FrancophonIA/ELRC3.0 huggingface dataset:
English: The study showed statistically significant results of rituximab and low-dose prednisone over standarddose prednisone in achieving CRoff ≥ 2 months at month 24 in PV patients (see Table 18).
Maltese: L-istudju wera riżultati statistikament sinifikanti ta' rituximab u doża baxxa ta' prednisone fuq doża standard ta' prednisone fil-kisba ta' CRoff għal ≥ xahrejn f'xahar 24 f'pazjenti b'PV (ara Tabella 18).
English: Non-Hodgkin's lymphoma and chronic lymphocytic leukaemia
Maltese: L-Esperjenza klinika f'limfoma mhux ta' Hodgkin u f'lewkimja limfoċitika kronika
English: Haematological toxicities
Maltese: GĦAMLA FARMAĊEWTIKA
English: Clinical experience in non-Hodgkin's lymphoma and in chronic lymphocytic leukaemia
Maltese: Esperjenza minn limfoma mhux ta' Hodgkin u lewkimja limfoċitika kronika)
English: The most frequently reported serious infection in the rituximab group was pneumonia at a frequency of 4%.
Maltese: L-aktar infezzjoni serja irrappurtata b'mod frekwenti fil-grupp ta' rituximab kienet pnewmonja bi frekwenza ta' 4%.
English: 4 Includes observations collected as part of routine laboratory monitoring.
Maltese: Inkluż osservazzjonijiet miġbura bħala parti minn sorveljanza ta' rutina tal-laboratorju.
English: EXP
Maltese: PFS
English: In contrast, three patients (1.5%) had cerebrovascular events in the CHOP group, all of which occurred during the follow-up period.
Maltese: B'kuntrast, tliet pazjenti (1.5%) fil-grupp ta' CHOP kellhom avvenimenti ċerebrovaskulari li lkoll seħħew waqt il-perjodu ta' segwitu.
English: The Physician information about Ritemvia should contain the following key elements:
Maltese: Informazzjoni għat-tabib dwar Ritemvia għandha tinkludi l-punti essenzjali li ġejjin:
English: In the clinical trial studying induction of remission with severe active GPA and MPA, IRRs were defined as any adverse event occurring within 24 hours of an infusion and considered to be infusion-related by investigators in the safety population.
Maltese: Fil-prova klinika li studjat l-induzzjoni ta' remissjoni b'GPA u MPA attivi severi, IRRs kienu definiti bħala kwalunkwe avveniment avvers li seħħ fi żmien 24 siegħa wara infużjoni u li huwa meqjus bħala relatat mal-infużjoni mill-investigaturi fil-popolazzjoni ta' sigurtà.
English: Mild or moderate infusion-related reactions (IRRs) (section 4.8) usually respond to a reduction in the rate of infusion.
Maltese: Reazzjonijiet assoċjati mal-infużjoni (IRRs - infusion-related reactions) ħfief jew moderati (sezzjoni 4.8) ġeneralment jirrispondu għal tnaqqis fir-rata tal-infużjoni.
English: The final analysis confirmed that RCHOP treatment was associated with a clinically relevant and statistically significant improvement in the duration of event-free survival (the primary efficacy parameter; where events were death, relapse or progression of lymphoma, or institution of a new anti-lymphoma treatment) (p=0.0001).
Maltese: R-CHOP kienet assoċjata ma' titjib klinikament rilevanti u statistikament sinifikanti fit-tul ta' żmien ta' sopravivenza mingħajr episodji (il-parametru primarju tal-effikaċja; fejn l-episodji kienu l-mewt, l-esperjenza ta' limfoma mill-ġdid jew il-progressjoni tagħha, jew il-bidu ta' kura ġdida kontra l-limfoma) (p = 0.0001).
English: This variability in V1 (27.1% and 19.0%) contributed by the range in BSA (1.53 to 2.32 m2) and concurrent CHOP therapy, respectively, were relatively small.
Maltese: V1 varja mal-erja tas-superfiċje tal-ġisem (BSA) u mat-terapija CHOP. Din il-varjabilità f'V1 (27.1% u 19.0%) ikkontribwita mill-firxa f'BSA (1.53 sa 2.32 m2) u mit-terapija CHOP fl-istess waqt, rispettivament, kienet relattivament żgħira.
English: The prepared infusion solution of rituximab in 5% glucose solution is physically and chemically stable for 24 hours at 2 °C - 8 °C and subsequently 12 hours at room temperature (not more than 30 °C).
