FrancophonIA/ELRC3.0 huggingface dataset:
English: Cmax = maximum ofatumumab concentration at the end of infusion, AUC = exposure to ofatumumab over a dosing period, CL = ofatumumab clearance after multiple doses, T½ = terminal half-life Numbers rounded to three significant digits
Maltese: Cmax: konċentrazzjoni massima ta' ofatumumab fi tmiem l-infużjoni, AUC: l-espożizzjoni għal ofatumumab wara perjodu ta' dożaġġ, CL: it-tneħħija ta' ofatumumab wara dożi multipli, T½: half-life terminali
English: There are limited pharmacokinetic data in patients with severe renal impairment (creatinine clearance <30 ml/min).
Maltese: Hemm dejta farmakokinetika limitata f'pazjenti b'indeboliment qawwi tal-kliewi (tneħħija tal-krejatinina <30 ml/min).
English: First and second infusions
Maltese: Infużjonijiet 1 u 2
English: Of the 1,168 patients receiving ofatumumab in clinical trials for CLL, 682 patients (58%) experienced an infection.
Maltese: Mill-1,168 pazjent li rċivew ofatumumab fi provi kliniċi għal CLL, total ta' 682 pazjent (58%) kellhom infezzjoni.
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.
Maltese: L-età medjana kienet ta' 69 sena (medda: 35 sa 92 sena), 27% tal-pazjenti kellhom ≥75 sena, 63% kienu rġiel u 89% bojod.
English: Study OMB110913 (randomised, open-label, parallel-arm, multicentre trial) evaluated the efficacy of ofatumumab in combination with fludarabine and cyclophosphamide compared with fludarabine and cyclophosphamide in 365 patients with relapsed CLL (defined as a patient who has received at least one prior CLL therapy and previously achieved a complete or partial remission/response, but after a period of six or more months demonstrated evidence of disease progression).
Maltese: Studju OMB110913 (prova randomised, open-label, bi grupp parallel, b'aktar minn ċentru wieħed) evalwa l-effikaċja ta' ofatumumab f'kombinazzjoni ma' fludarabine u cyclophosphamide meta mqabbel ma' fludarabine u cyclophosphamide fi 365 pazjent b'CLL li rkadat (definit bħala pazjent li rċieva mill-inqas terapija preċedenti waħda għal CLL u qabel laħaq remissjoni/rispons komplut jew parzjali, imma wara perjodu ta' sitt xhur jew aktar wera evidenza ta' progressjoni tal-marda).
English: There is a potential for immunogenicity with therapeutic proteins such as ofatumumab.
Maltese: Hemm possibbiltà għal immunoġeniċità bi proteini terapewtiċi bħal ma huwa ofatumumab.
English: Abbreviations: β2M = beta-2-microglobulin, CI = confidence interval; CIRS-G = Cumulative Illness Rating Scale for Geriatrics, CLL = chronic lymphocytic leukaemia, CrCl = creatinine clearance, ECOG = Eastern Cooperative Oncology Group, IGHV = Immunoglobulin Heavy Chain Variable Region, IRC = Independent Review Committee, N = number, NR = not reached, PFS = progression-free survival, ZAP-70 = zeta-chain-associated protein kinase 70.
Maltese: Abbrevjazzjonijiet: β2M = beta-2-mikroglobulina, CI = intervall ta' kunfidenza; CIRS-G = Skala ta' Klassifikazzjoni tal-Mard Kumulattiv għall-Ġerjatriċi, CLL = lewkimja limfoċitika kronika, CrCl = ikklirjar tal-kreatinina, ECOG= Eastern Cooperative Oncology Group, IGHV = Reġjun Varjabbli tal-Katina Tqila tal-Immunoglobulina, IRC = Kumitat ta' Reviżjoni
English: Limited data are available in the heterogeneous non-white population and in patients with an ECOG performance status of PS = 2.
Maltese: Dejta limitata hija disponibbli fil-popolazzjoni eteroġena mhux bajda u f'pazjenti bi status talprestazzjoni tal-ECOG ta' PS=2.
English: Bowel obstruction has been reported in patients receiving anti-CD20 monoclonal antibody therapy, including ofatumumab.
Maltese: Sadd fil-musrana kien irrappurtat f'pazjenti li kienu qed jirċievu terapija b'antikorp monoklonali kontra CD20, inkluż b'ofatumumab.
