FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence of ADRs of all grades and grade 3 /4 ADR was similar in elderly patients compared to younger patients (<65 years).
Maltese: L-inċidenza ta' ADRs ta' kull grad u ta' ADRs ta' grad 3/4 kienet simili f'pazjenti anzjani meta mqabbel ma' pazjenti iżgħar (<65 sena).
English: +myocardial infarction4 and 6,
Maltese: +Infart mijokardijaku
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: Wara 24 xahar, stimi ta' sopravivenza globali kienu ta' 68.2 % fil-grupp ta' R-CHOP imqabbel ma' 57.4 % fil-grupp ta' CHOP. Analiżi sussegwenti tat-tul tas-sopravivenza globali, imwettqa b'tul ta' segwitu medjan ta' 60 xahar, ikkonfermat il-benefiċċju ta' kura b'R-CHOP fuq dik ta' CHOP (p=0.0071), li tirrappreżenta tnaqqis fir-riskju ta' 32 %.
English: This medicine contains 2.3 mmol (or 52.6 mg) sodium per 10 mL vial and 11.5 mmol (or 263.2 mg) per 50 mL vial.
Maltese: Din il-mediċina fiha 2.3 mmol (jew 52.6 mg) ta' sodium f'kull kunjett ta' 10 mL u 11.5 mmol (jew 263.2 mg) f'kull kunjett ta' 50 mL.
English: During maintenance treatment, the incidence of grade 3/4 cardiac disorders was comparable between patients treated with MabThera and observation.
Maltese: Waqt kura ta' manteniment, l-inċidenza ta' disturbi kardijaċi ta' grad 3/4 kienet komparabbli bejn pazjenti kkurati b'MabThera u l-osservazzjoni.
English: The prepared infusion solution of MabThera in 5% D-glucose solution is physically and chemically stable for 24 hours at 2 °C - 8 °C plus an additional 12 hours at room temperature.
Maltese: • Wara dilwizzjoni asettika f'soluzzjoni ta' D-glucose Is-soluzzjoni għal infużjoni mħejjija ta' MabThera f'soluzzjoni ta' 5% D-glucose hija fiżikament u kimikament stabbli għal 24 siegħa f'temperatura ta' 2°C - 8°C u sussegwentement għal 12-il siegħa oħra f'temperatura tal-kamra.
English: Primary efficacy
Maltese: Sensittività eċċessiva
English: Previously untreated patients with CD20-positive, Follicular Lymphoma Grade 1, 2 or 3a (n=283) were enrolled in the stage 2.
Maltese: Pazjenti li ma kinux ikkurati qabel b'Limfoma Follikulari pożittiva għal CD20 ta' Grad 1, 2 jew 3a (n=283) kienu rreġistrati fit-tieni stadju.
English: Initiate at a rate of 250mg/hour for the first 30 minutes and then 600 mg/hour for the next 90 minutes.
Maltese: Ibda b'rata ta' 250mg/siegħa għall-ewwel 30 minuta u wara 600 mg/siegħa għad-90 minuta ta' wara.
English: MabThera is used for the treatment of rheumatoid arthritis.
Maltese: MabThera jintuża għall-kura tal-artrite rewmatika.
English: FC (N = 276)
Maltese: (N = 276)
English: MabThera 100 mg concentrate for solution for infusion MabThera 500 mg concentrate for solution for infusion rituximab
Maltese: MabThera 100 mg konċentrat għal soluzzjoni għal infużjoni MabThera 500 mg konċentrat għal soluzzjoni għal infużjoni rituximab
English: FC) for the first-line study (Table 10a and Table 10b) and 552 patients (276 R-FC, 276 FC) for the relapsed/refractory study (Table 11) were analysed for efficacy.
Maltese: Total ta' 810 pazjent (403 R-FC, 407 FC) għall-istudju primarju (Tabella 10a u Tabella 10b) u 552 pazjent (276 R-FC, 276 FC) għall-istudju dwar CLL li reġgħet tfaċċat/refrattarja (Tabella 11) kienu analizzati għall-effikaċja.
English: In a non-randomised study, patients with relapsed low-grade NHL who received MabThera monotherapy when compared to healthy untreated controls had a lower rate of response to vaccination with tetanus recall antigen (16% vs. 81%) and Keyhole Limpet Haemocyanin (KLH) neoantigen (4% vs. 76% when assessed for >2-fold increase in antibody titer).
