FrancophonIA/ELRC3.0 huggingface dataset:
English: Survival rates (event-free survival, overall survival) are presented by type of disease in Table 1.
Danish: Overlevelsesraten (hændelsesfri overlevelse, samlet overlevelse) for hver sygdomstype vises i tabel 1.
English: It is unknown whether dinutuximab beta is excreted in human milk.
Danish: Det vides ikke, om dinutuximab beta udskilles i human mælk.
English: Qarziba contains dinutuximab beta, which belongs to a group of medicines called ‘monoclonal antibodies'.
Danish: Qarziba indeholder dinutuximab beta, der tilhører en gruppe lægemidler, der kaldes monoklonale antistoffer.
English: Eye problems
Danish: • Øjenproblemer
English: During and after the infusion, you will be checked regularly for infusion-related side effects.
Danish: Du vil løbende blive kontrolleret for infusionsrelaterede bivirkninger under og efter infusionen.
English: Dinutuximab beta has major influence on the ability to drive and use machines.
Danish: Dinutuximab beta påvirker i væsentlig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Treatment must be interrupted in patients who experience Grade 3 vision toxicity (i.e. subtotal vision loss per toxicity scale).
Danish: Behandlingen skal afbrydes hos patienter, der oplever grad 3 okulær toksicitet (dvs. næsten totalt synstab ift.
English: The daily dose of gabapentin is increased to 2×10 mg/kg/day orally, the next day and to 3×10 mg/kg/day orally, the day before the onset of dinutuximab beta infusion and thereafter.
Danish: Dosis af gabapentin øges til 2×10 mg/kg/dag oralt den næste dag og til 3×10 mg/kg/dag oralt dagen før påbegyndelse af infusion af dinutuximab beta og derefter.
English: Neurological disorders of the eye
Danish: Neurologiske øjensygdomme
English: Therefore, your doctor will give you an appropriate pain treatment starting 3 days before and continuing during use of Qarziba.
Danish: Derfor vil din læge give dig passende smertebehandling fra 3 dage før og under behandlingen med Qarziba.
English: • adequate renal function: creatinine clearance or glomerular filtration rate (GRF)
Danish: • tilstrækkelig nyrefunktion: kreatininclearance eller glomerulær filtrationshastighed (GFR)
English: Nonopioid analgesics Nonopioid analgesics should be used permanently during the treatment, e.g. paracetamol or ibuprofen.
Danish: Ikke-opioide analgetika, f.eks. paracetamol eller ibuprofen, skal anvendes permanent under behandlingen.
English: In the presence of human effector cells, including peripheral blood nuclear cells and granulocytes from normal human donors, dinutuximab beta was found to mediate the lysis of human neuroblastoma and melanoma cell lines in a dose-dependent manner.
Danish: Ved tilstedeværelse af humane effektorceller, inklusive nukleære celler fra perifert blod og granulocytter fra raske humane donorer, blev dinutuximab beta fundet at fremkalde lyse i cellelinjer med humant neuroblastom og melanom på en dosisafhængig måde.
English: • abnormal blood or urine tests (blood cells and other components, liver function, renal function)
Danish: • unormale blod- eller urinprøver (blodceller og andre bestanddele i blodet, leverfunktion,
English: Treatment with opioids is standard with dinutuximab beta.
Danish: Behandling med opioid er standard ved behandling med dinutuximab beta.
English: • a type of allergy (serum sickness) with fever, rash, joint inflammation
Danish: • en type allergi (serumsygdom) med feber, udslæt, betændelse i led
English: Pain typically occurs during the first infusion of dinutuximab beta and decreases over the treatment courses.
Danish: Smerter opstår typisk i løbet af den første infusion af dinutuximab beta og aftager over behandlingsserierne.
English: Once opened, Qarziba is intended for immediate use.
Danish: Efter åbning bør Qarziba anvendes med det samme.
English: In the case of overdose, patients should be carefully observed for signs or symptoms of adverse reactions and supportive care administered, as appropriate.
