FrancophonIA/ELRC3.0 huggingface dataset:
English: The pre-specified primary analysis was conducted at a median observation time of 25 months from randomization, maintenance therapy with rituximab resulted in a clinically relevant and statistically significant improvement in the primary endpoint of investigator assessed progression-free 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'
English: Patients randomised to the rituximab group received an initial intravenous infusion of 1000 mg rituximab on Study Day 1 in combination with 0.5 mg/kg/day oral prednisone tapered off over 3 months if they had moderate disease or 1 mg/kg/day oral prednisone tapered off over 6 months if they had severe disease, and a second intravenous infusion of 1000 mg on Study Day 15.
Maltese: 1000 mg rituximab fil-Jum 1 tal-Istudju flimkien ma' 0.5 mg/kg/jum ta' prednisone mill-ħalq li tnaqqas għax-xejn fuq perjodu ta' 3 xhur jekk kellhom marda moderata jew 1 mg/kg/jum ta' prednisone mill-ħalq li tnaqqas għax-xejn fuq perjodu ta' 6 xhur jekk kellhom marda severa, u t-tieni infużjoni fil-vini ta' 1000 mg fil-Jum 15 tal-Istudju.
English: Possible mechanisms of effector-mediated cell lysis include complement-dependent cytotoxicity (CDC) resulting from C1q binding, and antibody-dependent cellular cytotoxicity (ADCC) mediated by one or more of the Fcγ receptors on the surface of granulocytes, macrophages and NK cells.
Maltese: Il-mekkaniżmi possibli ta' lisi taċ-ċellula effector-mediated jinkludu ċitotossiċità dipendenti mill-kompliment (CDC) li tirriżulta minn irbit ta' C1q, u ċitotossiċità ċellulari dipendenti fuq l-antikorp (ADCC) medjata mirriċetturi Fcγ, wieħed jew aktar, fuq il-wiċċ tal-granuloċiti, makrofaġi u ċelluli NK.
English: Only the highest frequency observed in the trials is reported 1 includes reactivation and primary infections; frequency based on R-FC regimen in relapsed/refractory CLL 2 see also section infection below
Maltese: 1 tinkludi riattivazzjoni u infezzjonijiet primarji; frekwenza ibbażata fuq kors ta' R-FC f'CLL li reġgħet tfaċċat/refrattarja
English: In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis, methylprednisolone given intravenously for 1 to 3 days at a dose of 1,000 mg per day is recommended prior to the first infusion of Rixathon (the last dose of methylprednisolone may be given on the same day as the first infusion of Rixathon).
Maltese: F'pazjenti bi granulomatosi b'polianġite (ta' Wegener) jew polianġite mikroskopika, methylprednisolone mogħti fil-vini għal 1 sa 3 ijiem b'doża ta' 1000 mg kuljum huwa rrakkomandat qabel l-ewwel infużjoni ta' Rixathon (l-aħħar doża ta' methylprednisolone tista' tingħata fl-istess jum bħall-ewwel infużjoni ta' Rixathon).
English: Table 11 Treatment of relapsed/refractory chronic lymphocytic leukaemia - overview of efficacy results for rituximab plus FC vs. FC alone (25.3 months median observation time)
Maltese: Tabella 11 Kura ta' lewkimja limfoċitika kronika li reġgħet tfaċċat/refrattarja - sommarju tar-riżultati tal-effikaċja għal rituximab flimkien ma' FC vs.
English: Infusionrelated reactions3 (hypertension, nausea, rash, pyrexia, pruritus, urticaria, throat irritation, hot flush, hypotension, rhinitis, rigors, tachycardia, fatigue, oropharyngeal pain, peripheral oedema, erythma)
Maltese: B'mod anqas frekwenti, xi pazjenti jistgħu jesperjenzaw uġigħ fis-sit tal-infużjoni, infafet, ħakk, taqligħ (dardir), għeja, uġigħ ta' ras, diffikultajiet tan-nifs, żieda fil-pressjoni, tħarħir, skumdità filgerżuma, nefħa fl-ilsien jew fil-gerżuma, imnieħer iqattar jew jieklok, rimettar, fwawar jew palpitazzjonijiet, attakk ta' qalb jew għadd baxx ta' plejtlits.
