FrancophonIA/ELRC3.0 huggingface dataset:
English: Paediatric use The use of LITAK in children has not been investigated (see section 4.2).
Croatian: Pedijatrijska primjena Primjena lijeka LITAK u djece nije ispitivana (vidjeti dio 4.2).
English: Procedures for proper handling and disposal of antineoplastic medicinal products should be used.
Croatian: Potrebno je pridržavati se postupaka za pravilno rukovanje antineoplastičkim lijekovima i njihovo odlaganje.
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).
Croatian: Vrlo česte teške komplikacije, koje u nekim slučajevima s smrtnim ishodom, čine oportunističke infekcije (npr. Pneumocistitis carinii, Toxoplasmosa gondii, listeria, kandida, herpes virusi, citomegalovirus i atipične mikobakterije).
English: The single substitution of hydrogen for chlorine at position 2 distinguishes cladribine from its natural counterpart 2'-deoxyadenosine and renders the molecule resistant to deamination by adenosine deaminase.
Croatian: Zamjena klora vodikom u položaju 2 razlikuje kladribin od njegovog prirodnog analoga 2'-deoksiadenozina te molekulu čini otpornom na dezaminaciju adenozin-deaminazom.
English: Very common: decreased appetite Uncommon: cachexia
Croatian: Vrlo često: smanjen apetit Manje često: kaheksija
English: Cladribine is teratogenic in mice (at doses of 1.5-3.0 mg/kg/day, given on gestation days 6-15).
Croatian: Kladribin je teratogen za miševe (u dozama od 1,5-3 mg/kg/dan, primijenjen 6.-15. gestacijskog dana).
English: Patients with symptoms of bone marrow depression should be treated with caution, since further suppression of bone marrow function should be anticipated.
Croatian: Potreban je oprez kod liječenja bolesnika sa simptomima depresije koštane srži, jer se može očekivati daljnja supresija funkcije koštane srži.
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.
Croatian: Predlijek kladribin metabolizira se unutar stanice uglavnom pomoću deoksicitidin-kinaze do 2-klorodeoksiadenozin-5'-monofosfata koji se dalje fosforilira u difosfat pomoću nukleozidmonofosfat-kinaze i u aktivni metabolit 2-klorodeoksiadenozin-5'-trifosfat (CdATP) pomoću nukleozid-difosfat-kinaze.
English: Do not remove the rubber stopper of the vial.
Croatian: Nemojte ukloniti gumeni čep s bočice.
English: How to use LITAK
Croatian: Kako primjenjivati LITAK
English: Reduced ossification was observed at 1.0 mg/kg/day.
Croatian: Smanjeno okoštavanje primijećeno je kod doze od 1,0 mg/kg/dan.
English: Put the used syringe in the puncture-proof container.
Croatian: Odložite upotrijebljenu štrcaljku u spremnik otporan na probadanje.
English: If LITAK contacts the skin or eyes, rinse the involved surface immediately with copious amounts of water.
Croatian: Ako LITAK dođe u dodir s kožom ili očima, zahvaćeno područje isperite obilnom količinom vode.
English: It is recommended that patients receiving cladribine should receive irradiated cellular blood components/products to prevent transfusion-related graft-versus-host disease (Ta-GVHD).
Croatian: Bolesnicima koji primaju kladribin preporučuje se davati ozračene derivate krvnih stanica kako bi se spriječila reakcija presatka protiv domaćina povezana s transfuzijom (Ta-GVHD).
English: Do not use LITAK after the expiry date which is stated on the vial label and the outer carton after EXP.
Croatian: LITAK se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici bočice i kutiji iza „Rok valjanosti” ili kratice „EXP”.
English: LITAK is indicated for the treatment of hairy cell leukaemia.
Croatian: LITAK je indiciran za liječenje leukemije vlasastih stanica.
English: OUTER CARTON (5-VIAL PACK)
Croatian: KUTIJA (PAKIRANJE OD 5 BOČICA)
English: However, a toxicity study conducted with cynomolgus monkeys has shown that cladribine suppresses maturation of rapidly generating cells, including testicular cells.
Croatian: Međutim, ispitivanja toksičnosti provedena na makaki majmunima pokazala su da kladribin suprimira sazrijevanje stanica koje se brzo dijele, uključujući testikularne stanice.
English: Unlike other nucleoside analogues, cladribine is toxic in rapidly proliferating cells as well as in resting cells.
