natgillin/translations-raw huggingface dataset:
The efficacy and safety of palifermin have only been established in association with conditioning regimens for autologous haematopoietic stem cell support that comprise total body irradiation and high dose chemotherapy (cyclophosphamide and etoposide) (see section 5.1). 
Djelotvornost i sigurnost palifermina utvrđena je samo za režime kondicioniranja za terapiju autolognim krvotvornim matičnim stanicama koji uključuju ozračivanje cijelog tijela i visoke doze kemoterapije (ciklofosfamid i etopozid) (vidjeti dio 5.1).
Systemic toxicity (clinical signs and/or changes in body weight) and adverse effects on male and female fertility parameters were seen at doses ≥ 300 micrograms/kg/day (5-fold higher than the recommended human dose). 
Sistemska toksičnost (klinički znakovi i/ili promjene tjelesne težine) i štetni učinci na muške i ženske parametre plodnosti primijećeni su pri dozama ≥ 300 mikrograma/kg/dan (peterostruko viša doza od preporučene doze za ljude).
No overt cases of pancreatitis have been reported in this patient population. 
U ovoj populaciji bolesnika nisu prijavljeni očiti slučajevi pankreatitisa.
The diluent should be injected slowly into the Kepivance vial. 
Otapalo treba polako injicirati u bočicu s lijekom Kepivance.
Do not shake or vigorously agitate the vial. 
Bočicu ne tresti niti snažno mućkati.
There was no evidence of a delay in time to haematopoietic recovery in patients who received palifermin as compared to patients who received placebo. 
Nije dokazan odgođeni hematopoetski oporavak u bolesnika koji su primali palifermin u usporedbi s ispitanicima koji su primali placebo.
Kepivance is used to treat oral mucositis (soreness, dryness and inflammation of the mouth) which has occurred as a side effect of treatments for your blood cancer. 
Kepivance se koristi za liječenje oralnog mukozitisa (bol, suhoća i upala usta) koji nastaje kao nuspojava u liječenju raka krvi.
In patients with end-stage renal disease (requiring dialysis) palifermin clearance was decreased by 10% (n = 6). 
U bolesnika u terminalnoj fazi bolesti bubrega (koja zahtijeva dijaliza), klirens palifermina bio je manji za 10% (n = 6).
Kepivance is indicated to decrease the incidence, duration and severity of oral mucositis in adult patients with haematological malignancies receiving myeloablative radiochemotherapy associated with a high incidence of severe mucositis and requiring autologous haematopoietic stem cell support. 
Kepivance je indiciran za smanjenje incidencije, trajanja i težine oralnog mukozitisa u odraslih bolesnika s hematološkim malignim bolestima koji primaju mijeloablativnu radiokemoterapiju povezanu s visokom stopom incidencije teškog mukozitisa i kojima je potrebna terapija autolognim krvotvornim matičnim stanicama.
Kepivance contains the active substance palifermin which is a protein produced by biotechnology in a bacteria called Escherichia coli. 
Kepivance sadrži djelatnu tvar palifermin, protein proizveden biotehnologijom u bakteriji
The pharmacokinetics of palifermin were studied in healthy volunteers and patients with haematological malignancies. 
5.2 Farmakokinetička svojstva Farmakokinetička svojstva palifermina ispitivana su u zdravih dobrovoljaca i bolesnika s hematološkim malignim bolestima.
• swelling (oedema) of the face or mouth; 
• oticanje (edem) lica ili usta;
Kepivance has not been tested in pregnant women. 
Trudnoća i dojenje Kepivance nije ispitivan na trudnicama.
Fractionation of increased levels of amylase revealed the increase to be predominantly salivary in origin. 
Frakcioniranjem povišenih razina amilaze utvrđeno je da se uglavnom radi o amilazi iz sline.
It is not known whether Kepivance is present in human milk. 
Nije poznato izlučuje li se Kepivance u majčino mlijeko.
• change in colour of the mouth or tongue; 
• promjena boje usne šupljine ili jezika;
Kepivance should not be administered if discolouration or particulates are observed. 
Kepivance se ne smije primijeniti ako uočite promjenu boje ili čestice.
The last of the three doses given before chemotherapy andradiotherapy, must be given at least 24 to 48 hours before the chemotherapy and radiotherapy starts. 
