FrancophonIA/ELRC3.0 huggingface dataset:
English: Special populations No differences in efficacy or safety were observed between different age subgroups.
Danish: Særlige populationer Der blev ikke observeret forskelle i effekt og sikkerhed mellem forskellige aldersundergrupper.
English: • You will be given a pregnancy test before treatment starts.
Danish: • Du skal have taget en graviditetstest, før behandlingen starter.
English: • Check if your cancer is getting worse.
Danish: • Undersøge, om din kræft forværres.
English: One individual treatment dose comprises 1 to 3 infusion bags.
Danish: En individuel behandling består af 1 til 3 infusionsposer.
English: Corticosteroids may be administered in cases of life-threatening emergencies.
Danish: Kortikosteroider kan administreres i tilfælde af livstruende nødstilfælde.
English: Talk to your doctor if you need to have any vaccinations.
Danish: Tal med lægen, hvis du skal have vaccinationer.
English: ORR was consistent across all subgroups.
Danish: ORR var overensstemmende på tværs af alle subgrupper.
English: This is so your doctor can check if your treatment is working and help you if you have any side effects.
Danish: Dette vil gøre det muligt for lægen at holde øje med, om din behandling virker og hjælpe dig, hvis du får bivirkninger.
English: Included as part of the annual reports of the non-interventional PASS
Danish: Opdaterede rapporter: Inkluderet som en del af de årlige sikkerhedsrapporter af ikke-interventions PASS
English: Duration of remission (DOR)7
Danish: Varighed af remission (DOR)7
English: AUC0-28d (copies/μg*day)
Danish: AUC0-28d (kopier/μg*dag)
English: Patients treated with Kymriah may develop secondary malignancies or recurrence of their cancer.
Danish: Patienter, der behandles med Kymriah kan udvikle sekundære maligniteter eller tilbagefald af deres cancer.
English: • Look for signs of infection; any infection will be treated before you are given Kymriah.
Danish: • Se efter tegn på infektion; alle eventuelle infektioner vil blive behandlet, før du får Kymriah.
English: • Administer tocilizumab.
Danish: • Administrer tocilizumab.
English: • Your white blood cells are frozen and sent away to make Kymriah.
Danish: • Dine hvide blodlegemer fryses ned og sendes afsted til fremstilling af Kymriah.
English: Requires remission status to be maintained for at least 28 days without clinical evidence of relapse.
Danish: Kræver, at remissionsstatus opretholdes i mindst 28 dage uden klinisk påvisning af recidiv.
English: Cmax (copies/μg)
Danish: Cmax (kopier/μg)
English: Do not thaw the product until it is ready to be used.
Danish: Produktet må ikke optøs før det er klar til at blive brugt.
English: • Kymriah is a one-time treatment.
Danish: • Kymriah er en engangsbehandling.
English: potassium, magnesium)
Danish: kalium, magnesium)
English: Tmax (day)
Danish: Tmax (dag)
English: - Active graft-versus-host disease (GVHD).
Danish: - Aktiv graft-versus-host sygdom (GVHD).
English: The primary endpoint was analysed on all patients whose Kymriah was manufactured at the Novartis US facility.
Danish: Det primære endepunkt blev analyseret hos alle patienter for hvem Kymriah blev fremstillet på Novartis US-centeret.
English: • Check your lungs, heart and blood pressure.
Danish: • Undersøge dine lunger, dit hjerte og dit blodtryk.
English: Duration of response (DOR)
Danish: Varighed af respons (DOR)
English: T cells are important for your immune system (the body's defences) to work properly.
Danish: T-celler er vigtige for, at dit immunforsvar (kroppens forsvarsmekanisme) kan fungere, som det skal.
English: Mean (standard deviation) Median (minimum - maximum) Age category (years) - n (%) <10 years ≥10 years and <18 years ≥18 years
Danish: Middelværdi (standardafvigelse) Median (minimal - maksimal) Aldersgruppe (år) - n (%) <10 år ≥10 år and <18 år ≥18 år
English: Patients should be closely monitored for signs or symptoms of these events, including fever.
