FrancophonIA/ELRC3.0 huggingface dataset:
English: In a pharmacokinetic/pharmacodynamic cross study analysis, race had no apparent effect on nelarabine, ara-G, or intracellular ara-GTP pharmacokinetics.
Croatian: U ukriženoj analizi rezultata farmakokinetičkih/farmakodinamičkih ispitivanja, rasa nije imala nikakvoga očitog utjecaja na farmakokinetiku nelarabina, ara-G, odnosno intracelularnog ara-GTP-a.
English: Atriance contains sodium
Croatian: Atriance sadrži natrij
English: The appropriate dose of nelarabine must be transferred into polyvinylchloride (PVC) or ethyl vinyl acetate (EVA) infusion bags or glass containers and administered intravenously as a two-hour infusion in adult patients and as a one-hour infusion in paediatric patients.
Croatian: Odgovarajuća doza nelarabina se mora prenijeti u polivinilkloridnu (PVC) ili etilvinilacetatnu (EVA) infuzijsku vrećicu ili staklenu bočicu i primijeniti intravenski kao dvosatna infuzija u odraslih bolesnika, a kao jednosatna infuzija u pedijatrijskih bolesnika.
English: If you have any concerns, discuss them with your doctor.
Croatian: Ukoliko imate bilo kakvih dvojbi, raspravite ih sa svojim liječnikom.
English: Limited clinical pharmacology data are available for patients below the age of 4 years.
Croatian: Malobrojni su klinički farmakološki podaci primjenjivi na bolesnike mlađe od 4 godine.
English: There are no or limited amount of data from the use of nelarabine in pregnant women.
Croatian: Nema podataka ili je količina podataka ograničena o terapijskoj primjeni nelarabina u trudnica.
English: The most frequently occurring adverse events were fatigue; gastrointestinal disorders; haematological disorders; respiratory disorders; nervous system disorders (somnolence, peripheral neurological disorders [sensory and motor], dizziness, hypoaesthesia, paraesthesia, headache); and pyrexia.
Croatian: Najčešće nuspojave su bile umor, poremećaji probavnoga sustava; hematološki poremećaji; respiratorni poremećaji; neurološki poremećaji (somnolencija, poremećaji perifernog živčanog sustava [senzorni i motorički], omaglica, hipoestezija, parestezija, glavobolja); i pireksija.
English: It is likely that nelarabine overdose would result in severe neurotoxicity (possibly including paralysis, coma), myelosuppression and potentially death.
Croatian: Predoziranje nelarabinom vjerojatno bi rezultiralo teškom neurotoksičnošću (uključujući moguću paralizu i komu), mijelosupresijom, a potencijalno i smrtnim ishodom.
English: These reactions have included altered mental states including severe somnolence, confusion and coma, central nervous system effects including convulsions, ataxia and status epilepticus, and peripheral neuropathy including hypoesthesia ranging from numbness and paresthesias to motor weakness and paralysis.
Croatian: Te nuspojave uključuju promjene mentalnog statusa, uključujući i izrazitu somnolenciju, konfuziju i komu, zatim djelovanje na središnji živčani sustav, uključujući konvulzije, ataksiju i epileptički status, te perifernu neuropatiju uključujući hipoesteziju u rasponu od utrnulosti i parestezija do motoričke slabosti i paralize.
English: Therefore, close monitoring for neurological reactions is strongly recommended, and nelarabine must be discontinued at the first sign of neurological reactions of NCI CTCAE Grade 2 or greater.
Croatian: Stoga se izričito preporučuje nadzirati neurološki status bolesnika te se lijek mora ukinuti na prvi znak neuroloških nuspojava NCI CTCAE 2. ili višeg stupnja.
English: The apparent clearance of ara-G (Cl/F) is comparable between the two groups [9.5 l/h/m
Croatian: Klirens ara-G (Cl/F), zabilježen 1. dana liječenja usporediv je u obje ispitivane skupine [9,5 l/h/m
English: It is not known whether Atriance is passed on through breast milk.
Croatian: Nije poznato izlučuje li se Atriance u majčino mlijeko.
English: Patients treated with nelarabine are potentially at risk of suffering from somnolence during and for several days after treatment.
Croatian: U bolesnika liječenih nelarabinom postoji mogućnost somnolencije tijekom primjene nelarabina i nekoliko dana nakon liječenja.
