FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not have MabThera if you have an active infection or a serious problem with your immune system.
Maltese: Tiħux MabThera jekk ikollok infezzjoni attiva jew problema serja bis-sistema immuni tiegħek.
English: Twenty nine (0.48%) post-dose observations (all from trial BP22333) were below the quantification limit.
Maltese: Disgħa u għoxrin (0.48%) osservazzjoni wara d-doża (kollha minn prova BP22333) kienu taħt il-limitu ta' kwantifikazzjoni.
English: Colourless type I glass vial with butyl rubber stopper with aluminium over seal and a pink plastic flip-off disk, containing 1400 mg/11.7 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 roża, li fih 1400 mg/11.7 mL ta' rituximab.
English: Rituximab pharmacokinetics following single dose administration of MabThera subcutaneous 375 mg/ m2, 625 mg/ m2 and 800 mg/ m2 were compared with MabThera intravenous 375 mg/ m2 in FL
Maltese: Wara għoti ta' doża waħda ta' MabThera 375 mg/ m 2, 625 mg/ m u 800 mg/ m taħt il-ġilda il-farmakokinetika ta' rituximab kienet imqabbla ma' MabThera 375 mg/ m fil-vini f'pazjenti b'FL.
English: SC for Chronic Lymphocytic Leukaemia
Maltese: SC għal Lewkimja Limfoċitika Kronika
English: The median duration of response was 37.7 months in the R-CVP group and was 13.5 months in the CVP group (p < 0.0001, log-rank test).
Maltese: It-tul medjan ta' rispons kien ta' 37.7 xhur fil-grupp ta' R-CVP u ta' 13.5 xhur fil-grupp ta' CVP (p < 0.0001, test log-rank).
English: Mean Cmax for serum rituximab following first infusion ranged from 157 to 171 µg/mL for 2 x 500 mg dose and ranged from 298 to 341 µg/mL for 2 x 1000 mg dose.
Maltese: Cmax medja għal rituximab fis-serum wara l-ewwel infużjoni varjat minn 157 sa 171 µg/mL għad-doża ta' 2 x 500 mg u varjat minn 298 sa 341 µg/mL għad-doża ta' 2 x 1000 mg.
English: Angina pectoris, cardiac arrhythmias such as atrial flutter and fibrillation, heart failure and/or myocardial infarction have occurred in patients treated with MabThera.
Maltese: Anġina pektoris, arritmija kardijaka bħal taħbit u fibrillazzjoni atrijali, insuffiċjenza tal-qalb u/jew infart mijokardijaku dehru f'pazjenti trattati b'MabThera.
English: Specific studies to determine the effects of rituximab or rHuPH20 on fertility have not been performed.
Maltese: Ma sarux studji speċifiċi sabiex jiġu determinati l-effetti ta' rituximab jew ta' rHuPH20 fuq il-fertilità.
English: b The 95.1% confidence level reflects an additional 0.001 alpha to account for an interim efficacy analysis.
Maltese: 1% jirrifletti 0.001 alpha oħra biex ipattu għall-analiżi interim tal-effikaċja.
English: Following two intravenous infusions of MabThera at a dose of 1000 mg, two weeks apart, the mean terminal half-life was 20.8 days (range, 8.58 to 35.9 days), mean systemic clearance was 0.23 L/day (range, 0.091 to 0.67 L/day), and mean steady-state distribution volume was 4.6 l (range, 1.7 to 7.51 L).
Maltese: 8 ġurnata (medda, 8.58 sa 35.9 ġurnata), il-medja tat-tneħħija sistemika kienet ta' 0.23 L/jum (medda, 0.091 sa 0.67 L/jum), u l-medja tal-volum tad-distribuzzjoni fi stat fiss kienet ta' 4.6 l (medda, 1.7 sa 7.51 L).
