FrancophonIA/ELRC3.0 huggingface dataset:
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentim popisom datuma EU (EURD popis) predviđenim člankom 107.c stavkom 7. Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: In some instances, these patients experienced an increase in the number of circulating leukaemia cells.
Croatian: U nekim je slučajevima u tih bolesnika došlo do povećanja broja cirkulirajućih leukemičnih stanica.
English: Do not use Mozobil
Croatian: Nemojte primjenjivati Mozobil
English: Paediatric (1 to less than 18 years)
Croatian: Pedijatrijski bolesnici (od navršene 1 do manje od 18 godina)
English: Systemic Exposure (AUC0-10h) comparisons of fixed and weight based regimens
Croatian: Tablica 2. Usporedbe sistemske izloženosti (AUC0-10h) fiksnog režima i režima temeljenog na tjelesnoj težini
English: The safety and efficacy of Mozobil in children (1 to less than 18 years) were studied in an open label, multicenter, controlled study (see sections 4.8, 5.1, and 5.2).
Croatian: Sigurnost i djelotvornost primjene lijeka Mozobil u djece (od navršene 1 do manje od 18 godina) ispitivani su u otvorenom, multicentričnom, kontroliranom ispitivanju (vidjeti dijelove 4.8, 5.1 i 5.2).
English: The elimination half-life (t1/2) in plasma is 3-5 hours.
Croatian: Poluvrijeme eliminacije (t½) u plazmi iznosi 3 do 5 sati.
English: Mozobil contains the active substance plerixafor which blocks a protein on the surface of blood stem cells.
Croatian: Mozobil sadrži djelatnu tvar pleriksafor koja blokira protein na površini matičnih krvnih stanica.
English: Treatment lasts 2 to 4 consecutive days (in some cases up to 7 days), until enough stem cells have been collected for your transplant.
Croatian: Liječenje traje 2 do 4 dana zaredom (u nekim slučajevima i do 7 dana), dok se ne prikupi dovoljno matičnih stanica za presađivanje.
English: From chemotherapy/ablative treatment in preparation of transplantation through 12 months post-transplantation, no significant differences in the incidence of adverse reactions were observed across treatment groups.
Croatian: U razdoblju od kemoterapije/ablativnog liječenja u pripremi za transplantaciju do 12 mjeseci nakon transplantacije nisu zabilježene značajne razlike među skupinama u incidenciji nuspojava.
English: Appropriate precautions should be taken because of the potential for these reactions.
Croatian: Zbog mogućnosti nastanka navedenih reakcija potrebno je poduzeti odgovarajuće mjere opreza.
English: 37 Hollands Road Haverhill, Suffolk CB9 8PU United Kingdom
Croatian: 37 Hollands Road Haverhill, Suffolk CB9 8PU
English: All events occurred at least 14 days after last Mozobil administration.
Croatian: Svi su se slučajevi dogodili najmanje 14 dana nakon posljednje primjene lijeka Mozobil.
English: 1105 BP Amsterdam The Netherlands.
Croatian: 1105 BP Amsterdam Nizozemska.
English: If mobilisation is poor, Mozobil is used to help collect blood stem cells from the patient, for collection, storage and reintroduction (transplantation),
Croatian: Ako je mobilizacija slaba, Mozobil se primjenjuje kako bi pospješio prikupljanje matičnih krvnih stanica od bolesnika, za prikupljanje, pohranu i ponovno uvođenje (presađivanje),
English: What Mozobil is and what it is used for What you need to know before you use Mozobil How to use Mozobil
Croatian: Što je Mozobil i za što se koristi Što morate znati prije nego počnete primjenjivati Mozobil Kako primjenjivati Mozobil
English: Breast-feeding should be discontinued during treatment with Mozobil.
Croatian: Dojenje je potrebno prekinuti za vrijeme liječenja lijekom Mozobil.
English: Paraesthesia is commonly observed in oncology patients undergoing autologous transplantation following multiple disease interventions.
Croatian: Parestezija Parestezija je često zabilježena u onkoloških bolesnika podvrgnutih autolognoj transplantaciji, i to nakon brojnih intervencija povezanih s bolešću.
