FrancophonIA/ELRC3.0 huggingface dataset:
English: Although rituximab is not myelosuppressive in monotherapy, caution should be exercised when considering treatment of patients with neutrophils < 1.5 x 109/L and/or platelet counts < 75 x 109/L as clinical experience in this population is limited.
Maltese: Għalkemm rituximab mhux mijelosuppressiv fil-monoterapija, għandha tingħata attenzjoni meta tiġi kkunsidrata l-kura ta' pazjenti b'newtrofili < 1.5 x 109/L u/jew għadd ta' plejtlits < 75 x 109/L, minħabba li l-esperjenza klinika f'din il-popolazzjoni hija limitata.
English: Table 13 Radiographic outcomes at 1 year (mITT population)
Maltese: Tabella 13 Riżultati radjugrafiċi wara sena (popolazzjoni mITT)
English: The “primary” statistical test for “response” was the trend test of CR versus PR versus non-response (p < 0.0001) Abbreviations: NA, not available; ORR: overall response rate; CR: complete response; PR: partial response
Maltese: NA, mhux disponibbli; ORR: rata ta' rispons globali; CR: rispons totali; PR: rispons parzjali
English: Hypogammaglobulinaemia (IgG or IgM below the lower limit of normal) has been observed in RA patients treated with rituximab.
Maltese: Ipogammaglobulinimja (IgG jew IgM taħt il-limitu l-aktar baxx tan-normal) ġiet osservata f'pazjenti b'RA kkurati b'rituximab.
English: In the maintenance therapy clinical trial, 7/57 (12%) patients in the rituximab arm experienced at least one infusion-related reaction.
Maltese: Fil-prova klinika dwar terapija ta' manteniment, 7/57 (12%) pazjent fil-grupp ta' rituximab kellhom mill-inqas reazzjoni relatata mal-infużjoni waħda.
English: During maintenance treatment, the incidence of grade 3/4 cardiac disorders was comparable between patients treated with rituximab and observation.
Maltese: Waqt kura ta' manteniment, l-inċidenza ta' disturbi kardijaċi ta' grad 3/4 kienet komparabbli bejn pazjenti kkurati b'rituximab u l-osservazzjoni.
English: This medicinal product contains 263.2 mg sodium per 50 mL vial, equivalent to 13.2% of the WHO recommended maximum daily intake of 2 g sodium for an adult.For the full list of excipients, see section 6.1.
Maltese: Dan il-prodott mediċinali fih 263,2 mg sodium f'kull kunjett ta '50 mL, ekwivalenti għal 13,2% talammont massimu rakkomandat mill-WHO ta 2 g sodium li għandu jittieħed kuljum minn adult.
English: Study Treatment, N
Maltese: Kura, N
English: albumin, B symptoms, bulky disease, extranodal sites, bone marrow involvement), the risk ratios for event-free survival and overall survival (R-CHOP compared with CHOP) were less than 0.83 and 0.95 respectively.
Maltese: Fis-sottogruppi ta' pazjenti kollha (sess, età, IPI aġġustat, skont l-età, stadju ta' Ann Arbor, ECOG, mikroglobulina β2, LDH, albumina, sintomi B, bulky disease, siti ekstranodali, involvement tal-mudullun), il-proporzjon tar-riskju għal sopravivenza mingħajr episodji u ta' sopravivenza ġenerali (R-CHOP ikkumparat ma' CHOP) kienu inqas minn 0.83 u 0.95 rispettivament.
English: Clinical experience in pemphigus vulgaris
Maltese: Esperjenza klinika f'pemphigus vulgaris
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit web tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu.
English: Neutropenia
Maltese: Nazzjonali
English: Musculoskeletal pain
Maltese: Spażmi fil-muskoli
English: Skin and subcutaneous tissue disorders
Maltese: Analiżi tas-sottogruppi
English: ANNEX II
Maltese: ADRs. Tabella 5
English: • recurrence of a previous Hepatitis B infection c)
Maltese: • infezzjoni tal-Epatite B terġa' titfaċċa ċ)
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 rituximab 375 mg/m2 plus CHOP (R-CHOP).