English: EFS - Event Free Survival TTP - Time to progression or death PFS - Progression-Free Survival TTF - Time to Treatment Failure OS rates - survival rates at the time of the analyses
Maltese: TTP - Żmien sa progressjoni jew mewt PFS - Sopravivenza Mingħajr Progressjoni TTF - Żmien sal-Falliment tal-Kura Rati ta' OS - rati ta' sopravivenza fiż-żmien tal-analiżi
English: Each 50 mL vial contains 500 mg of rituximab.
Maltese: Kull kunjett ta' 50 mL fih 500 mg ta' rituximab.
English: Geometric mean Ctrough and geometric mean AUCτ from the BP22333 and BO22334 trials are summarized in Table 8.
Maltese: Il-medja ġeometrika ta' Ctrough u l-medja ġeometrika tal-AUCτ mill-provi BP22333 u BO22334 huma miġbura fil-qosor f'Tabella 8.
English: Table 5 Adverse drugs reactions for MabThera-treated pemphigus vulgaris patients in the clinical study up to month 24
Maltese: Reazzjonijiet avversi tal-mediċina għal pazjenti b'pemphigus vulgaris ittrattati b'MabThera fl-istudju kliniku sa xahar 24
English: Dyspepsia, diarrhoea, gastro-oesophageal reflux, mouth ulceration, upper abdominal pain
Maltese: Dispepsja, dijarea, rifluss gastro-esofagali, ulċeri fil-ħalq, uġigħ fil-parti ta' fuq tal-addome
English: In a randomised, open-label trial, a total of 399 previously untreated elderly patients (age 60 to 80 years) with diffuse large B cell lymphoma received standard CHOP chemotherapy (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 1-5) every 3 weeks for eight cycles, or MabThera 375 mg/m2 plus
Maltese: Fi prova randomised, open label, total ta' 399 pazjent anzjan li ma kinux ikkurati qabel (età minn 60 sa 80 sena) b'limfoma taċ-ċellula B kbira mifruxa ngħataw kimoterapija CHOP standard (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m sa massimu ta' 2 mg fl-ewwel ġurnata, u prednisolone 40 mg/m 2/jum fi ġranet 1-5) kull 3 ġimgħat għal tmien ċikli, jew
English: Metabolism and nutritional disorders hypercholesterolemia
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni
English: In the relapsed/refractory study, the median progression-free survival (primary endpoint) was 30.6 months in the R-FC group and 20.6 months in the FC group (p=0.0002, log--rank test).
Maltese: Fl-istudju dwar CLL li reġgħet tfaċċat/refrattarja, s-sopravivenza mingħajr progressjoni (punt finali primarju) medjana kienet ta' 30.6 xhur fil-grupp ta' R-FC u 20.6 xhur fil-grupp ta' FC (p=0.0002, test log-rank).
English: R-FC (N=408)
Maltese: (N=408)
English: Table 7 Overview of efficacy results for MabThera maintenance vs. observation at the protocol-defined primary analysis and after 9 years median follow-up (final analysis)
Maltese: Tabella 7 Sommarju tar-riżultati tal-effikaċja għal manteniment b'MabThera kontra osservazzjoni fl-analiżi primarja definita mill-protokoll u wara segwitu medjan ta' 9 snin (analiżi finali)
English: Dysgeusia peripheral neuropathy, facial nerve palsy5
Maltese: Newropatija periferali, paralisi tan-nerv tal-wiċċ5
English: Table 2 Efficacy results for SABRINA (BO22334) (Intent to Treat Population) Pooled Stages 1 & 2 N = 410
Maltese: Tabella 2 Riżultati tal-effikaċja għal SABRINA (BO22334) (Popolazzjoni b'Intenzjoni li Tiġi kkurata)
English: MabThera 500 mg concentrate for solution for infusion Clear Type I glass vials with butyl rubber stopper containing 500 mg of rituximab in 50 mL.
Maltese: MabThera 500 mg konċentrat għal soluzzjoni għal infużjoni Kunjetti tal-ħġieġ ta' Tip I ċar b'tapp tal-lastku butyl li fihom 500 mg ta' rituximab f'50 mL.