Croatian: Za razliku od drugih nukleozidnih analoga, kladribin je toksičan za stanice koje se brzo dijele kao i za stanice u mirovanju.
English: Like other nucleoside analogues, treatment with cladribine is associated with myelosuppression and profound and prolonged immunosuppression.
Croatian: Kao i kod drugih analoga nukleozida, liječenje kladribinom povezano je s mijelosupresijom te dubokom i produljenom imunosupresijom.
English: The risk of severe myelotoxicity and long-lasting immunosuppression is increased in patients with a disease-related bone marrow infiltration or a previous myelosuppressive treatment.
Croatian: Rizik od teške mijelotoksičnosti i dugotrajne imunosupresije povećan je u bolesnika s infiltracijom koštane srži povezanom s bolešću ili u bolesnika koji su prethodno primali mijelosupresivno liječenje.
English: After subcutaneous bolus injection of a 0.14 mg/kg cladribine dose, a Cmax of 91 ng/ml is reached on average after 20 minutes only.
Croatian: Nakon supkutane bolus injekcije doze kladribina od 0,14 mg/kg tjelesne težine, Cmax od 91 ng/ml u prosjeku se postiže već nakon 20 minuta.
English: If LITAK contacts the skin or mucous membranes, rinse the area immediately with copious amounts of water.
Croatian: Ako LITAK dođe u dodir s kožom ili sluznicom, odmah isperite zahvaćeno područje obilnom količinom vode.
English: Common: second malignancies * Rare: tumour lysis syndrome *
Croatian: Često: sekundarne zloćudne bolesti* Rijetko: sindrom lize tumora*
English: Return any portion of the contents remaining after use to your doctor or pharmacist for proper disposal.
Croatian: Neupotrijebljeni sadržaj vratite svome liječniku ili ljekarniku koji će ga odstraniti na odgovarajući način.
English: Very common: headache, dizziness Common: insomnia, anxiety
Croatian: Vrlo često: glavobolja, omaglica Često: insomnija, anksioznost
English: OUTER CARTON (1-VIAL PACK)
Croatian: KUTIJA (PAKIRANJE OD 1 BOČICE)
English: Non-haematologic tissues seem to be unaffected, explaining the low incidence of non-haematopoietic toxicity of cladribine
Croatian: Čini se da kladribin ne djeluje na nehematološka tkiva, što objašnjava nisku incidenciju nehematopoetske toksičnosti kladribina.
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).
Croatian: Antineoplastička sredstva poput kladribina koja ometaju sintezu DNK, RNK i proteina, mogu imati štetne učinke na gametogenezu u ljudi (vidjeti dijelove 4.4 i 4.6).
English: The renal excretion of unmetabolised cladribine occurs within 24 hours and accounts for 15% and 18% of the dose after 2-hour intravenous and subcutaneous administration, respectively.
Croatian: Bubrežno izlučivanje nemetaboliziranog kladribina odvija se unutar 24 sata i tako se izluči 15% odnosno 18% doze nakon dvosatne intravenske odnosno potkožne primjene.
English: Pull the needle out of the vial.
Croatian: Izvadite iglu iz bočice.
English: Put used syringes into a puncture-proof container and keep it out of the reach and sight of children.
Croatian: Odložite štrcaljke u spremnik otporan na probadanje i čuvajte izvan dohvata i pogleda djece.
English: LITAK has a major effect on the ability to drive and use machines.
Croatian: LITAK značajno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Very common: abnormal breath sounds, abnormal chest sounds, cough
Croatian: Vrlo često: abnormalan šum disanja, abnormalni zvukovi u prsima, kašalj
English: Cytotoxic medicinal products should be handled with caution.
Croatian: S citotoksičnim lijekovima treba oprezno rukovati.
English: You must take adequate contraceptive precautions during therapy and for at least six months after your last LITAK dose.
Croatian: Morate primjenjivati odgovarajuću kontracepcijsku zaštitu tijekom liječenja i najmanje šest mjeseci nakon posljednje doze lijeka LITAK.
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.
Croatian: Kad bolesnik ne daje sam sebi LITAK, preporučuje se uporaba rukavica i zaštitne odjeće za jednokratnu uporabu tijekom rukovanja i primjene lijeka LITAK.
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.
Croatian: Budući da postoji mogućnost ozbiljnih nuspojava u dojenčadi, dojenje je kontraindicirano tijekom liječenja kladribinom i 6 mjeseci nakon posljednje doze kladribina.
