FrancophonIA/ELRC3.0 huggingface dataset:
English: Mobilisation and engraftment data from supportive Phase II studies (plerixafor 0.24 mg/kg dosed on the evening or morning prior to apheresis) in patients with non-Hodgkin's lymphoma, Hodgkin's disease, or multiple myeloma were similar to those data for the Phase III studies.
Slovenian: Podatki o mobilizaciji in vcepitvi iz podpornih študij faze II (pleriksafor v odmerku 0,24 mg/kg zvečer ali zjutraj pred aferezo) pri bolnikih z ne-Hodgkinovim limfomom, Hodgkinovo boleznijo ali multiplim mielomom so bili zelo podobni podatkom iz študij faze III.
English: An in vitro general receptor activity screen showed that plerixafor, at a concentration (5 µg/ml) several fold higher than the maximum human systemic level, has moderate or strong binding affinity for a number of different receptors predominantly located on pre-synaptic nerve endings in the central nervous system (CNS) and/or the peripheral nervous system (PNS) (N-type calcium channel, potassium channel SKCA, histamine H3, acetylcholine muscarinic M1 and M2, adrenergic α1B and α2C, neuropeptide Y/Y1 and glutamate NMDA polyamine receptors).
Slovenian: Splošno in vitro presejalno testiranje za receptorsko aktivnost je pokazalo, da ima pleriksafor pri koncentraciji (5 µg/ml), ki je večkrat višja od najvišje sistemske ravni pri človeku, zmerno ali močno vezavno afiniteto za številne različne receptorje, ki se nahajajo predvsem na predsinaptičnih živčnih končičih v centralnem živčnem sistemu in/ali perifernem živčnem sistemu (kalcijev kanalček tipa N, kalijev kanalček SKCA, histaminski H3, acetilholinski muskarinski M1 in M2, adrenergični α1B in α2C, nevropeptidni Y/Y1 in glutamatni NMDA poliaminski receptorji).
English: Safety data for Mozobil in conjunction with G-CSF in oncology patients with lymphoma and multiple myeloma were obtained from 2 placebo-controlled Phase III studies (301 patients) and 10 uncontrolled Phase II studies (242 patients).
Slovenian: Podatki o varnosti zdravila Mozobil v povezavi z G-CSF pri onkoloških bolnikih z limfomom in multiplim mielomom so zbrali v 2 s placebom kontroliranih študijah faze III (301 bolnik), in v 10 nekontroliranih študijah faze II (242 bolnikov).
English: In study AMD3100-3102, 7 patients (all from the placebo + G-CSF group) entered the Rescue procedure.
Slovenian: V študiji AMD3100-3102 so 7 bolnikov (vseh sedem iz skupine, ki je prejemala placebo in G-CSF) vključili v postopek reševanja.
English: The efficacy and safety of Mozobil were evaluated in an open label, multi-center, controlled study in paediatric patients with solid tumors (including neuroblastoma, sarcoma, Ewing sarcoma) or lymphoma who were eligible for autologous hematopoietic stem cell transplantation (DFI12860).
Slovenian: Učinkovitost in varnost zdravila Mozobil so ocenili v odprti, multicentrični kontrolirani študiji pri pediatričnih bolnikih s parenhimskimi tumorji (vključno z nevroblastomom, sarkomom, Ewingovim sarkomom) ali limfomom, ki so bili primerni za avtologno presaditev hematopoetskih matičnih celic
English: Systemic exposure at No Observed Adverse Effect Level for teratogenic effects in rats and rabbits was of the same magnitude or lower as found at therapeutic doses in patients.
Slovenian: Sistemska izpostavljenost teratogenim učinkom pri odmerkih, ko niso opazili neželenih učinkov (No Observed Adverse Effect Level) pri podganah in zajcih je bila istega obsega ali manjša kot pri odmerkih za zdravljenje pri ljudeh.
English: Plerixafor inhibited tumour growth in in vivo models of non-Hodgkin's lymphoma, glioblastoma, medulloblastoma, and acute lymphoblastic leukaemia when dosed intermittently.
Slovenian: Pleriksafor je zaviral rast tumorjev v in vivo modelih ne-Hodgkinovega limfoma, glioblastoma, meduloblastoma in akutne limfoblastne levkemije, ko so ga odmerjali v presledkih.
