FrancophonIA/ELRC3.0 huggingface dataset:
English: For the only patient who did not achieve TI, a reduction of 75.8% in transfusion volume requirements and a reduction of 74.9% in transfusion frequency were observed between hospital discharge and through last study visit when compared to their pre-study levels of RBC transfusions.
Danish: For den eneste patient, som ikke opnåede TI, blev der observeret en reduktion i transfusionsvolumenet på 75,8 %, og en reduktion af transfusionsfrekvensen på 74,9 % mellem udskrivningen fra hospitalet og indtil det sidste forsøgsbesøg, når dette blev sammenlignet med niveauerne i RBC-transfusioner inden studiet.
English: • Prolonged bleeding or bleeding without injury such as nosebleeds, bleeding from gums, or vaginal bleeding.
Danish: • Længerevarende blødning eller blødning uden personskade, f.eks. næseblod, blødning fra tandkødet eller vaginal blødning.
English: Do not infuse Zynteglo if the information on the patient specific-label on the infusion bag does not match the intended patient.
Danish: Infusion af Zynteglo må ikke udføres, hvis informationen på den patientspecifikke etiket på infusionsposen ikke svarer den patient, det er beregnet til.
English: Name and address of the manufacturer(s) responsible for batch release apceth Biopharma GmbH Haidgraben 5
Danish: Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse apceth Biopharma GmbH Haidgraben 5
English: • The patient/carer guide shall contain the following key messages: o Treatment with Zynteglo is in theory associated with the risk of development of malignancy.
Danish: • Vejledningen til patient/plejer skal indeholde følgende hovedbudskabers: o I teorien er behandling med Zynteglo forbundet med risiko for udvikling af malignitet.
English: Patients who experience neutrophil engraftment failure should receive rescue treatment with the back-up collection (see section 4.2).
Danish: Patienter, som oplever mislykket neutrofil engraftment, bør modtage akut behandling med reservebeholdningen (se pkt.
English: A risk of bleeding exists before platelet engraftment and may continue after platelet engraftment in patients who have continued thrombocytopenia.
Danish: Der er risiko for blødning før engraftment af trombocytter, som kan vare ved efter engraftment af trombocytter hos patienter med vedvarende trombocytopeni.
English: Healthcare professionals handling Zynteglo should take appropriate precautions (wearing gloves, protective clothing and eye protection) to avoid potential transmission of infectious diseases.
Danish: Sundhedspersonale, som håndterer Zynteglo, skal tage relevante forholdsregler (bære handsker, beskyttelsestøj og øjenbeskyttelse) for at undgå potentiel overførsel af smitsomme sygdomme.
English: For patients with at least 6 months of follow-up, HbAT87Q generally increased steadily after Zynteglo infusion and stabilised by approximately Month 6 to 9 post infusion.
Danish: For patienter med mindst 6 måneders opfølgning, var der en generel og vedvarende stigning i HbAT87Q efter infusionen med Zynteglo, som stabiliseredes ca. 6 til 9 måneder efter infusionen.
English: The Summary of Product Characteristics (SmPC) for the iron chelator and the myeloablative conditioning agent must be consulted for the recommendations regarding co-administration with CYP3A substrates.
Danish: Der henvises til produktresuméet for jernkelatoren og midlet til myeloablativ konditionering for anbefalinger vedrørende samtidig administration af CYP3A-substrater.
English: 20 mL fluoro-ethylenepropylene infusion bag(s), each packed in a transparent pouch inside a metal cassette.
Danish: Infusionspose(r) på 20 ml af fluoro-ethylenepropylen, som hver er emballeret i en gennemsigtig indvendig lomme inden i en metalkassette.
English: Bone marrow biopsies taken before treatment were consistent with a diagnosis of TDT, including a low myeloid/erythroid ratio (N=15, HGB-207), reflective of erythroid hyperplasia.
Danish: Knoglemarvsbiopsier taget inden behandling var overensstemmende med diagnosen TDT, herunder en lav myeloid/erythroid-ratio (N=15, HGB-207), som viste erythroid hyperplasi.