English: After opening the vial, Mozobil should be used immediately.
Croatian: Nakon otvaranja bočice, Mozobil se mora odmah primijeniti.
English: • dry mouth, numbness around the mouth
Croatian: • suha usta, utrnulost područja oko usta
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.emea.europa.eu/.
English: These events were generally mild or moderate and occurred within approximately 30 min after Mozobil administration.
Croatian: Te su nuspojave općenito bile blage ili umjerene, a pojavile su se u roku od približno 30 minuta nakon primjene lijeka Mozobil.
English: Symptoms responded to treatments (e.g., antihistamines, corticosteroids, hydration or supplemental oxygen) or resolved spontaneously.
Croatian: Simptomi su reagirali na liječenje (npr. antihistaminike, kortikosteriode, hidraciju ili primjenu kisika) ili bi se povukli spontano.
English: Plerixafor improves the release of stem cells into the blood stream (mobilisation).
Croatian: Pleriksafor poboljšava otpuštanje matičnih stanica u krvotok (mobilizacija).
English: CD34+ cells mobilised by plerixafor are functional and capable of engraftment with long-term repopulating capacity.
Croatian: CD34+ stanice koje pleriksafor mobilizira su funkcionalne i mogu se usaditi s dugotrajnom sposobnošću umnažanja.
English: The exposure to plerixafor in these studies ranged from 1 to 7 consecutive days (median = 2 days).
Croatian: Izloženost pleriksaforu u tim se ispitivanjima kretala u rasponu od 1 do 7 uzastopnih dana (medijan = 2 dana).
English: Carcinogenicity studies with plerixafor have not been conducted.
Croatian: Nisu provedena ispitivanja kancerogenosti pleriksafora.
English: Fixed 20 mg (n=30) 0.24 mg/kg (n=31) Ratio (90% CI)
Croatian: Fiksni 20 mg (n=30) 0,24 mg/kg (n=31) Omjer (90% CI)
English: The apparent volume of distribution of plerixafor in humans is 0.3 l/kg demonstrating that plerixafor is largely confined to, but not limited to, the extravascular fluid space.
Croatian: Prividni volumen distribucije pleriksafora u ljudi iznosi 0,3 l/kg, što pokazuje da pleriksafor uglavnom ostaje u tekućini ekstravaskularnog prostora, ali nije na nju ograničen.
English: No notable differences in the incidence of adverse reactions were observed in these elderly patients when compared with younger ones.
Croatian: U starijih bolesnika nisu zabilježene značajne razlike u incidenciji nuspojava u usporedbi s mlađim bolesnicima.
English: Hyperleukocytosis
Croatian: Hiperleukocitoza
English: Other medicines and Mozobil
Croatian: Drugi lijekovi i Mozobil
English: In the two placebo-controlled clinical studies of plerixafor, 24% of patients were ≥ 65 years old.
Croatian: U dvama placebom kontroliranim kliničkim ispitivanjima pleriksafora 24% bolesnika imalo je 65 godina ili više.
English: You should not use Mozobil if you are pregnant, since there is no experience with Mozobil in pregnant women.
Croatian: Ne smijete primati Mozobil ako ste trudni jer nema iskustva s primjenom Mozobila u trudnica.
English: ** From post-marketing experience
Croatian: **Na temelju iskustva nakon stavljanja lijeka u promet
English: Each ml contains approximately 5 mg (0.2 mmol) of sodium.
Croatian: Jedan ml sadrži približno 5 mg (0,2 mmol) natrija.
English: The dose of haematopoietic stem cells used for each transplant was determined by the investigator and all haematopoietic stem cells that were collected were not necessarily transplanted.
Croatian: Dozu krvotvornih matičnih stanica za svaku transplantaciju odredio je ispitivač, ali nisu nužno bile transplantirane sve prikupljene krvotvorne matične stanice.
English: Based on population pharmacokinetic modeling and similar to adults, µg/kg-based dosage results in increase in plerixafor exposure with increasing body weight in paediatric patients.
