FrancophonIA/ELRC3.0 huggingface dataset:
English: The following convention has been utilised for the classification of frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from the available data).
Danish: Følgende termer er anvendt til klassifikation af frekvenser: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Because the timecourse of intracellular ara-GTP was prolonged, its elimination half-life could not be accurately estimated.
Danish: Da tidsforløbet for intracellulær ara-GTP var forlænget, kunne dets halveringstid ikke fastsættes nøjagtigt.
English: The potential risk in humans is unknown, however, exposure during pregnancy will likely lead to anomalies and malformations of the foetus.
Danish: Den potentielle risiko for mennesker kendes ikke, men eksponering under graviditet vil sandsynligvis føre til abnormiteter og misdannelser hos fosteret.
English: There are no or limited amount of data from the use of nelarabine in pregnant women.
Danish: Der foreligger ingen eller begrænset data fra anvendelse af nelarabin til gravide kvinder.
English: Atriance is not recommended for pregnant women.
Danish: Atriance bør ikke anvendes til gravide kvinder.
English: This treatment may vary, depending on the results of regular blood tests.
Danish: Behandlingen kan variere afhængigt af resultaterne af de regelmæssige blodprøver.
English: Atriance may reduce the number of white blood cells and lower your resistance to infection (including pneumonia).
Danish: Atriance kan nedsætte antallet af hvide blodceller og nedsætte din modstandskraft over for en infektion (herunder lungebetændelse).
English: Blood tests during treatment
Danish: Blodprøver under behandling
English: This medicine contains at least 23 mg sodium per dose.
Danish: Dette lægemiddel indeholder mindst 23 mg natrium pr. dosis.
English: Nelarabine is for intravenous use only and must not be diluted prior to administration.
Danish: Nelarabin er kun til intravenøs anvendelse og må ikke fortyndes før administration.
English: This can lead to severe bleeding from relatively small injuries such as a small cut.
Danish: Dette kan føre til alvorlig blødning fra forholdsvis små skader, som f.eks små rifter.
English: Your dose of Atriance may need to be adjusted.
Danish: Dosis af Atriance skal muligvis justeres.
English: Time to complete response in both classifications of response ranged from 2.9 to 11.7 weeks.
Danish: Tid til komplet respons i begge responsgrupper varierede mellem 2,9 og 11,7 uger.
English: • Lowered blood pressure.
Danish: • Nedsat blodtryk.
English: If you are an elderly person, you could be more sensitive to nervous system side effects (see the list above under “Warnings and precautions”).
Danish: Hvis du er ældre, kan du være mere følsom over for bivirkninger i nervesystemet (se afsnittet herover ”Advarsler og forsigtighedsregler”).
English: If you feel tired or weak, do not drive, and do not use any tools or machines.
Danish: Hvis du føler dig træt eller svag, må du ikke køre bil, motorcykel eller cykel, eller arbejde med værktøj eller maskiner.
English: Do not try and become pregnant/father a child until your doctor advises you it is safe to do so.
Danish: Forsøg ikke at blive gravid eller gøre en kvinde gravid, før lægen giver dig besked om, at det er sikkert.
English: Peripheral neurological disorders (sensory and motor)
Danish: Perifere neurologiske forstyrrelser (sensoriske og motoriske)
English: In this case, its cells are called lymphoblasts.
Danish: I dette tilfælde hedder cellerne lymfoblaster.
English: The majority of side effects reported with Atriance were seen in adults, children and adolescents.
Danish: Hovedparten af de bivirkninger, der er indrapporteret for Atriance, er set hos voksne, børn og unge.
English: Ask your doctor for advice before taking any medicine.
Danish: Spørg lægen til råds, inden du tager nogen anden form for medicin.
English: Nine of these 31 patients failed to respond to prior induction (refractory patients).
Danish: 9 af disse 31 patienter havde ikke haft respons på tidligere induktion (refraktære patienter).
English: Duration of response (in both classifications of response (n=5) ranged between 15 and 195+ weeks.
