FrancophonIA/ELRC3.0 huggingface dataset:
English: In male and female rats, administration of dinutuximab resulted in no adverse effects on reproductive organs at exposures that were at least 60-fold higher than those observed clinically.
Danish: Hos han- og hunrotter forårsagede dinutuximab ingen bivirkninger på reproduktionsorganerne ved eksponeringer, der var mindst 60 gange højere end de klinisk observerede.
English: • Administer supportive measures (see section 4.4).
Danish: • Giv understøttende behandling (se pkt.
English: • You should not breastfeed during treatment with this medicine.
Danish: • Du må ikke amme, mens du bliver behandlet med dette lægemiddel.
English: • It is recommended to use contraception for 6 months after discontinuation of this medicine.
Danish: • Det anbefales at anvende prævention i 6 måneder efter afslutning af behandling med dette lægemiddel.
English: One carton contains one vial.
Danish: Én karton indeholder ét hætteglas.
English: Electrolytes should be monitored daily during therapy with Unituxin.
Danish: Elektrolytter skal monitoreres dagligt under behandling med Unituxin.
English: It is recommended that treatment for such reactions include hydrocortisone administered by intravenous bolus, and epinephrine administered by intravenous bolus once every 3-5 minutes as necessary according to clinical response.
Danish: Det anbefales, at behandling af sådanne reaktioner omfatter hydrocortison administreret som intravenøs bolus og epinephrin administreret som intravenøs bolus hver 3.-5. minut efter behov ifølge klinisk respons.
English: • Delay course initiation until creatinine clearance or glomerular filtration rate (GFR) is at least 70 mL/min/1.73 m2 Systemic infection or sepsis
Danish: • Udsæt initiering af behandlingsforløbet indtil en kreatininclearance eller glomerulær filtrationsrate (GFR) på mindst 70 ml/min/1,73 m2 Systemisk infektion eller sepsis
English: Neuralgia, peripheral neuropathy, headache
Danish: Neuralgi, perifer neuropati, hovedpine
English: During the last two weeks in each of the six courses, subjects in both the control and the dinutuximab immunotherapy arms were also given oral isotretinoin at a dose of 160 mg/m2/day (given as 80 mg/m2 twice daily).
Danish: De sidste to uger i hvert af de seks behandlingsforløb fik forsøgspersonerne i både kontrol- og dinutuximab-immunterapiarmen også oral isotretinoin i en dosis på 160 mg/m2/dag (givet som 80 mg/m2 to gange dagligt).
English: Infusion reactions generally occurred during or within 24 hours of completing the Unituxin infusion.
Danish: Infusionsreaktioner forekom generelt under eller inden for 24 timer efter afslutning af Unituxin-infusionen.
English: Device-related infection, infection susceptibility increased, bacteraemia, enterocolitis
Danish: Udstyrsrelateret infektion, øget følsomhed over for infektioner, bakteriæmi, enterokolitis
English: It is administered on Days 4-7 during Courses 1, 3, and 5 (each course lasting approximately 24 days) and on Days 8-11 during Courses 2 and 4 (each course lasting approximately 28 days).
Danish: Det administreres på dag 4-7 i behandlingsforløb 1, 3 og 5 (hvert behandlingsforløb varer ca. 24 dage) og på dag 8-11 i behandlingsforløb 2 og 4 (hvert behandlingsforløb varer ca. 28 dage).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Unituxin 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 Unituxin i en eller flere undergrupper af den pædiatriske population med neuroblastom (se pkt.
English: • Delay course initiation until CNS toxicity is Grade 1 or resolved and/or seizure disorder is well controlled Hepatic dysfunction
Danish: • Udsæt initiering af behandlingsforløbet, indtil CNS-toksiciteten er grad 1 eller ophørt, og/eller krampelidelsen er velkontrolleret Leverdysfunktion
English: Unituxin is to be administered by intravenous infusion over five courses at a daily dose of 17.5 mg/m2.
