FrancophonIA/ELRC3.0 huggingface dataset:
English: As there is little experience on resumption of treatment following prolonged interruption, caution is to be used due to the theoretical increased risk of hypersensitivity reaction.
Danish: Da der kun er lidt erfaring med genoptagelse af behandlingen efter længere tids afbrydelse, skal der udvises forsigtighed på grund af den teoretiske øgede risiko for en overfølsomhedsreaktion.
English: The solution must be diluted further before it can be infused.
Danish: Opløsningen skal fortyndes yderligere, inden den kan infunderes.
English: Administration of Naglazyme should be carried out in an appropriate clinical setting where resuscitation equipment to manage medical emergencies would be readily available.
Danish: Administration af Naglazyme bør foretages på et passende klinisk sted, hvor genoplivningsudstyr til håndtering af medicinske nødsituationer er hurtigt tilgængeligt.
English: Water for injections
Danish: Vand til injektioner,
English: The following information is intended for medical or healthcare professionals only: Naglazyme should not be mixed with other medicinal products in the same infusion, except for those mentioned below.
Danish: Følgende oplysninger er kun til læger og sundhedspersonale: Naglazyme må ikke blandes med andre lægemidler i samme infusion end med dem, der er anført nedenfor.
English: Detailed clinical status information will be collected at study entry and on an annual basis for at least 15 years.
Danish: Der vil blive indsamlet detaljerede oplysninger om klinisk status ved forsøgspersonens indtræden i forsøget samt på årlig basis i mindst 15 år.
English: Other measures (urinary GAG, antibodies) are assessed more frequently.
Danish: Andre målinger (urin-GAG, antistoffer) vil blive vurderet hyppigere.
English: The rationale for enzyme replacement therapy is to restore a level of enzymatic activity sufficient to hydrolyze the accumulated substrate and to prevent further accumulation.
Danish: Rationalet for enzymsubstitutionsbehandling er at genoprette et niveau af enzymatisk aktivitet, som er tilstrækkeligt til at hydrolysere det akkumulerede substrat og til at forhindre yderligere akkumulation.
English: Treatment with Naglazyme showed improvement, or lack of worsening, of facial dysmorphism.
Danish: Behandling med Naglazyme viste forbedret, eller mangel på forværring af, facial dysmorfisme.
English: Warnings and precautions - If you are treated with Naglazyme, you may develop infusion-associated reactions.
Danish: Advarsler og forsigtighedsregler - Hvis du bliver behandlet med Naglazyme, kan du få infusionsrelaterede reaktioner.
English: Adverse reactions are listed in Table 1 by System Organ Class.
Danish: Bivirkninger er opstillet i Tabel 1 efter systemorganklasse.
English: Institution of positive-airway pressure during sleep as well as potential tracheostomy in clinically appropriate situations should also be considered.
Danish: Iværksættelse af positivt luftvejs-tryk (positive-airway pressure) under søvn samt potentiel trakeostomi i klinisk passende situationer bør ligeledes overvejes.
English: - The active substance is galsulfase.
Danish: - Aktivt stof: Galsulfase.
English: Infusion reactions began as early as Week 1 and as late as Week 146 of Naglazyme treatment, and occurred during multiple infusions though not always in consecutive weeks.
Danish: Infusionsreaktioner begyndte allerede i Uge 1 og så sent som i Uge 146 af Naglazyme-behandlingen og forekom under flere infusioner, men ikke altid i konsekutive uger.
English: Caution must be exercised in the management and treatment of patients with compromised airways 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 patienter med kompromitterede luftveje ved begrænsning af brugen eller omhyggelig monitorering af antihistamin og anden sedativ medicin.
English: Several patients have received their total dose of Naglazyme at approximately twice the recommended infusion rate without apparent adverse events.
Danish: Adskillige patienter har modtaget deres totale dosis Naglazyme ved cirka to gange den anbefalede infusionshastighed tilsyneladende uden hændelser.
English: The safety and efficacy of Naglazyme in patients older than 65 years has not been established, and no alternative dose regimen can be recommended in these patients.
Danish: Sikkerheden og effekten af Naglazyme hos patienter over 65 år er ikke påvist, og der kan ikke anbefales et alternativt doseringsregimen til disse patienter.
English: Common reactions have a frequency of 1/100 to <1/10.
Danish: Almindelige bivirkninger har en hyppighed på 1/100 til <1/10.
