natgillin/translations-raw huggingface dataset:
Any patient who experiences a severe non-hematologic toxicity (US NCI CTC Grade 3 toxicity) on a third occasion, a severe toxicity that does not recover within 14 days (excluding nausea/vomiting) or a life-threatening or disabling non-infectious non-hematologic toxicity (US NCI CTC Grade 4 toxicity) should be withdrawn from treatment with clofarabine (see section 4.2).
Pri bolnikih, pri katerih se tudi tretjič pojavijo hudi nehematološki toksični učinki (3. stopnje po CTC NCI v ZDA), ki se ne izboljšajo v 14 dneh (z izjemo navzeje/bruhanja), ali življenje ogrožujoči ali onesposabljajoči nenalezljivi nehematološki toksični učinki (4. stopnje po CTC NCI v ZDA), je treba zdravljenje s klofarabinom prekiniti (glejte poglavje 4.2).
The limited data available indicate that clofarabine may accumulate in patients with decreased creatinine clearance (see sections 4.4 and 5.2).
Maloštevilni podatki, ki so na voljo, kažejo, da se klofarabin pri bolnikih z zmanjšanim kreatininskim očistkom lahko kopiči (glejte poglavji 4.4 in 5.2).
Overall remission (CR + CRp)
Skupna remisija (PR + PRt)
All patients
Vsi bolniki ni na voljo
No fertility studies have been conducted.
Študij plodnosti niso opravili.
The pharmacokinetics of clofarabine were studied in 40 patients aged between 2 to 19 years old with relapsed or refractory ALL or AML.
Absorpcija in porazdelitev Farmakokinetiko klofarabina so preučevali pri 40 bolnikih, starih od 2 do 19 let s ponovljeno ali neodzivno ALL ali AML.
Dose reduction for patients experiencing non-haematological toxicities
Zmanjšanje odmerka pri bolnikih, pri katerih se pojavijo nehematološki toksični učinki
The median age of treated patients (37 males, 24 females) was 12 years old.
24 ženskih) je bila 12 let.
Glomerulonephropathy was reported in rats at exposure levels 3 to 5 fold higher than the clinical AUC after 6 dosing cycles of clofarabine.
Pri podganah so pri odmerkih, ki so bili 3- do 5- krat večji od kliničnih vrednosti AUC, po 6 ciklih odmerjanja poročali o glomerulonefropatiji.
However, for patients with a body surface area > 0.38 m2, the contents of between 1 to 7 vials will be required to produce the recommended daily dosage of clofarabine.
Vendar pa bo pri bolnikih s telesno površino > 0,38 m2 za priporočeni dnevni odmerek klofarabina potrebnih 1 do 7 vial.
Common: Haematuria*, renal failure, acute renal failure
Pogosti: hematurija*, odpoved ledvic, akutna odpoved ledvic
The concomitant use of medicinal products that have been associated with hepatic toxicity should be avoided wherever possible (see sections 4.5 and 4.8).
ki so povezana s toksičnimi učinki na jetra, se je treba izogibati, kadar koli je to mogoče (glejte poglavji 4.5 in 4.8).
The concomitant use of medicinal products that have been associated with renal toxicity and those eliminated by tubular secretion such as NSAIDs, amphotericin B, methotrexate, aminosides, organoplatines, foscarnet, pentamidine, cyclosporin, tacrolimus, acyclovir and valganciclovir, should be avoided particularly during the 5 day clofarabine administration period; preference should be given to those medicinal products that are not known to be nephrotoxic (see sections 4.5 and 4.8).
Sočasni uporabi zdravil, ki so povezana s toksičnim učinkom na ledvice, in zdravil, ki se izločajo s tubularno sekrecijo, kot so nesteroidna protivnetna zdravila (NSAIDs), amfotericin B, metotreksat, aminoglikozidi, organske spojine s platino, foskarnet, pentamidin, ciklosporin, takrolimus, aciklovir in valganciklovir, se je treba izogibati, zlasti med 5-dnevnim obdobjem odmerjanja klofarabina; prednost je treba dati tistim zdravilom, za katere je znano, da niso nefrotoksična (glejte poglavji 4.5 in 4.8).
Each 20 ml vial contains 70.77 mg of sodium .
Ena 20 ml viala vsebuje 70,77 mg natrija.
