FrancophonIA/ELRC3.0 huggingface dataset:
English: Date of first authorisation: 26 August 2010 Date of latest renewal: 19 June 2015
Danish: Dato for første tilladelse: 26. august 2010 Dato for seneste fornyelse af tilladelsen: 19. juni 2015
English: Extension Study 044
Danish: Forlængelsesstudie 044
English: N=30, 6 and 34 for the 3 above groups.
Danish: N = henholdsvis 30, 6 og 34 for de 3 ovenstående grupper.
English: VPRIV should not be used in children under the age of 2 years.
Danish: VPRIV bør ikke anvendes hos børn under 2 år.
English: However, no data are available for children under the age of 4 years.
Danish: Der er dog ingen tilgængelige data for børn under 4 år.
English: From a microbiological point of view, the medicinal product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør lægemidlet anvendes med det samme.
English: • Patient evaluation and selection;
Danish: • Patientevaluering og -udvælgelse,
English: Studies in treatment naïve patients
Danish: Studie med behandlingsnaive patienter
English: - You may be given additional medicines to treat or help prevent future reactions.
Danish: - Du kan eventuelt få yderligere medicin til behandling eller forebyggelse af fremtidige reaktioner.
English: An IRR often appears as a hypersensitivity reaction.
Danish: En IRR optræder ofte som en overfølsomhedsreaktion.
English: 400 Units
Danish: 400 enheder
English: • Safety information;
Danish: • Sikkerhedsoplysninger,
English: The total volume of infusion should be delivered over a period of 60 minutes.
Danish: Det samlede volumen infusion skal indgives over en periode på 60 minutter.
English: No infusion-related reactions were reported for this patient.
Danish: Der blev ikke rapporteret nogen infusionsrelaterede reaktioner for denne patient.
English: See section 5.1 for further information.
Danish: 5.1 for yderligere oplysninger.
English: In some cases vomiting can be serious (reported from post-marketing experience).
Danish: I nogle tilfælde kan opkastning være alvorlig (indberettet efter markedsføring).
English: There are 5 potential N-linked glycosylation sites, four of which are occupied.
Danish: Der er 5 potentielle N-bundne glykosyleringssteder, hvoraf fire er optagede.
English: Elderly population (≥65 years)
Danish: Ældre population (≥ 65 år)
English: There are also links to other websites about rare diseases and treatments.
Danish: Der er også links til websteder om sjældne sygdomme og om, hvordan de behandles.
English: Your doctor will monitor your response to treatment and may change your dose (up or down) over time.
Danish: Din læge vil overvåge dit behandlingsrespons og kan ændre din dosis (øge eller reducere) over tid.
English: 57 patients were treatment-naïve.
Danish: 57 patienter var behandlingsnaive.
English: Most side effects occurred during the infusion or shortly after.
Danish: De fleste bivirkninger optrådte under infusionen eller kort tid derefter.
English: Pre-treatment with antihistamines and/or corticosteroids may prevent subsequent reactions in those cases where symptomatic treatment was required.
Danish: Præbehandling med antihistaminer og/eller kortikosteroider kan forebygge efterfølgende reaktioner i de tilfælde, hvor symptomatisk behandling var påkrævet.
English: • Emergency plan provided by the prescriber including who to call and what to do in the case of a serious hypersensitivity reaction.
Danish: • Nødplan udfærdiget af den ordinerende instans, herunder information om, hvem der skal ringes til, og hvad der skal gøres i tilfælde af en alvorlig overfølsomhedsreaktion.
English: If the dates of submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Danish: Hvis tidsfristen for en PSUR og for opdatering af en RMP er sammenfaldende, kan de fremsendes samtidig.
English: • Description on how to prepare and administer the infusion including safety information;
Danish: • Beskrivelse af, hvordan infusionen skal forberedes og administreres, herunder sikkerhedsoplysninger,
English: Read all of this leaflet carefully before this medicine is used because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden dette lægemiddel anvendes, da den indeholder vigtige oplysninger.
