FrancophonIA/ELRC3.0 huggingface dataset:
English: CD34+ cells mobilised by plerixafor are functional and capable of engraftment with long-term repopulating capacity.
Slovenian: Celice CD34+, ki jih mobilizira pleriksafor, so funkcionalne in se lahko vcepljajo z dolgoročno sposobnostjo razmnoževanja.
English: EU/1/09/537/001
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/09/537/001
English: No notable differences in the incidence of adverse reactions were observed in these elderly patients when compared with younger ones.
Slovenian: Bistvenih razlik v pojavnosti neželenih učinkov pri teh starejših bolnikih v primerjavi z mlajšimi bolniki niso opazili.
English: This protein “ties” blood stem cells to the bone marrow.
Slovenian: Ta protein „veže“ krvne matične celice na kostni mozeg.
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.
Slovenian: Rezultati študije za ugotavljanje razpona odmerkov pri mladih miniaturnih svinjah ter študije ugotavljanja razpona in definitivne študije pri mladih podganah so bili podobni kot pri odraslih miših, podganah in psih.
English: • dry mouth, numbness around the mouth
Slovenian: • suha usta, otrplost okoli ust,
English: The effect of plerixafor on spleen size in patients has not been specifically evaluated in clinical studies.
Slovenian: Učinek pleriksaforja na velikost vranice pri bolnikih še ni bila specifično ocenjen v kliničnih študijah.
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.
Slovenian: Rezultati so pokazali, da v primeru mobilizacije tumorskih celic, število mobiliziranih tumorskih celic ni povečano pri uporabi zdravila Mozobil skupaj z G-CSF v primerjavi s samim G-CSF.
English: 37 Hollands Road Haverhill, Suffolk CB9 8PU United Kingdom
Slovenian: 37 Hollands Road Haverhill, Suffolk CB9 8PU Velika Britanija ali
English: 1105 BP Amsterdam The Netherlands.
Slovenian: 1105 BP Amsterdam Nizozemska.
English: • anaphylactic reactions, including anaphylactic shock
Slovenian: • anafilaktične reakcije, vključno z anafilaktičnim šokom,
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.
Slovenian: Postopki mobilizacije in afereze morajo biti izvedeni v sodelovanju z onkološkimhematološkim centrom, ki ima ustrezne izkušnje na tem področju in kjer lahko natančno nadzirajo krvotvorne predniške celice.
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.
Slovenian: Eno ali več navedenih ugotovitev so navadno opazili pri sistemski izpostavljenosti, ki je bila enaka ali rahlo višja, kot je klinična izpostavljenost pri ljudeh.
English: The recommended daily dose of plerixafor by subcutaneous injection (SC) is:
Slovenian: Priporočeni dnevni odmerek pleriksaforja s subkutanim injiciranjem (s.c.) je:
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.
Slovenian: Navidezni volumen porazdelitve pleriksaforja pri ljudeh je 0,3 l/kg, kar kaže, da pleriksafor v glavnem ostaja v tekočini ekstravaskularnega prostora, ni pa nanj omejen.
English: SDF-1α and CXCR4 play major roles in embryo-foetal development.
Slovenian: SDF-1α in CXCR4 igrata pomembni vlogi pri razvoju ploda in zarodka.
English: An increase of nonHodgkin's lymphoma growth was noted after a continuous administration of plerixafor for 28 days.
Slovenian: Povečano rast neHodgkinovega limfoma so zabeležili po 28-dnevnem neprekinjenem dajanju pleriksaforja.
English: These events were generally mild or moderate and occurred within approximately 30 min after Mozobil administration.
Slovenian: Navedeni neželeni učinki so bili na splošno blagi ali zmerni ter so se pojavili približno 30 minut po prejetju zdravila Mozobil.
English: The potential effects of plerixafor on male fertility and postnatal development have not been evaluated in non-clinical studies.
Slovenian: Možne vplive pleriksaforja na moško rodnost ter na postnatalni razvoj še niso ocenili v nekliničnih študijah.
English: Mozobil contains the active substance plerixafor which blocks a protein on the surface of blood stem cells.
Slovenian: Zdravilo Mozobil vsebuje učinkovino pleriksafor, ki blokira protein na površini krvnih matičnih celic.
English: Each ml contains approximately 5 mg (0.2 mmol) of sodium.
Slovenian: En ml vsebuje približno 5 mg (0,2 mmol) natrija.
English: Systemic Exposure (AUC0-10h) comparisons of fixed and weight based regimens
Slovenian: Primerjava sistemske izpostavljenosti (AUC0-10h) med uporabo fiksnega odmerka in odmerka na podlagi telesne mase
English: How long will Mozobil be given?
