FrancophonIA/ELRC3.0 huggingface dataset:
English: Fasturtec is to be used immediately prior to and during the initiation of chemotherapy only, as at the present, there is insufficient data to recommend multiple treatment courses.
Croatian: Fasturtec se primjenjuje samo neposredno prije i tijekom uvođenja kemoterapije, s obzirom da trenutno nema dovoljno podataka koji bi podržali višekratno ponavljanje terapije.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 February 2001
Croatian: Datum prvog odobrenja: 23. veljače 2001.
English: To ensure accurate measurement of uric acid plasma level during treatment with Fasturtec, a strict sample handling procedure must be followed (see section 6.6).
Croatian: Kako bi se osiguralo precizno mjerenje koncentracije mokraćne kiseline u plazmi tijekom liječenja lijekom Fasturtec, mora se strogo poštivati postupak rukovanja uzorcima (vidjeti dio 6.6).
English: In adults (≥ the age of 18 years), age, gender, baseline liver enzymes and creatinine clearance did not impact the pharmacokinetics of rasburicase.
Croatian: U odraslih bolesnika (≥ 18 godina) dob, spol, početne vrijednosti jetrenih enzima i klirens kreatinina nisu utjecali na farmakokinetiku razburikaze.
English: Tumour lysis can also result in hyperphosphataemia, hyperkalaemia and hypocalcaemia.
Croatian: Liza tumora može rezultirati i hiperfosfatemijom, hiperkalijemijom i hipokalcijemijom.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Fasturtec is a recombinant urate-oxidase enzyme produced by genetically modified Saccharomyces cerevisiae strain.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Fasturtec je rekombinantni enzim urat-oksidaza, koji se proizvodi na genetički modificiranom soju Saccharomyces cerevisiae.
English: • difficulty in breathing or swallowing
Croatian: • otežano disanje ili gutanje
English: The reconstituted solution contains no preservative.
Croatian: Rekonstituirana otopina ne sadrži konzervanse.
English: (frequency not known) which may be fatal - low blood pressure (hypotension) - wheezing or difficulty in breathing (bronchospasm) - blood disorders such as a disorder of the blood in which red blood cells are abnormally broken down (haemolysis), destroyed (haemolytic anaemia), or abnormal blood pigment levels
Croatian: (učestalost nepoznata) koji može biti smrtonosan - nizak krvni tlak (hipotenzija) - piskanje u plućima ili otežano disanje (bronhospazam) - poremećaji krvi, kao što je poremećaj kod kojeg se crvene krvne stanice abnormalno razgrađuju
English: Do not use Fasturtec if you: - are allergic (hypersensitive) to rasburicase, other uricases or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Fasturtec: - ako ste alergični (preosjetljivi) na razburikazu, druge urikaze ili neki drugi sastojak ovog lijeka
English: Clinical experience with Fasturtec demonstrates that patients should be closely monitored for the onset of allergic-type undesirable effects, especially severe hypersensitivity reactions including anaphylaxis (see section 4.8).
Croatian: Kliničko iskustvo s lijekom Fasturtec pokazuje da bolesnike treba pomno nadzirati zbog mogućeg nastupa nuspojava alergijskog tipa, posebice teških reakcija preosjetljivosti, uključujući anafilaksiju (vidjeti dio 4.8).
English: Fasturtec should be administered under the supervision of a physician trained in chemotherapy of haematological malignancies.
Croatian: Fasturtec se mora primjenjivati pod nadzorom liječnika obučenog za primjenu kemoterapije u bolesnika s malignim hematološkim bolestima.
English: When chemotherapy is given, cancer cells are destroyed, releasing large amounts of uric acid into the bloodstream.
Croatian: Kod primjene kemoterapije uništavaju se stanice raka, oslobađajući velike količine mokraćne kiseline u krvotok.
English: *One enzyme activity unit (EAU) corresponds to the enzyme activity that converts 1 µmol of uric acid into allantoin per minute under the operating conditions described: +30 °C ± 1 °C TEA pH 8.9 buffer.
