FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Zdravljenje in preventiva akutne hiperurikemije z namenom preprečevanja akutne okvare ledvic pri odraslih, otrocih in mladostnikih (starih od 0 do 17 let) s hematološkimi malignimi obolenji z visoko tumorsko obremenitvijo in s tveganjem za hiter razkroj tumorja ali njegovo zmanjšanje po pričetku kemoterapije.
English: Paediatric population As no adjustment is necessary, the recommended dose is 0.20 mg/kg/day.
Slovenian: Pediatrična populacija Prilagoditev odmerka ni potrebna, zato je priporočen odmerek 0,20 mg/kg/dan.
English: The powder is an entire or broken white to off white pellet.
Slovenian: Prašek je iz belih do belkastih celih ali zdrobljenih pelet.
English: The uric acid response rate (proportion of patients with plasma uric acid levels ≤7.5 mg/dl from day 3 to day 7 after initiation of antihyperuricemic treatment) was 87% in arm A, 78% in arm B, and 66% in arm C. The response rate in arm A was significantly greater than in arm C (p=0.0009); the response rate was higher for arm B compared to arm C although this difference was not statistically significant.
Slovenian: Delež odziva sečne kisline (delež bolnikov s plazemskimi nivoji sečne kisline ≤7,5 mg/dl od dneva 3 do dneva 7 po začetku antihiperurikemičnega zdravljenja) je bila 87% v skupini A, 78% v skupini B in 66% v skupini C. Delež odziva v skupini A je bila signifikantno višja kot v skupini C (p=0,0009); stopnja odziva v skupini B je bila višja kot v skupini C, vendar razlika ni bila statistično signifikantna.
English: The recommended dose for Fasturtec is 0.20 mg/kg/day.
Slovenian: Priporočen odmerek zdravila Fasturtec je 0,20 mg/kg/dan.
English: Tumour lysis can also result in hyperphosphataemia, hyperkalaemia and hypocalcaemia.
Slovenian: Razkroj tumorjev lahko povzroči tudi hiperfosfatemijo, hiperkalemijo in hipokalcemijo.
English: The reconstituted solution contains no preservative.
Slovenian: Rekonstituirana raztopina ne vsebuje konzervansov.
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.
Slovenian: Glede na mehanizem delovanja zdravila Fasturtec, bi preveliko odmerjanje povzročilo nizke do nedoločljivo nizke koncentracije sečne kisline v plazmi in povečano nastajanje vodikovega peroksida.
English: Results from animal studies could not be interpreted due to the presence of endogenous urate oxidase in standard animal models.
Slovenian: Rezultatov študij na živalih ni moč interpretirati zaradi prisotnosti endogene uratne oksidaze v standardnih živalskih modelih.
English: The required volume of the reconstituted solution depends on the patient's body weight.
Slovenian: Potrebni volumen rekonstituirane raztopine je odvisen od telesne mase bolnika.
English: Samples must be immersed in an ice/water bath.
Slovenian: Vzorce morate potopiti v kopel z ledom in vodo.
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.
Slovenian: Povprečni volumen porazdelitve pri bolnikih je bil 110 - 127 ml/kg pri pediatričnih bolnikih in 75,8 do 138 ml/kg pri odraslih bolnikih, kar je primerljivo z normalnim žilnim volumnom.
English: • rash, itching or hives (nettle-type rash) on the skin
Slovenian: • izpuščaj, srbenje ali koprivnica (urtikarija) na koži
English: Results showed a significantly more rapid onset of action of Fasturtec in comparison with allopurinol.
Slovenian: Rezultati so pokazali bistveno hitrejši pričetek učinka pri zdravilu Fasturec kot pri alopurinolu.
English: A cross-study comparison revealed that after administration of rasburicase at 0.15 or 0.20 mg/kg, the geometric mean values of body-weight normalized clearance were approximately 40% lower in Japanese (n=20) than that in Caucasians (n=26).
Slovenian: Navzkrižna primerjalna študija je pokazala, da je po jemanju razburikaze v odmerku 0,15 ali 0,20 mg/kg, geometrična srednja vrednost očistka normaliziranega na telesno maso pri Japoncih (n=20) približno 40% nižja, kot pri kavkazijcih.
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%).
