FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration in the evening compared to morning administration may lower the risk of relapse.
Danish: Administration om aftenen sammenlignet med om morgenen kan reducere risikoen for recidiv.
English: It is possible that the levels of other anti-epileptic medicinal products may also be altered.
Danish: Det er muligt, at niveauet af andre antiepileptika også kan ændre sig.
English: The frequency of NUDT15 c.415C>T has an ethnic variability of approximately 10 % in East Asians, 4 % in Hispanics, 0.2 % in Europeans and 0 % in Africans.
Danish: Hyppigheden af NUDT15 c.415C>T har en etnisk variabilitet på ca. 10 % hos østasiater, 4 % hos latinamerikanere, 0,2 % hos europæere og 0 % hos afrikanere.
English: Long term use increases the risk of dental caries and it is essential that adequate dental hygiene is maintained.
Danish: Langvarig brug øger risikoen for dental karies, og det er meget vigtigt, at en tilstrækkelig tandhygiejne opretholdes.
English: Do not pass it on to others.
Danish: Lad derfor være med at give medicinen det til andre.
English: Safe handling of the suspension
Danish: Sikker håndtering af suspensionen
English: These new white blood cells are immature (not fully formed) and unable to grow and work properly.
Danish: De nye hvide blodlegemer er umodne (ikke færdigdannede) og kan ikke vokse og fungere korrekt.
English: - Do not use this medicine after the expiry date which is stated on the carton and the bottle after ‘EXP'.
Danish: - Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og flasken efter Exp.
English: This is a fast-growing disease which increases the number of new white blood cells.
Danish: Det er en sygdom, som udvikler sig hurtigt, og som øger antallet af nye hvide blodlegemer.
English: - you have a condition where your body produces too little of the enzyme called TPMT
Danish: - har en lidelse, hvor din krop producerer for lidt af et enzym ved navn TPMT
English: Date of latest renewal: 18 November 2016
Danish: Dato for første markedsføringstilladelse: 09. marts 2012 Dato for seneste fornyelse: 18. november 2016
English: The apparent body clearance is 4832 ± 2562 ml/min/m2.
Danish: Den åbenbare clearance er 4832 ± 2562 ml/min/m2.
English: Liver dysfunction and gastroenteritis may also occur.
Danish: Leverdysfunktion og gastroenteritis kan også forekomme.
English: - Your doctor may also ask for other blood and urine tests to monitor your uric acid levels.
Danish: - Din læge kan også bede om andre blod- og urinprøver for at overvåge dit urinsyreniveau.
English: See also section 4.
Danish: Se punkt 4.
English: (thiopurine methyltransferase), as your doctor may need to adjust the dose.
Danish: (thiopurinmethyltransferase), da lægen måske skal justere din dosis.
English: The bottle should be shaken vigorously for at least 30 seconds to ensure the oral suspension is well mixed.
Danish: Flasken skal rystes kraftigt i mindst 30 sekunder for at sikre, at den orale suspension er godt blandet.
English: Ask your doctor if you would like more explanation about this disease.
Danish: Spørg din læge, hvis du vil have mere at vide om sygdommen.
English: - Any unexpected bruising or bleeding, as this could mean that too few blood cells of a particular type are being produced
Danish: En hvilken som helst uventet blodudtrædning eller blødning, da det kan betyde, at der produceres for få blodlegemer af en bestemt type
English: Some laboratories offer testing for TPMT deficiency, although these tests have not been shown to identify all patients at risk of severe toxicity.
Danish: Nogle laboratorier foretager test af TPMT-mangel, selvom disse test ikke har vist sig at identificere alle patienter med risiko for svær toksicitet.
English: Approximately 7% of an oral dose is excreted as unchanged 6-mercaptopurine within 12 hours after administration.
Danish: Omkring 7 % af en oral dosis udskilles som uændret 6-mercaptopurin inden for 12 timer efter administrationen.
English: A detrimental effect on these activities cannot be predicted from the pharmacology of the active substance.