Maltese: Fi studju mhux randomised, pazjenti b'NHL ta' grad baxx li rkadat li rċevew monoterapija ta' MabThera meta mqabbel ma' kontrollif'saħħithom mhux ikkurati kellhom rata ta' rispons aktar baxxa għal tilqim b'tetanus recall antigen (16 % vs. 81 %) u b'Keyhole Limpet Haemocyanin (KLH) neoantigen (4 % vs. 76 % meta stmat għal żjieda ta' > darbtejn fit-titer tal-antikorp).
English: In these patients the rate of clinically relevant infection while on MabThera 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'MabThera 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: • MabThera subcutaneous formulation (n= 205): first cycle MabThera intravenous formulation plus 7 cycles of MabThera subcutaneous formulation in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks.
Maltese: • Formulazzjoni għall-għoti taħt il-ġilda ta' MabThera (n=205): l-ewwel ċiklu formulazzjoni għall-għoti fil-vini ta' MabThera u 7 ċikli ta' formulazzjoni għall-għoti taħt il-ġilda ta' MabThera flimkien ma' sa 8 ċikli ta' kimoterapija CHOP jew CVP mogħtija kull 3 ġimghat.
English: Studies with MabThera intravenous formulation 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 MabThera plus FC.There were no differences reported for the incidence of anaemia.
Maltese: Studji bil-formulazzjoni għall-għoti fil-vini ta' MabThera, dwar CLL mhux ittrattata minn qabel jew li reġgħet tfaċċat/ma rrispondietx għat-trattament stabbilew li f'sa 25% tal-pazjenti ttrattati b'R-FC newtropenija kienet imtawwla (definita bħala għadd ta' newtrofili li baqa' taħt 1x109/L bejn jum 24 u jum 42 wara l-aħħar doża) jew seħħet b'bidu ittardjat (definita bħala għadd ta' newtrofili taħt 1x109/L aktar tard minn 42 jum wara l-aħħar doża f'pazjenti bl-ebda newtropenija imtawwla minn qabel jew li rkupraw qabel jum 42) wara trattament b'MabThera flimkien ma' FC.
English: MabThera 100 mg concentrate for solution for infusion MabThera 500 mg concentrate for solution for infusion
Maltese: MabThera 100 mg konċentrat għal soluzzjoni għal infużjoni MabThera 500 mg konċentrat għal soluzzjoni għal infużjoni
English: Mean terminal elimination half-life ranged from 15 to 16 days for the 2 x 500 mg dose group and 17 to 21 days for the 2 × 1000 mg dose group.
Maltese: Il-half-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 × 1000 mg. Cmax medja kienet 16 sa 19% ogħla wara t-tieni infużjoni meta mqabbel mal-ewwel infużjoni għaż-żewġ dożi.
English: During the treatment course in studies with MabThera in combination with chemotherapy, grade 3/4 leucopenia (R-CHOP 88% vs. CHOP 79%, R-FC 23% vs. FC 12%), neutropenia (R-CVP 24% vs. CVP 14%; R-CHOP 97% vs. CHOP 88%, R-FC 30% vs. FC 19% in previously untreated CLL), pancytopenia (R-FC 3% vs. FC 1% in previously untreated CLL) were usually reported with higher frequencies when compared to chemotherapy alone.
Maltese: Waqt il-kors ta' kura fi studji b'MabThera flimkien ma' kimoterapija, lewkopenija ta' grad 3/4 (R-CHOP 88% vs CHOP 79%, R-FC 23% vs FC 12%), newtropenija (R-CVP 24% vs CVP 14%;
English: A longer period may be appropriate in patients with an increased risk of hypersensitivity reactions.
Maltese: Perijodu itwal għnadu mnejn ikun xieraq f'pazjenti b'riskju akbar ta' reazzjonijiet ta' sensittività eċċessiva.
English: The following terms have been reported as adverse events during clinical trials, however, were reported at a similar or lower incidence in the MabThera arms compared to control arms: haematotoxicity, neutropenic infection, urinary tract infection, sensory disturbance, pyrexia.
Maltese: It-termini li ġejjin kienu rrappurtati bħala avvenimenti avversi waqt provi kliniċi, iżda kienu rrappurtati b'inċidenza simili jew aktar baxxa fil-gruppi b'MabThera meta mqabbel mal-gruppi ta' kontroll: ematotossiċità, infezzjoni newtropenika, infezzjoni fl-apparat urinarju, disturb sensorjali, deni.