English: The difference between the treatment groups with respect to overall survival showed a significant clinical difference (p=0.029, log-rank test stratified by center): survival rates at 53 months were 80.9 % for patients in the R-CVP group compared to 71.1 % for patients in the CVP group.
Maltese: Id-differenza bejn il-gruppi ta' kura f'dak li jikkonċerna is-sopravivenza globali wriet differenza klinika sinifikanti (p=0.029, test log-rank stratifikat biċ-ċentru): rati ta' sopravivenza wara 53 xahar kienu 80.9% għall-pazjenti fil-grupp ta' R-CVP meta mqabbel ma' 71.1% għall-pazjenti fil-grupp ta' CVP.
English: Patients were followed beyond week 24 for long term endpoints, including radiographic assessment at 56 weeks and at 104 weeks.
Maltese: Il-pazjenti ġew segwiti lil hinn minn ġimgħa 24 għal punti finali fuq perijodu fit-tul, fosthom evalwazzjoni radjografika wara 56 ġimgħa u wara 104 ġimgħat.
English: CRR
Maltese: CR
English: Marketing Authorisation Holder Roche Registration GmbH Emil-Barell-Strasse 1
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Roche Registration GmbH
English: During MabThera maintenance treatment for up to 2 years, leucopoenia (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: Matul kura ta' manteniment b'MabThera għal perijodu sa sentejn, lewkopenija (5% kontra 2%, grad 3/4) u newtropenija (10% kontra 4%, grad 3/4) kienu rrappurtati b'inċidenza ogħla meta mqabbel ma' osservazzjoni.
English: Seropositive (n=514)
Maltese: (n=514)
English: For subjects weighing 60-90 kg and < 60 kg, average Ctrough values following intravenous dosing were approximately 16% and 34% lower compared to the subcutaneous regimen, respectively.
Maltese: Għal individwi li jiżnu 60-90 kg u < 60 kg, valuri medji ta' Ctrough wara dożaġġ fil-vini kienu madwar 16% u 34% inqas meta mqabbla mal-kors ta' taħt il-ġilda, rispettivament.
English: Data in approximately 180 patients pre--treated with MabThera have demonstrated clinical benefit (including CR) and are supportive for MabThera re--treatment.
Maltese: Tagħrif minn madwar 180 pazjent ittrattati minn qabel b'MabThera wera benefiċċju kliniku (inkluż CR) u jsostni trattament mill-ġdid b'MabThera.
English: In the NHL phase 3 trial SABRINA (BO22334), local cutaneous reactions were reported in up to 20% of patients receiving subcutaneous MabThera.
Maltese: Fil-prova ta' fażi 3 dwar NHL SABRINA (BO22334), reazzjonijiet lokali fil-ġilda kienu irrappurtati f'sa 20% tal-pazjenti li kienu qed jirċievu MabThera taħt il-ġilda.
English: Clinical experience of MabThera concentrate for solution for infusion in CLL
Maltese: Esperjenza klinika ta' MabThera konċentrat għal soluzzjoni għal infużjoni f'CLL
English: MabThera is provided in sterile, preservative-free, non-pyrogenic, single use vials.
Maltese: MabThera huwa disponibbli f'kunjetti sterili, mingħajr preservattivi, mhux piroġeniċi, għall-użu ta' darba biss.
English: Table 17 Complete remission at 6-months by disease status MabThera
Maltese: Tabella 17 Remissjoni kompluta wara 6 xhur skont l-istat tal-marda MabThera
English: Maintenance treatment with MabThera led to a clinically relevant and statistically significant improvement in the primary endpoint, PFS, (time from maintenance randomisation to relapse, disease progression or death) when compared to observation alone (p< 0.0001 log-rank test).The median PFS was 42.2 months in the MabThera maintenance arm compared to 14.3 months in the observation arm.
Maltese: Kura ta' manteniment b'MabThera wasslet għal titjib klinikament rilevanti u statistikament sinifikanti fil-punt finali primarju, PFS, (żmien minn randomisation ta' manteniment sa osservazzjoni mill-ġdid tal-marda, progressjoni tal-marda jew mewt) meta mqabbel ma' osservazzjoni waħedha (p< 0.0001 test log-rank).