Danish: En negativ virkning på disse aktiviteter kan ikke forudsiges på baggrund af det aktive stofs farmakologi.
English: This belongs to a group of medicines called cytotoxics (also called chemotherapy).
Danish: Det tilhører en gruppe af lægemidler kaldet cytotoksika (også kaldet kemoterapi).
English: Do not take Xaluprine at the same time as milk or dairy products, as they can make the medicine less effective.
Danish: Tag ikke Xaluprine samtidig med mælk eller mælkeprodukter, da de kan gøre medicinen mindre effektiv.
English: If you accidentally get some in your eyes or nose, flush the area with water.
Danish: Hvis du ved et uheld får noget i øjne eller næse, skal du skylle området med vand.
English: Therefore the daily dose of Xaluprine should be taken in the evening.
Danish: Derfor bør den daglige dosis Xaluprine tages om aftenen.
English: Careful monitoring of the phenytoin serum levels is recommended.
Danish: Omhyggelig monitorering af serumniveauet af fenytoin anbefales.
English: Photosensitivity reaction
Danish: Fotosensibiliserende reaktion
English: Hydration and urine alkalinisation may minimize potential renal complications.
Danish: Hydrering og alkalinisering af urinen kan minimere eventuelle nyrekomplikationer.
English: The incidence of hepatotoxicity varies considerably and can occur with any dose but more frequently when the recommended dose is exceeded.
Danish: Incidensen af hepatotoksicitet varierer betragteligt og kan forekomme med alle doser, men hyppigere, når den anbefalede dosis overskrides.
English: Bacterial and viral infections, infections associated with neutropenia
Danish: Bakterielle og virale infektioner, infektioner forbundet med neutropeni
English: Therefore, immunisations with live organism vaccines are not recommended.
Danish: Derfor anbefales immunisering med levende vacciner ikke.
English: Reliable contraception must be used to avoid pregnancy whilst you or your partner are taking Xaluprine.
Danish: Der skal anvendes pålidelig prævention for at undgå graviditet, mens du eller din partner tager Xaluprine.
English: It is not expected that Xaluprine will affect your ability to drive or use machines but no studies have been done to confirm this.
Danish: Det forventes ikke, at Xaluprine vil påvirke din evne til at føre motorkøretøj eller betjene maskiner, men der er ikke foretaget undersøgelser, som bekræfter dette.
English: Xaluprine is for oral use and requires redispersing (by shaking vigorously at least for 30 seconds) prior to dosing.
Danish: Xaluprine er beregnet til oral brug og skal genopløses (ved at ryste kraftigt i mindst 30 sekunder) før dosering.
English: 100 ml glass bottle Bottle adaptor
Danish: 100 ml glasflaske Flaskeadapter
English: Serologic testing prior to starting treatment should be considered with respect to hepatitis B. Local guidelines may be considered, including prophylactic therapy for cases which have been confirmed positive by serologic testing.
Danish: Serologisk testning før påbegyndelse af behandling bør overvejes med hensyn til hepatitis B. Lokale retningslinjer kan tages under overvejelse, herunder profylaktisk behandling ved tilfælde, der er blevet bekræftet positive vha. serologisk testning.
English: Do not take Xaluprine if you are planning to have a baby without first speaking to your doctor for advice.
Danish: Tag ikke Xaluprine, hvis du planlægger at få et barn, uden først at spørge din læge til råds.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Hvis din læge har fortalt dig, at du har intolerans over for visse sukkerarter, skal du kontakte lægen, inden du tager dette lægemiddel.
English: Talk to your doctor if you have any of the following side effects which may also happen with this medicine:
Danish: Søg læge, hvis du får nogen af de følgende bivirkninger, som også kan optræde med denne medicin:
English: Both men and women should continue to use effective contraception for at least 3 months after stopping treatment.
Danish: Både mænd og kvinder skal fortsætte med at anvende effektiv prævention i mindst 3 måneder efter, at behandlingen er stoppet.
