FrancophonIA/ELRC3.0 huggingface dataset:
English: In the maintenance therapy clinical trial, the incidence of all-grade neutropenia was 0% for MabTheratreated patients vs 5% for azathioprine treated patients.
Maltese: Fil-prova klinika dwar terapija ta' manteniment, l-inċidenza ta' newtropenija ta' kull grad kienet ta' 0% għall-pazjenti ttrattati b'MabThera vs 5% għall-pazjenti ttrattati b'azathioprine.
English: MabThera contains sodium
Maltese: MabThera fih is-sodium
English: The proportion of patients with a tumour response (CR, CRu, PR) was significantly higher (p< 0.0001 Chi-Square test) in the R-CVP group (80.9 %) than the CVP group (57.2 %).
Maltese: Il-proporzjon ta' pazjenti b'rispons tat-tumur (CR, CRu, PR) kien sinifikattivament ogħla (p< 0.0001 test Chi-Square) fil-grupp ta' R-CVP (80.9%) milli fil-grupp ta' CVP (57.2%).
English: The pharmacokinetics of rituximab were assessed following two intravenous (IV) doses of 500 mg and 1000 mg on Days 1 and 15 in four studies.
Maltese: Il-farmakokinetika ta' rituximab kienet evalwata wara żewġ dożi fil-vini (IV) ta' 500 mg u 1000 mg fi Ġranet 1 u 15 f'erba' studji.
English: Median EFS: 36 Not reached p < 0.0001
Maltese: EFS medjanuu: 36 Ma ntlaħaqx p < 0.0001
English: Symptoms included pain, swelling, induration, haemorrhage, erythema, pruritus and rash (see section 4.8).
Maltese: Sintomi jinkludu uġigħ, nefħa, ebusija, emorraġija, eritema, ħakk u raxx (ara sezzjoni 4.8).
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), and very rare (<1/10,000).
Maltese: Il-frekwenzi huma definiti bħala komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), u rari ħafna (<1/10,000).
English: MabThera may be used for the treatment of several different conditions in adults.
Maltese: MabThera jista' jintuża għall-kura ta' diversi kundizzjonijiet differenti fl-adulti.
English: Geometric mean AUCτ cycle 2 (q2m)
Maltese: Medja ġeometrika tal-AUCτ ċiklu 2 (q2m)
English: and 6
Maltese: 4 u 6
English: The overall safety profile was consistent with the well-established safety profile for MabThera in approved autoimmune indications, including GPA/MPA.
Maltese: Il-profil ta' sigurtà globali kien konsistenti mal-profil ta' sigurtà stabbilit sew għal MabThera f'indikazzjonijiet awtoimmuni approvati, li jinkludu GPA/MPA.
English: What MabThera is
Maltese: MabThera.
English: • After aseptic dilution in sodium chloride solution The prepared infusion solution of MabThera in 0.9% sodium chloride solution is physically and chemically stable for 30 days at 2 °C - 8 °C plus an additional 24 hours at ≤ 30 °C.
Maltese: • Wara dilwizzjoni asettika f'soluzzjoni ta' sodium chloride Is-soluzzjoni għal infużjoni mħejjija ta' MabThera f'soluzzjoni ta' 0.9% sodium chloride hija fiżikament u kimikament stabbli għal 7 ijiem f'temperatura ta' 2°C - 8°C u sussegwentement għal 24 siegħa oħra f'temperatura ta' ≤ 30°C.
English: IRRs for patients with granulomatosis with polyangiitis, microscopic polyangiitis and pemphigus vulgaris were consistent with those seen for rheumatoid arthritis patients in clinical trials (see section
Maltese: IRRs għall-pazjenti bi granulomatosi b'polianġite, polianġite mikroskopika u pemphigus vulgaris kienu konsistenti ma' dawk osservati f'pazjenti b'artrite rewmatika fi provi kliniċi (ara sezzjoni 4.8).
English: MabThera maintenance treatment significantly prolonged median PFS in patients responding to CHOP induction therapy (median PFS 37.5 months vs. 11.6 months, p< 0.0001) as well as in those responding to R-CHOP induction (median PFS 51.9 months vs. 22.1 months, p=0.0071).
Maltese: Il-kura ta' manteniment b'MabThera tawlet b'mod sinifikanti l-PFS medjana fil-pazjenti li rrispondew għat-terapija ta' induzzjoni CHOP (PFS medjana 37.5 xhur vs 11.6 xhur, p< 0.0001) kif ukoll f'dawk li rrispondew għall-induzzjoni b'R-CHOP (PFS medjana ta' 51.9 xhur vs 22.1 xahar, p=0.0071).
