FrancophonIA/ELRC3.0 huggingface dataset:
English: Xaluprine must not be used in people who are hypersensitive (allergic) to mercaptopurine or any of the other ingredients.
Danish: Xaluprine bør ikke anvendes til personer, der er overfølsomme (allergiske) over for mercaptopurin eller andre af indholdsstofferne.
English: The added benefit of Xaluprine is that, as an oral suspension, it will provide more accuracy in dosing and it is easier to be taken by children.
Danish: Den ekstra fordel ved Xaluprine er, at en oral suspension gør doseringen nøjagtigere og er lettere at tage for børn.
English: A study was also carried out to compare the bioavailability of Xaluprine, which is an oral suspension, with that of the tablet.
Danish: Derudover blev der udført en undersøgelse, der sammenligner biotilgængeligheden af Xaluprine (oral suspension) med biotilgængeligheden af tabletten.
English: 6mercaptopurine prevents them from dividing and they eventually die, thereby slowing down the progression of the leukaemia.
Danish: 6-mercaptopurin forhindrer dem i at dele sig, så de til sidst dør.
English: The medicine is taken by mouth, using the syringe provided in the pack, once per day in the evening.
Danish: Lægemidlet indtages gennem munden en gang dagligt om aftenen ved brug af den medfølgende sprøjte.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Xaluprine can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Xaluprine findes på EMA's websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: For the full list of all side effects, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger fremgår af indlægssedlen.
English: The CHMP noted that mercaptopurine is established as an important treatment for ALL and that the only authorised form in the EU is a 50 mg tablet, making it difficult to adjust the dose for smaller children.
Danish: CHMP konstaterede, at mercaptopurin er et vigtigt middel til behandling af ALL, men at den eneste godkendte form i EU er 50 mg tabletten.
English: The active substance in this medicine, mercaptopurine has a similar chemical structure to purine, which is one of the fundamental chemicals that make up DNA.
Danish: Det aktive stof i dette lægemiddel, mercaptopurin, svarer i sin kemiske opbygning til purin, som er en af byggestenene i dna.
English: Other information about Xaluprine
Danish: Andre oplysninger om Xaluprine:
English: What is the risk associated with Xaluprine?
Danish: Hvilken risiko er der forbundet med Xaluprine?
English: EPAR summary for the public mercaptopurine
Danish: EPAR - sammendrag for offentligheden
English: The dose is determined for each patient mainly by body surface area and may be adjusted according to its effects in the blood.
Danish: Dosis afpasses til den enkelte patient, primært ud fra legemsoverfladen.
English: Why has Xaluprine been approved?
Danish: Hvorfor blev Xaluprine godkendt?
English: Xaluprine is used to treat children, adolescents and adults who have acute lymphoblastic leukaemia (ALL), a cancer of the lymphocytes (a type of white blood cell).
Danish: Xaluprine anvendes til behandling af børn, unge og voksne med akut lymfoblastisk leukæmi (ALL).
English: What is Xaluprine?
Danish: Hvad er Xaluprine?
English: The bioavailability study showed that Xaluprine is comparable to the tablets, but it works in a more predictable way and has a higher rate of absorption, for which reason the dose will need to be adjusted when a patient switches from one formulation to the other.
Danish: Biotilgængelighedsundersøgelsen viste, at Xaluprine er sammenligneligt med tabletterne, men dets virkning er mere forudsigelig, og det optages bedre.
English: What is Xaluprine used for?
Danish: Hvad anvendes Xaluprine til?
English: How has Xaluprine been studied?
Danish: Hvordan blev Xaluprine undersøgt?
English: What benefit has Xaluprine shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Xaluprine?
English: How is Xaluprine used?
Danish: Hvordan anvendes Xaluprine?
English: How does Xaluprine work?
Danish: Hvordan virker Xaluprine?
English: All these reactions were uncommon.
Danish: Alle disse reaktioner var ikke almindelige.