English: BSA (m2) Dose (mg)
Danish: BSA (m2) Dosis (mg)
English: Shake the bottle vigorously for at least 30 seconds to ensure the medicine is well mixed (figure 1).
Danish: Ryst flasken kraftigt i mindst 30 sekunder for at sikre, at medicinen er godt blandet (Figur 1).
English: Anyone handling Xaluprine should wash their hands before and after administering a dose.
Danish: Alle, som håndterer Xaluprine, skal vaske hænder før og efter administration af en dosis.
English: As there is no known antidote the blood picture should be closely monitored and general supportive measures, together with appropriate blood transfusion, instituted if necessary.
Danish: Da der ikke er nogen kendt antidot, bør blodbilledet nøje overvåges, og der skal om nødvendigt indsættes generelle understøttende foranstaltninger sammen med relevant blodtransfusion.
English: Monitoring of liver function tests may allow early detection of hepatotoxicity.
Danish: Monitorering af leverfunktionstest kan muliggøre tidlig påvisning af hepatotoksicitet.
English: Both sexually active men and women should use effective methods of contraception during treatment and for at least three months after receiving the last dose.
Danish: Både seksuelt aktive mænd og kvinder skal anvende sikker kontraception under behandlingen og i mindst tre måneder efter den sidste dosis.
English: Symptoms and signs
Danish: Tegn og symptomer
English: Prior exposure to or infection with varicella zoster virus should be taken into consideration prior to starting treatment.
Danish: Der skal tages højde for forudgående eksponering over for eller infektion med varicella-zoster-virus før påbegyndelse af behandlingen.
English: - Your doctor may sometimes change your dose of Xaluprine as a result of these tests.
Danish: - Din læge kan af og til ændre din dosis af Xaluprine på grund af disse test.
English: The suspension is pink to brown in colour.
Danish: Suspensionen har en lyserød til brun farve.
English: † In the paediatric population.
Danish: † Hos den pædiatriske population
English: In all species, the degree of embryotoxicity and the type of malformations are dependent on the dose and stage of the gestation at the time of administration.
Danish: Hos alle arter afhænger graden af embryotoksicitet og typen af misdannelser af dosis og drægtighedens stadie på administrationstidspunktet.
English: The usual starting dose for adults, adolescents and children is between 25-75 mg/m2 body surface area each day.
Danish: Den sædvanlige startdosis for voksne, unge og børn er mellem 25-75 mg/m2 legemsoverfladeareal dagligt.
English: The following events have been identified as adverse reactions.
Danish: Følgende hændelser er identificeret som bivirkninger.
English: You should take your medicine at least 1 hour before or 2 hours after having milk or dairy products.
Danish: Du skal tage medicinen mindst én time før eller to timer efter indtagelse af mælk eller mælkeprodukter.
English: Patients with NUDT15 variant
Danish: Patienter med NUDT15-variant
English: Shake vigorously before use for at least 30 seconds.
Danish: Ryst kraftigt før brug i mindst 30 sekunder.
English: Hold the syringe under water and move the plunger up and down several times to make sure the inside of the syringe is clean.
Danish: Hold sprøjten under vand, og bevæg stemplet op og ned flere gange for at sikre, at indersiden af sprøjten er ren.
English: No studies on the effect on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj og betjene maskiner.
English: If you are a parent or care giver administering the medicine, wash your hands before and after administering a dose.
Danish: Hvis du er forælder eller plejeperson, som giver medicinen, skal du vaske dine hænder før og efter, at du giver en dosis.
English: Xaluprine is hepatotoxic and liver function tests should be monitored weekly during treatment.
Danish: Xaluprine er hepatotoksisk, og leverfunktionstest skal overvåges ugentligt under behandlingen.
English: - When you take Xaluprine your doctor will take regular blood tests.
Danish: - Når du tager Xaluprine, vil lægen regelmæssigt tage blodprøver.
