FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: U kliničkim ispitivanjima bolesnika s ne-Hodgkinovim limfomom dodavanje rituksimaba protokolu mobilizacije pleriksaforom i G-CSF-om nije utjecalo na sigurnost bolesnika niti na broj CD34+ stanica.
English: No significant differences in the incidence of adverse reactions were observed for oncology patients by disease, age, or gender.
Croatian: onkoloških bolesnika nisu zabilježene značajne razlike u incidenciji nuspojava s obzirom na bolest, dob ili spol.
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.
Croatian: Nakon primjene doze od 0,24 mg/kg u zdravih dobrovoljaca s normalnom funkcijom bubrega približno 70% doze izlučeno je u nepromijenjenu obliku mokraćom unutar 24 sata nakon primjene.
English: Dose adjustment in elderly patients with creatinine clearance ≤ 50 ml/min is recommended (see Renal impairment above).
Croatian: Prilagođavanje doze preporučuje se u starijih bolesnika s klirensom kreatinina ≤ 50 ml/min (vidjeti dio Oštećenje funkcije bubrega).
English: However, these effects do not seem to occur more frequently when you use Mozobil.
Croatian: Međutim, ne čini se da je njihova učestalost veća pri primjeni lijeka Mozobil.
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).
Croatian: Budući da je Mozobil sterilan lijek bez konzervansa, premještanje sadržaja iz bočice u prikladnu štrcaljku za supkutanu primjenu treba provesti primjenjujući aseptičku tehniku (vidjeti dio 6.3).
English: • if you have low platelet counts.
Croatian: • ako imate visok broj leukocita • ako imate nizak broj trombocita
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.
Croatian: Dodatni učinci pleriksafora redovito uočeni u ispitivanjima ponovljenih doza na životinjama uključivali su povišenu razinu cirkulirajućih leukocita te pojačano izlučivanje kalcija i magnezija urinom u štakora i pasa, blago povećanje težine slezene u štakora te proljev i tahikardiju u pasa.
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).
Croatian: Djelotvornost i sigurnost lijeka Mozobil ocijenjeni su u otvorenom, multicentričnom, kontroliranom ispitivanju u pedijatrijskih bolesnika sa solidnim tumorima (uključujući neuroblastom, sarkom, Ewingov sarkom) ili limfomom koji su ispunjavali uvjete za autolognu transplantaciju krvotvornih matičnih stanica
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.
Croatian: U ispitivanjima raspodjele u štakora koncentracija radioaktivno obilježenog pleriksafora utvrđena je u reproduktivnim organima (testisima, jajnicima, maternici) 2 tjedna nakon jednokratne doze ili ponovljenih doza primijenjenih tijekom 7 dana u mužjaka te nakon ponovljenih doza primijenjenih tijekom 7 dana u ženki.
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.
Croatian: Podaci o mobilizaciji i usađivanju iz potpornih ispitivanja faze II (pleriksafor u dozi od 0,24 mg/kg primijenjen navečer ili ujutro prije afereze) u bolesnika s ne-Hodgkinovim limfomom, Hodgkinovom bolešću ili multiplim mijelomom slični su ovim podacima iz ispitivanja faze III.
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).
Croatian: Pleriksafor se in vitro ne metabolizira preko ljudskih jetrenih mikrosoma niti ljudskih primarnih hepatocita te ne iskazuje inhibicijsko djelovanje in vitro prema enzimima CYP450 (1A2, 2A6, 2B6, 2C8, 2C9, 2C19,
English: • stomach symptoms such as pain, swelling or discomfort
Croatian: • simptomi u trbuhu, poput bolova, oticanja ili osjećaja nelagode
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.
Croatian: U placebom kontroliranim ispitivanjima faze III incidencija parestezije bila je 20,6% u skupini koja je primala pleriksafor i 21,2% u skupini koja je primala placebo.
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.
Croatian: Pleriksafor je derivat biciklama, selektivni reverzibilni antagonist kemokinskog receptora CXCR4 koji blokira vezanje njemu srodnog liganda, iz stromalnih stanica dobivenog čimbenika-1α (engl. stromal cellderived factor-1α, SDF-1α) poznatog i kao CXCL12.