Posljednja od tri doze koja se daje prije kemoterapije i zračenja mora se dati najmanje 24 do 48 sati prije početka kemoterapije i zračenja.
Haematopoietic recovery following PBPC infusion was similar between patients who received Kepivance or placebo, and there were no observed differences in disease progression or survival. 
Hematopoetski oporavak nakon infuzije progenitornih stanica iz periferne krvi bio je sličan u bolesnika koji su primili Kepivance i onih koji su primili placebo te nisu ustanovljene razlike u napredovanju bolesti ili preživljenju.
Pain and arthralgia are other common adverse reactions, consistent with Kepivance treated patients having received less opioid analgesia than placebo-treated patients (see Table 2). 
Bol i artralgija su česte nuspojave u bolesnika liječenih Kevipanceom koji su primili manje opioidnih analgetika od bolesnika liječenih placebom (vidjeti Tablicu 2.).
In a single dose study the clearance of palifermin was approximately 30% lower in 8 healthy subjects aged 66-73 years after a dose of 90 micrograms/kg than in younger subjects (≤ 65 years) after a dose of 180 micrograms/kg. 
U ispitivanju jednokratne doze klirens palifermina bio je približno 30% niži u 8 zdravih ispitanika u dobi od 66 do 73 godine koji su primili dozu od 90 mikrograma/kg u odnosu na mlađe ispitanike (≤ 65 godina) koji su primili dozu od 180 mikrograma/kg.
p-value* 
SZO**
The first three doses should be administered prior to myeloablative therapy, with the third dose 24 to 48 hours before myeloablative radiochemotherapy. 
Prve 3 doze treba primijeniti prije mijeloablativnog liječenja, tako da se 3. doza primijeni 24 do 48 sati prije mijeloablativne radiokemoterapije.
Palifermin was administered as a daily intravenous injection of 60 micrograms/kg for 3 consecutive days prior to initiation of cytotoxic therapy and for 3 consecutive days following infusion of peripheral blood progenitor cells with nine days between the last pre dose and first post dose. 
Palifermin je primijenjen u obliku dnevne intravenske injekcije od 60 mikrograma/kg kroz 3 uzastopna dana prije početka citotoksične terapije i kroz 3 uzastopna dana nakon infuzije progenitornih stanica iz periferne krvi s devet dana razmaka između posljednje doze prije i prve doze nakon terapije.
L-histidine, mannitol, sucrose, polysorbate 20 and diluted hydrochloric acid 
L-histidin, manitol, saharoza, polisorbat 20 i razrijeđena kloridna kiselina
Very common (affects more than 1 user in 10) side effects are: 
Vrlo često (mogu se javiti u više od 1 od 10 osoba):
Do not use this medicine after the expiry date which is stated on the carton and vial label, after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju i naljepnici bočice iza Rok valjanosti/EXP.
No adverse effects on reproductive/fertility parameters were observed at doses of up to 100 micrograms/kg/day. 
Nisu utvrđeni štetni učinci na parametre reprodukcije/plodnosti pri dozama do 100 mikrograma/kg/dan.
No gender-related differences were observed in the pharmacokinetics of palifermin. 
U farmakokinetici palifermina nisu primjećene razlike s obzirom na spol.
In a small multiple-dose study in paediatric patients (1 to 16 years old) receiving 40, 60 or 80 micrograms/kg/day for 3 days pre- and post- HSCT, there was no effect of age on the pharmacokinetics of palifermin although a large variability was observed in the estimated parameters. 
U ispitivanju višestrukih doza provedenom na malom broju pedijstrijskih bolesnika (u dobi od 1 do 16 godina) koji su primali 40, 60 ili 80 mikrograma/kg/dan 3 dana prije i nakon transplantacije krvotvornih matičnih stanica, dob nije utjecala na farmakokinetiku palifermina iako su primijećene velike razlike u procijenjenim parametrima.
If heparin is used to maintain an intravenous line, sodium chloride solution should be used to rinse the line prior to and after Kepivance administration (see section 6.2). 
Ako se heparin primjenjuje za održavanje venskog puta, potrebno je prije i nakon primjene Kepivancea venski put isprati otopinom natrijeva klorida (vidjeti dio 6.2).
Safety and efficacy has not been evaluated in patients with hepatic impairment (see section 5.2). 
