FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: • fever, coughing, difficulty breathing, wheezing, possible symptoms of infections of the lungs or airways (respiratory tract) including pneumonia
Slovenian: • zvišana telesna temperatura, kašelj, oteženo dihanje, piskajoče dihanje, kar so možni simptomi okužbe pljuč ali dihalnih poti (dihal), kar vključuje tudi pljučnico,
English: Novartis Europharm Limited Frimley Business Park Camberley GU16 7SR United Kingdom
Slovenian: Novartis Europharm Limited Frimley Business Park Camberley GU16 7SR Velika Britanija
English: Arzerra should be permanently discontinued in patients who develop an anaphylactic reaction to the medicinal product.
Slovenian: Zdravilo Arzerra je treba bolnikom, pri katerih pride do anafilaktične reakcije na zdravilo, dokončno ukiniti.
English: The overall response rate (ORR) was also assessed by an IRC using the 2008 NCI-WG guidelines.
Slovenian: Odbor IRC je ocenil tudi celokupni delež odziva (ORR) na podlagi leta 2008 posodobljenih smernic NCI-WG.
English: During infusion, the rate should be increased every 30 minutes to a maximum of 400 ml/h (see section 6.6).
Slovenian: Med infundiranjem je treba hitrost povečevati vsakih 30 minut do največ 400 ml/uro (glejte poglavje 6.6).
English: ------Chlorambucil (N=226) Median 13.1 months____Ofatumumab + Chlorambucil (N=221)
Slovenian: ----klorambucil (N=226) mediana 13,1 meseca
English: An open-label, two arm, randomised study (OMB114242) was conducted in patients with bulky fludarabine refractory CLL who had failed at least 2 prior therapies (n=122) comparing Arzerra monotherapy (n=79) to physicians' choice (PC) of therapy (n=43).
Slovenian: Pri bolnikih z masivno, proti fludarabinu odporno KLL in vsaj 2 neuspešnima predhodnima zdravljenjema (n = 122) so opravili odprto, randomizirano študijo z dvema skupinama (OMB114242), v kateri so monoterapijo z zdravilom Arzerra (n = 79) primerjali z zdravljenjem po zdravnikovi izbiri (n = 43).
English: Table 1 Summary of PFS with Arzerra in combination with chlorambucil compared with chlorambucil in previously untreated CLL
Slovenian: Povzetek PFS z zdravilom Arzerra v kombinaciji s klorambucilom v primerjavi s klorambucilom pri predhodno nezdravljeni KLL
English: You will be given medicines such as anti-histamines, steroids or pain relievers to help reduce any reaction.
Slovenian: Kot pomoč za zmanjšanje morebitne reakcije boste dobili zdravila, npr. antihistaminike, steroide ali zdravila proti bolečinam.
English: See leaflet for further information.
Slovenian: Za več podatkov glejte navodilo za uporabo.
English: Edetate disodium (E386) Hydrochloric acid (E507) (for pH-adjustment) Water for injections
Slovenian: dinatrijev edetat (E386), klorovodikova kislina (E507) (za uravnavanje pH), voda za injekcije
English: Patient median age was 64 years (range: 41 to 87 years), and the majority were male (73%) and white (96%).
Slovenian: Mediana starost bolnikov je bila 64 let (razpon: od 41 do 87 let) in večina je bila moških (73 %) in belcev (96 %).
English: No clinically relevant pharmacokinetic interactions were observed between ofatumumab and fludarabine, cyclophosphamide,bendamustine, chlorambucil, or its active metabolite, phenylacetic acid mustard.
Slovenian: Med ofatumumabom in fludarabinom, ciklofosfamidom, bendamustinom, klorambucilom ali njegovim aktivnim presnovkom, fenilacetoiperitom, niso opažali klinično pomembnih farmakokinetičnih interakcij.
English: The primary endpoint was ORR assessed by the investigator according to the 2008 IWCLL guidelines.
Slovenian: Primarni opazovani dogodek je bil celokupni delež odziva po oceni raziskovalca na podlagi smernic IWCLL 2008.
English: Cardiac disorders
Slovenian: Kardiovaskularne bolezni
English: Peripheral B-cell counts decreased after the first ofatumumab infusion in patients with haematological malignancies.
