FrancophonIA/ELRC3.0 huggingface dataset:
English: Talk to your doctor or nurse before using this medicine.
Danish: Kontakt lægen eller sundhedspersonalet, før De bruger dette lægemiddel.
English: The chemical and physical stability of the diluted solution has been demonstrated for 8 hours at 25°C.
Danish: Kemisk og fysisk stabilitet af den fortyndede opløsning er påvist i 8 timer ved 25°C.
English: - The calculated volume of Elaprase should be withdrawn from the appropriate number of vials.
Danish: - Den beregnede mængde Elaprase trækkes op af det tilsvarende antal hætteglas.
English: Elaprase contains sodium
Danish: Elaprase indeholder natrium
English: The most severe episode occurred in a patient with a febrile respiratory illness and was associated with hypoxia during the infusion, resulting in a short seizure.
Danish: Den mest alvorlige episode opstod hos en patient med en respiratorisk sygdom med feber og var forbundet med hypoxi under infusionen, hvilket medførte et kortvarigt anfald.
English: Liver volume normalised by Month 24 for 73% (52 out of 71) of patients with hepatomegaly at baseline.
Danish: Levervolumen normaliseredes ved måned 24 for 73 % (52 ud af 71) af patienterne med hepatomegali ved baseline.
English: All patients received weekly idursulfase up to 3.2 years in an extension to this study (TKT024EXT).
Danish: Alle patienter fik idursulfase en gang ugentligt i op til 3,2 år i et forlængelsesstudie (TKT024EXT).
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene for fremsendelse af PSUR´er for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Table 1: Adverse reactions from clinical trials and post-marketing experience in patients treated with Elaprase.
Danish: Tabel 1: Bivirkninger, der er indberettet i forbindelse med kliniske studier og efter markedsføringen hos patienter i behandling med Elaprase.
English: Pack sizes of 1, 4 and 10 vials.
Danish: Pakningsstørrelser med 1, 4 og 10 hætteglas.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products - enzymes, ATC code: A16AB09.
Danish: Farmakoterapeutisk klassifikation: Andre midler til fordøjelsesorganer og stofskifte - enzymer, ATC-kode: A16AB09.
English: In some patients glycosaminoglycan accumulates also in the brain.
Danish: Hos nogle patienter ophobes glykosaminoglykan også i hjernen.
English: The most common were infusion-related reactions, 202 of which were reported in 22 out of 32 patients following administration of a total of 1580 infusions.
Danish: De hyppigste var infusionsrelaterede reaktioner, hvoraf 202 blev indberettet for 22 ud af 32 patienter efter indgivelse af i alt 1.580 infusioner.
English: The patients in the weekly treatment group experienced a clinically significant 15% mean improvement in FEV1 at the end of the study.
Danish: Patienterne i gruppen med ugentlig behandling oplevede en klinisk signifikant 15% middelforbedring i FEV1 ved studiets afslutning.
English: The nature of your genotype (a genetic make up of all active genes in human cells, which determines one's specific, individual characteristics) may influence your therapeutic response to this medicine, as well as your risk of developing antibodies and infusion-related side effects.
Danish: Deres genotype (den genetiske sammensætning af alle aktive gener i humane celler, der afgør den enkeltes specifikke, individuelle egenskaber) kan have betydning for, hvordan De reagerer på behandlingen med dette lægemiddel, og for risikoen for, at De udvikler antistoffer og infusionsrelaterede bivirkninger.
English: It is supplied in a glass vial as a clear to slightly opalescent, colourless solution.
Danish: Det leveres i et hætteglas som en gennemsigtig til let opaliserende farveløs opløsning.
English: Across clinical studies, serious adverse reactions were reported in a total of 5 patients who received 0.5 mg/kg weekly or every other week.
Danish: På tværs af de kliniske studier blev der indberettet alvorlige bivirkninger for i alt 5 patienter, der fik 0,5 mg/kg ugentligt eller hver anden uge.
English: Statistically significant increases from treatment baseline in absolute FVC volume were seen at most visits for all treatment groups combined and for each of the prior TKT024 treatment groups.
Danish: Der sås statistisk signifikante stigninger fra behandlingsbaseline i absolut FVC-volumen ved de fleste besøg for alle behandlingsgrupper og for hver af de tidligere TKT024-behandlingsgrupper.
English: Mean changes from 0.07 l to 0.31 l and percent ranged from 6.3% to 25.5% (maximum at Month 30).
Danish: Middelændringer lå i intervallet 0,07 l til 0,31 l, og procentvise ændringer lå i intervallet 6,3 % til 25,5 % (højest ved måned 30).
