natgillin/translations-raw huggingface dataset:
- you are planning to have a baby. 
- načrtujete nosečnost.
After first opening: 56 days. 
Po prvem odpiranju: 56 dni.
They therefore cannot fight infections and may cause bleeding. 
Zato se ne morejo boriti proti okužbam in lahko povzročajo krvavitve.
The suspension is pink to brown in colour. 
Suspenzija je rožnate do rjave barve.
This is a fast-growing disease which increases the number of new white blood cells. 
To je hitro razvijajoča se bolezen, pri kateri se povečuje število novih belih krvnih celic.
These new white blood cells are immature (not fully formed) and unable to grow and work properly. 
Nove bele krvne celice niso zrele (niso popolnoma razvite) ter ne morejo pravilno rasti in delovati.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09 March 2012 
Datum prve odobritve: 09. Marec 2012
It is possible that the levels of other anti-epileptic medicinal products may also be altered. 
Možno je, da se spremenijo tudi ravni drugih antiepileptikov.
This is to check the number and type of cells in your blood and to ensure your liver is working correctly. 
Tako bo preveril število in vrsto celic v krvi ter preveril, ali vaša jetra pravilno delujejo.
Keep the bottle tightly closed (see section 6.6). 
Steklenico shranjujte tesno zaprto (glejte poglavje 6.6).
This is excreted in the urine. 
Ta se izloča z urinom.
Your doctor will prescribe the correct dose for you. 
Zdravnik vam bo predpisal primeren odmerek.
The infectious disease and complications may be more severe in these patients than in non-treated patients. 
Pri teh bolnikih so lahko okužbe in zapleti hujši kot pri nezdravljenih bolnikih.
- Do not use this medicine after the expiry date which is stated on the carton and the bottle after ‘EXP'. 
- Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in steklenici poleg oznake „EXP“.
Long term use increases the risk of dental caries and it is essential that adequate dental hygiene is maintained. 
Dolgotrajna uporaba poveča tveganje za zobni karies, zato je treba vzdrževati ustrezno zobno higieno.
† In the paediatric population. 
† Pri pediatrični populaciji.
Some laboratories offer testing for TPMT deficiency, although these tests have not been shown to identify all patients at risk of severe toxicity. 
Nekateri laboratoriji ponujajo testiranje pomanjkanja TPMT, čeprav ti testi ne zagotavljajo, da bodo odkriti vsi bolniki, pri katerih obstaja tveganje hude toksičnosti.
(≥1/1000 to < 1/100), rare (≥1/10,000 to < 1/1000) and very rare (< 1/10,000). 
(≥ 1/1 000 do < 1/100), redki (≥ 1/10 000 do < 1/1 000), zelo redki (< 1/10 000).
Remove the syringe from your mouth. 
Brizgo vzemite iz ust.
This includes herbal medicines. 
To vključuje tudi zdravila rastlinskega izvora.
The following events have been identified as adverse reactions. 
Naslednji dogodki so bili ugotovljeni kot neželeni učinki.
In particular, tell your doctor, nurse or pharmacist if you are taking any of the following: 
Še zlasti morate zdravnika, medicinsko sestro ali farmacevta obvestiti, če jemljete katero od naslednjih zdravil:
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. 
Ker ni znanega antidota, je treba pozorno spremljati krvno sliko in po potrebi začeti z izvajanjem splošnih podpornih ukrepov skupaj z ustrezno transfuzijo krvi.
Both men and women should continue to use effective contraception for at least 3 months after stopping treatment. 
Tako moški kot ženske naj nadaljujejo z uporabo učinkovite kontracepcije vsaj tri mesece po prenehanju zdravljenja.
However, 
Vendar pa
When you use the medicine follow the instructions below: 
Pri uporabi zdravila upoštevajte naslednja navodila:
The usual starting dose for adults, adolescents and children is between 25-75 mg/m2 body surface area each day. 
Običajni začetni odmerek pri odraslih, mladostnikih in otrocih je med 25 in 75 mg/m2 telesne površine na dan.
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. 
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
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. 
Pogostnost NUDT15 c.415C>T je odvisna od etnične pripadnosti, približno 10 % pri bolnikih iz Vzhodne Azije, 4 % pri Latinoameričanih, 0,2 %
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu 
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
See also section 4. 
Glejte poglavje 4.