English: The mean (90% CI) Cmax with the oral suspension was 39% (22% - 58%) higher than the tablet although there was less between-subject variability (%C.V) with the oral suspension (46%) than the tablet (69%).
Danish: Gennemsnitlig (90 % CI) Cmax med oral suspension var 39 % (22 % - 58 %) højere end tabletten, selvom der var mindre variabilitet mellem forsøgspersonerne (% C.V) med den orale suspension (46 %) end tabletten (69 %).
English: - Any yellowing of the whites of the eyes or skin (jaundice)
Danish: En hvilken som helst gulfarvning af det hvide i øjnene eller huden (gulsot)
English: It is recommended that newborns of women exposed to mercaptopurine during pregnancy are monitored for haematological and immune system disturbances.
Danish: Det anbefales, at nyfødte børn af kvinder, som har været eksponeret for mercaptopurin under graviditeten, monitoreres for hæmatologiske forstyrrelser og forstyrrelser i immunsystemet.
English: NUDT15-gene mutation
Danish: NUDT15-genmutation
English: Active measures (such as the use of activated charcoal or gastric lavage) may not be effective in the event of 6-mercaptopurine overdose unless the procedure can be undertaken within 60 minutes of ingestion.
Danish: Aktive foranstaltninger (som anvendelse af aktivt kul eller ventrikelskylning) er muligvis ikke effektive ved overdosis af 6-mercaptopurin, medmindre proceduren kan gennemføres inden for 60 minutter efter indtagelsen.
English: The dose should not be taken with milk or dairy products (see section 4.5).
Danish: Dosen må ikke tages sammen med mælk eller mælkeprodukter (se pkt.
English: 1 ml and 5 ml dosing syringes.
Danish: 1 ml og 5 ml doseringssprøjter.
English: Stomatitis, diarrhoea, vomiting, nausea
Danish: Stomatitis, diarré, opkastning, kvalme
English: Xaluprine should be taken at least 1 hour before or 2 hours after milk or dairy products.
Danish: Xaluprine skal tages mindst én time før eller to timer efter indtagelse af mælk eller mælkeprodukter.
English: Swallow the dose of oral suspension then drink some water, making sure no medicine is left in your mouth.
Danish: Synk dosen af oral suspension, og drik derefter lidt vand for at sikre, at der ikke er mere medicin i munden.
English: Gastrointestinal effects, including nausea, vomiting and diarrhoea and anorexia may be early symptoms of overdose having occurred.
Danish: Gastrointestinale bivirkninger, herunder kvalme, opkastning og diarré samt anoreksi, kan være tidlige symptomer på, at der er sket en overdosering.
English: Store the syringe in a hygienic place with the medicine.
Danish: Opbevar sprøjten et hygiejnisk sted sammen med medicinen.
English: Therefore close monitoring of blood counts is necessary.
Danish: Derfor er nøje monitorering af blodtal nødvendigt.
English: Repeat the above for each dose as instructed by your doctor or pharmacist.
Danish: Gentag ovenstående for hver dosis efter lægens eller apotekspersonalets anvisninger.
English: Pull the plunger back to the point on the scale that corresponds to the dose prescribed (figure 5).
Danish: Træk stemplet tilbage til punktet på skalaen, som svarer til den ordinerede dosis (Figur 5).
English: Mutagenicity and carcinogenicity
Danish: Mutagenicitet og carcinogenicitet
English: PHARMACEUTICAL FORM Oral suspension.
Danish: LÆGEMIDDELFORM Oral suspension.
English: The elimination half-life of 6-mercaptopurine is 90 ± 30 minutes, but the active metabolites have a longer half-life (approximately 5 hours) than the parent compound.
Danish: Halveringstiden af 6-mercaptopurin er 90 ± 30 minutter, men de aktive metabolitter har længere halveringstid (cirka 5 timer) end udgangsstoffet.
English: If you are already pregnant, you must talk to your doctor before taking Xaluprine.
