natgillin/translations-raw huggingface dataset:
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.
V primeru bolezni krvi, pri katerih pride do nenormalne razgradnje rdečih krvnih celic (hemoliza) ali nenormalnih vrednosti krvnih barvil (methemoglobinemija), vam bo vaš zdravnik nemudoma in za stalno ukinil zdravljenje z zdravilom Fasturtec.
Adverse reactions possibly attributable to Fasturtec and reported in the clinical trials, are listed below, by system organ class and by frequency.
Neželeni učinki , ki bi jih lahko pripisali zdravilu Fasturtec in o katerih so poročali v kliničnih preskušanjih, so glede na organske sisteme in pogostnost navedeni spodaj.
• coughing or wheezing
• kašelj ali piskanje
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IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM sanofi-aventis groupe
Tell your doctor if you have ever had any allergic type reactions due to other medicines; Fasturtec can cause allergic-type reactions, such as severe anaphylaxis including anaphylactic shock (sudden lifethreatening or fatal allergic reactions).
Obvestite svojega zdravnika, če ste kadarkoli ob uporabi drugih zdravil imeli kakršnokoli alergijsko reakcijo: zdravilo Fasturtec lahko izzove alergijske reakcije, kot je anafilaksija, vključno z anafilaktičnim šokom (nenadna, življensko nevarna ali smrtna alergijska reakcija).
How to use Fasturtec
Kako uporabljati zdravilo Fasturtec
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preobčutljivost za zdravilno učinkovino ali katerokoli izmed pomožnih snovi navedeno v poglavju 6.1.
What you need to know before you are given Fasturtec
Kaj morate vedeti, preden boste uporabili zdravilo Fasturtec
The most commonly reported adverse reactions were nausea, vomiting, headache, fever, and diarrhea.
Najbolj pogosto poročani neželeni učinki so bili: slabost, bruhanje, glavobol, povišana telesna temperatura in driska.
Time to first confirmation of normal levels of uric acid in hyperuricaemic patients is four hours for Fasturtec and 24 hours for allopurinol.
Čas, potreben za doseganje normalnih ravni sečne kisline pri bolnikih s hiperurikemijo, je pri zdravilu Fasturec 4 ure in pri alopurinolu 24 ur.
The solvent contains no preservative.
Raztopina ne vsebuje konzervansov.
In turn, this allows efficient excretion of the serum phosphate load preventing further deterioration of renal function from calcium/phosphorus precipitation.
To omogoča učinkovito izločanje serumskih fosfatov, kar preprečuje nadaljnje poslabšanje delovanja ledvic zaradi obarjanja kalcija in fosforja.
During treatment with Fasturtec, your doctor will carry out blood tests to check the levels of uric acid and decide how long you will be treated for.
Med zdravljenjem z zdravilom Fasturtec vam bo vaš zdravnik s krvnimi preiskavami preveril raven sečne kisline in določil čas trajanja vašega zdravljenja.
Administration of rasburicase does not require any change in the timing or schedule of initiation of cytoreductive chemotherapy.
Zaradi uporabe razburikaze ni potrebno spreminjati urnika ali načrta začetka citoreduktivne kemoterapije.
Infusion: The final solution should be infused over 30 minutes.
Infuzija: Infuzija končne raztopine mora trajati 30 minut.
It is unknown whether rasburicase is excreted in human milk.
Ni znano, ali se razburikaza izloča v materinem mleku.
In case of severe allergic reaction, treatment should immediately and permanently be discontinued and appropriate therapy initiated.
V primeru hude alergijske reakcije morate takoj prekiniti zdravljenje z zdravilom Fasturtec in začeti z ustreznim zdravljenjem alergijskih reakcij.
EXP Use immediately after reconstitution or dilution
Uporabite takoj po rekonstituciji ali redčenju
The pharmacokinetics of rasburicase were evaluated in both paediatric and adult patients with leukaemia, lymphoma or other haematological malignancies.
Farmakokinetiko razburikaze so vrednotili tako pri pediatričnih, kot pri odraslih bolnikih z levkemijo, limfomom ali drugimi hematološkimi obolenji.
Rasburicase like other proteins, has the potential to induce allergic responses in humans, such as anaphylaxis, including anaphylactic shock, with potential fatal outcome.
Tako kot drugi proteini, tudi razburikaza lahko povzroči alergijske reakcije pri človeku, kot je anafilaksija, vključno z anafilaktičnim šokom, s potencialno smrtnim izidom.
Fasturtec is to be given to you before or during the start of your course of chemotherapy.
Fasturtec vam bodo dali tik pred kemoterapijo ali med njenim začetkom.