English: low sodium, low phosphate, decrease in protein, or decrease in albumin
Danish: fosfat, nedsat protein eller nedsat albumin
English: • Remove each metal cassette from liquid nitrogen storage and remove each infusion bag from the metal cassette.
Danish: • Tag hver metalkassette ud af beholderen med flydende nitrogen, og tag hver infusionspose ud af metalkassetten.
English: • have abnormal bruising or bleeding (such as bruising without injury, blood in your urine, stool, vomit, or cough up blood).
Danish: • har unormale blå mærker eller blødning (f.eks. blå mærker uden at du er kommet til skade, blod i din urin, blod i afføringen, opkastning, eller at du hoster blod op).
English: Zynteglo must be administered in a qualified treatment centre by a physician(s) with experience in HSC transplantation and in the treatment of patients with TDT.
Danish: Zynteglo skal administreres på et kvalificeret behandlingscenter af en læge(-r) med erfaring i transplantation af hæmatopoietiske stamceller (HSC) og erfaring i behandling af patienter med transfusionsafhængig β-thalassæmi (TDT).
English: • After thaw, mix the medicinal product gently by massaging the infusion bag until all of the contents are uniform.
Danish: • Efter optøning blandes lægemidlet forsigtigt ved at massere infusionsposen, indtil hele indholdet er ensartet.
English: An in vitro immortalisation (IVIM) assay conducted with BB305 LVV-transduced mouse bone marrow cells (BMCs) showed minimal mutagenic potential (Fitness Score ≈ 0.1 × 10-4).
Danish: En in vitro immortaliseringsanalyse (IVIM), der blev udført med lentiviral vektor BB305-transducerede knoglemarvsceller fra mus (hæmatopoietiske stamceller), udviste et minimalt mutagent potentiale (fitness-score ≈ 0,1×10-4).
English: Infusion related reactions to Zynteglo
Danish: Infusionsrelaterede reaktioner på Zynteglo
English: • The Guide for healthcare professionals shall contain the following key elements: o Warnings and precautions of the mobilisation agents and the myeloablative conditioning agent must be considered.
Danish: • Vejledningen til sundhedspersonale skal indeholde de følgende hovedelementer: o Advarsler og forsigtighedsregler i forbindelse med midler til mobilisering og midlet til myeloablativ konditionering skal tages i betragtning.
English: Do not overthaw the medicinal product.
Danish: Undlad at optø lægemidlet for længe.
English: A total of 28.6% of patients (12/42; HGB-204, HGB-205, HGB-207, HGB-212) received G-CSF within 21 days after Zynteglo infusion.
Danish: I alt 28,6 % af patienterne (12/42; HGB-204, HGB-205, HGB-207, HGB-212) fik G-CSF inden for 21 dage efter infusion med Zynteglo.
English: o Treatment with Zynteglo is associated with the risk of delayed platelet engraftment that could lead to an increased tendency for bleeding.
Danish: o Behandling med Zynteglo er forbundet med risikoen for forsinket engraftment af trombocytter, som kan resultere i øget blødningstendens.
English: Infuse as soon as possible and no more than 4 hours after thawing.
Danish: Infundér så hurtigt som muligt og højst 4 timer efter optøning.
English: In the 3 patients who did not achieve TI, reductions of 100%, 86.9% and 26.8% in transfusion volume requirements and of 100%, 85.3% and 20.7% in transfusion frequency were observed between Month 6 through Month 24 visit when compared to their pre-study levels of RBC transfusions.
Danish: I de 3 patienter, der ikke opnåede TI, blev reduktioner af transfusionsvolumenerne på 100 %, 86,9 % og 26,8 % og af transfusionshyppighederne på 100 %, 85,3 % og 20,7 % observeret ved besøgene i 6. måned og indtil måned 24, sammenlignet med niveauerne af deres RBC-transfusioner før studiets start.
English: If more than one infusion bag is provided, administer each infusion bag completely before proceeding to thaw and infuse the next bag.
Danish: Hvis mere end én infusionspose leveres, administreres hver enkelt infusionspose helt, før den næste pose optøs og infunderes.
English: Ear and labyrinth disorders
Danish: Øre og labyrint vertigo
English: Delayed platelet engraftment
Danish: Forsinket engraftment af trombocytter
English: **Transfusion independence (TI): a weighted average Hb ≥9 g/dL without any RBC transfusions for a continuous period of ≥12 months at any time during the study after medicinal product infusion.