Croatian: Na temelju populacijskog farmakokinetičkog modeliranja i slično odraslima, doziranje temeljeno na µg/kg rezultira u povećanju izloženosti pleriksaforu s povećanjem tjelesne težine u pedijatrijskih bolesnika.
English: • if you have or have had any heart problems.
Croatian: • ako imate ili ste imali srčanih tegoba • ako imate tegoba s bubrezima.
English: One or more of these findings were usually observed at systemic exposures in the same order of magnitude or slightly higher than the human clinical exposure.
Croatian: Jedna ili više od navedenih promjena obično su uočene pri sustavnoj izloženosti koja je bila istog reda veličine ili nešto veća od kliničke izloženosti u ljudi.
English: If you want to know more about G-CSF ask your doctor and read the corresponding package leaflet.
Croatian: Ako želite saznati nešto više o čimbeniku poticanja rasta granulocita, upitajte o tome svog liječnika i pročitajte uputu priloženu uz lijek.
English: Results showed that, in case tumour cells are mobilised, the number of tumour cells mobilised is not increased upon Mozobil plus G-CSF compared to G-CSF alone.
Croatian: Rezultati su pokazali da u slučaju da su tumorske stanice mobilizirane, broj mobiliziranih tumorskih stanica nije povećan nakon primjene lijeka Mozobil u kombinaciji s G-CSF-om u usporedbi s primjenom samo G-CSF-a.
English: Mozobil may influence the ability to drive and use machines.
Croatian: Mozobil može utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: These findings suggest that plerixafor has a low potential for involvement in P450-dependent drug-drug interactions.
Croatian: Ti nalazi upućuju na nizak potencijal pleriksafora za interakcije s lijekovima ovisnima o P450.
English: Warnings and precautions Talk to your doctor before using Mozobil.
Croatian: Razgovarajte sa svojim liječnikom prije nego primijenite Mozobil.
English: • 0.24 mg/kg of body weight (see section 5.1).
Croatian: • 0,24 mg/kg tjelesne težine (vidjeti dio 5.1).
English: Exposure margins in the juvenile rat study at the maximum tolerated dose (MTD) were ≥18 fold when compared with the highest clinical paediatric dose in children up to 18 years of age.
Croatian: Granice izloženosti u ispitivanju mladih štakora s maksimalnom podnošljivom dozom (engl. maximum tolerated dose, MTD) bile su ≥ 18-struke u usporedbi s najvećom kliničkom pedijatrijskom dozom u djece do 18 godina starosti.
English: Only one patient aged less than 2 years old was randomized to the plerixafor treatment arm.
Croatian: Samo je jedan bolesnik u dobi manjoj od 2 godine bio randomiziran u skupinu koja je primala pleriksafor.
English: • allergic reactions such as skin rash, swelling around the eyes, shortness of breath
Croatian: • alergijske reakcije poput kožnog osipa, oticanja područja oko očiju, nedostatka zraka
English: The mobilisation and apheresis procedures should be performed in collaboration with an oncology-haematology centre with acceptable experience in this field and where the monitoring of haematopoietic progenitor cells can be correctly performed.
Croatian: Postupci mobilizacije i afereze moraju se provoditi u suradnji s onkološko-hematološkim centrom s potrebnim iskustvom na tom području i u kojem je moguće primjereno pratiti progenitorske krvotvorne stanice.
English: Your dose will depend on your body weight, which should be measured the week before you receive your first dose.
Croatian: Doza ovisi o tjelesnoj težini koju treba izmjeriti tjedan dana prije primanja prve doze.
English: Or Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Croatian: Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Irska
English: In clinical studies, the dose of plerixafor has been calculated based on body weight in patients up to 175% of ideal body weight.
Croatian: U kliničkim su ispitivanjima doze pleriksafora određivane na temelju tjelesne težine u bolesnika čija je težina iznosila do 175% idealne tjelesne težine.
English: In vitro tests showed that plerixafor was not metabolised by P450 CYP enzymes, did not inhibit or induce P450 CYP enzymes.
