FrancophonIA/ELRC3.0 huggingface dataset:
English: Among patients who were originally randomised to weekly idursulfase in TKT024, mean maximum improvement in distance walked during six minutes occurred at Month 20 and mean percent predicted FVC peaked at Month 16.
Danish: Blandt de patienter, der oprindeligt blev randomiseret til idursulfase én gang ugentligt i TKT024, skete den højeste gennemsnitlige forbedring i gangafstand på seks minutter i måned 20, og den gennemsnitlige, procentmæssige forudsete FVC var højest i måned 16.
English: SPECIFIC OBLIGATION TO COMPLETE POSTAUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Danish: SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER SÆRLIGE OMSTÆNDIGHEDER
English: Severe or potentially life-threatening hypersensitivity is a contraindication to rechallenge, if hypersensitivity is not controllable (see section 4.3).
Danish: Alvorlig og potentielt livstruende overfølsomhed kontraindicerer geneksponering, hvis overfølsomheden ikke kan kontrolleres (se pkt.
English: The complete deletion/ large rearrangement genotype was most commonly associated with development of high titre of antibodies and neutralising antibodies to idursulfase and was most likely to display a muted response to the medicinal product.
Danish: Komplet deletion/større rearrangement-genotypen var oftest forbundet med udvikling af høje antistoftitre og neutraliserende antistoffer mod idursulfase, og denne genotype havde også størst sandsynlighed for at udvikle dæmpet respons over for lægemidlet.
English: Assessment of long term pulmonary morbidity (e.g., incidence of infections, pulmonary function status) and mortality Assessment of long term cardiovascular morbidity (e.g., incidence of events, and echocardiography data, where available) and mortality Assessment of long term urinary GAG excretion patterns Assessment of long term antibody levels, isotype and correlation to other therapeutic parameters
Danish: Vurdering af den langsigtede pulmonale morbiditet (f.eks. incidens af infektioner, lungefunktionsstatus) og mortalitet Vurdering af den langsigtede kardiovaskulære morbiditet (f.eks. incidens af hændelser og ekkokardiografi-data, hvis tilgængelige) og mortalitet
English: Antibodynegative patients were found exclusively in the missense mutation genotype group (see sections 4.4 and 5.1).
Danish: Antistofnegative patienter blev udelukkende fundet i gruppen med missense-mutationsgenotype (se pkt.
English: Iduronate-2-sulfatase functions to catabolize the glycosaminoglycans (GAG) dermatan sulfate and heparan sulfate by cleavage of oligosaccharide-linked sulfate moieties.
Danish: Iduronat-2-sulfatase virker ved at katabolisere glykosaminglykanerne (GAG) dermatansulfat og heparansulfat ved spaltning af oligosaccharidforbundne sulfatdele.
English: The most common symptoms are itching, rash, hives, fever, headache, increased blood pressure, and flushing (redness).
Danish: De mest almindelige symptomer er kløe, udslæt, nældefeber, feber, hovedpine, forhøjet blodtryk og rødmen (flushing).
English: Adverse reactions that were reported for the 32 patients treated with 0.5 mg/kg idursulfase weekly in the TKT024 phase II/III 52-week placebo-controlled study were almost all mild to moderate in severity.
Danish: De bivirkninger, der blev indberettet for de 32 patienter, som blev behandlet med 0,5 mg/kg idursulfase ugentligt i det placebokontrollerede, 52 ugers fase II/III-studie TKT024, var næsten alle lette til moderate i styrke.
English: Cmax (μg/mL) Mean ± SD AUC0-∞ (min*μg/mL) Mean ± SD CL (mL/min/kg) Mean ± SD Vss (mL/kg) Mean ± SD
Danish: Cmaks (μg/ml) Gn.snit ± SD AUC0-∞ (min*μg/ml) Gn.snit ± SD CL (ml/min/kg) Gn.snit ± SD Vss (ml/kg) Gn.snit ± SD
English: Fifty-four percent of patients tested positive for neutralizing antibodies at least once and half of the patients tested positive for neutralizing antibodies on at least three consecutive study visits.