Danish: **Transfusionsuafhængighed (TI): et vægtet gennemsnitligt Hb på ≥9 g/dl uden RBC-transfusioner i en sammenhængende periode på ≥12 måneder under hele studiet efter infusion af lægemidlet.
English: Flush all Zynteglo remaining in the infusion bag and any associated tubing with at least 50 mL of 0.9% sodium chloride solution to ensure as many cells as possible are infused into the patient.
Danish: Udskyl alt det resterende Zynteglo, der er tilbage i infusionsposen og eventuelle slanger med mindst 50 ml 0,9 % natriumkloridopløsning for at sikre, at det højest mulige antal celler infunderes i patienten.
English: The modified virus is used to insert a functional beta-globin gene into your blood stem cells.
Danish: Den ændrede virus anvendes til at indsætte et virksomt beta-globingen i dine blodstamceller.
English: Reliable methods of contraception include intra-uterine device or a combination of oral contraceptive (also know as the pill) and condoms.
Danish: Pålidelige kontraceptionsmetoder inkluderer spiral, eller en kombination at p-piller og kondomer.
English: • Infuse Zynteglo as soon as possible and no more than 4 hours after thawing.
Danish: • Infundér Zynteglo så hurtigt som muligt og højst 4 timer efter optøning.
English: It is unknown whether Zynteglo is excreted in human milk.
Danish: Det er ukendt, om Zynteglo udskilles i human mælk.
English: All patients in HGB-204 restarted iron chelation and continue to use iron chelators.
Danish: Alle patienter i HGB-204 genstartede jernkelering og fortsatte med at anvende jernkelatorer.
English: The concentration is 1.2-20 × 106 CD34+ cells (blood stem cells) per millilitre.
Danish: Koncentrationen er 1,2-20 × 106 CD34+ celler (blodstamceller) pr. milliliter.
English: United Kingdom bluebird bio (UK) Limited Tel: +44 (0) 207 660 0754
Danish: United Kingdom bluebird bio (UK) Limited Tlf.: +44 (0) 207 660 0754
English: • pain in back, bone, skin, limbs, anus, or muscles
Danish: • smerter i ryg, knogler, hud, ekstremiteter, anus eller muskler
English: • bone or muscle pain
Danish: • knogle- eller muskelsmerter
English: Contents of the pack and other information What Zynteglo contains
Danish: Pakningsstørrelser og yderligere oplysninger Zynteglo indeholder
English: Patients were considered to be transfusion-dependent if they had a history of transfusions of at least 100 mL/kg/year of RBCs or with ≥8 transfusions of RBCs per year in the 2 years preceding enrolment.
Danish: Patienter blev anset for at være transfusionsafhængige, hvis de havde en anamnese med erythrocyt transfusioner på mindst 100 ml/kg/år erythrocyt eller ≥8 erythrocyttransfusioner erythrocyt pr. år i 2 år før inklusion i studiet.
English: See Method of Administration below and section 6.6 for details on Zynteglo administration and handling.
Danish: 6.6 for oplysninger om administration og håndtering af Zynteglo.
English: At least 6 days before Zynteglo infusion
Danish: Mindst 6 dage før infusion med Zynteglo
English: Dose: {N.N} × 106 CD34+ cells/kg
Danish: Dosis: {N.N} × 106 CD34+ celler/kg
English: Zynteglo is given by a drip (infusion) into a vein.
Danish: Zynteglo gives ved hjælp af et drop (infusion) i en vene.
English: • abnormal liver tests
Danish: • abnorme levertests
English: After thaw, mix the medicinal product gently by massaging the infusion bag until all of the contents are uniform.
Danish: Efter optøning blandes lægemidlet forsigtigt ved at massere infusionsposen, indtil hele indholdet er ensartet.
English: 85521 Ottobrunn GERMANY
Danish: 85521 Ottobrunn TYSKLAND
English: Women of childbearing potential and men capable of fathering a child must use a reliable method of contraception (intra-uterine device or combination of hormonal and barrier contraception) from start of mobilisation through at least 6 months after administration of Zynteglo.