English: Frequency is defined as very common (1/10), common (1/100 to <1/10), and uncommon (≥1/1,000 to <1/100).
Danish: Hyppigheden defineres som meget almindelig ( 1/10), almindelig ( 1/100 til < 1/10) og ikke almindelig (≥ 1/1.000 til < 1/100).
English: ** produced in an HT-1080 human fibroblast cell line by recombinant DNA technology.
Danish: ** Produceres i en human HT-1080-fibroblast-cellelinje ved hjælp af rekombinant dna-teknologi.
English: The required vials are removed from the refrigerator.
Danish: De nødvendige hætteglas tages ud af køleskabet.
English: Home administration under the supervision of a healthcare professional may be considered only for those patients who have received at least three infusions and were tolerating their infusions well.
Danish: Indgivelse i hjemmet under supervision af en sundhedsfaglig person kan overvejes, men kun for de patienter, der har fået mindst tre infusioner, og som tolererede infusionerne godt.
English: Information is presented by system organ class and frequency according to MedDRA convention.
Danish: Oplysningerne gives for hver systemorganklasse og hyppighed i overensstemmelse med MedDRAkonventionen.
English: Fertility Animal studies show no evidence of impaired fertility.
Danish: Fertilitet Dyrestudier viser ingen tegn på nedsat fertilitet.
English: Dose adjustments can be made on an individual basis based on achievement and maintenance of therapeutic goals.
Danish: Dosisjustering kan foretages for den enkelte patient baseret på opnåelse og fastholdelse af terapeutiske mål.
English: Overall velaglucerase alfa group (N=39)
Danish: Samlet velaglucerase alfa-gruppe (n = 39)
English: The studies allowed the inclusion of patients 2 years and older and the safety and efficacy profiles are expected to be similar down to the age of 2 years.
Danish: I studierne var inklusion af patienter i alderen 2 år og opefter tilladt, og sikkerheds- og effektprofilen forventes at være den samme ned til 2 års-alderen.
English: The majority of these side effects were mild in intensity.
Danish: De fleste af disse bivirkninger var af mild intensitet.
English: Gaucher disease may become more active in a woman during pregnancy and for a few weeks after birth.
Danish: Gauchers sygdom kan blive mere aktiv hos kvinder, der er gravide, og i nogle uger efter fødslen.
English: Contains sodium, see leaflet for further information.
Danish: Indeholder natrium, se indlægssedlen for yderligere oplysninger.
English: *Liver and spleen volume is normalized as a percentage of body weight.
Danish: * Lever- og miltvolumen er normaliseret som en procentdel af kropsvægten.
English: VPRIV should not be infused with other medicines in the same infusion as the compatibility in solution with other medicines has not been evaluated.
Danish: VPRIV må ikke indgives sammen med andre lægemidler i samme infusion, da kompatibiliteten ved opløsning sammen med andre lægemidler ikke er blevet evalueret.
English: Ask your doctor or pharmacist for advice before this medicine is used.
Danish: Spørg din læge eller apoteket til råds, før dette lægemiddel anvendes.
English: Table 2: Results at 24 months - Change from Baseline - Study 044 ITT Population Clinical Parameters
Danish: Tabel 2: Resultater efter 24 måneder - Ændring fra baseline - studie 044 (ITT-population) Kliniske parametre
English: The majority of hypersensitivity reactions usually occur up to 12 hours post infusion.
Danish: De fleste overfølsomhedsreaktioner forekommer sædvanligvis op til 12 timer efter infusion.
English: The following information is intended for healthcare professionals only.
Danish: Følgende oplysninger er tiltænkt læger og sundhedspersonale:
English: Use aseptic technique.
Danish: Brug aseptisk teknik.
English: Velaglucerase alfa is a glycoprotein.
Danish: Velaglucerase alfa er et glykoprotein.