English: Treatment with MabThera in combination with methotrexate over multiple courses resulted in sustained improvements in the clinical signs and symptoms of RA, as indicated by ACR, DAS28-ESR and EULAR responses which was evident in all patient populations studied (Figure 2).
Maltese: Kura b'MabThera flimkien ma' methotrexate fuq korsijiet multipli wasslet għal titjib sostnut fis-sinjali u sintomi kliniċi ta' RA, kif indikat mir-risponsi ACR, DAS28-ESR u EULAR li kien evidenti fil-popolazzjonijiet kollha ta' pazjenti studjati (Figura 2).
English: PFS - Progression-Free Survival (proportion with event, disease progression/relapse or death from any cause) a - at end of Induction b - at time of final analysis (median follow-up 58 months)
Maltese: PFS - Sopravivenza Mingħajr Progressjoni (proporzjon b'avveniment, progressjoni/irkadar tal-marda jew mewt minn kwalunkwe kawża) a - fi tmiem l-Induzzjoni b - fiż-żmien tal-analiżi finali (segwitu medjan ta' 58 xahar)
English: In the maintenance therapy clinical trial, no clinically meaningful differences between the two treatment arms or decreases in total immunoglobulin, IgG, IgM or IgA levels were observed throughout the trial.
Maltese: Fil-prova klinika dwar terapija ta' manteniment, matul il-prova kollha ma ġiet osservata l-ebda differenza klinikament sinifikanti bejn iż-żewġ gruppi ta' trattament jew tnaqqis fil-livelli totali talimmunoglobulina, IgG, IgM jew IgA.
English: In an open-label randomised trial, a total of 322 previously untreated patients with follicular lymphoma were randomised to receive either CVP chemotherapy (cyclophosphamide 750 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 1 -5) every 3 weeks for 8 cycles or MabThera 375 mg/m2 in combination with CVP (R-CVP).
Maltese: Fi prova klinika tat-tip open-label u randomised, total ta' 322 pazjent b'limfoma follikulari li ma kinux irċevew kura qabel ġew randomised biex jirċievu kimoterapija CVP (cyclophosphamide 750 mg/m vincristine 1.4 mg/m sa massimu ta' 2 mg fl-ewwel jum, u prednisolone 40 mg/m 2/jum mill-ewwel sal-ħames jum) kull 3 ġimgħat għal 8 ċikli jew MabThera 375 mg/m flimkien ma' CVP (R-CVP).
English: Table 4 Overview of efficacy results for MabThera maintenance vs. observation at the protocol-defined primary analysis and after 9 years median follow-up (final analysis)
Maltese: Tabella 4 Sommarju tar-riżultati tal-effikaċja għal manteniment b'MabThera kontra osservazzjoni fl-analiżi primarja definita mill-protokoll u wara segwitu medjan ta' 9 snin (analiżi finali)
English: Excipients: This medicinal product contains 2.3 mmol (or 52.6 mg) sodium per 10 mL vial and 11.5 mmol (or 263.2 mg) sodium per 50 mL vial.
Maltese: Dan il-prodott mediċinali fih 2.3 mmol (jew 52.6 mg) ta' sodium f'kull kunjett ta' 10 mL u 11.5 mmol (jew 263.2 mg) ta' sodium f'kull kunjett ta' 50 mL.
English: Severe skin reactions such as Toxic Epidermal Necrolysis (Lyell's Syndrome) and Stevens - Johnson syndrome, some with fatal outcome, have been reported (see section 4.8).
Maltese: Kienu rrappurtati reazzjonijiet severi fil-ġilda bħal Nekrolisi Tossika tal-Epidermide (Sindrome ta' Lyell) u s-Sindrome ta' Stevens-Johnson, uħud b'riżultat fatali (ara sezzjoni 4.8).