Croatian: Ispitivanja in vitro pokazala su da se pleriksafor ne metabolizira putem enzima CYP P450 te da on ne inhibira niti inducira enzime CYP P450.
English: Rescue patients
Croatian: “Spašeni” bolesnici
English: Heart attacks
Croatian: Srčani udar
English: However, mobilization of PB CD34+ count was observed in stage 2 of the trial.
Croatian: Međutim, mobilizacija populacije CD34+ zabilježena je u koraku 2 ispitivanja.
English: Renal impairment had no effect on Cmax..
Croatian: Oštećenje funkcije bubrega nije utjecalo na Cmax.
English: This type of syringe has major graduations for 0.1 ml and minor graduations for 0.01 ml and therefore is suitable to administer plerixafor, at a dose of 240 µg/kg, to paediatric patients of at least 9 kg body weight.
Croatian: Ovaj tip štrcaljke ima glavne oznake za 0,1 ml i dodatne oznake za 0,01 ml te je stoga prikladan za primjenu pleriksafora u dozi od 240 µg/kg u pedijatrijskih bolesnika od najmanje 9 kg tjelesne težine.
English: The trial was conducted in patients weighing 70 kg or less (median: 63.7 kg , min: 34.2 kg, max: 70 kg).
Croatian: Ispitivanje je provedeno u bolesnika tjelesne težine 70 kg ili manje (medijan: 63,7 kg, minimalno: 34,2 kg, maksimalno: 70 kg).
English: Frequencies are defined according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Croatian: <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Histopathology findings of extramedullary haematopoiesis were observed in the liver and spleen of rats and/or dogs.
Croatian: Histopatološki nalazi ekstramedularne hematopoeze zabilježeni su u jetri i slezeni štakora i/ili pasa.
English: Mozobil therapy should be initiated and supervised by a physician experienced in oncology and/or haematology.
Croatian: Liječenje lijekom Mozobil mora započeti i nadgledati liječnik iskusan u onkologiji i/ili hematologiji.
English: You will receive your first dose 6 to 11 hours before apheresis (collection of your blood stem cells).
Croatian: Prvu dozu primit ćete 6 do 11 sati prije afereze (prikupljanja matičnih krvnih stanica).
English: The results from single dose subcutaneous studies in rats and mice showed plerixafor can induce transient but severe neuromuscular effects (uncoordinated movement), sedative-like effects (hypoactivity), dyspnoea, ventral or lateral recumbency, and/or muscle spasms.
Croatian: Rezultati istraživanja s primjenom jednokratne supkutane doze u štakora i miševa pokazali su da pleriksafor može izazvati prolazne, ali ozbiljne neuromuskularne učinke (nekoordinirane pokrete), učinke slične učincima sedativa (hipoaktivnost), dispneju, ležanje na trbuhu ili na boku i/ili grčeve u mišićima.
English: One of these events occurred 4 days after last Mozobil administration.
Croatian: Jedan od tih slučajeva zabilježen je 4 dana nakon posljednje primjene lijeka Mozobil.
English: Based on increasing exposure with increasing body weight, the plerixafor dose should not exceed 40 mg/day.
Croatian: Budući da se izloženost povećava s porastom tjelesne težine, doza pleriksafora ne smije biti viša od 40 mg na dan.
English: The results of the dose range-finding study in juvenile miniature pigs and the range-finding and definitive studies in juvenile rats were similar to those observed in adult mice, rats, and dogs.
Croatian: Rezultati ispitivanja za određivanje raspona doza provedenih kod mladih minijaturnih svinja te ispitivanja za određivanje raspona doza i završnih ispitivanja kod mladih štakora bili su slični rezultatima u odraslih miševa, štakora i pasa.
English: Age over 60 and/ or prior myelosuppressive chemotherapy and/or extensive prior chemotherapy and/or a peak circulating stem cell count of less than 20 stem cells/microliter, have been identified as predictors of poor mobilisation.
Croatian: Dob iznad 60 godina i/ili prethodna mijelosupresivna kemoterapija i/ili ekstenzivna prethodna kemoterapija i/ili vršna koncentracija cirkulirajućih matičnih stanica manja od 20 matičnih stanica/mikrolitru, identificirani su kao pokazatelji loše mobilizacije.
