FrancophonIA/ELRC3.0 huggingface dataset:
English: What you need to know before VPRIV is used
Danish: Det skal du vide, før VPRIV anvendes
English: VPRIV may be given to children and adolescents (2 to 17 years of age) at the same dose and frequency as in adults.
Danish: VPRIV kan gives til børn og unge (2-17 år) med samme dosis og hyppighed som hos voksne.
English: - The other ingredients are sucrose, sodium citrate dihydrate, citric acid monohydrate and polysorbate 20 (see section 2 “VPRIV contains sodium”).
Danish: - Øvrige indholdsstoffer: saccharose, natriumcitratdihydrat, citronsyremonohydrat og polysorbat 20 (se punkt 2 'VPRIV indeholder natrium').
English: Must be administered through a 0.22 µm filter.
Danish: Skal indgives gennem et 0,22 µm-filter.
English: The active substance of VPRIV is velaglucerase alfa, which is produced by gene activation technology in a human cell line.
Danish: Det aktive stof i VPRIV er velaglucerase alfa, der fremstilles ved en teknologi, der involverer aktivering af gener i en human cellelinje.
English: The most common adverse reactions were infusion-related reactions.
Danish: De hyppigste bivirkninger var infusionsrelaterede reaktioner.
English: • Annex: Package Leaflet, Infusion diary, Patient Reconstitution Guide, Emergency plan.
Danish: • Bilag: Indlægsseddel, infusionsdagbog, patientens rekonstitutionsvejledning, nødplan.
English: Prepare VPRIV as follows:
Danish: Forbered VPRIV således:
English: The effect on height was assessed in the study 044 (see section 5.1, Extension Study 044).
Danish: Effekten på højde blev vurderet i studie 044 (se pkt.
English: Patients were required to have a stable dose of imiglucerase for at least 6 months prior to study enrolment.
Danish: Patienterne skulle være behandlet med en stabil dosis imiglucerase i mindst 6 måneder før inklusion i studiet.
English: Other medicines and VPRIV
Danish: Brug af anden medicin sammen med VPRIV
English: This medicinal product contains 12.15 mg sodium per vial.
Danish: Dette lægemiddel indeholder 12,15 mg natrium pr. hætteglas.
English: Uncommon side effects are: - blurry vision (may be associated with an infusion-related reaction) - vomiting
Danish: Ikke almindelige bivirkninger: - Sløret syn (kan være forbundet med en reaktion på infusionen) - Opkastning
English: - if you are severely allergic to velaglucerase alfa or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er svært allergisk over for velaglucerase alfa eller et af de øvrige indholdsstoffer i VPRIV (angivet i punkt 6).
English: Each 400 Units vial is reconstituted with 4.3 ml of sterile water for injections.
Danish: Hvert hætteglas med 400 enheder rekonstitueres med 4,3 ml sterilt vand til injektionsvæsker.
English: In the clinical trials, one of 94 (1%) patients developed IgG-class antibodies to velaglucerase alfa.
Danish: I de kliniske studier udviklede én af de 94 (1 %) patienter antistoffer af IgG-klassen mod velaglucerase alfa.
English: The manual for patients with Gaucher Disease who receive home infusion should contain the following key elements:
Danish: Manualen til patienter med Gauchers sygdom, der får infusioner i hjemmet, bør indeholde følgende nøgleelementer:
English: Velaglucerase alfa serum concentrations rose rapidly for the first 20 minutes of the 60-minute infusion before leveling off, and Cmax was typically attained between 40 and 60 minutes after the start of the infusion.
Danish: Serumkoncentrationerne af velaglucerase alfa steg hurtigt i de første 20 minutter af den 60 minutter lange infusion, før de fladede ud, og Cmax blev typisk nået mellem 40 og 60 minutter efter påbegyndelse af infusionen.
English: Prior to further dilution, the solution in the vials should be visually inspected; the solution should be clear to slightly opalescent and colourless; the solution should not be used if it is discoloured or if foreign particulate matter is present.