English: Patients were between 4 and 71 years old at the time of first treatment with VPRIV, and included 46 male and 48 female patients.
Danish: Patienterne var mellem 4 og 71 år på tidspunktet for første behandling med VPRIV, og der var 46 mandlige og 48 kvindelige patienter.
English: After preparation, your doctor or nurse will give the medicine to you through a drip into a vein (by intravenous infusion) over a period of 60 minutes.
Danish: Efter forberedelsen giver lægen eller sygeplejersken dig dette lægemiddel gennem drop i en blodåre (intravenøs infusion) over en periode på 60 minutter.
English: The steady state volume of distribution was approximately 10% of the body weight.
Danish: Fordelingsvolumen ved steady state var ca. 10 % af kropsvægten.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger på drægtigheden, den embryonale/føtale udvikling, fødslen eller den postnatale udvikling.
English: This should be taken into consideration by patients on a controlled sodium diet.
Danish: Dette bør tages med i overvejelserne hos patienter på kontrolleret natriumdiæt.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2C to 8C under protection from light.
Danish: Kemisk og fysisk brugsstabilitet er påvist i 24 timer ved opbevaring ved 2 °C - 8 °C og beskyttet mod lys.
English: Normal spleen is defined as 0.2% of body weight; normal liver as 2.5% of body weight Note: Imputation was applied to intermittent missing data.
Danish: En normal milt defineres som 0,2 % af kropsvægten; en normal lever som 2,5 % af kropsvægten Bemærk: Imputering blev anvendt ved intermitterende manglende data.
English: In studies with VPRIV additional side effects have also been reported:
Danish: I studie med VPRIV blev en række andre bivirkninger også indberettet:
English: Aseptic technique must be used.
Danish: Der skal benyttes aseptisk teknik.
English: • Requirements for home infusion (home condition, patient assessment, emergency treatment);
Danish: • Krav til infusion i hjemmet (hjemmets forhold, vurdering af patienten, nødbehandling),
English: There are no or limited amount of data from the use of velaglucerase alfa in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af velaglucerase alfa til gravide kvinder.
English: Cartons with 1, 5 or 25 vials.
Danish: Kartoner med 1, 5 eller 25 hætteglas.
English: Infusion-related-reactions
Danish: Infusionsrelaterede reaktioner
English: • Organisation of home infusion/preparation of infusion;
Danish: • Organisation af infusion i hjemmet/forberedelse af infusionen,
English: In treatment-naïve patients, the majority of infusion-related reactions occurred during the first 6 months of treatment.
Danish: Hos behandlingsnaive patienter optrådte størstedelen af de infusionsrelaterede reaktioner i løbet af de første 6 behandlingsmåneder.
English: • About the disease, treatment and home infusion;
Danish: • Om sygdommen, behandling og infusion i hjemmet,
English: The safety and efficacy profiles were similar between paediatric and adult patients.
Danish: Sikkerheds- og effektprofilen var den samme for pædiatriske og voksne patienter.
English: These are called infusion-related reactions and may affect more than 1 in 10 people (very common).
Danish: De hedder derfor infusionsrelaterede reaktioner og kan forekomme hos mere end 1 ud af 10 patienter (meget almindelig hyppighed).
English: To be administered as a 60-minute intravenous infusion.
Danish: Indgives som en 60-minutters intravenøs infusion.
English: *An enzyme unit is defined as the amount of enzyme that is required to convert one micromole of p-nitrophenyl β-D-glucopyranoside to p-nitrophenol per minute at 37ºC.
Danish: * En enzymenhed defineres som den mængde af enzym, der kræves for at konvertere én mikromol p-nitrophenyl β-D-glucopyranosid til p-nitrophenol pr. minut ved 37 ºC.
English: These medicines may include antihistamines, antipyretics, and corticosteroids.