English: Nelarabine was mutagenic to L5178Y/TK mouse lymphoma cells with and without metabolic activation.
Croatian: Nelarabin se pokazao mutagenim za stanice mišjega limfoma L5178Y/TK, nakon metaboličke aktivacije i bez nje.
English: Duration of response in both classifications of response ranged between 4.7 and 36.4 weeks and median overall survival was 13.1 weeks [95 % CI: 8.7-17.4] and survival at one year was 14 % [95 % CI: 3 %-26 %].
Croatian: U oba slučaja trajanje odgovora kretalo se od 4,7 do 36,4 tjedana, a medijan ukupnoga preživljenja iznosio je 13,1 tjedan [95%-ni CI: 8,7-17,4], dok je preživljenje nakon godine dana iznosilo 14% [95%-ni CI:
English: In addition to the adverse reactions seen in the pivotal clinical studies, there are also data from 875 patients from NCI studies/compassionate use programme (694 patients) and Phase I (181 patients) studies of nelarabine.
Croatian: Uz nuspojave uočene u okviru ključnih kliničkih ispitivanja, postoje i podaci o nuspojavama prikupljenim na uzorku od 875 bolesnika obrađenih u okviru studija koje je proveo NCI, kao i podaci prikupljeni tijekom programa milosrdne primjene (694 bolesnika) i podaci prikupljeni u ispitivanjima faze I (181 bolesnik).
English: Atriance can make people feel drowsy or sleepy, both during and for some days after treatment.
Croatian: Atriance može izazvati mamurnost ili pospanost, kako za vrijeme trajanja liječenja, tako i nekoliko dana nakon njegovog završetka.
English: Atriance 5 mg/ml solution for infusion
Croatian: Atriance 5 mg/ml otopina za infuziju
English: For patients at risk of hyperuricaemia, the use of allopurinol should be considered.
Croatian: U bolesnika u kojih postoji rizik od razvoja hiperuricemije, valja razmotriti primjenu alopurinola.
English: Consideration to appropriate birth control is recommended to be discussed with your doctor.
Croatian: O primjerenim metodama kontrole začeća uputno je porazgovarati sa svojim liječnikom.
English: Median overall survival was 20.6 weeks [95 % CI: 10.4-36.4].
Croatian: Medijan ukupnoga preživljenja iznosio je 20,6 tjedana [95%-ni CI: 10,4-36,4].
English: It is unknown whether nelarabine or its metabolites are excreted in human breast milk.
Croatian: Nije poznato izlučuju li se nelarabin, odnosno njegovi metaboliti, u majčino mlijeko.
English: • Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Croatian: • Pri slučajnom kontaktu s kožom ili očima kontaktna površina mora se odmah obilno isprati vodom.
English: • Build up of fluid around the lungs leading to chest pain and difficulty in breathing (pleural effusion); wheezing
Croatian: • Nakupljanje tekućine oko pluća, što dovodi do bolova u prsnom košu i otežanoga disanja (pleuralni izljev), zviždanje u prsima.
English: • All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
Croatian: • Sve predmete korištene tijekom primjene ili čišćenja, uključujući rukavice, treba odložiti u posebno odvojen otpad visokog rizika, namijenjen za spaljivanje.
English: Your doctor also needs to know the following before you are given this medicine:
Croatian: Prije nego li Vam propiše ovaj lijek, Vaš liječnik mora znati i sljedeće:
English: Five of the 28 patients (18 %) [95 % CI: 6 %-37 %] treated with nelarabine achieved a complete response (bone marrow blast counts ≤ 5 %, no other evidence of disease, and full recovery of peripheral blood counts).
Croatian: U 5 od 28 bolesnika (18%) [95%-ni CI: 6%-37%] liječenih nelarabinom postignut je potpuni terapijski odgovor (broj blasta u koštanoj srži ≤ 5%, izostanak bilo kakvih drugih pokazatelja bolesti, te potpun oporavak svih staničnih loza u perifernoj krvi).
English: • Weight loss and loss of appetite (anorexia); stomach pains; sore mouth, mouth ulcers or inflammation.
Croatian: • Gubitak na tjelesnoj težini i gubitak apetita (anoreksija); bolovi u trbuhu; upala usne šupljine, ranice u usnoj šupljine ili upala.
English: Limited clinical pharmacology data are available for patients below the age of 4 years (see section 5.2).