English: Body weight of 83 kg was selected as the cut-off point to transition patients from fixed to weight based dosing (83 kg x 0.24 mg = 19.92 mg/kg).
Croatian: Tjelesna težina od 83 kg označena je kao granična točka za prijelaz bolesnika s fiksnog doziranja na doziranje temeljeno na tjelesnoj težini (83 kg x 0,24 mg = 19,92 mg/kg).
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).
Croatian: Podaci o sigurnosti primjene lijeka Mozobil u kombinaciji s G-CSF-om u onkoloških bolesnika s limfomom i multiplim mijelomom prikupljeni su u dva placebom kontrolirana ispitivanja faze III (301 bolesnik) te u deset nekontroliranih ispitivanja faze II (242 bolesnika).
English: Thrombocytopenia is a known complication of apheresis and has been observed in patients receiving Mozobil.
Croatian: Trombocitopenija je poznata komplikacija afereze koja je uočena u bolesnika koji su primali Mozobil.
English: • you have pain in the upper left abdomen (belly) or your left shoulder
Croatian: • ako osjetite bolove u gornjemu lijevom dijelu trbuha ili lijevom ramenu.
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).
Croatian: Općeniti in vitro probir na aktivnost receptora pokazao je da pleriksafor pri koncentraciji (5 µg/ml) nekoliko puta višoj od maksimalne sustavne razine u ljudi ima umjeren ili jak afinitet vezanja za različite receptore, pretežno smještene na presinaptičkim krajevima živaca u središnjem živčanom sustavu i/ili perifernom živčanom sustavu (kalcijev kanal N-tipa, kalijev kanal SKCA, histaminski receptor H3, muskarinski acetilkolinski receptori M1 i M2, adrenergički receptori α1B i α2C, neuropeptidni receptori
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.
Croatian: Nema dovoljno kliničkog iskustva za odgovarajuću preporuku o alternativnom doziranju u bolesnika u kojih je klirens kreatinina < 20 ml/min kao niti za preporuku o doziranju u bolesnika na hemodijalizi.
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
Croatian: • ako se ubrzo nakon primanja lijeka Mozobil pojavi osip, oticanje područja oko očiju, zaduha ili nedostatak zraka, ošamućenost pri ustajanju ili sjedenju, osjećaj nesvjestice ili nesvjestica,
English: In Mozobil oncology and healthy volunteer clinical studies, less than 1% of subjects experienced vasovagal reactions (orthostatic hypotension and/or syncope) following subcutaneous administration of plerixafor doses ≤0.24 mg/kg.
Croatian: U kliničkim ispitivanjima lijeka Mozobil na onkološkim bolesnicima i zdravim dobrovoljcima u manje od 1% ispitanika zabilježene su vazovagalne reakcije (ortostatska hipotenzija i/ili sinkopa) nakon supkutane primjene pleriksafora u dozi od ≤0,24 mg/kg.
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).
Croatian: Četrdeset pet pedijatrijskih bolesnika (od navršene 1 do manje od 18 godina) bilo je randomizirano, 2:1, primjenom 0,24 mg/kg lijeka Mozobil plus standardna mobilizacija (G-CSF plus ili minus kemoterapija) nasuprot kontroli (samo standardna mobilizacija).
English: For the purpose of haematopoietic stem cell mobilisation, plerixafor may cause mobilisation of leukaemic cells and subsequent contamination of the apheresis product.
Croatian: U svrhu mobilizacije krvotvornih matičnih stanica, pleriksafor može izazvati mobilizaciju leukemičnih stanica i posljedičnu kontaminaciju produkta afereze.
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).
Croatian: U bolesnika čiji je klirens kreatinina 20 - 50 ml/min potrebno je dozu pleriksafora smanjiti za jednu trećinu na 0,16 mg/kg na dan (vidjeti dio 5.2).
English: Gender A population pharmacokinetic analysis showed no effect of gender on pharmacokinetics of plerixafor.
Croatian: Populacijska farmakokinetička analiza nije ukazala na utjecaj spola na farmakokinetiku pleriksafora.