Danish: Denne medicin kan omfatte antihistaminer, febernedsættende medicin og kortikosteroider.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, and toxicity to reproduction and development.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser samt reproduktionstoksicitet og udvikling.
English: It is not known whether velaglucerase alfa is excreted in human milk.
Danish: Det er ukendt, om velaglucerase alfa udskilles i human mælk.
English: Patients who have Gaucher disease and become pregnant may experience a period of increased disease activity during pregnancy and the puerperium.
Danish: Patienter, der har Gauchers sygdom, og som bliver gravide, kan opleve en periode med øget sygdomsaktivitet i løbet af graviditeten og puerperiet.
English: 20 ml glass vial containing a white to off-white powder.
Danish: 20 ml-hætteglas indeholdende et hvidt til offwhite pulver.
English: There was no indication of significant improvements of the neurological manifestations of type 3 Gaucher disease except for one patient in this study.
Danish: Der var ingen indikation for signfikante forbedringer af de neurologiske manifestationer for Gauchers sygdom, type 3, undtagen for en patient i dette studie.
English: The infusion should be initiated within 24 hours from the time of reconstitution.
Danish: Infusionen bør påbegyndes inden for 24 timer fra tidspunktet for rekonstitueringen.
English: Doses higher than 60 Units/kg have not been studied.
Danish: Doser over 60 enheder/kg er ikke blevet undersøgt.
English: By month 57, 8 out of the 8 patients had achieved a reduction of at least 2 points in the lumbar spine Bone Marrow Burden (BMB) score as assessed by MRI scan.
Danish: I måned 57 havde alle 8 patienter opnået en reduktion på mindst to point i BMB-score (Bone Marrow Burden) for lænden vurderet ved MRI-skanning.
English: In contrast, no significant change in femoral neck BMD was observed.
Danish: Derimod blev der ikke observeret nogen signifikant ændring i BMD i lårbenshalsen.
English: Ten patients who completed Study 025 enrolled in an open-label extension study (025EXT), 8 of whom completed the study.
Danish: Ti patienter, der gennemførte studie 025, blev inkluderet i et åbent forlængelsesstudie (025EXT), og 8 af dem gennemførte studiet.
English: Sodium citrate dihydrate (E331) Citric acid monohydrate (E330) Polysorbate 20
Danish: Natriumcitratdihydrat (E331) Citronsyremonohydrat (E330) Polysorbat 20
English: The maximum dose of velaglucerase alfa in clinical studies was 60 Units/kg.
Danish: Den maksimale dosis af velaglucerase alfa i kliniske studier var 60 enheder/kg.
English: There were no apparent pharmacokinetic differences between male and female patients with type 1 Gaucher disease.
Danish: Der var ingen åbenlyse farmakokinetiske forskelle mellem mandlige og kvindelige patienter med Gauchers sygdom, type 1.
English: The only adverse reaction leading to discontinuation of treatment was an infusion-related reaction.
Danish: Den eneste bivirkning, der førte til afbrydelse af behandlingen, var en infusionsrelateret reaktion.
English: The safety profile in these patients was similar to that observed in other clinical trials.
Danish: Sikkerhedsprofilen hos disse patienter svarede til den, der er set i andre kliniske studier.
English: If you are tolerating your infusions well in the clinic, your doctor or nurse may administer your infusions at home.
Danish: Hvis du tåler dine infusioner godt på klinikken, kan lægen eller en sygeplejerske give dig infusionerne i dit hjem.
English: The build-up of this material causes the signs and symptoms found in Gaucher disease.
Danish: Ophobningen af dette stof medfører de tegn og symptomer, der ses ved Gauchers sygdom.
English: In Studies 025EXT and 034, patients were offered home therapy.
Danish: I studie 025EXT og 034 blev patienterne tilbudt at få behandlingen i deres hjem.
English: The number of vials to be reconstituted is determined based on the individual patient's weight and the prescribed dose.
