FrancophonIA/ELRC3.0 huggingface dataset:
English: There were 140 patients with ALL or LL enrolled and evaluated for safety; median age was 10 years (range 1 to 26).
Slovenian: Varnost so ocenjevali pri 140 vključenih bolnikih z ALL ali LL, z mediano starostjo 10 let (v razponu od 1 do 26).
English: The following adverse reactions (Grade ≥ 3) were observed at a higher incidence in the bortezomib containing treatment regimen as compared with a historical control study in which the backbone regimen was given alone: in Block 1 peripheral sensory neuropathy (3% versus 0%); ileus (2.1% versus 0%); hypoxia (8% versus 2%).
Slovenian: V shemi zdravljenja z dodanim zdravilom bortezomibom so se naslednji neželeni učinki (stopnje ≥ 3) pojavili pogosteje kot v predhodni kontrolni študiji, kjer so bolniki prejemali samo osnovno shemo zdravljenja: v 1. sklopu periferna senzorična nevropatija (3% proti 0%), ileus (2,1% proti 0%), hipoksija (8% proti 2%).
English: The usual starting dose of Bortezomib SUN is 1.3 mg/m2 body surface area twice a week.
Slovenian: Običajni začetni odmerek zdravila Bortezomib SUN je 1,3 mg/m2 telesne površine dvakrat na teden.
English: Patients with previously treated light-chain (AL) Amyloidosis An open label non randomised Phase I/II study was conducted to determine the safety and efficacy of bortezomib in patients with previously treated light-chain (AL) Amyloidosis.
Slovenian: Bolniki s predhodno zdravljeno amiloidozo lahkih verig (AL-amiloidoza) V odprti, nerandomizirani študiji faze I/II so ugotavljali varnost in učinkovitost bortezomiba pri bolnikih s predhodno zdravljeno AL-amiloidozo.
English: * Based on posology modifications in Phase II and III multiple myeloma studies and post-marketing experience.
Slovenian: * Na podlagi prilagoditev odmerjanja v študijah faze II in III pri bolnikih z diseminiranim plazmocitomom in izkušenj v obdobju trženja.
English: Once weekly Bortezomib SUN (cycles 5-9)
Slovenian: Odmerjanje zdravila Bortezomib SUN enkrat na teden (krogi 5-9)
English: There was no evidence of cumulative thrombocytopenia.
Slovenian: Znakov kumulativne trombocitopenije ni bilo.
English: The median duration of complete response was 42.1 months in the BzmbR-CAP group compared with 18 months in the R-CHOP group.
Slovenian: Mediana trajanja popolnega odziva je bila 42,1 meseca v skupini BzmbR-CAP in 18 mesecev v skupini R-CHOP.
English: The kinetics of proteasome inhibition were evaluated in vitro, and bortezomib was shown to dissociate from the proteasome with a t½ of 20 minutes, thus demonstrating that proteasome inhibition by bortezomib is reversible.
Slovenian: Kinetiko zaviranja proteasoma so ovrednotili in vitro in pri tem pokazali, da poteka disociacija bortezomiba s proteasoma z razpolovnim časom t½ = 20 minut, kar pomeni, da je zavora proteasoma, ki jo doseže bortezomib, povratna.
English: These effects have been observed in patients with multiple myeloma affected by an advanced osteolytic disease and treated with bortezomib.
Slovenian: Te učinke so opazili pri bolnikih z diseminiranim plazmocitomom z napredovalo osteolitično boleznijo, ki so prejemali bortezomib.
English: Therefore, this specific regimen with concomitant administration with high-dose cytarabine (2 g/m2 per day) by continuous infusion over 24 hours is not recommended.
Slovenian: Zato ta režim dajanja s sočasnim velikim odmerkom citarabina v 24-urni kontinuirani infuziji (2 g/m2
English: Cochran Mantel-Haenszel test. b Refers to response rate after second transplant for subjects who received a second transplant (42/240 [18% ] in BzmbDx group and 52/242 [21%] in VDDx group).
Slovenian: b Nanaša se na stopnjo odgovora po drugi presaditvi pri posameznikih, pri katerih je bila le-ta izvedena (42/240 [18%] v skupini VcDx in 52/242 [21%] v skupini VDDx).
English: In addition, the incidence of Grade 3 or higher peripheral neuropathies was 10% lower, and the discontinuation rate due to peripheral neuropathies 8% lower for the subcutaneous group as compared to the intravenous group.
