FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse reactions occurring more frequently with Mozobil than placebo and considered related to Mozobil during mobilisation and apheresis in phase III studies
Croatian: Nuspojave koje su javljale češće kod primjene lijeka Mozobil nego kod primjene placeba, a smatraju se povezanim s primjenom lijeka Mozobil tijekom mobilizacije i afereze u ispitivanjima faze III
English: The fixed 20 mg dose showed 1.43-fold higher exposure (AUC0-10h) than the 0.24 mg/kg dose (Table 2).
Croatian: 1,43 puta veću izloženost (AUC0-10h) nego doza od 0,24 mg/kg (Tablica 2).
English: Vials should be inspected visually prior to administration and not used if there is particulate matter or discolouration.
Croatian: Prije primjene bočicu je potrebno vizualno pregledati, a lijek se ne smije primijeniti ako se uoče čestice ili promjena boje.
English: You may also have an increase in white blood cells count (leucocytosis), in your blood tests.
Croatian: Također se na Vašim krvnim testovima može vidjeti porast broja bijelih krvnih stanica (leukocitoza).
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).
Croatian: 5.2 Farmakokinetička svojstva Farmakokinetika pleriksafora procijenjena je u bolesnika s limfomom i multiplim mijelomom u kliničkim dozama od 0,24 mg/kg nakon prethodnog liječenja G-CSF-om (10 µg/kg jedanput na dan tijekom 4 uzastopna dana).
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.
Croatian: Smatra se da su leukocitoza i porast broja cirkulirajućih krvotvornih progenitornih stanica koje potiče pleriksafor posljedica prekida vezanja kemokinskog receptora CXCR4 za njegov srodni ligand, što dovodi do pojave kako zrelih tako i pluripotentnih stanica u sustavnom krvotoku.
English: Data from animal models also suggest modulation of foetal haematopoiesis, vascularisation, and cerebellar development by SDF-1α and CXCR4.
Croatian: Podaci dobiveni na životinjskim modelima također upućuju na to da SDF-1α i CXCR4 utječu na hematopoezu, vaskularizaciju i razvoj malog mozga fetusa.
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.
Croatian: Lijek se primjenjuje supkutanom injekcijom 6 - 11 sati prije početka svake afereze nakon prethodnog četverodnevnog liječenja čimbenikom poticanja rasta granulocita (engl.
English: In two Phase III randomised-controlled studies patients with non-Hodgkin's lymphoma or multiple myeloma received Mozobil 0.24 mg/kg or placebo on each evening prior to apheresis.
Croatian: U dvama randomiziranim kontroliranim ispitivanjima faze III bolesnici s ne-Hodgkinovim limfomom i multiplim mijelomom primali su Mozobil u dozi od 0,24 mg/kg ili placebo svaku večer prije afereze.
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.
Croatian: 24h) u pedijatrijskih bolesnika od 2 do <6 godina (1905 ng.h/ml), 6 do <12 godina (3063 ng.h/ml) i 12 to <18 godina (4015 ng.h/ml), pri doziranju od 320 µg/kg bila je bliža izloženosti odraslih koji primaju dozu od 240 µg/kg.
English: Clinical judgment should be exercised when administering Mozobil to patients with peripheral blood neutrophil counts above 50 x 10
Croatian: Prije primjene lijeka Mozobil u bolesnika koji u perifernoj krvi imaju više od 50 x 109
English: Myocardial infarction
Croatian: Opis odabranih nuspojava Infarkt miokarda
English: At the same weight-based dosing regimen of 240 µg/kg, the plerixafor mean exposure (AUC0-24h) is lower in paediatric patients aged 2 to <6 years (1410 ng.h/mL), 6 to <12 years (2318 ng.h/mL), and 12 to <18 years (2981 ng.h/mL) than in adults (4337 ng.h/mL).
Croatian: Pri istom režimu doziranja od 240 µg/kg temeljenom na težini, srednja izloženost pleriksaforu (AUC0-24h) je manja u pedijatrijskih bolesnika u dobi od 2 do <6 godina (1410 ng.h/ml), 6 do <12 godina (2318 ng.h/ml) nego u odraslih (4337 ng.h/ml).
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).
