FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be made aware of the risk of bleeding events that are not easily identifiable, such as internal bleeding.
Danish: Patienter bør gøres opmærksomme på risikoen for blødning, der ikke er let at identificere, som f.eks. indre blødning.
English: o Signs and symptoms of bleeding and the need to contact the physician if any signs of unusual or prolonged bleeding or any other relevant signs are present.
Danish: o Tegn og symptomer på blødning og behovet for at kontakte lægen, hvis der forekommer tegn på udsædvanlig eller langvarig blødning eller andre relevante tegn.
English: • dizziness, or sensation of feeling off balance or like the room is spinning
Danish: • svimmelhed eller fornemmelse af ubalance, som om værelset drejer rundt
English: This means that your blood may not be able to clot as well as normal and you may be prone to bleeding.
Danish: Det betyder, at dit blod måske ikke kan størkne, så godt som det plejer, og du kan have tendens til blødning.
English: During the long-term follow-up, your doctor will monitor you for any signs of leukaemia or lymphoma.
Danish: Under den langvarige opfølgning vil din læge overvåge dig for tegn på leukæmi eller lymfom.
English: This is equivalent to 20-78% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Det svarer til 20-78 % af det anbefalede maksimale daglige indtag af natrium i kosten for en voksen.
English: Do not leave the medicinal product unattended and do not submerge the infusion ports if thawed in a water bath.
Danish: Efterlad ikke lægemidlet uden opsyn, og nedsænk ikke infusionsportene i vand, hvis det optøs i et vandbad.
English: Precautions to be taken before handling or administering the medicinal product
Danish: Sikkerhedsforanstaltninger der skal tages før håndtering og administration af lægemidlet
English: Your name and date of birth, as well as coded information identifying you as the patient, are printed onto each infusion bag and each metal container.
Danish: Dit navn og fødselsdato samt kodede oplysninger, der identificerer dig som patienten, påtrykkes på hver infusionspose og på hver metalbeholder.
English: Prior to launch of Zynteglo in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational and controlled distribution programme,
Danish: Inden lancering af Zynteglo i hver medlemsstat skal indehaveren af markedsføringstilladelsen (MAH) blive enig om indholdet og formatet af programmet til undervisning og kontrolleret distribution,
English: Why of bags will vary by patient.
Danish: Antallet af poser vil variere med patienten.
English: You should carry the Patient Alert Card with you at all times and show it to your doctor or nurse when you see them or if you are admitted to the hospital.
Danish: Du skal altid bære patientkortet på dig og vise det til lægen eller sygeplejersken, når du møder dem, eller hvis du indlægges på hospitalet.
English: According to available data, the frequency, type, and severity of adverse reactions in adolescents 12-17 years of age are similar to adults with the exception of VOD and pyrexia that occurred more frequently in adolescents.
Danish: Ifølge de tilgængelige data er hyppigheden, typen og sværhedsgraden af bivirkninger hos unge mellem 12-17 år den samme som hos voksne med undtagelse af VOD og pyreksi, som forekom hyppigere hos unge.
English: Patients seropositive for human immunodeficiency virus (HIV) or human T-lymphotropic virus (HTLV)
Danish: Patienter, som er seropositive for human immundefekt virus (hiv) eller humant T-lymfotropt virus (HTLV)
English: The traceability requirements of cell-based advanced therapy medicinal products must apply.
Danish: Sporbarhedskravene til cellebaserede avancerede lægemidler skal gøres gældende.
English: Phlebotomy can be used in lieu of iron chelation, when appropriate.
Danish: Flebotomi kan anvendes i stedet for jernkelering, når det er relevant.
English: • excess water in the body
Danish: • overskud af vand i kroppen
English: This information is provided in the Patient Alert Card which should be given to the patient after treatment.
Danish: Disse oplysninger findes på patientkortet, som skal udleveres til patienten efter behandling.