Danish: Før yderligere fortynding skal opløsningen i hætteglassene inspiceres visuelt; opløsningen bør være klar til lettere opaliserende og farveløs; opløsningen må ikke bruges, hvis den er misfarvet, eller hvis der ses fremmedpartikler i den.
English: Use in the age group 4 to 17 is supported by evidence from controlled studies in adults and paediatric [20 of 94 (21%)] patients.
Danish: Brugen hos patienter i aldersgruppen 4-17 år understøttes af evidens fra kontrollerede studie hos voksne og pædiatriske (20 ud af 94 (21 %)) patienter.
English: It should not be shaken.
Danish: Det må ikke rystes.
English: • Manual for patients with Gaucher Disease who receive home infusion;
Danish: • Manual til patienter med Gauchers sygdom, der får infusioner i hjemmet,
English: All patients received at least 2 years of ERT and were followed for a mean of 4.5 years (min. 2.3 years, max 5.8 years).
Danish: Alle patienter fik mindst to års enzymerstatningsterapi og blev fulgt i gennemsnitligt 4,5 år (min. 2,3 år, maks.
English: VPRIV contains sodium
Danish: VPRIV indeholder natrium
English: The accumulation of glucocerebroside in the liver and spleen leads to organomegaly.
Danish: Ophobningen af glucocerebrosid i leveren og milten medfører organomegali.
English: - The active substance is velaglucerase alfa.
Danish: - Aktivt stof: velaglucerase alfa.
English: Water for Injections
Danish: Sterilt vand til injektionsvæsker
English: None of the subjects in the pharmacokinetic studies were positive for anti-velaglucerase alfa antibodies on the days of pharmacokinetic evaluation.
Danish: Ingen af forsøgsdeltagerne i de farmakokinetiske studier blev testet positiv for anti-velaglucerase alfa-antistoffer på dagene for farmakokinetisk evaluering.
English: This enzymatic deficiency causes an accumulation of glucocerebroside primarily in macrophages, giving rise to foam cells or "Gaucher cells".
Danish: Denne enzymmangel forårsager en ophobning af glucocerebrosid primært i makrofager, og det medfører skumceller eller 'Gaucher-celler'.
English: Caution should be exercised when prescribing to pregnant women.
Danish: Der skal udvises forsigtighed ved ordination til gravide.
English: The mean haemoglobin concentration and platelet count of patients previously treated with imiglucerase were maintained throughout the study and remained within the reference intervals.
Danish: Den gennemsnitlige hæmoglobinkoncentration og det gennemsnitlige trombocyttal hos patienter, der tidligere var blevet behandlet med imiglucerase, blev fastholdt gennem hele studiet og forblev inden for referenceintervallerne.
English: • Organisation: Home environment/Caregiver/Treating physician;
Danish: • Organisation: hjemlige omgivelser/plejer/behandlende læge,
English: VPRIV may be given to the elderly (aged over 65 years) at the same dose and frequency as in adults.
Danish: VPRIV kan gives til ældre (personer over 65 år) med samme dosis og hyppighed som hos andre voksne.
English: The educational materials for the use of VPRIV in home infusion are aimed at providing guidance on how to manage risk of infusion-related reactions including allergic-type hypersensitivity reactions in a home setting.
Danish: Uddannelsesmaterialet til infusion af VPRIV i hjemmet er beregnet som en vejledning i håndteringen af risikoen for infusionsrelaterede reaktioner, herunder overfølsomhedsreaktioner af allergitypen, i hjemlige omgivelser.
English: Treatment should be approached with caution in patients who have exhibited symptoms of hypersensitivity to velaglucerase alfa or other enzyme replacement therapy.
Danish: Behandlingen skal iværksættes med forsigtighed hos patienter, der har udvist symptomer på overfølsomhed over for velaglucerase alfa eller anden enzymerstatningsterapi.
English: After the end of the infusion, velaglucerase alfa serum concentrations fell rapidly in a monophasic or biphasic fashion with a mean t1/2 ranging from 5 to 12 minutes at doses of 15, 30, 45, and 60 Units/kg.
