FrancophonIA/ELRC3.0 huggingface dataset:
English: - The other ingredients are sodium chloride, hydrochloric acid (concentrated) and sodium hydroxide for pH adjustment and water for injections.
Slovenian: - Druge sestavine zdravila so natrijev klorid, klorovodikova kislina (koncentrirana) in natrijev hidroksid za uravnavanje pH ter voda za injiciranje.
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.
Slovenian: Po subkutanem injiciranju odmerka v višini 0,24 mg/kg bolnikom, ki so predhodno prejemali 4-dnevno predzdravljenje z G-CSF, je bila najvišja koncentracija pleriksaforja v plazmi (Cmax) 887 ± 217 ng/ml, najvišja sistemska izpostavljenost (AUC0-24) pleriksaforja pa je bila 4337 ± 922 ng.hr/ml.
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).
Slovenian: Kot mejna telesna masa za prehod bolnikov s fiksnega odmerka na odmerek na podlagi telesne mase je bila izbrana telesna masa 83 kg (83 kg x 0,24 mg = 19,92 mg/kg).
English: The median PB CD34+ cell counts at baseline were 15 cells/µl in the Mozobil arm versus 35 cells/µl in control arm.
Slovenian: Mediano izhodiščno število celic PB CD34+ na začetku je bilo v skupini z zdravilom Mozobil 15 celic/µl in v kontrolni skupini 35 celic/µl.
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).
Slovenian: Povprečna vrednost AUC0-24 pleriksaforja pri osebah z blago okvaro ledvic (CrCl 51-80 ml/min) je bila 5410 ng.hr/ml, z zmerno okvaro ledvic (CrCl 31-50 ml/min) 6780 ng.hr/ml ter s hudo okvaro ledvic (CrCl ≤ 30 ml/min) 6990 ng.hr/ml, kar je višje kot izpostavljenost opažena pri zdravih osebah z normalnim delovanjem ledvic (5070 ng·hr/ml).
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.
Slovenian: V kliničnih študijah faze III. pri bolnikih s presadkom je bil v skupinah z zdravilom Mozobil in placebom podoben povprečni čas do vcepitve nevtrofilcev (10-11 dni), povprečni čas do vcepitve trombocitov (18-20 dni) in trajnost vcepitve do 12 mesecev po presaditvi.
English: What Mozobil contains - The active substance is plerixafor.
Slovenian: Kaj vsebuje zdravilo Mozobil - Zdravilna učinkovina je pleriksafor.
English: Uncommon side effects (may affect up to 1 in 100 people)
Slovenian: Občasni neželeni učinki (pojavijo se pri največ 1 od 100 bolnikov)
English: CD34+ cells/kg was 3 days for both treatment groups, and the safety profile between the groups was similar.
Slovenian: Mediani čas, potreben za doseganje vrednosti ≥ 5 × 106 celic CD34+/kg, je bil v obeh terapevtskih skupinah 3 dni in varnostne značilnosti so bile med skupinama podobne.
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).
Slovenian: Ob enaki odmerni shemi na podlagi telesne mase (240 µg/kg) je povprečna izpostavljenost pleriksaforju (AUC0-24h) pri pediatričnih bolnikih v starosti od 2 do < 6 let (1410 ng.h/ml), od 6 do < 12 let (2318 ng.h/ml) in od 12 do < 18 let (2981 ng.h/ml) manjša kot pri odraslih (4337 ng.h/ml).
English: Common Hyperhidrosis, erythema Musculoskeletal and connective tissue disorders Common Arthralgia, musculoskeletal pain General disorders and administration site conditions Very common Injection and infusion site reactions Common Fatigue, malaise
Slovenian: Bolezni kože in podkožja pogosti hiperhidroza, eritem Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti artralgija, bolečine v mišicah in kosteh Splošne težave in spremembe na mestu aplikacije zelo pogosti reakcije na mestu injiciranja in infundiranja pogosti utrujenost, občutek neugodja
English: Therefore, plerixafor is not recommended for haematopoietic stem cell mobilisation and harvest in patients with leukaemia.
Slovenian: Zatorej pleriksaforja ne priporočamo za mobilizacijo in zbiranje krvotvornih matičnih celic pri bolnikih z levkemijo.
English: Platelet counts should be monitored in all patients receiving Mozobil and undergoing apheresis.