Danish: Varigheden af respons (i begge responsklassifikationer (n = 5) varierede mellem 15 og 195+ uger.
English: In an exploratory analysis, increasing age, especially age 65 years and older, appeared to be associated with increased rates of neurological adverse events.
Danish: I en eksplorativ analyse viste højere alder, især 65 år og ældre, at være forbundet med øgede forekomster af neurologiske bivirkninger.
English: The following information is intended for medical or healthcare professionals only:
Danish: Nedenstående oplysninger til læger og sundhedspersonale:
English: Some of the side effects were reported more often in adult patients.
Danish: Nogle bivirkninger er set oftere hos voksne patienter.
English: You will have an infusion (a drip) once a day on days 1, 3 and 5 of treatment.
Danish: Du vil få en infusion (intravenøst drop) 1 gang om dagen på dag 1, 3 og 5 i en behandling.
English: Patients must be cautioned that somnolence can affect performance of skilled tasks, such as driving.
Danish: Patienterne skal advares om, at denne sovetrang kan påvirke evnen til at udføre krævende opgaver som f.eks. at køre bil.
English: Very common: 102
Danish: Meget almindelig: 102
English: It is usually dripped into your arm over a period of about 2 hours.
Danish: Det dryppes normalt ind i armen i løbet af en periode på ca. 2 timer.
English: Your doctor will check for these symptoms regularly during treatment.
Danish: Din læge vil regelmæssigt undersøge dig for disse symptomer under behandlingen.
English: (214 %) in adult and paediatric patients, respectively, on day 1 (n = 65 adults, n = 21 paediatric patients).
Danish: (214 %) hos voksne og pædiatriske patienter på dag 1 (n = 65 voksne, n = 21 pædiatriske patienter).
English: • Violent, uncontrollable muscular contractions often accompanied by unconsciousness that can be due to an epileptic attack (seizures).
Danish: • Voldsomme, ukontrollerbare muskelsammentrækninger, der hyppigt er ledsaget af bevidstløshed, som kan skyldes et epileptisk anfald (krampeanfald).
English: It is usually dripped into your arm over a period of about 1 hour.
Danish: Det dryppes normalt ind i armen i løbet af en periode på ca. 1 time.
English: Your doctor will check for these symptoms regularly during treatment (see also section 4, "Possible side effects").
Danish: Lægen vil regelmæssigt undersøge dig for disse symptomer under behandlingen (se også punkt 4 ”Bivirkninger”).
English: Remember to tell your doctor if you start to take any other medicines while you are on Atriance.
Danish: Husk at fortælle det til lægen, hvis du begynder på at tage anden medicin, mens du er i behandling med Atriance.
English: Decreased renal function, which is more common in the elderly, may reduce ara-G clearance (see section 4.2).
Danish: Nedsat nyrefunktion, som er mere almindeligt hos ældre, kan nedsætte ara-G clearance (se pkt.
English: Men with partners who are pregnant or could become pregnant should use condoms during treatment with nelarabine and for at least three months following cessation of treatment.
Danish: Mænd med partnere, som er gravide eller har mulighed for at blive gravid, skal anvende kondom under behandling med nelarabin og i mindst tre måneder efter afslutning af behandlingen.
English: If pregnancy occurs during treatment with Atriance, you must tell your doctor immediately.
Danish: Hvis graviditet opstår under behandling med Atriance, skal du straks fortælle det til lægen.
English: Your doctor will take appropriate precautions to minimise the risk of this.
Danish: Lægen vil tage de relevante forholdsregler for at undgå, at dette sker.
English: Immunisation using a live organism vaccine has the potential to cause infection in immunocompromised hosts.
Danish: Immunisering med vacciner med levende organismer kan forårsage infektion hos immunokompromitterede værter.
English: It is unknown whether nelarabine or its metabolites are excreted in human breast milk.
Danish: Det er ukendt, om nelarabin eller dets metabolitter udskilles i human mælk.
English: Atriance has major influence on the ability to drive and use machines.
Danish: Atriance påvirker i væsentlig grad evnen til at føre motorkøretøj og betjene maskiner.
