FrancophonIA/ELRC3.0 huggingface dataset:
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, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 1-5) every 3 weeks for 8 cycles or rituximab 375 mg/m2 in combination with CVP (R-CVP).
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, 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: Muscle spasms Arthralgia
Maltese: Spażmi fil-muskoli Artralġja
English: Ritemvia is provided in sterile, preservative-free, non-pyrogenic, single use vials.
Maltese: Ritemvia jiġi fornut f'kunjetti sterili, mingħajr preservattivi, mhux piroġeniċi, li jintużaw darba biss.
English: Figure 1: Change from baseline of DAS28-ESR by baseline autoantibody status
Maltese: Bidla mil-linja bażi ta' DAS28-ESR skont l-istat tal-awtoantikorpi fil-linja bażi:
English: Pneumocystis jirovecii pneumonia (PCP) prophylaxis is recommended for patients with GPA/MPA or PV during and following rituximab treatment, as appropriate according to local clinical practice guidelines.
Maltese: Profilassi ta' pnewmonja kkawżata minn Pneumocystis jirovecii (PCP - Pneumocystis jirovecii pneumonia) hija rakkomandata għall-pazjenti b'GPA/MPA jew PV matul u wara trattament b'rituximab, kif xieraq skont il-linji gwida lokali dwar il-prattika klinika.
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 - 1177 µg/mL) after the eighth infusion.
Maltese: dożi lil 37 pazjent b'NHL, Cmax medja żdiedet ma' kull infużjoni ta' wara, varjat minn medja ta' 243 µg/mL (firxa, 16-582 µg/mL) wara l-ewwel infużjoni għal 550 µg/mL (firxa, 171-1177 µg/mL)
English: Severe infections were reported in about 4% of patients treated with rituximab monotherapy.
Maltese: Infezzjonijiet severi kienu rrappurtati f'madwar 4% tal-pazjenti kkurati b'rituximab bħala monoterapija.
English: 1 Frequency category derived from laboratory values collected as part of routine laboratory monitoring in clinical trials 2 Frequency category derived from post-marketing data.
Maltese: 2 Kategorija ta' frekwenza derivata minn dejta ta' wara t-tqegħid fis-suq.
English: Renal and urinary disorders renal failure4
Maltese: Disturbi filkliewi u fissistema urinarja insuffiċjenza tal-kliewi4
English: Clear Type I glass vials with butyl rubber stopper containing 500 mg of rituximab in 50 mL.
Maltese: Kunjetti tal-ħġieġ ta' Tip I ċar b'tapp tal-lastku butyl li fihom 500 mg ta' rituximab f'50 mL.
English: Clear Type I glass vials with butyl rubber stopper containing 100 mg of rituximab in 10 mL.
Maltese: Kunjetti tal-ħġieġ ta' Tip I ċar b'tapp tal-lastku butyl li fihom 100 mg ta' rituximab f'10 mL.
English: Table 5 Adverse drugs reactions for rituximab-treated pemphigus vulgaris patients in the clinical study up to month 24 System Organ Class
Maltese: Reazzjonijiet avversi tal-mediċina għal pazjenti b'pemphigus vulgaris ittrattati b'rituximab fl-istudju kliniku sa xahar 24
English: Tabulated list of adverse reactions
Maltese: Reazzjonijiet ematoloġiċi avversi
English: Infusion related adverse reactions of all kinds have been observed in 77% of patients treated with rituximab (including cytokine release syndrome accompanied by hypotension and bronchospasm in 10% of patients) see section 4.8.
Maltese: Reazzjonijiet avversi ta' kull tip li għandhom x'jaqsmu mal-infużjoni kienu osservati f'77% talpazjenti kkurati b'rituximab (inkluż is-sindrome tar-reħa taċ-ċitokina flimkien ma' pressjoni baxxa u bronkospażmu f'10% tal-pazjenti) ara sezzjoni 4.8.
English: b) Granulomatosis with polyangiitis or microscopic polyangiitis
Maltese: b) Granulomatosi b'polianġite jew polianġite mikroskopika
English: They were characterised by pulmonary events and in some cases included rapid tumour lysis and features of tumour lysis syndrome in addition to fever, chills, rigors, hypotension, urticaria, angioedema and other symptoms (see section 4.8).
