natgillin/translations-raw huggingface dataset:
Der foreligger ingen data om clofarabins farmakokinetik, sikkerhed eller effekt hos spædbørn.
There are no data on the pharmacokinetics, safety or efficacy of clofarabine in infants.
Almindelig: Perikardieeffusion*, takykardi,*
Common: Pericardial effusion*, tachycardia*
Clofarabin er et lægemiddel, der hører til gruppen af kræftmedicin.
Clofarabine is one of a family of medicines called anticancer medicines.
Fertilitetsforsøg er ikke udført.
No fertility studies have been conducted.
Hidtil er den højeste døgndosis administreret til mennesker 70 mg/m2 5 dage i træk (2 pædiatriske ALL-patienter).
To date, the highest daily dose administered to human beings is 70 mg/m2 for 5 consecutive days (2 paediatric ALL patients).
Patienter med fremskreden ALL eller AML kan have konfunderende lidelser, der gør det vanskeligt at vurdere kausaliteten af bivirkninger på grund af den tilgrundliggende sygdoms mange forskellige symptomer og dens progression samt ledsagende behandling med en lang række andre lægemidler.
Patients with advanced stages of ALL or AML may have confounding medical conditions that make causality of adverse events difficult to assess due to the variety of symptoms related to the underlying disease, its progression and the co-administration of numerous medicinal products.
In vitro-forsøg har vist, at clofarabin hæmmer cellevækst i og er cytotoksisk over for en lang række hurtigt prolifererende hæmatologiske og solide tumorcellelinier.
In vitro studies have demonstrated that clofarabine inhibits cell growth in and is cytotoxic to a variety of rapidly proliferating haematological and solid tumour cell lines.
Dosisafhængig toksicitet i de mandlige kønsorganer sås hos mus, rotter og hunde.
Dose related toxicities on male reproductive organs were observed in mice, rats and dogs.
Almindelig: Anoreksi, nedsat appetit, dehydrering Ikke kendt: Hyponatriæmi
Common: Anorexia, decreased appetite, dehydration Frequency not known: Hyponatremia
Grænsen for udviklingstoksicitetsforsøg ansås at være 6 mg/m2/dag hos rotter og 1,2 mg/m2/dag hos kaniner.
The threshold for developmental toxicity was considered to be 6 mg/m2/day in rats and 1.2 mg/m2/day in rabbits.
Lægemidlet må ikke blandes med andre lægemidler end dem, der er anført under pkt.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Kvinder, som kan blive gravide: Du skal anvende sikker prævention under behandling med clofarabin.
Women who are able to get pregnant: you must use effective contraception during treatment with clofarabine.
Meget almindelig: Palmar-plantar erytrodysæstesi, pruritus
Very common: Palmar-plantar erythrodysaesthesia syndrome, pruritus
Selv om forekomst af transplantationer ikke var et af studiets endepunkter, fik 10/61 patienter (16 %) HSCT efter behandling med clofarabin (af disse havde 3 opnået CR og 2 CRp, 3 havde opnået PR, 1 patient blev af IRRP henregnet under behandlingssvigt, og 1 blev af IRRP anset for ikke-evaluerbar).
Although transplantation rate was not a study endpoint, 10/61 patients (16%) went on to receive a HSCT after treatment with clofarabine (3 after achieving a CR, 2 after a CRp, 3 after a PR, 1 patient that was considered a treatment failure by the IRRP and 1 that was considered not evaluable by the IRRP).
Den mest almindelige nyretoksicitet hos pædiatriske patienter var forhøjet kreatinin.
The most prevalent renal toxicity in paediatric patients was elevated creatinine.
Farmakoterapeutisk klassifikation: Antineoplastiske midler, antimetabolitter, purin-analoger, ATCkode: L01BB06
Pharmacotherapeutic group: Antineoplastic agents, antimetabolites, purine analogues, ATC code: L01BB06.