English: Plerixafor has been shown to cause increased resorptions, decreased foetal weights, retarded skeletal development and increased foetal abnormalities in rats and rabbits.
Croatian: Pokazalo se da pleriksafor uzrokuje povećanu resorpciju, smanjenu težinu fetusa, zastoj u razvoju koštanog sustava i povećanu učestalost abnormalnosti fetusa u štakora i kunića.
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).
Croatian: • u odraslih bolesnika s limfomom (rakom bijelih krvnih stanica) ili multiplim mijelomom (rakom plazma stanica u koštanoj srži).
English: • 0.24 mg/kg of body weight for patients weighing > 83 kg.
Croatian: • 0,24 mg/kg tjelesne težine za bolesnike koji teže >83kg.
English: Uncommon Allergic reaction* Anaphylactic reactions, including anaphylactic shock (see section 4.4) **
Croatian: anafilaktičke reakcije, uključujući anafilaktički šok (vidjeti dio 4.4) **
English: CD34+ cells/kg was 3 days for both treatment groups, and the safety profile between the groups was similar.
Croatian: Medijan vremena za dostizanje ≥ 5 × 106 CD34+ stanica/kg bio je 3 dana za obje ispitivane skupine te je sigurnosni profil između skupina bio sličan.
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.
Croatian: U farmakodinamičkim ispitivanjima pleriksafora u kombinaciji s G-CSF-om u zdravih dobrovoljaca, pri čemu je primijenjen isti režim doziranja kao i u ispitivanjima na bolesnicima, ravnomjerno povišenje broja CD34+ stanica u perifernoj krvi uočeno je 4 do 18 sati nakon primjene pleriksafora, s maksimalnim odgovorom u razdoblju između 10 i 14 sati.
English: Manufacturer Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom.
Croatian: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Ujedinjeno Kraljevstvo. ili
English: For transplanted patients in the Phase III studies, median time to neutrophil engraftment (10-11 days), median time to platelet engraftment (18-20 days) and graft durability up to 12 months post-transplantation were similar across the Mozobil and placebo groups.
Croatian: U bolesnika koji su u ispitivanjima faze III podvrgnuti transplantaciji medijan vremena do usađivanja neutrofila (10-11 dana), medijan vremena do usađivanja trombocita (18-20 dana) i trajnost usatka do 12 mjeseci nakon transplantacije bili su podjednaki u skupini koja je dobivala Mozobil i u skupini koja je primala placebo.
English: How is Mozobil given?
Croatian: Kako se Mozobil primjenjuje?
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.
Croatian: U ispitivanju AMD3100-3101 62 bolesnika (10 u skupini koja je primala Mozobil + G-CSF i 52 u skupini koja je primala placebo + G-CSF) u kojih nije bilo moguće mobilizirati dovoljan broj CD34+ stanica i tako omogućiti postupak transplantacije, uključeno je u otvoreni postupak “spašavanja” lijekom Mozobil i
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).
Croatian: Farmakokinetika pleriksafora procijenjena je u 48 pedijatrijskih bolesnika (od navršene 1 do manje od 18 godina) sa solidnim tumorima kod supkutanih doza od 0,16; 0,24 i 0,32 mg/kg sa standardnom mobilizacijom (G-CSF plus ili minus kemoterapija).
English: In clinical trials, Mozobil has been commonly used for 2 to 4 (and up to 7) consecutive days.
Croatian: U kliničkim se ispitivanjima Mozobil obično primjenjivao 2 do 4 (čak i do 7) uzastopnih dana.
English: In pharmacodynamic studies in healthy volunteers of plerixafor alone, peak mobilisation of CD34+ cells was observed from 6 to 9 hours after administration.
Croatian: U farmakodinamičkim ispitivanjima na zdravim dobrovoljcima koji su primali samo pleriksafor, maksimalna mobilizacija CD34+ stanica uočena je 6 do 9 sati nakon primjene.
English: The potential effects of plerixafor on male fertility and postnatal development have not been evaluated in non-clinical studies.
Croatian: Mogući učinci pleriksafora na mušku plodnost te postnatalni razvoj nisu ispitani u pretkliničkim ispitivanjima.