Danish: Patienterne skal monitoreres tæt for tegn eller symptomer på disse hændelser, herunder feber.
English: Annual safety reports and 5-yearly interim reports
Danish: Opdaterede rapporter: Årlige sikkerhedsrapporter og 5-årlige interimrapporter
English: They usually happen in the first 8 weeks after the infusion, but can also develop later:
Danish: De forekommer som regel inden for de første 8 uger efter infusion, men kan også forekomme senere:
English: There are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with Kymriah.
Danish: Der utilstrækkelige eksponeringsdata til at give en anbefaling vedrørende varigheden af kontraception efter behandling med Kymriah.
English: Do not use this medicine if the infusion bag is damaged or leaking.
Danish: Brug ikke lægemidlet, hvis infusionsposen er beskadiget eller lækker.
English: - After the first 10 days following the infusion, the patient should be monitored at the physician's discretion.
Danish: - Efter de første 10 dage efter infusionen, bør patienten monitoreres efter lægens skøn.
English: This can lead to weight gain and difficulty breathing
Danish: Dette kan føre til vægtøgning og åndedrætsbesvær
English: Graft-versus-host disease
Danish: Graft-versus-host sygdom
English: This is because other medicines can affect the way Kymriah works.
Danish: Grunden er, at andre lægemidler kan påvirke, hvordan Kymriah virker.
English: DLBCL: No dose adjustment is required in patients over 65 years of age.
Danish: DLBCL: Der kræves ingen dosisjustering hos patienter over 65 år.
English: In the event that a secondary malignancy occurs, the company should be contacted to obtain instructions on patient samples to collect for testing.
Danish: Hvis en sekundær malignitet forekommer, bør firmaet kontaktes for at få instruktioner om opsamling af patientprøver til analyse.
English: No non-clinical reproductive safety studies were conducted as no adequate animal model is available.
Danish: Der blev ikke udført prækliniske studier af reproduktionssikkerhed, da der ikke findes nogen fyldestgørende dyremodel.
English: In addition to T cells, NK cells may be present.
Danish: Foruden T-celler kan NK-celler være til stede.
English: • Fever, which may be a symptom of an infection.
Danish: • Haft feber, som kan være et symptom på en infektion.
English: • Plan to stay within 2 hours' travel from the hospital where you were treated for at least 4 weeks after you have been given Kymriah.
Danish: • Planlæg at opholde dig inden for 2 timers transporttid fra hospitalet, hvor du blev behandlet, i mindst 4 uger efter at du har fået Kymriah.
English: For example, Kymriah should not be washed (spun down and resuspended in new media) prior to infusion.
Danish: For eksempel må Kymriah ikke vaskes (blive centrifugeret fra og opslæmmet i nye medier) forud for infusion.
English: The majority of patients (101/111, 91%) received bridging therapy for disease stabilisation.
Danish: Størstedelen af patienterne (101/111, 91 %) fik brobyggende behandling til stabilisering af sygdommen.
English: A genomic insertion site analysis of the lentiviral vector was performed on Kymriah products from 14 individual donors (12 patients and 2 healthy volunteers).
Danish: En genomisk analyse af den lentivirale vektors insertionssted blev udført på Kymriah-produkter fra 14 individuelle donorer (12 patienter og 2 raske frivillige).
English: Early Tmax may not be representative of the true maximal expansion, rather the amount of transgene present in the catheter from which sample was collected.
Danish: Tidlig Tmax er ikke nødvendigvis et udtryk for den sande maksimale ekspansion, snarere mængden af transgen til stede i det kateter, fra hvilket prøven blev indsamlet.
English: Contraception for women and men Discuss pregnancy with your doctor if you have received Kymriah.
Danish: Prævention for kvinder og mænd Drøft graviditet med din læge, hvis du har fået Kymriah.
English: Screening for HBV, HCV and HIV must be performed in accordance with clinical guidelines before collection of cells for manufacturing.
