FrancophonIA/ELRC3.0 huggingface dataset:
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 għall-kura ta' induzzjoni (CR/CRu jew PR).
English: Figure 1: Change from baseline of DAS28-ESR by baseline autoantibody status
Maltese: Figura 1: Bidla mil-linja bażi ta' DAS28-ESR skont l-istat tal-awtoantikorpi fil-linja bażi:
English: Overall, 4% of patients in the MabThera arm experienced adverse events leading to discontinuation.
Maltese: B'mod globali, 4% tal-pazjenti filgrupp ta' MabThera kellhom avvenimenti avversi li wasslu għal waqfien.
English: Patients received 2 x 1000 mg of MabThera separated by an interval of two weeks; in addition to methotrexate (10-25 mg/week).
Maltese: Il-pazjenti rċevew 2 x 1000 mg ta' MabThera separati b'intervall ta' ġimagħtejn; flimkien ma' methotrexate (10-25 mg/ġimgħa).
English: Each vial contains 1600 mg/ 13.4 mL rituximab.
Maltese: Kull kunjett fih 1600 mg/13.4 mL rituximab.
English: 3Infusion-related reactions (hypertension, nausea, rash, pyrexia, pruritus, urticaria, throat irritation, hot flush, hypotension, rhinitis, rigors, tachycardia, fatigue, oropharyngeal pain, peripheral oedema, erythema)
Maltese: Reazzjonijiet relatati mal-infużjoni (presjoni għolja, tqalligħ, raxx, deni, ħakk, urtikarja, irritazzjoni fil-griżmejn, fwawar pressjoni baxxa, rinite, tertir, takikardija, għeja, uġigħ orofarinġali, edima periferali, eritema)
English: Of 356 patients evaluated for anti-drug antibody (ADA), 1.1 % (4 patients) were positive.
Maltese: Mit-356 pazjent evalwat għall-antikorp kontra l-mediċina (ADA - anti-drug antibody), 1.1 % (4 pazjenti) kienu pożittivi.
English: In studies evaluating MabThera in combination with chemotherapy, the incidence of grade 3 and 4 cardiac arrhythmias, predominantly supraventricular arrhythmias such as tachycardia and atrial flutter/fibrillation, was higher in the R-CHOP group (14 patients, 6.9%) as compared to the CHOP group (3 patients, 1.5%).
Maltese: Fi studji li vvalutaw MabThera flimkien ma' kimoterapija, l-inċidenza ta' arritmija kardijaka ta' grad 3 u 4, l-aktar arritmija supraventrikolari bħal takikardija u taħbit irregolari/fibrillazzjoni atrijali, kienet ogħla fil-grupp ta' R-CHOP (14-il pazjent, 6.9%) meta mqabbel mal-grupp ta' CHOP (3 pazjenti, 1.5%).
English: In the MabThera group, 48% of patients achieved CR at 12 months, and 39% of patients achieved CR at 18 months.
Maltese: Fil-grupp ta' MabThera, 48% tal-pazjenti laħqu CR wara 12-il xahar, u 39% tal-pazjenti laħqu CR wara 18-il xahar.
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 4).
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 4).
English: In a prospective, open label, international, multi-centre, phase III trial, 465 patients with relapsed/refractory follicular lymphoma were randomised in a first step to induction therapy with either CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone; n=231) or MabThera plus CHOP (R-CHOP, n=234).
Maltese: III, 465 pazjent b'limfoma follikulari li reġgħet tfaċċat/reżistenti kienu randomised fl-ewwel pass għal terapija ta' induzzjoni b'CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone; n=231) jew MabThera flimkien ma' CHOP (R-CHOP, n=234).
English: Each vial contains 1400 mg/11.7 mL rituximab.
Maltese: Kull kunjett fih 1400 mg/11.7 mL rituximab.
English: b) If you are being treated for chronic lymphocytic leukaemia When you are treated with MabThera in combination with chemotherapy, you will receive MabThera infusions on day 0 cycle 1 then day 1 of each cycle for 6 cycles in total.
Maltese: b) Jekk qed tiġi kkurat/a għall-lewkimja limfoċitika kronika Meta tkun qed tiġi kkurat b'MabThera flimkien ma' kimoterapija, inti se tirċievi infużjonijiet ta' MabThera f'ġurnata 0 ta' ċiklu 1 u wara f'ġurnata 1 ta' kull ċiklu għal total ta' 6 ċikli.
English: In SAWYER (BO25341), severe administration-related reactions (Grade ≥3) were reported in four patients (5%) following MabThera subcutaneous administration.