Croatian: U bolesnika s različitim stupnjevima oštećenja funkcije bubrega klirens pleriksafora smanjio se nakon jedne doze od 0,24 mg/kg, pri čemu je uočena pozitivna korelacija s klirensom kreatinina (CrCl).
English: Therefore, plerixafor is not recommended for haematopoietic stem cell mobilisation and harvest in patients with leukaemia.
Croatian: Stoga se ne preporučuje primjena pleriksafora za mobilizaciju i prikupljanje krvotvornih matičnih stanica u bolesnika s leukemijom.
English: Mean values of AUC0-24 of plerixafor in subjects with mild (CrCl 51-80 ml/min), moderate (CrCl 31-50 ml/min) and severe (CrCl ≤ 30 ml/min) renal impairment were 5410, 6780, and 6990 ng.hr/ml, respectively, which were higher than the exposure observed in healthy subjects with normal renal function (5070 ng·hr/ml).
Croatian: (CrCl 31-50 ml/min) odnosno teškim (CrCl ≤ 30 ml/min) oštećenjem funkcije bubrega bile su 5410, 6780 odnosno 6990 ng.hr/ml, što predstavlja veću izloženost od one opažene u zdravih ispitanika s normalnom funkcijom bubrega (5070 ng·hr/ml).
English: • 20 mg fixed dose or 0.24 mg/kg of body weight for patients weighing ≤ 83 kg (see section
Croatian: • fiksna doza od 20 mg ili 0,24 mg/kg tjelesne težine za bolesnike koji teže ≤83 kg (vidjeti dio 5.2).
English: Mozobil may cause dizziness and fatigue.
Croatian: Mozobil može prouzročiti omaglicu i umor.
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.
Croatian: Medijan povećanja broja CD34+ u perifernoj krvi od početne vrijednosti do dana afereze bilo je 3,2 puta u skupini koja je primala Mozobil u odnosu na 1,4 puta u kontrolnoj skupini.
English: It is recommended to use contraception if you are of child-bearing age.
Croatian: Preporučuje se primjena kontracepcije u žena generativne dobi.
English: Effect on the spleen
Croatian: Učinak na slezenu
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).
Croatian: Mozobil je u kombinaciji s čimbenikom poticanja rasta granulocita (G-CSF) indiciran za povećanje mobilizacije krvotvornih matičnih stanica u perifernu krv u svrhu prikupljanja i autologne transplantacije u odraslih bolesnika s limfomom ili multiplim mijelomom iz čije se koštane srži stanice slabo mobiliziraju (vidjeti dio 4.2).
English: Of these patients, 100% (7 out of 7) mobilised ≥ 2 x10 6/kg CD34+ cells and had successful engraftment.
Croatian: U 55% bolesnika (34 od 62) mobilizirano je ≥ 2 x 106/kg CD34+ stanica uz uspješno usađivanje.
English: Not known Splenomegaly, splenic rupture (see section
Croatian: Poremećaji krvi i limfnog sustava nepoznato splenomegalija, ruptura slezene (vidjeti dio 4.4)**
English: Individuals receiving Mozobil in conjunction with G-CSF who report left upper abdominal pain and/or scapular or shoulder pain should be evaluated for splenic integrity.
Croatian: U bolesnika koji primaju Mozobil u kombinaciji s G-CSF-om, a žale se na bol u gornjem lijevom abdomenu i/ili bol u lopatici odnosno ramenu, potrebno je provjeriti cjelovitost slezene.
English: Study AMD3100-3101 efficacy results - CD34+ cell mobilisation in non-Hodgkin's lymphoma patients
Croatian: Tablica 3. Rezultati djelotvornosti u ispitivanju AMD3100-3101 - mobilizacija CD34+ stanica u bolesnika s ne-Hodgkinovim limfomom
English: - The other ingredients are sodium chloride, hydrochloric acid (concentrated) and sodium hydroxide for pH adjustment and water for injections.
Croatian: - Druge pomoćne tvari su natrijev klorid, kloridna kiselina (koncentrirana) i natrijev hidroksid za podešavanje pH, te voda za injekcije.
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.