Maltese: Is-soluzzjoni għal infużjoni mħejjija ta' rituximab hija fiżikament u kimikament stabbli għal 24 siegħa f'temperatura ta' 2 °C - 8°C u sussegwentement għal 12-il siegħa f'temperatura tal-kamra (mhux aktar minn 30 °C).
English: • Periodic Safety Update Reports
Maltese: • Rapporti perjodiċi aġġornati dwar is-sigurtà
English: • low number of red blood cells (anaemia)
Maltese: • numru baxx ta' ċelluli ħomor tad-demm (anemija)
English: Progression‐free survival (PFS) Overall survival
Maltese: Progressjoni TTF - Żmien sal-Falliment tal-Kura
English: Contraindications for use in non-Hodgkin's lymphoma and chronic lymphocytic leukaemia Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għall-proteini tal-ġrieden, jew għal kwalunkwe wieћed mill-eċċipjenti l-oħra elenkati fis-sezzjoni 6.1.
English: No patients in the rituximab arm had fatal adverse events.
Maltese: L-ebda pazjent filgrupp ta' rituximab ma kellu avvenimenti avversi fatali.
English: In a prospective, open label, international, multicentre, phase III trial, 465 patients with relapsed/refractory follicular lymphoma were randomised in a first step to induction therapy with either CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone; n=231) or rituximab plus CHOP (R-CHOP, n=234).
Maltese: 465 pazjent b'limfoma follikulari li reġgħet tfaċċat/refrattarja ntgħażlu b'mod każwali fl-ewwel pass għal terapija ta' induzzjoni b'CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone;
English: Overall response rate* chi-squared test p value odds ratio (95% CI)
Maltese: It-test statistiku “primarju” għar-“rispons” kien it-test tat-tendenza ta' CR kontra PR kontra l-ebda rispons (p < 0.0001)
English: All patients treated with rituximab for rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris must be given the patient alert card with each infusion.
Maltese: Il-pazjenti kollha kkurati bi rituximab għall-artrite rewmatika, granulomatosi b'polianġite, polianġite mikroskopika jew pemphigus vulgaris għandhom jingħataw kartuna ta' twissija tal-pazjent ma' kull infużjoni.
English: Patients received 2 x 1000 mg intravenous infusions of rituximab or placebo in combination with MTX.
Maltese: Il-pazjenti rċevew 2 x 1,000 mg infużjonijiet fil-vini ta' rituximab jew plaċebo flimkien ma' MTX.
English: Pregnancy
Maltese: infużjoni
English: Diffuse large B cell non-Hodgkin's lymphoma
Maltese: Limfoma mhux ta' Hodgkin taċ-ċellula B kbira mxerrda
English: • you are allergic to rituximab, other proteins which are like rituximab, or any of the other ingredients of this medicine (listed in section 6)
Maltese: • inti allerġiku għal rituximab, proteini oħrajn li huma simili għal rituximab, jew għal xi ingredjenti oħra ta' din il-mediċina (imniżżla f'taqsima 6)
English: Ritemvia contains sodium
Maltese: Id-dehra ta' Ritemvia u l-kontenuti tal-pakkett
English: log-rank p value hazard ratio (95% CI) risk reduction
Maltese: valur p log-rank proporzjon ta' periklu (CI ta' 95%) tnaqqis tar-riskju
English: The most commonly reported events considered as ADRs were infusion-related reactions and infections.
Maltese: L-avvenimenti rrappurtati bl-aktar mod komuni meqjusa bħala ADRs kienu reazzjonijiet relatati malinfużjoni u infezzjonijiet.
English: Patients treated with rituximab in combination with methotrexate had a significantly greater reduction in disease activity score (DAS28) than patients treated with methotrexate alone (Table 12).
Maltese: Il-pazjenti kkurati b'rituximab flimkien ma' methotrexate kellhom tnaqqis sinifikanti akbar fil-punteġġ tal-attività tal-marda (DAS28) mill-pazjenti kkurati b'methotrexate waħdu (Tabella 12).
English: Cytokine release syndrome may be clinically indistinguishable from acute hypersensitivity reactions.
Maltese: Sindrome tar-reħa ta' ċitokina jista' ma jingħarafx klinikament minn reazzjonijiet akuti ta' sensittività eċċessiva.
English: This syndrome may be associated with some features of tumour lysis syndrome such as hyperuricaemia, hyperkalaemia, hypocalcaemia, hyperphosphataemia, acute renal failure, elevated lactate dehydrogenase (LDH) and may be associated with acute respiratory failure and death.