English: Tell your doctor immediately if you have any of the following during or after treatment with LITAK: - any signs of infections (such as flu-like symptoms) - fever
Croatian: Ako imate neke od sljedećih simptoma tijekom ili nakon liječenja lijekom LITAK, odmah obavijestite svog liječnika: - ikakve znakove infekcije (kao što su simptomi slični gripi) - vrućicu
English: Very common: nausea, vomiting, constipation, diarrhoea Common: gastrointestinal pain, flatulence Rare: ileus
Croatian: Vrlo često: mučnina, povraćanje, konstipacija, proljev Često: gastrointestinalna bol, flatulencija Rijetko: ileus
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).
Croatian: Umjereno do teško oštećenje funkcije bubrega (klirens kreatinina ≤ 50 ml/min) ili umjereno do teško oštećenje funkcije jetre (Child-Pugh score > 6) (vidjeti dio 4.4).
English: What do I need for the injection?
Croatian: Što mi je potrebno za davanje injekcije?
English: You should not father a child during treatment and up to 6 months after treatment with LITAK.
Croatian: Ne smijete začeti dijete tijekom i do 6 mjeseci nakon liječenja lijekom LITAK.
English: Detailed instructions are contained in the Package Leaflet.
Croatian: Detaljne upute nalaze se u uputi o lijeku.
English: 5 vials each containing 5 ml solution for injection
Croatian: 5 bočica, svaka sadrži 5 ml otopine za injekciju
English: How do I prepare the injection?
Croatian: Kako pripremiti injekciju?
English: However, an in vitro study revealed cross-resistance between cladribine and nitrogen mustard (chlormethine); for cytarabine, one author has described an in vivo cross-reaction without loss of activity.
Croatian: Međutim, ispitivanje in vitro pokazalo je križnu rezistenciju između kladribina i dušikovog plikavca (klormetina), dok jedan autor navodi križnu reakciju kladribina i citarabina in vivo bez gubitka djelovanja.
English: Therefore, simultaneous administration of nucleoside analogues with cladribine is not advisable.
Croatian: Stoga se ne preporučuje istovremena primjena nukleozidnih analoga i kladribina.
English: Remove the syringe from the wrapping without touching the tip of the syringe.
Croatian: Izvadite štrcaljku iz omota bez dodirivanja vrha štrcaljke.
English: Effects on sternal ossification were seen at 1.5 and 3.0 mg/kg/day.
Croatian: Utjecaj na okoštavanje primijećen je za doze od 1,5 i 3,0 mg/kg/dan.
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.
Croatian: Često opaženi simptomi predoziranja su mučnina, povraćanje, proljev, teška depresija koštane srži (uključujući anemiju, trombocitopeniju, leukopeniju i agranulocitozu), akutna bubrežna insuficijencija, kao i ireverzibilna neurološka toksičnost (parapareza/kvadripareza), Guillain-Barréov sindrom i Brown-Séquardov sindrom.
English: In patients with a high tumour burden, prophylactic allopurinol therapy to control serum levels of uric acid, together with adequate or increased hydration, should be commenced 24 hours before the start of chemotherapy.
Croatian: U bolesnika s velikom tumorskom masom, 24 sata prije početka kemoterapije treba započeti s profilaktičkim liječenjem alopurinolom radi kontrole razine mokraćne kiseline u serumu zajedno s odgovarajućom ili povećanom hidracijom.
English: Secondary malignancies are expected to occur in patients with hairy cell leukaemia.
Croatian: Sekundarne zloćudne bolesti očekivana su pojava kod bolesnika s leukemijom vlasastih stanica.
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.
Croatian: Za liječenje leukemije vlasastih stanica preporučuje se jedan ciklus liječenja lijekom LITAK koji se daje supkutanom bolus injekcijom u dnevnoj dozi od 0,14 mg/kg tjelesne težine tijekom 5 uzastopnih dana.
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.
Croatian: Savjetuje se poseban oprez i pažljiva procjena omjera rizika i koristi ako se razmatra primjena kladribina u bolesnika s povećanim rizikom za infekcije, znakovima zatajenja ili infiltracije koštane srži, u bolesnika koji su prethodno primali mijelosupresivnu terapiju, kao i u bolesnika u kojih postoje znakovi ili se sumnja na bubrežnu i jetrenu insuficijenciju.
English: If you are injecting LITAK yourself, first you must receive adequate training by your doctor or nurse.
Croatian: Ako sami ubrizgavate LITAK, liječnik ili medicinska sestra prvo Vam moraju pokazati kako se to radi.