Danish: 54% af patienterne blev testet positive for neutraliserende antistoffer mindst én gang, og halvdelen af patienterne blev testet positive for neutraliserende antistoffer ved mindst tre på hinanden følgende besøg.
English: The longer term effects of antibody development on response to treatment have not been established.
Danish: Den langsigtede effekt, som udviklingen af antistoffer kan have på patientens reaktion på behandlingen, er ikke klarlagt.
English: The active substance is idursulfase, which is a form of the human enzyme iduronate-2-sulfatase.
Danish: - Aktivt stof: idursulfase, som er en form af det humane enzym iduronat-2-sulfatase.
English: Patients who tested antibody-positive displayed less reduction in urinary output of glycosaminoglycans than antibody-negative patients.
Danish: Patienter, der blev testet positive for antistoffer, havde en mindre reduktion i glykosaminoglykaner i urinen end de patienter, der blev testet negative.
English: Patients who have experienced anaphylactoid/anaphylactic reactions should be treated with caution when readministering idursulfase, appropriately trained personnel and equipment for emergency resuscitation (including epinephrine) should be available during infusions.
Danish: Patienter, der har haft anafylaktoide/anafylaktiske reaktioner, skal behandles med forsigtighed ved fornyet indgift af idursulfase, og under infusionen skal der være personale med passende uddannelse til stede og adgang til genoplivningsudstyr (herunder adrenalin).
English: These events did not recur with subsequent infusions using a slower infusion rate and administration of pre-infusion medicinal products, usually low-dose steroids, antihistamine, and beta-agonist nebulisation.
Danish: Disse virkninger recidiverede ikke ved efterfølgende infusioner med en lavere infusionshastighed og indgivelse af lægemidler inden infusion - sædvanligvis lavdosissteroider, antihistaminer og beta-agonister administreret med nebulisator.
English: • Pain in the joints
Danish: • Smerter i led
English: What Elaprase contains
Danish: Elaprase indeholder:
English: % Predicted FVC 4.2 (1.6)
Danish: Kombineret (6MWT og %FVC) 6MWT (m) % forventet FVC 4,2 (1,6) FVC absolut volumen (l)
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: De kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Patients with the complete deletion/large rearrangement genotype Paediatric patients with the complete deletion/large rearrangement genotype have a high probability of developing antibodies, including neutralizing antibodies, in response to exposure to idursulfase.
Danish: Patienter med komplet deletion/større rearrangement-genotype Pædiatriske patienter med komplet deletion/større rearrangement-genotype har høj sandsynlighed for at udvikle antistoffer, herunder neutraliserende antistoffer som reaktion på eksponering for idursulfase.
English: This causes cells to function abnormally, thereby causing problems for various organs in your body which can lead to tissue destruction and organ malfunction and failure.
Danish: Dette skaber problemer i forskellige organer i kroppen, hvilket kan medføre vævsødelæggelse, organforstyrrelser og organsvigt.
English: What you need to know before you use Elaprase
Danish: Det skal De vide, før De får Elaprase
English: Available data in animals have shown excretion of idursulfase in milk (see section 5.3).
Danish: De tilgængelige data fra dyrestudier viser, at idursulfase udskilles i mælk (se pkt.
English: Infusion-site swelling, face oedema, oedema peripheral Injury, poisoning and procedural complications Infusion-related reaction
Danish: Hævelse på infusionsstedet, ansigtsødem, perifert ødem Traumer, forgiftninger og behandlingskomplikationer Infusionsrelateret reaktion
English: Patients with this genotype have a higher probability of developing infusion-related adverse events and tend to show a muted response as assessed by decrease in urinary output of glycosaminoglycans, liver size and spleen volume compared to patients with the missense genotype.
Danish: Patienter med denne genotype har en højere risiko for at udvikle infusionsrelaterede bivirkninger og viser tendens til dæmpet respons vurderet ud fra reduktionen af udskillelse af glykosaminglykaner i urinen, lever- og miltvolumina sammenlignet med patienter med missensegenotype.
