natgillin/translations-raw huggingface dataset:
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.
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.
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.
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).
Median tid til progression (uger)**
Median time to progression (weeks)** (95% CI)
For instruktioner om fortynding af lægemidlet før administration, se pkt.
For instructions on dilution of the medicinal product before administration (see section 6.6).
Almindelig: Kontusion
Common: Contusion
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).
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).
ANVENDELSESMETODE Læs indlægssedlen inden brug
METHOD OF ADMINISTRATION Read the package leaflet before use
CRp = Komplet remission uden fuldstændig normalisering af trombocyttal
CRp = Complete remission in the Absence of Total Platelet Recovery
Hætteglas af type I-glas med en grå fluorpolymer-belagt klorobutyl-gummiprop, flip-off plombering af polypropylen og aluminiumsforsegling.
Type I glass vial with grey chlorobutyl fluoropolymer coated rubber stopper, polypropylene flip-off cap and aluminium overseal.
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 %.
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%.
Dosisreduktion hos patienter med hæmatologisk toksicitet
Dose reduction for patients experiencing haematological toxicities
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 20 mg/20 ml
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 20 mg/20 ml
Almindelig: Hyperbilirubinæmi, gulsot, veneokklusion, stigninger i alanin- (ALAT)* og aspartat- (ASAT)* aminotransferaser, leversvigt Ikke almindelig: Hepatitis
Common: Hyperbilirubinaemia, jaundice, veno-occlusive disease, increases in alanine (ALT)* and aspartate (AST)* aminotransferases, hepatic failure Uncommon: Hepatitis
50 % af patienterne fik mindst én bivirkning tilhørende hjerte organklassen.
Fifty percent of patients experienced at least one cardiac disorders adverse reaction.
Almindelig: Overfølsomhed
Common: Hypersensitivity
Leveren er et potentielt organ for clofarabintoksicitet, og 25,2 % af patienterne oplevede mindst ét tilfælde af bivirkninger fra lever- og galdeveje (se pkt.
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).
Øvrige indholdsstoffer: Natriumchlorid og vand til injektionsvæsker.
The other ingredients are sodium chloride and water for injections.
Clofarabins clearance synes at være langt hurtigere end den glomerulære filtrationshastighed, hvilket indikerer, at elimination via nyrerne foregår som filtration og tubulær sekretion.
Clofarabine clearance rates appear to be much higher than glomerular filtration rates suggesting filtration and tubular secretion as kidney elimination mechanisms.
De fleste patienter, som responderer på clofarabin, opnår respons efter 1 - 2 behandlingscykler (se pkt.
The majority of patients who respond to clofarabine achieve a response after 1 or 2 treatment cycles (see section 5.1).
• Nyre- og leverfunktion skal kontrolleres før og efter behandlingen samt i løbet af aktiv behandling.
• Renal and hepatic function prior to, during active treatment and following therapy.
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.
One patient discontinued treatment due to grade 4 hyperbilirubinaemia considered as related to clofarabine after receiving 52 mg/m2/day clofarabine.
Patienter, der gennemgik transplantation under fortsat remission* CRp
Patients who underwent transplant while in continued remission*
Plasmaproteinbinding Serum-albumin Elimination:
Plasma protein binding Serum albumin Elimination: β half-life of clofarabine
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.
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.
Studiets hovedresultater for effekt gengives i tabellen nedenfor.
The table below summarises the key efficacy results for this study.
Hovedstudiets effektresultater hos patienter (≤ 21 år ved første diagnosticering) med recidiverende eller refraktær ALL efter mindst to forudgående behandlingsregimer Responskategori
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
Brug af anden medicin sammen med Ivozall
Other medicines and Ivozall
Størstedelen af de rapporterede tilfælde var forbundet med trombocytopeni (se pkt.
The majority of the cases were associated with thrombocytopaenia (see section 4.8).
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.
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.
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.
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
EVENTUELLE ANDRE SÆRLIGE ADVARSLER Cytostatikum
OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Intravenøs anvendelse efter fortynding Skal fortyndes før brug.
METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use after dilution Dilute before use.
Instruktioner vedrørende håndtering
Instructions for handling
Opbevaringsforhold efter fortynding af lægemidlet, se pkt.
For storage conditions after dilution of the medicinal product, see section 6.3
Almindelig: Agitation, rastløshed, ændring i mental status
Very common: Anxiety Common: Agitation, restlessness, mental status change
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.
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.