Croatian: Slične su nuspojave zabilježene u bolesnika s limfomom i multiplim mijelomom koji su primali Mozobil u kontroliranim ispitivanjima faze III i u nekontroliranim ispitivanjima, uključujući ispitivanje faze II u kojem je Mozobil primjenjivan kao monoterapija za mobilizaciju krvotvornih matičnih stanica.
English: Recommended concomitant medicinal products
Croatian: Preporučeni lijekovi za istodobnu primjenu
English: Platelet counts should be monitored in all patients receiving Mozobil and undergoing apheresis.
Croatian: Potrebno je kontrolirati broj trombocita u svih bolesnika u postupku afereze koji primaju Mozobil.
English: Based on the pharmacodynamic mechanism of action, plerixafor is suggested to cause congenital malformations when administered during pregnancy.
Croatian: S obzirom na farmakodinamički mehanizam djelovanja pleriksafora, pretpostavlja se da njegova primjena u trudnoći može prouzročiti prirođene anomalije.
English: Patients were primarily treated with daily doses of 0.24 mg/kg plerixafor by subcutaneous injection.
Croatian: Bolesnici su prvenstveno liječeni supkutanim injekcijama pleriksafora u dozi od 0,24 mg/kg na dan.
English: The potential risk associated with this effect is expected to be low for the intended short term duration of dosing plerixafor in humans.
Croatian: S obzirom na preporučeno kratko vrijeme primjene pleriksafora u ljudi očekuje se bi potencijalan rizik povezan s prethodno opisanim učinkom trebao biti malen.
English: Administration of Mozobil in conjunction with G-CSF increases circulating leukocytes as well as haematopoietic stem cell populations.
Croatian: Primjena lijeka Mozobil u kombinaciji s G-CSF-om povećava broj cirkulirajućih leukocita i broj krvotvornih matičnih stanica.
English: Mozobil 20 mg/ml solution for injection Plerixafor
Croatian: Mozobil 20 mg/ml otopina za injekciju pleriksafor
English: Study AMD3100-3102 efficacy results - CD34+ cell mobilisation in multiple myeloma patients
Croatian: Tablica 5. Rezultati djelotvornosti u ispitivanju AMD3100-3102 - mobilizacija CD34+ stanica u bolesnika s multiplim mijelomom
English: Mozobil 20 mg/ml solution for injection
Croatian: Mozobil 20 mg/ml otopina za injekciju
English: Plerixafor did not act as a substrate or inhibitor of P-glycoprotein in an in vitro study.
Croatian: U jednom in vitro ispitivanju pleriksafor nije djelovao kao supstrat niti inhibitor p-glikoproteina.
English: Mozobil and G-CSF Placebo and G-CSF
Croatian: Mozobil i G-CSF
English: Each ml solution for injection contains 20 mg plerixafor.
Croatian: Jedan ml otopine za injekciju sadrži 20 mg pleriksafora.
English: The median PB CD34+ cell counts at baseline were 15 cells/µl in the Mozobil arm versus 35 cells/µl in control arm.
Croatian: Na početku je medijan broja CD34+ stanica u perifernoj krvi iznosio 15 stanica/μl u skupini koja je primala Mozobil nasuprot 35 stanica/μl u kontrolnoj skupini.
English: In preclinical studies, higher absolute and relative spleen weights associated with extramedullary haematopoiesis were observed following prolonged (2 to 4 weeks) daily plerixafor subcutaneous administration in rats at doses approximately 4 fold higher than the recommended human dose.
Croatian: U pretkliničkim istraživanjima u štakora su tijekom dugotrajne (2 do 4 tjedna) svakodnevne supkutane primjene pleriksafora u dozama približno 4 puta većima od preporučene doze za ljude zabilježene veće apsolutne i relativne težine slezene povezane s ekstramedularnom hematopoezom.
English: Placebo and G-CSF (n = 154)
Croatian: Placebo i G-CSF (n = 154)
English: What Mozobil looks like and contents of the pack Mozobil is supplied as a clear colourless or pale yellow solution for injection in a glass vial with a non-latex rubber stopper.
Croatian: Mozobil je dostupan u obliku bistre, bezbojne do blijedožute otopine za injekciju u staklenoj bočici s gumenim čepom koji ne sadrži lateks.
