FrancophonIA/ELRC3.0 huggingface dataset:
English: • adequate liver function: alanine aminotransferase (ALT)/ aspartate aminotransferase (AST)
Danish: • tilstrækkelig leverfunktion: alanin-aminotransferase (ALAT)/aspartat-aminotranferase (ASAT)
English: No effects on cardiovascular functions (ECG, blood pressure) were observed in monkeys.
Danish: Der blev ikke observeret virkninger på kardiovaskulære funktioner (EKG, blodtryk) hos aber.
English: Neuroblastoma is a type of cancer that grows from abnormal nerve cells in the body, in particular in the glands above the kidneys.
Danish: Neuroblastom er en type cancer, der vokser fra abnorme nerveceller i kroppen, og specielt i kirtler over nyrerne.
English: Qarziba has several side effects that may affect your ability to drive and use machines.
Danish: Qarziba har adskillige bivirkninger, der kan påvirke dine evner til at køre bil og betjene maskiner.
English: • dilated pupils or abnormal pupil reactions
Danish: • større pupiller eller unormale pupilreaktioner
English: For patients with moderate (Grade 2) neuropathy (motor with or without sensory), treatment should be interrupted and may be resumed after neurologic symptoms resolve.
Danish: For patienter med moderat (grad 2) neuropati (motorisk med eller uden sensorisk neuropati) skal behandlingen afbrydes og først genoptages, når de neurologiske symptomer er forsvundet.
English: • pain Pain is one of the most common side effects of Qarziba.
Danish: Smerter er en af de hyppigste bivirkninger ved Qarziba.
English: Non-interventional post-authorisation safety study (PASS): In order to collect data on pain and its management, effect on peripheral and central nervous system, including visual impairment, long-term safety and long-term effectiveness, the MAH should submit the results of a study based on data deriving from a registry of patients with high risk neuroblastoma.
Danish: Ikke-interventionssikkerhedsundersøgelse efter tilladelse til markedsføring (PASS): For at indsamle oplysninger om smerter og håndtering heraf, effekt på det perifere og centrale nervesystem, herunder synsnedsættelse, og den langsigtede sikkerhed og virkning skal indehaveren af markedsføringstilladelsen indsende resultaterne af et studie baseret på data fra et register over patienter med højrisiko-neuroblastom.
English: Talk to your doctor before you receive Qarziba if you are of childbearing age.
Danish: Tal med din læge, før du skal have Qarziba, hvis du er en kvinde i den fødedygtige alder.
English: The observed Cmax levels were slightly higher (16.5 micrograms/mL) and were reached on the fifth infusion.
Danish: De observerede Cmax-niveauer var lidt højere (16,5 mikrogram/ml) og blev nået under den femte infusion.
English: In patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy, Qarziba should be combined with interleukin-2 (IL-2).
Danish: Hos patienter med relaps/refraktær sygdom i anamnesen og hos patienter, som ikke har opnået fuldstændigt respons på førstelinjebehandling, skal Qarziba kombineres med interleukin-2 (IL-2).
English: INFORMATION IN BRAILLE Qarziba
Danish: INFORMATION I BRAILLESKRIFT Qarziba
English: It must be administered by a healthcare professional prepared to manage severe allergic reactions including anaphylaxis in an environment where full resuscitation services are immediately available.
Danish: Det skal administreres af sundhedspersonale med erfaring i håndtering af alvorlige allergiske reaktioner, heriblandt anafylaksi, i omgivelser, hvor fuldt genoplivningsudstyr er umiddelbart tilgængeligt.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder den entydige identifikator.
English: Therefore, ADA formation would be predicted to have a slight impact (less than 10% decrease) on exposure within 24 hours after administration, under non-steady state conditions.
Danish: Derfor forventes det, at dannelse af ADA'er har en lille indvirkning på eksponeringen (fald på mindre end 10 %) inden for 24 timer efter administration, før steady state er nået.
English: Occasional occurrences of peripheral neuropathy have been reported with Qarziba.
