natgillin/translations-raw huggingface dataset:
No studies on the effect on the ability to drive and use machines have been performed.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Študij vpliva na sposobnost vožnje in upravljanja s stroji niso izvajali.
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.
Pri bolnikih z zmanjšanim delovanjem ali dednim nedelovanjem TPMT obstaja povečano tveganje za hudo toksičnost pri uporabi običajnih odmerkov merkaptopurina, zaradi česar je treba običajno bistveno zmanjšati odmerek.
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.
Ker 6-merkaptopurin deluje na celično deoksiribonukleinsko kislino (DNA), je potencialno kancerogen, pri zdravljenju pa je treba upoštevati tudi možno teoretično tveganje za kancerogenezo.
METHOD AND ROUTE(S) OF ADMINISTRATION Take as directed by your doctor using the dosing syringes provided.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Jemljite po zdravnikovih navodilih z uporabo priloženih brizg za odmerjanje.
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.
Toksičnost za ledvice Med indukcijo remisije, ko prihaja do hitre celične lize, je treba spremljati vrednost sečne kisline v krvi in urinu, saj se lahko razvije hiperurikemija in/ali hiperurikozurija s tveganjem nefropatije zaradi sečne kisline.
The first step is catalysed by hypoxanthine-guanine phosphoribosyl transferase yielding thioinosine monophosphate (TIMP).
Prvi korak katalizira hipoksantin-gvanin-fosforibozil-transferaza, ki tvori tioinozin monofosfat (TIMP).
Both TIMP and mTIMP are inhibitors of phosphoribosyl pyrophosphate amidotransferase, an enzyme which is important in de novo purine synthesis.
Tako TIMP kot mTIMP sta zaviralca fosforibozil-pirofosfat-amidotransferaze, encima, ki je pomemben pri de novo sintezi purina.
Concomitant use with yellow fever vaccine (see section 4.5)
Sočasna uporaba s cepivom proti rumeni mrzlici (glejte poglavje 4.5).
Secondary leukaemia and myelodysplasia
Sekundarna levkemija in mielodisplazija
Photosensitivity reaction
Občutljivostna reakcija na svetlobo
Xaluprine is used for acute lymphoblastic leukaemia (also called acute lymphocytic leukaemia or ALL).
Zdravilo Xaluprine se uporablja za akutno limfoblastno levkemijo (imenovano tudi akutna limfocitna levkemija ali ALL).
Carcinogenicity Given its genotoxic potential, 6-mercaptopurine is potentially carcinogenic.
Ob upoštevanju genotoksičnega potenciala 6-merkaptopurina je le-ta potencialno kancerogen.
Haematological toxicity is likely to be more profound with chronic overdose than with a single ingestion of Xaluprine.
Verjetno je, da do izrazitejše hematološke toksičnosti pride pri kroničnem prevelikem odmerjanju in ne pri enkratnem zaužitju zdravila Xaluprine.
Effects of other medicinal products on mercaptopurine When allopurinol and Xaluprine are administered concomitantly it is essential that only a quarter of the usual dose of Xaluprine is given since allopurinol decreases the rate of metabolism of 6-mercaptopurine via xanthine oxidase.
Učinki drugih zdravil na merkaptopurin Pri sočasni uporabi alopurinola in zdravila Xaluprine je zelo pomembno, da se uporablja le četrtina siceršnjega odmerka zdravila Xaluprine, saj alopurinol zmanjšuje hitrost presnavljanja 6-merkaptopurina prek ksantin-oksidaze.
Combination with xanthine oxidase inhibitors
Kombiniranje z zaviralci ksantin-oksidaze
Always use the syringes provided to take your medicine.
Za jemanje zdravila vedno uporabite priloženi brizgi.
If you forget to take Xaluprine
Če ste pozabili vzeti zdravilo Xaluprine
The smaller 1 ml syringe (purple), marked from 0.1 ml to 1 ml, is for measuring doses of less than or equal to 1 ml.
Manjša 1 ml brizga (vijolična) je označena z lestvico od 0,1 do 1 ml in je namenjena odmerjanju odmerkov, manjših ali enakih 1 ml.