Danish: Efter afslutningen af infusionen faldt serumkoncentrationen af velaglucerase alfa hurtigt på monofasisk eller bifasisk vis med en gennemsnitlig t1/2 fra 5 til 12 minutter for 15, 30, 45 og 60 enheder/kg-doserne.
English: In this one event, the antibodies were determined to be neutralising in an in vitro assay.
Danish: I dette ene tilfælde vurderedes antistofferne at være neutraliserende i en in vitroanalyse.
English: A total of 95 patients (73 adult and 22 paediatric) who participated in studies 032, 034, and 039 enrolled in the open label extension study and were treated with velaglucerase alfa.
Danish: I alt 95 patienter (73 voksne og 22 børn/unge), som deltog i studierne 032, 034 og 039, fortsatte i det åbne forlængelsesstudie og blev behandlet med velaglucerase alfa.
English: • Guide for Healthcare Professionals Treating Patients with Gaucher Disease;
Danish: • Vejledning til læger og sundhedspersonale, som behandler patienter med Gauchers sygdom,
English: In this lysosomal storage disorder (LSD), clinical features are reflective of the distribution of Gaucher cells in the liver, spleen, bone marrow, skeleton, and lungs.
Danish: I denne lysosomale ophobningssygdom (lysosomal storage disease) er de kliniske karakteristika en afspejling af fordelingen af Gaucher-celler i leveren, milten, knoglemarven, skelettet og lungerne.
English: In Study 025EXT, 7 of 10 patients received home therapy at least once during 60 months of treatment.
Danish: I studie 025EXT fik 7 ud af 10 patienter behandling i hjemmet mindst én gang i løbet af 60 måneders behandling.
English: Response to treatment
Danish: Behandlingsrespons
English: Patients were required to have Gaucher disease-related anaemia and either thrombocytopenia or organomegaly.
Danish: Patienterne skulle lide af anæmi relateret til Gauchers sygdom og enten trombocytopeni eller organomegali.
English: In Study 034, 25 of 40 patients received home therapy at least once during the 12-month study.
Danish: I studie 034 fik 25 ud af 40 patienter behandling i hjemmet mindst én gang i løbet af det 12 måneder lange studie.
English: Any unused medicine or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere information om VPRIV findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Sustained clinical activity continued to be demonstrated during treatment as observed by improvements in haemoglobin concentrations and platelet counts and reduced liver and spleen volumes.
Danish: Der blev påvist fortsat klinisk aktivitet under behandlingen, observeret som forbedringer i hæmoglobinkoncentration og trombocyttal samt reduceret lever- og miltvolumen.
English: Each vial will contain an extractable volume of 4.0 ml (100 Units/ml).
Danish: Hvert hætteglas indeholder nu en volumen til udtagelse på 4,0 ml (100 enheder/ml).
English: The Guide for Healthcare Professionals Treating Patients with Gaucher Disease should contain the following key elements:
Danish: Vejledningen til læger og sundhedspersonale, der behandler patienter med Gauchers sygdom, bør indeholde følgende nøgleelementer:
English: An infusion-related reaction is defined as any adverse drug reaction occurring within 24 hours after the initiation of velaglucerase alfa infusion.
Danish: En infusionsrelateret reaktion defineres som en bivirkning, der opstår inden for 24 timer efter, infusionen med velaglucerase alfa er påbegyndt.
English: If you are currently being treated for Gaucher disease with another ERT and your doctor wants to change you to VPRIV, you can initially receive VPRIV at the same dose and frequency you had been receiving the other ERT.
Danish: Hvis du er i behandling for Gauchers sygdom med en anden enzymerstatningsterapi, og din læge ønsker at skifte dig over til VPRIV, kan du indledningsvis få VPRIV i samme dosis og med samme hyppighed, som gjaldt for den anden enzymerstatningsterapi.
English: Velaglucerase alfa exhibited an approximately linear (i.e. first-order) pharmacokinetic profile, and Cmax and AUC increased approximately proportional to the dose over the dose range 15 to 60 Units/kg.