Maltese: iperkalimja, ipokalċimja, iperfosfatimja, insuffiċjenza akuta tal-kliewi, lactate dehydrogenase (LDH) elevat u tista' tkun assoċjata ma' kollass respiratorju akut u mewt.
English: Skin and subcutaneous tissue disorders alopecia toxic epidermal necrolysis (Lyell's syndrome), StevensJohnson syndrome5
Maltese: sindrome ta' Stevens-Joh nson, nekrolisi tossika talepidermi de (sindrome ta' Lyell)7
English: The median PFS was 42.2 months in the rituximab maintenance arm compared to 14.3 months in the observation arm.
Maltese: Il-PFS medjana kienet ta' 42.2 xhur fil-grupp ta' manteniment b'rituximab, ipparagunat ma' 14.3 xhur fil-grupp ta' osservazzjoni.
English: Oktal Pharma d.o.o.
Maltese: Dan il-prodott mediċinali fih is-sodium.
English: • you have severe heart failure or severe uncontrolled heart disease and have granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris.
Maltese: • għandek insuffiċjenza severa tal-qalb jew marda severa tal-qalb mhux ikkontrollata u għandek granulomatosi b'polianġite, polianġite mikroskopika jew pemphigus vulgaris.
English: Patients were randomised in a 1:1 ratio to receive either oral cyclophosphamide daily (2 mg/kg/day) for 3-6 months or rituximab (375 mg/m2) once weekly for 4 weeks.
Maltese: Il-pazjenti kienu randomised fi proporzjon ta' 1:1 biex jirċievu cyclophosphamide orali kuljum (2 mg/kg/jum) għal 3-6 xhur jew rituximab (375 mg/m2) darba fil-ġimgħa għal 4 ġimgħat.
English: Non-Hodgkin's lymphoma
Maltese: Limfoma mhux ta' Hodgkin
English: This is equivalent to 2.6% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 2,6% tal-ammont massimu rakkomandat ta' sodium li ghandu jittieħed kuljum mad-dieta minn adult.
English: Nervous system disorders headache paraesthesia, migraine, dizziness, sciatica
Maltese: Disturbi fis sistema nervuża parestesija, ipoestesija,
English: The antibody is produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures.
Maltese: L-antikorp huwa magħmul permezz ta' koltura ta' suspensjoni ta' ċelluli mammiferi (ovarju talħamster Ċiniż) u ppurifikat bi kromatografija tal-affinità u skambju tal-jone, inkluża l-inattivazzjoni virali speċifika u proċeduri tat-tneħħija.
English: Investigation s decreased
Maltese: Investigazzjoni jiet livelli mnaqqsa ta' IgG
English: The antigen is expressed on > 95% of all B cell non-Hodgkin's lymphomas.
Maltese: L-antiġen huwa espress fuq > 95% tal-limfomi mhux ta' Hodgkin taċ-ċellula B.
English: Rituximab was administered as an intravenous infusion at a first-cycle dose of 375 mg/m2 increased to 500 mg/m2 each cycle for 5 doses in combination with fludarabine and cyclophosphamide in CLL patients.
Maltese: Rituximab ingħata bħala infużjoni fil-vini b'doża tal-ewwel ċiklu ta' 375 mg/m2 b'żieda għal 500 mg/m2 kull ċiklu għal 5 dożi flimkien ma' fludarabine u cyclophosphamide f'pazjenti b'CLL.
English: Figure 4: Number of patients who were off or minimal corticosteroid (≤ 10mg/day) therapy over time
Maltese: Numru ta' pazjenti li kienu mingħajr terapija b'kortikosterojdi jew fuq terapija minima ta' kortikosterojdi (≤10mg/jum) maż-żmien
English: Decreased haemoglobin
Maltese: Tumuri malinni
English: The incidence of infusion-related symptoms decreased substantially with subsequent infusions and is < 1% of patients by the eighth cycle of rituximab-containing treatment.
Maltese: L-inċidenza ta' sintomi relatati mal-infużjoni naqset b'mod sostanzjali b'infuzjonijiet sussegwenti u hija < 1% talpazjenti mat-tmien ċiklu ta' kura li tinkludi rituximab.
English: It is recommended that immunoglobulin levels are determined prior to initiating treatment with rituximab.
Maltese: Huwa rakkomandat li l-livelli ta' immunoglobulina jiġu determinati qabel ma tinbeda l-kura bi rituximab.