English: All patients n=99
Maltese: Pazjenti kollha n=99
English: Cardiac events were reported as serious adverse events (including atrial fibrillation, myocardial infarction, left ventricular failure, myocardial ischaemia) in 3% of patients treated with MabThera compared to <1% on observation.
Maltese: Avvenimenti kardijaċi kienu rrappurtati bħala avvenimenti avversi severi (inkluż fibrillazzjoni atrijali, infart mijokardijaku, insuffiċjenza ventrikolari tax-xellug, iskemija mijokardijaka) f'3% tal-pazjenti kkurati b'MabThera meta mqabbel ma' <1% fuq osservazzjoni.
English: FC (N = 409)
Maltese: (N = 409)
English: ORR in patients previously treated with autologous bone marrow transplant (ABMT) was 78% versus 43% in patients with no ABMT.
Maltese: ORR f'pazjenti trattati preċedentement bi trapjant awtologu tal-mudullun (ABMT) kienet ta' 78% kontra 43% f'pazjenti mingħajr ABMT.
English: Among the 3189 patients treated with MabThera, 1135 (36%) experienced at least one IRR with 733/3189 (23%) of patients experiencing an IRR following first infusion of the first exposure to MabThera.
Maltese: Fost 3189 pazjent kkurat b'MabThera, 1135 (36%) kellhom esperjenza ta' mill-inqas IRR waħda b'733/3189 (23%) tal-pazjenti li kellhom IRR wara l-ewwel infużjoni tal-ewwel esponiment għal MabThera.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikata fuq il-portal elettroniku Ewropew tal-mediċini.
English: PML, reactivation of hepatitis B
Maltese: PML, attivazzjoni mill-ġdid tal-epatite B
English: Figure 2: ACR responses for 4 treatment courses (24 weeks after each course (within patient, within visit) in patients with an inadequate response to TNF-inhibitors (n=146)
Maltese: Figura 2: Rispons ACR għal 4 korsijiet ta' kura (24 ġimgħa wara kull kors (fil-pazjent, fil-vista) f'pazjenti b'rispons mhux adegwat għall-inibituri ta' TNF (n=146)
English: Of the 99 patients treated with MabThera, 12 (12%) experienced at least one IRR.
Maltese: Mid-99 pazjent ikkurati b'MabThera, 12 (12%) kellhom mill-inqas IRR wieħed.
English: Subsequent doses of MabThera can be infused at an initial rate of 100 mg/h, and increased by 100 mg/h increments at 30 minute intervals, to a maximum of 400 mg/h.
Maltese: Dożi sussegwenti ta' MabThera jistgħu jiġu infużi b'rata inizjali ta' 100 mg/siegħa, u miżjuda b'żidiet ta' 100 mg/siegħa f'intervalli ta' 30 minuta, sa massimu ta' 400 mg/siegħa.
English: • MabThera subcutaneous (n= 88); 1st cycle of MabThera intravenous 375 mg/m2 in combination with chemotherapy plus subsequent cycles (2-6) of MabThera subcutaneous 1600mg in combination with chemotherapy.
Maltese: • MabThera taħt il-ġilda (n= 88); l-ewwel ċiklu ta' MabThera 375 mg/m fil-vini flimkien ma' kimoterapija u ċikli sussegwenti (2-6) ta' MabThera 1600mg taħt il-ġilda flimkien ma' kimoterapija.
English: Adverse drug reactions presented in Table 5 were adverse events which occurred at a rate of ≥ 5% among MabThera-treated PV patients, with a ≥ 2% absolute difference in incidence between the MabThera-treated group and the standard-dose prednisone group up to month 24.
Maltese: Ir-reazzjonijiet avversi tal-mediċina ppreżentati fit-Tabella 5 kienu avvenimenti avversi li seħħew b'rata ta' ≥ 5% fost il-pazjenti b'PV ittrattati b'MabThera, b'differenza assoluta ta' ≥ 2% fl-inċidenza bejn il-grupp ittrattat b'MabThera u l-grupp b'doża standard ta' prednisone sa xahar 24.
English: In a prospective, open label, international, multi-center, phase III trial 1193 patients with previously untreated advanced follicular lymphoma received induction therapy with R-CHOP (n=881), R-CVP (n=268) or R-FCM (n=44), according to the investigators' choice.