English: 45.5 + 2.3 x ((Height (cm) x 0.394) - 60).
Croatian: 45,5 + 2,3 x ((visina (cm) x 0,394) - 60).
English: * The frequency of allergic reactions presented is based on adverse reactions that occurred in the oncology studies (679 patients).
Croatian: * Učestalost prikazanih alergijskih reakcija temelji se na nuspojavama koje su se dogodile u onkološkim ispitivanjima
English: Median age was 5.3 years (min: max 1:18) in the Mozobil arm versus 4.7 years (min:max 1:17) in the control arm.
Croatian: Medijan dobi iznosio je 5,3 godina (min:max 1:18) u skupini koja je primala Mozobil nasuprot 4,7 godina (min:max 1:17) u kontrolnoj skupini.
English: Plerixafor was not genotoxic in an adequate battery of genotoxicity tests.
Croatian: Pleriksafor nije pokazao genotoksično djelovanje u odgovarajućem nizu genotoksičnih testova.
English: Cases of anaphylactic reactions, including anaphylactic shock, have been reported from world-wide post-marketing experience.
Croatian: Slučajevi anafilaktičkih reakcija, uključujući anafilaktički šok, zabilježeni su temeljem iskustva iz svijeta nakon stavljanja lijeka u promet.
English: Patients with leukemia, persistent high percentage marrow involvement prior to mobilization, or previous stem cell transplantation were excluded.
Croatian: Bolesnici s leukemijom, stalnim visokim postotkom zahvaćenosti koštane srži prije mobilizacije ili s prethodnom transplantacijom matičnih stanica bili su isključeni.
English: Lack of temporal relationship in 8 of 9 patients coupled with the risk profile of patients with myocardial infarction does not suggest Mozobil confers an independent risk for myocardial infarction in patients who also receive G-CSF.
Croatian: Izostanak vremenske povezanosti u 8 od 9 bolesnika te profil bolesnika koji su pretrpjeli infarkt miokarda ne upućuju na to da primjena lijeka Mozobil predstavlja neovisan rizik za infarkt miokarda u bolesnika koji primaju i G-CSF.
English: For low weight patients, up to 45 kg of body weight, 1 ml syringes for use in infant patients can be used.
Croatian: Za bolesnike male tjelesne težine, do 45 kg tjelesne težine, mogu se koristiti štrcaljke od 1 ml za primjenu u male djece.
English: How much Mozobil is given?
Croatian: Kolika je doza lijeka Mozobil?
English: The fixed 20 mg dose also showed numerically higher response rate (5.2% [60.0% vs 54.8%] based on the local lab data and 11.7% [63.3% vs 51.6%] based on the central lab data) in attaining the target of ≥ 5 × 10
Croatian: Fiksna doza od 20 mg također je pokazala brojčano veću stopu odgovora (5,2% [60,0% nasuprot 54,8%] na temelju podataka iz lokalnog laboratorija i 11,7% [63,3% nasuprot 51,6%] na temelju podataka iz središnjeg laboratorija) u postizanju ciljne vrijednosti ≥ 5 × 106 CD34+ stanica/kg nego doza temeljena na mg/kg.
English: The primary analysis showed that 80% of patients in the Mozobil arm experienced at least a doubling of the PB CD34+ count, observed from the morning of the day preceding the first planned apheresis to the morning prior to apheresis, versus, 28.6 % of patients in the control arm (p=0.0019).
Croatian: Primarna analiza pokazala je da 80% bolesnika u skupini koja je primala Mozobil doživjelo barem udvostručenje broja CD34+ u perifernoj krvi, uočeno od jutra na dan koji prethodi prvoj planiranoj aferezi do jutra na dan same afereze nasuprot 28,6% bolesnika u kontrolnoj skupini (p=0,0019).
English: This protein “ties” blood stem cells to the bone marrow.
Croatian: Taj protein "veže" matične krvne stanice u koštanoj srži.