English: For patients of more than 45 kg, a1 ml or 2 ml syringe with graduations that allow a volume to 0.1 ml to be measured can be used.
Croatian: Za bolesnike iznad 45 kg, može se koristiti štrcaljka od 1 ml ili 2 ml s oznakama koje omogućuju mjerenje volumena od 0,1 ml.
English: In clinical studies, 7 of 679 oncology patients experienced myocardial infarctions after haematopoietic stem cell mobilisation with plerixafor and G-CSF.
Croatian: U kliničkim je ispitivanjima 7 od 679 onkoloških bolesnika pretrpjelo infarkt miokarda nakon mobilizacije krvotvornih matičnih stanica pleriksaforom i G-CSF-om.
English: You will first receive G-CSF, then you will be given Mozobil Mobilisation will be started by first giving you another medicine called G-CSF (granulocyte-colony stimulating factor).
Croatian: Prvo ćete primiti čimbenik poticanja rasta granulocita, a zatim će Vam dati Mozobil Mobilizacija će početi nakon što prvo primite lijek koji se zove čimbenik poticanja rasta granulocita
English: In study AMD3100-3102, 7 patients (all from the placebo + G-CSF group) entered the Rescue procedure.
Croatian: U ispitivanju AMD3100-3102 je u postupak “spašavanja” uključeno 7 bolesnika (svi iz skupine koja je primala placebo + G-CSF).
English: The recommended adult dose is either a 20 mg (fixed dose) or 0.24 mg/kg body weight/day.
Croatian: Preporučena doza za odrasle je ili 20 mg (fiksna doza) ili 0,24 mg/kg tjelesne težine na dan.
English: In the two Phase III studies in non-Hodgkin's lymphoma and multiple myeloma patients (AMD3100-3101 and AMD3100-3102, respectively), a total of 301 patients were treated in the Mozobil and G-CSF group and 292 patients were treated in the placebo and G-CSF group.
Croatian: U dvama ispitivanjima faze III u bolesnika s ne-Hodgkinovim limfomom (AMD3100-3101) i multiplim mijelomom (AMD3100-3102) ukupno je 301 bolesnik primao Mozobil i G-CSF, a 292 bolesnika placebo i G-CSF.
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).
Croatian: Primjena lijeka Mozobil manje se često povezuje s potencijalnim sustavnim reakcijama nakon supkutane injekcije, poput urtikarije, periorbitalnog edema, dispneje ili hipoksije (vidjeti dio 4.8).
English: Cases of splenic enlargement and/or rupture have been reported following the administration of Mozobil in conjunction with growth factor G-CSF.
Croatian: Slučajevi povećanja i/ili rupture slezene prijavljeni su nakon primjene lijeka Mozobil u kombinaciji s G-CSF faktorom rasta.
English: There was an imbalance between treatment arms in peripheral blood CD34+ counts on the day prior to first apheresis (i.e. prior to administration of plerixafor), with less circulating PB CD34+ in the plerixafor arm.
Croatian: Postojala je neravnoteža između ispitivanih skupina u broju CD34+ stanica u perifernoj krvi na dan koji prethodi prvoj aferezi (tj. prije primjene pleriksafora) pri čemu je manje cirkulirajućih CD34+ stanica u perifernoj krvi bilo u skupini koja je primala pleriksafor.
English: You should not breast-feed if you are using Mozobil, since it is not known if Mozobil is excreted in human milk.
Croatian: Ne smijete dojiti ako primate Mozobil jer nije poznato izlučuje li se Mozobil u majčino mlijeko.
English: It is important to tell your doctor if you are, think you may be or are planning to become pregnant.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svome liječniku.
English: How to use Mozobil
Croatian: Kako primjenjivati Mozobil
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.
Croatian: U starijih bolesnika općenito je potrebno pažljivo određivati dozu jer se sa starijom dobi povećava učestalost oslabljene funkcije bubrega.
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.