Maltese: F'SAWYER (BO25341), reazzjonijiet severi relatati mal-għoti (Grad ≥3) kienu rrappurtati f'erba' pazjenti (5%) wara għoti ta' MabThera taħt il-ġilda.
English: In the maintenance therapy clinical trial, 7/57 (12%) patients in the MabThera arm experienced at least one infusion-related reaction.
Maltese: Fil-prova klinika dwar terapija ta' manteniment, 7/57 (12%) pazjent fil-grupp ta' MabThera kellhom mill-inqas reazzjoni relatata mal-infużjoni waħda.
English: Other medicines and MabThera
Maltese: Mediċini oħra u MabThera
English: The risk of acute administration-related reactions associated with the subcutaneous formulation of MabThera was assessed in two open-label trials involving patients with follicular lymphoma during induction and maintenance (SABRINA/BO22334) and during maintenance only (SparkThera/BP22333).
Maltese: Ir-riskju ta' reazzjonijiet akuti relatati mal-għoti assoċjati mal-formulazzjoni għall-għoti taħt il-ġilda ta' MabThera ġie evalwat f'żewġ provi open-label li kienu jinvolvu pazjenti b'limfoma follikulari matul l-induzzjoni u l-manteniment (SABRINA/BO22334) u matul il-manteniment biss (SparkThera/BP22333).
English: The overall rate of infection was approximately 94 per 100 patient years in MabThera treated patients.
Maltese: Ir-rata globali ta' infezzjoni kienet bejn wieħed u ieħor 94 għal kull 100 sena ta' pazjent fil-pazjenti ttrattati b'MabThera.
English: Results from trial BP22333 are presented in section 5.2.
Maltese: Riżultati mill-prova BP22333 huma ppreżentati f'sezzjoni 5
English: Similarly, the geometric mean AUC (CV%) values at Cycle 6 were higher among the subcutaneous group than the intravenous group; 4088 µg•day/mL (34.2) versus 3630 µg•day/mL (32.8) respectively) with a resulting adjusted geometric mean ratio [90% CI] of 1.10 [0.98-1.24].
Maltese: B'mod simili, valuri tal--medja ġeometrika tal-AUC (CV%) f'Ċiklu 6 kienu ogħla fil-grupp ta' għoti taħt il-ġilda milli fil-grupp ta' għoti fil-vini; 4088 µg•jum/mL (34.2) kontra 3630 µg•jum/mL (32.8) rispettivament) b'riżultat tal-proporzjon aġġustat tal-medja ġeometrika [CI ta' 90%] ta' 1.10 [0.98-1.24].
English: Baseline tumour load was available only in trial BO22334.
Maltese: Il-kobor tat-tumur fil-linja bażi kien disponibbli biss fil-prova BO22334.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial contains 1600 mg/13.4 mL rituximab.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett wieħed fih 1600 mg/13.4 mL ta' rituximab.
English: Significant benefit from maintenance treatment with MabThera was also seen for the secondary endpoints event-free survival (EFS), time to next anti-lymphoma treatment (TNLT) time to next chemotherapy (TNCT) and overall response rate (ORR) in the primary analysis (Table 4).
Maltese: Kien osservat ukoll benefiċċju sinifikanti minn kura ta' manteniment b'MabThera għall-punti finali sekondarji ta' sopravivenza mingħajr avvenimenti (EFS - event-free survival), żmien sal-kura kontra l-limfoma li jmiss (TNLT - time to next anti-lymphoma treatment), żmien sal-kimoterapija li jmiss (TNCT - time to next chemotherapy) u rata ta' rispons globali (ORR - overall response rate) fl-analiżi primarja (Tabella 4).
English: No patients in the MabThera arm had fatal adverse events.
Maltese: L-ebda pazjent filgrupp ta' MabThera ma kellu avvenimenti avversi fatali.
English: All patients were followed until month 28 (10 or 6 months, respectively, after the last MabThera infusion or azathioprine dose).
Maltese: Il-pazjenti kollha kienu segwiti sa xahar 28 (10 jew 6 xhur, rispettivament, wara l-aħħar infużjoni ta' MabThera jew doża ta' azathioprine).
English: Patient subpopulations - MabThera monotherapy
Maltese: Sottopopolazzjonijiet ta' pazjenti - MabThera bħala terapija kombinata
English: Severe infections were reported in about 4% of patients treated with MabThera monotherapy.