Sigurnost i djelotvornost u bolesnika s oštećenjem funkcije jetre nije procijenjena (vidjeti dio 5.2).
There was a lower incidence of severe oral mucositis in patients receiving 80 micrograms/kg/day but no effect on the incidence of acute graft-versus-host disease (GVHD). 
U bolesnika koji su primali dozu od 80 mikrograma/kg/dan bila je niža incidencija teškog oralnog mukozitisa, ali nije bilo učinka na incidenciju akutne reakcije presatka protiv primatelja (GVHD).
The frequency listed below is defined using the following convention: very common (> 1/10), common (≥ 1/100 to < 1/10), not known (frequency cannot be estimated from available data). 
(≥ 1/100 i < 1/10), nepoznato (ne može se procijeniti iz dostupnih podataka).
A randomised, placebo-controlled, double-blind study was conducted post-approval to evaluate the efficacy of palifermin given pre- or pre- and post- chemotherapy (CT). 
Nakon stavljanja lijeka u promet provedeno je randomizirano, placebom kontrolirano, dvostruko slijepo ispitivanje radi ocjenjivanja djelotvornosti palifermina primijenjenog prije ili i prije i nakon kemoterapije.
The incidence of severe (grades 3 and 4) oral mucositis in the 3 groups was 36.8%, 38.3% and 23.9% for the placebo, pre/post CT and pre-CT groups respectively, with no statistical significance being demonstrated. 
Incidencija teškog (stupnjevi 3 i 4) oralnog mukozitisa u te 3 skupine iznosila je 36,8% za placebo skupinu, 38,3% u skupini koja je lijek primila prije i nakon kemoterapije te 23,9% u skupini koja je lijek primila prije kemoterapije, bez statističke značajnosti.
The first of the three doses given after the chemotherapy and radiotherapy must be given at least 7 days after the most recent 
Prva od tri doze koja se daje nakon kemoterapije i zračenja mora se dati najmanje 7 dana nakon posljednje doze Kepivancea.
No accumulation of palifermin occurred after 3 consecutive daily doses of 20 and 40 micrograms/kg (healthy volunteers) or 60 micrograms/kg (adult patients) or 40 to 80 
Nije došlo do nakupljanja palifermina nakon uzimanja dnevnih doza od 20 do 40 mikrograma/kg (zdravi dobrovoljci) ili 60 mikrograma/kg (odrasli bolesnici) ili 40 do 80 mikrograma/kg (pedijatrijski bolesnici) kroz 3 uzastopna dana.
• redness, bumps or swelling of the tongue; 
• crvenilo, kvržice ili oticanje jezika;
Kepivance left at room temperature for more than 1 hour should be discarded. 
Ako Kepivance ostane na sobnoj temperaturi dulje od 1 sata, treba ga baciti.
Once reconstituted, Kepivance contains 5 mg/ml of palifermin. 
Nakon pripreme za primjenu, Kepivance sadrži 5 mg/ml palifermina
Palifermin should therefore not be given to patients with known or suspected non-haematological malignancies. 
Palifermin se stoga ne smije primjenjivati u bolesnika u kojih se je potvrđena ili postoji sumnja na nehematološku malignu bolest.
- The other ingredients are mannitol, sucrose, L-histidine, polysorbate 20 and diluted 
- Ostali sastojci su manitol, saharoza, L-histidin, polisorbat 20 i razrijeđena kloridna kiselina.
Reconstituted Kepivance should not be left at room temperature for more than one hour, and should be protected from light. 
Kepivance se nakon pripreme ne smije čuvati dulje od sat vremena na sobnoj temperaturi te ga je potrebno zaštititi od svjetla.
Kepivance treatment should be supervised by a physician experienced in the use of anti-cancer 
Liječenje Kepivanceom treba nadzirati liječnik s iskustvom u primjeni onkološkog liječenja.
If heparin is used to maintain an intravenous line, sodium chloride solution should be used to rinse the line prior to and after Kepivance administration, since palifermin has been shown to bind to heparin 
Ako se heparin primjenjuje za održavanje venskog puta, venski put je prije i nakon primjene lijeka Kepivance potrebno isprati otopinom natrijeva klorida, budući da je utvrđeno da se u in vitro uvjetima palifermin veže za heparin.