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 (ara sezzjoni 4.8).
English: In the induction of remission clinical trial, 24% of patients in the rituximab group (single course) and 23% of patients in the cyclophosphamide group developed CTC grade 3 or greater neutropenia.
Maltese: Fil-prova klinika dwar l-induzzjoni ta' remissjoni, 24% tal-pazjenti fil-grupp ta' rituximab (kors wieħed) u 23% tal-pazjenti fil-grupp ta' cyclophosphamide żviluppaw newtropenija ta' CTC grad 3 jew aktar.
English: The vial contains 500 mg of rituximab.
Maltese: Kull kunjett fih 500 mg ta' rituximab.
English: This is equivalent to 13.2% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 13,2% tal-ammont massimu rakkomandat ta' sodium li ghandu jittieħed kuljum mad-dieta minn adult.
English: Using a cox regression analysis, the risk of experiencing progressive disease or death was reduced by 61% with rituximab maintenance treatment when compared to observation (95% CI; 45%-72%).
Maltese: Bl-użu ta' analiżi tar-rigressjoni cox, ir-riskju li jkunu esperjenzati mard progressiv jew mewt tnaqqas b'61% bil-kura ta' manteniment ta' rituximab meta mqabbel mal-osservazzjoni (CI ta' 95%; 45% - 72%).
English: Eligible patients had active rheumatoid arthritis, diagnosed according to the criteria of the American College of Rheumatology (ACR).
Maltese: Il-pazjenti eliġibbli kellhom artrite rewmatika attiva, iddijanjostikata skont il-kriterji tal-Kulleġġ Amerikan tar-Rewmatoloġija (ACR).
English: serious viral infection2 pneumocys tis jirovecii
Maltese: infezzjoni serja ikkawżata minn virus2
English: In the clinical trial on induction of remission, the incidence of malignancy in rituximab-treated patients in the granulomatosis with polyangiitis and microscopic polyangiitis clinical study was 2.00 per 100 patient years at the study common closing date (when the final patient had completed the follow-up period).
Maltese: Fil-prova klinika dwar l-induzzjoni ta' remissjoni, l-inċidenza ta' tumuri malinni f'pazjenti kkurati b'rituximab fl-istudju kliniku dwar granulomatosi b'polianġite u polianġite mikroskopika kienet ta' 2.00 għal kull 100 sena ta' pazjent fid-data komuni tat-tmiem tal-istudju (meta l-aħħar pazjent kien temm il-perjodu ta' visti ta' wara).
English: Posology
Maltese: Konnettivi
English: Studies in previously untreated and relapsed/refractory CLL have established that in up to 25% of patients treated with R-FC neutropenia was prolonged (defined as neutrophil count remaining below 1x109/L between day 24 and 42 after the last dose) or occurred with a late onset (defined as neutrophil count below 1x109/L later than 42 days after last dose in patients with no previous prolonged neutropenia or who recovered prior to day 42) following treatment with rituximab plus FC.
Maltese: Studji dwar CLL mhux ikkurata minn qabel u li reġgħet tfaċċat/refrattarja stabbilew li f'sa 25% tal-pazjenti kkurati b'R-FC in-newtropenija kienet imtawwla (definita bħala għadd ta' newtrofili li baqa taħt 1x109/L bejn jum 24 u jum 42 wara laħħar doża) jew seħħet b'bidu ttardjat (definita bħala għadd ta' newtrofili taħt 1x109/L aktar tard minn 42 ġurnata wara l-aħħar doża f'pazjenti bl-ebda newtropenija mtawwla minn qabel jew li rkupraw qabel jum 42) wara kura b'rituximab flimkien ma' FC.
English: In the event of relapse, patients may receive 1000 mg IV.
Maltese: F'każ ta' rkadar, il-pazjenti jistgħu jirċievu 1,000 mg IV.
English: In CLL, the overall incidence of grade 3 or 4 cardiac disorders was low both in the first-line study (4% R-FC, 3% FC) and in the relapsed/refractory study (4% R-FC, 4% FC).