Maltese: Infezzjonijiet severi kienu rrappurtati f'madwar 4% tal-pazjenti kkurati b'MabThera bħala monoterapija.
English: In rheumatoid arthritis patients, immediate depletion of B cells in the peripheral blood was observed following two infusions of 1000 mg MabThera separated by a 14 day interval.
Maltese: F'pazjenti li għandhom artrite rewmatika, tnaqqis immedjat taċ-ċelluli B fid-demm periferali kien osservat wara żewġ infużjonijiet ta' 1000 mg MabThera separati b'intervall ta' 14-il ġurnata.
English: The risk of disease progression was reduced by 46 % and the risk of relapse by 51 %.
Maltese: Ir-riskju ta' progressjoni fil-mard kien imnaqqas b'46% u r-riskju li terġa' titfaċċa b'51%.
English: Premedication and prophylactic medications
Maltese: IL-PRODOTT MEDIĊINALI
English: MabThera should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3) or severely immunocompromised patients (e.g. where levels of CD4 or CD8 are very low).
Maltese: MabThera m'għandux jingħata lil pazjenti b'infezzjoni attiva, severa (eż. tuberkulożi, sepsis u infezzjonijiet opportunistiċi, ara sezzjoni 4.3) jew pazjenti immunokompromessi severament (eż. fejn il-livelli ta' CD4 jew CD8 ikunu baxxi ħafna).
English: Consultation with a neurologist should be considered as clinically indicated.
Maltese: Konsultazzjoni ma' Newrologu għandha tiġi kkunsidrata bħala klinikament indikata.
English: Aseptically withdraw the necessary amount of MabThera, and dilute to a calculated concentration of 1 to 4 mg/mL rituximab into an infusion bag containing sterile, pyrogen-free sodium chloride 9 mg/mL (0.9%) solution for injection or 5% D-Glucose in water.
Maltese: Neħħi b'mod assetiku l-ammont neċessarju ta' MabThera, u iddilwa għal konċentrazzjoni kkalkulata ta' minn 1 sa 4 mg/mL ta' rituximab f'borża tal-infużjoni li jkun fiha, soluzzjoni għall-injezzjoni sterili u mingħajr piroġeni ta' sodium chloride 9 mg/mL (0.9 %)jew 5 % D-Glucose fl-ilma.
English: Depending on the severity of the IRR and the required interventions, temporarily or permanently discontinue MabThera.
Maltese: Skont is-severità tal-IRR u l-interventi meħtieġa, waqqaf MabThera temporanjament jew b'mod permanenti.
English: During MabThera maintenance treatment for up to 2 years, leucopenia (5% vs. 2%, grade 3/4) and neutropenia (10% vs. 4%, grade 3/4) were reported at a higher incidence when compared to observation.
Maltese: Waqt kura ta' manteniment b'MabThera sa sentejn, lewkopenija (5% vs 2%, grad 3/4) u newtropenija (10% vs 4%, grad 3/4) kienu rrappurtati f'inċidenza ogħla meta mqabbel mal-osservazzjoni.
English: Kaplan-Meier Estimate of Median Time to Event (Months)
Maltese: Stima Kaplan-Meier tal-Perijodu Medjan sa Avveniment (xhur)
English: A two-stage phase Ib trial to investigate the pharmacokinetics, safety and tolerability of MabThera subcutaneous formulation in patients with follicular lymphoma (FL) as part of maintenance treatment.
Maltese: Ib biex tinvestiga il-farmakokinetika, is-sigurtà u t-tollerabilità tal-formulazzjoni għall-għoti taħt il-ġilda ta' MabThera f'pazjenti b'limfoma follikulari (FL - follicular lymphoma) bħala parti minn kura ta' manteniment.
English: A two-part phase Ib, multicenter, randomized, open-label, parallel-group trial (SAWYER BO25341) was conducted in patients with previously untreated CLL, to investigate the non-inferiority of the pharmacokinetic profile, together with efficacy and safety of MabThera subcutaneous formulation in combination with chemotherapy.
Maltese: Ib f'żewġ partijiet, b'aktar minn ċentru wieħed, randomised, open-label, bi grupp parallel (SAWYER BO25341) f'pazjenti b'CLL mhux ittrattata minn qabel, biex tinvestiga n-nuqqas ta' inferjorità tal-profil farmakokinetiku, flimkien mal-effikaċja u s-sigurtà tal-formulazzjoni għall-għoti taħt il-ġilda ta' MabThera flimkien ma'kimoterapija.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial contains 1400 mg/11.7 mL rituximab.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett wieħed fih 1400 mg/11.7 mL ta' rituximab.