Slovenian: Dodatno je bila pri subkutani skupini incidenca perifernih nevropatij stopnje 3 ali več za 10 % manjša in za 8 % manjša pogostnost prekinitve zdravljenja zaradi perifernih nevropatij, v primerjavi s skupino, ki je zdravilo prejemala intravensko.
English: Induction Transplant Regimens Graph shall contain the following key elements:
Slovenian: Diagram režima uvajanja pred transplantacijo mora vsebovati naslednje ključne elemente
English: What you need to know before you are given Bortezomib SUN You should NOT be given Bortezomib SUN - if you are allergic to bortezomib, boron or to any of the other ingredients of this medicine
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Bortezomib SUN Ne uporabljajte zdravila Bortezomib SUN: - če ste alergični na bortezomib, bor ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: In patients with MCL, transient neutropenia that was reversible between cycles was observed, with no evidence of cumulative neutropenia.
Slovenian: Pri bolnikih z MCL so opažali prehodno nevtropenijo, ki je bila med krogi zdravljenja reverzibilna.
English: Patients on oral antidiabetic agents receiving bortezomib treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetics.
Slovenian: Pri bolnikih, ki so prejemali peroralne antidiabetike in bortezomib, je potrebno skrbno spremljanje koncentracije glukoze v krvi in prilagoditi odmerek antidiabetika.
English: Eighteen percent of patients achieved, or had an improved response [MR (11%) or PR (7%)] with combination treatment.
Slovenian: [MR (11 %) ali PR (7 %)] pri kombiniranem zdravljenju.
English: Hepatitis B Virus (HBV) reactivation and infection Mantle cell lymphoma
Slovenian: Reaktivacija in okužba z virusom hepatitisa B (HBV) Limfom plaščnih celic
English: Patients diagnosed with PML had prior or concurrent immunosuppressive therapy.
Slovenian: Bolniki s PML so že pred diagnozo prejemali ali sočasno prejemajo imunosupresivno zdravljenje.
English: In particular, tell your doctor if you are using medicines containing any of the following active substances: - ketoconazole, used to treat fungal infections - ritonavir, used to treat HIV infection - rifampicin, an antibiotic used to treat bacterial infections - carbamazepine, phenytoin or phenobarbital used to treat epilepsy - St. John's Wort (Hypericum perforatum), used for depression or other conditions - oral antidiabetics
Slovenian: Še posebej morate svojega zdravnika obvestiti, če jemljete zdravila, ki vsebujejo katero izmed naslednjih učinkovin: - ketokonazol, ki se uporablja za zdravljenje glivičnih okužb - ritonavir, ki se uporablja za zdravljenje okužbe z virusom HIV - rifampicin, antibiotik, ki se uporablja za zdravljenje bakterijskih okužb
English: Therefore, platelet counts should be monitored prior to each dose of bortezomib.
Slovenian: Zato je treba pred dajanjem vsakega odmerka bortezomiba določiti število trombocitov.
English: Inhibition of the proteasome results in cell cycle arrest and apoptosis.
Slovenian: Zavora proteasoma povzroči ustavitev celičnega ciklusa in apoptozo.
English: In vitro studies with human liver microsomes and human cDNA-expressed cytochrome P450 isozymes indicate that bortezomib is primarily oxidatively metabolised via cytochrome P450 enzymes, 3A4, 2C19, and 1A2.
Slovenian: In vitro študije na človeških jetrnih mikrosomih in izocimih citokroma P450 z izraženo človeško cDNA kažejo, da se bortezomib v prvi vrsti oksidativno presnovi z encimi citokroma P450, 3A4, 2C19 in 1A2.
English: The incidence of all grade peripheral neuropathy with bortezomib administered intravenously was lower in the historical studies with bortezomib administered intravenously than in study MMY-3021.
Slovenian: Pogostnost vseh stopenj periferne nevropatije pri dajanju bortezomiba intravensko je bila v že prej opravljenih študijah nižja kot v študiji MMY-3021.
English: A hazard ratio < 1 indicates an advantage for BzmbR-CAP. c Based on Kaplan-Meier product limit estimates.
Slovenian: Razmerje tveganja < 1 predstavlja prednost za skupino BzmbR-CAP. c Ocena po metodi Kaplan-Meier.
English: Bortezomib causes reduction of tumour growth in vivo in many preclinical tumour models, including multiple myeloma.
Slovenian: Bortezomib je povzročil zmanjšanje rasti tumorja in vivo v mnogih predkliničnih tumorskih modelih, vključno z modelom diseminiranega plazmocitoma.