Slovenian: 4 ure po prvem odmerku je obstajala statistično značilna razlika v spremembi srednje vrednosti izhodiščne koncentracije sečne kisline v plazmi (p < 0,0001) med skupinama bolnikov, ki so prejemali zdravilo Fasturtec (-86,0 %) in alopurinol (-12,1 %).
English: Only clear and colourless solutions without particles should be used.
Slovenian: Uporabite lahko samo bistro in brezbarvno raztopino brez delcev.
English: Powder in vial: store in a refrigerator (2°C - 8°C).
Slovenian: Prašek v viali: Shranjujte v hladilniku (2 C - 8 C).
English: What Fasturtec looks like and contents of the pack
Slovenian: Izgled zdravila Fasturtec in vsebina pakiranja
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
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.
Slovenian: Pri zdravih prostovoljcih so opazili izrazito odvisnost zmanjšanja ravni sečne kisline v plazmi od odmerka, pri odmerkih od 0,05 mg/kg do 0,20 mg/kg zdravila Fasturtec.
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.
Slovenian: Akutno povečanje koncentracije sečne kisline v plazmi, do katerega pride po razkroju velikega števila rakastih celic in med citoreduktivno kemoterapijo, lahko povzroči okvaro ledvične funkcije in odpoved ledvic zaradi obarjanja kristalov sečne kisline v ledvičnih tubulih.
English: Fasturtec should be administered under the supervision of a physician trained in chemotherapy of haematological malignancies.
Slovenian: Bolnik mora jemati zdravilo Fasturtec pod nadzorom zdravnika specialista za kemoterapijo hematoloških malignih obolenj.
English: sanofi-aventis groupe 54, rue La Boétie F - 75008 Paris France
Slovenian: sanofi-aventis groupe 54, rue La Boétie F - 75008 Paris Francija
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
English: As metabolism is expected to occur by peptide hydrolysis, an impaired liver function is not expected to affect the pharmacokinetics.
Slovenian: Razgradnja naj bi potekala s hidrolizo peptidov, zato ne pričakujemo, da bi zmanjšano delovanje jeter vplivalo na farmakokinetiko.
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).
Slovenian: V randomizirani (1:1:1), multicentrični, odprti študiji, je 275 odraslih bolnikov z levkemijo in limfomom s tveganjem za hiperurikemijo in sindrom lize tumorja (tumour lysis syndrome (TLS)) prejemalo bodisi razburikazo v odmerku 0,2 mg/kg/dan intravenozno 5 dni (skupina A: n=92), razburikazo v odmerku 0,2 mg/kg/dan intravenozno, od dneva 1 do dneva 3, ki ji je sledil alopurinol peroralno v odmerku 300 mg enkrat dnevno, od dneva 3 do dneva 5 (prekrivanje na dan 3: odmerka razburikaze in alopurinola si sledita na približno 12 ur) (skupina B: n=92), ali alopurinol peroralno v odmerku 300 mg enkrat dnevno 5 dni (skupina C: n=91).
English: In addition this rapid control of uric acid in this population is accompanied by improvements in renal function.
Slovenian: Poleg tega je hitro uravnavanje koncentracije sečne kisline pri teh bolnikih spremljalo izboljšanje delovanja ledvic.
English: Fasturtec is provided as a powder for concentrate for solution for infusion (powder for sterile concentrate) with a solvent.
Slovenian: Fasturtec je na voljo kot prašek za koncentrat za raztopino za infundiranje (prašek za sterilni koncentrat) z vehiklom.
English: For storage conditions after reconstitution or dilution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja po rekonstituciji ali redčenju zdravila glejte poglavje 6.3.
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.
Slovenian: Če morate nadzorovati raven sečne kisline pri bolniku, morate upoštevati stroga navodila za ravnanje z vzorci, da bi na najmanjšo mero zmanjšali možnosti ex vivo razgradnje analita.
English: België/Belgique/Belgien Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00
Slovenian: België /Belgique/Belgien Sanofi-aventis Belgium Tél/Tel: +32 (0)2 710 54 00
English: Uric acid levels were <2 mg/dl in 96% of patients in the two arms containing rasburicase and 5% of patients in the allopurinol arm at 4 hours of the day 1 dose.
Slovenian: Nivoji sečne kisline so bili v 4 urah po odmerku na dan 1, <2 mg/dl pri 96% bolnikov v obeh skupinah, ki je prejemala razburikazo in pri 5% bolnikov v skupini, ki je prejemala alopurinol.
