FrancophonIA/ELRC3.0 huggingface dataset:
English: Velaglucerase alfa is manufactured to contain predominantly high-mannose-type glycans to facilitate internalisation of the enzyme by the phagocytic target cells via the mannose receptor.
Danish: Velaglucerase alfa fremstilles på en måde, så det hovedsageligt indeholder højmannoseglykaner for at facilitere internaliseringen af enzymet ved de fagocytiske målceller gennem mannosereceptoren.
English: How VPRIV is used
Danish: Sådan skal VPRIV anvendes
English: No patients developed IgE antibodies to velaglucerase alfa.
Danish: Ingen patienter udviklede IgE-antistoffer mod velaglucerase alfa.
English: - If you experience any of the symptoms, you must tell your doctor immediately.
Danish: - Hvis du oplever et eller flere af symptomerne, skal du fortælle det til lægen med det samme.
English: Patients previously treated with imiglucerase received a median of 8 velaglucerase alfa infusions with median duration of treatment of 15.1 weeks.
Danish: For de patienter, der tidligere var blevet behandlet med imiglucerase, var det mediane antal modtagne velaglucerase alfa-infusioner 8 med en median behandlingsvarighed på 15,1 uger.
English: Similar treatment effects were seen through 48 months in the paediatric population who received 9 months of imiglucerase followed by velaglucerase alfa.
Danish: Lignende behandlingseffekt sås i løbet af 48 måneder hos den pædiatriske population, der fik imiglucerase i 9 måneder efterfulgt af velaglucerase alfa.
English: If you are breast feeding or considering breast-feeding, you should talk to your doctor before this medicine is used.
Danish: Hvis du ammer eller overvejer at amme, skal du tale med lægen, før dette lægemiddel anvendes.
English: VPRIV requires reconstitution and dilution, and is intended for intravenous infusion only.
Danish: VPRIV skal rekonstitueres og fortyndes og er udelukkende beregnet til intravenøs infusion.
English: VPRIV is for single-use only and is administered through a 0.22 µm filter.
Danish: VPRIV er kun til engangsbrug og indgives gennem et 0,22 µm-filter.
English: The safety profile of VPRIV in clinical studies involving children and adolescents aged 4 to 17 years was similar to that observed in adult patients.
Danish: Sikkerhedsprofilen af VPRIV i kliniske studier med børn og unge i alderen 4 til 17 år svarede til sikkerhedsprofilen hos voksne patienter.
English: Extractable volume
Danish: Volumen til udtagelse
English: Velaglucerase alfa increases haemoglobin concentration and platelet counts and reduces liver and spleen volumes in patients with type 1 Gaucher disease.
Danish: Velaglucerase alfa øger hæmoglobinkoncentrationen og trombocyttallet samt mindsker lever- og miltvolumen hos patienter med Gauchers sygdom, type 1.
English: VPRIV is supplied in a vial as a packed powder which is mixed with sterile water and further diluted in sodium chloride 9 mg/ml (0.9%) solution prior to intravenous infusion.
Danish: VPRIV leveres i et hætteglas som fast pulver, som skal blandes med sterilt vand og yderligere fortyndes i en 9 mg/ml (0,9 %)-natriumchloridopløsning før infusion i en blodåre.
English: Gaucher disease is a genetic disorder caused by a missing or defective enzyme named glucocerebrosidase.
Danish: Gauchers sygdom er en genetisk lidelse, der skyldes et manglende eller dårligt fungerende enzym, der hedder glucocerebrosidase.
English: Among 31 treatment-naïve adult patients treated with velaglucerase alfa, the mean lumbar spine BMD Z-score at baseline was -1.820 (95% CI: -2.21, -1.43) and increased by 0.62 (95% CI: 0.39, 0.84) from baseline following 24 months of treatment with velaglucerase alfa.
Danish: Hos 31 behandlingsnaive voksne patienter, der blev behandlet med velaglucerase alfa, var den gennemsnitlige Z-score for BMD i lændehvirvlerne ved baseline -1,820 (95 %-KI: -2,21; -1,43) og steg med 0,62 (95 %-KI: 0,39; 0,84) fra baseline efter 24 måneders behandling med velaglucerase alfa.
English: Ask your pharmacist how to throwaway medicines you no longer use.
