FrancophonIA/ELRC3.0 huggingface dataset:
English: Study Total number (adolescents)
Danish: Samlet antal (unge)
English: Iron chelators should be discontinued 7 days prior to initiation of conditioning.
Danish: Jernkelatorer bør seponeres 7 dage før start på konditionering.
English: The dose of G-CSF should be decreased by half if white blood cell (WBC) count is >100 × 109/L prior to the day of apheresis.
Danish: Dosis af G-CSF skal reduceres til halvdelen, hvis celletallet for hvide blodlegemer (WBC) er >100 × 109/l dagen før aferese.
English: There are no data on the effects of Zynteglo on human fertility.
Danish: Der er ingen data om virkningen af Zynteglo på human fertilitet.
English: o Statement that the patient was treated with gene therapy and should not donate blood, organs, tissues, or cells.
Danish: o Erklæring om, at patienten blev behandlet med genterapi og ikke må donere blod, organer, væv eller celler.
English: The MAH shall ensure that in each Member State where Zynteglo is marketed, all healthcare professionals and patients/carers who are expected to prescribe, dispense and/or use Zynteglo have access to/are provided with the following educational package to be disseminated through professional bodies:
Danish: MAH'en skal i hver medlemsstat, hvor Zynteglo markedsføres, sikre sig, at alt sundhedspersonale og patienter/plejere, som forventes at ordinere, udlevere og/eller bruge Zynteglo har adgang til/modtager følgende undervisningspakke til videreformidling af information gennem faglige organisationer:
English: Zynteglo is used to treat a serious genetic disease called transfusion-dependent beta-thalassaemia (TDT), which includes the disease commonly known as beta-thalassaemia major, in people 12 years and older.
Danish: Zynteglo bruges til behandling af en alvorlig, genetisk sygdom kaldet transfusionsafhængig beta-thalassæmi (TDT), som inkluderer sygdommen almindeligt kendt som beta-thalassæmi major hos personer på 12 år eller mere.
English: Of the 11 patients followed for at least 6 months after Zynteglo infusion, 6 patients did not restart iron chelation or receive phlebotomy, 3 patients restarted iron chelation, and 2 patients received phlebotomy to reduce iron levels.
Danish: Af de 11 patienter, der blev fulgt i mindst 6 måneder efter infusion med Zynteglo, påbegyndte 6 patienter ikke jernkelering igen, og de modtog ikke flebotomi, 3 patienter påbegyndte jernkelering igen og 2 patienter fik flebotomi for at reducere jernniveauerne.
English: Iron chelation should be stopped at least 7 days prior to myeloablative conditioning.
Danish: Jernkelering bør stoppes mindst 7 dage før myeloablativ konditionering.
English: If an infusion bag is compromised, follow the local guidelines and contact bluebird bio immediately.
Danish: Hvis en infusionspose er beskadiget, følg de lokale retningslinjer og kontakt omgående bluebird bio.
English: After treatment with Zynteglo, you will be asked to enrol in a registry for at least 15 years in order to better understand the long-term effects of Zynteglo.
Danish: Efter behandlingen med Zynteglo vil du blive bedt om at tilmelde dig et register i mindst 15 år, som har til formål at fremme forståelsen for de langvarige effekter af Zynteglo.
English: o The need to explain and to ensure that patients understand: - potential risks of treatment with Zynteglo - signs of leukaemia/lymphoma and what action to take - content of patient's guide - the need to carry the patient alert card and show it to every healthcare professional - enrolment in the drug product Registry o Scope of the Registry and how to enrol patients
Danish: o Nødvendigheden af at forklare og sikre sig, at patienter forstår: - mulige risici forbundet med behandling med Zynteglo - tegn på leukæmi/lymfom, og hvad de skal gøre - indhold af patientvejledningen - behovet for altid at bære patientkortet og vise det til alt sundhedspersonale - tilmeldning til lægemiddelregisteret o Registerets rammer og tilmelding af patienter
English: Failure of neutrophil engraftment is a short-term but potentially severe risk, defined as failure to achieve 3 consecutive absolute neutrophil counts (ANC) ≥500 cells/µL obtained on different days by Day 43 after infusion of
Danish: Mislykket neutrofil engraftment er en kortvarig men potentielt alvorlig risiko, der defineres som manglende opnåelse af 3 på hinanden følgende absolutte neutrofiltal (ANC) på ≥500 celler/µl, der er opnået på forskellige dage indtil dag 43 efter infusion af Zynteglo.