English: The enzymatic oxidation of uric acid leads to stoichiometric formation of hydrogen peroxide.
Slovenian: Encimatska oksidacija sečne kisline povzroča stehiometrični nastanek vodikovega peroksida.
English: If you suddenly notice: - a swelling of the face, lips, tongue or other part of your body - a shortness of breath, wheezing or breathing problems - a rash, itching or hives
Slovenian: Če nenadoma opazite: - zatekanje obraza, ustnic, jezika ali drugih delov telesa - kratko sapo, sopenje ali težave pri dihanju - izpuščaj, srbečico ali koprivnico to nemudoma povejte zdravniku, medicinski sestri ali bolnišničnemu farmacevtu, saj so to lahko znaki hude alergijske reakcije (anafilaksa).
English: Danmark sanofi-aventis Denmark A/S Tlf: +45 45 16 70 00
Slovenian: Nederland sanofi-aventis Denmark A/S Tlf: +45 45 16 70 00
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.
Slovenian: V primerjalni randomizirani študiji tretje faze delani pri 52 pediatričnih bolnikih, so pri 27 bolnikih, ki so bili zdravljeni z razburikazo uporabili priporočene odmerke 0,20 mg/kg/dan, intravensko, od 4 do 7 dni (<5 let: n=11, 6-12 let, n=11; 13-17 let: n=5) in 25 bolnikov z dnevno dozo alopurinola od 4 do 8 dni.
English: Rasburicase is a highly potent uricolytic agent that catalyses enzymatic oxidation of uric acid into allantoin, a water soluble product, easily excreted by the kidneys in the urine.
Slovenian: Razburikaza je zelo močna urikolitična učinkovina, ki katalizira encimatsko oksidacijo sečne kisline v alantoin, vodotopno snov, ki jo ledvice zlahka izločajo v urinu.
English: Luxembourg/Luxemburg Sanofi Belgium
Slovenian: Luxembourg/Luxemburg Sanofi-aventis Belgium
English: Hydrogen peroxide is a by-product of the conversion of uric acid to allantoin.
Slovenian: Vodikov peroksid je stranski produkt spreminjanja sečne kisline v alantoin.
English: Marketing Authorisation Holder sanofi-aventis groupe 54, rue La Boétie F-75008 Paris France
Slovenian: Imetnik dovoljenja za promet z zdravilom sanofi-aventis groupe 54, rue La Boétie F-75008 Paris Francija
English: Administration of Fasturtec reduces the uric acid levels to below normal levels and by this mechanism reduces the chance of development of renal failure due to precipitation of uric acid crystals in renal tubules as a consequence of hyperuricaemia.
Slovenian: Uporaba zdravila Fasturtec zmanjša raven sečne kisline pod normalne vrednosti in na ta način zmanjša možnost razvoja okvare ledvic, do katere bi prišlo zaradi prisotnosti kristalov sečne kisline v ledvičnih tubulih kot posledica hiperurikemije.
English: In such case, treatment should immediately and permanently be discontinued and appropriate measures initiated (see section 4.8).
Slovenian: V takih primerih morate takoj ukiniti zdravljenje z zdravilom Fasturtec in ustrezno zdraviti neželene učinke (glejte poglavje 4.8).
English: After infusion of rasburicase at a dose of 0.20 mg/kg/day, steady state is achieved at day 2 - 3.
Slovenian: Po infuziji razburikaze v odmerku 0,20 mg/kg/dan se vzpostavi stanje dinamičnega ravnovesja 2.- 3. dan.
English: Common side effects (may affect up to 1 in 10 people): - allergic reactions, mainly rashes and urticaria.
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): - alergijske reakcije, večinoma izpuščaji in koprivnica.
English: The interpretation of the non-clinical studies is hampered due to the presence of endogenous urate oxidase in standard animal models.
Slovenian: Rezultate predkliničnih študij je težko tolmačiti zaradi prisotnosti endogene urat-oksidaze pri standardnih živalskih modelih.
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.
Slovenian: Razburikazo uporabljamo za zdravljenje ali preprečevanje visoke ravni sečne kisline v krvi, ki se pojavi pri odraslih, otrocih in mladostnikih (starih od 0 do 17 let) z boleznimi krvnih celic (hematološka obolenja), ki bodo ali so že pričeli s kemoterapijo.
