FrancophonIA/ELRC3.0 huggingface dataset:
English: • leakage of the drug into the surrounding tissue at the site of injection, which may cause swelling or redness
Danish: • udsivning af lægemidlet til det omgivende væv ved infusionsstedet, hvilket kan resultere i hævelse og rødme
English: • increased body temperature
Danish: • forhøjet legemstemperatur
English: If you are given more Aldurazyme than needed No case of overdose of Aldurazyme has been reported.
Danish: Hvis du har fået mere Aldurazyme end nødvendigt Der er ikke rapporteret tilfælde af overdosering.
English: As with any intravenous protein product, severe allergic-type hypersensitivity reactions are possible.
Danish: Som for alle intravenøse proteinprodukter er der mulighed for svære allergiske overfølsomhedsreaktioner.
English: Following 26 weeks of therapy, Aldurazyme-treated patients showed improved respiratory function and walking ability as compared to placebo as indicated below.
Danish: Efter 26 ugers behandling udviste de patienter, der var behandlet med Aldurazyme, forbedret åndedrætsfunktion og forbedret evne til at gå sammenlignet med placebogruppen, og som vist i nedenstående.
English: If you are treated with Aldurazyme, you may develop infusion-associated reactions.
Danish: Hvis du behandles med Aldurazyme, kan du udvikle infusionsrelaterede reaktioner.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer of the biological active substance BioMarin Pharmaceutical Inc, Galli Drive Facility, 46 Galli Drive, Novato, CA 94949, USA Name and address of the manufacturer responsible for batch release Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom Genzyme Ireland Ltd, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof BioMarin Pharmaceutical Inc, Galli Drive Facility, 46 Galli Drive, Novato, CA 94949, USA Navn og adresse på fremstilleren ansvarlig for batchfrigivelse Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Storbritannien Genzyme Irland Ltd. IDA Industrial Park, Old Kilmeaden Road, Waterford, Irland Den printede indlægsseddel for lægemidlet skal angive navn og adresse på fremstilleren ansvarlig for batchfrigivelsen.
English: After intravenous infusion, laronidase is rapidly removed from the circulation and taken up by cells into lysosomes, most likely via mannose-6 phosphate receptors.
Danish: Efter intravenøs infusion tages laronidase hurtigt ud af kredsløbet og optages af cellerne til lysosomer, sandsynligvis via mannose-6 fosfatreceptorer.
English: You may be given additional medication such as antihistamines and paracetamol to help prevent allergic-type reactions.
Danish: Du vil muligvis få anden medicin, for eksempel antihistaminer og paracetamol, som skal hjælpe til at forebygge de allergiske reaktioner.
English: The volume of distribution decreased with continued treatment, possibly related to antibody formation and/or decreased liver volume.
Danish: Den distribuerede mængde faldt ved fortsat behandling, muligvis på grund af dannelse af antistoffer og/eller faldende levervolumen.
English: Remove the required vials from the refrigerator approximately 20 minutes in advance in order to allow them to reach room temperature (below 30˚C).
Danish: Tag det nødvendige antal hætteglas ud af køleskabet ca. 20 minutter før, så de kan opnå stuetemperatur (under 30°C).
English: Side effects were mainly seen while patients were being given the medicine or shortly after (infusionassociated reactions).
Danish: Bivirkningerne blev hovedsageligt observeret, mens patienterne fik medicinen eller kort tid derefter (infusionsrelaterede reaktioner).
English: 6MWT (meters)
Danish: 6MWT (meter)
English: 1 The decrease in percent predicted FVC is not clinically significant over this timeframe, and absolute lung volumes continued to increase commensurate with changes in height in growing paediatric patients.
Danish: 1 Faldet i procent forventet FVC er ikke klinisk signifikant inden for denne tidsramme, og de absolutte lungevolumina fortsatte med at stige i takt med ændringerne i højden hos pædiatriske patienter i vækst.
English: ADRs to Aldurazyme reported during the Phase 3 study and its extension in a total of 45 patients age 5 years and older and treated up to 4 years are listed below using the following categories of frequency: very common (≥1/10); common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: ADR'er, der er indberettet under fase 3-studiet og dettes forlængelse med i alt 45 patienter i alderen 5 år og ældre, der blev behandlet i op til 4 år, er anført nedenfor med anvendelse af følgende frekvenskategorier: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Patients treated with Aldurazyme should be closely monitored and all cases of infusion-associated reactions, delayed reactions and possible immunological reactions reported.