Maltese: III, 1193 pazjenti b'limfoma follikulari avanzata mhux ikkurata minn qabel irċevew terapija ta' induzzjoni b'R-CHOP (n=881), R-CPV (n=268) jew R-FCM (n=44), skont l-għażla tal-investigaturi.
English: • The active ingredient in MabThera is called rituximab.
Maltese: • Is-sustanza attiva f'MabThera hija msejħa rituximab.
English: Following second infusion, mean Cmax ranged from 183 to 198 µg/mL for the 2 × 500 mg dose and ranged from 355 to 404 µg/mL for the 2 × 1000 mg dose.
Maltese: Wara t-tieni infużjoni, Cmax medja varjat minn 183 sa 198 µg/mL għad-doża ta' 2 × 500 mg u varjat minn 355 sa 404 µg/mL għad-doża ta' 2 × 1000 mg.
English: This compares favourably with the TTP achieved after the prior course of MabThera (12.4 months).
Maltese: Dan jikkompara b'mod favorevoli -ma' TTP milħuq wara l-kors preċedenti ta' MabThera (12.4 xhur).
English: In the clinical trial on induction of remission, which included 99 MabThera-treated patients, the overall rate of infection was approximately 237 per 100 patient years (95% CI 197 - 285) at the 6-month primary endpoint.
Maltese: Fil-prova klinika dwar l-induzzjoni ta' remissjoni, li kienet tinkludi 99 pazjent ittrattati b'MabThera, ir-rata globali ta' infezzjoni kienet ta' madwar 237 għal kull 100 sena ta' pazjent (CI ta' 95% 197 - 285) fil-punt finali primarju ta' 6 xhur.
English: In patients with rheumatoid arthritis, granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis in disease remision or pemphigus vulgaris, premedication with 100 mg intravenous methylprednisolone should be completed 30 minutes prior to MabThera infusions to decrease the incidence and severity of infusion related reactions (IRRs).
Maltese: F'pazjenti b'artrite rewmatika, granulomatosi b'polianġite (ta' Wegener) jew polianġite mikroskopika f'remissjoni tal-marda jew pemphigus vulgaris, medikazzjoni minn qabel b'100 mg methylprednisolone fil-vini għandha tiġi kompluta 30 minuta qabel infużjonijiet ta' MabThera biex titnaqqas l-inċidenza u s-severità ta' reazzjonijiet relatati mal-infuzjoni (IRRs - infusion related reactions).
English: Table 13 Radiographic outcomes at 1 year (mITT population) Placebo+MTX MabThera+MTX 2 × 1000 mg
Maltese: Tabella 13 Riżultati radjugrafiċi wara sena (popolazzjoni mITT) Plaċebo+MTX
English: The serum MabThera Cmax at Cycle 6 was lower in the subcutaneous arm than the intravenous, with geometric mean (CV%) values of 202 (36.1) μg/mL and 280 (24.6) μg/mL with the resulting geometric mean ratio (Cmax, SC/Cmax, IV) of 0.719 (90% CI: 0.653, 0.792).
Maltese: Cmax ta' MabThera fis-serum f'Ċiklu 6 kienet aktar baxxa fil-grupp ta' għoti taħt il-ġilda milli f'dak ta' għoti fil-vini, b'valuri tal-medja ġeometrika (CV%) ta' 202 (36.1) μg/mL u 280 (24.6) μg/mL b'riżultat tal-proporzjon tal-medja ġeometrika (Cmax, SC/Cmax, IV) ta' 0.719 (CI ta' 90%: 0.653, 0.792).
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1000), rari ħafna (< 1/10,000) u mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial contains 10 mg/mL rituximab.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett wieħed fih 10 mg/mL rituximab.
English: +left ventricular failure, +supraventricu lar tachycardia, +ventricular tachycardia, +angina, +myocardial ischaemia, bradycardia severe cardiac disorders 4 and 6
Maltese: +Insuffiċjenza tal-ventriklu tax-xellug, +takikardija supraventrikul ari, +takikardija ventrikulari, +anġina, +iskemija mijokardijaka, bradikardija
English: The information provided in this section pertains to the use of MabThera in oncology.
Maltese: L-informazzjoni pprovduta f'din is-sezzjoni tappartjieni għall-użu ta' MabThera fl-onkoloġija.
English: The safety information collected during post marketing experience reflects the expected adverse reaction profile as seen in clinical trials for MabThera (see section 4.4).