Danish: Unituxin skal administreres ved intravenøs infusion over fem behandlingsforløb i en daglig dosis på 17,5 mg/m2.
English: Unituxin contains sodium
Danish: Unituxin indeholder natrium
English: Regular dosing every 4-6 hours is recommended when IL-2 is coadministered.
Danish: Regelmæssig dosering hver 4.-6. anbefales, når der samtidig administreres IL-2.
English: • Infections of the blood - tell your doctor if you notice fever, shaking chills, or feel faint or dizzy.
Danish: • Infektioner i blodet - fortæl det til lægen, hvis du bemærker feber eller kulderystelser, eller hvis du føler dig svag eller svimmel.
English: From a microbiological point of view, the diluted solution should be used immediately.
Danish: Af mikrobiologiske hensyn skal den fortyndede opløsning anvendes straks.
English: During courses (months) 2 and 4
Danish: I behandlingsforløb (måned) 2 og 4
English: From a microbiological point of view, unless the method of opening/reconstituting/dilution precludes the risks of microbial contamination, the product should be used immediately.
Danish: Af mikrobiologiske hensyn skal produktet anvendes straks, medmindre metoden for åbning/rekonstituering/fortynding udelukker risiko for mikrobiologisk kontaminering.
English: It is recommended that women of childbearing potential use contraception for 6 months after discontinuation of treatment with Unituxin.
Danish: Det anbefales, at kvinder i den fødedygtige alder anvender kontraception i 6 måneder efter seponering af behandling med Unituxin.
English: It is recommended to administer oral metolazone or intravenous furosemide every 6-12 hours as required.
Danish: Det anbefales at administrere oral metolazon eller intravenøs furosemid hver 6.-12. time efter behov.
English: No cases of dinutuximab overdose have been reported.
Danish: Der er ikke indberettet tilfælde af overdosering med dinutuximab.
English: • If it is possible for you to become pregnant and you are not using contraception, talk to your doctor before being given this medicine.
Danish: • Hvis du er i stand til at blive gravid, og du ikke bruger prævention, skal du tale med din læge, før du får dette lægemiddel.
English: Electrolyte abnormalities occurring in at least 25 % of patients who received Unituxin included hyponatraemia and hypokalaemia.
Danish: Elektrolytanomalier forekom hos mindst 25 % af de patienter, der fik Unituxin, herunder hyponatriæmi og hypokaliæmi.
English: Unituxin has major influence on the ability to drive and use machines.
Danish: Unituxin påvirker i væsentlig grad evnen til at føre motorkøretøj og betjene maskiner.
English: This means it is essentially ‘sodiumfree'.
Danish: Det er dermed i alt væsentlig ‘natriumfrit'.
English: Non-interventional post authorisation safety study (PASS): In order to evaluate the long-term safety outcomes of dinutuximab in high-risk neuroblastoma patients (including central and peripheral nervous system, prevalence of organ dysfunction, long-term effects on growth and endocrine development, hearing loss, cardiac toxicity and survival data) the applicant should conduct and submit the results of a safety registry.
Danish: Ikke-interventionelt sikkerhedsstudie efter udstedelse af markedsføringstilladelse (PASS): For at evaluere de langsigtede sikkerhedsresultater af dinutuximab hos højrisikoneuroblastompatienter (inklusive centralnervesystemet og det perifere nervesystem, forekomsten af organdysfunktion, langsigtede virkninger på væksten og den endokrine udvikling, høretab, hjertetoksicitet og overlevelsesdata) skal ansøgeren foretage og indsende resultaterne af en sikkerhedsregistrering.
English: Unituxin is used with three other medicines: - Isotretinoin - GM-CSF - IL-2
Danish: Unituxin gives sammen med tre andre lægemidler: - Isotretinoin - GM-CSF - IL-2
English: If tolerated, increase GM-CSF or IL-2 to full dose the next day.