Danish: Der skal foretages screening for HBV, HCV og HIV i henhold kliniske retningslinjer før indsamling af celler til fremstilling.
English: 1Primary refractory: Never had a morphologic complete remission (CR) prior to the study; 2Relapsed disease: Had at least one relapse prior to the study
Danish: 1Primær refraktær: Aldrig haft en morfologisk komplet remission (CR) før studiet; 2 Recidiverende sygdom: Havde mindst et tilbagefald før studiet
English: Patients are counted only for the worst grade observed post baseline.
Danish: Patienterne er kun talt med for den sværeste grad observeret efter baseline.
English: Studies B2202 (N=75) + C2201 (N=111)
Danish: Studie B2202 (N=75) + C2201 (N=111) Meget almindelig (≥1/10)
English: It usually takes about 3 to 4 weeks to make Kymriah but the time may vary.
Danish: Det tager normalt omkring 3 til 4 uger at fremstille Kymriah, men fremstillingstiden kan variere.
English: Common: may affect up to 1 in every 10 people
Danish: Almindelige: kan forekomme hos op til 1 ud af 10 personer
English: Effects of Kymriah on male and female fertility have not been evaluated in animal studies.
Danish: Kymriahs effekt på den mandlige og kvindelige fertilitet er ikke blevet undersøgt i dyrestudier.
English: • Your doctor will take some of your blood using a catheter placed in your vein (a procedure called leukapheresis).
Danish: • Lægen vil udtage noget af dit blod gennem et kateter, der er anlagt i din vene (en procedure, som kaldes leukaferese).
English: - Patients should be instructed to remain within proximity of a qualified clinical facility for at least 4 weeks following infusion.
Danish: - Patienter bør instrueres i at være i nærheden af et kvalificeret behandlingscenter i mindst 4 uger efter infusion.
English: • Signs and symptoms of blood clots
Danish: • Tegn og symptomer på blodpropper
English: Pharmacotherapeutic group: other antineoplastic agents, ATC code: not yet assigned
Danish: Farmakoterapeutisk klassifikation: andre antineoplastiske stoffer, ATC-kode: endnu ikke tildelt.
English: Before you are given Kymriah tell your doctor or nurse if you are taking any medicines that weaken your immune system such as corticosteroids, since these medicines may interfere with the effect of Kymriah.
Danish: Før du får Kymriah, skal du fortælle din læge eller sygeplejerske, hvis du tager andet medicin, der kan svække dit immunforsvar, såsom kortikosteroider, da denne medicin kan påvirke virkningen af Kymriah.
English: There are not enough data to determine whether there are any differences in efficacy or safety between different age subgroups, although the clinical benefit and safety experience in elderly patients with DLBCL above the age of 65 years (23% of the study population) were comparable to the overall population.
Danish: Der er ikke nok data til at bestemme, om der er forskel i effekten eller sikkerheden mellem forskellige aldersundergrupper, selvom de kliniske fordele og sikkerhedserfaringen hos ældre patienter med DLBCL over 65 år (23 % af studiepopulationen) var sammenlignelig med den samlede population.
English: Median (months) (95% CI)
Danish: Median (måneder) (95 % CI)
English: In patients achieving complete remission following Kymriah, resulting low immunoglobulin levels can increase the risk for infections.
Danish: Hos patienter, der opnår komplet remission efter Kymriah, kan resulterende lave immunglobulinniveauer øge risikoen for infektioner.
English: Tell your doctor immediately if you get any of the following side effects after the Kymriah infusion.
Danish: Fortæl det omgående til lægen, hvis du får nogen af de følgende bivirkninger, efter infusion med Kymriah.
English: There are no data from the use of Kymriah in pregnant women.
Danish: Der er ingen data fra anvendelse af Kymriah til gravide kvinder.
English: Juvenile animal studies
Danish: Studier hos unge dyr
English: The following information is intended for doctors only.
Danish: Nedenstående oplysninger er til læger.
