FrancophonIA/ELRC3.0 huggingface dataset:
English: - If you have an allergic reaction your doctor may slow down, or stop, your infusion.
Danish: - Hvis du får en allergisk reaktion, vil lægen muligvis nedsætte infusionshastigheden eller afbryde infusionen.
English: All patients treated with NAGLAZYME (59/59) reported at least one AE.
Danish: Alle patienter, der er behandlet med Naglazyme (59/59), indberettede mindst en utilsigtet hændelse.
English: 46 Galli Drive, Novato, CA 94949 United States of America
Danish: BioMarin Pharmaceutical Inc. 46 Galli Drive, Novato, CA 94949 USA
English: You may need to be given additional medicines to prevent an allergic reaction (e.g. antihistamines and/or corticosteroids) or to reduce fever (antipyretics).
Danish: Du kan have brug for medicin for at forebygge allergiske reaktioner (fx antihistaminer og/eller kortikosteroider) eller for at sætte feberen ned (antipyretika).
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, single-dose toxicity, repeated-dose toxicity or on general reproductive performance or embryo-foetal development in rats or rabbits.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter en enkelt dosis, toksicitet efter gentagne doser eller på generel reproduktiv evne eller embryoføtal udvikling hos rotter eller kaniner.
English: Interim results will be provided in the CSP Annual Reports.
Danish: Interimresultater vil blive tilvejebragt i de årlige CSP rapporter.
English: Higher antibody levels (≥ 65610 Dilution Fraction) will be compared with the subject's urinary GAG values with a view to assess potential impacts on efficacy.
Danish: Højere antistofniveauer (≥ 65610 DF) vil blive sammenlignet med forsøgspersonens urin-GAG værdier med henblik på at vurdere den potentielle indflydelse på effekten.
English: Out of the 59 patients treated with Naglazyme in the clinical studies, 54 were tested for IgG antibodies.
Danish: Ud af de 59 patienter, behandlet med Naglazyme i de kliniske studier, blev 54 testet for IgGantistoffer.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 mg/5 ml
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 5 mg/5 ml
English: After 24 weeks of treatment the mean ( Standard Deviation [SD]) maximum plasma concentration (Cmax) was 2,357 (± 1,560) ng/ml and the mean ( SD) area under the plasma concentration-time curve (AUC0-t) was 5,860 ( 4,184) h  ng/ml.
Danish: Efter 24 ugers behandling var middel ( Standard Deviation [SD]) maksimumplasmakoncentrationen (Cmax) 2.357 (± 1.560) ng/ml, og middel ( SD) areal under plasmakoncentration-tidskurven (AUC0-t) var 5.860 ( 4.184) h  ng/ml.
English: Each 5 ml vial contains 0.8 mmol (18.4 mg) of sodium.
Danish: Hvert 5 ml hætteglas indeholder 0,8 mmol (18,4 mg) natrium.
English: Limited data are available in patients < 1 year of age (see section 5.1).
Danish: Der findes kun begrænsede data vedrørende behandling af patienter < 1 år (se pkt.
English: 6.6 Special precautions for disposal and other handling Each vial of Naglazyme is intended for single use only.
Danish: 6.6 Regler for destruktion og anden håndtering Hvert hætteglas med Naglazyme er kun beregnet til engangsbrug.
English: Sodium chloride
Danish: Natriumchlorid,
English: Do not take Naglazyme if it contains visible particles.
Danish: Brug ikke Naglazyme, hvis du ser partikler i opløsningen.
English: Other reactions with known frequency were reported from 59 patients treated with Naglazyme from all five clinical trials.
Danish: Andre bivirkninger med kendt frekvens blev indberettet af 59 patienter behandlet med Naglazyme fra alle fem kliniske studier.
English: The mean ( SD) volume of distribution (Vz) was 316 ( 752) ml/kg and the mean ( SD) plasma clearance (CL) was 7.9 ( 14.7) ml/min/kg.
