FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Xaluprine.
Danish: Hvis du ikke er sikker på, om noget af ovenstående gælder for dig, så tal med din læge eller apotekspersonalet, før du begynder at tage Xaluprine.
English: Additional side effects in children Low blood sugar (hypoglycaemia) - the frequency is unknown.
Danish: Hos børn kan endvidere ses følgende bivirkninger Lavt blodsukker (hypoglykæmi) - hyppigheden er ikke kendt.
English: A more recent epidemiological report suggests that there is no increased risk of preterm births, low birth weight at term, or congenital abnormalities in women exposed to mercaptopurine during pregnancy.
Danish: Af en nyere epidemiologisk rapport fremgår det, at der muligvis ikke er nogen øget risiko for for tidlig fødsel, lav fødselsvægt eller medfødte abnormiteter hos børn af kvinder, som tager mercaptopurin under graviditeten.
English: Patients treated with 6-mercaptopurine alone or in combination with other immunosuppressive agents, including corticosteroids, have shown increased susceptibility to viral, fungal and bacterial infections, including severe or atypical infection, and viral reactivation.
Danish: Patienter, der behandles med 6-mercaptopurin alene eller i kombination med andre immunosuppressive midler, herunder kortikosteroider, har vist en øget modtagelighed over for virale, bakterielle og svampeinfektioner, herunder alvorlig eller atypisk infektion samt viral reaktivering.
English: Xaluprine treatment should be supervised by a physician or other healthcare professionals experienced in the management of patients with ALL.
Danish: Behandling med Xaluprine skal overvåges af en læge eller andet sundhedspersonale med erfaring inden for behandling af patienter med ALL.
English: The majority of reported cases were in children under the age of six or with a low body mass index.
Danish: De fleste indberettede tilfælde forekom hos børn under 6 år eller med et lavt BMI.
English: You may feel sick, vomit or have diarrhoea.
Danish: Du kan få kvalme, kaste op eller få diarré.
English: This problem could be exacerbated by coadministration with active substances that inhibit TPMT, such as olsalazine, mesalazine or sulfasalazine.
Danish: Dette problem kan forværres ved samtidig administration af aktive stoffer, som hæmmer TPMT, såsom olsalazin, mesalazin eller sulfasalazin.
English: Take the medicine pack and this leaflet with you.
Danish: Medbring medicinens emballage og denne indlægsseddel.
English: 6-mercaptopurine is hepatotoxic in animals and man.
Danish: 6-mercaptopurin er hepatotoksisk hos dyr og mennesker.
English: As this medicine contains sucrose, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Danish: Da dette lægemiddel indeholder sakkarose, bør patienter med sjældne arvelige problemer som fruktoseintolerans, glukose-galaktose-malabsorption eller sukrase-isomaltase-insufficiens ikke tage det.
English: Remove the bottle cap (figure 2) and push the adaptor firmly into the top of the bottle and leave in place for future doses (figure 3).
Danish: Tag flaskens kapsel af (Figur 2), tryk adapteren fast ned i flaskens top, og lad den sidde til fremtidige doser (Figur 3).
English: Since impaired renal function may result in slower elimination of mercaptopurine and its metabolites and therefore a greater cumulative effect, consideration should be given to reduced starting doses in patients with impaired renal function.
Danish: Da nedsat nyrefunktion kan resultere i langsommere eliminering af mercaptopurin og dets metabolitter og derfor en større kumulativ effekt, bør det overvejes at reducere startdosis hos patienter med nedsat nyrefunktion.
English: The 6-mecaptopurine oral suspension and tablet are not bioequivalent with respect to peak plasma concentration, and therefore intensified haematological monitoring of the patient is advised on switching formulations (see section 5.2).
Danish: 6-mecaptopurin oral suspension og tablet er ikke bioækvivalente med hensyn til maksimal plasmakoncentration, og der tilrådes derfor intensiveret hæmatologisk monitorering af patienten ved skift af formulering (se pkt.