English: The final analysis confirmed that R-CHOP 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 kliniku rilevanti u statistikament sinifikanti fit-tul ta' żmien ta' sopravivenza mingħajr avvenimenti (il-parametru primarju tal-effikaċja; fejn l-avvenimenti kienu mewt, osservazzjoni mill-ġdid jew progressjoni tal-limfoma, jew bidu ta' kura ġdida kontra l-limfoma) (p = 0.0001).
English: In Trial 1, conducted in patients with inadequate response or intolerance to one or more TNF inhibitor therapies, receiving MabThera in combination with methotrexate demonstrated significantly less radiographic progression than patients originally receiving methotrexate alone at 56 weeks.
Maltese: Fi Prova 1, imwettaq f'pazjenti b'rispons inadegwat jew intolleranza għal terapija waħda jew aktar ta' inibizzjoni ta' TNF, li kienu qed jirċievu MabThera flimkien ma' methotrexate kienet murija progressjoni radjugrafika sinifikattivament anqas mill-pazjenti li oriġinarjament irċevew methotrexate waħdu wara 56 ġimgħa.
English: The incidence of ADRs of all grades and grade 3/4 ADR was similar in elderly patients compared to younger patients (<65 years).
Maltese: L-inċidenza ta' ADRs ta' kull grad u ta' ADRs ta' grad 3/4 kienet simili f'pazjenti anzjani meta mqabbel ma' pazjenti ta' età iżgħar (<65 sena).
English: Minor relapses (not life threatening and not involving major organ damage) occurred in seven patients in the MabThera 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' MabThera (12%) u fi tmien pazjenti filgrupp ta' azathioprine (14%).
English: MabThera 500 mg concentrate for solution for infusion Each mL contains 10 mg of rituximab.
Maltese: MabThera 500 mg konċentrat għal soluzzjoni għal infużjoni Kull mL fih 10 mg ta' rituximab.
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: 10.49 years log-rank p value hazard ratio (95% CI) risk reduction Secondary efficacy Overall survival (median)
Maltese: 49 sena valur p log-rank proporzjon ta' periklu (CI ta' 95%) tnaqqis tar-riskju
English: Elderly No dose adjustment is required in elderly patients (aged >65 years).
Maltese: M'hemmx bżonn ta' aġġustament fid-doża f'pazjenti anzjani (età ta' >65 sena).
English: • Skin reactions including hives, itching and rash
Maltese: • Reazzjonijiet fil-ġilda inkluż ħorriqija, ħakk u raxx
English: The study showed statistically significant results of MabThera 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' MabThera 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: No difference between the R-CHOP and CHOP group was observed in the incidence of other grade 3 and 4 cardiac events including heart failure, myocardial disease and manifestations of coronary artery disease.
Maltese: Ma kienet osservata l-ebda differenza bejn il-grupp ta' R-CHOP u CHOP fl-inċidenza ta' avvenimenti kardijaċi oħra ta' grad 3 u 4 inkluż insuffiċjenza tal-qalb, mard mijokardijaku u manifestazzjonijiet tal-marda tal-arterji koronarji.
English: Cases of posterior reversible encephalopathy syndrome (PRES) / reversible posterior leukoencephalopathy syndrome (RPLS) have been reported.
Maltese: (RPLS - reversible posterior leukoencephalopathy syndrome).
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: • you are allergic to hyaluronidase (an enzyme that helps to increase the absorption of injected active substance)
Maltese: • inti allerġiku għal hyaluronidase (enzima li tgħin biex iżżid l-assorbiment tas-sustanza attiva injettata)
English: The safety profile of MabThera in patients with PV was consistent with that observed in RA and GPA/MPA patients.
Maltese: Il-profil ta' sigurtà ta' MabThera f'pazjenti b'PV kien konsistenti ma' dak osservat f'pazjenti b'RA u GPA/MPA.
English: In a population pharmacokinetic analysis in 403 follicular lymphoma patients who received subcutaneous and/or intravenous MabThera, single or multiple infusions of MabThera as a single agent or in combination with chemotherapy, the population estimates of nonspecific clearance (CL1), initial specific clearance (CL2) likely contributed by B cells or tumour burden, and central compartment volume of distribution (V1) were 0.194 L/day, 0.535 L/day, and 4.37 L/day, respectively.