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).
Croatian: Kladribin je predlijek koji nakon parenteralne primjene brzo ulazi u stanice gdje se unutar stanice fosforilira u aktivni nukleotid 2-klorodeoksiadenozin-5'-trifosfat (CdATP) pomoću deoksicitidinkinaze (dCK).
English: There are no studies available using cladribine in patients with renal or hepatic impairment (see also section 4.2 and section 4.4).
Croatian: Nema dostupnih ispitivanja kladribina u bolesnika s oštećenjem funkcije bubrega ili jetre (vidjeti dio 4.2 i 4.4).
English: Blood counts
Croatian: Krvna slika
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.
Croatian: Unutarstanično vrijeme zadržavanja kladribin-nukleotida in vivo je produljeno u odnosu na vrijeme zadržavanja u plazmi: u leukemijskim stanicama izmjeren je početni poluvijek t1/2 od 15 sati i krajnji od 30 sati.
English: An increased incidence of opportunistic infections is expected during, and for 6 months following, therapy with cladribine.
Croatian: Povećana incidencija oportunističkih infekcija očekuje se tijekom liječenja kladribinom i 6 mjeseci nakon liječenja.
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).
Croatian: LITAK je kontraindiciran u bolesnika s umjerenim do teškim oštećenjem funkcije bubrega (klirens kreatinina ≤ 50 ml/min) ili umjerenim do teškim oštećenjem funkcije jetre (Child-Pugh score > 6) (vidjeti dijelove 4.3, 4.4 i 5.2).
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.
Croatian: Ostali rijetki slučajevi sa smrtnim ishodom zabilježeni u vezi s kemoterapijom lijekom LITAK bili su sekundarne zloćudne bolesti, moždani i kardiovaskularni infarkti, reakcija presatka protiv domaćina uzrokovana brojnim transfuzijama neozračene krvi, kao i sindrom lize tumora s hiperuricemijom, metaboličkom acidozom i akutnim zatajenjem bubrega.
English: Men being treated with cladribine should be advised not to father a child up to 6 months after treatment and to seek advice of cryoconservation of sperm prior to treatment because of the possibility of infertility due to therapy with cladribine (see section 4.4).
Croatian: Muškarci koji se liječe kladribinom ne bi smjeli začeti dijete do 6 mjeseci nakon liječenja te mogu potražiti savjet o kriokonzervaciji sperme prije liječenja, budući da liječenje kladribinom može uzrokovati neplodnost (vidjeti dio 4.4).
English: LITAK should warm up to room temperature prior to administration.
Croatian: Prije primjene LITAK treba ugrijati do sobne temperature.
English: Cladribine is a cytotoxic medicinal product, which is mutagenic to cultured mammalian cells.
Croatian: Kladribin je citotoksični lijek, mutagen za kulture stanica sisavaca.
English: Where should I give my injection?
Croatian: Gdje treba dati injekciju?
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.
Croatian: Ozbiljne nuspojave poput ileusa, teškog zatajenja jetre, zatajenja bubrega, srčanog zatajenja, atrijske fibrilacije, srčane dekompenzacije, apopleksije, neuroloških smetnji u govoru i gutanju, sindroma lize tumora s akutnim bubrežnim zatajenjem, s transfuzijom povezane reakcije presatka protiv domaćina, Steven-Johnsonovog sindroma/Lyellovog sindroma (toksična epidermalna nekroliza), hemolitičke anemije, hipereozinofilije (s eritematoznim kožnim osipom, svrbežom i edemom lica) su rijetke.
English: Common: myalgia, arthralgia, arthritis, bone pain
Croatian: Često: mijalgija, artralgija, artritis, bol u kostima
English: Each ml solution contains 2 mg cladribine.
Croatian: Jedan ml otopine sadrži 2 mg kladribina.
English: Each ml of solution contains 2 mg of cladribine (2-CdA).
Croatian: 1 ml otopine za injekciju sadrži 2 mg kladribina (2-CdA).
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Croatian: Natrijev hidroksid (za podešavanje pH) Kloridna kiselina (za podešavanje pH) Voda za injekcije
English: Very rare: cholecystitis
Croatian: Vrlo rijetko: kolecistitis
English: There are no data on the use of LITAK in patients with renal or hepatic impairment.
Croatian: Nema podataka o primjeni lijeka LITAK u bolesnika s oštećenjem funkcije bubrega ili jetre.
