natgillin/translations-raw huggingface dataset:
Ofatumumab should be a colourless to pale yellow solution.
Ofatumumab mora biti brezbarvna do svetlo rumena raztopina.
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)
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)
Hazard Ratio=0.67 95% CI (0.51,0.88) p-value=0.0032
razmerje ogroženosti=0.67 95% CI (0.51,0.88) p-vrednost=0.0032
For previously untreated CLL, the recommended dosage and schedule is:
Pri predhodno nezdravljeni KLL sta priporočena shema in časovni razpored odmerjanja:
If any adverse reactions are observed, infusion rates should be reduced (see section 4.2).
Če se pojavijo kakšne neželene reakcije, je treba hitrost infundiranja zmanjšati (glejte poglavje 4.2).
The majority of infusion-related reactions were Grade 1 or Grade 2 in severity.
Po intenzivnosti je bila večina z infundiranjem povezanih reakcij 1. ali 2. stopnje.
Arzerra must not be administered as an intravenous push or bolus.
Zdravila Arzerra ne smete dajati intravensko s potiskom ali v bolusu.
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.
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
You may need extra check-ups while you are being treated with Arzerra.
Med zdravljenjem z zdravilom Arzerra boste morda potrebovali dodatne kontrole.
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.
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.
What Arzerra looks like and contents of the pack Arzerra is a colourless to pale yellow concentrate for solution for infusion.
Izgled zdravila Arzerra in vsebina pakiranja Zdravilo Arzerra je brezbarvni do svetlo rumen koncentrat za raztopino za infundiranje.
The recommended dose and schedule is 12 doses administered as follows:
Priporočena sta naslednja shema in razpored odmerjanja z 12 odmerki:
Patients refractory to fludarabine and alemtuzumab n=95
Bolniki, pri katerih je bolezen neodzivna na zdravljenje s fludarabinom in alemtuzumabom n = 95
Breast-feeding is not recommended during treatment with Arzerra and for 12 months after the last dose.
Dojenje ni priporočljivo med zdravljenjem z zdravilom Arzerra in še 12 mesecev po zadnjem odmerku.
• Subsequent cycles (up to a maximum of 6 cycles in total): 1000 mg on day 1 every 28 days.
• nadaljnji ciklusi (do skupno največ 6 ciklusov): 1.000 mg na 1. dan vsakih 28 dni
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.
Varnost imunizacij z živimi oslabljenimi ali inaktiviranimi cepivi in zmožnost za primarni ali anamnestični odziv na njihovo uporabo med zdravljenjem z ofatumumabom nista raziskana.
Also contains: arginine, sodium acetate (E262), sodium chloride, polysorbate 80 (E433), edetate disodium (E386), hydrochloric acid (E507), water for injections.
Vsebuje tudi: arginin, natrijev acetat (E262), natrijev klorid, polisorbat 80 (E433), dinatrijev edetat (E386), klorovodikovo kislino (E507), vodo za injekcije.
• difficulty in breathing, shortness of breath, chest tightness, cough
• težko dihanje, kratka sapa, tiščanje v prsih, kašelj,
Figure 1 Kaplan-Meier estimates of IRC-assessed PFS in previously untreated CLL
Kaplan-Meierjeve ocene PFS po oceni neodvisnega odbora za pregled (IRC) pri predhodno nezdravljeni KLL
Limited data are available in the heterogeneous non-white population and in patients with an ECOG performance status of 2.
Za heterogeno populacijo nebelcev in za bolnike s stanjem zmogljivosti 2 po ECOG je na voljo malo podatkov.
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.
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.
Additionally a group of patients (n=16) who were intolerant/ineligible for fludarabine treatment and/or intolerant to alemtuzumab treatment were treated with Arzerra.
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.
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.
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.
Arzerra is used to treat chronic lymphocytic leukaemia (CLL).
Zdravilo Arzerra se uporablja za zdravljenje kronične limfocitne levkemije (KLL).
Arzerra 1000 mg is available in a pack containing 1 vial.