English: The percentage of patients reporting ADRs upon re-treatment with further courses of rituximab was similar to the percentage of patients reporting ADRs upon initial exposure (any grade and grade 3/4 ADRs).
Maltese: Il-perċentwal ta' pazjenti li rrappurtaw ADRs wara kura mill-ġdid b'aktar korsijiet ta' rituximab kien simili għall-perċentwal ta' pazjenti li rrappurtaw ADRs wara li kienu esposti fil-bidu (kwalunkwe grad u ADRs ta' grad 3/4).
English: The overall incidence of IRRs in clinical trials was 23% with the first infusion and decreased with subsequent infusions.
Maltese: Fi provi kliniċi l-inċidenza globali ta' IRRs kienet ta' 23% bl-ewwel infużjoni u naqset b'infużjonijiet sussegwenti.
English: • feeling dizzy
Maltese: • uġigħ fiż-żaqq
English: Progression-free survival (PFS) Overall survival
Maltese: (PFS) Sopravivenza globali
English: Neutropenia can occur several months after the administration of rituximab (see section 4.4).
Maltese: Newtropenija tista' sseħħ diversi xhur wara l-għoti ta' rituximab (ara sezzjoni 4.4).
English: • What to do if you think you might be getting an infection.
Maltese: • qatt kellek jew jista' jkun li għandek infezzjoni tal-epatite.
English: The efficacy and safety of rituximab in alleviating the symptoms and signs of rheumatoid arthritis in patients with an inadequate response to TNF-inhibitors was demonstrated in a pivotal randomised, controlled, double-blind, multicentre trial (Trial 1).
Maltese: L-effikaċja u s-sigurtà ta' rituximab fis-solliev tas-sintomi u s-sinjali tal-artrite rewmatika f'pazjenti b'rispons mhux adegwat għall-inibituri ta' TNF ġew murija fi prova pivitali randomised, ikkontrollata, double-blind, b'aktar minn ċentru wieħed (Prova 1).
English: This medicine contains 52.6 mg sodium (main component of cooking/table salt) in each 10 mL vial.
Maltese: Din il-mediċina fiha 52,6 mg sodium (il-komponent prinċipali tal-melħ tat-tisjir / li jintuża mal-ikel) f'kull kunjett ta '10 mL.
English: Gastrointesti nal disorders nausea vomiting , diarrhoea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation abdominal enlargement gastro-intestin al perforation7
Maltese: stomatite, stitikezza, dispepsja, anoressija, irritazzjoni fil griżmejn tkabbir taladdome perforazzjoni gastro-intest inali7
English: Fatigue Pyrexia
Maltese: gastro-enterite, tinea pedis
English: Patient's
Maltese: KLINIKU
English: Table 2 Summary of adverse drug reactions reported in clinical trials or during post-marketing surveillance occurring in patients with rheumatoid arthritis receiving rituximab
Maltese: Tabella 2 Sommarju ta' reazzjonijiet avversi tal-mediċina rrappurtati fi provi kliniċi jew waqt sorveljanza ta' wara t-tqegħid fis-suq li seħħew f'pazjenti b'artrite rewmatika li kienu qed jirċievu rituximab
English: Dyspnoea
Maltese: ipokalċimja
English: N/A N/A
Maltese: 3%) a
English: At Week 24, patients who were seropositive to RF and/or anti-CCP at baseline had a significantly increased probability of achieving ACR20 and 50 responses compared to seronegative patients (p=0.0312 and p=0.0096) (Table 15).
Maltese: F'Ġimgħa 24, pazjenti li kienu seropożittivi għal RF u/jew għall-anti-CCP fil-linja bażi kellhom probabbiltà akbar b'mod sinifikanti li jilħqu rispons ACR20 u 50 meta mqabbel ma' pazjenti seronegattivi (p = 0.
English: This medicine contains 263.2 mg sodium (main component of cooking/table salt) in each 50 mL vial.
Maltese: Din il-mediċina fiha 263,2 mg sodium (il-komponent prinċipali tal-melħ tat-tisjir / li jintuża mal-ikel) f'kull kunjett ta '50 mL.
English: Ritemvia is used for the treatment of patients with moderate to severe pemphigus vulgaris.
Maltese: Ritemvia jintuża għat-trattament ta' pazjenti b'pemphigus vulgaris moderat sa sever.
