natgillin/translations-raw huggingface dataset:
In pharmacodynamic studies in healthy volunteers of plerixafor alone, peak mobilisation of CD34+ cells was observed from 6 to 9 hours after administration.
U farmakodinamičkim ispitivanjima na zdravim dobrovoljcima koji su primali samo pleriksafor, maksimalna mobilizacija CD34+ stanica uočena je 6 do 9 sati nakon primjene.
The potential effects of plerixafor on male fertility and postnatal development have not been evaluated in non-clinical studies.
Mogući učinci pleriksafora na mušku plodnost te postnatalni razvoj nisu ispitani u pretkliničkim ispitivanjima.
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.
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.
In clinical studies, 7 of 679 oncology patients experienced myocardial infarctions after haematopoietic stem cell mobilisation with plerixafor and G-CSF.
U kliničkim je ispitivanjima 7 od 679 onkoloških bolesnika pretrpjelo infarkt miokarda nakon mobilizacije krvotvornih matičnih stanica pleriksaforom i G-CSF-om.
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).
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
In study AMD3100-3102, 7 patients (all from the placebo + G-CSF group) entered the Rescue procedure.
U ispitivanju AMD3100-3102 je u postupak “spašavanja” uključeno 7 bolesnika (svi iz skupine koja je primala placebo + G-CSF).
The recommended adult dose is either a 20 mg (fixed dose) or 0.24 mg/kg body weight/day.
Preporučena doza za odrasle je ili 20 mg (fiksna doza) ili 0,24 mg/kg tjelesne težine na dan.
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.
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.
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).
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).
Cases of splenic enlargement and/or rupture have been reported following the administration of Mozobil in conjunction with growth factor G-CSF.
Slučajevi povećanja i/ili rupture slezene prijavljeni su nakon primjene lijeka Mozobil u kombinaciji s G-CSF faktorom rasta.
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.
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.
You should not breast-feed if you are using Mozobil, since it is not known if Mozobil is excreted in human milk.
Ne smijete dojiti ako primate Mozobil jer nije poznato izlučuje li se Mozobil u majčino mlijeko.
It is important to tell your doctor if you are, think you may be or are planning to become pregnant.
Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svome liječniku.
How to use Mozobil
Kako primjenjivati Mozobil
In general, care should be taken in dose selection for elderly patients due to the greater frequency of decreased renal function with advanced age.
U starijih bolesnika općenito je potrebno pažljivo određivati dozu jer se sa starijom dobi povećava učestalost oslabljene funkcije bubrega.
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.
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.
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.
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.
In Mozobil clinical studies of oncology patients, there have been rare reports of severe gastrointestinal events, including diarrhoea, nausea, vomiting, and abdominal pain.
U kliničkim ispitivanjima lijeka Mozobil na onkološkim bolesnicima rijetko su prijavljene teške nuspojave probavnog sustava koje uključuju proljev, mučninu, povraćanje i bol u abdomenu.
Rarely, gastrointestinal side effects may be severe (diarrhoea, vomiting, stomach pain and nausea).
U rijetkim slučajevima nuspojave probavnog sustava mogu biti teške (proljev, povraćanje, bol u trbuhu i mučnina).
The weight used to calculate the dose of plerixafor should be obtained within 1 week before the first dose of plerixafor.
Tjelesnu težinu na temelju koje se određuje potrebna doza pleriksafora potrebno je izmjeriti unutar tjedan dana prije prve primjene lijeka.
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.
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.
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).
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).
Plerixafor inhibited tumour growth in in vivo models of non-Hodgkin's lymphoma, glioblastoma, medulloblastoma, and acute lymphoblastic leukaemia when dosed intermittently.
Pri intermitentnom doziranju pleriksafor je inhibirao rast tumora u in vivo modelima ne-Hodgkinova limfoma, glioblastoma, meduloblastoma i akutne limfoblastične leukemije.
Elderly A population pharmacokinetic analysis showed no effect of age on pharmacokinetics of plerixafor.
Stariji bolesnici Populacijska farmakokinetička analiza nije ukazala na utjecaj dobi na farmakokinetiku pleriksafora.
Fold increase in peripheral blood CD34+ cell count following Mozobil administration
Stupanj porasta broja CD34+ stanica u perifernoj krvi nakon primjene lijeka Mozobil
Genzyme Ireland Ltd. IDA Industrial Park Old Kilmeaden Road Waterford, Ireland
IDA Industrial Park Old Kilmeaden Road Waterford, Irska
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.
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.
Each vial contains 24 mg plerixafor in 1.2 ml solution.
Jedna bočica sadrži 24 mg pleriksafora u 1,2 ml otopine.