English: Table 3 Summary of response to Arzerra in patients with refractory CLL
Maltese: Tabella 3. Sommarju tar-rispons għal Arzerra f'pazjenti b'CLL refrattarja
English: • memory loss, trouble with thinking, and difficulty with walking or loss of vision (possible symptoms of progressive multifocal leukoencephalopathy)
Maltese: • telf ta' memorja, problemi biex taħseb, u diffikultà biex timxi jew telf tal-vista (jistgħu jkunu sintomi ta' lewkoenċefalopatija multifokali progressiva)
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
Maltese: Indipendenti, MRD = marda residwa minima, N = numru, ORR = rata ta' rispons ġenerali
English: The primary endpoint was median progression-free survival (PFS) as assessed by a blinded Independent Review Committee (IRC) using the International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines (2008).
Maltese: Il-punt aħħari primarju kien is-sopravvivenza medjana ħielsa minn progressjoni (PFS) kif ivvalutata minn Kumitat ta' Reviżjoni Indipendenti (IRC) mgħammad li uża l-linji gwida aġġornati (2008) tanNational Cancer Institute-sponsored Working Group (NCI-WG) tal-International Workshop for Chronic Lymphocytic Leukaemia (IWCLL).
English: • yellow skin and eyes, nausea, loss of appetite, dark urine (possible symptoms of an infection or reactivation of hepatitis B virus)
Maltese: • ġilda u għajnejn sofor, dardir, nuqqas ta' aptit, awrina skura (jistgħu jkunu sintomi ta' infezzjoni jew riattivazzjoni tal-virus tal-epatite B)
English: IGHV unmutated & ZAP-70 negative (n=27)
Maltese: IGHV mhux mutata u ZAP-70 negattiva (n=27)
English: The B-cell tumours include CLL (generally associated with lower levels of CD20 expression) and non-Hodgkin's lymphomas (where >90% of tumours have high levels of CD20 expression).
Maltese: It-tumuri taċ-ċellula B jinkludu CLL (ġeneralment assoċjata ma' livelli aktar baxxi ta' espressjoni ta' CD20) u limfomi mhux ta' Hodgkin (fejn >90% tattumuri għandhom livelli għoljin ta' espressjoni ta' CD20).
English: The results of this study demonstrated that Arzerra in combination with bendamustine is an effective therapy providing an ORR of 95% (95% CI: 85, 99) and a CR of 43%.
Maltese: Ir-riżultati ta' dan l-istudju wrew li Arzerra mogħti flimkien ma' bendamustine huwa terapija effettiva li tipprovdi ORR ta' 95% (95% CI: 85, 99) u CR ta' 43%.
English: Arzerra is available in packs of 3 vials.
Maltese: Arzerra huwa disponibbli f'pakketti ta' 3 kunjetti.
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).
Maltese: Fl-istudju pivitali (OMB110913, ofatumumab flimkien ma' fludarabine u cyclophosphamide 181 pazjent; fludarabine u cyclophosphamide 178 pazjent) f'pazjenti b'CLL li rkadat, newtropenija fit-tul kienet irrappurtata fi 38 (11%) pazjent (18-il pazjent [10%] ittrattati b'ofatumumab flimkien ma' fludarabine u cyclophosphamide imqabbla ma' 20 pazjenti [11%] fil-grupp ta' fludarabine u cyclophosphamide).
English: How to store Arzerra
Maltese: Tilqim u Arzerra
English: - The other ingredients are arginine, sodium acetate (E262), sodium chloride, polysorbate 80
Maltese: - Is-sustanzi mhux attivi l-oħra huma arginine, sodium acetate (E262), sodium chloride,
English: Ofatumumab is a protein for which the expected metabolic pathway is degradation to small peptides and individual amino acids by ubiquitous proteolytic enzymes.
Maltese: Ofatumumab huwa proteina li ir-rotta metabolika mistennija tagħha hija degradazzjoni f'peptidi żgħar u amino acids individwali permezz ta' enzimi proteolitiċi preżenti kullimkien.
English: 1000 mg dose - Use one 1000 mg/50 ml vial (50 ml total, 50 ml per vial):
Maltese: Doża ta' 1000 mg- Uża kunjett ta' 1000 mg/50 ml (total ta' 50 ml, 50 ml kull kunjett):
English: Store the diluted infusion solution between 2C and 8 C and use within 24 hours.