Danish: I tilfælde af overdosering skal patienterne overvåges nøje for symptomer på bivirkninger og have understøttende behandling efter behov.
English: Mean plasma Cmax levels, observed during 8-hour infusions (20 mg/m2/day on five consecutive days), were determined in another study (n=15).
Danish: Gennemsnitlig plasma-Cmax, observeret under 8-timers-infusioner (20 mg/m2/dag 5 på hinanden følgende dage), blev bestemt i et andet studie (n=15).
English: Dinutuximab beta is a protein for which the expected metabolic pathway is degradation to small peptides and individual amino acids by ubiquitous proteolytic enzmes.
Danish: Dinutuximab beta er et protein, og den forventede metaboliseringsvej er nedbrydning til små peptider og aminosyrer af proteolytiske enzymer, der findes overalt.
English: Oral gabapentin should be tapered off after weaning off intravenous morphine infusion, at the latest after dinutuximab beta infusion therapy has stopped.
Danish: Oral gabapentin skal nedtrappes efter afvænning fra intravenøs infusion af morfin, og senest efter infusionsbehandlingen med dinutuximab beta er stoppet.
English: IL-2 is administered as 6×106 IU/m2/day, resulting in an overall dose of 60×106 IU/m2/course.
Danish: IL-2 administreres som 6×106 IE/m2/dag, resulterende i en samlet dosis på 60×106 IE/m2/serie.
English: Clear Type I glass vial (6 mL) with a halobutyl rubber stopper and aluminium flip-off cap, containing a minimum extractable volume of 4.5 mL concentrate for solution for infusion.
Danish: Klart type I-hætteglas (6 ml) med halobutyl-gummiprop og aluminiums flip-off hætte, indeholdende et ekstraherbart volumen på mindst 4,5 ml koncentrat til infusionsvæske, opløsning.
English: • grade 3 or 4 anaphylaxis
Danish: • grad 3 eller 4 anafylaksi
English: ≥ 20,000/µL, haemoglobin > 8.0 g/dL
Danish: hæmoglobin > 8,0 g/dl
English: Examples of medicines that suppress the immune system are corticosteroids used to reduce inflammation or prevent organ transplant rejection.
Danish: Eksempler på medicin, der svækker immunsystemet, er kortikosteroider, der anvendes til at behandle inflammation (betændelseslignende reaktioner) og forebygge afstødning af et transplantat.
English: Treatment with Qarziba consists of 5 consecutive courses, each course comprising 35 days.
Danish: Behandling med Qarziba består af 5 på hinanden følgende behandlingsserier, hvor hver serie varer 35 dage.
English: • inflammation of the mouth and lips (stomatitis)
Danish: • betændelse i mundhulen og på læber (stomatitis)
English: Occurrence of haematologic toxicities has been reported with Qarziba, such as erythropenia, thrombocytopenia or neutropenia.
Danish: Hæmatologisk toksicitet er blevet rapporteret med Qarziba, såsom erytrocytopeni, trombocytopeni og neutropeni.
English: Dilated pupils with sluggish light reflex +/- photophobia
Danish: Udvidede pupiller med svag lysreaktion +/- fotofobi
English: Intravenous antihistamine, epinephrine (adrenaline) and prednisolone for intravenous administration should be immediately available at the bedside during administration of dinutuximab beta to manage life-threatening allergic reactions.
Danish: Antihistamin, adrenalin og prednisolon til intravenøs administration skal være tilgængeligt ved patientsengen under administration af dinutuximab beta til øjeblikkelig behandling af livstruende allergiske reaktioner.
English: Neuropathic pain usually occurs at the beginning of the treatment and premedication with analgesics, including intravenous opioids, prior to each infusion of dinutuximab beta is required.
Danish: Neuropatiske smerter forekommer normalt i begyndelsen af behandlingen, og præmedicinering med analgetika, inklusive intravenøs opioid, er nødvendig før hver infusion af dinutuximab beta.
