FrancophonIA/ELRC3.0 huggingface dataset:
English: • Respiratory status, blood pressure, fluid balance and weight throughout and immediately after the 5 day clofarabine administration period.
Danish: • Respirationsstatus, blodtryk, væskebalance og vægt bør kontrolleres løbende under og umiddelbart efter de fem dages aktiv behandling med clofarabin.
English: within 10 days.
Danish: - 6. uge.
English: Ivozall contains the active substance clofarabine.
Danish: Ivozall indeholder det aktive stof clofarabin.
English: Safety and efficacy have been assessed in studies of patients ≤ 21 years old at initial diagnosis (see section 5.1).
Danish: Sikkerhed og effekt er evalueret i undersøgelser med patienter ≤ 21 år på diagnosticeringstidspunktet (se pkt.
English: However, possible symptoms of overdose are expected to include nausea, vomiting, diarrhoea and severe bone marrow suppression.
Danish: Symptomerne på overdosering forventes dog at omfatte kvalme, opkastning, diarre og svær knoglemarvssuppression.
English: The no-observable effect level for maternal toxicity in rats was 18 mg/m2/day and in rabbits was more than 12 mg/m2/day.
Danish: Det ikke-observerbare effektniveau for maternel toksicitet hos rotter var 18 mg/m2/dag, mens det hos kaniner var over 12 mg/m2/dag.
English: Pericardial effusion and pericarditis were reported as an adverse reaction in 9% (10/115) of patients.
Danish: Perikardiel ekssudation og pericarditis optrådte som bivirkning hos 9 % (10/115) af patienterne.
English: Ivozall must not be mixed with or concomitantly administered using the same intravenous line as other medicinal products (see section 6.2).
Danish: Ivozall må ikke blandes med eller administreres samtidig med andre lægemidler via det samme intravenøse drop (se pkt.
English: If persistent leukaemia is not evident, it is recommended that the dose for the next cycle be reduced by 25% of the previous dose following recovery of ANC to ≥ 0.75 × 109/l.
Danish: Hvis der ikke er tegn på persisterende leukæmi, anbefales det at reducere dosis til næste cyklus med 25 % i forhold til den forudgående dosis, efter at ANC atter er ≥0,75 x 109/l.
English: However, the final dilution volume may vary depending on the patient's clinical status and physician discretion.
Danish: Volumenet af den færdige opløsning kan dog variere noget afhængigt af patientens kliniske status og lægens skøn.
English: Tell your doctor if you are on a controlled sodium diet as it could affect how you will be given your medicine.
Danish: Du skal informere din læge, hvis du er på diæt med kontrolleret natriumindhold, da det kan påvirke hvordan du skal have medicinen.
English: • Ribonucleotide reductase inhibition with reduction of cellular deoxynucleotide triphosphate (dNTP) pools.
Danish: • Hæmning af ribonukleotidreduktase med reduktion af cellulære deoxynukleotidphosphat-pools (dNTP-pools).
English: Ivozall is for single use only.
Danish: Ivozall er kun til engangsbrug.
English: The following parameters should be closely monitored in patients undergoing treatment with clofarabine:
Danish: Det er vigtigt at overvåge følgende parametre nøje hos patienter i behandling med clofarabin:
English: Nearly all patients (98%) experienced at least one adverse event considered by the study investigator to be related to clofarabine.
Danish: Næsten alle patienter (98 %) fik mindst én bivirkning, der af investigator ansås for at være relateret til clofarabin.
English: Patients should be monitored for signs and symptoms of enterocolitis.
Danish: Patienter skal overvåges for tegn og symptomer på enterocolitis.
English: Most patients received conditioning regimens that included busulfan, melphalan, and/or the combination of cyclophosphamide and total body irradiation.
Danish: De fleste patienter fik bestemte regimer, der indeholdt busulfan, mephalan og/eller kombination af cyclophosphamid og helkropsbestråling.