English: 1.2 Before administration, visually inspect the solution for particulate matter and discolouration.
Slovenian: 1.2 Pred dajanjem vizualno preverite, ali raztopina vsebuje delce in ali je barva spremenjena.
English: Overall, bortezomib was administered for the treatment of multiple myeloma in 3,974 patients.
Slovenian: Za zdravljenje diseminiranega plazmocitoma je bortezomib prejelo skupno 3.974 bolnikov.
English: Although in patients aged ≥ 75 years, both BzmbR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the BzmbR-CAP groups was 68%, compared to 42% in the R-CHOP group.
Slovenian: Čeprav so bolniki, stari ≥ 75 let, slabše prenašali oba režima zdravljenja, BzmbR-CAP in R-CHOP, je bila stopnja resnih neželenih učinkov v skupini BzmbR-CAP 68 % v primerjavi z 42 % v skupini R
English: Uncommon Cushing's syndrome*, Hyperthyroidism*, Inappropriate antidiuretic hormone secretion
Slovenian: Cushingov sindrom*, hipertiroidizem*, motnje izločanja antidiuretičnega hormona
English: The median TTP was 6.5 months for the bortezomib monotherapy patients compared with 9.3 months for the bortezomib plus pegylated liposomal doxorubicin combination therapy patients.
Slovenian: TTP je bila 6,5 meseca pri bolnikih, ki so prejemali samo bortezomib, v primerjavi z 9,3 meseca pri tistih, ki so prejemali kombinirano zdravljenje z bortezomibom in pegiliranim liposomskim doksorubicinom.
English: Rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m2.
Slovenian: 375 mg/m2 rituksimaba, 750 mg/m2 ciklofosfamida in 50 mg/m2doksorubicina.
English: Overall response (CR+CRu+PR)h n(%)
Slovenian: Celokupni odziv (CR+CRu+PR)h n(%)
English: In this case, the duration of a treatment cycle is 42 days (6 weeks).
Slovenian: V tem primeru traja en krog 42 dni (6 tednov).
English: A total of 74 evaluable patients were administered dexamethasone in combination with bortezomib.
Slovenian: Odziv na zdravljenje so ocenili pri skupaj 74 bolnikih, ki so prejeli deksametazon v kombinaciji z bortezomibom.
English: Following intravenous bolus administration of a 1.0 mg/m2 and 1.3 mg/m2 dose to 11 patients with multiple myeloma and creatinine clearance values greater than 50 ml/min, the mean first-dose maximum plasma concentrations of bortezomib were 57 and 112 ng/ml, respectively.
Slovenian: Absorpcija Po intravenski aplikaciji bolusnega odmerka 1,0 mg/m2 in 1,3 mg/m2 11 bolnikom z diseminiranim plazmocitomom in očistkom kreatinina, večjim kot 50 ml/min, sta bili povprečni vrednosti najvišjih plazemskih koncentracij bortezomiba po prvem odmerku 57 in 112 ng/ml.
English: Bortezomib was not genotoxic when tested in the in vitro mutagenicity assay (Ames assay) and in vivo micronucleus assay in mice.
Slovenian: Bortezomib se ni izkazal za genotoksičnega v in vitro preskusu mutagenosti (Amesov preskus) in v in vivo mikronukleusnem preskusu pri miših.
English: visual loss or disturbances and shortness of breath - memory loss, trouble thinking, difficulty with walking or loss of vision.
Slovenian: izguba ali motnje vida ali težko dihate, - če doživite izgubo spomina, imate težave z mišljenjem, s hojo ali se vam poslabša vid.
English: Subcutaneous or intravenous use only.
Slovenian: Samo za subkutano ali intravensko uporabo.
English: The incidence of herpes zoster among patients in the BzmbR-CAP arm was 10.7% for patients not administered antiviral prophylaxis compared to 3.6% for patients administered antiviral prophylaxis (see section 4.4).
Slovenian: Pogostnost virusa herpes zoster v skupini BzmbR-CAP je bila 10,7 % pri bolnikih, ki niso prejemali protivirusnih zdravil, pri bolnikih, ki so prejemali protivirusna zdravila, pa 3,6 % (glejte poglavje 4.4).
English: Note: An OR > 1 indicates an advantage for Bzmb-containing induction therapy.
Slovenian: Opomba: OR > 1 kaže na prednost uvajalnega zdravljenja z Bzmb.