English: Common side effects (may affect up to 1 in 10 people) are:
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter) er:
English: Other medicines and Elaprase
Danish: Brug af anden medicin sammen med Elaprase
English: This medicine is a concentrate for solution for infusion.
Danish: Dette lægemiddel er et koncentrat til infusionsvæske, opløsning.
English: Mannose-6-phosphate (M6P) residues on the oligosaccharide chains allow specific binding of the enzyme to the M6P receptors on the cell surface, leading to cellular internalization of the enzyme, targeting to intracellular lysosomes and subsequent catabolism of accumulated GAG.
Danish: Mannose-6-phosphat (M6P)-residuer på oligosaccharidkæderne giver mulighed for specifik binding af enzymet til M6P-receptorer på celleoverfladen.
English: In the post-hoc immunogenicity analysis of data from TKT024/024EXT studies, 51% (32/63) patients treated with 0.5mg/kg weekly idursulfase had at least 1 blood sample that tested positive for antiidursulfase antibodies, and 37 % (23/63) tested positive for antibodies on at least 3 consecutive study visits.
Danish: I post-hoc immunogenicitetsanalysen af data fra TKT024/024EXT-studier blev 51 % (32/63) af de patienter, der blev behandlet med 0,5 mg/kg idursulfase ugentligt, testet positive for anti- idursulfaseantistoffer i mindst 1 blodprøve, og 37 % (23/63) blev testet positive for antistoffer ved mindst 3 på hinanden følgende besøg.
English: The mean and percent changes from treatment baseline were greatest in the group of patients from the TKT024 study who had received the weekly dosing, across all time points.
Danish: På alle tidspunkter var de gennemsnitlige og procentvise ændringer fra behandlingsbaseline størst i gruppen af patienter fra TKT024-studiet, som havde fået en ugentlig dosis.
English: Pharmacokinetic parameters measured during the first infusion at week 1 of studies TKT024 (0.5 mg/kg weekly arm) and HGT-ELA-038 are displayed in table 3 and table 4 below as a function of age and body weight, respectively.
Danish: De farmakokinetiske (FK) parametre, som blev målt under den første infusion i uge 1 i studierne TKT024 (gruppen, der fik 0,5 mg/kg ugentligt) og HGT-ELA-038, vises som funktion af henholdsvis alder og kropsvægt i tabel 3 og 4 nedenfor.
English: • Rapid heartbeat, irregular heartbeat, bluish skin
Danish: • Hurtig hjerterytme, uregelmæssig hjerterytme, blåfarvning af huden
English: Dibasic sodium phosphate heptahydrate Monobasic sodium phosphate monohydrate Water for injections
Danish: Dinatriumphosphatheptahydrat Natriumdihydrogenphosphatmonohydrat Vand til injektionsvæsker
English: Always use this medicine exactly as your doctor has told you.
Danish: Brug altid Elaprase nøjagtigt efter lægens anvisning.
English: Care must be taken to ensure the sterility of the prepared solutions since Elaprase does not contain any preservative or bacteriostatic agent; aseptic technique must be observed.
Danish: Der skal udvises forsigtighed for at sikre, at de klargjorte opløsninger er sterile, da Elaprase ikke indeholder noget konserveringsmiddel eller bakteriostatisk middel.
English: Elaprase is used as enzyme replacement therapy to treat children and adults with Hunter syndrome (Mucopolysaccharidosis II) when the level of the enzyme iduronate-2-sulfatase in the body is lower than normal, helping improve the symptoms of the disease.
Danish: Elaprase bruges som enzymerstatningsbehandling til børn og voksne med Hunter syndrom (mukopolysaccharidose II), hvis niveauet af enzymet iduronat-2-sulfatase i kroppen er under det normale niveau.
English: All patients with the complete deletion/large rearrangement genotype developed antibodies, and the majority of them (7/8) also tested positive for neutralizing antibodies on at least 3 consecutive occasions.
Danish: Alle patienter med komplet deletion/større rearrangement-genotype udviklede antistoffer, og flertallet af dem (7/8) blev også testet positive for neutraliserende antistoffer ved mindst 3 på hinanden følgende besøg.