English: Additional effects of plerixafor consistently noted in repeated dose animal studies included increased levels of circulating white blood cells and increased urinary excretion of calcium and magnesium in rats and dogs, slightly higher spleen weights in rats, and diarrhoea and tachycardia in dogs.
Slovenian: Dodatni učinki pleriksaforja, ki so jih redno beležili v študijah s ponavljajočimi odmerki pri živalih, vključujejo zvišane vrednosti levkocitov v obtoku in zvišane vrednosti izločenega kalcija in magnezija v urinu pri podganah in psih, rahlo povečano maso vranice pri podganah ter drisko in tahikardijo pri psih.
English: Patients with creatinine clearance 20-50 ml/min should have their dose of plerixafor reduced by one-third to 0.16 mg/kg/day (see section 5.2).
Slovenian: Pri bolnikih z vrednostjo kreatinina 20-50 ml/min znižajte odmerek pleriksaforja za eno tretjino, in sicer na 0,16 mg/kg/dan (glejte poglavje 5.2).
English: • stomach symptoms such as pain, swelling or discomfort
Slovenian: • simptomi, povezani z želodcem, kot so bolečine, otekanje ali neugodje,
English: Effect on the spleen
Slovenian: Vpliv na vranico
English: Patients with leukemia, persistent high percentage marrow involvement prior to mobilization, or previous stem cell transplantation were excluded.
Slovenian: Vključeni niso bili bolniki z levkemijo, trajno zvišanim odstotkom zajetosti kostnega mozga pred mobilizacijo oz. bolniki s predhodno opravljeno presaditvijo matičnih celic.
English: Plerixafor has been shown to cause increased resorptions, decreased foetal weights, retarded skeletal development and increased foetal abnormalities in rats and rabbits.
Slovenian: Pokazali so, da pleriksafor povzroča zvišane stopnje resorpcije, nižje mase zarodka, upočasnjen razvoj kosti in povečane nepravilnosti zarodka pri podganah in zajcih.
English: Pins and needles and numbness are common in patients being treated for cancers.
Slovenian: Mravljinčenje in otrplost sta pogosta pojava pri bolnikih, ki se zdravijo zaradi raka.
English: • 0.24 mg/kg of body weight for patients weighing > 83 kg.
Slovenian: • 0,24 mg/kg telesne mase za bolnike, ki tehtajo >83 kg.
English: How much Mozobil is given?
Slovenian: Koliko zdravila Mozobil boste prejeli?
English: In the placebo-controlled studies, fold increase in peripheral blood CD34+ cell count (cells/l) over the 24-hour period from the day prior to the first apheresis to just before the first apheresis was evaluated (Table 7).
Slovenian: V s placebom kontroliranih študijah so ocenili n-kratno povečanje celic CD34+ (celic/l) v periferni krvi v razdobju 24 ur od dneva pred prvo aferezo do tik pred prvo aferezo (Preglednica 7).
English: Manufacturer Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom.
Slovenian: Izdelovalec Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Velika Britanija ali
English: • In adults who have lymphoma (a cancer of the white blood cells) or multiple myeloma (a cancer that affects plasma cells in the bone marrow).
Slovenian: • pri odraslih bolnikih z limfomom (rak levkocitov) in multiplim mielomom (rak, ki prizadene plazemske celice v kostnem mozgu).
English: • sweating, generalised redness of the skin, joint pains, pains in muscles and bones
Slovenian: • potenje, splošna pordelost kože, bolečine v sklepih, mišicah in kosteh.
English: Clinical judgment should be exercised when administering Mozobil to patients with peripheral blood neutrophil counts above 50 x 10
Slovenian: Upoštevati je treba ustrezno klinično oceno, kadar se zdravilo Mozobil daje bolnikom, katerih vrednost nevtrofilcev v periferni krvi je več kot 50 x 109/l.
English: Mozobil may influence the ability to drive and use machines.
Slovenian: Zdravilo Mozobil lahko vpliva na sposobnost vožnje in upravljanja s stroji.
English: • dizziness, feeling tired or unwell
Slovenian: • omotica, občutek utrujenosti ali slabo počutje,
English: Mozobil has been uncommonly associated with potential systemic reactions related to subcutaneous injection such as urticaria, periorbital swelling, dyspnoea, or hypoxia (see section 4.8).