English: The exposure (Cmax and AUC24h on day 1 and day 10 during a 10-day infusion) is predicted to be similar in subjects with ages less than or equal to 12 years and decreases slightly for older, heavier subjects.
Danish: Eksponeringen (Cmax og AUC24 timer på dag 1 og dag 10 under en 10-dages-infusion) forventes at være nogenlunde ens hos patienter ≤ 12 år og at falde let hos ældre og tungere patienter.
English: The efficacy of dinutuximab beta has been evaluated in a randomised controlled trial comparing the administration of dinutuximab beta with or without IL-2 in the first-line treatment of patients with high-risk neuroblastoma and in two single-arm studies in the relapsed/refractory setting.
Danish: Effektiviteten af dinutuximab beta er blevet evalueret i et randomiseret kontrolleret forsøg, der sammenlignede administration af dinutuximab beta med eller uden IL-2 i førstelinjebehandlingen af patienter med højrisiko-neuroblastom, og i to enkeltarms-studier med relaps/refraktært neuroblastom.
English: In animals, dedicated fertility studies have not been conducted, but no adverse effects on reproductive organs were observed in toxicity studies performed in Guinea pig and cynomolgous monkey.
Danish: Hvad angår dyrestudier er der ikke blevet udført specifikke fertilitetsstudier, men der blev ikke observeret nogen uønskede virkninger på reproduktionsorganerne i toksicitetsstudier med marsvin og cynomolgusaber.
English: Hepatobiliary disorders hepatocellular injury
Danish: Hepatobiliære forstyrrelser hepatocellulær skade
English: • The active substance is dinutuximab beta.
Danish: • Aktivt stof: dinutuximab beta.
English: The combination of Qarziba with IL-2 increases the risk of adverse drug reactions compared to Qarziba without IL-2, especially for pyrexia (92% vs. 79%), CLS (50% vs. 25%), pain related to dinutuximab beta (75% vs. 63%), hypotension (43% vs. 26%), and peripheral neuropathy (14% vs. 7%), respectively.
Danish: Kombination af Qarziba og IL-2 øger risikoen for bivirkninger sammenlignet med Qarziba uden IL-2, specielt med hensyn til pyreksi (92 % mod 79 %), CLS (50 % mod 25 %), smerter relateret til dinutuximab beta (75 % med 63 %), hypotension (43 % med 26 %), og perifer neuropati (14 % mod 7
English: It is recommended to use contraception for 6 months after discontinuation of treatment with Qarziba.
Danish: Det anbefales at anvende kontraception 6 måneder efter, at behandlingen med Qarziba er afsluttet.
English: Dinutuximab beta target (GD2) is expressed on neuronal tissues, especially during embryofetal development, and may cross the placenta; therefore, Qarziba may cause fetal harm when administered to pregnant women.
Danish: Target for dinutuximab beta (GD2) udtrykkes på neuronale væv, specielt under den embryoføtale udvikling, og kan passere placenta; derfor kan Qarziba forårsage fosterskader, hvis det administreres til gravide kvinder.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
Danish: MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE PAKNINGSENHEDER
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 20 mg/4.5 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 20 mg/4,5 ml
English: Findings of note included changes (decrease) in thymus weight as well as bone marrow changes (atrophy affecting myeloid and erythroid precursor cell lines).
Danish: Relevante fund omfattede ændringer i thymusvægt (nedsættelse) og knoglemarv (atrofi, der påvirker myeloide og erytroide precursor-cellelinjer).
English: Other frequent adverse reactions were hypersensitivity (63%), vomiting (57%), diarrhoea (51%), capillary leak syndrome (40%) and hypotension (39%).
Danish: Andre hyppige bivirkninger var overfølsomhed (63 %), opkastning (57 %), diarré (51 %), kapillærlækage-syndrom (40 %) og hypotension (39 %).
English: In order to evaluate the long-term survival effect of dinutuximab, the MAH will submit at least 5-year survival data for patients included in studies APN311-202 and APN311-302.
