FrancophonIA/ELRC3.0 huggingface dataset:
English: - atypical haemolytic uraemic syndrome (aHUS) - an illness that affects the blood system and kidney symptoms may include flu-like symptoms that do not go away, confusion, lethargy, loss of appetite, or dark coloured urine.
Danish: - atypisk hæmolytisk uræmisk syndrom (aHUS) - en sygdom, der påvirker blodsystemet og nyrerne symptomer kan inkludere influenzalignende symptomer, der ikke forsvinder, forvirring, sløvhed, nedsat appetit eller mørk urin.
English: Granulocytes were found to be more effective than PBMCs in mediating dinutuximab dependent cytotoxicity of neuroblastoma cells, with enhanced cell lysis observed with the addition of GM-CSF.
Danish: Granulocytter har vist sig at være mere effektive end PBMC'er til mediering af dinutuximabafhængig cytotoksicitet for neuroblastomceller, og forstærket cellelysis blev observeret med tilføjelse af GMCSF.
English: In clinical trials, scheduled dinutuximab doses of up to 120 mg/m2 (60 mg/m2/day) have been administered with an adverse reaction profile similar to that described in section 4.8.
Danish: I kliniske forsøg er der blevet administreret planlagte doser dinutuximab på op til 120 mg/m2 (60 mg/m2/dag) med en bivirkningsprofil, der svarede til den, der er beskrevet i pkt.
English: • Problems with your nerves - you may notice numbness, tingling or burning in your hands, feet, legs or arms, reduced sensation or weakness with movement (peripheral neuropathy).
Danish: • Problemer med nerverne - du vil måske bemærke følelsesløshed, en prikkende eller brændende fornemmelse i hænder, fødder, ben eller arme, nedsat følesans eller svækkede bevægelser (perifer neuropati).
English: If you notice any of these effects, tell your doctor or nurse straight away.
Danish: Hvis du bemærker en eller flere af disse virkninger, skal du straks fortælle det til lægen eller sygeplejersken.
English: Characteristic symptoms and signs include hypotension, generalized oedema, ascites, dyspnoea, pulmonary oedema and acute renal failure associated with hypoalbuminaemia and haemoconcentration.
Danish: Karakteristiske tegn og symptomer omfatter hypotension, generaliseret ødem, ascites, dyspnø, lungeødem og akut nyresvigt forbundet med hypoalbuminæmi og hæmokoncentration.
English: Serious infusion reactions requiring urgent intervention including blood pressure support, bronchodilator therapy, corticosteroids, infusion rate reduction, infusion interruption, or permanent discontinuation of Unituxin included facial and upper airway oedema, dyspnoea, bronchospasm, stridor, urticaria, and hypotension.
Danish: Alvorlige infusionsreaktioner, som krævede akut intervention, herunder blodtryksunderstøttelse, bronkodilatorterapi, kortikosteroider, nedsættelse af infusionshastigheden, afbrydelse af infusionen eller permanent seponering af Unituxin, omfattede ansigts- og øvre lufvejsødem, dyspnø, bronkospasme, stridor, urticaria og hypotension.
English: Unituxin should not be administered as an intravenous push or bolus.
Danish: Intravenøs administration af Unituxin må ikke foretages som skud eller bolus.
English: The treatment regimen consists of dinutuximab, GM-CSF, IL-2, and isotretinoin, administered over six consecutive courses.
Danish: Behandlingsregimet består af dinutuximab, GM-CSF, IL-2 og isotretinoin, administreret over seks på hinanden følgende behandlingsforløb.
English: Eye disorders may occur, especially with repeated courses (see section 4.8).
Danish: Øjenlidelser kan forekomme, især med gentagne behandlingsforløb (se pkt.
English: This is very common during treatment (affecting more than 1 in 10 people).
Danish: Det er meget almindeligt under behandlingen (forekommer hos flere end 1 ud af 10 personer).
English: An opioid, such as morphine sulphate, is recommended to be administered by intravenous infusion prior to each dinutuximab infusion and continued as an intravenous infusion during and until 2 hours after completion of the treatment.
Danish: Det anbefales at administrere et opioid, såsom morfinsulfat, ved intravenøs infusion før hver infusion med dinutuximab og at fortsætte med intravenøs infusion under og indtil 2 timer efter, at behandlingen er slut.