English: Elaprase is supplied in pack sizes of 1, 4 and 10 vials per carton.
Danish: Elaprase leveres i pakningsstørrelser med 1, 4 eller 10 hætteglas pr. Karton.
English: The decreases in mean liver volume were seen regardless of age, disease severity, IgG antibody status or neutralising antibody status.
Danish: Faldene i gennemsnitlig levervolumen blev observeret uanset alder, sværhedsgrad af sygdommen, IgG-antistofstatus eller neutraliserende antistofstatus.
English: Method of administration For instructions on dilution of the medicinal product before administration, see section 6.6.
Danish: Administration For instruktioner om fortynding af lægemidlet før administration, se pkt.
English: Elaprase should not be infused with other medicinal products in the infusion tubing.
Danish: Elaprase må ikke indgives sammen med andre lægemidler i infusionsslangen.
English: The longer-term effects of antibody development on clinical outcomes have not been established.
Danish: Den mere langsigtede indflydelse af antistofdannelsen på de kliniske resultater er ikke fastlagt.
English: Based on its metabolism in cellular lysosomes, idursulfase would not be a candidate for cytochrome P450 mediated interactions.
Danish: På grund af produktets metabolisme i cellulære lysosomer vil idursulfase ikke medføre cytokrom P450-medierede interaktioner.
English: Calculate the total dose to be administered and number of Elaprase vials needed.
Danish: Beregn den samlede dosis, der skal indgives, samt det antal hætteglas med Elaprase, der er behov for.
English: Patients in the TKT024 and HGT-ELA-038 studies were also stratified across five weight categories; as shown in the following table:
Danish: Patienterne i TKT024- og HGT-ELA-038-studierne var desuden stratificeret i fem vægtkategorier som vist i følgende tabel:
English: Elaprase contains an active substance called idursulfase which works by acting as a replacement for the enzyme that is at a low level, thereby breaking down this carbohydrate in affected cells.
Danish: Elaprase indeholder et aktivt stof, der hedder idursulfase, og dette stof virker som erstatning for det enzym, der er på et lavt niveau, hvorved kulhydratet i de påvirkede celler nedbrydes.
English: • Difficulty breathing, cough, low oxygen levels in your blood
Danish: • Åndedrætsbesvær, hoste, lavt iltniveau i blodet
English: Idursulfase treatment resulted in up to 60% reduction in urine output of glycosaminoglycans and in reductions of liver and spleen size: results were comparable to those found in study TKT024.
Danish: Idursulfase-behandling bevirkede en reduktion på op til 60% i udskillelse af glykosaminglykaner i urinen og i reduktion af lever- og miltvolumina; resultaterne svarede til resultaterne i studie TKT024.
English: Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single dose toxicity, repeated dose toxicity, toxicity to reproduction and development and to male fertility.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, enkeltdosistoksicitet, toksicitet efter gentagne doser, reproduktions- og udviklingstoksicitet samt fertilitet hos hanner.
English: This medicine has no or negligible influence on the ability to drive and use machines.
Danish: Dette lægemiddel påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: If you are treated with Elaprase you may experience side effects during or following an infusion (see section 4 Possible side effects).
Danish: Hvis De behandles med Elaprase, vil De muligvis opleve nogle bivirkninger under eller efter en infusion (se pkt.
English: After dilution this medicine is given through a vein (drip feed).
Danish: Efter fortynding gives dette lægemiddel i en vene (med drop).
English: If you suffer from Hunter syndrome, a carbohydrate called glycosaminoglycan which is normally broken down by your body, is not broken down and slowly accumulates in various organs in your body.
Danish: Hvis De lider af Hunters syndrom, vil et kulhydrat, der hedder glykosaminoglykan, og som normalt nedbrydes i kroppen, ikke blive nedbrudt og vil derfor langsomt ophobes i forskellige celler i kroppen.
English: Chemical and physical in-use stability has been demonstrated for 8 hours at 25°C.
Danish: 3 år Den kemiske og fysiske stabilitet efter åbning er påvist i 8 timer ved 25°C.
English: • Abdominal pain, nausea, vomiting, frequent and/or loose stools
Danish: • Mavesmerter, kvalme, opkastning, hyppig og/eller løs afføring
English: The decreases in liver and spleen volumes observed at the end of study TKT024 (week 53) were maintained during the extension study (TKT024EXT) in all patients regardless of the prior treatment they had been assigned.
Danish: Faldene i lever- og miltvolumen observeret ved afslutningen af studie TKT024 (uge 53) blev fastholdt i forlængelsesstudiet (TKT024EXT) hos alle patienter, uanset hvilken behandling de tidligere var blevet tildelt.
