natgillin/translations-raw huggingface dataset:
Clofarabine must first diffuse or be transported into target cells where it is sequentially phosphorylated to the mono- and bi-phosphate by intracellular kinases, and then finally to the active conjugate, clofarabine 5'-triphosphate.
Klofarabin mora najprej difundirati ali se transportirati v ciljne celice, kjer ga znotrajcelične kinaze zaporedno fosforilirajo v mono- in difosfate, in na koncu v aktivni konjugat, klofarabin 5'-trifosfat.
Total diluted volume 100 ml
Skupni volumen po razredčitvi 100 ml
- (Number of patients with a CR + Number of patients with a CRp) ÷ Number of eligible patients who received clofarabine
• (število bolnikov s PR + število bolnikov s PRt) ÷ število primernih bolnikov, ki so prejemali klofarabin
Although transplantation rate was not a study endpoint, 10/61 patients (16%) went on to receive a HSCT after treatment with clofarabine (3 after achieving a CR, 2 after a CRp, 3 after a PR, 1 patient that was considered a treatment failure by the IRRP and 1 that was considered not evaluable by the IRRP).
Čeprav stopnja transplantacije ni bila končna točka študije, je po zdravljenju s klofarabinom 10/61 bolnikov (16 %) prejelo HSCT (3 po PR, 2 po PRt, 3 po DR, zdravljenje 1 bolnika je bilo ocenjeno kot neuspelo po IRRP, zdravljenje enega po so pri IRRP označili kot zdravljenje, ki ga ni mogoče oceniti).
A total of 83% of patients experienced at least 1 infection after clofarabine treatment, including fungal, viral and bacterial infections (see section 4.4).
Pri 83 % bolnikov je prišlo do najmanj 1 pojava okužbe po zdravljenju s klofarabinom, vključno z glivičnimi, virusnimi in bakterijskimi okužbami (glejte poglavje 4.4).
Tell your doctor if you are using or have recently used: - medicines for heart disease; - any medicine that changes your blood pressure; - medicines that affect your liver or kidneys; - any other medicines including those obtained without a prescription.
Druga zdravila in zdravilo Evoltra Obvestite zdravnika, če jemljete ali ste pred kratkim jemali: - zdravila za srčne bolezni; - kakršnakoli zdravila, ki vplivajo na krvni tlak; - zdravila, ki vplivajo na jetra ali ledvice; - katerokoli zdravilo, tudi če ste ga dobili brez recepta.
The most frequent haematological laboratory abnormalities observed in patients treated with clofarabine were anaemia (83.3%; 95/114); leucopaenia (87.7%; 100/114); lymphopaenia (82.3%; 93/113), neutropaenia (63.7%; 72/113), and thrombocytopaenia (80.7%; 92/114).The majority of these events were of grade  3.
Najpogostejše hematološke laboratorijske nenormalnosti, ki so jih opazili pri bolnikih, ki so se zdravili s klofarabinom, so bile anemija (83,3 %; 95/114), levkopenija (87,7 %; 100/114), limfopenija (82,3 %; 93/113), nevtropenija (63,7 %; 72/113) in trombocitopenija (80,7 %; 92/114).
• Periodic Safety Updated Reports
• Redno posodobljena poročila o varnosti zdravila (PSUR)
What Evoltra is and what it is used for What you need to know before you use Evoltra How to use Evoltra
Kaj je zdravilo Evoltra in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Evoltra Kako uporabljati zdravilo Evoltra Možni neželeni učinki
Your treatment with Evoltra has been prescribed by a qualified doctor experienced in treating leukaemia.
Zdravljenje z zdravilom Evoltra vam je predpisal zdravnik, ki ima izkušnje z zdravljenjem levkemije.
Evoltra is used to treat children (≥ 1 year old), teenagers and young adults up to 21 years old with acute lymphoblastic leukaemia (ALL) when previous treatments have not worked or have stopped working.
Zdravilo Evoltra se uporablja za zdravljenje otrok, najstnikov in mladih odraslih do starosti 21 let z akutno limfoblastno levkemijo (ALL), pri katerih predhodna zdravljenja niso delovala ali so prenehala delovati.