English: Zynteglo has not been studied in patients >65 years of age.
Danish: Zynteglo er ikke undersøgt hos patienter >65 år.
English: After you receive Zynteglo, you may have a low number of platelets in your blood.
Danish: Når du har fået Zynteglo, kan det medføre et lavt antal blodplader i dit blod.
English: Five patients are evaluable for assessment of TI. Of these, 4/5 (80.0%, 95% CI 28.4-99.5%) achieved TI at last follow-up.
Danish: Fem patienter kan evalueres for vurdering af TI. Af disse, opnåede 4/5 (80,0 %, 95 % CI 28,4-99,5 %) TI under den sidste opfølgning.
English: Conventional mutagenicity, carcinogenicity and reproductive and developmental toxicity studies have not been conducted.
Danish: Konventionelle studier af mutagenicitet, karcinogenicitet og reproduktions- og udviklingstoksicitet er ikke blevet udført.
English: • This medicinal product contains genetically modified human blood cells.
Danish: • Dette lægemiddel indeholder genetisk modificerede humane blodceller.
English: A negative serum pregnancy test must be confirmed prior to the start of mobilisation and re-confirmed prior to conditioning procedures and before medicinal product administration.
Danish: Det skal bekræftes, at en serumgraviditetsprøve er negativ, inden start af mobilisering, og dette skal bekræftes igen, før der foretages konditioneringsprocedurer samt før administrationen af lægemidlet.
English: Only a few patients have been included in the clinical studies with genotypes characterised by low endogenous β-globin production phenotypically similar to patients with a β0/β0 genotype, such as patients homozygous for IVS-I-110 or IVS-I-5.
Danish: Kun nogle få patienter har været inkluderet i kliniske studier med genotyper karakteriseret ved lav endogen β-globin produktion, der fænotypisk ligner patienter med en β0/β0-genotype, såsom patienter, der er homozygotiske for IVS-I-110 eller IVS-I-5.
English: Interim report: at each annual renewal
Danish: Forløbig rapport: årligt ved fornyelse
English: Women of childbearing potential/Contraception in males and females There are insufficient exposure data to provide a precise recommendation on duration of contraception following treatment with Zynteglo.
Danish: Kvinder i den fertile alder/kontraception hos mænd og kvinder Der foreligger ikke tilstrækkelige eksponeringsdata til, at der kan gives en nøjagtigt anbefaling af, i hvor lang tid der skal anvendes kontraception efter behandling med Zynteglo.
English: After completion of the 4-day course of myeloablative conditioning, there must be a minimum of 48 hours of washout before Zynteglo infusion.
Danish: Efter afslutningen af forløbet med myeloablativ konditionering af 4 dages varighed skal der gå mindst 48 timer med udvaskning inden infusion med Zynteglo.
English: The median (min, max) age in the studies was 19.0 (12, 34) years, 56.3% were females, 59.4% were Asian, and 40.6% White/Caucasian.
Danish: i studierne var 19,0 (12; 34) år, 56,3 % var kvinder, 59,4 % var asiater og 40,6 % var hvide/kaukasiere.
English: Tell your doctor immediately if side effects become severe or serious.
Danish: Fortæl det straks til lægen, hvis bivirkningerne bliver alvorlige.
English: In clinical trials, no patients failed to engraft bone marrow, as measured by neutrophil engraftment (N=42).
Danish: I kliniske studier var der ingen patienter, hvor transplantation af knoglemarv mislykkedes, hvilket blev målt ved neutrofil engraftment (N=42).