English: Men being treated with cladribine should be advised not to father a child up to 6 months after treatment and to seek advice of cryoconservation of sperm prior to treatment because of the possibility of infertility due to therapy with cladribine (see sections 4.6 and 5.3).
Croatian: Muškarci liječeni kladribinom ne bi smjeli začeti dijete do 6 mjeseci nakon liječenja te mogu potražiti savjet o kriokonzervaciji sperme prije liječenja, budući da liječenje kladribinom može uzrokovati neplodnost (vidjeti dijelove 4.6 i 5.3).
English: Women of childbearing potential must use effective contraception during treatment with cladribine and for 6 months after the last cladribine dose.
Croatian: Žene u reproduktivnoj dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja kladribinom i 6 mjeseci nakon posljednje doze kladribina.
English: Elderly patients should be treated by individual assessment and careful monitoring of the blood counts and of the renal and hepatic function.
Croatian: Starije bolesnike treba liječiti prema procjeni svakog zasebnog slučaja, te je potrebno pažljivo praćenje krvne slike i funkcije bubrega i jetre.
English: Heart failure.
Croatian: Srčani poremećaji
English: LITAK contains the active substance cladribine.
Croatian: LITAK sadrži djelatnu tvar kladribin.
English: Very common: injection site reactions, fever, fatigue, chills, asthenia
Croatian: Vrlo često: reakcije na mjestu primjene injekcije, vrućica, umor, zimica, astenija
English: Contains sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injections
Croatian: Sadrži natrijev klorid, natrijev hidroksid (za podešavanje pH), kloridnu kiselinu (za podešavanje pH) i vodu za injekcije
English: Long-term studies in animals to evaluate the carcinogenic potential of cladribine have not been conducted.
Croatian: Nisu provedena dugoročna ispitivanja kancerogenosti kladribina u životinja.
English: Common: shortness of breath, pulmonary interstitial infiltrates mostly due to infectious aetiology, mucositis Uncommon: pharyngitis
Croatian: Često: nedostatak zraka, plućni intersticijski infiltrati uglavnom infektivne etiologije, mukozitis Manje često: faringitis
English: Adverse reactions that have been reported are listed in the table below by frequency category and system organ class.
Croatian: Nuspojave koje su bile prijavljene navedene su u sljedećoj tablici prema prikazu učestalosti nuspojava i klasifikaciji organskih sustava.
English: LITAK 2 mg/ml solution for injection
Croatian: LITAK 2 mg/ml otopina za injekciju
English: Store in a refrigerator
Croatian: Čuvati u hladnjaku Ne zamrzavati.
English: Very rare: lung embolism
Croatian: Vrlo rijetko: plućna embolija
English: You must not breast-feed while you are treated with LITAK and for at least six months after your last LITAK dose.
Croatian: Ne smijete dojiti tijekom liječenja lijekom LITAK i najmanje šest mjeseci nakon posljednje doze lijeka LITAK.
English: Each vial contains 10 mg of cladribine in 5 ml of solution.
Croatian: Jedna bočica sadrži 10 mg kladribina u 5 ml otopine.
English: 1 vial containing 5 ml solution for injection
Croatian: 1 bočica sadrži 5 ml otopine za injekcije
English: LITAK is supplied as a ready-to-use solution for injection.
Croatian: LITAK dolazi u obliku otopine za injekciju spremne za primjenu.
English: LITAK is contraindicated in patients with moderate to severe renal impairment or with moderate to severe hepatic impairment (see section 4.3).
Croatian: LITAK je kontraindiciran u bolesnika s umjerenim do teškim oštećenjem funkcije bubrega ili jetre (vidjeti dio 4.3).
English: Very common: rash, localised exanthema, diaphoresis Common: pruritus, skin pain, erythema, urticaria Rare: Stevens-Johnson syndrome/Lyell syndrome
Croatian: Poremećaji kože i potkožnog tkiva Vrlo često: osip, lokalizirani egzantem, dijaforeza Često: pruritus, kožna bol, eritem, urtikarija Rijetko: Stevens-Johnsonov sindrom /Lyellov sindrom
English: LITAK 2 mg/ml solution for injection cladribine
Croatian: LITAK 2 mg/ml otopina za injekciju kladribin
English: Push the needle through the rubber stopper of the vial and turn the vial and the syringe upside down.
Croatian: Gurnite iglu kroz gumeni čep bočice i preokrenite bočicu i štrcaljku.
English: Your must not use LITAK if you are pregnant.
Croatian: Ako ste trudni, ne smijete primjenjivati LITAK.