FrancophonIA/ELRC3.0 huggingface dataset:
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).
Maltese: Numru ta' studji in vitro dwar l-attività ma' riċetturi varji wrew li plerixafor, f'konċentrazzjoni ta' (5 µg/ml), diversi drabi ogħla mil-livell sistemiku massimu uman, għandu affinità moderata jew qawwija ta' twaħħil ma' numru ta' riċetturi differenti, li l-biċċa l-kbira tagħhom jinsabu fuq it-truf ta' nervaturi pre-sinattiċi fis-sistema nervuża ċentrali (CNS) u/jew fis-sistema nervuża periferika (PNS) (riċetturi tal-kanal tal-calcium ta' tip N, tal-kanal tal-potassium SKCA, tal-istamina H3, talacetylcholine muscarinic M1 u M2, adrenerġiċi α1B u α2C, tan-neuropeptide Y/Y1 u tal-polyamine glutamate NMDA).
English: • 0.24 mg/kg of body weight (see section 5.1).
Maltese: • 0.24 mg/kg ta' piż tal-ġisem (ara sezzjoni 5.1).
English: In clinical studies, 7 of 679 oncology patients experienced myocardial infarctions after haematopoietic stem cell mobilisation with plerixafor and G-CSF.
Maltese: Fi studji kliniċi, 7 minn 679 pazjent tal-onkoloġija kellhom infarti mijokardijaċi wara mobilizzazzjoni taċ-ċelluli staminali ematopojetiċi bi plerixafor u G-CSF.
English: Frequencies are defined according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Maltese: Ilfrekwenzi huma definiti skont din il-prattika li ġejja: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1000), rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli.
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.
Maltese: Fl-istudju AMD3100-3101, 62 pazjent (10 fil-grupp tal-Mozobil + G-CSF u 52 fil-grupp tal-plaċebo +G-CSF), li ma setgħux jimmobilizzaw numru suffiċjenti ta' celluli CD34+ u għaldaqstant ma setgħux ikomplu għal trapjant, iddaħħlu fi proċedura Rescue open-label b'Mozobil u G-CSF.
English: • diarrhoea, nausea (feeling sick), injection site redness or irritation
Maltese: • dijarea, nawseja (tħossok imdardar), ħmura jew irritazzjoni fil-post fejn tingħata l-injezzjoni
English: The major route of elimination of plerixafor is urinary.
Maltese: Ir-rotta principali tal-eliminazzjoni ta' plerixafor hi mill-awrina.
English: Mozobil and G-CSF Placebo and G-CSF
Maltese: Mozobil u G-CSF Plaċebo u G-CSF
English: Excipients: sodium chloride, hydrochloric acid (concentrated) and sodium hydroxide for pH adjustment and water for injections.
Maltese: Eċċipjenti: sodium chloride, hydrochloric acid (konċentrat), sodium hydroxide għal aġġustament talpH u ilma għal injezzjonijiet.
English: How is Mozobil given?
Maltese: Kemm idum jingħata Mozobil?
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.
Maltese: Abbażi ta' mudell ta' farmakokinetika ta' popolazzjoni, l-espożizzjonijiet medji ta' plerixafor (AUC0-24h) f'pazjenti pedjatriċi ta' età minn 2 sa <6 snin (1905 ng.h/mL), 6 sa <12-il sena (3063 ng.h/mL), u 12 sa <18-il sena (4015 ng.h/mL), f'doża ta' 320 µg/kg huma aktar viċin għall-espożizzjoni f'adulti li qegħdin jirċievu 240 µg/kg.
English: Mozobil 20 mg/ml solution for injection Plerixafor
Maltese: Mozobil 20 mg/ml soluzzjoni għall-injezzjoni
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.
Maltese: Ibbażat fuq dejta limitata b'dożi ogħla mid-doża rakkomandata u sa 0.48 mg/kg, il-frekwenza ta' disturbi gastro-intestinali, reazzjonijiet vasovagali, ipotensjoni ortostatika u/jew sinkope, jistgħu jkunu ogħla.
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).
Maltese: Bl-istess skeda ta' dożaġġ skont il-piż ta' 240 µg/kg, l-espożizzjoni medja ta' plerixafor (AUC0-24h) hija inqas f'pazjenti pedjatriċi ta' età minn 2 sa <6 snin (1410 ng.h/mL), 6 sa <12-il sena (2318 ng.h/mL), u 12 to <18-il sena (2981 ng.h/mL) milli fl-adulti (4337 ng.h/mL).
English: • 0.24 mg/kg of body weight for patients weighing > 83 kg.