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: Kontraindikazzjonijiet għall-użu f'limfoma mhux ta' Hodgkin u lewkimja limfoċitika kronika Sensittività eċċessiva għas-sustanza attiva jew għall-proteini tal-ġrieden, jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Experience from pemphigus vulgaris
Maltese: Esperjenza b'pemphigus vulgaris
English: Rituximab was administered as two intravenous infusions separated by an interval of 15 days.
Maltese: Rituximab ingħata bħala żewġ infużjonijiet IV separati b'intervall ta' 15-il jum.
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 infusionrelated 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: The ADRs listed in Table 3 were all adverse events which occurred at an incidence of ≥ 5% in the rituximab group and at a higher frequency than the comparator group.
Maltese: L-ADRs elenkati f'Tabella 3 kienu l-avvenimenti avversi kollha li seħħew b'inċidenza ta' ≥ 5% fil grupp ta' rituximab u bi frekwenza ogħla mill-grupp ta' paragun.
English: The rate of overall infections and serious infections was not increased after the development of low IgA, IgG or IgM.
Maltese: Ir-rata ta' infezzjonijiet globali u infezzjonijiet serji ma żdiditx wara l-iżvilupp ta' IgA, IgG jew IgM baxxi.
English: OS rates,
Maltese: Bronkite,
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'żjieda għal 500 mg/m2 kull ċiklu għal 5 dożi flimkien ma' fludarabine u cyclophosphamide f'pazjenti b'CLL.
English: The HCP educational leaflet about Rixathon for non-oncology indications contains the following key elements: - The need for close supervision during administration in an environment where full resuscitation facilities are immediately available - The need to check, prior to Rixathon treatment, for infections, for immunosuppression, for prior/current medication affecting the immune system, and recent history of, or planned, vaccination, and a history of infusion-related reaction - The need to monitor patients for infections, especially PML, during and after Rixathon treatment - Detailed information on the risk of PML, the need for timely diagnosis of PML and appropriate measures to diagnose PML - The need to advise patients on the risk of infections and PML, including the symptoms to be aware of and the need to contact their doctor immediately if they experience any.
Maltese: Għandhom ikunu disponibbli għall-użu immedjat prodotti mediċinali għall-kura ta' reazzjonijiet ta' sensittività eċċessiva, eż. epinefrina (adrenalina), antistamini u glukokortikojdi, f'każ li jkun hemm reazzjoni allerġika waqt l-amministrazzjoni ta' rituximab. Manifestazzjonijiet kliniċi ta' anafilassi jistgħu jidhru simili għal manifestazzjonijiet kliniċi tas-sindrome tar-reħa taċ-ċitokina (deskritt aktar 'il fuq).
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 Sistema tal-Klassifika tal-Organi Reazzjoni avversa tal-mediċina1
English: Rixathon 100 mg concentrate for solution for infusion Rixathon 500 mg concentrate for solution for infusion rituximab
Maltese: Rixathon 100 mg konċentrat għal soluzzjoni għal infużjoni Rixathon 500 mg konċentrat għal soluzzjoni għal infużjoni rituximab
English: Diarrhoea Dyspepsia Constipation
Maltese: Disturbi gastro-intestinali Dijarea
English: Secondary efficacy Overall survival (median) 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: Efficacy in autoantibody (RF and or anti-CCP) seropositive patients Patients seropositive to Rheumatoid Factor (RF) and/or anti-Cyclic Citrullinated Peptide (anti-CCP) 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 (anti
English: Infusion-related reactions*
Maltese: (DFS)**
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: Dawn kienu kkaratterizzati minn avvenimenti pulmonari u f'xi każijiet inkludew lisi rapida tat-tumur u karatteristiċi tas-sindrome tallisi tat-tumur flimkien ma' deni, tertir, rogħda, pressjoni baxxa, urtikarja, anġjoedima u sintomi oħrajn
English: Granulomatosis with polyangiitis and microscopic polyangiitis
Maltese: Granulomatosi b'polianġite u polianġite mikroskopika
English: This medicine contains 2.3 mmol (or 52.6 mg) sodium per 10 mL vial.
Maltese: Dan il-prodott mediċinali fih 2.3 mmol (52.6 mg) ta' sodium f'kull kunjett ta' 10 mL.