Pull the plunger back to the point on the scale that corresponds to the dose prescribed (figure 5).
Nato bat brizge potisnite na položaj na merilni lestvic, ki ustreza vašemu predpisanemu odmerku (Slika 5).
Approximately 7% of an oral dose is excreted as unchanged 6-mercaptopurine within 12 hours after administration.
peroralnega odmerka se izloča kot nespremenjen 6-merkaptopurin v 12 urah po uporabi.
Xaluprine should be taken at least 1 hour before or 2 hours after milk or dairy products.
Zdravilo Xaluprine se mora vzeti vsaj eno uro pred zaužitjem mleka ali mlečnih izdelkov ali dve uri po njem.
- Sensitivity to sunlight causing skin reactions
- občutljivost na sončno svetlobo, ki povzroča kožne reakcije Dodatni neželeni učinki pri otrocih
This may be harmful for people with phenylketonuria.
Škoduje lahko ljudem s fenilketonurijo.
Evidence of the teratogenicity of 6-mercaptopurine in humans is equivocal.
Dokazi o teratogenosti 6-merkaptopurina pri ljudeh niso zanesljivi.
To decrease the risk of exposure, parents and care givers should wear disposable gloves when handling Xaluprine.
Za zmanjšanje tveganja izpostavljenosti naj starši in negovalci pri uporabi zdravila Xaluprine uporabljajo rokavice za enkratno uporabo.
Pharmacotherapeutic group: antineoplastic agents, antimetabolites, purine analogues, ATC code: L01BB02
Farmakoterapevtska skupina: antineoplastiki, antimetaboliti, analogi purinskih baz, oznaka ATC:
Patients with inherited mutated NUDT15 gene are at increased risk for severe 6-mercaptopurine toxicity, (see 4.4).
Bolniki s podedovanim mutiranim genom NUDT15 so izpostavljeni povečanemu tveganju za hudo toksičnost zaradi 6-merkaptopurina (glejte poglavje 4.4).
If you take more Xaluprine than you should, tell your doctor or go to a hospital immediately.
Če ste vzeli večji odmerek zdravila Xaluprine, kot bi smeli Če ste vzeli večjo količino zdravila Xaluprine, kot bi smeli, nemudoma pokličite zdravnika ali pojdite v bolnišnico.
Avoid contact of Xaluprine with your skin, eyes or nose.
Pazite, da zdravilo Xaluprine ne pride v stik s kožo, očmi ali nosom.
*inflammatory bowel disease (IBD) is an unlicensed indication
*vnetna črevesna bolezen je indikacija, ki ni odobrena
Hepatosplenic T-cell lymphoma* (see section 4.4)
Jetrnovranični T-celični limfom* (glejte poglavje 4.4)
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.
6-merkaptopurin je neaktivno predzdravilo, ki deluje kot antagonist purina, vendar je potreben celični privzem in znotrajcelični anabolizem v nukleotide tiogvanina za citotoksičnost.
Take the medicine pack and this leaflet with you.
Ovojnino zdravila in navodilo za uporabo vzemite s seboj.
The 6-mercaptopurine metabolites inhibit de novo purine synthesis and purine nucleotide interconversions.
Presnovki 6-merkaptopurina zavirajo de novo sintezo purina in interkonverzijo purinskih nukleotidov.
Biliary stasis, hepatotoxicity
Zastoj žolča, hepatotoksičnost
Xaluprine contains aspartame (E951) which contains a source of phenylalanine.
Zdravilo Xaluprine vsebuje aspartam (E951), ki je izvor fenilalanina.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Xaluprine.
Če niste prepričani, ali kaj od naštetega velja za vas, se pred jemanjem zdravila Xaluprine posvetujte z zdravnikom ali s farmacevtom.
The histological findings in man have shown hepatic necrosis and biliary stasis
Histološke ugotovitve pri ljudeh so pokazale nekrozo jeter in zastoj žolča.
The intracellular anabolism of 6-merpactopurine is catalysed by several enzymes to eventually form 6-thioguanine nucleotides (TGNs), but a variety of intermediary TGNs are formed en route to the TGNs.