English: If these reactions occur, immediate discontinuation of Naglazyme is recommended and appropriate medical treatment should be initiated.
Danish: Hvis disse reaktioner opstår, anbefales det øjeblikkeligt at afbryde behandlingen med Naglazyme og initiere passende behandling.
English: It did not prevent the progression of skeletal dysplasia and development of hernias and did not prevent the progression of corneal clouding.
Danish: Det forhindrede ikke progression af skeletal dysplasi og udvikling af brok, og det forhindrede ikke progression af corneal opacitet.
English: They accumulate in many tissues in the body, which causes the symptoms of MPS VI.
Danish: De ophobes i mange af kroppens væv, hvilket forårsager symptomerne af MPS VI.
English: The mean ( SD) elimination half-life (t1/2) was 22.8 ( 10.7) minutes at Week 24.
Danish: Middel ( SD) eliminationshalveringstiden (t1/2) var 22,8 ( 10,7) minutter ved uge 24.
English: After intravenous infusion, galsulfase is rapidly removed from the circulation and taken up by cells into lysosomes, most likely via mannose-6 phosphate receptors.
Danish: Efter intravenøs infusion fjernes galsulfase hurtigt fra kredsløbet og optages af celler ind i lysosomer, højst sandsynlig via mannose-6 fosfat receptorer.
English: It is recommended that the diluted Naglazyme solution be administered to patients using an infusion set equipped with a 0.2 µm in-line filter.
Danish: Det anbefales, at den fortyndede Naglazyme opløsning administreres til patienterne ved brug af et infusionssæt, der er udstyret med et 0,2 µm in-line filter.
English: This can replace the natural enzyme which is lacking in MPS VI patients.
Danish: Dette enzym kan erstatte det naturlige enzym, som mangler hos patienter med MPS VI.
English: It is not known whether galsulfase is excreted in milk, therefore breast-feeding should be stopped during Naglazyme treatment.
Danish: Det vides ikke, hvorvidt galsulfase udskilles i modermælk, og derfor bør amning ophøre under behandling med Naglazyme.
English: This medicine contains a recombinant enzyme called galsulfase.
Danish: Dette lægemiddel indeholder et gensplejset (rekombinant) enzym, der kaldes galsulfase.
English: ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OF THE MARKETING AUTHORISATION C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
Danish: BILAG II A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN C. SÆRLIGE FORPLIGTELSER, SOM SKAL OPFYLDES AF INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: The infusion can be restarted with a reduction of the infusion rate to 50% - 25% of the rate at which the reaction occurred.
Danish: Infusionen kan genoptages med en reduktion i infusionshastighed til 50% - 25% af den hastighed, ved hvilken reaktionen opstod.
English: A brief update will be submitted as part of the Annual Reassessments.
Danish: En kort opdatering vil blive indsendt som del af de årlige revurderinger.
English: Samples for total antibody will be collected at specific intervals.
Danish: Prøver for totalt antistof vil blive indsamlet med specifikke intervaller.
English: From a microbiological safety point of view, Naglazyme should be used immediately.
Danish: Med hensyn til mikrobiologisk sikkerhed bør Naglazyme anvendes omgående.
English: Patients who could walk more than 5 meters (m) but less than 250 m in 6 minutes of a 12 Minute Walk test or less than 400 m at the 12 minute time point at baseline were enrolled in the study.
Danish: Patienter, som ved baseline kunne gå mere end 5 meter (m) men mindre end 250 m på 6 minutter i en 12 minutters gangtest eller mindre end 400 m ved 12 minutters tidspunktet, blev rekrutteret i studiet.
English: Adverse reactions reported during the Post Marketing period are included at a frequency category of “unknown”.
Danish: Bivirkninger, som er indberettet i perioden efter markedsføring, er inkluderet med frekvenskategorien ”ukendt”.
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation , is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilance-systemet, som er beskrevet i Modul 1.8.1 i markedsføringstilladelsen, er på plads og fungerer, før og mens produktet markedsføres.
English: When using 100 ml bags, the volume of Naglazyme may be added directly to the infusion bag.
Danish: Når der anvendes 100 ml poser, kan Naglazyme volumenet tilføres direkte til infusionsposen.
English: Evaluate the safety and efficacy of Naglazyme in 10 children less than
Danish: Evaluere sikkerheden og effekten af Naglazyme hos 10 børn under 5 år,
English: Evaluate the effect of Naglazyme on pregnancy and lactation.