Danish: Antallet af hætteglas, der skal rekonstitueres, bestemmes ud fra den enkelte patients vægt og den ordinerede dosis.
English: • Infusion diary;
Danish: • Infusionsdagbog,
English: Women with Gaucher disease who are pregnant or considering pregnancy should talk with their doctor before this medicine is used.
Danish: Kvinder med Gauchers sygdom, som er gravide eller overvejer at blive gravide, skal tale med lægen, før dette lægemiddel anvendes.
English: The MAH shall ensure that in each Member State where VPRIV is marketed, all healthcare professionals and patients/carers who are expected to prescribe, dispense or use VPRIV have access to/are provided with the following educational package:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, alt sundhedspersonale og alle patienter/plejere, som forventes at ordinere, udlevere eller anvende VPRIV, i alle medlemslande, hvor VPRIV markedsføres, har adgang til/fået udleveret følgende uddannelsespakke:
English: 63 kDa, has 497 amino acids, and the same amino acid sequence as the naturally occurring human enzyme, glucocerebrosidase.
Danish: Monomeren er ca. 63 kDa, har 497 aminosyrer og den samme aminosyresekvens som det naturligt forekommende humane enzym, glucocerebrosidase.
English: Infusion-related reactions (IRR) were the most commonly observed adverse reactions in patients treated in clinical studies.
Danish: Infusionsrelaterede reaktioner (IRR) var den hyppigst observerede bivirkning hos patienter, der blev behandlet i kliniske studier.
English: When this enzyme is missing or does not work properly, a substance called glucocerebroside builds up inside cells in the body.
Danish: Når dette enzym mangler eller ikke fungerer korrekt, ophobes et stof, der hedder glucocerebrosid, inde i kroppens celler.
English: Therefore, it was not possible to evaluate the effect of antibody response on the pharmacokinetic profile of velaglucerase alfa.
Danish: Det var derfor ikke muligt at evaluere virkningen af antistof-responset på den farmakokinetiske profil for velaglucerase alfa.
English: Talk to your doctor before VPRIV is used - If you are treated with VPRIV, you may experience side effects during or following the infusion (see section 4, possible side effects).
Danish: Kontakt lægen, før VPRIV bruges - Hvis du bliver behandlet med VPRIV, kan du opleve bivirkninger under eller efter infusionen (se punkt 4.
English: Elderly (≥65 years old)
Danish: Ældre patienter (≥ 65 år)
English: The most serious adverse reactions in patients in clinical trials were hypersensitivity reactions.
Danish: De mest alvorlige bivirkninger hos patienter i kliniske studier var overfølsomhedsreaktioner.
English: Phase I/II study HGT-GCB-068 was conducted to explore the efficacy and safety of velaglucerase alfa ERT in treatment naïve children and adolescents with type 3 Gaucher disease.
Danish: Fase I/II-studiet HGT-GCB-068 blev udført for at undersøge virkningen og sikkerheden af velaglucerase alfa ERT hos behandlingsnaive børn og unge med Gauchers sygdom, type 3.
English: A risk-benefit assessment is required for women with Gaucher disease who are considering pregnancy.
Danish: Der kræves en vurdering af fordele og risici for kvinder med Gauchers sygdom, der overvejer at blive gravide.
English: To further evaluate the relationship, in cases of severe infusion-related reactions and in cases of lack or loss of effect patients should be tested for the presence of antibodies and the results reported to the company.
Danish: Med henblik på at undersøge dette forhold nærmere skal patienterne i tilfælde af svære infusionsrelaterede reaktioner og i tilfælde af manglende effekt eller tab af effekt testes for tilstedeværelse af antistoffer, og resultaterne indberettes til virksomheden.
English: Antibodies may play a role in treatment-related reactions found with the use of velaglucerase alfa.
Danish: Antistoffer kan spille en rolle i de behandlingsrelaterede reaktioner, der er observeret ved brug af velaglucerase alfa.
