FrancophonIA/ELRC3.0 huggingface dataset:
English: The median age of treated patients (37 males, 24 females) was 12 years old.
Danish: Medianalderen hos de behandlede patienter (37 drenge, 24 piger) var 12 år.
English: Ivozall should not be handled by pregnant women.
Danish: Ivozall bør ikke håndteres af gravide kvinder.
English: • No evidence of circulating blasts or extramedullary disease
Danish: • Ingen tegn på blaster i kredsløb eller ekstramedullær sygdom
English: Immediate discontinuation of therapy, careful observation and initiation of appropriate supportive measures are recommended.
Danish: Omgående seponering af lægemidlet, nøje observation og indledning af passende understøttende behandling anbefales.
English: Children weighing < 20 kg
Danish: Børn med vægt < 20 kg
English: At this time, treatment may be reinitiated at the full dose.
Danish: På dette tidspunkt kan behandlingen genoptages med normal dosis.
English: This is equivalent to 3.53% of the recommended maximum daily intake of sodium for an adult.
Danish: Det svarer til 3,53 % af det anbefalede maksimale daglige indtag af natrium for en voksen.
English: During treatment with Ivozall, your doctor will carry out regular blood tests and other tests to monitor your health.
Danish: Under behandling med Ivozall vil din læge jævnligt tage blodprøver og udføre andre undersøgelser for at checke dit helbred.
English: Responses were seen in different immunophenotypes of ALL, including pre-B cell and T-cell.
Danish: Respons sås hos forskellige immunfænotyper af ALL, inklusive præ-B-celle- og T-celle-ALL.
English: The 12 patients who achieved an overall remission (CR + CRp) had a median survival time of 66.6 weeks as of the data collection cut-off date.
Danish: De 12 patienter, som opnåede total remission (CR + CRp) havde en median overlevelsestid på 66,6 uger ved skæringspunktet for dataindsamling.
English: Children and adolescents (≥ 1 year old)
Danish: Børn og unge (≥ 1 år)
English: Ask your doctor to explain what can be done to protect you or allow you to have a family.
Danish: Spørg din læge til råds om, hvad du kan gøre for at beskytte dig eller fortsat kunne få børn.
English: amphotericin B); - any other medicines including those obtained without a prescription.
Danish: amphotericin B); - andre lægemidler, også hvis der er tale om ikke-receptpligtige lægemidler.
English: This has occurred more frequently within 30 days of treatment, and in the setting of combination chemotherapy.
Danish: Dette er hyppigst forekommet inden for 30 dage efter behandlingsstart og i forbindelse med kombinationskemoterapi.
English: This means that because of the rarity of this disease it has been impossible to get complete information on the reference medicine.
Danish: Det betyder, at det grundet sygdommens sjældenhed ikke har været muligt at indhente fuldstændige oplysninger om referencelægemidlet.
English: 82515 Wolfratshausen
Danish: 82515 Wolfratshausen Tyskland
English: Its antitumour activity is believed to be due to 3 mechanisms:
Danish: Dets tumorbekæmpende virkning menes at kunne henføres til 3 virkemåder:
English: It is a clear colourless solution that is prepared and diluted before it is used.
Danish: Det er en klar, farveløs opløsning, der tilberedes og fortyndes før brug.
English: Adult population (including elderly)
Danish: Voksen population (inklusive ældre)
English: Clofarabine was teratogenic in rats and rabbits.
Danish: Clofarabin var teratogent hos rotter og kaniner.
English: Systemic clearance
Danish: Systemisk clearance
English: However, the majority of these hypotensive events were reported in patients who had confounding severe infections.
Danish: De fleste af disse hypotensive episoder forekom dog hos patienter, som havde konfunderende svære infektioner.
English: • - (Number of patients with a CR + Number of patients with a CRp) ÷ Number of eligible patients who received clofarabine
Danish: • (Antal patienter med CR + antal patienter med CRp)antal valgbare patienter, der fik clofarabin
English: Men must also use effective contraception while they or their partner are treated with clofarabine.
Danish: Mænd skal ligeledes anvende sikker prævention, mens de eller deres partner behandles med clofarabin.
English: No carcinogenicity studies have been performed.
Danish: Carcinogenicitetsforsøg er ikke udført.
English: Clofarabine should not be used during pregnancy unless clearly necessary.
Danish: Clofarabin må ikke anvendes under graviditet, medmindre det er tvingende nødvendigt.
English: ORPHELIA Pharma
Danish: ANDET ORPHELIA Pharma
English: There are no data on the use of clofarabine in pregnant women.
Danish: Der foreligger ingen data om anvendelse af clofarabin til gravide kvinder.