Maltese: L-informazzjoni ta' sigurtà miġbura matul l-esperjenza ta' wara t-tqegħid fis-suq tirrifletti l-profil ta' reazzjonijiet avversi mistenni kif deher fi provi kliniċi ta' MabThera (ara sezzjoni 4.4).
English: Available data suggest that clinical response is usually achieved within 16 - 24 weeks of an initial treatment course.
Maltese: Id-data disponibbli tissuġġerixxi li r-rispons kliniku normalment jintlaħaq fi żmien 16 - 24 ġimgħa wara kors ta' kura inizjali.
English: Cases of hepatitis B reactivation, including those with a fatal outcome, have been reported in rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis patients receiving MabThera.
Maltese: Każijiet ta' attivazzjoni mill-ġdid tal-epatite B, inkluż dawk b'riżultat fatali, kienu rrappurtati f'pazjenti b'artrite rewmatika, granulomatosi b'polianġite u polianġite mikroskopika li kienu qed jirċievu MabThera.
English: Examples of these serious viral infections are infections caused by the herpes viruses (Cytomegalovirus, Varicella Zoster Virus and Herpes Simplex Virus), JC virus (progressive multifocal leukoencephalopathy (PML)) and hepatitis C virus.
Maltese: Eżempji ta' dawn l-infezzjonijiet virali serji huma infezzjonijiet ikkawżati mill-virusis tal-herpes (Cytomegalovirus, Virus tal-Varicella Zoster u Virus tal-Herpes Simplex), virus JC (lewkoenċefalopatija multifokali progressiva (PML)) u virus tal-epatite Ċ.
English: Very rare cases of progressive multifocal leukoencephalopathy (PML) have been reported during post-marketing use of MabThera in NHL and CLL (see section 4.8).
Maltese: Każijiet rari ħafna ta' lewkoenċefalopatija multifokali progressiva (PML) kienu rrappurtati waqt l-użu ta' wara t-tqegħid fis-suq ta' MabThera f'NHL u CLL (ara sezzjoni 4.8).
English: Table 10b First-line treatment of chronic lymphocytic leukaemia Hazard ratios of progression-free survival according to Binet stage (ITT) - 48.1 months median observation time Progression-free survival (PFS)
Maltese: Tabella 10b Kura preferita ta' lewkimja limfoċitika kronika Proporzjonijiet ta' periklu ta' sopravivenza mingħajr progressjoni skont l-istadju Binet (ITT) - perijodu medjan ta' osservazzjoni ta' 48.1 xahar Sopravivenza Mingħajr Progressjoni (PFS)
English: Stage 1 enrolled previously untreated patients (n=127) CD20-positive, Follicular Lymphoma (FL) Grade 1, 2 or 3a.
Maltese: Fl-ewwel stadju ġew irreġistrati pazjenti li ma kinux ikkurati qabel (n=127) b'Limfoma Follikulari (FL - follicular lymphoma) pożittiva għal CD20 ta' Grad 1, 2 jew 3a.
English: MARKETING AUTHORISATION NUMBER(S) MabThera 100 mg concentrate for solution for infusion EU/1/98/067/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ MabThera 100 mg konċentrat għal soluzzjoni għal infużjoni EU/1/98/067/001
English: From month 12 to month 18, 8 relapses were observed in the MabThera group compared with four in the cyclophosphamide group.
Maltese: Minn xahar 12 sa xahar 18, kienu osservati 8 rikaduti fil-grupp ta' MabThera meta mqabbel ma' erbgħa fil-grupp ta' cyclophosphamide.
English: System Organ Class Adverse drug reaction1
Maltese: Klassi tas-Sistemi u tal-Organi Reazzjoni avversa tal-mediċina
English: Table 2b First-line treatment of chronic lymphocytic leukaemia Hazard ratios of progression-free survival according to Binet stage (ITT) - 48.1 months median observation time Progression-free survival (PFS)
Maltese: Tabella 2b Trattament preferit ta' lewkimja limfoċitika kronika Proporzjonijiet ta' periklu ta' sopravivenza mingħajr progressjoni skont l-istadju Binet (ITT) - żmien medjan ta' osservazzjoni ta' 48.1 xahar Sopravivenza mingħajr progressjoni (PFS)
English: Clinical manifestations of anaphylaxis may appear similar to clinical manifestations of the cytokine release syndrome (described above).
Maltese: Manifestazzjonijiet kliniċi ta' anafilassi jistgħu jidhru simili għall-manifestazzjonijiet tas-sindrome tar-reħa ta' ċitokina (deskritt fuq).