English: o The Summary of Product Characteristics o Guide for healthcare professionals o Guide for handling and method of administration
Danish: o Produktresumé o Vejledning til sundhedspersonale o Vejledning i håndtering og administration
English: All patients must be advised on signs of leukaemia and to seek immediate medical attention if these signs are present.
Danish: Alle patienter skal vejledes om tegn på leukæmi og instrueres om straks at søge lægehjælp, hvis sådanne tegn forekommer.
English: Patients should be assessed for renal impairment defined as creatinine clearance ≤70 mL/min/1.73 m2 to ensure HSC transplantation is appropriate.
Danish: Patienter skal vurderes for nedsat nyrefunktion, hvilket er defineret som en kreatininclearance på ≤ 70 ml/min/1,73 m2 for at sikre, at transplantation med hæmatopoietiske stamceller (HSC) er relevant.
English: All patients were administered G-CSF and plerixafor to mobilise stem cells prior to the apheresis procedure.
Danish: Alle patienter fik G-CSF og plerixafor for at mobilisere stamceller inden afereseproceduren.
English: {DD month YYYY}
Danish: DD måned ÅÅÅÅ
English: They usually happen within the first few days and several weeks after receiving chemotherapy medicine, but can also develop much later.
Danish: De forekommer normalt inden for de første få dage og flere uger, efter at du har fået kemoterapi, men de kan også forekomme meget senere.
English: Pre-treatment conditioning
Danish: Forbehandling ved konditionering
English: The planned dose of G-CSF was 10 µg/kg/day in patients with a spleen, and 5 µg/kg/day in patients without a spleen, given on Days 1 through 5 of mobilisation in the morning.
Danish: Den planlagte dosis af G-CSF var 10 µg/kg/dag hos patienter med milt, og 5 µg/kg/dag hos patienter uden milt, og den blev givet om morgenen på mobiliseringsdag 1 til og med dag 5.
English: See Lot Information Sheet for number of infusion bags and CD34+ cells per kg for this patient.
Danish: Se lot-informationsarket for at få oplyst antallet af infusionsposer og CD34+ celler pr. kg for denne patient.
English: In this study, there was no evidence of toxicity, genotoxicity or oncogenesis (tumorigenicity) related to BB305 LVV integration, and no toxicity related to production of βA-T87Q-globin.
Danish: I dette studie var der ingen tegn på toksicitet, genotoksicitet eller onkogenese (tumorigenicitet), der var relateret til integration af LVV BB305, og der var ingen toksicitet i forbindelse med produktionen af βA-T87Q-globin.
English: Zynteglo is a clear to slightly cloudy, colourless to yellow or pink dispersion of cells that is supplied in one or more clear infusion bags, each packed in a transparent pouch inside a closed metal container.
Danish: Zynteglo er en klar til let uklar, farveløs til gul eller lyserød dispersion af celler, som leveres i en eller flere klare infusionsposer, som hver er emballeret i en gennemsigtig indvendig lomme indeni en metalkassette.
English: If the liver biopsy demonstrates bridging fibrosis, cirrhosis, or active hepatitis, HSC transplantation with myeloablative conditioning is not appropriate.
Danish: Hvis leverbiopsien viser brodannende fibrose, cirrose eller aktiv hepatitis, er transplantation af hæmatopoietiske stamceller (HSC) med myeloablativ konditionering ikke relevant.
English: For most patients, the minimum number of CD34+ cells to manufacture Zynteglo was collected with 1 cycle of mobilisation and apheresis.
Danish: For de fleste patienter blev minimumantallet af CD34+ celler til fremstilling af Zynteglo høstet i forbindelse med 1 cyklus af mobilisering og aferese.
English: Data are available on the risk of infertility with myeloablative conditioning.
Danish: Data vedrørende risikoen for infertilitet i forbindelse med myeloablativ konditionering er tilgængelige.
English: Three patients in HGB-205 started phlebotomy.
Danish: Tre patienter i HGB-205 startede med flebotomi.