English: ORPHELIA Pharma 85 boulevard Saint-Michel 75005 PARIS France
Danish: 85 boulevard Saint-Michel 75005 Paris
English: Clofarabine may cause serious birth defects when administered during pregnancy.
Danish: Clofarabin kan medføre alvorlige medfødte misdannelser, når det gives under graviditet.
English: There is currently limited experience of patients receiving more than 3 treatment cycles (see section 4.4).
Danish: Der er endnu kun begrænsede erfaringer med patienter, der har fået over 3 behandlingscykler (se pkt.
English: Clofarabine has high affinity for one of the activating phosphorylating enzymes, deoxycytidine kinase, which exceeds that of the natural substrate, deoxycytidine.
Danish: Clofarabin har høj affinitet til et af de aktiverende phosphorylerende enzymer, deoxycytidinkinase, som overstiger affiniteten til det naturlige substrat deoxycytidin.
English: Adverse reactions considered to be related to clofarabine reported at frequencies ≥ 1/1,000 (i.e. in > 1/115 patients) in clinical trials and post-marketing
Danish: Bivirkninger, der anses for at være relateret til clofarabin, og som blev rapporteret i kliniske forsøg med hyppighed ≥ 1/1000 (dvs. hos > 1/115 patienter) og efter markedsføring
English: If you use more Ivozall than you should If you think you may have been given too much medicine, tell your doctor straight away.
Danish: Hvis du har fået for meget Ivozall Hvis du tror, at du har fået for meget medicin, skal du omgående fortælle det til din læge.
English: Patients receiving clofarabine may experience vomiting and diarrhoea; they should, therefore, be advised regarding appropriate measures to avoid dehydration.
Danish: Patienter, der får clofarabin, kan kaste op og få diarre og skal derfor rådgives om foranstaltninger, der kan forebygge dehydrering.
English: Do not use this medicine after the expiry date which is stated on the vial label and box after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på hætteglassets etiket og på æsken efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Ivozall contains sodium
Danish: Ivozall indeholder natrium
English: Therefore, it is unlikely to interact with active substances which inhibit or induce cytochrome P450 enzymes.
Danish: Derfor er det usandsynligt, at clofarabin skulle reagere med aktive stoffer, der hæmmer eller inducerer cytochrom P450-enzymer.
English: A total of 83% of patients experienced at least 1 infection after clofarabine treatment, including fungal, viral and bacterial infections (see section 4.4).
Danish: I alt 83 % af patienterne fik mindst 1 infektion efter behandling med clofarabin, herunder svampe-, virus- og bakterieinfektioner (se pkt.
English: Storage at low temperatures, i.e. below 15°C, might lead to formation of particles, which can be redissolved by letting the vial warm to room temperature and gentle swirling until all visible particles have dissolved.
Danish: Opbevaring ved lave temperaturer, dvs. under 15 °C, kan medføre dannelse af partikler, som kan opløses igen ved at lade hætteglasset opnå stuetemperatur og forsigtigt omryste det, indtil alle synlige partikler er forsvundet.
English: 1.45 to 2.40
Danish: 1,45 til 2,40
English: Clofarabine must first diffuse or be transported into target cells where it is sequentially phosphorylated to the mono- and bi-phosphate by intracellular kinases, and then finally to the active conjugate, clofarabine 5'-triphosphate.
Danish: Clofarabin må først diffundere eller transporteres til målceller, hvor det fortløbende phosphoryleres til mono- og biphosphat af intracellulære kinaser og til sidst til det aktive konjugat clofarabin5'-triphosphat.
English: There are no data on the pharmacokinetics, safety or efficacy of clofarabine in infants.
Danish: Der foreligger ingen data om clofarabins farmakokinetik, sikkerhed eller effekt hos spædbørn.
English: Common: Pericardial effusion*, tachycardia*
Danish: Almindelig: Perikardieeffusion*, takykardi,*
English: Clofarabine is one of a family of medicines called anticancer medicines.
Danish: Clofarabin er et lægemiddel, der hører til gruppen af kræftmedicin.