English: When MabThera is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied (see section 4.8).
Maltese: Meta MabThera jingħata flimkien ma' kimoterapija, għandu jsir tnaqqis fid-doża standard għall-prodotti mediċinali kimoterapewtiċi (ara sezzjoni 4.8).
English: In the clinical trial evaluating MabThera maintenance treatment in relapsed/refractory follicular lymphoma, median IgG levels were below the lower limit of normal (LLN) (< 7 g/L) after induction treatment in both the observation and the MabThera groups.
Maltese: Fil-prova klinika li vvalutat kura ta' manteniment b'MabThera f'limfoma follikulari li rkadat jew reġgħet tfaċċat, livelli medjana ta' IgG kienu taħt il-limitu l-baxx tan-normal (LLN) (< 7 g/L) wara l-kura ta' induzzjoni kemm fil-grupp ta' osservazzjoni kif ukoll f'dak ta' MabThera.
English: Hypogammaglobulinaemia (IgA, IgG or IgM below the lower limit of normal) has been observed in granulomatosis with polyangiitis and microscopic polyangiitis patients treated with MabThera.
Maltese: Ipogammaglobulinimja (IgA, IgG jew IgM inqas mil-limitu l-aktar baxx tan-normal) kienet osservata f'pazjenti bi granulomatosi b'polianġite u polianġite mikroskopika kkurati b'MabThera.
English: The rate of serious cardiac events was 2.1 per 100 patient years (95% CI 3 -15).
Maltese: Ir-rata ta' avvenimenti serji tal-qalb kienet ta' 2.1 għal kull 100 sena ta' pazjent (CI ta' 95% 3 -15).
English: The risk of disease progression was reduced by 46% and the risk of relapse by 51%.
Maltese: Ir-riskju ta' progressjoni tal-marda kien imnaqqas b'46 % u r-riskju li terġa' titfaċċa b'51 %.
English: Table 9 Maintenance phase: overview of efficacy results MabThera vs. observation (28 months median observation time) Efficacy Parameter
Maltese: Tabella 9 Fażi ta' manteniment: deskrizzjoni ġenerali tar-riżultati tal-effikaċja MabThera vs. osservazzjoni (perijodu medjan ta' osservazzjoni ta' 28 xahar) Parametru tal-Effikaċja
English: GLSG'00 CHOP, 205 R-CHOP, 223 18
Maltese: R-CHOP, 223
English: MabThera 1600 mg Rituximab
Maltese: MabThera 1600 mg
English: The risk of acute administration-related reactions associated with the subcutaneous formulation of MabThera was assessed in -three clinical trials: SparkThera and SABRINA (the two trials in NHL) and SAWYER the CLL trial.
Maltese: Ir-riskju ta' reazzjonijiet akuti relatati mal-għoti assoċjati mal-formulazzjoni għall-għoti taħt il-ġilda ta' MabThera ġie evalwat fi tliet provi kliniċi: SparkThera u SABRINA (iż-żewġ provi dwar NHL) u SAWYER il-prova ta' CLL.
English: In a further clinical study, a total of 57 severe, active GPA and MPA patients in disease remission were treated with MabThera for the maintenance of remission (see section 5.1).
Maltese: Fi studju kliniku addizzjonali, total ta' 57 pazjent b'GPA u MPA attivi u severi f'remissjoni tal-marda kienu ttrattati b'MabThera għall-manteniment tar-remissjoni (ara sezzjoni 5.1).
English: Cases of hepatitis B reactivation have been reported in subjects receiving MabThera including fulminant hepatitis with fatal outcome.
Maltese: F'individwi li kienu qed jirċievu MabThera kienu rrappurtati każijiet ta' riattivazzjoni ta' epatite B, inkluż epatite fulminanti b'riżultat fatali.
English: Consultation with a Neurologist should be considered as clinically indicated.
Maltese: Konsultazzjoni ma' newrologu għandha tiġi kkunsidrata bħala indikata klinikament.
English: Infections and Infestations upper respiratory tract infection, urinary tract infections
Maltese: Infezzjoni fl-apparat respiratorju ta' fuq, infezzjonijiet fl-apparat urinarju
English: d) Granulomatosis with polyangiitis or microscopic polyangiitis MabThera is used for the treatment of granulomatosis with polyangiitis (formerly called Wegener's granulomatosis) or microscopic polyangiitis, taken in combination with corticosteroids.