English: NAPP Pharmaceuticals Ltd. Tel: +44 1223 424444
Maltese: Tel: +44 1223 424444
English: 10.49 years log-rank p value hazard ratio (95% CI) risk reduction
Maltese: Sopravivenza globali (medjana) valur p log-rank proporzjon ta' periklu (CI ta' 95%) tnaqqis tar-riskju
English: Neutropenia was not associated with an observed increase in serious infection in rituximab-treated patients.
Maltese: In-newtropenija ma kinitx assoċjata ma' żieda osservata ta' infezzjoni serja f'pazjenti kkurati b'rituximab.
English: In patients with granulomatosis with polyangiitis or microscopic polyangiitis, the number of peripheral blood B cells decreased to <10 cells/μL after two weekly infusions of rituximab 375 mg/m2, and remained at that level in most patients up to the 6 month time point.
Maltese: F'pazjenti bi granulomatosi b'polianġite jew polianġite mikroskopika, in-numru ta' ċelluli B fid-demm periferali naqas għal < 10 ċelluli/μL wara infużjonijiet ta' rituximab 375 mg/m2 kull ġimagħtejn u fil-biċca l-kbira tal-pazjenti baqa' f'dan il-livell sa 6 xhur.
English: The safety profile of rituximab in patients with moderate to severe rheumatoid arthritis (RA) is summarised in the sections below.
Maltese: Il-profil ta' sigurtà ta' rituximab f'pazjenti b'artrite rewmatika (RA) moderata sa severa huwa miġbur fil-qosor fis-sezzjonijiet taħt.
English: Infusion-related reactions
Maltese: reazzjonijiet relatati mal-infużjoni
English: log-rank p value hazard ratio (95% CI) risk reduction Overall response rate* chi-squared test p value odds ratio (95% CI)
Maltese: Rata ta' rispons komplut (CR/CRu)* valur p minn test chi-squared proporzjon ta' probbabiltà (CI ta'
English: Clinical laboratory findings
Maltese: Analiżi finali
English: 3infusion-related reactions (hypertension, nausea, rash, pyrexia, pruritus, urticaria, throat irritation, hot flush, hypotension, rhinitis, rigors, tachycardia, fatigue, oropharyngeal pain, peripheral oedema, erythma)
Maltese: raxx, deni, ħakk, urtikarja, irritazzjoni fil griżmejn, fwawar pressjoni baxxa, rinite, tertir, takikardija, għeja,
English: Infusion related reactions
Maltese: Reazzjonijiet relatati mal-infużjoni
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 talkampjuni kienu żgħar.
English: 3 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: Staphylococcus) u pazjent wieħed (3%) fil-grupp b'doża standard ta' prednisone kellu infezzjoni serja (pnewmonja kkawżata minn Pneumocystis jirovecii).
English: IgG immunoglobulins are known to cross the placental barrier.
Maltese: IgG huma magħrufa li jgħaddu mill-barriera tal-plaċenta.
English: How to store Ritemvia
Maltese: X'inhu Ritemvia
English: Psychiatric Disorders
Maltese: Disturbi Psikjatriċi
English: The vial contains 100 mg of rituximab.
Maltese: Kull kunjett fih 100 mg ta' rituximab.
English: Concomitant/sequential use of other DMARDs in rheumatoid arthritis The concomitant use of rituximab and anti-rheumatic therapies other than those specified under the rheumatoid arthritis indication and posology is not recommended.
Maltese: Użu konkomitanti/sekwenzjali ta' DMARDs oħra f'artrite rewmatika L-użu konkomitanti ta' rituximab u terapiji anti-rewmatiċi għajr dawk speċifikati taħt l-indikazzjoni u l-pożoloġija għall-artrite rewmatika mhux rakkomandat.
English: The safety and efficacy of Ritemvia in children below 18 years has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Ritemvia fi tfal taħt 18-il sena ma ġewx stabbiliti.
English: The recommended initial rate for infusion is 50 mg/h; after the first 30 minutes, it can be escalated in 50 mg/h increments every 30 minutes, to a maximum of 400 mg/h.
Maltese: Ir-rata inizjali rakkomandata għall-infużjoni hija ta' 50 mg/siegħa; wara l-ewwel 30 minuta, din tista' tiżdied b'żidiet ta' 50 mg/siegħa kull 30 minuta, sa massimu ta' 400 mg/siegħa.
English: The proportion of CTC Grade 3 events, and of IRRs leading to withdrawal decreased by course and were rare from course 3 onwards.