Slovenian: Pri bolnikih s hematološkimi malignomi se je število perifernih celic B zmanjšalo po prvi infuziji ofatumumaba.
English: • slow heart beat
Slovenian: • počasen srčni utrip
English: • anaphylactic reaction including anaphylactic shock, where symptoms include breathlessness or difficulty breathing, wheezing or coughing, light-headedness, dizziness, changes in levels of consciousness, hypotension, with or without mild generalised itching, skin reddening, swelling of the face and/or throat, blue discolouration of the lips, tongue or skin
Slovenian: • anafilaktična reakcija, ki lahko vključuje anafilaktični šok, s simptomi, ki so med drugim lahko zadihanost ali oteženo dihanje, piskajoče dihanje ali kašelj, občutek pred izgubo zavesti, omotičnost, spremenjena raven zavesti, nizek krvni tlak, prisotno ali odsotno blago srbenje po celem telesu, pordelost kože, otekanje v obraz in/ali žrelo oziroma grlo, pomodrelost ustnic,
English: No dose adjustment is recommended for mild to moderate renal impairment (creatinine clearance >30 ml/min) (see section 5.2).
Slovenian: Pri blagi do zmerni okvari ledvic (očistek kreatinina > 30 ml/min) odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: Contact your doctor immediately if you experience constipation, a swollen abdomen or abdominal pain.
Slovenian: Takoj obvestite zdravnika, če pride do zaprtja (zapeke), otekanja trebuha ali bolečin v trebuhu.
English: The remaining infusions will then be given once a month for up to 6 months.
Slovenian: Preostale infuzije boste nato dobili enkrat na mesec do 6 mesecev.
English: IGHV unmutated & ZAP-70 positive (n=122)
Slovenian: IGHV nemutirani in ZAP-70 pozitivni (n = 122)
English: Arzerra contains sodium
Slovenian: Zdravilo Arzerra vsebuje natrij
English: Any unused infusion solution should be discarded 24 hours after preparation.
Slovenian: Vso neporabljeno raztopino za infundiranje morate zavreči 24 ur po pripravi.
English: Bowel obstruction has been reported in patients receiving anti-CD20 monoclonal antibody therapy, including ofatumumab.
Slovenian: Pri bolnikih, ki so jih zdravili z monoklonskimi protitelesi proti CD20, vključno z ofatumumabom, je opisana zapora črevesa.
English: When ofatumumab was administered as single agent in patients with refractory CLL, the median decrease in B-cell counts was 22% after the first infusion and 92% at the eighth weekly infusion.
Slovenian: Pri odmerjanju ofatumumaba kot samostojnega zdravila se je pri bolnikih z neodzivno KLL število celic B po prvi infuziji mediano zmanjšalo za 22 % in ob osmi tedenski infuziji za 92 %.
English: IgG1 molecules such as ofatumumab are catabolised by ubiquitous proteolytic enzymes, which are not restricted to hepatic tissue; therefore, changes in hepatic function are unlikely to have any effect on the elimination of ofatumumab.
Slovenian: Molekule IgG1, kot je ofatumumab, se razgradijo s povsod prisotnimi proteolitičnimi encimi, ki niso omejeni na jetrno tkivo.
English: Patients received ofatumumab as intravenous infusions (cycle 1: 300 mg on day 1 and 1000 mg on day 8; subsequent cycles: 1000 mg on day 1 every 28 days).
Slovenian: Bolniki so prejemali ofatumumab v intravenskih infuzijah (1. ciklus: 300 mg 1. dan in 1.000 mg 8. dan; nadaljnji ciklusi: 1.000 mg 1. dan vsakih 28 dni).
English: Infusion rate (ml/hour)
Slovenian: Nadaljnje infuzije* hitrost infundiranja (ml/uro) hitrost infundiranja (ml/uro)
English: • difficulty and pain when passing urine, exaggerated sense of needing to urinate, urinary tract infections
Slovenian: • bolečine pri uriniranju ali oteženo uriniranje, pretiran občutek nuje po uriniranju, okužbe sečil,
English: For relapsed CLL, the recommended dosage and schedule is:
Slovenian: Pri ponovitvi KLL sta priporočena shema in časovni razpored odmerjanja:
English: The median age was 69 years (range: 35 to 92 years), 27% patients were ≥75 years of age, 63% were male and 89% were white.