Danish: Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: 9/l), liver volume was reduced from 1.40 to 1.24 times normal (mean reduction of 6%) and spleen volume was reduced from 14.5 to 9.50 times normal (mean reduction of 40%).
Danish: 9/l), levervolumen reduceredes fra 1,40 til 1,24 gange normalstørrelsen (gennemsnitlig reduktion på 6 %), og miltvolumen reduceredes fra 14,5 til 9,50 gange normalstørrelsen (gennemsnitlig reduktion på 40 %).
English: Velaglucerase alfa was initially administered in a dose-escalating fashion in the first 3 patients (15, 30, 60 Units/kg) and the 9 remaining patients began treatment with 60 Units/kg.
Danish: Velaglucerase alfa blev indledningsvis indgivet på en dosiseskalerende måde hos de første 3 patienter (15, 30 og 60 enheder/kg), og de sidste 9 patienter fik en startdosis på 60 enheder/kg.
English: Velaglucerase alfa supplements or replaces beta-glucocerebrosidase, the enzyme that catalyzes the hydrolysis of glucocerebroside to glucose and ceramide in the lysosome, reducing the amount of accumulated glucocerebroside and correcting the pathophysiology of Gaucher disease.
Danish: Velaglucerase alfa supplerer eller erstatter betaglucocerebrosidase (det enzym, der katalyserer hydrolysen af glucocerebrosid til glukose og ceramid i lysosomet), hvorved mængden af ophobet glucocerebrosid mindskes, og hvorved patofysiologien for Gauchers sygdom korrigeres.
English: It is given by a doctor or nurse by intravenous infusion.
Danish: Det gives som intravenøs infusion af en læge eller en sygeplejerske.
English: The calculated volume of medicinal product is withdrawn from the appropriate number of vials.
Danish: Den beregnede mængde lægemiddel udtages fra det antal hætteglas, der skal bruges.
English: After a minimum of 12 months of continuous treatment with velaglucerase alfa, all patients qualified to have the dose of velaglucerase alfa reduced in a step-wise fashion from 60 to 30 Units/kg after achieving at least 2 of the 4 “Year 1” therapeutic goals of ERT for type 1 Gaucher disease.
Danish: Efter mindst 12 måneders løbende behandling med velaglucerase alfa var alle patienter kvalificerede til at få velaglucerase alfa-dosen reduceret gradvist fra 60 til 30 enheder/kg efter at have nået mindst 2 af de 4 terapeutiske mål for år 1 for enzymerstatningsterapien for Gauchers sygdom, type 1.
English: This increase in haemoglobin concentration was demonstrated to be clinically and statistically non-inferior to imiglucerase (mean treatment difference of change from baseline to 9 months [velaglucerase alfa - imiglucerase]: 0.135 g/dl).
Danish: Det blev påvist, at stigningen i hæmoglobinkoncentration var klinisk og statistisk noninferior over for imiglucerase (gennemsnitlig forskel i ændring mellem behandlingerne fra baseline til 9 måneder [velaglucerase alfaimiglucerase]: 0,135 g/dl).
English: However a few patients experienced an allergic skin reaction which may affect up to 1 in 10 people (common) such as severe rash or itching.
Danish: Få patienter oplevede dog en allergisk hudreaktion såsom svært udslæt eller kløe, som kan forekomme hos op til 1 ud af 10 patienter (almindelig hyppighed).
English: Patients who switched from long-term imiglucerase treatment to velaglucerase alfa (N=38)
Danish: Patienter, der skiftede fra langvarig imiglucerase-behandling til velaglucerase alfa (n
English: It is for single-use only and is administered through a 0.22 µm filter.
Danish: Det er kun til engangsbrug og indgives gennem et 0,22 µm-filter.
English: The Marketing Authorisation Holder (MAH) must agree on the content and format of the educational materials for use of VPRIV in home infusion, including communication media, distribution modalities and any other aspects of the programme, with the National Competent Authority.
Danish: • Yderligere risikominimeringsforanstaltninger Indehaveren af markedsføringstilladelsen og den nationale kompetente myndighed skal være enige om indholdet og formen af uddannelsesmaterialet til infusion af VPRIV i hjemmet, herunder kommunikationsmedier, distributionsmetoder og eventuelle andre aspekter af programmet.