English: • If abnormalities remain stable or improve before the next course administer dinutuximab at 0.875 mg/m2/h and full dose GM-CSF or IL-2.
Danish: • Hvis abnormiteterne forbliver stabile eller bedres før næste behandlingsforløb, administreres dinutuximab ved 0,875 mg/m2/t og fuld dosis GM-CSF eller IL-2.
English: Interleukin-2 (IL-2): 3 MIU/m 2/day administered by continuous intravenous infusion over 96 hours on Days 1-4 and4.5 MIU/m2/day on Days 8-11.
Danish: Interleukin-2 (IL-2): 3 MIE/m2/dag administreret ved kontinuerlig intravenøs infusion over 96 timer på dag 1-4 og 4,5 MIE/m2/dag på dag 8-11.
English: IL-2 was administered concurrently with dinutuximab as a continuous intravenous infusion for four days during Week 1 of Courses 2 and 4 at a dose of 3.0 MIU/m2/day, and during Week 2 of Courses 2 and 4 at a dose of 4.5 MIU/m2/day.
Danish: IL-2 blev administreret sideløbende med dinutuximab som en kontinuerlig intravenøs infusion i fire dage i uge 1 af behandlingsforløb 2 og 4 i en dosis på 3,0 MIE/m2/dag og i uge 2 i behandlingsforløb 2 og 4 i en dosis på 4,5 MIE/m2/dag.
English: Uncommon photophobia, mydriasis
Danish: Sløret syn, fotofobi, mydriasis
English: Other medicines and Unituxin
Danish: Brug af anden medicin sammen med Unituxin
English: Urinary retention, proteinuria, haematuria
Danish: Urinretention, proteinuri, hæmaturi
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 17.5 mg/5 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 17,5 mg/5 ml
English: Dinutuximab has been shown to bind to neuroblastoma cell lines known to express GD2 in vitro.
Danish: Det er påvist, at dinutuximab binder sig til neuroblastomcellelinjer, hvorpå ekspression af GD2 vides at finde sted in vitro.
English: There is insufficient information on the excretion of dinutuximab in human milk.
Danish: Data for udskillelse af dinutuximab i human mælk er utilstrækkelige.
English: Intravenous use after dilution
Danish: Intravenøs anvendelse efter fortynding
English: • If patient has CNS metastases, delay course initiation and give platelet transfusion to maintain platelet count at least 50,000/μL.
Danish: • Hvis patienten har CNS-metastaser: Udsæt initiering af behandlingsforløbet, og giv trombocyttransfusion, så trombocyttallet holdes på mindst 50.000/μl.
English: Intravenous sodium chloride 9 mg/mL (0.9%) solution for injection (10 mL/kg) should be administered over one hour just prior to the dinutuximab infusion.
Danish: Intravenøs natriumkloridopløsning 9 mg/ml (0,9 %) til injektion (10 ml/kg) bør administreres i løbet af én time umiddelbart før infusion af dinutuximab.
English: How Unituxin will be given 4.
Danish: Sådan vil du få Unituxin 4.
English: Adverse reactions are defined as those adverse events that occurred at a higher frequency in the dinutuximab, GMCSF, IL-2 and isotretinoin-treated group compared with the isotretinoin-treated control group during the ANBL0032 randomised, controlled, pivotal study, and that have a plausible mechanistic relationship to treatment with dinutuximab.
Danish: Bivirkninger defineres som utilsigtede hændelser, der forekom hyppigere i den gruppe, der blev behandlet med dinutuximab, GMCSF, IL-2 og isotretinoin, sammenlignet med kontrolgruppen, som blev behandlet med isotretinoin, i det randomiserede, kontrollerede hovedforsøg, ANBL0032, og som havde en plausibel mekanistisk sammenhæng med behandlingen med dinutuximab.
English: Blood and lymphatic system disorders
Danish: Blod og lymfesystem Anæmi
English: Like all medicines, this medicine, which is given with GM-CSF, IL-2 and isotretinoin can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel, der gives sammen med GM-CSF, IL-2 og isotretinoin, kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Grade 3 or 4 Onset of symptoms
Danish: Grad 3 eller 4 Symptomdebut
English: See section 4 for more information about pain side effects.