Histological evidence of hepatic effects was seen in dogs following acute administration of high doses, but was also not accompanied by changes in serum chemistry.
Po akutnem odmerjanju velikih odmerkov so pri psih opazili histološke dokaze učinkov na jetra, vendar tudi njih niso spremljale spremembe v serumski kemiji.
Median duration of remission (weeks) (95% CI)
Mediana trajanja remisije (tedni) (IZ 95 %)
• Prophylactic administration of allopurinol should be considered if hyperuricemia (tumour lysis)
• Če sumite na hiperurikemijo (tumorsko lizo), je treba razmisliti o profilaktični uporabi alopurinola.
Very common: Headache Common: Somnolence, peripheral neuropathy, paraesthesia, dizziness, tremor
Pogosti: somnolenca, periferna nevropatija, parestezija, omotica, tremor
What you need to know before you use Ivozall
Kaj je zdravilo Ivozall in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Ivozall Kako uporabljati zdravilo Ivozall
LIST OF EXCIPIENTS Excipients: Sodium chloride and water for injections.
Pomožne snovi: natrijev klorid in voda za injekcije.
• Patients should receive intravenous fluids throughout the 5 day clofarabine administration period to reduce the effects of tumour lysis and other events.
• Za zmanjšanje učinkov tumorske lize in drugih dogodkov naj bolniki med 5-dnevnim obdobjem prejemanja klofarabina dobivajo intravenske tekočine.
Enterocolitis may lead to necrosis, perforation or sepsis complications and may be associated with fatal outcome (see section 4.8).
Enterokolitis lahko povzroči nekrozo, perforacijo ali zaplete s sepso in ga je mogoče povezati s smrtnim izidom (glejte poglavje 4.8).
Of the 17 ALL patients, 2 achieved a complete remission (12%; CR) and 2 a partial remission (12%; PR) at varying doses.
Devet izmed 17 bolnikov z ALL je prejemalo 52 mg/m2 klofarabina na dan. Od 17 bolnikov z ALL je pri različnih odmerkih prišlo do popolne remisije pri 2 (12 %; PR), do delne remisije pa pri 2 (12 %; DR).
It should be filtered through a sterile 0.2 micrometre syringe filter (the use of hydrophilic PVDF syringe filter is recommended) and then diluted in sodium chloride 9 mg/ml (0.9%) intravenous transparent PVC or polyolefine (polypropylene) infusion bags to produce a total volume according to the examples given in the table below.
Filtrirati ga je treba skozi 0,2-mikrometrski filter v brizgi (priporočljiva je uporaba hidrofilnega PVDF-filtra v brizgi) in nato razredčiti v prozornih infuzijskih vrečkah iz PVC ali poliolefina (polipropilena) z 0,9 % raztopino natrijevega klorida (9 mg/ml) za intravensko infundiranje do prostornine, navedene v primerih v tabeli spodaj.
The following parameters should be closely monitored in patients undergoing treatment with clofarabine:
Pri bolnikih, ki prejemajo klofarabin, je treba pozorno spremljati naslednje parametre:
Patients with cardiac disease and those taking medicinal products known to affect blood pressure or cardiac function should be closely monitored during treatment with clofarabine (see sections 4.5 and
Srčne bolezni Bolnike s srčnimi boleznimi in bolnike, ki jemljejo zdravila, za katere je znano, da vplivajo na krvni tlak ali delovanje srca, je treba med zdravljenjem s klofarabinom skrbno spremljati (glejte poglavji 4.5 in 4.8).
Clofarabine AUC0-24 hours by baseline estimated creatinine clearance in patients aged between 2 to 19 years old with relapsed or refractory ALL or AML (n = 11 / n = 12) following administration of multiple doses of clofarabine by intravenous infusion (creatinine clearance estimated using Schwartz formula)
2 do 19 let s ponovljeno ali neodzivno ALL ali AML (n = 11/n = 12) po intravenskem infundiranju več odmerkov klofarabina (kreatininski očistek je bil ocenjen po Schwartzovi formuli)
Clofarabine is not detectably metabolised by the cytochrome P450 (CYP) enzyme system.
Klofarabin se ne presnavlja z encimskim sistemom citokrom P450 (CYP) v količini, ki bi jo bilo mogoče zaznati.
Enterocolitis may lead to necrosis, perforation or sepsis complications and may be associated with fatal outcome (see section 4.4).
