FrancophonIA/ELRC3.0 huggingface dataset:
English: 0.4 mL of solution in a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a yellow polypropylene plunger rod.
Danish: 0,4 ml injektionsvæskei en klar, sprøjtecylinder af farveløst, neutralt type I-glas med påsat nål og nålebeskyttelse, lukket med en prop af chlorobutylgummi og en gul stempelstang af polypropylen.
English: 0.6 mL of solution in a clear, colourless type I neutral glass graduated syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and an orange polypropylene plunger rod.
Danish: 0,6 ml injektionsvæske i en klar sprøjtecylinder med målestreger af farveløst, neutralt type I glas med påsat nål og nålebeskyttelse, lukket med en prop af chlorbutylgummi og en orange stempelstang af polypropylen.
English: 1.0 mL of solution in a clear, colourless type I neutral glass graduated syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a black polypropylene plunger rod.
Danish: 1,0 ml injektionsvæske i en klar sprøjtecylinder af farveløst, neutralt type I-glas med påsat nål og nålebeskyttelse, lukket med en prop af chlorobutylgummi og en sort stempelstang af polypropylen.
English: Withdraw the required volume of diluted solution with a syringe for administration into the IV line.
Danish: Udtag den nødvendige volumen fortyndet opløsning med en sprøjte og injicer det i droppet.
English: Changing of anticoagulant treatment
Danish: Forebyggelse af trombose under hæmodialyse
English: What Thorinane is and what it is used for What you need to know before you use Thorinane How to use Thorinane
Danish: Det skal du vide, før du begynder at bruge Thorinane Brug ikke Thorinane:
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu og på Lægemiddelstyrelsens hjemmeside http://www.laegemiddelstyrelsen.dk..
English: To avoid bruising, do not rub the injection site after you have injected yourself.
Danish: Undlad at gnide på indsprøjtningsstedet bagefter, så du ikke får et blåt mærke.
English: Headache.
Danish: nyrefunktion.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: - Kontakt lægen, apotekspersonalet eller sundhedspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: • you have had a heart valve fitted
Danish: • hvis du tidligere har haft mavesår
English: 31 March every year
Danish: 31. marts hvert år
English: You may need to stay in hospital.
Danish: De vil muligvis skulle blive på hospitalet.
English: Date of first authorisation: 08 January 2007 Date of latest renewal: 09 September 2016
Danish: Dato for første markedsføringstilladelse: 8. januar 2007 Dato for seneste fornyelse: 9. september 2016
English: Reductions were evident by week 18 and were maintained to week 53.
Danish: Reduktionerne var åbenbare fra uge 18 og blev fastholdt indtil uge 53.
English: Age (years)
Danish: Alder (år)
English: 111 20 Stockholm Sweden
Danish: 111 20 Stockholm Sverige
English: The infusion will normally last for 1 to 3 hours and will be given every week.
Danish: Infusionen varer normalt 1 til 3 timer og gives hver uge.
English: The results are presented in Table 2.
Danish: Resultaterne er anført i tabel 2.
English: The current medical standards for emergency treatment are to be observed.
Danish: Gældende medicinske standarder for akut behandling skal overholdes.
English: A higher volume of distribution at steady state (Vss) was observed in the lowest weight groups.
Danish: En højere distributionsvolumen ved steady state (Vss) blev observeret i de laveste vægtgrupper.
English: There is no clinical experience in patients over 65 years of age.
Danish: Der er ingen klinisk erfaring med patienter over 65 år.
English: One patient was unclassified / unclassifiable.
Danish: Én patient var ikke klassificeret/uklassificérbar.
English: Frequency is given as very common (≥1/10), common (≥1/100 to <1/10) or uncommon (≥1/1,000 to <1/100).
Danish: Hyppighed er angivet som meget almindelig (≥1/10), almindelig (≥1/100 til <1/10) eller ikke almindelig (≥1/1.000 til <1/100).
English: Most of the time you can still be given this medicine even if these symptoms occur.
Danish: For det meste kan De alligevel få dette lægemiddel, selvom disse symptomer opstår.
English: • Increased blood pressure, decreased blood pressure
Danish: • Forhøjet blodtryk, nedsat blodtryk
English: • Infusion-related reaction (see section entitled “Warnings and precautions”)
Danish: • Infusionsrelaterede reaktioner (se punktet 'Advarsler og forsigtighedsregler')
English: The recommended dosage in children and adolescents is the same as in adults.
Danish: Den anbefalede dosis til børn og unge er den samme som til voksne.
