FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a fast-growing disease which increases the number of new white blood cells.
Croatian: To je brzonapredujuća bolest koja povećava broj novih bijelih krvnih stanica.
English: The apparent body clearance is 4832 ± 2562 ml/min/m2.
Croatian: Prividni tjelesni klirens iznosi 4832 ± 2562 ml/min/m2.
English: Tell your doctor or pharmacist if you are taking or, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
English: Therefore the daily dose of Xaluprine should be taken in the evening.
Croatian: Stoga je dnevnu dozu Xaluprina potrebno uzeti navečer.
English: Take the medicine pack and this leaflet with you.
Croatian: Ponesite pakiranje lijeka i ovu uputu sa sobom.
English: Wash the syringe with warm ‘soapy' water and rinse well.
Croatian: Operite štrcaljku toplom „pjenušavom“ vodom i dobro isperite.
English: (≥1/1000 to < 1/100), rare (≥1/10,000 to < 1/1000) and very rare (< 1/10,000).
Croatian: (≥1/1000 i < 1/100), rijetko (≥1/10 000 i < 1/1000) i vrlo rijetko (< 1/10 000).
English: It is important to take Xaluprine in the evening to make the medicine more effective.
Croatian: Važno je uzeti Xaluprine navečer kako bi lijek bio djelotvorniji.
English: The infectious disease and complications may be more severe in these patients than in non-treated patients.
Croatian: Zarazna bolest i komplikacije mogu biti puno teže u tih bolesnika za razliku od neliječenih bolesnika.
English: The following events have been identified as adverse reactions.
Croatian: Sljedeći događaji mogu se identificirati kao nuspojave.
English: † In the paediatric population.
Croatian: †U pedijatrijskoj populaciji.
English: Photosensitivity reaction
Croatian: Reakcija fotoosjetljivosti
English: Xaluprine may harm your sperm or eggs.
Croatian: Xaluprine može oštetiti Vašu spermu ili jajašca.
English: Monitoring of liver function tests may allow early detection of hepatotoxicity.
Croatian: Praćenje testova jetrene funkcije može omogućiti rano otkrivanje hepatotoksičnosti.
English: Do not take Xaluprine if you are planning to have a baby without first speaking to your doctor for advice.
Croatian: Nemojte uzimati Xaluprine ako planirate imati dijete bez prethodnog savjetovanja sa svojim liječnikom.
English: See also section 4.
Croatian: Vidjeti i dio 4.
English: The dose should not be taken with milk or dairy products (see section 4.5).
Croatian: Dozu se ne smije uzeti s mlijekom ili mliječnim proizvodima (vidjeti dio 4.5).
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.
Croatian: Ne očekuje se da će Xaluprine utjecati na Vašu sposobnost upravljanja vozilima i strojevima, ali nisu provedena ispitivanja koja bi to potvrdila.
English: Do not take Xaluprine at the same time as milk or dairy products, as they can make the medicine less effective.
Croatian: Nemojte uzimati Xaluprine u isto vrijeme s mlijekom ili mliječnim proizvodima jer mogu smanjiti djelotvornost lijeka.
English: When you use the medicine follow the instructions below:
Croatian: Kada koristite lijek, pridržavajte se sljedećih uputa:
English: Xaluprine is for oral use and requires redispersing (by shaking vigorously at least for 30 seconds) prior to dosing.
Croatian: Xaluprine je namijenjen za peroralnu primjenu i zahtijeva redisperziju (snažnim protresanjem najmanje 30 sekundi) prije doziranja.
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.
Croatian: Seksualno aktivni muškarci i žene moraju koristiti djelotvorne metode kontracepcije za vrijeme trajanja liječenja i najmanje tri mjeseca nakon primitka posljednje doze.
English: - Your doctor may also ask for other blood and urine tests to monitor your uric acid levels.
Croatian: - Vaš liječnik može također zahtijevati druge pretrage krvi i mokraće kako bi pratio razinu mokraćne kiseline.
English: The usual starting dose for adults, adolescents and children is between 25-75 mg/m2 body surface area each day.
Croatian: Uobičajena početna doza za odrasle osobe, adolescente i djecu je između 25 i 75 mg/m2 tjelesne površine svakoga dana.
English: If you are already pregnant, you must talk to your doctor before taking Xaluprine.
Croatian: Ako ste već trudni, morate razgovarati s liječnikom prije uzimanja Xaluprinea.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/727/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/727/001
English: This is excreted in the urine.