English: Additionally, two female oncology patients in the compassionate use programme experienced myocardial infarction following haematopoietic stem cell mobilisation with plerixafor and G-CSF.
Croatian: Uz to su infarkt miokarda pretrpjele i dvije onkološke bolesnice u programu milosrdne primjene lijeka nakon mobilizacije krvotvornih matičnih stanica pleriksaforom i G-CSF-om.
English: Method of administration Mozobil is for subcutaneous injection.
Croatian: Lijek Mozobil se primjenjuje supkutanom injekcijom.
English: Geometric Mean AUC
Croatian: Geometrijska srednja vrijednost AUC-a
English: Mozobil and G-CSF (n = 150)
Croatian: Mozobil i G-CSF (n = 150)
English: cells/kg in ≤ 2 apheresis days and successful engraftment p-value calculated using Cochran-Mantel-Haenszel statistic blocked by baseline platelet count Statistically significantly more patients achieved ≥ 6 x 10
Croatian: Bolesnici koji su postigli ≥ 6 x 106 stanica/kg u ≤ 2 afereze i uspješno usađivanje ap-vrijednost izračunata je primjenom Cohran-Mantel-Haenszelove statistike i ograničena početnim brojem trombocita bstatistički je značajno više bolesnika postiglo ≥ 6 x 106 stanica/kg u ≤ 2 dana afereze kod primjene lijeka Mozobil i G-CSF-a
English: Clear type I glass 2 ml vial with a chlorobutyl/butyl rubber stopper and aluminium seal with a plastic flip-off cap. Each vial contains 1.2 ml solution.
Croatian: Bočica od prozirnog stakla tipa I, volumena 2 ml, s klorbutilnim/butilnim gumenim čepom i aluminijskim zaštitnim zatvaračem s plastičnom „flip-off“ kapicom.
English: Mozobil is given by subcutaneous injection (under your skin).
Croatian: Mozobil se daje potkožnom (supkutanom) injekcijom.
English: Each ml contains 20 mg plerixafor.
Croatian: Jedan ml sadrži 20 mg pleriksafora.
English: Excipients: sodium chloride, hydrochloric acid (concentrated) and sodium hydroxide for pH adjustment and water for injections.
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: natrijev klorid, kloridna kiselina (koncentrirana) i natrijev hidroksid za podešavanje pH te voda za injekcije.
English: No dose modifications are necessary in elderly patients with normal renal function.
Croatian: Stariji bolesnici (> 65 godina) U starijih bolesnika s normalnom funkcijom bubrega nije potrebno prilagođavati dozu.
English: Hydrochloric acid, concentrated (pH adjustment) Sodium hydroxide (pH adjustment) Water for injections
Croatian: 6.1 Popis pomoćnih tvari natrijev klorid kloridna kiselina, koncentrirana (za podešavanje pH) natrijev hidroksid (za podešavanje pH) voda za injekcije
English: An increase of nonHodgkin's lymphoma growth was noted after a continuous administration of plerixafor for 28 days.
Croatian: Nakon kontinuirane primjene pleriksafora tijekom 28 dana zabilježeno je povećanje rasta ne-Hodgkinova limfoma.
English: Patients achieving ≥ 6 x 10
Croatian: Bolesnici koji su postigli ≥ 2 x 106 stanica/kg u
English: Vistor hf.
Croatian: G-CSF-om.
English: Placebo and G-CSF (n = 148)
Croatian: Placebo i G-CSF (n = 148)
English: Mozobil contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free'.
Croatian: Natrij Mozobil sadrži manje od 1 milimola natrija (23 mg) po dozi, tj. zanemarive količine natrija.
English: Each vial contains 1.2 ml solution.
Croatian: Jedna bočica sadrži 1,2 ml otopine.
English: Therefore, you should avoid driving if you feel dizzy, tired or unwell.
Croatian: Ako osjećate omaglicu, umor ili se osjećate loše, nemojte voziti.
English: This leaflet was last approved in.
Croatian: Ova uputa je zadnji puta revidirana u Ostali izvori informacija
English: In a compassionate use programme, Mozobil and G-CSF have been administered to patients with acute myelogenous leukaemia and plasma cell leukaemia.