2,41 til 2,50
2.41 to 2.50
Patienter, der ikke gennemgik transplantation CR
Patients who did not undergo transplant
De foreliggende oplysninger er baseret på data fra kliniske forsøg, hvor 115 patienter (> 1 og ≤ 21 år) enten med ALL eller akut myeloid leukæmi (AML) fik mindst én dosis clofarabin i den anbefalede dosis på 52 mg/m dagligt x 5.
The information provided is based on data generated from clinical trials in which 115 patients (> 1 and ≤ 21 years old) with either ALL or acute myeloid leukaemia (AML) received at least one dose of clofarabine at the recommended dose of 52 mg/m2 daily x 5.
Patienter med ALL måtte ikke være egnet til behandling med et større kurativt potentiale og skulle være nået til andet eller senere recidiv og/eller være refraktære, dvs. de havde ikke opnået remission efter mindst de sidste to regimer.
Patients with ALL must not have been eligible for therapy of higher curative potential and must have been in second or subsequent relapse and/or refractory i.e. failed to achieve remission after at least two prior regimens.
Der foreligger kun begrænsede data om sikkerhed og effekt af clofarabin ved anvendelse ud over 3 behandlingscykler.
There are currently limited data on the safety and efficacy of clofarabine when administered for more than 3 treatment cycles.
Hvis du ammer, skal du indstille amningen, før du begynder at få clofarabin, og du må ikke amme under din behandling og i 3 måneder efter afslutning af din behandling.
If you are breast-feeding, you must stop breast-feeding before starting the treatment, and must not breast-feed during your treatment and within 3 months after completion of your treatment.
De hyppigste hæmatologiske laboratorieanomalier, der blev observeret hos patienter, som blev behandlet med clofarabin, var anæmi (83,3 %; 95/114); leukopeni (87,7 %; 100/114); lymfopeni (82,3 %; 93/113), neutropeni (63,7 %; 72/113) og trombocytopeni (80,7 %; 92/114).
The most frequent haematological laboratory abnormalities observed in patients treated with clofarabine were anaemia (83.3%; 95/114); leucopaenia (87.7%; 100/114); lymphopaenia (82.3%; 93/113), neutropaenia (63.7%; 72/113), and thrombocytopaenia (80.7%; 92/114).The majority of these events were of grade ≥ 3.
Fortæl lægen, hvis du bruger anden medicin eller har gjort det for nyligt: - hjertemedicin (f.eks. amiodaron, valsartan); - medicin, der påvirker blodtrykket (f.eks. captopril, propranolol); - medicin, der påvirker lever (f.eks. paracetamol, diclofenac) eller nyrer (f.eks. ibuprofen,
Tell your doctor if you are using or have recently used: - medicines for heart disease (e.g. amiodarone, valsartan); - any medicine that changes your blood pressure (e.g. captopril, propranolol); - medicines that affect your liver (e.g. paracetamol, diclofenac) or kidneys (e.g. ibuprofen,
Det var kendetegnet ved en mindre fortykkelse af den glomerulære basalmembran og kun mindre beskadigelse af tubuli og var ikke forbundet med forandringer i diverse serumværdier.
It was characterised by minor thickening of the glomerular basement membrane with only slight tubular damage and was not associated with changes in serum chemistry.
(9,1 til 42)
(9.1 to 42)
De rapporteredes at medføre eksponering (Cmax), der var ca. 7-13 gange (efter mindst 3 behandlingscykler) eller 16-35 gange (efter en til flere behandlingscykler) højere end klinisk eksponering.
They were reported at exposure levels (Cmax) approximately 7 to 13 fold (after 3 or more dosing cycles) or 16 to 35 fold (after one or more dosing cycles) higher than clinical exposures.
Det skyldtes sandsynligvis de øgede degenerative og regenerative forandringer på grund af behandlingscyklerne og var ikke forbundet med forandringer i serumværdier.