Znotrajcelični anabolizem 6-merkaptopurina se katalizira z več encimi, ki ga v končni fazi pretvorijo v 6-tiogvanin nukleotide (TGN), vendar se v postopku do oblikovanja končnih TGN oblikuje več vmesnih TGN.
Wash the syringe with warm ‘soapy' water and rinse well.
Brizgo operite s toplo milnico in jo dobro sperite.
Xaluprine should not be handled by women who are or planning to be pregnant or breast-feeding.
Z zdravilom Xaluprine ne smejo rokovati ženske, ki so noseče, načrtujejo nosečnost ali dojijo.
TPMT genotyping or phenotyping can be used to identify patients with absent or reduced TPMT activity.
Za ugotavljanje, ali pri bolnikih ni delovanja TPMT ali pa je zmanjšano, se lahko uporablja genotipizacija ali fenotipizacija TPMT.
6-mercaptopurine is metabolised by the polymorphic TPMT enzyme.
6-merkaptopurin se presnavlja s polimorfnim encimom TPMT.
The larger 5 ml syringe (white), marked 1 ml to 5 ml, is for measuring doses of more than 1 ml.
Večja 5 ml brizga (bela) je označena z lestvico od 1 ml do 5 ml in je namenjena odmerjanju odmerkov, večjih od 1 ml.
Special populations
Posebne populacije Starejši:
It comes in glass bottles of 100 ml capped with a child-resistant closure.
Na voljo je v 100 ml steklenici, ki je zaprta z zaporko, varno za otroke.
These patients generally require dose reduction; particularly those being NUDT15 variant homozygotes (see 4.4).
Pri teh bolnikih je običajno potrebno zmanjšanje odmerka, predvsem pri homozigotnih variantah NUDT15 (glejte poglavje 4.4).
However, it is advisable to monitor renal and hepatic function in these patients, and if there is any impairment, consideration should be given to reducing the Xaluprine dose.
Pri teh bolnikih se priporoča spremljanje delovanja ledvic in jeter, v primeru kakršne koli okvare pa je treba proučiti možnost zmanjšanja odmerka zdravila Xaluprine.
Two dosing syringes (a purple syringe graduated to 1 ml and a white syringe graduated to 5 ml) are provided for accurate measurement of the prescribed dose of the oral suspension.
Priloženi sta dve brizgi za odmerjanje (vijolična brizga z merilno skalo do 1 ml in bela brizga z merilno skalo do 5 ml) za natančno odmerjanje predpisanega odmerka peroralne suspenzije.
Wipe up spillages immediately.
Razlitje zdravila nemudoma obrišite.
Allopurinol and other xanthine oxidase inhibitors decrease the rate of catabolism of 6-mercaptopurine.
Alopurinol in drugi zaviralci ksantin-oksidaze zmanjšujejo hitrost razgradnje 6-merkaptopurina.
If Xaluprine comes into contact with skin, eyes or nose, it should be washed immediately and thoroughly with soap and water.
Če pride zdravilo Xaluprine v stik s kožo, očmi ali nosom, ga morate takoj temeljito izprati z milom in vodo.
Keep the bottle tightly closed to protect the integrity of the product and minimise the risk of accidental spillage.
Steklenica naj bo tesno zaprta, da je zagotovljena integriteta zdravila in se zmanjša tveganje nenamernega razlitja.
Pull the plunger of the syringe back so that the medicine is drawn from the bottle into the syringe.
Bat brizge povlecite navzdol, tako da zdravilo povlečete iz steklenice v brizgo.
D CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
4.6 Fertility, pregnancy and lactation
4.6 Plodnost, nosečnost in dojenje Kontracepcija pri moških in ženskah
Talk to your child´s doctor if this happens.
Če se to zgodi, se posvetujte z otrokovim zdravnikom.
It also contains sodium methyl parahydroxybenzoate and sodium ethyl parahydroxybenzoate which may cause allergic reaction (possibly delayed).
Vsebuje tudi natrijev metilparahidroksibenzoat in natrijev etilparahidroksibenzoat, ki lahko povzročata alergijske reakcije (lahko tudi zapoznele).