Maltese: F'analiżi tal-farmakokinetika tal-popolazzjoni f'403 pazjenti b'limfoma follikulari li rċevew MabThera taħt il-ġilda u/jew fil-vini, infużjonijiet singoli jew multipli ta' MabThera bħala sustanza waħedha jew flimkien ma' kimoterapija, l-istimi tal-popolazzjoni ta' tneħħija mhux speċifika (CL1), tneħħija speċifika inizjali (CL2) li x'aktarx kienet kontributa minn ċelluli B jew mill-kobor tat-tumur, u l-volum ta' distribuzzjoni fil-kompartiment ċentrali (V1) kienu ta' 0.194
English: • MabThera intravenous formulation (n= 205): 8 cycles of MabThera intravenous formulation in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks.
Maltese: • Formulazzjoni għall-għoti fil-vini ta' MabThera (n=205): 8 ċikli ta' formulazzjoni għall-għoti fil-vini ta' MabThera flimkien ma' sa 8 ċikli ta' kimoterapija CHOP jew CVP mogħtija kull 3 ġimghat.
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: Rkadar ta' kondizzjonijiet kardijaċi eżistenti minn qabel bħal anġina pectoris jew insuffiċjenza tal-qalb konġestiva jew disturbi kardijaċi severi (insuffiċjenza tal-qalb, infart mijokardijaku, fibrillazzjoni atrijali), edima pulmonari, insuffiċjenza ta' ħafna organi, sindrome tal-lisi tat-tumur, sindrome tar-reħa ta' cytokine, insuffiċjenza tal-kliewi, u insuffiċjenza respiratorja kienu rrappurtati bi frekwenza aktar baxxa jew bi frekwenza mhux magħrufa.
English: Psychiatric disorders depression, anxiety
Maltese: Disturb depressiv persistenti Depressjoni kbira
English: **: only applicable to patients achieving a CR;
Maltese: **: japplika biss għall-pazjenti li laħqu CR;
English: Injury, Poisoning and Procedural Complications Infusion-related reactions* Skin and Subcutaneous Tissue Disorders Alopecia Pruritus Urticaria Skin disorder Psychiatric Disorders Persistent depressive disorder Major depression Irritability Infections and Infestations Herpes virus infection Herpes zoster Oral herpes Conjunctivitis General Disorders and Administration Site Conditions Fatigue Pyrexia Nervous System Disorders Headache Dizziness Gastrointestinal Disorders Abdominal pain upper Cardiac Disorders Tachycardia Musculoskeletal and Connective Tissue Disorders Musculoskeletal pain Neoplasms Benign, Malignant and Unspecified (incl cysts and polyps) Skin papilloma * Infusion-related reactions included symptoms collected on the next scheduled visit after each infusion, and adverse events occurring on the day of or one day after the infusion.
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' MabThera. Manifestazzjonijiet kliniċi ta' anafilassi jistgħu jidhru simili għal manifestazzjonijiet kliniċi tas-sindrome tar-reħa taċ-ċitokina (deskritt aktar 'il fuq).
English: In the induction of remission clinical trial, 24% of patients in the MabThera 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' MabThera (kors wieħed) u 23% tal-pazjenti fil-grupp ta' cyclophosphamide żviluppaw newtropenija ta' CTC grad 3 jew aktar.
English: chemotherapy treatment; ORR: overall response rate; NR: not reached at time of clinical cut-off, OR: odds ratio.
Maltese: Tqassir: NA, mhux disponibbli; ORR: rata ta' rispons globali; CR: rispons komplut; PR: rispons parzjali
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeletrali
English: The estimated half-life of Mabthera subcutaneous formulation of 1600 mg is 30 days, the estimated clearance is 0.22 L/day and the volume of distribution of the central compartment is 4.65 L.
Maltese: Il--half-life stmata tal-formulazzjoni għall-għoti taħt il-ġilda ta' MabThera 1600 mg hija 30 ġurnata, it-tneħħija stmata hija 0.22 L/jum u l-volum ta' distribuzzjoni tal-kompartiment ċentrali huwa 4.65 L.
English: 9.25 years log-rank p value hazard ratio (95% CI) risk reduction TNLT (median)
Maltese: 4.04 snin 9.25 sena valur p log-rank proporzjon ta' periklu (CI ta' 95%) tnaqqis tar-riskju
English: The clinical relevance of the development of anti-rituximab antibodies or anti-rHuPH20 antibodies after treatment with MabThera subcutaneous formulation is not known.