Maltese: Fi prova tat-tip open label magħmula b'għażla każwali, total ta' 399 pazjent anzjani mhux trattati preċedentement (età -minn 60 sa 80 sena) b'limfoma taċ-ċellula B kbira mxerrda ngħataw kimoterapija CHOP standard (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 sa massimu ta' 2 mg fl-ewwel ġurnata, u prednisolone 40 mg/m2/ġurnata fil-ġranet 1-5) kull 3 ġimgħat għal tmien ċikli, jew rituximab 375 mg/m2 kif ukoll CHOP (R-CHOP).
English: Table 17 Complete remission at 6-months by disease status Rituximab
Maltese: Tabella 17 Remissjoni kompluta wara 6 xhur skont l-istat tal-marda Rituximab
English: Trial 1 evaluated 517 patients that had experienced an inadequate response or intolerance to one or more TNF inhibitor therapies.
Maltese: Prova 1 evalwat 517-il pazjent li kienu esperjenzaw rispons inadegwat jew intolleranza għal terapija waħda jew aktar ta' inibizzjoni tat-TNF.
English: Experience from pemphigus vulgaris
Maltese: ċ) Pemphigus vulgaris
English: In a non-randomised study, patients with relapsed low-grade NHL who received rituximab monotherapy when compared to healthy untreated controls had a lower rate of response to vaccination with tetanus recall antigen (16% vs. 81%) and Keyhole Limpet Haemocyanin (KLH) neoantigen (4% vs. 76% when assessed for >2-fold increase in antibody titer).
Maltese: Fi studju mhux randomised, pazjenti b'NHL ta' grad baxx li rkadat li rċevew monoterapija ta' rituximab meta mqabbel ma' kontrollif'saħħithom mhux ikkurati kellhom rata ta' rispons aktar baxxa għal tilqim b'tetanus recall antigen (16% vs. 81%) u b'Keyhole Limpet Haemocyanin (KLH) neoantigen (4% vs. 76% meta stmat għal żieda ta' > darbtejn fit-titer tal-antikorp).
English: In patients treated with cyclophosphamide (followed by azathioprine for maintenance of complete remission), 39% of patients achieved CR at 12 months, and 33% of patients achieved CR at 18 months.
Maltese: F'pazjenti kkurati b'cyclophosphamide (segwit minn azathioprine għall-manteniment ta' remissjoni kompluta), 39% tal-pazjenti laħqu CR wara 12-il xahar, u 33% tal-pazjenti laħqu CR wara 18-il xahar.
English: Do not have Ritemvia if you have an active infection or a serious problem with your immune system.
Maltese: Tiħux Ritemvia jekk ikollok infezzjoni attiva jew problema serja bis-sistema immuni tiegħek.
English: Data in approximately 180 patients pre-treated with rituximab have demonstrated clinical benefit (including CR) and are supportive for rituximab re-treatment.
Maltese: Tagħrif minn madwar 180 pazjent ikkurati minn qabel b'rituximab wera benefiċċju kliniku (inkluż CR) u jsostni kura mill-ġdid b'rituximab.
English: Cases of posterior reversible encephalopathy syndrome (PRES) / reversible posterior leukoencephalopathy syndrome (RPLS) have been reported.
Maltese: F'kondizzjonijiet awtoimmuni kienu rrappurtati każijiet ta' sindrome ta' enċefalopatija posterjuri riversibbli (PRES - posterior reversible encephalopathy syndrome) sindrome ta' lewkoenċefalopatija riversibbli posterjuri (RPLS - reversible posterior leukoencephalopathy).
English: Angina pectoris, cardiac arrhythmias such as atrial flutter and fibrillation, heart failure and/or myocardial infarction have occurred in patients treated with rituximab.
Maltese: Anġina pektoris, arritmija kardijaka bħal taħbit u fibrillazzjoni atrijali, insuffiċjenza tal-qalb u/jew infart mijokardijaku dehru f'pazjenti trattati b'rituximab.