Where follow-up data are available, the majority of bilirubin elevations returned to  grade 2 within 10 days.
Podatki iz nadaljnjega spremljanja, kjer so na voljo, kažejo, da se je večina povišanih vrednosti bilirubina znižala na  2. stopnjo v 10 dneh.
Very common: Febrile neutropaenia Common: Neutropaenia
Zelo pogosti: febrilna nevtropenija Pogosti: nevtropenija
Clofarabine AUC 0-24 hours (ng*h/ml)
AUC 0-24 ur klorafabina (ng*h/ml)
This is equivalent to 3.08 mmol (or 70.77 mg) of sodium and should be taken into consideration for patients on a controlled sodium diet.
To ustreza 3,08 mmol (ali 70,77 mg) natrija, kar je treba upoštevati pri bolnikih, ki imajo dieto z malo natrija.
Multivariate analysis showed that the pharmacokinetics of clofarabine are weight dependent and although white blood cell (WBC) count was identified as having an impact on clofarabine pharmacokinetics, this did not appear sufficient to individualise a patient's dosage regimen based on their WBC count.
Multivariantna analiza je pokazala, da je farmakokinetika klofarabina odvisna od telesne mase in čeprav so ugotovili, da število belih krvnih celic vpliva na farmakokinetiko klofarabina, ta učinek ni bil zadosten, da bi odmerjanje za posameznega bolnika določili na podlagi števila belih krvnih celic.
Fifty percent of patients experienced at least one cardiac disorders adverse event.
Pri petdesetih odstotkih bolnikov je prišlo do vsaj enega neželenega dogodka v povezavi s srčnimi boleznimi.
Adult population (including elderly)
Odrasli (vključno s starejšimi bolniki)
However, because of the potential for serious adverse reactions in nursing infants, breastfeeding should be discontinued prior to, during and following treatment with Evoltra (see section 4.3).
Vendar je zaradi možnosti resnih neželenih učinkov pri dojenčkih treba dojenje prekiniti pred zdravljenjem z zdravilom Evoltra, med njim ali po njem (glejte poglavje 4.3).
Frequency not known: C. difficile colitis
Pogostnost neznana: kolitis zaradi C. difficile
If you are the parent of a child who is being treated with Evoltra, tell the doctor if any of them apply to your child.
Če ste starši otroka, ki ga zdravijo z zdravilom Evoltra, obvestite zdravnika, če katerikoli od njih velja za vašega otroka.
Evoltra may not be suitable for you: - 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;
Zdravilo Evoltra 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; - če imate ali ste imeli srčno bolezen.
Severe hepatotoxic events have been reported in a Phase 1/2 combination study of clofarabine in paediatric patients with relapsed or refractory acute leukaemia.
Poročali so o hudih hepatotoksičnih dogodkih v fazi 1/2 združene klinične študije s klofarabinom pri pediatričnih bolnikih s ponovljeno ali neodzivno akutno levkemijo.
To date, there are limited data on the pharmacokinetics of clofarabine in paediatric patients with decreased creatinine clearance.
Do sedaj še ni dovolj podatkov o farmakokinetiki klofarabina pri pediatričnih bolnikih z zmanjšanim kreatininskim očistkom.
Tell your doctor if any of these conditions apply to you.
Obvestite zdravnika, če katerikoli od teh stanj velja za vas.
It should be filtered through a sterile 0.2 micrometre syringe filter 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 0,2-mikrometrski filter v brizgi in nato razredčiti z 0,9 % raztopino natrijevega klorida (9 mg/ml) za intravensko infundiranje do prostornine, navedene v primerih v tabeli spodaj.
Concentrate for solution for infusion 20 mg/20 ml
koncentrat za raztopino za infundiranje 20 mg/20 ml
In addition, clofarabine possesses greater resistance to cellular degradation by adenosine deaminase and decreased susceptibility to phosphorolytic cleavage than other active substances in its class whilst the affinity of clofarabine triphosphate for DNA polymerase  and ribonucleotide reductase is similar to or greater than that of deoxyadenosine triphosphate.