Danish: Du finder flere oplysninger om smertebivirkninger i punkt 4.
English: • Delay initiation of first course until absolute phagocyte count (APC) is at least 1,000/μL.
Danish: • Udsæt initiering af første behandlingsforløb indtil et absolut fagocyttal (APC) på mindst 1.000/μl.
English: Capillary leak syndrome Grade 3 (severe) Onset of symptoms
Danish: Kapillærlækagesyndrom Grad 3 (svær) Symptomdebut
English: Electrolyte abnormalities have been reported in patients who received Unituxin.
Danish: Der er rapporteret elektrolytanomalier hos patienter, der fik Unituxin.
English: GM-CSF was administered at a dose of 250 μg/m2/day during Courses 1, 3, and 5 and dosed daily for 14 days.
Danish: GM-CSF blev administreret i en dosis på 250 μg/m2/dag under behandlingsforløb 1, 3 og 5 med daglig dosering i 14 dage.
English: The 5 year estimates of OS were 74 % for dinutuximab immunotherapy compared to 57 % for isotretinoin alone (log-rank test p = 0.030).
Danish: Femårs-estimaterne for OS var 74 % for dinutuximab-immunterapi sammenlignet med 57 % for isotretinoin alene (log-rank test p =
English: For severe pain, the Unituxin infusion rate should be decreased to 0.875 mg/m2/hour.
Danish: Ved svær smerte bør Unituxin-infusionshastigheden nedsættes til 0,875 mg/m2/time.
English: • Delay course initiation until dyspnoea at rest has been resolved and/or peripheral oxygen saturation is at least 94 % on room air. Renal dysfunction
Danish: • Udsæt initiering af behandlingsforløbet indtil ingen hviledyspnø og/eller en perifer oxygenmætning på mindst 94 % på rumluft.
English: The required volume of dinutuximab should be withdrawn and injected into a 100 mL bag of sodium chloride 9 mg/mL (0.9 %) solution for injection.
Danish: Det nødvendige volumen dinutuximab skal trækkes op og injiceres i en 100 ml pose med en 9 mg/ml (0,9 %) natriumkloridopløsning til injektioner.
English: Dinutuximab: 17.5 mg/m2/day, administered by intravenous infusion over 10-20 hours.
Danish: Dinutuximab: 17,5 mg/m2/dag, administreret ved intravenøs infusion over 10-20 timer.
English: The primary intent-to-treat (ITT) analysis found an improvement in EFS associated with dinutuximab immunotherapy plus isotretinoin, as compared to isotretinoin alone.
Danish: Den primære intent-to-treat (ITT)-analyse fandt en forbedring af EFS i forbindelse med dinutuximabimmunterapi plus isotretinoin sammenlignet med isotretinoin alene.
English: The diluted solution for infusion must be used within 24 hours of preparation.
Danish: Den fortyndede injektionsvæske skal anvendes inden for 24 timer efter fremstillingen.
English: These are very common (may affect more than 1 in 10 people).
Danish: Det er meget almindeligt (kan forekomme hos flere end 1 ud af 10 personer).
English: • Capillary Leak Syndrome due to leakage of blood components through small blood vessel wallsthis may cause rapid swelling to arms, legs and other parts of your body, rapid drop in blood pressure, lightheadedness and breathing difficulties
Danish: • Kapillærlækagesyndrom på grund af lækage af blodkomponenter gennem små blodkarvægge - det kan forårsage hurtig hævelse på arme, ben og andre kropsdele, hurtigt blodtryksfald, svimmelhed samt vejrtrækningsbesvær.
English: Capillary leak syndrome was a very common adverse reaction (45 % of patients) that occurred more frequently when Unituxin was co-administered with IL-2; it was severe (> Grade 3) in 14% of patients.
Danish: Kapillærlækagesyndrom var en meget almindelig bivirkning (45 % af patienterne), som forekom hyppigere, når Unituxin blev administreret samtidig med IL-2.
English: What Unituxin is
Danish: Hvad er Unituxin?
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL of concentrate contains 3.5 mg of dinutuximab.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 ml koncentrat indeholder 3,5 mg dinutuximab.
English: Healthcare professionals are asked to report any suspected adverse reactions.
Danish: Læger og sundhedspersonale anmodes om at indberette alle bivirkninger.