Maltese: F'CLL, l-inċidenza globali ta' disturbi tal-qalb ta' grad 3 jew 4 kienet baxxa kemm fl-istudju primarju (4% R-FC, 3% FC) kif ukoll fl-istudju dwar CLL li reġgħet tfaċċat/refrattarja (4% R-FC, 4% FC).
English: Maintenance doses of 500 mg IV were administered at months 12 and 18.
Maltese: Dożi ta' manteniment ta' 500 mg IV ingħataw fix-xhur 12 u 18.
English: Rarely Ritemvia can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML.
Maltese: B'mod rari Ritemvia jista' jikkawża infezzjoni serja fil-moħħ, imsejħa “lewkoenċefalopatija multifokali progressiva” jew PML.
English: Of the patients originally receiving methotrexate alone, 81% received rituximab either as rescue between weeks 16-24 or in the extension trial, before week 56.
Maltese: 81% rċevew rituximab jew bħala salvataġġ bejn ġimgħa 16-24 jew fil-prova ta' estensjoni, qabel ġimgħa 56.
English: In these patients the rate of clinically relevant infection while on rituximab was 6.01 per 100 patient years compared to 4.97 per 100 patient years following treatment with the biologic DMARD.
Maltese: F'dawn il-pazjenti ir-rata ta' infezzjoni ta' rilevanza klinika waqt terapija b'rituximab kienet ta' 6.01 għal kull 100 sena tal-pazjent meta mqabbel ma 4.97 għal kull 100 sena tal-pazjent wara kura b'DMARD bijoloġiku.
English: OPH Oktal Pharma d.o.o.
Maltese: Orion Pharma AB
English: At 24 months, estimates for overall survival were 68.2% in the R-CHOP arm compared to 57.4% in the CHOP arm. A subsequent analysis of the duration of overall survival, carried out with a median follow-up duration of 60 months, confirmed the benefit of R-CHOP over CHOP treatment (p=0.0071), representing a risk reduction of 32%.
Maltese: F'xahar 24, l-estimi ta' sopravivenza globali kienu ta' 68.2% fil- grupp ta' R-CHOP ikkumparati ma' 57.4% fil-grupp ta' CHOP. Analiżi sussegwenti tat-tul tas-sopravivenza globali, imwettqa b'tul ta' żmien medjan ta' segwitu ta' 60 xahar, ikkonfermat il-benefiċċju tal-kura R-CHOP fuq dik CHOP (p = 0.0071), li tirrappreżenta tnaqqis ta'
English: • tight or painful muscles
Maltese: • uġigħ fil-muskoli
English: Figure 2: ACR responses for 4 treatment courses (24 weeks after each course (within patient, within visit) in patients with an inadequate response to TNF-inhibitors (n=146)
Maltese: Rispons ACR għal 4 korsijiet ta' kura (24 ġimgħa wara kull kors (fil-pazjent, filvista) f'pazjenti b'rispons mhux adegwat għall-inibituri ta' TNF (n = 146)
English: n=98 n=48 n=50
Maltese: n = 48
English: Seropositive (n=506)
Maltese: (n = 506)
English: If any doubt exists, further evaluation, including MRI scan preferably with contrast, cerebrospinal fluid (CSF) testing for JC Viral DNA and repeat neurological assessments, should be considered.
Maltese: Jekk ikun hemm xi dubju, għandhom jiġu kkunsidrati aktar valutazzjonijiet, inkluż scan tal-MRI preferibilment b'kuntrast, ittestjar tal-fluwidu ċerebrospinali (CSF - cerebrospinal fluid) għal DNA tal-virus JC u valutazzjonijiet newroloġiċi ripetuti.
English: Date of first authorisation: 13 July 2017 Date of latest renewal:
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 13 ta 'Lulju, 2017
English: Rate
Maltese: Epistassi
English: Included patients were 21 to 75 years of age and had newly diagnosed or relapsing disease in complete remission after combined treatment with glucocorticoids and pulse cyclophosphamide.
Maltese: Pazjenti nklużi kellhom età minn 21 sa 75 sena u kellhom marda ddijanjostikata għall-ewwel darba jew li rkadiet f'remissjoni kompluta wara trattament ikkombinat bi glukokortikojdi u pulse cyclophosphamide.