English: Asthma, bronchiolitis obliterans, lung disorder,
Maltese: bronkolite obliterans, disturb filpulmun, ipoxja
English: Dyspepsia, diarrhoea, gastrooesophageal reflux, mouth ulceration, upper abdominal pain
Maltese: Disturbi fil-koagulazzj oni, anemija aplastika, anemija emolitika, limfadenopati ja
English: Influenza-like illness Oedema peripheral
Maltese: Marda tixbah lill-influwenza Edima periferali Disturbi gastro-intestinali Dijarea
English: The Fab domain of rituximab binds to the CD20 antigen on B lymphocytes and the Fc domain can recruit immune effector functions to mediate B cell lysis.
Maltese: Il-parti Fab ta' rituximab tintrabat mal-antiġen CD20 fuq limfoċiti B u l-parti Fc tkun tista' tqabbad funzjonijiet li jaffetwaw l-immunità sabiex iservu ta' medjaturi fil-lisi taċ-ċellula B.
English: Mean Cmax for serum rituximab following first infusion was 170 to 175 μg/mL for 2 x 500 mg dose and 317 to 370 μg/mL for 2 x 1,000 mg dose.
Maltese: 170 sa 175 µg/mL għad-doża ta' 2 × 500 mg u 317 sa 370 µg/mL għad-doża ta' 2 × 1000 mg. Cmax wara t-tieni infużjoni, kienet ta' 207 µg/mL għad-doża ta' 2 × 500 mg u varjat minn 377 sa 386 µg/mL għad-doża ta' 2 × 1000 mg.
English: Structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (mTSS) and its components, the erosion score and joint space narrowing score.
Maltese: Ħsara strutturali fil-ġogi kienet evalwata b'mod radjugrafiku, u imfissra bħala bidla fil-punteġġ Sharp Totali Modifikat (mTSS) u l-komponenti tiegħu, il-punteġġ tat-tgħawwir u l-punteġġ ta' tidjiq tal ispazju bejn il-ġogi.
English: 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: ORR: rata ta' rispons globali; CR: rispons totali; PR: rispons parzjali
English: • bacterial or viral infections, bronchitis
Maltese: • infezzjonijiet ikkawżati mill-batterja jew minn virusis, bronkite
English: • Relapsed/refractory follicular lymphoma
Maltese: • Limfoma follikulari mhux ikkurata minn qabel
English: Table 17 Complete remission at 6-months by disease status Rituximab Cyclophosphamide Difference (CI 95%)
Maltese: Cyclophosphamide Differenza (CI 95%)
English: Blood and Neutropenia Anaemia,
Maltese: Anemija,
English: Tinnitus, ear pain
Maltese: Medjan, Xhur
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: Eritematosus Sistemika (SLE) u vaskulite kienu rrappurtati każijiet rari ħafna ta' lewkoenċefalopatija multifokali progressiva (PML) fatali.
English: Table 8 Induction phase: overview of efficacy results for CHOP vs. R-CHOP (31 months median observation time)
Maltese: Tabella 8 Fażi ta' induzzjoni: deskrizzjoni ġenerali tar-riżultati tal-effikaċja għal CHOP
English: All patients Newly diagnosed Relapsing n=99 n=48 n=51
Maltese: Iddijanjostikati għall-ewwel darba n = 48
English: The primary outcome measure was the rate of major relapse at month 28.
Maltese: Kull ċiklu għandu tul ta' 28 ġurnata.
English: Based on the population pharmacokinetic analysis of data in 97 patients with granulomatosis with polyangiitis and microscopic polyangiitis who received 375 mg/m2 rituximab once weekly for four doses, the estimated median terminal elimination half-life was 23 days (range, 9 - 49 days).
Maltese: Ibbażat fuq l-analiżi farmakokinetika tal-popolazzjoni ta' data minn 97 pazjent bi granulomatosi b'polianġite u polianġite mikroskopika li rċevew 375 mg/m2 rituximab darba fil-ġimgħa għal erba'
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'infużjonijiet sussegwenti u hija < 1% talpazjenti mat-tmien ċiklu ta' kura b'(li fiha) rituximab.
English: Vomiting, diarrhoea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation
Maltese: stomatite, stitikezza, dispepsja, anoressija, irritazzjoni fil griżmejn
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 rrakkomandata 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: • lower immunity - because of lower levels of anti-bodies called “immunoglobulins” (IgG) in the blood which help protect against infection
Maltese: (IgG - immunoglobulins) fid-demm li jgħinu jipproteġu kontra l-infezzjonijiet.