Croatian: Enzyme Activity Unit, EAU) odgovara enzimskoj aktivnosti potrebnoj za pretvorbu 1 μmol mokraćne kiseline u alantoin po minuti, uz sljedeće uvjete djelovanja: +30°C ± 1°C, pufer TEA pH 8,9.
English: However, the in-use stability has been demonstrated for 24 hours between +2°C and 8°C.
Croatian: Međutim, stabilnost lijeka u primjeni dokazana je do 24 sata, uz čuvanje na temperaturi od 2°C do 8°C.
English: In case of disorders of the blood in which red blood cells are abnormally broken down (haemolysis) or abnormal blood pigment levels (methaemoglobinaemia), your doctor will immediately and permanently discontinue treatment with Fasturtec.
Croatian: U slučaju krvnih poremećaja kod kojih se crvene krvne stanice prekomjerno razgrađuju (hemoliza) ili dolazi do stvaranja prekomjernih razina krvnog pigmenta (methemoglobinemija), liječnik će Vam odmah i trajno prestati davati Fasturtec.
English: In such case, treatment should immediately and permanently be discontinued and appropriate measures initiated (see section 4.8).
Croatian: U tom se slučaju mora odmah i trajno prekinuti liječenje te započeti s odgovarajućim terapijskim mjerama (vidjeti dio 4.8).
English: * Anaphylactic shock including potential fatal outcome ** From post-marketing experience + Uncommon G3/4 ++ Common G3/4
Croatian: * anafilaktički šok uključujući mogući smrtni ishod ** iskustvo nakon stavljanja lijeka u promet + manje često, stupanj 3/4 ++ često, stupanj 3/4
English: In order to prevent possible haemolytic anaemia induced by hydrogen peroxide, rasburicase is contraindicated in patients with these disorders.
Croatian: Kako bi se spriječila moguća hemolitička anemija uzrokovana vodikovim peroksidom, razburikaza je kontraindicirana u bolesnika s takvim poremećajima.
English: Results from animal studies could not be interpreted due to the presence of endogenous urate oxidase in standard animal models.
Croatian: Rezultati istraživanja na životinjama ne mogu se interpretirati zbog prisutnosti endogene uratne oksidaze u standardnim životinjskim modelima.
English: The concentration of rasburicase in the final solution for infusion depends on the patient's body weight.
Croatian: Koncentracija razburikaze u konačnoj otopini za infuziju ovisi o tjelesnoj težini bolesnika.
English: At 4 hours post first dose, there was a significant difference in the mean percentage change from baseline plasma uric acid concentration (p <0.0001) in the Fasturtec group (86.0%) compared to that for the allopurinol group (-12.1%).
Croatian: 4 sata nakon primjene prve doze zabilježena je značajna razlika u prosječnom postotku promjene koncentracije mokraćne kiseline u plazmi u odnosu na početnu (p < 0,0001) u skupini koja je primala Fasturtec (-86,0%), u usporedbi sa skupinom koja je primala alopurinol (-12,1%).
English: For single-use only, any unused solution should be discarded.
Croatian: Samo za jednokratnu primjenu; neiskorištenu otopinu treba baciti.
English: The duration of treatment with Fasturtec may be up to 7 days, the exact duration should be based upon adequate monitoring of uric acid levels in plasma and clinical judgment.
Croatian: Liječenje lijekom Fasturtec može trajati do 7 dana, a točno trajanje terapije treba odrediti na temelju odgovarajućeg praćenja vrijednosti mokraćne kiseline u plazmi te kliničke prosudbe.
English: Fasturtec is concomitantly administered as supportive care to cytoreductive chemotherapy of advanced malignancies, the causality of adverse events is therefore difficult to assess due to the significant burden of adverse events expected from the underlying disease and its treatment.
Croatian: Fasturtec se kao potporno liječenje primjenjuje istodobno s citoreduktivnom kemoterapijom uznapredovalih malignih bolesti te je, stoga, teško utvrditi uzročnost nuspojava s obzirom na značajan broj nuspojava koje se očekuju zbog postojeće bolesti i njezina liječenja.
English: In turn, this allows efficient excretion of the serum phosphate load preventing further deterioration of renal function from calcium/phosphorus precipitation.