De forgiftninger, der observeredes hos disse patienter, omfattede opkastning, hyperbilirubinæmi, forhøjede aminotransferaser og makulopapulært udslæt.
The toxicities observed in these patients included vomiting, hyperbilirubinaemia, elevated transaminase levels and maculo-papular rash.
(6,7 til 12,6)
(6.7 to 12.6)
Dosisreduktion hos patienter med ikke-hæmatologisk toksicitet:
Dose reduction for patients experiencing non-haematological toxicities
Tilfælde af enterocolitis, herunder neutropenisk colitis, caecitis og C. difficile colitis, er blevet indberettet under behandling med clofarabin.
Occurrences of enterocolitis, including neutropaenic colitis, caecitis, and C. difficile colitis, have been reported during treatment with clofarabine.
Clofarabin skal seponeres, hvis der forekommer udslæt med afskalning af huden eller bulløst udslæt, eller hvis der er mistanke om SJS eller TEN.
Clofarabine must be discontinued for exfoliative or bullous rash, or if SJS or TEN is suspected.
LÆGEMIDLETS NAVN OG ADMINISTRATIONSVEJ(E) Ivozall 1 mg/ml sterilt koncentrat clofarabin
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ivozall 1 mg/ml sterile concentrate clofarabine
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.
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).
Infektiøse hændelser
Infectious events
Det skal du vide, før du begynder at få Ivozall
What you need to know before you use Ivozall
Patienter, der gennemgik transplantation efter alternativ behandling eller recidiv* CRp
Patients who underwent transplant after alternative therapy or relapse*
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).
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).
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.
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.
CR * Remissionsvarighed vurderet på tidspunktet for transplantation ** Patient gennemgik transplantation efter alternativ behandling *** Patient gennemgik transplantation efter recidiv
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'.
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.
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.
Blødninger, herunder cerebrale, gastrointestinale og pulmonale blødninger er rapporteret og kan være dødelige.
Haemorrhage, including cerebral, gastrointestinal and pulmonary haemorrhage, has been reported and may be fatal.
Clorafabins indflydelse på evnen til at føre bil og betjene maskiner er ikke undersøgt.
No studies on the effects of clofarabine on the ability to drive and use machines have been performed.
• M2-knoglemarv (≥ 5 % og ≤ 25 % blaster)udseende som for normale progenitorceller
• 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
Forsinket ovarieatrofi eller degeneration og apoptose i endometriet optrådte hos hunmus ved den eneste anvendte dosis clofarabin på 225 mg/m2/dag.
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.
Clofarabin udskilles hovedsageligt via nyrerne.
Clofarabine is predominately excreted via the kidneys.
Behandlingssvigt
Treatment failure
Ældre (> 65 år)
Elderly (≥ 65 years old)
Clofarabintriphosphats halveringstid
Half-life of clofarabine triphosphate
Median varighed af remission (uger)
Duration of Remission (weeks)
6 tilfælde ansås for at være relateret til clofarabin, hvoraf følgende ansås for at være alvorlige: Akut cholecystitis (1 tilfælde), cholelithiasis (1 tilfælde), hepatocellulær skade (1 tilfælde, hvor patienten døde (se ovenfor)) og hyperbilirubinæmi (1 tilfælde, hvor patienterne indstillede behandlingen (se ovenfor)).
Six events were considered to be related to clofarabine of which acute cholecystitis (1 event), cholelithiasis (1 event), hepatocellular damage (1 event; patient died (see above)) and hyperbilirubinaemia (1 event; the patient discontinued therapy (see above)) were considered to be serious.
(66,6 til -)
(66.6 to -)
Imidlertid blev clofarabins farmakokinetik hos voksne med recidiverende eller refraktær AML efter administration af en enkelt dosis clofarabin på 40 mg/ m2 givet som intravenøs infusion over 1 time sammenlignet med farmakokinetikken beskrevet ovenfor hos patienter mellem 2 og 19 år med recidiverende eller refraktær ALL eller AML efter administration af clofarabin 52 mg/m2 som intravenøs infusion over 2 timer 5 dage i træk.
However, the pharmacokinetics of clofarabine in adults with relapsed or refractory AML following administration of a single dose of 40 mg/m2 clofarabine by intravenous infusion over 1 hour were comparable to those described above in patients aged between 2 to 19 years old with relapsed or refractory ALL or AML following administration of 52 mg/m2 clofarabine by intravenous infusion over 2 hours for 5 consecutive days.
