FrancophonIA/ELRC3.0 huggingface dataset:
English: Aseptically withdraw the necessary amount of Ritemvia, and dilute to a calculated concentration of 1 to 4 mg/mL rituximab into an infusion bag containing sterile, pyrogen-free sodium chloride 9 mg/mL (0.9%) solution for injection or 5% D-Glucose in water.
Maltese: minn 1 sa 4 mg/mL ta' rituximab f'borża tal-infużjoni li jkun fiha, soluzzjoni għall-injezzjoni sterili u mingħajr piroġeni ta' klorur tas-sodju 9 mg/mL (0.9%) jew 5% D-Glucose fl-ilma.
English: Patient subpopulations - rituximab combination therapy Elderly patients (≥ 65 years)
Maltese: Sottopopolazzjonijiet ta' pazjenti - rituximab bħala terapija kombinata Pazjenti anzjani (≥ 65 sena):
English: levels4
Maltese: IgG4
English: Hypogammaglobulinaemia
Maltese: Ipogammaglobulinimja
English: Patients were between 19 and 79 years of age and had not received prior therapies for pemphigus.
Maltese: Il-pazjenti kellhom bejn 19 u 79 sena u ma kinux irċevew terapiji għal pemphigus fil-passat.
English: In the clinical trial evaluating rituximab maintenance treatment in relapsed/refractory follicular lymphoma, median IgG levels were below the lower limit of normal (LLN) (< 7 g/L) after induction treatment in both the observation and the rituximab groups.
Maltese: Fil-prova klinika li vvalutat kura ta' manteniment b'rituximab f'limfoma follikulari li rkadat jew reġgħet tfaċċat, livelli medjana ta' IgG kienu taħt il-limitu l-baxx tan-normal (LLN) (< 7 g/L) wara lkura ta' induzzjoni kemm fil-grupp ta' osservazzjoni kif ukoll f'dak ta' rituximab.
English: A maintenance infusion of 500 mg IV should be administered at months 12 and 18, and then every 6 months thereafter if needed, based on clinical evaluation.
Maltese: Infużjoni ta' manteniment ta' 500 mg IV għandha tingħata fix-xhur 12 u 18, u mbagħad kull 6 xhur wara dan jekk meħtieġ, abbażi ta' evalwazzjoni klinika.
English: All IRRs were CTC Grade 1 or 2.
Maltese: L-IRRs kollha kienu ta' Grad CTC 1 jew 2.
English: Of 356 patients evaluated for anti-drug antibody (ADA), 1.1% (4 patients) were positive.
Maltese: Mit-356 pazjent evalwat għall-antikorp kontra l-mediċina (ADA - anti-drug antibody), 1.1% (4 pazjenti) kienu pożittivi.
English: CELLTRION Inc.,
Maltese: Inc.,
English: In the overall experience of rituximab repeat treatment over one year in rheumatoid arthritis, the proportions of patients with positive antibody titres against S. pneumoniae, influenza, mumps, rubella, varicella and tetanus toxoid were generally similar to the proportions at baseline.
Maltese: Fl-esperjenza globali ta' kura ripetuta ta' rituximab fuq medda ta' sena f'artrite rewmatika, ilproporzjon ta' pazjenti b'titri ta' antikorpi pożittivi kontra S. pneumoniae, influwenza, ħosba, rubella, varicella u tossojdi tat-tetanus ġeneralment kienu simili għall-proporzjonijiet fil-linja bażi.
English: The incidence of thrombocytopenia was low (<1%, grade 3/4) and was not different between treatment arms.
Maltese: L-inċidenza ta' tromboċitopenija kienet baxxa (< 1%, grad 3/4) u ma kinitx differenti bejn il-gruppi ta' kura.
English: You will always be given Ritemvia as a drip (intravenous infusion).
Maltese: Inti dejjem se tingħata Ritemvia bħala dripp (infużjoni fil-vini).
