FrancophonIA/ELRC3.0 huggingface dataset:
English: Nelarabine is excreted by the kidney to a small extent (5 to 10 % of the administered dose).
Danish: Nelarabin udskilles kun i ringe grad via nyrerne (5 - 10 % af den indgivne dosis).
English: If a patient becomes pregnant during treatment with nelarabine, they should be informed of the possible risk to the foetus.
Danish: Patienter, der bliver gravide under behandling med nelarabin, skal informeres om den mulige risiko for fosteret.
English: Nelarabine and ara-G are extensively distributed throughout the body based on combined Phase I pharmacokinetic data at nelarabine doses of 104 to 2,900 mg/m2.
Danish: Nelarabin og ara-G fordeles i vid udstrækning i hele kroppen, baseret på kombinerede fase I farmakokinetiske data for nelarabindoser på 104 - 2.900 mg/m2.
English: Patients receiving nelarabine are recommended to receive intravenous hydration according to standard medical practice for the management of hyperuricaemia in patients at risk of tumour lysis syndrome.
Danish: Det anbefales, at patienter i behandling med nelarabin får intravenøs hydrering i henhold til standard klinisk praksis for behandling af hyperurikæmi hos patienter med risiko for tumor-lysis-syndrom.
English: Renal and urinary disorders Blood creatinine increased
Danish: Nyrer og urinveje Forhøjet blodkreatinin
English: Water for injections Hydrochloric acid (to adjust the pH) Sodium hydroxide (to adjust the pH)
Danish: Vand til injektionsvæsker Saltsyre (til pH justering) Natriumhydroxid (til pH justering)
English: The mean apparent clearance (Cl/F) of ara-G was about 7 % lower in patients with mild renal impairment than in patients with normal renal function (see section 4.2).
Danish: Den umiddelbare middelclearance af ara-G var ca. 7 % lavere hos patienter med let nedsat nyrefunktion end hos patienter med normal nyrefunktion (se pkt.
English: Aspartate aminotransferase increased
Danish: Forhøjede aminotransferaser
English: • The other ingredients are sodium chloride, water for injections, hydrochloric acid, sodium hydroxide (see section 2 “Atriance contains sodium”).
Danish: • Øvrige indholdsstoffer: Natriumchlorid, vand til injektionsvæsker, saltsyre, natriumhydroxid (se afsnit 2 ”Atriance indeholder natrium”).
English: The type of leukaemia relates to the type of white blood cell mainly involved.
Danish: Typen af leukæmi er forbundet med typen af hvide blodceller, som overvejende bliver dannet.
English: There is no known antidote for nelarabine overdose.
Danish: Der findes ingen kendt antidot i tilfælde af overdosering med nelarabin.
English: • a type of lymphoma, called T-cell lymphoblastic lymphoma.
Danish: • en type lymfom kaldet T-celle lymfoblastær lymfom.
English: The normal procedures for proper handling and disposal of cytotoxic anti-tumour medicinal products should be adopted, namely:
Danish: De almindelige procedurer for korrekt håndtering og destruktion af cytotoksiske tumorhæmmende lægemidler skal følges dvs.:
English: • Muscle pain.
Danish: • Muskelsmerter.
English: Neurotoxicity is the dose-limiting toxicity of nelarabine.
Danish: Neurotoksicitet er den dosisbegrænsende toksicitet for nelarabin.
English: Tell your doctor if any of these apply to you.
Danish: Tal med lægen, hvis noget af ovennævnte gælder for dig.
English: However, no undesirable effects were seen in the testes or ovaries of monkeys given nelarabine intravenously at doses up to approximately 32 % of the adult human dose on a mg/m basis for 30 consecutive days.
Danish: Men der er ikke set uønskede virkninger i testes eller ovarier hos aber, der fik nelarabin intravenøst i doser op til ca. 32 % af den humane voksne dosis baseret på mg/m i 30 på hinanden følgende dage.