Det bør filtreres gennem et sterilt 0,2 mikrometer sprøjtefilter (brug af et hydrofilt PVDF-sprøjtefilter anbefales) og derefter fortyndes med en natriumchlorid 9 mg/ml (0,9 %) intravenøs infusion for at frembringe et samlet volumen i henhold til eksemplerne i tabellen nedenfor.
It should be filtered through a sterile 0.2 micrometre syringe filter (the use of hydrophilic PVDF syringe filter is recommended) ) and then diluted with sodium chloride 9 mg/ml (0.9%) intravenous infusion to produce a total volume according to the examples given in the table below.
forventes.
is expected.
Hvis en patient ved en senere lejlighed atter oplever den samme alvorlige forgiftning, skal behandlingen indstilles, indtil laboratorieundersøgelserne er vendt tilbage til baselineværdier, eller toksicitetsreaktionerne ikke længere er alvorlige, og fordelene ved fortsat behandling med clofarabin overstiger risikoen ved at fortsætte.
Should a patient experience the same severe toxicity on a second occasion, treatment should be delayed until the toxicity resolves to baseline parameters or to the point where it is no longer severe and the potential benefit of continued treatment with clofarabine outweighs the risk of such continuation.
Svær knoglemarvssuppression, herunder neutropeni, anæmi og trombocytopeni, er observeret hos patienter, der blev behandlet med clofarabin.
Severe bone marrow suppression, including neutropaenia, anaemia and thrombocytopaenia have been observed in patients treated with clofarabine.
64 patienter ud af 115 (55,7 %) fik mindst én vaskulær bivirkning.
Sixty-four patients of 115 (55.7%) experienced at least one vascular disorders adverse reaction.
(42,0 til -)
(42.0 to -)
Patienter i behandling med clofarabin bør evalueres og kontrolleres for symptomer på henfald af tumorceller og frigivelse af cytokin (f.eks. takypnø, takykardi, hypotension, lungeødem), som kan udvikle sig til systemisk inflammatorisk respons-syndrom (SIRS), kapillær lækage-syndrom og/eller organdysfunktion (se pkt.
Patients undergoing treatment with clofarabine should be evaluated and monitored for signs and symptoms of tumour lysis syndrome and cytokine release (e.g. tachypnoea, tachycardia, hypotension, pulmonary oedema) that could develop into Systemic Inflammatory Response Syndrome (SIRS), capillary leak syndrome and/or organ dysfunction (see section 4.8).
Meget almindelig: Hovedpine Almindelig: Døsighed, perifer neuropati, paræstesi, svimmelhed, tremor
Very common: Headache Common: Somnolence, peripheral neuropathy, paraesthesia, dizziness, tremor
Imidlertid tyder de foreliggende data på, at clofarabin akkumuleres hos disse patienter (se nedenstående figur)
However, these data indicate that clofarabine may accumulate in such patients (see figure below).
Tilfælde af hepatitis og leversvigt, inklusive tilfælde med dødeligt udfald, er blevet rapporteret ved clofarabinbehandling (se pkt.
Cases of hepatitis and hepatic failure, including fatal outcomes, have been reported with clofarabine treatment (see section 4.8).
Brug af engangshandsker og beskyttelsestøj anbefales ved håndtering af clofarabin.
The use of disposable gloves and protective garments is recommended when handling clofarabine.
21 hændelser (18,3 %) ansås for at være relateret til clofarabin, og følgende ansås for alvorlige: kateterrelateret infektion (1 tilfælde), sepsis (2 tilfælde) og septisk shock (2 tilfælde, 1 patient døde (se ovenfor)).
Twenty-one (18.3%) events were considered to be related to clofarabine of which catheter related infection (1 event), sepsis (2 events) and septic shock (2 events; 1 patient died (see above)) were considered to be serious.
Clofarabins AUC0-24 timer for kreatininclearance bestemt ved baseline hos patienter mellem 2 - 19 år med recidiverende eller refraktær ALL eller AML (n = 11 / n = 12) efter administration af gentagne doser af clofarabin som intravenøs infusion (kreatininclearance bestemt i henhold til Schwartz's formel)
Clofarabine AUC0-24 hours by baseline estimated creatinine clearance in patients aged between 2 to 19 years old with relapsed or refractory ALL or AML (n = 11 / n = 12) following administration of multiple doses of clofarabine by intravenous infusion (creatinine clearance estimated using Schwartz formula)
Stevens-Johnsons syndrom (SJS) og toksisk epidermal nekrolyse (TEN), herunder tilfælde med letalt udfald, er blevet rapporteret (se pkt.
Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), including fatal cases, have been reported (see section 4.8).
68 patienter (59 %) fik mindst én alvorlig bivirkning, der kunne henføres til clofarabin.
Sixty-eight patients (59%) experienced at least one serious clofarabine-related adverse event.
(3,4 til 5,1)
(3.4 to 5.1)
Der er observeret nyresvigt eller akut nyresvigt som følge af infektioner, sepsis og tumorlysesyndrom (se pkt.
Renal failure or acute renal failure have been observed as a consequence of infections, sepsis and tumour lysis syndrome (see section 4.8).
Hvert af hætteglassene indeholder 20 ml koncentrat infusionsvæske, opløsning, og de er pakket i en æske.
The vials contain 20 ml concentrate for solution for infusion and are packaged in a box.
Reproduktionstoksicitet inklusive teratogenicitet er set i dyreforsøg (se pkt.
Studies in animals have shown reproductive toxicity including teratogenicity (see section 5.3).
(58,67 til -)
(58.6 to -)
Under håndtering af Ivozall anbefales brug af engangshandsker og beskyttelsestøj.
The use of disposable gloves and protective garments is recommended when handling Ivozall.
Ivozall indeholder:
What Ivozall contains
Den anbefalede dosis i monoterapi er 52 mg/m legemsoverflade og administreres som intravenøs infusion over 2 timer dagligt 5 dage i træk.
The recommended dose in monotherapy is 52 mg/m2 of body surface area administered by intravenous infusion over 2 hours daily for 5 consecutive days.
Efter markedsføring er alvorlige hepatotoksiske reaktioner på VOD hos pædiatriske og voksne patienter, der har fået behandling med clofarabin, blevet associeret med letalt udfald.
In the post-marketing period, following treatment with clofarabine, serious hepatotoxic adverse reactions of VOD in paediatric and adult patients have been associated with a fatal outcome.
41 patienter ud af 115 (35,7 %) fik mindst én bivirkning fra nyrer eller urinveje.
Forty-one patients of 115 (35.7%) experienced at least one renal and urinary disorders adverse reaction.
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN ORPHELIA Pharma
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Clofarabins sikkerhedsprofil er ikke klarlagt hos patienter med svær nyreinsufficiens eller hos patienter, som er i dialyse (se afsnit 4.3).
The safety profile of clofarabine has not been established in patients with severe renal insufficiency or patients receiving renal replacement therapy (see section 4.3).
Hvis en patient oplever en eller flere alvorlige toksicitetsreaktioner (grad 3 toksicitet ifølge det amerikanske National Cancer Institutes Common Toxicity Criteria (NCI-CTC) eksklusive kvalme og opkastning), skal behandlingen udsættes, indtil laboratorieundersøgelser er vendt tilbage til baselineværdier, eller toksicitetsreaktionerne ikke længere er alvorlige, og de potentielle fordele ved fortsat behandling med clofarabin overstiger risikoen ved at fortsætte.
If a patient experiences one or more severe toxicities (US National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grade 3 toxicities excluding nausea and vomiting), treatment should be delayed until the toxicities resolve to baseline parameters or to the point where they are no longer severe and the potential benefit of continued treatment with clofarabine outweighs the risk of such continuation.
23 patienter ud af 115 fik en vaskulær bivirkning, der blev anset for at være relateret til clofarabin, hvoraf den hyppigst rapporterede var flushing (13 ikke alvorlige tilfælde) og hypotension (5 tilfælde, hvoraf alle ansås for alvorlig, se pkt.
Twenty-three patients out of 115 experienced a vascular disorder considered to be related to clofarabine, the most frequently reported being flushing (13 events; not serious) and hypotension (5 events; all of which were considered to be serious; see section 4.4).
(9,7 til 47,9)
(9.7 to 47.9)
Den maksimale tolererede dosis clofarabin identificeret i det ovenfor beskrevne fase I-studie, 52 mg/m2/dag, blev administreret som intravenøs infusion 5 dage i træk hver 2.
The maximum tolerated dose identified in the phase I study described above of 52 mg/m2/day clofarabine was administered by intravenous infusion for 5 consecutive days every 2 to 6 weeks.
Erfaringsgrundlaget er endnu utilstrækkeligt til at påvise sikkerhed og effekt af clofarabin hos patienter på 65 år og derover.
There are currently insufficient data to establish the safety and efficacy of clofarabine in patients 65 years of age or older.
(15,4 til 56,1)
(15.4 to 56.1)