English: In the placebo treatment group 128 infusion-related reactions were reported in 21 out of 32 patients following administration of a total of 1612 infusions.
Danish: I placebogruppen blev 128 infusionsrelaterede reaktioner indberettet for 21 ud af 32 patienter efter indgivelse af i alt 1.612 infusioner.
English: Idursulfase is secreted as a 525 amino acid glycoprotein and contains 8 N-linked glycosylation sites that are occupied by complex, hybrid, and high-mannose type oligosaccharide chains.
Danish: Idursulfase udskilles som et 525-aminosyre glykoprotein og indeholder 8 Nforbundne glykosyleringssteder, som optages af oligosaccharidkæder af den komplekse, hybride og højmannose type.
English: Mean cardiac LVMI remained stable over 36 months of idursulfase treatment within each TKT024 treatment group.
Danish: Det gennemsnitlige kardielle LVMI forblev stabilt i den 36 måneders idursulfase-behandlingsperiode inden for hver TKT024-behandlingsgruppe.
English: A clear to slightly opalescent, colourless solution.
Danish: En gennemsigtig til let opaliserende, farveløs opløsning.
English: Spleen volume normalised by Months 12 and 24 for 9.7% of patients in the TKT024 Weekly group with splenomegaly.
Danish: Miltvolumen normaliseredes ved måned 12 og 24 hos 9,7 % af patienterne i TKT024-én-gang-ugentligt-gruppen med splenomegali.
English: Treatment of Hunter syndrome patients with intravenous idursulfase provides exogenous enzyme for uptake into cellular lysosomes.
Danish: Behandling af patienter med Hunter syndrom med intravenøs idursulfase tilvejebringer et eksogent enzym til optagelse i cellulære lysosomer.
English: Approximately half of the patients in the weekly treatment group (15 of 32; 47%) had left ventricular hypertrophy at baseline, defined as LVM index 103 g/m2.
Danish: Cirka halvdelen af patienterne i gruppen med ugentlig behandling (15 ud af 32; 47%) havde venstre ventrikulær hypertrofi ved baseline; defineret som et LVM-indeks på 103 g/m2.
English: This medicine will be given to you under the supervision of a doctor or nurse who is knowledgeable in the treatment of Hunter syndrome or other inherited metabolic disorders.
Danish: De vil få dette lægemiddel indsprøjtet under overvågning af en læge eller sygeplejerske, der har erfaring med behandling af Hunters syndrom eller andre arvelige stofskiftesygdomme.
English: Dizziness, tremor
Danish: Svimmelhed, tremor
English: The primary efficacy endpoint was a two-component composite score based on the sum of the ranks of the change from baseline to the end of the study in the distance walked during six minutes (6minute walk test or 6MWT) as a measure of endurance, and % predicted forced vital capacity (FVC) as a measure of pulmonary function.
Danish: Denne score var baseret på ranksummen af ændringen fra baseline til studiets afslutning i den tilbagelagte gådistance i 6 minutter (6-minute walk test eller 6MWT) som en måling af udholdenhed og på procentdelen af forventet forced vital capacity (FVC) som en måling af lungefunktion.
English: A total of 11 of 31 (36%) patients in the weekly treatment group versus 5 of 31 (16%) patients in the placebo group had an increase in FEV1 of at least 0.2 l at or before the end of the study, indicating a dose-related improvement in airway obstruction.
Danish: I alt 11 ud af 31 (36%) patienter i gruppen med ugentlig behandling kontra 5 ud af 31 (16%) patienter i placebogruppen havde en stigning i FEV1 på mindst 0,2 l ved eller inden studiets afslutning, hvilket tydede på en dosisrelateret forbedring i luftvejsobstruktionen.
English: 5 to 11 (n=11)
Danish: 5 til 11 (n=11)
English: OUTER CARTON
Danish: UDVENDIG KARTON
English: Of the 25 patients with abnormally large livers at baseline in the weekly treatment group, 80% (20 patients) had reductions in liver volume to within the normal range by the end of the study.
Danish: Ud af de 25 patienter med abnormt stor lever ved baseline i gruppen med ugentlig behandling havde 80% (20 patienter) reduktioner i levervolumen til inden for det normale område ved studiets afslutning.
English: The safety and efficacy of Elaprase has been shown in three clinical studies: two randomised, placebo-controlled clinical studies (TKT008 and TKT024) in adults and children above the age of 5 years and one open-label, safety study (HGT-ELA-038) in children between the age of 16 months and 7.5 years.