Arzerra 1000 mg je na voljo v pakiranju, ki vsebuje 1 vialo.
Of the 1,168 patients receiving ofatumumab in clinical trials for CLL, 682 patients (58%) experienced an infection.
Od 1.168 bolnikov, ki so v kliničnih študijah prejemali ofatumumab zaradi KLL, se je 682 bolnikom (58 %) pojavila okužba.
The safe use of ofatumumab in humans during lactation has not been established.
Varnost uporabe ofatumumaba med obdobjem dojenja pri človeku ni ugotovljena.
• Cycle 1: 300 mg on day 1 followed 1 week later by 1000 mg on day 8
• 1. ciklus: 300 mg 1. dan, nato čez 1 teden 1.000 mg 8. dan
Arzerra is administered by intravenous infusion; therefore, absorption is not applicable.
Zdravilo Arzerra se uporablja v intravenski infuziji, zato podatki o absorpciji niso smiselno potrebni.
Pre-medication attenuates infusion-related reactions but these may still occur, predominantly during the first infusion.
Uporaba premedikacije zmanjša z infundiranjem povezane reakcije, ki pa se kljub temu lahko pojavijo, predvsem med prvim infundiranjem.
No formal studies were conducted to examine the effect of hepatic impairment.
Formalnih študij za preučitev vpliva okvare jeter niso izvedli.
• breathlessness, cough
• zadihanost, kašelj
Ofatumumab has also been shown to induce cell lysis in both high and low CD20 expressing cells and in rituximabresistant cells.
Prav tako je dokazano, da ofatumumab povzroči lizo celic z veliko in majhno izraženostjo CD20 in v celicah, odpornih proti rituksimabu.
Your doctor may treat you with a suitable anti-viral medicine to help prevent this.
Da bi to preprečil, vam bo zdravnik morda predpisal ustrezno protivirusno zdravilo.
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.
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.
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).
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]).
Arzerra is indicated in combination with fludarabine and cyclophosphamide for the treatment of adult patients with relapsed CLL.
Zdravilo Arzerra je v kombinaciji s fludarabinom in ciklofosfamidom indicirano za zdravljenje odraslih bolnikov s ponovitvijo KLL.
3 vials
3 viale
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%.
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 %.
The ORR was higher for OFA+FC versus FC (84% versus 68%, p=0.0003).
Celokupni delež odziva je bil v skupini OFA+FC višji kot v skupini FC (84 % v primerjavi z 68 %, p = 0,0003).
• 2000 mg weekly for 7 doses (infusions 2 to 8) followed 4-5 weeks later by
• 2.000 mg enkrat na teden (sedem odmerkov, kar je 2. do 8. infuzija), nato nadaljevanje čez
Patients with benefit/patients with abnormality at baseline (%) Patients refractory to fludarabine and alemtuzumab
Bolniki z doseženo koristjo/bolniki z izhodiščno nepravilnostjo (%) Bolniki, pri katerih je bolezen neodzivna na zdravljenje s fludarabinom in alemtuzumabom
Arzerra 100 mg is available in a pack containing 3 vials.
Arzerra 100 mg je na voljo v pakiranju, ki vsebuje 3 viale.
These may affect up to 1 in 10 people:
Pojavijo se lahko pri več kot 1 od 10 oseb:
The diluted solution for infusion must be used within 24 hours of preparation.
Razredčeno raztopino za infundiranje je treba uporabiti v 24 urah po pripravi.
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.
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.
The ORR in this group was 43% (95.3% CI: 33, 53).
Celokupni delež odziva v tej skupini je bil 43 % (95,3 % IZ: 33, 53).
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).
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).
The ORR was 49% in patients refractory to fludarabine and alemtuzumab (see Table 3 for a summary of the efficacy data from the study).
Celokupni delež odziva je bil pri bolnikih, neodzivnih na fludarabin in alemtuzumab, 49 % (za povzetek podatkov o učinkovitosti v tej študiji glejte preglednico 3).
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
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
Discard any unused solution after this time.