Therefore the daily dose of Xaluprine should be taken in the evening. 
Zato se mora dnevni odmerek zdravila Xaluprine jemati zvečer.
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. 
Pri vseh vrstah je stopnja embriotoksičnosti in vrsta nepravilnosti odvisna od odmerka in stopnje gestacije v času uporabe zdravila.
The dose should not be taken with milk or dairy products (see section 4.5). 
Odmerek zdravila se ne sme jemati z mlekom ali mlečnimi izdelki (glejte poglavje 4.5).
Careful monitoring of the phenytoin serum levels is recommended. 
Priporoča se pozorno spremljanje ravni fenitoina v serumu.
Administration in the evening compared to morning administration may lower the risk of relapse. 
Uporaba zdravila zvečer v primerjavi z uporabo zjutraj lahko zniža tveganje za ponovitev.
Safe handling 
Varno ravnanje
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. 
Učinek 6-merkaptopurina na plodnost pri človeku ni znan, obstajajo pa poročila o uspešnem očetovstvu/materinstvu po zdravljenju v otroštvu ali v obdobju mladostništva.
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. 
Spolno aktivne ženske in moški morajo med zdravljenjem in še najmanj tri mesece po prejemu zadnjega odmerka zdravila uporabljati učinkovito metodo kontracepcije.
Monitoring of liver function tests may allow early detection of hepatotoxicity. 
Spremljanje delovanja jeter lahko omogoča zgodnje odkritje hepatotoksičnosti.
Xaluprine may harm your sperm or eggs. 
Zdravilo Xaluprine lahko škoduje vaši spermi ali jajčecem.
The apparent body clearance is 4832 ± 2562 ml/min/m2. 
4832 ± 2562 ml/min/m 2.
Local guidelines may be considered, including prophylactic therapy if necessary. 
Upoštevate lahko lokalne smernice, vključno s profilakso po potrebi.
Hold the syringe under water and move the plunger up and down several times to make sure the inside of the syringe is clean. 
Brizgo držite pod vodo in večkrat premaknite bat navzgor in navzdol, da zagotovite, da bo notranjost brizge čista.
- Your doctor may also ask for other blood and urine tests to monitor your uric acid levels. 
- Zdravnik bo morda opravil tudi druge preiskave krvi in urina, s katerimi bo spremljal raven sečne kisline.
Do not take Xaluprine at the same time as milk or dairy products, as they can make the medicine less effective. 
Ne jemljite zdravila Xaluprine skupaj z mlekom ali mlečnimi izdelki, saj je lahko zaradi njih zdravilo manj učinkovito.
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). 
Če suspenzija pride v stik s kožo ali sluznico, jo je treba takoj temeljito izprati z milom in vodo (glejte poglavje 6.6).
The majority of reported cases were in children under the age of six or with a low body mass index. 
Večina poročanih primerov je bila povezana z otroci, mlajšimi od šest let, z majhnim indeksom telesne mase.
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. 
Odmerek se določa z natančnim spremljanjem hematotoksičnosti in se mora previdno prilagajati, da ustreza potrebam posameznega bolnika v skladu z uporabljenim protokolom zdravljenja.
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%). 
Povprečna (90-odstotni IZ) vrednost Cmax pri peroralni suspenziji je bila 39 % (22 % - 58 %) večja kot pri tableti, čeprav je bilo manj variabilnosti med posamezniki (% C.V) pri uporabi peroralne suspenzije (46 %) kot pri uporabi tablet (69 %).
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%. 
Pri peroralni uporabi odmerka 75 mg/m2 pri sedmih pediatričnih bolnikih je bila povprečna biološka uporabnost uporabljenega odmerka 16 %, z razponom od 5 do 37 %.
Liver dysfunction and gastroenteritis may also occur. 
Pojavita se lahko tudi nepravilno delovanje jeter in gastroenteritis.
Bacterial and viral infections, infections associated with neutropenia 
Bakterijske in virusne okužbe, z nevtropenijo povezane okužbe
This rare type of T cell lymphoma has an aggressive disease course and is usually fatal (see also section 4.8). 
Ta redka oblika T-celičnega limfoma ima agresiven potek bolezni in je navadno smrtna (glejte tudi poglavje 4.8).
6-mercaptopurine is hepatotoxic in animals and man. 