English: 50 mL vial - Pack of 1 vial
Maltese: Kunjett ta' 50 mL - Pakkett ta' kunjett wieħed
English: Data from extended follow-up of patients in the study (median follow-up 9 years) confirmed the longterm benefit of MabThera maintenance therapy in terms of PFS, EFS, TNLT and TNCT (Table 7).
Maltese: Data mis-segwitu estiż ta' pazjenti fl-istudju (segwitu medjan ta' 9 snin) ikkonfermat il-benefiċċju fittul ta' terapija ta' manteniment b'MabThera f'termini ta' PFS, EFS, TNLT u TNCT (Tabella 7).
English: A total of 23/99 (23%) MabThera-treated patients from the induction of remission trial tested positive for ADA by 18 months.
Maltese: Total ta' 23/99 (23%) pazjent ikkurat b'MabThera mill-prova dwar l-induzzjoni ta' remissjoni kienu pożittivi għal ADA wara 18-il xahar.
English: Muscle spasms
Maltese: Cyclophosphamide
English: In the overall experience of MabThera repeat treatment over one year in rheumatoid arthritis, the proportions of patients with positive antibody titres against S. pneumoniae, influenza, mumps, rubella, varicella and tetanus toxoid were generally similar to the proportions at baseline.
Maltese: Fl-esperjenza globali ta' kura ripetuta ta' MabThera fuq medda ta' sena f'artrite rewmatika, il-proporzjon ta' pazjenti b'titri ta' antikorpi pożittivi kontra S. pneumoniae, influwenza, ħosba, rubella, varicella u tossojdi ta-tetanus ġeneralment kienu simili għall-proporzjonijiet fil-linja bażi.
English: Decreased haemoglobin Metabolism and nutrition disorders Hyperkalaemia
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Iperkalimja
English: The response rates for the analysis of 176 patients in SAWYER Part 2 are shown in Table 2.
Maltese: Ir rati ta' rispons għall-analiżi ta' 176 pazjent fil-Parti 2 ta' SAYWER huma murija fit-Tabella 2.
English: Animal studies did not reveal deleterious effects of rituximab or recombinant human hyaluronidase (rHuPH20) on reproductive organs.
Maltese: Studji fuq l-annimali ma żvelaw l-ebda effetti ta' ħsara ta' rituximab jew ta' hyaluronidase rikombinanti uman (rHuPH20) fuq l-organi riproduttivi.
English: Mean Change in SF-36 PHS
Maltese: Bidla medja f'SF-36
English: Subgroup analysis PFS
Maltese: Analiżi tas-Sottogruppi
English: Ninety-nine patients were treated for induction of remission of GPA and MPA in a clinical trial with MabThera (375 mg/m2, once weekly for 4 weeks) and glucocorticoids (see section 5.1).
Maltese: Disgħa u disgħin pazjent kienu ttrattati għall-induzzjoni ta' remissjoni ta' GPA u MPA fi prova klinika b'MabThera (375 mg/m2, darba fil-ġimgħa għal 4 ġimgħat) u glukokortikojdi (ara sezzjoni 5.1).
English: MabThera is available as a medicine given as a drip (called MabThera 100 mg or MabThera 500 mg, concentrate for solution for infusion) and as a medicine for injection under your skin: called MabThera 1400 mg or MabThera 1600 mg, solution for subcutaneous injection).
Maltese: MabThera huwa disponibbli bħala mediċina li tingħata bħala dripp (imsejħa MabThera 100 mg jew MabThera 500 mg, konċentrat għal soluzzjoni għall-infużjoni) u bħala mediċina għall-injezzjoni taħt il-ġilda (imsejħa MabThera 1400 mg jew MabThera 1600 mg, soluzzjoni għall-injezzjoni taħt il-ġilda).
English: • The other ingredients are sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid and water for injections.
Maltese: • Is-sustanzi l-oħra huma sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid u ilma għall-injezzjonijiet.
English: For the 60 re-treatments on study, the ORR was 38% (CI95% 26% - 51%; 10% CR, 28% PR) with a projected median TTP for responding patients of 17.8 months (range 5.4 - 26.6).
Maltese: Għas-60 kura mill-ġdid fl-istudju, L-ORR kienet ta' 38% (CI95% 26% - 51%; 10% CR, 28% PR) b'TTP medjan ipproġettat għal pazjenti li rrispondew ta' 17.8 xhur (firxa minn 5.4 sa 26.6 xhur).