English: From a microbiological safety point of view, the diluted product should be used immediately.
Danish: Fra et mikrobiologisk, sikkerhedsmæssigt synspunkt bør det fortyndede lægemiddel anvendes straks.
English: P-value (compared with placebo)
Danish: P-værdi (sammenlignet med placebo)
English: Since more than one infusion-related reaction may have occurred during any single infusion, the above numbers are likely to overestimate the true incidence of infusion reactions.
Danish: Da mere end én infusionsrelateret reaktion kan være opstået under en enkelt infusion, er ovenstående tal sandsynligvis en overvurdering af den faktiske forekomst af infusionsrelaterede reaktioner.
English: Institution of positive-airway pressure may be necessary in some cases.
Danish: I nogle tilfælde kan det være nødvendigt at iværksætte et positivt luftvejstryk.
English: These data will be re-evaluated annually and outcomes reported and discussed within the Annual Reassessments.
Danish: Disse data vil blive revurderet årligt, og resultaterne vil blive indberettet og gennemgået i de årlige revurderinger.
English: This endpoint differed significantly from placebo for patients treated weekly (p=0.0049).
Danish: Dette endepunkt var signifikant anderledes end placebo for de patienter, der blev behandlet ugentligt (p=0,0049).
English: Heterozygous females were not studied in the clinical trials.
Danish: Heterozygote kvinder blev ikke undersøgt i de kliniske studier.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2 to 8°C.
Danish: Hvis infusionsvæsken ikke anvendes straks, er opbevaringstider og -betingelser efter fortynding og inden anvendelse brugerens eget ansvar og bør ikke være mere end 24 timer ved 2-8ºC.
English: Enzyme replacement therapy is usually administered as a long-term treatment.
Danish: Enzymsubstitutionsbehandling er som regel en langvarig behandling.
English: Specific Obligation 5 - To evaluate the following long term clinical endpoints primarily through the HOS.
Danish: Specifik forpligtelse 5: At evaluere nedenstående langsigtede kliniske endepunkter, primært via HOS.
English: Store in a refrigerator Do not freeze
Danish: Opbevares i køleskab Må ikke nedfryses
English: Check with your doctor if you are not sure.
Danish: Tal med din læge, hvis du ikke er sikker.
English: No formal medicinal product interaction studies have been conducted with idursulfase.
Danish: Der er ikke udført formelle lægemiddelinteraktionsstudier med idursulfase.
English: Idursulfase has a molecular weight of approximately 76 kD.
Danish: Idursulfase har en molekylærvægt på cirka 76 kD.
English: No clinical data exist demonstrating a benefit on the neurological manifestations of the disorder.
Danish: Der findes ingen kliniske data, som påviser en fordel for så vidt angår de neurologiske manifestationer af sygdommen.
English: The occurrence of an adverse reaction in a single patient is defined as common in view of the number of patients treated.
Danish: En bivirkning hos en enkelt patient defineres som almindelig i forhold til det behandlede antal patienter.
English: Side effects for which frequency is not known (cannot be estimated from available data) are: • Serious allergic reactions
Danish: Bivirkninger, hvis hyppighed ikke kendes (kan ikke vurderes ud fra tilgængelige data): • Alvorlige overfølsomhedsreaktioner
English: ▼This medicine is subject to additional monitoring.
Danish: Dette lægemiddel er underlagt supplerende overvågning.
English: Adverse reactions only reported during the post marketing period are also included in the table with a frequency “not known” (cannot be estimated from the available data).
Danish: Bivirkninger, der kun er indberettet i postmarketingperioden, er også vist i tabellen med angivelse af hyppighed som 'ikke kendt' (kan ikke estimeres ud fra forhåndenværende data).
English: These patients should be closely monitored and infused in an appropriate clinical setting.
Danish: Disse patienter skal overvåges nøje og infunderes under passende kliniske forhold.
English: * idursulfase is produced by recombinant DNA technology in a continuous human cell line.
Danish: * idursulfase er fremstillet ved hjælp af rekombinant DNA-teknologi i en kontinuerlig human cellelinje.
English: Do not use Elaprase
Danish: Brug ikke Elaprase
English: The overall neutralizing antibody rate was 26/107 patients (24%).
Danish: Den overordnede neutraliserende antistoffrekvens var 26/107 patienter (24%).
English: You may be given additional medicines such as antihistamines and corticosteroids to treat or help prevent allergic-type reactions.
Danish: De vil muligvis få flere lægemidler, for eksempel antihistaminer og kortikosteroider, til at behandle eller hjælpe til at forebygge allergilignende reaktioner.
