FrancophonIA/ELRC3.0 huggingface dataset:
English: Procedures for proper handling and disposal of antineoplastic medicinal products should be used.
Slovenian: Uporabljati je treba postopke za ustrezno ravnanje in odlaganje zdravil z delovanjem na novotvorbe.
English: Cladribine is an antineoplastic and immunosuppressive substance that can induce considerable toxic adverse reactions, such as myelo- and immunosuppression, long-lasting lymphocytopenia, and opportunistic infections.
Slovenian: Kladribin je antineoplastična in imunosupresivna učinkovina, ki lahko povzroči znatne toksične neželene učinke, kot so mielo- in imunosupresija, dolgotrajna limfocitopenija in oportunistične okužbe.
English: Warnings and precautions Talk to your doctor or pharmacist before using LITAK.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila LITAK se posvetujte z zdravnikom ali farmacevtom.
English: The biexponential decline of the serum concentration of cladribine after subcutaneous bolus injection is comparable to elimination parameters after 2-hour intravenous infusion with an initial and terminal half-life of approximately 2 hours and 11 hours, respectively.
Slovenian: Bieksponentni padec serumske koncentracije kladribina po subkutani bolusni injekciji je primerljiv z eliminacijskimi spremenljivkami po 2-urni intravenski infuziji z začetnim in terminalnim razpolovnim časom približno 2 uri oziroma 11 ur.
English: What do I need for the injection?
Slovenian: Kaj potrebujem za injekcijo?
English: Elderly patients should be treated by individual assessment and careful monitoring of the blood counts and of the renal and hepatic function.
Slovenian: Starejše bolnike je treba zdraviti po individualni oceni in s skrbnim spremljanjem krvne slike ter delovanja ledvic in jeter.
English: LITAK should be injected into the tissue just under the skin (subcutaneous injection).
Slovenian: Zdravilo LITAK si injicirajte v tkivo tik pod kožo (subkutana injekcija).
English: Common: tachycardia, heart murmur, hypotension, epistaxis, myocardial ischemia *
Slovenian: Pogosti: tahikardija, srčni šum, hipotenzija, epistaksa, ishemija miokarda *
English: Special handling precautions (see package leaflet)
Slovenian: Posebna navodila za ravnanje (glej navodilo za uporabo).
English: Cladribine shows complete bioavailability after parenteral administration; the mean area under the plasma concentration versus time curve (AUC) is comparable after continuous or intermittent 2-hour intravenous infusion and after subcutaneous injection.
Slovenian: Kladribin izkazuje popolno biološko razpoložljivost po parenteralnem dajanju; povprečna površina pod krivuljo koncentracije v odvisnosti od časa (AUC) je primerljiva po neprekinjeni ali intermitentni 2-urni intravenski infuziji in po subkutanem injiciranju.
English: Non-haematological adverse reactions are generally mild to moderate in severity.
Slovenian: Nehematološki neželeni učinki so v splošnem blagi do zmerni.
English: Packs contain 1 or 5 vials, each with 5 ml of solution.
Slovenian: Pakiranje vsebujejo 1 ali 5 vial, od katerih vsaka vsebuje 5 ml raztopine.
English: OUTER CARTON (1-VIAL PACK)
Slovenian: ŠKATLA (PAKIRANJE Z 1 VIALO)
English: Remove the injection needle from the wrapping and place it firmly on the tip of the syringe.
Slovenian: Iz ovitka vzemite injekcijsko iglo in jo trdno pritrdite na konico brizge.
English: There are no studies available using cladribine in patients with renal or hepatic impairment (see also section 4.2 and section 4.4).
Slovenian: O uporabi kladribina pri bolnikih z okvarjenim delovanjem ledvic ali jeter ni nobenih študij (glej tudi poglavje 4.2 in poglavje 4.4).
English: Very rare: cholecystitis
Slovenian: Zelo redki: holecistitis
English: Cytotoxic medicinal products should be handled with caution.
Slovenian: S citotoksičnimi zdravili je treba ravnati previdno.
English: The mean plasma clearance amounts to 794 ml/min after intravenous infusion and to 814 ml/min after subcutaneous bolus injection at a dose of 0.10 mg/kg body weight/day.
Slovenian: Povprečni plazemski očistek je 794 ml/min po intravenski infuziji in 814 ml/min po subkutani bolusni injekciji v odmerku 0,10 mg/kg telesne mase/dan.