Endogenous KGF is an epithelial cell specific growth factor which is produced by mesenchymal cells and is naturally upregulated in response to epithelial tissue injury. 
Endogeni čimbenik rasta keratinocita je specifičani čimbenik rasta epitelnih stanica kojeg proizvode mezenhimalne stanice, a prirodno se aktivira pri ozljedi epitelnog tkiva.
In a postmarketing clinical trial investigating multiple myeloma patients receiving melphalan 200 mg/m2 as conditioning regimen, palifermin administration with four days between the last pre dose and the first post dose did not show a therapeutic benefit in the frequency or duration of severe oral mucositis compared to placebo. 
U kliničkom ispitivanju nakon stavljanja lijeka u promet koje je uključivalo bolesnike s multiplim mijelomom koji su u sklopu protokola kondicioniranja primali melfalan u dozi od 200 mg/m2 ustanovljeno je da, u usporedbi s placebom, primjena palifermina s četiri dana razmaka između posljednje doze prije i prve doze nakon liječenja ne pokazuje terapijsku korist po pitanju učestalosti ili trajanja teškog oralnog mukozitisa.
KGF receptors are known to be expressed on the lens of the eye. Cataractogenic effects of palifermin cannot be excluded (see section 5.1). 
Kataraktogeni učinci palifermina ne mogu se isključiti (vidjeti dio 5.1).
Renal impairment Dose adjustment in patients with renal impairment is not necessary (see section 5.2). 
Nije potrebna prilagodba doze u bolesnika s oštećenjem funkcije bubrega (vidjeti dio 5.2).
The pharmacokinetic profile in patients with hepatic insufficiency has not been assessed. 
Farmakokinetički profil u bolesnika s oštećenom funkcijom jetre nije procijenjivan.
The incidence of ulcerative oral mucositis was 57.9% in the placebo arm, 68.7% in the pre/post CT group and 51.4% in the pre-CT group. 
Incidencija ulcerativnog oralnog mukozitisa iznosila je 57,9% u placebo skupini, 68,7% u skupini koja je lijek primala prije i nakon kemoterapije te 51,4% u skupini koja je lijek primila prije kemoterapije.
For storage conditions after reconstitution of the medicinal product, see section 6.3. 
Uvjete čuvanja nakon pripreme lijeka za primjenu vidjeti u dijelu 6.3.
It is not known whether Kepivance is excreted in human milk, therefore Kepivance should not be administered to women who are breast-feeding. 
Nije poznato izlučuje li se Kepivance u majčino mlijeko te se stoga ne preporučuje primjena
Dose limiting toxicities were observed in 36% (5 of 14) patients receiving 6 doses of 80 micrograms/kg/day administered intravenously over 2 weeks (3 doses preceding and three doses following myeloablative therapy). 
Toksičnost ovisna o dozi primijećena je u 36% (5 od 14) bolesnika koji su u razdoblju od 2 tjedna intravenski primili 6 doza od 80 mikrograma/kg/dan (3 doze prije i 3 doze nakon mijeloablativnog liječenja).
There is no experience with Kepivance doses greater than 80 micrograms/kg/day administered intravenously in patients over 2 weeks (3 doses preceding and 3 doses following myeloablative 
Nema iskustva u primjeni doza Kepivancea većih od 80 mikrograma/kg/dan primijenjenih intravenski u bolesnika u razdoblju od 2 tjedna (3 doze prije i 3 doze nakon mijeloablativnog liječenja).
Cataractogenic effects of palifermin cannot be excluded following results of ophthalmologic examinations in a subset of patients (n = 66; 14 in the placebo group, 52 in the palifermin group) who were followed for 12 months after the acute phase of the above post-approval study. 
Prema rezultatima oftalmoloških pregleda u podskupini ispitanika (n = 66; 14 u skupini koja je primala placebo, 52 u skupini koja je primala palifermin) koja je praćena tijekom 12 mjeseci nakon akutne faze spomenutog ispitivanja provedenog nakon registracije lijeka, ne mogu se isključiti kataraktogeni učinci palifermina.
Post- myeloablative radiochemotherapy: 
Prije mijeloablativne radiokemoterapije:
The safety and efficacy of Kepivance has not been established in patients with KGF receptor expressing non-haematological malignancies. 