Poleg tega je klofarabin odpornejši na razgradnjo z adenozin deaminazo v celici in je manj dovzeten za fosforolitično cepljenje kot druge zdravilne učinkovine v tej skupini zdravil, medtem ko je afiniteta klofarabin trifosfata za DNA-polimerazo  in ribonukleotid-reduktazo podobna ali večja kot pri deoksiadenozin trifosfatu.
The threshold for developmental toxicity was considered to be 6 mg/m 2/day in rats and 1.2 mg/m 2/day in rabbits.
Odmerek, pri katerem je prišlo do razvojne toksičnosti, je bil 6 mg/m2/dan pri podganah in 1,2 mg/m2/dan pri kuncih.
The safety and efficacy of clofarabine were evaluated in a phase I, open-label, non-comparative, dose-escalation study in 25 paediatric patients with relapsed or refractory leukaemia (17 ALL; 8 AML) who had failed standard therapy or for whom no other therapy existed.
Varnost in učinkovitost klofarabina so ocenili v odprti, neprimerjalni študiji s povečevanjem odmerka 1. faze, pri 25 pediatričnih bolnikih s ponovljeno ali neodzivno levkemijo (17 ALL; 8 AML), pri katerih standardno zdravljenje ni bilo uspešno ali pri katerih ni bilo drugega zdravljenja.
Tell your doctor if any of these apply to you.
Obvestite zdravnika, če karkoli od tega velja za vas.
• Complete blood and platelet counts should be obtained at regular intervals, more frequently in patients who develop cytopaenias.
• V rednih intervalih je treba opraviti pregled celotne krvne slike in štetje trombocitov, pogosteje pri bolnikih, pri katerih se pojavi citopenija.
Pericardial effusion and pericarditis were reported as an adverse event in 9% (10/115) of patients.
O perikardnem izlivu in perikarditisu so poročali pri 9 % (10/115) bolnikov.
Evoltra is a potent antineoplastic agent with potentially significant haematological and non-haematological adverse reactions (see section 4.8).
Zdravilo Evoltra je močan antineoplastik z morebitno pomembnimi hematološkimi in nehematološkimi neželenimi učinki (glejte poglavje 4.8).
This medicine has been authorised under “Exceptional Circumstances”.
Zdravilo je pridobilo dovoljenje za promet v »izjemnih okoliščinah«.
There are currently limited data on the safety and efficacy of clofarabine when administered for more than 3 treatment cycles.
Podatkov o varnosti in učinkovitosti klofarabina, kadar se odmerja več kot 3 cikle zdravljenja, so trenutno omejeni.
The information provided is based on data generated from clinical trials in which 115 patients (> 1 and ≤ 21 years old) with either ALL or acute myeloid leukaemia (AML) received at least one dose of clofarabine at the recommended dose of 52 mg/m daily x 5.
Informacije o neželenih učinkih temeljijo na podatkih iz kliničnih preskušanj, pri katerih je 115 bolnikov (starih > 1 in ≤ 21 let) z ALL ali akutno mieloidno levkemijo (AML) prejelo vsaj en odmerek klofarabina v priporočenem odmerku 52 mg/m2 dnevno x 5.
There are currently insufficient data to establish the safety and efficacy of clofarabine in adult patients (see section 5.2).
Trenutno ni na voljo dovolj podatkov, da bi ocenili varnost in učinkovitost klofarabina pri odraslih bolnikih (glejte poglavje 5.2).
If you are the parent of a child who is being treated with Evoltra, tell the doctor if any of the above conditions apply to your child.
Če ste starši otroka, ki ga zdravijo z zdravilom Evoltra, obvestite zdravnika, če katerikoli od teh stanj velja za vašega otroka.
In addition, clofarabine delayed tumour growth and, in some cases, caused tumour regression in an assortment of human and murine tumour xenografts implanted in mice.
Poleg tega je klofarabin upočasnil rast tumorjev ter v nekaterih primerih povzročil regresijo tumorjev pri različnih človeških in glodavskih heterolognih transplantatih, presajenih na miši.