Danish: Patienter, der behandles med Aldurazyme, skal overvåges nøje, og alle tilfælde af infusionsrelaterede reaktioner, forsinkede reaktioner og eventuelle immunologiske reaktioner skal indberettes.
English: The safety and efficacy of Aldurazyme was assessed in a randomised, double-blind, placebo controlled, Phase 3 Study of 45 patients, ranging in age from 6 to 43 years.
Danish: Sikkerheden og virkningen af Aldurazyme blev vurderet i en randomiseret, dobbelt-blind, placebokontrolleret fase 3-studie med 45 patienter i alderen fra 6 til 43 år.
English: Careful consideration should be given to the patient's clinical status prior to administration of Aldurazyme.
Danish: Der skal tages nøje hensyn til patientens kliniske status inden indgivelse af Aldurazyme.
English: Because there are no data available in neonates exposed to laronidase via breast milk, it is recommended to stop breast-feeding during Aldurazyme treatment.
Danish: Da der ikke findes nogen data om nyfødte, der udsættes for laronidase via modermælk, anbefales det at afbryde amning under behandling med Aldurazyme.
English: Inform your doctor if you are using medicines containing chloroquine or procaine, due to a possible risk of decreasing the action of Aldurazyme.
Danish: Underret din læge, hvis du anvender medicin, der indeholder chloroquin eller procain på grund af en mulig risiko for, at Aldurazymes virkning nedsættes.
English: Pyrexia, infusion site reaction
Danish: Pyreksi, reaktioner på infusionsstedet
English: Four patients (three in the Phase 3 study and one in the Phase 2 study) showed marginal to low level in vitro inhibition of laronidase enzymatic activity, which did not appear to impact clinical efficacy and/or urinary GAG reduction.
Danish: Fire patienter (tre i fase 3 studiet og en i fase 2 studiet) udviste marginal til lav hæmning in vitro af laronidase-enzymatisk aktivitet, der ikke syntes at påvirke den kliniske effekt og/eller reduktion af GAG i urinen.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single dose toxicity, repeated dose toxicity and toxicity to reproduction.
Danish: De prækliniske data viser ingen særlige risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, enkeltdosis-toksicitet, toksicitet efter gentagne doser og reproduktionstoksicitet.
English: Therefore Aldurazyme should not be used during pregnancy unless clearly necessary.
Danish: Derfor bør Aldurazyme ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: Aldurazyme is an artificial enzyme called laronidase.
Danish: Aldurazyme er et kunstigt enzym, der kaldes for laronidase.
English: The infusion can be restarted with a reduction of the infusion rate to 1/2 - 1/4 the rate of the infusion at which the reaction occurred.
Danish: Infusionen kan genoptages med en reduktion af infusionshastigheden til 1/2 til 1/4 af den infusionshastighed, hvor reaktionen optrådte.
English: To date there are no clinical data that demonstrate any benefit on the neurological manifestations of the disorder.
Danish: Til dato findes der ingen kliniske data, der påviser en nyttevirkning på sygdommens neurologiske manifestationer.
English: All patients subsequently enrolled in an open label extension study where they all received 100 U/kg of Aldurazyme every week for an additional 3.5 years (182 weeks).
Danish: Alle patienter blev efterfølgende optaget i en openlabel forlængelsesstudie, hvor de alle fik 100 E/kg Aldurazyme hver uge i yderligere 3,5 år (182 uger).
English: After intravenous administration of laronidase with an infusion time of 240 minutes and at a dose of 100 U/kg body weight pharmacokinetic properties were measured at Weeks 1, 12 and 26.
Danish: Efter intravenøs indgivelse af laronidase med en infusionstid på 240 minutter og ved en dosis på 100 E/kg kropsvægt blev de farmakokinetiske egenskaber målt i ugerne 1, 12 og 26.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til intravenøs brug.
English: Patients with an acute underlying illness at the time of Aldurazyme infusion appear to be at greater risk for IARs.
Danish: Patienter med en akut tilgrundliggende sygdom på tidspunktet for infusion med Aldurazyme forekommer at have større risiko for IAR.
English: Almost all patients developed IgG antibodies to laronidase.
Danish: Stort set alle patienter udviklede IgG-antistoffer mod laronidase.
English: Of the 26 patients with abnormal liver volumes at pre-treatment baseline, 22 (85%) achieved a normal liver size by the end of the study.
Danish: Ud af de 26 patienter med unormale levervolumina ved baseline inden behandling opnåede 22 (85%) normal leverstørrelse ved studiets afslutning.