Maltese: • 0.24 mg/kg ta' piż tal-ġisem għal pazjenti li jiżnu > 83 kg.
English: The fixed 20 mg dose showed 1.43-fold higher exposure (AUC0-10h) than the 0.24 mg/kg dose (Table 2).
Maltese: Id-doża fissa ta' 20 mg wriet espożizzjoni (AUC0-10h) li kienet 1.43-darbiet ogħla mid-doża ta' 0.24 mg/kg dose (Tabella 2).
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).
Maltese: Il-valuri medji ta' AUC0-24 ta' plerixafor f'persuni b'indeboliment ħafif tal-kliewi (CrCl 5180 ml/min), moderat (CrCl 31-50 ml/min) u sever (CrCl ≤ 30 ml/min) kienu 5410, 6780, u 6990 ng.siegħa/ml, rispettivament, u dawn kienu ogħla mill-espożizzjoni osservata f'persuni b'saħħithom li kellhom funzjoni normali tal-kliewi (5070 ng·siegħa/ml).
English: The safety and efficacy of Mozobil in children (1 to less than 18 years) were studied in an open label, multicenter, controlled study (see sections 4.8, 5.1, and 5.2).
Maltese: Is-sigurtà u l-effikaċja ta' Mozobil fit-tfal (sena sa inqas minn 18-il sena) ġew studjati f'studju kkontrollat, open-label u multiċentriku (ara sezzjonijiet 4.8, 5.1 u 5.2).
English: Plerixafor is rapidly absorbed following subcutaneous injection, reaching peak concentrations in approximately 30-60 minutes (tmax).
Maltese: Plerixafor jiġi assorbit malajr wara injezzjoni minn taħt il-ġilda u jilħaq il-konċentrazzjonijiet massimi wara madwar 30-60 minuta (tmax).
English: Your medicine will be injected by a doctor or a nurse.
Maltese: Il-mediċina tiegħek ser tiġi injettata minn tabib jew infermier/a.
English: Other medicines and Mozobil
Maltese: Mediċini oħra u Mozobil
English: In Mozobil clinical studies of oncology patients, there have been rare reports of severe gastrointestinal events, including diarrhoea, nausea, vomiting, and abdominal pain.
Maltese: Fi studji kliniċi b'Mozobil fuq pazjenti tal-onkoloġija, kien hemm rapporti rari ta' avvenimenti gastrointestinali severi, li jinkludu dijarea, nawseja, rimettar u uġigħ addominali.
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.
Maltese: Iż-żieda medjana fl-għadd ta' ċelluli PB CD34+ millinja bażi sal-ġurnata ta' afereżi kienet ta' 3.2 darbiet fil-fergħa ta' Mozobil kontra 1.4 darbiet filfergħa ta' kontroll.
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
Maltese: Id-doża fissa ta' 20 mg wriet ukoll rata ta' rispons, sabiex tinkiseb il-mira ta' ≥ 5 × 106 CD34+ celluli/kg, li mil-lat numeriku kien ogħla (5.2% [60.0% vs 54.8%] skont id-dejta mill-laboratorju lokali u 11.7% [63.3% vs 51.6%] skont id-dejta mill-laboratorju ċentrali) milli d-doża bbażata fuq il-mg/kg.
English: Marketing Authorisation Holder Genzyme Europe B.V.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Genzyme Europe B.V.
English: The recommended daily dose of plerixafor by subcutaneous injection (SC) is:
Maltese: subcutaneous injection ) hi:
English: Median age was 5.3 years (min: max 1:18) in the Mozobil arm versus 4.7 years (min:max 1:17) in the control arm.
Maltese: L-età medjana kienet ta' 5.3 snin (min: max 1:18) fil-fergħa ta' Mozobil kontra 4.7 snin (min:max 1:17) fil-fergħa ta' kontroll.
English: • flatulence, constipation, indigestion, vomiting
Maltese: • gass, stitikezza, indiġestjoni, rimettar
English: In study AMD3100-3102, 7 patients (all from the placebo + G-CSF group) entered the Rescue procedure.
Maltese: Fl-istudju AMD3100-3102, 7 pazjenti (kollha mill-grupp tal-plaċebo + G-CSF) daħlu fil-proċedura Rescue.
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.
Maltese: Plerixafor hu derivattiv bicyclam, antagonist riversibbli selettiv tar-riċettur chemokine CXCR4 u jimblokka t-twaħħil tal-ligand relatat tiegħu, fattur-1α derivat miċ-ċelluli stromali (SDF-1α), magħruf ukoll bħala CXCL12.