English: Response durations are confounded in patients who received a HSCT.
Danish: Varighed af respons er konfunderet hos patienter, der fik HSCT.
English: Children < 1 year old
Danish: Børn under 1 år
English: It is unknown whether clofarabine or its metabolites are excreted in human breast milk.
Danish: Det vides ikke, om clofarabin eller dets metabolitter udskilles i human modermælk.
English: Accordingly, longer infusion times should be considered in children weighing < 20 kg (see section 4.2).
Danish: Længere infusionstid bør derfor overvejes hos børn, der vejer < 20 kg (se pkt.
English: Young men and women must use effective contraception during and after treatment.
Danish: Unge mænd og kvinder skal anvende sikker prævention under og efter behandlingen.
English: In addition, clofarabine treatment should be discontinued if the patient develops hypotension for any reason during the 5 days of administration.
Danish: Desuden bør behandling med clofarabin seponeres, hvis patienten udvikler hypotension under de fem dages administration, uanset årsagen.
English: Estimated creatinine clearance (ml/min)
Danish: Skønnet kreatininclearance (ml/min)
English: Clinical efficacy: To enable systematic evaluation of the responses seen in patients, an unblinded Independent Response Review Panel (IRRP) determined the following response rates based on definitions produced by the Children's Oncology Group:
Danish: Klinisk virkning: Med henblik på systematisk evaluering af de responser, som er set hos patienter, har et ublindet uafhængigt responsvurderingsudvalg (Independent Response Review Panel - IRRP) bestemt følgende responsrater baseret på definitioner udarbejdet af Children's Oncology Group:
English: Of the 17 ALL patients, 2 achieved a complete remission (12%; CR) and 2 a partial remission (12%; PR) at varying doses.
Danish: Ud af de 17 ALL-patienter opnåede 2 komplet remission (12 %, CR) og 2 partiel remission (12 %, PR) med forskellige doser.
English: If the product comes into contact with eyes, skin or mucous membranes, rinse immediately with copious amounts of water.
Danish: Hvis produktet kommer i kontakt med øjne, hud eller slimhinder, skal der øjeblikkeligt skylles med rigelige mængder vand.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne præsenteret i en rækkefølge med faldende alvorlighed.
English: If you think that you have missed a dose, tell your doctor straight away.
Danish: Hvis du mener, at du er gået glip af en dosis, skal du omgående fortælle det til din læge.
English: • Prophylactic administration of allopurinol should be considered if hyperuricemia (tumour lysis)
Danish: • Profylaktisk administration af allopurinol bør overvejes, hvis hyperurikæmi (tumorlyse)
English: • Recovery of peripheral counts (platelets ≥ 100 x 109/l and ANC ≥ 1.0 x 109/l)
Danish: • Det perifere blodbillede normaliseret (trombocyttal ≥ 100 x 109/l og ANC ≥ 1,0 x 109/l)
English: Your doctor will monitor your health and may change your dose depending on your response to the treatment.
Danish: Din læge vil holde øje med dit helbred og kan ændre doseringen i forhold til, hvordan du reagerer på behandlingen.
English: Cytotoxic medicinal products should be handled with caution.
Danish: Cytotoksiske lægemidler bør håndteres med forsigtighed.
English: MARKETING AUTHORISATION NUMBER EU/1/19/1396/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/19/1396/001
English: Administration of clofarabine resulted in a dramatic and rapid reduction in peripheral leukaemia cells in 31 of the 33 patients (94%) who had a measurable absolute blast count at baseline.
Danish: Administration af clofarabin medførte en dramatisk og hurtig reduktion af perifere leukæmiceller hos 31 ud af de 33 patienter (94 %), som havde et måleligt absolut blasttal ved baseline.
English: • Patients who met all of the criteria for a CR except for recovery of platelet counts to > 100 x 109/l
Danish: • Patienter, der overholder alle kriterierne for CR undtagen normalisering af trombocyttal til > 100 x 109/l
English: Special precautions for administration
Danish: Særlige forsigtighedsregler ved administration
English: Clofarabine is eliminated by a combination of renal and non-renal excretion.
Danish: Clofarabin elimineres via en kombination af renal og ikke-renal udskillelse.
English: The recommended dosage should be administered by intravenous infusion although it has been administered via a central venous catheter in ongoing clinical trials.
Danish: Den anbefalede dosis bør administreres som intravenøs infusion, selvom opløsningen er blevet administreret via et centralt venekateter i igangværende kliniske forsøg.
English: If the ANC does not recover by 6 weeks from the start of a treatment cycle, a bone marrow aspirate / biopsy should be performed to determine possible refractory disease.