English: Very common (affects more than 1 in 10 people) - a drop in the number of white blood cells and platelets (may show up in blood tests)
Danish: Meget almindelige (rammer mere end 1 ud af 10) - et fald i antallet af hvide blodlegemer og blodplader (kan vise sig ved blodprøver)
English: Women who are pregnant, planning to be or breast-feeding should not handle Xaluprine.
Danish: Kvinder, som er gravide, som planlægger at blive gravide, eller som ammer, må ikke håndtere Xaluprine.
English: Immunisation using a live organism vaccine has the potential to cause infection in immunocompromised hosts.
Danish: Ved immunisering med vacciner med levende organismer er der risiko for infektion hos immunkompromitterede værter.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Take as directed by your doctor using the dosing syringes provided.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Tages efter lægens anvisninger med de medfølgende doseringssprøjter.
English: Having vaccines while you are taking Xaluprine If you are going to have a vaccination it is important to speak to your doctor or nurse before you have it. Vaccination with live vaccines (like polio, measles, mumps and rubella) is not recommended, as these vaccines may give you an infection if you have them whilst you are taking Xaluprine.
Danish: Hvis du skal have en vaccination, er det vigtigt at tale med din læge eller sundhedspersonalet, før du får den. Vaccinationer med levende vacciner (som polio, mæslinger, fåresyge og røde hunde) anbefales ikke, da disse vacciner kan give dig en infektion, hvis du får dem, mens du tager Xaluprine.
English: Xaluprine is indicated for the treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children.
Danish: Xaluprine er indiceret til behandling af akut lymfoblastær leukæmi (ALL) hos voksne, unge og børn.
English: Push the tip of the dosing syringe into the hole in the adaptor (figure 4).
Danish: Skub spidsen af doseringssprøjten ned i adapterens hul (Figur 4).
English: TPMT genotyping or phenotyping can be used to identify patients with absent or reduced TPMT activity.
Danish: Bestemmelse af TPMT-genotype eller -fænotype kan anvendes til at identificere patienter uden eller med reduceret TPMT-aktivitet.
English: When allopurinol and 6-mercaptopurine are administered concomitantly it is essential that only a quarter of the usual dose of 6-mercaptopurine is given.
Danish: Når allopurinol og 6-mercaptopurin administreres samtidig, er det essentielt, at der kun gives en fjerdedel af den sædvanlige dosis 6-mercaptopurin.
English: It comes in glass bottles of 100 ml capped with a child-resistant closure.
Danish: Det findes i glasflasker på 100 ml med et børnesikret låg.
English: Substantial dose reductions are generally required for homozygous-TPMT deficiency patients to avoid the development of life threatening bone marrow suppression.
Danish: Der kræves generelt væsentlige dosisreduktioner til homozygote patienter med TPMT-mangel for at undgå udvikling af livstruende knoglemarvssuppression.
English: 6-mercaptopurine causes embryolethality and severe teratogenic effects in the mouse, rat, hamster and rabbit at doses that are non-toxic to the mother.
Danish: 6-mercaptopurin forårsager embryoletalitet og svære teratogene virkninger hos mus, rotte, hamster og kanin i doser, som ikke er toksiske for moderen.
English: Wash the syringe with warm ‘soapy' water and rinse well.
Danish: Vask sprøjten med varmt sæbevand, og skyl den godt.
English: Cross-resistance usually exists between 6-mercaptopurine and 6-thioguanine.
Danish: Der er som regel krydsresistens mellem 6-mercaptopurin og 6-thioguanin.
English: Xaluprine should only be given to you by a specialist doctor who is experienced in treating blood problems.
Danish: Xaluprine må kun gives til dig af en speciallæge med erfaring i behandling af blodsygdomme.
English: Tell your doctor before starting treatment whether or not you have had chickenpox, shingles or hepatitis B (a liver disease caused by a virus).
Danish: Fortæl det til lægen før du starter behandlingen, om du har haft skoldkopper, helvedesild eller hepatitis B (en leversygdom forårsaget af en virus).