Danish: Kvinder i den fertile alder og mænd, der kan gøre en kvinde gravid, skal bruge en pålidelig kontraceptionsmetode (spiral eller en kombination af hormonel kontraception og barrieremetode) fra påbegyndelsen af mobilisering og herefter i mindst 6 måneder efter infusion af Zynteglo.
English: PARTICULARS TO APPEAR ON THE LOT INFORMATION SHEET INCLUDED WITH EACH SHIPMENT FOR ONE PATIENT
Danish: MÆRKNING, DER SKAL ANFØRES PÅ LOT-INFORMATIONSARKET, DER MEDFØLGER I HVER FORSENDELSE TIL EN PATIENT
English: One patient in HGB-205 restarted iron chelation and continues to use iron chelators.
Danish: En patient i HGB-205 genstartede jernkelering og fortsatte med at anvende jernkelatorer.
English: Healthcare professionals handling Zynteglo should take standard precautions (wearing gloves, protective clothing and eye protection) to avoid potential transmission of infectious diseases.
Danish: Sundhedspersonale, som håndterer Zynteglo, skal tage almindelige sikkerhedsforanstaltninger (bære handsker, beskyttelsestøj og øjenbeskyttelse) for at undgå overførsel af smitsomme sygdomme.
English: • dizziness, tiredness
Danish: • svimmelhed, træthed
English: • Each infusion bag should be inspected for any breaches of integrity before thawing and infusion.
Danish: • Hver infusionspose bør kontrolleres for eventuel lækage før optøning og infusion.
English: The effect of administration of Zynteglo to mothers on their breast-fed children has not been studied.
Danish: Effekten af Zynteglo på børn, når det gives til ammende mødre, er ikke undersøgt.
English: No cases of leukaemia or lymphoma have been reported in clinical studies with Zynteglo in patients with TDT.
Danish: Der er ikke indberettet tilfælde af leukæmi eller lymfom fra kliniske studier med Zynteglo hos patienter med transfusionsafhængig TDT.
English: The treating physician should confirm that HSC transplantation is appropriate for the patient before myeloablative conditioning is initiated (see section 4.4).
Danish: Den behandlende læge skal bekræfte, at transplantation med hæmatopoietiske stamceller er relevant for patienten, før myeloablativ konditionering indledes (se pkt.
English: Store in the vapour phase of liquid nitrogen at ≤-140°C until ready for thaw and administration.
Danish: Opbevares i dampfasen i flydende nitrogen ved ≤ -140 °C, indtil de er klar til optøning og administration.
English: 3521AZ Utrecht The Netherlands
Danish: 3521AZ Utrecht Holland
English: • low oxygen level in blood
Danish: • lavt iltniveau i blodet
English: Insertion site analysis (ISA) of pre-transplantation transduced mouse BMCs and human CD34+ HSCs showed no enrichment for insertion in or near cancer-related genes.
Danish: En analyse af insertionsstedet (ISA) i transducerede erythrocytter (BMC'er) fra mus inden transplantation og i humane CD34+ hæmatopoietiske stamceller (HSC'er) viste ingen berigelse for insertion i eller i nærheden af cancerrelaterede gener.
English: - are allergic to any of the ingredients of this medicine (listed in section 6) - are pregnant or breast-feeding - have previously received gene therapy of your blood stem cells - are allergic to any of the ingredients in the medicines you will be given for mobilisation and chemotherapy (see section 3).
Danish: - er gravid eller ammer - tidligere har fået genterapi af dine blodstamceller - er allergisk over for et eller flere af indholdsstofferne i det lægemiddel, du vil få udleveret til mobilisering og kemoterapi (se pkt.
English: (mL/kg/year) median (min, max)
Danish: (ml/kg/år) median (min, max)
English: Package leaflet: Information for the patient or carer Zynteglo 1.2-20 × 106 cells/mL dispersion for infusion
Danish: Indlægsseddel: Information til patienten eller behandleren Zynteglo 1,2-20 × 106 celler/ml infusionsvæske, dispersion
English: The median (min, max) busulfan dose was 3.50 (2.5, 5.0) mg/kg/day (N=32).