English: CD20 does not circulate in the plasma as a free antigen and, thus, does not compete for antibody binding.
Maltese: CD20 ma jiċċirkolax fil-plażma bħala antiġen liberu u, għaldaqstant, ma jikkompetix għall-irbit tal-antikorp.
English: Rarely MabThera can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML.
Maltese: B'mod rari MabThera jista' jikkawża infezzjoni serja fil-moħħ, imsejħa “lewkoenċefalopatija multifokali progressiva” jew PML.
English: Upon administration of MabThera at a dose of 375 mg/m2 as an intravenous infusion at weekly intervals for 8 doses to 37 patients with NHL, the mean Cmax increased with each successive infusion, spanning from a mean of 243 µg/mL (range, 16 - 582 µg/mL) after the first infusion to 550 µg/mL (range, 171 - 1177 µg/mL) after the eighth infusion.
Maltese: Mal-għoti ta' MabThera f'doża ta' 375 mg/m bħala infużjoni fil-vini f'intervalli ta' kull ġimgħa għal 8 dożi lil 37 pazjent b'NHL, Cmax medja żdiedet ma' kull infużjoni ta' wara, varjat minn medja ta' 243 µg/mL (firxa, 16 - 582 µg/mL) wara l-ewwel infużjoni għal 550 µg/mL (firxa, 1711177 µg/mL) wara t-tmin infużjoni.
English: Nasopharyngitis
Maltese: Anafilassi
English: late neutropenia3
Maltese: Newtropenija1
English: The most frequent ADRs following receipt of MabThera in clinical studies were IRRs (refer to Table 2).
Maltese: Fi studji kliniċi, l-aktar ADRs frekwenti wara t-teħid ta' MabThera kienu IRRs (irreferi għal Tabella 2).
English: In two open-label randomised trials, a total of 817 previously untreated patients and 552 patients with relapsed/refractory CLL were randomised to receive either FC chemotherapy (fludarabine 25 mg/m2, cyclophosphamide 250 mg/m2, days 1-3) every 4 weeks for 6 cycles or MabThera in combination with FC (R-FC).
Maltese: F'żewġ provi open-label u randomised, total ta' 817-il pazjent li ma kienux ittrattati minn qabel u 552 pazjent b'CLL li reġgħet tfaċċat/ma rrispondietx għat-trattament kienu randomised biex jirċievu kimoterapija ta' FC (fludarabine 25 mg/m2, cyclophosphamide 250 mg/m2, ġranet 1-3) kull 4 ġimgħat għal 6 ċikli jew MabThera flimkien ma' FC (R-FC).
English: During the treatment course in studies with MabThera in combination with chemotherapy, grade 3/4 leucopoenia (R-CHOP 88% vs. CHOP 79%), neutropenia (R-CVP 24% vs. CVP 14%; R-CHOP 97% vs. CHOP 88%), were usually reported with higher frequencies when compared to chemotherapy alone.
Maltese: Matul il-kors ta' kura fi studji b'MabThera flimkien ma' kimoterapija, lewkopenija ta' grad 3/4 (R-CHOP 88% kontra CHOP 79%), newtropenija (R-CVP 24% kontra CVP 14%;
English: They were characterized by pulmonary events and in some cases included rapid tumour lysis and features of tumour lysis syndrome in addition to fever, chills, rigors, hypotension, urticaria, angioedema and other symptoms (see section 4.8).
Maltese: Dawn kienu kkaratterizzati minn avvenimenti pulmonari u f'xi każijiet inkludew lisi rapida tat-tumur u karatteristiċi tas-sindrome tal-lisi tat-tumur flimkien ma' deni, dehxa ta' bard, tregħid, pressjoni baxxa, urtikarja, anġjoedima u sintomi oħrajn (ara sezzjoni 4.8).
English: Examples of these serious viral infections are infections caused by the herpes viruses (Cytomegalovirus, Varicella Zoster Virus and Herpes Simplex Virus), JC virus (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 (PML) u virus tal-epatite Ċ.