Slovenian: Zdravilo Mozobil se občasno povezuje z možnimi sistemskimi reakcijami, povezanimi s subkutanim injiciranjem, kot so urtikarija, periorbitalno otekanje, dispneja ali hipoksija (glejte poglavje 4.8).
English: In pharmacodynamic studies in healthy volunteers of plerixafor alone, peak mobilisation of CD34+ cells was observed from 6 to 9 hours after administration.
Slovenian: V farmakodinamičnih študijah na zdravih prostovoljcih, ki so prejemali sam pleriksafor, so opazili najvišjo mobilizacijo celic CD34+ v času od 6 do 9 ur po prejetju odmerka.
English: In clinical studies, 7 of 679 oncology patients experienced myocardial infarctions after haematopoietic stem cell mobilisation with plerixafor and G-CSF.
Slovenian: V kliničnih študijah je pri 7 izmed 679 onkoloških bolnikov prišlo do srčnega infarkta po mobilizaciji krvotvornih matičnih celic s pleriksaforjem in G-CSF.
English: Paediatric patients (1 to less than 18 years) Mozobil is indicated in combination with G-CSF to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either: - pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with G-CSF (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or - who previously failed to collect sufficient haematopoietic stem cells (see section 4.2).
Slovenian: Pediatrični bolniki (od 1 do manj kot 18 let) Zdravilo Mozobil je v kombinaciji z G-CSF indicirano pri otrocih z limfomi ali parenhimskimi malignimi tumorji za spodbuditev mobilizacije krvotvornih matičnih celic v periferno kri za odvzem in poznejšo avtologno presaditev, in sicer: - preventivno, če je pričakovano, da število matičnih celic v obtoku na predvideni dan odvzema po ustrezni mobilizaciji z G-CSF (s kemoterapijo ali brez nje) ne bo zadostno glede na želeno število pridobljenih hematopoetskih matičnih celic, ali - v primeru predhodnega neuspešnega odvzema zadostne količine hematopoetskih matičnih celic (glejte poglavje 4.2).
English: The adverse reactions reported in patients with lymphoma and multiple myeloma who received Mozobil in the controlled Phase III studies and uncontrolled studies, including a Phase II study of Mozobil as monotherapy for haematopoietic stem cell mobilisation, are similar.
Slovenian: Neželeni učinki, o katerih so poročali pri bolnikih z limfomom in multiplim mielomom, ki so prejemali zdravilo Mozobil v kontroliranih študijah faze III ter v nekontroliranih študijah, vključno s študijo faze II z zdravilom Mozobil v monoterapiji za mobilizacijo krvotvornih matičnih celic, so si podobni.
English: White blood cell counts should be monitored during Mozobil therapy.
Slovenian: Število levkocitov v krvi je treba spremljati med zdravljenjem z zdravilom Mozobil.
English: • 20 mg fixed dose or 0.24 mg/kg of body weight for patients weighing ≤ 83 kg (see section
Slovenian: • 20 mg fiksni odmerek ali 0,24 mg/kg telesne mase za bolnike, ki tehtajo ≤ 83 kg (glejte poglavje
English: Warnings and precautions Talk to your doctor before using Mozobil.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila Mozobil se posvetujte z zdravnikom.
English: You should not breast-feed if you are using Mozobil, since it is not known if Mozobil is excreted in human milk.
Slovenian: Ne dojite, če uporabljate zdravilo Mozobil, saj ni znano, ali se izloča v materino mleko.
English: • if you have low platelet counts.
Slovenian: • če imate nizko koncentracijo trombocitov,
English: Histopathology findings of extramedullary haematopoiesis were observed in the liver and spleen of rats and/or dogs.
Slovenian: Opazili so histopatološke spremembe ekstramedularne hematopoeze v jetrih in vranici pri podganah in/ali psih.
English: Gender A population pharmacokinetic analysis showed no effect of gender on pharmacokinetics of plerixafor.
Slovenian: Populacijska farmakokinetična analiza je pokazala, da spol nima nobenega vpliva na farmakokinetiko pleriksaforja.
English: In Mozobil clinical studies of oncology patients, there have been rare reports of severe gastrointestinal events, including diarrhoea, nausea, vomiting, and abdominal pain.
