FrancophonIA/ELRC3.0 huggingface dataset:
English: In the pivotal study of MCRC patients, fistulas (anal, enterovesical, enterocutaneous, colovaginal, intestinal sites) were reported in 9 of 611 patients (1.5 %) treated with the ZALTRAP/FOLFIRI
Danish: I det pivotale studie med mCRC-patienter blev der indberettet fistler (anale, enterovesikale, enterokutane, kolovaginale, intestinale) hos 9 ud af 611 patienter (1,5 %) i ZALTRAP-armen og hos 3 ud af 605 patienter (0,5 %) i placeboarmen.
English: Stratified hazard ratio (95 % CI)
Danish: Stratificeret hazard-ratio (95 % CI)
English: Severe hypersensitivity reactions (including bronchospasm, dyspnoea, angioedema, and anaphylaxis) (see sections 4.3 and 4.4)
Danish: Svære overfølsomhedsreaktioner (inklusive bronkospasme, dyspnø, angioødem og anafylaksi) (se pkt.
English: There have been no formal studies with ZALTRAP in patients with renal impairment (see section 5.2).
Danish: Der er ikke gennemført formelle studier med ZALTRAP hos patienter med nedsat leverfunktion (se pkt.
English: GI perforation (1)
Danish: Ikke almindelig GI-perforation (1)
English: Grade 3 GI fistula formation occurred in 2 patients treated with ZALTRAP (0.3 %) and in 1 placebo-treated patient (0.2 %).
Danish: Grad 3 GI-fisteldannelse forekom hos 2 patienter, som blev behandlet med ZALTRAP (0,3 %), og hos en patient, som blev behandlet med placebo (0,2 %).
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med ZALTRAP Fortæl altid lægen eller på apoteket, hvis du bruger anden medicin eller har gjort det for nylig.
English: Fistula formation involving GI and non-GI sites has occurred in patients treated with ZALTRAP.
Danish: Fisteldannelse, både fra GI-kanalen og udenfor GI-kanalen, er forekommet hos patienter, som blev behandlet med ZALTRAP.
English: Grade 3-4 ATE occurred in 1.7 % of patients treated with ZALTRAP and 1.0 % of patients treated with placebo (see section
Danish: Grad 3-4 ATE forekom hos 1,7 % af de patienter, som blev behandlet med ZALTRAP, og hos 1,0 % af de placebobehandlede patienter (se pkt.
English: Grade 3-4 haemorrhage including GI haemorrhage, haematuria, and post-procedural haemorrhage was reported in 2.9 % of patients receiving the ZALTRAP/FOLFIRI regimen compared with 1.7 % of patients receiving the placebo/FOLFIRI regimen.
Danish: Grad 3-4 blødning inklusive GI-blødning, hæmaturi og postoperativ blødning blev indberettet hos 2,9 % af patienterne i ZALTRAP-armen og hos 1,7 % i placeboarmen.
English: In the pivotal study for MCRC, compromised wound healing was reported in 3 patients (0.5 %) treated with the ZALTRAP/FOLFIRI regimen and 5 patients (0.8 %) treated with the placebo/FOLFIRI regimen.
Danish: I det pivotale studie med mCRC-patienter blev kompromitteret sårheling indberettet hos 3 af patienterne (0,5 %) i ZALTRAP-armen og hos 5 af patienterne (0,8 %) i placeboarmen.
English: Shelf-life after dilution in the infusion bag
Danish: Holdbarhed efter fortynding i infusionspose
English: One 8 ml vial of concentrate contains 200 mg aflibercept.
Danish: Et 8 ml hætteglas med koncentrat indeholder 200 mg aflibercept.
English: What you need to know before you are given ZALTRAP
Danish: Det skal du vide, før du begynder at bruge ZALTRAP
English: In the pivotal study of MCRC patients, neutropenia (all grades) has been reported in 67.8 % of patients treated with ZALTRAP/FOLFIRI and 56.3 % of patients treated with placebo/FOLFIRI.
Danish: I det pivotale studie med mCRC-patienter blev der indberettet neutropeni (alle grader) hos 67,8 % af patienterne i ZALTRAP-armen og hos 56,3 % i placeboarmen.