English: These findings were demonstrated in patients with refractory leukaemia or lymphoma given a dose of 1,500 mg/m nelarabine (adults) or a 650 mg/m
Danish: Disse resultater blev vist hos patienter med refraktær leukæmi eller lymfom efter en dosis på 1.500 mg/m nelarabin (voksen) eller 650 mg/m
English: • if you (or your child, if he/she is being treated) are allergic to nelarabine or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du (eller dit barn, hvis det er dit barn, der bliver behandlet) er allergisk over for nelarabin eller et af de øvrige indholdsstoffer i Atriance (angivet i punkt 6).
English: Carcinogenicity testing of nelarabine has not been performed.
Danish: Der er ikke foretaget karcinogenicitetstest på nelarabin.
English: A total of 6 patients (21 %) [95 % CI: 8 %-41 %] achieved a complete response with or without haematological recovery.
Danish: I alt 6 patienter (21 %) [95 % CI: 8 % - 41 %] opnåede komplet respons med eller uden hæmatologisk restitution.
English: Nelarabine and ara-G are partially eliminated by the kidneys.
Danish: Nelarabin og ara-G udskilles delvis via nyrerne.
English: Nelarabine showed in vitro cytotoxicity to monocytes and macrophages.
Danish: Nelarabin har in vitro vist cytotoksicitet over for monocytter og makrofager.
English: The normal procedures for proper handling and disposal of anti-tumour medicinal products should be adopted, namely:
Danish: De almindelige procedurer for korrekt håndtering og destruktion af tumorhæmmende lægemidler skal følges dvs.:
English: The safety profile from pivotal clinical studies at the recommended doses of nelarabine in adults (1,500 mg/m2) and children (650 mg/m2) is based on data from 103 adults and 84 paediatric patients respectively.
Danish: Sikkerhedsprofilen fra pivotale kliniske studier med de anbefalede doser nelarabin til voksne (1.500 mg/m2) og børn (650 mg/m2) baserer sig på data fra hhv. 103 voksne og 84 pædiatriske patienter.
English: Nelarabine at a dose of 1500 mg/m2/day was administered intravenously over two hours on days 1, 3 and 5 of a 21 day cycle.
Danish: Nelarabin i doser på 1.500 mg/m2/døgn blev givet intravenøst over 2 timer på dag 1, 3 og 5 i en cyklus på 21 dage.
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows: nelarabine caused histopathological changes to the central nervous system (white matter vacuolation and degenerative changes in cerebrum, cerebellum and spinal cord) of monkeys after daily treatment with nelarabine for 23 days, at exposures below the human therapeutic exposure.
Danish: Bivirkninger, som ikke er set i de kliniske studier, men set hos dyr efter eksponering, der svarer til klinisk eksponering og med mulig relevans over for klinisk anvendelse, er følgende: Nelarabin forårsagede histopatologiske ændringer i centralnervesystemet (den hvide substans, vakuolisering og degenerative ændringer i cerebrum, cerebellum og rygmarv) hos aber efter daglig behandling med nelarabin i 23 dage ved eksponering under den humane, terapeutiske eksponering.
English: • The active substance of Atriance is nelarabine.
Danish: • Aktivt stof: Nelarabin.
English: For ara-G, mean VSS/F values were 44.8 l/m
Danish: For ara-G var middel VSS hhv. 44,8 l/m
English: Intracellular ara-GTP accumulated with repeated administration of nelarabine.
Danish: Intracellulær ara-GTP ophobes efter gentagen administration af nelarabin.
English: Accumulation of ara-GTP in leukaemic blasts allows for preferential incorporation of ara-GTP into deoxyribonucleic acid (DNA) leading to inhibition of DNA synthesis.
Danish: Akkumulering af ara-GTP i leukæmiske stamceller giver mulighed for selektiv indarbejdning af araGTP i deoxyribonukleinsyre (DNA), som fører til hæmning af DNA-syntesen.
English: Severe nervous system side effects have been reported with the use of Atriance.
Danish: Der er set alvorlige bivirkninger i nervesystemet ved brug af Atriance.
English: • Changes in the sense of feeling in hands or feet, muscle weakness appearing as difficulty getting up from a chair, or difficulty walking (peripheral neuropathy); reduced sensitivity to light touch, or pain; abnormal sensations such as burning and, prickling, a sensation of something crawling on the skin.
