FrancophonIA/ELRC3.0 huggingface dataset:
English: Within these 1616 cases, 805 (49.80 %) ADRs involved “skin and subcutaneous tissue disorders” SOC, of which 305 (37.9%) were serious cases including life threatening and fatal cases.
Maltese: SOC “disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda”, li minnhom 305 (37.9%) kienu każi serji li kienu jinkludu każi ta' periklu għall-ħajja u każi fatali.
English: On 20 December 2012 France informed the European Medicines Agency, pursuant to Article 107i of Directive 2001/83/EC, of their consideration to revoke the marketing authorisations for Tetrazepam containing medicines further to the evaluation of data resulting from pharmacovigilance activities.
Maltese: Fl-20 ta' Diċembru 2012, Franza infurmat lill-Aġenzija Ewropea għall-Mediċini, skont l-Artikolu 107i tadDirettiva 2001/83/KE, bil-ħsieb tagħha li tirrevoka l-awtorizzazzjonijiet għat-tqegħid fis-suq għal mediċini li fihom it-tetrażepam wara l-valutazzjoni tad-dejta li ħarġet mill-attivitajiet ta' farmakoviġilanza.
English: Allergic tests were performed in several cases.
Maltese: Saru testijiet għal allerġiji f'diversi każi.
English: A specific analysis about the most relevant serious adverse cutaneous reactions reported by the MAH in relationship of their nature and severity was made in the MAH's response to the PRAC list of questions.
Maltese: Analiżi speċifika dwar l-aktar reazzjonijiet avversi serji tal-ġilda rilevanti rapportata mid-detentur talawtorizzazzjoni għat-tqegħid fis-suq (MAH) fir-rigward tan-natura u s-severità tagħhom saret fit-tweġiba tad-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għal-lista ta' mistoqsijiet tal-PRAC.
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given Ritemvia.
Maltese: Qabel ma tingħata Ritemvia, inti se tingħata mediċini oħra (medikazzjoni ta' qabel) sabiex jiġu evitati jew jitnaqqsu l-effetti sekondarji possibbli.
English: 20 Academy-ro 51 beon-gil Yeonsu-gu, Incheon, 22014, Republic of Korea
Maltese: 20 Academy-ro 51 beon-gil Yeonsu-gu, Incheon, 22014, Repubblika tal-Korea
English: Patients in a severely immunocompromised state.
Maltese: Pazjenti fi stat immunokompromess sever.
English: Block 7, City North Business Campus, Stamullen, Co. Meath K32 YD60, Ireland
Maltese: Block 7, City North Business Campus, Stamullen, Co. Meath K32 YD60, Irlanda
English: Cyclophosphamide Difference (CI 95%)
Maltese: Cyclophosphamide Differenza (CI 95%)
English: 95.1%b CI (−3.2%, 24.3%) a
Maltese: 95.1%b CI (−3.2%, 24.
English: Azathioprine 59 56 52 50 47 47 44 44 42 41 40 39 36 34 0 Rituximab 58 56 56 56 55 54 54 54 54 54 54 54 52 50 0
Maltese: Azathiopri 59 56 52 50 47 47 44 44 42 41 40 39 36 34 0 Rituximab 58 56 56 56 55 54 54 54 54 54 54 54 52 50 0
English: - CI = confidence interval.
Maltese: CI = intervall ta' kunfidenza.
English: Azathioprine 0 0 3 3 5 5 8 8 9 9 9 10 13 15 17 Rituximab 0 0 0 0 1 1 1 1 1 1 1 1 3 3 3 Number of subjects at risk
Maltese: Azathiopri 0 0 3 3 5 5 8 8 9 9 9 10 13 15 17 Rituximab 0 0 0 0 1 1 1 1 1 1 1 1 3 3 3 Numru ta' Individwi f'Riskju
English: Placebo+MTX
Maltese: Plaċebo+MTX
English: Name:_______________________ Doctor's
Maltese: Isem il-Pazjent:_______________________
English: Figure 3:
Maltese: Figura 2:
English: Observation (N = 167)
Maltese: Osservazzjoni (N = 167)
English: Significant difference from placebo at the primary time point: * p < 0.05, **p < 0.001 ***p ≤ 0.0001 MCID HAQ-DI ≥0.22, MCID SF-36 PHS >5.42, MCID SF-36 MHS >6.33
Maltese: Differenza sinifikanti mill-plaċebo fil-punt ta' ħin primarju: * p < 0.05, **p < 0.001, ***p ≤ 0.0001 MCID HAQ-DI ≥ 0.22, MCID SF-36 PHS > 5.42, MCID SF-36 MHS > 6.33
English: p-value a
Maltese: valur p a
English: Rituximab maintenance treatment reduced the risk of death by 56% (95% CI; 22%-75%).