Danish: Hvis dette tolereres, øges GM-CSF eller IL-2 til fuld dosis den næste dag.
English: Augmentation of ADCC in the presence of GM-CSF and IL-2 provided the rationale for combining these cytokines with dinutuximab in clinical studies.
Danish: Den forstærkede ADCC i tilstedeværelse af GM-CSF og IL-2 udgjorde rationalet for at kombinere disse cytokiner med dinutuximab i kliniske studier.
English: Peripheral neuropathy Grade 2 peripheral motor neuropathy
Danish: Perifer neuropati Perifer motorisk neuropati af grad 2
English: • If patient tolerated 50 % dose of GM-CSF or IL-2, start at this dose and dinutuximab rate of 0.875 mg/m2/h.
Danish: • Hvis patienten tolererede 50 % af dosis for GM-CSF eller IL-2, begyndes ved denne dosis og en dinutuximab-hastighed på 0,875 mg/m2/t.
English: These medicines will be given to you over six courses.
Danish: Du får disse lægemidler som seks behandlingsforløb.
English: (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100).
Danish: Frekvenskategorierne er defineret som: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100).
English: Dinutuximab is a chimeric human/mouse monoclonal antibody produced in a murine myeloma cell line (Sp2/0) by recombinant DNA technology.
Danish: Dinutuximab er et kimært monoklonalt antistof fra mennesker/mus, som er fremstillet i en murin myelomcellelinje (Sp2/0) ved rekombinant DNA-teknologi.
English: Unituxin should be discontinued if pain is not adequately controlled despite infusion rate reduction and institution of maximum supportive measures.
Danish: Unituxin bør seponeres, hvis smerten ikke er tilstrækkeligt kontrolleret trods nedsættelse af infusionshastigheden og iværksættelse af maksimale understøttende foranstaltninger.
English: Then increase to full dose if tolerated for the remainder of
Danish: Øg derefter til fuld dosis, hvis det tolereres, i resten af
English: Paracetamol should be administered orally 20 minutes prior to starting each dinutuximab infusion, and repeated every 4-6 hours as needed.
Danish: Der bør administreres paracetamol oralt 20 minutter før den enkelte infusion med dinutuximab påbegyndes, og igen hver 4.-6. time efter behov.
English: Hyperthyroidism
Danish: Hyperthyroidisme
English: Unituxin is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT).
Danish: Unituxin er indiceret til behandling af højrisiko-neuroblastom hos patienter i alderen 12 måneder til 17 år, som tidligere har fået induktionskemoterapi og i det mindste opnået et partielt respons, efterfulgt af myeloablativ terapi og autolog stamcelletransplantation (ASCT).
English: In this study, 27 children with high-risk neuroblastoma (age: 3.9 ± 1.9 years) received up to 5 cycles of Unituxin at 17.5 mg/m2/day as an intravenous infusion over 10 to 20 hours for 4 consecutive days every 28 days.
Danish: I dette studie fik 27 børn med højrisiko-neuroblastom (alder: 3,9 ± 1,9 år) 5 cyklusser med Unituxin i en dosis på 17,5 mg/m2/dag som intravenøs infusion over 10 til 20 timer i 4 på hinanden følgende dage hver 28. dag.
English: Prior to starting each treatment course, refer to Table 3 for a list of criteria that must be evaluated.
Danish: Før de enkelte behandlingsforløb påbegyndes, skal de kriterier, der er angivet i tabel 3, evalueres.
English: This means it is essentially ‘sodium free'.
Danish: Det er dermed i alt væsentligt ‘natriumfrit'.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at ambient conditions (less than 25°C).
Danish: Det er påvist, at det brugsklare produkt er kemisk og fysisk stabilt i 24 timer ved omgivende betingelser (under 25 °C).
English: Ibuprofen should not be administered if there is evidence of thrombocytopenia, bleeding, or renal dysfunction.
Danish: Der bør ikke administreres ibuprofen, hvis der er tegn på trombocytopeni, blødning eller nyredysfunktion.