English: No fertility studies have been conducted.
Danish: Fertilitetsforsøg er ikke udført.
English: To date, the highest daily dose administered to human beings is 70 mg/m2 for 5 consecutive days (2 paediatric ALL patients).
Danish: Hidtil er den højeste døgndosis administreret til mennesker 70 mg/m2 5 dage i træk (2 pædiatriske ALL-patienter).
English: 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.
Danish: 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.
English: 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.
Danish: In vitro-forsøg har vist, at clofarabin hæmmer cellevækst i og er cytotoksisk over for en lang række hurtigt prolifererende hæmatologiske og solide tumorcellelinier.
English: Dose related toxicities on male reproductive organs were observed in mice, rats and dogs.
Danish: Dosisafhængig toksicitet i de mandlige kønsorganer sås hos mus, rotter og hunde.
English: Common: Anorexia, decreased appetite, dehydration Frequency not known: Hyponatremia
Danish: Almindelig: Anoreksi, nedsat appetit, dehydrering Ikke kendt: Hyponatriæmi
English: The threshold for developmental toxicity was considered to be 6 mg/m2/day in rats and 1.2 mg/m2/day in rabbits.
Danish: Grænsen for udviklingstoksicitetsforsøg ansås at være 6 mg/m2/dag hos rotter og 1,2 mg/m2/dag hos kaniner.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Lægemidlet må ikke blandes med andre lægemidler end dem, der er anført under pkt.
English: Women who are able to get pregnant: you must use effective contraception during treatment with clofarabine.
Danish: Kvinder, som kan blive gravide: Du skal anvende sikker prævention under behandling med clofarabin.
English: Very common: Palmar-plantar erythrodysaesthesia syndrome, pruritus
Danish: Meget almindelig: Palmar-plantar erytrodysæstesi, pruritus
English: 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).
Danish: 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).
English: The most prevalent renal toxicity in paediatric patients was elevated creatinine.
Danish: Den mest almindelige nyretoksicitet hos pædiatriske patienter var forhøjet kreatinin.
English: Pharmacotherapeutic group: Antineoplastic agents, antimetabolites, purine analogues, ATC code: L01BB06.
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, antimetabolitter, purin-analoger, ATCkode: L01BB06
English: 2.41 to 2.50
Danish: 2,41 til 2,50
English: Patients who did not undergo transplant
Danish: Patienter, der ikke gennemgik transplantation CR
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: There are currently limited data on the safety and efficacy of clofarabine when administered for more than 3 treatment cycles.
Danish: Der foreligger kun begrænsede data om sikkerhed og effekt af clofarabin ved anvendelse ud over 3 behandlingscykler.
English: 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.
Danish: 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.
English: 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.
Danish: 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).
English: 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,
Danish: 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,
English: 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.
Danish: 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.
English: (9.1 to 42)
Danish: (9,1 til 42)
English: 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.
Danish: 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.
English: 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.
Danish: Det skyldtes sandsynligvis de øgede degenerative og regenerative forandringer på grund af behandlingscyklerne og var ikke forbundet med forandringer i serumværdier.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 20 mg/20 ml
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ENHEDER 20 mg/20 ml
English: Your treatment with Ivozall has been prescribed by a qualified doctor experienced in treating leukaemia.
Danish: Behandling med Ivozall er ordineret til dig af en speciallæge med erfaring i behandling af leukæmi.
English: (4.6 to 38.3)
Danish: (4,6 til 38,3)
English: If a patient develops a clinically significant infection, clofarabine treatment may be withheld until the infection is clinically controlled.
Danish: Hvis en patient udvikler en klinisk betydningsfuld infektion, kan clofarabin seponeres, indtil infektionen er velkontrolleret.
English: 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.
Danish: 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.
English: ALT and AST occurred within 10 days of clofarabine administration and returned to ≤ grade 2 within 15 days.
Danish: 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.
English: Females of childbearing potential and sexually active males must use effective methods of contraception during treatment.