English: Cladribine is a cytotoxic medicinal product, which is mutagenic to cultured mammalian cells.
Slovenian: Kladribin je citotoksično zdravilo, ki je mutageno za sesalske celice v kulturah.
English: Very common severe complications, in some cases with fatal outcome, are opportunistic infections (e.g. Pneumocystis carinii, Toxoplasma gondii, listeria, candida, herpes viruses, cytomegalovirus and atypical mycobacteria).
Slovenian: Zelo pogosti hudi zapleti, v nekaterih primerih s smrtnim izidom, so oportunistične okužbe (npr. Pneumocystis carinii, Toxoplasma gondii, Listeria, Candida, herpes virusi, citomegalovirus in atipična mikobakterija).
English: Uncommon: somnolence, paraesthesia, lethargy, polyneuropathy, confusion, ataxia
Slovenian: Občasni: zaspanost, parestezije, letargija, polinevropatija, zmedenost, ataksija
English: OUTER CARTON (5-VIAL PACK)
Slovenian: ŠKATLA (PAKIRANJE S 5 VIALAMI)
English: The intracellular retention time of cladribine nucleotides in vivo is clearly prolonged as compared to the retention time in the plasma: Half-lives t1/2 of initially 15 hours and subsequently more than 30 hours were measured in leukaemic cells.
Slovenian: Znotrajcelični retencijski čas kladribinovih nukleotidov in vivo je jasno podaljšan v primerjavi z retencijskim časom v plazmi: v levkemičnih celicah so izmerili razpolovne čase t1/2 ob začetku 15 ur in kasneje več kot 30 ur.
English: Patients undergoing treatment with cladribine should be closely monitored for signs of haematologic and non-haematologic toxicities.
Slovenian: Bolnike, ki jih zdravimo s kladribinom, moramo skrbno spremljati za primer pojava znakov hematoloških in nehematoloških toksičnosti.
English: Patients with active infection should be treated for the underlying condition prior to receiving therapy with cladribine.
Slovenian: Bolnike z aktivno okužbo je treba pred prejemanjem zdravljenja s kladribinom zdraviti za predhodno okužbo.
English: In rabbits, cladribine is teratogenic at doses of 3.0 mg/kg/day (given on gestation days 7-19).
Slovenian: Pri kuncih je kladribin teratogen v odmerkih 3,0 mg/kg/dan (danih na dneve gestacije 7-19).
English: Effects on sternal ossification were seen at 1.5 and 3.0 mg/kg/day.
Slovenian: Učinke na zakostenevanje prsnice so opažali pri 1,5 in 3,0 mg/kg/dan.
English: After injecting the liquid, remove the needle.
Slovenian: Po injiciranju tekočine iglo izvlecite.
English: How to use LITAK
Slovenian: Kako uporabljati zdravilo LITAK
English: Cladribine is eliminated mainly by the kidneys.
Slovenian: Kladribin se izloča predvsem preko ledvic.
English: What LITAK looks like and contents of the pack LITAK is available in glass vials containing 5 ml of clear, colourless solution for injection.
Slovenian: Zdravilo LITAK je na voljo v steklenih vialah, ki vsebujejo 5 ml bistre, brezbarvne raztopine za injiciranje.
English: An influence of cladribine on the activity of other antineoplastic agents has not been observed in vitro (e.g. doxorubicin, vincristine, cytarabine, cyclophosphamide) and in vivo.
Slovenian: Vpliva kladribina na aktivnost drugih zdravil z delovanjem na novotvorbe niso opažali in vitro (npr. doksorubicin, vinkristin, citarabin, ciklofosfamid) ter in vivo.
English: Cladribine is teratogenic in mice (at doses of 1.5-3.0 mg/kg/day, given on gestation days 6-15).
Slovenian: Kladribin je teratogen pri miših (v odmerkih od 1,5-3,0 mg/kg/dan, danih na dneve gestacije 6-15).
English: The recommended posology for hairy cell leukaemia is a single course of LITAK given by subcutaneous bolus injection at a daily dose of 0.14 mg/kg body weight for 5 consecutive days.
Slovenian: Priporočeni odmerek za zdravljenje dlakavocelične levkemije je enkratni cikel zdravila LITAK, danega s podkožnim bolusnim injiciranjem v dnevnem odmerku 0,14 mg/kg telesne mase 5 zaporednih dni.