Danish: Hvis du allerede er gravid, skal du tale med lægen, før du tager Xaluprine.
English: It is important that you use the correct dosing syringe for your medicine.
Danish: Det er vigtigt, at du bruger den korrekte doseringssprøjte til din medicin.
English: TPMT testing cannot substitute for haematological monitoring in patients receiving Xaluprine.
Danish: TPMT-test kan ikke erstatte hæmatologisk monitorering hos patienter, som får Xaluprine.
English: Slowly and gently push the plunger down to gently squirt the medicine into the inside of your cheek and swallow it. DO NOT forcefully push down the plunger, or squirt the medicine to the back of your mouth or throat, as you may choke.
Danish: Pres langsomt og forsigtigt stemplet ned, så medicinen forsigtigt sprøjtes ind på indersiden af kinden, og synk den. Du må IKKE trykke kraftigt på stemplet eller sprøjte medicinen om bag i munden eller halsen, da du kan få den galt i halsen.
English: There have also been reports of congenital abnormalities and spontaneous abortion following either maternal or paternal exposure.
Danish: Der har også været rapporter om medfødte abnormiteter og spontan abort, efter at enten moderen eller faderen har været eksponeret.
English: Low blood sugar has sometimes been seen in children, mainly in children under the age of six or with a low body mass index.
Danish: Der er undertiden set lavt blodsukker hos børn, navnlig hos børn under 6 år eller med et lavt BMI.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Nova Laboratories Ireland Limited
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Nova Laboratories Ireland Limited
English: - Any signs of fever or infection (sore throat, sore mouth or urinary problems)
Danish: Et hvilket som helst tegn på feber eller infektion (ondt i halsen, ømhed i munden eller urinvejsproblemer)
English: To assist accurate and consistent dose delivery to the stomach water should be taken after each dose of Xaluprine.
Danish: For at fremme nøjagtig og konsekvent dosisafgivelse til maven bør der drikkes vand efter hver dosis Xaluprine.
English: However, the choice of method should be consistent from day to day.
Danish: Du skal imidlertid benytte samme metode hver dag.
English: Local guidelines may be considered, including prophylactic therapy if necessary.
Danish: Lokale retningslinjer kan, om nødvendigt, tages under overvejelse, herunder profylaktisk behandling.
English: - Do not get vaccinated with yellow fever vaccine whilst you are taking Xaluprine because it may be fatal.
Danish: - Du må ikke blive vaccineret mod gul feber, mens du tager Xaluprine, da det kan være dødeligt.
English: Animal studies indicate embryotoxic and embryolethal effects (see section 5.3).
Danish: Dyreforsøg har påvist embryotoksisk og embryoletal virkning (se pkt.
English: In a comparative bioavailability study in healthy adult volunteers (n=60), 50mg of Xaluprine oral suspension was demonstrated to be bioequivalent to the reference 50mg tablet for AUC, but not Cmax.
Danish: I en sammenlignende undersøgelse af biotilgængelighed hos raske frivillige (n=60) blev 50 mg Xaluprine oral suspension påvist at være bioækvivalent med 50 mg referencetabletten for AUC, men ikke Cmax.
English: The dose is governed by cautiously monitored haematotoxicity and the dose should be carefully adjusted to suit the individual patient in accordance with the employed treatment protocol.
Danish: Dosen fastlægges på baggrund af omhyggeligt monitoreret hæmatotoksicitet, og dosen skal justeres nøje for at tilpasses den enkelte patient i overensstemmelse med den anvendte behandlingsprotokol.
English: If you have an inherited mutation in the NUDT15-gene (a gene which is involved in the break-down of Xaluprine in the body), you have a higher risk of infections and hair loss and your doctor may in this case give you a lower dose.
Danish: Hvis du har en nedarvet mutation i NUDT15-genet (et gen, som er medvirkende til nedbrydningen af Xaluprine i kroppen), har du en højere risiko for infektioner og hårtab, og din læge kan derfor give dig en lavere dosis.