Maltese: d) Granulomatosi b'polianġite jew polianġite mikroskopika MabThera jintuża għat-trattament ta' granulomatosi b'polianġite (li qabel kienet tissejjaħ granulomatosi ta' Wegener) jew polianġite mikroskopika, fejn jittieħed flimkien ma' kortikosterojdi.
English: In a subgroup analysis, the ORR was higher in patients with IWF B, C, and D histological subtypes as compared to IWF A subtype (58 % vs. 12%), higher in patients whose largest lesion was < 5 cm vs. > 7 cm in greatest diameter (53% vs. 38%), and higher in patients with chemosensitive relapse as compared to chemoresistant (defined as duration of response < 3 months) relapse (50% vs. 22%).
Maltese: F'analiżi tas-sottogruppi, ORR kien ogħla f'pazjenti b'sottotipi istoloġiċi IWF B, Ċ u D kif ikkomparati mas-sottotip IWF A (58 % kontra 12%), ogħla f'pazjenti li l-akbar leżjoni tagħhom kienet < 5 ċm kontra > 7 ċm fl-akbar dijametru (53% kontra 38%), u ogħla f'pazjenti li reġgħu esperjenzaw il-kimosensittività meta kkumparata ma' dawk li reġgħu esperjenzaw il-kimoreżistenza (definita bħala tul ta' rispons ta' < 3 xhur) (50% kontra 22%).
English: PML).
Maltese: Progressiva jew PML).
English: At month 28, major relapse (defined by the reappearance of clinical and/or laboratory signs of vasculitis activity ([BVAS] > 0) that could lead to organ failure or damage or could be life threatening) occurred in 3 patients (5%) in the MabThera group and 17 patients (29%) in the azathioprine group (p=0.0007).
Maltese: F'xahar 28, irkadar maġġuri (definit permezz ta' dehra mill-ġdid ta' sinjali kliniċi u/jew tal-laboratorju ta' attività ta' vaskulite ([BVAS] > 0) li setgħu jwasslu għal falliment jew ħsara fl-organi jew li setgħu jkunu ta' periklu għall-ħajja) seħħ fi 3 pazjenti (5%) fil-grupp ta' MabThera u fi 17-il pazjent (29%) fil-grupp ta' azathioprine (p=0.0007).
English: You will always be given MabThera as a drip (intra-venous infusion).
Maltese: Inti dejjem se tingħata MabThera bħala dripp (infużjoni fil-vini).
English: In the CLL first-line study, Binet stage C patients experienced more adverse events in the R-FC arm compared to the FC arm (R-FC 83% vs. FC 71%).
Maltese: FL-istudju primarju dwar CCL, pazjent fl-istadju Binet Ċ kellhom aktar avvenimenti avversi fil-grupp R-FC meta mqabbel mal-grupp FC (R-FC 83% vs.
English: Colourless type I glass vial with butyl rubber stopper with aluminium over seal and a blue plastic flip-off disk, containing 1600 mg/13.4 mL of rituximab.
Maltese: Kunjett tal-ħġieġ tat-tip I bla kulur b'tapp tal-lasktu butyl b'siġill fuq kollox tal-aluminju u b'disk flip-off tal-plastik blu, li fih 1600 mg/13.4 mL ta' rituximab.
English: • Weight loss
Maltese: • depressjoni fit-tul
English: MabThera + low-dose prednisone (n = 38)
Maltese: MabThera + doża baxxa ta' prednisone
English: In the phase 3 SABRINA trial (BO22334), local cutaneous reaction were reported in up to 20% of patients receiving subcutaneous MabThera.
Maltese: Fil-prova ta' fażi 3 SABRINA (BO22334), reazzjonijiet lokali fil-ġilda kienu irrappurtati f'sa 20% tal-pazjenti li kienu qed jirċievu MabThera taħt il-ġilda.
English: Cycle 5 (pre-dose Cycle 6) were higher among the MabThera subcutaneous group than the MabThera intravenous group; 97.5 µg/mL (42.6) versus 61.5 µg/mL (63.9) respectively with a resulting adjusted geometric mean ratio [90% CI] of 1.53 [1.27-1.85].
Maltese: Il--valuri tal--medja ġeometrika ta' Ctrough (CV%) f'Ċiklu 5 (qabel id-doża ta' Ċiklu 6) kienu ogħla fil-grupp ta' għoti taħt il-ġilda ta' MabThera milli fil-grupp ta' għoti fil-vini ta' MabThera; 97.5 µg/mL (42.6) kontra 61.5 µg /mL (63.9) rispettivament b'riżultat tal-proporzjon aġġustat tal-medja ġeometrika [CI ta' 90%] ta' 1.53 [1.27-1.85].