Danish: Middel ( SD) distributionsvolumenet (Vz) var 316 ( 752) ml/kg, og middel ( SD) plasmaclearance (CL) var 7,9 ( 14,7) ml/min/kg.
English: For the first hour the infusion rate will be slow (approximately 2.5% of the total solution), with the remaining volume (approximately 97.5%) being taken over the next 3 hours.
Danish: I den første time vil infusionshastigheden være langsom (cirka 2,5 % af den totale opløsning), mens det resterende volumen (cirka 97,5 %) indgives i løbet af de næste tre timer.
English: 5 years of age will be treated with the 1 mg/kg dose for at least one year.
Danish: der har været behandlet med en dosis på 1 mg/kg i mindst ét år.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and should normally not be longer than 24 hours at 2C - 8C followed by up to 24 hours at room temperature (23C27C) during administration.
Danish: Hvis det ikke anvendes omgående, er brugsopbevaringstid og -forhold brugerens ansvar, og det bør normalt ikke strække sig ud over 24 timer ved 2 °C - 8 °C efterfulgt af op til 24 timer ved stuetemperatur (23 C - 27 C) under administration.
English: Due to the low number of patients in clinical trials, adverse event (AE) data from all Naglazyme studies have been pooled and reviewed in a single, clinical trial safety analysis.
Danish: På grund af det lave antal patienter i de kliniske forsøg er bivirkningsdata fra alle Naglazyme-studier samlet i en pulje og gennemgået i en enkelt samlet sikkerhedsanalyse af de kliniske forsøg.
English: In patients who have experienced allergic reactions during infusion with Naglazyme, caution should be exercised upon rechallenge; appropriately trained personnel and equipment for emergency resuscitation (including epinephrine) should be available during infusions.
Danish: Hos patienter, der har oplevet allergiske reaktioner under Naglazyme-infusionen, skal der udvises forsigtighed ved fornyet udsættelse for stoffet; personale med passende uddannelse og udstyr til genoplivning (herunder adrenalin) skal være til rådighed under infusionen.
English: Interim results will be provided in the annual re-assessment reports.
Danish: Interimresultater vil blive tilvejebragt i de årlige revurderingsrapporter.
English: Treated patients also experienced a mean decrease in urinary glycosaminoglycan excretion of 238 ± 17.8 μg/mg creatinine ( Standard Error [SE]) following 24 weeks of treatment relative to placebo-treated patients.
Danish: Behandlede patienter oplevede desuden en gennemsnitlig reduktion i udskillelsen af glycosaminoglycan i urinen på 238 ± 17,8 μg/mg kreatinin ( standardfejl [SE]) efter 24 ugers behandling i forhold til patienter i placebo-gruppen.
English: Reduced or absent N-acetylgalactosamine 4-sulfatase activity results in the accumulation of dermatan sulfate in many cell types and tissues.
Danish: Nedsat eller manglende N-acetylgalactosamine 4-sulfatase aktivitet resulterer i akkumulation af dermatansulfat i mange celletyper og væv.
English: Very common side effects (these may affect more than 1 in 10 people):
Danish: Meget almindelige bivirkninger (disse kan optræde hos flere end 1 ud af 10 patienter):
English: The cause of clinical relevance of the hepatic toxicity (bile duct hyperplasia / periportal inflammation) seen at clinically relevant doses in the repeated dose monkey toxicity study is not known.
Danish: Årsagen til hepatisk toksicitet (galdegangshyperplasi / periportal inflammation), som blev observeret ved klinisk relevante doser i gentagen dosis toksicitetsforsøg med aber, kendes ikke.
English: Following 24 weeks of therapy, Naglazyme-treated patients experienced a 92 ± 40 m improvement in the distance walked in 12 minutes relative to placebo-treated patients (p = 0.025).
Danish: Efter 24 ugers behandling oplevede Naglazyme-behandlede patienter en 92 ± 40 m forbedring i den afstand, de kunne gå i løbet af 12 minutter, i forhold til patienter i placebo-gruppen (p = 0,025).