English: In the PV population, 5 (13%) patients in the rituximab group and 3 (8%) patients in the standard prednisone group had moderate disease and 33 (87%) patients in the rituximab group and 33 (92%) of patients in the standard-dose prednisone group had severe disease according to disease severity defined by Harman's criteria.
Maltese: Fil-popolazzjoni b'PV, 5 (13%) pazjenti fil-grupp ta' rituximab u 3 (8%) pazjenti fil-grupp ta' prednisone standard kellhom marda moderata u 33 (87%) pazjent fil-grupp ta' rituximab u 33 (92%) pazjent fil-grupp b'doża standard ta' prednisone kellhom marda severa skont is-severità tal-marda ddefinita mill-kriterji ta' Harman.
English: Specific studies to determine the effects of rituximab on fertility have not been performed.
Maltese: Ma sarux studji speċifiċi sabiex jiġu determinati l-effetti ta' rituximab fuq il-fertilità.
English: In the rituximab group, 48% of patients achieved CR at 12 months, and 39% of patients achieved CR at 18 months.
Maltese: Fil-grupp ta' rituximab, 48% tal-pazjenti laħqu CR wara 12-il xahar, u 39% tal-pazjenti laħqu CR wara 18-il xahar.
English: Hypogammaglobulinaemia (IgA, IgG or IgM below the lower limit of normal) has been observed in granulomatosis with polyangiitis and microscopic polyangiitis patients treated with rituximab.
Maltese: Ipogammaglobulinimja (IgA, IgG jew IgM inqas mil-limitu l-aktar baxx tan-normal) kienet osservata f'pazjenti bi granulomatosi b'polianġite u polianġite mikroskopika kkurati b'rituximab.
English: The proportion of patients experiencing an infusion-related reaction was 29% (11 patients), 40% (15 patients), 13% (5 patients), and 10% (4 patients) following the first, second, third, and fourth infusions, respectively.
Maltese: Il-proporzjon ta' pazjenti li kellhom reazzjoni relatata mal-infużjoni kien ta' 29% (11-il pazjent), 40% (15-il pazjent), 13% (5 pazjenti), u 10% (4 pazjenti) wara l-ewwel, it-tieni, it-tielet, u r-raba' infużjoni, rispettivament.
English: Among the 3189 patients treated with rituximab, 1,135 (36%) experienced at least one IRR with 733/3,189 (23%) of patients experiencing an IRR following first infusion of the first exposure to rituximab.
Maltese: Fost 3,189 pazjent kkurat b'rituximab, 1,135 (36%) kellhom esperjenza ta' mill-inqas IRR waħda b'733/3,189 (23%) tal-pazjenti li kellhom IRR wara l-ewwel infużjoni tal-ewwel esponiment għal rituximab.
English: Following second infusion, mean Cmax ranged from 183 to 198 μg/mL for the 2 × 500 mg dose and ranged from 355 to 404 μg/mL for the 2 × 1000 mg dose.
Maltese: Wara t-tieni infużjoni, Cmax medja varjat minn 183 sa 198 μg/mL għad-doża ta' 2 × 500 mg u varjat minn 355 sa 404 μg/mL għad-doża ta' 2 × 1,000 mg.
English: a) Non-Hodgkin's Lymphoma
Maltese: a) Limfoma Mhux ta' Hodgkin
English: The pharmacokinetic (PK) parameters in the anti-TNF inadequate responder population, following the same dosage regimen (2 × 1000 mg, IV, 2 weeks apart), were similar with a mean maximum serum concentration of 369 μg/mL and a mean terminal half-life of 19.2 days.