English: Pharmacotherapeutic group: antineoplastic agents, antimetabolites, purine analogues, ATC code: L01BB02
Danish: Farmakoterapeutisk klassifikation: antineoplastiske midler, antimetabolitter, purinanaloger; ATC-kode: L01BB02
English: The dose should not be taken with milk or dairy products since they contain xanthine oxidase, an enzyme which metabolises 6mercaptopurine and might therefore lead to reduced plasma concentrations of mercaptopurine.
Danish: Dosen må ikke tages sammen med mælk eller mælkeprodukter, da de indeholder xanthinoxidase, et enzym, som metaboliserer 6-mercaptopurin og derfor kan føre til reducerede plasmakoncentrationer af mercaptopurin.
English: Carcinogenicity Given its genotoxic potential, 6-mercaptopurine is potentially carcinogenic.
Danish: Carcinogenicitet På grund af det genotoksiske potentiale er 6-mercaptopurin potentielt kræftfremkaldende.
English: Put the cap back on the bottle with the adaptor left in place.
Danish: Sæt hætten på flasken igen, og lad adapteren blive siddende.
English: This rare type of T cell lymphoma has an aggressive disease course and is usually fatal (see also section 4.8).
Danish: Denne sjældne type T-celle lymfom har et meget aggressivt sygdomsforløb og er sædvanligvis fatal (se også pkt.
English: It is recommended that the healthcare professional advises the patient or carer which syringe to use to ensure that the correct volume is administered.
Danish: Det anbefales, at sundhedspersonalet rådgiver patienten eller plejepersonen med hensyn til, hvilken sprøjte der skal anvendes, for at sikre, at der gives en korrekt mængde.
English: When oral anticoagulants are coadministered with 6-mercaptopurine, a reinforced monitoring of INR (International Normalised Ratio) is recommended (see section 4.5).
Danish: Hvis der gives orale antikoagulantia sammen med 6-mercaptopurin, anbefales en intensiveret monitorering af INR (International Normalised Ratio) (se pkt.
English: Haematological toxicity is likely to be more profound with chronic overdose than with a single ingestion of Xaluprine.
Danish: Hæmatologisk toksicitet kan sandsynligvis være sværere med kronisk overdosis end med en enkelt indtagelse af Xaluprine.
English: Vaccinations with other live organism vaccines are not recommended in immunocompromised individuals (see section 4.4).
Danish: Vaccination med andre levende vacciner anbefales ikke hos immunkompromitterede personer (se pkt.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: * In patients with inflammatory bowel disease (IBD), an unlicensed indication.
Danish: *Hos patienter med inflammatorisk tarmsygdom, en uautoriseret indikation.
English: Patients with little or no inherited TPMT activity are at increased risk for severe toxicity from conventional doses of mercaptopurine and generally require substantial dose reduction.
Danish: Patienter med ringe eller ingen nedarvet TPMT-aktivitet har øget risiko for svær toksicitet fra konventionelle doser af mercaptopurin og kræver generelt en væsentlig dosisreduktion.
English: Ask your doctor, pharmacist or midwife for advice.
Danish: Spørg lægen, apotekspersonalet eller jordemoderen til råds.
English: Let the syringe dry completely before you use that syringe again for dosing.
Danish: Lad sprøjten tørre helt, før du bruger den igen til dosering af medicinen.
English: Secondary leukaemia and myelodysplasia
Danish: Sekundær leukæmi og myelodysplasi
English: In view of its action on cellular deoxyribonucleic acid (DNA) 6-mercaptopurine is potentially carcinogenic and consideration should be given to the theoretical risk of carcinogenesis with this treatment.
Danish: I lyset af påvirkningen af cellernes deoxyribonukleinsyre (dna) er 6-mercaptopurin potentielt kræftfremkaldende, og denne behandlings teoretiske risiko for carcinogenese bør tages i betragtning.
English: Your doctor or pharmacist will advise you of the correct syringe to use, either the 1 ml (purple syringe) or the 5 ml (white syringe) in order to give the correct dose.