Maltese: Il-proporzjon ta' avvenimenti ta' CTC ta' Grad 3 u ta' IRRs li wasslu għal waqfien naqsu matul il-korsijiet u kienu rari mit-3 kors 'il quddiem.
English: Reactivation of hepatitis B infection has also been very rarely reported in rheumatoid arthritis patients receiving rituximab (see section 4.4).
Maltese: Attivazzjoni mill-ġdid ta' infezzjoni tal-epatite B kienet irrappurtata wkoll b'mod rari ħafna f'pazjenti b'artrite rewmatika li kienu qed jirċievu rituximab (ara sezzjoni 4.4).
English: Relapsed/Refractory follicular lymphoma
Maltese: Limfoma follikulari li Rkadat/Reġgħet tfaċċat
English: Three cases had no reported adverse event.
Maltese: 3reazzjonijiet relatati mal infużjoni
English: The number of rituximab plus low-dose prednisone patients off prednisone therapy or on minimal therapy (prednisone dose of 10 mg or less per day) compared to standard-dose prednisone patients over the 24-month treatment period shows a steroid-sparing effect of rituximab (Figure 4).
Maltese: In-numru ta' pazjenti li jirċievu rituximab flimkien ma' doża baxxa ta' prednisone mingħajr terapija bi prednisone jew fuq terapija minima (doża ta' prednisone ta' 10 mg jew inqas kuljum) meta mqabbla ma' pazjenti li jirċievu prednisone b'doża standard matul il-perjodu ta' trattament ta' 24 xahar juri effett ta' rituximab li jnaqqas l-użu ta' sterojdi (Figura 4).
English: Patients in the rituximab group who relapsed could receive an additional infusion of rituximab 1000 mg in combination with reintroduced or escalated prednisone dose.
Maltese: Il-pazjenti fil-grupp ta' rituximab li rkadew setgħu jirċievu infużjoni addizzjonali ta' rituximab 1,000 mg flimkien ma' doża ta' prednisone introdotta mill-ġdid jew miżjuda.
English: Seropositive (n=514)
Maltese: (n = 514)
English: Chronic lymphocytic leukaemia
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Table 10a First-line treatment of chronic lymphocytic leukaemia Overview of efficacy results for rituximab plus FC vs. FC alone - 48.1 months median observation time Efficacy Parameter
Maltese: FC waħdu - perjodu medjan ta' osservazzjoni ta' 48.1 xahar Parametru tal-Effikaċja
English: log-rank p value hazard ratio (95% CI) risk reduction TNCT (median)
Maltese: 2) L-aħħar rispons tat-tumur kif evalwat mill-investigatur.
English: In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis, methylprednisolone given intravenously for 1 to 3 days at a dose of 1000 mg per day is recommended prior to the first infusion of Ritemvia (the last dose of methylprednisolone may be given on the same day as the first infusion of Ritemvia).
Maltese: F'pazjenti bi granulomatosi b'polianġite (ta' Wegener) jew polianġite mikroskopika, methylprednisolone mogħti fil-vini għal 1 sa 3 ijiem b'doża ta' 1,000 mg kuljum huwa rakkomandat qabel l-ewwel infużjoni ta' Ritemvia (l-aħħar doża ta' methylprednisolone tista' tingħata fl-istess jum bħall-ewwel infużjoni ta' Ritemvia).
English: CD20 is found on both normal and malignant B cells, but not on haematopoietic stem cells, pro-B cells, normal plasma cells or other normal tissue.
Maltese: CD20 jinsab kemm fuq ċelluli B normali kif ukoll fuq dawk kanċerużi, iżda mhux fuq ċelluli staminali ematopoetiċi, ċelluli pro-B, ċelluli tal-plażma normali jew tessuti normali oħrajn.
English: The reported cases had recognised risk factors for PRES/RPLS, including the patients' underlying disease, hypertension, immunosuppressive therapy and/or chemotherapy.
Maltese: Il-każijiet irrappurtati kellhom fatturi ta' riskju rikonoxxuti għal PRES/RPLS, inkluż il-marda eżistenti tal-pazjenti, pressjoni għolja, terapija immunosoppressiva u/jew kimoterapija.
English: The most common symptoms were allergic reactions like headache, pruritus, throat irritation, flushing, rash, urticaria, hypertension, and pyrexia.
Maltese: L-aktar sintomi komuni kienu reazzjonijiet allerġiċi bħal uġigħ ta' ras, ħakk, irritazzjoni fil-griżmejn, fwawar, raxx, urtikarja, pressjoni għolja, u deni.