The majority of elevations in ALT and AST occurred within 10 days of clofarabine administration and returned to  grade 2 within 15 days.
Do večine pojavov povišanih vrednosti ALT in AST je prišlo v 10 dneh po odmerjanju klofarabina ter so se znižale na  2. stopnjo v 15 dneh.
(59%), febrile neutropaenia (35%), headache (24%), rash (21%), diarrhoea (20%), pruritus (20%), pyrexia (19%), palmar-plantar erythrodysaesthesia syndrome (15%), fatigue (14%), anxiety (12%), mucosal inflammation (11%), and flushing (11%).
Najpogosteje so poročali o navzei (61 % bolnikov), bruhanju (59 %), febrilni nevtropeniji (35 %), glavobolu (24 %), osipu (21 %), diareji (20 %), srbenju (20 %), pireksiji (19 %), sindromu palmarno-plantarne eritrodisestezije (15 %), utrujenosti (14 %), tesnobi (12 %), vnetju sluznice (11 %) in oblivanju (11 %).
Common: Septic shock*, sepsis, bacteraemia, pneumonia, herpes zoster, herpes simplex, oral candidiasis
Pogosti: septični šok*, sepsa, bakteremija, pljučnica, herpes zoster, herpes simpleks, oralna kandidoza
They were reported at exposure levels (Cmax) approximately 7 to 13 fold (after 3 or more dosing cycles) or 16 to 35 fold (after one or more dosing cycles) higher than clinical exposures.
O toksičnih učinkih so poročali pri izpostavljenosti (Cmax), ki je bila približno 7- do 13-krat (po 3 ali več ciklih odmerjanja) ali 16- do 35-krat (po enem ali več ciklih
- little or no urine, drowsiness, nausea, vomiting, breathlessness, loss of appetite and /or weakness (possible signs of acute kidney failure or kidney failure).
- malo ali nič urina, zaspanost, slabost, bruhanje, zasoplost, izguba apetita in/ali oslabelost (možni znaki akutne odpovedi ledvic ali odpovedi ledvic).
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) ter celična degeneracija epididimisa in degeneracija seminifernega epitela pri psih pri klinično ustrezni izpostavljenosti (> 7,5 mg klofarabina/m2/dan).
Patients should be monitored for renal toxicity and clofarabine should be discontinued as necessary.
Bolnike je treba spremljati glede toksičnosti za ledvice in, če je potrebno, prekiniti zdravljenje s klofarabinom.
• Complete disappearance of circulating blasts
• popolno izginotje blastov v krvnem obtoku
To date, the highest daily dose administered to human beings is 70 mg/m for 5 consecutive days (2 paediatric ALL patients).
Največji odmerek, ki so ga odmerili pri človeku, je 70 mg/m2 5 dni zaporedoma (2 pediatrična bolnika z ALL).
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2
Če ni porabljeno takoj, je uporabnik odgovoren za čas in pogoje shranjevanja pred uporabo, ti pa ne bi smeli trajati dlje kot 24 ur pri 2 °C do 8 °C, razen če se je redčenje izvedlo v nadzorovanih in preverjeno aseptičnih okoliščinah.
Patients who have previously received a hematopoietic stem cell transplant (HSCT) may be at higher risk for hepatotoxicity suggestive of veno-occlusive disease (VOD) following treatment with clofarabine (40 mg/m2) when used in combination with etoposide (100 mg/m2) and cyclophosphamide
Bolniki s predhodno presaditvijo krvotvornih matičnih celic (hematopoietic stem cell transplant, HSCT) so lahko izpostavljeni povišanemu tveganju za hepatotoksično sugestivno venookluzivno bolezen (veno-occlusive disease, VOD) po zdravljenju s klofarabinom (40 mg/m2), kadar se le-ta uporablja skupaj z etopozidom (100 mg/m2) in ciklofosfamidom (440 mg/m2).
Accordingly, longer infusion times should be considered in children weighing  20 kg (see section 4.2).