English: Grade 3-4 GI perforation events occurred in 0.8 % of patients treated with ZALTRAP and 0.2 % of patients treated with placebo (see section 4.4).
Danish: Grad 3-4 GIperforation forekom hos 0,8 % af de patienter, som blev behandlet med ZALTRAP, og hos 0,2 % af de patienter, som blev behandlet med placebo (se pkt.
English: The most common adverse reactions (all grades, ≥ 20 % incidence) reported at least 2 % greater incidence for the ZALTRAP/FOLFIRI regimen as compared to the placebo/FOLFIRI regimen in order of decreasing frequency were leucopenia, diarrhoea, neutropenia, proteinuria, increased aspartate aminotransferase (AST), stomatitis, fatigue, thrombocytopenia, increased alanine aminotransferase (ALT), hypertension, weight loss, decreased appetite, epistaxis, abdominal pain, dysphonia, increased serum creatinine, and headache (see Table 1).
Danish: De hyppigst rapporterede bivirkninger (alle grader, ≥20 % forekomst) med mindst 2 % højere forekomst for ZALTRAP/FOLFIRI-regimet end for placebo/FOLFIRI-regimet var, med faldende frekvens: leukopeni, diarré, neutropeni, proteinuri, forhøjet aspartataminotransferase (ASAT),
English: In the pivotal study of MCRC patients, all grades VTE occurred in 9.3 % of patients treated with the ZALTRAP/FOLFIRI regimen and 7.3 % of patients treated with the placebo/FOLFIRI regimen.
Danish: I det pivotale studie med mCRC-patienter blev der rapporteret alle grader af VTE hos 9,3 % af patienterne i ZALTRAP-armen og hos 7,3 % i placeboarmen.
English: The safety of ZALTRAP in combination with FOLFIRI was evaluated in 1,216 patients previously treated for metastatic colorectal cancer, of which 611 patients were treated with ZALTRAP 4 mg/kg every two weeks (one cycle) and 605 patients were treated with placebo/FOLFIRI in a phase III study.
Danish: 611 patienter blev behandlet med ZALTRAP 4 mg/kg hver anden uge (en cyklus), og 605 patienter blev behandlet med placebo/FOLFIRI.
English: Grade 3 compromised wound healing was reported in 2 patients (0.3 %) treated with the ZALTRAP/FOLFIRI regimen and in none of the patients treated with the placebo/FOLFIRI regimen.
Danish: Kompromitteret sårheling i grad 3 blev indberettet hos 2 af patienterne (0,3 %) i ZALTRAP-armen og hos ingen af patienterne i placeboarmen.
English: In the pivotal study of MCRC patients, severe hypersensitivity reactions have been reported in 0.3 % of patients treated with the ZALTRAP/FOLFIRI regimen and 0.5 % of patients treated with the placebo/FOLFIRI regimen (see section 4.4).
Danish: I det pivotale studie med mCRC-patienter er der rapporteret om svære overfølsomhedsreaktioner hos 0,3 % af patienterne i ZALTRAP-armen og hos 0,5 % i placeboarmen (se pkt.
English: One 4 ml vial of concentrate contains 100 mg aflibercept.
Danish: Et 4 ml hætteglas med koncentrat indeholder 100 mg aflibercept.
English: Arterial thromboembolism (1) Venous thromboembolism (1)
Danish: Arteriel tromboemboli (1) Venøs tromboemboli (1)
English: Venous thromboembolic events
Danish: Venøs tromboemboli
English: In the pivotal study of MCRC patients, GI perforation (all grades) was reported in 3 of 611 patients (0.5 %) treated with the ZALTRAP/FOLFIRI regimen and 3 of 605 patients (0.5 %) treated with the placebo/FOLFIRI regimen.
Danish: I det pivotale studie med mCRC-patienter blev der indberettet GI-perforation (alle grader) hos 3 ud af 611 patienter i ZALTRAP-armen og hos 3 ud af 605 patienter i placeboarmen.
English: In the pivotal study of MCRC patients, episodes of bleeding/haemorrhage (all grades) was reported in 37.8 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 19.0 % of patients treated with the placebo/FOLFIRI regimen.
