CI)
English: Median TFST, months (95% CI)
Danish: Median TFST, måneder (95 % CI)
English: HR (95% CI); P-value
Danish: HR (95 % CI); P-værdi
English: HR (95% CI) ; P-value
Danish: HR (95 % CI); p-værdi
English: TAGRISSO 80 mg tablets osimertinib
Danish: TAGRISSO 80 mg tabletter osimertinib
English: TAGRISSO 40 mg tablets osimertinib
Danish: TAGRISSO 40 mg tabletter osimertinib
English: Median TSST, months (95% CI)
Danish: Median TSST, måneder (95 % CI)
English: TAGRISSO 40 mg film-coated tablets TAGRISSO 80 mg film-coated tablets osimertinib
Danish: TAGRISSO 40 mg filmovertrukne tabletter TAGRISSO 80 mg filmovertrukne tabletter osimertinib
English: Median OS, Months (95% CI)
Danish: Median OS, måneder (95 % CI)
English: Contraception - information for women and men You must use effective contraception during treatment.
Danish: Du skal bruge effektiv prævention under behandlingen.
English: If you are not sure, talk to your doctor, pharmacist or nurse before taking TAGRISSO.
Danish: Spørg lægen, apotekspersonalet eller sundhedspersonalet, før du tager TAGRISSO, hvis du er i tvivl.
English: What you need to know before you take TAGRISSO 3.
Danish: Det skal du vide, før du begynder at tage TAGRISSO Sådan skal du tage TAGRISSO Bivirkninger
English: TAGRISSO 80 mg film-coated tablets osimertinib
Danish: TAGRISSO 80 mg filmovertrukne tabletter osimertinib
English: TAGRISSO 40 mg film-coated tablets osimertinib
Danish: TAGRISSO 40 mg filmovertrukne tabletter osimertinib
English: HRQL and physical functioning improvement analysis Patients on TAGRISSO had significantly greater chances of achieving a clinically meaningful improvement of greater than or equal to 10 points on the global health status and physical functioning of the EORTC-C30 questionnaire compared with chemotherapy during the study period Odds Ratio (OR) global health status: 2.11, (95% CI 1.24, 3.67, p=0.007); OR physical functioning 2.79 (95% CI 1.50, 5.46, p=0.002).
Danish: Analyse af HRQL og af forbedring af fysiske funktioner Patienter, der fik TAGRISSO, havde signifikant større chancer for at opnå klinisk betydende forbedringer større end eller lig med 10 point i den generelle helbredsstatus og fysiske funktioner på EORTC-C30-spørgeskemaet i studieperioden, sammenlignet med kemoterapi.
English: The OS analysis was not adjusted for the potentially confounding effects of crossover (94 [67%] patients on the chemotherapy arm received subsequent osimertinib treatment).
Danish: HR=hazard ratio; CI=konfidensinterval; NC=kan ikke beregnes Alle effektresultater er baseret på RECIST, investigators vurdering Den første analyse af OS blev udført ca. 4 måneder efter den primære analyse af PFS. OS-analysen blev ikke justeret for de potentielt konfunderende effekter af overkrydsning (94 [67 %] patienter i kemoterapiarmen fik efterfølgende behandling med osimertinib).
English: Discontinuation due to adverse reactions was 4.3%.
Danish: Hos 4,3 % af patienterne blev behandlingen seponeret på grund af bivirkninger.
English: Diarrhoea
Danish: Lunge
English: Uncommon (0.7%)
Danish: Ikke almindelig (0,7 %) 0,1 %
English: Interstitial lung disease
Danish: der hedder "interstitiel lungesygdom")
English: How TAGRISSOworks
Danish: Sådan virker TAGRISSO
English: Lusduna is used once a day at the same time each day.
Danish: Lusduna gives én gang om dagen på samme tidspunkt hver dag.
English: The full EPAR for Lusduna can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Lusduna findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Lusduna.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Lusduna.
English: By controlling the level of blood glucose, the symptoms of diabetes are reduced and complications are avoided.
Danish: Ved at kontrollere blodsukkerniveauet kan man reducere symptomerne på diabetes og forhindre komplikationer.
English: This means that Lusduna is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Danish: Det betyder, at Lusduna svarer til et biologisk lægemiddel (også kaldet "referencelægemidlet"), der allerede er godkendt i Den Europæiske Union (EU).
English: Diabetes is a disease in which the level of blood sugar is high, either because the body cannot produce insulin (type 1 diabetes) or because the body does not make enough insulin or cannot use it effectively (type 2 diabetes).
Danish: Diabetes er en sygdom, hvor niveauet af blodsukker er forhøjet, enten fordi kroppen ikke kan producere insulin (type 1-diabetes), eller fordi kroppen ikke producerer nok insulin eller ikke kan anvende insulinet effektivt (type 2-diabetes).
English: What measures are being taken to ensure the safe and effective use of Lusduna?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Lusduna?
English: Other information about Lusduna
Danish: Andre oplysninger om Lusduna
English: The reference medicine for Lusduna is Lantus.
Danish: Referencelægemidlet for Lusduna er Lantus.
English: It contains the active substance insulin glargine.
Danish: Det indeholder det aktive stof insulin glargin.
English: Lusduna is a ‘biosimilar medicine'.
Danish: Lusduna er et "biosimilært" lægemiddel.
English: The most common side effect with Lusduna (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose).
Danish: Den hyppigste bivirkning ved Lusduna (som kan forekomme hos mere end 1 ud af 10 personer) er lavt blodsukker (hypoglykæmi).
English: What is Lusduna and what is it used for?
Danish: Hvad er Lusduna, og hvad anvendes det til?
English: The Committee recommended that Lusduna be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Lusduna.
English: It is given by injection under the skin in the belly, the thigh, or the upper arm.
Danish: Lusduna gives som en injektion under huden i maven, låret eller overarmen.
English: Insulin glargine, the active substance in Lusduna, enters the bloodstream more slowly than human insulin after injection and so it works for longer.
Danish: Insulin glargin, det aktive stof i Lusduna, træder ind i blodbanen efter injektionen, men langsommere end humant insulin, så det virker i længere tid.
English: In the first supportive study, involving 506 patients with type 1 diabetes, the average HbA1c score was reduced from 8.0 to 7.4% with both Lusduna and Lantus.
Danish: I den første understøttende undersøgelse, der omfattede 506 patienter med type 1-diabetes, blev den gennemsnitlige HbA1c-værdi reduceret fra 8,0 til 7,4 % for både Lusduna og Lantus.
English: How is Lusduna used?
Danish: Hvordan anvendes Lusduna?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Lusduna has been shown to have a comparable quality, safety and effectiveness to Lantus.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Lusdunas og Lantus' kvalitet, sikkerhed og virkning svarer til hinanden.