Danish: Velaglucerase alfa havde en nogenlunde lineær (dvs. førsteordens-) farmakokinetisk profil, og Cmax og AUC steg nogenlunde proportionalt til dosis i dosisområdet 15 til 60 enheder/kg.
English: A severe allergic reaction, with difficulty breathing, swelling of the face, lips, tongue or throat occured.
Danish: En svær allergisk reaktion med vejrtrækningsbesvær, hævelse i ansigt, læber, tunge eller hals er set.
English: Adverse reactions reported in patients with type 1 Gaucher disease are listed in Table 1.
Danish: Bivirkninger, der blev indberettet hos patienter med Gauchers sygdom, type 1, er opstillet i tabel 1.
English: Immune system disorders hypersensitivity reactions (includes dermatitis allergic and anaphylactic/anaphylactoid reactions)
Danish: Overfølsomhedsreaktioner (omfatter allergisk dermatitis og anafylaktiske/anafylaktoide reaktioner)
English: In the paediatric population (ages 4 to 17 years studied), increases in the mean height Z-score were seen through 60 months of treatment in the overall treatment-naïve population, suggesting a beneficial treatment effect with velaglucerase alfa on linear growth.
Danish: Hos den pædiatriske population (i alderen 4-17 år) steg den gennemsnitlige Z-score for højde i løbet af 60 måneders behandling i den samlede behandlingsnaive population, hvilket tyder på en positiv behandlingseffekt med velaglucerase alfa på lineær vækst.
English: Pack sizes of 1, 5 and 25 vials.
Danish: Pakningsstørrelser: 1, 5 og 25 hætteglas.
English: VPRIV has no or negligible influence on the ability to drive or use machines.
Danish: VPRIV påvirker ikke eller i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Infusion-related reaction, asthenia/fatigue, pyrexia/body temperature increased
Danish: Infusionsrelateret reaktion, asteni/træthed, pyreksi/øget kropstemperatur
English: The mean absolute increase from baseline in haemoglobin concentrations was 1.624 g/dl (±0.223 SE) following 9 months of treatment with velaglucerase alfa.
Danish: Den gennemsnitlige absolutte stigning fra baseline i hæmoglobinkoncentrationer var 1,624 g/dl (± 0,223 SE) efter 9 måneders behandling med velaglucerase alfa.
English: Do not use this medicine after the expiry date which is stated on the carton and label after ‘EXP'.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Appropriate medical support, including adequately trained personnel in emergency measures, should be readily available when velaglucerase alfa is administered.
Danish: Passende klinisk støtte, herunder personale med tilstrækkelig træning i nødhjælpsprocedurer, skal være umiddelbart tilgængelig, når velaglucerase alfa indgives.
English: Twenty of the 94 patients (21%) who received velaglucerase alfa during clinical studies were in the paediatric and adolescent age range (4 to 17 years).
Danish: Tyve af de 94 patienter (21 %), der blev behandlet med velaglucerase alfa i kliniske studier, var børn og unge (4 til 17 år).
English: In this study, haemoglobin concentration, platelet count, liver volume and spleen volume were assessed in treatment-naïve patients after 24 months of treatment.
Danish: I dette studie blev hæmoglobinkoncentration, trombocyttal, levervolumen og miltvolumen vurderet hos de behandlingsnaive patienter efter 24 måneders behandling.
English: Study 058 was an open-label clinical safety study in 211 patients including 205 patients previously treated with imiglucerase 6 treatment-naïve patients and 57 patients aged 65 years or older (56/57 had switched from imiglucerase to velaglucerase alfa).
Danish: Studie 058 var et åbent klinisk sikkerhedsstudie hos 211 patienter, herunder 205 patienter, der tidligere var blevet behandlet med imiglucerase, 6 behandlingsnaive patienter og 57 patienter i alderen 65 år og derover (56/57 var skiftet fra imiglucerase til velaglucerase alfa).
English: In this small, exploratory study, the non-neurological efficacy findings and the safety profile of intravenous velaglucerase alfa in type 3 Gaucher patients were consistent with those observed in patients with type 1 Gaucher disease.
