FrancophonIA/ELRC3.0 huggingface dataset:
English: Neoplasms benign and malignant (including cysts and polyps) and Immune systems disorders Administration of clofarabine results in a rapid reduction in peripheral leukaemia cells.
Danish: Benigne, maligne og uspecificerede tumorer (inkl.cyster og polypper) og immunsystemet Administration af clofarabin medfører et hurtigt fald i perifere leukæmiceller.
English: Clofarabine should be discontinued immediately if substantial increases in creatinine, liver enzymes and/or bilirubin are observed.
Danish: Clofarabin bør omgående seponeres i tilfælde af voldsomme stigninger i kreatinin, leverenzymer og/eller bilirubin.
English: Patients should be monitored for renal toxicity and clofarabine should be discontinued as necessary.
Danish: Patienterne bør monitoreres for renal toksicitet og clofarabin bør seponeres om nødvendigt.
English: Those most frequently reported were nausea (61% of patients), vomiting (59%), febrile neutropaenia (35%), headache (24%), rash (21%), diarrhoea (20%), pruritus (20%), pyrexia (19%), palmar-plantar erythrodysaesthesia syndrome (15%), fatigue (14%), anxiety (12%), mucosal inflammation (11%), and flushing (11%).
Danish: De hyppigst rapporterede bivirkninger var kvalme (61 % af patienterne), opkastning (59 %), febril neutropeni (35 %), hovedpine (24 %), udslæt (21 %), diarre (20 %), pruritus (20 %), pyreksi (19 %), palmar-plantar erytrodysæstesi-syndrom (15 %), træthed (14 %), angst (12 %), slimhindeinflammation (11 %) og flushing (11 %).
English: Glomerulonephropathy was reported in rats at exposure levels 3 to 5 fold higher than the clinical AUC after 6 dosing cycles of clofarabine.
Danish: Glomerulonefropati rapporteredes hos rotter efter 3-5 gange større eksponering end det kliniske AUC efter 6 behandlingscykler med clofarabin.
English: A multi-centre, phase II, open-label, non-comparative study of clofarabine was conducted to determine the overall remission (OR) rate in heavily pretreated patients (≤ 21 years old at initial diagnosis) with relapsed or refractory ALL defined using the French-American-British classification.
Danish: Et fase II-, åbent, non-komparativt multicenterstudie med clofarabin blev udført for at bestemme total remission (TR) hos tungt behandlede patienter (≤ 21 år ved første diagnosticering) med recidiverende eller refraktær ALL defineret i henhold til fransk-amerikansk-britisk klassifikation.
English: In the event of a second clinically significant infection, clofarabine treatment should be withheld until the infection is clinically controlled and may be reinitiated at a 25% dose reduction.
Danish: I tilfælde af en yderligere klinisk betydningsfuld infektion bør clofarabin seponeres, indtil infektionen er velkontrolleret, og den kan genoptages, hvis dosis reduceres med 25 %.
English: In addition, clofarabine delayed tumour growth and, in some cases, caused tumour regression in an assortment of human and murine tumour xenografts implanted in mice.
Danish: Endvidere forhalede clofarabin tumorvækst og medførte i nogle tilfælde tumorregression hos en række humane og murine tumorxenoplantater implanteret hos mus.
English: Clofarabine should be discontinued immediately if patients show early signs or symptoms of SIRS, capillary leak syndrome or substantial organ dysfunction and appropriate supportive measures instituted.
Danish: Clofarabin bør omgående seponeres, hvis patienten udviser nogle af de tidlige symptomer på SIRS, kapillær lækage-syndrom eller omfattende organdysfunktion, og passende understøttende behandling iværksættes.
English: Population pharmacokinetic data from adult and paediatric patients suggest that patients with stable moderate renal impairment (creatinine clearance 30 - < 60 ml/min) receiving a 50% dose reduction achieve similar clofarabine exposure to those with normal renal function receiving a standard dose.
