FrancophonIA/ELRC3.0 huggingface dataset:
English: The quantitative information regarding strength, CD34+ cells, and dose for the medicinal product is provided in the Lot Information Sheet.
Danish: De kvantitative oplysninger vedrørende koncentration, CD34+-celler og dosis for lægemidlet er angivet i lot-informationsarket.
English: NA = Not applicable.
Danish: NA = Ikke relevant.
English: All patients with non-β0/β0 genotypes received anti-seizure prophylaxis with agents other than phenytoin prior to initiating busulfan.
Danish: Alle patienter med non-β0/β0 genotyper fik anti-epileptisk profylakse med andre midler end phenytoin inden start af busulfan.
English: Pre-treatment transfusion volumes
Danish: Transfusionsvolumen før behandling
English: To prepare your bone marrow for treatment with Zynteglo.
Danish: For at gøre din knoglemarv klar til behandling med Zynteglo.
English: Patients with TDT experience iron overload due to chronic red blood cell (RBC) transfusions that can lead to end organ damage.
Danish: Patienter med TDT kan opleve jernophobning på grund af kronisk transfusion af røde blodlegemer (RBC), hvilket kan føre til skade på de indre organer.
English: No correlation was observed between incidence of bleeding and delayed platelet engraftment.
Danish: Der blev ikke observeret nogen korrelation mellem blødning og forsinket engraftment af trombocytter.
English: The finished product is composed of one or more infusion bags which contain a dispersion of 1.2-20 × 106 cells/mL suspended in cryopreservative solution.
Danish: Det færdige produkt består af en eller flere infusionsposer, som indeholder en dispersion af 1,2-20 × 106 celler/ml suspenderet i en kryopræserveret opløsning.
English: Tel: +39 029 475 9755 (800 728 026)
Danish: Tlf: +39 029 475 9755 (800 728 026)
English: Consult the SmPC of the myeloablative conditioning agent for information on the need for effective contraception in patients who undergo conditioning.
Danish: Der henvises til produktresuméet for midlet til myeloablativ konditionering for oplysninger om behovet for effektiv kontraception hos patienter, som gennemgår konditionering.
English: Precautions to be taken for the disposal of the medicinal product
Danish: Forholdsregler ved bortskaffelse af lægemidlet
English: Approximately 2 months before treatment with Zynteglo, you will be given a mobilisation medicine that will move your blood stem cells from your bone marrow into your blood stream.
Danish: Ca. 2 måneder før behandling med Zynteglo vil du få udleveret et mobiliseringslægemiddel, som transporterer dine blodstamceller fra din knoglemarv til din blodbane.
English: Cryostor CS5 Sodium chloride
Danish: Cryostor CS5 Natriumklorid
English: The back-up collection may be needed for rescue treatment if there is: 1) compromise of Zynteglo after initiation of myeloablative conditioning and before Zynteglo infusion, 2) primary engraftment failure, or 3) loss of engraftment after infusion with Zynteglo (see section 4.4).
Danish: Reservebeholdningen kan blive nødvendig som livreddende behandling, hvis der er: 1) Kompromittering af Zynteglo efter påbegyndelse af myeloablativ konditionering og før infusion med Zynteglo, 2) svigt af det primære transplantat, eller 3) tab af implantat efter infusion med Zynteglo (se pkt.
English: These studies are conducted with improved transduction compared to Phase 1/2 studies, resulting in increased average number of functional copies of the transgene (βA-T87Q-globin) integrated in the autologous CD34+ cells.
Danish: Disse forsøg udføres med forbedret transduktion i forhold til fase 1/2-studierne, hvilket resulterer i et forøget gennemsnitligt antal funktionelle kopier af transgenet (βA-T87Q-globin), som er integreret i de autologe CD34+ celler.
English: Restarting iron chelation after Zynteglo infusion may be necessary and should be based on clinical practice (see sections 4.5 and 5.1).
Danish: Genstart af jernkelering efter infusion med Zynteglo kan være nødvendig og skal være baseret på klinisk praksis (se pkt.
English: o Details on reporting of adverse effects.