Maltese: Il-kura ta' manteniment b'rituximab naqqset ir-riskju ta' mewt b'56% (CI ta' 95%; 22% - 75%).
English: p-value (Wald test, not
Maltese: valur p (test ta'Wald,
English: 9.32 years
Maltese: 9.32 sena
English:  Infections, see section 4.4.
Maltese: • Infezzjonijiet, ara sezzjoni 4.4.
English: Sodium chloride Tri-sodium citrate dihydrate Polysorbate 80
Maltese: Klorur tas-sodju Tri-sodium citrate dihydrate Polisorbat 80
English: Treatment difference (Rituximab --cyclophosphamide)
Maltese: Differenza fil-kura (Rituximab - cyclophosphamide)
English: M39021 CVP, 159 R-CVP, 162 53
Maltese: CVP, 159 R-CVP, 162
English: Log-Rank p value
Maltese: Log-rank valur p
English: Median TTP:
Maltese: TTP medjan:
English: Primary analysis (median FU: 25 months)
Maltese: Analiżi primarja (FU medjan: 25 xahar)
English: MCP, 96 R-MCP,
Maltese: OSHO-39 MCP, 96 R-MCP, 105
English: 7 includes fatal cases
Maltese: 7 inkluż każijiet fatali
English: Ritemvia contains the active substance “rituximab”.
Maltese: Ritemvia fih is-sustanza attiva “rituximab”.
English: 5 Includes fatal cases
Maltese: 5 Inkluż każijiet fatali
English: Biotec House, Central Park, Western Avenue Bridgend Industrial Estate Bridgend, CF31 3RT, UK
Maltese: Biotec House, Central Park, Western Avenue Bridgend Industrial Estate Bridgend, CF31 3RT, Ir-Renju Unit
English: EULAR Response (%)
Maltese: Rispons EULAR (%)
English: Immunomodulatory medicinal products may increase the risk of malignancy.
Maltese: Il-prodotti mediċinali immunomodulatorji jistgħu jżidu r-riskju ta' tumuri malinni.
English: 95% CI b
Maltese: CI ta' 95%b
English: Psychiatric disorders depression, nervousness,
Maltese: Disturbi psikjatriċi depressjoni, nervi,
English: Median TTF/PFS/ EFS mo
Maltese: TTF/PFS/EFS Medjana Xhur
English: This is usually given every 3 weeks up to 8 times.
Maltese: Din normalment tingħata kull 3 ġimgħat sa 8 darbiet.
English: Herpes virus infection Herpes zoster Oral herpes Conjunctivitis
Maltese: Infezzjoni mill-virus herpes Herpes zoster
English: This is a type of protein called a “monoclonal antibody”.
Maltese: Din hija tip ta' proteina msejħa “antikorp monoklonali”.
English: Table 12 Clinical response outcomes at primary endpoint in Trial 1 (ITT population)
Maltese: Tabella 12 Riżultati tar-rispons kliniku fil-ħin tal-punt finali primarju fi Prova 1 (popolazzjoni ITT)
English: Infusion-related reactions*
Maltese: Reazzjonijiet relatati mal-infużjoni*
English: IgG levels
Maltese: Livelli ta' IgG
English: A total of 321 patients (162 R-CVP, 159 CVP) received therapy and were analysed for efficacy.
Maltese: Total ta' 321 pazjent (162 R-CVP, 159 CVP) irċevew it-terapija u ġew analizzati għall-effikaċja.
English: lung infiltration
Maltese: infiltrati filpulmun
English:  Cardiovascular events, see section 4.4.
Maltese: • Avvenimenti kardjovaskulari, ara sezzjoni 4.4.
English: • mood disorders such as irritability and depression
Maltese: • disturbi fil-burdata bħal irritabilità u depressjoni
English: Bronchitis Rhinitis
Maltese: Bronkite Rinite
English: Investigations decreased IgM levels4
Maltese: Investigazzjonijiet livelli mnaqqsa ta' IgM4
English: Infusion-related reactions in the pemphigus vulgaris clinical study were common (58%).
Maltese: Reazzjonijiet relatati mal-infużjoni fl-istudju kliniku dwar pemphigus vulgaris kienu komuni (58%).
English: Other serious ADRs reported include hepatitis B reactivation and PML (see section 4.4.)