English: Long-term efficacy with multiple course therapy
Maltese: Effikaċja fit-tul b'terapija ta' korsijiet multipli
English: Repeated treatment courses with Ritemvia are possible.
Maltese: Mhux rakkomandat tnaqqis fid-doża ta' Ritemvia.
English: The safety profile of rituximab in combination with short-term, low-dose glucocorticoids in the treatment of patients with pemphigus vulgaris was studied in a Phase 3, randomised, controlled, multicenter, open-label study in pemphigus patients that included 38 pemphigus vulgaris (PV) patients randomised to the rituximab group.
Maltese: b'aktar minn ċentru wieħed, open-label f'pazjenti b'pemphigus li kien jinkludi 38 pazjent b'pemphigus vulgaris (PV) mħalltin għall-grupp ta' rituximab.
English: Additional reactions reported in some cases were myocardial infarction, atrial fibrillation, pulmonary oedema and acute reversible thrombocytopenia.
Maltese: Reazzjonijiet oħra rrappurtati f'xi każijiet kienu infart mijokardijaku, fibrillazzjoni atrijali, edima pulmonari u tromboċitopenija riversibbli akuta.
English: Rituximab maintenance treatment significantly prolonged median PFS in patients responding to CHOP induction therapy (median PFS 37.5 months vs. 11.6 months, p< 0.0001) as well as in those responding to R-CHOP induction (median PFS 51.9 months vs. 22.1 months, p=0.0071).
Maltese: 11.6 xhur, p< 0.0001) kif ukoll f'dawk li rrispondew għall-induzzjoni b'R-CHOP (PFS medjana 51.9 xhur vs 22.1 xahar, p = 0.0071).
English: The incidence of ADRs of any grade was similar in these two groups.
Maltese: L-inċidenza ta' ADRs ta' kull grad kienet simili f'dawn iż-żewġ gruppi.
English: +left ventricular failure, +supraventricular tachycardia, +ventricular severe cardiac disorders4 and 6
Maltese: +insuffiċjenza ventrikulari tax-xellug, +takikardja supraventrikula ri, +takikardja ventrikulari,
English: Developmental toxicity studies have been performed in cynomolgus monkeys at doses up to 100 mg/kg (treatment on gestation days 20-50) and have revealed no evidence of toxicity to the foetus due to rituximab.
Maltese: Studji dwar l-effett tossiku fuq l-iżvilupp ġew imwettqa fuq xadini cynomolgus b'dożi sa 100 mg/kg (kura f'jum 20-50 tat-tqala) u ma wrew l-ebda evidenza ta' tossiċità għall-fetu minħabba rituximab.
English: Patients were followed beyond week 24 for long-term endpoints, including radiographic assessment at 56 weeks and at 104 weeks.
Maltese: Il-pazjenti ġew segwiti lil hinn minn ġimgħa 24 għal punti finali fuq perjodu fit-tul, fosthom evalwazzjoni radjografika wara 56 ġimgħa u wara 104 ġimgħat.
English: There were no differences reported for the incidence of anaemia.
Maltese: Ma kienx hemm differenzi rrappurtati għallinċidenza ta' anemija.
English: Based on a population pharmacokinetic analysis in 298 NHL patients who received single or multiple infusions of rituximab as a single agent or in combination with CHOP therapy (applied rituximab doses ranged from 100 to 500 mg/m2), the typical population estimates of nonspecific clearance (CL1), specific clearance (CL2) likely contributed by B cells or tumour burden, and central compartment volume of distribution (V1) were 0.14 L/day, 0.59 L/day, and 2.7 L, respectively.
Maltese: Ibbażat fuq analiżi tal-farmakokinetika tal-popolazzjoni f'298 pazjent b'NHL li rċevew infużjonijiet singoli jew multipli ta' rituximab bħala sustanza waħedha jew flimkien ma' terapija CHOP (id-dożi ta' rituximab applikati varjaw minn 100 sa 500 mg/m2), l-estimi tipiċi tal-popolazzjoni tat-tneħħija mhux speċifika (CL1), tat-tneħħija speċifika (CL2) probabbli kkontribwita minn ċelluli B jew mill-massa tattumur, u tal-volum ta' distribuzzjoni fil-kompartiment ċentrali (V1) kienu ta' 0.14
English: Blood and lymphatic system disorders neutropenia1
Maltese: Disturbi tad-demm u tas-sistema limfatika newtropenija1
English: Mean terminal elimination half-life ranged from 15 to 16 days for the 2 × 500 mg dose group and 17 to 21 days for the 2 × 1000 mg dose group.