These likely represent the superimposition of degenerative and regenerative changes as a result of treatment cycles, and were not associated with changes in serum chemistry.
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ENHEDER 20 mg/20 ml
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 20 mg/20 ml
Behandling med Ivozall er ordineret til dig af en speciallæge med erfaring i behandling af leukæmi.
Your treatment with Ivozall has been prescribed by a qualified doctor experienced in treating leukaemia.
(4,6 til 38,3)
(4.6 to 38.3)
Hvis en patient udvikler en klinisk betydningsfuld infektion, kan clofarabin seponeres, indtil infektionen er velkontrolleret.
If a patient develops a clinically significant infection, clofarabine treatment may be withheld until the infection is clinically controlled.
Patienterne bør dog oplyses om, at de kan få bivirkninger i form af svimmelhed, uklarhed eller besvimelsesanfald under behandlingen, og at de i så fald ikke bør køre bil eller betjene maskiner.
However, patients should be advised that they may experience undesirable effects such as dizziness, light-headedness or fainting spells during treatment and told not to drive or operate machines in such circumstances.
De fleste tilfælde af forhøjet ALAT og ASAT forekom inden for 10 dage efter administration af clofarabin og returnerede til ≤ grad 2 inden for 15 dage.
ALT and AST occurred within 10 days of clofarabine administration and returned to ≤ grade 2 within 15 days.
Fertile kvinder og seksuelt aktive mænd skal anvende sikker kontraception under behandlingen.
Females of childbearing potential and sexually active males must use effective methods of contraception during treatment.
Det blev observeret, at frekvensen og bivirkningernes sværhedsgrad, især infektion, knoglemarvssuppression (neutropeni) og hepatotoksicitet, er øget, når clofarabin anvendes i kombinationsbehandling.
It was observed that the frequency and severity of adverse reactions, in particular infection, myelosuppression (neutropenia) and hepatotoxicity, are increased when clofarabine is used in in combination.
Incidensen af disse toksiciteter afhang af såvel den indgivne dosis clofarabin som behandlingsvarighed.
The incidence of these toxicities was dependent on both the dose of clofarabine administered and the duration of treatment.
Der er påvist kemisk og fysisk stabilitet i 7 dage ved stuetemperatur og på køl (2-8 °C) i et koncentrationsområde på 0,15-0,83 mg/ml efter fortynding med natriumchlorid 9 mg/ml (0,9 %).
Chemical and physical in-use stability has been demonstrated for seven days at room temperature and under refrigeration (2°C - 8°C) at a concentration range of 0.15 mg/ml to 0.83 mg/ml after dilution with sodium chloride 9 mg/ml (0.9%).
*ITT = intention to treat **Patienter, der var i live og i remission på tidspunktet for sidste opfølgning, indgik på dette tidspunkt i analysen.
**Patients alive and in remission at the time of last follow up were censored at that time point for the analysis.
Der er indberettet alvorlige hepatotoksiske hændelser i et fase 1/2-kombinationsstudie med anvendelse af clofarabin til pædiatriske patienter med recidiveret eller refraktær akut leukæmi.
Severe hepatotoxic events have been reported in a Phase 1/2 combination study of clofarabine in paediatric patients with relapsed or refractory acute leukaemia.
Clofarabin er en purin-nukleosid-antimetabolit.
Clofarabine is a purine nucleoside anti-metabolite.
Patienterne skal informeres om at søge læge, hvis de får symptomer på svimmelhed, besvimelsesanfald eller nedsat urinproduktion.
Patients should be instructed to seek medical advice if they experience symptoms of dizziness, fainting spells, or decreased urine output.
Endvidere besidder clofarabin større modstandsevne over for cellulær nedbrydning af adenosindeaminase og mindre modtagelighed for phosphorolytisk spaltning end andre aktive stoffer i denne klasse, mens clofarabintriphosphats affinitet til DNA-polymerase α og ribonukleotidreduktase svarer til eller overstiger affiniteten til deoxyadenosintriphosphat.