English: Upon study completion, all patients showed reductions in liver size and 50% (9/18) had normal liver size.
Danish: Ved studiets afslutning udviste alle patienter reduceret leverstørrelse, og 50% (9/18) havde normal leverstørrelse.
English: Aldurazyme is used to treat patients with MPS I disease (Mucopolysaccharidosis I).
Danish: Aldurazyme bruges til at behandle patienter med MPS I (mukopolysakkaridose I).
English: However, severe systemic allergic reaction (anaphylactic reaction) has been observed in patients during or up to 3 hours after Aldurazyme infusions.
Danish: Alvorlige systemiske, allergiske reaktioner (anafylaktisk reaktion) er blevet observeret hos patienter under eller op til 3 timer efter infusion af Aldurazyme.
English: If you miss an infusion of Aldurazyme If you have missed an Aldurazyme infusion, please contact your doctor.
Danish: Hvis du har glemt at få Aldurazyme Hvis du er gået glip af en Aldurazyme-infusion, skal du kontakte din læge.
English: Purified laronidase is a glycoprotein with a molecular weight of approximately 83 kDa. Laronidase is comprised of 628 amino acids after cleavage of the N-terminus.
Danish: Renset laronidase er et glykoprotein med en molekylevægt på ca. 83 kD. Laronidase består af 628 aminosyrer efter spaltning af N-terminus.
English: The proportion of patients with mild left ventricular hypertrophy decreased from 53% (10/19) to 17% (3/18), and mean left ventricular mass normalized for body surface area decreased by 0.9 Z-Score (n=17).
Danish: Andelen af patienter med mild venstre ventrikulær hypertrofi faldt fra 53% (10/19) til 17% (3/18), og den gennemsnitlige venstre ventrikulære masse, normaliseret for legemsoverfladeareal, faldt med 0,9 Z-score (n=17).
English: Aldurazyme treatment should be supervised by a physician experienced in the management of patients with MPS I or other inherited metabolic diseases.
Danish: Behandling med Aldurazyme skal superviseres af en læge med erfaring i behandling af patienter med MPS I eller andre arvelige metaboliske sygdomme.
English: The younger patients with the severe phenotype (< 2.5 years) and all 4 patients with the intermediate phenotype exhibited a normal rate of mental development, whereas the older patients with a severe phenotype made limited or no gains in cognition.
Danish: De yngre patienter med den alvorlige fænotype (< 2,5 år) og alle 4 patienter med den intermediære fænotype udviste normal mental udviklingsrate, hvorimod de ældre patienter med en alvorlig fænotype kun udviste begrænset eller ingen udvikling i kognition.
English: Based on the Phase 3 clinical trial, almost all patients are expected to develop IgG antibodies to laronidase, mostly within 3 months of initiation of treatment.
Danish: På basis af den kliniske fase 3-undersøgelse forventes næsten alle patienter at udvikle IgG-antistoffer over for laronidase, for det meste inden for 3 måneder efter behandlingens påbegyndelse.
English: MPS I disease
Danish: MPS I-sygdom
English: Aldurazyme should not be administered simultaneously with chloroquine or procaine due to a potential risk of interference with the intracellular uptake of laronidase.
Danish: Aldurazyme bør ikke indgives samtidig med chloroquine eller procain på grund af en eventuel risiko for indgriben i den intracellulære optagelse af laronidase.
English: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom.
Danish: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Storbritannien.
English: Consequently, impaired liver function is not expected to affect the pharmacokinetics of laronidase in a clinically significant way.
Danish: Derfor ventes svækket leverfunktion ikke at påvirke laronidases farmakokinetik på nogen klinisk signifikant måde.
English: The primary efficacy endpoints were changes in percent of predicted normal FVC and absolute distance travelled in the six-minute walk test (6MWT).
Danish: De primære virkningsslutpunkter var ændringer i procent for forudset normal FVC og absolut afstand, der blev tilbagelagt i den seks minutters gangtest (6MWT).
English: To be taken into consideration by patients on a controlled sodium diet.
Danish: Dette skal tages med i betragtning ved patienter, som er på en kontrolleret natriumdiæt.
English: • redness of the skin
Danish: • rødmen af huden
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH CHILDREN
Danish: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
English: Laronidase is a protein and is expected to be metabolically degraded through peptide hydrolysis.
Danish: Laronidase er et protein, der forventes at blive nedbrudt metabolsk via peptidhydrolyse.