Maltese: Ilhalf-life medja tat-tneħħija terminali varjat minn 15 sa 16-il ġurnata għall-grupp tad-doża ta' 2 x 500 mg u minn 17 sa 21 ġurnata għall-grupp tad-doża ta' 2 × 1,000 mg. Cmax medja kienet 16 sa 19%
English: Results from other supportive studies using rituximab in combination with other chemotherapy regimens (including CHOP, FCM, PC, PCM, bendamustine and cladribine) for the treatment of previously untreated and/or relapsed/refractory CLL patients have also demonstrated high overall response rates with benefit in terms of PFS rates, albeit with modestly higher toxicity (especially myelotoxicity).
Maltese: Riżultati minn studji oħra ta' sapport bl-użu ta' rituximab flimkien ma' korsijiet oħra ta' kimoterapija (inkluż CHOP, FCM, PC, PCM, bendamustine u cladribine) għall-kura ta' pazjenti b'CLL mhux ikkurata minn qabel u/jew li reġgħet tfaċċat/refrattarja ukoll urew rati ta' rispons globali għolja b'benefiċċju f'termini ta' rati ta' PFS, għalkemm b'tossiċità kemmxejn ogħla (speċjalment majelotossiċità).
English: Minor relapses (not life threatening and not involving major organ damage) occurred in seven patients in the rituximab group (12%) and eight patients in the azathioprine group (14%).
Maltese: Irkadar minuri (mhux ta' periklu għall-ħajja u li ma jinvolvix ħsara f'organi prinċipali) seħħ f'seba' pazjenti fil-grupp ta' rituximab (12%) u fi tmien pazjenti fil- grupp ta' azathioprine (14%).
English: Toxic Epidermal Necrolysis (Lyell's syndrome) and Stevens-Johnson syndrome, some with fatal outcome, have been reported very rarely.
Maltese: Nekrolisi Tossika tal-Epidermide (sindrome ta' Lyell) u s-sindrome ta' Stevens-Johnson, uħud b'riżultat fatali, kienu rrappurtati b'mod rari ħafna.
English: Rituximab infusions were administered after an intravenous infusion of 100 mg methylprednisolone; patients also received treatment with oral prednisone for 15 days.
Maltese: L-infużjonijiet ta' rituximab ngħataw wara infużjoni fil-vini ta' 100 mg methylprednisolone; il-pazjenti rċevew ukoll kura bi prednisone orali għal 15-il jum.
English: At week 48 seropositive patients were 2-3 times more likely to achieve ACR responses compared to seronegative patients.
Maltese: F'ġimgħa 48 pazjenti seropożittivi kienu 2-3 darbiet aktar probabbli li jiksbu risponsi ACR meta mqabbel ma' pazjenti seronegattivi.
English: The proportions of rituximab treated patients showing a minimal clinically important difference (MCID) in HAQ-DI (defined as an individual total score decrease of >0.22) was also higher than among patients receiving methotrexate alone (Table 14).
Maltese: Ilproporzjonijiet ta' pazjenti kkurati b'rituximab li wrew differenza minima ta' importanza klinika (MCID) f'HAQ-DI (definita bħala tnaqqis fil-punteġġ individwali totali ta' > 0.22) kienu wkoll ogħla minn dawk fost pazjenti li rċevew methotrexate waħdu (Tabella 14).
English: - * Worst case imputation a Non-inferiority was demonstrated since the lower bound (−3.2%) was higher than the pre-determined non-inferiority margin (− 20%).
Maltese: * Imputazzjoni tal-agħar każ a Nuqqas ta' inferjorità intweriet peress li l-parti l-baxxa ( - 3.2%) kienet ogħla mill-marġni ta' nuqqas ta' inferjorità determinat minn qabel ( - 20%).