Danish: Evaluere virkningen af Naglazyme på graviditet og amning
English: Renal elimination of galsulfase is considered a minor pathway for clearance (see section 4.2).
Danish: Renal elimination af galsulfase betragtes som en mere ubetydelig clearance-rute (se pkt.
English: In case of a single severe IAR, the infusion should be stopped until the symptoms are resolved and treatment with antihistamines and paracetamol should be considered.
Danish: I tilfælde af en enkelt svær IAR bør infusionen standses, indtil symptomerne ophører, og behandling med antihistaminer og paracetamol bør overvejes.
English: Patients received either 1 mg/kg of galsulfase or placebo every week for a total of 24 weeks.
Danish: Patienterne modtog enten 1 mg/kg galsulfase eller placebo hver uge i løbet af i alt 24 uger.
English: Data collected in the post-marketing phase will also be examined to determine if a suitable Naglazyme maintenance dose can be recommended relative to the efficacy endpoints used in the clinical studies.
Danish: Data, indsamlet efter markedsføringen, vil ligeledes blive undersøgt med henblik på at fastslå, hvorvidt en egnet Naglazyme vedligeholdelsesdosis kan anbefales, relativt til de effektmål der blev anvendt i de kliniske forsøg.
English: Based on data obtained during Naglazyme clinical trials, the majority of patients are expected to develop IgG antibodies to galsulfase within 4-8 weeks of treatment initiation.
Danish: Baseret på data, der er fremskaffet under kliniske forsøg med Naglazyme, forventes størstedelen af patienterne at udvikle IgG antistoffer over for galsulfase inden for 4-8 uger efter behandlingens start.
English: The primary efficacy endpoint was the numbers of meters walked in 12 minutes at Week 24 compared to the number of meters walked at baseline.
Danish: Det primære endepunkt var antallet af meter gået i 12 minutter ved uge 24 sammenlignet med antallet af meter gået ved baseline.
English: Pack sizes: 1 and 6 vials.
Danish: Pakningsstørrelser: 1 og 6 hætteglas.
English: This leaflet was last revised in MM/YYYY
Danish: Denne indlægsseddel blev senest ændret den MM/YYYY
English: Consequently, impaired liver function is not expected to affect the pharmacokinetics of galsulfase in a clinically significant way.
Danish: Derfor forventes forringet leverfunktion ikke at have klinisk signifikant indflydelse på farmakokinetikken af galsulfase.
English: Naglazyme should not be used during pregnancy unless clearly necessary.
Danish: Naglazyme bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE
English: This medicine may improve the symptoms of MPS VI.
Danish: Denne medicin kan muligvis lindre symptomerne på MPS VI.
English: Diluted solutions:
Danish: Fortyndede opløsninger:
English: Information will also be collected on clinical status, adverse events, assessments of immunogenicity and potential effects on antibody formation.
Danish: Der vil endvidere blive indsamlet oplysninger om klinisk status, uønskede hændelser, vurdering af immunogenicitet og potentielle virkninger på antistofdannelse.
English: Reactions of unknown frequency were reported post-marketing.
Danish: Bivirkninger med ukendt frekvens blev indberettet efter markedsføring.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy or embryo-foetal development (see section 5.3).
Danish: Dyreforsøg viser ikke direkte eller indirekte skadelige virkninger for graviditet eller embryoets/fostrets udvikling (se pkt.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator
English: - If you have a fever, or if you are having difficulty breathing before this medicine is given, talk with your doctor about delaying your Naglazyme infusion.
Danish: - Hvis du har feber eller svært ved at trække vejret, inden du får medicinen, skal du tale med din læge om at udskyde Naglazyme-infusionen.
English: Naglazyme is supplied as a concentrate for solution for infusion.
Danish: Naglazyme leveres som et koncentrat til infusionsopløsning.
English: 1Reactions reported more frequently in the active arm of the placebo-controlled study than the placebo arm; frequency determined from 39 patients of the blinded Phase 3 study.
Danish: 1Bivirkninger, der rapporteredes hyppigere i den aktive arm i det placebo-kontrollerede studie end i placebo-armen; hyppighed bestemt ud fra 39 patienter i det blindede fase 3-studie.
English: If you have missed a Naglazyme infusion, please contact your doctor.
Danish: Hvis du har glemt af få en Naglazyme-infusion, bør du kontakte din læge.
English: Side effects were mainly seen while patients were being given the medicine or shortly after (“infusion associated reactions”).