English: o All patients should receive annual monitoring of complete blood counts and total haemoglobin levels to monitor for leukaemia/lymphoma and maintenance of efficacy, respectively.
Danish: o Alle patienter bør monitoreres årligt med komplet blodtælling og total hæmoglobin med henblik på hhv. monitorering for leukæmi/lymfom og fortsat effekt.
English: • life-threatening inflammatory response to an infection along with low white blood cell count
Danish: • en livstruende betændelsesreaktion over for en infektion samtidig med et lavt antal hvide blodlegemer
English: These cells must be collected from the patient and be cryopreserved prior to myeloablative conditioning and infusion with Zynteglo.
Danish: Disse celler skal indsamles fra patienten og være kryopræserverede før myeloablativ konditionering og infusion med Zynteglo.
English: MRI of the liver should be performed on all patients prior to myeloablative conditioning.
Danish: MR-scanning af leveren skal udføres på alle patienter inden myeloablativ konditionering.
English: Interim results: at each annual renewal
Danish: Foreløbige resultater: årligt ved fornyelse
English: Do not use this medicine after the expiry date which is stated on the outer container label(s) and infusion bag label(s).
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten/etiketterne på den ydre beholder og på infusionsposens/-posernes etiket(ter).
English: Some side effects observed in clinical studies with Zynteglo are related to mobilisation and blood stem cell collection or to the chemotherapy medicine used to prepare your bone marrow for treatment with Zynteglo.
Danish: Nogle af de bivirkninger, der er blevet observeret i kliniske studier med Zynteglo, er relateret til mobilisering og indsamling af blodstamceller eller til kemoterapimedicinen, der anvendes til at forberede din knoglemarv til behandling med Zynteglo.
English: Signs of leukaemia and the need to obtain urgent medical care if these signs are present.
Danish: Tegn på leukæmi og behovet for straks at søge lægehjælp, hvis disse tegn forekommer.
English: Additional studies with human CD34+ HSCs administered to immunodeficient, myeloablated mice demonstrated no toxicity, tumorigenicity or genotoxicity.
Danish: Yderligere studier med humane CD34+ HSC'er, som administreres til immundeficiente myeloablaterede mus, udviste ingen toksicitet, tumorigenicitet eller genotoksicitet.
English: Nevertheless, there is a theoretical risk of leukaemia or lymphoma after treatment with Zynteglo.
Danish: Ikke desto mindre er der en teoretisk risiko for leukæmi eller lymfom efter behandling med Zynteglo.
English: o Information on the possibility of false positivity of certain commercial HIV tests because of Zynteglo.
Danish: o Information om muligheden for et falsk positivt resultat på visse kommercielle hiv test, som forårsages af Zynteglo.
English: Most side effects occur during or within a few days after treatment with Zynteglo but can occur later.
Danish: De fleste bivirkninger opstår under eller inden for et par dage efter behandlingen med Zynteglo, men de kan også forekomme på et senere tidspunkt.
English: Zynteglo is shipped from the manufacturing facility to the infusion centre storage facility in a cryoshipper, which may contain multiple metal cassettes intended for a single patient.
Danish: Zynteglo sendes fra produktionsanlægget til infusionscenterets centrallager i en kryoboks, som kan indeholde flere metalkassetter, der er beregnet til en enkelt patient.
English: • low number of immature (not fully developed) red blood cells
Danish: • lavt antal umodne (ikke færdigudviklede) røde blodlegemer
English: Local biosafety guidelines should be followed for unused medicinal products or waste material.
Danish: De lokale retningslinjer for biosikkerhed skal følges ved håndtering af ubrugt lægemiddel eller affaldsmaterialer.
English: It is recommended that patients with MRI results demonstrating liver iron content ≥15 mg/g undergo liver biopsy for further evaluation.
Danish: Det anbefales, at patienter med MR-scanningsresultater, der viser et jernindhold i leveren på ≥15 mg/g, får taget en leverbiopsi til yderligere evaluering.
English: There is no clinical experience with the use of erythropoiesis-stimulating agents in patients treated with Zynteglo.