English: You must not receive this medicine - If you have experienced severe or life-threatening allergic (hypersensitive) reactions to galsulfase or any of the other ingredients of Naglazyme and re-administration of the medicine was not successful.
Danish: Brug ikke Naglazyme: - Hvis du har oplevet alvorlige eller livstruende allergiske reaktioner (overfølsomhed) over for galsulfase eller et af de øvrige indholdsstoffer i Naglazyme, og næste indgivelse af medicinen ikke var en succes.
English: The initial infusion rate is adjusted so that approximately 2.5% of the total solution is infused during the first hour, with infusion of the remaining volume (approximately 97.5%) over the next 3 hours.
Danish: Den første infusionshastighed justeres således, at ca. 2,5 % af den totale opløsning infunderes i løbet af den første time, mens det resterende volumen (ca. 97,5 %) infunderes i løbet af de næste 3 timer.
English: One vial of 5 ml contains 5 mg galsulfase.
Danish: Ét hætteglas af 5 ml indeholder 5 mg galsulfase.
English: • Bluish skin
Danish: • Blålig hud
English: Patients should be monitored for signs and symptoms of spinal/cervical cord compression (including back pain, paralysis of limbs below the level of compression, urinary and faecal incontinence) and given appropriate clinical care.
Danish: Patienterne skal monitoreres for tegn og symptomer på spinal-/rygmarvskompression (herunder rygsmerter, lammelse af ekstremiteter under kompressionsniveauet, urin- og fækal inkontinens) og gives relevant klinisk pleje.
English: 100 ml infusion bags should be considered for patients who are susceptible to fluid volume overload and weigh less than 20 kg; in this case the infusion rate (ml/min) should be decreased so that the total duration remains no less than 4 hours.
Danish: 100 ml infusionsposer skal overvejes til patienter, som er følsomme over for væske-overload, og som vejer mindre end 20 kg; i dette tilfælde bør infusionshastigheden (ml/min) nedsættes således, at den totale varighed ikke bliver mindre end 4 timer.
English: The secondary efficacy endpoints were the rate of stairs climbed in three minutes and the urinary glycosaminoglycan excretion of treated patients compared to placebo at Week 24.
Danish: De sekundære endepunkter var hastigheden af hvor mange trin patienten kunne gå op ad i tre minutter samt den urinære glycosaminoglycan udskillelse fra behandlede patienter sammenlignet med placebo-gruppen ved uge 24.
English: One ml of Naglazyme contains 1 mg galsulfase.
Danish: Én ml Naglazyme indeholder 1 mg galsulfase.
English: In the Naglazyme clinical trials, IARs were usually manageable by interrupting or slowing the rate of infusion and by (pre-) treating the patient with antihistamines and/or antipyretics (paracetamol), thus enabling the patient to continue treatment.
Danish: I de kliniske forsøg med Naglazyme kunne IAR'erne sædvanligvis håndteres ved at afbryde infusionen eller nedsætte infusionshastigheden samt ved at (for-) behandle patienten med antihistaminer og/eller antipyretika (paracetamol), hvilket gjorde det muligt for patienten at fortsætte behandlingen.
English: The recommended dose regimen for galsulfase is 1 mg/kg body weight administered once every week as an intravenous infusion over 4 hours.
Danish: Det anbefalede doseringsregimen for galsulfase er 1 mg/kg legemsvægt administreret én gang om ugen som en intravenøs infusion over 4 timer.
English: • Poor hearing
Danish: • Nedsat hørelse
English: If a physician suspects an IgE mediated reaction they have been advised in the protocol to request IgE antibody presence to be conducted by the MAH.
Danish: Hvis en læge mistænker en IgE-medieret reaktion, rådes han/hun ifølge protokollen til at anmode om, at indehaveren af markedsføringstilladelsen gennemfører prøver til at bekræfte tilstedeværelse af IgE-antistof.
English: The recommended dose is 1 mg/kg body weight administered once every week through a drip into a vein (by intravenous infusion).