Slovenian: Spremljati je treba število trombocitov v krvi pri vseh bolnikih, ki prejemajo zdravilo Mozobil in pri katerih se izvaja afereza.
English: Mozobil contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free'.
Slovenian: Zdravilo Mozobil vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni »brez natrija«.
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.
Slovenian: Mediana starost je bila v skupini z zdravilom Mozobil 5,3 leta (najnižja:najvišja 1:18) in v primerjalni skupini 4,7 leta (najvišja:najnižja 1:17).
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.
Slovenian: Na dan pred prvo aferezo (tj. pred uporabo pleriksaforja) je med terapevtskima skupinama obstajalo neravnovesje v številu CD34+ v periferni krvi in skupina s pleriksaforjem je imela v obtoku manj PB CD34+.
English: The fixed 20 mg dose showed 1.43-fold higher exposure (AUC0-10h) than the 0.24 mg/kg dose (Table 2).
Slovenian: S fiksnim odmerkom 20 mg je bila izpostavljenost (AUC0-10h) 1,43-krat večja kot z odmerkom 0,24 mg/kg (preglednica 2).
English: Each vial contains 1.2 ml solution.
Slovenian: Ena viala vsebuje 1,2 ml raztopine.
English: Rarely, gastrointestinal side effects may be severe (diarrhoea, vomiting, stomach pain and nausea).
Slovenian: Neželeni učinki prebavil so redko resni (driska, bruhanje, bolečine v želodcu in siljenje na bruhanje).
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.
Slovenian: V dveh randomiziranih in kontroliranih študijah faze III so bolniki z ne-Hodgkinovim limfomom ali multiplim mielomom vsak večer pred aferezo prejemali zdravilo Mozobil v odmerku 0,24 mg/kg ali placebo.
English: How is Mozobil given?
Slovenian: Kako boste prejeli zdravilo Mozobil?
English: Mozobil is given by subcutaneous injection (under your skin).
Slovenian: Zdravilo Mozobil vam bodo dali s subkutanim injiciranjem (pod kožo).
English: For the purpose of haematopoietic stem cell mobilisation, plerixafor may cause mobilisation of leukaemic cells and subsequent contamination of the apheresis product.
Slovenian: Namen pleriksaforja je mobilizacija krvotvornih matičnih celic, vendar pa lahko hkrati povzroči tudi mobilizacijo levkemičnih celic in posledično kontaminacijo afereznega pripravka.
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.
Slovenian: V dveh študijah faze III pri bolnikih z ne-Hodgkinovim limfomom (AMD3100-3101) in multiplim mielomom (AMD3100-3102) so zdravili 301 bolnikov v skupini z zdravilom Mozobil in G-CSF ter
English: No dose modifications are necessary in elderly patients with normal renal function.
Slovenian: Pri starejših bolnikih z normalnim delovanjem ledvic odmerka ni treba prilagajati.
English: What Mozobil is and what it is used for What you need to know before you use Mozobil How to use Mozobil
Slovenian: Kaj je zdravilo Mozobil in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Mozobil Kako uporabljati zdravilo Mozobil Možni neželeni učinki
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.
Slovenian: V kliničnih študijah z zdravilom Mozobil pri onkoloških bolnikih in na zdravih prostovoljcih je po subkutanem prejemanju odmerkov ≤ 0,24 mg/kg pleriksaforja pri manj kot 1 % oseb prišlo do vazovagalnih reakcij (ortostatska hipotenzija in/ali sinkopa).
English: Excipients: sodium chloride, hydrochloric acid (concentrated) and sodium hydroxide for pH adjustment and water for injections.
Slovenian: Pomožne snovi: natrijev klorid, klorovodikova kislina (koncentrirana) in natrijev hidroksid za uravnavanje pH ter voda za injiciranje.
English: After opening the vial, Mozobil should be used immediately.
Slovenian: Zdravilo Mozobil je treba uporabiti takoj po odprtju viale.
English: Only one patient aged less than 2 years old was randomized to the plerixafor treatment arm.
Slovenian: V terapevtsko skupino s pleriksaforjem je bil randomiziran le en bolnik, mlajši od 2 let.
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.
Slovenian: V predkliničnih študijah so po daljšem (od 2 do 4 tednov) dnevnem subkutanem dajanju pleriksaforja podganam, kjer je bil odmerek približno 4-krat višji od priporočenga odmerka pri ljudeh opazili povečano absolutno in relativno maso vranice, povezano z ekstramedularno hematopoezo.