English: Only 1 out of 163 patients assessed developed anti-velaglucerase alfa antibodies during the study.
Danish: Kun 1 ud af 163 vurderede patienter udviklede anti-velaglucerase alfa-antistoffer i løbet af studiet.
English: This medicine is only to be used under appropriate medical supervision of a doctor who is knowledgeable in the treatment of Gaucher disease.
Danish: Dette lægemiddel må kun bruges under passende medicinsk overvågning af en læge med erfaring i behandling af Gauchers sygdom.
English: Tell your doctor if you have previously experienced an infusion-related reaction with other ERT for Gaucher disease.
Danish: Fortæl det til lægen, hvis du tidligere har oplevet en infusionsrelateret reaktion med andre enzymerstatningsterapier mod Gauchers sygdom.
English: There is no experience with overdose of velaglucerase alfa.
Danish: Der er ingen erfaring med overdosering af velaglucerase alfa.
English: For patients developing anaphylaxis in a home setting it should be considered to continue treatment in a clinical setting.
Danish: For patienter, der udvikler anafylaksi under hjemmebehandling, skal det overvejes at fortsætte behandlingen på klinikken.
English: Elderly patients may be treated within the same dose range (15 to 60 units/kg) as other adult patients.
Danish: Ældre patienter kan behandles med doser inden for samme interval (15-60 enheder/kg) som andre voksne patienter.
English: Haemoglobin concentration and platelet counts were evaluated as changes from baseline, which was defined as the end of the patient's treatment with imiglucerase.
Danish: Hæmoglobinkoncentration og trombocyttal blev evalueret som ændringer fra baseline, hvor baseline var defineret som slutningen på patientens behandling med imiglucerase.
English: Normalized Liver Volume* (%BW) Normalized Spleen Volume* (%BW) Excludes patients with splenectomy.
Danish: Normaliseret levervolumen* (% kropsvægt) Normaliseret miltvolumen* (% kropsvægt) Omfatter ikke splenektomerede patienter.
English: Mean change from baseline (95% CI)
Danish: Gennemsnitlig ændring fra baseline (95 %KI)
English: Prevention and Management of infusion related reactions including hypersensitivity reactions The management of infusion-related reactions should be based on the severity of the reaction, and include slowing the infusion rate, treatment with medicinal products such as antihistamines, antipyretics and/or corticosteroids, and/or stopping and resuming treatment with increased infusion time.
Danish: Forebyggelse og håndtering af infusionsrelaterede reaktioner, herunder overfølsomhedsreaktioner Håndteringen af infusionsrelaterede reaktioner bør baseres på sværhedsgraden af reaktionen og omfatter nedsættelse af infusionshastigheden, behandling med lægemidler såsom antihistaminer, antipyretika og/eller kortikosteroider og/eller afbrydelse af behandlingen og genoptagelse deraf med øget infusionstid.
English: - If the reaction is severe, your doctor will stop the intravenous infusion immediately and start giving you appropriate medical treatment.
Danish: - Hvis reaktionen er svær, vil lægen stoppe den intravenøse infusion med det samme og begynde at give dig passende medicinsk behandling.
English: The high clearance of velaglucerase alfa from serum (mean 6.7 to 7.6 ml/min/kg) is consistent with the rapid uptake of velaglucerase alfa into macrophages via mannose receptors.
Danish: Den høje clearance af velaglucerase alfa fra serum (gennemsnitligt 6,7 til 7,6 ml/min/kg) er konsistent med den hurtige optagelse af velaglucerase alfa i makrofager via mannosereceptorer.
English: The European Medicines Agency has waived the obligation to submit the results of studies with VPRIV in all subsets of the paediatric population with type 2 Gaucher disease.
Danish: Det Europæiske Lægemiddelagentur har dispenseret for kravet om at fremlægge resultaterne af studie med VPRIV hos alle undergrupper i den pædiatriske population med Gauchers sygdom, type 2.