6-merkaptopurin je hepatotoksičen za živali in ljudi.
Xaluprine with food and drink 
Zdravilo Xaluprine skupaj s hrano in pijačo
Repeat the above for each dose as instructed by your doctor or pharmacist. 
Zgornji postopek ponovite pri vsakem jemanju odmerka v skladu z navodili zdravnika ali farmacevta.
A detrimental effect on these activities cannot be predicted from the pharmacology of the active substance. 
Škodljivega vpliva na tovrstne aktivnosti ni mogoče predvideti na podlagi farmakologije učinkovine.
- After first opening of the bottle, discard any unused contents after 56 days. 
- 56 dni po prvem odprtju steklenice zavrzite neporabljeno vsebino.
It is important that you use the correct dosing syringe for your medicine. 
Pomembno je, da za jemanje zdravila uporabite pravilno brizgo za odmerjanje.
Animal studies indicate embryotoxic and embryolethal effects (see section 5.3). 
Raziskave pri živalih kažejo na embriotoksične učinke in smrt zarodka (glejte poglavje 5. 3).
TPMT testing cannot substitute for haematological monitoring in patients receiving Xaluprine. 
Preverjanje delovanja TPMT ne more nadomestiti hematološkega spremljanja bolnikov, ki prejemajo zdravilo Xaluprine.
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. 
Nedavno epidemiološko poročilo kaže, da ni povečanega tveganja za prezgodnji porod, nizko porodno težo ob predvidenem roku ali prirojene nepravilnosti pri ženskah, ki so bile med nosečnostjo izpostavljene merkaptopurinu.
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. 
Če imate podedovano mutacijo gena NUDT15 (gena, vključenega v razgradnjo zdravila Xaluprine v telesu), ste izpostavljeni povečanemu tveganju za okužbe in izgubo las, zato vam lahko zdravnik v tem primeru predpiše manjši odmerek.
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. 
Pred zdravljenjem je treba razmisliti o serološkem testiranju za hepatitis B. Upoštevate lahko lokalne smernice, vključno s profilakso pri bolnikih, pri katerih je bilo serološko testiranje pozitivno.
Macrophage activation syndrome 
Sindrom aktivacije makrofagov.
The bottle should be shaken vigorously for at least 30 seconds to ensure the oral suspension is well mixed. 
Steklenico pred uporabo močno pretresajte vsaj 30 sekund, da zagotovite, da bo peroralna suspenzija dobro premešana.
The administration of 6-mercaptopurine with food may decrease systemic exposure slightly but this is unlikely to be of clinical significance. 
Uporaba 6-merkaptopurina skupaj s hrano lahko nekoliko zmanjša sistemsko izpostavljenost, vendar pa ni verjetno, da bi bilo zmanjšanje klinično pomembno.
Women who are pregnant, planning to be or breast-feeding should not handle Xaluprine. 
Ženske, ki so noseče, načrtujejo nosečnost ali dojijo, ne smejo ravnati z zdravilom Xaluprine.
For mercaptopurine there is a lack of modern clinical documentation which can serve as support for accurately determining the frequency of adverse reactions. 
Za merkaptopurin ni zadostne sodobne klinične dokumentacije, ki bi lahko podprla natančno določanje pogostnosti neželenih učinkov.
You may feel sick, vomit or have diarrhoea. 
Morda vam bo slabo, boste bruhali ali dobili drisko.
Patients with NUDT15 variant 
Bolniki z varianto NUDT15
Sometimes the doctor may change your dose of Xaluprine for example as a result of different tests. 
Zdravnik lahko vaš odmerek zdravila Xaluprine spremeni, na primer na podlagi izvidov različnih testov.
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. 
Razpolovni čas izločanja 6-merkaptopurina je 90 ± 30 minut, vendar je pri aktivnih presnovkih razpolovni čas daljši (približno 5 ur) kot pri matični spojini.
Swallow the dose of oral suspension then drink some water, making sure no medicine is left in your mouth. 
Pogoltnite odmerek peroralne suspenzije in nato popijte malo vode, tako da zdravilo ne bo ostalo v vaših ustih.
There have been reports of premature birth and low birth weight following maternal exposure to 6-mercaptopurine. 
Poročali so o prezgodnjem rojstvu in nizki porodni teži po izpostavljenosti matere 6-merkaptopurinu.