English: Paraesthesia, migraine, dizziness, sciatica
Maltese: Rimettar, dijarea, uġigħ addominali,
English: Severe skin reactions such as Toxic Epidermal Necrolysis (Lyell's syndrome) and Stevens-Johnson syndrome, some with fatal outcome, have been reported (see section 4.8).
Maltese: Lyell) u s-sindrome ta' Stevens-Johnson, uħud b'riżultat fatali (ara sezzjoni 4.8).
English: In studies evaluating rituximab in combination with chemotherapy, the incidence of grade 3 and 4 cardiac arrhythmias, predominantly supraventricular arrhythmias such as tachycardia and atrial flutter/fibrillation, was higher in the R-CHOP group (14 patients, 6.9%) as compared to the CHOP group (3 patients, 1.5%).
Maltese: Fi studji li vvalutaw rituximab flimkien ma' kimoterapija, l-inċidenza ta' arritmija kardijaka ta' grad 3 u 4, l-aktar arritmija supraventrikolari bħal takikardija u taħbit irregolari/fibrillazzjoni atrijali, kienet ogħla fil-grupp ta'
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: Din issindrome tista' tiġi assoċjata ma' xi karatteristiċi tas-sindrome tal-lisi tat-tumur bħall-iperuriċemija, iperkalimja, ipokalċimja, iperfosfatimja, insuffiċjenza akuta tal-kliewi, lactate dehydrogenase (LDH)
English: All patients treated with Rixathon for rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris must be given the patient alert card with each infusion.
Maltese: Jekk qed tiġi kkurat/a għall-artrite rewmatika, granulomatosi b'polianġite, polianġite mikroskopika jew pemphigus vulgaris, se ssib dan it-tagħrif fil-Kartuna ta' Twissija tal-Pazjent li tak it-tabib tiegħek ukoll.
English: Concomitant/sequential use of other DMARDs in rheumatoid arthritis The concomitant use of Rixathon 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' Rixathon u terapiji anti-rewmatiċi għajr dawk speċifikati taħt l-indikazzjoni u l-pożoloġija għall-artrite rewmatika mhux rakkomandat.
English: Eligible patients had active rheumatoid arthritis, diagnosed according to the criteria of the American College of Rheumatology (ACR).
Maltese: iddijanjostikata skont il-kriterji tal-Kulleġġ Amerikan tar-Rewmatoloġija (ACR).
English: Lek Pharmaceuticals d.d.
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: Chemical and physical stability of Rixathon diluted in 0.9% sodium chloride solution has been demonstrated for 30 days at 2°C - 8°C and subsequently 24 hours at room temperature (≤25°C).
Maltese: Stabbiltà kimika u fiżika ta' Rixathon dilwit f'soluzzjoni ta' 0.9% sodium chloride ġiet murija għal
English: Patients in both arms received 1,000 mg of pulse intravenous methylprednisolone (or another equivalent-dose glucocorticoid) per day for 1 to 3 days, followed by oral prednisone (1 mg/kg/day, not exceeding 80 mg/day).
Maltese: segwit minn prednisone orali (1 mg/kg/jum, sa massimu ta' 80 mg/jum).
English: Hearing loss5
Maltese: Telf tas smigħ5
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: • infections of the blood (sepsis), pneumonia, shingles, cold, bronchial tube infections, fungal infections, infections of unknown origin, sinus inflammation, hepatitis B
Maltese: • infezzjonijiet fid-demm (sepsi), pnewmonja, ħruq ta' Sant Antnin, riħ, infezzjonijiet fit-tubi tal bronki, infezzjonijiet ikkawżati mill-moffa, infezzjonijiet ta' oriġini mhux magħrufa,
English: Rixathon is used for the treatment of patients with moderate to severe pemphigus vulgaris.
Maltese: e) Pemphigus vulgaris Rixathon jintuża għat-trattament ta' pazjenti b'pemphigus vulgaris moderat sa sever.
English: b The 95.1% confidence level reflects an additional 0.001 alpha to account for an interim efficacy analysis.
Maltese: 1% jirrifletti 0.001 alpha oħra biex ipattu għall-analiżi interim taleffikaċja
English: Non-Hodgkin's lymphoma and chronic lymphocytic leukaemia
Maltese: Limfoma mhux ta' Hodgkin u lewkimja limfoċitika kronika
English: Tachycardia
Maltese: Fwawar
English: • severe vision loss
Maltese: • telf sever tal-vista.
