FrancophonIA/ELRC3.0 huggingface dataset:
English: CIRS-G ≤10 (n=310) CIRS-G >10 (n=137) CrCl <70 ml/min (n=214) CrCl ≥70 ml/min (n=227) 17p or 11q deletion (n=90) IGHV mutated (≤98%) (n=177) IGHV unmutated (>98%) (n=227) β2M ≤3500 μg/l (n=109) β2M >3500 μg/l (n=322) ZAP-70 positive (n=161) ZAP-70 intermediate (n=160) ZAP-70 negative (n=100) IGHV mutated & ZAP-70 negative (n=60)
Slovenian: Delecija 17p ali 11q (n = 90) IGHV mutiran (≤ 98 %) (n = 177) IGHV nemutiran (> 98 %) (n = 227) β2M ≤ 3.500 μg/l (n = 109) β2M > 3.500 μg/l (n = 322) ZAP-70 pozitivni (n = 161) ZAP-70 vmesni (n = 160) ZAP-70 negativni (n = 100) IGHV mutirani in ZAP-70 negativni (n = 60)
English: Hazard Ratio=0.67 95% CI (0.51,0.88) p-value=0.0032
Slovenian: razmerje ogroženosti=0.67 95% CI (0.51,0.88) p-vrednost=0.0032
English: For previously untreated CLL, the recommended dosage and schedule is:
Slovenian: Pri predhodno nezdravljeni KLL sta priporočena shema in časovni razpored odmerjanja:
English: If any adverse reactions are observed, infusion rates should be reduced (see section 4.2).
Slovenian: Če se pojavijo kakšne neželene reakcije, je treba hitrost infundiranja zmanjšati (glejte poglavje 4.2).
English: The majority of infusion-related reactions were Grade 1 or Grade 2 in severity.
Slovenian: Po intenzivnosti je bila večina z infundiranjem povezanih reakcij 1. ali 2. stopnje.
English: Arzerra must not be administered as an intravenous push or bolus.
Slovenian: Zdravila Arzerra ne smete dajati intravensko s potiskom ali v bolusu.
English: Ofatumumab has a small volume of distribution, with mean Vss values ranging from 1.7 to 8.1 l across studies, dose levels, and infusion number.
Slovenian: Ofatumumab ima majhen volumen porazdelitve; povprečna vrednost Vss v različnih študijah, z različnimi odmerki in različnim številom infuzij sega od 1,7 do 8,1 l. Biotransformacija
English: You may need extra check-ups while you are being treated with Arzerra.
Slovenian: Med zdravljenjem z zdravilom Arzerra boste morda potrebovali dodatne kontrole.
English: For the highest dose group, the median time to progression was 15.6 weeks (95% CI: 15,22.6) in the full analysis population, and 23 weeks (CI: 20,31) in responders.
Slovenian: V skupini z največjim odmerkom je bil mediani čas do napredovanja 15,6 tedna (95 % IZ: od 15 do 22,6) v celotni analizirani populaciji in 23 tednov (IZ: od 20 do 31) pri odzivnih bolnikih.
English: What Arzerra looks like and contents of the pack Arzerra is a colourless to pale yellow concentrate for solution for infusion.
Slovenian: Izgled zdravila Arzerra in vsebina pakiranja Zdravilo Arzerra je brezbarvni do svetlo rumen koncentrat za raztopino za infundiranje.
English: The recommended dose and schedule is 12 doses administered as follows:
Slovenian: Priporočena sta naslednja shema in razpored odmerjanja z 12 odmerki:
English: Patients refractory to fludarabine and alemtuzumab n=95
Slovenian: Bolniki, pri katerih je bolezen neodzivna na zdravljenje s fludarabinom in alemtuzumabom n = 95
English: Breast-feeding is not recommended during treatment with Arzerra and for 12 months after the last dose.
Slovenian: Dojenje ni priporočljivo med zdravljenjem z zdravilom Arzerra in še 12 mesecev po zadnjem odmerku.
English: • Subsequent cycles (up to a maximum of 6 cycles in total): 1000 mg on day 1 every 28 days.
Slovenian: • nadaljnji ciklusi (do skupno največ 6 ciklusov): 1.000 mg na 1. dan vsakih 28 dni
English: The safety of, and ability to generate a primary or anamnestic response to, immunisation with live attenuated or inactivated vaccines during treatment with ofatumumab has not been studied.
Slovenian: Varnost imunizacij z živimi oslabljenimi ali inaktiviranimi cepivi in zmožnost za primarni ali anamnestični odziv na njihovo uporabo med zdravljenjem z ofatumumabom nista raziskana.