English: • Physician educational material • Patient information pack
Danish: • Undervisningsmateriale til læger • Informationspakke til patienter
English: In order to further confirm the appropriateness of the acceptance criteria, the MAH should re-evaluate the acceptance criteria for attributes related to potency tests using batch release data and clinical results after 6 months follow-up of 20 patients treated with commercial batches.
Danish: For yderligere at bekræfte relevansen af acceptkriterierne, skal MAH reevaluere acceptkriterierne for egenskaber relateret til styrkebestemmelse ved brug af batchfrigivelsesdata og kliniske resultater efter 6 månders opfølgning af 20 patienter behandlet med kommercielle batch.
English: Tell your doctor immediately if you get any of the following side effects after receiving chemotherapy medicine.
Danish: Fortæl det straks til lægen, hvis du oplever nogle af følgende bivirkninger efter at have modtaget kemoterapimedicin.
English: Busulfan dose adjustments were made as needed based on pharmacokinetic monitoring.
Danish: Dosen af busulfan blev justeret efter behov baseret på farmakokinetisk monitorering.
English: Zynteglo must not be re-frozen.
Danish: Zynteglo må ikke fryses igen.
English: Patients not receiving prophylaxis for VOD appeared to be at an increased risk for developing VOD.
Danish: Patienter, som ikke fik profylakse for VOD, lod til at have større risiko for at udvikle VOD.
English: Pharmacotherapeutic group: Other haematological agents, ATC code: not yet assigned Mechanism of action
Danish: Farmakoterapeutisk klassifikation: Andre hæmatologiske midler, ATC-kode: endnu ikke tildelt
English: o Enrolment in the drug product Registry.
Danish: o Tilmeldning til lægemiddelregisteret.
English: People with this condition cannot make enough haemoglobin, a protein in the blood that carries oxygen.
Danish: Mennesker med denne sygdom kan ikke producere nok hæmoglobin, et protein i blodet, der transporterer ilt.
English: Events were mild and included abdominal pain, hot flush, dyspnoea, and non-cardiac chest pain in 9.5%, 2.4%, 2.4%, and 2.4% of patients, respectively.
Danish: Hændelser var milde og inkluderede mavesmerter, hedestigninger, dyspnø, og ikke-kardiale brystsmerter hos hhv. 9,5 %, 2,4 %, 2,4 %, og 2,4 % af patienter.
English: The blood stem cells can then be collected by a machine that separates blood components (apheresis machine).
Danish: Blodstamcellerne kan herefter indsamles ved hjælp af en maskine, som adskiller blodkomponenter (aferesemaskine).
English: A clear to slightly cloudy, colourless to yellow or pink dispersion.
Danish: En klar til let uklar, farveløs til gul eller lyserød dispersion.
English: • low level of red and white blood cells, sometimes with a fever
Danish: • lavt niveau af røde og hvide blodlegemer, undertiden med feberstigning
English: • decrease in speed of air leaving your lungs
Danish: • fald i hastigheden hvormed luften udåndes af dine lunger
English: You should discuss possible side effects due to the mobilisation medicines and chemotherapy medicine with your doctor.
Danish: Du bør drøfte mulige bivirkninger i forbindelse med mobiliserende lægemidler og kemoterapimedicin med din læge.
English: Engraftment failure as measured by neutrophil engraftment
Danish: Mislykket engraftment målt ved neutrofil engraftment
English: Zynteglo has not been studied in patients with HIV-1, HIV-2, HTLV-1, or HTLV-2.
Danish: Zynteglo er ikke blevet undersøgt hos patienter med hiv-1, hiv-2, HTLV-1, eller HTLV-2.
English: A patient may have multiple infusion bags.
Danish: Én patient kan have flere infusionsposer.
English: Local biosafety guidelines applicable for such products should be followed.
Danish: De lokale retningslinjer for biosikkerhed, der er gældende for sådanne produkter, skal følges.
English: • Zynteglo will only be available through bluebird bio qualified treatment centres to ensure traceability of the patient`s cells and manufactured drug product between the treating hospital and manufacturing site.