Croatian: Podaci o farmakološkim karakteristikama lijeka u uvjetima kliničke primjene u bolesnika mlađih od 4 godine, su ograničeni (vidjeti dio 5.2.).
English: Metabolism and nutrition disorders Hypoglycaemia
Croatian: Poremećaji metabolizma i prehrane Hipoglikemija
English: Of the 39 patients who had received two or more prior induction regimens, 5 (13 %) [95 % CI: 4 %27 %] achieved a complete response (bone marrow blast counts ≤ 5 %, no other evidence of disease, and full recovery of peripheral blood counts) and 9 (23 %) [95 % CI: 11 %-39 %] achieved complete responses with or without full haematological recovery.
Croatian: Od 39 bolesnika koji su prethodno prošli dva ili više indukcijska terapijska protokola, u 5 (13%) [95%-ni CI: 4%-27%] postignut je potpuni odgovor (broj blasta u koštanoj srži ≤ 5%, izostanak bilo kakvih pokazatelja bolesti, te potpuni oporavak svih staničnih loza u perifernoj krvi), dok je u njih 9 (23%) [95%-ni CI: 11%-39%] postignut potpuni odgovor s ili bez oporavka krvne slike.
English: • Muscle pain.
Croatian: • Bol u mišićima.
English: Atriance 5 mg/ml solution for infusion nelarabine
Croatian: Atriance 5 mg/ml otopina za infuziju nelarabin
English: - Staff should be trained in how to handle and transfer the medicinal product.
Croatian: - Osoblje treba biti obučeno za rukovanje i prijenos ovog lijeka.
English: Complete blood counts including platelets must be monitored regularly (see sections 4.2 and 4.8).
Croatian: Nužno je redovito kontrolirati kompletnu krvnu sliku, uključujući i broj trombocita (vidjeti dijelove 4.2 i 4.8).
English: The normal procedures for proper handling and disposal of anti-tumour medicinal products should be adopted, namely:
Croatian: Trebalo bi slijediti uobičajene postupke za ispravno rukovanje i odlaganje antitumorskih lijekova:
English: In a cross-study analysis using data from four Phase I studies, the pharmacokinetics of nelarabine and ara-G were characterized in patients aged less than 18 years and adult patients with refractory leukaemia or lymphoma.
Croatian: U unakrsnoj analizi podataka iz četiri ispitivanja faze I, farmakokinetika nelarabina i ara-G ispitivana je u bolesnika mlađih od 18 godina, te u odraslih bolesnika oboljelih od refraktorne leukemije ili refraktornoga limfoma.
English: Nelarabine at a dose of 1500 mg/m2/day was administered intravenously over two hours on days 1, 3 and 5 of a 21 day cycle.
Croatian: Nelarabin u dozi od 1500 mg/m2/dan primjenjivan je putem dvosatne intravenske infuzije, i to 1., 3. i 5. dan 21-dnevnoga ciklusa.
English: Eighty-four (84) patients, 39 of whom had received two or more prior induction regimens and 31 whom had received one prior induction regimen, were treated with 650 mg/m2/day of nelarabine administered intravenously over 1 hour daily for 5 consecutive days repeated every 21 days.
Croatian: Osamdeset i četiri bolesnika (84), od kojih je 39 prethodno primilo 2 ili više indukcijskih terapijskih protokola, a 31 jedan indukcijski protokol, liječeno je dozom nelarabina od 650 mg/m2/dan, primijenjenom kroz 5 uzastopnih dana u obliku jednosatne intravenske infuzije.
English: Clinical efficacy and data
Croatian: Klinička djelotvornost i sigurnost
English: Stopping treatment with Atriance Your doctor will decide when to stop the treatment.
Croatian: Prekid liječenja lijekom Atriance Trajanje liječenja odredit će Vaš liječnik.
English: • Muscle weakness (possibly associated with peripheral neuropathy - see above), joint pain, back pain; pains in hands and feet including a sensation of pins and needles sensation and numbness.
Croatian: • Slabost mišića (potencijalno povezana s perifernom neuropatijom - vidjeti gore), bol u zglobovima, križobolja; bol u šakama i stopalima, uključujući i osjećaj „bockanja“ i utrnulost.
English: No data are available to provide a dose advice for patients with Clcr less than 50 ml/min.