Danish: I det pivotale studie med mCRC-patienter blev der indberettet blødningsepisoder (alle grader) hos 37,8 % af patienterne i ZALTRAP-armen og hos 19,0 % i placeboarmen.
English: ZALTRAP 25 mg / ml concentrate for solution for infusion aflibercept
Danish: ZALTRAP 25 mg/ml koncentrat til infusionsopløsning aflibercept
English: Grade 3-4 fistula occurred in 0.2 % of patients treated with ZALTRAP and 0.1 % of patients treated with placebo (see section 4.4).
Danish: Grad 3-4 fistler forekom hos 0,2 % af de patienter, som blev behandlet med ZALTRAP, og 0,1 % af de patienter, som blev behandlet med placebo (se pkt.
English: Grade 3-4 events occurred in 11 patients (1.8 %) treated with the ZALTRAP/FOLFIRI regimen and 3 patients (0.5 %) treated with the placebo/FOLFIRI regimen.
Danish: Hændelser af grad 3-4 forekom hos 11 patienter (1,8 %) i ZALTRAP-armen og hos 3 patienter (0,5 %) i placeboarmen.
English: Grade 3-4 neutropenia was observed in 36.7 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 29.5 % patients treated with the placebo/FOLFIRI regimen.
Danish: Neutropeni i grad 3-4 forekom hos 36,7 % af patienterne i ZALTRAP-armen og hos 29,5 % i placeboarmen.
English: Pulmonary embolism occurred in 4.6 % of patients treated with the ZALTRAP/FOLFIRI regimen and 3.5 % of patients treated with the placebo/FOLFIRI regimen.
Danish: Lungeemboli forekom hos 4,6 % af patienterne i ZALTRAP-armen og hos 3,5 % i placeboarmen.
English: Aflibercept treatment should be discontinued in patients who develop fistula (see section 4.2).
Danish: Aflibercept bør seponeres hos patienter, der udvikler fistel (se pkt.
English: Grade 3-4 VTE occurred in 7.9 % of patients treated with the ZALTRAP/FOLFIRI regimen and in 6.3 % of patients treated with the placebo/FOLFIRI regimen.
Danish: VTE i grad 3-4 forekom hos 7,9 % af patienterne i ZALTRAP-armen og hos 6,3 % i placeboarmen.
English: Grade 3-4 diarrhoea was reported in 19.3 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 7.8 % of patients treated with the placebo/FOLFIRI regimen.
Danish: Diarré i grad 3-4 blev indberettet hos 19,3 % af patienterne i ZALTRAP-armen og hos 7,8 % i placeboarmen.
English: Aflibercept treatment should be discontinued in patients who experience GI perforation (see section 4.2).
Danish: Aflibercept bør seponeres hos patienter, der oplever GI-perforation (se pkt.
English: Grade 3-4 compromised wound healing occurred in 0.2 % of patients treated with ZALTRAP and none of patients treated with placebo (see section 4.4).
Danish: Grad 3-4 kompromitteret sårheling forekom hos 0,2 % af patienterne i ZALTRAP-armen og hos ingen af patienterne i placeboarmen (se pkt.
English: One vial of 8 ml of concentrate contains 200 mg of aflibercept.
Danish: Et hætteglas med 8 ml koncentrat indeholder 200 mg aflibercept.
English: Abdominal pain Abdominal pain upper
Danish: Abdominalsmerter Øvre mavesmerter
English: One vial of 4 ml of concentrate contains 100 mg of aflibercept.
Danish: Et hætteglas med 4 ml koncentrat indeholder 100 mg aflibercept.
English: Hypertension (1) Haemorrhage (1)
Danish: Vaskulære sygdomme Meget almindelig Hypertension (1) Blødning (1)
English: Grade 3-4 neutropenic infection/sepsis occurred in 1.5 % of patients treated with the ZALTRAP/FOLFIRI regimen and 1.2 % of patients treated with the placebo/FOLFIRI regimen (see section 4.4).
Danish: Grad 3-4 neutropenisk infektion/sepsis forekom hos 1,5 % af patienterne i ZALTRAP-armen og hos 1,2 % i placeboarmen (se pkt.