Slovenian: Mediana starost je bila 69 let (razpon: od 35 do 92 let), 27 % bolnikov je bilo starih ≥ 75 let, 63 % je bilo moških in 89 % je bilo belcev.
English: This medicinal product contains 34.8 mg sodium per 300 mg dose, 116 mg sodium per 1000 mg dose and 232 mg sodium per 2000 mg dose.
Slovenian: To zdravilo vsebuje 34,8 mg natrija v 300 mg odmerku, 116 mg natrija v 1.000 mg odmerku in 232 mg natrija v 2.000 mg odmerku.
English: Baseline calculated creatinine clearance was not found to be a significant factor on ofatumumab pharmacokinetics in a cross-study population analysis in patients with calculated creatinine clearance values ranging from 26 to 287 ml/min.
Slovenian: V analizi populacije več študij se izhodiščno izračunani očistek kreatinina pri bolnikih z očistkom kreatinina od 26 do 287 ml/min ni izkazal za pomemben dejavnik farmakokinetike ofatumumaba.
English: Arzerra contains 34.8 mg sodium in each 300 mg dose, 116 mg sodium in each 1000 mg dose and 232 mg sodium in each 2000 mg dose.
Slovenian: Zdravilo Arzerra vsebuje 34,8 mg natrija v vsakem 300 mg odmerku, 116 mg natrija v vsakem 1.000 mg odmerku in 232 mg natrija v vsakem 2.000 mg odmerku.
English: Baseline disease characteristics and prognostic markers were balanced between treatment arms and representative of a relapsed CLL population.
Slovenian: Izhodiščne karakteristike bolezni in prognostični označevalci so bili v obeh študijskih skupinah enakovredno razporejeni in reprezentativni za populacijo bolnikov s ponovitvijo KLL.
English: When ofatumumab was administered in combination with fludarabine and cyclophosphamide in patients with relapsed CLL, the median decrease from baseline was 60% after the first infusion and complete depletion (100%) was reached after 4 cycles.
Slovenian: Pri odmerjanju ofatumumaba v kombinaciji s fludarabinom in ciklofosfamidom je pri bolnikih s ponovitvijo KLL po prvi infuziji prišlo do medianega zmanjšanja števila celic B od izhodiščne vrednosti za 60 %, po 4 ciklusih pa je prišlo do popolne odsotnosti celic B (zmanjšanja njihovega števila za 100 %).
English: Lymphocyte count ≥50% decrease Normalisation (≤4x10
Slovenian: Število limfocitov ≥ 50 % zmanjšanje Normalizacija (≤ 4 x 10 Popolno izginotje konstitutivnih simptomov b
English: • increase in potassium, phosphate and uric acid in the blood that can cause kidney problems (tumour lysis syndrome) The symptoms of this condition include:
Slovenian: • zvišanje kalija, fosfata in sečne kisline v krvi lahko povzroči težave z ledvicami (sindrom lize tumorja).
English: Arzerra in combination with chlorambucil or bendamustine is indicated for the treatment of adult patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy.
Slovenian: Predhodno nezdravljena kronična limfocitna levkemija (KLL) Zdravilo Arzerra je v kombinaciji s klorambucilom ali bendamustinom indicirano za zdravljenje odraslih bolnikov s KLL, ki še niso prejemali predhodnega zdravljenja in niso primerni za zdravljenje na podlagi fludarabina.
English: • blockage in the gut (intestine), which may feel like stomach pain.
Slovenian: • zapora črevesa, ki lahko povzroči bolečine v trebuhu.
English: Subsequent infusions
Slovenian: Nadaljnje infuzije
English: If an infusion-related ADR is observed during infusion, see below section “Dose modification and reinitiation of therapy after infusion-related ADRs”.
Slovenian: Če v času infundiranja pride do neželenega učinka, povezanega z infundiranjem, glejte spodaj poglavje “Prilagoditev odmerka in ponoven začetek zdravljenja po nastopu z infundiranjem povezanih neželenih učinkov zdravila”.
English: Before diluting Arzerra
Slovenian: Pred redčenjem zdravila Arzerra
English: IGHV mutated & ZAP-70 positive (n=35)
Slovenian: IGHV mutirani in ZAP-70 pozitivni (n = 35)
English: The remaining infusions will then be given once a month for four months.