English: Also contains: arginine, sodium acetate (E262), sodium chloride, polysorbate 80 (E433), edetate disodium (E386), hydrochloric acid (E507), water for injections.
Slovenian: Vsebuje tudi: arginin, natrijev acetat (E262), natrijev klorid, polisorbat 80 (E433), dinatrijev edetat (E386), klorovodikovo kislino (E507), vodo za injekcije.
English: • difficulty in breathing, shortness of breath, chest tightness, cough
Slovenian: • težko dihanje, kratka sapa, tiščanje v prsih, kašelj,
English: Figure 1 Kaplan-Meier estimates of IRC-assessed PFS in previously untreated CLL
Slovenian: Kaplan-Meierjeve ocene PFS po oceni neodvisnega odbora za pregled (IRC) pri predhodno nezdravljeni KLL
English: Limited data are available in the heterogeneous non-white population and in patients with an ECOG performance status of 2.
Slovenian: Za heterogeno populacijo nebelcev in za bolnike s stanjem zmogljivosti 2 po ECOG je na voljo malo podatkov.
English: Of the 1,168 patients receiving ofatumumab in clinical trials, 420 patients (36%) experienced an adverse event associated with a decreased neutrophil count; 129 (11%) experienced a serious adverse event associated with a decreased neutrophil count.
Slovenian: Od 1.168 bolnikov, ki so prejemali ofatumumab v kliničnih študijah, so se 420 bolnikom (36 %) pojavili neželeni učinki, povezani z zmanjšanim številom nevtrofilcev; 129 bolnikov (11 %) pa je imelo resen neželen učinek, povezan z zmanjšanim številom nevtrofilcev.
English: Additionally a group of patients (n=16) who were intolerant/ineligible for fludarabine treatment and/or intolerant to alemtuzumab treatment were treated with Arzerra.
Slovenian: Poleg tega so z zdravilom Arzerra zdravili še skupino bolnikov (n = 16), ki niso prenašali ali niso bili primerni za zdravljenje s fludarabinom in/ali niso prenašali zdravljenja z alemtuzumabom.
English: The binding of ofatumumab to the membrane-proximal epitope of the CD20 molecule induces recruitment and activation of the complement pathway at the cell surface, leading to complementdependent cytotoxicity and resultant lysis of tumour cells.
Slovenian: Vezava ofatumumaba na membransko proksimalni epitop molekule CD20 povzroči okrepitev in aktivacijo poti komplementa na celični površini; to povzroči od komplementa odvisno citotoksičnost in posledično lizo tumorskih celic.
English: Arzerra is used to treat chronic lymphocytic leukaemia (CLL).
Slovenian: Zdravilo Arzerra se uporablja za zdravljenje kronične limfocitne levkemije (KLL).
English: Arzerra 1000 mg is available in a pack containing 1 vial.
Slovenian: Arzerra 1000 mg je na voljo v pakiranju, ki vsebuje 1 vialo.
English: Of the 1,168 patients receiving ofatumumab in clinical trials for CLL, 682 patients (58%) experienced an infection.
Slovenian: Od 1.168 bolnikov, ki so v kliničnih študijah prejemali ofatumumab zaradi KLL, se je 682 bolnikom (58 %) pojavila okužba.
English: The safe use of ofatumumab in humans during lactation has not been established.
Slovenian: Varnost uporabe ofatumumaba med obdobjem dojenja pri človeku ni ugotovljena.
English: • Cycle 1: 300 mg on day 1 followed 1 week later by 1000 mg on day 8
Slovenian: • 1. ciklus: 300 mg 1. dan, nato čez 1 teden 1.000 mg 8. dan
English: Arzerra is administered by intravenous infusion; therefore, absorption is not applicable.
Slovenian: Zdravilo Arzerra se uporablja v intravenski infuziji, zato podatki o absorpciji niso smiselno potrebni.
English: Pre-medication attenuates infusion-related reactions but these may still occur, predominantly during the first infusion.
Slovenian: Uporaba premedikacije zmanjša z infundiranjem povezane reakcije, ki pa se kljub temu lahko pojavijo, predvsem med prvim infundiranjem.
English: No formal studies were conducted to examine the effect of hepatic impairment.
Slovenian: Formalnih študij za preučitev vpliva okvare jeter niso izvedli.