Danish: Farmakokinetiske populationsdata fra voksne og pædiatriske patienter tyder på, at patienter med stabil, moderat nyreinsufficiens (kreatininclearance 30 - < 60 ml/min), der får halv dosis, opnår en clofarabineksponering svarende til personer med normal nyrefunktion, som får standarddosis.
English: Genotoxicity studies demonstrated that clofarabine was not mutagenic in the bacterial reverse mutation assay, but did induce clastogenic effects in the non-activated chromosomal aberration assay in Chinese Hamster Ovary (CHO) cells and in the in vivo rat micronucleus assay.
Danish: Genotoksicitetsforsøg viste, at clofarabin ikke var mutagent i en tilbagemutationstest med bakterier, men var klastogent i en ikke-aktiveret kromosomal aberrationstest af ovarieceller fra kinesiske hamstere og i en in vivo-mikronukleustest hos rotter.
English: Each box contains 1 vial.
Danish: Hver æske indeholder 1 hætteglas.
English: It is important to drink plenty of water to avoid dehydration.
Danish: For at undgå væskemangel er det vigtigt at drikke rigeligt vand.
English: Body surface area must be calculated using the actual height and weight of the patient before the start of each cycle.
Danish: Inden indledning af hver cyklus skal legemsoverfladen beregnes ud fra patientens faktiske højde og vægt.
English: There is no clinical study experience in paediatric patients with renal insufficiency (defined in clinical studies as serum creatinine ≥ 2 x ULN for age) and clofarabine is predominately excreted via the kidneys.
Danish: Der er ingen erfaring fra kliniske studier hos pædiatriske patienter med nyreinsufficiens (defineret i kliniske undersøgelser som serum-kreatinin ≥ 2 x ULN for aldersgruppen), og clofarabin udskilles hovedsageligt via nyrerne.
English: Use in patients with severe renal insufficiency or severe hepatic impairment.
Danish: Anvendelse til patienter med alvorlig nyreinsufficiens eller svært nedsat leverfunktion.
English: Three patients died of adverse events considered by the study investigator to be related to treatment with clofarabine: one patient died from respiratory distress, hepatocellular damage, and capillary leak syndrome; one patient from VRE sepsis and multi-organ failure; and one patient from septic shock and multi-organ failure.
Danish: Tre patienter døde af bivirkninger, som af forsøgets investigator blev anset for at være relateret til clofarabin: Én patient døde af respirationshæmning, hepatocellulær skade og kapillær lækage-syndrom; én døde af vancomycinresistent Enterococcus-sepsis (VRE-sepsis) og multiorgansvigt; og én døde af septisk shock og multiorgansvigt.
English: Prophylactic anti-emetic medicinal products should be considered.
Danish: Profylaktisk behandling med antiemetika bør overvejes.
English: Overall Survival (weeks)
Danish: Total overlevelse (uger)
English: Patients with moderate renal impairment (creatinine clearance 30 - < 60 ml/min) require a 50% dose reduction (see section 5.2).
Danish: Til patienter med moderat nyreinsufficiens (kreatininclearance 30 - <60 ml/min) skal dosis reduceres med 50 % (se pkt.
English: Hepatic effects were observed in rats following chronic administration of clofarabine.
Danish: Hos rotter sås leverpåvirkning efter kronisk administration af clofarabin.
English: The safety and efficacy of clofarabine were evaluated in a phase I, open-label, non-comparative, doseescalation study in 25 paediatric patients with relapsed or refractory leukaemia (17 ALL; 8 AML) who had failed standard therapy or for whom no other therapy existed.
Danish: Clofarabins sikkerhed og effekt blev evalueret i et fase I, åbent, non-komparativt dosiseskaleringsstudie med 25 pædiatriske patienter med recidiverende eller refraktær leukæmi (17 ALL, 8 AML), som ikke havde opnået bedring med standardbehandling, eller som ikke kunne få anden behandling.
English: It was also active against quiescent lymphocytes and macrophages.
Danish: Clofarabin var også virksomt mod hvilende lymfocytter og makrofager.