Danish: • Zynteglo vil kun være tilgængeligt gennem bluebird bio-kvalificerede behandlingscentre for at garantere sporbarheden af patientens celler og det fremstillede lægemiddel mellem det behandlende hospital og produktionsstedet.
English: • increased concentration of haemoglobin in cells
Danish: • øget koncentration af hæmoglobin i cellerne
English: - The other ingredients are a solution used to preserve frozen cells and sodium chloride.
Danish: - Øvrige indholdsstoffer: en opløsning, som bruges til at bevare frosne celler og natriumklorid.
English: It is made specifically for each patient, using the patient's own (also called autologous) blood stem cells.
Danish: Det er fremstillet specielt til hver enkelt patient ved hjælp af patientens egne blodstamceller (kaldet autologe celler).
English: Serological testing
Danish: Serologisk testning
English: Because of this defect, people with TDT are anaemic and need frequent blood transfusions to survive.
Danish: Som følge af denne defekt er personer med TDT anæmiske (har blodmangel), og de har brug for hyppige blodtransfusioner for at overleve.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen, hvis du tager anden medicin eller har gjort det for nylig, eller hvis du muligvis vil tage anden medicin.
English: Magyarország, Malta, Norge, Österreich, Polska, Portugal, România, Slovenija, Slovenská republika, Suomi/Finland, Sverige bluebird bio (Netherlands) B.V.
Danish: België/Belgique/Belgien, България, Česká republika, Danmark, Eesti, Ελλάδα, España, Hrvatska, Irland, Ísland, Κύπρος, Latvija, Lietuva, Luxembourg/Luxembourg, Magyarország, Malta, Norge, Österreich, Polska, Portugal, România, Slovenija, Slovenská republika, Suomi/Finland, Sverige bluebird bio (Netherlands) B.V.
English: 2.2 Qualitative and quantitative composition
Danish: Kvalitativ og kvantitativ sammensætning
English: DOSE OF THE MEDICINAL PRODUCT Total Number of Infusion Bags: __
Danish: LÆGEMIDLETS DOSIS Samlet antal infusionsposer: __
English: All patients who experienced VOD received treatment with defibrotide and recovered.
Danish: Alle patienter, som oplevede VOD, blev behandlet med defibrotid og kom sig.
English: Unused medicine must be disposed of in compliance with the local biosafety guidelines.
Danish: Ikke anvendt lægemiddel skal bortskaffes i henhold til de lokale retningslinjer for biosikkerhed.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 General description
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Generel beskrivelse
English: Zynteglo is made specifically for you, using your own blood stem cells.
Danish: Zynteglo er fremstillet specielt til dig ved brug af dine egne blodstamceller.
English: Interim results: - at each annual renewal - Dec. 2024 - Dec. 2034
Danish: Forløbige resultater: - årligt hved fornyelse - Dec. 2024 - Dec. 2034
English: The safety of Zynteglo was evaluated in 42 patients with TDT.
Danish: Sikkerheden i forbindelse med Zynteglo blev vurderet hos 42 patienter med TDT.
English: If a third day of collection was needed, plerixafor and G-CSF dosing was extended to Day 6.
Danish: Hvis det var nødvendigt med en tredje høstdag, blev dosering med plerixafor og G-CSF udskudt til dag 6.
English: The patient information pack should contain:
Danish: • Patientinformationspakken skal indeholde:
English: Exploratory analyses were performed to confirm resolution of dyserythropoiesis, the fundamental physiologic characteristic of TDT, in the bone marrow.
Danish: Der blev udført eksplorative analyser for at bekræfte resolution af dyserytropoiese, de grundliggende fysiologiske karaktertræk af TDT, i knoglemarven.
English: Paediatric population The safety and efficacy of Zynteglo in children <12 years of age have not yet been established.
Danish: Pædiatrisk population Sikkerheden og effekten af Zynteglo hos børn <12 år er endnu ikke klarlagt.