Enterokolitis lahko povzroči nekrozo, perforacijo ali zaplete s sepso in ga je mogoče povezati s smrtnim izidom (glejte poglavje 4.4).
VOD cases reported during the post-marketing period in paediatric and adult patients have been associated with a fatal outcome (see section 4.4).
Primeri venookluzivne bolezni jeter (VOD), o katerih so poročali med spremljanjem zdravila po dajanju le tega v promet pri pediatričnih in odraslih bolnikih so bili povezani s smrtnim izidom (glejte poglavje 4.4).
Median overall survival (weeks) (95% CI)
Mediana skupnega preživetja (tedni) (IZ 95 %)
Very common: Fatigue, pyrexia, mucosal inflammation Common: Multi-organ failure, systemic inflammatory response syndrome*, pain, chills, irritability, oedema, peripheral oedema, feeling hot, feeling abnormal
Pogosti: odpoved več organov, sindrom sistemskega vnetnega odziva*, bolečina, mrzlica, razdražljivost, edem, periferni edem, občutek vročine, nenormalno počutje
Clofarabine should be discontinued immediately if patients show early signs or symptoms of SIRS, capillary leak syndrome or substantial organ dysfunction and appropriate supportive measures instituted.
Če se pri bolnikih pojavijo zgodnji znaki ali simptomi sindroma SIRS, sindroma kapilarnih razpok ali znatnega nepravilnega organov, je treba zdravljenje s klofarabinom takoj prekiniti, nato pa izvajati ustrezne podporne ukrepe.
Non-infectious events
Dogodki, ki niso povezani z okužbami
The use of disposable gloves and protective garments is recommended when handling Ivozall.
Pri ravnanju z zdravilom Ivozall je priporočeno uporabljati rokavice za enkratno uporabo in zaščitna oblačila.
In the post-marketing period, following treatment with clofarabine, serious hepatotoxic adverse reactions of VOD in paediatric and adult patients have been associated with a fatal outcome.
Med spremljanjem zdravila po njegovem dajanju v promet so pri pediatrični populaciji in odraslih po zdravljenju s klofarabinom poročali o hudih hepatotoksičnih dogodkih (VOD), povezanih s smrtnim izidom.
The no-observable effect level for maternal toxicity in rats was 18 mg/m2/day and in rabbits was more than 12 mg/m2/day.
je bil pri podganah 18 mg/m2/dan, pri kuncih pa več kot 12 mg/m2/dan.
It should be filtered through a sterile 0.2 micrometre syringe filter (the use of hydrophilic PVDF syringe filter is recommended) ) and then diluted with sodium chloride 9 mg/ml (0.9%) intravenous infusion to produce a total volume according to the examples given in the table below.
Filtrirati ga je treba skozi sterilen 0,2-mikrometrski filter v brizgi (priporočljiva je uporaba hidrofilnega PVDF-filtra v brizgi) in nato razredčiti z 0,9 % raztopino natrijevega klorida (9 mg/ml) za intravensko infundiranje do prostornine, navedene v primerih v spodnji tabeli.
Therefore, the potential benefit and risks associated with continued therapy in patients who do not show haematological and/or clinical improvement after 2 treatment cycles should be assessed by the treating physician (see section 4.4).
Zato mora lečeči zdravnik pri bolnikih, ki po 2 ciklih zdravljenja ne kažejo hematološkega in/ali kliničnega izboljšanja, oceniti morebitne koristi in tveganja, povezana z nadaljnjim zdravljenjem (glejte poglavje 4.4).
The 12 patients who achieved an overall remission (CR + CRp) had a median survival time of 66.6 weeks as of the data collection cut-off date.
12 bolnikih, pri katerih je prišlo do skupne remisije (PR + PRt), je bila mediana časa preživetja
Therefore, the potential benefit and risks associated with continued therapy in patients who do not show haematological and/or clinical improvement after 2 treatment cycles should be assessed by the treating physician.
Zato mora lečeči zdravnik pri bolnikih, ki po 2 ciklih zdravljenja ne kažejo hematološkega in/ali kliničnega izboljšanja, oceniti morebitne koristi in tveganja, povezana z nadaljnjim zdravljenjem.
In the event of a second clinically significant infection, clofarabine treatment should be withheld until the infection is clinically controlled and may be reinitiated at a 25% dose reduction.