English: This medicinal product contains 1.29 mmol sodium per vial.
Danish: Dette lægemiddel indeholder 1,29 mmol natrium pr. hætteglas.
English: Some of the IARs were severe.
Danish: Nogle af IAR'erne var alvorlige.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om Aldurazyme, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Laronidase is a recombinant form of human α-L-iduronidase and is produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture.
Danish: Laronidase er en rekombinant form af human α-L-iduronidase og fremstilles ved hjælp af rekombinant DNA-teknologi med cellekultur fra hamsterovarier (CHO).
English: Do not use vials exhibiting particles or discoloration.
Danish: Brug ikke hætteglas, der udviser partikler eller misfarvning.
English: The recommended dose group had the fewest number of patients who experienced ADRs and IARs.
Danish: Gruppen på den anbefalede dosis havde det færreste antal patienter, som fik ADR'er og IAR'er.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1 VIAL, 10 VIALS, 25 VIALS)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON (1 HÆTTEGLAS, 10 HÆTTEGLAS, 25 HÆTTEGLAS)
English: To address the heterogeneity in disease manifestation across patients, using a composite endpoint that summed up clinically significant changes across five efficacy variables (percent predicted normal FVC, 6MWT distance, shoulder flexion range of motion, AHI, and visual acuity) the global response was an improvement in 26 patients (58%), no change in 10 patients (22%), and a deterioration in 9 patients (20%).
Danish: På grund af uensartethed i manifestationer af sygdommen blandt patienterne var den globale respons med anvendelse af et kombineret endpoint, som opsummerede klinisk signifikante ændringer på tværs af fem effektvariabler (procent forventet normal FVC, 6MWT-distance, bevægelsesinterval for skulderfleksion, AHI og synskarphed), en forbedring hos 26 patienter (58%), ingen ændring hos 10 patienter (22%) og en forværring hos 9 patienter (20%).
English: The majority of the related adverse events in the clinical trials were classified as infusion-associated reactions (IARs), experienced by 53% of the patients in the Phase 3 study (treated for up to 4 years) and 35% of the patients in the under 5 study (up to 1 year of treatment).
Danish: Størstedelen af de relaterede bivirkninger i de kliniske undersøgelser blev klassificeret som infusionsrelaterede reaktioner (IAR), som opstod for 53% af patienterne i fase 3-studiet (behandlet i op til 4 år) og for 35% af patienterne i studiet af patienter under 5 år (op til 1 års behandling).
English: • feeling hot, feeling cold
Danish: • følelse af varme, følelse af kulde
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 100 U (approximately 0.58 mg) of laronidase.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 ml indeholder 100 enheder (ca. 0,58 mg) laronidase.
English: By the end of the Phase 3 study (or at time of early study withdrawal), 13/45 patients had no detectable antibodies by radioimmunoprecipitation (RIP) assay, including 3 patients that had never seroconverted.
Danish: Ved afslutningen af fase 3-studiet (eller på tidspunktet for frafald i studiet) havde 13/45 patienter ingen påviselige antistoffer ifølge en radioimmunpræcipitations-analyse (RIP), hvilken omfattede 3 patienter, som aldrig havde serokonverteret.
English: A single patient with pre-existing airway compromise developed a severe reaction three hours from the start of the infusion (at week 62 of treatment) consisting of urticaria and airway obstruction, requiring tracheostomy.
Danish: En enkelt patient, der havde en allerede eksisterende luftvejslidelse, udviklede en svær reaktion tre timer efter infusionens start (ved behandlingens uge 62), der bestod af urticaria og luftvejsobstruktion, der krævede trakeostomi.
English: Although patients representing the full range of the disease spectrum were enrolled, the majority of the patients were of the intermediate phenotype, with only one patient exhibiting the severe phenotype.
Danish: Skønt der blev optaget patienter, der repræsenterede sygdommens fulde spektrum, var de fleste af patienterne i den mellemste fænotype, og kun én patient udviste svær fænotype.
English: Preclinical data did not reveal any significant adverse finding (see section 5.3).
Danish: Prækliniske data afslørede ingen signifikante negative fund (se pkt.
English: There are no clinical data on the effects of laronidase on fertility.
Danish: Der findes ikke kliniske data vedrørende laronidases virkning på fertilitet.
English: Some of the symptoms of such a severe allergic reaction were life-threatening and included extreme difficulty breathing, swelling of the throat, low blood pressure, and low oxygen level in the body.