Po tem času vso neuporabljeno raztopino zavrzite.
• shingles, cold sores (possible symptoms of herpes viral infection that can potentially be severe).
• pasovec, ustnični herpes (možni simptomi okužbe, ki jo povzroča kateri od herpesvirusov in je lahko huda).
1) Before diluting Arzerra
1) Pred redčenjem zdravila Arzerra
Hazard ratio P value p<0.001
Razmerje ogroženosti Vrednost p p < 0,001
Previously untreated CLL
Predhodno nezdravljena KLL
Table 3 Summary of response to Arzerra in patients with refractory CLL
Povzetek odziva na zdravilo Arzerra pri bolnikih z refraktarno KLL
In all patients with CLL, ofatumumab induces rapid and profound B-cell depletion, whether given as a single agent or in combination.
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.
• Do not shake; mix diluted solution by gentle inversion.
• Ne stresajte, ampak razredčeno raztopino premešajte s previdnim obračanjem.
In patients who develop reactivation of HBV while receiving Arzerra, Arzerra and any concomitant chemotherapy should be interrupted immediately, and appropriate treatment instituted.
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.
Arzerra is for intravenous infusion and must be diluted prior to administration.
Zdravilo Arzerra je namenjeno za intravensko infundiranje in ga je treba pred uporabo razredčiti.
Table 4 Summary of clinical improvement with a minimum duration of 2 months in refractory patients with abnormalities at baseline
Povzetek minimalno 2 meseca trajajočega kliničnega izboljšanja pri refraktarnih bolnikih z izhodiščnimi nepravilnostmi
Effects on male and female fertility have not been evaluated in animal studies.
V študijah na živalih niso ocenjevali učinkov na plodnost samcev in samic.
• memory loss, trouble with thinking, and difficulty with walking or loss of vision (possible symptoms of progressive multifocal leukoencephalopathy)
• slabšanje spomina, oteženo razmišljanje in težave pri hoji ali poslabšanje vida (možni simptomi progresivne multifokalne levkoencefalopatije)
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.
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).
Discontinuation of HBV antiviral therapy should be discussed with physicians with expertise in managing hepatitis B.
O prenehanju protivirusnega zdravljenja HBV se je treba posvetovati z zdravnikom, ki ima izkušnje z zdravljenjem hepatitisa B.
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.
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.
The remaining infusions will then be given once a month for up to 11 months.
Preostale infuzije boste nato dobili enkrat na mesec do 11 mesecev.
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).
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).
• the bone marrow failing to produce enough red or white blood cells
• nezadostno nastajanje rdečih ali belih krvnih celic v kostnem mozgu.
- The other ingredients are arginine, sodium acetate (E262), sodium chloride, polysorbate 80
- Druge sestavine zdravila so arginin, natrijev acetat (E262), natrijev klorid, polisorbat 80 (E433),
At 6 months after the last dose, the median reductions in B-cell counts were >99%.
Šest mesecev po zadnjem odmerku je bilo mediano zmanjšanje števila celic B
The CD20 molecule is not shed from the cell surface and is not internalised following antibody binding.
Po vezavi protitelesa se molekula CD20 ne odstrani s celične površine in se ne internalizira.
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.
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 %).
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).
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).
Resumption of Arzerra in patients whose HBV reactivation resolves should be discussed with physicians with expertise in managing hepatitis B.
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.
What Arzerra contains - The active substance is ofatumumab.
Kaj vsebuje zdravilo Arzerra - Učinkovina je ofatumumab.
• rapid heart beat
• hitro bitje srca,
Table 2 Summary of secondary outcomes of Arzerra in combination with chlorambucil compared with chlorambucil in previously untreated CLL
Povzetek sekundarnih izidov z zdravilom Arzerra v kombinaciji s klorambucilom v primerjavi s klorambucilom pri predhodno nezdravljeni KLL
Progressive multifocal leukoencephalopathy (PML) Progressive multifocal leukoencephalopathy (PML), a serious and life-threatening brain condition, has been reported with medicines like Arzerra.