Danish: o Oplysninger om indberetning af bivirkninger.
English: This medicine contains 391-1564 mg sodium (main component of cooking/table salt) in each dose.
Danish: Dette lægemiddel indeholder 391-1564 mg natrium (hovedingrediensen i tilberednings-/bordsalt) pr. dosis.
English: HSC transplantation with myeloablative conditioning is not appropriate for patients with TDT who have evidence of severely elevated iron in the heart i.e., patients with cardiac T2* <10 msec by magnetic resonance imaging (MRI).
Danish: Transplantation af hæmatopoietiske stamceller (HSC) med myeloablativ konditionering er ikke relevant for patienter med transfusionsafhængig TDT, som har tegn på forhøjet indhold af jern i hjertet i alvorlig grad, dvs. patienter med kardiologisk T2* på <10 msek ved magnetisk resonans-scanning (MR-scanning).
English: Zynteglo is not expected to interact with the hepatic cytochrome P-450 family of enzymes or drug transporters.
Danish: Zynteglo forventes ikke at interagere med enzymer, der hører til hepatisk cytokrom P-450-familien, heller ikke med lægemiddeltransportører.
English: Zynteglo is intended solely for autologous use.
Danish: Zynteglo er udelukkende beregnet til autolog anvendelse.
English: o Package leaflet o A patient/carer guide o A patient alert card
Danish: o Indlægsseddel o En vejledning til patient/plejer o Et patientkort
English: • The patient alert card shall contain the following key messages: o Information of risk of delayed platelet engraftment, potentially leading to bleeds, and theoretical risks.
Danish: • Patientkortet skal indeholde de følgende hovedbudskaber: o Information om risikoen for forsinket engraftment af trombocytter, som potentielt kan medføre blødning og teoretiske risici.
English: Talk to your doctor before you are given Zynteglo.
Danish: Kontakt lægen, før du får Zynteglo.
English: Each metal cassette contains one infusion bag with Zynteglo.
Danish: Hver metalkassette indeholder én infusionspose med Zynteglo.
English: Therefore, patients who have received Zynteglo should not be screened for HIV infection using a PCR-based assay.
Danish: Derfor bør patienter, som har fået Zynteglo, ikke screenes for hiv-infektion med en PCR-baseret analyse.
English: (See section 4.4 for guidance on platelet monitoring and management.)
Danish: 4.4 for vejledning vedrørende monitorering og håndtering af trombocytter.)
English: • Access the medicinal product infusion bag and infuse per the administration site's standard procedures for administration of cell therapy products.
Danish: • Tilgå infusionsposen med lægemidlet, og infundér det i henhold til centerets standardprocedurer for administration af celleterapiprodukter.
English: CD34+ Cells
Danish: CD34+ celler
English: There are no reports of LVV-mediated insertional mutagenesis resulting in oncogenesis.
Danish: Der foreligger ingen rapporter om lentiviral vektor (LVV)-medieret insertionel mutagenese, der har medført onkogenese.
English: BATCH NUMBER, CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT, AND EXPIRY DATE
Danish: BATCHNUMMER, INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER OG UDLØBSDATO
English: • The Guide to handling and method of administration for healthcare professionals shall contain the following key elements: o Instructions on receiving and storing of Zynteglo and how to check Zynteglo prior to administration o Instructions about the thawing of Zynteglo o Instructions on protective equipment and treatment of spills.
Danish: • Vejledning i håndtering og administrationsmetode for sundhedspersonale skal indeholde de følgende hovedelementer: o Instruktioner i modtagelse og opbevaring af Zynteglo, og hvordan Zynteglo kontrolleres inden administration o Instruktioner vedrørende optøning af Zynteglo o Instruktioner vedrørende sikkerhedsudstyr og håndtering af spild.
English: The safety of immunisation with live viral vaccines during or following Zynteglo treatment has not been studied.
Danish: Sikkerheden af immunisering med levende virusvacciner eller efter behandling med Zynteglo er ikke blevet undersøgt.