Danish: Fertile kvinder og seksuelt aktive mænd skal anvende sikker kontraception under behandlingen.
English: 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.
Danish: Det blev observeret, at frekvensen og bivirkningernes sværhedsgrad, især infektion, knoglemarvssuppression (neutropeni) og hepatotoksicitet, er øget, når clofarabin anvendes i kombinationsbehandling.
English: The incidence of these toxicities was dependent on both the dose of clofarabine administered and the duration of treatment.
Danish: Incidensen af disse toksiciteter afhang af såvel den indgivne dosis clofarabin som behandlingsvarighed.
English: 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%).
Danish: 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 %).
English: **Patients alive and in remission at the time of last follow up were censored at that time point for the analysis.
Danish: *ITT = intention to treat **Patienter, der var i live og i remission på tidspunktet for sidste opfølgning, indgik på dette tidspunkt i analysen.
English: Severe hepatotoxic events have been reported in a Phase 1/2 combination study of clofarabine in paediatric patients with relapsed or refractory acute leukaemia.
Danish: 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.
English: Clofarabine is a purine nucleoside anti-metabolite.
Danish: Clofarabin er en purin-nukleosid-antimetabolit.
English: Patients should be instructed to seek medical advice if they experience symptoms of dizziness, fainting spells, or decreased urine output.
Danish: Patienterne skal informeres om at søge læge, hvis de får symptomer på svimmelhed, besvimelsesanfald eller nedsat urinproduktion.
English: 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.
Danish: 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.
English: Tell your doctor if any of these conditions apply to you.
Danish: Fortæl din læge, hvis et af disse punkter passer på dig.
English: Ivozall is a potent antineoplastic agent with potentially significant haematological and non-haematological adverse reactions (see section 4.8).
Danish: Ivozall er et potent antineoplastisk middel, som kan have betydelige hæmatologiske og ikkehæmatologiske bivirkninger (se pkt.
English: However, as clofarabine is not detectably metabolised by the cytochrome P450 (CYP) enzyme system, pathways of non-renal elimination currently remain unknown.
Danish: Da clofarabin imidlertid ikke metaboliseres af cytochrom P450- (CYP-) enzymsystemet, er de renale eliminationsprocesser aktuelt ikke afdækket.
English: Clofarabine is not detectably metabolised by the cytochrome P450 (CYP) enzyme system.
Danish: Clofarabin metaboliseres ikke i påviselig grad via cytochrom P450-(CYP)-enzymsystemet.
English: Bleeding events have been observed in the setting of thrombocytopaenia.
Danish: Blødningshændelser er blevet observeret i forbindelse med trombocytopeni.
English: 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).
Danish: 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).
English: Intravenous infusion of 52 mg/m2 clofarabine produced equivalent exposure across a wide range of weights.
Danish: Intravenøs infusion af clofarabin 52 mg/m2 gav samme eksponering inden for et stort vægtområde.
English: No relationship between clofarabine or clofarabine triphosphate exposure and either efficacy or toxicity has been established in this population.
Danish: En sammenhæng mellem eksponering for clofarabin eller clofarabintriphosphat og enten effekt eller toksicitet er ikke påvist hos denne population.
English: 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.
Danish: 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.
English: Procedures for proper handling of antineoplastic agents should be observed.
Danish: Procedurerne for korrekt håndtering af antineoplastiske midler skal overholdes.
English: Cardiac effects were observed in rats consistent with cardiomyopathy and contributed to signs of cardiac failure after repeated cycles of treatment.
Danish: Hos rotter sås hjertepåvirkning, der svarede til kardiomyopati og fremstod som symptomer på hjerteinsufficiens efter gentagne behandlingscykler.
English: 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).
Danish: 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).
English: However, the pericardial effusion was clinically significant in 2 patients with some associated haemodynamic compromise.
Danish: Perikardiel ekssudation var imidlertid klinisk signifikant hos 2 patienter, som var noget hæmodynamisk kompromitterede.