Danish: Der er ingen klinisk erfaring med anvendelse af erythropoiesis-stimulerende midler hos patienter behandlet med Zynteglo.
English: If leukaemia or lymphoma is detected in any patient who received Zynteglo, blood samples should be collected for integration site analysis.
Danish: Hvis leukæmi eller lymfom er påvist i en patient, som modtog Zynteglo, bør der indsamles blodprøver til analyse af integrationsstedet.
English: Very Common (≥10%)
Danish: Meget almindelig (≥ 10 %)
English: Zynteglo must not be used during pregnancy because of myeloablative conditioning (see section 4.3).
Danish: Zynteglo må ikke anvendes under graviditet pga. myeloablativ konditionering (se pkt.
English: Preparation for the infusion
Danish: Forberedelse af infusion
English: Phenytoin was not used for anti-seizure prophylaxis because of its well understood induction of glutathione-S-transferase and cytochrome P450 and resultant increased clearance of busulfan, and because of the widespread availability of effective anti-seizure medications that do not affect busulfan metabolism.
Danish: Phenytoin blev ikke anvendt som profylakse mod krampeanfald, da der er god forståelse for induktionen af glutathion-S-transferase og cytokrom P450 og den resulterende øgede clearance af busulfan, og da effektive lægemidler som profylakse mod krampeanfald, der ikke påvirker metabolismen af busulfan, er vidt tilgængelige.
English: • increase or decrease in blood protein
Danish: • stigning eller fald i protein i blodet
English: • bruising, bleeding or pain from catheter or injection site
Danish: • blå mærker, blødning eller smerter fra kateter eller injektionssted
English: • enlarged spleen which may result in pain in your upper left belly or left shoulder
Danish: • forstørret milt, som kan give dig smerter i den øverste venstre del af maven eller i venstre skulder
English: o Patient alert card and the need to carry it on their person and tell any treating healthcare professional that they were treated with Zynteglo.
Danish: o Patientkort og behovet for altid at bære det og fortælle det behandlende sundhedspersonale, at de blev behandlet med Zynteglo.
English: One serious event of hypotension due to epistaxis occurred in a patient, with onset 11 days after Zynteglo treatment.
Danish: Der forekom ét alvorligt tilfælde af hypotension på grund af epistaxis hos en patient, som begyndte 11 dage efter behandling med Zynteglo.
English: All patients should be tested for HIV-1/2 and HTLV-1/2 prior to mobilisation and apheresis to ensure acceptance of the apheresis material for Zynteglo manufacturing (see section 4.2).
Danish: Alle patienter bør testes for HIV-1/2 og HTLV-1/2 før mobilisering og aferese for at sikre accept af aferesematerialet til fremstilling af Zynteglo (se pkt.
English: Once thawed: maximum 4 hours at room temperature (20°C-25°C).
Danish: Optøet: Højst 4 timer ved stuetemperatur (20 °C til 25 °C).
English: The added gene from Zynteglo will not be passed on to your children.
Danish: Genet, der tilføres via Zynteglo, videregives ikke til dine fremtidige børn.
English: • numbness and pain in hands and feet
Danish: • følelsesløshed og smerter i hænder og fødder
English: If Zynteglo cannot be administered after chemotherapy or if the modified stem cells do not take hold (engraft) in your body, the doctor may give you an infusion of your own original blood stem cells that were collected and stored before the treatment started (see also section 3, How Zynteglo is given).
Danish: Hvis Zynteglo ikke kan administreres efter kemoterapi, eller hvis de modificerede stamceller ikke accepteres af din krop (engraft), vil lægen muligvis give dig en infusion af dine egne blodstamceller, der blev indsamlet og opbevaret før behandlingsstart (se også pkt.
English: Adding a new gene into the DNA of your blood stem cells could theoretically cause leukaemia or lymphoma, although no patients have developed leukaemia or lymphoma in clinical trials with Zynteglo.