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). 
Odstranite zaporko steklenice (Slika 2) in v zgornji del steklenice močno potisnite nastavek ter ga pustite nameščenega za naslednje odmerke (Slika 3).
There have also been reports of congenital abnormalities and spontaneous abortion following either maternal or paternal exposure. 
Obstajajo tudi poročila o prirojenih nepravilnostih in spontanih splavih po izpostavljenosti matere ali očeta.
Talk to your doctor if you have any of the following side effects which may also happen with this medicine: 
Posvetujte se z zdravnikom, če se pri vas pojavijo navedeni neželeni učinki, ki so lahko tudi posledica jemanja tega zdravila:
- When you take Xaluprine your doctor will take regular blood tests. 
- Med zdravljenjem z zdravilom Xaluprine bo zdravnik opravljal redne krvne preiskave.
Uric acid is a natural body chemical, levels of which can rise while taking Xaluprine. 
Sečna kislina je naravna kemična snov v telesu, raven katere se lahko med jemanjem zdravila Xaluprine poveča.
It is not expected that Xaluprine will affect your ability to drive or use machines but no studies have been done to confirm this. 
Vpliv na sposobnost upravljanja vozil in strojev Za zdravilo Xaluprine ni verjetno, da vpliva na vašo sposobnost vožnje ali upravljanja strojev, vendar pa niso bile izvedene nobene študije, ki bi to potrdile.
Shake vigorously before use for at least 30 seconds. 
Pred uporabo močno pretresajte vsaj 30 sekund.
Xaluprine may harm your sperm or eggs (see ‘Pregnancy, breast-feeding and fertility' below). 
Zdravilo Xaluprine lahko škoduje vaši spermi ali jajčecem (glejte poglavje „Nosečnost, dojenje in plodnost“).
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. 
Odmerek se ne sme jemati z mlekom ali mlečnimi izdelki, saj ti vsebujejo ksantin-oksidazo, encim, ki presnavlja 6-merkaptopurin in lahko zato povzroča manjšo koncentracijo merkaptopurina v plazmi.
It is recommended that the healthcare professional advises the patient or carer which syringe to use to ensure that the correct volume is administered. 
Priporočljivo je, da zdravstveni delavci svetujejo bolnikom ali negovalcem, katero brizgo naj uporabljajo, da bodo zagotovili uporabo pravilne količine.
The optimal starting dose for homozygous deficient patients has not been established (see section 4.4). 
Optimalni začetni odmerek pri bolnikih s homozigotnim pomanjkanjem ni bil določen (glejte poglavje 4.4).
Blood levels of anti-epileptic medicines may need to be monitored and doses adjusted if necessary. 
Morda bo treba spremljati ravni zdravil proti epilepsiji v krvi in po potrebi prilagoditi odmerek.
Xaluprine treatment should be supervised by a physician or other healthcare professionals experienced in the management of patients with ALL. 
Zdravljenje z zdravilom Xaluprine mora nadzorovati zdravnik ali drugi zdravstveni delavci, ki imajo izkušnje z zdravljenjem bolnikov z ALL.
Stomatitis, diarrhoea, vomiting, nausea 
Stomatitis, driska, bruhanje, navzea
However, the choice of method should be consistent from day to day. 
Vendar pa mora biti način jemanja zdravila ves čas enak.
The adverse reactions are displayed by system organ class and frequency: very common (≥1/10), common (≥1/100 to < 1/10), uncommon 
Neželeni učinki so navedeni po organskem sistemu in pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni
Turn the bottle upside down (figure 5). 
Steklenico obrnite na glavo (Slika 5).
Taking Xaluprine could put you at greater risk of: - developing a serious condition called Macrophage Activation Syndrome (excessive activation of white blood cells associated with inflammation), which usually occurs in people who have certain types of arthritis 
Zaradi jemanja zdravila Xaluprine se poveča tveganje za: - pojav resnega stanja, imenovanega sindrom aktivacije makrofagov (čezmerna aktivacija belih krvničk, povezana z vnetjem), kar se običajno pojavi pri osebah, ki imajo določene vrste artritisa.
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. 
Zdravnik ali farmacevt vam bo svetoval, katero brizgo morate uporabljati, 1 ml (vijolično) ali 5 ml (belo), da boste vzeli pravilen odmerek.