In addition, clofarabine possesses greater resistance to cellular degradation by adenosine deaminase and decreased susceptibility to phosphorolytic cleavage than other active substances in its class whilst the affinity of clofarabine triphosphate for DNA polymerase α and ribonucleotide reductase is similar to or greater than that of deoxyadenosine triphosphate.
Fortæl din læge, hvis et af disse punkter passer på dig.
Tell your doctor if any of these conditions apply to you.
Ivozall er et potent antineoplastisk middel, som kan have betydelige hæmatologiske og ikkehæmatologiske bivirkninger (se pkt.
Ivozall is a potent antineoplastic agent with potentially significant haematological and non-haematological adverse reactions (see section 4.8).
Da clofarabin imidlertid ikke metaboliseres af cytochrom P450- (CYP-) enzymsystemet, er de renale eliminationsprocesser aktuelt ikke afdækket.
However, as clofarabine is not detectably metabolised by the cytochrome P450 (CYP) enzyme system, pathways of non-renal elimination currently remain unknown.
Clofarabin metaboliseres ikke i påviselig grad via cytochrom P450-(CYP)-enzymsystemet.
Clofarabine is not detectably metabolised by the cytochrome P450 (CYP) enzyme system.
Blødningshændelser er blevet observeret i forbindelse med trombocytopeni.
Bleeding events have been observed in the setting of thrombocytopaenia.
Patienter, der tidligere har fået et hæmatopoietisk stamcelletransplantat (HSCT), kan have øget risiko for hepatotoksicitet, der tyder på veneokklusion (VOD), efter behandling med clofarabin (40 mg/m2), når det anvendes sammen med etoposid (100 mg/m2) og cyclophosphamid (440 mg/m2).
Patients who have previously received a hematopoietic stem cell transplant (HSCT) may be at higher risk for hepatotoxicity suggestive of veno-occlusive disease (VOD) following treatment with clofarabine (40 mg/m2) when used in combination with etoposide (100 mg/m2) and cyclophosphamide (440 mg/m2).
Intravenøs infusion af clofarabin 52 mg/m2 gav samme eksponering inden for et stort vægtområde.
Intravenous infusion of 52 mg/m2 clofarabine produced equivalent exposure across a wide range of weights.
En sammenhæng mellem eksponering for clofarabin eller clofarabintriphosphat og enten effekt eller toksicitet er ikke påvist hos denne population.
No relationship between clofarabine or clofarabine triphosphate exposure and either efficacy or toxicity has been established in this population.
Endvidere havde 50/113 patienter, der fik clofarabin, svært forhøjet ALAT (mindst NCI-CTC-grad 3), 36/100 havde forhøjet ASAT og 15/114 patienter forhøjet bilirubin.
In addition, 50/113 patients receiving clofarabine had at least severely (at least US NCI CTC Grade 3) elevated ALT, 36/100 elevated AST and 15/114 elevated bilirubin levels.
Procedurerne for korrekt håndtering af antineoplastiske midler skal overholdes.
Procedures for proper handling of antineoplastic agents should be observed.
Hos rotter sås hjertepåvirkning, der svarede til kardiomyopati og fremstod som symptomer på hjerteinsufficiens efter gentagne behandlingscykler.
Cardiac effects were observed in rats consistent with cardiomyopathy and contributed to signs of cardiac failure after repeated cycles of treatment.
13 tilfælde af tumorlysesyndrom, kapillær lækagesyndrom eller SIRS er blevet indberettet; SIRS (2 tilfælde, som begge blev anset for alvorlige), kapillær lækage-syndrom (4 tilfælde, hvoraf 3 blev anset for at være alvorlige og relaterede) og tumorlysesyndrom (7 tilfælde, hvoraf 6 blev anset for relaterede og 3 for at være alvorlige).