Danish: I dette lille, eksplorative studie var fundene for ikke-neurologisk virkning og sikkerhedsprofilen ved intravenøs administration af velaglucerase alfa hos patienter med Gauchers sygdom, type 3 i overensstemmelse med det observerede hos patienter med Gauchers sygdom, type 1.
English: Each 400 Units vial of this medicine contains 12.15 mg sodium.
Danish: Hvert hætteglas med 400 enheder af denne medicin indeholder 12,15 mg natrium.
English: Clinically meaningful improvements from baseline were observed in haemoglobin concentration and platelet counts as early as 3 months and in liver and spleen volumes at both 6 months and 9 months following the initiation of treatment with velaglucerase alfa.
Danish: Klinisk betydningsfulde forbedringer fra baseline blev observeret i hæmoglobinkoncentrationen og trombocyttallene allerede efter 3 måneder og i lever- og miltvolumen efter både 6 og 9 måneder efter start på behandling med velaglucerase alfa.
English: The safety profile of VPRIV in clinical studies involving patients aged 65 years and above was similar to that observed in other adult patients.
Danish: Sikkerhedsprofilen for VPRIV i kliniske studier med patienter i alderen 65 år og derover svarede til den, der blev observeret hos andre voksne patienter.
English: Patients currently treated with imiglucerase enzyme replacement therapy for type 1 Gaucher disease may be switched to VPRIV, using the same dose and frequency.
Danish: Patienter, der aktuelt behandles med enzymerstatningsterapi med imiglucerase for Gauchers sygdom, type 1, kan skiftes over til VPRIV under anvendelse af samme dosis og doseringshyppighed.
English: There were no statistically significant differences between velaglucerase alfa and imiglucerase in changes in platelet counts and liver and spleen volumes after 9 months of velaglucerase alfa treatment, and in the time to first haemoglobin response (defined as 1 g/dl increase from baseline).
Danish: Der var ingen statistisk signifikante forskelle mellem velaglucerase alfa og imiglucerase i ændringer i trombocyttal samt lever- og miltvolumen efter 9 måneders velaglucerase alfa-behandling og i tiden til første hæmoglobinrespons (defineret som en stigning på 1 g/dl fra baseline).
English: Close monitoring of the pregnancy and clinical manifestations of Gaucher disease is necessary for the individualisation of therapy.
Danish: Det er nødvendigt at foretage nøje overvågning af graviditeten og de kliniske manifestationer af Gauchers sygdom med henblik på at tilpasse behandlingen til den enkelte patient.
English: - If the reactions are severe and/or there is a loss of effect from this medicine, your doctor will perform a blood test to check for antibodies which may affect the outcome of your treatment - Most of the time you can still be given VPRIV even if you experience one of these reactions.
Danish: - Hvis reaktionerne er svære, og/eller virkningen af medicinen er nedsat, vil lægen tage en blodprøve for at tjekke for antistoffer, der kan påvirke behandlingsresultatet.
English: Do not use if the solution is discoloured or if foreign particles are present.
Danish: Brug ikke opløsningen, hvis den er misfarvet, eller hvis der ses fremmedpartikler.
English: The data described below reflect exposure of 94 patients with type 1 Gaucher disease who received velaglucerase alfa at doses ranging from 15 to 60 Units/kg every other week in 5 clinical studies.
Danish: De nedenfor beskrevne data afspejler eksponeringen af 94 patienter med Gauchers sygdom, type 1, som fik velaglucerase alfa i doser på 15 til 60 enheder/kg hver anden uge i 5 kliniske studier.
English: VPRIV contains a substance called velaglucerase alfa which is designed to replace the missing or defective enzyme, glucocerebrosidase, in patients with Gaucher disease.
Danish: VPRIV indeholder et stof, der hedder velaglucerase alfa, og det er designet til at erstatte det manglende eller dårligt fungerende enzym, glucocerebrosidase, hos patienter med Gauchers sygdom.