Slovenian: Preostale infuzije boste nato dobivali štiri mesece po enkrat na mesec.
English: Previously untreated CLL and relapsed CLL
Slovenian: Predhodno nezdravljena KLL in ponovitev KLL
English: IGHV unmutated & ZAP-70 negative (n=27)
Slovenian: IGHV nemutirani in ZAP-70 negativni (n = 27)
English: Refractory CLL:
Slovenian: Refraktarna KLL:
English: *If the previous infusion was completed without severe infusion-related ADRs.
Slovenian: * Če se je predhodno infundiranje končalo brez hudih z infundiranjem povezanih neželenih učinkov zdravila.
English: Previously untreated CLL and relapsed CLL:
Slovenian: Predhodno nezdravljena KLL in ponovitev KLL:
English: One ml contains 20 mg ofatumumab.
Slovenian: 1 ml vsebuje 20 mg ofatumumaba.
English: Arzerra is indicated for the treatment of CLL in adult patients who are refractory to fludarabine and alemtuzumab.
Slovenian: Zdravilo Arzerra je indicirano za zdravljenje odraslih bolnikov s KLL, pri katerih je bolezen neodzivna na zdravljenje s fludarabinom in alemtuzumabom.
English: No teratogenicity or maternal toxicity were observed in an animal reproduction study with administration of ofatumumab to pregnant monkeys (see section 5.3).
Slovenian: V študiji vpliva na sposobnost razmnoževanja pri živalih, v kateri so ofatumumab odmerjali brejim opicam, niso opažali teratogenosti ali maternalne toksičnosti ofatumumaba (glejte poglavje 5.3).
English: *If the second infusion was completed without severe infusion-related ADRs.
Slovenian: * Če se je drugo infundiranje končalo brez hudih z infundiranjem povezanih neželenih učinkov zdravila.
English: As a result, ofatumumab clearance values were lower and t½ values were significantly larger after later infusions than after the initial infusion; during repeated weekly infusions, ofatumumab AUC and Cmax values increased more than the expected accumulation based on first infusion data.
Slovenian: Med ponavljajočimi se infundiranji vsak teden sta se AUC in Cmax ofatumumaba povečali bolj kot pričakovano kopičenje na podlagi podatkov o prvi infuziji.
English: 300 mg dose - Use three 100 mg/5 ml vials (15 ml total, 5 ml per vial):
Slovenian: Odmerek 300 mg - Uporabite tri viale s 100 mg/5 ml (skupaj 15 ml, 5 ml na vialo):
English: The clinical status of the patient and the ADR profile of ofatumumab should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills (see section 4.8).
Slovenian: Pri oceni bolnikove zmožnosti za opravljanje nalog, ki zahtevajo presojo, motorične ali kognitivne sposobnosti, je treba upoštevati bolnikovo klinično stanje in značilnosti neželenih učinkov ofatumumaba (glejte poglavje 4.8).
English: If the infusion rate had not been increased from the starting rate of 12 ml/hour prior to interrupting due to an ADR, the infusion should be restarted at 12 ml/hour, the standard starting infusion rate.
Slovenian: Če hitrost infundiranja do prekinitve infundiranja zaradi neželenega učinka ni bila večja od začetne hitrosti 12 ml/uro (tj. še ni bila povečana), je treba infundiranje znova začeti s standardno začetno hitrostjo 12 ml/uro.
English: No formal studies of Arzerra in patients with renal impairment have been performed.
Slovenian: Študij z zdravilom Arzerra pri bolnikih z okvaro ledvic ni bilo.
English: Patient median age was 61 years (range: 27 to 82 years), the majority were male (58%), and all were white.
Slovenian: Mediana starost bolnikov je bila 61 let (razpon: 27 do 82 let), večina je bila moških (58 %) in vsi so bili belci.
English: The overall survival results showed a HR=0.78 (56.4 months versus 45.8 months for the OFA+FC arm versus FC arm; 95% CI: 0.56-1.09; p=0.1410).
Slovenian: Rezultati za celokupno preživetje (OS) so pokazali razmerje ogroženosti 0,78 (56,4 meseca v skupini OFA+FC v primerjavi s 45,8 meseca v skupini FC; 95% IZ: 0,56-1,09; p = 0,1410).