Slovenian: Kako dolgo boste prejemali zdravilo Mozobil?
English: These findings suggest that plerixafor has a low potential for involvement in P450-dependent drug-drug interactions.
Slovenian: Navedene ugotovitve kažejo, da ima pleriksafor nizko možnost vključevanja v medsebojna delovanja z učinkovinami, ki so odvisna od P450.
English: Plerixafor is a bicyclam derivative, a selective reversible antagonist of the CXCR4 chemokine receptor and blocks binding of its cognate ligand, stromal cell-derived factor-1 (SDF-1), also known as CXCL12.
Slovenian: Pleriksafor je derivat biciklama, ki je selektivni reverzibilni antagonist kemokinskega receptorja CXCR4 in blokira vezavo njemu sorodnega liganda, in sicer iz stromalnih celic pridobljenega 1 faktorja (SDF-1 - stromal cell-derived factor-1), znanega tudi kot CXCL12.
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.
Slovenian: Stopnje izpostavljenosti v študiji mladih podgan pri največjem dovoljenem odmerku (MTD) so bile ≥ 18-krat večje v primerjavi z najvišjim kliničnim pediatričnim odmerkom pri otrocih do 18. leta starosti.
English: Vasovagal reactions, orthostatic hypotension, and/or syncope can occur following subcutaneous injections (see section 4.8).
Slovenian: Vazovagalne reakcije, ortostatska hipotenzija in/ali sinkopa se lahko pojavijo po subkutanem injiciranju (glejte poglavje 4.8).
English: In clinical studies, the dose of plerixafor has been calculated based on body weight in patients up to 175% of ideal body weight.
Slovenian: V kliničnih študijah so odmerek pleriksaforja izračunali na osnovi telesne mase pri bolnikih z do največ 175 % idealne telesne mase.
English: Genzyme Ireland Ltd. IDA Industrial Park Old Kilmeaden Road Waterford, Ireland
Slovenian: Genzyme Ireland Ltd. IDA Industrial Park Old Kilmeaden Road Waterford, Irska
English: Other medicines and Mozobil
Slovenian: Druga zdravila in zdravilo Mozobil
English: Data from animal models also suggest modulation of foetal haematopoiesis, vascularisation, and cerebellar development by SDF-1α and CXCR4.
Slovenian: Podatki iz živalskih modelov tudi kažejo na spreminjanje hematopoeze, vaskularizacije in cerebelarnega razvoja pri zarodkih zaradi SDF-1α in CXCR4.
English: Paraesthesia is commonly observed in oncology patients undergoing autologous transplantation following multiple disease interventions.
Slovenian: Parestezijo so pogosto opazili pri onkoloških bolnikih z avtologno presaditvijo in po večkratnih posegih zaradi bolezni.
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.
Slovenian: Nezadostna časovna povezanost pri 8 izmed 9 bolnikov, skupaj s profilom tveganja bolnikov z miokardnim infarktom, ne pomeni, da zdravilo Mozobil predstavlja neodvisno tveganje za miokardni infarkt pri bolnikih, ki hkrati prejemajo G-CSF.
English: It is unknown whether plerixafor is excreted in human milk.
Slovenian: Ni znano, če se pleriksafor izloča v materino mleko.
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.
Slovenian: Odmerek krvotvornih matičnih celic, uporabljenih za vsak presadek, je določil raziskovalec; vse krvotvorne matične celice, ki so bile zbrane, niso bile tudi presajene.
English: Based on the pharmacodynamic mechanism of action, plerixafor is suggested to cause congenital malformations when administered during pregnancy.
Slovenian: Zaradi farmakodinamičnega mehanizma delovanja se domneva, da pleriksafor lahko povzroča kongenitalne malformacije, če se jemlje med nosečnostjo.
English: It should be administered by subcutaneous injection 6 to 11 hours prior to initiation of each apheresis following 4 day pre-treatment with G-CSF.
Slovenian: Subkutano injiciranje naj se izvede od 6 do 11 ur pred pričetkom vsake afereze po 4-dnevnem predzdravljenju z G-CSF.
English: No significant differences in the incidence of adverse reactions were observed for oncology patients by disease, age, or gender.
Slovenian: Bistvenih razlik v pojavnosti neželenih učinkov pri onkoloških bolnikih glede na bolezen, starost ali spol niso opazili.
English: • allergic reactions such as skin rash, swelling around the eyes, shortness of breath
Slovenian: • alergijske reakcije, kot so kožni izpuščaj, otekanje okoli oči, kratka sapa,
English: In the placebo-controlled Phase III studies, the incidence of paraesthesia was 20.6% and 21.2% in the plerixafor and placebo groups, respectively.