Danish: Din læge eller apotekspersonalet rådgiver dig om, hvilken sprøjte du skal bruge, enten 1 ml (violet) eller 5 ml (hvid), for at give den korrekte dosis.
English: The bioavailability of oral 6-mercaptopurine shows considerable inter-individual variability, which probably results from its first-pass metabolism.
Danish: Oralt 6-mercaptopurins biotilgængelighed har en betydelig variabilitet hos forskellige individer, hvilket sandsynligvis skyldes first-pass-metabolismen.
English: To decrease the risk of exposure, parents and care givers should wear disposable gloves when handling Xaluprine.
Danish: For at reducere risikoen for eksponering bør forældre og plejepersoner bære engangshandsker ved håndtering af Xaluprine.
English: This is usually reversible if 6-mercaptopurine therapy is stopped soon enough but fatal liver damage has occurred.
Danish: Dette er som regel reversibelt, hvis behandlingen med 6-mercaptopurin afbrydes i tide, men der er forekommet fatal leverskade.
English: There have been reports of premature birth and low birth weight following maternal exposure to 6-mercaptopurine.
Danish: Der har været rapporter om for tidlig fødsel og lav fødselsvægt, efter at moderen har været eksponeret for 6-mercaptopurin.
English: This medicinal product contains aspartame (E951), a source of phenylalanine.
Danish: Dette lægemiddel indeholder aspartam (E951), en kilde til fenylalanin.
English: - If you suddenly feel unwell (even with a normal temperature) and have abdominal pain and sickness, as this could be a sign of an inflamed pancreas
Danish: Hvis du pludselig føler dig dårligt tilpas (også selvom du har normal temperatur) og får mavesmerter og utilpashed, kan det være et tegn på betændelse i bugspytkirtlen
English: During remission induction when rapid cell lysis is occurring, uric acid levels in blood and urine should be monitored as hyperuricaemia and/or hyperuricosuria may develop, with the risk of uric acid nephropathy.
Danish: Under remissionsinduktion, når der forekommer hurtig cellelyse, skal urinsyreniveauet i blod og urin overvåges, da der kan udvikles hyperurikæmi og/eller hyperurikosuri med risiko for urinsyrenefropati.
English: Switching between tablet and oral suspension and vice versa A tablet form of 6-mercaptopurine is also available.
Danish: Skift mellem tabletter og oral suspension og vice versa 6-mercaptopurin findes også i tabletform.
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 25° C. Hold flasken tæt tillukket.
English: This may be harmful for people with phenylketonuria.
Danish: Det kan være skadeligt for personer med fenylketonuri.
English: Xaluprine is cytotoxic.
Danish: Xaluprine er cytotoksisk.
English: Amber type III glass bottle with tamper evident child-resistant closure (HDPE with expanded polyethylene liner) containing 100 ml of oral suspension.
Danish: Ravfarvet type III-glasflaske med børnesikret lukning (HDPE med ekspanderet membran af polyethylen) med 100 ml oral suspension.
English: Concomitant use with yellow fever vaccine (see section 4.5)
Danish: Samtidig brug af vaccine mod gul feber (se pkt.
English: 6-mercaptopurine displays diurnal variation in pharmacokinetics and efficacy.
Danish: 6-mercaptopurin udviser daglig variation i farmakokinetik og effekt.
English: Genotypic testing of NUDT15 variants may be considered before initiating 6-mercaptopurine therapy.
Danish: Det kan overvejes at udføre genotypisk testning af NUDT15-varianter før påbegyndelse af behandling med 6-mercaptopurin.
English: Since there is a potential for reduced elimination of mercaptopurine, consideration should be given to reduced starting doses in patients with impaired hepatic function.
Danish: Da der er mulighed for nedsat eliminering af mercaptopurin, bør det overvejes at reducere startdosis hos patienter med nedsat leverfunktion.
English: Turn the bottle upside down (figure 5).
Danish: Vend flasken på hovedet (Figur 5).
English: Xaluprine is used for acute lymphoblastic leukaemia (also called acute lymphocytic leukaemia or ALL).