Temu ustrezno je treba pri otrocih, ki tehtajo  20 kg, razmisliti o daljšem času infundiranja (glejte poglavje 4.2).
CRp = Complete Remission in the Absence of Total Platelet Recovery
PRt = Popolna remisija brez popolne obnovitve števila trombocitov
If a patient becomes pregnant during treatment with clofarabine, they should be informed of the possible hazard to the foetus.
Če bolnice med zdravljenjem s klofarabinom zanosijo, jih je treba obvestiti o morebitnih tveganjih za plod.
Dosing commenced at 11.25 with escalation to 15, 30, 40, 52 and 70 mg/m2/day by intravenous infusion for 5 days every
Odmerjanje se je začelo pri 11,25, odmerek pa so nato povečevali na 15, 30, 40, 52 in 70 mg/m2/dan z intravensko infuzijo 5 dni zaporedoma, vsakih 2 do 6 tednov, glede na toksične učinke in odziv.
Treatment cycles should be repeated every 2 to 6 weeks (from the starting day of the previous cycle) following recovery of normal haematopoiesis (i.e. ANC ≥ 0.75 × 10
Cikle zdravljenja je treba ponoviti vsakih 2 do 6 tednov (od začetnega dne prejšnjega cikla) po vzpostavitvi normalne hematopoeze (tj. ANC (Absolute Neutrophile Count - absolutno število nevtrofilcev) ≥ 0,75 × 109/l) in izhodiščnega delovanja organov.
Common: Hyperbilirubinaemia, jaundice, venoocclusive disease, increases in alanine (ALT)* and aspartate (AST)* aminotransferases, hepatic failure Uncommon: Hepatitis
Pogosti: hiperbilirubinemija, zlatenica, venookluzivna bolezen, povečanje vrednosti alanin- (ALT)* in aspartat(AST)* aminotransferaz, jetrna odpoved Občasni: hepatitis
Yearly, simultaneously with submission of Periodic Safety Update reports
Vsako leto, sočasno s predložitvijo Redno posodobljenih poročil o varnosti zdravila (PSUR).
• An M1 marrow that did not qualify for CR or CRp
• kostni mozeg M1, ki ni izpolnil pogojev za PR ali PRt
How to use Evoltra
Kako uporabljati zdravilo Evoltra
The pharmacokinetics of clofarabine were studied in 40 patients aged between 2 to 19 years old with relapsed or refractory ALL or AML.
Farmakokinetiko klofarabina so preučevali pri 40 bolnikih, starih od 2 do 19 let s ponovljeno ali neodzivno ALL ali AML.
Four renal adverse events in 115 patients were considered to be related to clofarabine, none of which were serious; haematuria (3 events) and acute renal failure (1 event) (see sections 4.3 and 4.4).
Za štiri neželene dogodke izmed 115 bolnikov so menili, da so povezani z uporabo klofarabina, med njimi nobeden ni bil resen: hematurija (3 dogodki) in akutna ledvična odpoved (1 dogodek) (glejte poglavji 4.3 in 4.4).
If persistent leukaemia is not evident, it is recommended that the dose for the next cycle be reduced by 25% of the previous dose following recovery of ANC to ≥ 0.75 × 10
Če ni znakov persistentne levkemije, se po vzpostavitvi vrednosti ANC ≥ 0,75 × 109/l priporoča zmanjšanje odmerka naslednjega cikla za 25 % prejšnjega odmerka.
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)
AUC0-24 ur klofarabina po ocenjenem izhodiščnem kreatininskem očistku pri bolnikih, starih 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)
The MAH shall provide yearly updates on any new information concerning efficacy and safety of the product in paediatric patients with acute lymphoblastic leukaemia who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response.
Imetnik dovoljenja za promet z zdravilom bo zagotovil letne posodobitve glede vseh novih informacij o učinkovitosti in varnosti zdravila pri pediatričnih bolnikih z akutno limfoblastno levkemijo, ki jim je bolezen recidivirala ali so odporni (potem ko so prejeli vsaj dve predhodni shemi) in pri katerih ni pričakovati, da bi katera koli druga terapevtska možnost prinesla trajen odziv.