Slovenian: V s placebom kontroliranih študijah faze III je bila pojavnost parestezije 20,6 % v skupini s pleriksaforjem ter 21,2 % v skupini s placebom.
English: Plerixafor improves the release of stem cells into the blood stream (mobilisation).
Slovenian: Pleriksafor izboljša sproščanje matičnih celic v krvni obtok (mobilizacija).
English: Based on increasing exposure with increasing body weight, the plerixafor dose should not exceed 40 mg/day.
Slovenian: Ob povečevanju odmerka z naraščajočo telesno maso, odmerek pleriksaforja ne sme preseči 40 mg/dan.
English: It is not recommended to use Mozobil for stem cell mobilisation if you have leukaemia (a cancer of the blood or bone marrow).
Slovenian: Uporabe zdravila Mozobil ne priporočamo za mobilizacijo matičnih celic, če imate levkemijo (rak krvi ali kostnega mozga).
English: • if you have a history of feeling faint or lightheaded on standing or sitting or have fainted before upon injections.
Slovenian: • če ste v preteklosti imeli občutek omedlevice ali omotice, kadar ste stali ali sedeli, ali če ste v preteklosti omedleli zaradi injiciranja,
English: Hyperleukocytosis
Slovenian: Hiperlevkocitoza
English: The stem cells can then be collected by a machine that separates blood constituents (apheresis machine), and subsequently frozen and stored until your transplant.
Slovenian: Matične celice se lahko potem zberejo z napravo, ki loči krvne sestavine (naprava za aferezo) ter nato zamrznejo in shranijo do presaditve.
English: Following a single dose of 0.24 mg/kg plerixafor, clearance was reduced in subjects with varying degrees of renal impairment and was positively correlated with creatinine clearance (CrCl).
Slovenian: Po enkratnem odmerku pleriksaforja v višini 0,24 mg/kg je bil očistek znižan pri osebah z različnimi stopnjami okvare ledvic in je bil v pozitivni korelaciji z očistki kreatinina (CrCl).
English: Mozobil therapy should be initiated and supervised by a physician experienced in oncology and/or haematology.
Slovenian: Zdravljenje z zdravilom Mozobil naj prične in nadzoruje zdravnik z izkušnjami v onkologiji in/ali hematologiji.
English: In general, care should be taken in dose selection for elderly patients due to the greater frequency of decreased renal function with advanced age.
Slovenian: Na splošno je potrebna previdnost pri izbiri odmerka pri starejših bolnikih, saj se s starostjo pogosto poslabša delovanje ledvic.
English: Adverse reactions are listed by System Organ Class and frequency.
Slovenian: Neželeni učinki so prikazani glede na organske sisteme in pogostost.
English: For low weight patients, up to 45 kg of body weight, 1 ml syringes for use in infant patients can be used.
Slovenian: Za bolnike z majhno telesno maso do 45 kg je mogoče uporabiti 1-ml brizgo za uporabo pri dojenčkih.
English: Symptoms responded to treatments (e.g., antihistamines, corticosteroids, hydration or supplemental oxygen) or resolved spontaneously.
Slovenian: Simptomi so bili odpravljeni z zdravljenjem (npr., z antihistaminiki, kortikosteroidi, hidracijo ali dodajanjem kisika) ali so izginili sami od sebe.
English: Vials should be inspected visually prior to administration and not used if there is particulate matter or discolouration.
Slovenian: Pred uporabo viale vizualno preglejte in jih ne uporabite, če je vsebina obarvana ali če opazite vidne delce.
English: You should not use Mozobil if you are pregnant, since there is no experience with Mozobil in pregnant women.
Slovenian: Ne uporabite zdravila Mozobil, če ste noseči, saj ni izkušenj z zdravilom Mozobil pri nosečnicah.
English: Sanofi S.p.A.
Slovenian: Italia Sanofi S.p.A.
English: Geometric Mean AUC
Slovenian: Geometrična sredina AUC
English: Of these patients, 100% (7 out of 7) mobilised ≥ 2 x10 6/kg CD34+ cells and had successful engraftment.
Slovenian: Od teh bolnikov jih je 100 % (7 od 7) mobiliziralo ≥ 2 x106/kg celic CD34+ in so prestali uspešno presaditev.
English: In some instances, these patients experienced an increase in the number of circulating leukaemia cells.
Slovenian: V nekaterih primerih se je pri teh bolnikih zvišalo število levkemičnih celic v obtoku.
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.