6-mercaptopurine, in common with other antimetabolites, is mutagenic and causes chromosomal aberrations in vitro and in vivo in mice and rats.
6-mekaptopurin je podobno kot drugi antimetaboliti mutagen in povzroča kromosomske aberacije in vitro in in vivo pri miših in podganah.
The main route of elimination for 6-mercaptopurine is by metabolism.
Glavna pot izločanja 6-merkaptopurina je s presnavljanjem.
Your pack of Xaluprine contains a bottle of medicine, a cap, a bottle adaptor and two dosing syringes (a purple 1 ml syringe and a white 5 ml syringe).
Vaše pakiranje zdravila Xaluprine vsebuje steklenico zdravila, zaporko, nastavek za steklenico in dve brizgi za odmerjanje (vijolična 1 ml brizga in bela 5 ml brizga).
Treatment with 6-mercaptopurine causes bone marrow suppression leading to leucopenia and thrombocytopenia and, less frequently, to anaemia.
Zdravljenje s 6-merkaptopurinom povzroča supresijo kostnega mozga, kar vodi v levkopenijo in trombocitopenijo, redkeje pa tudi anemijo.
One ml of suspension contains 3 mg aspartame, 1 mg methyl hydroxybenzoate (as the sodium salt), 0.5 mg ethyl hydroxybenzoate (as the sodium salt) and sucrose (trace).
En ml suspenzije vsebuje 3 mg aspartama, 1 mg metilhidroksibenzoata (v obliki natrijeve soli), 0,5 mg etilhidroksibenzoata (v obliki natrijeve soli) in saharozo (v sledeh).
TPMT also catalyses the S-methylation of the principle nucleotide metabolite, TIMP, to form methylthioinosine monophosphate (mTIMP).
TPMT katalizira tudi S-metilacijo glavnega presnovka nukleotida TIMP v metiltioinozin monofosfat (mTIMP).
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.
V perifernih limfocitih bolnikov z levkemijo, pri bolnikih s karcinomom ledvičnih celic, ki so prejemali nedoločen odmerek 6-merkaptopurina, in pri bolnikih s kronično boleznijo ledvic, ki so bili zdravljeni z odmerkom 0,4 - 1,0 mg/kg/dan, je bilo opaženo večje število kromosomskih aberacij.
The patient should be instructed to discontinue Xaluprine immediately if jaundice becomes apparent (see section 4.8).
Bolnika je treba seznaniti, da mora v primeru pojava zlatenice nemudoma prekiniti zdravljenje z zdravilom Xaluprine (glejte poglavje 4.8).
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Nova Laboratories Ireland Limited
Nova Laboratories Ireland Limited
This medicinal product contains aspartame (E951), a source of phenylalanine.
Zdravilo vsebuje aspartam (E951), vir fenilalanina.
MARKETING AUTHORISATION HOLDER Nova Laboratories Ireland Limited 3rd Floor, Ulysses House Foley Street, Dublin 1
Nova Laboratories Ireland Limited 3rd Floor, Ulysses House Foley Street, Dublin 1
Inhibition of the anticoagulant effect of warfarin, when given with 6-mercaptopurine, has been reported.
Poročali so o zaviranju antikoagulantnega učinka varfarina pri uporabi s 6-merkaptopurinom.
Substantial dose reductions are generally required for homozygous-TPMT deficiency patients to avoid the development of life threatening bone marrow suppression.
Običajno je treba pri bolnikih s homozigotnim pomanjkanjem TPMT bistveno zmanjšati odmerek, da se prepreči razvoj življenjsko nevarne supresije kostnega mozga.
Your can take your medicine with food or on an empty stomach but the choice of method should be consistent from day to day.
Zdravilo se lahko vzame skupaj s hrano ali na tešče, vendar pa mora biti način uporabe zdravila ves čas enak.
If you are not sure how much medicine to take, always ask your doctor or nurse.
Če niste prepričani, kakšen odmerek zdravila morate vzeti, vprašajte svojega zdravnika ali medicinsko sestro.
This problem could be exacerbated by coadministration with active substances that inhibit TPMT, such as olsalazine, mesalazine or sulfasalazine.