Danish: Hvis ANC ikke er normaliseret 6 uger efter starten på en behandlingscyklus, bør der udføres knoglemarvsaspiration/-biopsi for at påvise eventuel refraktær sygdom.
English: However, Cmax is inversely proportional to patient weight and, therefore, small children may have a higher Cmax at the end of infusion than a typical 40 kg child given the same dose of clofarabine per m2.
Danish: Imidlertid er Cmax omvendt proportional med patientens vægt, og små børn kan derfor have et højere Cmax ved infusionens afslutning end et typisk barn på 40 kg, der får samme dosis clofarabin pr. m2.
English: • Disruption of mitochondrial membrane integrity with the release of cytochrome C and other proapoptotic factors leading to programmed cell death even in non-dividing lymphocytes.
Danish: • Nedbrydning af mitokondriel membranintegritet med frigivelse af cytochrom C og andre proapoptotiske faktorer, der medfører programmeret celledød selv hos lymfocytter som ikke er i deling.
English: If you forget to use Ivozall
Danish: Hvis du har glemt at få Ivozall
English: Toxicology studies of clofarabine in mice, rats and dogs showed that rapidly proliferating tissues were the primary target organs of toxicity.
Danish: Toksikologiske undersøgelser af clofarabin hos mus, rotter og hunde viste, at hurtigt profilerende væv var hovedmålorganerne for toksicitet.
English: • Complete blood and platelet counts should be obtained at regular intervals, more frequently in patients who develop cytopaenias.
Danish: • Komplet blodstatus og trombocyttal skal indhentes regelmæssigt, dog hyppigere hos patienter, som får cytopeni.
English: In addition, at initiation of treatment, most patients in the clinical studies had haematological impairment as a manifestation of leukaemia.
Danish: Ved initiering af behandlingen havde de fleste patienter i de kliniske forsøg desuden abnormt blodbillede som en manifestation af leukæmien.
English: These infections may lead to septic shock, respiratory failure, renal failure, and/or multi-organ failure.
Danish: Disse infektioner kan føre til septisk shock, respirationssvigt, nyresvigt, og/eller multiorgansvigt.
English: The minimal effects seen at lower doses suggest that there is a threshold for toxicities on the heart and nonlinear plasma pharmacokinetics in the rat may play a role in the observed effects.
Danish: Den mindste virkning observeret ved lavere doser tyder på, at der er en tærskel for hjertetoksicitet, og non-lineær plasmafarmakokinetik hos rotter kan medvirke til de observerede virkninger.
English: If a patient becomes pregnant during treatment with clofarabine, she should be informed of the possible hazard to the foetus.
Danish: Hvis en patient bliver gravid under behandlingen med clofarabin, skal hun informeres om den mulige risiko for fostret.
English: Clear, practically colourless solution with a pH of 4.5 to 7.5 and an osmolarity of 270 to 310 mOsm/l, free from visible particles.
Danish: En klar, næsten farveløs opløsning med pH 4,5 - 7,5 og osmolaritet på 270 - 310 mOsm/l, uden synlige partikler.
English: • Patients should receive intravenous fluids throughout the 5 day clofarabine administration period to reduce the effects of tumour lysis and other events.
Danish: • Patienterne skal have intravenøs væsketerapi i hele den 5 dage lange periode med administration af clofarabin for at nedsætte virkningerne af tumorlyse og andre hændelser.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C unless dilution has taken place under controlled and validated aseptic conditions.
Danish: Hvis det ikke bruges med det samme, er opbevaringstider og -forhold efter fortynding brugerens ansvar og bør sædvanligvis ikke overstige 24 timer ved 2-8 °C, medmindre fortynding har fundet sted under kontrollerede og validerede aseptiske forhold.
English: See section 2 “Ivozall contains sodium”.
Danish: 2 "Ivozall indeholder natrium".
English: Dose excreted in urine
Danish: Dosis udskilt med urinen
English: An infusion time of > 2 hours should be considered to help reduce symptoms of anxiety and irritability, and to avoid unduly high maximum concentrations of clofarabine (see section 5.2).
Danish: En infusionstid på > 2 timer bør overvejes med henblik på at bidrage til reduktion af symptomer såsom angst og irritabilitet og for at undgå unødigt høje maksimale koncentrationer af clofarabin (se pkt.
English: 75.4 to 124.8
Danish: 75,4 til 124,8
English: In the majority of patients (8/10), the pericardial effusion and pericarditis were deemed to be asymptomatic and of little or no clinical significance on echocardiographic assessment.