English: • GM-CSF is given as either an injection under the skin or as a drip into one of your veins each day for
Danish: • Du får GM-CSF enten som indsprøjtning eller som drop i en af dine vener hver dag i 14 dage.
English: As this medicinal product is used in combination with GM-CSF, IL-2, and isotretinoin, it is difficult to ascertain the causal relationship of each adverse reaction to a particular medicinal product.
Danish: Da dette lægemiddel anvendes i kombination med GM-CSF, IL-2 og isotretinoin, er det vanskeligt at afgøre den enkelte bivirknings årsagssammenhæng med et bestemt lægemiddel.
English: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before being 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 eller sundhedspersonalet til råds, før du får dette lægemiddel.
English: What you need to know before you are given Unituxin 3.
Danish: Det skal du vide, før du begynder at få Unituxin 3.
English: Antihistamine premedication (e.g. hydroxyzine or diphenhydramine) should be administered by intravenous injection approximately 20 minutes before starting each dinutuximab infusion.
Danish: Præmedicinering med antihistamin (f.eks. hydroxyzin eller diphenhydramin) bør administreres ved intravenøs injektion ca. 20 minutter før, den enkelte infusion af dinutuximab påbegyndes.
English: • If tolerated without worsening symptoms, administer dinutuximab at 1.75 mg/m2/h for subsequent courses.
Danish: • Hvis det tolereres uden forværring af symptomerne, administreres dinutuximab ved 1,75 mg/m2/t i de efterfølgende behandlingsforløb.
English: Unituxin is a cancer medicine that contains the active substance dinutuximab.
Danish: Unituxin er lægemiddel til behandling af kræft, og det indeholder det aktive stof dinutuximab.
English: Supportive measures should be instituted including control of hydration status, electrolyte abnormalities, hypertension, and anaemia.
Danish: Der bør iværksættes understøttende foranstaltninger, herunder kontrol af hydreringen, elektrolytanomalier, hypertension og anæmi.
English: Subgroup analyses of EFS and OS response indicated that patients with minimal residual disease, DNA hyperploidy, and those having received a purged bone marrow may not have benefited from dinutuximab immunotherapy.
Danish: Delgruppeanalyser af EFS- og OS-respons indikerede, at patienter med minimal residualsygdom, DNAhyperploidi samt patienter, der havde fået en renset knoglemarv, ikke nødvendigvis har haft gavn af dinutuximab-immunterapi.
English: Cytokine release syndrome
Danish: Cytokin release syndrom Serumsygdom
English: Dinutuximab is a monoclonal chimeric antibody composed of murine variable heavy and light chain regions and the human constant region for the heavy chain IgG1 and light chain kappa.
Danish: Dinutuximab er et monoklonalt kimært antistof, som er sammensat af murine variable tung- og letkædede regioner og den humane konstante region for det tungkædede IgG1 og letkædede kappa.
English: Adverse reactions reported in four clinical studies (ANBL0032, ANBL0931, CCG-0935A, and DIV-NB201) of dinutuximab in patients (N=984) with high-risk neuroblastoma are summarized in Table 5.
Danish: Tabel 5 opsummerer bivirkninger indberettet i fire kliniske studier (ANBL0032, ANBL0931, CCG-0935A, og DIV-NB-201) af dinutuximab hos patienter (N=984) med højrisiko-neuroblastom.
English: Long-term overall survival was evaluated with 5 years of follow up after the EFS analysis and continued to demonstrate a survival advantage for patients who received dinutuximab immunotherapy compared to those who received isotretinoin alone.
Danish: Den samlede langtidsoverlevelse blev evalueret med 5 års opfølgning efter EFS-analysen og viste fortsat en overlevelsesfordel for patienter, der fik dinutuximab-immunterapi, sammenlignet med dem, der fik isotretinoin alene.
English: • Pain - tell your doctor or nurse if you get any pain.