Danish: Lejlighedsvis forekomst af perifær neuropati er blevet rapporteret i forbindelse med Qarziba.
English: The population pharmacokinetic model included allometric scaling (reference weight of 18.1 kg) on clearance and volume of distribution with exponents of 0.75 and 1, respectively.
Danish: Den anvendte populationsfarmakokinetiske model inkluderede allometrisk skalering (referencevægt på 18,1 kg) af clearance og fordelingsvolumen med eksponenter på hhv. 0,75 og 1.
English: • a condition in which some of the small veins in the liver are obstructed (veno-occlusive disease)
Danish: • en tilstand, hvor nogle af de små blodårer i leveren er stoppede (veno-okklusiv sygdom)
English: • life-threatening infection (sepsis)
Danish: • livstruende infektion (blodforgiftning - sepsis)
English: The safety of dinutuximab beta has been evaluated in 514 patients with high-risk and relapsed/refractory neuroblastoma, who received it as a continuous infusion (98) or as repeated daily infusions (416).
Danish: Sikkerheden af dinutuximab beta er blevet evalueret hos 514 patienter med højrisiko- og relaps/refraktær neuroblastom, der fik det som en kontinuerlig infusion (98) eller som gentagne daglige infusioner (416).
English: No non-clinical studies to evaluate the potential of dinutuximab beta to cause carcinogenicity, genotoxicity or developmental and reproductive toxicity have been conducted.
Danish: Der er ikke blevet udført ikke-kliniske studier til evaluering af dinutuximab betas potentiale til at forårsage karcinogenicitet, genotoksicitet eller udviklings- og reproduktionstoksicitet.
English: Rapid drop in blood pressure, light-headedness and breathing difficulties are further signs.
Danish: Hurtigt fald i blodtrykket, svimmelhed og åndedrætsbesvær er yderligere tegn.
English: Hydrochloric acid (for pH adjustment)
Danish: Saltsyre (til justering af pH)
English: The European Medicines Agency will review any new information which may become available every year and this SmPC will be updated as necessary.
Danish: Det Europæiske Lægemiddelagentur vil hvert år vurdere nye oplysninger om lægemidlet, og produktresuméet vil om nødvendigt blive ajourført.
English: Pre-medication should always be considered before starting each infusion (see section 4.4).
Danish: Præmedicinering skal altid overvejes før start af hver enkelt infusion (se pkt.
English: No animal data are available on teratogenicity or embryotoxicity.
Danish: Der er ingen tilgængelige data fra dyrestudier hvad angår teratogenicitet og embryotoksicitet.
English: Qarziba is used to treat neuroblastoma that has a high risk of coming back after a series of treatments, which include a stem cell transplantation for rebuilding the immune system.
Danish: Qarziba anvendes til at behandle neuroblastom, der har en høj risiko for at vende tilbage, efter en række behandlinger, der omfatter en stamcelletransplantation til genopbygning af immunsystemet.
English: It is recommended that treatment for such reactions include prednisolone administered by intravenous bolus, and epinephrine administered by intravenous bolus every 3 to 5 minutes as necessary, according to clinical response.
Danish: Det anbefales, at behandling af sådanne reaktioner inkluderer prednisolon administreret ved intravenøs bolus, og adrenalin administreret ved intravenøs bolus hver 3.-5. minut efter behov i henhold til det kliniske respons.
English: • agitation, anxiety
Danish: • ophidselse, nervøsitet
English: • formation of blood clots in the small blood vessels (disseminated intravascular coagulation)
Danish: • dannelse af blodpropper i de små blodkar (dissemineret intravaskulær koagulation)
English: • unable to pass urine or passing reduced urine volume
Danish: • manglende evne til at lade vandet eller lader en mindre mængde urin
English: • prolonged grade 2 peripheral motor neuropathy
Danish: • længerevarende grad 2 perifer motorisk neuropati
English: Tell your doctor if you are using, have recently used or might use any other medicines.