Maltese: ADRs serji oħra irrappurtati jinkludu riattivazzjoni ta' epatite B u PML (ara sezzjoni 4.4.).
English: 48-months p = 0.0096
Maltese: 48-xahar p = 0.0096
English: However, the possible risk for the development of solid tumours cannot be excluded at this time.
Maltese: Iżda, attwalment il-possibbiltà ta' riskju għall-iżvilupp ta' tumuri solidi ma jistax jiġi eskluż.
English: • The active ingredient in Ritemvia is called rituximab.
Maltese: • Is-sustanza attiva fi Ritemvia hija msejħa rituximab.
English: The most frequently reported events were tachycardia (4%) and atrial fibrillation (3%) (see section 4.4).
Maltese: L-aktar avvenimenti rrappurtati b'mod frekwenti kienu takikardija (4%) u fibrillazzjoni tal-atriju (3%) (ara sezzjoni 4.4).
English: +myocardial infarction4 and 6, arrhythmia, +atrial fibrillation, tachycardia, +cardiac
Maltese: +infart mijokardijaku4 u 6, arritmija, +fibrillazjoni atrijali, takikardja, +disturb fil-qalb
English: CHVP-IFN, R-CHVPIFN, 175
Maltese: CHVP-IFN, 183 R-CHVP-IF N,
English: Final analysis (median FU: 9.0 years)
Maltese: (FU medjan: 9.0 snin)
English: * at end of maintenance/observation; final analysis results based on median follow-up of 73 months.
Maltese: * fl-aħħar tal-manteniment/osservazzjoni; riżultati tal-analiżi finali abbażi ta' segwitu medjan ta' 73 xahar.
English: Kaplan-Meier estimated progression-free rates at 12 months were 78% in the rituximab maintenance group vs. 57% in the observation group.
Maltese: Kaplan-Meier -tar-rati ta' nuqqas ta' progressjoni wara 12-il xahar kienu 78% fil-grupp ta' manteniment b'rituximab vs 57% fil-grupp ta' osservazzjoni.
English: Mean change DAS28-ESR ‐1.97** Significance levels were defined as * p<0.05, **p<0.001, ***p<0.0001.
Maltese: Livelli ta' sinifikanza kienu definiti bħala * p< 0.05, **p< 0.001, ***p< 0.0001.
English: Ritemvia is indicated in adults for the following indications:
Maltese: Ritemvia huwa indikat f'adulti għall-indikazzjonijiet li ġejjin:
English: late neutropenia3
Maltese: newtropenija ittardjata3
English: Musculo-skeletal disorders arthralgia / musculoskeletal pain, osteoarthritis, bursitis
Maltese: Disturbi muskolu skeletriċi artralġja / uġigħ muskolu-skeletrali, osteoartrite, bursite
English: Ritemvia is a biosimilar medicinal product.
Maltese: Ritemvia huwa prodott mediċinali bijoloġiku simili.
English: A total of 392/3095 (12.7%) patients with rheumatoid arthritis tested positive for ADA in clinical studies following therapy with rituximab.
Maltese: Total ta' 392/3095 (12.7%) pazjent b'artrite rewmatika kienu pożittivi għal ADA fi studji kliniċi wara terapija b'rituximab.
English: Persistent depressive disorder Major depression Irritability
Maltese: Disturb depressiv persistenti Depressjoni kbira Irritabilità
English: Severe (grade 3/4) neutropenia was reported in 4.2%, anaemia in 1.1% and thrombocytopenia in 1.7% of the patients.
Maltese: Newtropenija severa (grad 3/4) kienet irrappurtata f'4.2%, anemija f'1.1% u tromboċitopenija f'1.7% tal-pazjenti.
English: % SF‐36 PHS MCID
Maltese: PHS SF-36 PHS MCID% Bidla medja f'SF-36
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
Maltese: Barcode 2D li jkollu l-identifikatur uniku inkluż.
English: 18-months p = 0.016
Maltese: 18-xahar p = 0.016
English: A total of 1078 patients responded to induction therapy, of which 1018 were randomised to rituximab maintenance therapy (n=505) or observation (n=513).
Maltese: Total ta' 1,078 pazjent irrispondew għal terapija ta' induzzjoni, li minnhom 1,018 kienu randomised għal terapija ta' manteniment b'rituximab (n = 505) jew għal osservazzjoni (n = 513).