Croatian: Ona se izlučuje urinom.
English: In particular, tell your doctor, nurse or pharmacist if you are taking any of the following:
Croatian: Posebice obavijestite svog liječnika, medicinsku sestru ili ljekarnika ako uzimate bilo što od sljedećeg:
English: Local guidelines may be considered, including prophylactic therapy if necessary.
Croatian: Mogu se razmotriti lokalne smjernice, uključujući profilaktičko liječenje, prema potrebi.
English: If you take more Xaluprine than you should
Croatian: Ako uzmete više Xaluprinea nego što ste trebali
English: Let the syringe dry completely before you use that syringe again for dosing.
Croatian: Ostavite štrcaljku da se potpuno osuši prije nego ju ponovno upotrijebite za doziranje.
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.
Croatian: Učinak 6-merkaptopurina na plodnost u ljudi nije poznat, ali postoje izvješća o uspješnom očinstvu/majčinstvu nakon liječenja tijekom djetinjstva ili adolescencije.
English: Some laboratories offer testing for TPMT deficiency, although these tests have not been shown to identify all patients at risk of severe toxicity.
Croatian: Neki laboratoriji provode testiranje deficita TPMT iako se nije pokazalo da takvi testovi otkrivaju sve bolesnike pod rizikom od izrazite toksičnosti.
English: Swallow the dose of oral suspension then drink some water, making sure no medicine is left in your mouth.
Croatian: Progutajte dozu oralne suspenzije i potom popijte malo vode, vodeći računa da nimalo lijeka ne ostane u ustima.
English: What Xaluprine is and what it is used for
Croatian: Što je Xaluprine i za što se koristi
English: Your doctor will prescribe the correct dose for you.
Croatian: Vaš će Vam liječnik propisati točnu dozu.
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.
Croatian: U svih vrsta stupanj embriotoksičnosti i tip malformacija ovise o dozi i stadiju gestacije u vrijeme primjene.
English: A detrimental effect on these activities cannot be predicted from the pharmacology of the active substance.
Croatian: Štetni učinak na ove aktivnosti ne može se predvidjeti iz farmakoloških svojstava djelatne tvari.
English: The bottle should be shaken vigorously for at least 30 seconds to ensure the oral suspension is well mixed.
Croatian: Bočicu je potrebno snažno tresti najmanje 30 sekundi kako biste osigurali da je oralna suspenzija dobro promiješana.
English: - When you take Xaluprine your doctor will take regular blood tests.
Croatian: - Kada uzimate Xaluprine, liječnik će Vam redovito raditi krvne pretrage.
English: - Do not get vaccinated with yellow fever vaccine whilst you are taking Xaluprine because it may be fatal.
Croatian: Nemojte se cijepiti cjepivom protiv žute groznice dok uzimate Xaluprine jer to može biti smrtonosno.
English: The majority of reported cases were in children under the age of six or with a low body mass index.
Croatian: U većini prijavljenih slučajeva djeca su bila mlađa od 6 godina ili su imala nizak indeks tjelesne mase.
English: Reliable contraception must be used to avoid pregnancy whilst you or your partner are taking Xaluprine.
Croatian: Potrebno je koristiti pouzdanu metodu zaštite od trudnoće dok Vi ili Vaš partner uzimate Xaluprine.
English: Bacterial and viral infections, infections associated with neutropenia
Croatian: Bakterijske i virusne infekcije, infekcije povezane s neutropenijom
English: Careful monitoring of the phenytoin serum levels is recommended.
Croatian: Preporučuje se pažljivo praćenje serumskih razina fenitoina.
English: Therefore, immunisations with live organism vaccines are not recommended.
Croatian: Stoga se ne preporučuje imunizacija živim cjepivima.
English: Ask your doctor, pharmacist or midwife for advice.
Croatian: Upitajte svog liječnika, ljekarnika ili primalju za savjet.
English: If you take more Xaluprine than you should, tell your doctor or go to a hospital immediately.
Croatian: Ako uzmete više Xaluprinea nego što ste trebali, obavijestite svog liječnika ili odmah otiđite u bolnicu.
English: If you are receiving immunosuppressive therapy, taking Xaluprine could put you at greater risk of:
Croatian: Ako primate terapiju imunosupresivima, uzimanje Xaluprinea moglo bi vas dovesti do povećanog rizika od:
English: Liver dysfunction and gastroenteritis may also occur.
Croatian: Može doći i do disfunkcije jetre i gastroenteritisa.