Danish: Fortæl det altid til lægen, hvis du bruger anden medicin eller har gjort det for nylig.
English: Occurrence of a severe infusion related reaction (including CRS) requires immediate discontinuation of dinutuximab beta therapy and may necessitate emergency treatment.
Danish: Forekomst af en alvorlig infusionsrelateret reaktion (inklusive CRS) kræver øjeblikkelig afbrydelse af dinutuximab beta-behandlingen og kan nødvendiggøre akut behandling.
English: Treatment of disease before immunotherapy included intensive chemotherapy regimen followed by autologous stem cell transplantation (ASCT), radiotherapy, and surgery.
Danish: Behandling før immunterapi inkluderede intensiv kemoterapi efterfulgt af autolog stamcelletransplantation (ASCT), stråleterapi og kirurgi.
English: Cytokine release syndrome frequently manifests itself within minutes to hours of initiating the first infusion and is characterised by systemic symptoms such as fever, hypotension and urticaria.
Danish: Cytokinfrigivelsessyndrom viser sig ofte inden for minutter til timer efter start af den første infusion og er karakteriseret ved systemiske symptomer såsom feber, hypotension og urticaria.
English: • If continous morphine infusion is required for more than 5 days, treatment should be gradually reduced by 20% per day after the last day of dinutuximab beta infusion.
Danish: • Hvis kontinuerlig morfininfusion er nødvendig i mere end 5 dage, skal behandlingen gradvist reduceres med 20 % dagligt efter den sidste dag med infusion af dinutuximab beta.
English: It is given into one of your veins (intravenous infusion) usually by using special tubes (catheters) and a pump.
Danish: Det vil blive sprøjtet direkte ind i din blodåre (intravenøs infusion), normalt ved anvendelse af specielle slanger (katetre) og en pumpe.
English: After weaning off intravenous morphine, in case of severe neuropathic pain, oral morphine sulphate (0.2 to 0.4 mg/kg every 4 to 6 hours) can be administered on demand.
Danish: Efter afvænning fra intravenøs morfin og i tilfælde af alvorlige neuropatiske smerter kan morfinsulfat (0,2-0,4 mg/kg hver 4.-6. timer) administreres oralt efter behov.
English: Based on the physician's evaluation of the severity of adverse drug reactions to dinutuximab beta, patients may undergo a dose reduction of 50% or a temporary interruption of the infusion.
Danish: Baseret på lægens vurdering af sværhedsgraden af de uønskede reaktioner på dinutuximab beta kan dosis nedsættes med 50 % eller infusionen afbrydes midlertidigt.
English: These included impaired visual accommodation that is correctable with eye glasses, as well as mydriasis (13%), blurred vision (3%) or photophobia (3%), which were usually reversible after treatment discontinuation.
Danish: Disse inkluderede nedsat akkomodationsevne, der kan korrigeres med briller, samt mydriasis (13 %), sløret syn (3 %) eller fotofobi (3 %), som normalt var reversible efter behandlingsophør.
English: These included 64% male and 36% female patients with a median age of 3 years (0.6 to 20); 89% had a tumour INSS stage 4 and MYCN amplification was reported in 44% of the cases.
Danish: Disse omfattede 64 % mandlige og 36 % kvindelige patienter med en medianalder på 3 år (0,6 til 20); 89 % havde neuroblastom INSS-trin 4, og MYCN-amplifikation blev rapporteret hos 44 %.
English: Severe eye disorders were also reported including ophthalmoplegia (2%) and optic atrophy.
Danish: Alvorlige øjenforstyrrelser blev også rapporteret inklusive oftalmoplegi (2 %) og optikusatrofi.
English: Before receiving Qarziba, you will have blood tests to check your liver, lung, renal and bone marrow functions.
Danish: Før du får Qarziba, vil du få taget blodprøver for at kontrollere, hvordan din lever, dine lunger og nyrer samt din knoglemarv fungerer.
English: Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures.