Maltese: Il-parametri farmakokinetiċi (PK) fil-popolazzjoni li rrispondiet b'mod inadegwat għall-mediċini kontra TNF, bl-użu tal-istess reġim ta' dożaġġ (2 x 1,000 mg, IV, ġimagħtejn 'il bogħod minn xulxin), kienu simili b'konċentrazzjoni massima medja fis-serum ta' 369 μg/mL u half-life terminali medja ta'
English: Rituximab N=505
Maltese: N=505
English: The efficacy and safety of rituximab in combination with short-term, low-dose glucocorticoid (prednisone) therapy were evaluated in newly diagnosed patients with moderate to severe pemphigus (74 pemphigus vulgaris [PV] and 16 pemphigus foliaceus [PF]) in this randomised, open-label, controlled, multicenter study.
Maltese: L-effikaċja u s-sigurtà ta' rituximab flimkien ma' terapija b'doża baxxa ta' glukokortikojdi (prednisone) għal perjodu qasir kienu evalwati f'pazjenti ddijanjostikati għall-ewwel darba b'pemphigus moderat sa sever (74 pemphigus vulgaris [PV] u 16 pemphigus foliaceus [PF]) f'dan listudju randomised, open-label, ikkontrollat, b'aktar minn ċentru wieħed.
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: Table 7 Overview of efficacy results for rituximab maintenance vs. observation at the protocol-defined primary analysis and after 9 years median follow-up (final analysis)
Maltese: Tabella 7 Sommarju tar-riżultati tal-effikaċja għal manteniment b'rituximab kontra osservazzjoni fl-analiżi primarja definita mill-protokoll u wara segwitu medjan ta' 9 snin (analiżi finali)
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 rituximab.
Maltese: sensittività eċċessiva, eż. epinefrina (adrenalina), antistamini u glukokortikojdi, f'każ li jkun hemm reazzjoni allerġika waqt l-amministrazzjoni ta' rituximab.
English: Rituximab, administered as an intravenous infusion at a dose of 375 mg/m2 at weekly intervals for 4 doses to 203 patients with NHL naive to rituximab, yielded a mean Cmax following the fourth infusion of 486 µg/mL (range, 77.5 to 996.6 µg/mL).
Maltese: Rituximab mogħti f'doża ta' 375 mg/m2 bħala infużjoni fil-vini f'intervalli ta' kull ġimgħa għal 4 dożi lil 203 pazjent b'NHL li qatt ma kienu ħadu rituximab qabel, ipproduċa Cmax medja wara r-raba' infużjoni ta' 486 µg/mL (firxa, 77.5 sa 996.6 µg/mL).
English: The median duration of response was 37.7 months in the R-CVP group and was 13.5 months in the CVP group (p < 0.0001, log-rank test).
Maltese: Il-tul medjan ta' rispons kien 37.7 xhur fil-grupp ta' R-CVP u kien ta' 13.5 xhur fil-grupp ta' CVP (p < 0.0001, test log-rank).
English: Following two intravenous infusions of rituximab at a dose of 1000 mg, two weeks apart, the mean terminal half-life was 20.8 days (range, 8.58 to 35.9 days), mean systemic clearance was 0.23 L/day (range, 0.091 to 0.67 L/day), and mean steady-state distribution volume was 4.6 L (range, 1.7 to 7.51 L).
Maltese: 8 ġurnata (medda, 8.58 sa 35.9 ġurnata), il-medja tat-tneħħija sistemika kienet ta' 0.23 L/jum (medda, 0.091 sa 0.67 L/jum), u l-medja tal-volum taddistribuzzjoni fi stat fiss kienet ta' 4.6 l (medda, 1.7 sa 7.51 L).
English: Rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulgaris
Maltese: Artrite rewmatika, granulomatosi b'polianġite u polianġite mikroskopika, u pemphigus vulgaris
English: Week 48
Maltese: 49 sena
English: Similar effects have been observed in animal studies (see section 5.3).
Maltese: Effetti simili kienu osservati fi studji fuq l-annimali (ara sezzjoni 5.3).