English: Adverse reactions reported in the paediatric population were, in general, similar to those reported in adults.
Danish: De bivirkninger, der blev rapporteret hos den pædiatriske population, svarede generelt til dem, der blev rapporteret hos voksne.
English: Specific Obligation 4 - To submit data regarding immunogenicity after reexposure to idursulfase within Annual Reassessments.
Danish: Specifik forpligtelse 4: At indsende data vedrørende immunogenicitet efter reeksponering for idursulfase i de årlige revurderinger.
English: Infusion at home may be considered for patients who have received several months of treatment in the clinic and who are tolerating their infusions well.
Danish: Infusion i patientens hjem kan overvejes hos patienter, der er blevet behandlet i adskillige måneder på hospitalet, og som tolererer infusionen godt.
English: Upon internalization by cells, it is localized within cellular lysosomes, thereby limiting distribution of the protein.
Danish: Ved internalisering af celler lokaliseres det inden i cellulære lysosomer og begrænser dermed proteinets distribution.
English: Specific Obligation 1 - Hunter Outcome Survey (HOS): available data and updates will be provided within Annual Reassessments.
Danish: Specifik forpligtelse 1: HOS (Hunter Outcome Survey): Tilgængelige data og opdateringer vil blive formidlet i de årlige revurderinger.
English: Adverse reactions are listed in table 1 with information presented by system organ class and frequency.
Danish: Bivirkningerne er vist i tabel 1 med oplysninger angivet efter systemorganklasse og hyppighed.
English: In individual cases, socalled ‘neutralising antibodies' may develop, which may diminish activity of Elaprase and your response to treatment.
Danish: I enkelte tilfælde kan der udvikles såkaldt neutraliserende antistoffer, som kan mindske Elaprases aktivitet og din reaktion på behandlingen.
English: Urine GAG levels were normalized below the upper limit of normal (defined as 126.6 µg GAG/mg creatinine) in 50% of the patients receiving weekly treatment.
Danish: Niveauerne af GAG i urin blev normaliseret til under den øvre grænse for normen (defineret som 126,6 µg GAG/mg kreatinin) hos 50% af de patienter, der fik behandling ugentligt.
English: There is no known interaction of this medicine with other medicines.
Danish: Der findes ingen kendt interaktion mellem dette lægemiddel og andre lægemidler.
English: Paediatric population The dose for children and adolescents is the same as for adults, 0.5 mg/kg body weight weekly.
Danish: Pædiatrisk population Dosis til børn og unge er den samme som til voksne, 0,5 mg/kg legemsvægt ugentligt.
English: The higher the urinary GAG levels at baseline, the greater the magnitude of decreases in urinary GAG with idursulfase treatment.
Danish: Jo højere GAGniveauerne i urin var ved baseline, desto større var faldene i GAG i urinen med idursulfasebehandling.
English: Once diluted, the solution should be mixed gently, but not shaken.
Danish: Efter fortynding skal opløsningen blandes forsigtigt, men ikke omrystes.
English: There are no data or limited amount of data from the use of idursulfase in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af idursulfase til gravide kvinder.
English: In the fourth patient, who had less severe underlying disease, spontaneous resolution occurred shortly after the infusion was interrupted.
Danish: Hos den fjerde patient, som havde en mindre alvorlig tilgrundliggende sygdom, opstod der spontan resolution kort tid efter seponering af infusionen.
English: Over time the number of these infusion-associated reactions decreases.
Danish: Med tiden falder antallet af disse infusionsrelaterede virkninger.
English: Idursulfase is produced in a human cell line by genetic engineering technology (it involves the introduction of genetic information into human cells in the lab, which will then produce the desired product).
Danish: Idursulfase produceres i en human cellelinje ved hjælp af en genetisk teknologi (genetisk information indføres i humane celler i et laboratorium, hvilket får cellerne til at fremstille det ønskede produkt).
English: If you have problems breathing, with or without bluish skin, tell your doctor straight away and seek immediate medical assistance.
Danish: Hvis De har problemer med at trække vejret - med eller uden blåfarvning af huden - skal De straks informere Deres læge og øjeblikkeligt søge lægehjælp.
English: - The number of vials to be diluted should be determined based on the individual patient's weight and the recommended dose of 0.5 mg/kg.
Danish: - Det antal hætteglas, der skal fortyndes, fastlægges på baggrund af patientens vægt og den anbefalede dosis på 0,5 mg/kg.