English: Twenty-one percent (13/63) tested positive for neutralizing antibodies at least once and 13 % (8/63) tested positive for neutralizing antibodies on at least 3 consecutive study visits.
Danish: 21 % (13/63) blev testet positive for neutraliserende antistoffer mindst én gang, og 13 % (8/63) blev testet positive for neutraliserende antistoffer ved mindst 3 på hinanden følgende besøg.
English: Swollen tongue, dyspepsia
Danish: Hævet tunge, dyspepsi
English: Patients who developed a high titre of antibodies displayed less response to idursulfase as assessed by urine output of glycosaminoglycans and by liver and spleen size.
Danish: Patienter, der udviklede en høj antistoftiter, udviste mindre respons over for idursulfase vurderet ud fra udskillelse af glykosaminglykaner i urinen og lever- og miltvolumina.
English: Excipient with known effect Each vial contains 0.482 mmol of sodium.
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på Hvert hætteglas indeholder 0,482 mmol natrium.
English: Each vial of Elaprase is intended for single use only and contains 6 mg of idursulfase in 3 ml of solution.
Danish: Hætteglassene med Elaprase er kun beregnet til engangsbrug og indeholder 6 mg idursulfase i 3 ml koncentrat.
English: Patients with renal or hepatic impairment There is no clinical experience in patients with renal or hepatic insufficiency.
Danish: Patienter med nedsat nyre- eller leverfunktion Der er ingen klinisk erfaring med patienter med nedsat nyre- eller leverfunktion (se pkt.
English: ≥ 40 and < 50 (n=5)
Danish: ≥40 og <50 (n=5)
English: During clinical trials, the most common infusion-related reactions included cutaneous reactions (rash, pruritus, urticaria), pyrexia, headache, hypertension, and flushing.
Danish: I kliniske studier omfattede de mest almindelige infusionsrelaterede reaktioner kutane reaktioner (udslæt, pruritus, urticaria), pyreksi, hovedpine, hypertension og flushing.
English: At their final visit 21/31 patients in the TKT024 Weekly group, 24/32 in the TKT024 EOW group and 18/31 patients in the TKT024 placebo group had final normalised urine GAG levels that were below the upper limit of normal.
Danish: Ved det afsluttende besøg havde 21 ud af 31 patienter i TKT024-gruppen med idursulfase én gang ugentligt, 24 ud af 32 i TKT024-gruppen, der fik idursulfase hver anden uge, og 18 ud af 31 patienter i TKT024-placebogruppen endelige normaliserede GAG-niveauer i urin, som lå under den øvre normalgrænse.
English: During the 53-week study, 67.9% (19 of 28) of patients had at least one blood sample that tested positive for anti-idursulfase antibodies, and 57.1% (16 of 28) tested positive for antibodies on at least three consecutive study visits.
Danish: Under det 53 uger lange studie blev 67,9% (19/28) af patienterne testet positive for antiidursulfase-antistoffer i mindst én blodprøve, og 57,1% (16/28) blev testet positive for antistoffer ved mindst tre på hinanden følgende besøg.
English: A total of 108 male Hunter syndrome patients with a broad spectrum of symptoms were enrolled in the two randomized, placebo-controlled clinical studies, 106 continued treatment in two open-label, extension studies.
Danish: I alt 108 mandlige patienter med Hunter syndrom og med et bredt spektrum af symptomer blev inkluderet i de to randomiserede, placebokontrollerede kliniske studier.
English: In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded by your healthcare professional.
Danish: For at forbedre sporbarheden af biologiske lægemidler skal din læge eller sundhedspersonalet tydeligt registrere handelsnavnet og batchnummeret på det indgivne lægemiddel.
English: Patients with complete deletion/large rearrangement genotype have a higher probability of developing infusion related adverse events (see section 4.4).
Danish: Patienter med komplet deletion/større rearrangement-genotypen har større sandsynlighed for at udvikle infusionsrelaterede bivirkninger (se pkt.