English: The pharmacokinetics of clofarabine were studied in 40 patients aged between 2 to 19 years old with relapsed or refractory ALL or AML.
Danish: Clofarabins farmakokinetik blev undersøgt hos 40 patienter mellem 2 og 19 år med recidiverende eller refraktær ALL eller AML.
English: If you are the parent of a child who is being treated with Ivozall, tell the doctor if any of them apply to your child.
Danish: Hvis du er forælder til et barn, som bliver behandlet med Ivozall, skal du fortælle lægen, hvis et af disse punkter passer på dit barn.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLAS
English: It will be given to you as an infusion through a long thin tube which goes into a vein (a drip), or into a small medical appliance that is inserted under the skin (port-a-cath) if you (or your child) have one implanted.
Danish: Du får medicinen via et drop - det vil sige som infusion gennem en lang tynd slange i en vene (drop), eller i en lille medicinsk enhed, der indsættes under huden (centralt venekateter), hvis du (eller dit barn) har fået indlagt et sådant.
English: Suppression of bone marrow should be anticipated.
Danish: Knoglemarvssuppression må forventes.
English: Do not use Ivozall - - if you are allergic to clofarabine or any of the other ingredients of this medicine (listed in section 6); - if you are breast-feeding (please read the section “Pregnancy and breast-feeding” below); - if you have severe kidney or liver problems.
Danish: Begynd ikke at få Ivozall: - hvis du er allergisk (overfølsom) over for clofarabin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6); - hvis du ammer (se afsnittet 'Graviditet og amning'); - hvis du lider af en alvorlig lever- eller nyresygdom.
English: The patients were enrolled into a single phase I (n = 12) or two phase II (n = 14 / n = 14) safety and efficacy studies, and received multiple doses of clofarabine by intravenous infusion (see section 5.1).
Danish: Disse patienter indgik i en enkelt fase I-undersøgelse (n = 12) eller to fase II-undersøgelser (n = 14 / n = 14) af sikkerhed og effekt, hvor de fik gentagne doser clofarabin som intravenøs infusion (se pkt.
English: Median time to progression (weeks)** (95% CI)
Danish: Median tid til progression (uger)**
English: For instructions on dilution of the medicinal product before administration (see section 6.6).
Danish: For instruktioner om fortynding af lægemidlet før administration, se pkt.
English: Common: Contusion
Danish: Almindelig: Kontusion
English: Three of these events were subsequently assessed as being related to clofarabine: pericardial effusion (2 events; 1 of which was serious) and pericarditis (1 event; not serious).
Danish: Tre af disse tilfælde blev efterfølgende vurderet til at være relateret til clofarabin: perikardiel ekssudation (to tilfælde, hvoraf et var alvorligt) og pericarditis (et tilfælde, der ikke var alvorligt).
English: METHOD OF ADMINISTRATION Read the package leaflet before use
Danish: ANVENDELSESMETODE Læs indlægssedlen inden brug
English: CRp = Complete remission in the Absence of Total Platelet Recovery
Danish: CRp = Komplet remission uden fuldstændig normalisering af trombocyttal
English: Type I glass vial with grey chlorobutyl fluoropolymer coated rubber stopper, polypropylene flip-off cap and aluminium overseal.
Danish: Hætteglas af type I-glas med en grå fluorpolymer-belagt klorobutyl-gummiprop, flip-off plombering af polypropylen og aluminiumsforsegling.
English: Should patients experience an ANC < 0.5 × 109/l for more than 4 weeks from the start of the last cycle, it is recommended that the dose for the next cycle be reduced by 25%.
Danish: Til patienter, hos hvem ANC holder sig < 0,5 × 109/l i over 4 uger efter start på den forudgående cyklus, anbefales det at reducere dosis til næste cyklus med 25 %.