English: Binet stage A Binet stage B Binet stage C CI: Confidence Interval
Maltese: Stadju binet A Stadju binet B Stadju binet Ċ
English: A total of 810 patients (403 R-FC, 407 FC) for the first-line study (Table 10a and Table 10b) and 552 patients (276 R-FC, 276 FC) for the relapsed/refractory study (Table 11) were analysed for efficacy.
Maltese: Total ta' 810 pazjent (403 R-FC, 407 FC) għall-istudju primarju (Tabella 10a u Tabella 10b) u 552 pazjent (276 R-FC, 276 FC) għall-istudju dwar CLL li reġgħet tfaċċat/refrattarja (Tabella 11) kienu analizzati għall-effikaċja.
English: 53-months p=0.029
Maltese: 53-xahar p = 0.029
English: respiratory failure4
Maltese: insuffiċjenza respiratorja4
English: Maintenance treatment
Maltese: Terapija ta' manteniment
English: Rituximab mean clearance and volume of distribution were 0.313 L/day (range, 0.116 to 0.726 L/day) and 4.50 L (range 2.25 to 7.39 L) respectively.
Maltese: It-tneħħija u l-volum ta' distribuzzjoni medji ta' rituximab kienu ta' 0.313 L/jum (firxa, 0.116 sa 0.726 L/jum) u 4.50 L (firxa 2.25 sa 7.39 L) rispettivament.
English: The trial demonstrated non-inferiority of rituximab to cyclophosphamide for complete remission (CR) at 6 months (Table 16).
Maltese: Il-prova wriet nuqqas ta' inferjorità ta' rituximab għal cyclophosphamide għal remissjoni kompluta (CR - complete remission) wara 6 xhur (Tabella 16).
English: Non-oncology indications:
Maltese: Indikazzjonijiet mhux tal-onkoloġija:
English: BATCH NUMBER
Maltese: CHOP NR
English: The incidence, types and severity of IRRs were consistent with that observed historically.
Maltese: L-inċidenza, tipi u severità ta' IRRs kienu konsistenti ma' dak osservat storikament.
English: Clinical experience in granulomatosis with polyangiitis (Wegener's) and microscopic polyangiitis
Maltese: Esperjenza klinika fi granulomatosi b'polianġite (ta' Wegener) u polianġite mikroskopika
English: In the maintenance therapy clinical trial, 30/57 (53%) patients in the rituximab arm experienced infections.
Maltese: Fil-prova klinika dwar terapija ta' manteniment, 30/57 (53%) pazjent fil-grupp ta' rituximab kellhom infezzjonijiet.
English: The overall response rate (ORR) in the intent-to-treat (ITT) population was 48% (CI95% 41% - 56%) with a 6% complete response (CR) and a 42% partial response (PR) rate.
Maltese: Ir-rata ta' rispons ġenerali (ORR) fil-popolazzjoni bl-intenzjoni li tiġi trattata (ITT) kienet ta' 48% (CI95% 41% - 56%) b'rispons komplut (CR) ta' 6% u rata ta' rispons parzjali (PR) ta' 42%.
English: Seronegative (n=106)
Maltese: Seronegattivi (n = 106)
English: R‐CHOP
Maltese: R-CHOP NR
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 4.8).
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: Maintenance infusions of rituximab 500 mg were administered at months 12 and 18.
Maltese: Infużjonijiet ta' manteniment ta' rituximab 500 mg ingħataw fix-xhur 12 u 18.
English: 1 mL contains 10 mg of rituximab.
Maltese: 1 mL fih 10 mg ta' rituximab.
English: This includes rheumatoid arthritis and off-label autoimmune diseases, including Systemic Lupus Erythematosus (SLE) and vasculitis.
Maltese: Dan jinkludi artrite rewmatika u mard awtoimmuni off-label ieħor, inkluż Lupus Eritematosus Sistemika (SLE) u vaskulite.
English: Patients could receive 1000 mg IV at the time of relapse (see section 5.1).
Maltese: 1,000 mg IV fiż-żmien tal-irkadar (ara sezzjoni 5.1).
English: An analysis of overall survival confirmed the significant benefit of rituximab maintenance over observation (p=0.0039 log-rank test).
Maltese: Analiżi tas-sopravivenza globali kkonfermat il-vantaġġ sinifikanti ta' manteniment b'rituximab fuq l-osservazzjoni (p = 0.0039 test logrank).