English: When LITAK is not self-administered by the patient, the use of disposable gloves and protective garments is recommended when handling and administering LITAK.
Slovenian: Če si zdravila LITAK ne daje bolnik sam, se za ravnanje in dajanje zdravila LITAK priporoča uporaba rokavic za enkratno uporabo in zaščitnih oblačil.
English: Therefore, simultaneous administration of nucleoside analogues with cladribine is not advisable.
Slovenian: Zato ne priporočamo sočasnega dajanja nukleozidnih analogov s kladribinom.
English: Dispose the puncture-proof container as instructed by your doctor, nurse or pharmacist.
Slovenian: Vsebnik, odporen proti vbodom, odstranite v skladu z navodili vašega zdravnika, medicinske sestre ali farmacevta.
English: If LITAK contacts the skin or eyes, rinse the involved surface immediately with copious amounts of water.
Slovenian: Če pride zdravilo LITAK v stik s kožo ali očmi, začnite prizadeto površino takoj spirati z obilnimi količinami vode.
English: Where should I give my injection?
Slovenian: Kam naj si dam mojo injekcijo?
English: There are no data on the use of LITAK in patients with renal or hepatic impairment.
Slovenian: Podatkov o uporabi zdravila LITAK pri bolnikih z okvarjenim delovanjem ledvic ali jeter ni.
English: During the first month following treatment, myelosuppression is most notable and red blood cell or platelet transfusions may be required.
Slovenian: V prvem mesecu po zdravljenju je zavrtje delovanja kostnega mozga najbolj opazno, morda bodo potrebne celo transfuzije eritrocitov ali trombocitov.
English: Do not remove the rubber stopper of the vial.
Slovenian: Ne snemite gumijastega zamaška viale.
English: Be sure that the tip of the needle is in the solution.
Slovenian: Preverite, da je konica igle v raztopini.
English: Cladribine is a purine nucleoside analogue acting as an antimetabolite.
Slovenian: Kladribin je purinski nukleozidni analog, ki deluje kot zaviralec celične presnove.
English: Blood counts
Slovenian: Krvna slika
English: Cladribine causes serious birth defects when administered during pregnancy.
Slovenian: Kladribin povzroča resne okvare ploda, če ga jemljejo nosečnice.
English: The prodrug cladribine is metabolised intracellularly, predominantly by deoxycytidine kinase, to 2-chlorodeoxyadenosine-5'-monophosphate, that is further phosphorylated to the diphosphate by nucleoside monophosphate kinase and to the active metabolite 2-chlorodeoxyadenosine-5'-triphosphate (CdATP) by nucleoside diphosphate kinase.
Slovenian: Predzdravilo kladribin se presnavlja znotrajcelično, predvsem z deoksicitidinsko kinazo, v 2klorodeoksiadenozin-5'-monofosfat, ki se nadalje fosforilira v difosfat z nukleozidno monofosfatno kinazo in v aktivni presnovek 2-klorodeoksiadenozin-5'-trifosfat (CdATP) z nukleozidno difosfatno kinazo.
English: Do not use LITAK after the expiry date which is stated on the vial label and the outer carton after EXP.
Slovenian: Zdravila LITAK ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na oznaki viale in na škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Particular caution is advised and risks/benefits should be carefully evaluated if administration of cladribine is considered in patients with increased infection risk, manifested bone marrow failure or infiltration, myelosuppressive pre-treatments, as well as in patients with suspected or manifested renal and hepatic insufficiency.
Slovenian: Priporočamo posebno previdnost in skrbno vrednotenje tveganj/koristi, če razmišljamo o dajanju kladribina bolnikom s povečanim tveganjem za okužbo, očitno odpovedjo ali infiltracijo kostnega mozga, predhodnimi mielosupresivnimi zdravljenji, in tudi pri bolnikih s sumom na popuščanje delovanja ledvic in jeter ali očitnim popuščanjem delovanja ledvic in jeter.
English: Prevention of tumour lysis syndrome
Slovenian: Preprečevanje sindroma tumorskega razpada
English: In case you miss an injection of a dose, tell your doctor immediately.
Slovenian: Če izpustite injiciranje enega odmerka, o tem nemudoma obvestite svojega zdravnika.
English: The risk requires assessment on a case-by-case basis (see section
Slovenian: Tveganje zahteva oceno na podlagi posameznega primera (glejte poglavje 4.2).