Croatian: To omogućava učinkovito izlučivanje serumskih fosfata, što sprječava daljnje slabljenje funkcije bubrega uzrokovano taloženjem kalcija i fosfora.
English: If you are given more Fasturtec than you should be If it does occur, the doctor will closely monitor the effects on your red blood cells and treat any symptoms that follow.
Croatian: Ako se to dogodi, liječnik će pomno nadzirati učinak lijeka na crvene krvne stanice i liječiti bilo koje simptome koji mogu uslijediti.
English: Rasburicase is produced by genetechnology in a microorganism named Saccharomyces cerevisiae.
Croatian: Razburikaza se proizvodi genskom tehnologijom na mikroorganizmu koji se zove Saccharomyces cerevisiae.
English: No studies on the effects on the ability to drive and use machines have been performed.
Croatian: Nisu provedena ispitivanja o utjecaju na sposobnost upravljanja vozilima i rada sa strojevima.
English: There are no data from the use of rasburicase in pregnant women.
Croatian: Nema podataka o primjeni razburikaze u trudnica.
English: Powder in vial: store in a refrigerator (2°C - 8°C).
Croatian: Prašak u bočici: čuvati u hladnjaku (2°C - 8°C).
English: Rasburicase like other proteins, has the potential to induce allergic responses in humans, such as anaphylaxis, including anaphylactic shock, with potential fatal outcome.
Croatian: Razburikaza, kao i drugi proteini, može prouzročiti alergijske reakcije u ljudi, kao što je anafilaksija, uključujući anafilaktički šok s mogućim smrtnim ishodom.
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji nakon „Rok valjanosti“.
English: The mean volume of distribution ranged from 110 - 127 ml/kg in paediatric patients and from 75.8 to 138 ml/kg in adult patients, respectively, which is comparable to the physiological vascular volume.
Croatian: Prosječan volumen distribucije kreće se u rasponu od 110-127 ml/kg u pedijatrijskih bolesnika, odnosno od 75,8-138 ml/kg u odraslih bolesnika, što je usporedivo s fiziološkim krvožilnim volumenom.
English: Thus patients suspected of receiving an overdose should be monitored for haemolysis, and general supportive measures should be initiated as no specific antidote for Fasturtec has been identified.
Croatian: Stoga, kod sumnje na predoziranje bolesnike treba nadzirati zbog moguće hemolize te započeti s općim potpornim mjerama jer nije poznat specifičan antidot za Fasturtec.
English: The pharmacokinetics of rasburicase were evaluated in both paediatric and adult patients with leukaemia, lymphoma or other haematological malignancies.
Croatian: Farmakokinetika razburikaze ispitana je i u pedijatrijskih i u odraslih bolesnika s leukemijom, limfomom ili drugim malignim hematološkim bolestima.
English: The use of several vials may be necessary to obtain the quantity of rasburicase required for one administration.
Croatian: Možda će biti potrebno upotrijebiti nekoliko bočica lijeka da se dobije količina razburikaze potrebna za jednu primjenu.
English: The interpretation of the non-clinical studies is hampered due to the presence of endogenous urate oxidase in standard animal models.
Croatian: Interpretacija nekliničkih ispitivanja je otežana zbog prisutnosti endogene uratne oksidaze u standardnim životinjskim modelima.
English: The solvent contains no preservative.
Croatian: Otapalo ne sadrži konzervanse.
English: - Muscle contraction involuntary**
Croatian: - nevoljne mišićne kontrakcije*
English: Fasturtec is not recommended in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se primjena lijeka Fasturtec u žena generativne dobi koje ne koriste kontracepciju.
English: If it is necessary to monitor a patient's uric acid level, a strict sample-handling procedure must be followed to minimise ex vivo degradation of the analyte.
Croatian: Ako je neophodno pratiti razinu mokraćne kiseline u bolesnika, mora se strogo poštivati postupak rukovanja uzorcima kako bi se na najmanju moguću mjeru svela degradacija analita ex vivo.
English: Administration of rasburicase does not require any change in the timing or schedule of initiation of cytoreductive chemotherapy.
Croatian: Primjena razburikaze ne zahtijeva promjenu vremena ili plana uvođenja citoreduktivne kemoterapije.