English: Dose reduction for patients experiencing haematological toxicities
Danish: Dosisreduktion hos patienter med hæmatologisk toksicitet
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 20 mg/20 ml
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 20 mg/20 ml
English: Common: Hyperbilirubinaemia, jaundice, veno-occlusive disease, increases in alanine (ALT)* and aspartate (AST)* aminotransferases, hepatic failure Uncommon: Hepatitis
Danish: Almindelig: Hyperbilirubinæmi, gulsot, veneokklusion, stigninger i alanin- (ALAT)* og aspartat- (ASAT)* aminotransferaser, leversvigt Ikke almindelig: Hepatitis
English: Fifty percent of patients experienced at least one cardiac disorders adverse reaction.
Danish: 50 % af patienterne fik mindst én bivirkning tilhørende hjerte organklassen.
English: Common: Hypersensitivity
Danish: Almindelig: Overfølsomhed
English: The liver is a potential target organ for clofarabine toxicity and 25.2% of patients experienced at least one hepato-biliary disorders adverse reaction (see sections 4.3 and 4.4).
Danish: Leveren er et potentielt organ for clofarabintoksicitet, og 25,2 % af patienterne oplevede mindst ét tilfælde af bivirkninger fra lever- og galdeveje (se pkt.
English: The other ingredients are sodium chloride and water for injections.
Danish: Øvrige indholdsstoffer: Natriumchlorid og vand til injektionsvæsker.
English: Clofarabine clearance rates appear to be much higher than glomerular filtration rates suggesting filtration and tubular secretion as kidney elimination mechanisms.
Danish: Clofarabins clearance synes at være langt hurtigere end den glomerulære filtrationshastighed, hvilket indikerer, at elimination via nyrerne foregår som filtration og tubulær sekretion.
English: The majority of patients who respond to clofarabine achieve a response after 1 or 2 treatment cycles (see section 5.1).
Danish: De fleste patienter, som responderer på clofarabin, opnår respons efter 1 - 2 behandlingscykler (se pkt.
English: • Renal and hepatic function prior to, during active treatment and following therapy.
Danish: • Nyre- og leverfunktion skal kontrolleres før og efter behandlingen samt i løbet af aktiv behandling.
English: One patient discontinued treatment due to grade 4 hyperbilirubinaemia considered as related to clofarabine after receiving 52 mg/m2/day clofarabine.
Danish: En patient afbrød behandlingen på grund af hyperbilirubinæmi grad 4, der blev anset for at være relateret til clofarabin, efter at have fået clofarabin 52 mg/m2/dag.
English: Patients who underwent transplant while in continued remission*
Danish: Patienter, der gennemgik transplantation under fortsat remission* CRp
English: Plasma protein binding Serum albumin Elimination: β half-life of clofarabine
Danish: Plasmaproteinbinding Serum-albumin Elimination:
English: Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response.
Danish: Behandling af pædiatriske patienter med recidiverende eller refraktær akut lymfatisk leukæmi (ALL), efter at de har fået mindst to tidligere behandlingsregimer, og hos hvem ingen andre behandlingsformer forventes at kunne opnå et varigt respons.
English: The table below summarises the key efficacy results for this study.
Danish: Studiets hovedresultater for effekt gengives i tabellen nedenfor.
English: Efficacy results from the pivotal study in patients (≤ 21 years old at initial diagnosis) with relapsed or refractory ALL after at least two prior regimens
Danish: Hovedstudiets effektresultater hos patienter (≤ 21 år ved første diagnosticering) med recidiverende eller refraktær ALL efter mindst to forudgående behandlingsregimer Responskategori
English: Other medicines and Ivozall
Danish: Brug af anden medicin sammen med Ivozall
English: The majority of the cases were associated with thrombocytopaenia (see section 4.8).
Danish: Størstedelen af de rapporterede tilfælde var forbundet med trombocytopeni (se pkt.
English: Increases in postimplantation loss, reduced foetal body weights and decreased litter sizes together with increases in the number of malformations (gross external, soft tissue) and skeletal alterations (including retarded ossification) were reported in rats receiving doses which produced approximately 2 to 3 fold the clinical exposure (54 mg/m2/day) and in rabbits receiving 12 mg/m2/day clofarabine.