English: Ritemvia 500 mg concentrate for solution for infusion
Maltese: Ritemvia 500 mg konċentrat għal soluzzjoni għal infużjoni
English: The safety profile of rituximab in patients with PV was consistent with that observed in RA and GPA/MPA patients.
Maltese: Il-profil ta' sigurtà ta' rituximab f'pazjenti b'PV kien konsistenti ma' dak osservat f'pazjenti b'RA u GPA/MPA.
English: Population pharmacokinetic analysis of the same data gave similar mean values for systemic clearance and half-life, 0.26 L/day and 20.4 days, respectively.
Maltese: L-analiżi farmakokinetika talpopolazzjoni tal-istess informazzjoni ta' valuri medji simili għat-tneħħija sistemika u l-half-life, 0.26
English: Late neutropenia
Maltese: Disturbi vaskulari
English: Table 9 Maintenance phase: overview of efficacy results rituximab vs. observation (28 months median observation time)
Maltese: Tabella 9 Fażi ta' manteniment: deskrizzjoni ġenerali tar-riżultati tal-effikaċja rituximab vs. osservazzjoni (perjodu medjan ta' osservazzjoni ta' 28 xahar) Parametru tal-Effikaċja
English: Look out for the following possible signs of infection:
Maltese: Infezzjonijiet Għid lit-tabib tiegħek immedjatament jekk ikollok sinjali ta' infezzjoni li jinkludu:
English: In the relapsed/refractory CLL study grade 3/4 thrombocytopenia was reported in 11% of patients in the R-FC group compared to 9% of patients in the FC group.
Maltese: Fl-istudju dwar CLL li reġgħet tfaċċat/refrattarja, kienet irrappurtata tromboċitopenija ta' grad ¾ fi 11% tal-pazjenti fil-grupp ta' R-FC meta mqabbel ma' 9% tal-pazjenti fil-grupp ta' FC.
English: Efficacy in autoantibody (RF and or anti-CCP) seropositive patients Patients seropositive to Rheumatoid Factor (RF) and/or anti-Cyclic Citrullinated Peptide (antiCCP) who were treated with rituximab 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 (antiCCP) li kienu kkurati b'rituximab flimkien ma' methotrexate urew rispons mtejjeb meta mqabbel ma' pazjenti negattivi għat-tnejn.
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: The pre-specified primary analysis was conducted at a median observation time of 25 months from randomisation, maintenance therapy with rituximab resulted in a clinically relevant and statistically significant improvement in the primary endpoint of investigator assessed progressionfree survival (PFS) as compared to observation in patients with previously untreated follicular lymphoma (Table 7).
Maltese: L-analiżi primarja speċifikata minn qabel twettqet fi żmien medjan ta' osservazzjoni ta' 25 xahar mir randomization, f'pazjenti b'limfoma follikulari mhux ikkurati minn qabel, terapija ta' manteniment b'rituximab wasslet għal titjib klinikament rilevanti u statistikament sinifikanti fil-punt finali primarju ta' sopravivenza mingħajr progressjoni (PFS) evalwata mill-investigatur meta mqabbla ma' osservazzjoni (Tabella 7).
English: Three patients (8%) in the rituximab group experienced a total of 5 serious infections (Pneumocystis jirovecii pneumonia, infective thrombosis, intervertebral discitis, lung infection, Staphylococcal sepsis) and one patient (3%) in the standard-dose prednisone group experienced a serious infection (Pneumocystis jirovecii pneumonia).
Maltese: Tliet pazjenti (8%) fil-grupp ta' rituximab kellhom total ta' 5 infezzjonijiet serji (pnewmonja kkawżata minn Pneumocystis jirovecii, trombożi infettiva, infezzjoni fl-ispazju bejn id-diski vertebrali, infezzjoni fil-pulmun u sepsis ikkawżata minn
English: 4.06 years
Maltese: 2.6 snin
English: Rituximab should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3).
