FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 197 patients aged 15 years or older with severely, active granulomatosis with polyangiitis (75%) and microscopic polyangiitis (24%) were enrolled and treated in an active-comparator, randomised, double-blind, multicenter, non-inferiority trial.
Maltese: Total ta' 197 pazjent b'età minn 15-il sena 'l fuq bi granulomatosi b'polianġite attiva severa (75%) u polianġite mikroskopika (24%) kienu rreġistrati u kkurati fi prova b'paragun attiv, randomised,
English: Cases of grade 3 or 4 arrhythmia (including ventricular and supraventricular tachycardia) and angina pectoris during infusion were reported.
Maltese: Kienu rrappurtati każijiet ta' arritmija ta' grad 3 jew 4 (inkluż takikardija ventrikulari u supraventrikulari) u anġina pectoris waqt l-infużjoni.
English: During rituximab 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'rituximab sa sentejn, lewkopenija (5% vs 2%, grad 3/4) u newtropenija (10%
English: CHOP R-CHOP
Maltese: R-CHOP NR
English: 48-months p=0.0096
Maltese: 48-xahar p = 0.009
English: Serious infections, including fatalities, can occur during therapy with rituximab (see section 4.8).
Maltese: Infezzjonijiet serji, fosthom fatalitajiet, jistgħu jseħħu waqt terapija b'rituximab (ara sezzjoni 4.8).
English: • multiple-organ failure.
Maltese: • insuffiċjenza ta' ħafna organi.
English: The incidence of thrombocytopenia was low (< 1%, grade 3/4) and was not different between treatment arms.
Maltese: tromboċitopenija kienet baxxa (< 1%, grad 3/4) u ma kinitx differenti bejn il-gruppi ta' kura.
English: Subsequent doses of Rixathon can be infused at an initial rate of 100 mg/h, and increased by 100 mg/h increments at 30 minute intervals, to a maximum of 400 mg/h.
Maltese: Dożi sussegwenti ta' Rixathon jistgħu jiġu infużi b'rata inizjali ta' 100 mg/siegħa, u miżjuda b'żidiet ta' 100 mg/siegħa f'intervalli ta' 30 minuta, sa massimu ta' 400 mg/siegħa.
English: Progression-free survival (PFS) Overall survival
Maltese: Sopravivenza mingħajr progressjoni (PFS) Sopravivenza globali
English: Symptoms of infusion-related reactions were similar in type and severity to those seen in RA and GPA/MPA patients.
Maltese: reazzjonijiet relatati mal-infużjoni kienu simili fit-tip u fis-severità għal dawk osservati f'pazjenti b'RA u GPA/MPA.
English: NA NA NA
Maltese: Uġigħ ta' ras
English: In patients with rheumatoid arthritis, granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis in disease remission or pemphigus vulgaris, premedication with 100 mg intravenous methylprednisolone should be completed 30 minutes prior to Rixathon infusions to decrease the incidence and severity of infusion related reactions (IRRs).
Maltese: F'pazjenti b'artrite rewmatika, granulomatosi b'polianġite (ta' Wegener) jew polianġite mikroskopika f'remissjoni tal-marda jew pemphigus vulgaris, medikazzjoni minn qabel b'100 mg methylprednisolone fil-vini għandha tiġi kompluta 30 minuta qabel infużjonijiet ta' Rixathon biex titnaqqas l-inċidenza u s-severità ta' reazzjonijiet relatati mal-infuzjoni (IRRs - infusion related reactions).
English: Mean change in SF-36 PHS
Maltese: Bidla medja f'SF-36
English: The 10 mL vial contains 100 mg of rituximab (10 mg/mL).
Maltese: Il-kunjett ta' 10 mL fih 100 mg ta' rituximab (10 mg/mL).
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,
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/m2,
English: The safety information collected during post marketing experience reflects the expected adverse reaction profile as seen in clinical trials for rituximab (see section 4.4).
Maltese: L-informazzjoni ta' sigurtà miġbura matul l-esperjenza ta' wara t-tqegħid fis-suq tirrifletti l profil ta' reazzjonijiet avversi mistenni kif deher fi provi kliniċi ta' rituximab (ara sezzjoni 4.4).
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,
English: 1 Frequency category derived from laboratory values collected as part of routine laboratory monitoring in clinical trials
Maltese: 1 Kategorija ta' frekwenza derivata minn valuri tal-laboratorju miġbura bħala parti minn sorveljanza ta' rutina tallaboratorju fi provi kliniċi
English: % HAQ-DI MCID Mean change in FACIT-T
Maltese: Bidla medja f'HAQ-DI HAQ-DI MCID% Bidla medja f'FACIT-T
English: Kaplan-Meier estimate of median time to event (months)
Maltese: Stima Kaplan-Meier tal-Perjodu Medjan sa Avveniment (xhur)
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and very rare (< 1/10,000).