English: Patients were classified into the following groups: missense (13), complete deletion/large rearrangement (8), and frameshift/ splice site mutations (5).
Danish: Patienterne blev inddelt i følgende grupper: missense-mutationer (13), komplet deletion/større rearrangement-mutationer (8) og frameshift/splice site-mutationer (5).
English: The frequency of infusion-related reactions decreased over time with continued treatment.
Danish: Hyppigheden af de infusionsrelaterede reaktioner faldt i takt med den fortsatte behandling.
English: This medicine has been authorised under “exceptional circumstances”.
Danish: Dette lægemiddel er godkendt under ”særlige omstændigheder”.
English: Store in a refrigerator (2C - 8C)
Danish: Opbevares i køleskab (2C - 8C)
English: There is no experience with overdoses of this medicine.
Danish: Der er ingen erfaring med overdoser af dette lægemiddel.
English: The fifth patient, who had preexisting cardiopathy, was diagnosed with ventricular premature complexes and pulmonary embolism during the study.
Danish: Den femte patient, som havde eksisterende kardiopati, blev diagnosticeret med ventrikulære præmature komplekser og lungeemboli under studiet.
English: This medicine contains 11.1 mg sodium (main component of cooking/table salt) in each vial.
Danish: Dette lægemiddel indeholder 11,1 mg natrium (hovedkomponent i madlavnings-/bordsalt) i hvert hætteglas.
English: Elaprase is indicated for the long-term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II).
Danish: Elaprase er indiceret til langtidsbehandling af patienter med Hunter syndrom (mukopolysakkaridose II, MPS II).
English: Instructions for use, handling and disposal
Danish: Instruktioner vedrørende anvendelse og håndtering samt bortskaffelse
English: It was not possible, however, to accurately predict individual clinical outcome based on antibody response or genotype.
Danish: Det var imidlertid ikke muligt præcist at forudsige individuelle, kliniske resultater ud fra antistofrespons eller genotype.
English: Caution must be exercised in the management and treatment of such patients by limitation or careful monitoring of antihistamine and other sedative medicinal product use.
Danish: Der skal udvises forsigtighed i forbindelse med håndtering og behandling af sådanne patienter i form af begrænsning eller nøje overvågning af anvendelsen af antihistaminer og andre sedative præparater.
English: Of these 6 (40%) had normalised LVM by the end of the study.
Danish: (40%) normaliseret LVM ved studiets afslutning.
English: Four patients experienced a hypoxic episode during one or several infusions, which necessitated oxygen therapy in 3 patients with severe underlying obstructive airway disease (2 with a pre-existing tracheostomy).
Danish: Fire patienter oplevede en episode med hypoxia under en eller flere infusioner, hvilket nødvendiggjorde iltbehandling til 3 patienter med alvorlig tilgrundliggende obstruktiv luftvejssygdom (2 med eksisterende trakeostomi).
English: Home infusions should be performed under the surveillance of a physician or other healthcare professional.
Danish: Infusion i hjemmet bør gives under opsyn af en læge eller anden sundhedsperson.
English: Clinical study HGT-ELA-038 evaluated immunogenicity in children 16 months to 7.5 years of age.
Danish: Det kliniske studie HGT-ELA-038 evaluerede immunogeniciteten hos børn i alderen 16 måneder til 7,5 år.
English: Idursulfase is taken up by selective receptor-mediated mechanisms involving binding to mannose 6phosphate receptors.
Danish: Idursulfase optages af selektive receptormedierede mekanismer, hvilket involverer binding til mannose-6-phosphat-receptorer.
English: Very common Common
Danish: Almindelig Ikke almindelig
English: There is no experience with overdoses of Elaprase.
Danish: Der er ingen erfaring med overdoser af Elaprase.
English: Related reactions in the placebo group were similar in nature and severity to those in the treated group.
Danish: De relaterede reaktioner i placebogruppen svarede i karakter og styrke til dem i behandlingsgruppen.
English: Patients with the most severe pulmonary impairment at baseline (as measured by % predicted FVC) tended to show the least improvement.
Danish: Patienterne med de sværeste tilfælde af nedsat lungefunktion ved baseline (målt ved procentmæssig forudset FVC) syntes at fremvise de mindste forbedringer.
English: Late emergent symptoms and signs of anaphylactoid/anaphylactic reactions have been observed as long as 24 hours after an initial reaction.
Danish: Sent opståede symptomer og tegn på anafylaktoide/anafylaktiske reaktioner er blevet observeret helt op til 24 timer efter en første reaktion.