Če znova pride do klinično pomembne okužbe, je treba zdravljenje s klofarabinom prekiniti, dokler okužba ni klinično nadzorovana, nato pa se zdravljenje lahko nadaljuje z odmerkom, zmanjšanim za
if you have suffered a severe reaction after previously using this medicine; if you have kidney disease, or used to have it; if you have liver disease, or used to have it; if you have heart disease, or used to have it.
Zdravilo Ivozall morda ni primerno za vas: - če ste po uporabi tega zdravila v preteklosti imeli hude reakcije; - če imate ali ste imeli bolezen ledvic; - če imate ali ste imeli bolezen jeter;
Accordingly, longer infusion times should be considered in children weighing < 20 kg (see section 4.2).
< 20 kg, razmisliti o daljšem času infundiranja (glejte poglavje 4.2).
Intravenous infusion of 52 mg/m2 clofarabine produced equivalent exposure across a wide range of weights.
Pri intravenskem infundiranju 52 mg klofarabina/m je bila izpostavljenost pri bolnikih z zelo različno telesno maso enaka.
There are currently insufficient data to establish the safety and efficacy of clofarabine in adult patients (see section 5.2).
Odrasli (vključno s starejšimi bolniki) Trenutno ni na voljo dovolj podatkov, da bi ocenili varnost in učinkovitost klofarabina pri odraslih bolnikih (glejte poglavje 5.2).
Forty-one patients of 115 (35.7%) experienced at least one renal and urinary disorders adverse reaction.
Pri enainštiridesetih bolnikih izmed 115 (35,7 %) so poročali o vsaj enem neželenem učinku bolezni ledvic ali sečil.
Ivozall contains sodium
Zdravilo Ivozall vsebuje natrij
CR * Duration of remission censored at the time of transplant ** Patient received a transplant following alternate therapy *** Patient received a transplant following relapse The reference medicinal product containing clofarabine has been authorised under ‘exceptional circumstances'.
** Pri bolniku je bila izvedena presaditev po alternativnem zdravljenju *** Pri bolniku je bila izvedena presaditev po relapsu
Patients who did not undergo transplant
bolniki brez presaditve PR
Severe hepatotoxic events have been reported in a Phase 1/2 combination study of clofarabine in paediatric patients with relapsed or refractory acute leukaemia.
2. fazi združene klinične študije s klofarabinom pri pediatričnih bolnikih s ponovljeno ali neodzivno akutno levkemijo.
Clofarabine was teratogenic in rats and rabbits.
Pri podganah in kuncih je bil klofarabin teratogen.
Each 20 ml vial contains 20 mg of clofarabine.
Vsaka 20 ml viala vsebuje 20 mg klofarabina.
Eleven events in 115 patients were considered to be related to clofarabine, none of which were serious and the most frequently reported cardiac disorder was tachycardia (35%) (see section 4.4); 6.1% (7/115) patient's tachycardia were considered to be related to clofarabine.
Med srčnimi boleznimi so najpogosteje poročali o tahikardiji (35 %) (glejte poglavje 4.4); 6,1 % (7/115) pojavov tahikardije povezujejo s klofarabinom.
Thus, the concomitant use of medicinal products that have been associated with renal toxicity and those eliminated by tubular secretion such as NSAIDs, amphotericin B, methotrexate, aminosides, organoplatines, foscarnet, pentamidine, cyclosporin, tacrolimus, acyclovir and valganciclovir, should be avoided particularly during the 5 day clofarabine administration period (see sections 4.4, 4.8 and 5.2).
Klofarabin se izloča pretežno skozi ledvice, zato se je treba izogibati sočasni uporabi zdravil, ki so povezana s toksičnim učinkom na ledvice, in zdravil, ki se izločajo s tubularno sekrecijo, kot so nesteroidna protivnetna zdravila (NSAIDs), amfotericin B, metotreksat, aminoglikozidi, organske spojine s platino, foskarnet, pentamidin, ciklosporin, takrolimus, aciklovir in valganciklovir, zlasti med 5-dnevnim obdobjem odmerjanja klofarabina (glejte poglavja 4.4, 4.8 in 5.2).