Croatian: Mobilizacija tumorskih stanica u bolesnika koji boluju od leukemije U programu milosrdne primjene, Mozobil i G-CSF primjenjivani su u bolesnika s akutnom mijelogeničnom leukemijom i plazmastaničnom leukemijom.
English: Some patients have experienced dizziness, fatigue or vasovagal reactions; therefore caution is advised when driving or operating machines.
Croatian: Neki su bolesnici osjetili omaglicu, umor ili vazovagalne reakcije.
English: Tumour cell mobilisation in patients with lymphoma and multiple myeloma When Mozobil is used in conjunction with G-CSF for haematopoietic stem cell mobilisation in patients with lymphoma or multiple myeloma‚ tumour cells may be released from the marrow and subsequently collected in the leukapheresis product.
Croatian: Kada se Mozobil primjenjuje u kombinaciji s G-CSF-om za mobilizaciju krvotvornih matičnih stanica u bolesnika s limfomom ili multiplim mijelomom, može doći do oslobađanja tumorskih stanica iz koštane srži i njihova nakupljanja u produktu leukafereze.
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.
Croatian: Jedna bočica pleriksafora napunjena je za isporuku 1,2 ml vodene otopine za injekciju pleriksafora 20
English: cells/kg) numbers of CD34+ cells/kg within a given number of days, as well as the primary composite endpoints which incorporated successful engraftment are presented in Tables 3 and 5; the proportion of patients reaching optimal numbers of CD34+ cells/kg by apheresis day are presented in Tables 4 and 6.
Croatian: U Tablicama 3 i 5 prikazani su optimalni (5 ili 6 x 106 stanica/kg) i minimalni (2 x 106 stanica/kg) broj CD34+ stanica/kg unutar zadanog broja dana te primarni kompozitni ishodi koji su uključivali i uspješno usađivanje; u Tablicama 4 i 6 navedeni su udjeli bolesnika kod kojih je dosegnut optimalan broj CD34+ stanica/kg po danu afereze.
English: Mozobil and G-CSF (n = 148)
Croatian: Mozobil i G-CSF (n = 148)
English: Based on increasing exposure with increasing body weight the dose should not exceed 27 mg/day if the creatinine clearance is lower than 50 ml/min.
Croatian: 27 mg na dan ako je klirens kreatinina manji od 50 ml/min.
English: • dizziness, feeling tired or unwell
Croatian: • omaglica, umor ili loše osjećanje
English: One ml of solution contains 20 mg plerixafor.
Croatian: Jedan ml otopine sadrži 20 mg pleriksafora.
English: Any unused solution should be discarded.
Croatian: Neupotrijebljenu otopinu potrebno je zbrinuti.
English: Of these patients, 55 % (34 out of 62) mobilised ≥ 2 x10
Croatian: U 100% tih bolesnika (7 od 7) mobilizirano je ≥ 2 x 106/kg
English: Common Vomiting, abdominal pain, stomach discomfort, dyspepsia, abdominal distention, constipation, flatulence, hypoaesthesia oral, dry mouth
Croatian: flatulencija, oralna hipoestezija, suhoća usta
English: Plerixafor did not act as a substrate or inhibitor of P-glycoprotein in an in vitro study with MDCKII and MDCKII-MDR1 cell models.
Croatian: U jednom ispitivanju in vitro sa staničnim modelima MDCKII i MDCKII-MDR1 pleriksafor nije djelovao kao supstrat ili inhibitor P-glikoproteina.
English: In clinical trials, patients with risk factors for a heart attack uncommonly suffered heart attacks after being given Mozobil and G-CSF.
Croatian: U kliničkim su ispitivanjima bolesnici pod rizikom od srčanog udara manje često doživljavali srčani udar nakon primjene lijeka Mozobil i čimbenika poticanja rasta granulocita.
English: • diarrhoea, nausea (feeling sick), injection site redness or irritation
Croatian: • proljev, mučnina, crvenilo ili nadraženost na mjestu primjene injekcije
English: Sanofi AB
Croatian: SANOFI BULGARIA EOOD
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.
Croatian: (aparat za aferezu) te kasnije zamrznuti i pohraniti do presađivanja.
English: It is not recommended to use Mozobil for stem cell mobilisation if you have leukaemia (a cancer of the blood or bone marrow).