Slovenian: V kliničnih študijah z zdravilom Mozobil pri onkoloških bolnikih so redko poročali o resnih neželenih učinkih na prebavila, vključno z drisko, navzeo, bruhanjem in bolečinami v trebuhu.
English: The major route of elimination of plerixafor is urinary.
Slovenian: Pleriksafor se v glavnem izloča z urinom.
English: Very common side effects (may affect more than 1 in 10 people)
Slovenian: Zelo pogosti neželeni učinki (pojavijo se pri več kot 1 od 10 bolnikov)
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.
Slovenian: Med navedenim 24-urnim obdobjem je bil prvi odmerek 0,24 mg/kg pleriksaforja ali placeba injiciran 1011 ur pred aferezo.
English: Elderly A population pharmacokinetic analysis showed no effect of age on pharmacokinetics of plerixafor.
Slovenian: Populacijska farmakokinetična analiza je pokazala, da starost nima nobenega vpliva na farmakokinetiko pleriksaforja.
English: Adverse reactions occurring more frequently with Mozobil than placebo and considered related to Mozobil during mobilisation and apheresis in phase III studies
Slovenian: Neželeni učinki, ki so se pojavili bolj pogosto pri zdravilu Mozobil kot pri placebu in ki naj bi bili povezani z zdravilom Mozobil, med mobilizacijo in aferezo v študijah faze III.
English: Thrombocytopenia is a known complication of apheresis and has been observed in patients receiving Mozobil.
Slovenian: Trombocitopenija je znana komplikacija pri aferezi in se je pojavila tudi pri bolnikih, ki so prejemali zdravilo Mozobil.
English: In pharmacodynamic studies in healthy volunteers of plerixafor in conjunction with G-CSF administered at identical dose regimen to that in studies in patients, a sustained elevation in the peripheral blood CD34+ count was observed from 4 to 18 hours after plerixafor administration with peak response between 10 and 14 hours.
Slovenian: V farmakodinamičnih študijah na zdravih prostovoljcih, ki so prejemali pleriksafor skupaj z G-CSF v enakem odmerjanju kot v študijah na bolnikih, so opazili nepretrgano zviševanje števila celic CD34+ v periferni krvi od 4 do 18 ur po prejetju pleriksaforja, z najvišjo vrednostjo med 10 in 14 ur.
English: There are no adequate data on the use of plerixafor in pregnant women.
Slovenian: Nosečnost Podatkov o uporabi pleriksaforja pri nosečnicah ni oziroma so omejeni.
English: All events occurred at least 14 days after last Mozobil administration.
Slovenian: Do vseh pojavov je prišlo vsaj 14 dni po zadnjem odmerku zdravila Mozobil.
English: Plerixafor-induced leukocytosis and elevations in circulating haematopoietic progenitor cell levels are thought to result from a disruption of CXCR4 binding to its cognate ligand, resulting in the appearance of both mature and pluripotent cells in the systemic circulation.
Slovenian: Smatra se, da so s pleriksaforjem povzročena levkocitoza in zvišane vrednosti krvotvornih predniških celic v obtoku posledica motnje vezave CXCR4 na njemu sorodnega liganda, kar se kaže kot pojav tako zrelih kot pluripotentnih celic v sistemskem obtoku.
English: Following a 0.24 mg/kg dose in healthy volunteers with normal renal function, approximately 70% of the dose was excreted unchanged in urine during the first 24 hours following administration.
Slovenian: Pri zdravih prostovoljcih z normalnim delovanjem ledvic se je po prejemu odmerka v višini 0,24 mg/kg prvih 24 ur približno 70 % odmerka izločilo z urinom v nespremenjeni obliki.
English: Common Vomiting, abdominal pain, stomach discomfort, dyspepsia, abdominal distention, constipation, flatulence, hypoaesthesia oral, dry mouth
Slovenian: Bolezni prebavil zelo pogosti driska, navzea pogosti bruhanje, bolečine v trebuhu, neugodje v želodcu, dispepsija, napihnjenost trebuha, konstipacija, flatulenca, hipestezija ust, suha usta
English: Each vial contains 24 mg plerixafor in 1.2 ml solution.
Slovenian: Ena viala vsebuje 24 mg pleriksaforja v 1,2 ml raztopine.