English: • if you are allergic (hypersensitive) to ofatumumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Zdravila Arzerra ne smete prejeti: - če ste alergični (preobčutljivi) na ofatumumab ali katero koli sestavino tega zdravila (navedeno
English: The Arzerra concentrate must be diluted in sodium chloride 9 mg/ml (0.9%) solution for injection prior to administration, using aseptic technique.
Slovenian: Koncentrat zdravila Arzerra je treba pred uporabo razredčiti z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje, upoštevaje aseptičen postopek.
English: There was no statistically significant difference in the primary endpoint of IRC assessed PFS (5.4 vs. 3.6 months, HR=0.79, p=0.27).
Slovenian: Primarna končna točka, preživetje brez napredovanja po oceni neodvisnega odbora za pregled, se ni statistično značilno razlikovala (5,4 meseca v primerjavi s 3,6 meseca, razmerje ogroženosti 0,79, p = 0,27).
English: How to store Arzerra
Slovenian: Kako boste prejemali zdravilo Arzerra
English: Complete blood counts, including neutrophil and platelet counts, should be obtained at regular intervals during Arzerra therapy and more frequently in patients who develop cytopenias.
Slovenian: Med zdravljenjem z zdravilom Arzerra je treba redno kontrolirati celotno krvno sliko, vključno s številom nevtrofilcev in trombocitov; pri bolnikih, ki se jim pojavijo citopenije, morajo biti takšne kontrole pogostejše.
English: Patients received Arzerra as monthly intravenous infusions (cycle 1 300 mg on day 1 and 1000 mg on day 8; subsequent cycles: 1000 mg on day 1 every 28 days) in combination with intravenous bendamustine 90 mg/m on days 1 and 2 every 28 days.
Slovenian: Bolniki so prejemali zdravilo Arzerra v intravenski infuziji vsak mesec (1. ciklus 300 mg 1. dan in 1.000 mg 8. dan, nadaljnji ciklusi: 1.000 mg 1. dan vsakih 28 dni) v kombinaciji z intravenskim bendamustinom 90 mg/m na 1. in 2. dan vsakih 28. dni.
English: If the preceding infusion(s) has (have) been completed without severe infusion-related ADRs, the subsequent infusions can start at a rate of 25 ml/hour and should be increased every 30 minutes up to a maximum of 400 ml/hour (see section 6.6).
Slovenian: Če so bile predhodne infuzije (ena ali več) dokončane brez hudih neželenih učinkov zdravila, povezanih z infundiranjem, je mogoče naslednje infuzije začeti s hitrostjo 25 ml/uro in hitrost povečevati vsakih 30 minut do največ 400 ml/uro (glejte poglavje 6.6).
English: • Use a reliable method of contraception to avoid becoming pregnant while you are being treated with Arzerra, and for 12 months after your last dose of Arzerra.
Slovenian: • Da ne boste zanosili, morate med zdravljenjem z zdravilom Arzerra in še najmanj 12 mesecev po zadnjem odmerku zdravila Arzerra uporabljati zanesljivo kontracepcijo.
English: Thirteen (7%) patients treated with ofatumumab in combination with fludarabine and cyclophosphamide, and 5 (3%) patients treated with fludarabine and cyclophosphamide had late-onset neutropenia.
Slovenian: Do pozne nevtropenije je prišlo pri trinajstih bolnikih (7 %) izmed tistih, ki so prejemali ofatumumab v kombinaciji s fludarabinom in ciklofosfamidom, in pri 5 bolnikih (3 %) izmed tistih, ki so prejemali fludarabin in ciklofosfamid.
English: Uncommon side effects These may affect up to 1 in 100 people:
Slovenian: Občasni neželeni učinki Ti se lahko pojavijo pri največ 1 od 100 oseb:
English: In the event of a severe ADR, the infusion should be interrupted and restarted at 12 ml/hour when the patient's condition is stable.
Slovenian: V primeru hudih neželenih učinkov zdravila je treba infundiranje prekiniti in ga znova začeti s hitrostjo 12 ml/uro, ko je bolnikovo stanje stabilno.