English: • breathlessness, cough
Slovenian: • zadihanost, kašelj
English: Ofatumumab has also been shown to induce cell lysis in both high and low CD20 expressing cells and in rituximabresistant cells.
Slovenian: Prav tako je dokazano, da ofatumumab povzroči lizo celic z veliko in majhno izraženostjo CD20 in v celicah, odpornih proti rituksimabu.
English: Your doctor may treat you with a suitable anti-viral medicine to help prevent this.
Slovenian: Da bi to preprečil, vam bo zdravnik morda predpisal ustrezno protivirusno zdravilo.
English: Patient median age was 61 years (range: 32 to 90 years, 7% were 75 years of age or older), 60% were male and 16%, 55% and 28% of patients were Binet stage A, B and C, respectively.
Slovenian: Mediana starost bolnikov je bila 61 let (razpon: od 32 do 90 let, 7 % bolnikov je bilo starih 75 let ali več), 60 % je bilo moških in 16 %, 55 % oziroma 28 % bolnikov je imelo stadij A, B oziroma C po Binetu.
English: Reactivation has also occurred in patients who appear to have resolved hepatitis B infection (i.e. HBsAg negative, anti-HBc positive, and hepatitis B surface antibody [antiHBs] positive).
Slovenian: Reaktivacija se je pojavila tudi pri bolnikih, pri katerih je okužba s hepatitisom B na videz izginila (tj. HBsAg-negativni, anti-HBc-pozitivni in pozitivni za protitelesa proti površinskemu antigenu virusa hepatitisa B [anti-HBs]).
English: Arzerra is indicated in combination with fludarabine and cyclophosphamide for the treatment of adult patients with relapsed CLL.
Slovenian: Zdravilo Arzerra je v kombinaciji s fludarabinom in ciklofosfamidom indicirano za zdravljenje odraslih bolnikov s ponovitvijo KLL.
English: 3 vials
Slovenian: 3 viale
English: When ofatumumab was administered in combination with chlorambucil in patients with previously untreated CLL, the median decreases in B-cell counts after the first cycle and prior to the sixth monthly cycle were 94% and >99%.
Slovenian: Pri odmerjanju ofatumumaba v kombinaciji s klorambucilom pri bolnikih s predhodno nezdravljeno KLL se je število celic B po prvem ciklusu mediano zmanjšalo za 94 % in pred šestim mesečnim ciklusom za > 99 %.
English: The ORR was higher for OFA+FC versus FC (84% versus 68%, p=0.0003).
Slovenian: Celokupni delež odziva je bil v skupini OFA+FC višji kot v skupini FC (84 % v primerjavi z 68 %, p = 0,0003).
English: • 2000 mg weekly for 7 doses (infusions 2 to 8) followed 4-5 weeks later by
Slovenian: • 2.000 mg enkrat na teden (sedem odmerkov, kar je 2. do 8. infuzija), nato nadaljevanje čez
English: Patients with benefit/patients with abnormality at baseline (%) Patients refractory to fludarabine and alemtuzumab
Slovenian: Bolniki z doseženo koristjo/bolniki z izhodiščno nepravilnostjo (%) Bolniki, pri katerih je bolezen neodzivna na zdravljenje s fludarabinom in alemtuzumabom
English: Arzerra 100 mg is available in a pack containing 3 vials.
Slovenian: Arzerra 100 mg je na voljo v pakiranju, ki vsebuje 3 viale.
English: These may affect up to 1 in 10 people:
Slovenian: Pojavijo se lahko pri več kot 1 od 10 oseb:
English: The diluted solution for infusion must be used within 24 hours of preparation.
Slovenian: Razredčeno raztopino za infundiranje je treba uporabiti v 24 urah po pripravi.
English: Cases have been reported in patients who are hepatitis B surface antigen (HBsAg) positive and also in those who are hepatitis B core antibody (anti-HBc) positive but HBsAg negative.
Slovenian: Primeri so bili opisani pri bolnikih, ki so pozitivni za površinski antigen virusa hepatitisa B (HBsAg), in tudi pri tistih, ki so pozitivni za protitelesa proti središčnemu antigenu virusa hepatitisa B (antiHBc), a so bili HBsAg-negativni.
English: First infusion
Slovenian: Prva infuzija
English: The ORR in this group was 43% (95.3% CI: 33, 53).
Slovenian: Celokupni delež odziva v tej skupini je bil 43 % (95,3 % IZ: 33, 53).
English: (N=226)
Slovenian: Klorambucil (N = 226)
English: Nine patients (4%) treated with ofatumumab and chlorambucil, and three patients treated with chlorambucil alone had late-onset neutropenia (defined as Grade 3 or 4 neutropenia starting at least 42 days after the last treatment).