English: Therefore, use in these patients should be avoided.
Danish: Derfor bør anvendelsen til disse patienter undgås.
English: Safety and efficacy were maintained throughout all cycles.
Danish: Sikkerhed og virkning blev opretholdt i alle cyklusser.
English: The effects were reversible or partially reversible after the recovery period.
Danish: Virkningerne var reversible eller delvist reversible efter rekonvalescensperioden.
English: Hypokalaemia and hypomagnesaemia should be corrected prior to administration.
Danish: Hypokaliæmi og hypomagnesæmi bør korrigeres før administration.
English: The usual dose is 1 capsule.
Danish: Den sædvanlige dosis er 1 kapsel.
English: Akynzeo contains two medicines (‘active substances') called:
Danish: Akynzeo indeholder to lægemidler ('aktive stoffer'), der kaldes:
English: The following convention has been used for classification of frequency: Very common (≥1/10),
Danish: Den følgende konvention er blevet anvendt til klassifikation af hyppigheden: Meget almindelig (≥ 1/10),
English: Akynzeo should not be taken by children and adolescents under 18 years.
Danish: Akynzeo må ikke tages af børn og unge under 18 år.
English: Dialysis studies have not been performed.
Danish: Der er ikke blevet udført dialysestudier.
English: Recent guidance has updated these regimens to highly emetogenic.
Danish: Nylige retningslinjer har opdateret disse programmer til at være højemetogene.
English: • You can take Akynzeo with or without food.
Danish: • Du kan tage Akynzeo sammen med eller uden mad.
English: No antiemetic treatment
Danish: Ingen antiemetisk behandling
English: • Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på æsken og blisteren efter 'Exp'.
English: If this happens, do not drive or use any tools or machines.
Danish: Hvis dette forekommer, må du ikke føre motorkøretøj eller betjene værktøj eller maskiner.
English: In case of overdose, the medicinal product should be discontinued and general supportive treatment and monitoring should be provided.
Danish: I tilfælde af en overdosering skal lægemidlet seponeres, og der skal sørges for generel støttebehandling og overvågning.
English: All patients received a single oral dose of dexamethasone.
Danish: Alle patienter fik en enkelt oral dosis dexamethason.
English: A pregnancy test should be performed on all pre-menopausal women prior to treatment.
Danish: Der skal udføres en graviditetstest hos alle præmenopausale kvinder før behandlingen.
English: • Take the capsule about 1 hour before you start your chemotherapy cycle.
Danish: • Tag kapslen ca. 1 time, før du begynder din kemoterapi-cyklus.
English: The hard capsule should be swallowed whole.
Danish: Den hårde kapsel skal sluges hel.
English: • chest pain (not related to the heart)
Danish: • brystsmerter (ikke relateret til hjertet)
English: Caution should be exercised when using this medicinal product in patients over 75 years, due to the long half-life of the active substances and the limited experience in this population.
Danish: Der bør udvises forsigtighed, når dette lægemiddel anvendes til patienter over 75 år på grund af den lange halveringstid af de aktive stoffer og den begrænsede erfaring i denne population.
English: Plasma concentrations followed a first order absorption process and reached Cmax in approximately 5 hours.
Danish: Plasmakoncentrationerne fulgte en 1. ordens absorptionsproces og nåede Cmaks på ca. 5 timer.
English: • rifampicin - to treat tuberculosis (TB) and other infections.
Danish: • rifampicin - til at behandle tuberkulose (TB) og andre infektioner.
English: Days 2 to 3
Danish: Dag 2 til 3
English: Women of childbearing potential/ contraception in females
Danish: Kvinder i den fertile alder/kontraception hos kvinder
English: Following oral administration, palonosetron is well absorbed with its absolute bioavailability reaching 97%.
Danish: Efter oral administration er palonosetron velabsorberet med en absolut biotilgængelighed, der når op til 97 %.