English: Remove the syringe from the wrapping without touching the tip of the syringe.
Slovenian: Brizgo vzemite iz ovitka, ne da bi se dotaknili konice brizge.
English: Moderate to severe renal impairment (creatinine clearance ≤ 50 ml/min) or moderate to severe hepatic impairment (Child-Pugh score > 6) (see also section 4.4).
Slovenian: Zmerno do hudo okvarjeno delovanje ledvic (očistek kreatinina ≤ 50 ml/min) ali zmerno do hudo okvarjeno delovanje jeter (število točk po Child-Pughu ≥ 6) (glej tudi poglavje 4.4).
English: Further rare cases with fatal outcome, reported in association with LITAK chemotherapy, were second malignancy, cerebro- and cardiovascular infarctions, graft-versus-host disease caused by multiple transfusions of non-irradiated blood, as well as tumour lysis syndrome with hyperuricaemia, metabolic acidosis, and acute renal failure.
Slovenian: Nadaljnji redki primeri s smrtnim izidom, o katerih so poročali v povezavi s kemoterapijo z zdravilom LITAK, so bili sekundarni malignomi, cerebro- in kardiovaskularni infarkti, bolezen graft-versus-host, povzročena z večkratnimi transfuzijami neobsevane krvi, kot tudi sindrom tumorskega razpada s hiperurikemijo, presnovno acidozo ter akutna ledvična odpoved.
English: Women of childbearing potential must use effective contraception during treatment with cladribine and for 6 months after the last cladribine dose.
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem s kladribinom in še šest mesecev po zadnjem odmerku kladribina.
English: Cladribine is a prodrug which is taken up rapidly in cells after parenteral administration, and is phosphorylated intracellularly to the active nucleotide 2-chlorodeoxyadenosine-5'-triphosphate (CdATP) by deoxycytidine kinase (dCK).
Slovenian: Kladribin je predzdravilo, ki ga celice po parenteralnem dajanju hitro privzamejo, znotrajcelično se fosforilira v aktivni nukleotid 2-klorodeoksiadenozin-5'-trifosfat (CdATP) z deoksicitidinsko kinazo (dCK).
English: Forty-three percent of patients with hairy cell leukaemia experienced infectious complications at standard dose regimen.
Slovenian: Triinštirideset odstotkov bolnikov z dlakavocelično levkemijo je imelo ob standardnem režimu odmerjanja zaplete zaradi okužbe.
English: Return any portion of the contents remaining after use to your doctor or pharmacist for proper disposal.
Slovenian: Morebitno neuporabljeno vsebino vrnite vašemu zdravniku ali farmacevtu, da jo bodo pravilno zavrgli.
English: If LITAK contacts the skin or mucous membranes, rinse the area immediately with copious amounts of water.
Slovenian: V kolikor pride zdravilo LITAK v stik s kožo ali sluznicami, področje nemudoma sperite z obilnimi količinami vode.
English: Antineoplastic agents, such as cladribine, which interfere with DNA, RNA and protein synthesis, might be expected to have adverse effects on human gametogenesis (see section 5.3).
Slovenian: Za zdravila z delovanjem na novotvorbe, kot je kladribin, ki motijo tvorbo DNA, RNA in beljakovin, bi lahko pričakovali, da imajo neželene učinke na gametogenezo pri človeku (glejte poglavje 5.3).
English: Because of the potential for serious adverse reactions in nursing infants, lactation is contraindicated during treatment with cladribine and for 6 months after the last cladribine dose.
Slovenian: Zaradi možnosti za resne neželene učinke pri dojenčkih je dojenje v času zdravljenja s kladribinom in še šest mesecev po zadnjem odmerku kladribina kontraindicirano.
English: Very common: abnormal breath sounds, abnormal chest sounds, cough
Slovenian: Zelo pogosti: nenormalni dihalni zvoki, nenormalni zvoki nad prsnim košem, kašelj
English: Antineoplastic agents, such as cladribine, which interfere with DNA, RNA and protein synthesis, might be expected to have adverse effects on human gametogenesis (see sections 4.4 and 4.6).
Slovenian: Za zdravila z delovanjem na novotvorbe, kot je kladribin, ki motijo tvorbo DNA, RNA in beljakovin, bi lahko pričakovali, da imajo neželene učinke na gametogenezo pri človeku (glejte poglavji 4.4 in 4.6).