Slovenian: Omejeni podatki o odmerkih nad priporočenim odmerkom in do 0,48 mg/kg kažejo, da bi lahko prišlo do višje pogostosti bolezni prebavil, vazovagalnih reakcij, ortostatske hipotenzije in/ali sinkope.
English: This leaflet was last approved in.
Slovenian: Navodilo je bilo nazadnje revidirano
English: The trial was conducted in patients weighing 70 kg or less (median: 63.7 kg , min: 34.2 kg, max: 70 kg).
Slovenian: Preskušanje so izvedli pri bolnikih s telesno maso 70 kg ali manj (mediana: 63,7 kg, najmanj: 34,2 kg, največ: 70 kg).
English: What Mozobil is and what it is used for
Slovenian: Kaj je zdravilo Mozobil in za kaj ga uporabljamo
English: Common Insomnia Uncommon Abnormal dreams, nightmares
Slovenian: Psihiatrične motnje pogosti insomnija občasni nenormalne sanje, nočne more
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.
Slovenian: Rezultati študij z enkratnim subkutanim odmerkom pri podganah in miših so pokazali, da lahko pleriksafor povzroči prehodne, vendar resne, živčno-mišične učinke (nekoordinirano gibanje), učinke, podobne sedativnim (hipoaktivnost), dispnejo, ležanje na trebuhu ali na strani in/ali mišične krče.
English: Clear, colourless to pale yellow solution, with a pH of 6.0-7.5 and an osmolality of 260 - 320 mOsm/kg.
Slovenian: Prozorna, brezbarvna do bledo rumena raztopina, s pH 6,0 - 7,5 in osmolalnostjo 260-320 mOsm/kg.
English: • 0.24 mg/kg of body weight (see section 5.1).
Slovenian: • 0,24 mg/kg telesne mase (glejte poglavje 5.1).
English: Fixed 20 mg (n=30) 0.24 mg/kg (n=31) Ratio (90% CI)
Slovenian: Fiksni odmerek 20 mg (n = 30) Odmerek 0,24 mg/kg (n = 31) Razmerje (90 % IZ)
English: In in vitro studies with human hepatocytes, plerixafor does not induce CYP1A2, CYP2B6, and CYP3A4 enzymes.
Slovenian: V in vitro študijah s človeškimi hepatociti pleriksafor ni induciral encimov CYP1A2, CYP2B6, in CYP3A4.
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.
Slovenian: Na podlagi populacijskega farmakokinetičnega modeliranja in podobno kot pri odraslih odmerjanje na podlagi µg/kg tudi pri pediatričnih bolnikih povzroči povečanje izpostavljenosti pleriksaforju s povečevanjem telesne mase.
English: • if you are allergic to plerixafor or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila Mozobil, • če ste alergični na pleriksafor ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: If mobilisation is poor, Mozobil is used to help collect blood stem cells from the patient, for collection, storage and reintroduction (transplantation),
Slovenian: Pri nezadostni mobilizaciji se zdravilo Mozobil uporablja za zbiranje krvnih matičnih celic bolnika za zbiranje, shranjevanje in vnos (presaditev)
English: Or Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Slovenian: Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Irska.
English: How to use Mozobil
Slovenian: Kako uporabljati zdravilo Mozobil
English: • you have pain in the upper left abdomen (belly) or your left shoulder
Slovenian: • če občutite bolečine v zgornjem levem delu trebuha ali levi rami.
English: In vitro tests showed that plerixafor was not metabolised by P450 CYP enzymes, did not inhibit or induce P450 CYP enzymes.
Slovenian: In vitro testiranja so pokazala, da encimi P450 CYP niso presnovili pleriksaforja ter da pleriksafor ni zaviral ali spodbujal P450 CYP encimov.
English: Dose adjustment in elderly patients with creatinine clearance ≤ 50 ml/min is recommended (see Renal impairment above).
Slovenian: Prilagoditev odmerka priporočamo pri starejših bolnikih z vrednostjo kreatinina ≤ 50 ml/min (glejte „Okvara ledvic“ zgoraj).
English: The recommended dose for children, 1 to less than 18 years of age is 0.24 mg/kg of body weight/day.
Slovenian: Priporočeni odmerek pri otrocih, starih od 1 do manj kot 18 let, je 0,24 mg/kg telesne mase.
English: The exposure to plerixafor in these studies ranged from 1 to 7 consecutive days (median = 2 days).
Slovenian: V navedenih študijah so bolniki prejemali pleriksafor od 1 do 7 zaporednih dni (povprečje = 2 dni).
English: 45.5 + 2.3 x ((Height (cm) x 0.394) - 60).
Slovenian: 45,5 + 2,3 x ((višina (cm) x 0,394) - 60).