English: Deposits in the bone marrow and splenic sequestration lead to clinically significant anaemia and thrombocytopenia.
Danish: Aflejring i knoglemarven og sekvestrering i milten medfører klinisk signifikant anæmi og trombocytopeni.
English: Common side effects are: - stomach ache/feeling sick (nausea) - easy bleeding / easy bruising - skin flushing - rapid heart beat - rash/hives - developing antibodies to VPRIV (see section 2)
Danish: Almindelige bivirkninger: - Mavesmerter/kvalme - Tendens til blødning/blå mærker - Rødme - Hurtig hjerterytme - Udslæt/nældefeber - Udvikling af antistoffer mod VPRIV (se punkt 2)
English: Caution should be exercised when prescribing to a breast-feeding woman.
Danish: Der skal udvises forsigtighed ved ordination til en ammende kvinde.
English: Vascular disorders hypertension, hypotension, flushing
Danish: Hypertension, hypotension, rødme
English: Similar results were seen in treatment-naïve patients who received 9 months of imiglucerase followed by velaglucerase alfa for 15 months.
Danish: Lignende resultater sås hos behandlingsnaive patienter, der fik imiglucerase i 9 måneder efterfulgt af velaglucerase alfa i 15 måneder.
English: Very common side effects are: - bone pain - joint pain - back pain - weakness/loss of strength/tiredness
Danish: Meget almindelige bivirkninger: - Knoglesmerter - Ledsmerter - Rygsmerter - Svaghed/tab af styrke/træthed
English: Patients received doses ranging from 30 to 60 Units/kg (median dose 35 Units/kg) every other week for up to 84 months (7 years).
Danish: Patienterne fik velaglucerase alfa i doser fra 30 til 60 enheder/kg (mediandosis var 35 enheder/kg) hver anden uge i op til 84 måneder (7 år).
English: Some solution will remain in the vial:
Danish: Der vil være en rest af opløsningen tilbage i glasset.
English: These treatment effects on haemoglobin, platelet count, organ volumes, bone mineral density and height were maintained through the end of the study.
Danish: Disse behandlingseffekter på hæmoglobinkoncentration, trombocyttal, organvolumen, knoglemineraltæthed og højde blev fastholdt gennem hele studiet.
English: Fifty-four patients were naïve to ERT and 40 patients switched from imiglucerase to VPRIV.
Danish: 54 patienter var ikke tidligere behandlet med enzymerstatningsterapi, og 40 patienter skiftede fra imiglucerase til VPRIV.
English: Clinical studies have evaluated doses ranging from 15 to 60 Units/kg every other week.
Danish: Der er i kliniske studier evalueret doser fra 15 til 60 enheder/kg indgivet hver anden uge.
English: Velaglucerase alfa 60 Units/kg given intravenously every other week demonstrated clinically meaningful increases from baseline in mean haemoglobin concentration (+2.4 g/dl) and platelet count (+50.9 x 10
Danish: Velaglucerase alfa 60 enheder/kg indgivet intravenøst hver anden uge viste klinisk betydningsfulde stigninger i forhold til baseline i gennemsnitlig hæmoglobinkoncentration (+2,4 g/dl) og trombocyttal (+50,9 x 10
English: Patients transferring from imiglucerase were administered velaglucerase alfa infusions every other week at the same number of units as imiglucerase within the range of 15 to 60 Units/kg.
Danish: Patienter, der skiftede fra imiglucerase, fik velaglucerase alfa-infusioner hver anden uge med samme antal enheder som imiglucerase-dosen inden for intervallet 15-60 enheder/kg.
English: Each vial is reconstituted using sterile water for injections:
Danish: Hvert hætteglas rekonstitueres, idet der anvendes sterilt vand til injektionsvæsker: Hætteglassets størrelse
English: Gastrointestinal disorders abdominal pain/abdominal pain upper,
Danish: Mave-tarm-kanalen Abdominalsmerter/smerter i øvre abdomen
English: Patients received either 60 Units/kg of velaglucerase alfa (N=17) or 60 Units/kg of imiglucerase (N=17) every other week.
Danish: Patienterne fik enten 60 enheder/kg velaglucerase alfa (N = 17) eller 60 enheder/kg imiglucerase (N = 17) hver anden uge.