English: If severe allergic reactions occur, your doctor will stop the infusion immediately, and start giving you suitable treatment.
Danish: Hvis alvorlige allergiske reaktioner opstår, vil lægen straks standse infusionen og derefter påbegynde en passende behandling til Dem.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development.
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger, hvad angår drægtighed, embryonal/føtal udvikling, fødsel eller postnatal udvikling.
English: No patient discontinued treatment due to an infusion reaction during clinical studies.
Danish: Ingen patienter fik behandlingen seponeret som følge af en infusionsrelateret reaktion i de kliniske studier.
English: Management of patients must be decided on an individual basis (see section 4.8).
Danish: Behandlingen af patienterne skal fastlægges individuelt (se pkt.
English: If you experience an allergic side effect following administration of this medicine, you should contact your doctor immediately.
Danish: Hvis De oplever en allergisk bivirkning efter indgivelse af dette lægemiddel, skal De straks kontakte Deres læge.
English: In addition, mean liver volume decreased to a near maximum extent by Month 8 in all patients previously treated, with a slight increase observed at Month 36.
Danish: Desuden faldt det gennemsnitlige levervolumen i næsten maksimal udstrækning ved måned 8 hos alle patienter, der tidligere var blevet behandlet, med en lille stigning ved måned 36.
English: It is not known whether idursulfase is excreted in human breast milk.
Danish: Det er ukendt, om idursulfase udskilles i human mælk.
English: The study included patients with a documented deficiency in iduronate-2sulfatase enzyme activity, a percent predicted FVC <80%, and a broad spectrum of disease severity.
Danish: Studiet inkluderede patienter med dokumenteret mangel på iduronat-2-sulfatase-enzymaktivitet, en forventet FVC på <80% og et bredt spektrum af sværhedsgrad af sygdommen.
English: Elaprase is administered at a dose of 0.5 mg/kg body weight every week by intravenous infusion over a 3 hour period, which may be gradually reduced to 1 hour if no infusion-associated reactions are observed (see section 4.4).
Danish: Elaprase indgives i en dosis på 0,5 mg/kg legemsvægt hver uge ved intravenøs infusion over 3 timer, som gradvist kan reduceres til 1 time, hvis der ikke observeres infusionsrelaterede reaktioner (se pkt.
English: Adverse reaction (preferred term)
Danish: Bivirkning (foretrukken term) Meget almindelig
English: Patients using supplemental oxygen should have this treatment readily available during infusion in the event of an infusion-related reaction.
Danish: For patienter, der får ekstra ilt, skal denne behandling være umiddelbart til rådighed under infusion i tilfælde af en infusionsrelateret reaktion.
English: Mean treatment difference compared with placebo (SE)
Danish: Middel behandlingsforskel sammenlignet med placebo (SE)
English: Results from pivotal clinical study at 0.5 mg/kg per week (Study TKT024).
Danish: Resultater fra centralt klinisk studie ved 0,5 mg/kg om ugen (TKT024-studiet).
English: Changes in urinary GAG levels were the earliest signs of clinical improvement with idursulfase treatment and the greatest decreases in urinary GAG were seen within the first 4 months of treatment in all treatment groups; changes from Month 4 to 36 were small.
Danish: Ændring i GAG-niveauer i urin var det tidligste tegn på klinisk forbedring med idursulfase-behandling, og de største fald i GAG i urinen sås inden for de første fire måneder af behandlingen i alle behandlingsgrupper; ændringer fra måned 4 til måned 36 var små.
English: Overall, there was no apparent trend in either systemic exposure or clearance rate of idursulfase with respect to either age or body weight.
Danish: Overordnet var der ingen åbenbar tendens mht. systemisk eksponering eller clearancehastighed for idursulfase, hvad angår alder eller kropsvægt.
English: The recommended dose is an infusion of 0.5 mg (half a milligram) for every kg you weigh
Danish: Den anbefalede dosis er infusion af 0,5 mg (et halvt milligram) for hvert kilogram, De vejer.
English: In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler skal det administrerede produkts handelsnavn og batchnummer tydeligt registreres.
English: After 105 weeks of exposure to idursulfase, neither antibody status nor genotype affected reductions in liver and spleen size or distance walked in the 6-minute walk test or forced vital capacity measurements.
Danish: Efter 105 ugers eksponering for idursulfase havde hverken antistof-status eller genotype nogen indvirkning på reducering af lever- eller miltstørrelse, på tilbagelagt distance i 6-minutters gangtesten eller på målinger af forceret vitalkapacitet.