Danish: • Ændringer i følesansen i hænder og fødder, muskelsvaghed udtrykt som vanskelighed ved at komme op af en stol eller svært ved at gå (perifer neuropati); nedsat følsomhed ved let berøring, eller smerter; en unormal fornemmelse på huden som f.eks. brændende, prikkende følelse, en fornemmelse af at noget kravler på huden.
English: Clear glass (Type I) vial with a bromobutyl rubber stopper, and an aluminium seal with a red snap-off cap.
Danish: Hætteglas af klart glas (Type I) med en bromobutyl-gummiprop og en aluminiumforsegling med en rød snap-off-hætte.
English: This medicinal product contains 1.725 mg/ml (75 micromols/ml) of sodium.
Danish: Denne medicin indeholder 1,725 mg/ml (75 mikromol/ml) natrium.
English: Intracellular ara-GTP concentrations in leukaemic blasts were quantifiable for a prolonged period after nelarabine administration.
Danish: Intracellulær ara-GTP koncentationer i leukæmiske stamceller kunne kvantificeres i en længere periode efter administration af nelarabin.
English: Nelarabine is a pro-drug of the deoxyguanosine analogue ara-G. Nelarabine is rapidly demethylated by adenosine deaminase (ADA) to ara-G and then phosphorylated intracellularly by deoxyguanosine kinase and deoxycytidine kinase to its 5'-monophosphate metabolite.
Danish: Nelarabin er et pro-drug af deoxyguanosin analog ara-G. Nelarabin demethyleres hurtigt af adenosindeaminase (ADA) til ara-G, som derefter phosphoryleres intracellulært af deoxyguanosinkinase og deoxycytidinkinase til dets 5'-monophosphatmetabolit.
English: • Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Danish: • Ved uforvarende kontakt med hud eller øjne skal området omgående behandles med rigelige mængder vand.
English: In a cross-study analysis using data from four Phase I studies, the pharmacokinetics of nelarabine and ara-G were characterized in patients aged less than 18 years and adult patients with refractory leukaemia or lymphoma.
Danish: I en krydsanalyse af data fra 4 fase I-studier blev farmakokinetikken af nelarabin og ara-G undersøgt hos patienter under 18 år og voksne patienter med refraktær leukæmi eller lymfom.
English: Limited clinical pharmacology data are available for patients below the age of 4 years.
Danish: Kun begrænsede klinisk-farmakologiske data er tilgængelige for patienter under 4 år.
English: - Personnel handling this medicinal product during handling/transfer should wear protective clothing including mask, goggles and gloves.
Danish: - Personale, der håndterer dette lægemiddel, bør bære beskyttelsesdragt inklusive maske, briller og handsker.
English: Nelarabine has been administered in clinical studies up to a dose of 75 mg/kg (approximately 2,250 mg/m2) daily for 5 days to a paediatric patient, up to a dose of 60 mg/kg (approximately 2,400 mg/m2) daily for 5 days to 5 adult patients and up to 2,900 mg/m in a further 2 adults on days 1,
Danish: Nelarabin er i kliniske studier givet i doser på op til 75 mg/kg (ca. 2.250 mg/m 2) daglig i 5 dage til en pædiatrisk patient, i doser på op til 60 mg/kg (ca. 2.400 mg/m 2) daglig i 5 dage til 5 voksne patienter og op til 2.900 mg/m til yderligere 2 voksne på dag 1, 3 og 5.
English: - All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
Danish: - Alt udstyr brugt til administration eller rengøring inklusive handsker, bør anbringes i en højrisiko-affaldssæk til forbrænding ved høj temperatur.
English: Nelarabine and 9-β-Darabinofuranosylguanine (ara-G) are partially renally excreted (see section 5.2).
Danish: Nelarabin og -9-β-D arabinofuranosylguanin (ara-G) udskilles delvis via nyrerne (se pkt.
English: (104 %) and 125 l/h/m
Danish: (104 %) og 125 l/time/m
English: Nelarabine however, is known to be genotoxic to mammalian cells (see section 5.3).