English: KYMRIAH will only be supplied to hospitals and associated centres that are qualified and only if the healthcare professionals involved in the treatment of a patient have completed the educational programme.
Danish: Kymriah vil kun blive udleveret til hospitaler og tilhørende centre, som er kvalificerede og kun hvis det sundhedspersonale, der er involveret i behandlingen af patienterne, har gennemført uddannelsesprogrammet.
English: Table 2 Adverse drug reactions observed in clinical studies
Danish: Tabel 2 Bivirkninger observeret i kliniske studier
English: Cytokine release syndrome requiring moderate to aggressive intervention - one or more of the following:
Danish: Cytokinfrigivelsessyndrom der kræver moderat til aggresiv intervention - en eller flere af følgende:
English: Pain includes pain and pain in extremity.
Danish: Smerte omfatter smerte og smerte i ekstremiteter.
English: 34% of the patients experienced an infection of any type within 8 weeks.
Danish: 34 % af patienterne oplevede en infektion af enhver type inden for 8 uger.
English: One patient died due to disease progression and the remaining three patients achieved a CR or CRi and remain alive 1.5-2 years after infusion.
Danish: Én patient døde grundet progression af sygdommen og de resterende tre patienter opnåede CR eller CRi og var fortsat i live 1,5-2 år efter infusionen.
English: Precautions to be taken for transport and disposal of the medicinal product
Danish: Forholdsregler for transport og bortskaffelse af lægemidlet
English: There was no evidence for preferential integration near genes of concern or preferential outgrowth of cells harbouring integration sites of concern.
Danish: Der var ingen tegn på foretrukken integration nær gener, som kunne give anledning til bekymring, eller foretrukken udvækst af celler med integrationssteder, som kunne give anledning til bekymring.
English: The median time to resolution of cytokine release syndrome was 7 days.
Danish: Mediantiden til resolution af cytokinfrigivelsessyndrom var 7 dage.
English: The infection will be treated before the Kymriah infusion.
Danish: Infektionen vil blive behandlet, før infusionen af Kymriah.
English: - Your doctor will give you a Patient Alert Card. Read it carefully and follow the instructions on it. - Always show the Patient Alert Card to the doctor or nurse when you see them or if you go to hospital.
Danish: Læs det omhyggeligt, og følg instruktionerne på det. - Vis altid patientoplysningskortet til lægen eller sygeplejersken, når du mødes med dem, eller hvis du skal på hospitalet.
English: No animal studies have been conducted with Kymriah to assess whether it can cause foetal harm when administered to a pregnant woman (see section 5.3).
Danish: Der er ikke udført dyreforsøg med Kymriah for at vurdere, om det kan forårsage fosterskader ved administration til en gravid kvinde (se pkt.
English: There is no evidence that the presence of pre-existing and treatment-induced anti-mCAR19 antibodies impacts the safety or effectiveness of Kymriah.
Danish: Der er ingen evidens for, at tilstedeværelsen af præ-eksisterende og behandlingsinducerende anti-mCAR19antistoffer påvirker sikkerheden eller effekten af Kymriah.
English: • Tingling or numbness, also in fingers and toes
Danish: • Prikken eller følelsesløshed, også i fingre og tæer
English: Updated reports: September 2019, November
Danish: Opdaterede rapporter: September 2019, november 2020
English: Package leaflet: Information for the patient or carer
Danish: Indlægsseddel: Information til patienten eller plejepersonalet
English: The T cells are taken from your blood and a new gene is put into the T cells so that they can then find the cells causing your cancer.
Danish: T-cellerne tages fra dit blod og der indsættes et nyt gen i T-cellerne, så de kan finde de celler, der er årsag til din kræft.
English: There are no data on the effect of Kymriah on fertility.
Danish: Der findes ingen data om indvirkningen af Kymriah på fertilitet.
English: • Check your blood for uric acid and for how many cancer cells there are in your blood.
Danish: • Undersøge dit blod for urinsyre, og måle hvor mange kræftceller der er i dit blod.