English: • Warning on the risk of infections and PML, including the symptoms
Maltese: • Twissija dwar ir-riskju ta' infezzjonijiet u PML, inkluż is-sintomi
English: late neutropenia2
Maltese: newtropenija ttardjata2
English: Clinically and statistically significant improvement was also noted on all individual components of the ACR response (tender and swollen joint counts, patient and physician global assessment, disability index scores (HAQ), pain assessment and C-Reactive Proteins (mg/dL).
Maltese: Titjib klinikament u statistikament sinifikanti ġie nnotat ukoll fuq il-komponenti individwali kollha tar-rispons ACR (għadd ta' ġogi sensittivi u minfuħin, evalwazzjoni globali mill-pazjent u t-tabib, punteġġi fuq l-indiċi tad-diżabilità (HAQ), evalwazzjoni tal-uġigħ u Proteini Reattivi għal C (mg/dL).
English: Age, gender and WHO performance status had no effect on the pharmacokinetics of rituximab.
Maltese: Età, sess, u WHO performance status ma kellhom l-ebda effett fuq ilfarmakokinetika ta' rituximab.
English: In patients with rheumatoid arthritis, 283 patients received subsequent therapy with a biologic DMARD following rituximab.
Maltese: F'pazjenti b'artrite rewmatika, 283 pazjent irċevew terapija sussegwenti b'DMARD bijoloġiku wara rituximab.
English: CHOP, 205 R-CHOP,
Maltese: CHOP, 205
English: % SF‐36 MHS MCID † Outcome at 24 weeks
Maltese: MHS SF-36 MHS MCID%
English: Excipients: sodium chloride, tri-sodium citrate dihydrate, polysorbate 80, water for injections.
Maltese: Eċċipjenti: klorur tas-sodju, tri-sodium citrate dihydrate, polisorbat 80, ilma għall-injezzjonijiet.
English: The estimated median terminal elimination half-life of rituximab was 22 days (range, 6.1 to 52 days).
Maltese: Il-medjan tal-half-life tal-eliminazzjoni terminali stmata ta' rituximab kienet 22 ġurnata (firxa, 6.1 sa 52 ġurnata).
English: Herpes zoster Nasopharyngitis
Maltese: Herpes zoster
English: c)
Maltese: PR)
English: 42-months p = 0.029
Maltese: 42-xahar p = 0.029
English: In clinical trials fewer than 1% (17/3189) of patients experienced a serious IRR.
Maltese: Fi provi kliniċi inqas minn 1% (17/3189) tal-pazjenti kellhom IRR serja.
English: Very rare side effects (may affect up to 1 in 10,000 people):
Maltese: Effetti sekondarji rari ħafna (jistgħu jaffettwaw sa persuna waħda minn kull 10,000):
English: Infections were predominately mild to moderate.
Maltese: L-infezzjonijiet b'mod predominanti kienu ħfief sa moderati.
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 10b).
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 (i.e. stadji Binet A-C) (Tabella 10b).
English: PML, reactivation of hepatitis B
Maltese: PML, attivazzjoni mill-ġdid talepatite B
English: Rituximab 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 (RCHOP, R-CVP or R-FCM) and regardless of the quality of response to induction treatment (CR, CRu or PR).
Maltese: Kura ta' manteniment b'rituximab 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: Rarely fatal cases reported 5 signs and symptoms of cranial neuropathy.
Maltese: Każijiet fatali rrappurtati b'mod rari 5 sinjali u sintomi ta' newropatija kranjali.
English: R-CHOP
Maltese: R-FC
English: 38 months
Maltese: 32 sena
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 rituximab 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'rituximab meta mqabbel ma' < 1% fuq osservazzjoni.
English: Influenza-like illness Oedema peripheral
Maltese: Marda tixbah lill-influwenza Edima periferali
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: Pharmacotherapeutic group: antineoplastic agents, monoclonal antibodies, ATC code: L01XC02.
Maltese: Kategorija farmakoterapewtika: sustanzi antineoplastiċi, antikorpi monoklonali, kodiċi ATC:
English: The two adverse events that were reported were flu-like symptoms, with a dose of 1.8 g of rituximab and fatal respiratory failure, with a dose of 2 g of rituximab.
Maltese: Iż-żewġ avvenimenti avversi li ġew irrappurtati kienu sintomi li jixbħu lill-influwenza, b'doża ta' 1.8 g ta' rituximab, u insuffiċjenza respiratorja fatali, b'doża ta' 2 g ta' rituximab.