English: Infectious events (predominantly bacterial and viral) occurred in approximately 30-55% of patients during clinical trials in patients with NHL and in 30-50% of patients during clinical trials in patients with CLL
Maltese: Avvenimenti infettivi (fil-biċċa l-kbira kkawżati minn batterja jew virusis) seħħew f'madwar 30-55% tal-pazjenti waqt provi kliniċi f'pazjenti b'NHL u f'30-50% tal-pazjenti waqt provi kliniċi f'pazjenti b'CLL.
English: 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: Kienu rrappurtati reazzjonijiet severi fil-ġilda bħal Nekrolisi Tossika tal-Epidermide (Sindrome ta' Lyell) u s-Sindrome ta' Stevens-Johnson, uħud b'riżultat fatali (ara sezzjoni 4.8).
English: Urinary tract infection Bronchitis
Maltese: Infezzjoni fl-apparat tal-awrina Bronkite
English: Date of first infusion:
Maltese: Data tal-aħħar tiġdid:
English: Depending on the severity of the IRR and the required interventions, temporarily or permanently discontinue rituximab.
Maltese: Skont is-severità tal-IRR u l-interventi meħtieġa, waqqaf rituximab temporanjament jew b'mod permanenti.
English: Vascular disorders hypertension, orthostatic hypotension, hypotension vasculitis (predominate ly cutaneous), leukocytoclas tic vasculitis
Maltese: Disturbi vaskulari pressjoni għolja, pressjoni ortostatika baxxa, pressjoni baxxa vaskulite (primarjame nt fil-ġilda),
English: The difference between the treatment groups with respect to overall survival showed a significant clinical difference (p=0.029, log-rank test stratified by centre): survival rates at 53 months were 80.9% for patients in the R-CVP group compared to 71.1% for patients in the CVP group．
Maltese: Id-differenza bejn il-gruppi ta' kura f'dak li jikkonċerna is-sopravivenza globali wriet differenza klinika sinifikanti (p = 0.029, test log-rank stratifikat biċ-ċentru): rati ta' sopravivenza wara 53 xahar kienu 80.9% għall-pazjenti fil-grupp ta' R-CVP meta mqabbel ma' 71.1% għall-pazjenti fil-grupp ta' CVP.
English: Rituximab should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3) or severely immunocompromised patients (e.g. where levels of CD4 or CD8 are very low).
Maltese: Rituximab m'għandux jingħata lil pazjenti b'infezzjoni attiva, severa (eż. tuberkulożi, sepsis u infezzjonijiet opportunistiċi, ara sezzjoni 4.3) jew pazjenti immunokompromessi severament (eż. fejn il-livelli ta' CD4 jew CD8 ikunu baxxi ħafna).
English: In a further clinical study, a total of 57 severe active GPA and MPA patients in disease remission were treated with rituximab for the maintenance of remission (see section 5.1)
Maltese: Fi studju kliniku addizzjonali, total ta' 57 pazjent b'GPA u MPA attivi u severi f'remissjoni tal-marda kienu ttrattati b'rituximab għall-manteniment tar-remissjoni (ara sezzjoni 5.1).
English: Very rare cases of progressive multifocal leukoencephalopathy (PML) have been reported during post-marketing use of rituximab in NHL and CLL (see section 4.8).
Maltese: Każijiet rari ħafna ta' lewkoenċefalopatija multifokali progressiva (PML) kienu rrappurtati waqt l-użu ta' wara t-tqegħid fis-suq ta' rituximab f'NHL u CLL (ara sezzjoni 4.8).
English: Event free survival Response rate (CR, nPR, or PR) CR rates
Maltese: Rata ta' rispons (CR, nPR, jew PR) Rati ta' CR
English: In rheumatoid arthritis patients, immediate depletion of B cells in the peripheral blood was observed following two infusions of 1000 mg rituximab separated by a 14 day interval.
Maltese: F'pazjenti morda bl-artrite rewmatika, tnaqqis immedjat taċ-ċelluli B fid-demm periferali ġie osservat wara żewġ infużjonijiet ta' 1,000 mg rituximab separati b'intervall ta' 14-il jum.