Croatian: Ne postoje podaci koji bi omogućili donošenje preporuke o visini doze primjerene za bolesnike čiji Clcr iznosi manje od 50 ml/min.
English: - Personnel handling this medicinal product during handling/transfer should wear protective clothing including mask, goggles and gloves.
Croatian: - Osoblje koje rukuje ovim lijekom mora prilikom rukovanja/prenošenja ovoga lijeka nositi zaštitnu odjeću, što uključuje i zaštitnu masku, zaštitne naočale i zaštitne rukavice.
English: Initial symptoms including nausea and vomiting, shortness of breath, an irregular heartbeat, clouding of urine, lethargy and/or joint discomfort.
Croatian: Početni simptomi uključuju mučninu i povraćanje, nedostatak zraka i nepravilni rad srca, zamućenje mokraće, bezvoljnost i/ili tegobe sa zglobovima.
English: Decreased renal function, which is more common in the elderly, may reduce ara-G clearance (see section 4.2).
Croatian: Smanjena bubrežna funkcija koja je češća u bolesnika starije životne dobi, može umanjiti klirens ara-G (vidjeti dio 4.2).
English: For ara-G, mean VSS/F values were 44.8 l/m
Croatian: Kada je riječ o ara-G, prosječna VSS/F vrijednost zabilježena u odraslih bolesnika iznosila je 44,8 l/m
English: Signs of an infection include: fever serious deterioration of your general condition local symptoms such as sore throat, sore mouth or urinary problems (for example, a burning sensation when urinating, which may be a urinary infection) Tell your doctor immediately if you get any of these.
Croatian: U znakove infekcije spadaju: vrućica ozbiljno pogoršanje Vašega općega zdravstvenoga stanja lokalni simptomi poput upale grla, upale usne šupljine ili problemi s mokrenjem (primjerice, pečenje pri mokrenju, koje može biti simptom infekcije mokraćnoga sustava).
English: This is to be taken into consideration if you are on a controlled sodium diet.
Croatian: To valja uzeti u obzir ako Vam je propisana dijeta s ograničenim unosom natrija.
English: Because the timecourse of intracellular ara-GTP was prolonged, its elimination half-life could not be accurately estimated.
Croatian: Kako je uslijed njegova nakupljanja u stanicama zadržavanje ara-GTP-a u organizmu bilo produljeno, poluvrijeme njegova izlučivanja iz organizma nije se moglo sa sigurnošću utvrditi.
English: • a type of leukaemia, called T-cell acute lymphoblastic leukaemia.
Croatian: • vrste leukemije nazvane akutnom limfoblastičnom leukemijom T-stanica.
English: Neurotoxicity is the dose-limiting toxicity associated with nelarabine therapy (see section 4.4).
Croatian: Neurotoksični učinci nelarabina, ovisni o dozi, ograničavajući su čimbenik u terapiji nelarabinom (vidjeti dio 4.4).
English: The effect of race on nelarabine and ara-G pharmacokinetics has not been specifically studied.
Croatian: Utjecaj rase bolesnika na farmakokinetiku nelarabina i ara-G nije specifično proučavan.
English: This lymphoma is caused by a mass of lymphoblasts, a type of white blood cell.
Croatian: Ovaj limfom uzrokovan je prisutnošću velikoga broja limfoblasta, podvrste bijelih krvnih stanica.
English: Water for injections Hydrochloric acid (to adjust the pH) Sodium hydroxide (to adjust the pH)
Croatian: 6.1 Popis pomoćnih tvari natrijev klorid voda za injekcije kloridna kiselina (za podešavanje pH) natrijev hidroksid (za podešavanje pH)
English: • Low blood levels of some substances: low calcium levels, which may cause muscle cramps, abdominal cramps or spasms low magnesium levels, which may cause muscle weakness, confusion, "jerky" movements, high blood pressure, irregular heart rhythms and decreased reflexes with severely low blood magnesium levels.
Croatian: • Niske razine nekih tvari u krvi: niska razina kalcija, što može uzrokovati grčenje mišića, grčevite bolove u trbuhu ili grčeve niska razina magnezija, što može uzrokovati slabost mišića, smetenost i trzajne kretnje, visoki krvni tlak, nepravilni rad srca i oslabljene reflekse, osobito ako je razina magnezija u krvi izrazito snižena. niska razina kalija može uzrokovati osjećaj slabosti niska razina glukoze može uzrokovati mučninu, znojenje, slabost, nesvjesticu, smetenost ili halucinacije.