Danish: busulfan dosis var 3,50 (2,5; 5,0) mg/kg/dag (N=32).
English: Treatment with Zynteglo involves the infusion and engraftment of CD34+ HSCs that have been genetically modified ex vivo with a LVV.
Danish: Behandling med Zynteglo involverer infusion og engraftment af CD34+ hæmatopoietiske stamceller (HSC'er), der er blevet genetisk modificerede ex vivo med en lentiviral vektor (LVV).
English: Table 1
Danish: Figur 1
English: • injection site reaction
Danish: • reaktioner på injektionsstedet
English: • spots on skin from bleeding under the skin
Danish: • pletter på huden på grund af blødninger i huden
English: Reproductive and developmental toxicity studies with Zynteglo were not performed.
Danish: Der er ikke udført studier af reproduktions- og udviklingstoksicitet i forbindelse med Zynteglo.
English: Of the patients with a non-β0/β0 genotype, 11/14 (78.6%, 95% CI 49.2%-95.3%) achieved TI by Month 24 (Table 5).
Danish: Af de patienter, der havde en non-β0/Β0 genotype, opnåede 11/14 patienter (78,6 %, 95 % CI 49,2 %-95,3 %) transfusionsuafhængighed (TI) efter 24 måneder (Tabel 5).
English: Although this medicine will not give you HIV infection, having Zynteglo in your blood may cause a false positive HIV test result with some commercial tests that recognise a piece of HIV used to make Zynteglo.
Danish: Selv om du ikke får en hiv-infektion, når du får dette lægemiddel, kan Zynteglo, når det findes i dit blod, give falsk-positive testresultater for hiv, når visse kommercielle tests anvendes.
English: Zynteglo infusion should be completed as soon as possible and no more than 4 hours after thawing.
Danish: Infusionen med Zynteglo skal udføres hurtigst muligt og højst 4 timer efter optøning.
English: • stomach pain, upset stomach, constipation, diarrhoea
Danish: • mavesmerter, dårlig mave, forstoppelse, diarré
English: • flushing (redness and warmth of skin) • pain in legs
Danish: • hedeture (rødmen og varme i huden)
English: • low blood calcium level
Danish: • lave calciumniveauer i blodet
English: Deutschland bluebird bio (Germany) GmbH Tel: +49 (0) 893 803 7456 (0800 181 0702)
Danish: Deutschland bluebird bio (Germany) GmbH Tlf.: +49 (0) 893 803 7456 (0800 181 0702)
English: More specifically, people with TDT do not make enough of a part of the haemoglobin called beta-globin, due to a gene defect.
Danish: På grund af en gendefekt producerer personer med TDT ikke nok af den del af hæmoglobinet, der kaldes beta-globin.
English: Risks associated with TDT and iron overload
Danish: Risici forbundet med transfusionsafhængig TDT og jernophobning
English: The Lot Information Sheet is included inside the lid of the cryoshipper used to transport Zynteglo.
Danish: Lot-informationsarket er placeret inden i låget på kryoboksen, der bruges til at transportere Zynteglo.
English: If you get any side effects, talk to your doctor or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge eller sundhedspersonalet.
English: Zynteglo adds functional copies of a modified β-globin gene into the patients' HSCs through transduction of autologous CD34+ cells with BB305 LVV, thereby addressing the underlying genetic cause of the disease.
Danish: Zynteglo fører funktionelle kopier af et modificeret β-globingen til patientens hæmatopoietiske stamceller via transduktion af autologe CD34+ celler ved hjælp af den lentivirale vektor BB305 og afhjælper derved den underliggende genetiske årsag til sygdommen.
English: A back-up collection of CD34+ stem cells of at least 1.5 × 106 CD34+ cells/kg (if collected by apheresis) or >1.0 × 108 TNC/kg (if collected by bone marrow harvest) is required.
Danish: En indsamling, der svarer til et antal CD34+-reservestamceller på mindst 1,5 × 106 CD34+-celler/kg (hvis de indsamles ved aferese) eller >1,0 × 108 totalt antal kerneholdige celler (Total Nucleated Cell count, TNC)/kg (hvis de indsamles ved knoglemarvshøst), er påkrævet.