Slovenian: Devet bolnikov (4 %), zdravljenih z ofatumumabom in klorambucilom, in trije bolniki, zdravljeni samo s klorambucilom, so imeli nevtropenijo s poznim nastankom (ki je opredeljena kot nevtropenija 3. ali 4. stopnje in se ne pojavi prej kot 42 dni po zadnjem zdravljenju).
English: The ORR was 49% in patients refractory to fludarabine and alemtuzumab (see Table 3 for a summary of the efficacy data from the study).
Slovenian: Celokupni delež odziva je bil pri bolnikih, neodzivnih na fludarabin in alemtuzumab, 49 % (za povzetek podatkov o učinkovitosti v tej študiji glejte preglednico 3).
English: Abbreviations: CI = confidence interval, CLL = chronic lymphocytic leukaemia, CR = complete response, IRC = Independent Review Committee, MRD = minimal residue disease, N = number, ORR = overall response rate
Slovenian: Okrajšave: IZ = interval zaupanja, KLL = kronična limfocitna levkemija, CR = popolni odziv, IRC = neodvisni odbor za pregled, MRD = minimalna rezidualna bolezen, N = število, ORR = celokupni delež odziva klorambucil ofatumumab in klorambucil
English: Discard any unused solution after this time.
Slovenian: Po tem času vso neuporabljeno raztopino zavrzite.
English: • shingles, cold sores (possible symptoms of herpes viral infection that can potentially be severe).
Slovenian: • pasovec, ustnični herpes (možni simptomi okužbe, ki jo povzroča kateri od herpesvirusov in je lahko huda).
English: 1) Before diluting Arzerra
Slovenian: 1) Pred redčenjem zdravila Arzerra
English: Hazard ratio P value p<0.001
Slovenian: Razmerje ogroženosti Vrednost p p < 0,001
English: Previously untreated CLL
Slovenian: Predhodno nezdravljena KLL
English: Table 3 Summary of response to Arzerra in patients with refractory CLL
Slovenian: Povzetek odziva na zdravilo Arzerra pri bolnikih z refraktarno KLL
English: In all patients with CLL, ofatumumab induces rapid and profound B-cell depletion, whether given as a single agent or in combination.
Slovenian: Ofatumumab pri vseh bolnikih s KLL sproži hitro in izrazito zmanjšanje števila celic B, če ga prejemajo kot samostojno zdravilo ali če ga prejemajo v kombinaciji.
English: Immunisations
Slovenian: Imunizacije
English: • Do not shake; mix diluted solution by gentle inversion.
Slovenian: • Ne stresajte, ampak razredčeno raztopino premešajte s previdnim obračanjem.
English: In patients who develop reactivation of HBV while receiving Arzerra, Arzerra and any concomitant chemotherapy should be interrupted immediately, and appropriate treatment instituted.
Slovenian: Bolnikom, ki se jim med prejemanjem zdravila Arzerra, reaktivira HBV, je treba nemudoma ukiniti zdravilo Arzerra in morebitno sočasno kemoterapijo ter jim uvesti ustrezno zdravljenje.
English: Arzerra is for intravenous infusion and must be diluted prior to administration.
Slovenian: Zdravilo Arzerra je namenjeno za intravensko infundiranje in ga je treba pred uporabo razredčiti.
English: Table 4 Summary of clinical improvement with a minimum duration of 2 months in refractory patients with abnormalities at baseline
Slovenian: Povzetek minimalno 2 meseca trajajočega kliničnega izboljšanja pri refraktarnih bolnikih z izhodiščnimi nepravilnostmi
English: Effects on male and female fertility have not been evaluated in animal studies.
Slovenian: V študijah na živalih niso ocenjevali učinkov na plodnost samcev in samic.
English: • memory loss, trouble with thinking, and difficulty with walking or loss of vision (possible symptoms of progressive multifocal leukoencephalopathy)
Slovenian: • slabšanje spomina, oteženo razmišljanje in težave pri hoji ali poslabšanje vida (možni simptomi progresivne multifokalne levkoencefalopatije)
English: Gender had a modest effect (12%) on ofatumumab central volume of distribution in a cross-study population analysis, with higher Cmax and AUC values observed in female patients (48% of the patients in this analysis were male and 52% were female); these effects are not considered clinically relevant, and no dose adjustment is recommended.