English: Tel: +31 (0) 303 100 450 e-mail: medinfo@bluebirdbio.com
Danish: Tlf.: +31 (0) 303 100 450 e-mail: medinfo@bluebirdbio.com
English: (First Infusion Bag)
Danish: (første infusionspose)
English: βA-T87Q-globin expression is designed to correct the β/α-globin imbalance in erythroid cells of patients with TDT and has the potential to increase total Hb to normal levels and eliminate dependence on chronic RBC transfusions.
Danish: Ekspressionen af ΒA-T87Q-globin er designet til at korrigere ubalancen i β/α-globin-forholdet i erythroide celler hos patienter med TDT, og det kan potentielt øge total Hb til normale niveauer og eliminere nødvendigheden af fortsatte erythrocyttransfusioner erythrocyt (RBC).
English: All patients completed HGB-204 and HGB-205 and enrolled for long-term follow-up in the LTF-303 study.
Danish: Alle patienter gennemførte HGB-204 og HGB-205, og de blev inkluderet i LTF-303-studiet med henblik på langtidsopfølgning.
English: If iron chelation is needed, consider administration of non-myelosuppressive iron chelators (see sections 4.2 and 5.1).
Danish: Hvis jernkelering er nødvendig, skal administration af ikke-myelosuppressive jernkelatorer overvejes (se pkt.
English: • inflammation or infection of hair follicles
Danish: • betændelse eller infektion i hårfolliklerne
English: Following platelet engraftment, all patients maintained platelet levels of ≥20 × 109/L in the absence of platelet transfusions.
Danish: Efter engraftment af trombocytter havde alle patienter stadig trombocytniveauer ≥ 20 × 109/l uden transfusion af trombocytter.
English: Expose the sterile port on the infusion bag by tearing off a protective wrap covering the port.
Danish: Eksponér den sterile port på infusionsposen ved at trække i den beskyttende emballering, som dækker porten.
English: Frequencies are defined as: very common (≥1/10), and common (≥1/100 and <1/10).
Danish: Bivirkningerne er anført efter systemorganklasse og hyppighed i henhold til MedDRA. Hyppigheder defineres som: meget almindelig (≥ 1/10), og almindelig (≥ 1/100 og <1/10).
English: o The short-term potential risk of treatment with Zynteglo represents failure of engraftment, which shall be managed by administration of rescue cells.
Danish: o Den kortvarige potentielle risiko forbundet med behandling med Zynteglo er mislykket engraftment, som skal behandles med akut administration af celler fra reservebeholdningen.
English: The infusion bag(s) must be kept inside the metal cassette(s) until ready to thaw and use.
Danish: Infusionspose(-erne) skal opbevares inden i metalkassetten/ metalkassetterne, indtil de er klar til optøning og brug.
English: • have symptoms that could be from internal bleeding, such as unusual stomach or back pain, or severe headache
Danish: • får symptomer på en indre blødning, f.eks. usædvanlige mave- eller rygsmerter, eller kraftig hovedpine
English: For 8 patients who had sufficient on-study follow-up to obtain a 12-month follow-up bone marrow assessment, myeloid/erythroid ratios for 7 patients increased from a range of 0.1 to 0.5 at baseline to a range of 0.6 to 1.9 approximately 12 months after Zynteglo infusion, suggesting that Zynteglo improves erythropoiesis in patients with TDT.
Danish: For 8 patienter med tilstrækkelig opfølgning under studiet til, at der kunne foretages en opfølgende vurdering af knoglemarven efter 12 måneder, var myeloid/erythroid-ratioen forøget hos 7 patienter fra intervallet 0,1 til 0,5 ved baseline til intervallet 0,6 til 1,9 cirka 12 måneder efter infusion af Zynteglo, hvilket antyder, at Zynteglo forbedrer erythropoiesen hos patienter med TDT.
English: • increase or decrease in white blood cells
Danish: • stigning eller fald i hvide blodlegemer
English: Women who could become pregnant and men capable of fathering a child must start using a reliable method of contraception from before their blood stem cells are collected and continue until at least 6 months after receiving Zynteglo.