Danish: Xaluprine anvendes til akut lymfoblastisk leukæmi (også kaldet akut lymfocytisk leukæmi eller ALL).
English: Parents / care givers and patients should be advised to keep Xaluprine out of the reach and sight of children, preferably in a locked cupboard.
Danish: Forældre/plejepersoner og patienter bør informeres om at holde Xaluprine utilgængeligt for børn, helst i et lukket skab.
English: Pull the plunger of the syringe back so that the medicine is drawn from the bottle into the syringe.
Danish: Træk sprøjtens stempel tilbage, så medicinen trækkes op fra flasken og ind i sprøjten.
English: Gently put the tip of the syringe into your mouth and to the inside of your cheek.
Danish: Placer forsigtigt sprøjtens spids inde i din mund på indersiden af kinden.
English: May be harmful for people with phenylketonuria.
Danish: Kan være skadeligt for personer med fenylketonuri.
English: 6-mercaptopurine is an inactive pro-drug which acts as a purine antagonist but requires cellular uptake and intracellular anabolism to thioguanine nucleotides for cytotoxicity.
Danish: 6-mercaptopurin er et inaktivt pro-drug, som virker som en purinantagonist, men kræver celleoptagelse og intracellulær anabolisme over for thioguaninnukleotider for cytotoksicitet.
English: Bone marrow suppression is reversible if 6-mercaptopurine is withdrawn early enough..
Danish: Knoglemarvssuppression er reversibel, hvis 6-mercaptopurin afbrydes tidligt nok.
English: Hepatosplenic T-cell lymphoma* (see section 4.4)
Danish: Hepatosplenisk T-celle lymfom* (se pkt.
English: Patients should be closely monitored for dose related adverse reactions.
Danish: Patienter skal monitoreres nøje for dosisrelaterede bivirkninger.
English: The effect of 6-mercaptopurine therapy on human fertility is unknown but there are reports of successful fatherhood/motherhood after receiving treatment during childhood or adolescence.
Danish: Virkningen af behandling med 6-mercaptopurin på fertilitet hos mennesker kendes ikke, men der er rapporter om, at både mænd og kvinder har fået børn efter at være blevet behandlet som børn eller unge.
English: When administered orally at a dosage of 75 mg/m2 to 7 paediatric patients, the bioavailability averaged 16% of the administered dose, with a range of 5 to 37%.
Danish: til 7 pædiatriske patienter var biotilgængeligheden i gennemsnit 16 % af den administrerede dosis inden for et område på 5 til 37 %.
English: Evidence of the teratogenicity of 6-mercaptopurine in humans is equivocal.
Danish: Evidensen for 6-mercaptopurins teratogenicitet hos mennesker er usikker.
English: Do not stop taking your medicine unless your doctor tells you to or you may get a relapse of your condition.
Danish: Du må ikke stoppe med at tage din medicin, medmindre lægen siger det.
English: Cytotoxicity and haematological monitoring
Danish: Cytotoksicitet og hæmatologisk monitorering
English: The active substance is mercaptopurine (as monohydrate).
Danish: Aktivt stof: mercaptopurin (som monohydrat).
English: There is low entry of 6-mercaptopurine into the cerebrospinal fluid.
Danish: Der er lav optagelse af 6-mercaptopurin i cerebrospinalvæsken.
English: Both TIMP and mTIMP are inhibitors of phosphoribosyl pyrophosphate amidotransferase, an enzyme which is important in de novo purine synthesis.
Danish: Både TIMP og mTIMP hæmmer fosforibosylpyrofosfat-amidotransferase, et enzym, som er væsentligt i de novo purinsyntese.
English: Hepatosplenic T-cell lymphoma has been reported in patients with inflammatory bowel disease* treated with azathioprine (the prodrug to 6-mercaptopurine) or 6-mercaptopurine, either with or without concomitant treatment with anti-TNF alpha antibody.