English: Cycles 1 to 4
Slovenian: krog 2 do 4b
English: Reduce Bortezomib SUN to 1.0 mg/m2
Slovenian: zmanjšajte odmerek zdravila Bortezomib SUN na 1,0 mg/m2
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Slovenian: Če se ne porabi takoj, je za čas in pogoje shranjevanja zdravila po rekonstituciji odgovoren uporabnik.
English: Rambla de Catalunya 53-55 08007 Barcelona España tel. +34 93 342 78 90
Slovenian: Rambla de Catalunya 53-55 08007 Barcelona
English: Patients eligible for stem cell transplantation
Slovenian: Bolniki, primerni za presaditev krvotvornih matičnih celic
English: Dose adjustments during treatment and re-initiation of treatment for monotherapy Bortezomib SUN treatment must be withheld at the onset of any Grade 3 non-haematological or any Grade 4 haematological toxicities, excluding neuropathy as discussed below (see also section 4.4).
Slovenian: Prilagoditev odmerjanja med zdravljenjem in pri ponovni uvedbi zdravljenja v obliki monoterapije Zdravljenje z zdravilom Bortezomib SUN morate prekiniti ob pojavu katere koli nehematološke toksičnosti 3. stopnje ali katere koli hematološke toksičnosti 4. stopnje, z izjemo nevropatije, kot je opisano v nadaljevanju (glejte tudi poglavje 4.4).
English: Grade 4 (life-threatening consequences; urgent intervention indicated) and/or severe autonomic neuropathy
Slovenian: Stopnja 4 (posledice, ki ogrožajo življenje;potrebno je nujno ukrepanje ) in/ali močna avtonomna nevropatija ukinite zdravljenje z zdravilo Bortezomib SUN
English: In the Phase III study in patients with previously untreated multiple myeloma, the overall incidence of herpes zoster reactivation was more common in patients treated with Bortezomib+Melphalan+Prednisone compared with Melphalan+Prednisone (14% versus 4% respectively).
Slovenian: V študiji faze III pri bolnikih s predhodno nezdravljenim diseminiranim plazmocitomom je bila splošna pojavnost reaktivacije virusa herpes zoster pri bolnikih, zdravljenih z bortezomibom+melfalanom+prednizonom, pogostejša kot pri bolnikih, zdravljenih z melfalanom+prednizonom (14 % v primerjavi s 4 %).
English: Patients who developed orthostatic hypotension on bortezomib (injected intravenously) did not have evidence of orthostatic hypotension prior to treatment with bortezomib.
Slovenian: Bolniki, pri katerih se pojavi ortostatska hipotenzija med zdravljenjem z bortezomibom (intravensko), pred uporabo bortezomiba niso imeli nobenih znakov ortostatske hipotenzije.
English: Dexamethasone was administered in combination with bortezomib to 83 patients in Cycle 1 with an additional 11 patients receiving dexamethasone during the course of bortezomib retreatment cycles.
Slovenian: V 1. krogu zdravljenja je skupaj z bortezomibom prejemalo deksametazon 83 bolnikov, v nadaljnjih krogih zdravljenja z bortezomibom pa še dodatnih 11 bolnikov.
English: There have been rare reports of acute diffuse infiltrative pulmonary disease of unknown aetiology such as pneumonitis, interstitial pneumonia, lung infiltration, and acute respiratory distress syndrome (ARDS) in patients receiving bortezomib (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali bortezomib, so redko poročali o akutni difuzni infiltracijski pljučni bolezni neznane etiologije, kot so pnevmonitis, intersticijska pljučnica, infiltracija pljuč in sindrom akutne respiratorne stiske (SARS) (glejte poglavje 4.8).
English: One single autologous stem cell transplant was received by 105 (81%) patients and 78 (61%) patients in the BzmbTDx and TDx groups, respectively.
Slovenian: Eno avtologno presaditev krvotvornih matičnih celic so opravili pri 105 (81 %) bolnikih v skupini BzmbTDx in pri 78 (61 %) bolnikih v skupini TDx.
English: Median follow-up was 16.3 months.
Slovenian: Po vmesni analizi so še naprej spremljali preživetje; mediana je bila 16,3 meseca.
English: In the Phase II study, patients who did not obtain an optimal response to therapy with bortezomib alone were able to receive high-dose dexamethasone in conjunction with bortezomib.