English: Shake vigorously before use for at least 30 seconds.
Croatian: Prije uporabe snažno protresite najmanje 30 sekundi.
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.
Croatian: Poluvijek eliminacije 6-merkaptopurina iznosi 90 ± 30 minuta, ali aktivni metaboliti imaju dulji poluvijek (približno 5 sati) od ishodišnog spoja.
English: Xaluprine should be taken at least 1 hour before or 2 hours after milk or dairy products.
Croatian: Xaluprine je potrebno uzimati najmanje sat vremena prije ili 2 sata nakon uzimanja mlijeka ili mliječnih proizvoda.
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
Croatian: Ako Vam iznenada nije dobro (čak i s normalnom temperaturom) i imate bol u trbuhu i mučninu, jer to može biti znak upale gušterače.
English: Store the syringe in a hygienic place with the medicine.
Croatian: Čuvajte štrcaljku na higijenskom mjestu zajedno s lijekom.
English: Do not store above 25ºC.
Croatian: Ne čuvati na temperaturi iznad 25 °C.
English: If you are a parent or care giver administering the medicine, wash your hands before and after administering a dose.
Croatian: Ako ste roditelj ili njegovatelj koji primjenjuje lijek, operite ruke prije i nakon svake primjene lijeka.
English: - anti-epileptic medicines such as phenytoin, carbamazepine.
Croatian: - antiepileptike poput fenitoina, karbamazepina.
English: The administration of 6-mercaptopurine with food may decrease systemic exposure slightly but this is unlikely to be of clinical significance.
Croatian: Primjena 6-merkaptopurina s hranom može malo smanjiti sistemsku izloženost, ali nije vjerojatno da će to biti klinički značajno.
English: Other medicines and Xaluprine
Croatian: Drugi lijekovi i Xaluprine
English: 6-mercaptopurine is hepatotoxic in animals and man.
Croatian: 6-merkaptopurin je hepatotoksičan u životinja i ljudi.
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.
Croatian: U djece je ponekad primijećena niska razina šećera u krvi, većinom u djece mlađe od šest godina ili s niskim indeksom tjelesne mase.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09 March 2012
Croatian: Datum prvog odobrenja: 09. Ožujka 2012.
English: Avoid contact of Xaluprine with your skin, eyes or nose.
Croatian: Izbjegavajte kontakt Xaluprinea s kožom, očima ili nosom.
English: Patients with NUDT15 variant
Croatian: Bolesnici s varijantom NUDT15
English: - Keep this medicine out of the sight and reach of children, preferably in a locked cupboard.
Croatian: - Lijek čuvajte izvan pogleda i dohvata djece, po mogućnosti u zaključanom ormariću.
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.
Croatian: Ako imate naslijeđenu mutaciju gena NUDT15 (gena koji je uključen u razgradnju Xaluprinea u tijelu), imate veći rizik od razvoja infekcija i gubikta kose te vam u tom slučaju liječnik može dati manju dozu.
English: Pharmacotherapeutic group: antineoplastic agents, antimetabolites, purine analogues, ATC code: L01BB02
Croatian: Farmakoterapijska skupina: antineoplastični agensi, antimetaboliti, analozi purina, ATK oznaka: L01BB02
English: You may feel sick, vomit or have diarrhoea.
Croatian: Možete osjećati mučninu, povraćati ili imati proljev.
English: If the suspension comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water (see section 6.6).
Croatian: Ako suspenzija dođe u dodir s kožom ili sluznicama, potrebno je odmah temeljito isprati vodom i sapunom (vidjeti dio 6.6).
English: The incidence of hepatotoxicity varies considerably and can occur with any dose but more frequently when the recommended dose is exceeded.
Croatian: Incidencija hepatotoksičnosti značajno varira i može se razviti pri bilo kojoj dozi, ali je češća pri primjeni veće doze od preporučene.
English: Xaluprine may harm your sperm or eggs (see ‘Pregnancy, breast-feeding and fertility' below).
Croatian: Xaluprine može oštetiti vašu spermu ili jajašca (pogledajte „Trudnoća, dojenje i plodnost“ u nastavku).
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%).
Croatian: Srednji (90% CI) Cmax za oralnu suspenziju bio je 39% (22% - 58%) viši od onog kod tableta iako je varijabilnost između ispitanika (%C.V) bila manja pri primjeni oralne suspenzije (46%) nego tableta
English: Xaluprine should not be given to patients who are pregnant or likely to become pregnant without careful assessment of risk versus benefit.