Maltese: Ir-rilevanza klinika tal-iżvilupp ta' antikorpi kontra rituximab jew kontra rHuPH20 wara kura bil-formulazzjoni għall-għoti taħt il-ġilda ta' MabThera mhux magħrufa.
English: The serum rituximab Cmax at cycle 7 was similar between the two treatment arms, with geometric mean (CV%) values of 250.63 (19.01) μg/mL and 236.82 (29.41) μg/mL for the intravenous and the subcutaneous formulations respectively, with the resulting geometric mean ratio (Cmax, SC/Cmax, IV) of 0.941 (90% CI: 0.872, 1.015).
Maltese: 82 (29.41) μg/mL għall-formulazzjonijiet għall-għoti fil-vini u taħt il-ġilda rispettivament, b'riżultat tal-proporzjon tal-medja ġeometrika (Cmax, SC/Cmax, IV) ta' 0.941 (CI ta' 90%: 0.872, 1.015).
English: All patients treated with MabThera 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: In the clinical trial on induction of remission, the incidence of malignancy in MabThera 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'MabThera 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: LIST OF EXCIPIENTS
Maltese: + Iċċensurat
English: Neither age, sex, lymphoma grade, initial diagnosis, presence or absence of bulky disease, normal or high LDH nor presence of extranodal disease had a statistically significant effect (Fisher's exact test) on response to MabThera.
Maltese: L-età, is-sess, il-grad tal-limfoma, id-dijanjosi inizjali, il-preżenza jew in-nuqqas ta' bulky disease, LDH normali jew għoli u l-preżenza ta' mard ekstranodali ma kellhomx effett statistikament sinifikanti (it-test eżatt ta' Fisher) fuq ir-rispons għal MabThera.
English: Use of MabThera may be associated with an increased risk of progressive multifocal leukoencephalopathy (PML).
Maltese: L-użu ta' MabThera jista' jkun assoċjat ma' riskju akbar ta' lewkoenċefalopatija multifokali progressiva (PML - progressive multifocal leukoencephalopathy).
English: Of the patients originally receiving methotrexate alone, 81 % received MabThera either as rescue between weeks 16-24 or in the extension trial, before week 56.
Maltese: Mill-pazjenti li oriġinarjament kienu qegħdin jirċievu methotrexate waħdu, 81 % rċevew MabThera jew bħala salvataġġ bejn ġimgħa 16-24 jew fil-prova ta' estensjoni, qabel ġimgħa 56.
English: The safety profile of MabThera 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 MabThera group.
Maltese: Il-profil ta' sigurtà ta' MabThera flimkien ma' doża baxxa ta' glukokortikojdi għal perjodu qasir fittrattament ta' pazjenti b'pemphigus vulgaris ġie studjat fi studju ta' Fażi 3, randomised, ikkontrollat, b'aktar minn ċentru wieħed, open-label f'pazjenti b'pemphigus li kien jinkludi 38 pazjent b'pemphigus vulgaris (PV) randomised għall-grupp ta' MabThera.
English: MabThera intravenous
Maltese: Tumuri malinni
English: Cardiovascular reactions during clinical trials with MabThera monotherapy were reported in 18.8% of patients with the most frequently reported events being hypotension and hypertension.
Maltese: Reazzjonijiet kardjovaskulari waqt provi kliniċi b'monoterapija ta' MabThera kienu rrappurtati fi 18.8% tal-pazjenti u l-aktar avvenimenti rrappurtati b'mod frekwenti kienu pressjoni baxxa u pressjoni għolja.
English: Although MabThera 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 MabThera mhux mijelosuppressiv fil-monoterapija, għandha tingħata attenzjoni meta tiġi kkunsidrata l-kura ta' pazjenti b'newtrofili < 1.5 x 109/L u/jew għadd plejtlits < 75 x 109/L, minħabba li l-esperjenza klinika f'din il-popolazzjoni hija limitata.
English: Toxic Epidermal Necrolysis (Lyell's syndrome), Stevens-Johnson syndrome5
Maltese: Reazzjonijiet bl-imsiemer severi fil-ġilda, Sindrome ta' Stevens-Johns on, nekrolisi tossika tal-epidermide (Sindrome ta' Lyell)