English: Warnings and precautions Kymriah is made from your own white blood cells and should only be given to you.
Danish: Advarsler og forsigtighedsregler Kymriah er fremstillet af dine egne hvide blodlegemer og bør kun gives til dig.
English: Not reached (8.6, NE9) Not reached (8.6, NE)
Danish: Ikke nået (8,6, NE9) Ikke nået (8,6, NE)
English: HBV reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with medicinal products directed against B cells.
Danish: Reaktivering af HBV, hvilket i nogle tilfælde resulterende i fulminant hepatitis, leversvigt og dødsfald, kan forekomme hos patienter, der er i behandling med lægemidler rettet mod B-celler.
English: Final report of study results: December 2038
Danish: Endelig rapport af studieresultaterne: December 2038
English: The medicine can be used in children and young adults up to 25 years of age with this cancer.
Danish: Lægemidlet kan anvendes til børn og unge voksne op til 25 års alder med denne kræftform.
English: A risk to the breast-fed infant cannot be excluded.
Danish: En risiko for ammede spædbørn kan ikke udelukkes.
English: Kymriah is indicated for the treatment of:
Danish: Kymriah er indiceret til behandling af:
English: Kymriah should not be manipulated.
Danish: Der må ikke manipuleres med Kymriah.
English: Each bag contains 10 mL to 50 mL of dispersion.
Danish: Hver pose indeholder 10 ml til 50 ml dispersion.
English: Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: Inden for hver systemorganklasse er bivirkningerne ordnet efter hyppighed med den hyppigste bivirkning først ved brug af følgende konventioner: meget almindelig (≥1/10); almindelig (≥1/100 to <1/10); ikkealmindelig (≥1/1,000 to <1/100); sjælden (≥1/10,000 to <1/1,000); meget sjælden (<1/10,000); ikke kendt (kan ikke estimeres fra de tilgængelige data).
English: • during Kymriah treatment.
Danish: • under behandlingen med Kymriah.
English: Worsening respiratory distress, including pulmonary infiltrates, increasing oxygen requirement including high-flow oxygen and/or need for mechanical ventilation Rapid clinical deterioration
Danish: Forværring af respirationsbesvær, herunder pulmonale infiltrater, forøget behov for oxygen inklusiv high-flow oxygen og/eller behov for mekanisk ventilation Hurtig klinisk forværring
English: During the 30 to 60 minutes before you are given Kymriah you may be given other medicines.
Danish: Lægemidler, der gives før behandling med Kymriah Inden for 30 til 60 minutter før du får Kymriah, vil du måske få andre lægemidler.
English: The median time to resolution was 7 days for B-cell ALL and 12 days for DLBCL.
Danish: Mediantiden til resolution var 7 dage for B-celle ALL og 12 dage for DLBCL.
English: It is not known whether Kymriah has the potential to be transferred to the foetus via the placenta and could cause foetal toxicity, including B-cell lymphocytopenia.
Danish: Det vides ikke om Kymriah har potentiale til at blive overført til fosteret via placenta og kan forårsage føtal toksicitet, herunder B-celle lymfocytopeni.
English: The majority of patients who had cytopenias at day 28 following Kymriah treatment resolved to Grade 2 or below within three months after treatment.
Danish: Størstedelen af de patienter, der havde cytopenier ved dag 28 efter behandling med Kymriah, kom i bedring til grad 2 eller derunder inden for tre måneder efter behandling.
English: What Kymriah is
Danish: Hvad Kymriah er
English: See section 4.4 for the management of febrile neutropenia before and after Kymriah infusion.
Danish: 4.4 for håndtering af febril neutropeni før og efter infusion af Kymriah.
English: Kymriah must be administered in a qualified treatment centre.
Danish: Kymriah skal administreres på et kvalificeret behandlingscenter.
English: No pharmacokinetic or pharmacodynamic drug interaction studies with tisagenlecleucel have been performed.
Danish: Der er ikke udført farmakokinetiske eller farmkodynamiske lægemiddelinteraktionsstudier med tisagenlecleucel.