English: Cases of anaphylactic reactions, including anaphylactic shock, have been reported from world-wide post-marketing experience.
Slovenian: V obdobju trženja zdravila po vsem svetu so bili zabeleženi primeri anafilaktičnih reakcij, vključno z anafilaktičnim šokom.
English: Each ml contains 20 mg plerixafor.
Slovenian: En ml raztopine vsebuje 20 mg pleriksaforja.
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.
Slovenian: Če je vrednost kreatinina manjša kot 50 ml/min, odmerek pleriksaforja ne sme preseči 27 mg/dan, navkljub povečevanju odmerka na osnovi večje telesne mase.
English: Mozobil 20 mg/ml solution for injection Plerixafor
Slovenian: Mozobil 20 mg/ml raztopina za injiciranje pleriksafor
English: Additionally, two female oncology patients in the compassionate use programme experienced myocardial infarction following haematopoietic stem cell mobilisation with plerixafor and G-CSF.
Slovenian: Poleg tega je pri dveh onkoloških bolnicah v programih sočutne uporabe prišlo po mobilizaciji krvotvornih matičnih celic s pleriksaforjem in G-CSF do miokardnega infarkta.
English: Study AMD3100-3102 efficacy results - CD34+ cell mobilisation in multiple myeloma patients
Slovenian: Rezultati učinkovitosti v študiji AMD3100-3102 - Mobilizacija celic CD34+ pri bolnikih z multiplim mielomom cilj študije učinkovitostib
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.
Slovenian: Pri posameznikih, ki prejemajo zdravilo Mozobil skupaj z G-CSF in poročajo o bolečinah v levem zgornjem predelu trebušne votline in/ali pod lopaticami ali v ramenih morate pregledati vranico.
English: Study AMD3100-3101 efficacy results - CD34+ cell mobilisation in non-Hodgkin's lymphoma patients
Slovenian: Rezultati učinkovitosti v študiji AMD3100-3101 - Mobilizacija celic CD34+pri bolnikih z ne-Hodgkinovim limfomom cilj študije učinkovitostib
English: The weight used to calculate the dose of plerixafor should be obtained within 1 week before the first dose of plerixafor.
Slovenian: Maso za izračun odmerka pleriksaforja izmerite 1 teden pred prvim odmerkom pleriksaforja.
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.
Slovenian: Zdravilo Mozobil se dobavi v obliki bistre, brezbarvne ali bledo rumene raztopine za injiciranje v stekleni viali z gumijastim zamaškom, ki ne vsebuje lateksa.
English: You may also have an increase in white blood cells count (leucocytosis), in your blood tests.
Slovenian: Rezultati vaših krvnih testov lahko pokažejo zvišanje števila belih krvnih celic (levkocitoza).
English: In a compassionate use programme, Mozobil and G-CSF have been administered to patients with acute myelogenous leukaemia and plasma cell leukaemia.
Slovenian: Mobilizacija tumorskih celic pri bolnikih z levkemijo V programih sočutne uporabe so zdravilo Mozobil in G-CSF uporabili pri bolnikih z akutno mieloično levkemijo in plazmocelularno levkemijo.
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.
Slovenian: 2 ml viale iz prozornega stekla tipa I z zamaškom iz klorobutila/butila in pečatom iz aluminija s plastično dvižno zaporko.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 31. julij 2009
English: Mozobil and G-CSF (n = 150)
Slovenian: Mozobil in GCSF (n = 150)
English: Plerixafor did not act as a substrate or inhibitor of P-glycoprotein in an in vitro study.
Slovenian: Pleriksafor v študiji in vitro ni deloval kot substrat ali zaviralec glikoproteina P.
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.
Slovenian: Pleriksafor v študiji in vitro na celičnih modelih MDCKII in MDCKII-MDR1 ni deloval kot substrat ali zaviralec glikoproteina P.
English: Administration of Mozobil in conjunction with G-CSF increases circulating leukocytes as well as haematopoietic stem cell populations.
Slovenian: Jemanje zdravila Mozobil skupaj z G-CSF zviša tako število levkocitov kot število krvotvornih matičnih celic v obtoku.