English: M1, M2 and M3 metabolites were all shown to be pharmacologically active in an animal pharmacodynamic model, where M3 was most potent and M2 least active.
Danish: M1-, M2- og M3-metabolitterne viste sig alle at være farmakologisk aktive i en farmakodynamisk dyremodel, hvor M3 var mest potent, og M2 var mindst aktiv.
English: The hard capsule is filled with three tablets and one soft capsule.
Danish: Den hårde kapsel er fyldt med tre tabletter og en blød kapsel.
English: • you have any other heart problems • you have been told you have an imbalance of minerals in your blood such as potassium and magnesium that has not been corrected.
Danish: • du har haft andre hjerteproblemer • du har fået at vide, at mineralerne i dit blod ikke er i balance, såsom kalium og magnesium, og det ikke er blevet korrigeret.
English: There have also been reports of serotonin syndrome.
Danish: Der har også været rapporter om serotonergt syndrom.
English: The AUC was 30% higher in cancer patients than in healthy subjects.
Danish: AUC var 30 % højere for cancerpatienter end for raske personer.
English: Days 2 to 4
Danish: Dag 2 til 4
English: You may feel dizzy or tired after taking Akynzeo.
Danish: Du kan føle dig svimmel eller træt, efter du tager Akynzeo.
English: A total of 724 patients (99.9%) were treated with cyclophosphamide.
Danish: I alt 724 patienter (99,9 %) blev behandlet med cyklophosphamid.
English: • lack of energy (feeling weak)
Danish: • manglende energi (svaghedsfølelse)
English: After completion of cycle 1, patients had the option to participate in a multiple-cycle extension, receiving the same treatment as assigned in cycle 1.
Danish: Efter cyklus 1 var gennemført, havde patienterne mulighed for at deltage i et forlængelsesstudie med flere cyklusser, hvor de fik den samme behandling som tildelt i cyklus 1.
English: Stop taking Akynzeo and tell your doctor straight away if you notice the following serious side effectyou may need urgent medical treatment:
Danish: Hold op med at tage Akynzeo, og fortæl det straks til lægen, hvis du bemærker følgende alvorlige bivirkning - du kan have behov for akut medicinsk behandling:
English: There was no pre-specified limit of the number of repeat consecutive cycles for any patient.
Danish: Der var ingen præspecificeret grænse for antallet af på hinanden efterfølgende cyklusser for nogen af patienter.
English: It is not excluded that this effect may be more marked, and then clinically relevant, in cancer patients, notably those having abnormal renal function.
Danish: Det kan ikke udelukkes, at denne virkning kan være mere udpræget og dermed klinisk relevant hos cancerpatienter, især patienter med unormal nyrefunktion.
English: Elimination via both routes was estimated to be complete by Day 29-30 post-dose.
Danish: Det blev estimeret, at eliminering via begge veje var gennemført på Dag 20-30 efter doseringen.
English: The impact of nausea and vomiting on patients' daily lives was assessed using the Functional Living Index-Emesis (FLIE).
Danish: Påvirkningen af kvalme og opkastning på patienternes dagligdag blev vurderet med Functional Living Index-Emesis (FLIE).
English: EU/1/15/1001/001 1 hard capsule EU/1/15/1001/002 4x1 hard capsules
Danish: EU/1/15/1001/001 1 hård kapsel EU/1/15/1001/002 4x1 hård kapsel
English: No dosage adjustment is necessary for elderly patients.
Danish: Ingen dosisjustering er nødvendig for ældre patienter.
English: A summary of the key results from this study is shown in Table below.
Danish: En oversigt af de afgørende resultater fra dette studie vises i tabellen nedenfor.
English: Adverse reactions are listed below by MedDRA body system organ class and frequency.
Danish: Bivirkninger er opstillet nedenfor pr. MedDRA systemorganklasse og hyppighed.