Danish: For at vurdere effekten af dinutuximab beta på langtidsoverlevelse skal indehaveren af markedsføringstilladelsen indsende data for mindst 5 års overlevelse for patienter, der indgår i studierne APN311-202 og APN311-302.
English: For 8-hour daily infusions, the solution is administered at a rate of approximately 13 mL per hour.
Danish: Ved daglig infusion over 8 timer skal infusionsvæsken administreres med en hastighed på ca. 13 ml pr. time.
English: First-line patients who received autologous stem cell transplantation In study 3, patients with high-risk neuroblastoma were enrolled after they had received induction chemotherapy and achieved at least a partial response, then myeloablative therapy and stem cell transplantation.
Danish: Førstelinje-patienter, der har gennemgået autolog stamcelletransplantation I studie 3 blev patienter med højrisiko-neurobastom inkluderet, efter at de havde fået induktionskemoterapi og opnået mindst et delvist respons og derefter gennemgået myeloablativ terapi og stamcelletransplantation.
English: Neurotoxicity associated to dinutuximab beta is likely due to the induction of mechanical allodynia that may be mediated by the reactivity of dinutuximab beta with the GD2 antigen located on the surface of peripheral nerve fibres and myelin.
Danish: Neurotoksicitet associeret med dinutuximab beta skyldes sandsynligvis induktion af mekanisk allodyni, der kan fremkaldes af en reaktion mellem dinutuximab beta og GD2-antigenet på overfladen af perifere nervefibre og myelin.
English: If your doctor considers co-administration of interleukin-2, it will be given twice, by injection under the skin, each time for 5 consecutive days (before and during treatment with Qarziba).
Danish: Hvis din læge finder, at samtidig behandling med interleukin-2 er gavnlig, vil det blive givet som subkutan injektion 2 gange i hver serie, hver gang i 5 på hinanden følgende dage (før og under behandlingen med Qarziba).
English: Treatment with dinutuximab beta should be permanently discontinued if the following toxicities occur:
Danish: Dinutuximab beta skal seponeres permanent, hvis følgende bivirkninger forekommer:
English: 1 year
Danish: 1 år
English: Anaphylactic reactions may occur as early as within a few minutes of the first infusion with dinutuximab beta and are commonly associated with bronchospasm and urticaria.
Danish: Anafylaktiske reaktioner kan forekomme så tidligt som inden for få minutter efter start af den første dinutuximab beta-infusion og er typisk associeret med bronkospasme og urticaria.
English: The individual dose is determined based on the body surface area and should be a total of 100 mg/m2 per course.
Danish: Den individuelle dosis bestemmes ud fra legemsoverfladeareal og skal samlet være på 100 mg/m2 pr. serie.
English: Antihistamine premedication (e.g. diphenhydramine) should be administered by intravenous injection approximately 20 minutes before starting each dinutuximab beta infusion.
Danish: Præmedicinering med antihistamin (f.eks. diphenhydramin) skal administreres ved intravenøs injektion ca. 20 minutter før start på hver infusion med dinutuximab beta.
English: • rapid swelling of arms, legs and other body parts, rapid drop in blood pressure, light-headedness and breathing difficulties (capillary leak syndrome)
Danish: • hurtig opsvulmning af arme, ben og andre kropsdele, hurtigt blodtryksfald, svimmelhed og åndedrætsbesvær (kapillærlækage-syndrom)
English: What Qarziba contains
Danish: Qarziba indeholder:
English: • tissue swelling (in the face, lip, around the eye, in the lower limbs)
Danish: • hævelse (i ansigt, læber, rundt om øjnene, i benene)
English: Overall, these 98 patients had primary refractory neuroblastoma (40) or relapsed neuroblastoma (49) with an additional 9 patients enrolled after first-line therapy.
Danish: Af disse 98 patienter havde 40 primær refraktær neuroblastom, 49 havde recidiv af neuroblastom, og 9 patienter blev optaget efter førstelinje-behandlingen.