Croatian: Xaluprine se ne smije davati trudnim bolesnicama ili onima koje će vjerojatno ostati trudne bez pažljive procjene odnosa rizika i dobiti.
English: Women who are pregnant, planning to be or breast-feeding should not handle Xaluprine.
Croatian: Žene koje su trudne, koje planiraju zatrudnjeti ili dojiti ne smiju rukovati Xaluprineom.
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).
Croatian: Uklonite zatvarač bočice (slika 2) i čvrsto gurnite nastavak u gornji dio bočice i ostavite ga na mjestu za buduće doze (slika 3).
English: Do not stop taking your medicine unless your doctor tells you to or you may get a relapse of your condition.
Croatian: Nemojte prestati uzimati lijek osim ako Vam liječnik tako ne kaže jer bi moglo doći do povrata bolesti.
English: If you accidentally get some in your eyes or nose, flush the area with water.
Croatian: Ako lijek slučajno dođe u dodir s Vašim očima ili nosom, isperite područje vodom.
English: Macrophage activation syndrome
Croatian: Sindrom aktivacije makrofaga.
English: It is important that you use the correct dosing syringe for your medicine.
Croatian: Važno je koristiti ispravnu štrcaljku za doziranje lijeka.
English: Animal studies indicate embryotoxic and embryolethal effects (see section 5.3).
Croatian: Ispitivanja na životinjama upućuju na embriotoksičnost i smrtonosne učinke na embrij (vidjeti dio 5.3).
English: What you need to know before you take Xaluprine
Croatian: Što morate znati prije nego počnete uzimati Xaluprine
English: Therefore, when taking Xaluprine, avoid excessive exposure to sunlight, wear protective clothing and use protective sunscreen with a high protection factor - lymphoproliferative disorders o treatment with Xaluprine increases your risk of getting a type of cancer called lymphoproliferative disorder.
Croatian: Stoga pri uzimanju Xaluprinea izbjegavajte prekomjerno izlaganje sunčevoj svjetlosti, nosite zaštitnu odjeću i upotrebljavajte zaštitnu kremu za sunčanje s visokim zaštitnim faktorom. - limfoproliferativnih poremećaja o liječenje Xaluprineom povećava rizik od dobivanja vrste raka koji se naziva limfoproliferativni poremećaj.
English: This rare type of T cell lymphoma has an aggressive disease course and is usually fatal (see also section 4.8).
Croatian: Ovaj rijetki oblik T-staničnog limfoma ima agresivan tijek i obično je smrtonosan (vidjeti također dio 4.8).
English: Discard 56 days after first opening.
Croatian: Bacite lijek 56 dana nakon prvog otvaranja.
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.
Croatian: Novije epidemiološko izvješće ne ukazuje na povećani rizik od preuranjenog poroda, niske porođajne težine novorođenčeta ili kongenitalnih malformacija u žena izloženih merkaptopurinu tijekom trudnoće.
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.
Croatian: U komparativnom ispitivanju bioraspoloživosti u zdravih odraslih dobrovoljaca (n=60) 50 mg oralne suspenzije Xaluprina bilo je bioekvivalentno referentnoj tableti od 50 mg za AUC, ali ne i za Cmax.
English: Long term use increases the risk of dental caries and it is essential that adequate dental hygiene is maintained.
Croatian: Dugotrajna uporaba povećava rizik od zubnog karijesa te je neophodno provoditi odgovarajuću zubnu higijenu.
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.
Croatian: I drugi inhibitori ksantin oksidaze, poput febuksostata, također mogu smanjiti metabolizam merkaptopurina te se ne preporučuje istodobna primjena jer podaci nisu dostatni za određivanje odgovarajućeg smanjenja doze.
English: It is recommended that newborns of women exposed to mercaptopurine during pregnancy are monitored for haematological and immune system disturbances.
Croatian: Preporučuje se praćenje novorođenčadi žena izloženih merkaptopurinu tijekom trudnoće zbog mogućih poremećaja hematološkog i imunološkog sustava.
English: The bioavailability of oral 6-mercaptopurine shows considerable inter-individual variability, which probably results from its first-pass metabolism.
Croatian: Bioraspoloživost oralnog 6-merkaptopurina pokazuje znatnu interindividualnu varijabilnost, što je vjerojatno posljedica metabolizma prvog prolaza.
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.