Danish: • Smerte - fortæl det til lægen eller sundhedspersonalet, hvis du får smerter.
English: These studies support the current dinutuximab dosing regimen of 17.5 mg/m2/day administered for four consecutive days during five monthly courses.
Danish: Disse studier underbygger det nuværende dosisregime for dinutuximab på 17,5 mg/m2/dag administreret i fire på hinanden følgende dage under fem månedlige behandlingsforløb.
English: What Unituxin contains - The active substance is dinutuximab.
Danish: Unituxin indeholder - Aktivt stof: dinutuximab.
English: It is recommended that antihistamine medicinal product be repeated every 4-6 hours as required during infusion of Unituxin.
Danish: Det anbefales, at administration af antihistamin gentages hver 4.-6. time efter behov under infusion af Unituxin.
English: • Any kind of pain: in the stomach, throat, chest, face, hands, feet, legs or arms (such as numbness, tingling or burning) back, neck, joint, bone, muscle, mouth, eye, genitals.
Danish: • Enhver form for smerte: i mave, hals, bryst, ansigt, hænder, fødder, ben eller arme (for eksempel følelsesløshed, prikkende eller brændende fornemmelse), ryg, nakke, led, knogler, muskler, mund, øjne eller kønsorganer.
English: The 2-year estimates of EFS were 66 % among subjects receiving dinutuximab immunotherapy plus isotretinoin as compared with 48 % in subjects receiving isotretinoin alone (log-rank test p = 0.033) although this difference did not reach formal statistical significance according to the pre-specified plan for interim analyses.
Danish: Toårs-estimaterne for EFS var 66 % blandt forsøgspersoner, der fik dinutuximab-immunterapi plus isotretinoin, sammenlignet med 48 % hos forsøgspersoner, der fik isotretinoin alene (log-rank test p = 0,033), selvom denne forskel ikke nåede formel statistisk signifikans ifølge den præspecificerede plan for interimanalyser.
English: Clear Type I glass vial with a bromobutyl rubber stopper and aluminium flip-off seal containing 5 mL of concentrate for solution for infusion.
Danish: Klart type I-hætteglas med bromobutylgummiprop og flip-off-forsegling af aluminium indeholdende 5 ml koncentrat til infusionsvæske, opløsning.
English: Following ASCT, 226 subjects were randomly assigned 1:1 to either a standard therapy arm (six courses of isotretinoin) or a dinutuximab immunotherapy arm (five courses of dinutuximab in combination with alternating GM-CSF and IL-2; combined with isotretinoin concurrently for six courses).
Danish: Efter ASCT blev 226 forsøgspersoner fordelt tilfældigt i forholdet 1:1 på enten en standardbehandlingsarm (seks behandlingsforløb med isotretinoin) eller en dinutuximab-immunterapiarm (fem behandlingsforløb med dinutuximab i kombination med skiftevis GM-CSF og IL-2; kombineret med isotretinoin sideløbende i seks behandlingsforløb).
English: Talk to your doctor or nurse before you are given Unituxin if: - you have ever had fits (convulsions) - you have liver problems - you have a low number of white blood cells or platelets in your blood - shown in tests - you have breathing problems such as shortness of breath when resting - you have kidney problems - you have any infections.
Danish: Kontakt lægen eller sundhedspersonalet, før du får Unituxin, hvis: - du nogensinde har haft krampeanfald - du har leverproblemer - du har et lavt antal hvide blodlegemer eller blodplader i dit blod - målt i blodprøver - du har problemer med at trække vejret, f.eks. hvis du er stakåndet i hvile - du har nyreproblemer - du har en infektion.
English: Dinutuximab reacts specifically with the ganglioside GD2, which is highly expressed on the surface of neuroblastoma cells and minimally expressed on the surface of normal human neurons, peripheral pain fibres, and skin melanocytes.
Danish: Dinutuximab reagerer specifikt med gangliosidet GD2, som udviser en høj ekspression på overfladen af neuroblastomceller og en minimal ekspression på overfladen af normale humane neuroner, perifere smertefibre og hudmelanocytter.