Danish: Elaprases sikkerhed og virkning er blevet vist i tre kliniske studier: to randomiserede, placebokontrollerede kliniske studier (TKT008 og TKT024) med voksne og børn over 5 år og ét åbent sikkerhedsstudie (HGT-ELA-038) med børn i alderen mellem 16 måneder og 7,5 år.
English: Due to the missing or defective iduronate-2-sulfatase enzyme in patients with Hunter syndrome, glycosaminoglycans progressively accumulate in the cells, leading to cellular engorgement, organomegaly, tissue destruction, and organ system dysfunction.
Danish: På grund af det manglende eller utilstrækkelige iduronat-2-sulfatase-enzym hos patienter med Hunter syndrom akkumuleres glykosaminglykanerne progressivt i cellerne, hvilket fører til cellulær tilstopning, organomegali, vævsnedbrydning og dysfunktion i organsystemerne.
English: Cmax (μg/mL) Mean ± SD AUC0-∞ (min*μg/mL) CL (mL/min/kg) Mean ± SD Vss (mL/kg)
Danish: Cmaks (μg/ml) Gn.snit ± SD AUC0-∞ (min*μg/ml) CL (ml/min/kg) Gn.snit ± SD Vss (ml/kg)
English: 1.4 to 7.5 (n=27)
Danish: 1,4 til 7,5 (n=27)
English: Among all patients, mean % predicted FVC was significantly increased at Month 16, although by Month 36, it was similar to the baseline.
Danish: Blandt alle patienter steg den gennemsnitlige procentmæssige forudsete FVC-værdi signifikant ved måned 16, men ved måned 36 var den dog magen til baseline-værdien.
English: If you forget to use Elaprase
Danish: Hvis De har glemt at få Elaprase
English: This is equivalent to 0.6% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 0,6% af den anbefalede maksimale daglige indtagelse på 2 g natrium for en voksen.
English: In a 52-week, randomized, double-blind, placebo-controlled clinical study, 96 patients between the ages of 5 and 31 years received Elaprase 0.5 mg/kg every week (n=32) or 0.5 mg/kg every other week (n=32), or placebo (n=32).
Danish: I et 52 ugers randomiseret, dobbeltblindt, placebokontrolleret klinisk studie fik 96 patienter mellem 5 og 31 år Elaprase 0,5 mg/kg hver uge (n=32) eller 0,5 mg/kg hver anden uge (n=32) eller placebo (n=32).
English: Uncommon side effects (may affect up to 1 in 100 people) are: • Quickened breathing
Danish: Kkke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter) er: • Hurtig vejrtrækning
English: Hunter syndrome is an X-linked disease caused by insufficient levels of the lysosomal enzyme iduronate-2-sulfatase.
Danish: Hunters syndrom er en X-bunden arvelig sygdom, der skyldes utilstrækkelige niveauer af det lysosomale enzym iduronat-2-sulfatase.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from idursulfase therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med idursulfase seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Across 4 clinical studies (TKT008, TKT018, TKT024 and TKT024EXT), 53/107 patients (50%) developed anti-idursulfase IgG antibodies at some point.
Danish: På tværs af 4 kliniske studier (TKT008, TKT018, TKT024 og TKT024EXT) udviklede 53/107 patienter (50%) anti-idursulfase-IgG-antistoffer på et eller andet tidspunkt.
English: Of the 9 patients in the weekly treatment group with abnormally large spleens at baseline, 3 had spleen volumes that normalized by the end of the study.
Danish: Ud af de 9 patienter i gruppen med ugentlig behandling med abnormt stor milt ved baseline havde 3 miltvolumina, der var normaliserede ved studiets afslutning.
English: Very common side effects (may affect more than 1 in 10 people) are:
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 patienter) er:
English: Tel: +44(0)1256 894 959
Danish: Tlf: +44(0)1256 894 959 E-mail: medinfoEMEA@shire.com
English: For single use only Read the package leaflet before use Intravenous use
Danish: Kun til engangsbrug Læs indlægssedlen inden brug.
English: Idursulfase is a purified form of the lysosomal enzyme iduronate-2-sulfatase, produced in a human cell line providing a human glycosylation profile, which is analogous to the naturally occurring enzyme.
Danish: Idursulfase er en oprenset form af det lysosomale enzym iduronat-2-sulfatase, der produceres i en human cellelinje, og giver en human glykosyleringsprofil, der er analog med det naturligt forekommende enzym.
English: This treatment should be supervised by a physician or other healthcare professional experienced in the management of patients with MPS II disease or other inherited metabolic disorders.
Danish: Behandlingen bør overvåges af en læge eller andet behandlingspersonale, som har erfaring med behandling af patienter med MPS II-sygdommen eller andre nedarvede stofskifteforstyrrelser.