English: In pivotal clinical studies supporting the use of Mozobil, all patients received daily morning doses of 10 g/kg G-CSF for 4 consecutive days prior to the first dose of plerixafor and on each morning prior to apheresis.
Slovenian: V ključnih kliničnih študijah uporabe zdravila Mozobil so vsi bolniki prejemali G-CSF v odmerku 10 g/kg vsako jutro 4 zaporedne dni pred prvim odmerkom pleriksaforja ter vsako jutro pred aferezo.
English: Uncommon Allergic reaction* Anaphylactic reactions, including anaphylactic shock (see section 4.4) **
Slovenian: Bolezni krvi in limfatičnega sistema pogostnost neznana splenomegalija, ruptura vranice (glejte poglavje 4.4)** Bolezni imunskega sistema občasni alergijske reakcije* anafilaktične reakcije, vključno z anafilaktičnim šokom (glejte poglavje 4.4)**
English: Recommended concomitant medicinal products
Slovenian: Priporočena zdravila za sočasno jemanje
English: Placebo and G-CSF (n = 154)
Slovenian: placebo in GCSF (n = 154)
English: Hydrochloric acid, concentrated (pH adjustment) Sodium hydroxide (pH adjustment) Water for injections
Slovenian: 6.1 Seznam pomožnih snovi natrijev klorid klorovodikova kislina, koncentrirana (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH) voda za injiciranje
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)..
English: Fold increase in peripheral blood CD34+ cell count following Mozobil administration
Slovenian: N-kratno povečanje celic CD34+ v periferni krvi po prejetju zdravila Mozobil študija
English: cells/kg in ≤ 4 apheresis days and successful engraftment a p-value calculated using Pearson's Chi-Squared test Statistically significantly more patients achieved ≥ 5 x 10
Slovenian: pvrednost a bolniki z ≥ 5 x 106 celicami/kg v ≤ 4 dneh afereze in uspešnim vcepljanjem bolniki z ≥ 2 x 106 celicami/kg v ≤ 4 dneh afereze in uspešnim vcepljanjem a p-vrednost je izračunana na osnovi Pearsonovega testa hi kvadrat (Chi-Squared).
English: Placebo and G-CSF (n = 148)
Slovenian: placebo in GCSF (n = 148)
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.
Slovenian: Kadar se zdravilo Mozobil uporablja skupaj z G-CSF za mobilizacijo krvotvornih matičnih celic pri bolnikih z limfomom ali multiplim mielomom, se lahko tumorske celice sprostijo iz kostnega mozga in nato zberejo v levkafereznem pripravku.
English: Of these patients, 55 % (34 out of 62) mobilised ≥ 2 x10
Slovenian: Od teh bolnikov jih je 55 % (34 od 62) mobiliziralo ≥ 2 x 106/kg celic CD34+ in so prestali uspešno presaditev.
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
Slovenian: pvrednost a bolniki z ≥ 6 x 106 celicami/kg v ≤ 2 dneh afereze in uspešnim vcepljanjem a p-vrednost je izračunana na osnovi statističnega postopka Cochran-Mantel-Haenszel in omejena z izhodiščno vrednostjo trombocitov.
English: Mozobil and G-CSF Placebo and G-CSF
Slovenian: Mozobil in G-CSF placebo in G-CSF mediano povprečn o (SD) mediano povprečn o (SD)
English: Mozobil and G-CSF (n = 148)
Slovenian: Mozobil in GCSF (n = 148)
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Slovenian: ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI Zavrzite neuporabljeno raztopino.
English: Common side effects (may affect up to 1 in 10 people)
Slovenian: Pogosti neželeni učinki (pojavijo se pri največ 1 od 10 bolnikov)
English: Method of administration Mozobil is for subcutaneous injection.
Slovenian: Zdravilo Mozobil se subkutano injicira.
English: Common Dizziness, headache
Slovenian: Bolezni živčevja pogosti omotica, glavobol
English: MARKETING AUTHORISATION NUMBER
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Mozobil 20 mg/ml solution for injection
Slovenian: IME ZDRAVILA Mozobil 20 mg/ml raztopina za injiciranje
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.
Slovenian: Bolniki so 4 zaporedne dni pred prvim odmerkom pleriksaforja vsako jutro pred aferezo prejemali G-CSF v odmerku 10 g/kg ali placebo.