English: What you need to know before you are given Unituxin
Danish: Det skal du vide, før du begynder at få Unituxin
English: Findings of note included treatment related adverse reactions of the liver in rats (characterized by centrilobular congestion, abnormal cell division, hepatocellular necrosis and pericentral vein/interlobular fibrosis) which may be related to circulatory disturbances and changes indicative of increased haematopoiesis (high reticulocyte ratio and/or platelet count, increased cellularity of the haematopoietic cells in the femoral and sternal bone marrow, and/or extramedullary haematopoiesis in the liver and spleen).
Danish: Bemærkelsesværdige fund omfattede behandlingsrelaterede bivirkninger i leveren hos rotter (kendetegnet ved centrilobulær kongestion, abnorm celledeling, hepatocellulær nekrose og pericentral venefibrose/interlobulær fibrose), som kan være relateret til kredsløbsforstyrrelser, og forandringer, der tyder på forhøjet hæmatopoiese (høj retikulocytratio og/eller højt trombocyttal, øget cellularitet af de hæmatopoietiske celler i knoglemarven i femur og sternum og/eller ekstramedullær hæmatopoiese i lever og milt).
English: Dinutuximab was administered at a dose equivalent to 17.5 mg/m2/day on four consecutive days (Days 4-7) of Courses 1-5.
Danish: Dinutuximab blev administreret i en dosis svarende til 17,5 mg/m2/dag i fire på hinanden følgende dage (dag 4-7) i behandlingsforløb 1-5.
English: Hence, this medicinal product is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Unituxin bør ikke anvendes under graviditeten og til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: • Rapid swelling of the arms, legs and other parts of your body, rapid drop in blood pressure, lightheadedness and breathing difficulties (Capillary Leak Syndrome).
Danish: • Hurtig hævelse på arme, ben og andre kropsdele, hurtigt blodtryksfald, svimmelhed samt vejrtrækningsbesvær (kapillærlækagesyndrom)
English: • For IL-2 courses, administer IL-2 at 50 % of the dose starting the next day and continue for the remainder of the course.
Danish: • For behandlingsforløb med IL-2 påbegyndes administrationen af IL-2 med 50 % af dosis næste dag og fortsættes gennem resten af
English: The 3-year estimates of OS were 80 % compared with 67 % among subjects receiving dinutuximab immunotherapy plus isotretinoin and isotretinoin alone, respectively (log-rank test p = 0.0165).
Danish: Treårs-estimaterne for OS var 80 % sammenlignet med 67 % blandt forsøgspersoner, der fik henholdsvis dinutuximab-immunterapi plus isotretinoin og isotretinoin alene (log-rank test p = 0,0165).
English: If not tolerated, reduce rate to 0.875 mg/m2/h.
Danish: Hvis dette ikke tolereres, nedsættes hastigheden til 0,875 mg/m2/t.
English: Haemolytic uraemic syndrome in the absence of documented infection and resulting in renal insufficiency, electrolyte abnormalities, anaemia, and hypertension has been reported.
Danish: Der er rapporteret hæmolytisk uræmisk syndrom uden dokumenteret infektion og som har resulteret i nyreinsufficiens, elektrolytanomalier, anæmi og hypertension.
English: Severe allergic reactions are more likely when dinutuximab is co-administered with IL-2.
Danish: Der er større sandsynlighed for svære allergiske reaktioner, når dinutuximab administreres samtidig med IL2.
English: Breast-feeding should be discontinued during treatment with Unituxin.
Danish: Amning skal ophøre under behandling med Unituxin.
English: • If you are breastfeeding, talk to your doctor or nurse before being given this medicine.
Danish: • Hvis du ammer, skal du tale med din læge eller sundhedspersonalet, før du får dette lægemiddel.
English: ANBL0032 was a randomised, controlled study that evaluated the effects of dinutuximab administered in combination with GM-CSF, IL-2, and isotretinoin compared with isotretinoin alone in high-risk neuroblastoma subjects.
Danish: ANBL0032 var et randomiseret, kontrolleret forsøg, som evaluerede virkningerne af dinutuximab administreret i kombination med GM-CSF, IL-2 og isotretinoin sammenlignet med isotretinoin alene hos forsøgspersoner med højrisiko-neuroblastom.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 1 hætteglas
English: Unituxin should be discontinued if pain is not adequately controlled despite infusion rate reduction and institution of maximum supportive measures (see sections 4.2 and 4.8).