English: For storage conditions after reconstitution or dilution of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja nakon rekonstitucije ili razrjeđivanja lijeka vidjeti u dijelu 6.3.
English: Fasturtec should immediately and permanently be discontinued in patients having developed methaemoglobinaemia, and appropriate measures initiated (see section 4.8).
Croatian: Primjena lijeka Fasturtec mora se odmah i trajno obustaviti u bolesnika u kojih se razvije methemoglobinemija te treba započeti s odgovarajućim terapijskim mjerama (vidjeti dio 4.8).
English: How to use Fasturtec
Croatian: Kako primjenjivati Fasturtec
English: The enzymatic oxidation of uric acid leads to stoichiometric formation of hydrogen peroxide.
Croatian: Enzimska oksidacija mokraćne kiseline dovodi do stehiometrijskog stvaranja vodikova peroksida.
English: Caution should be used in patients with a history of atopic allergies.
Croatian: Oprez je potreban u bolesnika s atopijskim alergijama u povijesti bolesti.
English: Fasturtec has not been investigated in the patients with hyperuricemia in the context of myeloproliferative disorders.
Croatian: Fasturtec nije ispitivan u bolesnika s hiperuricemijom kao posljedicom mijeloproliferativnih poremećaja.
English: sanofi-aventis groupe 54, rue La Boétie F - 75008 Paris France
Croatian: sanofi-aventis groupe 54, rue La Boétie F - 75008 Pariz Francuska
English: NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET sanofi-aventis groupe
English: EXP Use immediately after reconstitution or dilution
Croatian: Upotrijebiti odmah nakon rekonstitucije ili razrjeđivanja.
English: Results showed a significantly more rapid onset of action of Fasturtec in comparison with allopurinol.
Croatian: Rezultati su pokazali da Fasturtec ima značajno brži početak djelovanja nego alopurinol.
English: Add the content of one ampoule of solvent to one vial containing rasburicase and mix by swirling very gently under controlled and validated aseptic conditions.
Croatian: Dodajte sadržaj jedne ampule s otapalom u jednu bočicu s razburikazom i promiješajte laganim kružnim pokretima u kontroliranim i validiranim aseptičkim uvjetima.
English: The solvent is a colourless and clear liquid.
Croatian: Otapalo je bezbojna i bistra tekućina.
English: Rare (may affect up to 1 in 1,000 people): - runny or blocked nose, sneezing, facial pressure or pain (rhinitis).
Croatian: Rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba): - curenje iz nosa ili začepljen nos, kihanje, pritisak ili bol na licu (rinitis).
English: The recommended dose for Fasturtec is 0.20 mg/kg/day.
Croatian: Preporučena doza lijeka Fasturtec je 0,20 mg/kg na dan.
English: Rasburicase is used to treat or prevent high blood levels of uric acid from occurring in adults, children and adolescents (aged 0 to 17 years) with disorders of the blood cells (haematological diseases) who are about to receive or are receiving chemotherapy treatment.
Croatian: Razburikaza se koristi za liječenje ili sprečavanje nastanka visoke razine mokraćne kiseline u krvi odraslih bolesnika, djece i adolescenata (u dobi od 0 do 17 godina) s poremećajem krvnih stanica (hematološkim bolestima), koji trebaju primiti ili primaju kemoterapiju.
English: Infusion: The final solution should be infused over 30 minutes.
Croatian: Infuzija: Konačno pripremljenu otopinu treba primijeniti infuzijom tijekom 30 minuta.
English: Adverse reactions possibly attributable to Fasturtec and reported in the clinical trials, are listed below, by system organ class and by frequency.
Croatian: U nastavku su navedene nuspojave koje je moguće povezati s lijekom Fasturtec, a prijavljene su u kliničkim ispitivanjima, razvrstane prema klasifikaciji organskih sustava i učestalosti.
English: Special populations Renally or hepatically impaired patients: No dose adjustment is necessary.
Croatian: Bolesnici s oštećenjem bubrega ili jetre: nije potrebno prilagođavati dozu.
English: In healthy volunteers, a marked dose-related decrease in plasma uric acid levels was observed across the dose range 0.05 mg/kg to 0.20 mg/kg of Fasturtec.