Danish: Den anbefalede dosis er 1 mg/kg legemsvægt administreret én gang om ugen gennem et drop i venen (som en intravenøs infusion).
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle mistænkte bivirkninger via det nationale rapporteringssystem anført i Appendiks V. 4.9 Overdosering
English: Only clear and colourless solutions without visible particles should be used.
Danish: Kun klare og farveløse opløsninger uden synlige partikler må anvendes.
English: A comprehensive antibody analysis based on data from three clinical studies has been carried out in 48 patients.
Danish: Der er udført en omfattende antistofanalyse hos 48 patienter på baggrund af data fra tre kliniske studier.
English: Naglazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis VI (MPS VI; N-acetylgalactosamine 4-sulfatase deficiency; Maroteaux-Lamy syndrome) (see section 5.1).
Danish: Naglazyme er indiceret til brug til langvarig enzymsubstitutionsbehandling hos patienter med bekræftet diagnose af Mucopolysaccharidose VI (MPS VI; N-acetylgalactosamine 4-sulfatase mangel; Maroteaux-Lamy syndrom) (se pkt.
English: Laryngeal oedema, hypoxia, tachypnoea
Danish: Laryngealt ødem, hypoksi, takypnø
English: The solution is to be visually inspected for particulate matter prior to use.
Danish: Opløsningen skal undersøges visuelt for partikler inden brug.
English: • Pain (including ear, abdominal, joint, chest pain)
Danish: • Smerte (herunder smerter i øre, mave, led og bryst)
English: When you experience such a reaction, you should immediately contact your doctor.
Danish: Hvis du får sådanne reaktioner, skal du omgående kontakte en læge.
English: Chemical and physical in-use stability has been demonstrated for up to 4 days at room temperature (23C - 27C).
Danish: Kemisk og fysisk stabilitet i brug er påvist i op til 4 dage ved stuetemperatur (23 C - 27 C).
English: The three clinical studies performed with Naglazyme focused on assessing the systemic manifestations of MPS VI such as endurance, joint mobility, joint pain and stiffness, upper airway obstruction, manual dexterity and visual acuity.
Danish: De tre kliniske studier udført med Naglazyme fokuserede på at vurdere de systemiske manifestationer af MPS VI såsom udholdenhed, bevægelighed i led, ledsmerte og -stivhed, obstruktion af de øvre luftveje, manuel behændighed og synsskarphed.
English: Preparation of the Naglazyme Infusion (Use Aseptic Technique)
Danish: Forberedelse til Naglazyme infusion (der skal anvendes aseptisk teknik)
English: With administration of Naglazyme it is recommended that patients be administered pre-treatment medicinal products (antihistamines with or without antipyretics) approximately 30-60 minutes prior to the start of the infusion, to minimise the potential occurrence of IARs.
Danish: I forbindelse med administration af Naglazyme anbefales det, for at minimere den potentielle forekomst af IAR'er, at patienterne forbehandles med medicin (antihistaminer med eller uden antipyretika) cirka 30 - 60 minutter inden starten på infusionen.
English: The European Medicines Agency will review any new information on the medicine every year and this leaflet will be updated as necessary.
Danish: Det europæiske Lægemiddelagentur vurderer hvert år ny information vedrørende Naglazyme, og denne indlægsseddel vil om nødvendigt blive opdateret.
English: Very common adverse reactions are those with a frequency of 1/10.
Danish: Meget almindelige bivirkninger er bivirkninger med en hyppighed på 1/10.
English: Mucopolysaccharide storage disorders are caused by the deficiency of specific lysosomal enzymes required for the catabolism of glycosaminoglycans (GAGs).
Danish: Mucopolysaccharidose skyldes mangel på specifikke lysosomale enzymer, der er nødvendige i kataboliseringen af glycosaminoglycans (GAGs).
English: Treated patients experienced a 5.7 stair per minute improvement in the 3 Minute Stair Climb relative to placebo-treated patients.