English: The majority of these events occurred within 1 hour of Mozobil administration.
Croatian: Većina tih reakcija zabilježena je unutar jednog sata od primjene lijeka Mozobil.
English: 50 + 2.3 x ((Height (cm) x 0.394) - 60);
Croatian: 50 + 2,3 x ((visina (cm) x 0,394) - 60);
English: The recommended dose for children, 1 to less than 18 years of age is 0.24 mg/kg of body weight/day.
Croatian: Preporučena doza za djecu, od navršene 1 do manje od 18 godina je 0,24 mg/kg tjelesne težine na dan.
English: Safety pharmacology studies with intravenously administered plerixafor in rats showed respiratory and cardiac depressant effects at systemic exposure slightly above the human clinical exposure, whilst subcutaneous administration elicited respiratory and cardiovascular effects only at higher systemic levels.
Croatian: Ispitivanja sigurnosne farmakologije uz intravensku primjenu pleriksafora u štakora pokazala su učinke depresije disanja i rada srca pri sustavnoj izloženosti nešto višoj od kliničke izloženosti u ljudi, dok je supkutana primjena imala učinak na dišni sustav i srce samo kod viših razina sustavne izloženosti.
English: During that 24-hour period, the first dose of plerixafor 0.24 mg/kg or placebo was administered 10-11 hours prior to apheresis.
Croatian: Tijekom tog 24-satnog razdoblja prva doza pleriksafora od 0,24 mg/kg ili placeba primijenjena je 10-11 sati prije afereze.
English: Clear, colourless to pale yellow solution, with a pH of 6.0-7.5 and an osmolality of 260 - 320 mOsm/kg.
Croatian: Bistra, bezbojna do blijedožuta otopina pH vrijednosti od 6,0-7,5 i osmolalnosti od 260-320 mOsm/kg.
English: Plerixafor has to be drawn up into a syringe size type which should be selected according to the weight of the patient.
Croatian: Pleriksafor se mora uvući u štrcaljku čija se veličina određuje sukladno težini bolesnika.
English: • sweating, generalised redness of the skin, joint pains, pains in muscles and bones
Croatian: • znojenje, prošireno crvenilo kože, bolovi u zglobovima, mišićima i kostima.
English: It is unknown whether plerixafor is excreted in human milk.
Croatian: Nije poznato izlučuje li se pleriksafor u majčino mlijeko.
English: • if you have a history of feeling faint or lightheaded on standing or sitting or have fainted before upon injections.
Croatian: • ako ste ikada osjetili nesvjesticu ili ošamućenost pri ustajanju ili sjedenju, ili ako ste se ikada onesvijestili nakon primanja injekcije
English: In in vitro studies with human hepatocytes, plerixafor does not induce CYP1A2, CYP2B6, and CYP3A4 enzymes.
Croatian: U in vitro ispitivanjima na ljudskim hepatocitima pleriksafor nije inducirao enzime CYP1A2, CYP2B6 ni CYP3A4.
English: Common Insomnia Uncommon Abnormal dreams, nightmares
Croatian: Psihijatrijski poremećaji često nesanica manje često abnormalni snovi, noćne more
English: Based on limited data at doses above the recommended dose and up to 0.48 mg/kg the frequency of gastrointestinal disorders, vasovagal reactions, orthostatic hypotension, and/or syncope may be higher.
Croatian: S obzirom na ograničene podatke kod primjene doza viših od preporučenih, a najviše do 0,48 mg/kg, učestalost poremećaja probavnog sustava, vazovagalnih reakcija, ortostatske hipotenzije i/ili sinkope može biti povećana.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Mozobil in children aged 0 to 1 year in myelosuppression caused by chemotherapy to treat malignant disorders, which requires an autologous haematopoietic stem cell transplant (see section 4.2 for information on paediatric use).
Croatian: Pedijatrijska populacija Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Mozobil u djece od dobi od 0 do 1 godine u mijelosupresiji uzrokovanoj kemoterapijom za liječenje zloćudnih bolesti, za koju je potrebna autologna transplantacija krvotvornih matičnih stanica (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).