Slovenian: Navzkrižna populacijska analiza je pokazala zmeren vpliv (12 %) spola na centralni volumen porazdelitve ofatumumaba; pri ženskah so ugotovili večji vrednosti Cmax in AUC (48 % bolnikov v tej analizi je bilo moških in 52 % žensk).
English: Discontinuation of HBV antiviral therapy should be discussed with physicians with expertise in managing hepatitis B.
Slovenian: O prenehanju protivirusnega zdravljenja HBV se je treba posvetovati z zdravnikom, ki ima izkušnje z zdravljenjem hepatitisa B.
English: Due to the risk of infection, administration of live attenuated vaccines should be avoided during and after treatment with ofatumumab, until B-cell counts are normalised.
Slovenian: Odziv na cepljenje bi lahko oslabel v primeru zmanjšanja števila celic B. Zaradi tveganja okužbe se je treba med zdravljenjem z ofatumumabom in po njem izogibati uporabi živih cepiv, dokler se število celic B ne normalizira.
English: The remaining infusions will then be given once a month for up to 11 months.
Slovenian: Preostale infuzije boste nato dobili enkrat na mesec do 11 mesecev.
English: Arzerra in combination with chlorambucil showed a statistically significant (71%) improvement in median PFS compared with chlorambucil alone (HR: 0.57; 95% CI: 0.45, 0.72) (see Table 1 and Figure 1).
Slovenian: Zdravilo Arzerra v kombinaciji s klorambucilom je v primerjavi s samimi klorambucilom statistično značilno (za 71 %) izboljšalo mediano PFS (razmerje ogroženosti: 0,57; 95 % IZ: 0,45, 0,72) (glejte preglednico 1 in sliko 1).
English: • the bone marrow failing to produce enough red or white blood cells
Slovenian: • nezadostno nastajanje rdečih ali belih krvnih celic v kostnem mozgu.
English: - The other ingredients are arginine, sodium acetate (E262), sodium chloride, polysorbate 80
Slovenian: - Druge sestavine zdravila so arginin, natrijev acetat (E262), natrijev klorid, polisorbat 80 (E433),
English: At 6 months after the last dose, the median reductions in B-cell counts were >99%.
Slovenian: Šest mesecev po zadnjem odmerku je bilo mediano zmanjšanje števila celic B
English: The CD20 molecule is not shed from the cell surface and is not internalised following antibody binding.
Slovenian: Po vezavi protitelesa se molekula CD20 ne odstrani s celične površine in se ne internalizira.
English: Of the 1,168 patients receiving ofatumumab in clinical trials for CLL, the most frequently observed ADRs were infusion-related reactions which occurred in 711 patients (61%) at any time during treatment.
Slovenian: Pri 1.168 bolnikih, ki so v kliničnih študijah prejemali ofatumumab zaradi KLL, so bili najpogosteje opaženi neželeni učinki zdravila z infundiranjem povezane reakcije: te so se kadar koli med zdravljenjem pojavile pri 711 bolnikih (61 %).
English: In the pivotal study for untreated CLL (OMB110911; ofatumumab plus chlorambucil 217 patients, chlorambucil alone 227 patients), prolonged neutropenia (defined as Grade 3 or 4 neutropenia not resolved between 24 and 42 days after last dose of study treatment) was reported in 41 patients (9%) (23 patients [11%] treated with ofatumumab and chlorambucil, 18 patients [8%] treated with chlorambucil alone).
Slovenian: V ključni študiji nezdravljene KLL (OMB110911; 217 bolnikov je prejemalo ofatumumab in klorambucil, 227 bolnikov pa samo klorambucil) so o dolgotrajni nevtropeniji (ki je opredeljena kot nevtropenija 3. ali 4. stopnje in ne mine od 24. do 42. dne po zadnjem odmerku študijskega zdravila) poročali pri 41 bolnikih (9 %) (pri 23 bolnikih [11 %], zdravljenih z ofatumumabom in klorambucilom ter pri 18 bolnikih [8 %], ki so dobivali samo klorambucil).
English: Resumption of Arzerra in patients whose HBV reactivation resolves should be discussed with physicians with expertise in managing hepatitis B.
Slovenian: O ponovni uvedbi zdravila Arzerra pri bolnikih, pri katerih reaktivacija HBV izgine, se je treba posvetovati z zdravnikom, ki ima izkušnje z zdravljenjem hepatitisa B.
English: What Arzerra contains - The active substance is ofatumumab.
Slovenian: Kaj vsebuje zdravilo Arzerra - Učinkovina je ofatumumab.