English: • enlarged liver
Danish: • forstørret lever
English: Before infusion, it must be confirmed that the patient's identity matches the unique patient information on the Zynteglo infusion bag(s).
Danish: Før infusion skal det bekræftes, at patientens identitet matcher de unikke patientoplysninger på infusionsposen(-erne) med Zynteglo.
English: Zynteglo is indicated for the treatment of patients 12 years and older with transfusion-dependent β-thalassaemia (TDT) who do not have a β0/β0 genotype, for whom haematopoietic stem cell (HSC) transplantation is appropriate but a human leukocyte antigen (HLA)-matched related HSC donor is not available (see sections 4.4 and 5.1).
Danish: Zynteglo er indiceret til behandling af patienter på 12 år og ældre med transfusionsafhængig β-thalassæmi (TDT), som ikke har en β0/β0-genotype, hvor en hæmatopoietisk stamcelletransplantation (HSC) er indiceret, men hvor der ikke kan findes en egnet human leukocytantigen (HLA) forligelig donor (se pkt.
English: • stomach discomfort with nausea and vomiting
Danish: • ubehag i maven med kvalme og opkastning
English: Ovarian failure, Menstruation irregular, Premature menopause, Blood follicle stimulating hormone increased, Blood testosterone decreased
Danish: Det reproduktive system og mammae vaginalblødning ovarieinsufficiens, uregelmæssig menstruation, præmatur menopause, forhøjet follikelstimulerende hormon i blodet, nedsat mængde testosteron i blodet
English: • Confirm that patient identity matches the unique patient identification information located on the Zynteglo infusion bag(s).
Danish: • Bekræft, at patientens identitet matcher de unikke patient-id-oplysninger, der findes på infusionsposen(-erne) med Zynteglo.
English: Manufacturer apceth Biopharma GmbH Haidgraben 5
Danish: Fremstiller apceth Biopharma GmbH Haidgraben 5
English: Approximately 2 months before Zynteglo infusion
Danish: Ca. 2 måneder før infusion med Zynteglo
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu<, and on the website of {name of MS Agency (link)}>.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu< og på Lægemiddelstyrelsens hjemmeside http://www.laegemiddelstyrelsen.dk>.
English: You should not be given Zynteglo if you are breast-feeding.
Danish: Du må ikke få Zynteglo, hvis du ammer.
English: Zynteglo 1.2-20 × 106 cells/mL dispersion for infusion.
Danish: Zynteglo 1,2-20 × 106 celler/ml infusionsvæske, dispersion.
English: Previous treatment with HSC gene therapy.
Danish: Tidligere behandling med genterapi med hæmatopoietiske stamceller (HSC).
English: Strength cells/mL)
Danish: (× 106 celler /ml)
English: Thaw and administration
Danish: Dosering og administration
English: C-reactive protein increased, Aspergillus test positive, Blood potassium decreased, Weight decreased, Blood alkaline phosphatase decreased, Blood magnesium decreased, Forced expiratory flow decreased, Protein total decreased, Blood albumin decreased, Reticulocyte count decreased, Reticulocyte percentage decreased
Danish: Undersøgelser forhøjet C-reaktivt protein, positiv test for aspergillus, nedsat indhold af kalium i blodet, vægttab, nedsat alkalisk fosfatase i blodet, nedsat indhold af magnesium i blodet, nedsat forceret eksspiratorisk flow, nedsat total
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING - METAL CASSETTE NAME OF THE MEDICINAL PRODUCT
Danish: MÆRKNING DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE METALKASSETTE
English: • feeling cold
Danish: • kuldefornemmelse
English: 3521AZ Utrecht The Netherlands medinfo@bluebirdbio.com
Danish: 3521AZ Utrecht Holland medinfo@bluebirdbio.com
English: Precautions regarding bleeding consequences of thrombocytopenia need to be taken.
Danish: Der skal tages sikkerhedsforanstaltninger relateret til blødning, som kan forårsages af trombocytopeni.
English: After Zynteglo infusion, patient iron levels were managed at physician discretion.
Danish: Efter infusion med Zynteglo blev jernniveauerne hos patienten bedømt efter lægens skøn.