Systemic inflammatory response syndrome (SIRS) or capillary leak syndrome SIRS, capillary leak syndrome (signs and symptoms of cytokine release, e.g., tachypnea, tachycardia, hypotension, pulmonary oedema) were reported as an adverse event in 5% (6/115) of paediatric patients (5 ALL, 1 AML) (see section 4.4).
O sindromu SIRS, sindromu kapilarnih razpok (znaki in simptomi izločanja citokinov, npr. tahipneja, tahikardija, hipotenzija, pljučni edem) kot o neželenem učinku so poročali pri 5 % (6/115) pediatričnih bolnikov (5 ALL, 1 AML) (glejte poglavje 4.4).
Excipients: Sodium chloride and water for injections.
Pomožne snovi: natrijev klorid in voda za injekcije.
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.
Če se pri bolniku pojavi en ali več hudih toksičnih učinkov (3. stopnje po splošnih merilih toksičnosti (CTC - Common Toxicity Criteria) Narodnega inštituta za zdravljenje raka (NCI - National Cancer 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.
Individual duration remission and survival data for patients who achieved CR or CRp
Posamično trajanje remisije in podatki o preživetju za bolnike, ki so dosegli PR ali PRt najboljši odgovor čas do SR (tedni)
OUTER CARTON
ZUNANJA KARTONSKA ŠKATLA
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).
Sočasni uporabi zdravil, ki so povezana s toksičnimi učinki na jetra, se je treba izogibati, kadarkoli je to mogoče (glejte poglavji 4.5 in 4.8).
Type I glass vial with bromobutyl rubber stopper, polypropylene flip-off cap and aluminium overseal.
Viala iz stekla tipa I z zamaškom iz bromobutilne gume, polipropilensko dvižno zaporko in aluminijastim tesnilom.
Adverse reactions considered to be related to clofarabine reported at frequencies ≥ 1/1,000 (i.e. in > 1/115 patients) in clinical trials and post-marketing
Neželeni učinki, za katere so v kliničnih preskušanjih in v obdobju trženja ocenili, da so povezani z uporabo klofarabina in so o njih poročali s pogostnostjo ≥ 1/1.000 (tj. pri > 1/115 bolnikov)
Sixty-four patients of 115 (55.7%) experienced at least one vascular disorders adverse event.
Pri štiriinšestdesetih bolnikih izmed 115 (55,7 %) je prišlo do vsaj enega neželenega dogodka v povezavi z žilnimi boleznimi.
The use of disposable gloves and protective garments is recommended when handling Evoltra.
Pri ravnanju z zdravilom Evoltra je priporočeno uporabljati rokavice za enkratno uporabo in zaščitna oblačila.
However, the pharmacokinetics of clofarabine in adults with relapsed or refractory AML following administration of a single dose of 40 mg/m clofarabine by intravenous infusion over 1 hour were comparable to those described above in patients aged between 2 to 19 years old with relapsed or refractory ALL or AML following administration of 52 mg/m clofarabine by intravenous infusion over 2 hours for 5 consecutive days.
Farmakokinetika pri odraslih bolnikih s ponovljeno ali neodzivno AML po intravenskem infundiranju enkratnega odmerka klofarabina 40 mg/m2 v 1 uri je bila primerljiva z zgoraj opisano farmakokinetiko pri bolnikih, starih od 2 do 19 let, s ponovljeno ali neodzivno ALL ali AML po intravenskem infundiranju 52 mg klofarabina/m2 v 2 urah 5 dni zaporedoma.
• Prophylactic administration of allopurinol should be considered if hyperuricemia (tumour lysis) is expected.
• Če sumite na hiperurikemijo (tumorsko lizo), je treba razmisliti o profilaktični uporabi alopurinola.
9/l for more than 4 weeks from the start of the last cycle, it is recommended that the dose for the next cycle be reduced by 25%.
Če je vrednost ANC pri bolnikih več kot 4 tedne od začetka zadnjega cikla < 0,5 × 109/l, se priporoča zmanjšanje odmerka v naslednjem ciklu za 25 %.