Maltese: Aħżen l-infużjoni ddilwita f'temperatura bejn 2 C u 8 C u uża fi żmien 24 siegħa.
English: PFS benefit with the addition of Arzerra was observed in all patients, including those with poor-risk biological features (such as 17p or 11q deletion, unmutated IGHV, β2M >3500 μg/l, and ZAP-70 expression).
Maltese: Ilbenefiċċju fil-PFS biż-żieda ta' Arzerra ġie osservat fil-pazjenti kollha, inklużi dawk b'karatteristiċi bijoloġiċi ta' riskju baxx (bħal tħassir ta' 17p jew 11q, IGHV mhux mutata, β2M >3500 μg/l, u espressjoni ta' ZAP-70).
English: Subsequent infusions
Maltese: Infużjonijiet sussegwenti
English: • Cycle 1: 300 mg on day 1 followed 1 week later by 1000 mg on day 8
Maltese: • Ċiklu 1: 300 mg fil-jum 1 segwita ġimgħa wara minn 1000 mg fil-jum 8
English: • Withdraw 50 ml of ofatumumab from the 1000 mg vial and inject into the 1000 ml bag
Maltese: • Iġbed 50 ml ta' ofatumumab mill-kunjett ta' 1000 mg u injetta fil-borża ta' 1000 ml
English: At the end of organogenesis (day 48 of gestation), the ofatumumab exposure (AUCinf) corresponded to 0.46 to 3.6 times the human exposure after the eighth infusion of the maximum recommended human dose (MRHD) of 2000 mg. At day 100 of gestation, depletion of B-cells relating to the pharmacological activity of ofatumumab were observed in foetal cord blood and foetal splenic tissues.
Maltese: Fi tmiem l-organoġenesi (jum 48 tal-ġestazzjoni), l-espożizzjoni għal ofatumumab (AUCinf) tikkorrispondi għal 0.46 sa 3.6 drabi l-espożizzjoni fil-bniedem wara t-tmien infużjoni tal-ogħla doża rrakkomandata għall-bniedem (MRHD) ta' 2000 mg.
English: Patients refractory to fludarabine and alemtuzumab n=95
Maltese: Pazjenti li ma weġbux għal kura bi fludarabine u alemtuzumab n=95
English: Hepatitis B virus (HBV) infection and reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, has occurred in patients treated with medicinal products classified as CD20directed cytolytic antibodies, including Arzerra.
Maltese: Infezzjoni bil-virus tal-epatite B (HBV) u attivazzjoni mill-ġdid, li f'xi każijiet wasslet għal epatite fulminanti, insuffiċjenza epatika u mewt, seħħet f'pazjenti li rċevew kura bi prodotti mediċinali kklassifikati bħala antikorpi ċitolitiċi kontra CD20, inkluż Arzerra.
English: For patients who show evidence of prior (HBsAg negative, anti-HBc positive) hepatitis B infection, physicians with expertise in managing hepatitis B should be consulted regarding monitoring and initiation of HBV antiviral therapy.
Maltese: Għal pazjenti li juru evidenza ta' infezzjoni preċedenti (negattivi għal HBsAg, pożittivi għal anti-HBc) tal-epatite B, tobba b'esperjenza fil-ġestjoni tal-epatite B għandhom jiġu kkonsultati dwar il-monitoraġġ u l-bidu ta' terapija antivirali kontra l-HBV.
English: Lymphadenopathy 50% improvement Complete resolution Splenomegaly 50% improvement Complete resolution Hepatomegaly 50% improvement Complete resolution Haemoglobin <11 g/dl at baseline to >11 g/dl post baseline Platelet counts ≤100x10 increase or >100x10 Neutrophils <1x10
Maltese: Għadd tal-plejtlits ≤100x10 żieda ta' >50% jew >100x10 bażi Newtrofili <1x10
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.
Maltese: Mill-1,168 pazjent li ngħataw ofatumumab fi provi kliniċi, 420 pazjent (36%) kellhom avveniment avvers assoċjat ma' għadd imnaqqas ta' newtrofil; 129 (11%) kellhom aveniment avvers serju assoċjat ma' għadd imnaqqas ta' newtrofil.
English: The CD20 molecule is not shed from the cell surface and is not internalised following antibody binding.