Danish: Før behandling af recidiverende neuroblastom skal alle aktivt progressive sygdomme stabiliseres ved andre egnede foranstaltninger.
English: CLS is characterised by a loss of vascular tone and extravasation of plasma proteins and fluid into the extravascular space.
Danish: CLS er karakteriseret ved tab af vaskulær tonus og ekstravasation af plasmaproteiner og væske til det ekstravaskulære rum.
English: This leaflet was last revised in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest ændret {MM.RRRR}.
English: Most had an initial diagnosis of INSS stage 4 disease without MYCN amplification (16% of the subjects had MYCN amplified tumours and in 14% this information was missing).
Danish: De fleste af disse havde en startdiagnose med INSS (International Neuroblastoma Staging System) trin 4 sygdom uden MYCN-amplifikation (16 % af patienterne havde MYCN-amplifikation, og denne information manglede for 14 %).
English: The container should be inspected visually for particulates prior to administration.
Danish: Inden administration skal beholderen inspiceres visuelt for partikler.
English: Capillary leak syndrome (CLS)
Danish: Kapillærlækage-syndrom (CLS)
English: The overall response rate (complete response plus partial response) in patients with evidence of disease at baseline was 36% (95% confidence interval [25; 48]) and was more favourable in patients with refractory disease (41% [23; 57]) than in patients with relapsed disease (29% [15; 46]).
Danish: Den samlede responsrate (fuldstændigt respons plus delvist respons) hos patienter med evidens for sygdom ved baseline var 36 % (95 % konfidensinterval [25; 48]) og var mere favorabel hos patienter med refraktær sygdom (41 % [23; 57]) end hos patienter med relaps (29 % [15; 46]).
English: Administration of the infusion
Danish: Administration af infusionen
English: The development of anti-drug antibodies is a class effect of monoclonal chimeric antibodies.
Danish: Udvikling af anti-drug-antistoffer er en klasseeffekt ved humaniserede monoklonale antistoffer.
English: You may only use Qarziba if your doctor assesses that benefits outweigh risks for a foetus.
Danish: Du må kun få Qarziba, hvis din læge vurderer, at dine fordele ved behandlingen opvejer risiciene for fosteret.
English: In case of bronchial and/or pulmonary hypersensitivity reaction, inhalation with epinephrine (adrenaline) is recommended and should be repeated every 2 hours, according to clinical response.
Danish: I tilfælde af bronkial og/eller pulmonal overfølsomhedsreaktion anbefales inhalation af adrenalin, som skal gentages hver 2. time afhængigt af klinisk respons.
English: The most frequent hypersensitivity reactions included hypotension (39%), urticaria (18%) and bronchospasm (4%).
Danish: De hyppigste overfølsomhedsreaktioner inkluderede hypotension (39 %), urticaria (18 %) og bronkospasme (4 %).
English: Treatment should be permanently discontinued in patients experiencing any objective prolonged weakness attributable to dinutuximab beta administration.
Danish: Behandlingen skal seponeres permanent hos patienter, der oplever længerevarende objektiv svaghed, der kan tilskrives administration af dinutuximab beta.
English: • or five daily infusions of 20 mg/m2 administered over 8 hours, on the first 5 days of each course
Danish: • eller fem daglige infusioner med 20 mg/m2 administreret over 8 timer, på de første 5 dage af hver behandlingsserie.
English: • a continuous infusion over the first 10 days of each course (a total of 240 hours) at the daily dose of 10 mg/m2
Danish: • Kontinuerlig infusion over de første 10 dage i hver behandlingsserie (samlet 240 timer) med en daglig dosis på 10 mg/m2
English: Acute grade 3 or 4, or extensive chronic graft-versus-host disease (GvHD)
Danish: Akut grad 3 eller 4 eller massiv kronisk graft versus host-sygdom (GvHD).