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).
Maltese: Il-farmakokinetika ta' plerixafor ġiet evalwata f'48 pazjent pedjatriku (sena sa inqas minn 18-il sena) b'tumuri solidi f'dożi minn taħt il-ġilda ta' 0.16, 0.24 u 0.32 mg/kg b'mobilizzazzjoni standard (GCSF flimkien jew mingħajr kimoterapija).
English: Fertility The effects of plerixafor on male and female fertility are not known (see section 5.3).
Maltese: Fertilità L-effetti ta' plerixafor fuq il-fertilità maskili u femminili mhumiex magħrufa (ara sezzjoni 5.3).
English: Clinical data with this dose adjustment are limited.
Maltese: Dejta klinika b'dan l-aġġustament fid-doża hi limitata.
English: Pharmacotherapeutic group: Other immunostimulants; ATC code: L03AX16
Maltese: Immunostimulanti oħrajn, Kodiċi ATC:
English: Data from animal models also suggest modulation of foetal haematopoiesis, vascularisation, and cerebellar development by SDF-1α and CXCR4.
Maltese: Dejta minn mudelli ta' annimali tissuġġerixxi wkoll modulazzjoni ta' ematopoiesi tal-fetu, vaskularizzazzjoni u żvilupp ċerebellari minn SDF-1α u CXCR4.
English: cells/kg in ≤ 4 apheresis days with Mozobil and G-CSF (n=141; 95.3%) than with placebo and G-CSF (n=136; 88.3%), p=0.031.
Maltese: 3%) milli bil-plaċebo u G-CSF (n=136; 88.3%), p=0.031.
English: Age over 60 and/ or prior myelosuppressive chemotherapy and/or extensive prior chemotherapy and/or a peak circulating stem cell count of less than 20 stem cells/microliter, have been identified as predictors of poor mobilisation.
Maltese: Età ta' aktar minn 60 sena u/jew kimoterapija majelosuppressiva preċedenti u/jew kimoterapija estensiva preċedenti u/jew l-ogħla għadd ta' ċelluli staminali li jkunu qed jiċċirkolaw ikun anqas minn 20 ċellula staminali/mikrolitru, ġew identifikati bħala indikaturi li l-mobilizzazzjoni se tkun dgħajfa.
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.
Maltese: Fi studji kliniċi dwar Mozobil f'pazjenti tal-onkoloġija u f'voluntiera b'saħħithom, inqas minn 1% talindividwi kellhom reazzjonijiet vasovagali (ipotensjoni ortostatika u/jew sinkope) wara l-għoti taħt ilġilda ta' dożi ta' plerixafor ta' ≤0.24 mg/kg.
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.
Maltese: Wara l-għoti minn taħt il-ġilda ta' doża ta' 0.24 mg/kg lil pazjenti li kienu diġà rċivew 4 ijiem ta' G-CSF bħala kura minn qabel, il-konċentrazzjoni massima fil-plażma (Cmax) u l-espożizzjoni sistemika (AUC0-24) ta' plerixafor kienu ta' 887 ± 217 ng/ml u 4337 ± 922 ng.siegħa/ml, rispettivament.
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.
Maltese: 6% u 21.2% fil-grupp ta' plerixafor u plaċebo, rispettivament.
English: Mozobil contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free'.
Maltese: Mozobil fih inqas minn mmol 1 ta' sodium (23 mg) f'kull doża, i.e. essenzjalment ‘ħieles missodium'.
English: Study AMD3100-3102 efficacy results - CD34+ cell mobilisation in multiple myeloma patients
Maltese: Riżultati tal-effikaċja ta' Studju AMD3100-3102 - mobilizzazzjoni taċ-ċelluli CD34+ f'pazjenti b'majeloma multipla
English: • 20 mg fixed dose or 0.24 mg/kg of body weight for patients weighing ≤ 83 kg (see section
Maltese: • doża fissa ta' 20 mg jew 0.24 mg/kg ta' piż tal-ġisem għal pazjenti li jiżnu ≤83 kg (ara sezzjoni 5.2).
English: Each vial contains 24 mg plerixafor in 1.2 ml solution.
Maltese: Kull kunjett fih 24 mg ta' plerixafor f'1.2 ml ta' soluzzjoni.