Sigurnost i djelotvornost Kepivancea nije utvrđena u bolesnika s nehematološkim malignim bolestima koje izražavaju receptore za čimbenike rasta keratinocita.
The palifermin clinical program in the setting of myelotoxic therapy requiring haematopoietic stem cell (HSC) support included 650 patients with haematologic malignancies enrolled in 3 randomised, placebo-controlled clinical studies and a pharmacokinetic study. 
Klinička djelotvornost i sigurnost U klinički program primjene palifermina u ustanovama za mijelotoksičnu terapiju s potpornom primjenom krvotvornih matičnih stanica bilo je uključeno 650 bolesnika s hematološkim malignim bolestima koji su sudjelovali u 3 randomizirana, placebom kontrolirana klinička ispitivanja te jedno farkmakokinetičko ispitivanje.
Haematologic malignancies do not express the KGF receptor. 
Hematološke maligne stanice ne izražavaju receptor za čimbenike rasta keratinocita.
In studies in rats, no adverse effects on reproductivity/fertility parameters were observed at doses of up to 100 micrograms/kg/day. 
U istraživanjima na štakorima nisu utvrđeni štetni učinci na reproduktivni sustav/plodnost pri dozama do 100 mikrograma/kg/dan.
These NOAEL doses were associated with systemic exposures (based on AUC) up to 9.7 and 2.1 times, respectively, anticipated clinical exposure. 
Te doze pri kojima nisu uočeni štetni učinci bile su povezane sa sustavnim izlaganjem (na temelju AUC-a) do 9,7 puta većim za štakore i 2,1 puta većim za kuniće od predviđenog kliničkog izlaganja.
6 vials containing powder for solution for injection 
6 bočica s praškom za otopinu za injekciju
Palifermin 
Nuspojave
The conditioning regimen consisted of total body irradiation (TBI), etoposide and cyclophosphamide. 
Režim kondicioniranja sastojao se od ozračivanja cijelog tijela te primjene etopozida i ciklofosfamida.
These patient-reported outcomes were highly correlated to the clinician grading of 
Ovi ishodi koje su prijavili ispitanici u velikoj mjeri odgovaraju kliničkom stupnjevanju oralnog mukozitisa prema ljestvici SZO-a.
Palifermin is a growth factor that primarily stimulates epithelial cells through the KGF receptor. 
Palifermin je čimbenik rasta koji prvenstveno stimulira epitelne stanice putem receptora za čimbenike rasta keratinocita.
Each vial contains 6.25 mg of palifermin. 
Svaka bočica sadrži 6,25 mg palifermina.
What Kepivance looks like and contents of the pack Kepivance is a white powder supplied in vials. 
Kepivance je bijeli prašak koji se isporučuje u bočicama.
The recommended dosage of Kepivance is 60 micrograms/kg/day, administered as an intravenous bolus injection for three consecutive days before and three consecutive days after myeloablative radiochemotherapy for a total of six doses. 
Preporučena doza Kepivancea iznosi 60 mikrograma/kg/dan, primijenjena u obliku intravenske bolus injekcije kroz 3 uzastopna dana prije i 3 uzastopna dana nakon mijeloablativne radiokemoterapije,
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or to 
Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 ili na proteine dobivene iz Escherichie coli.
• hand-and-foot skin-reaction (palms of the hands or soles of the feet tingle, become numb, 
• kožne promjene na rukama i stopalima (trnci u dlanovima ili tabanima, utrnulost, bolnost,
Kepivance is a growth factor that stimulates the proliferation of KGF receptor expressing epithelial cells. 
Kepivance je čimbenik rasta koji potiče proliferaciju epitelnih stanica koje izražavaju receptore za čimbenike rasta keratinocita.