Maltese: Il-molekula CD20 ma tixxerridx mill-wiċċ taċ-ċellula u ma tiġix assimilata wara li tintrabat mal-antikorp.
English: Other medicines and Arzerra
Maltese: Mediċini oħra u Arzerra
English: During infusion, the rate should be increased every 30 minutes to a maximum of 400 ml/h (see section 6.6).
Maltese: Matul l-ewwel infużjoni, irrata għandha tiżdied kull 30 minuta sa massimu ta' 400 ml/h (ara sezzjoni 6.6).
English: Patient median age was 64 years (range: 41 to 87 years), and the majority were male (73%) and white (96%).
Maltese: Il-medjan tal-età tal-pazjenti kien 64 sena (medda: 41 sa 87 sena), u l-maġġoranza kienu rġiel (73%) u bojod (96%).
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).
Maltese: Fi studju pivotali għal CLL mhux ikkurata (OMB110911; ofatumumab flimkien ma' chlorambucil 217-il pazjent, chlorambucil waħdu 227 pazjent), newtropenija mtawla (definita bħala newtropenija tal-Grad 3 jew 4 mhux solvuta bejn 24 u 42 jum wara l-aħħar doża tal-istudju dwar il-kura) ġiet irrapportata f'41 pazjent (9%) (23 pazjent [11%] ikkurati b'ofatumumab u chlorambucil, 18-il pazjent [8%] ikkurati b'chlorambucil biss).
English: This includes 643 patients treated with ofatumumab as monotherapy (in patients with relapsed or refractory CLL) and 525 patients treated with ofatumumab in combination with chemotherapy (chlorambucil or bendamustine or fludarabine and cyclophosphamide).
Maltese: Dan jinkludi 643 pazjent ikkurati b'ofatumumab bħala monoterapija (f'pazjenti b'CLL rikaduta jew refrattarja) u 525 pazjent ikkurati b'ofatumumab f'taħlita ma' kimoterapija (chlorambucil or bendamustine jew fludarabine u cyclophosphamide).
English: Efficacy endpoint or haematological parameter a
Maltese: Mira tal-effikaċja jew parametru ematoloġiku a
English: Hazard Ratio=0.67 95% CI (0.51,0.88) p-value=0.0032
Maltese: HR=0.66 (CI ta' 95%: 0.51, 0.85, p=0.0009).
English: Arzerra is used to treat chronic lymphocytic leukaemia (CLL).
Maltese: Arzerra jintuża biex jikkura lewkimja limfoċitika kronika (CLL).
English: Progressive multifocal leukoencephalopathy (PML) Progressive multifocal leukoencephalopathy (PML), a serious and life-threatening brain condition, has been reported with medicines like Arzerra.
Maltese: Lewkoenċefalopatija multifokali progressiva (PML) Lewkoenċefalopatija multifokali progressiva (PML), kundizzjoni tal-moħħ serja u ta' periklu għallħajja, kienet irrappurtata b'mediċini bħal Arzerra.
English: Age was not found to be a significant factor for ofatumumab pharmacokinetics in a cross-study population pharmacokinetic analysis of patients ranging in age from 21 to 87 years of age.
Maltese: L-età ma nsabitx li kienet fattur sinifikanti għall-farmakokinetika ta' ofatumumab f'analiżi cross-study ta' farmakokinetika ta' popolazzjoni li l-età tagħhom kienet tvarja fuq medda bejn 21 u 87 sena.
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).
Maltese: L-ORR kienet ta' 49% f'pazjent li ma weġbux għal kura bi fludarabine u alemtuzumab (ara Tabella 3 għal sommarju tad-dejta ta' effikaċja mill-istudju).
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/.
English: Sepsis (including neutropenic sepsis and septic shock) herpes viral infection, urinary tract
Maltese: Sepsis (li tinkludi sepsis newtropenika u xokk settiku), infezzjoni bl-erpete virali, infezzjoni flapparat tal-awrina
English: Ofatumumab is a human monoclonal antibody (IgG1) that binds specifically to a distinct epitope encompassing both the small and large extracellular loops of the CD20 molecule.
Maltese: Ofatumumab huwa antikorp monoklonali uman (IgG1) li jintrabat b'mod speċifiku ma' epitope distint li jiġbor fih kemm il-ħoloq ekstraċellulari żgħar u kbar tal-molekula CD20.