Maltese: Il-frekwenzi huma definiti bħala komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000
English: • producing more tears, tear duct problems, inflamed eye (conjunctivitis)
Maltese: • tipproduċi aktar dmugħ, problemi fil-kanali tad-dmugħ, għajn infjammata (konġuntivite)
English: Hepatitis-B reactivation
Maltese: Infezzjonijiet tal-epatite B
English: Bacterial infections, viral infections, +bronchitis
Maltese: Infezzjonijiet mill-batterja, infezzjonijiet mill-virus, +bronkite
English: In the maintenance therapy clinical trial, the incidence of all-grade neutropenia was 0% for rituximabtreated patients vs 5% for azathioprine treated patients.
Maltese: Fil-prova klinika dwar terapija ta' manteniment, l-inċidenza ta' newtropenija ta' kull grad kienet ta' 0% għall-pazjenti ttrattati b'rituximab vs 5% għall-pazjenti ttrattati b'azathioprine.
English: • After aseptic dilution in glucose solution:
Maltese: • Wara dilwizzjoni asettika f'soluzzjoni ta' glucose:
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: 48% (CI95% 41% - 56%) b'rispons komplut (CR) ta' 6% u rata ta' rispons parzjali (PR) ta' 42%.
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,
English: vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 15) every 3 weeks for 8 cycles or rituximab 375 mg/m2 in combination with CVP (R-CVP).
Maltese: vincristine 1.4 mg/m2 sa massimu ta' 2 mg fl-ewwel jum, u prednisolone 40 mg/m2/jum mill-ewwel sal-ħames jum) kull 3 ġimgħat għal 8 ċikli jew rituximab 375 mg/m2 flimkien ma' CVP (R-CVP).
English: +Left ventricular failure, +supraventri cular tachycardia, +ventricular tachycardia, +angina, +myocardial ischaemia, bradycardia
Maltese: +Insuffiċjenza ventrikulari tax-xellug, +takikardja supraventriku lari, +takikardja ventrikulari,
English: Infusion-related reactions2
Maltese: Reazzjonijiet relatati mal-infużjoni2
English: Aseptically withdraw the necessary amount of Rixathon, 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' Rixathon, 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: Of the ninety nine patients treated with rituximab, 12 (12%) experienced at least one IRR.
Maltese: Mid-99 pazjent kkurati b'rituximab, 12 (12%) kellhom mill-inqas IRR wieħed.
English: Follicular lymphoma
Maltese: Limfoma follikulari Monoterapija
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 jew virusis) seħħew f'madwar 30-55% tal-pazjenti waqt provi kliniċi f'pazjenti b'NHL u f'30-50% tal-pazjenti waqt provi kliniċi f'pazjenti b'CLL.
English: Ninety-nine patients were treated for induction of remission of GPA and MPA in a clinical trial with rituximab (375 mg/m2, once weekly for 4 weeks) and glucocorticoids (see section 5.1).
Maltese: Disgħa u disgħin pazjent kienu ttrattati għall-induzzjoni ta' remissjoni ta' GPA u MPA fi prova klinika b'rituximab (375 mg/m2, darba fil-ġimgħa għal 4 ġimgħat) u glukokortikojdi (ara sezzjoni 5.1).
English: Bronchitis Rhinitis
Maltese: Tnaqqis tarRiskju
English: Heart failure4and 6
Maltese: Insuffiċjenza tal-qalb4 u 6
English: Urinary tract infection Bronchitis
Maltese: Infezzjonijiet u infestazzjonijiet Bronkite
English: 1 vial contains 10 mg/mL rituximab.
Maltese: Kunjett wieħed fih 10 mg/mL ta' rituximab.
English: Examples of these serious viral infections are infections caused by the herpes viruses (Cytomegalovirus, Varicella Zoster Virus and Herpes Simplex Virus), JC virus (progressive multifocal leukoencephalopathy [PML]) and hepatitis C virus.
Maltese: Virus tal-Herpes Simplex), virus JC (lewkoenċefalopatija multifokali progressiva [PML]) u virus talepatite Ċ.
English: The alert card contains important safety information for patients regarding potential increased risk of infections, including progressive multifocal leukoencephalopathy (PML).
Maltese: Il-kartuna ta' twissija fiha tagħrif importanti dwar is-sigurtà għall-pazjenti dwar il-potenzjal ta' riskju akbar ta' infezzjonijiet, inkluż lewkoenċefalopatija multifokali progressiva (PML).
English: Rixathon 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: Rixathon 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: 150 patients originally randomised to placebo + MTX in Trial 1 received at least one course of RTX + MTX by one year * p < 0.05, ** p < 0.001.