English: • Unintentional rhythmic shaking of one or more limbs (tremors).
Danish: • En utilsigtet rytmisk rysten af et eller flere lemmer (skælven).
English: Concomitant administration may reduce the efficacy of nelarabine and/or change the adverse event profile of either active substance.
Danish: Samtidig administration kan reducere effekten af nelarabin og/eller ændre bivirkningsprofilen for begge de aktive stoffer.
English: There was a single additional report of biopsy confirmed progressive multifocal leukoencephalopathy in the adult population.
Danish: Der var en enkelt supplerende rapport med biopsiverificeret progressiv multifokal leukoencefalopati i den voksne population.
English: If you have any questions about your illness, talk to your doctor.
Danish: Hvis du har spørgsmål om din sygdom, skal du tale med lægen om det.
English: Post-marketing data
Danish: Data efter markedsføring
English: Four (44 %) of the nine refractory patients experienced a complete response to nelarabine.
Danish: 4 (44 %) af disse 9 refraktære patienter opnåede et komplet respons på nelarabin.
English: For patients at risk of hyperuricaemia, the use of allopurinol should be considered.
Danish: For patienter med risiko for hyperurikæmi bør det overvejes at anvende allopurinol.
English: Intracellular Cmax for ara-GTP appeared within 3 to 25 hours on day 1.
Danish: Intracellulær Cmax for ara-GTP blev set i løbet af 3 - 25 timer på dag 1.
English: Rarely, it can lead to even more severe bleeding (haemorrhage).
Danish: I sjældne tilfælde kan det føre til mere alvorlig blødning (blodtab).
English: Patients treated with nelarabine are potentially at risk of suffering from somnolence during and for several days after treatment.
Danish: Patienter, der behandles med nelarabin, har potentiel risiko for at lide af sovetrang under og i adskillige dage efter behandlingen.
English: Therefore, immunisations with live organism vaccines are not recommended.
Danish: Derfor frarådes vaccination med levende organismer.
English: Tell a doctor if any of these becomes troublesome.
Danish: Tal med lægen, hvis noget af dette bliver generende.
English: Adults (1,500 mg/m N=103
Danish: Voksne (1.500 mg/m N = 103
English: Atriance contains sodium
Danish: Atriance indeholder natrium
English: Clinical efficacy and data
Danish: Klinisk effekt og data
English: • Clumsiness and lack of coordination affecting balance, walking, limb or eye movements, or speech.
Danish: • Klodsethed og manglende koordination, der påvirker balance, gang, eller bevægelse af lemmer eller øjne, samt tale.
English: A doctor or nurse will give you the dose of Atriance as an infusion (a drip).
Danish: En læge eller en sygeplejerske vil give dig en dosis af Atriance som en infusion (intravenøst drop).
English: It may harm a baby if conceived before, during or soon after treatment.
Danish: Det kan skade et foster, hvis det er undfanget før, undervejs eller lige efter behandling.
English: Two paediatric patients had fatal neurological events.
Danish: To pædiatriske patienter havde en letal neurologisk bivirkning.
English: Children (650 mg/m N=84
Danish: Børn (650 mg/m N = 84
English: Pharmacotherapeutic group: Antineoplastic agents, antimetabolites, purine analogues, ATC code: L01B B 07
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, antimetabolitter, purinanaloger, ATCkode: L01B B 07
English: Nelarabine and ara-G are rapidly eliminated from plasma with a half-life of approximately 30 minutes and 3 hours, respectively.
Danish: Nelarabin og ara-G elimineres hurtigt fra plasma med en halveringstid på hhv. ca. 30 minutter og 3 timer.
English: Atriance is supplied in packs of 1 vial or 6 vials.
Danish: Atriance findes i pakninger med 1 hætteglas eller 6 hætteglas.
English: Based on the pharmacological action of the compound, undesirable effects on fertility are possible.
Danish: Ud fra stoffets farmakologiske virkning er der risiko for uønskede virkninger på fertiliteten.