Danish: En øget forekomst af fostertab efter implantation, reduceret føtal legemsvægt og reduceret kuldstørrelse sammen med et øget antal misdannelser (store eksterne misdannelser, bløde væv) og skeletale forandringer (inklusive forsinket ossifikation) rapporteredes hos rotter, der fik clofarabin i doser, som svarede til ca. 2-3 gange den kliniske eksponering (54 mg/m2/dag), og hos kaniner, der fik 12 mg/m2/dag.
English: Patients with cardiac disease and those taking medicinal products known to affect blood pressure or cardiac function should be closely monitored during treatment with clofarabine (see sections 4.5 and
Danish: Patienter med hjertesygdom eller patienter, som tager lægemidler, der er kendt for at påvirke blodtryk eller hjertefunktion, bør kontrolleres nøje under behandling med clofarabin (se pkt.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Cytostatikum
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use after dilution Dilute before use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Intravenøs anvendelse efter fortynding Skal fortyndes før brug.
English: Instructions for handling
Danish: Instruktioner vedrørende håndtering
English: For storage conditions after dilution of the medicinal product, see section 6.3
Danish: Opbevaringsforhold efter fortynding af lægemidlet, se pkt.
English: Very common: Anxiety Common: Agitation, restlessness, mental status change
Danish: Almindelig: Agitation, rastløshed, ændring i mental status
English: Stevens - Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), including fatal cases, have been reported in patients who were receiving or had recently been treated with clofarabine.
Danish: Stevens-Johnsons syndrom (SJS) og toksisk epidermal nekrolyse (TEN), herunder tilfælde med letalt udfald, er blevet rapporteret hos patienter, som bliver eller for nylig er blevet behandlet med clofarabin.
English: The toxicities observed in these patients included vomiting, hyperbilirubinaemia, elevated transaminase levels and maculo-papular rash.
Danish: De forgiftninger, der observeredes hos disse patienter, omfattede opkastning, hyperbilirubinæmi, forhøjede aminotransferaser og makulopapulært udslæt.
English: (6.7 to 12.6)
Danish: (6,7 til 12,6)
English: Dose reduction for patients experiencing non-haematological toxicities
Danish: Dosisreduktion hos patienter med ikke-hæmatologisk toksicitet:
English: Occurrences of enterocolitis, including neutropaenic colitis, caecitis, and C. difficile colitis, have been reported during treatment with clofarabine.
Danish: Tilfælde af enterocolitis, herunder neutropenisk colitis, caecitis og C. difficile colitis, er blevet indberettet under behandling med clofarabin.
English: Clofarabine must be discontinued for exfoliative or bullous rash, or if SJS or TEN is suspected.
Danish: Clofarabin skal seponeres, hvis der forekommer udslæt med afskalning af huden eller bulløst udslæt, eller hvis der er mistanke om SJS eller TEN.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ivozall 1 mg/ml sterile concentrate clofarabine
Danish: LÆGEMIDLETS NAVN OG ADMINISTRATIONSVEJ(E) Ivozall 1 mg/ml sterilt koncentrat clofarabin
English: Systemic inflammatory response syndrome (SIRS) or capillary leak syndrome SIRS, capillary leak syndrome (signs and symptoms of cytokine release, e.g., tachypnea, tachycardia, hypotension, pulmonary oedema) were reported as an adverse reaction in 5% (6/115) of paediatric patients (5 ALL, 1 AML) (see section 4.4).
Danish: Systemisk inflammatorisk responssyndrom (SIRS) eller kapillær lækage-syndrom SIRS, kapillær lækage-syndrom (tegn og symptomer på frigivelse af cytokiner, f.eks. takypnø, takykardi, hypotension, lungeødem) rapporteredes som bivirkninger hos 5 % (6/115) af de pædiatriske patienter (5 med ALL, 1 med AML) (se pkt.