English: ‡ (day)
Danish: ‡ (dag)
English: The full analysis set (FAS) includes all patients infused with Kymriah.
Danish: Det fulde analysedatasæt (FAS) inkluderer alle patienter infunderet med Kymriah.
English: Patients may continue to exhibit cytopenias for several weeks following Kymriah infusion and should be managed according to standard guidelines.
Danish: Patienter kan fortsætte med at have cytopenier i flere uger efter infusion af Kymriah og bør håndteres i henhold til standardretningslinjer.
English: Cerebral haemorrhage** Neuralgia
Danish: Cerebral blødning** Neuralgi
English: • Your doctor will give you Kymriah by infusion, which means it will be given as a drip through a tube in your vein.
Danish: • Lægen vil give dig Kymriah ved infusion, hvilket betyder, at det vil blive givet som et drop gennem et rør i din blodåre.
English: It is not recommended that patients receive Kymriah within 4 months of undergoing an allogeneic stem cell transplant (SCT) because of the potential risk of Kymriah worsening GVHD.
Danish: Det anbefales ikke, at patienter får Kymriah inden for 4 måneder efter at have gennemgået en allogen stamcelletransplantation (SCT) grundet den potentielle risiko for, at Kymriah forværrer GVHD.
English: Educational programme
Danish: Uddannelsesprogram
English: You should not be given Kymriah:
Danish: Du må ikke få Kymriah:
English: Infections may also occur during cytokine release syndrome and may increase the risk of a fatal event.
Danish: Infektioner kan også forekomme under cytokinfrigivelsessyndrom og kan forøge risikoen for et dødeligt udfald.
English: To minimise the risks associated with KYMRIAH treatment, the MAH must ensure that hospitals and their associated centres that dispense KYMRIAH are specially qualified in accordance with the agreed control distribution programme.
Danish: For at minimere de risici, som er forbundet med behandling af Kymriah, skal indehaveren af markedsføringstilladelsen sikre at hospitaler og deres tilhørende centre, som dispenserer Kymriah, er særligt kvalificerede i overensstemmelse med det aftalte kontrollerede distributionsprogram.
English: Seven patients who achieved CR/CRi after Kymriah infusion went to transplant while in remission.
Danish: Syv patienter, der opnåede CR/CRi efter infusion af Kymriah, fik transplantation, mens de var i remission.
English: If these side effects become severe or serious, tell your doctor immediately.
Danish: Hvis nogle af disse bivirkninger bliver kraftige eller alvorlige, skal du straks fortælle dette til din læge.
English: Corticosteroids should not be used at any time except in the case of a life-threatening emergency (see section 4.4).
Danish: Kortikosteroider bør ikke bruges på noget tidspunkt undtagen i tilfælde af livstruende nødstilfælde (se pkt.
English: Nominal one-sided exact p-value based on H0: Rate of MRD negative remission ≤15% vs. Ha: >15%.
Danish: Nominel ensidet eksakt p-værdi baseret på H0: Rate af MRD-negativ remission ≤15 % versus Ha: >15 %.
English: Risk factors for developing severe cytokine release syndrome in adult DLBCL patients are not known.
Danish: Risikofaktorer for udvikling af svær cytokinfrigivelsessyndrom i voksne DLBCL patienter er ikke kendt.
English: Tisagenlecleucel continues to expand and persist following administration of tocilizumab and corticosteroids.
Danish: Tisagenlecleucel fortsætter med at ekspandere og forbliver i kroppen efter administration af tocilizumab og kortikosteroider.
English: Adverse drug reactions from these clinical studies (Table 2) are listed by MedDRA system organ class.
Danish: Bivirkningerne fra disse kliniske studier (tabel 2) er angivet i henhold til MedDRA-systemorganklasse.
English: Acute lymphoblastic leukaemia (ALL)
Danish: Akut lymfoblastær leukæmi (ALL)
English: • Anxiety, irritability
Danish: • Angst, irritabilitet