English: Glycerol monocaprylocaproate (type I) Glycerol
Danish: Glycerolmonocaprylocaproat (type I) Glycerol
English: This is because it is not known whether the medicine passes into breast milk.
Danish: Dette skyldes, at det er ukendt, om lægemidlet udskilles i brystmælk.
English: The third major metabolite, M2, is > 97% bound to plasma proteins.
Danish: Den tredje større metabolit, M2, er > 97 % bundet til plasmaproteiner.
English: Antiemetic activity of Akynzeo was maintained throughout repeat cycles for those patients continuing in each of the multiple cycles.
Danish: Den antiemetiske aktivitet af Akynzeo blev opretholdt i alle de gentagne cyklusser for de patienter, der fortsatte i de flere cyklusser.
English: A summary of the key results from this study is shown in Table 3 below.
Danish: En oversigt over de afgørende resultater fra dette studie vises i tabel 3 nedenfor.
English: Post-marketing data indicates that the adverse reactions profile is generally similar to that seen in clinical trials.
Danish: Data fra efter markedsføring indikerer, at bivirkningsprofilen generelt svarer til den, der er observeret i kliniske studier.
English: There was a supra-proportional increase in Cmax and AUC parameters for doses from 10 mg to 300 mg.
Danish: Der var en supra-proportional forhøjelse i parametre for Cmaks og AUC for doser fra 10 mg til 300 mg.
English: If you think you have forgotten to take your dose, tell your doctor straight away.
Danish: Hvis du tror, du har glemt at tage din dosis, skal du straks fortælle det til lægen.
English: Approximately 62% of palonosetron is bound to plasma proteins.
Danish: Ca. 62 % palonosetron er bundet til plasmaproteiner.
English: One 300 mg/0.5 mg capsule should be administered approximately one hour prior to the start of each chemotherapy cycle.
Danish: En 300 mg/0,5 mg kapsel bør administreres ca. en time før start af hver kemoterapi-cyklus.
English: Effect of ketoconazole and rifampicin
Danish: Virkningen af ketoconazol og rifampicin
English: Butylhydroxyanisole (E320)
Danish: Butylhydroxyanisol (E320)
English: Very rare (<1/10,000),
Danish: Meget sjælden (< 1/10.000),
English: Breast-feeding should be discontinued during treatment with this medicinal product and for 1 month after the last dose.
Danish: Amning bør afbrydes under behandling med dette lægemiddel og i 1 måned efter den sidste dosis.
English: • ring in the ear
Danish: • ringen i øret
English: When netupitant was administered on Day 8 of a 12-day regimen of digoxin, no changes in digoxin pharmacokinetics were observed.
Danish: Da netupitant blev administreret på Dag 8 i et 12-dages program med digoxin blev der ikke observeret nogen ændringer i farmakokinetikken for digoxin.
English: The underlying mechanisms are not fully understood, but because of the high doses employed and since the medicinal product is intended for single application in humans, these findings are not considered relevant for clinical use.
Danish: Den underliggende mekanisme er ikke helt forstået, men som følge af de høje administrerede doser, og da lægemidlet er beregnet til en enkelt administration hos mennesker, anses disse fund ikke for at være relevante for klinisk anvendelse.
English: * p-value from Cochran-Mantel-Haenszel test, stratified by age class and region.
Danish: Samlet fase * p-værdi fra Cochran-Mantel-Haenszel-test, stratificeret pr. aldersklasse og region.
English: The amount of unchanged palonosetron excreted in the urine represented approximately 40% of the administered dose.
Danish: Mængden af uændret palonosetron, der blev udskilt i urinen, udgjorde ca. 40 % af den administrerede dosis.
English: All patients were additionally treated with either doxorubicin (68.0%) or epirubicin (32.0%).
Danish: Alle patienterne blev endvidere behandlet med enten doxorubicin (68,0 %) eller epirubicin (32,0 %).