Danish: Kvinder, som kan blive gravide, og mænd, som kan gøre en kvinde gravid, skal påbegynde at bruge en pålidelig kontraceptionsmetode, inden deres blodstamceller indsamles og fortsætte dermed i mindst 6 måneder efter behandling med Zynteglo.
English: In the event that more than one infusion bag is provided, all infusion bags must be administered.
Danish: I tilfælde af, at mere end én infusionspose leveres, skal alle infusionsposer infunderes.
English: Before receiving Zynteglo you will be given chemotherapy in order to remove your existing bone marrow.
Danish: Inden du får Zynteglo, vil du få kemoterapi for at fjerne din eksisterende knoglemarv.
English: It is unknown whether Zynteglo transduced cells have the potential to be transferred in utero to a foetus.
Danish: Det vides ikke, om celler, der er transduceret med Zynteglo, har potentiale til at blive overført til fostre in utero.
English: Each infusion bag contains approximately 20 mL of Zynteglo.
Danish: Hver infusionspose indeholder ca. 20 ml Zynteglo.
English: • changes in blood chemistry which may indicate low calcium, low potassium, low magnesium,
Danish: • ændringer i blodkemi, som kan angive et lavt indhold af calcium, kalium, magnesium, natrium,
English: The total number of infusion bags to be administered should also be confirmed with the Lot Information Sheet (see section 4.4).
Danish: Det samlede antal infusionsposer, som skal administreres, skal også bekræftes via lot-informationsarket (se pkt.
English: ISA of post-transplantation BMCs demonstrated no preferred integration in the proximity of or within genes associated clinically (for gamma retroviral vectors) with either clonal dominance or leukaemia, and no evidence of clonal dominance was observed.
Danish: En analyse af insertionsstedet (ISA) efter transplantation af BMC'er påviste ikke foretrukken integration i nærheden af eller i gener, der er klinisk forbundet (for retrovirale gamma-vektorer) med enten klonal dominans eller leukæmi, og der blev ikke observeret tegn på klonal dominans.
English: Administer each infusion bag via intravenous infusion over a period of less than 30 minutes.
Danish: Administrer hver infusionspose via intravenøs infusion over en tidsperiode på under 30 minutter.
English: Patients should be made aware of the risk of bleeding until platelet recovery has been achieved.
Danish: Patienterne bør gøres opmærksomme på risikoen for blødning, indtil der er opnået stabilitet i antallet af trombocytter.
English: Tables 1, 2, and 3 are lists of adverse reactions attributed to mobilisation/apheresis, myeloablative conditioning, and Zynteglo, respectively, experienced by patients with TDT in clinical trials with Zynteglo.
Danish: Tabel 1, 2 og 3 viser lister over bivirkninger i forbindelse med hhv. mobilisering/aferese, myeloablativ konditionering og Zynteglo, som patienter med TDT har oplevet under deltagelse i kliniske studier med Zynteglo.
English: If you are concerned about having children, you should discuss this with your doctor before treatment.
Danish: Hvis du er bekymret for, om det får indflydelse på din evne til at få børn, bør du tale med din læge før behandlingen.
English: Apheresis material from patients with a positive test for HIV will not be accepted for Zynteglo manufacturing.
Danish: Aferesematerialet fra patienter med en positiv test for hiv accepters ikke til produktion af Zynteglo.
English: In HGB-207 and HGB-212 prophylaxis for VOD/hepatic sinusoidal obstruction syndrome was required per institutional practice with ursodeoxycholic acid or defibrotide.
Danish: I HGB-207 og HGB-212 studierne var profylakse imod hepatisk sinus-obstruktion syndrom med ursodeoxycholsyre eller defibrotid nødvendigt ifølge institutionens praksis.
English: • other pain
Danish: • andre former for smerter
English: This is because Zynteglo is a gene therapy medicine.
Danish: Dette skyldes, at Zynteglo er et lægemiddel til genterapi.
English: Platelet engraftment is defined as 3 consecutive platelet values ≥20 × 109/L obtained on different days after Zynteglo infusion, with no platelet transfusions administered for 7 days immediately preceding and during the evaluation period.