English: The estimated median terminal elimination half-life of MabThera subcutaneous formulation was 29.7 days (range, 9.9 to 91.2 days).The analysis data set contained 6003 quantifiable samples from 403 patients administered SC and/or IV rituximab in trials BP22333 (3736 samples from 277 patients) and BO22334 (2267 samples from126 patients).
Maltese: L-analiżi tas-sett ta' data kien fiha 6003 kampjuni li setgħu jiġu kkwantifikati minn 403 pazjent li ngħataw rituximab SC u/jew IV fil-provi BP22333 (3736 kampjun minn 277 pazjent) u BO22334 (2267 kampjun minn 126 pazjent).
English: Do not take MabThera if:
Maltese: Tiħux MabThera jekk:
English: The Fab domain of rituximab binds to the CD20 antigen on B lymphocytes and the Fc domain can recruit immune effector functions to mediate B cell lysis.
Maltese: Il-parti Fab ta' rituximab teħel mal-antiġen CD20 fuq il-limfoċiti B u l-parti Fc tista' tirrekluta funzjonijiet ta' effector immuni biex timmedja lisi taċ-ċellula B.
English: MabThera maintenance treatment provided consistent benefit in all predefined subgroups tested: gender (male, female), age (< 60 years, >= 60 years), FLIPI score (<=1, 2 or >= 3), induction therapy (R-CHOP, R-CVP or R-FCM) and regardless of the quality of response to induction treatment (CR,CRu or PR).
Maltese: Kura ta' manteniment b'MabThera ipprovdiet benefiċċju konsistenti fis-sottogruppi kollha ittestjati li kienu definiti minn qabel: sess (maskili, femminili), età (<60 sena, >= 60 sena), punteġġ FLIPI (<=1, 2 jew >= 3), terapija ta' induzzjoni (R-CHOP, R-CVP jew R-FCM) u rrispettivament mill-kwalità ta' rispons għat-terapija ta' induzzjoni (CR, CRu jew PR).
English: Angina pectoris, atrial fibrillation, heart failure, myocardial infarction
Maltese: Anġina pectoris, fibrillazzjoni atrijali, insuffiċjenza tal-qalb, infart mijokardijaku
English: Mean pre-therapeutic antibody titers against a panel of antigens (Streptococcus pneumoniae, influenza A, mumps, rubella and varicella) were maintained for at least 6 months after treatment with MabThera.
Maltese: It-titri medji tal-antikorpi ta' qabel it-terapija kontra sensiela ta' antigens (Streptococcus pneumoniae, influwenza A, gattone, rubella u varicella) inżammu għal mill-inqas 6 xhur wara kura b'MabThera.
English: Geometric mean AUC values at cycle 7 µg.day/mL
Maltese: Medja ġeometrika tal-valuri tal-AUC f'ċiklu 7 µg.kuljum/mL
English: Using a cox regression analysis, the risk of experiencing progressive disease or death was reduced by 61% with MabThera maintenance treatment when compared to observation (95% CI; 45%-72%).
Maltese: Bl-użu ta' analiżi tar-rigressjoni cox, ir-riskju ta' esperjenza ta' marda progressiva jew mewt kien imnaqqas b'61 % permezz ta' kura ta' manteniment b'MabThera meta mqabbel ma' osservazzjoni (CI ta' 95 %; 45 %-72 %).
English: The most common infections in the MabThera group were herpes simplex and zoster infections, bronchitis, urinary tract infection, fungal infection and conjunctivitis.
Maltese: L-aktar infezzjonijiet komuni fil-grupp ta' MabThera kienu infezzjonijiet ta' herpes simplex u zoster, bronkite, infezzjoni flapparat tal-awrina, infezzjoni fungali u konġuntivite.
English: The complete response rate after cycle 8 was 76.2% in the R-CHOP group and 62.4% in the CHOP group (p=0.0028).
Maltese: Ir-rata ta' rispons komplut wara t-8 ċiklu kienet ta' 76.2 % fil-grupp ta' R-CHOP u ta' 62.4 % fil-grupp ta' CHOP (p=0.0028).
English: Exploratory analyses showed response rates among BSA, chemotherapy and gender subgroups were not notably different from the ITT population.
Maltese: Analiżi esploratorja wriet li rati ta' rispons fost sottogruppi ta' BSA, kimoterapija u sess ma kinux differenti b'mod notevoli mill-popolazzjoni ITT.