Fasturtec is not recommended in women of childbearing potential not using contraception.
Uporaba zdravila Fasturtec se ne priporoča plodnim ženskam, ki ne uporabljajo kontracepcije.
Fertility There are no data regarding the effect of rasburicase on fertility.
Plodnost Podatkov o učinku razburikaze na plodnost ni.
Store in the original package in order to protect from light
Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo
Not known
Neznani
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).
Ne uporabljajte zdravila Fasturtec, če ste: - alergični na (preobčutljivi za) razburikazo, druge urikaze ali katerokoli sestavino tega zdravila
The use of several vials may be necessary to obtain the quantity of rasburicase required for one administration.
Morda boste morali uporabiti več vial, da bi dobili količino razburikaze, potrebne za en odmerek.
Rasburicase is a tetrameric protein with identical subunits of a molecular mass of about 34 kDa.
Razburikaza je tetramerni protein z identičnimi podenotami in molekulsko maso približno 34 kDa.
Finally, plasma must be maintained in an ice/water bath and analysed for uric acid within 4 hours.
Končno, plazmo morate hraniti v posodici z ledom in vodo ter analizirati količino sečne kisline v 4 urah.
Rare (may affect up to 1 in 1,000 people): - runny or blocked nose, sneezing, facial pressure or pain (rhinitis).
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): - izcedek iz nosu ali zamašen nos, kihanje, pritisk na obraz ali bolečina (rinitis).
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.
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.
Paediatric population As no adjustment is necessary, the recommended dose is 0.20 mg/kg/day.
Pediatrična populacija Prilagoditev odmerka ni potrebna, zato je priporočen odmerek 0,20 mg/kg/dan.
The powder is an entire or broken white to off white pellet.
Prašek je iz belih do belkastih celih ali zdrobljenih pelet.
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.
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.
The recommended dose for Fasturtec is 0.20 mg/kg/day.
Priporočen odmerek zdravila Fasturtec je 0,20 mg/kg/dan.
Tumour lysis can also result in hyperphosphataemia, hyperkalaemia and hypocalcaemia.
Razkroj tumorjev lahko povzroči tudi hiperfosfatemijo, hiperkalemijo in hipokalcemijo.
The reconstituted solution contains no preservative.
Rekonstituirana raztopina ne vsebuje konzervansov.
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.
Glede na mehanizem delovanja zdravila Fasturtec, bi preveliko odmerjanje povzročilo nizke do nedoločljivo nizke koncentracije sečne kisline v plazmi in povečano nastajanje vodikovega peroksida.
Results from animal studies could not be interpreted due to the presence of endogenous urate oxidase in standard animal models.
Rezultatov študij na živalih ni moč interpretirati zaradi prisotnosti endogene uratne oksidaze v standardnih živalskih modelih.
The required volume of the reconstituted solution depends on the patient's body weight.
Potrebni volumen rekonstituirane raztopine je odvisen od telesne mase bolnika.
Samples must be immersed in an ice/water bath.
Vzorce morate potopiti v kopel z ledom in vodo.
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.
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.
• rash, itching or hives (nettle-type rash) on the skin
• izpuščaj, srbenje ali koprivnica (urtikarija) na koži
Results showed a significantly more rapid onset of action of Fasturtec in comparison with allopurinol.
Rezultati so pokazali bistveno hitrejši pričetek učinka pri zdravilu Fasturec kot pri alopurinolu.
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).
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.
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%).
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 %).
Only clear and colourless solutions without particles should be used.
Uporabite lahko samo bistro in brezbarvno raztopino brez delcev.
Powder in vial: store in a refrigerator (2°C - 8°C).
Prašek v viali: Shranjujte v hladilniku (2 C - 8 C).
What Fasturtec looks like and contents of the pack
Izgled zdravila Fasturtec in vsebina pakiranja
Do not use this medicine after the expiry date which is stated on the carton after EXP.
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.
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.
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.
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.
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.
Fasturtec should be administered under the supervision of a physician trained in chemotherapy of haematological malignancies.
Bolnik mora jemati zdravilo Fasturtec pod nadzorom zdravnika specialista za kemoterapijo hematoloških malignih obolenj.
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A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
As metabolism is expected to occur by peptide hydrolysis, an impaired liver function is not expected to affect the pharmacokinetics.
Razgradnja naj bi potekala s hidrolizo peptidov, zato ne pričakujemo, da bi zmanjšano delovanje jeter vplivalo na farmakokinetiko.
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).
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).
In addition this rapid control of uric acid in this population is accompanied by improvements in renal function.