English: Observation N=513
Maltese: Osservazzjoni Rituximab N=513
English: • Detailed information on the risk of infections and PML
Maltese: • Informazzjoni dettaljata dwar ir-riskju ta' infezzjonijiet u PML
English: Non-Hodgkin's lymphoma (NHL)
Maltese: Limfoma mhux ta' Hodgkin (NHL)
English: Similarly, a good to moderate European League Against Rheumatism (EULAR) response was achieved by significantly more rituximab treated patients treated with rituximab and methotrexate compared to patients treated with methotrexate alone (Table 12).
Maltese: B'mod simili, rispons European League Against Rheumatism (EULAR) tajjeb sa moderat ġie miksub minn ammont sinifikattivament akbar ta' pazjenti kkurati b'rituximab ikkurati b'rituximab u methotrexate meta mqabbel mal-pazjenti kkurati b'methotrexate waħdu (Tabella 12).
English: The ORR was 57% (95% Confidence interval (CI); 41% - 73%; CR 14%, PR 43%) with a projected median TTP for responding patients of 19.4 months (range 5.3 to 38.9 months).
Maltese: L-ORR kienet ta' 57% (Intervall ta' kunfidenza (CI) ta' 95%; 41% - 73%; CR 14%, RP 43%) TTP medjan ipproġettat għal pazjenti li rrispondew ta' 19.4 xhur (firxa minn 5.3 sa 38.9 xhur).
English: Rituximab induces B-cell depletion in about 70-80% of patients, but was associated with decreased serum immunoglobulins only in a minority of patients.
Maltese: Rituximab jikkaġuna tnaqqis taċ-ċellula B f'madwar 70-80% tal-pazjenti, iżda kien assoċjat ma' tnaqqis fl-immunoglobulini fis-serum bissf'minoranza ta' pazjenti.
English: Rituximab binds specifically to the transmembrane antigen, CD20, a non-glycosylated phosphoprotein, located on pre-B and mature B lymphocytes.
Maltese: Rituximab jintrabat speċifikament mal-antiġen trasmembran, CD20, fosfoproteina mhux glikosilat, li jinsab fuqlimfoċiti pre-B u B maturi.
English: Symptoms of infusion-related reactions were similar in type and severity to those seen in RA and GPA/MPA patients.
Maltese: Is-sintomi ta' reazzjonijiet relatati mal-infużjoni kienu simili fit-tip u fis-severità għal dawk osservati f'pazjenti b'RA u GPA/MPA.
English: Other symptoms included flushing, angioedema, bronchospasm, vomiting, nausea, urticaria/rash, fatigue, headache, throat irritation, rhinitis, pruritus, pain, tachycardia, hypertension, hypotension, dyspnoea, dyspepsia, asthenia and features of tumour lysis syndrome.
Maltese: Sintomi oħra inkludew fwawar, angjoedima, bronkospażmu, rimettar, tqalligħ, urtikarja/raxx, għeja, uġigħ ta' ras, irritazzjoni fil-griżmejn, rinite, ħakk, uġigħ, takikardja, pressjoni għolja, pressjoni baxxa, qtugħ ta' nifs, dispepsja, astenja u karatteristiċi tas-sindrome tal-lisi tat-tumur.
English: R-CVP led to a significant benefit over CVP for the primary endpoint, time to treatment failure (27 months vs. 6.6 months, p < 0.0001, log-rank test).
Maltese: R-CVP wassal għal benefiċcju sinifikanti fuq CVP għall-punt finaliprimarju, iżżmien sal-falliment tal-kura (27 xahar vs. 6.6 xhur, p < 0.0001, test log-rank).
English: In the clinical trial on induction of remission, cardiac events occurred at a rate of approximately 273 per 100 patient years (95% CI 149-470) at the 6-month primary endpoint.
Maltese: Fil-prova klinika dwar l-induzzjoni ta' remissjoni, avvenimenti tal-qalb seħħew b'rata ta' madwar 273 għal kull 100 sena ta' pazjent (CI ta' 95% 149-470) fil-punt finali primarju ta' 6 xhur.
English: Data from extended follow-up of patients in the study (median follow-up 9 years) confirmed the longterm benefit of rituximab 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'rituximab f'termini ta' PFS, EFS, TNLT u TNCT (Tabella 7).
English: In placebo-controlled periods of clinical trials, 0.94% (13/1382) of rituximab treated patients and 0.27% (2/731) of placebo-treated patients developed severe neutropenia.
Maltese: F'perijodi kkontrollati bil-plaċebo tal-provi kliniċi, 0.94% (13/1382) tal-pazjenti kkurati b'rituximab u 0.27% (2/731) tal-pazjenti ttrattati bil-plaċebo żviluppaw newtropenija severa.