English: Driving and using machines No information on the ability to drive and use machines is available.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Podatkov o vplivu na sposobnost upravljanja vozil in strojev ni na voljo.
English: In pivotal clinical studies, 246 paediatric patients ( mean age 7 years, range 0 to17) were treated with rasburicase at doses of 0.15 mg/kg/day or 0.20 mg/kg/day for 1 to 8 days (mainly 5 to 7 days).
Slovenian: V ključnih kliničnih študijah so 246 pediatričnih bolnikov (povprečna starost 7 let, v obdobju 0 do 17) zdravili z razburikazo v odmerkih 0,15 mg/kg/dan ali 0,20 mg/kg/dan od 1 do 8 dni (v glavnem od 5 do 7 dni).
English: Uncommon side effects (may affect up to 1 in 100 people): - severe hypersensitivity reactions, such as anaphylaxis (rare) including anaphylactic shock
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): - hude preobčutljivostne reakcije, kot je anafilaksija (redko), vključno z anafilaktičnim šokom
English: - have a history of haemolytic anaemia (an illness caused by red blood cells being abnormally broken down).
Slovenian: - imeli ali imate hemolitično anemijo (bolezen, ki nastane zaradi nenormalne razgradnje rdečih krvnih celic).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 7.5 mg
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 7,5 mg
English: Solvent: poloxamer 188, water for injection.
Slovenian: Vehikel: poloksamer 188, voda za injekcije.
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.
Slovenian: Natančen čas zdravljenja določimo na podlagi ustreznega kontroliranja ravni sečne kisline v plazmi in klinične presoje.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for concentrate for solution for infusion 3 vials and 3 ampoules
Slovenian: FARMACEVTSKA OBLIKA IN VSEBNOST Prašek in vehikel za koncentrat za raztopino za infundiranje 3 viale in 3 ampule
English: The mean terminal half-life was similar between paediatric and adult patients and ranged from 15.7 to 22.5 hours.
Slovenian: Očistek razburikaze je bil približno 3,5 ml/h/kg, povprečni razpolovni čas pa je bil podoben v pediatrični in v populaciji odraslih bolnikov in sicer od 15,7 do 22,5 ur.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for concentrate for solution for infusion 1 vial and 1 ampoule
Slovenian: FARMACEVTSKA OBLIKA IN VSEBNOST Prašek in vehikel za koncentrat za raztopino za infundiranje 1 viala in 1 ampula
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1.5 mg
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1,5 mg
English: Caution should be used in patients with a history of atopic allergies.
Slovenian: Posebej morate biti previdni pri bolnikih, ki so v preteklosti že imeli atopične alergije.
English: Fasturtec works by allowing uric acid to more easily be removed from the body by the kidneys.
Slovenian: Fasturtec deluje tako, da olajša izločanje sečne kisline iz telesa preko ledvic.
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.
Slovenian: Razburikaza lahko razgradi sečno kislino in vitro, zato morate biti dodatno pozorni pri ravnanju z vzorci za meritve sečne kisline v plazmi; glejte poglavje 6.6.
English: Powder and solvent for concentrate for solution for infusion (powder for sterile concentrate).
Slovenian: Prašek in vehikel za koncentrat za raztopino za infundiranje (prašek za sterilen koncentrat).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo morebitnih tveganj za človeka.
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.
Slovenian: V dolgoročnih študijah varnosti so se rezultati o učinkovitosti in varnosti iz analize podatkov 867 pediatričnih bolnikov ( povprečna starost 7,3 let), ki so dobivali razburikazo v odmerku 0,20 mg/kg/dan od 1 do 24 dni (v glavnem od 1 do 4 dni), skladali z izsledki ključnih kliničnih študij.
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.
Slovenian: Dodajte ampulo vehikla v vialo z razburikazo in nežno mešajte z vrtenjem v validiranih aseptičnih pogojih.
English: Rasburicase is produced by genetechnology in a microorganism named Saccharomyces cerevisiae.
Slovenian: Razburikazo proizvaja mikroorganizem po imenu Saccharomyces cerevisiae v gensko-tehnološkem postopku.