English: Do not use this medicine if you notice that there is discolouration or presence of foreign particles.
Danish: Brug ikke lægemidlet, hvis De ser misfarvning eller partikler i produktet.
English: Urine GAG levels (μg GAG/mg creatinine)
Danish: GAG-niveauer i urin (μg GAG/mg kreatinin) % ændring i levervolumen % ændring i miltvolumen
English: Concentrate for solution for infusion 3 ml
Danish: Koncentrat til infusionsvæske, opløsning 3 ml
English: Pharmacokinetic parameters at week 1 as a function of age in Studies TKT024 and HGT-ELA-038
Danish: Farmakokinetiske parametre ved uge 1 som funktion af alder i studierne TKT024 og HGT-ELA-038
English: Pharmacokinetic parameters at week 1 as a function of body weight in studies TKT024 and HGT-ELA-038
Danish: Farmakokinetiske parametre ved uge 1 som funktion af kropsvægt i studierne TKT024 og HGT-ELA-038
English: Typical organs where glycosaminoglycan accumulates are spleen, liver, lungs, heart, and connective tissue.
Danish: Glykosaminoglykan ophobes typisk i organer som milt, lever, lunger og hjerte samt i bindevæv.
English: All patients with the frameshift/splice site mutation genotype developed antibodies and 4/6 also tested positive for neutralizing antibodies on at least 3 consecutive study visits.
Danish: Alle patienter med frameshift (læserammeskift)/splice site (splejsningssekvens)mutationsgenotype udviklede antistoffer, og 4/6 blev også testet positive for neutraliserende antistoffer ved mindst 3 på hinanden følgende besøg.
English: Degradation of idursulfase is achieved by generally well understood protein hydrolysis mechanisms to produce small peptides and amino acids, consequently renal and liver function impairment is not expected to affect the pharmacokinetics of idursulfase.
Danish: Nedbrydning af idursulfase opnås ved generelt velforståede proteinhydrolyse-mekanismer, der producerer små peptider og aminosyrer.
English: Hypoxia, bronchospasm, cough
Danish: Hypoksi, bronkospasmer, hoste
English: Animal studies have shown excretion of idursulfase in breast milk.
Danish: Data fra dyrestudier har vist, at idursulfase udskilles i human mælk.
English: - The solution in the vials should not be used if it is discoloured or if particulate matter is present.
Danish: - Må ikke anvendes, hvis opløsningen i hætteglasset er misfarvet eller indeholder partikler.
English: ≥ 30 and < 40 (n=9)
Danish: ≥30 og <40 (n=9)
English: The most common of these infusion-related reactions included cutaneous reactions (rash, pruritus, urticaria, and erythema), pyrexia, flushing, wheezing, dyspnoea, headache, vomiting,
Danish: De mest almindelige af disse infusionsrelaterede reaktioner omfattede kutane reaktioner (udslæt, pruritus, urticaria og erytem), pyreksi, rødmen, pibende vejrtrækning, dyspnø,
English: Most side effects are mild to moderate and associated with the infusion, however some side effects may be serious.
Danish: De fleste bivirkninger er lette til moderate og forbundet med infusionen.
English: Do not infuse Elaprase concomitantly in the same intravenous line with other medicinal products.
Danish: Elaprase må ikke infunderes samtidigt med andre lægemidler i den samme intravenøse slange.
English: There have been post-marketing reports of anaphylactoid/anaphylactic reactions (see section 4.4).
Danish: Der har været indberetninger om anafylaktoide/anafylaktiske reaktioner efter markedsføring af produktet (se pkt.
English: The solution should not be shaken.
Danish: Opløsningen ikke omrystes.
English: Study TKT024
Danish: TKT024-studiet
English: Hypertension, Hypotension Respiratory, thoracic and mediastinal disorders Wheezing, dyspnoea
Danish: Luftveje, thorax og mediastinum Pibende vejrtrækning, dyspnø
English: 5 ml vial (type I glass) with a stopper (fluoro-resin coated butyl rubber), one piece seal and blue flipoff cap. Each vial contains 3 ml of concentrate for solution for infusion.