English: The administration of 6-mercaptopurine with food may decrease systemic exposure slightly but this is unlikely to be of clinical significance.
Danish: Administration af 6-mercaptopurin sammen med mad reducerer den systemiske eksponering en smule, men dette bliver sandsynligvis ikke klinisk signifikant.
English: Xaluprine may harm your sperm or eggs.
Danish: Xaluprine kan skade din sæd eller dine æg.
English: Xaluprine should not be handled by women who are or planning to be pregnant or breast-feeding.
Danish: Xaluprine bør ikke håndteres af kvinder, som er eller planlægger at blive gravide, eller som ammer.
English: When you are treated with Xaluprine the risk of viral, fungal and bacterial infections is increased and the infections may be more serious.
Danish: Når du behandles med Xaluprine øges risikoen for virale, bakterielle og svampeinfektioner, og infektionerne kan være mere alvorlige.
English: Xaluprine may harm your sperm or eggs (see ‘Pregnancy, breast-feeding and fertility' below).
Danish: Xaluprine kan skade din sæd eller dine æg (se ”Graviditet, amning og frugtbarhed” herunder).
English: More frequent monitoring may be advisable in those with pre-existing liver disease or receiving other potentially hepatotoxic therapy.
Danish: Hyppigere overvågning kan tilrådes hos patienter med tidligere eksisterende leversygdom, eller som får anden potentielt hepatotoksisk behandling.
English: The thioguanine nucleotides are also incorporated into nucleic acids and this contributes to the cytotoxic effects of the active substance.
Danish: Thioguanin-nukleotiderne er også inkorporeret i nukleinsyrer, hvilket er medvirkende til det aktive stofs cytotoksiske virkning.
English: Transient oligospermia
Danish: Forbigående oligospermi
English: Monitoring of the INR (International Normalised Ratio) value is recommended during concomitant administration with oral anticoagulants.
Danish: Det anbefales at monitorere INR-værdien (International Normalised Ratio) under samtidig administration af orale antikoagulantia.
English: Always use the syringes provided to take your medicine.
Danish: Brug altid de medfølgende sprøjter til at tage medicinen.
English: Xaluprine should not be given to patients who are pregnant or likely to become pregnant without careful assessment of risk versus benefit.
Danish: Xaluprine må ikke gives til patienter, som er gravide, eller som kan blive gravide, uden omhyggeligt at afveje risiko og fordele.
English: The principal toxic effect is on the bone marrow, resulting in myelosuppression.
Danish: Den primære toksiske virkning er i knoglemarven, hvilket resulterer i myelosuppression.
English: In particular, tell your doctor, nurse or pharmacist if you are taking any of the following:
Danish: I særdeleshed skal du fortælle det til lægen, sundhedspersonalet eller apotekspersonalet, hvis du tager nogen af følgende lægemidler:
English: Hypoglycaemia†
Danish: Hypoglykæmi†
English: The optimal starting dose for homozygous deficient patients has not been established (see section 4.4).
Danish: Den optimale startdosis for patienter med homozygot mangel er ikke fastlagt (se pkt.
English: Keep the bottle tightly closed to protect the integrity of the product and minimise the risk of accidental spillage.
Danish: Hold flasken tæt tillukket for at beskytte produktet og minimere risikoen for at komme til at spilde det.
English: Blood levels of anti-epileptic medicines may need to be monitored and doses adjusted if necessary.
Danish: Blodniveau ved antiepileptiske lægemidler skal måske overvåges, og om nødvendigt skal dosis justeres.
English: Also other xanthine oxidase inhibitors, such as febuxostat, may decrease the metabolism of mercaptopurine and concomitant administration is not recommended as data are insufficient to determine an adequate dose reduction.
Danish: Også andre xanthinoxidasehæmmere som febuxostat kan nedsætte mercaptopurins metabolisme, og samtidig administration anbefales ikke, da der foreligger utilstrækkelige data til at fastlægge en relevant dosisreduktion.