English: Nelarabine and ara-G did not significantly inhibit the activities of the major hepatic cytochrome P450 (CYP) isoenzymes CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4 in vitro.
Danish: Nelarabin og ara-G hæmmede ikke i signifikant grad aktiviteterne af de vigtigste levercytokrom P450 (CYP)-isoenzymer CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 eller CYP3A4 in vitro.
English: Atriance can make people feel drowsy or sleepy, both during and for some days after treatment.
Danish: Atriance kan få dig til at føle dig sløv eller søvnig både undervejs og i flere dage efter behandling.
English: Survival at one year was 29 % [95 % CI: 12 %-45 %].
Danish: Overlevelse efter 1 år var 29 % [95 % CI: 12 % - 45 %].
English: WARNING: Cytotoxic agent, special handling instructions (see package leaflet).
Danish: ADVARSEL: Cytotoksisk middel, særlige instruktioner vedrørende håndtering (se indlægssedlen).
English: Other mechanisms may contribute to the cytotoxic effects of nelarabine.
Danish: Andre mekanismer kan bidrage til nelarabins cytotoksiske virkning.
English: The prescribing physician should consider which regimen is appropriate when treating patients in this age range.
Danish: Lægen skal nøje overveje, hvilken dosering der passer bedst til behandling af patienter i denne aldersgruppe.
English: • The release of tumour cell contents (tumour lysis syndrome), which may put extra stress on your body.
Danish: • Frigivelse af indhold fra kræftceller (tumor-lysis-syndrom), der kan give ekstra stress i kroppen.
English: • Staff should be trained in how to handle and transfer the medicinal product.
Danish: • Personalet skal være uddannet i at håndtere og overføre lægemidlet.
English: Nelarabine must only be administered under the supervision of a physician experienced in the use of cytotoxic agents.
Danish: Nelarabin må kun gives under supervision af en læge, der har erfaring med anvendelse af cytotoksiske midler.
English: In vitro, T-cells are more sensitive than B-cells to the cytotoxic effects of nelarabine.
Danish: In-vitro er T-celler mere sensitive end B-celler over for nelarabins cytotoksiske virkning.
English: Atriance contains nelarabine which belongs to a group of medicines known as antineoplastic agents, used in chemotherapy to kill some types of cancer cells.
Danish: Atriance indeholder nelarabin, der tilhører en gruppe af lægemidler, som kaldes antineoplastiske midler, og som bruges i kemoterapi til at dræbe nogle typer kræftceller.
English: Your doctor should perform blood tests regularly during treatment to check for blood problems that have been associated with the use of Atriance.
Danish: Din læge vil regelmæssigt tage blodprøver under behandlingen for at undersøge, om der er nogen blodsygdomme, som kan skyldes brugen af Atriance.
English: Nelarabine and ara-G are not substantially bound to human plasma proteins (less than 25 %) in vitro, and binding is independent of nelarabine or ara-G concentrations up to 600 µM.
Danish: Nelarabin og ara-G er ikke overvejende bundet til humane plasmaproteiner (mindre end 25 %) in vitro, og bindingen er uafhængig af nelarabin eller ara-G i koncentrationer op til 600 µmol/l.
English: No accumulation of nelarabine or ara-G was observed in plasma after nelarabine administration on either a daily or a day 1, 3, 5 schedule.
Danish: Der blev ikke set nogen akkumulering af nelarabin eller ara-G i plasma efter administration af nelarabin daglig eller efter administration på dag 1, 3, 5.
English: Duration of response in both classifications of response ranged between 4.7 and 36.4 weeks and median overall survival was 13.1 weeks [95 % CI: 8.7-17.4] and survival at one year was 14 % [95 % CI: 3 %-26 %].
Danish: Varighed af respons i begge responsgrupper varierede mellem 4,7 og 36,4 uger, samlet median overlevelse var 13,1 uger [95 % CI: 8,7 - 17,4], og overlevelse efter 1 år var 14 % [95 % CI: 3 % - 26 %].
English: • your/your child's (if he/she is being treated) body surface area (which will be calculated by your doctor based on your height and weight).