English: Due to their immunosuppressive activity, concomitant treatment with corticosteroids is not recommended within 2 weeks prior to the first treatment course until 1 week after the last treatment course with dinutuximab beta, except for life-threatening conditions.
Danish: På grund af deres immunsupprimerende aktivitet frarådes samtidig behandling med kortikosteroider 2 uger før den første behandlingsserie og 1 uge efter den sidste behandlingsserie med dinutuximab beta med undtagelse af tilfælde, hvor der er tale om livstruende forhold.
English: The recommended dose is 100 mg dinutuximab beta per square metre of body surface per treatment course.
Danish: Den anbefalede dosis er 100 mg dinutuximab beta pr. kvadratmeter legemsoverfladeareal i hver behandlingsserie.
English: In the repeat-dose toxicity studies in Guinea pigs and cynomolgus monkeys, no adverse effects of dinutuximab beta were observed on reproductive organs at exposure levels above clinical levels.
Danish: I toksicitetsstudier med gentagne doser hos marsvin og cynomolgusaber blev der ikke observeret uønskede virkninger af dinutuximab beta på reproduktionsorganer ved eksponeringsniveauer over de kliniske niveauer.
English: • a brain disorder characterised by headache, confusion, seizures and loss of vision (posterior reversible encephalopathy syndrome)
Danish: • en forstyrrelse i hjernen karakteriseret ved hovedpine, forvirring, kramper og synstab (posteriort reversibelt encefalopati-syndrom)
English: The amount of solution to be infused per day (within a treatment course of 10 consecutive days) should be 48 mL; with 240 mL for a 5-day dose.
Danish: Det daglige infusionsvolumen (i en behandlingsserie på 10 på hinanden følgende dage) er 48 ml eller 240 ml til dosering i 5 dage.
English: Treatment of hypersensitivity reactions
Danish: Behandling af overfølsomhedsreaktioner
English: Dinutuximab beta has been administered to male and female juvenile Guinea pigs, as well as male and female young cynomolgus monkeys, as repeat-dose regimens that exceeded the recommended clinical dose.
Danish: Dinutuximab beta er blevet administreret til unge marsvin af begge køn samt unge cynomolgusaber af begge køn i et regime med gentagne doser, der oversteg den anbefalede kliniske dosis.
English: Infections and infestations infection (including pneumonia, skin infection, herpes virus infection, myelitis, encephalomyelitis), device related infection sepsis
Danish: Infektioner og parasitære sygdomme infektion (inklusive pneumoni, hudinfektion, herpes virus infektion, myelitis, encefalomyelitis), device-relateret infektion sepsis
English: Additionally, in vivo studies demonstrated that dinutuximab beta could suppress liver metastasis in a syngeneic liver metastasis mouse model.
Danish: I tillæg hertil er det vist i in vivo-studier, at dinutuximab beta kan undertrykke levermetastaser i en model med syngene levermetastaser fra mus.
English: Table 1: Event-free survival (EFS) and overall survival (OS) rates in relapsed and refractory patients
Danish: Tabel 1: Rater for hændelsesfri overlevelse (EFS) og samlet overlevelse (OS) hos patienter med relaps og refraktær sygdom
English: • respiratory failure, fluid in the lungs
Danish: • svigt af åndedrættet, væske i lungerne
English: Qarziba is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease.
Danish: Qarziba er indiceret til behandling af højrisiko-neuroblastom hos patienter ≥ 12 måneder, der tidligere har fået induktionskemoterapi og opnået i det mindste et delvist respons, efterfulgt af myeloablativ behandling og stamcelletransplantation, samt patienter med relaps eller refraktært neuroblastom med eller uden følgesygdomme i anamnesen.
English: Other intravenously co-administered agents should be delivered via a separate infusion line.
Danish: Andre samtidigt administrerede intravenøse lægemidler skal indgives gennem en separat infusionsslange.
English: Renal and hepatic impairment There are no data in patients with renal and hepatic impairment (see section 5.2).
Danish: Nedsat nyre- og leverfunktion Der findes ingen data for patienter med nedsat nyre- eller leverfunktion (se pkt.