English: Your doctor will advise you if and when you should start taking these medicines after Zynteglo infusion.
Danish: Din læge vil fortælle dig, om du skal tage, og hvornår du skal begynde at tage disse lægemidler efter infusion med Zynteglo.
English: • increase in female hormones
Danish: • stigning i kvindelige kønshormoner
English: The nature of Zynteglo is such that conventional studies on pharmacokinetics, absorption, distribution, metabolism, and elimination are not applicable.
Danish: Zynteglos egenskaber er sådan, at konventionelle undersøgelser af farmakokinetik, absorption, distribution, metabolisme, og elimination ikke er relevante.
English: Also contains Cryostor CS5 and sodium chloride.
Danish: Indeholder også Cryostor CS5 og natriumklorid.
English: Transfusion-dependent β-thalassaemia (TDT)
Danish: Transfusionsafhængig β-thalassæmi (TDT)
English: Before treatment with Zynteglo, your doctor will perform tests to make sure your heart and liver are functioning properly so you can be treated safely with Zynteglo.
Danish: Før behandling med Zynteglo, vil lægen udføre tests for at sikre, at dit hjerte og lever fungerer korrekt, så du kan behandles sikkert med Zynteglo.
English: • transfusion reaction
Danish: • transfusionsreaktion
English: Zynteglo can only be made if enough of the right kind of blood stem cells can be collected from your blood (CD34+ blood stem cells).
Danish: Zynteglo kan kun fremstilles, hvis der kan indsamles tilstrækkeligt med blodstamceller fra dit blod (CD34+ blodstamceller).
English: Myeloablative conditioning should not begin until the complete set of infusion bag(s) constituting the dose of Zynteglo has been received and stored at the administration site, and the availability of the back-up collection is confirmed.
Danish: Myeloablativ konditionering bør ikke påbegyndes, før hele sættet med infusionspose(r), som udgør dosis af Zynteglo, er blevet modtaget og opbevares på administrationsstedet, og tilgængeligheden af reservebeholdningen er bekræftet.
English: The MAH shall ensure that in each Member State where Zynteglo is marketed, a system aimed to control distribution to Zynteglo beyond the level of control ensured by routine risk minimisation measures.
Danish: MAH'en skal sikre sig, at der i hver medlemsstat, hvor Zynteglo markedsføres, er et system til at kontrollere distribution af Zynteglo udover det kontrolniveau, som ydes af rutinemæssige risikominimeringsforanstaltninger.
English: All material that has been in contact with Zynteglo (solid and liquid waste) should be handled and disposed of as potentially infectious waste in accordance with local biosafety guidelines.
Danish: Alt materiale, der har været i kontakt med Zynteglo (fast og flydende affald), skal håndteres og bortskaffes som potentielt smittefarligt affald i overensstemmelse med de lokale retningslinjer for biosikkerhed.
English: Patients are expected to enrol in a registry and will be followed long term in the registry in order to better understand the long-term safety and efficacy of Zynteglo.
Danish: Patienter forventes at tilmelde sig et register, og de vil blive fulgt over længere tid i registeret med henblik på at øge forståelsen af langtidssikkerheden og effekten af Zynteglo.
English: Store at ≤-140°C for up to a year.
Danish: Opbevar ≤-140 °C i op til et år.
English: After carefully removing the outer metal container, thaw each infusion bag at 37°C in a water bath or dry bath for approximately 2-4 minutes.
Danish: Når den udvendige metalbeholder forsigtigt er fjernet, optøs hver infusionspose ved 37 °C i et vandbad eller i tørbad i ca. 2-4 minutter.
English: Any blood products required within the first 3 months after Zynteglo infusion should be irradiated.
Danish: Alle blodprodukter, der skal indgives inden for de første 3 måneder efter infusion med Zynteglo, skal bestråles.
English: o The potential risk of loss of response to gene therapy may lead to loss of transfusion independence or increase transfusion needs for patients who did not reach transfusionindependence.