Danish: Nelarabin er dog kendt for at være genotoksisk for pattedyrsceller (se pkt.
English: • All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
Danish: • Alt udstyr brugt til administration eller rengøring inklusiv handsker, bør anbringes i en højrisiko-affaldssæk til forbrænding ved høj temperatur.
English: MRI evaluations of the 2 patients demonstrated findings consistent with a demyelinating process in the cervical spine.
Danish: MRIundersøgelser af de 2 patienter viste hændelser, som var overensstemmende med demyeliserende lidelser i columna cervicalis.
English: Five of the 28 patients (18 %) [95 % CI: 6 %-37 %] treated with nelarabine achieved a complete response (bone marrow blast counts ≤ 5 %, no other evidence of disease, and full recovery of peripheral blood counts).
Danish: 5 af de 28 patienter (18 %) [95 % CI: 6 % - 37 %], som blev behandlet med nelarabin, opnåede komplet respons (knoglemarvscelletal ≤ 5 %, ingen andre tegn på sygdom og fuld restitution af perifere blodtal).
English: (278 %) in adult and paediatric patients, respectively.
Danish: (278 %) for voksne og pædiatriske patienter.
English: Of the 39 patients who had received two or more prior induction regimens, 5 (13 %) [95 % CI: 4 %27 %] achieved a complete response (bone marrow blast counts ≤ 5 %, no other evidence of disease, and full recovery of peripheral blood counts) and 9 (23 %) [95 % CI: 11 %-39 %] achieved complete responses with or without full haematological recovery.
Danish: Af de 39 patienter, der havde fået 2 eller flere tidligere induktionsbehandlinger, oplevede 5 (13 %) [95 % CI: 4 % - 27 %] et komplet respons (knoglemarvscelletal ≤ 5 %, ingen andre tegn på sygdom, og fuldstændig restitution af perifere blodtal) og 9 (23 %) [95 % CI: 11 % - 39 %] opnåede komplet respons med eller uden fuldstændig hæmatologisk restitution.
English: Maternal body weight gain and foetal body weights were reduced in rabbits given a dose approximately 2-fold the adult human dose.
Danish: Moderens vægtøgning og fostrenes kropsvægt var nedsat hos kaniner efter en dosis på ca. 2 gange den humane voksne dosis.
English: Rhabdomyolysis and increased blood creatine phosphokinase have been identified during postapproval use of nelarabine.
Danish: Rabdomyolyse og forhøjet kreatinkinase i blodet er blevet identificeret ved anvendelse af nelarabin efter godkendelse.
English: It is not known whether Atriance is passed on through breast milk.
Danish: Det vides ikke, om Atriance udskilles i mælk.
English: Insufficient numbers of patients aged 65 years of age and older have been treated with nelarabine to determine whether they respond differently than younger patients (see sections 4.4 and 5.2).
Danish: Antallet af patienter på 65 år eller ældre, som har været i behandling med nelarabin, er ikke tilstrækkeligt til, at det kan fastslås, om de responderer anderledes end yngre patienter (se pkt.
English: Delaying subsequent dosing is an option for other toxicities, including haematological toxicity.
Danish: Udsættelse af efterfølgende doser er en mulighed ved anden toksicitet inkl.
English: Signs of an infection include: fever serious deterioration of your general condition local symptoms such as sore throat, sore mouth or urinary problems (for example, a burning sensation when urinating, which may be a urinary infection) Tell your doctor immediately if you get any of these.
Danish: Tegn på en infektion omfatter: feber alvorlig forringelse af din almindelige helbredstilstand lokale symptomer som f.eks. ondt i halsen, ondt i munden eller vandladningsproblemer (f.eks. en brændende fornemmelse ved vandladning, som kan være en urinvejsinfektion).
English: Instructions for handling and disposal of Atriance
Danish: Oplysninger om håndtering og destruktion af Atriance
English: • Personnel handling this medicinal product during handling/transfer should wear protective clothing including mask, goggles and gloves.