English: These reactions include; - headache - dizziness - fever/body temperature increased - decreased blood pressure or increased blood pressure - nausea and tiredness - chest discomfort - difficulty in breathing - itching
Danish: Disse reaktioner omfatter: - Hovedpine - Svimmelhed - Feber/øget kropstemperatur - Nedsat blodtryk eller forhøjet blodtryk - Kvalme og træthed - Brystgener - Vejrtrækningsbesvær - Kløe.
English: Paediatric subjects who switched from long-term imiglucerase to velaglucerase alfa in study 034 had greater mean height Z-scores at baseline and their mean height Z-scores remained stable over time.
Danish: De pædiatriske patienter, der skiftede fra langvarig imiglucerase til velaglucerase alfa i studie 034, havde en højere gennemsnitlig Z-score for højde ved baseline, og deres gennemsnitlige Z-score for højde forblev stabil over tid.
English: Due to the risk for hypersensitivity reactions including anaphylaxis appropriate medical support, including adequately trained personnel in emergency measures, should be readily available when velaglucerase alfa is administered.
Danish: På grund af risikoen for overfølsomhedsreaktioner, herunder anafylaksi, skal passende klinisk støtte, herunder personale med tilstrækkelig træning i nødhjælpsprocedurer, være umiddelbart tilgængelig, når velaglucerase alfa indgives.
English: Study in patients switching from imiglucerase treatment to VPRIV Study 034 was a 12-month, open-label safety study in 40 patients aged 2 years and older who had been receiving treatment with imiglucerase at doses ranging from 15 to 60 Units/kg for a minimum of 30 consecutive months.
Danish: Studie med patienter, der skifter fra imiglucerase-behandling til VPRIV Studie 034 var et 12-måneders, åbent sikkerhedsstudie med 40 patienter i alderen 2 år og opefter, som var blevet behandlet med imiglucerase i doser fra 15 til 60 enheder/kg i minimum 30 måneder i træk.
English: The range of velaglucerase alfa clearance in paediatric patients (N=7, age range 4 to 17 years) was contained within the range of clearance values in adult patients (N=15, age range 19 to 62 years).
Danish: Intervallet for velaglucerase alfa-clearance hos pædiatriske patienter (N = 7; aldersinterval 4-17 år) lå inden for intervallet for clearanceværdier hos voksne patienter (N = 15; aldersinterval 19-62 år).
English: 9/l), liver volume was reduced from 1.46 to 1.22 times normal (mean reduction of 17%) and spleen volume was reduced from 14.0 to 5.75 times normal (mean reduction of 50%).
Danish: 9/l), levervolumen reduceredes fra 1,46 til 1,22 gange normalstørrelsen (gennemsnitlig reduktion på 17 %), og miltvolumen reduceredes fra 14,0 til 5,75 gange normalstørrelsen (gennemsnitlig reduktion på 50 %).
English: This was a multicentre, open-label study in which 60 U/kg of velaglucerase alfa was administered by intravenous infusion every other week (EOW) over 12 months in 6 patients (2 to 17 years of age at enrolment) with a confirmed diagnosis of type 3 Gaucher disease.
Danish: Dette var et åbent multicenterstudie, hvor 60 E/kg velaglucerase alfa blev administreret ved intravenøs infusion hver anden uge i 12 måneder hos 6 patienter (i alderen 2 til 17 år ved inklusion) med en bekræftet diagnose på Gauchers sygdom, type 3.
English: Gaucher disease is an autosomal recessive disorder caused by mutations in the GBA gene which results in a deficiency of the lysosomal enzyme beta-glucocerebrosidase.
Danish: Gauchers sygdom er en autosomal recessiv sygdom, der skyldes mutationer i GBA-genet, som medfører en mangel på det lysosomale enzym betaglucocerebrosidase.
English: If anaphylactic or other acute reactions occur, in the clinic or home setting, immediately discontinue the infusion and initiate appropriate medical treatment.
Danish: Hvis der opstår anafylaktiske eller andre akutte reaktioner på klinikken eller i hjemmet, skal infusionen straks afbrydes og passende medicinsk behandling påbegyndes.