Danish: Unituxin bør seponeres, hvis smerten ikke er tilstrækkeligt kontrolleret trods nedsættelse af infusionshastigheden og iværksættelse af maksimale understøttende foranstaltninger (se pkt.
English: The pharmacokinetics of dinutuximab were evaluated in a clinical study of Unituxin in combination with GM-CSF, IL-2, and isotretinoin.
Danish: Dinutuximabs farmakokinetik blev evalueret i et klinisk studie med Unituxin i kombination med GM-CSF, IL-2 og isotretinoin.
English: Hypomagnesaemia, acidosis, hypoglycaemia,
Danish: Hypomagnesiæmi, acidose, hypoglykæmi
English: What Unituxin is used for
Danish: Hvad bruges Unituxin til?
English: In addition, overall survival (OS) was evaluated with 3 years of follow-up after the EFS analysis as a secondary endpoint with a significant improvement observed among ITT subjects randomly allocated to receive dinutuximab immunotherapy plus isotretinoin as compared with isotretinoin alone.
Danish: Derudover blev samlet overlevelse (OS) evalueret med 3 års opfølgning efter EFS-analysen som sekundært endepunkt, og der blev observeret en signifikant forbedring blandt de ITT-forsøgspersoner, der tilfældigt havde fået tildelt dinutuximabimmunterapi plus isotretinoin, sammenlignet med isotretinoin alene.
English: Neurological disorders of the eye
Danish: Neurologiske øjenlidelser
English: 160 mg/m2/day; for body weight up to 12 kg: 2.67 mg/kg administered orally twice daily for a total daily dose of 5.33 mg/kg/day (round dose up to nearest 10 mg).
Danish: Isotretinoin: for kropsvægt over 12 kg: 80 mg/m2 administreret oralt to gange dagligt for en samlet dosis på 160 mg/m2/dag; for kropsvægt op til 12 kg: 2,67 mg/kg administreret oralt to gange dagligt for en samlet dosis på 5,33 mg/kg/dag (rund dosis op til nærmeste 10 mg).
English: Atrial fibrillation, ventricular arrhythmia
Danish: Atrieflimren, ventrikulær arytmi
English: In animals, fertility studies have not been conducted; however in male and female rats, no adverse effects on reproductive organs were observed (see section 5.3).
Danish: Hos han- og hunrotter sås der dog ingen negative virkninger på reproduktionsorganer (se pkt.
English: • If symptoms resolve the following day, resume dinutuximab at tolerated rate without GM-CSF or IL-2.
Danish: • Hvis symptomerne ophører den følgende dag, genoptages dinutuximab med en tolereret hastighed uden GM-CSF eller IL-2.
English: Depending on the severity of the allergic reaction, the rate of infusion should be reduced or treatment discontinued (see sections 4.2 and 4.8).
Danish: Afhængigt af sværhedsgraden af den allergiske reaktion bør infusionshastigheden nedsættes, eller behandlingen bør seponeres (se pkt.
English: Grade 4(life-threatening) Onset of symptoms
Danish: Grad 4 (livstruende) Symptomdebut
English: Electrolyte abnormalities have been reported in patients who received Unituxin (see section 4.8).
Danish: Der er rapporteret elektrolytanomalier hos patienter, der fik Unituxin (se pkt.
English: Reporting of suspected adverse reactions that occur after authorisation of the medicinal product is important.
Danish: Når lægemidlet er godkendt, er indberetning af formodede bivirkninger vigtig.
English: • Resume dinutuximab at 0.875 mg/m2/h once BP is stable.
Danish: • Genoptag dinutuximab med 0,875 mg/m2/t, når BP er stabilt.
English: Table 2: Courses 2 and 4 dosing schedule for Unituxin and IL-2; Courses 2, 4, and 6 dosing schedule for isotretinoin
Danish: Tabel 2: Doseringsskema for behandlingsforløb 2 og 4 for Unituxin og IL-2; doseringsskema for behandlingsforløb 2, 4 og 6 for isotretinoin
English: • Administer dinutuximab at 0.875 mg/m2/h and resume GM-CSF or IL-2.