Danish: • din/dit barns (hvis det er dit barn, der bliver behandlet) kropsoverflade (som vil blive beregnet af lægen ud fra din højde og vægt)
English: Intracellular ara-GTP Cmax and AUC(0-t) values at the same dose level were 2- to 3- fold greater on average in adult female than in adult male patients.
Danish: Intracellulær ara-GTP Cmax og AUC(0-t)-værdier på samme dosisniveau var 2 - 3 gange større i gennemsnit hos voksne kvindelige patienter end hos voksne mandlige patienter.
English: In addition to the adverse reactions seen in the pivotal clinical studies, there are also data from 875 patients from NCI studies/compassionate use programme (694 patients) and Phase I (181 patients) studies of nelarabine.
Danish: Ud over de bivirkninger, der er observeret i de pivotale kliniske studier, er der også data fra 875 patienter fra NCI studier/program for udleveringstilladelse (694 patienter) og fase I-studier (181 patienter) med nelarabin.
English: No studies have been conducted in animals to assess the effects of nelarabine on fertility.
Danish: Der er ikke udført forsøg med dyr til vurdering af effekten af nelarabin på fertilitet.
English: (159 %) and 89.4 l/m
Danish: (159 %) og 89,4 l/m
English: Carcinogenicity and mutagenicity
Danish: Karcinogeniciet og mutagenicitet
English: • Swelling of parts of the body due to accumulation of abnormal amounts of fluid (oedema).
Danish: • Opsvulmen af nogle områder af kroppen pga. ophobning af unormale mængder væske (ødem).
English: The apparent clearance of ara-G (Cl/F) is comparable between the two groups [9.5 l/h/m
Danish: Den umiddelbare clearance for ara-G er sammenlignelig i de to grupper [9,5 l/time/m
English: The effect of nelarabine on fertility in humans is unknown.
Danish: Nelarabins virkning på fertiliteten hos mennesker kendes ikke.
English: This lymphoma is caused by a mass of lymphoblasts, a type of white blood cell.
Danish: Dette lymfom er forårsaget af en stor mængde lymfoblaster, som er en type hvide blodceller.
English: • Serious disease that destroys skeletal muscle characterized by the presence of myoglobin (a breakdown product of muscle cells) in the urine (Rhabdomyolysis), increase in blood creatine phosphokinase.
Danish: • Alvorlig sygdom, der ødelægger skeletmuskulaturen, og som er kendetegnet ved myoglobin (et nedbrydningsprodukt fra muskelceller) i urinen (rabdomyolyse), forhøjet kreatinkinase i blodet.
English: The monophosphate metabolite is subsequently converted to the active 5'-triphosphate from, ara-GTP.
Danish: Monophosphatmetabolitten omdannes derefter til den aktive 5'-triphosphat fra ara-GTP.
English: - Staff should be trained in how to handle and transfer the medicinal product.
Danish: - Personalet skal være uddannet i at håndtere og overføre lægemidlet.
English: You/your child (if he/she is being treated) will have an infusion (a drip) once a day for 5 days.
Danish: Du/dit barn (hvis det er dit, der bliver behandlet) vil få en infusion (intravenøst drop) 1 gang daglig i 5 dage.
English: You (or your child, if he/she is being treated) must not receive Atriance
Danish: Du (eller dit barn, hvis det er dit barn, der bliver behandlet) må ikke få Atriance
English: Ara-G is excreted by the kidney to a greater extent (20 to 30 % of the administered nelarabine dose).
Danish: Ara-G udskilles i højere grad via nyrerne (20 - 30 % af den indgivne nelarabindosis).
English: Leukaemia causes an abnormal increase in the number of white blood cells.
Danish: Leukæmi medfører en unormal forøgelse af antallet af hvide blodceller.
English: • Increases in blood creatinine levels (a sign of kidney problems, which might lead less frequent urination).
Danish: • Øget kreatininniveau (et tegn på nyreproblemer, der kan medføre færre vandladninger).
English: Patients with renal impairment must be closely monitored for toxicities when treated with nelarabine.