English: The recommended dose is 60 Units/kg given every other week.
Danish: Den anbefalede dosis er 60 enheder/kg, der indgives hver anden uge.
English: Haemoglobin concentration (g/dL) Platelet count (x 10
Danish: Hæmoglobinkoncentration (mmol/l) Trombocyttal (x 10
English: Improvement from baseline in mean lumbar spine and femoral neck bone mineral density (BMD) Z-scores were observed at month 24 (0.4; 95% CI 0.1, 0.7) and month 33 (0.4; 95% CI 0.2, 0.6), respectively.
Danish: Der blev observeret en forbedring fra baseline i gennemsnitlig Z-score for knoglemineraltæthed (BMD) i lænd og lårbenshals i måned 24 (0,4; 95 %KI 0,1; 0,7) og måned 33 (0,4; 95%-KI 0,2; 0,6).
English: In patients who switched from imiglucerase to velaglucerase alfa, haemoglobin concentrations and platelet counts were sustained at therapeutic levels through 12 months of treatment.
Danish: Hos patienter, der skiftede fra imiglucerase til velaglucerase alfa, fastholdtes hæmoglobinkoncentrationerne og trombocyttallene på terapeutiske niveauer gennem de 12 måneders behandling.
English: After seven years of treatment, the mean increase from baseline in Z-scores were 0.7 (95% CI 0.4, 1.0) for the lumbar spine and 0.5 (95% CI 0.2, 0.7) for the femoral neck.
Danish: Efter 7 års behandling var den gennemsnitlige stigning i Z-score fra baseline 0,7 (95%-KI 0,4; 1,0) for lænd og 0,5 (95 %-KI 0,2; 0,7) for lårbenshals.
English: In this study, BMD was assessed using dual x-ray absorptiometry of the lumbar spine and femoral neck.
Danish: I dette studie blev BMD målt ved DEXA-skanning af lændehvirvlerne og lårbenshalsen.
English: Treatment with velaglucerase alfa was administered as the same number of units and regimen as their imiglucerase dose.
Danish: Velaglucerase alfa blev indgivet med samme antal enheder og i samme regimen som den tidligere imiglucerase-dosis.
English: 20 ml vial (type I glass) with a stopper (fluoro-resin coated butyl rubber), one piece seal, and flip-off cap.
Danish: 20 ml-hætteglas (type 1-glas) med en prop (fluor-harpiks-beklædt butylgummi) og en lukkehætte i ét med en central plade til afrivning.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and must not exceed 24 hours at 2C to 8C.
Danish: Hvis det ikke anvendes med det samme, er opbevaringstider og -forhold før ibrugtagning brugerens ansvar.
English: Hypersensitivity reactions, including symptoms consistent with anaphylaxis, have been reported in patients in clinical studies and in post-marketing experience.
Danish: Der er indberettet overfølsomhedsreaktioner, herunder symptomer svarende til anafylaksi, hos patienter i kliniske studier og efter markedsføring.
English: No patients were classified at a more severe WHO classification of bone density compared to baseline.
Danish: I forhold til baseline havde ingen patienter en dårligere score i henhold til WHOklassifikationen for knogletæthed.
English: The calculated volume of medicinal product is withdrawn from the appropriate number of vials and the total volume required is diluted in 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: Den beregnede volumen lægemiddel udtages fra det antal hætteglas, der skal bruges, og den samlede nødvendige mængde fortyndes i 100 ml natriumchlorid 9 mg/ml (0,9 %)-opløsning til infusion.
English: VPRIV 400 Units powder for solution for infusion velaglucerase alfa
Danish: VPRIV 400 enheder pulver til infusionsvæske, opløsning velaglucerase alfa
English: In patients who switched from long-term imiglucerase to velaglucerase alfa, lumbar spine BMD was maintained at 24 months.
Danish: Hos patienter, der skiftede fra langvarig imiglucerase til velaglucerase alfa, var den lumbale BMD-score fastholdt ved 24 måneder.
English: Apart from symptoms associated with hypersensitivity reactions IRRs might show as fatigue, dizziness, pyrexia, blood pressure increase, pruritus, or vision blurred.