English: • vomiting, diarrhoea, constipation
Danish: • opkastning, diarré, forstoppelse
English: The patient should be primed with 10 mg/kg/day, starting 3 days prior to dinutuximab beta infusion.
Danish: Patienten skal præmedicineres med 10 mg/kg/dag med start 3 dage før infusion af dinutuximab beta.
English: Dinutuximab beta binds to the molecule known as disialoganglioside 2 (GD2), which is present on cancer cells, and this activates the body's immune system, causing it to attack the cancer cells.
Danish: Dinutuximab beta binder til et molekyle, der kaldes disialogangliosid 2 (GD2), der findes på kræftceller, og dette aktiverer kroppens immunsystem til at angribe kræftceller.
English: Eye disorders may occur as dinutuximab beta binds to optic nerve cells.
Danish: Øjensygdomme kan forekomme, eftersom dinutuximab beta binder til optiske nerveceller.
English: • shock due to decreased body fluid volume
Danish: • Shock pga. nedsat væskemængde i kroppen
English: 1 year 2 years
Danish: 1 år 2 år
English: • adequate bone marrow function: absolute neutrophil count ≥ 500/µL, platelet count
Danish: • tilstrækkelig knoglemarvsfunktion: absolut neutrofiltal ≥ 500/µl, trombocyttal ≥ 20.000/µl,
English: In order to better define the posology in children over the entire age range and the impact of HACAs on PD, efficacy and safety, the MAH will submit the results of an evaluation of plasma samples collected from patients in studies APN311-202v1-2-3 and APN311-304 according to an agreed protocol.
Danish: For bedre at kunne bestemme doseringen til børn i alle aldersgrupper, effekten af humane anti-kimæriske antistoffer på farmakodynamikken samt virkning og sikkerhed skal indehaveren af markedsføringstilladelsen indsende resultaterne af en vurdering af plasmaprøver fra patienter i studierne APN311-202v1-2-3 og APN311-304 i overensstemmelse med en godkendt protokol.
English: Most commonly, patients reported abdominal pain, pain in the extremities, back pain, chest pain, or arthralgia.
Danish: I de fleste tilfælde rapporterede patienterne om abdominalsmerter, ekstremitetssmerter, rygsmerter, brystsmerter og artralgi.
English: It is recommended that women of childbearing potential use contraception for 6 months after discontinuation of treatment with dinutuximab beta.
Danish: Det anbefales, at kvinder i den fertile alder anvender kontraception i 6 måneder efter, behandlingen med dinutuximab beta er ophørt.
English: • Subsequently, a dosing rate of 0.03 mg/kg/hour is recommended concomitantly with dinutuximab beta infusion.
Danish: • Efterfølgende anbefales en infusionshastighed på 0,03 mg morfin/kg/time samtidig med infusion af dinutuximab beta.
English: • The other ingredients are histidine, sucrose, polysorbate 20, water for injections, hydrochloric acid (for pH adjustment).
Danish: • Øvrige indholdsstoffer: histidin, saccharose, polysorbat 20, vand til injektionsvæsker, saltsyre (til pH-regulering).
English: Relapsed and refractory patients
Danish: Patienter med relaps og refraktære patienter
English: • grade 3 vision eye toxicity
Danish: • grad 3 okulær toksicitet
English: The solution for infusion should be administered via a peripheral or central intravenous line.
Danish: Infusionsvæsken skal administreres via et perifert eller centralt venekateter.
English: No cases of dinutuximab beta overdose have been reported.
Danish: Der er ikke rapporteret tilfælde af overdosering af dinutuximab beta.
English: • Before initiation of a continuous intravenous morphine infusion, a bolus infusion of 0.02 to 0.05 mg/kg/hour morphine should be started 2 hours before dinutuximab beta infusion.
Danish: • Før kontinuerlig intravenøs infusion af morfin skal en bolusinfusion på 0,02-0,05 mg morfin/kg/time påbegyndes 2 timer før infusionen af dinutuximab beta.