Danish: Engraftment af trombocytter (blodplader) defineres som 3 på hinanden følgende trombocytværdier på ≥20 × 109/l, som er opnået på forskellige dage efter infusion af Zynteglo, uden administrerede transfusioner af trombocytter i 7 dage umiddelbart før og under evalueringsperioden.
English: If a patient requires anti-retrovirals following exposure to HIV/HTLV, initiation of Zynteglo treatment should be delayed until an HIV western blot and viral load assay have been performed at 6 months post-exposure.
Danish: Hvis en patient har behov for anti-retrovirale lægemidler efter eksponering for hiv/HTLV, bør påbegyndelse af behandling med Zynteglo udsættes, indtil der foreligger en analyse af western blot hiv, og viruskoncentrationen 6 måneder efter eksponeringen.
English: - The active substance of Zynteglo consists of your own blood stem cells that contain functional copies of the beta-globin gene that can be measured in your blood.
Danish: - Aktivt stof i Zynteglo består af dine egne blodstamceller, som indeholder funktionelle kopier af beta-globingenet, der kan måles i dit blod.
English: • decrease in magnesium, calcium, potassium, phosphate, albumin, sodium in blood
Danish: • fald i magnesium, kalcium, kalium, fosfat, albumin, natrium i blodet
English: SAVE THIS DOCUMENT AND PREPARE TO HAVE IT AVAILABLE AT THE TIME OF ZYNTEGLO INFUSION.
Danish: GEM DETTE DOKUMENT, OG HAV DET VED HÅNDEN, NÅR ZYNTEGLO SKAL INFUNDERES.
English: Number of Infusion Bags
Danish: Antal infusionsposer
English: • inflammation of the throat
Danish: • Inflammation i halsen
English: A pharmacology, biodistribution, toxicity and genotoxicity study was conducted in a mouse model of β-thalassaemia.
Danish: Et studie, der undersøgte farmakologien, biodistributionen, toksiciteten og genotoksiciteten, blev gennemført i en musemodel for β-thalassæmi.
English: Once thawed store at room temperature (20°C-25°C) and use within 4 hours.
Danish: Når lægemidlet er optøet, skal det opbevares ved stuetemperatur (20 °C til 25 °C) og anvendes inden for 4 timer.
English: Common (≥1% - <10%)
Danish: Almindelig (≥ 1 % -< 10 %)
English: No correlation was observed between incidence of bleeding adverse events (AEs) and time to platelet engraftment.
Danish: Der blev ikke observeret nogen korrelation mellem tilfælde blødningsrelaterede bivirkninger (AE'er) og tid til engraftment af trombocytter.
English: 4417.0 (3030, 9087) μM*min (N=31).
Danish: for daglig AUC var 4417,0 (3030; 9087) μM*min (N=31).
English: • soreness of the mouth
Danish: • ømhed i munden
English: Bleeding is a potential complication of thrombocytopenia subsequent to myeloablative conditioning and treatment with Zynteglo.
Danish: Blødning er en mulig komplikation forbundet med trombocytopeni efter myeloablativ konditionering og behandling med Zynteglo.
English: • dry lips
Danish: • tørre læber
English: To add blood stem cells containing functional copies of the beta-globin into your bone marrow.
Danish: For at tilføje blodstamceller, som indeholder funktionelle kopier af beta-globin i din knoglemarv.
English: βA-T87Q-globin can be quantified relative to other globin species in peripheral blood using high performance liquid chromatography.
Danish: β A-T87Q-globin kan kvantificeres i forhold til andre globinarter i perifert blod ved hjælp af HPLC-teknik (High Performance Liquid Chromatography).
English: It may no longer be possible for you to become pregnant or father a child after receiving chemotherapy medicine.
Danish: Du vil måske ikke være i stand til at blive gravid eller vil ikke være i stand til at gøre en kvinde gravid, efter at du har fået kemoterapimedicin.
English: What you need to know before you are given Zynteglo 3.
Danish: Det skal du vide, før du får Zynteglo 3.
English: Neutrophil engraftment occurred on median (min, max) Day 19.5 (13, 38) after medicinal product infusion.