Adverse reactions occurring more frequently with Mozobil than placebo and considered related to Mozobil during mobilisation and apheresis in phase III studies
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
The fixed 20 mg dose showed 1.43-fold higher exposure (AUC0-10h) than the 0.24 mg/kg dose (Table 2).
1,43 puta veću izloženost (AUC0-10h) nego doza od 0,24 mg/kg (Tablica 2).
Vials should be inspected visually prior to administration and not used if there is particulate matter or discolouration.
Prije primjene bočicu je potrebno vizualno pregledati, a lijek se ne smije primijeniti ako se uoče čestice ili promjena boje.
You may also have an increase in white blood cells count (leucocytosis), in your blood tests.
Također se na Vašim krvnim testovima može vidjeti porast broja bijelih krvnih stanica (leukocitoza).
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).
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).
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.
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.
Data from animal models also suggest modulation of foetal haematopoiesis, vascularisation, and cerebellar development by SDF-1α and CXCR4.
Podaci dobiveni na životinjskim modelima također upućuju na to da SDF-1α i CXCR4 utječu na hematopoezu, vaskularizaciju i razvoj malog mozga fetusa.
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.
Lijek se primjenjuje supkutanom injekcijom 6 - 11 sati prije početka svake afereze nakon prethodnog četverodnevnog liječenja čimbenikom poticanja rasta granulocita (engl.
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.
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.
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.
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.
Clinical judgment should be exercised when administering Mozobil to patients with peripheral blood neutrophil counts above 50 x 10
Prije primjene lijeka Mozobil u bolesnika koji u perifernoj krvi imaju više od 50 x 109
Myocardial infarction
Opis odabranih nuspojava Infarkt miokarda
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).
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).
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).
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).
Therefore, plerixafor is not recommended for haematopoietic stem cell mobilisation and harvest in patients with leukaemia.
Stoga se ne preporučuje primjena pleriksafora za mobilizaciju i prikupljanje krvotvornih matičnih stanica u bolesnika s leukemijom.
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).
(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).
• 20 mg fixed dose or 0.24 mg/kg of body weight for patients weighing ≤ 83 kg (see section
• fiksna doza od 20 mg ili 0,24 mg/kg tjelesne težine za bolesnike koji teže ≤83 kg (vidjeti dio 5.2).
Mozobil may cause dizziness and fatigue.
Mozobil može prouzročiti omaglicu i umor.
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.
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.
It is recommended to use contraception if you are of child-bearing age.
Preporučuje se primjena kontracepcije u žena generativne dobi.
Effect on the spleen
Učinak na slezenu
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).
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).
Of these patients, 100% (7 out of 7) mobilised ≥ 2 x10 6/kg CD34+ cells and had successful engraftment.
U 55% bolesnika (34 od 62) mobilizirano je ≥ 2 x 106/kg CD34+ stanica uz uspješno usađivanje.
Not known Splenomegaly, splenic rupture (see section
Poremećaji krvi i limfnog sustava nepoznato splenomegalija, ruptura slezene (vidjeti dio 4.4)**
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.
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.
Study AMD3100-3101 efficacy results - CD34+ cell mobilisation in non-Hodgkin's lymphoma patients
Tablica 3. Rezultati djelotvornosti u ispitivanju AMD3100-3101 - mobilizacija CD34+ stanica u bolesnika s ne-Hodgkinovim limfomom
- The other ingredients are sodium chloride, hydrochloric acid (concentrated) and sodium hydroxide for pH adjustment and water for injections.
- Druge pomoćne tvari su natrijev klorid, kloridna kiselina (koncentrirana) i natrijev hidroksid za podešavanje pH, te voda za injekcije.
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.
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.
Recommended concomitant medicinal products
Preporučeni lijekovi za istodobnu primjenu
Platelet counts should be monitored in all patients receiving Mozobil and undergoing apheresis.
Potrebno je kontrolirati broj trombocita u svih bolesnika u postupku afereze koji primaju Mozobil.
Based on the pharmacodynamic mechanism of action, plerixafor is suggested to cause congenital malformations when administered during pregnancy.
S obzirom na farmakodinamički mehanizam djelovanja pleriksafora, pretpostavlja se da njegova primjena u trudnoći može prouzročiti prirođene anomalije.
Patients were primarily treated with daily doses of 0.24 mg/kg plerixafor by subcutaneous injection.
Bolesnici su prvenstveno liječeni supkutanim injekcijama pleriksafora u dozi od 0,24 mg/kg na dan.
The potential risk associated with this effect is expected to be low for the intended short term duration of dosing plerixafor in humans.
S obzirom na preporučeno kratko vrijeme primjene pleriksafora u ljudi očekuje se bi potencijalan rizik povezan s prethodno opisanim učinkom trebao biti malen.