English: However, mobilization of PB CD34+ count was observed in stage 2 of the trial.
Slovenian: Vendar so v 2. fazi preskušanja opažali mobilizacijo števila PB CD34+.
English: The recommended adult dose is either a 20 mg (fixed dose) or 0.24 mg/kg body weight/day.
Slovenian: Priporočeni odmerek pri odraslih je bodisi 20 mg (fiksni odmerek) bodisi 0,24 mg/kg telesne mase/dan.
English: In study AMD3100-3101, 62 patients (10 in the Mozobil + G-CSF group and 52 in the placebo + GCSF group), who could not mobilise sufficient numbers of CD34+ cells and thus could not proceed to transplantation, entered into an open-label Rescue procedure with Mozobil and G-CSF.
Slovenian: V študiji AMD3100-3101 so 62 bolnikov (10 v skupini, ki je prejemala zdravilo Mozobil in G-CSF, ter 52 v skupini, ki je prejemala placebo in G-CSF), ki niso mogli mobilizirati zadostnega števila celic CD34+ in pri katerih zaradi tega niso mogli opraviti transplantacije, vključili v odprt postopek reševanja z zdravilom Mozobil in G-CSF.
English: One of these events occurred 4 days after last Mozobil administration.
Slovenian: Do enega izmed teh dogodkov je prišlo 4 dni po zadnjem odmerku zdravila Mozobil.
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.
Slovenian: Takšne brizge imajo večjo gradacijo na 0,1 ml in manjšo gradacijo na 0,01 ml in so zato primerne za dajanje pleriksaforja v odmerku 240 µg/kg pediatričnim bolnikom s telesno maso vsaj 9 kg. Za bolnike s telesno maso 45 kg ali več je mogoče uporabi 1- ali 2-ml brizgo z gradacijo, ki omogoča odmerjanje količin do 0,1 ml.
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
Slovenian: Kar zadeva doseganje cilja ≥ 5 × 106 celic CD34+/kg, je bil delež odziva s fiksnim odmerkom 20 mg številsko večji (5,2 % [60,0 % v primerjavi s 54,8 %] na podlagi podatkov lokalnega laboratorija in 11,7 % [63,3 % v primerjavi z 51,6 %] na podlagi podatkov centralnega laboratorija) kot z odmerkom na podlagi mg/kg.
English: Adverse reactions that occurred more frequently with Mozobil and G-CSF than placebo and G-CSF and were reported as related in ≥1% of the patients who received Mozobil, during haematopoietic stem cell mobilisation and apheresis and prior to chemotherapy/ablative treatment in preparation for transplantation are shown in Table 1.
Slovenian: V Preglednici 1 so prikazani neželeni učinki, ki so se pojavili bolj pogosto pri skupini z G-CSF in zdravilom Mozobil kot pri skupini z G-CSF in placebom ter katere so zabeležili kot povezane z zdravljenjem pri ≥ 1 % bolnikov, ki so prejemali zdravilo Mozobil, in sicer med mobilizacijo krvotvornih matičnih celic in aferezo ter pred kemoterapijo/ablativnim zdravljenjem kot pripravo za presaditev.
English: In clinical trials, Mozobil has been commonly used for 2 to 4 (and up to 7) consecutive days.
Slovenian: V kliničnih preskušanjih so zdravilo Mozobil običajno dajali od 2 do 4 (in do 7) zaporedne dni.
English: Each vial of plerixafor is filled to deliver 1.2 ml of 20 mg/ml plerixafor aqueous solution for injection containing 24 mg of plerixafor.
Slovenian: Ena viala pleriksaforja je napolnjena tako, da odmeri 1,2 mg vodne raztopine pleriksaforja za injiciranje s koncentracijo 20 mg/ml, ki vsebuje 24 mg pleriksaforja.
English: The pharmacokinetics of plerixafor were evaluated in 48 paediatric patients (1 to less than 18 years) with solid tumours at subcutaneous doses of 0.16, 0.24 and 0.32 mg/kg with standard mobilisation (GCSF plus or minus chemotherapy).