English: Respiratory, thoracic and mediastinal disorders oropharyngeal pain*, nasal congestion*
Maltese: Disturbi respiratorji, toraċiċi u medjastinali skumdità fis-sider*, uġigħ orofarinġali*,
English: 2000 mg dose - Use two 1000 mg/50 ml vials (100 ml total, 50 ml per vial):
Maltese: Doża ta' 2000 mg - Uża żewġ kunjetti ta' 1000 mg/50 ml (total ta' 100 ml, 50 ml f'kull kunjett):
English: IGHV mutated & ZAP-70 positive (n=35)
Maltese: IGHV mutata u ZAP-70 pożittiva (n=35)
English: Store and transport refrigerated (2 C - 8C).
Maltese: Żommu kiesaħ waqt il-ħażna u l-ġarr (2 C - 8 C).
English: • skin rash
Maltese: • raxx fil-ġilda
English: Cases of progressive multifocal leukoencephalopathy (PML) resulting in death have been reported in CLL patients receiving cytotoxic pharmacotherapy, including ofatumumab.
Maltese: Każijiet ta' lewkoenċefalopatija multifokali progressiva (PML) li twassal għall-mewt kienu rrappurtati f'pazjenti b'CLL li kienu qed jirċievu farmakoterapija ċitotossika, inkluż ofatumumab.
English: Probability of Progression-free Survival
Maltese: Probabilità ta' Sopravivenza Mingħajr Progressjoni
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.
Maltese: Il-molekula CD20 hija fosfoproteina transmembranika espressa fuq il-limfoċiti B mill-istadju pre-B tal-limfoċit sa l-istadju tal-limfoċit B matur u fuq it-tumuri taċ-ċellula B.
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).
Maltese: Il-pazjenti rċevew ofatumumab bħala infużjonijiet fil-vini (ċiklu 1: 300 mg f'jum 1 u 1000 mg f'jum 8; ċikli sussegwenti: 1000 mg f'jum 1 kull 28 ġurnata).
English: IGHV unmutated & ZAP-70 positive (n=122)
Maltese: IGHV mhux mutata u ZAP-70 pożittiva (n=122)
English: In patients with CLL, tumour lysis syndrome (TLS) may occur with use of Arzerra.
Maltese: F'pazjenti b'CLL, sindrome tad-diżintegrazzjoni tat-tumur (TLS) tista' sseħħ bl-użu ta' Arzerra.
English: • Withdraw and discard 100 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection;
Maltese: • Iġbed u armi 100 ml minn borża ta' 1000 ml ta' soluzzjoni ta' sodium chloride 9 mg/ml (0.9%)
English: Patients received either 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 chlorambucil (10 mg/m2 orally on days 1-7 every 28 days) or chlorambucil alone (10 mg/m orally on days 1-7 every
Maltese: Ilpazjenti ngħataw Arzerra bħala infużjonijiet ġol-vina kull xahar (ċiklu 1: 300 mg fil-jum 1 u 1000 mg fil-jum 8; ċikli sussegwenti: 1000 mg fil-jum 1 kull 28 jum) mogħti f'taħlita ma' chlorambucil (10 mg/m orali fil-jiem 1-7 kull 28 jum) jew chlorambucil waħdu (10 mg/m orali fil-jiem 1-7 kull
English: Edetate disodium (E386) Hydrochloric acid (E507) (for pH-adjustment) Water for injections
Maltese: Hydrochloric acid (E507) (għal aġġustament tal-pH) Ilma għall-injezzjonijiet
English: Each vial contains 1000 mg ofatumumab in 50 ml.
Maltese: Kull kunjett fih 1000 mg ofatumumab f'50 ml.
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).
Maltese: Twettaq studju randomizzat, b'żewġ fergħat, b'tikketta mikxufa (OMB114242) f'pazjenti b'CLL refrattorja b'fludarabine voluminuż li ma ħadmux fuqhom tal-anqas żewġ terapiji preċedenti (n=122) li qabbel il-monoterapija b'Arzerra (n=79) mal-għażla tat-tobba (PC) ta' terapija (n=43).
English: Previously untreated CLL and relapsed CLL:
Maltese: CLL mhux ikkurata minn qabel u CLL li rkadat:
English: If you have been previously treated for CLL you will usually have a course of 12 infusions.
Maltese: Jekk qabel ingħatajt kura għal CLL inti normalment tieħu kors ta' 12-il infużjoni.