English: • severe vision loss
Maltese: Visit = Vista
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% filgrupp ta' rituximab u bi frekwenza ogħla mill-grupp ta' paragun.
English: Ear and labyrinth disorders tinnitus, ear pain hearing loss5
Maltese: sturdament, ansjetà disġewsja newropatija periferali, paralisi tannerv tal-wiċċ5
English: 1 vial contains 500 mg of rituximab.
Maltese: Kunjett wieħed fih 500 mg ta' rituximab.
English: Pneumocystis jirovecii pneumonia prophylaxis was required for all patients with CD4+ T-lymphocyte counts less than 250 per cubic millimeter.
Maltese: Profilassi ta' pnewmonja kkawżata minn Pneumocystis jirovecii kienet meħtieġa għall-pazjenti kollha b'għadd ta' limfoċiti T CD4+ ta' inqas minn 250 għal kull millimetru kubiku.
English: During this time, 81% of patients, from the original placebo group received rituximab between weeks 24 and 56, under an open label extension study protocol.
Maltese: F'dan iż-żmien, 81% tal-pazjenti mill-grupp oriġinali fuq il-plaċebo rċevew rituximab bejn ġimgħa 24 u ġimgħa 56, taħt protokoll ta' studju ta' estensjoni tat-tip open label.
English: • Detailed information on the risk of PML, the need for timely diagnosis of PML and appropriate measures to diagnose PML
Maltese: • Informazzjoni dettaljata dwar ir-riskju ta' PML, il-ħtieġa ta' dijanjosi f'waqtha ta' PML u miżuri xierqa biex tiġi dijanjostikata PML
English: Outcome†
Maltese: Riżultat†
English: Response rate and CR rates analysed using Chi-squared Test. NR: not reached; N/A: not applicable *: only applicable to patients achieving a CR, nPR, PR; **: only applicable to patients achieving a CR;
Maltese: *: japplika biss għall-pazjenti li laħqu CR, nPR, PR; **: japplika biss għall-pazjenti li laħqu CR;
English: Diarrhoea Dyspepsia Constipation
Maltese: Indikazzjonijiet kollha
English: Dyspnoea Epistaxis Nasal congestion
Maltese: Dijarea Dispepsja Stitikezza
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit web tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
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: 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 millħalq li tnaqqas għax-xejn fuq perjodu ta' 6 xhur jekk kellhom marda severa, u t-tieni infużjoni fil-vini ta' 1,000 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-komplimentari (CDC) li tirriżulta minn irbit ta' C1q, u ċitotossiċità ċellulari dipendenti fuq l-antikorp (ADCC) medjata mir-riċetturi Fcγ, wieħed jew aktar, fuq il-wiċċ tal-granuloċiti, makrofaġi u ċelluli NK.
English: Mean terminal elimination half-life after the second infusion, following the second course, was 19 days for 2 × 500 mg dose and ranged from 21 to 22 days for the 2 × 1000 mg dose.
Maltese: Il-half-life medja tat-tneħħija terminali wara t-tieni infużjoni, wara t-tieni kors, kienet ta' 19-il ġurnata għad-doża ta' 2 x 500 mg u varjat minn 21 sa 22 ġurnata għad-doża ta' 2 x 1,000 mg.
English: Table 3 Adverse drug reactions occurring at 6-months in ≥ 5% of patients receiving rituximab for induction of remission of GPA and MPA, and at a higher frequency than the comparator group, in the pivotal clinical study.
Maltese: Tabella 3 Reazzjonijiet avversi tal-mediċina li seħħew wara 6 xhur f'≥ 5% tal-pazjenti li rċevew rituximab għall-induzzjoni ta' remissjoni ta' GPA u MPA, u bi frekwenza ogħla mill-grupp ta' paragun Sistema tal-Ġisem Reazzjoni avversa
English: Multiple courses of treatment are associated with a similar ADR profile to that observed following first exposure.
Maltese: Korsijiet multipli ta' kura huma assoċjati ma' profil simili ta' ADR għal dak osservat wara l-ewwel esponiment.
English: disorder tachycardia, +angina, +myocardial ischaemia, bradycardia
Maltese: Disturbi gastrointestin ali tqalligħ rimettar, dijarea,