Croatian: U zdravih dobrovoljaca primijećeno je izrazito, o dozi ovisno, smanjenje razine mokraćne kiseline u plazmi, u rasponu doza od 0,05 mg/kg do 0,20 mg/kg Fasturteca.
English: Because rasburicase may degrade uric acid in vitro, special precautions must be used during sample handling for plasma uric acid measurements, see section 6.6.
Croatian: S obzirom da razburikaza može razgraditi mokraćnu kiselinu in vitro, potreban je poseban oprez pri rukovanju uzorcima za mjerenje mokraćne kiseline u plazmi, vidjeti dio 6.6.
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Croatian: Za uputu o pripremi i razrjeđivanju lijeka prije primjene, vidjeti dio 6.6.
English: In a randomized (1:1:1), multi-center, open-label study, 275 adult patients with leukemia and lymphoma at risk for hyperuricemia and tumour lysis syndrome (TLS) were treated with either rasburicase at a dose of 0.2 mg/kg/day, intravenously, for 5 days (arm A: n=92), rasburicase at a dose of 0.2 mg/kg/day, intravenously, from day 1 through day 3 followed by oral allopurinol at a dose of 300 mg once a day from day 3 through day 5 (overlap on day 3: rasburicase and allopurinol administered approximately 12 hours apart) (arm B: n=92), or oral allopurinol at a dose of 300 mg once a day for 5 days (arm C: n=91).
Croatian: U randomiziranom (1:1:1), multicentričnom, otvorenom ispitivanju je 275 odraslih bolesnika s leukemijom ili limfomom te rizikom za razvoj hiperuricemije i sindroma lize tumora liječeno razburikazom u dozi od 0,2 mg/kg na dan, intravenski tijekom 5 dana (skupina A: n=92), razburikazom u dozi od 0,2 mg/kg na dan, intravenski od 1. do 3. dana, a zatim alopurinolom u peroralnoj dozi od 300 mg jedanput na dan od 3. do 5. dana (preklapanje 3. dana: razburikaza i alopurinol primijenjeni su u razmaku od približno 12 sati) (skupina B: n=92), ili alopurinolom u peroralnoj dozi od 300 mg jedanput na dan tijekom 5 dana (skupina C: n=91).
English: Treatment and prophylaxis of acute hyperuricaemia, in order to prevent acute renal failure, in adults, children and adolescents (aged 0 to 17 years) with haematological malignancy with a high tumour burden and at risk of a rapid tumour lysis or shrinkage at initiation of chemotherapy.
Croatian: Liječenje i profilaksa akutne hiperuricemije radi prevencije akutnog zatajenja bubrega u odraslih bolesnika te djece i adolescenata (u dobi od 0 do 17 godina) s malignim hematološkim bolestima s velikim tumorskim opterećenjem, u kojih na početku kemoterapije postoji rizik od ubrzane lize ili smanjenja tumora.
English: In addition this rapid control of uric acid in this population is accompanied by improvements in renal function.
Croatian: Osim toga, u toj populaciji navedenu brzu kontrolu mokraćne kiseline prati i poboljšanje bubrežne funkcije.
English: The acute increase in plasma levels of uric acid subsequent to the lysis of large numbers of malignant cells and during cytoreductive chemotherapy may lead to impairment of renal function and renal failure resulting from the precipitation of crystals of uric acid in renal tubules.
Croatian: Akutni porast koncentracije mokraćne kiseline u plazmi nakon lize velikog broja malignih stanica i tijekom citoreduktivne kemoterapije može dovesti do oštećenja bubrežne funkcije i zatajenja bubrega, kao posljedice nakupljanja kristala mokraćne kiseline u bubrežnim tubulima.
English: In a randomised comparative phase III study, performed in 52 paediatric patients, 27 patients were treated with rasburicase at the recommended dose of 0.20 mg/kg/day, intravenously, for 4 to 7 days (< 5 years: n=11; 6-12 years: n=11; 13-17 years: n=5), and 25 patients with allopurinol daily oral doses for 4 to 8 days.