English: • pain in the stomach, throat, chest, face, hands, feet, legs, arms, back, neck, joint, or muscles
Danish: • smerter i mave, hals, bryst, ansigt, hænder, fødder, ben, arme, ryg, nakke, led eller muskler
English: • sudden constriction of the airways (bronchospasm, laryngospasm), rapid breathing
Danish: • pludselig blokering af luftvejene (bronkospasme, larynxspasme), hurtig vejrtrækning
English: Qarziba is a clear, colourless liquid, provided in a clear glass vial with a rubber stopper and aluminium seal.
Danish: Qarziba er en klar, farveløs væske, der leveres i et klart hætteglas med gummiprop og aluminiumsforsegling.
English: Qarziba will be given to you in five treatment courses of 35 days and the infusion will last 5 or 10 days in the beginning of each course.
Danish: Du vil få Qarziba i 5 behandlingsserier på hver 35 dage, og infusionen vil blive givet i 5 eller 10 dage i begyndelsen af hver behandlingsserie.
English: Markers for renal (eGFR) and hepatic (bilirubin) function did not show a relationship with exposure (Cmax and AUC24h on day 1 and day 10 during a 10-day infusion).
Danish: Markører for nyrefunktionen (eGFR) og leverfunktionen (bilirubin) viste ikke nogen relation til eksponeringen (Cmax og AUC24 timer på dag 1 og dag 10 under en 10-dages-infusion).
English: Tell your doctor immediately if you notice any of these problems.
Danish: Kontakt lægen med det samme, hvis du bemærker en eller flere af disse bivirkninger.
English: The effects of dinutuximab beta on fertility in humans are unknown.
Danish: Indvirkningen af dinutuximab beta på fertiliteten hos mennesker er ukendt.
English: Qarziba should not be used in women of childbearing potential not using contraception.
Danish: Qarziba bør ikke anvendes til kvinder i den fertile alder, som ikke anvender kontraception.
English: It is recommended to prepare 50 mL solution in a 50 mL syringe, or 250 mL in an infusion bag suitable for the employed infusion pump, i.e. an overfill of 2 mL (syringe) or 10 mL (infusion bag) to allow for dead volumes of the infusion systems.
Danish: Det anbefales at fremstille 50 ml infusionsvæske i en 50 ml sprøjte eller 250 ml i en infusionspose, der er egnet til den anvendte infusionspumpe, dvs. med en overfyldning på 2 ml (sprøjte) eller 10 ml (infusionspose) for at modregne dødvolumenet i infusionssystemet.
English: Mean plasma Cmax levels (around 12 micrograms/mL) were reached on the last day of infusion.
Danish: Gennemsnitlig plasma-Cmax (omkring 12 mikrogram/ml) blev nået den sidste infusionsdag.
English: It was combined with 13-cis retinoic in most patients and with IL-2 in 307 patients.
Danish: Det blev kombineret med isotretinoin (13-cis retinoinsyre, 13-cis RA) hos de fleste patienter og med IL-2 hos 307 patienter.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, monoklonale antistoffer, ATC-kode: L01XC
English: Adverse reactions are summarised in the table below.
Danish: Bivirkningerne er angivet i nedenstående tabel.
English: Prior to the treatment of relapsed neuroblastoma, your treating physician will stabilise any actively progressing disease by other suitable measures.
Danish: Før behandling af relaps af neuroblastom vil din læge stabilisere alle andre aktive progressive sygdomme med andre egnede midler.
English: The bone marrow changes were slight to severe and recovered after cessation of dosing.
Danish: Ændringerne i knoglemarven var små til alvorlige og forsvandt, da dosering ophørte.
English: There are no data on lactating women.
Danish: Der foreligger ingen data for ammende kvinder.
English: Cytokine release syndrome was also reported in 32% of the patients.
Danish: Cytokinfrigivelsessyndrom blev rapporteret hos 28 % af patienterne.
English: Do not use medicines that suppress the immune system from 2 weeks before the first dose of Qarziba until 1 week after the last treatment course, unless prescribed by your doctor.