English: Infectious events
Danish: Infektiøse hændelser
English: What you need to know before you use Ivozall
Danish: Det skal du vide, før du begynder at få Ivozall
English: Patients who underwent transplant after alternative therapy or relapse*
Danish: Patienter, der gennemgik transplantation efter alternativ behandling eller recidiv* CRp
English: These effects included bilateral degeneration of the seminiferous epithelium with retained spermatids and atrophy of interstitial cells in rats at exaggerated exposure levels (150 mg/m2/day), and cell degeneration of the epididymis and degeneration of the seminiferous epithelium in dogs at clinically relevant exposure levels (≥ 7.5 mg/m2/day clofarabine).
Danish: Disse virkninger omfattede bilateral degeneration af epitel i tubuli seminiferi med retention af spermatider og atrofi af interstitielle celler hos rotter ved meget høje eksponeringsniveauer af clofarabin (150 mg/m2/dag), og celledegeneration i epididymis samt degeneration af epitel i tubuli seminiferi hos hunde ved klinisk relevant eksponeringsniveauer (> 7,5 mg/m2/dag).
English: Dosing commenced at 11.25 with escalation to 15, 30, 40, 52 and 70 mg/m2/day by intravenous infusion for 5 days every 2 to 6 weeks depending on toxicity and response.
Danish: Administration begyndte med en dosis på 11,25 og eskalerede til 15, 30, 40, 52 og 70 mg/ m2/dag som intravenøs infusion i 5 dage hver 2.
English: CR * Duration of remission censored at the time of transplant ** Patient received a transplant following alternate therapy *** Patient received a transplant following relapse The reference medicinal product containing clofarabine has been authorised under ‘exceptional circumstances'.
Danish: CR * Remissionsvarighed vurderet på tidspunktet for transplantation ** Patient gennemgik transplantation efter alternativ behandling *** Patient gennemgik transplantation efter recidiv
English: Multivariate analysis showed that the pharmacokinetics of clofarabine are weight dependent and although white blood cell (WBC) count was identified as having an impact on clofarabine pharmacokinetics, this did not appear sufficient to individualise a patient's dosage regimen based on their WBC count.
Danish: En multivariatanalyse viste, at clofarabins farmakokinetik er vægtafhængig, og selvom det fremgik, at leukocyttallet påvirker clofarabins farmakokinetik, syntes dette ikke at være tilstrækkeligt til at fastsætte den enkelt patients behandlingsregime ud fra vedkommendes leukocyttal.
English: Haemorrhage, including cerebral, gastrointestinal and pulmonary haemorrhage, has been reported and may be fatal.
Danish: Blødninger, herunder cerebrale, gastrointestinale og pulmonale blødninger er rapporteret og kan være dødelige.
English: ITT* patients (n = 61)
Danish: (n = 61)
English: No studies on the effects of clofarabine on the ability to drive and use machines have been performed.
Danish: Clorafabins indflydelse på evnen til at føre bil og betjene maskiner er ikke undersøgt.
English: • An M2 bone marrow (≥ 5% and ≤ 25% blasts) and appearance of normal progenitor cells • An M1 marrow that did not qualify for CR or CRp
Danish: • M2-knoglemarv (≥ 5 % og ≤ 25 % blaster)udseende som for normale progenitorceller
English: Delayed ovarian atrophy or degeneration and uterine mucosal apoptosis were observed in female mice at the only dose used of 225 mg/m2/day clofarabine.
Danish: Forsinket ovarieatrofi eller degeneration og apoptose i endometriet optrådte hos hunmus ved den eneste anvendte dosis clofarabin på 225 mg/m2/dag.
English: Clofarabine is predominately excreted via the kidneys.
Danish: Clofarabin udskilles hovedsageligt via nyrerne.
English: Treatment failure
Danish: Behandlingssvigt
English: Elderly (≥ 65 years old)
Danish: Ældre (> 65 år)
English: Half-life of clofarabine triphosphate
Danish: Clofarabintriphosphats halveringstid
English: Duration of Remission (weeks)
Danish: Median varighed af remission (uger)