Sočasna uporaba učinkovin, ki zavirajo TPMT, kot so olsalazin, mesalazin ali sulfasalazin, lahko to težavo še poslabša.
Gently put the tip of the syringe into your mouth and to the inside of your cheek.
Konico brizge nežno položite v usta, proti notranji strani lica.
Since there is a potential for reduced elimination of mercaptopurine, consideration should be given to reduced starting doses in patients with impaired hepatic function.
Ker obstaja možnost zmanjšanega izločanja merkaptopurina, je pri bolnikih z okvarjenim delovanjem jeter treba razmisliti o zmanjšanju začetnega odmerka.
They generally require dose reduction, particularly those being NUDT15 variant homozygotes (see 4.2).
Običajno je potrebno zmanjšanje odmerka, predvsem pri bolnikih s homozigotnimi variantami NUDT15 (glejte poglavje 4.2).
Parents and care givers should avoid Xaluprine contact with skin or mucous membrane.
Varno ravnanje s suspenzijo Starši in negovalci se morajo izogibat stiku zdravila Xaluprine s kožo ali sluznico.
Patients should be closely monitored for dose related adverse reactions.
Pri bolnikih je treba skrbno spremljati morebiten pojav neželenih učinkov, povezanih z odmerkom.
- Do not take Xaluprine if you are allergic (hypersensitive) to mercaptopurine or any of the other ingredients of Xaluprine (see section 6).
Kaj morate vedeti, preden boste vzeli zdravilo Xaluprine - Ne jemljite zdravila Xaluprine, če ste alergični na (preobčutljivi za) merkaptopurin ali katero koli drugo sestavino zdravila Xaluprine (glejte poglavje 6).
Turn the bottle back the right way up and carefully remove the syringe from the adaptor, holding it by the barrel rather than the plunger.
Steklenico ponovno postavite v pokončni položaj in previdno odstranite brizgo iz nastavka, tako da držite brizgo in ne bata.
The active substance is mercaptopurine (as monohydrate).
Učinkovina je merkaptopurin (v obliki monohidrata).
One ml of suspension contains 20 mg of mercaptopurine monohydrate.
En ml suspenzije vsebuje 20 mg merkaptopurin monohidrata.
- tumours, including skin cancer.
Novotvorbe, vključno z limfoproliferativnimi boleznimi, kožnim rakom
If Xaluprine comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
Če pride zdravilo Xaluprine v stik s kožo ali sluznico, jo je treba takoj temeljito izprati z milom in vodo.
- Do not get vaccinated with yellow fever vaccine whilst you are taking Xaluprine because it may be fatal.
- Med jemanjem zdravila Xaluprine ne smete prejeti cepiva proti rumeni mrzlici, saj je lahko to smrtno nevarno.
Cases of symptomatic hypoglycaemia have been reported in children with ALL receiving 6-mercaptopurine (see section 4.8).
Pri otrocih z ALL, ki so prejemali 6-merkaptopurin, so poročali o primerih simptomatske hipoglikemije (glejte poglavje 4.8).
Cross-resistance usually exists between 6-mercaptopurine and 6-thioguanine.
Med 6-merkaptopurinom in 6-tiogvaninom običajno obstaja navzkrižna odpornost.
The incidence of hepatotoxicity varies considerably and can occur with any dose but more frequently when the recommended dose is exceeded.
Pojavnost hepatotoksičnosti se bistveno razlikuje in se lahko pojavi pri katerem koli odmerku,
Cytotoxic agents may decrease the intestinal absorption of phenytoin.
Citotoksična zdravila lahko zmanjšajo absorpcijo fenitoina v prebavilih.
How to take Xaluprine
Kako jemati zdravilo Xaluprine
Mutagenicity and carcinogenicity
Mutagenost in kancerogenost
Pancreatitis in off-label treatment of patients with inflammatory bowel disease Pancreatitis has been reported to occur at a frequency of ≥ 1/100 to < 1/10 (“common”) in patients treated for the unlicensed indication inflammatory bowel disease.
Poročali so, da se pankreatitis pojavlja s pogostostjo od ≥ 1/100 do < 1/10 („pogosto“) pri bolnikih, ki so jih zdravili zaradi vnetne bolezni črevesja, ki ni med indikacijami za uporabo tega zdravila.