English: Nephrotic syndrome occurred in 2 patients (0.5 %) treated with the ZALTRAP/FOLFIRI regimen compared to none of the patients treated with the placebo/FOLFIRI regimen.
Danish: Nefrotisk syndrom forekom hos 2 patienter (0,5 %) i ZALTRAP-armen og hos ingen patienter i placeboarmen.
English: Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of nephrotic syndrome was 0.5 % of patients treated with ZALTRAP and 0.1 % of patients treated with placebo (see section 4.4).
Danish: På tværs af de tre placebokontrollerede, kliniske fase III-studier (populationer med kolorektal-, pankreas- og lungecancer) var forekomsten af nefrotisk syndrom 0,5 % for patienter behandlet med ZALTRAP og 0,1 % for patienter behandlet med placebo (se pkt.
English: Hypersensitivity to aflibercept or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of VTE (all grades) was 7.1 % for patients treated with ZALTRAP and 7.1 % for patients treated with placebo.
Danish: På tværs af de tre placebokontrollerede, kliniske fase III studier (populationer med kolorektal-, pankreas- og lungecancer) var forekomsten af VTE (alle grader) 7,1 % for patienter behandlet med ZALTRAP, og 7,1 % for patienter behandlet med placebo.
English: Dyspnoea Epistaxis Dysphonia
Danish: Nedsat nyrefunktion
English: Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of ATE (all grades) was 2.3 % for patients treated with ZALTRAP and 1.7 % for patients treated with placebo.
Danish: På tværs af de tre placebokontrollerede, kliniske fase III-studier (populationer med kolorektal-, pankreas- og lungecancer) var forekomsten af ATE (alle grader) 2,3 % for patienter behandlet med ZALTRAP, og 1,7 % for patienter behandlet med placebo.
English: Dyspnoea Epistaxis
Danish: Epistaxis
English: • Severe haemorrhage
Danish: • mavesmerter
English: Grade 3-4 proteinuria occurred in 7.9 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 1.2 % of patients treated with the placebo/FOLFIRI regimen.
Danish: Proteinuri i grad 3-4 forekom hos 7,9 % af patienterne i ZALTRAP-armen og hos 1,2 % i placeboarmen.
English: Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of GI perforation (all grades) was 0.8 % for patients treated with ZALTRAP and 0.3 % for patients treated with placebo.
Danish: På tværs af de tre placebokontrollerede, kliniske fase III-studier (populationer med kolorektal-, pankreas- og lungecancer) var forekomsten af GI-perforation (alle grader) 0,8 % for patienter behandlet med ZALTRAP og 0,3 % for placebobehandlede patienter.
English: • 8 ml of concentrate in a 10 ml clear borosilicate glass vial (type I) sealed by a flanged stopper with flip-off cap and inserted coated sealing disc.
Danish: • 8 ml koncentrat i et 10 ml gennemsigtigt borsilikathætteglas (type I) forseglet med en flangeprop med flip-off hætte, og indsat forseglingsskive med overtræk.
English: Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of compromised wound healing (all grades) was 0.5 % for patients treated with ZALTRAP and 0.4 % for patients treated with placebo.
Danish: På tværs af de tre placebokontrollerede, kliniske fase III-studier (populationer med kolorektal-, pankreas- og lungecancer) var forekomsten af kompromitteret sårheling (alle grader) 0,5 % for patienter behandlet med ZALTRAP og 0,4 % for placebobehandlede patienter.
English: • 4 ml of concentrate in a 5 ml clear borosilicate glass vial (type I) sealed by a flanged stopper with flip-off cap and inserted coated sealing disc.
Danish: • 4 ml koncentrat i et 5 ml gennemsigtigt borsilikathætteglas (type I) forseglet med en flangeprop med flip-off hætte, og indsat forseglingsskive med overtræk.
English: Grade 3-4 GI perforation events occurred in all 3 patients (0.5 %) treated with the ZALTRAP/FOLFIRI regimen and in 2 patients (0.3 %) treated with the placebo/FOLFIRI regimen.
Danish: Grad 3-4 GI-perforation forekom hos alle 3 patienter (0,5 %) i ZALTRAP-armen, og hos 2 patienter (0,3 %) i placeboarmen.