English: Cytopenias, including prolonged and late-onset neutropenia, have been reported during ofatumumab therapy.
Maltese: Matul it-terapija b'afatumumab ġew irrapportati Ċitopeniji, inkluża newtropenija mtawla u li tibda tard.
English: There are no data on the effects of ofatumumab on human fertility.
Maltese: M'hemmx tagħrif dwar l-effetti ta' ofatumumab fuq il-fertilità umana.
English: No large changes in the mean QTc interval (i.e. >20 milliseconds) were detected.
Maltese: Ma ġiet osservata ebda bidla kbira fl-intervall QTc medju (jiġifieri, >20 millisekonda).
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).
Maltese: Disa' pazjenti [4%] kkurati b'ofatumumab u chlorambucil, u tliet pazjenti kkurati bi chlorambucil waħdu kellhom newtropenija li feġġet tard (definita bħala newtropenija tal-Grad 3 jew 4 li bdiet tal-inqas 42 jum wara l-aħħar kura).
English: With a median follow-up of approximately 34 months, 67 deaths (37%) in the OFA+FC arm and 69 deaths (38%) in the FC arm were reported.
Maltese: B'segwitu medjan ta' madwar 34 xahar, 67 mewta (37%) fil-grupp ta' OFA+FC u 69 mewta (38%) fil-grupp ta' FC kienu rrapurtati.
English: 2000 mg dose: Use 2 vials (100 ml total, 50 ml per vial) - Withdraw and discard 100 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection; - Withdraw 50 ml of ofatumumab from each of 2 vials and inject into the 1000 ml bag; - Do not shake; mix diluted solution by gentle inversion.
Maltese: Doża ta' 2000 mg: Uża 2 kunjetti (total ta' 100 ml, 5 0ml f'kull kunjett) - Iġbed u armi 100 ml minn borża ta' 1000 ml ta' soluzzjoni ta' sodium chloride 9 mg/ml (0.9%)
English: • producing less urine than normal
Maltese: • tipproduċi anqas awrina mis-soltu
English: Arzerra 100 mg is available in a pack containing 3 vials.
Maltese: Arzerra 100 mg huwa disponibbli f'pakkett li fih 3 kunjetti u żewġ settijiet ta' estensjoni.
English: Study OMB110911 (randomised, open-label, parallel-arm, multicentre) evaluated the efficacy of Arzerra in combination with chlorambucil compared with chlorambucil alone in 447 patients with previously untreated CLL considered inappropriate for fludarabine-based treatment (e.g. due to advanced age or presence of co-morbidities), with active disease and indicated for treatment.
Maltese: L-istudju OMB110911 (aleatorju, bi prova miftuħa, parallel-arm, multiċentru) evalwa l-effikaċja ta' Arzerra mogħti f'taħlita ma' chlorambucil meta mqabbel ma' chlorambucil waħdu f'447 pazjent b'CLL mhux ikkurata minn qabel meqjusin li mhumiex xierqa għal kura bbażata fuq fludarabine (eż. minħabba età kbira jew il-preżenza ta' komorbiditajiet), b'marda attiva u indikati għall-kura.
English: The primary endpoint of progression-free survival (PFS), as assessed by a blinded independent review committee (IRC) using the updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines (2008), was prolonged in the ofatumumab plus fludarabine-cyclophosphamide (OFA+FC) arm compared to the fludarabine-cyclophosphamide (FC) arm (28.9 months versus 18.8 months; HR: 0.67; 95% CI: 0.51-0.88, p=0.0032) resulting in a 10-month improvement in median PFS (see Figure 2).
Maltese: Il-punt finali primarju ta' sopravivenza mingħajr progressjoni (PFS - progression-free survival), kif evalwata minn kumitat ta' analiżi indipendenti (IRC - independent review committee) blinded bl-użu tal-linji gwida aggornati (2008) tal-Grupp ta' Ħidma Sponsorjat mill-Istitut Nazzjonali tal-Kanċer (NCI-WG - National Cancer Institute-sponsored Working Group), kien imtawwal fil-grupp ta' ofatumumab flimkien ma' fludarabine-cyclophosphamide (OFA+FC) meta mqabbel mal-grupp ta' fludarabine-cyclophosphamide (FC) (28.9 xhur kontra 18.8 xhur;