Danish: Hos de fleste patienter (8/10) ansås perikardiel ekssudation og pericarditis for at være asymptomatisk og uden eller kun med ubetydelig klinisk signifikans ifølge vurdering af ekkokardiogram.
English: Ivozall is used to treat children (≥ 1 year old), teenagers and young adults up to 21 years old with acute lymphoblastic leukaemia (ALL) when previous treatments have not worked or have stopped working.
Danish: Ivozall anvendes til at behandle børn (≥ 1 år) og unge i alderen op til 21 år med akut lymfoid leukæmi (ALL), når tidligere behandlinger ikke virkede eller er holdt op med at virke.
English: Ivozall is for intravenous use.
Danish: Ivozall er til intravenøs anvendelse.
English: Non-infectious events
Danish: Ikke-infektiøse hændelser
English: The European Medicines Agency will review any new information on the reference medicine every year and any updates for the reference medicine will also be included as appropriate in the information for Ivozall, such as this leaflet.
Danish: Det Europæiske Lægemiddelagentur vil hvert år vurdere nye oplysninger om referencelægemidlet, og eventuelle opdateringer for referencelægemidlet vil om nødvendigt også blive inkluderet i produktinformationen for Ivozall, såsom i denne indlægsseddel.
English: Your doctor will tell you when you need to be given this medicine.
Danish: Din læge giver dig besked, når du skal have behandlingen.
English: However, because of the potential for serious adverse reactions in nursing infants, breastfeeding should be discontinued prior to, during and following treatment with Ivozall (see section 4.3).
Danish: På grund af muligheden for alvorlige bivirkninger under amning af spædbørn skal amningen dog indstilles før, under og efter behandling med Ivozall (se pkt.
English: Patients should be monitored for signs and symptoms of infection and treated promptly.
Danish: Patienterne skal monitoreres for tegn og symptomer på infektion og behandles straks.
English: You need to allow for this if you are on a controlled sodium diet.
Danish: Du skal tage højde for dette, hvis du er på diæt med kontrolleret saltindhold.
English: This is equivalent to 3.08 mmol (or 70.77 mg) of sodium which is equivalent to 3.53% of the WHO recommended maximum daily intake of 2 g sodium for an adult and should be taken into consideration for patients on a controlled sodium diet.
Danish: Det svarer til 3,08 mmol (eller 70,77 mg) natrium, svarende til 3,53 % af den WHO anbefalede maksimale daglige indtagelse af 2 g natrium for en voksen, og der bør tages højde for dette hos patienter på diæt med kontrolleret natriumindhold.
English: Histological evidence of hepatic effects was seen in dogs following acute administration of high doses, but was also not accompanied by changes in serum chemistry.
Danish: Histologisk dokumentation af leverpåvirkning sås hos hunde efter akut administration af høje doser, men det var heller ikke ledsaget af forandringer i serumværdier.
English: Therefore, a safe and effective dosage recommendation for patients < 1 year old has yet to be established.
Danish: Det har derfor endnu ikke været muligt at fastsætte en sikker og effektiv dosisrekommandation for patienter under 1 år.
English: Total diluted volume 100 ml
Danish: Samlet fortyndet volumen 100 ml
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene for fremsendelse af PSUR´er for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: The diluted concentrate should be a clear, colourless solution.
Danish: Det fortyndede koncentrat bør være en klar, farveløs opløsning.
English: Each vial contains 70.77mg sodium (main component of cooking/table salt).
Danish: Et hætteglas indeholder 70,77 mg natrium (hovedbestanddelen i køkken-/bordsalt).
English: Clinical efficacy and safety
Danish: Klinisk virkning og sikkerhed:
English: Therapy must be initiated and supervised by a physician experienced in the management of patients with acute leukaemias.
Danish: Behandlingen skal indledes og superviseres af en læge med erfaring i behandling af patienter med akut leukæmi.
English: Haematuria was observed in 13% of patients overall.
Danish: Hæmaturi blev observeret hos 13 % af patienterne samlet set.
English: No apparent difference in pharmacokinetics was observed between patients with ALL or AML, or between males and females.
Danish: Der er tilsyneladende ingen forskel i farmakokinetikken hos patienter med ALL og AML, eller hos mænd og kvinder.
English: Forty-eight percent of patients had one or more ongoing infections prior to receiving treatment with clofarabine.
Danish: 48 % af patienterne havde haft en eller flere vedvarende infektioner før behandlingen med clofarabin.
English: Most of the cardiac adverse reactions were reported in the first 2 cycles.
Danish: De fleste af bivirkninger tilhørende hjerte organklassen blev indberettet inden for de første to cykler.