Thirteen events of tumour lysis syndrome, capillary leak syndrome or SIRS have been reported; SIRS (2 events; both were considered to be serious), capillary leak syndrome (4 events; 3 of which were considered serious and related) and tumour lysis syndrome (7 events; 6 of which were considered related and 3 of which were serious).
Perikardiel ekssudation var imidlertid klinisk signifikant hos 2 patienter, som var noget hæmodynamisk kompromitterede.
However, the pericardial effusion was clinically significant in 2 patients with some associated haemodynamic compromise.
Benigne, maligne og uspecificerede tumorer (inkl.cyster og polypper) og immunsystemet Administration af clofarabin medfører et hurtigt fald i perifere leukæmiceller.
Neoplasms benign and malignant (including cysts and polyps) and Immune systems disorders Administration of clofarabine results in a rapid reduction in peripheral leukaemia cells.
Clofarabin bør omgående seponeres i tilfælde af voldsomme stigninger i kreatinin, leverenzymer og/eller bilirubin.
Clofarabine should be discontinued immediately if substantial increases in creatinine, liver enzymes and/or bilirubin are observed.
Patienterne bør monitoreres for renal toksicitet og clofarabin bør seponeres om nødvendigt.
Patients should be monitored for renal toxicity and clofarabine should be discontinued as necessary.
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 %).
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%).
Glomerulonefropati rapporteredes hos rotter efter 3-5 gange større eksponering end det kliniske AUC efter 6 behandlingscykler med clofarabin.
Glomerulonephropathy was reported in rats at exposure levels 3 to 5 fold higher than the clinical AUC after 6 dosing cycles of clofarabine.
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.
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.
I tilfælde af en yderligere klinisk betydningsfuld infektion bør clofarabin seponeres, indtil infektionen er velkontrolleret, og den kan genoptages, hvis dosis reduceres med 25 %.
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.
Endvidere forhalede clofarabin tumorvækst og medførte i nogle tilfælde tumorregression hos en række humane og murine tumorxenoplantater implanteret hos mus.
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.
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.
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.
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.
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.
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.
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.
Hver æske indeholder 1 hætteglas.
Each box contains 1 vial.
For at undgå væskemangel er det vigtigt at drikke rigeligt vand.
It is important to drink plenty of water to avoid dehydration.
Inden indledning af hver cyklus skal legemsoverfladen beregnes ud fra patientens faktiske højde og vægt.
Body surface area must be calculated using the actual height and weight of the patient before the start of each cycle.
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.
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.
Anvendelse til patienter med alvorlig nyreinsufficiens eller svært nedsat leverfunktion.
Use in patients with severe renal insufficiency or severe hepatic impairment.
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.
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.
Profylaktisk behandling med antiemetika bør overvejes.
Prophylactic anti-emetic medicinal products should be considered.
Total overlevelse (uger)
Overall Survival (weeks)
Til patienter med moderat nyreinsufficiens (kreatininclearance 30 - <60 ml/min) skal dosis reduceres med 50 % (se pkt.
Patients with moderate renal impairment (creatinine clearance 30 - < 60 ml/min) require a 50% dose reduction (see section 5.2).
Hos rotter sås leverpåvirkning efter kronisk administration af clofarabin.
Hepatic effects were observed in rats following chronic administration of clofarabine.
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.
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.
Clofarabin var også virksomt mod hvilende lymfocytter og makrofager.
It was also active against quiescent lymphocytes and macrophages.
Clofarabins farmakokinetik blev undersøgt hos 40 patienter mellem 2 og 19 år med recidiverende eller refraktær ALL eller AML.
The pharmacokinetics of clofarabine were studied in 40 patients aged between 2 to 19 years old with relapsed or refractory ALL or AML.
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.
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.
MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLAS
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
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.
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.
Knoglemarvssuppression må forventes.
Suppression of bone marrow should be anticipated.