Oedema, oedema peripheral, pain and pyrexia 
Edem, periferni edem, bol i vrućica primjene
Efficacy and safety of palifermin were established in a randomised, double-blind, placebo-controlled study in which patients received high-dose cytotoxic therapy consisting of fractionated total-body irradiation (12 Gy total dose; Day -8 to -5), high-dose etoposide (60 mg/kg; Day -4), and high-dose cyclophosphamide (100 mg/kg; Day -2) followed by PBPC support for the treatment of haematological malignancies ((Non-Hodgkin's Lymphoma (NHL), Hodgkin's disease, Acute Myeloid Leukaemia (AML), Acute Lymphocytic Leukaemia (ALL), Chronic Myeloid Leukaemia (CML), Chronic Lymphocytic Leukaemia (CLL), or multiple myeloma). 
visoke doze etopozida (60 mg/kg; dan -4) i visoke doze ciklofosfamida (100 mg/kg; dan -2), nakon čega je primijenjena infuzija progenitornih stanica iz periferne krvi za liječenje hematoloških malignih bolesti (ne-Hodgkinovog limfoma (NHL), Hodgkinove bolesti, akutne mijeloične leukemije
A total of 27 paediatric patients with leukaemia were randomized to 40, 60 or 80 micrograms/kg/day of palifermin for 3 days pre- and post- hematopoietic stem cell transplantation (HSCT). 
Ukupno 27 pedijatrijskih bolesnika s leukemijom nasumično je raspoređeno u skupine koje su primale palifermin u dozi od 40, 60 ili 80 mikrograma/kg/dan 3 dana prije i nakon transplantacije krvotvornih matičnih stanica.
• an increase in the thickness in the mouth or tongue; 
• zadebljanje usne šupljine ili jezika;
In this study (n = 281), patients with multiple myeloma received conditioning with melphalan (200 mg/m2) prior to autologous haematopoietic stem cell transplantation. 
U sklopu ispitivanja (n = 281) bolesnici s multiplim mijelomom kondicionirani su melfalanom
Median (25th, 75th percentile) Cumulative Dose (morphine mg equivalents) Patient Incidence of Total Parenteral Nutrition (TPN) 
Opioidna analgezija za oralni mukozitis: Medijan (25., 75. percentila) dana 11 (8, 14) Medijan (25., 75. percentila) Kumulativna doza (ekvivalent morfija u mg) Incidencija bolesnika na totalnoj parenteralnoj prehrani Incidencija febrilne neutropenije u bolesnika
It differs from endogenous human KGF in that the first 23 N-terminal amino acids have been deleted to improve 
Od endogenog humanog čimbenika rasta keratinocita razlikuje se po tome što su prve 23
The last three doses should be administered post myeloablative radiochemotherapy; the first of these doses should be administered after, but on the same day of haematopoietic stem cell infusion and at least seven days after the most recent Kepivance administration (see section 4.4). 
doze treba primijeniti nakon liječenja, ali isti dan kao i infuziju krvotvornih matičnih stanica i najmanje sedam dana nakon zadnje primjenjene doze Kepivancea (vidjeti dio 4.4).
Package leaflet: Information for the user Kepivance 6.25 mg powder for solution for injection palifermin 
Uputa o lijeku: Informacija za korisnika Kepivance 6,25 mg prašak za otopinu za injekciju palifermin
Oral mucosal hypertrophy / Hypertrophy of tongue papillae,Oral mucosal discolouration / Tongue discolouration, Tongue disorder (e.g. redness, bumps), Tongue oedema 
Hipertrofija oralne sluznice /hipertrofija jezičnih papila, promjena boje oralne sluznice/promjena boje jezika,
In fertility/general reproductive toxicity studies in rats, palifermin treatment was associated with systemic toxicity (clinical signs and/or changes in body weight) and adverse effects on male and female reproductive/fertility parameters at doses greater than or equal to 300 micrograms/kg/day. 
U ispitivanjima toksičnosti za plodnost i opće reproduktivne toksičnosti na štakorima pri dozama višim ili jednakim 300 mikrograma/kg/dan liječenje paliferminom bilo je povezano sa sistemskom toksičnošću (klinički pokazatelji i/ili promjene u tjelesnoj težini) i štetnim učincima na muške i ženske parametre reprodukcije/plodnosti.
Palifermin is a human keratinocyte growth factor (KGF), produced by recombinant DNA technology 
Keratinocyte growth factor - KGF) koji se proizvodi tehnologijom rekombinantne DNK u stanicama Escherichia coli.
Patient incidence of WHO Grade 4 oral Median (25th, 75th percentile) days of 
Incidencija oralnog mukozitisa stupnja 4 prema ljestvici SZO u bolesnika Medijan (25., 75. percentila) dana oralnog mukozitisa stupnja 2/3/4 prema ljestvici SZO