English: Tumour cell mobilisation in leukaemia patients
Slovenian: Mobilizacija tumorskih celic pri bolnikih z limfomom ali multiplim mielomom
English: Skin and subcutaneous tissue disorders
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA raztopina za injiciranje
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.
Slovenian: Kot napovedniki slabe mobilizacije so se (bodisi posamezno bodisi skupaj) izkazali starost nad 60 let, predhodna mielosupresivna kemoterapija, obsežna predhodna kemoterapija in največje število matičnih celic v obtoku manj kot 20 matičnih celic/mikroliter.
English: • if you have high white blood cell counts.
Slovenian: • če imate visoko koncentracijo levkocitov,
English: cells/kg in ≤ 4 apheresis days with Mozobil and G-CSF (n=130; 86.7%) than with placebo and G-CSF (n=70; 47.3%), p<0.001.
Slovenian: b Statistično značilno več bolnikov je doseglo ≥ 5 x 106 celic/kg v ≤ 4 dneh afereze z zdravilom Mozobil in G-CSF (n = 89; 59,3 %) kot s placebom in G-CSF (n = 29; 19,6 %), p < 0,001; statistično značilno več bolnikov je doseglo ≥ 2 x 106 celic/kg v ≤ 4 dneh afereze z zdravilom Mozobil in G-CSF (n = 130; 86,7 %) kot s placebom in G-CSF (n = 70; 47,3 %), p < 0,001.
English: Cases of splenic enlargement and/or rupture have been reported following the administration of Mozobil in conjunction with growth factor G-CSF.
Slovenian: Po prejemanju zdravila Mozobil skupaj z rastnim faktorjem G-CSF so poročali o primerih povečanja in/ali rupture vranice.
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.
Slovenian: V študijah faze III so pri 7 % bolnikov, ki so prejemali zdravilo Mozobil ter pri 1 % bolnikov, ki so prejemali placebo, opazili vrednost levkocitov v krvi v višini 100 x 109/l ali več na dan pred aferezo ali na katerikoli dan med aferezo.
English: Proportion a in Placebo and G-CSF (n=150
Slovenian: delež a v skupini placebo in G-CSF (n = 150 b)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 24 mg/1,2 ml
English: Proportion a in Placebo and G-CSF (n=142
Slovenian: delež a v skupini placebo in G-CSF (n = 142 b)
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.
Slovenian: V preglednicah 4 in 6 je predstavljen delež bolnikov, ki so dosegli najvišje število celic CD34+/kg z aferezo.
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.
Slovenian: Bolniki so vsako jutro 4 dni pred prvim odmerkom pleriksaforja ali placeba ter vsako jutro pred aferezo prejemali G-CSF v odmerku 10 μg/kg.
English: One ml of solution contains 20 mg plerixafor.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN En ml vsebuje 20 mg pleriksaforja.
English: In clinical trials, patients with risk factors for a heart attack uncommonly suffered heart attacks after being given Mozobil and G-CSF.
Slovenian: V kliničnih preskušanjih je po prejemanju zdravila Mozobil in G-CSF pri bolnikih z dejavniki tveganja za srčno kap občasno prišlo do srčne kapi.
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
Slovenian: b Statistično značilno več bolnikov je doseglo ≥ 6 x 106 celic/kg v ≤ 2 dneh afereze z zdravilom Mozobil in G-CSF (n = 106; 71,6 %) kot s placebom in G-CSF (n = 53; 34,4 %), p < 0,001; statistično značilno več bolnikov je doseglo ≥ 6 x 106 celic/kg v ≤ 4 dneh afereze z zdravilom Mozobil in G-CSF (n = 112; 75,7 %) kot s placebom in G-CSF (n = 79; 51,3 %), p < 0,001; statistično značilno več bolnikov je doseglo ≥ 2 x 106 celic/kg v ≤ 4 dneh afereze z zdravilom Mozobil in G-CSF (n = 141; 95,3 %) kot s placebom in G-CSF (n = 136; 88,3 %), p < 0,031.
English: Pins and needles and numbness
Slovenian: Mravljinčenje in otrplost
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).
Slovenian: V odprti, multicentrični kontrolirani študiji (DFI 12860) (glejte poglavje 5.1) so 30 bolnikov zdravili z 0,24 mg/kg zdravila Mozobil.
English: Your doctor may adjust the dose.
Slovenian: • če imate težave z ledvicami (zdravnik bo morda prilagodil odmerek),