English: Heart attacks
Slovenian: Srčna kap
English: Plerixafor has to be drawn up into a syringe size type which should be selected according to the weight of the patient.
Slovenian: Pleriksafor je treba izvleči v brizgo takšne velikosti, ki je ustreza glede na bolnikovo telesno maso.
English: In clinical studies of patients with Non-Hodgkin's lymphoma, the addition of rituximab to a mobilisation regimen of plerixafor and G-CSF did not impact patient safety or CD34+ cell yield.
Slovenian: V kliničnih študijah pri bolnikih z ne-Hodgkinovim limfomom dodatek rituksimaba k predpisanemu odmerjanju pleriksaforja in G-CSF za mobilizacijo ni vplival na varnost bolnikov ali na število CD34+ celic.
English: In rat distribution studies concentrations of radiolabelled plerixafor was detected in reproductive organs (testes, ovaria, uterus) two weeks after single or 7 daily repeated doses in males and after 7 daily repeated doses in females.
Slovenian: V študijah porazdelitve pri podganah so opazili koncentracije radioaktivno označenega pleriksaforja v reproduktivnih organih (moda, jajčniki, maternica) dva tedna po enkratnem odmerku ali po 7 dnevnih ponavljajočih odmerkih pri samcih ter po 7 dnevnih ponavljajočih odmerkih pri samicah.
English: Since Mozobil is supplied as a sterile, preservative-free formulation, aseptic technique should be followed when transferring the contents of the vial to a suitable syringe for subcutaneous administration (see section 6.3).
Slovenian: Ker je zdravilo Mozobil v obliki sterilnega pripravka brez konzervansov, morate uporabiti aseptični način za prenos vsebine viale v ustrezno brizgo za subkutano injiciranje (glejte poglavje 6.3).
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.
Slovenian: Študije farmakološke varnosti pleriksaforja danega intravensko pri podganah so pokazale zavirajoče učinke na dihala in srce pri sistemski izpostavljenosti, ki je bila rahlo višja, kot je klinična izpostavljenost pri ljudeh, medtem ko je subkutano dajanje izzvalo učinke na dihala in srce samo pri višjih sistemskih vrednostih.
English: Patients were primarily treated with daily doses of 0.24 mg/kg plerixafor by subcutaneous injection.
Slovenian: Bolniki so v glavnem prejemali dnevne odmerke pleriksaforja 0,24 mg/kg s subkutanim injiciranjem.
English: • shortly after receiving Mozobil, you experience rash, swelling around the eyes, shortness of breath or lack of oxygen, feeling lightheaded on standing or sitting, feeling faint or fainting
Slovenian: • se kmalu po prejetju zdravila Mozobil pojavijo izpuščaji, otekanje okoli oči, kratka sapa ali pomanjkanje kisika, občutek omotice, kadar stojite ali sedite, občutek omedlevice ali omedlevica;
English: Vasovagal reactions
Slovenian: Vazovagalne reakcije
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).
Slovenian: Primarna analiza je pokazala, da se je 80 % bolnikov v skupini z zdravilom Mozobil število PB CD34+ vsaj podvojilo (v obdobju od jutra na dan pred prvo načrtovano aferezo do jutra pred aferezo), pri bolnikih v kontrolni skupini pa je bil ta delež 28,6 % (p = 0,0019).
English: 50 + 2.3 x ((Height (cm) x 0.394) - 60);
Slovenian: 50 + 2,3 x ((višina (cm) x 0,394) - 60);
English: Plerixafor is not metabolised in vitro using human liver microsomes or human primary hepatocytes and does not exhibit inhibitory activity in vitro towards the major drug-metabolising CYP450 enzymes (1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4/5).
Slovenian: Pleriksafor se in vitro ne presnavlja preko mikrosomov v človeških jetrih ali človeških primarnih hepatocitov ter in vitro ne kaže zaviralne aktivnosti na glavne encime CYP450 (1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 in 3A4/5) za presnovo učinkovin.
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).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Mozobil pri otrocih, starih od 0 do 1 leta, pri mielosupresiji zaradi kemoterapije za zdravljenje malignih bolezni, ki zahteva avtologno presaditev krvotvornih matičnih celic (za informacije o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: There is insufficient clinical experience to make alternative posology recommendations for patients with a creatinine clearance <20 ml/min, as well as to make posology recommendations for patients on haemodialysis.
Slovenian: Ni dovolj kliničnih izkušenj, da bi lahko predlagali alternativno odmerjanje pri bolnikih z vrednostjo kreatinina < 20 ml/min, kakor tudi ne za alternativno odmerjanje pri bolnikih na hemodializi.