Danish: • Personale, der håndterer dette lægemiddel, skal bære beskyttelsesdragt inklusiv maske, briller og handsker.
English: • Problems with memory, feeling disoriented; blurred vision; altered or loss of sense of taste (dysgeusia).
Danish: • Hukommelsesbesvær, manglende orientering; sløret syn; ændret eller tab af smagssans (smagsforstyrrelse).
English: • High body temperature (fever); tiredness; feeling weak/loss of strength.
Danish: • Forhøjet temperatur (feber); træthed; en fornemmelse af svaghed/styrketab.
English: Adult clinical study in relapsed or refractory T-ALL and T-LBL In an open-label study carried out by the Cancer and Leukaemia Group B and the Southwest Oncology Group, the safety and efficacy of nelarabine were evaluated in 39 adults with T-cell acute lymphoblastic leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL).
Danish: Voksen klinisk studie med recidiverende eller refraktær T-ALL og T-LBL I et åbent studie udført af Cancer and Leukaemia Group B og Southwest Oncology Group blev nelarabins sikkerhed og effekt undersøgt hos 39 voksne med T-celle akut lymfoblastær leukæmi (TALL) eller lymfoblastær lymfom (T-LBL).
English: In a pharmacokinetic/pharmacodynamic cross study analysis, race had no apparent effect on nelarabine, ara-G, or intracellular ara-GTP pharmacokinetics.
Danish: I en farmakokinetisk/farmakodynamisk krydsanalyse havde race ikke nogen tydelig virkning på farmakokinetikken af nelarabin, ara-G eller intracellulær ara-GTP.
English: • a type of leukaemia, called T-cell acute lymphoblastic leukaemia.
Danish: • en type leukæmi kaldet T-celle akut lymfoblastær leukæmi.
English: It is provided in clear glass vials with a rubber stopper and sealed with an aluminium cap.
Danish: Hætteglasset er af klart glas med en gummiprop og forseglet med en aluminiumhætte.
English: Compared to controls, nelarabine caused increased incidences of foetal malformations, anomalies, and variations in rabbits when given at doses approximately 24 % of the adult human dose on a mg/m basis during the period of organogenesis.
Danish: Sammenlignet med kontrolgruppen, forårsagede nelarabin øgede forekomster af føtale misdannelser, anomali og afvigelser hos kaniner ved administration af doser på ca. 24 % af voksendosis baseret på mg/m i løbet af perioden for organdannelse.
English: Severe neurological reactions have been reported with the use of nelarabine.
Danish: Der er rapporteret alvorlige neurologiske bivirkninger ved brug af nelarabin.
English: Combined Phase 1 pharmacokinetic data at nelarabine doses of 104 to 2,900 mg/m indicate that the clearance (Cl) and Vss values for nelarabine and ara-G are comparable between the two groups.
Danish: Kombinerede fase I farmakokinetiske data ved nelarabindoser på 104 - 2.900 mg/m tyder på, at clearance og Vss-værdier for nelarabin og ara-G er sammenlignelige mellem de to grupper.
English: Do not use this medicine after the expiry date which is stated on the carton and vial.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og hætteglasset efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The most frequently occurring adverse events were fatigue; gastrointestinal disorders; haematological disorders; respiratory disorders; nervous system disorders (somnolence, peripheral neurological disorders [sensory and motor], dizziness, hypoaesthesia, paraesthesia, headache); and pyrexia.
Danish: De hyppigste bivirkninger var træthed, gastro-intestinale forstyrrelser, hæmatologiske forstyrrelser, respiratoriske forstyrrelser, forstyrrelser i nervesystemet (døsighed, perifere neurologiske forstyrrelser [sensoriske og motoriske], svimmelhed, hypoæstesi, paræstesi, hovedpine) og pyreksi.
English: • Increased amounts of bilirubin in your blood, which may cause yellowing of the skin and may make you feel lethargic.
Danish: • Øget indhold af stoffet bilirubin i dit blod, som kan give en gulfarvning af huden og gøre dig sløv.
English: In clinical studies, the 650 mg/m and 1,500 mg/m dose have both been used in patients in the age range 16 to 21 years.