Danish: Bortset fra symptomer, der er forbundet med overfølsomhedsreaktioner, kan IRR vise sig som træthed, svimmelhed, pyreksi, forhøjet blodtryk, pruritus eller sløret syn.
English: Severe allergic reaction to the active substance or to any of the excipients listed in section 6.1.
Danish: Svær overfølsomhedsreaktion over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: These are called infusion related reactions and might appear as a hypersensitivity reaction with symptoms like nausea, rash, difficulty in breathing, back pain, chest discomfort (chest tightness), hives, joint pain or headache.
Danish: Disse kaldes infusionsrelaterede reaktioner og kan vise sig som en overfølsomhedsreaktion med symptomer som kvalme, udslæt, vejrtrækningsbesvær, rygsmerter, brystgener (trykken for brystet), nældefeber, ledsmerter eller hovedpine.
English: Meaningful increases from baseline were observed in the 45 Units/kg dose group in haemoglobin concentration (+2.4 g/dl) and platelet count (+40.9 x 10
Danish: Der blev observeret betydningsfulde stigninger i forhold til baseline i gruppen, som fik dosen på 45 enheder/kg, for så vidt angår hæmoglobinkoncentration (+2,4 g/dl) og trombocyttal (+40,9 x 10
English: Patients were randomized to receive velaglucerase alfa at a dose of either 45 Units/kg (N=13) or 60 Units/kg (N=12) every other week.
Danish: Patienterne blev randomiseret til at få en velaglucerase alfa-dosis på enten 45 enheder/kg (N = 13) eller 60 enheder/kg (N = 12) hver anden uge.
English: It requires reconstitution and dilution and is intended for intravenous infusion only.
Danish: Det er nødvendigt at rekonstituere og fortynde VPRIV, der udelukkende er beregnet på intravenøs infusion.
English: - Apart from symptoms of hypersensitivity reactions infusion-related reactions might show as dizziness, high blood pressure, tiredness, fever, itching, or blurry vision.
Danish: - Udover symptomer på overfølsomhedsreaktioner kan infusionsrelaterede reaktioner vise sig som svimmelhed, højt blodtryk, træthed, feber, kløe eller sløret syn.
English: Patients transferring from a dose of <15 Units/kg imiglucerase were administered 15 Units/kg of velaglucerase alfa.
Danish: Patienter, der skiftede fra en dosis på < 15 enheder/kg imiglucerase, fik en velaglucerase alfa-dosis på 15 enheder/kg.
English: The most commonly observed symptoms of infusion-related reactions were: headache, dizziness, hypotension, hypertension, nausea, fatigue/asthenia, and pyrexia/body temperature increased (see section 4.4 for further information).
Danish: De hyppigst observerede symptomer på infusionsrelaterede reaktioner var: hovedpine, svimmelhed, hypotension, hypertension, kvalme, træthed/asteni og pyreksi/øget kropstemperatur (se pkt.
English: Symptoms consistent with anaphylaxis have been reported in patients in clinical studies and in post-marketing experience.
Danish: Der er blevet indberettet symptomer svarende til anafylaksi hos patienter i kliniske studier og efter markedsføring.
English: The total volume required is diluted in 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: Den samlede nødvendige mængde fortyndes i en 100 ml-opløsning af 9 mg/ml (0,9 %) natriumchlorid-infusionsvæske.
English: VIAL - 400 UNITS
Danish: HÆTTEGLAS - 400 ENHEDER
English: OUTER CARTON - 400 UNITS (25 vial pack)
Danish: YDRE KARTON - 400 ENHEDER (pakning med 25 hætteglas)
English: Excipient with known effect: One vial contains 12.15 mg sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Et hætteglas indeholder 12,15 mg natrium.
English: VPRIV treatment should be supervised by a physician experienced in the management of patients with Gaucher disease.
Danish: VPRIV bør indgives under supervision af en læge med erfaring i behandling af Gauchers sygdom.
English: Investigations activated partial thromboplastin time prolonged, neutralizing antibody positive
Danish: Forlængelse af aktiveret partiel tromboplastintid,
English: Bone involvement results in skeletal abnormalities and deformities as well as bone pain crises.
Danish: Knogleafficering medfører skeletanomalier og -misdannelser samt knoglesmerter med feber (knoglekriser).