English: The incidence of thrombocytopenia was low (<1 %, grade 3/4) and was not different between treatment arms.
Maltese: L-inċidenza ta' tromboċitopenija kienet baxxa (<1 %, grad 3/4) u ma kinitx differenti bejn il-gruppi ta' kura.
English: The incidence of thrombocytopenia was low (<1%, grade 3/4) and was not different between treatment arms.
Maltese: L-inċidenza ta' tromboċitopenija kienet baxxa (<1%, grad 3/4) u ma kinitx differenti bejn il-gruppi ta' kura.
English: 3Infusion related reactions (generalized oedema, bronchospasm, wheezing, laryngeal oedema, angioneurotic oedema, generalized pruritus, anaphylaxis, anaphylactoid reaction)
Maltese: Reazzjonijiet relatati mal-infużjoni (edima ġeneralizzata, bronkospażmu , tħarħir, edima fil-larinġi, edima anġjonewrotik a, ħakk ġeneralizzat, anafilassi, reazzjoni anafilattojda)
English: Fourteen patients (37%) in the MabThera group experienced treatment-related infections compared to 15 patients (42%) in the standard-dose prednisone group.
Maltese: Erbatax-il pazjent (37%) fil-grupp ta' MabThera kellhom infezzjonijiet relatati mat-trattament meta mqabbla ma' 15-il pazjent (42%) fil-grupp b'doża standard ta' prednisone.
English: Developmental toxicity studies have been performed in cynomolgus monkeys at doses up to 100 mg/kg (treatment on gestation days 20-50) and have revealed no evidence of toxicity to the foetus due to rituximab.
Maltese: Studji dwar l-effett tossiku fuq l-iżvilupp kienu mwettqa fuq xadini cynomolgus b'dożi sa 100 mg/kg (kura f'jiem 20-50 tat-tqala) u ma wrew l-ebda evidenza ta' tossiċità għall-fetu minħabba rituximab.
English: respiratory failure4,
Maltese: Sistema respiratorja:
English: The benefit in terms of PFS was consistently observed in most patient subgroups analysed according to disease risk at baseline (i.e. Binet stages A-C) (Table 2b).
Maltese: Il-benefiċċju f'termini ta' PFS kien osservat b'mod konsistenti fil-biċċa l-kbira tas-sottogruppi ta' pazjenti analizzati skont ir-riskju tal-marda fil-linja bażi (jiġifieri stadji Binet A-Ċ) (Tabella 2b).
English: Rituximab + Prednisone N=38
Maltese: Iddijanjostikati għall-ewwel darba n=48
English: In patients with relapsed/refractory CLL, the incidence of grade 3/4 hepatitis B infection (reactivation and primary infection) was 2% in R-FC vs 0% FC.
Maltese: F'pazjenti b'CLL li reġgħet tfaċċat/refrattarja, l-inċidenza ta' infezzjoni ta' epatite B ta' grad 3/4 (riattivazzjoni u infezzjoni primarja) kienet ta' 2% f'R-FC vs 0% FC.
English: Higher frequencies of infections overall, including grade 3 or 4 infections, were observed during MabThera maintenance treatment up to 2 years when compared to observation.
Maltese: Frekwenzi globalment ogħla ta' infezzjonijiet, inkluż infezzjonijiet ta' grad 3 jew 4, kienu osservati waqt kura ta' manteniment b'MabThera sa 2 snin meta mqabbla ma' osservazzjoni.
English: A total of 19/34 (56%) patients with PV, who were treated with MabThera, tested positive for ADA antibodies by 18 months.
Maltese: Total ta' 19/34 (56%) pazjent b'PV, li kienu ttrattati b'MabThera, kellhom test pożittiv għal antikorpi
English: 1 Frequency category derived from laboratory values collected as part of routine laboratory monitoring in clinical trials
Maltese: Livelli mnaqqsa ta' IgG 1 Kategorija ta' frekwenza derivata minn valuri tal-laboratorju miġbura bħala parti minn sorveljanza ta' rutina tal-laboratorju fi provi kliniċi Kategorija ta' frekwenza derivata minn data ta' wara t-tqegħid fis-suq.