English: The efficacy and safety of MabThera in combination with short-term, low-dose glucocorticoid (prednisone) therapy were evaluated in newly diagnosed patients with moderate to severe pemphigus (74 pemphigus vulgaris [PV] and 16 pemphigus foliaceus [PF]) in this randomised, open-label, controlled, multicenter study.
Maltese: L-effikaċja u s-sigurtà ta' MabThera flimkien ma' terapija b'doża baxxa ta' glukokortikojdi (prednisone) għal perjodu qasir kienu evalwati f'pazjenti ddijanjostikati għall-ewwel darba b'pemphigus moderat sa sever (74 pemphigus vulgaris [PV] u 16 pemphigus foliaceus [PF]) f'dan listudju randomised, open-label, ikkontrollat, b'aktar minn ċentru wieħed.
English: MabThera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.
Maltese: MabThera flimkien ma' methotrexate huwa indikat għall-kura ta' pazjenti adulti b'artrite rewmatika attiva severa li kellhom rispons inadegwat jew intolleranza għal mediċini anti-rewmatiċi oħra li jimmodifikaw il-marda (DMARD) fosthom terapija ta' inibizzjoni waħda jew aktar tal-fattur tan-nekrosi tat-tumuri (TNF).
English: The mean Cmax (N=15) was 408 µg/mL (range, 97 - 764 µg/mL) after the fifth 500 mg/m2
Maltese: Cmax medja (N=15) kienet ta' 408 µg/mL (firxa, 97 - 764 µg/mL) wara l-ħames infużjoni ta' 500 mg/m u l-half-life terminali medja kienet ta' 32 ġurnata (firxa, 14 - 62 ġurnata).
English: Mean pre-therapeutic antibody titres against a panel of antigens (Streptococcus pneumoniae, influenza A, mumps, rubella, varicella) were maintained for at least 6 months after treatment with MabThera.
Maltese: Il-medja tat-titri ta' tal-antikorpi qabel it-terapija kontra sensiela ta' antigens (Streptococcus pneumoniae, influwenza A, ħosba, rubella, varicella) inżammu għal tal-inqas 6 xhur wara kura b'MabThera.
English: Rituximab exposure increased dose proportional over the 375 mg/m2 to 800 mg/m2 subcutaneous dose range.
Maltese: L-esponiment għal rituximab żdied b'mod proporzjonali mad-doża fil-firxa ta' dożi ta' 375 mg/m sa 800 mg/m taħt il-ġilda.
English: MabThera should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3).
Maltese: MabThera m'għandux jingħata lill-pazjenti b'infezzjoni attiva, severa (eż. tuberkulosi, sepsi u infezzjonijiet opportunistiċi, ara sezzjoni 4.3).
English: Reactions where the medicine is injected
Maltese: Infezzjonijiet u infestazzjonijiet
English: Hypogammaglobulinaemia (IgG or IgM below the lower limit of normal) has been observed in RA patients treated with MabThera.
Maltese: Ipogammaglobulinimja (IgG jew IgM taħt il-limitu l-aktar baxx tan-normal) ġiet osservata f'pazjenti b'RA kkurati b'MabThera.
English: Rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris
Maltese: Artrite rewmatika, granulomatosi b'polianġite u polianġite mikroskopika, u pemphigus vulgaris
English: Efficacy in autoantibody (RF and or anti-CCP) seropositive patients Patients seropositive to Rheumatoid Factor (RF) and/or anti- Cyclic Citrullinated Peptide (anti-CCP) who were treated with MabThera in combination with methotrexate showed an enhanced response compared to patients negative to both.
Maltese: Effikaċja f'pazjenti seropożittivi għall-awtoantikorpi (RF u jew anti-CCP) Pazjenti seropożittivi għall-Fattur Rewmatiku (RF) u/jew għall-anti-Cyclic Citrullinated Peptide (anti-CCP) li kienu kkurati b'MabThera flimkien ma' methotrexate urew rispons mtejjeb meta mqabbel ma' pazjenti negattivi għat-tnejn.
English: Table 8 Induction phase: overview of efficacy results for CHOP vs. R-CHOP (31 months median observation time) CHOP R-CHOP p-value Risk Reduction1)
Maltese: R-CHOP (żmien medjan ta' osservazzjoni ta' 31 xahar) CHOP R-CHOP Valur p Tnaqqis tar-Riskju1)