Danish: Hepatosplenisk T-celle lymfom er rapporteret hos patienter med inflammatorisk tarmsygdom* behandlet med azathioprin (prodrug til to 6-mercaptopurin) eller 6-mercaptopurin, enten med eller uden samtidig behandling med antistof mod anti-TNF-alfa.
English: 6-mercaptopurine is also subject to S-methylation by the enzyme thiopurine S-methyltransferase (TPMT), yielding methylmercaptopurine, which is inactive.
Danish: 6-mercaptopurin gennemgår også S-methylering af enzymet thiopurin S-methyltransferase (TPMT), hvilket giver methylmercaptopurin, som er inaktivt.
English: The first step is catalysed by hypoxanthine-guanine phosphoribosyl transferase yielding thioinosine monophosphate (TIMP).
Danish: Det første skridt katalyseres af hypoxanthin-guanin fosforibosyltransferase som giver thioinosin-monofosfat (TIMP).
English: Uric acid is a natural body chemical, levels of which can rise while taking Xaluprine.
Danish: Urinsyre er et naturligt kemikalie i kroppen, og niveauet af urinsyre kan stige, mens du tager Xaluprine.
English: Careful monitoring of haematological parameters should be conducted during therapy.
Danish: Hæmatologiske parametre bør nøje monitoreres under behandlingen.
English: - Do not take Xaluprine if you are allergic (hypersensitive) to mercaptopurine or any of the other ingredients of Xaluprine (see section 6).
Danish: - Tag ikke Xaluprine, hvis du er overfølsom (allergisk) over for mercaptopurin eller et af de øvrige indholdsstoffer (se pkt.
English: Increases in chromosomal aberrations were observed in the peripheral lymphocytes of leukaemic patients, in a renal cell carcinoma patient who received an unstated dose of 6-mercaptopurine and in patients with chronic renal disease treated at doses of 0.4 - 1.0 mg/kg/day.
Danish: Stigninger i kromosomafvigelser blev observeret i de perifere lymfocytter hos leukæmipatienter, hos patienter med renalcellecarcinom, som fik en ikke defineret dosis 6-mercaptopurin, og hos patienter med kronisk nyresygdom behandlet med doser på 0,4 - 1,0 mg/kg/dag.
English: Your can take your medicine with food or on an empty stomach but the choice of method should be consistent from day to day.
Danish: Du kan tage medicinen sammen med mad eller på tom mave, men metoden skal være den samme hver dag.
English: There are individuals with an inherited deficiency of the TPMT enzyme activity who are very sensitive to the myelosuppresive effect of 6-mercaptopurine and prone to developing rapid bone marrow depression following the initiation of treatment with 6-mercaptopurine.
Danish: Der findes personer med en nedarvet mangel på TPMT-enzymaktivitet, som er meget følsomme over for 6-mercaptopurins myelosupprimerende virkning, og som har en tendens til at udvikle hurtig knoglemarvsdepression efter initiering af behandling med 6-mercaptopurin.
English: Common (affects less than 1 in 10 people) - feeling or being sick (nausea or vomiting) - liver damage - this may show up in blood tests - a drop in red blood cells which may make you tired, weak or breathless (called anaemia) - loss of appetite - diarrhoea - inflammation of the mouth (stomatitis)
Danish: Almindelige (rammer mindre end 1 ud af 10) - utilpashed (kvalme eller opkastning) - leverskade - kan vise sig ved blodprøver - et fald i antallet af røde blodlegemer, som kan gøre dig træt, svag eller stakåndet - kaldes anæmi - tab af appetit - diarré - betændelse i mundhulen (stomatitis)
English: 6-mercaptopurine is metabolised by the polymorphic TPMT enzyme.
Danish: 6-mercaptopurin metaboliseres af det polymorfiske TPMT-enzym.
English: The histological findings in man have shown hepatic necrosis and biliary stasis
Danish: De histologiske fund hos mennesker har vist hepatisk nekrose og galdestase.
English: Spillages must be wiped immediately.
Danish: Spildt suspension skal straks tørres op.
English: Concentrated raspberry juice Sucrose
Danish: Koncentreret hindbærsaft Sakkarose