Danish: Behandlede patienter oplevede en forbedring på 5,7 trin per minut i den 3 minutter lange trappe-test i forhold til patienter i placebo-gruppen.
English: People with MPS VI disease have either a low level, or no level, of an enzyme called N-acetylgalactosamine 4-sulfatase, which breaks down specific substances (glycosaminoglycans) in the body.
Danish: Mennesker med sygdommen MPS VI har enten et lavt niveau eller intet niveau af et enzym, der kaldes N-acetylgalactosamin-4-sulfatase, som nedbryder bestemte stoffer (glycosaminoglycans) i kroppen.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: Du kan finde yderligere information om Naglazyme på det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: For single use only Any unused solution should be discarded
Danish: Evt. ubrugt opløsning skal bortskaffes
English: In case of a mild or moderate IAR, treatment with antihistamines and paracetamol should be considered and/or a reduction in the infusion rate to half the rate at which the reaction occurred.
Danish: I tilfælde af en mild eller moderat IAR bør behandling med antihistaminer og paracetamol overvejes, og/eller infusionshastigheden bør reduceres til halvdelen af den hastighed, ved hvilken reaktionen opstod.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 1 mg galsulfase.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver ml opløsning indeholder 1 mg galsulfase.
English: Purified galsulfase, a recombinant form of human N-acetylgalactosamine 4-sulfatase, is a glycoprotein with a molecular weight of approximately 56 kD. Galsulfase is comprised of 495 amino acids after cleavage of the N-terminus.
Danish: Renfremstillet galsulfase, en rekombinant form af human N-acetylgalactosamine 4-sulfatase, er et glykoprotein med en molekylærvægt på cirka 56 kD. Galsulfase består af 495 aminosyrer efter spaltning af N-terminus.
English: Common side effects (these may affect up to 1 in 10 people):
Danish: Almindelige bivirkninger (disse kan optræde hos op til 1 ud af 10 patienter):
English: The most serious side effects were swollen face and fever (very common); longer than normal gaps between breaths, difficulty breathing, asthma and hives (common); and swelling of the tongue and throat, and serious allergic reaction to this medicine (unknown frequency).
Danish: De alvorligste bivirkninger var hævelse i ansigtet og feber (meget almindelig), længere afstand mellem vejrtrækningerne end normalt, vejrtrækningsbesvær, astma og nældefeber (almindelig) samt hævelse af tunge og svælg og en alvorlig allergisk reaktion på lægemidlet (ukendt hyppighed).
English: Each vial of Naglazyme is intended for single use only.
Danish: Hvert hætteglas med Naglazyme er kun beregnet til engangsbrug.
English: Severe or life-threatening hypersensitivity to the active substance or to any of the excipients, if hypersensitivity is not controllable.
Danish: Alvorlig eller livstruende overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne, hvis overfølsomheden ikke er kontrollabel.
English: Samples from those subjects who have a consistent increase in urinary GAG values together with high antibody levels will have their antibody samples assessed for evidence of neutralizing activities.
Danish: De forsøgspersoner, hvis prøver har en konsekvent stigning i urin-GAG værdierne sammen med høje antistofniveauer, vil få deres antistofprøver vurderet for tegn på neutraliserende aktiviteter.
English: For storage conditions of the diluted medicinal product, see section 6.3.
Danish: Opbevaringsforhold for det fortyndede lægemiddel, se pkt.
English: Severe, or potentially life-threatening hypersensitivity is a contraindication to rechallenge, if hypersensitivity is not controllable.
Danish: Alvorlig eller potentiel livstruende overfølsomhed er kontraindikation for fornyet udsættelse for stoffet, hvis overfølsomheden ikke er kontrollabel.
English: MPS VI is a heterogeneous and multisystemic disorder characterized by the deficiency of N-acetylgalactoasamine 4-sulfatase, a lysosomal hydrolase which catalyses the hydrolysis of sulfate moiety of the glycosaminoglycan, dermatan sulfate.