Danish: Nogle af symptomerne ved sådanne alvorlige reaktioner var livstruende og inkluderede ekstremt åndedrætsbesvær, hævelse i halsen, lavt blodtryk og lavt iltindhold i kroppen.
English: The presence of antibodies did not appear to be related to the incidence of IARs, although the onset of IARs typically coincided with the formation of IgG antibodies.
Danish: Tilstedeværelsen af antistoffer syntes ikke at være relateret til forekomsten af infusionsrelaterede reaktioner, selvom reaktionernes indtræden typisk faldt sammen med dannelsen af IgG-antistoffer.
English: Four patients underwent dosage increases to 200 U/kg for the last 26 weeks because of elevated urinary GAG levels at Week 22.
Danish: Fire patienter gennemgik dosisstigninger til 200 E/kg i mindst 26 uger som følge af forhøjede GAGniveauer i urinen ved uge 22.
English: Most patients seroconverted within 3 months of initiation of treatment; although seroconversion in patients under 5 years old with a more severe phenotype occurred mostly within 1 month (mean 26 days versus 45 days in patients 5 years and older).
Danish: De fleste patienter serokonverterede inden for 3 måneder fra påbegyndelse af behandling; dog opstod serokonvertering hos patienter under 5 år med en mere alvorlig fænotype oftest inden for 1 måned (mean 26 dage mod 45 dage hos patienter, der var 5 år eller ældre).
English: Pack size: 1, 10 and 25 vials per carton.
Danish: Pakningsstørrelser: 1, 10 og 25 hætteglas pr. karton.
English: Only clear and colourless solutions without visible particles should be used.
Danish: Kun klare og farveløse opløsninger uden synlige partikler bør anvendes.
English: Patients received either 100 U/kg of Aldurazyme or placebo every week for a total of 26 weeks.
Danish: Patienterne modtog enten 100 E/kg Aldurazyme eller placebo hver uge i 26 uger i alt.
English: One study mainly assessed the safety and pharmacokinetics of Aldurazyme in patients less than 5 years old, but some efficacy measurements were included as well.
Danish: Et studie vurderede hovedsagligt Aldurazymes sikkerhed og farmakokinetik hos patienter under 5 år, men nogle effektparametre var også inkluderet.
English: Method of administration Aldurazyme is to be administered as an intravenous infusion.
Danish: Administration Aldurazyme skal indgives som intravenøs infusion.
English: The third study was conducted to evaluate the pharmacodynamics and safety of different dose regimens of Aldurazyme.
Danish: Det tredje studie blev gennemført for at undersøge farmakodynamikken og sikkerheden ved forskellige dosisregimener med Aldurazyme.
English: There are inadequate data on the use of Aldurazyme in pregnant women.
Danish: Der foreligger utilstrækkelige data fra anvendelse af Aldurazyme til gravide kvinder.
English: In case of a single severe IAR, the infusion should be stopped until the symptoms are resolved and treatment with antihistamines and paracetamol/ibuprofen should be considered.
Danish: I tilfælde af en enkelt, svær IAR skal infusionen afbrydes, til symptomerne er fjernet, og behandling med antihistaminer og paracetamol/ibuprofen skal overvejes.
English: Aldurazyme contains sodium
Danish: Aldurazyme indeholder natrium
English: Reduced or absent α-L-iduronidase activity results in the accumulation of the GAGs, dermatan sulfate and heparan sulfate in many cell types and tissues.
Danish: Reduceret eller ikke eksisterende α-L-iduronidase-aktivitet medfører akkumulation af GAG, dermatansulfat og heparansulfat i mange celletyper og væv.
English: It is recommended to stop breast-feeding during treatment with Aldurazyme.
Danish: Det anbefales at ophøre med amning under behandling med Aldurazyme.
English: An infusion-associated reaction is any side effect occurring during the infusion or until the end of the infusion day (see section 4 “Possible Side Effects”).
Danish: En infusionsrelateret reaktion er en relateret bivirkning, der indtræder under infusionen eller inden infusionsdagen er gået (se punkt 4 “Bivirkninger”).
English: 5 ml concentrate for solution in a vial (type I glass) with a stopper (siliconised chlorobutyl rubber) and a seal (aluminium) with a flip-off cap (polypropylene).
Danish: 5 ml koncentrat til opløsning i et hætteglas (type I glas) med prop (silikoniseret klorobutyl-gummi) og en forsegling (aluminium) med aftagelig hætte (polypropylen).