Danish: Bivirkninger sås hovedsageligt, mens patienterne fik medicinen eller kort derefter (infusionsrelaterede reaktioner).
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report (PSUR).
Danish: I overensstemmelse med CHMP-retningslinjerne for risikostyringsprogrammer for lægemidler til human brug skal en opdateret RMP fremsendes samtidig med den efterfølgende periodiske sikkerhedsopdateringsrapport (PSUR).
English: - Please talk to your doctor if you experience muscle pain, numbness in your arms or legs, or any bowel or bladder problems as these may be caused by pressure on your spinal cord.
Danish: - Tal med din læge, hvis du får muskelsmerter, følelsesløshed i arme eller ben,eller blære- eller tarmproblemer, da det kan skyldes tryk på din rygmarv.
English: Currently available data are described in section 5.1.
Danish: Nuværende tilgængelige data er beskrevet i pkt.
English: - This medicine has not been tested in patients with kidney or liver problems.
Danish: - Dette lægemiddel er ikke blevet afprøvet hos patienter med nedsat nyre- eller leverfunktion.
English: An updated Risk Management Plan should be provided as per the CHMP Guideline on Risk Management System for medicinal products for human use.
Danish: Endvidere skal en opdateret plan for risikostyring tilvejebringes i henhold til CHMPvejledningen for risikostyringssystemer vedrørende lægemidler til human brug.
English: In an additional Phase 4, randomised, two-dose level study, four MPS VI patients <1 year of age were treated at 1 or 2 mg/kg/week for 53 to 153 weeks.
Danish: I et yderligere randomiseret, to-dosis, fase 4-studie blev fire MPS VI-patienter <1 år behandlet med 1 eller 2 mg/kg/uge i 53 til 153 uger.
English: GAG results approached the normal range for age in the Naglazyme treatment group.
Danish: GAG resultaterne nærmede sig normalområdet i henhold til alder i den Naglazyme-behandlede gruppe.
English: The majority of the patients presented with short stature, impaired endurance, and musculoskeletal symptoms.
Danish: Størstedelen af patienterne var ikke ret høje, udviste nedsat udholdenhed samt muskuloskeletale symptomer.
English: The safety and efficacy of Naglazyme was assessed in a randomised, double blind, placebo controlled, Phase 3 study of 39 MPS VI patients, ranging in age from 5 to 29 years.
Danish: Sikkerheden og effekten af Naglazyme blev undersøgt i et randomiseret, dobbeltblind, placebokontrolleret fase 3 studie med 39 MPS VI patienter i alderen fra 5 til 29 år.
English: Thirty-eight patients subsequently enrolled in an Open Label extension study where they received 1 mg/kg of galsulfase every week.
Danish: 38 patienter blev efterfølgende rekrutteret i et forlænget forsøg med åben etiket, hvor de modtog 1 mg/kg galsulfase hver uge.
English: Final CSP Study Report: 31 July activities.
Danish: Endelig CSP forsøgsrapport: 31. juli 2020
English: Treatment has been shown to improve walking and stairclimbing ability, and to reduce the levels of glycosaminoglycans in the body.
Danish: Behandlingen er vist at forbedre gang og trappegang og reducere niveauerne af glykosaminoglykaner i kroppen.
English: Although a larger proportion of subjects with high total antibody titres experienced recurrent infusion reactions, neither frequency nor severity could be predicted based on the anti-galsulfase antibody titre.
Danish: Selvom en større andel forsøgspersoner med høje totale antistoftitre oplevede tilbagevendende infusionsreaktioner, kunne hverken hyppighed eller sværhedsgrad forudsiges på baggrund af antigalsulfase-antistoftiteren.
English: The pharmacokinetics of galsulfase were evaluated in 13 patients with MPS VI who received 1 mg/kg of galsulfase as a 4 hour infusion.
Danish: Farmakokinetikken af galsulfase blev evalueret hos 13 patienter med MPS VI, som modtog 1 mg/kg galsulfase som en 4 timers infusion.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 002 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen er forpligtet til at foretage de undersøgelser og supplerende pharmacovigilance-aktiviteter, som er beskrevet i pharmacovigilance-planen ifølge aftalen i risikostyringsprogrammets (RMP) version 002, Modul 1.8.2 i markedsføringsansøgningen, og enhver efterfølgende opdatering af RMP, som er godkendt af CHMP.