Danish: Undgå at anvende medicin, der svækker immunsystemet, fra 2 uger før den første dosis af Qarziba og indtil 1 uge efter, den sidste behandlingsserie er afsluttet, medmindre din læge har ordineret det.
English: • leakage from small blood vessels (capillary leak syndrome) Leakage of blood components from small blood vessels may cause rapid swelling in arms, legs and other parts of the body.
Danish: • Sivning fra små blodkar (kapillærlækage-syndrom) Sivning af blodceller fra små blodkar kan forårsage hurtig opsvulmning i arme, ben og andre steder i kroppen.
English: It is recommended that antihistamine administration be repeated every 4 to 6 hours as required during dinutuximab infusion.
Danish: Det anbefales, at antihistamin administreres hver 4.-6. time efter behov under dinutuximab-infusionen.
English: Severe infusion-related reactions, including cytokine release syndrome (CRS), anaphylactic and hypersensitivity reactions, may occur despite the use of premedication.
Danish: Alvorlige infusionsrelaterede reaktioner, inklusive cytokinfrigivelsessyndrom (CRS), anafylaktiske reaktioner og overfølsomhedsreaktioner, kan forekomme på trods af præmedicinering.
English: The solution for infusion must be prepared under aseptic conditions.
Danish: Infusionsvæsken skal fremstilles under aseptiske forhold.
English: Concomitant use of intravenous immunoglobulins is not recommended as they may interfere with dinutuximab beta-dependent cellular cytotoxicity.
Danish: Samtidig anvendelse af intravenøst immunglobulin anbefales ikke, da det kan interferere med dinutuximab beta-afhængig cellulær cytotoksicitet.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: I hver hyppighedsgruppe er bivirkningerne opstillet efter aftagende sværhedsgrad.
English: • With continuous infusion, in response to the patient's pain perception, it may be possible to wean off morphine over 5 days by progressively decreasing its dosing rate (e.g. to 0.02 mg/kg/hour, 0.01 mg/kg/hour, 0.005 mg/kg/hour).
Danish: • Ved kontinuerlig infusion vil det, afhængigt af patientens smerteperception, eventuelt være muligt at afvænne patienten fra morfin over 5 dage ved en progressiv nedsættelse af dosis (f.eks. til 0,02 mg/kg/time, 0,01 mg/kg/time, 0,005 mg/kg/time).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Qarziba in one or more subsets of the paediatric population in neuroblastoma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Qarziba i en eller flere undergrupper af den pædiatriske population ved neuroblastom (se pkt.
English: Patients should not use or drive machines during treatment with dinutuximab beta.
Danish: Patienten må ikke føre motorkøretøj eller betjene maskiner under behandlingen med dinutuximab beta.
English: The most common adverse reactions were pyrexia (88%) and pain (77%) that occurred despite analgesic treatment.
Danish: De hyppigste bivirkninger var pyreksi (85 %) og smerter (71 %), der forekom på trods af analgetisk behandling.
English: Vaccinations should be avoided during administration of dinutuximab beta until 10 weeks after the last treatment course, due to immune stimulation through dinutuximab beta and possible risk for rare neurological toxicities.
Danish: Vaccinationer bør undgås under behandling med dinutuximab beta og indtil 10 uger efter den sidste behandlingsserie pga. immunstimulering via dinutuximab beta og mulig risiko for sjælden neurologisk toksicitet.
English: The patient specific daily dose of Qarziba is calculated based on body surface area (see section 4.2).
Danish: Den patientspecifikke daglige dosis af Qarziba beregnes på grundlag af legemsoverfladearealet (se pkt.
English: The pharmacokinetics of dinutuximab beta, based on 10-day continuous intravenous infusion of 10 mg/m2/day (equal to a total dose of 100 mg/m2/course) were evaluated in studies 1 and 2.
Danish: Farmakokinetikken af dinutuximab beta, baseret på 10 dages kontinuerlig intravenøs infusion af 10 mg/m2/dag (svarende til en samlet dosis på 100 mg/m2/serie) blev evalueret i studie 1 og 2.