Slovenian: Bolniki v preskušanju faze II, ki niso dosegli optimalnega odziva na zdravljenje z bortezomibom v monoterapiji, so poleg bortezomiba lahko prejemali tudi deksametazon v velikih odmerkih.
English: HRb (95% CI)=0.63 p-valued < 0.001
Slovenian: HRb (95 % CI)=0,63
English: In the BzmbR-CAP group, 22.5% of patients received platelet transfusions compared to 2.9% of patients in the R-CHOP group.
Slovenian: V skupini BzmbR-CAP je prejelo infuzijo trombocitov 22,5 % bolnikov, v skupini R-CHOP pa 2,9 % bolnikov.
English: * Survival update based on a median duration of follow-up at 60.1 months mo: months
Slovenian: * preživetje na osnovi podatkov po 60,1 mesecih spremljanja CI=interval zaupanja
English: In study IFM-2005-01 bortezomib combined with dexamethasone [BzmbDx, n=240] was compared to vincristine- doxorubicin-dexamethasone [VDDx, n=242].
Slovenian: V študiji IFM-2005-01 so primerjali kombinacijo bortezomiba in deksametazona [BzmbDx, n=240] s kombinacijo vinkristin-doksorubicin-deksametazon VDDx, n=242].
English: b Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: β2-microglobulin,
Slovenian: b Ocena razmerja tveganja na podlagi Coxovega proporcionalnega modela, prilagojena na podlagi stratifikacijskih dejavnikov: β2-mikroglobulin, albumin in regija.
English: When compared to patients with normal hepatic function, mild hepatic impairment did not alter dosenormalised bortezomib AUC.
Slovenian: Ob primerjavi z bolniki z normalnim delovanjem jeter pri bolnikih z blago jetrno okvaro ni bilo sprememb v povprečnem, na odmerek normaliziranem AUC bortezomiba.
English: Bzmb=Bortezomib SUN; M=melphalan, P=prednisone
Slovenian: Bzmb=bortezomib; Dex=deksametazon
English: 12.8 mo
Slovenian: 12,8 meseca
English: In a clinical trial, two patients (out of 2) given high-dose cytarabine (2 g/m2 per day) by continuous infusion over 24 hours with daunorubicin and bortezomib for relapsed acute myelogenous leukaemia died of ARDS early in the course of therapy, and the study was terminated.
Slovenian: V kliničnem preskušanju sta dva bolnika (od dveh), pri katerih so akutno mielogeno levkemijo zdravili z visokim odmerkom citarabina v 24-urni kontinuirani infuziji (2 g/m2 na dan) skupaj z daunorubicinom in bortezomibom, umrla zaradi SARS na začetku zdravljenja in študijo so zaključili.
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe, zastrupitve in Občasni padci, kontuzije
English: Potentially immunocomplex-mediated reactions Potentially immunocomplex-mediated reactions, such as serum-sickness-type reaction, polyarthritis with rash and proliferative glomerulonephritis have been reported uncommonly.
Slovenian: Morebitne reakcije, povzročene z imunskimi kompleksi Občasno so poročali o reakcijah, morda povzročenih z imunskimi kompleksi, kot so serumska bolezen, poliartritis z izpuščajem in proliferativni glomerulonefritis.
English: Following an intravenous bolus or subcutaneous injection of a 1.3 mg/m2 dose to patients with multiple myeloma (n=14 in the intravenous group, n=17 in the subcutaneous group), the total systemic exposure after repeat dose administration (AUClast) was equivalent for subcutaneous and intravenous administrations.
Slovenian: Pri bolnikih z diseminiranim plazmocitomom se po intravenski bolusni ali subkutani injekciji pri odmerku 1,3 mg/m2 (n=14 pri intravenski in n=17 pri subkutani skupini) je bila skupna sistemska izpostavljenost po ponovljenem odmerku (AUClast) ekvivalentna pri subkutanem in intravenskem dajanju.
English: You do not need to check the pH of the solution.
Slovenian: Vrednosti pH raztopine ni treba preverjati.
English: In subsequent doses, mean maximum observed plasma concentrations ranged from 67 to 106 ng/ml for the 1.0 mg/m2 dose and 89 to 120 ng/ml for the 1.3 mg/m2 dose.
Slovenian: Pri ponovljenih odmerkih so bile povprečne vrednosti najvišjih plazemskih koncentracij v razponu od 67 do 106 ng/ml pri odmerku 1,0 mg/m2 in od 89 do 120 ng/ml pri odmerku 1,3 mg/m2.