English: Powder: alanine mannitol disodium phosphate dodecahydrate disodium phosphate dihydrate sodium dihydrogen phosphate dihydrate
Slovenian: Prašek: alanin manitol natrijev hidrogenfosfat dodekahidrat natrijev hidrogenfosfat dihidrat natrijev dihidrogenfosfat dihidrat
English: Fasturtec is administered as a once daily 30 minute intravenous infusion in 50 ml of a sodium chloride 9 mg/ml (0.9%) solution (see section
Slovenian: Fasturtec se uporablja kot ena intravenska infuzija dnevno v trajanju 30 minut, in sicer v 50 ml 0,9-odstotne raztopine natrijevega klorida (9 mg/ml) (glejte poglavje 6.6).
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Boolezni dihal, prsnega koša in mediastinalneg a prostora
English: G6PD deficiency and other cellular metabolic disorders known to cause haemolytic anaemia.
Slovenian: Pomanjkanje glukoza-6-fosfat dehidrogenaze in vse ostale okvare celičnega metabolizma, ki povzročajo hemolitično anemijo.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Fasturtec is a recombinant urate-oxidase enzyme produced by genetically modified Saccharomyces cerevisiae strain.
Slovenian: Fasturtec je rekombinantni encim urat-oksidaza, ki ga proizvaja gensko spremenjen sev kvasovke Saccharomyces cerevisiae.
English: Tabulated list of adverse reactions MedDRA Organ system classes
Slovenian: Preglednica neželenih učinkov MedDRA Organski sistemi
English: Fasturtec is supplied as a pack of:
Slovenian: Fasturtec je pakiran v škatlice, ki vsebujejo:
English: - Anaphylaxis - Anaphylactic shock*
Slovenian: - anafilaksija - anafilaktični šok*
English: METHODS AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/170/001-002
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/170/001-002
English: - The other ingredients of the solvent are: poloxamer 188, water for injection.
Slovenian: - Pomožne snovi vehikla so: poloksamer 188, voda za injekcije.
English: After reconstitution, 1 ml of Fasturtec concentrate contains 1.5 mg rasburicase.
Slovenian: Po rekonstituciji vsebuje 1 ml koncentrata Fasturteca 1,5 mg razburikaze.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/170/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/170/001
English: Reconstitution required with the entire contents of the 5 ml solvent ampoule Intravenous use
Slovenian: Za rekonstitucijo morate porabiti celotno vsebino 5 ml ampule z vehiklom Intravenska uporaba
English: When chemotherapy is given, cancer cells are destroyed, releasing large amounts of uric acid into the bloodstream.
Slovenian: Rakaste celice, ki se razkrojijo med kemoterapijo, v krvni obtok sproščajo velike količine sečne kisline.
English: Renal elimination of rasburicase is considered to be a minor pathway for rasburicase clearance.
Slovenian: Izločanje skozi ledvice je manj pomembna pot očistka razburikaze.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/170/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA ZA PROMET EU/1/00/170/002
English: Fasturtec should immediately and permanently be discontinued in patients having developed methaemoglobinaemia, and appropriate measures initiated (see section 4.8).
Slovenian: Pri bolnikih, pri katerih se razvije methemoglobinemija, morate takoj ukiniti zdravljenje in uporabiti ustrezne ukrepe (glejte poglavje 4.8).
English: In clinical trials, haematological disorders such as haemolysis, haemolytic anaemia and methaemoglobinaemia are uncommonly caused by Fasturtec.
Slovenian: V kliničnih preskušanjih Fasturtec občasno povzroča hematološke motnje, kot sta hemoliza, hemolitična anemija in methemoglobinemija.
English: NAME OF THE MEDICINAL PRODUCT Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion.
Slovenian: IME ZDRAVILA Fasturtec 1,5 mg/ml prašek in vehikel za koncentrat za raztopino za infundiranje.
English: Fasturtec must be reconstituted with the entire volume of the supplied solvent (e.g. 1.5 mg rasburicase vial to be reconstituted with the 1 ml solvent ampoule; 7.5 mg rasburicase vial to be reconstituted with the 5 ml solvent ampoule).
Slovenian: Fasturtec je potrebno rekonstituirati s celotnim volumnom priloženega vehikla (npr. vialo z 1,5 mg razburikaze morate rekonstituirati z 1 ml ampulo vehikla; vialo s 7,5 mg razburikaze morate rekonstituirati s 5 ml ampulo vehikla).