English: • erythromycin - to treat bacterial infections
Danish: • erythromycin - til at behandle bakterieinfektioner
English: Patients continued into the Multiple-Cycle extension for up to 7 additional cycles of chemotherapy.
Danish: Patienterne fortsatte i forlængelsesfasen med flere cyklusser i op til 7 yderligere kemoterapi-cyklusser.
English: Since it may induce dizziness, somnolence or fatigue, patients should be cautioned not to drive or use machines if such symptoms occur.
Danish: Da det kan inducere svimmelhed, døsighed eller træthed, bør patienterne rådes til ikke at føre motorkøretøj eller betjene maskiner, hvis sådanne symptomer opstår.
English: Of these, 1438 patients (98.8%) completed cycle 1 and 1286 patients (88.4%) continued treatment in the multiple-cycle extension.
Danish: Ud af disse gennemførte 1438 patienter (98,8 %) cyklus 1, og 1286 patienter (88,4 %) fortsatte behandlingen i forlængelsesfasen med flere cyklusser.
English: You can also report side effects directly via the national reporting system listed in Appendix V By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: 1 hard capsule 4x1 hard capsules
Danish: 1 hård kapsel 4x1 hård kapsel
English: • some chemotherapy medicines - such as docetaxel or etoposide
Danish: • nogle kemoterapi-lægemidler - såsom docetaxel eller etoposid
English: • ketoconazole - to treat Cushing's syndrome
Danish: • ketoconazol - til at behandle Cushings syndrom
English: The ratios were time dependent with values decreasing gradually beyond 24 h post-dose, indicating that netupitant is being rapidly metabolized.
Danish: Forholdet var tidsafhængigt med værdier, der faldt gradvist fra 24 timer efter doseringen, hvilket indikerer, at netupitant metaboliseres hurtigt.
English: A total of 1450 patients (Akynzeo n=725; Palonosetron n=725) received study medication.
Danish: I alt 1450 patients (Akynzeo n=725, palonosetron n=725) fik studielægemiddel.
English: Women of childbearing potential must use effective contraception during therapy and up to one month after treatment with this medicinal product.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen og i op til en måned efter behandlingen med dette lægemiddel.
English: Netupitant is a selective antagonist of human substance P/neurokinin 1 (NK1) receptors.
Danish: Netupitant er en selektiv antagonist af humane substans P/neurokinin 1 (NK1)-receptorer.
English: If you decide not to take Akynzeo (or another similar medicine), your chemotherapy is likely to make you feel sick and be sick.
Danish: Hvis du beslutter dig for ikke at tage Akynzeo (eller et andet lignende lægemiddel), er det sandsynligt, at din kemoterapi kan få dig til at få kvalme eller kaste op.
English: • you have a blockage in your gut, or you have had constipation in the past • you or one of your close relatives has ever had a heart problem called ‘QT interval prolongation'
Danish: • du har en blokering i tarmen, eller hvis du tidligere har haft forstoppelse • du eller en af dine nære slægtninge nogensinde har haft et hjerteproblem, der kaldes
English: If you are allergic to peanut or soya, see your doctor straight away if you notice any signs of an allergic reaction.
Danish: Hvis du er allergisk over for jordnødder eller soja, skal du straks opsøge din læge, hvis du bemærker tegn på en allergisk reaktion.
English: Palonosetron is a 5-HT3 receptor antagonist with a strong binding affinity for this receptor and little or no affinity for other receptors.
Danish: Palonosetron er en 5-HT3-receptorantagonist med en kraftig bindingsaffinitet for denne receptor, og en lille eller ingen affinitet for andre receptorer.
English: Serotonin syndrome
Danish: Serotonergt syndrom
English: The clinical relevance of this effect is not established.
Danish: Den kliniske relevans af denne virkning er ikke klarlagt.
English: Do not take Akynzeo in the days after you have chemotherapy - unless you are about to have another chemotherapy cycle.