Common: Weight decreased
Pogosti: znižanje telesne mase
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJE
Suggested dilution schedule based on the recommended dosage of 52 mg/m2/day clofarabine
Predlagane razredčitve za priporočeni odmerek 52 mg klofarabina/m2/dan
One patient discontinued treatment due to grade 4 hyperbilirubinaemia considered as related to clofarabine after receiving 52 mg/m2/day clofarabine.
Zdravljenje je bilo prekinjeno pri enem bolniku, potem ko se je po prejemanju odmerka klofarabina 52 mg/m2/dan razvila hiperbilirubinemija 4. stopnje, ki naj bi bila povezana s klofarabinom.
Warnings and precautions Tell your doctor if any of these apply to you.
Obvestite zdravnika, če kar koli od tega velja za vas.
Very common: Flushing* Common: Hypotension*, capillary leak syndrome, haematoma
Pogosti: hipotenzija*, sindrom kapilarnih razpok, hematom
What Ivozall contains
Kaj vsebuje zdravilo Ivozall
200 ml *Each ml of concentrate contains 1 mg of clofarabine.
200 ml * Vsak ml koncentrata vsebuje 1 mg klofarabina.
These effects included bilateral degeneration of the seminiferous epithelium with retained spermatids and atrophy of interstitial cells in rats at exaggerated exposure levels (150 mg/m2/day), and cell degeneration of the epididymis and degeneration of the seminiferous epithelium in dogs at clinically relevant exposure levels (≥ 7.5 mg/m2/day clofarabine).
Med njimi je bila bilatelarna degeneracija seminifernega epitela z zadržanjem spermatid in atrofija intersticialnih celic pri podganah pri pretirani izpostavljenosti (150 mg/m2/dan)
The patients were enrolled into a single phase I (n = 12) or two phase II (n = 14 / n = 14) safety and efficacy studies, and received multiple doses of clofarabine by intravenous infusion (see section 5.1).
Bolniki so sodelovali v eni študiji varnosti in učinkovitosti I. faze (n = 12) ali dveh študijah varnosti in učinkovitosti II.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ivozall 1 mg/ml sterile concentrate clofarabine
IME ZDRAVILA IN POT(I) UPORABE Ivozall 1 mg/ml sterilni koncentrat klofarabin intravenska uporaba po redčenju
Ivozall 1 mg/ml concentrate for solution for infusion must be diluted prior to administration.
Zdravilo Ivozall 1 mg/ml koncentrat za raztopino za infundiranje je treba pred uporabo razredčiti.
Bleeding events have been observed in the setting of thrombocytopaenia.
Ob pojavu trombocitopenije so opažali krvavitve.
amphotericin B); - any other medicines including those obtained without a prescription.
- katero koli zdravilo, tudi če ste ga dobili brez recepta.
Therefore, clofarabine should be used with caution in patients with mild to moderate hepatic impairment (see sections 4.2 and 4.3).
Zato je treba klofarabin pri bolnikih z blago do zmerno okvaro jeter uporabljati previdno (glejte poglavji 4.2 in 4.3).
Driving and using machines Do not drive or use any tools or machines if you feel dizzy, light-headed or faint.
Če imate omotico, vrtoglavico ali omedlevico, ne vozite avtomobila in ne upravljajte orodij ali strojev.
You need to allow for this if you are on a controlled sodium diet.
Če ste na dieti z nadzorovanim vnosom natrija,
Clofarabine must be discontinued for exfoliative or bullous rash, or if SJS or TEN is suspected.
Ob nastanku eksfolativnih ali buloznih izpuščajev ali če se sumi na SJS ali TEN, je treba z zdravljenem s klofarabinom prenehati.
Common: Pain in extremity, myalgia, bone pain, chest wall pain, arthralgia, neck and back pain
Pogosti: bolečina v okončinah, mialgija, bolečina v kosteh, bolečina v prsni steni, artralgija, bolečina v vratu in hrbtu
Therefore, a safe and effective dosage recommendation for patients < 1 year old has yet to be established.
Podatkov o farmakokinetiki, varnosti in učinkovitosti klofarabina pri dojenčkih ni. Varna in učinkovita priporočila za odmerjanje pri bolnikih, starih < 1 leto, je treba še ugotoviti.