English: • toothache
Danish: • vægttab
English: Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of fistula (all grades) was 1.1 % for patients treated with ZALTRAP and 0.2 % for patients treated with placebo.
Danish: På tværs af de tre placebokontrollerede, kliniske fase III-studier (populationer med kolorektal-, pankreas- og lungecancer) var forekomsten af fisteldannelse (alle grader) 1,1 % for patienter behandlet med ZALTRAP og 0,2 % for placebobehandlede patienter.
English: If severe diarrhoea recurs on a subsequent cycle, the 5-FU bolus and infusion dose should also be reduced by 20 %.
Danish: 5-FU-bolus og -infusionsdosis ligeledes reduceres med 20 %.
English: ZALTRAP 25 mg/ml concentrate for solution for infusion
Danish: ZALTRAP 25 mg/ml koncentrat til infusionsvæske, opløsning
English: Fistula formation
Danish: Fisteldannelse
English: Concentrate for solution for infusion (sterile concentrate).
Danish: Koncentrat til infusionsvæske, opløsning (sterilt koncentrat) Koncentratet er en klar, farveløs til lysegul opløsning.
English: Grade 3-4 dehydration was reported in 4.3 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 1.3 % of patients treated with the placebo/FOLFIRI regimen (see section 4.4).
Danish: Dehydrering i grad 3-4 blev indberettet hos 4,3 % af patienterne i ZALTRAP-armen og hos 1,3 % i placeboarmen (se pkt.
English: • stomach pain
Danish: • tandpine
English: • Connections or passageways inside the body between internal organs and skin or other tissues (also called ‘fistula'): Common (may affect up to 1 in 10 people) - these abnormal tube-like connections or passageways can form for example, between the gut and your skin.
Danish: Almindeligt (kan påvirke op til 1 ud af 10 personer) - disse abnorme rørlignende forbindelser eller passager kan for eksempel dannes mellem tarmen og huden.
English: Tell your doctor or nurse straight away if you have any of these signs during or soon after an infusion of ZALTRAP.
Danish: Fortæl omgående lægen eller sygeplejersken, hvis du får disse symptomer under eller kort efter en infusion af ZALTRAP.
English: Hepatobiliary disorders Very common
Danish: Meget almindelig Hovedpine Almindelig
English: Hepatic impairment
Danish: Orofanryngeale smerter
English: Deutschland Sanofi-Aventis Deutschland GmbH
Danish: Nederland sanofi-aventis Netherlands B.V.
English: You may need to read it again.
Danish: du kan få brug for at læse den igen.
English: MedDRA Preferred Term
Danish: MedDRA Foretrukken term
English: Each infusion will take approximately 4 hours.
Danish: Hver infusion vil tage cirka fire timer.
English: Growth rate remained normal over this limited follow-up period.
Danish: Væksten forblev normal over denne begrænsede opfølgningsperiode.
English: As a result, these substances do not get broken down and processed by the body as they should.
Danish: Som resultat af dette bliver disse stoffer ikke nedbrudt og forarbejdet af kroppen, som de burde.
English: Improved hearing was noted in at least one ear for all four subjects.
Danish: Der blev observeret forbedret hørelse i mindst ét øre hos alle fire forsøgspersoner.
English: Peri- and post-natal toxicity has not been investigated.
Danish: Peri- og postnatal toksicitet er ikke blevet undersøgt.
English: Module 5 - Clinical
Danish: Modul 5 - klinisk
English: Specific Obligations:
Danish: Særlige forpligtelser:
English: The final study report under this CSP will be submitted by 31 July 2020.
Danish: Den endelige forsøgsrapport under denne CSP vil blive indsendt senest den 31. juli 2020.
English: The dose you receive is based on your body weight.
Danish: Dosis baseres på din vægt.
English: Although limited by the very small number of patients that were enrolled, the conclusions that can be drawn from this study are the following:
Danish: Selv om undersøgelsen var begrænset af det meget lille antal patienter, der var rekrutteret, er konklusionerne fra dette studie følgende:
English: Unopened vials: 3 years.
Danish: Uåbnede hætteglas: 3 år.
English: Several measures will be implemented to assess the Naglazyme dose.
Danish: Flere tiltag vil blive implementeret til vurdering af Naglazyme dosen.