English: When toxicity resolves re-initiate Bortezomib SUN treatment and reduce dose to 0.7 mg/m2 once per week.
Slovenian: Nato ponovno uvedite zdravljenje z zdravilom Bortezomib SUN in zmanjšajte odmerek na 0,7 mg/m2 enkrat na teden.
English: Adverse drug reactions identified as those with a ≥ 1% incidence, similar or higher incidence in the BzmbR-CAP arm and with at least a possible or probable causal relationship to the components of the BzmbR-CAP arm, are listed in Table 8 below.
Slovenian: V preglednici 8 so navedeni ugotovljeni neželeni učinki s pogostnostjo ≥ 1 %, ki je bila podobna ali večja v skupini BzmbR-CAP in z najmanj verjetno ali možno vzročno povezanostjo s komponentami v skupini BzmbR-CAP.
English: Bortezomib SUN 3.5 mg powder for solution for injection IS FOR SUBCUTANEOUS OR INTRAVENOUS USE.
Slovenian: Zdravilo Bortezomib SUN 3,5 mg prašek za raztopino za injiciranje je ZA SUBKUTANO ALI INTRAVENSKO UPORABO.
English: Day 1, 2, 3, 4 Day 8, 9, 10, 11
Slovenian: Dx 40 mg dan 1, 2, 3, 4 dan 8, 9, 10, 11
English: Therefore, the concomitant use of bortezomib with strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital and St. John's Wort) is not recommended, as efficacy may be reduced.
Slovenian: Ker se lahko zmanjša učinkovitost, se sočasna uporaba bortezomiba z močnimi induktorji encima CYP3A4 (npr. rifampicinom, karbamazepinom, fenitoinom, fenobarbitalom in šentjanževko) ne priporoča.
English: You will receive 4 cycles (12 weeks).
Slovenian: Prejeli boste 4 kroge zdravljenja (12 tednov).
English: There is no evidence to suggest that dose adjustments are necessary in patients over 65 years of age with multiple myeloma or with mantle cell lymphoma.
Slovenian: Ni dokazov, da je pri bolnikih, starejših od 65 let, z diseminiranim plazmocitomom ali limfomom plaščnih celic, potrebna prilagoditev odmerka.
English: - If several Bortezomib SUN doses in a cycle are withheld (≥ 3 doses during twice weekly administration or ≥ 2 doses during weekly administration)
Slovenian: Bortezomib SUN v enem krogu zdravljenja (≥ 3 odmerke pri odmerjanju dvakrat na teden ali ≥ 2 odmerka pri odmerjanju enkrat na teden)
English: Bortezomib SUN therapy should be withheld until symptoms of the toxicity have resolved to Grade 2 or better.
Slovenian: Zdravljenje z zdravilom Bortezomib SUN je treba prekiniti, dokler se simptomi toksičnosti ne povrnejo na 2. stopnjo ali še izboljšajo.
English: Platelet transfusion for the treatment of thrombocytopenia should be considered when clinically appropriate.
Slovenian: Če je klinično ustrezno, je treba za zdravljenje trombocitopenije razmisliti o transfuziji trombocitov.
English: Common Hypertension*, Hypotension*, Orthostatic hypotension
Slovenian: Pogosti hipertenzija*, hipotenzija*, ortostatska hipotenzija
English: Bortezomib SUN treatment must be withheld at the onset of any ≥ Grade 3 bortezomib-related non-haematological toxicities (excluding neuropathy) or ≥ Grade 3 haematological toxicities (see also section .4).
Slovenian: Zdravljenje z zdravilom Bortezomib SUN je treba prekiniti ob pojavu katere koli z uporabo bortezomiba povezane nehematološke toksičnosti stopnje ≥ 3 (razen nevropatije) ali hematološke toksičnosti stopnje ≥ 3 (glejte tudi poglavje 4.4).
English: Age The pharmacokinetics of bortezomib were characterized following twice weekly intravenous bolus administration of 1.3 mg/m2 doses to 104 paediatric patients (2-16 years old) with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).
Slovenian: Farmakokinetiko bortozomiba so ovrednotili po intravenski aplikaciji bolusnega odmerka 1,3 mg/m2 dvakrat na teden 104 pediatričnim bolnikom (starim 2-16 let) z akutno limfoblastno levkemijo (ALL
English: RECONSTITUTION FOR SUBCUTANEOUS INJECTION
Slovenian: REKONSTITUCIJA ZA SUBKUTANO INJICIRANJE