Danish: I kliniske studier blev både 650 mg/m og 1.500 mg/m anvendt til patienter i aldersgruppen 16 til
English: Adults and children in clinical studies were categorized into the three groups according to renal impairment: normal with Clcr greater than 80 ml/min (n = 56), mild with Clcr equalling 50 to 80 ml/min (n = 12), and moderate with Clcr less than 50 ml/min (n = 2).
Danish: Voksne og børn i kliniske studier blev delt op i 3 grupper efter nedsat nyrefunktion: normal nyrefunktion med clearance større end 80 ml/min (n = 56), let nedsat nyrefunktion med clearance på 50 - 80 ml/min (n = 12), og moderat nedsat nyrefunktion med clearance under 50 ml/min (n = 2).
English: Sodium warning
Danish: Advarsel om natrium
English: Very common: 80 (95%)
Danish: Meget almindelig: 80 (95 %)
English: - If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: (paediatrics).
Danish: (børn).
English: Limited clinical pharmacology data are available for patients below the age of 4 years (see section 5.2).
Danish: Kun begrænsede klinisk-farmakologiske data er tilgængelige for patienter under 4 år (se pkt.
English: The appropriate dose of nelarabine must be transferred into polyvinylchloride (PVC) or ethyl vinyl acetate (EVA) infusion bags or glass containers and administered intravenously as a two-hour infusion in adult patients and as a one-hour infusion in paediatric patients.
Danish: Den ønskede dosis nelarabin skal overføres til en infusionspose af polyvinylchlorid (PVC) eller ethylvinylacetat (EVA) eller til en glasbeholder og administreres intravenøst som infusion over 2 timer til voksne patienter og over 1 time til børn.
English: Nelarabine must be discontinued at the first sign of neurological events of National Cancer Institute Common Terminology Criteria Adverse Event (NCI CTCAE) grade 2 or greater.
Danish: Nelarabin skal seponeres ved første tegn på neurologiske hændelser af typen National Cancer Institute Common Toxicity Criteria grad 2 eller derover.
English: Eighty-four (84) patients, 39 of whom had received two or more prior induction regimens and 31 whom had received one prior induction regimen, were treated with 650 mg/m2/day of nelarabine administered intravenously over 1 hour daily for 5 consecutive days repeated every 21 days.
Danish: 84 patienter, hvoraf 39 havde fået 2 eller flere tidligere induktionsbehandlinger, og hvoraf 31 havde fået 1 tidligere induktionsbehandling, blev behandlet med 650 mg/m2/døgn nelarabin givet intravenøst over 1 time daglig i 5 på hinanden følgende dage gentaget hver 21. dag.
English: Sodium chloride
Danish: Natiumchlorid
English: • Muscle weakness (possibly associated with peripheral neuropathy - see above), joint pain, back pain; pains in hands and feet including a sensation of pins and needles sensation and numbness.
Danish: • Muskelsvaghed (muligvis i forbindelse med perifer neuropati - se ovenfor); ledsmerter, rygsmerter, smerter i hænder og fødder, bl.a. en stikkende og prikkende følelse, samt en fornemmelse af følelsesløshed.
English: Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
Danish: Nelarabin er indiceret til behandling af patienter med T-celle akut lymfoblastær leukæmi (T-ALL) og T-celle lymfoblastær lymfom (T-LBL), hvor sygdommen ikke har responderet på eller er recidiveret efter behandling med mindst to kemoterapiregimer.
English: The effect of race on nelarabine and ara-G pharmacokinetics has not been specifically studied.
Danish: Indflydelsen af race på farmakokinetikken af nelarabin og ara-G er ikke undersøgt specifikt.
English: There are insufficient data to support a dose adjustment recommendation for patients with a renal clearance of creatinine Clcr less than 50 ml/min.
Danish: Der er ikke tilstrækkelige data til at fastslå en anbefalet dosisjustering til personer med kreatininclearance på under 50 ml/min.
English: NEUROLOGICAL ADVERSE REACTIONS
Danish: NEUROLOGISKE BIVIRKNINGER