English: Reactivation of hepatitis B infection has also been very rarely reported in RA patients receiving rituximab (see section 4.4).
Maltese: Waqt terapija b'rituximab jista' jkun hemm infezzjonijiet serji, inkluż fatalitajiet (ara sezzjoni 4.8).
English: Upon administration of rituximab at a dose of 375 mg/m2 as an intravenous infusion at weekly intervals for 8 doses to 37 patients with NHL, the mean Cmax increased with each successive infusion, spanning from a mean of 243 µg/mL (range, 16 - 582 µg/mL) after the first infusion to 550 µg/mL (range, 171-1,177 µg/mL) after the eighth infusion.
Maltese: 243 µg/mL (firxa, 16-582 µg/mL) wara l-ewwel infużjoni għal 550 µg/mL (firxa, 171-1177 µg/mL)
English: For CLL patients whose lymphocyte counts are > 25 x 109/L it is recommended to administer prednisone/prednisolone 100 mg intravenous shortly before infusion with Rixathon to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome.
Maltese: Għall-pazjenti b'CLL li l-għadd ta' limfoċiti tagħhom huwa ta' > 25 x 109/L huwa rakkomandat li jingħata 100 mg prednisone/prednisolone fil-vini eżatt qabel infużjoni b'Rixathon biex jitnaqqsu r-rata u s-severità ta' reazzjonijiet akuti għall-infużjoni u/jew is-sindrome tar-reħa taċ-ċitokina.
English: Severe vision loss5
Maltese: Telf sever talvista5
English: Rixathon 100 mg concentrate for solution for infusion Rixathon 500 mg concentrate for solution for infusion
Maltese: Rixathon 100 mg konċentrat għal soluzzjoni għal infużjoni Rixathon 500 mg konċentrat għal soluzzjoni għal infużjoni
English: In a multi-centre, single-arm trial, 58 patients with relapsed or chemoresistant low grade or follicular B cell NHL, who had achieved an objective clinical response to a prior course of rituximab, were re-treated with 375 mg/m2 of rituximab as intravenous infusion weekly for four doses.
Maltese: Fi prova b'aktar minn ċentru wieħed, bi grupp wieħed, 58 pazjent b'NHL taċ-ċellula B follikulari jew ta' grad baxx, kimoreżistenti jew li reġgħet tfaċċat, li kienu laħqu rispons kliniku oġġettiv għal kors preċedenti ta' rituximab, ġew trattati mill-ġdid bi 375 mg/m2 ta' rituximab bħala infużjoni fil-vini kull ġimgħa għal erba' dożi.
English: Fatigue Pyrexia
Maltese: Soluzzjoni dilwita
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Maltese: 3 xhur) Parametru tal-Effikaċja
English: Medicinal products for the treatment of hypersensitivity reactions, e.g. epinephrine (adrenaline), antihistamines and glucocorticoids, should be available for immediate use in the event of an allergic reaction during administration of Rixathon.
Maltese: Għandhom ikunu disponibbli għall-użu immedjat prodotti mediċinali għall-kura ta' reazzjonijiet ta' sensittività eċċessiva, eż. epinefrina (adrenalina), antistamini u glukokortikojdi, f'każ li jkun hemm reazzjoni allerġika waqt l-amministrazzjoni ta' Rixathon.
English: Bronchospasm4, respiratory disease, chest pain, dyspnoea, increased cough,
Maltese: Bronkospażm u4, marda respiratorja,
English: The most common infections in the rituximab arm included upper respiratory tract infections, gastroenteritis, urinary tract infections and herpes zoster.
Maltese: L-aktar infezzjonijiet komuni fil-grupp ta' rituximab kienu jinkludu infezzjonijiet fl-apparat respiratorju ta' fuq, gastroenterite, infezzjonijiet fl-apparat tal awrina u herpes zoster.
English: Repeated treatment courses with Rixathon are possible.
Maltese: Korsijiet ta' ripetuti kura b'Rixathon huma possibbli.
English: The pharmacokinetic profile of rituximab when administered as 6 infusions of 375 mg/m2 in combination with 6 cycles of CHOP chemotherapy was similar to that seen with rituximab alone.
Maltese: Il-profil farmakokinetiku ta' rituximab meta mogħti bħala 6 infużjonijiet ta' 375 mg/m2 flimkien ma'
English: respectively.
Maltese: sentejn.