English: In two open-label randomised trials, a total of 817 previously untreated patients and 552 patients with relapsed/refractory CLL were randomised to receive either FC chemotherapy (fludarabine 25 mg/m2, cyclophosphamide 250 mg/m2, days 1-3) every 4 weeks for 6 cycles or rituximab in combination with FC (R-FC).
Maltese: F'żewġ provi open-label u randomised, total ta' 817 pazjent li ma kienux ikkurati minn qabel u 552 pazjent b'CLL li reġgħet tfaċċat/refrattarja kienu randomised biex jirċievu kimoterapija ta' FC (fludarabine 25 mg/m2, cyclophosphamide 250 mg/m2, ġranet 1-3) kull 4 ġimgħat għal 6 ċikli jew rituximab flimkien ma' FC (R-FC).
English: The most common infections in the rituximab group were herpes simplex and zoster infections, bronchitis, urinary tract infection, fungal infection and conjunctivitis.
Maltese: L-aktar infezzjonijiet komuni fil-grupp ta' rituximab kienu infezzjonijiet ta' herpes simplex u zoster, bronkite, infezzjoni fl apparat tal-awrina, infezzjoni fungali u konġuntivite.
English: Ritemvia, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA).
Maltese: Granulomatosi b'polianġite u polianġite mikroskopika Ritemvia, flimkien ma' glukokortikojdi, huwa indikat għat-trattament ta' pazjenti adulti bi granulomatosi b'polianġite (ta' Wegener) (GPA - granulomatosis with polyangiitis) attiva u severa u polianġite mikroskopika (MPA - microscopic polyangiitis).
English: In a subgroup analysis, the ORR was higher in patients with IWF B, C, and D histological subtypes as compared to IWF A subtype (58% vs. 12%), higher in patients whose largest lesion was < 5 cm vs. > 7 cm in greatest diameter (53% vs. 38%), and higher in patients with chemosensitive relapse as compared to chemoresistant (defined as duration of response < 3 months) relapse (50% vs. 22%).
Maltese: F'analiżi tas-sottogruppi, ORR kien ogħla f'pazjenti b'sottotipi istoloġiċi IWF B, Ċ u D kif ikkomparati mas-sottotip IWF A (58% kontra 12%), ogħla f'pazjenti li l-akbar leżjoni tagħhom kienet < 5 ċm kontra > 7 ċm fl-akbar dijametru (53% kontra 38%), u ogħla f'pazjenti li reġgħu esperjenzaw il-kimosensittività meta kkumparata ma' dawk li reġgħu esperjenzaw il-kimoreżistenza (definita bħala tul ta' rispons ta' < 3 xhur) (50% kontra 22%).
English: Premedication and prophylactic medications
Maltese: TAL-PRODOTT MEDIĊINALI
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: Mean Cmax for serum rituximab following first infusion ranged from 157 to 171 μg/mL for 2 × 500 mg dose and ranged from 298 to 341 μg/mL for 2 × 1000 mg dose.
Maltese: Cmax medja għal rituximab fis-serum wara l-ewwel infużjoni varjat minn 157 sa 171 μg/mL għad-doża ta' 2 x 500 mg u varjat minn 298 sa 341 μg/mL għad-doża ta' 2 x 1,000 mg.
English: 14 patients (37%) in the rituximab group experienced treatment-related infections compared to 15 patients (42%) in the standard-dose prednisone group.
Maltese: Erbatax-il pazjent (37%) fil-grupp ta' rituximab kellhom infezzjonijiet relatati mat-trattament meta mqabbla ma' 15-il pazjent (42%) fil-grupp b'doża standard ta' prednisone.
English: adjusted)
Maltese: infużjonijiet).
English: Overall, 4% of patients in the rituximab arm experienced adverse events leading to discontinuation.
Maltese: B'mod globali, 4% tal-pazjenti fil grupp ta' rituximab kellhom avvenimenti avversi li wasslu għal waqfien.