English: Special care should be taken when administering an infusion in patients with severe underlying airway disease.
Danish: Der skal udvises særlig forsigtighed ved indgivelse af en infusion til patienter med alvorlig bagvedliggende luftvejssygdom.
English: • Dizziness, tremor
Danish: • Svimmelhed, tremor
English: The solution should be inspected visually for particulate matter and discolouration prior to administration.
Danish: Infusionsvæsken skal inspiceres visuelt for partikler og misfarvning inden administration.
English: At most time points tested, patients who were from the original TKT024 weekly treatment group improved their walking distance to a greater extent that patients in the other 2 treatment groups.
Danish: På de fleste testede tidspunkter forbedrede patienter fra den oprindelige TKT024-gruppe med én ugentlig behandling deres gangafstand i højere grad end patienter fra de to andre behandlingsgrupper.
English: Idursulfase has no or negligible influence on the ability to drive and use machines.
Danish: Idursulfase påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: As a precautionary measure, it is preferable to avoid the use of idursulfase during pregnancy.
Danish: For en sikkerheds skyld bør idursulfase undgås under graviditeten.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen, apoteketspersonalet eller sundhedspersonalet, hvis De bruger anden medicin eller har gjort det for nylig.
English: Delaying the infusion in patients who present with an acute febrile respiratory illness should be considered.
Danish: Det bør overvejes at udsætte infusionen til patienter, som har akut luftvejssygdom med feber.
English: 12 to 18 (n=8)
Danish: 12 til 18 (n=8)
English: Analyses of genotypes of patients in study HGT-ELA-038
Danish: Analyse af genotype for patienter i studiet HGT-ELA-038
English: If you have experienced severe or potentially life-threatening allergic-type reactions to idursulfase or any of the other ingredients of this medicine (listed in section 6) and these cannot be controlled with appropriate medical treatment.
Danish: - hvis De har haft alvorlige eller muligvis livstruende overfølsomhedsreaktioner på idursulfase eller et af de øvrige indholdsstoffer i Elaprase (angivet i punkt 6), og hvis overfølsomhedsreaktionerne ikke kan kontrolleres med relevant medicinsk behandling.
English: This was an open-label, multicenter, single-arm study of idursulfase infusions in male Hunter syndrome patients between the age of 16 months and 7.5 years.
Danish: Dette var et åbent, multicenter- og enkeltgruppe-studie med idursulfase-infusion administreret til drenge med Hunter syndrom i alderen 16 måneder til 7,5 år.
English: The other ingredients are Polysorbate 20, sodium chloride, dibasic sodium phosphate, heptahydrate, monobasic sodium phosphate, monohydrate and water for injections.
Danish: - Øvrige indholdsstoffer: Polysorbat 20, natriumchlorid, dinatriumphosphatheptahydrat, natriumdihydrogenphosphatmonohydrat og vand til injektionsvæsker.
English: Among all patients, statistically significant mean increases from treatment baseline (TKT024 baseline for TKT024 idursulfase patients and Week 53 baseline for TKT024 placebo patients) were seen in the distance walked 6MWT at the majority of time points tested, with significant mean and percent increases ranging from 13.7m to 41.5m (maximum at Month 20) and from 6.4% to 13.3% (maximum at Month 24) respectively.
Danish: Blandt alle patienter blev der set statistisk signifikante middelstigninger fra behandlingsbaseline (TKT024-baseline for TKT024-idursulfase-patienter og uge 53-baseline for TKT024placebopatienter) i gangafstand på seks minutter på de fleste af de testede tidspunkter med signifikante gennemsnitlige og procentvise stigninger fra henholdsvis 13,7 m til 41,5 m (højest ved måned 20) og fra 6,4 % til 13,3 % (højest ved måned 24).
English: Please consult your doctor for additional information.
Danish: De kan få yderligere oplysninger om dette hos Deres læge.
English: Infusion-related reactions were treated or ameliorated by slowing the infusion rate, interrupting the infusion, or by administration of medicinal products, such as antihistamines, antipyretics, low-dose corticosteroids (prednisone and methylprednisolone), or beta-agonist nebulisation.
Danish: Infusionsrelaterede reaktioner blev behandlet eller bedret med en nedsættelse af infusionshastigheden, afbrydelse af infusionen eller med indgivelse af lægemidler såsom antihistaminer, antipyretika, lavdosiskortikosteroider (prednison og methylprednisolon) eller nebulisering med beta-agonister.
English: Patients treated with idursulfase may develop infusion-related reactions (see section 4.8).
Danish: Patienter, der behandles med idursulfase, kan udvikle infusionsrelaterede reaktioner (se pkt.