English: In addition to adverse reactions seen in RA clinical trials for MabThera, progressive multifocal leukoencephalopathy (PML) (see section 4.4) and serum sickness-like reaction have been reported during post marketing experience.
Maltese: Barra r-reazzjonijiet avversi osservati fil-provi kliniċi b'RA għal MabThera, waqt l-esperjenza ta' wara t-tqegħid fis-suq kienu rrappurtati lewkoenċefalopatija multifokali progressiva (PML) (ara sezzjoni 4.4) u reazzjoni li tixbaħ lill-marda tas-serum.
English: Structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (mTSS) and its components, the erosion score and joint space narrowing score.
Maltese: Ħsara strutturali fil-ġogi kienet evalwata b'mod radjugrafiku, u imfissra bħala bidla fil-punteġġ Sharp Totali Modifikat (mTSS) u l-komponenti tiegħu, il-punteġġ tat-tgħawwir u l-punteġġ ta' tidjiq tal-ispazju bejn il-ġogi.
English: In the first-line study, after a median observation time of 48.1 months, the median PFS was 55 months in the R-FC group and 33 months in the FC group (p < 0.0001, log-rank test).
Maltese: Fl-istudju primarju, wara żmien medjan ta' osservazzjoni ta' 48.1 xhur, il-PFS medjana kienet ta' 55 xahar fil-grupp ta' R-FC u ta' 33 xahar fil-grupp ta' FC (p < 0.0001, test log-rank).
English: Each 10mL vial contains 100 mg of rituximab.
Maltese: Kull kunjett ta' 10 mL fih 100 mg ta' rituximab.
English: The overall safety profile was consistent with the well-established safety profile of MabThera in RA and GPA/MPA and no new adverse drug reactions were reported.
Maltese: Il-profil ta' sigurtà globali kien konsistenti mal-profil ta' sigurtà stabbilit sew ta' MabThera f'RA u GPA/MPA u ma kinux irrappurtati reazzjonijiet avversi talmediċina ġodda.
English: The ADRs listed in Table 3 were all adverse events which occurred at an incidence of ≥ 5% in the MabThera group and at a higher frequency than the comparator group.
Maltese: L-ADRs elenkati f'Tabella 3 kienu l-avvenimenti avversi kollha li seħħew b'inċidenza ta' ≥ 5% fil-grupp ta' MabThera u bi frekwenza ogħla mill-grupp ta' paragun.
English: The proportions of MabThera treated patients showing a minimal clinically important difference (MCID) in HAQ-DI (defined as an individual total score decrease of >0.22) was also higher than among patients receiving methotrexate alone (Table 14).
Maltese: Il-proporzjonijiet ta' pazjenti kkurati b'MabThera li wrew differenza minima ta' importanza klinika (MCID) f'HAQ-DI (definita bħala tnaqqis fil-punteġġ individwali totali ta' >0.
English: Infectious events (predominantly bacterial and viral) occurred in approximately 30-55% of patients during clinical trials in patients with NHL and in 30-50% of patients during clinical trials in patients with CLL.
Maltese: Avvenimenti infettivi (fil-biċċa l-kbira kkawżati minn batterja u virusis) seħħew f'madwar 30-55 % tal-pazjenti waqt provi kliniċi f'pazjenti b'NHL u f'30-50 % tal-pazjenti waqt prova kliniċa f'pazjenti b'CLL.
English: There are limited data from clinical trials to fully assess the safety of the sequential use of other DMARDs (including TNF inhibitors and other biologics) following MabThera (see section 4.5).
Maltese: Hemm tagħrif limitat mill-provi kliniċi biex tkun evalwata b'mod sħiħ is-sigurtà tal-użu sekwenzjali ta' DMARDs oħra (inkluż inibituri ta' TNF u bijoloġiċi oħra) wara MabThera (ara sezzjoni 4.5).