English: Nelarabine is a pro-drug of the deoxyguanosine analogue ara-G. Nelarabine is rapidly demethylated by adenosine deaminase (ADA) to ara-G and then phosphorylated intracellularly by deoxyguanosine kinase and deoxycytidine kinase to its 5'-monophosphate metabolite.
Croatian: Nelarabin se pomoću adenozin deaminaze (ADA) brzo demetilira u ara-G i potom fosforilira u stanici pomoću deoksigvanozin kinaze i deoksicitidin kinaze u svoj 5'-monofosfatni metabolit.
English: - Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Croatian: - Pri nehotičnom doticaju s kožom ili očima, kontaktna površina mora se odmah isprati obilnom količinom vode.
English: • Increased amounts of bilirubin in your blood, which may cause yellowing of the skin and may make you feel lethargic.
Croatian: • Povišenje razine bilirubina u krvi, što može prouzročiti žutilo kože i osjećaj bezvoljnosti (letargičnost).
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Croatian: POSEBNE OBVEZE ZA ISPUNJAVANJE MJERA NAKON DAVANJA ODOBRENJA KOD ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U IZNIMNIM OKOLNOSTIMA
English: On the day 1, 3, and 5 schedule, Cmax and AUC(0-t) values on day 3 were approximately 50 % and 30 %, respectively, greater than Cmax and AUC(0-t) values on day 1.
Croatian: Pri primjeni lijeka 1., 3. i 5. dana terapijskoga ciklusa, vrijednost Cmax izmjerena 3. dana liječenja iznosila je oko 50%, a vrijednost AUC(0-t) oko 30%, što premašuje vrijednosti Cmax i AUC(0-t) izmjerenih 1. dana terapijskoga ciklusa.
English: Further data with respect to nelarabine and ara-G pharmacokinetics in the paediatric population are provided in other subsections.
Croatian: Dodatni podaci o farmakokinetici nelarabina i ara-G, prikupljeni ispitivanjima pedijatrijske populacije, izneseni su u drugim odlomcima ovoga teksta.
English: • Feeling drowsy and sleepy; headache; dizziness.
Croatian: • Omamljenost i pospanost; glavobolja; omaglica.
English: Musculoskeletal and connective tissue disorders Muscle weakness
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva Slabost mišića
English: Accumulation of ara-GTP in leukaemic blasts allows for preferential incorporation of ara-GTP into deoxyribonucleic acid (DNA) leading to inhibition of DNA synthesis.
Croatian: Nakupljanje ara-GTP-a u leukemičnim blastima omogućuje njegovu ugradnju prvenstveno u deoksiribonukleinsku kiselinu (DNK), što dovodi do kočenja sinteze DNK i posljedične smrti stanice.
English: Nelarabine has been administered in clinical studies up to a dose of 75 mg/kg (approximately 2,250 mg/m2) daily for 5 days to a paediatric patient, up to a dose of 60 mg/kg (approximately 2,400 mg/m2) daily for 5 days to 5 adult patients and up to 2,900 mg/m in a further 2 adults on days 1,
Croatian: U okviru kliničkih ispitivanja, nelarabin je u pedijatrijskih bolesnika primjenjivan do doze od 75 mg/kg (oko 2250 mg/m2) dnevno kroz 5 dana, do doze od 60 mg/kg (oko 2400 mg/m2) dnevno kroz
English: The normal procedures for proper handling and disposal of cytotoxic anti-tumour medicinal products should be adopted, namely:
Croatian: Valja se pridržavati uobičajenih postupaka propisanih za pravilno rukovanje i odlaganje u otpad citotoksičnih antitumorskih lijekova, što podrazumijeva sljedeće:
English: This treatment may vary, depending on the results of your regular blood tests.
Croatian: Ovakav način liječenja uobičajeno je ponavljati svaka tri tjedna, što se može mijenjati ovisno o rezultatima Vaših redovitih kontrolnih krvnih pretraga.
English: 5 every 21 days, 2 patients developed a significant grade 3 ascending sensory neuropathy.
Croatian: 1., 3. i 5. dan terapijskoga ciklusa ponavljanoga svakih 21 dan, 2 bolesnika razvila su klinički značajnu senzornu neuropatiju uzlaznoga tipa 3. stupnja.