English: Each glass vial is closed with a rubber stopper and aluminium over-seal, and contains 50 ml of concentrate (1000 mg of ofatumumab).
Slovenian: Vsaka steklena viala je zaprta z gumijastim zamaškom, ki ima prekrivno zaporo iz aluminija, in vsebuje 50 ml koncentrata (1000 mg ofatumumaba).
English: Hazard Ratio=0.57 95% CI (0.45, 0.72) p-value<0.001
Slovenian: mediana 22,4 meseca razmerje ogroženosti=0.5795% CI (0.45, 0.72) p-vrednost<0.001
English: No detrimental effects on such activities are predicted from the pharmacology of ofatumumab.
Slovenian: Glede na farmakologijo ofatumumaba ni pričakovati škodljivih vplivov na te dejavnosti.
English: The CD20 molecule is a transmembrane phosphoprotein expressed on B lymphocytes from the pre-B to mature B lymphocyte stage and on B-cell tumours.
Slovenian: Molekula CD20 je transmembranski fosfoprotein, izražen na limfocitih B od faze pred-B do faze zrelega limfocita B ter na tumorjih celic B. Tumorji celic B vključujejo KLL (ki je na splošno povezana z manjšo ekspresijo CD20) in neHodgkinove limfome (pri katerih ima > 90 % tumorjev veliko ekspresijo CD20).
English: Each glass vial is closed with a rubber stopper and aluminium over-seal, and contains 5 ml of concentrate (100 mg of ofatumumab).
Slovenian: Vsaka steklena viala je zaprta z gumijastim zamaškom, ki ima prekrivno zaporo iz aluminija, in vsebuje 5 ml koncentrata (100 mg ofatumumaba).
English: All patients should be screened for HBV infection by measuring HBsAg and anti-HBc before initiation of Arzerra treatment.
Slovenian: Pred začetkom zdravljenja z zdravilom Arzerra je treba pri vseh bolnikih opraviti presejanje glede okužbe s HBV z meritvijo HBsAg in anti-HBc.
English: Median time to next therapy was longer for the OFA+FC arm versus FC (48.1 months versus 40.1 months; HR: 0.73; 95% CI: 0.51-1.05).
Slovenian: Mediani čas do naslednjega zdravljenja je bil v skupini OFA+FC daljši kot v skupini FC (48,1 meseca v primerjavi s 40,1 meseca; razmerje ogroženosti: 0,73; 95% IZ: 0,51-1,05).
English: For instructions on dilution of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila glede redčenja zdravila pred dajanjem glejte poglavje 6.6. 4.3 Kontraindikacije
English: Anaphylactic reactions (including anaphylactic shock)*
Slovenian: Bolezni imunskega sistema preobčutljivost* anafilaktične reakcije (vključno z anafilaktičnim šokom)*
English: Flush line before and after ofatumumab administration with sodium chloride 9 mg/ml (0.9%) solution for injection to avoid this.
Slovenian: Da boste preprečili mešanje, intravenski kanal pred uporabo ofatumumaba in po njej izperite z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje.
English: No formal studies of Arzerra in patients with hepatic impairment have been performed.
Slovenian: Študij z zdravilom Arzerra pri bolnikih z okvaro jeter ni bilo.
English: The PFS in the monotherapy Arzerra arm was comparable to the results seen with Arzerra monotherapy in study Hx-CD20-406.
Slovenian: Preživetje brez napredovanja je bilo v skupini, ki je prejemala monoterapijo z zdravilom Arzerra, podobno kot med monoterapijo z zdravilom Arzerra v študiji Hx-CD20-406.
English: Even with premedication, severe reactions, including cytokine release syndrome, have been reported following use of ofatumumab.
Slovenian: Po uporabi ofatumumaba so celo v primeru premedikacije opisane hude reakcije, vključno s sindromom sproščanja citokinov.
English: Ofatumumab is eliminated in two ways: a target-independent route like other IgG molecules and a target-mediated route which is related to binding to B-cells.
Slovenian: Ofatumumab se izloča po dveh poteh: po ciljno neodvisni poti, tako kot druge molekule IgG, in po ciljni poti, povezani z vezavo na celice B. Po prvi infuziji ofatumumaba se je pojavilo hitro in dolgotrajno zmanjšanje števila celic B CD20