Slovenian: Farmakokinetiko pleriksaforja so ocenili pri 48 pediatričnih bolnikih (v starosti od 1 do manj kot 18 let) s parenhimskimi tumorji; zdravilo je bilo uporabljeno subkutano v odmerkih 0,16, 0,24 in 0,32 mg/kg skupaj s standardno mobilizacijo (G-CSF, s kemoterapijo ali brez nje).
English: Based on population pharmacokinetic modeling, the plerixafor mean exposures (AUC0-24h) in paediatric patients aged 2 to <6 years (1905 ng.h/mL), 6 to <12 years (3063 ng.h/mL), and 12 to <18 years (4015 ng.h/mL), at the dose of 320 µg/kg are closer to the exposure in adults receiving 240 µg/kg.
Slovenian: Na podlagi populacijskega farmakokinetičnega modeliranja so povprečne izpostavljenosti pleriksaforju (AUC0-24h) pri pediatričnih bolnikih v starosti od 2 do < 6 let (1905 ng.h/mL), od 6 do < 12 let (3063 ng.h/mL) in od 12 do < 18 let (4015 ng.h/mL) ob odmerku 320 µg/kg bližje izpostavljenostim pri odraslih, ki prejemajo 240 µg/kg.
English: The median increase in PB CD34+ cell counts from baseline to the day of apheresis was by 3.2 fold in the Mozobil arm versus by 1.4 fold in the control arm.
Slovenian: Mediano povečanje števila celic PB CD34+ od izhodišča do dneva afereze je bilo v skupini z zdravilom Mozobil 3,2-kratno in v kontrolni skupini 1,4-kratno.
English: • diarrhoea, nausea (feeling sick), injection site redness or irritation
Slovenian: • driska, navzea (občutek slabosti s siljenjem na bruhanje), rdečica ali draženje na mestu injiciranja
English: In order to compare the pharmacokinetics and pharmacodynamics of plerixafor following 0.24 mg/kg based and fixed (20 mg) doses, a trial was conducted in adult patients with NHL (N=61) who were treated with 0.24 mg/kg or 20 mg of plerixafor.
Slovenian: Za primerjavo farmakokinetike in farmakodinamike pleriksaforja po uporabi odmerka 0,24 mg/kg in fiksnega odmerka (20 mg) je bilo izvedeno preskušanje pri odraslih bolnikih z NHL (N = 61), ki so prejemali 0,24 mg/kg ali 20 mg pleriksaforja.
English: Percents determined by Kaplan Meier method b n includes all patients who received at least one day of apheresis
Slovenian: b n zajema vse bolnike, pri katerih se je izvajala afereza najmanj en dan.
English: Forty-five paediatric patients (1 to less than 18 years) were randomised, 2:1, using 0.24 mg/kg of Mozobil plus standard mobilisation (G-CSF plus or minus chemotherapy) versus control (standard mobilisation alone).
Slovenian: Petinštirideset pediatričnih bolnikov (starih od 1 do manj kot 18 let) je bilo v razmerju 2:1 randomiziranih na uporabo 0,24 mg/kg zdravila Mozobil v kombinaciji s standardno mobilizacijo (G-CSF, s kemoterapijo ali brez nje) ali primerjalnega zdravljenja (samo standardna mobilizacija).
English: Mozobil is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4.2).
Slovenian: Zdravilo Mozobil je indicirano v kombinaciji z granulocitne kolonije stimulirajočim faktorjem (G-CSF- granulocyte-colony stimulating factor) za pospeševanje mobilizacije krvotvornih matičnih celic v periferno kri, za zbiranje in kasnejšo avtologno presaditev pri odraslih bolnikih z limfomom ali multiplim mielomom, ki imajo nezadostno mobilizacijo celic (glejte poglavje 4.2).
English: Mozobil contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Slovenian: Zdravilo Mozobil vsebuje natrij To zdravilo v sebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni »brez natrija«
English: The pharmacokinetics of plerixafor have been evaluated in lymphoma and multiple myeloma patients at the clinical dose level of 0.24 mg/kg following pre-treatment with G-CSF (10 g/kg once daily for 4 consecutive days).
Slovenian: Farmakokinetiko pleriksaforja so ocenili pri bolnikih z limfomom in multiplim mielomom, ki so prejemali klinične odmerke v višini 0,24 mg/kg po predzdravljenju z G-CSF (10 g/kg enkrat dnevno 4 zaporedne dni).