Infectious events
Dogodki, povezani z okužbami
NAME OF THE MEDICINAL PRODUCT Ivozall 1 mg/ml concentrate for solution for infusion
IME ZDRAVILA Ivozall 1 mg/ml koncentrat za raztopino za infundiranje
A multi-centre, phase II, open-label, non-comparative study of clofarabine was conducted to determine the overall remission (OR) rate in heavily pretreated patients (≤ 21 years old at initial diagnosis) with relapsed or refractory ALL defined using the French-American-British classification.
Za določanje stopnje skupne remisije (SR) pri bolnikih, ki so prejemali intenzivno predhodno zdravljenje (starih ≤ 21 let ob prvi diagnozi) s ponovljeno ali neodzivno ALL, opredeljeno po francosko-ameriško-britanski klasifikaciji, so opravili večcentrično, odprto, neprimerjalno študijo klofarabina 2. faze.
Therefore, clofarabine should be used with caution in patients with mild to moderate renal insufficiency (see section 4.2 for dose adjustments).
Zato je treba klofarabin pri bolnikih z blago do zmerno okvarjenimi ledvicami uporabljati previdno (glejte poglavje 4.2 za prilagoditev odmerka).
- feeling numb or weak in the arms and legs, numbness of the skin, sleepiness, dizziness, tremor; - hearing problems; - water collecting around the heart, fast heartbeat; - low blood pressure, lump due to bad bruising; - leaking from tiny blood vessels, rapid breathing, nosebleeds, breathing difficulties,
- občutek žeje in temnejši urin kot navadno, manj urina kot navadno, zmanjšan apetit ali izguba apetita, izguba telesne mase; - agitacija, razdražljivost ali nemir; - občutek otrplosti ali šibkosti v rokah in nogah, otrplost kože, zaspanost, omotica, drhtenje; - težave s sluhom; - nabiranje vode okoli srca, hitro bitje srca; - nizek krvni tlak, otekline zaradi hudih modric; - krvavitve iz majhnih žil, hitro dihanje, krvavitve iz nosu, težave pri dihanju, zasoplost, kašelj;
Ivozall 1 mg/ml concentrate for solution for infusion clofarabine
Ivozall 1 mg/ml koncentrat za raztopino za infindiranje klofarabin
Therefore, clofarabine is contraindicated in patients with severe hepatic impairment (see section 4.3) and should be used with caution in patients with mild to moderate hepatic impairment (see section 4.4).
Zato je uporaba klofarabina pri bolnikih s hudo okvaro jeter kontraindicirana (glejte poglavje 4.3), pri bolnikih z blago do zmerno okvaro jeter pa ga je treba uporabljati previdno (glejte poglavje 4.4).
If a patient experiences one or more severe toxicities (US National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grade 3 toxicities excluding nausea and vomiting), treatment should be delayed until the toxicities resolve to baseline parameters or to the point where they are no longer severe and the potential benefit of continued treatment with clofarabine outweighs the risk of such continuation.
Institute) v ZDA, z izjemo navzee in bruhanja), je treba zdravljenje prestaviti, dokler se toksični učinki ne vrnejo na izhodiščne parametre ali do točke, ko niso več hudi in ko je morebitna korist nadaljevanja zdravljenja s klofarabinom večja od tveganja.
Any patient who experiences a severe toxicity on a third occasion, a severe toxicity that does not recover within 14 days (see above for exclusions), or a life-threatening or disabling toxicity (US NCI CTC Grade 4 toxicity) should be withdrawn from treatment with clofarabine (see section 4.4).
Pri bolnikih, pri katerih se tudi tretjič pojavijo hudi toksični učinki, ki se ne izboljšajo v 14 dneh (glejte izjeme zgoraj), ali življenje ogrožujoči ali onesposabljajoči toksični učinki (4. stopnje po CTC
Adverse reactions are listed by system organ class and frequency (very common (≥ 1/10); common
V spodnji tabeli so neželeni učinki navedeni po organskih sistemih in pogostnosti (zelo pogosti
Twenty-three patients out of 115 experienced a vascular disorder considered to be related to clofarabine, the most frequently reported being flushing (13 events; not serious) and hypotension (5 events; all of which were considered to be serious; see section 4.4).
Najpogosteje so poročali o oblivanju (13 dogodkov; niso bili resni) in hipotenziji (5 dogodkov; vsi so bili ocenjeni kot resni; glejte poglavje 4.4).
CRp
PRt
Renal clearance
Ledvični očistek