English: VPRIV 400 Units powder for solution for infusion
Danish: VPRIV 400 enheder pulver til infusionsvæske, opløsning
English: If anaphylactic or other acute reactions occur, immediately discontinue the infusion and initiate appropriate medical treatment.
Danish: Hvis der opstår anafylaktiske eller andre akutte reaktioner, skal infusionen straks afbrydes og passende medicinsk behandling påbegyndes (se pkt.
English: If you experience any side effect like these, please tell your doctor immediately.
Danish: Hvis du oplever nogen af disse bivirkninger, skal du fortælle det til lægen med det samme.
English: OUTER CARTON - 400 UNITS (5 vial pack)
Danish: YDRE KARTON - 400 ENHEDER (pakning med 5 hætteglas)
English: After reconstitution, one ml of the solution contains 100 Units of velaglucerase alfa.
Danish: Efter rekonstituering indeholder én ml af opløsningen 100 enheder velaglucerase alfa.
English: Study 039 was a 9-month, randomized, double-blind, non-inferiority, active-comparator (imiglucerase) controlled, parallel-group efficacy study in 34 patients aged 2 years and older who were naïve to ERT (defined as having not been treated with ERT for at least 12 months prior to study entry).
Danish: Studie 039 var et 9-måneders, randomiseret, dobbeltblindet, noninferioritets- og aktivt kontrolleret (imiglucerase) effektstudie med parallelle grupper med 34 patienter fra 2 år og opefter, der ikke tidligere var behandlet med enzymerstatningsterapi (defineret som, at de ikke havde fået enzymerstatningsterapi gennem de seneste 12 måneder før inklusion i studiet).
English: VPRIV is indicated for long-term enzyme replacement therapy (ERT) in patients with type 1 Gaucher disease.
Danish: VPRIV er indiceret til langsigtet enzymerstatningsterapi hos patienter med Gauchers sygdom, type 1.
English: Adverse drug reactions derived from post-marketing reports other than interventional clinical trials are printed in italics.
Danish: Bivirkninger indrapporteret efter markedsføring, bortset fra kliniske interventionsstudier, er angivet med kursiv.
English: Upon reconstitution, vials should be mixed gently.
Danish: Efter rekonstituering skal indholdet af hætteglassene blandes forsigtigt.
English: What VPRIV is and what it is used for What you need to know before VPRIV is used How VPRIV is used
Danish: Virkning og anvendelse Det skal du vide, før VPRIV anvendes Sådan skal VPRIV anvendes Bivirkninger
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products - enzymes, ATC code: A16AB10.
Danish: Farmakoterapeutisk klassifikation: Andre midler til fordøjelsesorganer og stofskifte - enzymer.
English: Respiratory, thoracic and mediastinal disorders dyspnea
Danish: Luftveje, thorax og mediastinum
English: Posology The recommended dose is 60 Units/kg administered every other week.
Danish: Dosering Den anbefalede dosis er 60 enheder/kg, der indgives hver anden uge.
English: Study 025 was a 9 month, open-label study in 12 adult (≥18 years) patients who were naïve to ERT (defined as having not been treated with ERT for at least 12 months prior to study entry).
Danish: Studie 025 var et 9-måneders åbent studie med 12 voksne (≥ 18 år) patienter, der ikke tidligere var behandlet med enzymerstatningsterapi (defineret som, at de ikke havde fået enzymerstatningsterapi gennem de seneste 12 måneder før inklusion i studiet).
English: What VPRIV contains
Danish: VPRIV indeholder:
English: One vial contains 400 Units of velaglucerase alfa.
Danish: Et hætteglas indeholder 400 enheder velaglucerase alfa.
English: OUTER CARTON - 400 UNITS (single vial pack)
Danish: YDRE KARTON - 400 ENHEDER (pakning med 1 hætteglas)
English: Reconstituted and diluted solution for infusion:
Danish: Rekonstitueret og fortyndet infusionsvæske, opløsning:
English: Vials should not be shaken.
Danish: Hætteglassene må ikke rystes.
English: One vial contains 400 Units* of velaglucerase alfa**.
Danish: Hvert hætteglas indeholder 400 enheder* velaglucerase alfa**.
English: Skin and subcutaneous tissue disorders rash, urticaria, pruritus
Danish: Kløe, urticaria, pruritus