Danish: • Administrer dinutuximab med 0,875 mg/m2/t, og genoptag GM-CSF eller IL-2.
English: • If symptoms recur with the addition of GM-CSF or IL-2 discontinue GMCSF or IL-2 and dinutuximab.
Danish: • Hvis symptomerne recidiverer med tilføjelse af GM-CSF eller IL-2, seponeres GM-CSF eller IL-2 og dinutuximab.
English: • Any kind of allergic reaction or other reaction at the injection site - symptoms may include a skin rash, hives, swelling in the face or throat, dizziness, a rapid heart beat or palpitations, being short of breath and difficulty breathing, fever, feeling sick, aches and pains in your joints .
Danish: • Enhver form for allergisk reaktion eller anden reaktion på injektionsstedet - symptomerne kan omfatte hududslæt, nældefeber, hævelse i ansigtet eller på halsen, svimmelhed, hurtig eller uregelmæssig hjerterytme, stakåndethed og vejrtrækningsbesvær, feber, kvalme samt ømhed og smerter i leddene.
English: Hypersensitivity (Grade 4) to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed (grad 4) over for det (de) aktive stof(fer) eller over for et eller flere af hjælpestofferne anført i pkt.
English: Uncommon side effects (may affect up to 1 in 100 people ): - unequal pupils - fluid in or around the lungs - kidney failure - over-active thyroid - serum sickness - an illness similar to an allergy - abnormal heart rhythm - swelling in the back part of the brain (Posterior Reversible Encephalopathy Syndrome) - symptoms may include high blood pressure, headache, fits, change in vision or behaviour, feeling drowsy or tired.
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer): - uens pupiller - væske i eller omkring lungerne - nyresvigt - overaktiv skjoldbruskkirtel - serumsygdom - en sygdom, der minder om allergi - unormal hjerterytme - hævelser ved den bageste del af hjernen (posterior reversibel encefalopati-syndrom) - symptomer kan inkludere højt blodtryk, hovedpine, krampeanfald, synsforstyrrelser, adfærdsændringer, sløvhed eller træthed.
English: Each 5 mL vial contains 17.2 mg sodium.
Danish: Hvert 5 ml hætteglas indeholder 17,2 mg natrium.
English: Laboratory test abnormalities
Danish: Unormale laboratorietestresultater
English: Table 4 provides dose modification guidance for dinutuximab, GM-CSF and IL-2.
Danish: I Tabel 4 findes der en dosisjusteringsvejledning for dinutuximab, GM-CSF og IL-2.
English: Granulocyte macrophage colony-stimulating factor (GM-CSF): 250 μg/m2/day, administered by either subcutaneous injection (strongly recommended) or intravenous infusion over 2 hours.
Danish: Granulocyt-makrofagkolonistimulerende faktor (GM-CSF): 250 μg/m2/dag, administreret ved enten subkutan injektion (anbefales kraftigt) eller intravenøs infusion over 2 timer.
English: • For GM-CSF courses, administer GM-CSF at 50 % of the dose starting the next day, and if tolerated, GM-CSF may be given at full dose after completing dinutuximab dosing for that course.
Danish: • For behandlingsforløb med GM-CSF påbegyndes administration af GMCSF med 50 % af dosis næste dag, og hvis det tolereres, kan GM-CSF gives i fuld dosis, når det pågældende behandlingsforløbs dosering med
English: The infusion is started at a dose rate of 0.875 mg/m2/h and continued at this rate for 30 minutes; the rate is then increased to 1.75 mg/m2/h and continued at this rate for the remainder of the infusion, if tolerated.
Danish: Derefter øges hastigheden til 1,75 mg/m2/t, og der fortsættes med denne hastighed under resten af infusionen, hvis det tolereres.
English: Pain typically occurred during the Unituxin infusion and was most commonly reported as abdominal pain, generalized pain, extremity pain, back pain, neuralgia, musculoskeletal chest pain, and arthralgia; 41% of patients suffered severe pain.
Danish: Smerte forekom typisk under Unituxin-infusionen, og de almindeligste indberetninger var mavesmerte, generaliseret smerte, smerte i ekstremiteter, rygsmerte, neuralgi, muskel- og knoglesmerte i brystet og artralgi.