Maltese: Rituximab m'għandux jingħata lill-pazjenti b'infezzjoni attiva, severa (eż. tuberkulosi, sepsi u infezzjonijiet opportunistiċi, ara sezzjoni 4.3).
English: Number of responders (response rate [%]) a p-value is from Fisher's exact test with mid-p correction b 95% confidence interval is corrected Newcombe interval
Maltese: avalur p huwa minn test eżatt ta' Fisher b'korrezzjoni mid-p b intervall ta' kunfidenza ta' 95% huwa intervall ta' Newcombe kkoreġut
English: Treatment with rituximab in combination with methotrexate over multiple courses resulted in sustained improvements in the clinical signs and symptoms of RA, as indicated by ACR, DAS28ESR and EULAR responses which was evident in all patient populations studied (Figure 2).
Maltese: Kura b'rituximab 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 filpopolazzjonijiet kollha ta' pazjenti studjati (Figura 2).
English: In Trial 1, conducted in patients with inadequate response or intolerance to one or more TNF inhibitor therapies, receiving rituximab in combination with methotrexate demonstrated significantly less radiographic progression than patients originally receiving methotrexate alone at 56 weeks.
Maltese: Fi Prova 1, imwettaq f'pazjenti b'rispons inadegwat jew intolleranza għal terapija waħda jew aktar ta' inibizzjoni ta' TNF, li kienu qed jirċievu rituximab flimkien ma' methotrexate kienet murija progressjoni radjugrafika sinifikattivament anqas mill-pazjenti li oriġinarjament irċevew methotrexate waħdu wara 56 ġimgħa.
English: Table 8 Induction phase: overview of efficacy results for CHOP vs. R-CHOP (31 months median observation time) CHOP
Maltese: Tabella 8 Fażi ta' induzzjoni: deskrizzjoni ġenerali tar-riżultati tal-effikaċja għal CHOP vs.
English: % HAQ‐DI MCID Mean change in FACIT‐T
Maltese: HAQ-DI MCID% Bidla medja f'FACIT-T
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 tal immunoglobulina, IgG, IgM jew IgA.
English: Unopened vial 4 years
Maltese: Kunjett mhux miftuħ 4 snin
English: Mean change in SF‐36 PHS
Maltese: Bidla medja f'SF-36
English: Very rare cases of fatal progressive multifocal leukoencephalopathy (PML) have been reported following use of rituximab for the treatment of rheumatoid arthritis and autoimmune diseases including Systemic Lupus Erythematosus (SLE) and vasculitis.
Maltese: Wara l-użu ta' rituximab għall-kura ta' artrite rewmatika u mard awtoimmuni inkluż Lupus Eritematosus Sistemika (SLE) u vaskulite kienu irrappurtati każijiet rari ħafna ta' lewkoenċefalopatija multifokali progressiva (PML) fatali.
English: In CLL, the overall incidence of grade 3 or 4 nervous system disorders was low both in the first-line study (4% R-FC, 4% FC) and in the relapsed/refractory study (3% R-FC, 3% FC).
Maltese: F'CLL, l-inċidenza globali ta' disturbi fis-sistema nervuża ta' grad 3 jew 4 kienet baxxa kemm fl-istudju primarju (4% R-FC, 4% FC) kif ukoll fl-istudju dwar CLL li reġgħet tfaċċat/refrattarja (3% R-FC, 3% FC).
English: The incidence of serious infections was similar in both arms (approximately 12%).
Maltese: L-inċidenza ta' infezzjonijiet serji kienet simili fiż-żewġ gruppi (madwar 12%).
English: In addition to adverse reactions seen in RA clinical trials for rituximab, 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 rituximab, waqt l-esperjenza ta' wara t-tqegħid fis-suq kienu rrapportati lewkoenċefalopatija multifokali progressiva (PML) (ara sezzjoni 4.4) u reazzjoni li tixbaħ lill-marda tas-serum.