Croatian: U randomiziranom komparativnom ispitivanju faze III, provedenom na 52 pedijatrijska bolesnika, 27 bolesnika je primalo terapiju razburikazom u preporučenoj dozi od 0,20 mg/kg/dan intravenski, tijekom 4 do 7 dana (< 5 godina: n=11; 6-12 godina: n=11; 13-17 godina: n=5), a 25 bolesnika primalo je alopurinol u dnevnim oralnim dozama tijekom 4 do 8 dana.
English: Powder and solvent for concentrate for solution for infusion (powder for sterile concentrate).
Croatian: Prašak i otapalo za koncentrat za otopinu za infuziju (prašak za sterilni koncentrat).
English: Rasburicase solution should be infused through a different line than that used for infusion of chemotherapeutic agents to prevent any possible drug incompatibility.
Croatian: Infuzijsku otopinu razburikaze treba primijeniti putem infuzijske linije različite od one kojom se daju kemoterapijski lijekovi, kako bi se spriječila moguća inkompatibilnost lijekova.
English: Common side effects (may affect up to 1 in 10 people): - allergic reactions, mainly rashes and urticaria.
Croatian: Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba): - alergijske reakcije, uglavnom osipi i koprivnjača.
English: After reconstitution, 1 ml of Fasturtec concentrate contains 1.5 mg rasburicase.
Croatian: Nakon rekonstitucije, 1 ml koncentrata lijeka Fasturtec sadrži 1,5 mg razburikaze.
English: Paediatric population As no adjustment is necessary, the recommended dose is 0.20 mg/kg/day.
Croatian: S obzirom da nije potrebno prilagođavati dozu, preporučena doza iznosi 0,20 mg/kg na dan.
English: In long term safety studies, an analysis of data from 867 paediatric patients (mean age 7.3 years, range 0 to17) treated with rasburicase at 0.20 mg/kg/day for 1 to 24 days (mainly 1 to 4 days) showed consistent findings with pivotal clinical studies in terms of efficacy and safety.
Croatian: U dugoročnim ispitivanjima sigurnosti primjene, rezultati analize podataka za 867 pedijatrijskih bolesnika (prosječna dob 7,3 godina, raspon od 0 do 17 godina) liječenih razburikazom u dozi od 0,20 mg/kg na dan tijekom 1 do 24 dana (većinom 1 do 4 dana) bili su sukladni rezultatima ključnih kliničkih ispitivanja u pogledu djelotvornosti i sigurnosti primjene.
English: After infusion of rasburicase at a dose of 0.20 mg/kg/day, steady state is achieved at day 2 - 3.
Croatian: Nakon infuzije razburikaze u dozi od 0,20 mg/kg na dan stanje dinamičke ravnoteže postiže se 2. ili 3. dana.
English: In view of the mechanism of action of Fasturtec, an overdose will lead to low or undetectable plasma uric acid concentrations and increased production of hydrogen peroxide.
Croatian: S obzirom na mehanizam djelovanja lijeka Fasturtec, predoziranje dovodi do male ili nemjerljive koncentracije mokraćne kiseline u plazmi te povećanog stvaranja vodikova peroksida.
English: Marketing Authorisation Holder sanofi-aventis groupe 54, rue La Boétie F-75008 Paris France
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet sanofi-aventis groupe 54, rue La Boétie F-75008 Pariz Francuska
English: Fasturtec works by allowing uric acid to more easily be removed from the body by the kidneys.
Croatian: Fasturtec djeluje tako da omogućuje lakše uklanjanje mokraćne kiseline iz tijela putem bubrega.
English: Uncommon side effects (may affect up to 1 in 100 people): - severe hypersensitivity reactions, such as anaphylaxis (rare) including anaphylactic shock
Croatian: Manje česte nuspojave (mogu se javiti u manje od 1 na 100 osoba): - teške reakcije preosjetljivosti, kao što je anafilaksija (rijetko) uključujući i anafilaktički šok
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 7.5 mg
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 7,5 mg
English: Anti-rasburicase antibodies have been detected in treated patients and healthy volunteers administered rasburicase.
Croatian: Protutijela na razburikazu utvrđena su u liječenih bolesnika i zdravih dobrovoljaca koji su primili razburikazu.