English: EU/1/09/537/001
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/537/001
English: Study AMD3100-3101 efficacy results - CD34+ cell mobilisation in non-Hodgkin's lymphoma patients
Maltese: Tabella 3. Riżultati tal-effikaċja ta' Studju AMD3100-3101 - mobilizzazzjoni taċ-ċelluli CD34+ f'pazjenti li kellhom limfoma mhux ta' Hodgkin
English: The median PB CD34+ cell counts at baseline were 15 cells/µl in the Mozobil arm versus 35 cells/µl in control arm.
Maltese: L-għadd medjan ta' ċelluli PB CD34+ fil-linja bażi kien ta' 15il ċellula/µl fil-fergħa ta' Mozobil kontra 35 cellula/µl fil-fergħa ta' kontroll.
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.
Maltese: Fi studji farmakodinamiċi f'voluntiera b'saħħithom b'plerixafor mogħti flimkien ma' G-CSF f'kors ta' doża identiku bħal dak mogħti fl-istudji li saru fuq pazjenti, kienet osservata żieda sostnuta fl-għadd ta' ċelluli CD34+ fid-demm periferali minn 4 sa 18-il siegħa wara l-għoti ta' plerixafor, bl-ogħla rispons li seħħ bejn 10 u 14-il siegħa.
English: The safety profile in this paediatric study was consistent with what has been observed in adults.
Maltese: Il-profil ta' sigurtà f'dan l-istudju pedjatriku kien konsistenti ma' dak li ġie osservat fl-adulti.
English: Symptoms responded to treatments (e.g., antihistamines, corticosteroids, hydration or supplemental oxygen) or resolved spontaneously.
Maltese: Is-sintomi rrispondew għall-kura (eż., antistamini, kortikosterojdi, idratazzjoni jew ossiġnu supplimentali) jew fiequ spontanjament.
English: In vitro tests showed that plerixafor was not metabolised by P450 CYP enzymes, did not inhibit or induce P450 CYP enzymes.
Maltese: Testijiet in vitro wrew li plerixafor ma kienx metabolizzat minn enzimi P450 CYP u ma inibixxiex jew stimola enzimi P450 CYP. Plerixafor ma aġixxiex bħala substrat jew inibitur ta' P-glikoproteina fi studju in vitro.
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).
Maltese: Il-farmakokinetika ta' plerixafor kienet evalwata f'pazjenti b'limfoma u b'majeloma multipla fil-livell ta' doża klinika ta' 0.24 mg/kg wara kura minn qabel b'G-CSF (10 µg/kg darba kuljum għal 4 ijiem konsekuttivi).
English: CD34+ cells mobilised by plerixafor are functional and capable of engraftment with long-term repopulating capacity.
Maltese: Iċ-ċelluli CD34+ mmobilizzati minn plerixafor huma funzjonali u kapaċi jagħmlu engraftment b'possibbiltà ta' ripopolazzjoni fit-tul.
English: Mozobil contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn mmol 1 ta' sodium (23 mg) f'kull doża, i.e. essenzjalment ‘ħielsa mis-sodium'.
English: Vasovagal reactions
Maltese: Reazzjonijiet vasovagali
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).
Maltese: Pazjenti bi tneħħija tal-krejatinina ta' 20-50 ml/min għandu jkollhom id-doża tagħhom ta' plerixafor imnaqqsa b'terz għal 0.16 mg/kg/jum (ara sezzjoni 5.2).
English: However, mobilization of PB CD34+ count was observed in stage 2 of the trial.
Maltese: Madankollu, il-mobilizzazzjoni tal-għadd ta' PB CD34+ ġie osservat fil-fażi 2 tal-prova.
English: (2 x 10
Maltese: (n = 150
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).
Maltese: B'mod arbitrarju ħamsa u erbgħin pazjent pedjatriku (sena sa inqas minn 18-il sena) ġew magħżula 2:1, għall-użu ta' 0.24 mg/kg ta' Mozobil flimkien ma' mobilizzazzjoni standard (G-CSF flimkien ma' jew mingħajr kimoterapija) kontra kontroll (mobilizzazzjoni standard waħdu).
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.
Maltese: Reazzjonijiet avversi li seħħew b'mod aktar frekwenti b'Mozobil u G-CSF milli bil-plaċebo u G-CSF u li kienu rrappurtati bħala li kienu marbuta malmediċina f' ≥ 1% tal-pazjenti li rċivew Mozobil, matul il-mobilizzazzjoni taċ-ċelluli staminali ematopojetiċi u l-aferesi u qabel il-kura kimoterapewtika/ablativa bħala preparazzjoni għat-trapjant, huma murija f'Tabella 1.
English: Each vial contains 1.2 ml solution.
Maltese: Kull kunjett fih 1.2 ml ta' soluzzjoni.