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.
Zato se med jemanjem zdravila Xaluprine čim bolj izogibajte izpostavljenosti sončnim žarkom, nosite zaščitna oblačila in uporabljajte zaščitna sredstva za sončenje z visokim zaščitnim faktorjem.
Volume (ml) BSA (m2) Dose (mg)
Prostorn ina (ml) TP (m2) Odmere k (mg)
Serum antiepileptic levels should be closely monitored during treatment with Xaluprine, making dose adjustments as necessary.
Med zdravljenjem z zdravilom Xaluprine je treba pozorno spremljati ravni antiepileptikov v serumu in po potrebi prilagajati odmerke teh zdravil.
The main adverse reaction of treatment with 6-mercaptopurine is bone marrow suppression leading to leucopenia and thrombocytopenia.
Glavni neželeni učinek pri zdravljenju s 6-merkaptopurinom je supresija kostnega mozga, ki vodi v levkopenijo in trombocitopenijo.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
PODATKI NA STIČNI OVOJNINI NALEPKA NA STEKLENICI
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.
Aktivni ukrepi (kot so uporaba aktivnega oglja ali izpiranje želodca) morda ne bodo učinkoviti v primeru prevelikega odmerjanja
Xaluprine contains sucrose.
Zdravilo Xaluprine vsebuje saharozo.
OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Citotoksično zdravilo.
Genotypic testing of NUDT15 variants may be considered before initiating 6-mercaptopurine therapy.
Pred uvedbo zdravljenja s 6-merkaptopurinom se lahko izvede genotipizacija variant NUDT15.
It is recommended that newborns of women exposed to mercaptopurine during pregnancy are monitored for haematological and immune system disturbances.
Priporoča se, da se pri novorojenčkih mater, ki so bile med nosečnostjo izpostavljene merkaptopurinu,
Xaluprine also contains sodium methyl parahydroxybenzoate (E219) and sodium ethyl parahydroxybenzoate (E215) which may cause allergic reactions (possibly delayed).
Zdravilo Xaluprine vsebuje tudi natrijev metilparahidroksibenzoat (E 219) in natrijev etilparahidroksibenzoat (E 215), ki lahko povzročita alergijske reakcije (lahko tudi zapoznele).
olsalazine, mesalazine or sulfazalazine) inhibit the TPMT enzyme, which metabolises 6-mercaptopurine, they should be administered with caution to patients receiving concurrent Xaluprine therapy (see section 4.4).
Ker obstajajo dokazi in vitro, da derivati aminosalicilatov (npr. olsalazin, mesalazin ali sulfalazin) zavirajo encim TPMT, ki presnavlja 6-merkaptopurin, je potrebna posebna previdnosti pri njihovi sočasni uporabi pri bolnikih, ki prejemajo tudi zdravilo Xaluprine (glejte poglavje 4.4).
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.
Pri bolnikih z vnetno črevesno boleznijo*, zdravljenih z azatioprinom (predzdravilo 6-merkaptopurina) ali 6-merkaptopurinom, bodisi s sočasnim zdravljenjem s protitelesi proti TNF alfa ali brez njega, so poročali o jetrnovraničnem T-celičnem limfomu.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Nizka raven sladkorja v krvi (hipoglikemija) - pogostnost ni znana Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
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.
Počasi in nežno potisnite bat navzdol ter nežno iztisnite zdravilo v usta proti notranji strani lic in ga pogoltnite.
If you are not sure about how much medicine to draw into the syringe, always ask your doctor or nurse for advice.
Če niste prepričani, koliko zdravila morate povleči v brizgo, se o tem posvetujete z zdravnikom ali medicinsko sestro.
Neoplasms including lymphoproliferative disorders, skin cancers (melanomas and non-melanomas), sarcomas (Kaposi's and non-Kaposi's) and uterine cervical cancer in situ (see section 4.4).
(melanomskim in nemelanomskim), sarkomom (Kaposijevim in neKaposijevim) in rakom materničnega vratu in situ (glejte poglavje 4.4)