Croatian: Ne preporučuje se primjena lijeka Mozobil za mobilizaciju matičnih stanica ako bolujete od leukemije
English: SANOFI BULGARIA EOOD Tел: +359 2 9705300
Croatian: Tел: +359 2 9705300
English: The effect of plerixafor on spleen size in patients has not been specifically evaluated in clinical studies.
Croatian: U kliničkim ispitivanjima nije posebno procijenjen učinak pleriksafora na veličinu slezene u bolesnika.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva često hiperhidroza, eritem
English: White blood cell counts should be monitored during Mozobil therapy.
Croatian: Tijekom liječenja lijekom Mozobil potrebno je kontrolirati diferencijalnu krvnu sliku.
English: Vasovagal reactions, orthostatic hypotension, and/or syncope can occur following subcutaneous injections (see section 4.8).
Croatian: Vazovagalne reakcije Nakon supkutane injekcije mogu se javiti vazovagalne reakcije, ortostatska hipotenzija i/ili sinkopa
English: Thirty patients were treated with 0.24 mg/kg of Mozobil in an open label, multicenter, controlled study (DFI 12860) (see section 5.1).
Croatian: kontroliranom ispitivanju (DFI 12860) (vidjeti dio 5.1).
English: G-CSF will help Mozobil to work properly in your body.
Croatian: Taj će lijek omogućiti pravilno djelovanje lijeka Mozobil u tijelu.
English: • flatulence, constipation, indigestion, vomiting
Croatian: • vjetrovi, zatvor, probavne tegobe, povraćanje
English: cells/kg in ≤ 4 apheresis days with Mozobil and G-CSF (n=112; 75.7%) than with placebo and G-CSF (n=79; 51.3%), p<0.001; statistically significantly more patients achieved ≥ 2 x 10
Croatian: (n = 106; 71,6%) nego kod primjene placeba i G-CSF-a (n = 53; 34,4%), p< 0,001; statistički je značajno više bolesnika postiglo ≥ 6 x 106 stanica/kg u ≤ 4 dana afereze kod primjene lijeka Mozobil i G-CSF-a (n = 112; 75,7%) nego kod primjene placeba i G-CSF-a (n = 79; 51,3%), p < 0,001; statistički je značajno više bolesnika postiglo ≥ 2 x 106 stanica/kg u ≤ 4 dana afereze kod primjene lijeka Mozobil i G-CSF-a (n = 141; 95,3%) nego kod primjene placeba i G-CSF-a (n = 136; 88,3%), p = 0,031.
English: Study AMD3100-3102 - Proportion of patients who achieved ≥ 6 x 10
Croatian: Tablica 6. Ispitivanje AMD3100-3102 - Udio bolesnika s multiplim mijelomom koji su postigli ≥ 6 x 106 CD34+ stanica/kg po danu afereze
English: 9/L or greater were observed, on the day prior to or any day of apheresis, in 7% patients receiving Mozobil and in 1% patients receiving placebo in the Phase III studies.
Croatian: U 7% bolesnika koji su primali Mozobil te u 1% bolesnika koji su primali placebo u ispitivanjima faze III na dan prije afereze ili na bilo koji dan afereze zabilježen je broj leukocita od 100 x 109/L ili veći.
English: 6/kg CD34+ cells and had successful engraftment.
Croatian: CD34+ stanica uz uspješno usađivanje.
English: The major route of elimination of plerixafor is urinary.
Croatian: Pleriksafor se uglavnom izlučuje mokraćom.
English: Patients received daily morning doses of G-CSF 10 μg/kg for 4 days prior to the first dose of plerixafor or placebo and on each morning prior to apheresis.
Croatian: 10 µg/kg tijekom 4 uzastopna dana prije primjene prve doze pleriksafora i svako jutro prije afereze.
English: Patients received daily morning doses of G-CSF 10 g/kg for 4 days prior to the first dose of plerixafor or placebo and on each morning prior to apheresis.
Croatian: Bolesnici su svako jutro tijekom 4 dana prije prve doze pleriksafora ili placeba te svako jutro prije afereze primili dozu od 10 µg/kg G-CSF-a na dan.
English: Psychiatric disorders
Croatian: Trombocitopenija