Croatian: Kako bi se usporedila farmakokinetika i farmakodinamika pleriksafora nakon doze od 0,24 mg/kg i fiksne (20 mg) doze, provedeno je ispitivanje u odraslih bolesnika s ne-Hodgkinovim limfomom (N=61) koji su bili liječeni s 0,24 mg/kg ili 20 mg pleriksafora.
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.
Croatian: Sustavna izloženost razini pri kojoj nisu opažene nuspojave (NOAEL) u smislu teratogenih učinaka u štakora i kunića bila je jednakog reda veličine ili nešto manja od one utvrđene u bolesnika nakon primjene terapijskih doza.
English: In Mozobil clinical studies of oncology patients, there have been rare reports of severe gastrointestinal events, including diarrhoea, nausea, vomiting, and abdominal pain.
Croatian: U kliničkim ispitivanjima lijeka Mozobil na onkološkim bolesnicima rijetko su prijavljene teške nuspojave probavnog sustava koje uključuju proljev, mučninu, povraćanje i bol u abdomenu.
English: Rarely, gastrointestinal side effects may be severe (diarrhoea, vomiting, stomach pain and nausea).
Croatian: U rijetkim slučajevima nuspojave probavnog sustava mogu biti teške (proljev, povraćanje, bol u trbuhu i mučnina).
English: The weight used to calculate the dose of plerixafor should be obtained within 1 week before the first dose of plerixafor.
Croatian: Tjelesnu težinu na temelju koje se određuje potrebna doza pleriksafora potrebno je izmjeriti unutar tjedan dana prije prve primjene lijeka.
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.
Croatian: U Tablici 1 prikazane su nuspojave koje su se javljale češće uz primjenu lijeka Mozobil i G-CSF-a nego uz primjenu placeba i G-CSF-a i koje su prijavljene kao povezane s liječenjem u ≥ 1% bolesnika koji su primali Mozobil tijekom mobilizacije krvotvornih matičnih stanica i afereze te prije kemoterapije/ablativnog liječenja u pripremi za transplantaciju.
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).
Croatian: U placebom kontroliranim ispitivanjima procijenjen je stupanj porasta broja CD34+ stanica u perifernoj krvi (stanice/µl) tijekom 24 sata od dana prije prve afereze do neposredno prije prve afereze (Tablica 7).
English: Plerixafor inhibited tumour growth in in vivo models of non-Hodgkin's lymphoma, glioblastoma, medulloblastoma, and acute lymphoblastic leukaemia when dosed intermittently.
Croatian: Pri intermitentnom doziranju pleriksafor je inhibirao rast tumora u in vivo modelima ne-Hodgkinova limfoma, glioblastoma, meduloblastoma i akutne limfoblastične leukemije.
English: Elderly A population pharmacokinetic analysis showed no effect of age on pharmacokinetics of plerixafor.
Croatian: Stariji bolesnici Populacijska farmakokinetička analiza nije ukazala na utjecaj dobi na farmakokinetiku pleriksafora.
English: Fold increase in peripheral blood CD34+ cell count following Mozobil administration
Croatian: Stupanj porasta broja CD34+ stanica u perifernoj krvi nakon primjene lijeka Mozobil
English: Genzyme Ireland Ltd. IDA Industrial Park Old Kilmeaden Road Waterford, Ireland
Croatian: IDA Industrial Park Old Kilmeaden Road Waterford, Irska
English: Following subcutaneous administration of a 0.24 mg/kg dose to patients after receiving 4-days of G-CSF pre-treatment, the maximal plasma concentration (Cmax) and systemic exposure (AUC0-24) of plerixafor were 887 ± 217 ng/ml and 4337 ± 922 ng·hr/ml, respectively.
Croatian: Nakon supkutano primijenjene doze od 0,24 mg/kg u bolesnika koji su prethodna 4 dana liječeni G-CSF-om, maksimalna koncentracija u plazmi (Cmax) bila je 887 ± 217 ng/ml, a sustavna izloženost (AUC0-24) pleriksaforu 4337 ± 922 ng.hr/ml.
English: Each vial contains 24 mg plerixafor in 1.2 ml solution.
Croatian: Jedna bočica sadrži 24 mg pleriksafora u 1,2 ml otopine.