Administration of Mozobil in conjunction with G-CSF increases circulating leukocytes as well as haematopoietic stem cell populations.
Primjena lijeka Mozobil u kombinaciji s G-CSF-om povećava broj cirkulirajućih leukocita i broj krvotvornih matičnih stanica.
Mozobil 20 mg/ml solution for injection Plerixafor
Mozobil 20 mg/ml otopina za injekciju pleriksafor
Study AMD3100-3102 efficacy results - CD34+ cell mobilisation in multiple myeloma patients
Tablica 5. Rezultati djelotvornosti u ispitivanju AMD3100-3102 - mobilizacija CD34+ stanica u bolesnika s multiplim mijelomom
Mozobil 20 mg/ml solution for injection
Mozobil 20 mg/ml otopina za injekciju
Plerixafor did not act as a substrate or inhibitor of P-glycoprotein in an in vitro study.
U jednom in vitro ispitivanju pleriksafor nije djelovao kao supstrat niti inhibitor p-glikoproteina.
Mozobil and G-CSF Placebo and G-CSF
Mozobil i G-CSF
Each ml solution for injection contains 20 mg plerixafor.
Jedan ml otopine za injekciju sadrži 20 mg pleriksafora.
The median PB CD34+ cell counts at baseline were 15 cells/µl in the Mozobil arm versus 35 cells/µl in control arm.
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.
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.
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.
Placebo and G-CSF (n = 154)
Placebo i G-CSF (n = 154)
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.
Mozobil je dostupan u obliku bistre, bezbojne do blijedožute otopine za injekciju u staklenoj bočici s gumenim čepom koji ne sadrži lateks.
Additionally, two female oncology patients in the compassionate use programme experienced myocardial infarction following haematopoietic stem cell mobilisation with plerixafor and G-CSF.
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.
Method of administration Mozobil is for subcutaneous injection.
Lijek Mozobil se primjenjuje supkutanom injekcijom.
Geometric Mean AUC
Geometrijska srednja vrijednost AUC-a
Mozobil and G-CSF (n = 150)
Mozobil i G-CSF (n = 150)
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
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
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.
Bočica od prozirnog stakla tipa I, volumena 2 ml, s klorbutilnim/butilnim gumenim čepom i aluminijskim zaštitnim zatvaračem s plastičnom „flip-off“ kapicom.
Mozobil is given by subcutaneous injection (under your skin).
Mozobil se daje potkožnom (supkutanom) injekcijom.
Each ml contains 20 mg plerixafor.
Jedan ml sadrži 20 mg pleriksafora.
Excipients: sodium chloride, hydrochloric acid (concentrated) and sodium hydroxide for pH adjustment and water for injections.
POPIS POMOĆNIH TVARI Pomoćne tvari: natrijev klorid, kloridna kiselina (koncentrirana) i natrijev hidroksid za podešavanje pH te voda za injekcije.
No dose modifications are necessary in elderly patients with normal renal function.
Stariji bolesnici (> 65 godina) U starijih bolesnika s normalnom funkcijom bubrega nije potrebno prilagođavati dozu.
Hydrochloric acid, concentrated (pH adjustment) Sodium hydroxide (pH adjustment) Water for injections
6.1 Popis pomoćnih tvari natrijev klorid kloridna kiselina, koncentrirana (za podešavanje pH) natrijev hidroksid (za podešavanje pH) voda za injekcije
An increase of nonHodgkin's lymphoma growth was noted after a continuous administration of plerixafor for 28 days.
Nakon kontinuirane primjene pleriksafora tijekom 28 dana zabilježeno je povećanje rasta ne-Hodgkinova limfoma.
Patients achieving ≥ 6 x 10
Bolesnici koji su postigli ≥ 2 x 106 stanica/kg u
Vistor hf.
G-CSF-om.
Placebo and G-CSF (n = 148)
Placebo i G-CSF (n = 148)
Mozobil contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free'.
Natrij Mozobil sadrži manje od 1 milimola natrija (23 mg) po dozi, tj. zanemarive količine natrija.
Each vial contains 1.2 ml solution.
Jedna bočica sadrži 1,2 ml otopine.
Therefore, you should avoid driving if you feel dizzy, tired or unwell.
Ako osjećate omaglicu, umor ili se osjećate loše, nemojte voziti.
This leaflet was last approved in.
Ova uputa je zadnji puta revidirana u Ostali izvori informacija
In a compassionate use programme, Mozobil and G-CSF have been administered to patients with acute myelogenous leukaemia and plasma cell leukaemia.
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.
Some patients have experienced dizziness, fatigue or vasovagal reactions; therefore caution is advised when driving or operating machines.
Neki su bolesnici osjetili omaglicu, umor ili vazovagalne reakcije.