Xaluprine should not be given to patients who are pregnant or likely to become pregnant without careful assessment of risk versus benefit. 
Nosečnost Zdravila Xaluprine ne smejo uporabljati bolnice, ki so noseče ali bodo verjetno zanosile, ne da bi se skrbno ocenilo razmerje med tveganji in koristmi.
In any case, close monitoring of blood counts is necessary. 
V vsakem primeru je potrebno pozorno spremljanje števila krvnih celic.
Xaluprine is indicated for the treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children. 
Zdravilo Xaluprine je indicirano za zdravljenje akutne limfoblastne levkemije (ALL) pri odraslih, mladostnikih in otrocih.
If you are a parent or care giver administering the medicine, wash your hands before and after administering a dose. 
Če ste starš ali negovalec, ki daje zdravilo, si pred dajanjem zdravila in po njem vedno umijte roke.
Low blood sugar has sometimes been seen in children, mainly in children under the age of six or with a low body mass index. 
Otroci in mladostniki Pri otrocih so včasih opazili nizke ravni sladkorja v krvi, predvsem pri otrocih, mlajših od šest let, z majhnim indeksom telesne mase.
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. 
Pri bolnikih, ki se zdravijo s samostojnim 6-merkaptopurinom ali njegovo kombinacijo z drugimi imunosupresivi, vključno s kortikosteroidi, se je pokazala povečana dovzetnost za virusne, glivične in bakterijske okužbe, vključno s hudo ali atipično okužbo, ter virusno reaktivacijo.
What Xaluprine is and what it is used for What you need to know before you take Xaluprine How to take Xaluprine 
Kaj je zdravilo Xaluprine in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Xaluprine Kako jemati zdravilo Xaluprine
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). 
Peroralna suspenzija in tableta 6-mekaptopurina nimata enake biološke uporabnosti vezano na najvišjo koncentracijo v plazmi, zato se pri zamenjavi formulacije priporoča okrepljeno hematološko spremljanje bolnikov (glejte poglavje 5.2).
It is important to take Xaluprine in the evening to make the medicine more effective. 
Pomembno je, da zdravilo Xaluprine jemljete zvečer, saj je tako učinkovitejše.
6-mercaptopurine has been identified in the colostrum and breast-milk of women receiving azathioprine treatment and thus women receiving Xaluprine should not breast-feed. 
6-merkaptopurin so našli v kolostrumu in v mleku žensk, ki so jemale azatioprin, zato ženske, ki se zdravijo z zdravilom Xaluprine, ne smejo dojiti.
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. 
Ker zdravilo vsebuje saharozo, ga ne smejo jemati bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze/galaktoze ali pomanjkanjem saharoze-izomaltaze.
This is usually reversible if 6-mercaptopurine therapy is stopped soon enough but fatal liver damage has occurred. 
Ta je običajno reverzibilna, če se zdravljenje s 6-merkaptopurinom prekine dovolj zgodaj, vendar pa že pride do jetrne okvare s smrtnim izidom.
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). 
Glede na fazo zdravljenja je začetni ali ciljni odmerek običajno med 25 in 75 mg/m2 telesne površine (TP) na dan, pri bolnikih z zmanjšanim delovanjem encima tiopurin metiltransferaza (TPMT) ali brez delovanja tega encima pa manjši (glejte poglavje 4.4).
Other xanthine oxidase inhibitors should be avoided (see section 4.5). 
Uporabi drugih zaviralcev ksantin-oksidaze se je treba izogibati (glejte poglavje 4.5).
If you are already pregnant, you must talk to your doctor before taking Xaluprine. 
Če ste že noseči, se morate pred jemanjem zdravila Xaluprine posvetovati z zdravnikom.
Therefore close monitoring of blood counts is necessary. 
Zato je potrebno pozorno spremljanje števila krvnih celic.
Xaluprine is hepatotoxic and liver function tests should be monitored weekly during treatment. 
Zdravilo Xaluprine je hepatotoksično in med zdravljenjem je potrebno tedensko spremljanje delovanja jeter.
If you accidentally get some in your eyes or nose, flush the area with water. 
Če nekaj zdravila kljub temu pride v oči ali nos, predel izperite z vodo.
Therefore, immunisations with live organism vaccines are not recommended. 
Zato cepljenje z živimi cepivi ni priporočljivo.