English: Genotoxic and carcinogenic potential are not expected.
Danish: Genotoksicitet og karcinogenicitet forventes ikke.
English: Pharmacokinetic parameters in Phase 1 patients have remained stable over the long term (through at least 194 weeks).
Danish: Farmakokinetikparametre hos fase 1 patienter har været stabile over lang tid (gennem mindst 194 uger).
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA PC
English: Your doctor or nurse will administer Naglazyme to you.
Danish: Din læge eller sygeplejerske vil give dig Naglazyme.
English: Your doctor may also give you additional medicines to manage any allergic reactions.
Danish: Lægen vil muligvis endvidere give dig supplerende medicin til behandling af eventuelle allergiske reaktioner.
English: Description:
Danish: Beskrivelse:
English: Polysorbate 80
Danish: Polysorbat 80,
English: 53/54 patients (98%) were positive for IgG antibodies to galsulfase.
Danish: 53/54 patienter (98 %) var positive for IgG-antistoffer over for galsulfase.
English: From a microbiological safety point of view, the product is to be used immediately.
Danish: Med hensyn til mikrobiologisk sikkerhed bør produktet anvendes omgående.
English: Substudies will be conducted within the CSP that will:
Danish: Inden for CSP vil der blive gennemført sub-studier, der skal:
English: • Poor reflexes
Danish: • Dårlige reflekser
English: There is no evidence for special considerations when Naglazyme is administered to the paediatric population.
Danish: Der er ingen evidens for særlige overvejelser, når Naglazyme administreres til den pædiatriske population.
English: Management of infusion-associated reactions
Danish: Håndtering af infusionsrelaterede reaktioner
English: Anaphylaxis, shock
Danish: Anafylaksi, shock
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 January 2006
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 24. januar 2006 Dato for seneste fornyelse af tilladelsen: 26. januar 2011
English: As for all lysosomal genetic disorders, it is of primary importance, especially in severe forms, to initiate treatment as early as possible, before appearance of non-reversible clinical manifestations of the disease.
Danish: Som for alle genetiske lysosomale lidelser er det af altafgørende vigtighed, især i forbindelse med svære former, at påbegynde behandling så hurtigt som muligt, inden der optræder ikke-reversible kliniske manifestationer fra sygdommen.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at få medicinen, da den indeholder vigtige oplysninger.
English: Urinary GAG levels decreased by more than 70%, consistent with results in older patients.
Danish: Urin-GAGværdierne faldt med mere end 70 %, hvilket var samstemmende med resultaterne hos ældre patienter.
English: The majority (42/59; 71%) of patients experienced at least one Adverse Drug Reaction.
Danish: Hovedparten (42/59, 71 %) af patienterne oplevede mindst en bivirkning på lægemidlet.
English: Other side effects with an unknown frequency:
Danish: Bivirkninger med ukendt hyppighed:
English: A key issue is to treat children aged <5 years suffering from a severe form of the disease, even though children <5 years were not included in the pivotal phase 3 study.
Danish: Det er yderst vigtigt at behandle unge patienter i alderen <5 år, der lider af en svær form af sygdommen, endda skønt patienter <5 år ikke var inkluderet i det yderst betydningsfulde fase 3 studie.
English: Galsulfase is a protein and is expected to be metabolically degraded through peptide hydrolysis.
Danish: Galsulfase er et protein, og det forventes at blive metabolisk degraderet via peptidhydrolyse.
English: Due to the small patient population, an adverse reaction in a single patient is classified as common.
Danish: På grund af den lille patientpopulation klassificeres en bivirkning hos en enkelt patient som almindelig.
English: This medicine contains Sodium
Danish: Denne medicin indeholder natrium
English: As with any intravenous protein medicinal product, severe allergic-type hypersensitivity reactions are possible.
Danish: Som ved ethvert intravenøst proteinlægemiddel er svære allergiske overfølsomhedsreaktioner mulige.
English: The molecule contains 6 N-linked oligosaccharide modification sites.
Danish: Molekylet indeholder 6 N-linkede oligosaccharid modifikationssteder.
English: Management of compromised airways
Danish: Håndtering i forbindelse med kompromitterede luftveje