English: How do I prepare the injection?
Slovenian: Kako pripravim injekcijo?
English: Frequently observed symptoms of overdose are nausea, vomiting, diarrhoea, severe bone marrow depression (including anaemia, thrombocytopenia, leukopenia, and agranulocytosis), acute renal insufficiency, as well as irreversible neurologic toxicity (paraparesis/quadriparesis), Guillain-Barré syndrome, and Brown-Séquard syndrome.
Slovenian: Pogosto opaženi simptomi prevelikega odmerjanja so siljenje na bruhanje, bruhanje, diareja, hudo zavrtje delovanja kostnega mozga (vključujoč anemijo, trombocitopenijo, levkopenijo in agranulocitozo), akutna ledvična odpoved, pa tudi ireverzibilna nevrološka toksičnost (paraparezo/kvadriparezo), Guillain-Barréjev sindrom in Brown-Séquardov sindrom.
English: Serious adverse reactions like ileus, severe hepatic failure, renal failure, cardiac failure, atrial fibrillation, cardiac decompensation, apoplexy, neurological disturbances in speech and swallowing, tumour lysis syndrome with acute renal failure, transfusion-related graft-versus-host disease, Stevens-Johnson syndrome/Lyell syndrome (toxic epidermal necrolysis), haemolytic anaemia, hypereosinophilia (with erythematous skin rash, pruritus, and facial oedema) are rare.
Slovenian: Resni neželeni učinki, kot je ileus, hudo odpovedovanje jeter, odpoved ledvic, odpoved srca, atrijska fibrilacija, dekompenzacija srca, apopleksija, nevrološke motnje govora in požiranja, sindrom tumorskega razpada z akutno ledvično odpovedjo, s transfuzijo povezana bolezen graft-versus-host, Stevens-Johnsonov sindrom/Lyellov sindrom (toksična epidermalna nekroliza), hemolitična anemija, hipereozinofilija (z eritematoznim izpuščajem kože, srbenjem in edemom obraza) so redki.
English: How do I give my injection?
Slovenian: Kako si dam mojo injekcijo?
English: No cytotoxic effect of cladribine could be observed in cell lines of solid tumours.
Slovenian: V celičnih linijah trdnih tumorjev niso opažali nobenega citotoksičnega učinka kladribina.
English: 5 vials each containing 5 ml solution for injection
Slovenian: 5 vial, od katerih vsaka vsebuje 5 ml raztopine za injiciranje
English: Cladribine is incorporated into DNA strands and inhibits DNA synthesis and repair.
Slovenian: Kladribin se vgradi v verige DNA in zavira tvorbo in popravljanje DNA.
English: An association with prolonged lymphopenia has been reported in several of these cases.
Slovenian: V več primerih so poročali o povezavi z dolgotrajno limfopenijo.
English: Push the needle through the rubber stopper of the vial and turn the vial and the syringe upside down.
Slovenian: Iglo potisnite skozi gumijasti zamašek viale in obrnite vialo z brizgo na glavo.
English: Paediatric use The use of LITAK in children has not been investigated (see section 4.2).
Slovenian: Uporaba pri otrocih in mladostnikih Uporabe zdravila LITAK pri otrocih niso raziskovali (glejte poglavje 4.2).
English: 1 vial containing 5 ml solution for injection
Slovenian: 1 viala, ki vsebuje 5 ml raztopine za injiciranje
English: Contains sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injections
Slovenian: Vsebuje natrijev klorid, natrijev hidroksid (za prilagajanje pH), klorovodikovo kislino (za prilagajanje pH) in vodo za injekcije
English: LITAK is contraindicated in patients with moderate to severe renal impairment (creatinine clearance ≤ 50 ml/min) or with moderate to severe hepatic impairment (Child-Pugh score > 6) (see sections 4.3, 4.4 and 5.2).
Slovenian: Zdravilo LITAK je pri bolnikih z zmerno do hudo okvarjenim delovanjem ledvic (očistek kreatinina ≤ 50 ml/min) ali z zmerno do hudo okvarjenim delovanjem jeter (število točk po Child-Pughu ≥ 6) kontraindiciran (glejte poglavja 4.3, 4.4 in 5.2).
English: Each ml solution contains 2 mg cladribine.
Slovenian: En ml raztopine vsebuje 2 mg kladribina.
English: LITAK is supplied as a ready-to-use solution for injection.