Croatian: Roditelje / njegovatelje i bolesnike potrebno je savjetovati da čuvaju Xaluprine izvan dohvata i pogleda djece, po mogućnosti u zaključanom ormariću.
English: 6-mercaptopurine displays diurnal variation in pharmacokinetics and efficacy.
Croatian: 6-merkaptopurin pokazuje diurnalne varijacije u farmakokinetici i djelotvornosti.
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Xaluprine.
Croatian: Ako niste sigurni odnosi li se išta od gore navedenog na Vas, porazgovarajte sa svojim liječnikom ili ljekarnikom prije uzimanja Xaluprinea.
English: - Keep the bottle tightly closed to prevent spoilage of the medicine and reduce the risk of accidental spillage.
Croatian: - Bočicu čuvati čvrsto zatvorenu kako bi se spriječilo kvarenje lijeka i smanjio rizik od slučajnog prolijevanja.
English: Xaluprine is hepatotoxic and liver function tests should be monitored weekly during treatment.
Croatian: Xaluprine je hepatotoksičan pa je potrebno svaki tjedan tijekom liječenja ponavljati testove jetrene funkcije.
English: Xaluprine should only be given to you by a specialist doctor who is experienced in treating blood problems.
Croatian: Xaluprine bi Vam trebao davati samo liječnik specijalist iskusan u liječenju poremećaja krvi.
English: Spillages must be wiped immediately.
Croatian: Proliveni lijek se mora odmah obrisati.
English: Gently put the tip of the syringe into your mouth and to the inside of your cheek.
Croatian: Nježno stavite vrh štrcaljke u usta i s unutarnje strane obraza.
English: More frequent monitoring may be advisable in those with pre-existing liver disease or receiving other potentially hepatotoxic therapy.
Croatian: Češće praćenje može biti preporučljivo u onih bolesnika koji imaju već postojeću bolest jetre ili u onih koji primaju potencijalno hepatotoksično liječenje.
English: TPMT testing cannot substitute for haematological monitoring in patients receiving Xaluprine.
Croatian: TPMT testiranje ne može biti zamjena za praćenje hematoloških parametara u bolesnika koji primaju Xaluprine.
English: Always take Xaluprine exactly as your doctor or pharmacist has told you.
Croatian: Uvijek uzmite Xaluprine točno onako kako je opisano u ovoj uputi ili kako su Vam rekli Vaš liječnik ili ljekarnik.
English: Xaluprine is indicated for the treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children.
Croatian: Xaluprine je indiciran za liječenje akutne limfoblastične leukemije (ALL) u odraslih, adolescenata i djece.
English: Depending on phase of treatment, starting or target doses generally vary between 25-75 mg/m2 body surface area (BSA) per day, but should be lower in patients with reduced or absent Thiopurine Methyl Transferase (TPMT) enzyme activity (see section 4.4).
Croatian: Ovisno o fazi liječenja, početne ili ciljne doze općenito se kreću između 25 i 75 mg/m2 tjelesne površine po danu, ali bi trebale biti niže u bolesnika s reduciranom ili odsutnom aktivnošću enzima tiopurin metiltransferaze (TPMT) (vidjeti dio 4.4).
English: Hypoglycaemia†
Croatian: Hipoglikemija†
English: Turn the bottle upside down (figure 5).
Croatian: Okrenite bočicu naopako (slika 5).
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.
Croatian: Dozu se ne smije uzeti s mlijekom ili mliječnim proizvodima jer oni sadrže ksantin oksidazu, enzim koji metabolizira 6-merkaptopurin i stoga može uzrokovati smanjene koncentracije merkaptopurina u plazmi.
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.
Croatian: Držite štrcaljku pod vodom i pomičite klip gore dolje nekoliko puta kako biste oprali unutrašnjost štrcaljke.
English: Hepatosplenic T-cell lymphoma* (see section 4.4)
Croatian: Hepatosplenični T-stanični limfom* (vidjeti dio 4.4)
English: Transient oligospermia
Croatian: Prolazna oligospermija
English: There have been reports of premature birth and low birth weight following maternal exposure to 6-mercaptopurine.
Croatian: Postoje izvješća o preuranjenom porodu i niskoj porođajnoj težini djeteta nakon izloženosti majke 6-merkaptopurinu.
English: If you get any of the following side effects, talk to your specialist doctor or go to hospital immediately:
Croatian: Ako primijetite bilo koju od sljedećih nuspojava, obratite se liječniku specijalistu ili odmah otiđite u bolnicu:
English: Unknown
Croatian: Nije poznato