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.
Your doctor may test the amount of electrolytes, such as magnesium and potassium, in your blood before and during your treatment with Arzerra.
Zdravnik vam bo pred zdravljenjem z zdravilom Arzerra in med zdravljenjem morda kontroliral količino elektrolitov, npr. količino magnezija in kalija v krvi.
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).
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).
During infusion, the rate should be increased every 30 minutes to a maximum of 200 ml/hour (see section 6.6).
Med infundiranjem je treba hitrost vsakih 30 minut povečati, do največ 200 ml/uro (glejte poglavje 6.6).
Ofatumumab had non-linear pharmacokinetics related to its decreasing clearance over time.
Farmakokinetika ofatumumaba je bila nelinearna zaradi njegovega očistka, ki se s časom zmanjšuje.
The initial rate of the first infusion of Arzerra should be 12 ml/h.
Začetna hitrost prve infuzije zdravila Arzerra mora biti 12 ml/uro.
In a few animals, increased red cell destruction occurred, presumably as a result of monkey anti-drug antibodies coating the red cells.
Pri nekaterih živalih se je večja razgradnja eritrocitov domnevno pojavila zaradi opičjih protiteles proti zdravilu na eritrocitih.
----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)
____FC (N=182) mediana 18,83 mesecev 95% CI (14.42,25.82)
Infusion-related reactions occur predominantly during the first infusion and tend to decrease with subsequent infusions.
Z infundiranjem povezane reakcije se pojavljajo večinoma pri prvem infundiranju in se med nadaljnjimi infundiranji po navadi zmanjšajo.
Insufficient data exist regarding the safety of resuming Arzerra in patients who develop HBV reactivation.
O varnosti ponovne uvedbe zdravila Arzerra pri bolnikih z reaktivacijo HBV ni dovolj podatkov.
• 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)
• 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)
Infusion-related reactions may include, but are not limited to, anaphylactoid events, bronchospasm, cardiac events (e.g. myocardial ischaemia/infarction, bradycardia), chills/rigors, cough, cytokine release syndrome, diarrhoea, dyspnoea, fatigue, flushing, hypertension, hypotension, nausea, pain, pulmonary oedema, pruritus, pyrexia, rash, and urticaria.
Z infundiranjem povezane reakcije med drugim lahko vključujejo anafilaktoidne dogodke, bronhospazem, srčne dogodke (npr.: miokardno ishemijo/infarkt, bradikardijo), mrzlico z drgetanjem, kašelj, sindrom sproščanja citokinov, drisko, dispnejo, utrujenost, zardevanje, hipertenzijo, hipotenzijo, navzeo, bolečino, pljučni edem, srbenje, zvišano telesno temperaturo, izpuščaj in urtikarijo.
• fever, coughing, difficulty breathing, wheezing, possible symptoms of infections of the lungs or airways (respiratory tract) including pneumonia
• zvišana telesna temperatura, kašelj, oteženo dihanje, piskajoče dihanje, kar so možni simptomi okužbe pljuč ali dihalnih poti (dihal), kar vključuje tudi pljučnico,
Arzerra should be permanently discontinued in patients who develop an anaphylactic reaction to the medicinal product.
Zdravilo Arzerra je treba bolnikom, pri katerih pride do anafilaktične reakcije na zdravilo, dokončno ukiniti.
The overall response rate (ORR) was also assessed by an IRC using the 2008 NCI-WG guidelines.
Odbor IRC je ocenil tudi celokupni delež odziva (ORR) na podlagi leta 2008 posodobljenih smernic NCI-WG.
During infusion, the rate should be increased every 30 minutes to a maximum of 400 ml/h (see section 6.6).
Med infundiranjem je treba hitrost povečevati vsakih 30 minut do največ 400 ml/uro (glejte poglavje 6.6).
------Chlorambucil (N=226) Median 13.1 months____Ofatumumab + Chlorambucil (N=221)
----klorambucil (N=226) mediana 13,1 meseca