Danish: forekom neutrofil engraftment på dag 19,5 (13; 38) efter infusion af lægemidlet.
English: No data from clinical studies are available regarding overdose of Zynteglo.
Danish: Der foreligger ingen data fra kliniske studier vedrørende overdosering af Zynteglo.
English: Mobilisation medicine is given To move the blood stem cells from your bone marrow into your blood stream.
Danish: Mobiliseringslægemiddel gives For at sørge for at transportere blodstamcellerne fra knoglemarven til din blodbane.
English: Anti-retroviral and hydroxyurea use
Danish: Anti-retrovirale lægemidler og anvendelse af hydroxyurea
English: It can only be given in a specialised hospital by doctors who are experienced in treating patients with TDT, administering bone marrow transplants, and using gene therapy medicines.
Danish: Det kan kun indgives ved en specialiseret hospitalsafdeling af læger med erfaring i behandling af patienter med transfusionsafhængig (TDT), foretagelse af knoglemarvstransplantationer og brug af denne type genterapi.
English: • fluid in or around the lung
Danish: • væske i eller omkring lungerne
English: Hepatic veno-occlusive disease
Danish: Hepatisk venookklusiv sygdom
English: Hb (g/dL) at 24 months*
Danish: Hb (g/dl) efter 24 måneder*
English: This medicinal product contains 391-1564 mg sodium per dose equivalent to 20 to 78% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Dette lægemiddel indeholder 391-1564 mg natrium pr. dosisækvivalent, hvilket svarer til 20-78 % af det maksimale daglige indtag for voksne på 2 g natrium, som anbefales af Verdenssundhedsorganisationen (World Health Organisation, WHO).
English: Drug-drug interactions between iron chelators and the myeloablative conditioning agent must be considered.
Danish: Lægemiddelinteraktioner mellem jernkelatorer og myeloablativ konditionering skal tages i betragtning.
English: Hb (g/dL) at 6 months*
Danish: Hb (g/dl) efter 6 måneder*
English: o Treatment with Zynteglo in the clinical trials was associated with delayed platelet engraftment.
Danish: o Behandling med Zynteglo i kliniske studierstudier var forbundet med forsinket engraftment af trombocytter.
English: Pre-treatment transfusions per year median (min, max)
Danish: Antal transfusioner per år før behandling median (min, max)
English: Pre-medication for infusion reactions was managed at physician discretion.
Danish: Præmedicinering for infusionsreaktioner blev givet i henhold til lægens skøn.
English: Each infusion bag should be administered in less than 30 minutes.
Danish: Hver infusionspose skal indgives på under 30 minutter.
English: You should stop taking medicines to remove iron from your body (so-called chelating agents: deferoxamine, deferiprone and/or deferasirox) 7 days before you start the chemotherapy before the infusion of Zynteglo (see section 3, How Zynteglo is given).
Danish: Du bør stoppe med at tage medicin, der fjerner jern fra kroppen (såkaldte kelatdannere: deferoxamin, deferipron og/eller deferasirox) i 7 dage, før du starter kemoterapi og inden infusionen af Zynteglo (se pkt.
English: • tingling or numbness of the hands, feet, or mouth
Danish: • snurren eller følelsesløshed i hænderne, fødderne eller munden
English: After you have been treated with Zynteglo, you will not be able to donate blood, organs, or tissues in the future.
Danish: Efter du er blevet behandlet med Zynteglo, må du ikke afgive blod, organer, eller væv i fremtiden.
English: o Treatment with Zynteglo is in theory associated with the risk of insertional mutagenesis, potentially leading to development of malignancy.
Danish: o I teorien er behandling med Zynteglo forbundet med risikoen for insertionel mutagenese, der potentielt kan medføre udvikling af malignitet.
English: Zynteglo is a type of medicine called gene therapy.
Danish: Zynteglo er en type medicin, der kaldes genterapi.
English: Standard procedures for patient management after HSC transplantation should be followed after Zynteglo infusion.
Danish: Standardprocedurer til patientbehandling efter transplantation med hæmatopoietiske stamceller bør følges efter infusion med Zynteglo.