English: Table 3: Clinical criteria that must be evaluated prior to the start of each treatment course of Unituxin
Danish: Tabel 3: Kliniske kriterier, der skal evalueres, før de enkelte behandlingsforløb med Unituxin påbegyndes
English: Chemical and physical in-use stability has been demonstrated at ambient conditions (less than 25 °C).
Danish: Det er påvist, at det brugsklare produkt er kemisk og fysisk stabilt ved omgivende betingelser (under 25 °C).
English: It is recommended that additional intravenous bolus doses of an opioid are administered as needed for treatment of pain up to once every 2 hours during the dinutuximab infusion.
Danish: Det anbefales at administrere yderligere intravenøse bolusdoser af et opioid efter behov til behandling af smerte op til en gang hver 2. time under infusionen med dinutuximab.
English: Pain Grade 4
Danish: Smerte Grad 4
English: Neurological disorders of the eye Dilated pupil with sluggish light reflex Onset of symptoms
Danish: Neurologiske øjenlidelser Dilaterede pupiller med langsom lysrefleks Symptomdebut
English: • If symptoms resolve that day, resume the next day with premedication in the intensive care setting (see section 4.4).
Danish: • Hvis symptomerne ophører samme dag, genoptages næste dag med præmedicinering på intensivafdeling (se pkt.
English: • Do not resume GM-CSF or IL-2 until the following day.
Danish: • Genoptag ikke GM-CSF eller IL-2 før dagen efter.
English: It is administered in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and isotretinoin.
Danish: Det administreres i kombination med granulocyt-makrofagkolonistimulerende faktorer (GM-CSF), interleukin-2 (IL-2) og isotretinoin.
English: Peripheral sensory neuropathy was reported in 3% of patients and peripheral motor neuropathy in 2% of patients; less than 1% of patients experienced serious peripheral neuropathy.
Danish: Der blev rapporteret perifer sensorisk neuropati hos 3 % af patienterne og perifer motorisk neuropati hos 2 % af patienterne.
English: Serum sickness Grade 4 (life-threatening)
Danish: Serumsygdom Grad 4 (livstruende)
English: Pre-medication should always be considered before starting each infusion (see section 4.4).
Danish: Præmedicinering skal altid overvejes, før den enkelte infusion påbegyndes (se pkt.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLAS
English: Hypokalaemia, hyponatraemia, hypocalcaemia, hypophosphataemia, hypoalbuminaemia, hyperglycaemia, decreased appetite
Danish: Hypokaliæmi, hyponatriæmi, hypokalciæmi, hypofosfatæmi, hypoalbuminæmi, hyperglykæmi, nedsat appetit
English: Lidocaine may be administered as an intravenous infusion (2 mg/kg in 50 mL of 0.9 % sodium chloride) over 30 minutes prior to the start of each dinutuximab infusion and continued via intravenous infusion at 1 mg/kg/h up to 2 hours after completion of the treatment.
Danish: Der kan administreres lidocain som intravenøs infusion (2 mg/kg i 50 ml 0,9 % natriumklorid) over 30 minutter, før den enkelte infusion med dinutuximab påbegyndes, og fortsat via intravenøs infusion med 1 mg/kg/t indtil 2 timer efter endt behandling.
English: A population pharmacokinetic analysis conducted on all clinical data available suggests that the disposition of dinutuximab is not altered by age, race, gender, concomitant medications (IL-2, GM-CSF) and the presence of capillary leak syndrome, renal or hepatic impairment.
Danish: En farmakokinetisk populationsanalyse, der omfattede alle tilgængelige kliniske data, antyder, at den systemiske clearance af dinutuximab ikke ændres af alder, race, køn og samtidig medicin (IL-2, GM-CSF) samt forekomst af kapillærlækagesyndrom og nedsat nyre- eller leverfunktion.