English: Exacerbations of pre-existing cardiac conditions such as angina pectoris or congestive heart failure or severe cardiac disorders (heart failure, myocardial infarction, atrial fibrillation), pulmonary oedema, multi-organ failure, tumour lysis syndrome, cytokine release syndrome, renal failure, and respiratory failure were reported at lower or unknown frequencies.
Maltese: Rkadar ta' kondizzjonijiet kardijaċi eżistenti minn qabel bħal anġina pectoris jew insuffiċjenza tal-qalb konġestiva jew disturbi kardijaċi severi (insuffiċjenza tal qalb, infart mijokardijaku, fibrillazzjoni atrijali), edima pulmonari, insuffiċjenza ta' ħafna organi, sindrome tal-lisi tat-tumur, sindrome tar-reħa ta' cytokine, insuffiċjenza tal-kliewi, u insuffiċjenza respiratorja kienu rrappurtati bi frekwenza aktar baxxa jew bi frekwenza mhux magħrufa.
English: Premedication with intravenous glucocorticoid significantly reduced the incidence and severity of IRRs (see sections 4.2 and 4.4).
Maltese: Medikazzjoni minn qabel b'glukokortikojdi fil-vina naqqset b'mod sinifikanti l-inċidenza u s-severità tal-IRRs (ara sezzjonijiet 4.2 u 4.4).
English: The primary outcome measure was achievement of complete remission at 6 months defined as a Birmingham Vasculitis Activity Score for Wegener's granulomatosis (BVAS/WG) of 0, and off glucocorticoid therapy.
Maltese: Il-kejl tar-riżultat primarju kien il-kisba ta' remissjoni kompluta wara 6 xhur definita bħala Punteġġ tal-Attività tal-Vaskulite ta' Birmingham għal granulomatosi ta' Wegener (BVAS/WG - Birmingham Vasculitis Activity Score for Wegener's granulomatosis) ta' 0, u waqfien tat-terapija bi glukokortikojd.
English: Blood and lymphatic system disorders neutropenia, leucopenia, +febrile neutropenia, +thrombocyto penia anaemia, +pancytopenia, +granulocytope nia coagulation disorders, aplastic anaemia, haemolytic anaemia, lymphadenop athy transient increase in serum IgM levels3
Maltese: +panċitopenija, +granuloċitopeni ja disturbi fil-koagulazzjo ni, anemija aplastika, anemija emolitika, limfadenopatija żieda temporanja fil-livelli ta' IgM fis-serum3
English: Cardiovascular reactions during clinical trials with rituximab monotherapy were reported in 18.8% of patients with the most frequently reported events being hypotension and hypertension.
Maltese: Waqt il-provi kliniċi b'monoterapija b'rituximab, reazzjonijet kardjovaskulari kienu rrappurtati fi 18.8% tal-pazjenti u l-aktar avvenimenti rrappurtati b'mod frekwenti kienu pressjoni baxxa u pressjoni għolja.
English: PK parameters for rituximab were comparable over the two treatment courses.
Maltese: Il-parametri PK għal rituximab kienu komparabbli tul iż-żewġ korsijiet ta' kura.
English: The most frequent reported or observed serious adverse drug reactions were:  IRRs (including cytokine-release syndrome, tumour-lysis syndrome), see section 4.4.
Maltese: • IRRs (inkluż sindrome tar-reħa ta' ċitokina, sindrome tal-lisi tat-tumur), ara sezzjoni 4.4.
English: In the maintenance therapy clinical trial, the incidence of all-grade neutropenia was 0% for rituximab-treated patients vs. 5% for azathioprine treated patients.
Maltese: 0% għall-pazjenti ttrattati b'rituximab vs 5% għall-pazjenti ttrattati b'azathioprine.
English: All patients received concomitant 60 mg oral prednisone on days 2-7 and 30 mg on days 8-14 following the first infusion.
Maltese: Il-pazjenti kollha rċevew ukoll 60 mg prednisone orali fi ġranet 2-7 u 30 mg fi ġranet 8-14 wara l-ewwel infużjoni.
English: Prednisone dose tapering and the decision to stop prednisone treatment after month 18 were left at the investigator's discretion.