English: Common: Septic shock*, sepsis, bacteraemia, pneumonia, herpes zoster, herpes simplex, oral candidiasis
Danish: Almindelig: Septisk shock*, sepsis, bakteriæmi, pneumoni, herpes zoster, herpes simplex, oral candidiasis
English: Before enrolling in the trial, 58 of the 61 patients (95%) had received 2 to 4 different induction regimens and 18/61 (30%) of these patients had undergone at least 1 prior haematological stem cell transplant (HSCT).
Danish: Før de indgik i forsøget, havde 58 ud af 61 patienter (95 %) fået 2 til 4 forskellige induktionsregimer, og 18/61 (30 %) af disse patienter havde fået mindst 1 tidligere hæmatologisk stamcelletransplantation (HSCT).
English: Driving and using machines Do not drive or use any tools or machines if you feel dizzy, light-headed or faint.
Danish: Kør ikke bil og brug ikke værktøj eller maskiner, hvis du føler dig svimmel, omtåget eller er ved at besvime.
English: (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100; rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000)) in the table below.
Danish: Bivirkningerne er anført efter systemorganklasse og hyppighed (meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100; sjælden (≥ 1/10.000 til < 1/1.000) og meget sjælden (< 1/10.000)) i nedenstående tabel.
English: 125.3 to 130.0
Danish: 125,3 til 130,0
English: Very common: Febrile neutropenia Common: Neutropenia
Danish: Meget almindelig: Febril neutropeni Almindelig: Neutropeni
English: • DNA polymerase α inhibition resulting in termination of DNA chain elongation and/or DNA synthesis / repair.
Danish: • DNA-polymerase α-hæmning, der afslutter DNA-kædens elongering og/eller DNAsyntese/reparation.
English: Because of the pre-existing immuno-compromised condition of these patients and prolonged neutropaenia that can result from treatment with clofarabine, patients are at increased risk for severe opportunistic infections, including severe sepsis, with potentially fatal outcomes.
Danish: Som følge af disse patienters immunkompromitterede tilstand og den længerevarende neutropeni, som behandling med clofarabin kan resultere i, har patienterne øget risiko for svære opportunistiske infektioner, herunder svær sepsis med potentielt letalt udfald.
English: Two paediatric reports (1.7%) of veno-occlusive disease (VOD) were considered related to study drug.
Danish: To indberetninger fra pædiatriske patienter (1,7 %) om veneokklusion (VOD) blev anset for at være relateret til studielægemidlet.
English: Uncommon side effects (may affect up to 1 in 100 people): - inflammation of the liver (hepatitis).
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter): - inflammation i leveren (hepatitis) som kan være dødelig.
English: As the effect of clofarabine treatment on human fertility is unknown, reproductive planning should be discussed with patients as appropriate.
Danish: Da det ikke vides, hvordan clofarabinbehandlingen påvirker human fertilitet, bør familieplanlægning tages op med patienterne efter behov.
English: Where follow-up data are available, the majority of bilirubin elevations returned to ≤ grade 2
Danish: Hvor opfølgende data er til rådighed, returnerede størstedelen af stigningerne i bilirubin til ≤ grad 2 inden for 10 dage.
English: Nine of 17 ALL patients were treated with clofarabine 52 mg/m2/day.
Danish: Ni af 17 ALL-patienter blev behandlet med clofarabin 52 mg/m2/dag.
English: In this regard, patients should be closely monitored when clofarabine is used in combined regimens.
Danish: I denne forbindelse skal patienter monitoreres nøje, når clofarabin anvendes i kombinationsbehandlinger.
English: In addition, clofarabine is unlikely to inhibit any of the major 5 human CYP isoforms (1A2, 2C9, 2C19, 2D6 and 3A4) or to induce 2 of these isoforms (1A2 and 3A4) at the plasma concentrations achieved following intravenous infusion of 52 mg/m2/day.
Danish: Endvidere er det usandsynligt, at clofarabin skulle hæmme et af de 5 største humane CYP-isoformer (1A2, 2C9, 2C19, 2D6 og 3A4) eller inducere 2 af disse isoformer (1A2 og 3A4) ved de plasma-koncentrationer, der opnås efter en intravenøs infusion af 52 mg/m2/dag.
English: It should be visually inspected for particulate matter and discolouration prior to administration.
Danish: Den bør inspiceres visuelt for partikelindhold og misfarvning før administration.
English: • An M1 bone marrow (≤ 5% blasts)
Danish: • M1-knoglemarv (≤ 5 % blaster)
English: Before Ivozall is given to you, it will be diluted in a sodium chloride solution (salt and water).
Danish: Før du får Ivozall, bliver lægemidlet fortyndet i en saltvandsopløsning (natriumchlorid).