Danish: o Den potentielle risiko for tab af respons på genterapi kan resultere i tab af transfusionsuafhængighed eller øge behovet for transfusion hos patienter, som ikke opnåede transfusionsuafhængighed.
English: • skin that is discoloured, blotchy, or darker or lighter than normal.
Danish: • hud, der er misfarvet, skjoldet eller mørkere eller lysere end normalt.
English: o Statement that the patient was treated with Zynteglo, including LOT number and treatment date(s).
Danish: o Erklæring om, at patienten blev behandlet med Zynteglo, herunder LOT-nummer og behandlingsdato(er).
English: • decreased testosterone
Danish: • nedsat testosteron
English: o Contact details where a health care professional can receive further information.
Danish: o Kontaktoplysninger til sundhedspersonale for at få mere information.
English: Infusion related reactions to Zynteglo were observed in 11.9% of patients and occurred on the day of Zynteglo infusion.
Danish: Infusionsrelaterede reaktioner på Zynteglo blev set hos 11,9 % af patienter og forekom på dagen med infusion af Zynteglo.
English: Zynteglo is prepared using parts of the human immunodeficiency virus (HIV), which have been altered so that they cannot cause HIV infection.
Danish: Zynteglo er fremstillet af dele af human immundefekt virus (HIV), der er blevet ændret, så de ikke kan forårsage hiv-infektion.
English: Prophylaxis for hepatic veno-occlusive disease (VOD) is recommended.
Danish: Profylakse mod hepatisk venookklusiv sygdom (VOD) anbefales.
English: Your children are still at risk of inheriting your original beta-globin gene.
Danish: Der er stadig en risiko for, at dine børn nedarver dit oprindelige beta-globingen.
English: Thawing of each infusion bag takes approximately 2 to 4 minutes.
Danish: Optøning af hver infusionspose tager ca. 2 til 4 minutter.
English: If you test positive for HIV following treatment, please contact your doctor or nurse.
Danish: Hvis du testes positiv for hiv efter behandling, skal du kontakte din læge eller sundhedspersonalet.
English: • premature menopause
Danish: • for tidlig menopause
English: The most serious adverse reaction attributed to Zynteglo was thrombocytopenia (2.4%).
Danish: Den mest alvorlige bivirkning i forbindelse med Zynteglo var trombocytopeni (2,4 %).
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, tell your doctor before you are given this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om at du er gravid eller planlægger at blive gravid, skal du spørge din læge til råds, før du får dette lægemiddel.
English: You will be given a Patient Alert Card which contains important safety information that you need to know about your treatment with Zynteglo.
Danish: Du vil få udleveret et patientkort, som indeholder vigtige sikkerhedsoplysninger, som du skal vide om din behandling med Zynteglo.
English: This leaflet was last revised in <{MM/YYYY}>
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}>
English: The planned dose of plerixafor was 0.24 mg/kg/day, given on Days 4 and 5 of mobilisation in the evening.
Danish: Den planlagte dosis plerixafor var 0,24 mg/kg/dag, som blev givet på mobiliseringsdag 4 og 5 om aftenen.
English: Date of Birth (DD/MM/YYYY): Weight at First Collection (kg): Patient ID:
Danish: Navn (efternavn, fornavn): Fødselsdato (DD/MM/ÅÅÅÅ): Vægt ved første indsamling (kg): Patient-ID:
English: Patients should be monitored annually for leukaemia or lymphoma (including with a complete blood count) for 15 years post treatment with Zynteglo.
Danish: Patienter bør monitoreres årligt for leukæmi eller lymfom (herunder med en komplet blodtælling) i 15 år efter behandlingen med Zynteglo.
English: It may take more than 1 day to collect enough blood stem cells to make Zynteglo and to store as replacement cells if Zynteglo cannot be given or does not work.
Danish: Det kan tage mere end 1 dag at indsamle at et tilstrækkeligt antal blodstamceller til fremstillingen af Zynteglo og til produktion af erstatningsceller, hvis Zynteglo kan ikke gives eller ikke virker.