Poleg tega je hitro uravnavanje koncentracije sečne kisline pri teh bolnikih spremljalo izboljšanje delovanja ledvic.
Fasturtec is provided as a powder for concentrate for solution for infusion (powder for sterile concentrate) with a solvent.
Fasturtec je na voljo kot prašek za koncentrat za raztopino za infundiranje (prašek za sterilni koncentrat) z vehiklom.
For storage conditions after reconstitution or dilution of the medicinal product, see section 6.3.
Za pogoje shranjevanja po rekonstituciji ali redčenju zdravila glejte poglavje 6.3.
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.
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.
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België /Belgique/Belgien Sanofi-aventis Belgium Tél/Tel: +32 (0)2 710 54 00
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.
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.
The enzymatic oxidation of uric acid leads to stoichiometric formation of hydrogen peroxide.
Encimatska oksidacija sečne kisline povzroča stehiometrični nastanek vodikovega peroksida.
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
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).
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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.
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.
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.
Razburikaza je zelo močna urikolitična učinkovina, ki katalizira encimatsko oksidacijo sečne kisline v alantoin, vodotopno snov, ki jo ledvice zlahka izločajo v urinu.
Luxembourg/Luxemburg Sanofi Belgium
Luxembourg/Luxemburg Sanofi-aventis Belgium
Hydrogen peroxide is a by-product of the conversion of uric acid to allantoin.
Vodikov peroksid je stranski produkt spreminjanja sečne kisline v alantoin.
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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.
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.
In such case, treatment should immediately and permanently be discontinued and appropriate measures initiated (see section 4.8).
V takih primerih morate takoj ukiniti zdravljenje z zdravilom Fasturtec in ustrezno zdraviti neželene učinke (glejte poglavje 4.8).
After infusion of rasburicase at a dose of 0.20 mg/kg/day, steady state is achieved at day 2 - 3.
Po infuziji razburikaze v odmerku 0,20 mg/kg/dan se vzpostavi stanje dinamičnega ravnovesja 2.- 3. dan.
Common side effects (may affect up to 1 in 10 people): - allergic reactions, mainly rashes and urticaria.
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): - alergijske reakcije, večinoma izpuščaji in koprivnica.
The interpretation of the non-clinical studies is hampered due to the presence of endogenous urate oxidase in standard animal models.
Rezultate predkliničnih študij je težko tolmačiti zaradi prisotnosti endogene urat-oksidaze pri standardnih živalskih modelih.
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.
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.
Driving and using machines No information on the ability to drive and use machines is available.
Vpliv na sposobnost upravljanja vozil in strojev Podatkov o vplivu na sposobnost upravljanja vozil in strojev ni na voljo.
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).
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).
Uncommon side effects (may affect up to 1 in 100 people): - severe hypersensitivity reactions, such as anaphylaxis (rare) including anaphylactic shock
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): - hude preobčutljivostne reakcije, kot je anafilaksija (redko), vključno z anafilaktičnim šokom
- have a history of haemolytic anaemia (an illness caused by red blood cells being abnormally broken down).
- imeli ali imate hemolitično anemijo (bolezen, ki nastane zaradi nenormalne razgradnje rdečih krvnih celic).
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 7.5 mg
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 7,5 mg
Solvent: poloxamer 188, water for injection.
Vehikel: poloksamer 188, voda za injekcije.
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.
Natančen čas zdravljenja določimo na podlagi ustreznega kontroliranja ravni sečne kisline v plazmi in klinične presoje.
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for concentrate for solution for infusion 3 vials and 3 ampoules
FARMACEVTSKA OBLIKA IN VSEBNOST Prašek in vehikel za koncentrat za raztopino za infundiranje 3 viale in 3 ampule
The mean terminal half-life was similar between paediatric and adult patients and ranged from 15.7 to 22.5 hours.
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.
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for concentrate for solution for infusion 1 vial and 1 ampoule
FARMACEVTSKA OBLIKA IN VSEBNOST Prašek in vehikel za koncentrat za raztopino za infundiranje 1 viala in 1 ampula
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1.5 mg
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1,5 mg
Caution should be used in patients with a history of atopic allergies.
Posebej morate biti previdni pri bolnikih, ki so v preteklosti že imeli atopične alergije.
Fasturtec works by allowing uric acid to more easily be removed from the body by the kidneys.
Fasturtec deluje tako, da olajša izločanje sečne kisline iz telesa preko ledvic.
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.
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.
Powder and solvent for concentrate for solution for infusion (powder for sterile concentrate).
Prašek in vehikel za koncentrat za raztopino za infundiranje (prašek za sterilen koncentrat).
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo morebitnih tveganj za človeka.