Maltese: 150 pazjent oriġinarjament randomised għal plaċebo + MTX fi Prova 1 irċevew tal-inqas kors wieħed ta' RTX + MTX wara sena *p < 0.05, **p < 0.001. Abbrevjazzjoni:
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: Vasculitis Activity Score for Wegener's granulomatosis) ta' 0, u waqfien tat-terapija bi glukokortikojd.
English: 10.49 years
Maltese: 49 sena
English: Rixathon is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
Maltese: Pemphigus vulgaris Rixathon huwa indikat għat-trattament ta' pazjenti b'pemphigus vulgaris (PV) moderat sa sever.
English: In the PV population, 5 (13%) patients in the rituximab group and 3 (8%) patients in the standard prednisone group had moderate disease and 33 (87%) patients in the rituximab group and 33 (92%) patients in the standard-dose prednisone group had severe disease according to disease severity defined by Harman's criteria.
Maltese: pazjenti fil-grupp ta' rituximab u 3 (8%) pazjenti fil-grupp ta' prednisone standard kellhom marda moderata u 33 (87%) pazjent fil-grupp ta' rituximab u 33 (92%) pazjent fil-grupp b'doża standard ta' prednisone kellhom marda severa skont is-severità tal-marda ddefinita mill-kriterji ta' Harman.
English: b) Chronic lymphocytic leukaemia
Maltese: b) Lewkimja limfoċitika kronika
English: In the clinical trial evaluating rituximab 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 rituximab groups.
Maltese: Fil-prova klinika li vvalutat kura ta' manteniment b'rituximab 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' rituximab.
English: p < 0.0001
Maltese: Ma ntlaħaqx p < 0.0001
English: Median EFS: 36 Not reached p < 0.0001
Maltese: TTP medjan: P< 0.0001
English: Severe cardiac disorders 4 and
Maltese: Disturbi kardijaċi severi4 u 6
English: Figure 4: Number of patients who were off or on minimal corticosteroid (≤10mg/day) therapy over time
Maltese: Figura 4: Numru ta' pazjenti li kienu mingħajr terapija b'kortikosterojdi jew fuq terapija minima ta' kortikosterojdi (≤10mg/jum) maż-żmien
English: Among the 3189 patients treated with rituximab, 1,135 (36%) experienced at least one IRR with 733/3,189 (23%) of patients experiencing an IRR following first infusion of the first exposure to rituximab.
Maltese: Fost 3189 pazjent kkurat b'rituximab, 1135 (36%) kellhom esperjenza ta' mill-inqas IRR waħda b'733/3189 (23%) tal-pazjenti li kellhom IRR wara l-ewwel infużjoni tal-ewwel esponiment għal rituximab.
English: Following two intravenous infusions of rituximab at a dose of 1,000 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 taddistribuzzjoni fi stat fiss kienet ta' 4.6 L (medda, 1.7 sa 7.51 L).
English: The proportion of patients experiencing an infusionrelated reaction was 29% (11 patients), 40% (15 patients), 13% (5 patients), and 10% (4 patients) following the first, second, third, and fourth infusions, respectively.
Maltese: Il-proporzjon ta' pazjenti li kellhom reazzjoni relatata mal-infużjoni kien ta' 29% (11-il pazjent), 40% (15-il pazjent), 13% (5 pazjenti), u 10% (4 pazjenti) wara l-ewwel, it-tieni, it-tielet, u r-raba' infużjoni, rispettivament.
English: The pharmacokinetics of rituximab were assessed following two intravenous doses of 500 mg and 1,000 mg on days 1 and 15 in four studies.
Maltese: Il-farmakokinetika ta' rituximab kienet evalwata wara żewġ dożi fil-vini (IV) ta' 500 mg u 1000 mg fi Ġranet 1 u 15 f'erba' studji.
English: 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 tal popolazzjoni tal-istess informazzjoni ta' valuri medji simili għat-tneħħija sistemika u l-half-life, 0.26
English: Rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulgaris
Maltese: Artrite rewmatika, granulomatosi b'polianġite, polianġite mikroskopika, u pemphigus vulgaris
English: The estimated median terminal elimination half-life of rituximab was 22 days (range, 6.1 to 52 days).
Maltese: 22 ġurnata (firxa, 6.1 sa 52 ġurnata).
English: In a randomised trial, patients with rheumatoid arthritis treated with rituximab and methotrexate had comparable response rates to tetanus recall antigen (39% vs. 42%), reduced rates to pneumococcal polysaccharide vaccine (43% vs. 82% to at least 2 pneumococcal antibody serotypes), and KLH neoantigen (47% vs. 93%), when given 6 months after rituximab as compared to patients only receiving methotrexate.