Danish: Indsættelsen af et nyt gen i DNA'et i dine blodstamceller kan i teorien forårsage leukæmi eller lymfom, omend ingen patienter udviklet leukæmi eller lymfom i kliniske studier med Zynteglo.
English: • Pain in the right upper abdomen under the ribs, yellowing of eyes or skin, rapid weight gain, swelling of arms, legs and abdomen, and trouble breathing.
Danish: • Smerter i den øverste højre del af maven under ribbenene, gulfarvning af øjne eller hud, hurtig vægtforøgelse, hævelse af arme, ben og mave samt åndedrætsbesvær.
English: What you need to know before you are given Zynteglo You must not be given Zynteglo if you:
Danish: Det skal du vide, før du får Zynteglo Du må ikke få Zynteglo, hvis du:
English: Work surfaces and material which have potentially been in contact with Zynteglo must be decontaminated with a viricidal disinfectant according to the manufacturer's instructions.
Danish: Arbejdsoverflader og materiale, der kan have været i kontakt med Zynteglo, skal dekontamineres med et desinfektionsmiddel mod vira i overensstemmelse med producentens anvisninger.
English: • changes and abnormalities in heart rhythm
Danish: • ændringer og abnormiteter i hjerterytmen
English: This means that further evidence on this medicinal product is awaited.
Danish: Det betyder, at der forventes yderligere dokumentation for dette lægemiddel.
English: All patients received full myeloablative conditioning with busulfan prior to treatment with Zynteglo.
Danish: Alle patienter fik myeloablativ konditionering med busulfan inden behandling med Zynteglo.
English: AUC0-24h was measured on Day 1 and informed the dose for Day 3; the median (min, max) estimated daily AUC was
Danish: AUC0-24t blev målt på dag 1 og bestemte dosen på dag 3; den estimerede median (min., maks.)
English: Mobilisation and blood stem cell collection
Danish: Mobilisering og indsamling af blodstamceller
English: Zynteglo works by adding functional copies of the beta-globin gene into these cells, so that the patient can make enough beta-globin to increase total haemoglobin, improve anaemia, and carry more oxygen around their body.
Danish: Zynteglo virker ved at indsætte funktionelle kopier af beta-globingenet i disse celler, så patienten kan producere tilstrækkeligt beta-globin for at øge den samlede hæmoglobin, afhjælpe anæmi og transportere mere ilt rundt i kroppen.
English: If the minimum dose of Zynteglo of 5.0 × 106 CD34+ cells/kg is not met after initial medicinal product manufacturing, the patient may undergo one or more additional cycles of mobilisation and apheresis, separated by at least 14 days, in order to obtain more cells for additional manufacture.
Danish: Hvis den minimale dosis Zynteglo på 5,0 × 106 CD34+ celler/kg ikke opnås efter den første lægemiddelproduktion, kan patienten blive bedt om at gennemgå en eller flere yderligere cyklusser med mobilisering og aferese med mindst 14 dages mellemrum for at opnå flere celler til yderligere fremstilling.
English: Patients treated with Zynteglo should not donate blood, organs, tissues or cells for transplantation at any time in the future.
Danish: Patienter, der behandles med Zynteglo, må ikke donere blod, organer, væv eller celler til transplantation på noget tidspunkt i fremtiden.
English: • Administer each infusion bag of Zynteglo via intravenous infusion over a period of less than 30 minutes.
Danish: • Administrer hver infusionspose med Zynteglo via intravenøs infusion over en tidsperiode på under 30 minutter.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Zynteglo in one or more subsets of the paediatric population in β-thalassaemia (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Zynteglo i en eller flere undergrupper af den pædiatriske population med β-thalassæmi (se pkt.
English: The pharmacology, toxicology and genotoxicity of the BB305 LVV used for transduction in the manufacture of Zynteglo were evaluated in vitro and in vivo.
Danish: Farmakologien, toksikologien og genotoksiciteten af den lentivirale vektor BB305, der er anvendt til transduktion under fremstillingen af Zynteglo, er blevet evalueret in vitro og in vivo.