English: In four patients <1 year of age, the overall safety profile of a higher dose (2 mg/kg/week) did not differ in a clinically meaningful manner from that of the recommended 1 mg/kg/week dose, and was consistent with the safety profile of Naglazyme in older children.
Danish: Hos fire patienter <1 år var den overordnede sikkerhedsprofil af en højere dosis (2 mg/kg/uge) ikke anderledes klinisk set end den anbefalede dosis på 1 mg/kg/uge, og den var samstemmende med sikkerhedsprofilen af Naglazyme hos ældre patienter.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes, ATC code: A16AB08
Danish: Farmakoterapeutisk klassifikation: Andre fordøjelseskanal- og metabolismeprodukter - enzymer ATC-kode: A16AB08.
English: Infusion reactions, defined as adverse reactions occurring during Naglazyme infusions or until the end of the infusion day, were observed in 33 (56%) of the 59 patients treated with Naglazyme across five clinical studies.
Danish: Infusionsreaktioner defineret som bivirkninger, der forekom under Naglazyme-infusionen eller i løbet af infusionsdagen, blev observeret hos 33 (56 %) af de 59 patienter, der blev behandlet med Naglazyme i fem kliniske studier.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/324/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/05/324/001
English: Naglazyme is used to treat patients with MPS VI disease (Mucopolysaccharidosis VI).
Danish: Naglazyme anvendes til behandling af patienter med MPS VI-sygdom (Mucopolysaccharidosis VI).
English: The CSP data will be analysed at yearly intervals and results will be submitted as annual reports.
Danish: CSP-dataene vil blive analyseret årligt, og resultaterne vil blive indsendt som årlige rapporter.
English: Reproduction studies have been performed in rats and rabbits at doses up to 3 mg/kg/day and have revealed no evidence of impaired fertility or harm to the embryo or foetus due to Naglazyme.
Danish: Reproduktionsstudier udført hos rotter og kaniner ved doser op til 3 mg/kg/dag har ikke afsløret evidens af nedsat fertilitet eller skade på embryo eller foster på grund af Naglazyme.
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 bivirkning, der optræder under infusionen, eller indtil afslutningen af infusionsdagen (se afsnit 4 ”Bivirkninger”).
English: To be taken into consideration by patients on a controlled sodium diet.
Danish: Dette skal tages i betragtning i forbindelse med behandling af patienter på en kontrolleret natriumdiæt.
English: Bradycardia, tachycardia, cyanosis
Danish: Bradykardi, takykardi, cyanose
English: To evaluate the long-term safety and efficacy data from Naglazyme treatment a Clinical Surveillance Program (CSP) will be conducted.
Danish: Med henblik på at evaluere de langsigtede sikkerheds- og effektdata fra Naglazyme-behandlingen vil der blive gennemført et klinisk overvågningsprogram (Clinical Surveillance Program - CSP).
English: Naglazyme treatment should be supervised by a physician experienced in the management of patients with MPS VI or other inherited metabolic diseases.
Danish: Behandling med Naglazyme bør overvåges af en læge med erfaring med behandling af patienter med MPS VI eller andre arvelige metaboliske sygdomme.
English: PSURs The MAH will continue to submit yearly PSURs, unless otherwise specified by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen skal fortsætte med at indsende årlige PSURs, medmindre andet specificeres af CHMP.
English: Vial (type I glass) with a stopper (siliconized chlorobutyl rubber) and a seal (aluminium) with a flipoff cap (polypropylene).
Danish: Hætteglas (type I glas) med en prop (silikoniseret chlorobutylgummi) og forsegling (aluminium) med en flip-off hætte (polypropylen).
English: The reactions are listed following the MedDRA frequency convention.
Danish: Bivirkningerne er opstillet i henhold til MedDRA-konventionen for hyppighed.
English: If you are given more Naglazyme than you should Naglazyme is administered under the supervision of a nurse or doctor, he or she will check that the correct dose has been given and act accordingly if necessary.
Danish: Naglazyme indgives under overvågning af en sygeplejerske eller læge, og han eller hun vil kontrollere, at den korrekte dosis gives og om nødvendigt give passende behandling.
English: Do not take use this medicine after the expiry date which is stated on the vial after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på hætteglasset efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Pharyngitis1, gastroenteritis1
Danish: Faryngitis1, gastroenteritis1
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Danish: Indehaveren af markedsføringstilladelsen forpligter sig til at gennemføre de undersøgelser og yderligere lægemiddelovervågningsaktiviteter, der er beskrevet detaljeret i pharmacovigilance-planen.