Maltese: 42%), u rati mnaqqsa għall-vaċċin ta' polysaccharide pnewmokokkali (43% vs. 82% għal tal-inqas żewġ serotipi ta' antikorpi pnewmokokkali), u KLH neoantigen (47% vs. 93%), meta mogħtija 6 xhur wara rituximab meta mqabbel ma' pazjenti li rċevew methotrexate biss.
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
English: Available data suggest that clinical response is usually achieved within 16 to 24 weeks of an initial treatment course.
Maltese: Id-data disponibbli tissuġġerixxi li r-rispons kliniku normalment jintlaħaq fi żmien 16 - 24 ġimgħa wara kors ta' kura inizjali.
English: In a further clinical study, a total of 57 severe, active GPA and MPA patients in disease remission were treated with rituximab 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'rituximab għall-manteniment tar-remissjoni (ara sezzjoni 5.1).
English: Exploratory analyses of the benefit of maintenance treatment showed a less pronounced effect in elderly patients (> 70 years of age), however sample sizes were small.
Maltese: Analiżi esploratorja tal-benefiċċju ta' kura ta' manteniment wera effett anqas evidenti f'pazjenti anzjani (> 70 sena), madankollu id daqsijiet tal-kampjuni kienu żgħar.
English: Fourteen patients (37%) in the rituximab group experienced treatment-related infections compared to 15 patients (42%) in the standard-dose prednisone group.
Maltese: Erbatax-il pazjent (37%) fil-grupp ta' rituximab kellhom infezzjonijiet relatati mat-trattament meta mqabbla ma' 15-il pazjent (42%) fil-grupp b'doża standard ta' prednisone.
English: • long lasting depression
Maltese: • depressjoni fit-tul
English: Angina pectoris, atrial fibrillation, heart failure, myocardial infarction
Maltese: Anġina pectoris, fibrillazzjoni atrijali,
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, DAS28-ESR 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: Headache
Maltese: uġigħ
English: • you have a severe active infection at the moment
Maltese: • bħalissa għandek infezzjoni attiva severa.
English: migraine, dizziness
Maltese: Korriment, Avvelenament u
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 centre): 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: Interstitial lung disease7
Maltese: Marda talinterstizju talpulmun7
English: This is because in a few cases, Rixathon could cause hepatitis B to become active again, which can be fatal in very rare cases.
Maltese: Rixathon jista' jġiegħel lill-epatite B terġa' ssir attiva, li tista' tkun fatali f'każijiet rari ħafna.
English: How to store Rixathon
Maltese: X'inhu Rixathon
English: Dysgeusia
Maltese: disfaġja,
English: 1 vial of 50 mL 2 vials of 50 mL
Maltese: 500 mg / 50 mL Kunjett ta' 50 mL 2 kunjetti ta' 50 mL
English: Anaphylaxis Tumour lysis syndrome, cytokine release syndrome4, serum sickness
Maltese: Anafilassi Sindrome tallisi tat-tumur, sindrome tarrilaxx taċ ċitokina4,
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%) filgrupp ta' azathioprine (p=0.0007).
English: Rituximab mean clearance and volume of distribution were 0.313 L/day (range, 0.116 - 0.726 L/day) and 4.50 L (range 2.25 - 7.39 L) respectively.
Maltese: L/jum) u 4.50 L (firxa 2.25 sa 7.39 L) rispettivament.
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% talpazjenti laħqu CR wara 18-il xahar.
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 × 109/L u/jew għadd ta' plejtlits < 75 × 109/L, minħabba li l-esperjenza klinika f'din il-popolazzjoni hija limitata.
English: Cases of posterior reversible encephalopathy syndrome (PRES)/reversible posterior leukoencephalopathy syndrome (RPLS) have been reported.
Maltese: Avvenimenti newroloġiċi 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: 50 mL vial: Clear Type I glass vials with butyl rubber stopper containing 500 mg of rituximab in 50 mL.
Maltese: Kunjett ta' 50 mL :Kunjetti tal-ħġieġ ta' Tip I ċari b'tapp tal-lastku butyl li fihom 500 mg ta' rituximab f'50 mL.
English: 4 Includes observations collected as part of routine laboratory monitoring.
Maltese: 4 Inkluż osservazzjonijiet miġbura bħala parti minn sorveljanza ta' rutina tal-laboratorju.
English: Upper respiratory tract infection, urinary tract infections
Maltese: Infezzjoni flapparat respiratorju ta' fuq, infezzjonijiet flapparat urinarju
English: In a prospective, open label, international, multi-centre, phase III trial 1,193 patients with previously untreated advanced follicular lymphoma received induction therapy with R-CHOP (n=881), R-CVP (n=268) or R-FCM (n=44), according to the investigators' choice.
Maltese: (n = 881), R-CPV (n = 268) jew R-FCM (n = 44), skont l-għażla tal-investigaturi.
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).