Maltese: Id-doża ta' prednisone mnaqqsa għax-xejn u d-deċiżjoni biex jitwaqqaf it-trattament bi prednisone wara xahar 18 tħallew għad-diskrezzjoni tal-investigatur.
English: There was no apparent negative impact of the presence of ADA on safety or efficacy in the maintenance therapy clinical trial.
Maltese: Ma kienx hemm impatt negattiv evidenti tal-preżenza ta' ADA fuq is-sigurtà jew l effikaċja fil-prova klinika dwar terapija ta' manteniment.
English: The prepared infusion solution of rituximab in 0.9% sodium chloride solution is physically and chemically stable for 30 days at 2 °C - 8 °C and subsequently 24 hours at room temperature (not more than 30 °C).
Maltese: Is-soluzzjoni għal infużjoni mħejjija ta' rituximab f'soluzzjoni ta' 0.9% sodium chloride hija fiżikament u kimikament stabbli għal 30 ijiem f'temperatura ta' 2 °C - 8°C u sussegwentement għal 24-il siegħa f'temperatura tal-kamra (mhux aktar minn 30
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 rituximab (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 rituximab (ara sezzjoni 4.5).
English: The most frequent ADRs following receipt of rituximab in clinical studies were IRRs (refer to Table 2).
Maltese: Fi studji kliniċi, l-aktar ADRs frekwenti wara t-teħid ta' rituximab kienu IRRs (irreferi għal Tabella 2).
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 rituximab 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' rituximab u fi 17-il pazjent (29%) fil grupp ta' azathioprine (p=0.0007).
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
Maltese: Proporzjonijiet ta' periklu ta' sopravivenza mingħajr progressjoni skont l istadju Binet (ITT) - perjodu medjan ta' osservazzjoni ta' 48.1 xahar Sopravivenza Mingħajr Progressjoni (PFS)
English: Patients with human anti-mouse antibody (HAMA) or anti-drug antibody (ADA) titres may have allergic or hypersensitivity reactions when treated with other diagnostic or therapeutic monoclonal antibodies.
Maltese: Pazjenti b'titres ta' antikorpi umani ta' kontra l-ġrieden (HAMA - human anti-mouse antibody) jew antikorp kontra l-mediċina (ADA - anti-drug antibody) jista' jkollhom reazzjonijiet allerġiċi jew ta' sensittività eċċessiva meta trattati b'antikorpi monoklonali dijanjostiċi jew terapewtiċi oħrajn.
English: EXPIRY DATE
Maltese: Newtropenija ttardjata
English: The rate of overall infections and serious infections was not increased after the development of low IgA, IgG or IgM.
Maltese: infezzjonijiet globali u infezzjonijiet serji ma żdiditx wara l-iżvilupp ta' IgA, IgG jew IgM baxxi.
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 talispazju bejn il-ġogi.
English: • allergic reactions that are most likely to occur during an infusion, but can occur up to 24
Maltese: • reazzjonijiet allerġiċi li huma l-aktar probabbli li jseħħu matul infużjoni, iżda jistgħu jseħħu sa 24 siegħa wara infużjoni
English: Table 4 Adverse drug reactions occurring in ≥ 5% of patients receiving rituximab for maintenance treatment of GPA and MPA, and at a higher frequency than the comparator group
Maltese: Tabella 4 Reazzjonijiet avversi tal-mediċina li seħħew f'≥ 5% tal-pazjenti li rċevew rituximab għal trattament ta' manteniment ta' GPA u MPA, u bi frekwenza ogħla mill-grupp ta' paragun Klassi tas-Sistemi u tal-Organi
English: Ritemvia 100 mg concentrate for solution for infusion
Maltese: Ritemvia 100 mg konċentrat għal soluzzjoni għal infużjoni
English: Rituximab has shown to be highly specific to the CD20 antigen on B cells.
Maltese: Rituximab wera li huwa speċifiku ħafna għall-antiġen CD20 fuq iċ-ċelluli B.
English: OS rates,
Maltese: Rati ta' OS,