Slovenian: Zdravilo LITAK je na voljo v obliki raztopine za injiciranje, pripravljene za uporabo.
English: Very common: rash, localised exanthema, diaphoresis Common: pruritus, skin pain, erythema, urticaria Rare: Stevens-Johnson syndrome/Lyell syndrome
Slovenian: Zelo pogosti: izpuščaj, omejen eksantem, čezmerno znojenje Pogosti: srbenje, bolečine na koži, eritem, urtikarija Redki: Stevens-Johnsonov sindrom/Lyellov sindrom
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Slovenian: Natrijev hidroksid (za uravnavanje pH) Klorovodikova kislina (za uravnavanje pH) Voda za injekcije
English: Cladribine is unlikely to cause alopecia; mild and transient alopecia for a few days was observed in 4/523 patients during the treatment, but could not clearly be associated with cladribine.
Slovenian: Blago in prehodno izpadanje las za nekaj dni so med zdravljenjem opažali pri 4/523 bolnikov, vendar tega niso mogli jasno povezati s kladribinom.
English: Increased resorptions, reduced live litter sizes, reduced foetal weights and increased foetal malformations of the head, trunk and appendages were seen at 3.0 mg/kg/day.
Slovenian: Pri odmerku 3,0 mg/kg/dan so opažali povečane resorpcije, zmanjšano število živih potomcev, znižane telesne mase plodov in povečano pojavnost malformacij glave, trupa in okončin ploda.
English: What LITAK contains - The active substance is cladribine.
Slovenian: Kaj vsebuje zdravilo LITAK - Učinkovina je kladribin.
English: An accumulation of active CdATP is observed predominantly in cells with a high dCK activity and a low deoxynucleotidase activity, particularly in lymphocytes and in other haematopoietic cells.
Slovenian: Predvsem v celicah z visoko aktivnostjo dCK in nizko aktivnostjo deoksinukleotidaze, posebno v limfocitih in drugih hematopoetskih celicah, opažamo kopičenje aktivne CdATP.
English: LITAK is contraindicated in patients with moderate to severe renal impairment or with moderate to severe hepatic impairment (see section 4.3).
Slovenian: Zdravilo LITAK je pri bolnikih z zmerno do hudo okvarjenim delovanjem ledvic ali z zmerno do hudo okvarjenim delovanjem jeter kontraindicirano (glejte poglavje 4.3).
English: Very common: pancytopenia/myelosuppression *, neutropenia, thrombocytopenia, anemia, lymphopenia Uncommon: haemolytic anaemia * Rare: hypereosinophilia
Slovenian: Zelo pogosti: pancitopenija/mielosupresija *, nevtropenija, trombocitopenija, anemija, limfopenija Občasni: hemolitična anemija * Redki: hipereozinofilija
English: Common: shortness of breath, pulmonary interstitial infiltrates mostly due to infectious aetiology, mucositis Uncommon: pharyngitis
Slovenian: Pogosti: zadihanost, pljučni intersticijski infiltrati večinoma infekcijske etiologije, mukozitis Občasni: faringitis
English: Very rare: lung embolism
Slovenian: Zelo redki: pljučna embolija
English: LITAK 2 mg/ml solution for injection
Slovenian: LITAK 2 mg/ml raztopina za injiciranje
English: Common: myalgia, arthralgia, arthritis, bone pain
Slovenian: Pogosti: mialgija, artralgija, artritis, kostna bolečina
English: Each vial contains 10 mg of cladribine in 5 ml of solution.
Slovenian: Ena viala vsebuje 10 mg kladribina v 5 ml raztopine.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 10 mg/5 ml
English: Heart failure.
Slovenian: Srčne bolezni
English: Very common: nausea, vomiting, constipation, diarrhoea Common: gastrointestinal pain, flatulence Rare: ileus
Slovenian: Zelo pogosti: slabost, bruhanje, zaprtje, diareja Pogosti: bolečine v prebavilih, flatulenca Redki: ileus
English: LITAK contains the active substance cladribine.
Slovenian: Zdravilo LITAK vsebuje učinkovino kladribin.
English: LITAK 2 mg/ml solution for injection cladribine
Slovenian: LITAK 2 mg/ml raztopina za injiciranje kladribin
English: Common: second malignancies * Rare: tumour lysis syndrome *
Slovenian: Pogosti: sekundarni malignomi * Redki: sindrom tumorskega razpada