Danish: MPS VI er en heterogen og multisystemisk lidelse, karakteriseret ved mangel på N-acetylgalactoasamine 4-sulfatase, en lysosomal hydrolase som katalyserer hydrolysen af sulfat-delen af glycosaminoglycan, dermatansulfat.
English: The current medical standards for emergency treatment are to be observed.
Danish: De gældende retningslinjer for førstehjælp skal efterfølges.
English: If you forget to take this medicine
Danish: Hvis du har glemt at få Naglazyme
English: BioMarin International Limited Shanbally, Ringaskiddy County Cork, P43 R298 Ireland
Danish: BioMarin International Limited Shanbally, Ringaskiddy County Cork, P43 R298 Irland
English: Diluted solutions: Chemical and physical in-use stability has been demonstrated for up to 4 days at room temperature (23C - 27C).
Danish: Fortyndede opløsninger: Kemisk og fysisk stabilitet i brug er påvist i op til 4 dage ved stuetemperatur (23 C - 27 C).
English: In case of a recurrent moderate IAR or re-challenge after a single severe IAR, pre-treatment should be considered (antihistamines and paracetamol and/or corticosteroids) and a reduction of the infusion rate to 50% - 25% of the rate at which the previous reaction occurred.
Danish: I tilfælde af en tilbagevendende moderat IAR eller genprovokation efter en enkelt svær IAR bør det overvejes at forbehandle patienten (antihistaminer og paracetamol og/eller kortikosteroider) og nedsætte infusionshastigheden til 50% - 25% af den hastighed, ved hvilken den tidligere reaktion opstod.
English: - The other ingredients are: sodium chloride, sodium phosphate monobasic, monohydrate, sodium phosphate dibasic, heptahydrate, polysorbate 80, water for injections.
Danish: - Øvrige indholdsstoffer: Natriumklorid, natriumfosfat monobasisk monohydrat, natriumfosfat dibasisk heptahydrat, polysorbat 80, vand til injektioner.
English: Any unused product or waste material is to be disposed of in accordance with local requirements.
Danish: Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinier.
English: Marketing Authorization Holder BioMarin International Limited Shanbally, Ringaskiddy County Cork, P43 R298
Danish: Indehaver af markedsføringstilladelsen BioMarin International Limited Shanbally, Ringaskiddy County Cork, P43 R298
English: Table 1: Frequency of adverse drug reactions with Naglazyme
Danish: Tabel 1: Frekvens af bivirkninger af lægemidler med Naglazyme MedDRA Systemorganklasse
English: Severe and serious liver toxicities will be assessed through the PSUR but also through analysis of these events in the CSP database.
Danish: Svær og alvorlig levertoksicitet vil blive vurderet i periodiske, opdaterede sikkerhedsindberetninger (Periodic Safety Update Reports - PSUR) men også ved analyse af disse uønskede hændelser i CSP-databasen.
English: The solution is to be mixed gently before infusion.
Danish: Opløsningen blandes forsigtigt inden infusionen.
English: Subjects enrolled in the program will have urinary glycosaminoglycan and samples for total antibodies routinely collected as specified in the Schedule of Activities.
Danish: Forsøgspersoner, som er rekrutteret i programmet, vil regelmæssigt få indsamlet urinær glycosaminoglycan samt prøver for totale antistoffer, som specificeret i Aktivitetsplanen.
English: Patients treated with Naglazyme have developed infusion-associated reactions (IARs), defined as any adverse reactions occurring during the infusion or until the end of the infusion day (see section 4.8).
Danish: Patienter behandlet med Naglazyme har udviklet infusionsrelaterede reaktioner (infusion-associated reactions - IAR'er), defineret som enhver bivirkning, der optræder under infusionen eller i løbet af infusionsdagen (se pkt.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægsseddel inden brug
English: Apnoea1, cough, respiratory distress, asthma, bronchospasm
Danish: Apnø1, hoste, respirationsbesvær, astma, bronkospasme