English: • Feeling generally weak and tired (temporary anaemia).
Croatian: • Općeniti osjećaj slabosti i umora (prolazna slabokrvnost).
English: Intracellular ara-GTP Cmax and AUC(0-t) values at the same dose level were 2- to 3- fold greater on average in adult female than in adult male patients.
Croatian: Pri istoj dozi, vrijednosti Cmax i AUC(0-t) intracelularnog ara-GTP-a u odraslih su oboljelih žena bile 2 do 3 puta više negoli u odraslih oboljelih muškaraca.
English: Each vial contains 50 ml.
Croatian: Svaka bočica sadrži 50 ml.
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows: nelarabine caused histopathological changes to the central nervous system (white matter vacuolation and degenerative changes in cerebrum, cerebellum and spinal cord) of monkeys after daily treatment with nelarabine for 23 days, at exposures below the human therapeutic exposure.
Croatian: Nuspojave koje nisu zabilježene u kliničkim ispitivanjima, ali su zapažene u životinja pri razinama izloženosti sličnim onima u ljudi i s mogućom važnošću za kliničku primjenu bile su sljedeće: u majmuna koji su kroz 23 dana bili svakodnevno tretirani nelarabinom u dozi nižoj od terapijske doze koja se primjenjuje u ljudi, nelarabin je uzrokovao histopatološke promjene u središnjem živčanom sustavu (vakuolizaciju i degenerativne promjene bijele tvari u velikom i malom mozgu te kralježničnoj moždini).
English: There are insufficient data to support a dose adjustment recommendation for patients with a renal clearance of creatinine Clcr less than 50 ml/min.
Croatian: Nedostatni su podaci koji bi potvrdili preporuku prilagodbe doze lijeka u bolesnika čiji klirens kreatinina (Clcr ) iznosi manje od 50 ml/min.
English: Mean plasma ara-G Cmax and AUCinf values were 115 µM (16 %) and 571 µM.h (30 %), respectively.
Croatian: Prosječna ara-G Cmax iznosila je 115 µM (16%), a vrijednost AUCinf 571 µM.h (30%).
English: In 28 adult patients, 24 hours after nelarabine infusion on day 1, mean urinary excretion of nelarabine and ara-G was 5.3 % and 23.2 % of the administered dose, respectively.
Croatian: U 28 odraslih bolesnika, 24 sata nakon infuzije nelarabina primijenjene 1. dana terapijskoga ciklusa, prosječno izlučivanje nelarabina putem mokraće iznosilo je 5,3%, a ara-G 23,2% primijenjene doze.
English: The principal route of metabolism for nelarabine is O-demethylation by adenosine deaminase to form ara-G, which undergoes hydrolysis to form guanine.
Croatian: Glavni metabolički put nelarabina jest O-demetilacija posredovana adenozin deaminazom, slijedom koje dolazi do stvaranja ara-G.
English: (159 %) and 89.4 l/m
Croatian: (159%), a ona u pedijatrijskih bolesnika 89,4 l/m
English: Compared to controls, nelarabine caused increased incidences of foetal malformations, anomalies, and variations in rabbits when given at doses approximately 24 % of the adult human dose on a mg/m basis during the period of organogenesis.
Croatian: U usporedbi s kontrolnom skupinom, nelarabin je uzrokovao porast incidencija fetalnih malformacija, anomalija i varijacija u zečeva koji su u razdoblju organogeneze bili tretirani dozama koje su iznosile
English: (104 %) and 125 l/h/m
Croatian: (104%), a u pedijatrijskih bolesnika 125 l/h/m
English: Combined Phase 1 pharmacokinetic data at nelarabine doses of 104 to 2,900 mg/m indicate that the clearance (Cl) and Vss values for nelarabine and ara-G are comparable between the two groups.
Croatian: Farmakokinetički podaci o nelarabinu primijenjenom u dozi od 104 do 2900 mg/m dobiveni u ispitivanjima faze I, pokazuju da su usporedive vrijednosti klirensa (Cl) i Vss vrijednosti nelarabina i ara-G, zabilježene u obje ispitivane skupine.
English: Nelarabine must only be administered under the supervision of a physician experienced in the use of cytotoxic agents.
Croatian: Nelarabin se smije primjenjivati isključivo pod nadzorom liječnika s iskustvom u primjeni citotoksičnih lijekova.