English: Hydrochloric acid, concentrated (pH adjustment) Sodium hydroxide (pH adjustment) Water for injections
Maltese: Hydrochloric acid, konċentrat (aġġustament tal-pH)
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.
Maltese: Fi studji kliniċi ta' pazjenti b'limfoma mhux ta' Hodgkin, iż-żieda ta' rituximab ma' kors talmobilizzazzjoni bi plerixafor u G-CSF, ma affettwax is-sigurtà tal-pazjent jew il-produzzjoni ta' ċelluli CD34+.
English: Elderly A population pharmacokinetic analysis showed no effect of age on pharmacokinetics of plerixafor.
Maltese: Analiżi farmakokinetika tal-popolazzjoni wriet li l-età m'għandha l-ebda effett fuq il-farmakokinetika ta' plerixafor.
English: Paediatric (1 to less than 18 years)
Maltese: Pazjenti pedjatriċi ( Sena sa inqas minn 18-il sena)
English: Of these patients, 100% (7 out of 7) mobilised ≥ 2 x10 6/kg CD34+ cells and had successful engraftment.
Maltese: Minn dawn il-pazjenti, 100% (7 minn 7) mmobilizzaw ≥ 2 x106/kg ċelluli CD34+ u kellhom engrafting b'suċċess.
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
Maltese: Pazjenti li kisbu ≥ 6 x 106 ċelluli/kg f'≤ jumejn ta' aferesi u engraftment li rnexxa a valur-p ikkalkulat bl-użu tal-istastika Cochran-Mantel-Haenszel imblukkata mill-għadd tal-plejtlits fil-linja bażi b Aktar pazjenti b'mod statistikament sinfikanti kisbu ≥ 6 x 106 ċelluli/kg f'≤ jumejn ta' aferesi b'Mozobil u G-CSF
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.
Maltese: Kull kunjett ta' plerixafor hija mimlija biex tagħti 1.2 ml ta' 20 mg/ml plerixafor soluzzjoni akweja għall-injezzjoni li fiha 24 mg ta' plerixafor.
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.
Maltese: Il-volum apparenti taddistribuzzjoni ta' plerixafor fil-bnedmin hu ta' 0.3 l/kg li juri li plerixafor hu fil-biċċa l-kbira tiegħu ristrett għal, iżda mhux limitat għal, l-ispazju tal-fluwidu ekstravaskulari.
English: Placebo and G-CSF (n = 154)
Maltese: (n = 154)
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.
Maltese: Il-marġni ta' espożizzjoni fl-istudju tal-far żgħażugħ fl-ogħla doża ttollerata (MTD maximum tolerated dose ) kienu ≥18 -il darba meta mqabbla mal-ogħla doża klinika pedjatrika fit-tfal sa 18-il sena.
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).
Maltese: - bħala prevenzjoni, meta l-għadd ta' ċelluli staminali li qed jiċċirkolaw fil-ġurnata prevista talġabra wara mobilizzazzjoni adegwata b'G-CSF (bi jew mingħajr kimoterapija) ma jkunx mistenni li jkun suffiċjenti fir-rigward tal-produzzjoni mixtieqa ta' ċelluli staminali ematopojetiċi, jew - min preċedentement ma rnexxielux jiġbor biżżejjed ċelluli staminali ematopojetiċi (ara sezzjoni 4.2).
English: Events included one or more of the following: urticaria (n = 2), periorbital swelling (n = 2), dyspnoea (n = 1) or hypoxia (n = 1).
Maltese: L-avvenimenti kienu jinkludu waħda jew aktar minn dawn li ġejjin: urtikarja (n = 2), nefħa periorbitali
English: Sodium chloride
Maltese: Mozobil fih sodium
English: Mozobil therapy should be initiated and supervised by a physician experienced in oncology and/or haematology.
Maltese: It-terapija b'Mozobil trid tinbeda u tiġi mmaniġġjata minn tabib b'esperjenza fl-onkoloġija u/jew ematoloġija.
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.
Maltese: Sabiex jitqabblu l-farmakokinetika u l-farmakodinamikata' plerixafor wara dożi bbażati fuq 0.24 mg/kg u dawk fissi (20 mg), sarte prova f'pazjenti adulti b'NHL (N=61) li ġew ittrattati b'0.24 mg/kg jew 20 mg ta'plerixafor.
English: • low red blood cell count by laboratory test (anaemia in children)
Maltese: • għadd baxx ta' ċelluli ħomor tad-demm skont test fil-laboratorju (anemija fit-tfal)