English: If you are a woman, you will be given a pregnancy test before starting mobilisation, before you are given chemotherapy, and before Zynteglo treatment in order to confirm that you are not pregnant.
Danish: Hvis du er kvinde, vil du få taget en graviditetstest inden start af mobilisering, inden du får kemoterapi og inden behandling med Zynteglo for at bekræfte, at du ikke er gravid.
English: • positive test for Apergillus (lung disease caused by fungus)
Danish: • positiv test for Apergillus (lungesygdom som skyldes svamp)
English: DONATION AND PRODUCT CODES
Danish: DONATIONS- OG PRODUKTKODER
English: For men, this may be sperm or testicular tissue.
Danish: For mænd kan dette være sæd eller testikelvæv.
English: The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.
Danish: Det Europæiske Lægemiddelagentur vil mindst én gang om året vurdere nye oplysninger om dette lægemiddel, og denne indlægsseddel vil om nødvendigt blive ajourført.
English: However, G-CSF use was not recommended for 21 days after Zynteglo infusion in Phase 3 studies.
Danish: G-CSF blev imidlertid ikke anbefalet 21 dage efter infusion med Zynteglo i fase 3-forsøg.
English: Patients with TDT may be at an increased risk of VOD following myeloablative conditioning compared with other patient populations.
Danish: Patienter med TDT har muligvis øget risiko for VOD efter myeloablativ konditionering sammenlignet med andre patientpopulationer.
English: Patients should be monitored for thrombocytopenia and bleeding according to standard guidelines.
Danish: Patienter bør monitoreres for trombocytopeni og blødning i overensstemmelse med de standardretningslinjerne.
English: Zynteglo has no influence on the ability to drive or use machines.
Danish: Zynteglo påvirker ikke evnen til at føre motorkøretøj og betjene maskiner.
English: The entire volume of each infusion bag should be infused.
Danish: Hele indholdet af hver infusionspose skal infunderes.
English: Most of these side effects occur during or within a few days after mobilisation and blood stem cell collection but can occur later.
Danish: De fleste af disse bivirkninger opstår under eller inden for et par dage efter mobilisering og indsamling af blodstamceller, men de kan også forekomme på et senere tidspunkt.
English: Your doctor will tell you when your platelet count has recovered to normal levels.
Danish: Din læge vil fortælle dig, hvornår dit blodpladetal (trombocyttal) er bedret til normale niveauer.
English: • rash with lesions, sometimes with pus
Danish: • udslæt med sår, undertiden med pus
English: • abnormal blood test results (decrease in magnesium and potassium, too much citrate, or increase in white blood cells)
Danish: • unormale resultater af blodtest (fald i magnesium og kalium, for meget citrat, eller forøget antal hvide blodlegemer)
English: It is recommended that patients maintain haemoglobin (Hb) ≥11 g/dL for 30 days prior to myeloablative conditioning.
Danish: Det anbefales, at patienter har et hæmoglobinniveau (Hb) på ≥ 11 g/dl i 30 dage før myeloablativ konditionering.
English: • soreness and swelling of the digestive tract lining which runs from the mouth to the anus
Danish: • ømhed og hævelse af fordøjelseskanalens slimhinde, der løber fra munden til anus
English: • yellowing of skin and eyes
Danish: • gulfarvning af hud og øjne
English: • Thaw Zynteglo at 37°C in a water bath or dry bath.
Danish: • Optø Zynteglo i et vandbad på 37 °C eller i tørbad.
English: It is important to note that patients who have received Zynteglo are likely to test positive by polymerase chain reaction (PCR) assays for HIV due to LVV provirus insertion, resulting in a false positive test for HIV.
Danish: Det er vigtigt at bemærke at patienter, som har fået Zynteglo, sandsynligvis vil testes positive med polymerasekædereaktion (PCR)-analyser af hiv på grund af insertioner af LVV provirus, hvilket medfører en falsk positiv test for hiv.