Danish: Patienter med nedsat nyrefunktion skal overvåges nøje for toksicitet, når de behandles med nelarabin.
English: Further data with respect to nelarabine and ara-G pharmacokinetics in the paediatric population are provided in other subsections.
Danish: Yderligere data, hvad angår nelarabin og ara-G farmakokinetik i den pædiatriske population findes i andre afsnit.
English: (32 %) and 32.1 l/m
Danish: (32 %) og 32,1 l/m
English: • Unusual bruising or bleeding, caused by a decrease in the number of clotting cells in the blood.
Danish: • Usædvanlige blå mærker eller blødninger, forårsaget af et fald i antallet af celler i blodet der får det til at størkne.
English: Thirteen (42 %) of the 31 patients treated with one prior induction regimen achieved a complete response overall.
Danish: 13 (42 %) af de 31 patienter, der tidligere havde modtaget 1 induktionsbehandling, opnåede et komplet respons.
English: Stopping treatment with Atriance Your doctor will decide when to stop the treatment.
Danish: Hvis du holder op med at bruge Atriance Lægen afgør, hvornår behandlingen skal stoppes.
English: Nelarabine was mutagenic to L5178Y/TK mouse lymphoma cells with and without metabolic activation.
Danish: Nelarabin var mutagen for L5178Y/TK muselymfomceller med og uden metabolisk aktivering.
English: • if you (or your child, if he/she is being treated) have recently been, or plan to be vaccinated with a live vaccine (for example polio, varicella, typhoid).
Danish: • hvis du/dit barn (hvis det er dit barn, der bliver behandlet) for nylig er blevet eller har planer om at blive vaccineret med en levende vaccine (f.eks. polio, skoldkopper, tyfus).
English: Both sexually active men and women should use effective methods of contraception during treatment with nelarabine.
Danish: Såvel seksuelt aktive mænd som kvinder skal anvende sikker prævention under behandling med nelarabin.
English: There have been reports of sometimes fatal opportunistic infections in patients receiving nelarabine therapy.
Danish: Der er rapporter om undertiden letal opportunistisk infektion hos patienter i nelarabinbehandling.
English: - Pregnant staff should be excluded from working with this medicinal product.
Danish: - Gravide medarbejdere bør ikke arbejde med dette lægemiddel.
English: On the day 1, 3, and 5 schedule, Cmax and AUC(0-t) values on day 3 were approximately 50 % and 30 %, respectively, greater than Cmax and AUC(0-t) values on day 1.
Danish: Ved administration på dag 1, 3, og 5 var Cmax og AUC(0-t)-værdier på dag 3 hhv. ca. 50 % og 30 % større end Cmax og AUC(0-t)-værdier på dag 1.
English: Median overall survival was 20.6 weeks [95 % CI: 10.4-36.4].
Danish: Median af samlet overlevelse var 20,6 uger [95 % Cl: 10,4 - 36,4].
English: Rhabdomyolysis, blood creatine phosphokinase increased (see “Postmarketing data”)
Danish: Rabdomyolyse, forhøjet kretinkinase i blodet (se Data efter markedsføring)
English: 6 x 50 ml vials 250 mg/50 ml 1 x 50 ml vial 250 mg/50 ml
Danish: 6 x 50 ml hætteglas 250 mg/50 ml 1 x 50 ml hætteglas 250 mg/50 ml
English: Any liquid waste from the preparation of the nelarabine solution for infusion may be flushed with large amounts of water.
Danish: Alt flydende affaldsmateriale fra klargøring af nelarabin infusionsvæske, opløsning kan skylles ud med rigelige mængder vand.
English: The dose of Atriance you are given will be based on:
Danish: Dosis af Atriance er baseret på følgende:
English: Full recovery from these reactions has not always occurred with cessation of nelarabine.
Danish: Disse bivirkninger har ikke altid været fuldt reversible efter seponering af nelarabin.
English: • Feeling generally weak and tired (temporary anaemia).
Danish: • Generel følelse af svaghed og træthed (forbigående anæmi).