Danish: 5 ml hætteglas (type I-glas) med en prop (fluororesin-belagt butylgummi), forsegling i ét stykke og blåt flip-off-låg.
English: It is recommended to deliver the total volume of infusion using a 0.2 µm in line filter.
Danish: Det anbefales at bruge et 0,2 µm inline-filter ved administration af det samlede infusionsvolumen.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (jf. bilag I: Produktresumé; pkt.
English: Anaphylactoid/anaphylactic reactions, which have the potential to be life threatening, have been observed in some patients treated with idursulfase up to several years after initiating treatment.
Danish: Hos nogle patienter, der blev behandlet med idursulfase, er der observeret anafylaktoide/anafylaktiske reaktioner, som potentielt kan være livstruende, op til adskillige år efter behandlingsstart.
English: ≥ 20 and < 30 (n=18)
Danish: ≥20 og <30 (n=18)
English: Anaphylactoid/ anaphylactic reaction
Danish: Anafylaktoid/ anafylaktisk reaktion
English: Tachypnoea
Danish: Takypnø
English: Elaprase 2 mg/ml sterile concentrate idursulfase
Danish: Elaprase 2 mg/ml koncentrat, sterilt idursulfase i.v.
English: Cyanosis, arrhythmia, tachycardia
Danish: Cyanose, arytmi, takykardi
English: Elaprase 2 mg/ml concentrate for solution for infusion idursulfase
Danish: Elaprase 2 mg/ml koncentrat til infusionsvæske, opløsning idursulfase
English: Additional clinical benefit analyses were performed on individual components of the primary endpoint composite score, absolute changes in FVC, changes in urine GAG levels, liver and spleen volumes, measurement of forced expiratory volume in 1 second (FEV1), and changes in left ventricular mass (LVM).
Danish: Andre kliniske fordelsanalyser blev udarbejdet på baggrund af individuelle dele af det primære endepunkts kombinerede score, de absolutte ændringer i FVC, ændringer i niveauerne af GAG i urin,
English: Anaphylactoid/anaphylactic reactions
Danish: Anafylaktoide/anafylaktiske reaktioner
English: • Hives, rash, itching, redness of the skin
Danish: • Nældefeber, udslæt, kløe, rødmen af huden
English: Study HGT-ELA-038
Danish: HGT-ELA-038-studiet
English: Each ml contains 2 mg of idursulfase*.
Danish: Hver ml indeholder 2 mg idursulfase*.
English: How to store Elaprase
Danish: Sådan får De Elaprase
English: Each vial contains 3 ml of concentrate for solution for infusion.
Danish: Hvert hætteglas indeholder 3 ml koncentrat til infusionsvæske, opløsning.
English: • Shortness of breath, wheezing
Danish: • Stakåndethed, pibende vejrtrækning
English: This medicinal product contains 0.482 mmol sodium (or 11.1 mg) per vial.
Danish: Dette lægemiddel indeholder 0,482 mmol (11,1 mg) natrium pr. hætteglas, svarende til 0,6% af den WHO anbefalede maksimale daglige indtagelse af 2 g natrium for en voksen.
English: abdominal pain, nausea, and chest pain.
Danish: hovedpine, opkastning, abdominalsmerter, kvalme og brystsmerter.
English: - The total volume required of Elaprase should be diluted in 100 ml of 9 mg/ml (0.9%) sodium chloride solution for infusion.
Danish: - Den nødvendige mængde Elaprase fortyndes i 100 ml af en 9 mg/ml (0,9%) natriumchlorid opløsning til infusion.
English: Elaprase 2 mg/ml concentrate for solution for infusion
Danish: Elaprase 2 mg/ml koncentrat til infusionsvæske, opløsning
English: It is recommended that administration is started as soon as possible.
Danish: Det anbefales, at infusionsvæsken indgives så hurtigt som muligt efter fortynding.
English: Gastrointestinal disorders Abdominal pain, nausea, diarrhoea, vomiting
Danish: Abdominalsmerter, kvalme, diaré, opkastning