Danish: Tag ikke Akynzeo i dagene, efter du har fået kemoterapi - medmindre du skal til at have en anden kemoterapicyklus.
English: Talk to your doctor, pharmacist or nurse before taking Akynzeo if: • you have liver problems
Danish: Kontakt lægen, apotekspersonalet eller sygeplejersken, før du tager Akynzeo, hvis: • du har problemer med leveren
English: In a population PK study, patients with a reduced creatinine clearance (CLCR) also had a reduced palonosetron clearance, but this reduction would not result in a significant change in palonosetron exposure.
Danish: I et populationsfarmakokinetisk studie havde patienter med en nedsat kreatininclearance (CLCR) også en reduceret palonosetronclearance, men denne reduktion førte til en signifikant ændring i palonosetroneksponeringen.
English: • sudden nervous breakdown, change in mood
Danish: • pludseligt nervøst sammenbrud, humørændring
English: Therefore, caution is recommended when netupitant is combined with digoxin or with other P-gp substrates such as dabigatran, or colchicine.
Danish: Derfor rådes der til forsigtighed, når netupitant kombineres med digoxin eller med andre P-gpsubstrater, såsom dabigatran eller colchicin.
English: Do not take Akynzeo if you are pregnant or if you are a woman of childbearing potential not using contraception.
Danish: Tag ikke Akynzeo, hvis du er gravid, eller hvis du er en kvinde i den fertile alder, som ikke anvender sikker prævention.
English: The safety and efficacy of Akynzeo capsules in the paediatric population have not been established.
Danish: Akynzeo kapslers sikkerhed og virkning hos den pædiatriske population er ikke klarlagt.
English: However, due to the large volume of distribution of palonosetron and netupitant, dialysis is unlikely to be an effective treatment for overdose.
Danish: Grundet det store fordelingsvolumen af palonosetron og netupitant er det imidlertid usandsynligt, at dialyse er en effektiv behandling af en overdosering.
English: Because of the antiemetic activity of netupitant and palonosetron, emesis induced by a medicinal product may not be effective.
Danish: Grundet den antiemetiske aktivitet af netupitant og palonosetron kan det forekomme, at emese induceret af et lægemiddel ikke er effektivt.
English: Palonosetron has a volume of distribution of approximately 8.3 ± 2.5 L/kg.
Danish: Palonosetron har et fordelingsvolumen på ca. 8,3 ± 2,5 l/kg.
English: In the ADME trial, less than 5% of all netupitant-related material was excreted in urine and less than 1% of the netupitant dose was eliminated unchanged in the urine and therefore any accumulation of netupitant or metabolites after a single dose would be negligible.
Danish: I ADME-studiet blev under 5 % af alt netupitant-relateret materiale udskilt i urinen, og under 1 % af netupitantdosis blev elimineret uændret i urinen, og derfor vil en akkumulering af netupitant eller metabolitter efter en enkelt dosis være ubetydelig.
English: Therefore, Akynzeo can be administered without dosage adjustment in patients with renal impairment.
Danish: Derfor kan Akynzeo administreres uden en dosisjustering hos patienter med nedsat nyrefunktion.
English: Acute psychosis Mood altered Sleep disorder
Danish: Akut psykose Humørændring Søvnforstyrrelse
English: Caution should be exercised in patients with severe hepatic impairment since limited data are available in these patients.
Danish: Der bør udvises forsigtighed hos patienter med svært nedsat leverfunktion, da der kun foreligger begrænsede data fra disse patienter.
English: It is unknown whether palonosetron or netupitant are excreted in human milk.
Danish: Det er ukendt, om palonosetron eller netupitant udskilles i human mælk.
English: This medicine contains sucrose, sorbitol, sodium and may contain soya - see section 2 for more information.
Danish: Denne medicin indeholder saccharose, sorbitol, natrium og kan indeholde soja - se punkt 2 for yderligere oplysninger.
English: Erythromycin and Midazolam
Danish: Erythromycin og midazolam