English: • rapid heart beat
Slovenian: • hitro bitje srca,
English: Table 2 Summary of secondary outcomes of Arzerra in combination with chlorambucil compared with chlorambucil in previously untreated CLL
Slovenian: Povzetek sekundarnih izidov z zdravilom Arzerra v kombinaciji s klorambucilom v primerjavi s klorambucilom pri predhodno nezdravljeni KLL
English: Progressive multifocal leukoencephalopathy (PML) Progressive multifocal leukoencephalopathy (PML), a serious and life-threatening brain condition, has been reported with medicines like Arzerra.
Slovenian: Progresivna multifokalna levkoencefalopatija (PML) Med uporabo zdravil, kot je zdravilo Arzerra, je bila opisana progresivna multifokalna levkoencefalopatija (PML); to je resna in smrtno nevarna bolezen možganov.
English: Your doctor may test the amount of electrolytes, such as magnesium and potassium, in your blood before and during your treatment with Arzerra.
Slovenian: Zdravnik vam bo pred zdravljenjem z zdravilom Arzerra in med zdravljenjem morda kontroliral količino elektrolitov, npr. količino magnezija in kalija v krvi.
English: In the pivotal study (OMB110913, ofatumumab plus fludarabine and cyclophosphamide 181 patients; fludarabine and cyclophosphamide 178 patients) in relapsed CLL patients, prolonged neutropenia was reported in 38 (11%) patients (18 patients [10%] treated with ofatumumab in combination with fludarabine and cyclophosphamide compared to 20 patients [11%] in the fludarabine and cyclophosphamide arm).
Slovenian: V ključni študiji (OMB110913; 181 bolnikov je prejemalo ofatumumab, fludarabin in ciklofosfamid, 178 bolnikov pa fludarabin in ciklofosfamid) pri bolnikih s ponovitvijo KLL so o dolgotrajni nevtropeniji poročali pri 38 bolnikih (11 %) (od tega pri 18 bolnikih [10 %] med tistimi, ki so prejemali ofatumumab v kombinaciji s fludarabinom in ciklofosfamidom, v primerjavi z 20 bolniki [11 %] v skupini s fludarabinom in ciklofosfamidom).
English: During infusion, the rate should be increased every 30 minutes to a maximum of 200 ml/hour (see section 6.6).
Slovenian: Med infundiranjem je treba hitrost vsakih 30 minut povečati, do največ 200 ml/uro (glejte poglavje 6.6).
English: Ofatumumab had non-linear pharmacokinetics related to its decreasing clearance over time.
Slovenian: Farmakokinetika ofatumumaba je bila nelinearna zaradi njegovega očistka, ki se s časom zmanjšuje.
English: The initial rate of the first infusion of Arzerra should be 12 ml/h.
Slovenian: Začetna hitrost prve infuzije zdravila Arzerra mora biti 12 ml/uro.
English: In a few animals, increased red cell destruction occurred, presumably as a result of monkey anti-drug antibodies coating the red cells.
Slovenian: Pri nekaterih živalih se je večja razgradnja eritrocitov domnevno pojavila zaradi opičjih protiteles proti zdravilu na eritrocitih.
English: ----OFA + FC (N=183) Median 28.94 months 95% CI (22.80, 35.88) ____FC (N=182) Median 18.83 months 95% CI (14.42,25.82)
Slovenian: ____FC (N=182) mediana 18,83 mesecev 95% CI (14.42,25.82)
English: Infusion-related reactions occur predominantly during the first infusion and tend to decrease with subsequent infusions.
Slovenian: Z infundiranjem povezane reakcije se pojavljajo večinoma pri prvem infundiranju in se med nadaljnjimi infundiranji po navadi zmanjšajo.
English: Insufficient data exist regarding the safety of resuming Arzerra in patients who develop HBV reactivation.
Slovenian: O varnosti ponovne uvedbe zdravila Arzerra pri bolnikih z reaktivacijo HBV ni dovolj podatkov.
English: • fever or, alternatively, a very low body temperature, chest pain, shortness of breath or rapid breathing, shaking, chills, confusion, dizziness, decreased urination and rapid pulse, (possible symptoms of blood infection)
Slovenian: • zvišana telesna temperatura ali pa močno znižana telesna temperatura, bolečina v prsnem košu, zadihanost ali pospešeno dihanje, tresenje, mrazenje, zmedenost, omotičnost, zmanjšano odvajanje vode (uriniranje) in hitro bitje srca (možni simptomi okužbe krvi)