English: Adverse drug reaction1
Maltese: Reazzjoni avversa tal-mediċina1
English: Cases of hepatitis B reactivation have been reported in subjects receiving rituximab including fulminant hepatitis with fatal outcome.
Maltese: F'individwi li kienu qed jirċievu rituximab kienu rrappurtati każijiet ta' riattivazzjoni ta' epatite B, inkluż epatite fulminanti b'riżultat fatali.
English: Immune system disorders infusion related reactions4, angioedema hypersensitivit y anaphylaxi s tumour lysis syndrome, cytokine release syndrome4, serum sickness infusion-related acute reversible thrombocytope nia4
Maltese: Disturbi fissistema immuni reazzjonijiet relatati mal infużjoni4, anġjoedima sensittività eċċessiva anafilassi sindrome tallisi tat-tumur, sindrome tarrilaxx taċ ċitokina4,
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: The incidence of IRR decreased with subsequent courses (see section 4.8).
Maltese: L-inċidenza ta' IRR naqset b'korsijiet sussegwenti (ara sezzjoni 4.8).
English: The following terms have been reported as adverse events during clinical trials, however, were reported at a similar or lower incidence in the rituximab-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'rituximab meta mqabbel mal-gruppi ta' kontroll: ematotossiċità, infezzjoni newtropenika, infezzjoni fl-apparat urinarju, disturb sensorjali, deni.
English: ORR was 38% (CI95% 26% - 51%; 10% CR, 28% PR) with a projected median TTP for responding patients of 17.8 months (range 5.4 - 26.6).
Maltese: Għas-60 kura mill-ġdid fl-istudju, L-ORR kienet ta' 38% (CI95% 26% - 51%; 10% CR, 28% PR) b'TTP medjan ipproġettat għal pazjenti li rrispondew ta' 17.8 xhur (firxa minn 5.4 sa 26.6 xhur).
English: The overall rate of infection was approximately 94 per 100 patient years in rituximab treated patients.
Maltese: Ir-rata globali ta' infezzjoni kienet bejn wieħed u ieħor 94 għal kull 100 sena ta' pazjent fil-pazjenti ttrattati b'rituximab.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTURI RESPONSABBLI
English: The majority of these subjects were also exposed to cytotoxic chemotherapy.
Maltese: ċitokini u/jew medjaturi kimiċi oħra.
English: In patients with relapsed/refractory CLL, the incidence of grade 3/4 hepatitis B infection (reactivation and primary infection) was 2% in R-FC vs. 0% FC.
Maltese: F'pazjenti b'CLL li reġgħet tfaċċat/refrattarja, l-inċidenza ta' infezzjoni ta' epatite B ta' grad 3/4 (riattivazzjoni u infezzjoni primarja) kienet ta' 2% f'R-FC vs 0% FC.
English: Significant benefit from maintenance treatment with rituximab was also seen for the secondary endpoints event-free survival (EFS), time to next anti-lymphoma treatment (TNLT) time to next chemotherapy (TNCT) and overall response rate (ORR) in the primary analysis (Table 7).
Maltese: Kien osservat ukoll benefiċċju sinifikanti minn kura ta' manteniment b'rituximab għall-punti finali sekondarji ta' sopravivenza mingħajr avvenimenti (EFS), żmien sal-kura li jmiss kontra l-limfoma (TNLT), żmien sal-kimoterapija li jmiss (TNCT) u rata ta' rispons globali (ORR) fl-analiżi primarja (Tabella 7).
English: Clinical experience in rheumatoid arthritis
Maltese: Esperjenza klinika f'artrite rewmatika
English: In addition, there was no apparent effect of fludarabine and cyclophosphamide on the pharmacokinetics of rituximab.
Maltese: Barra dan, ma kien hemm l-ebda effett evidenti ta' fludarabine u cyclophosphamide fuq il-farmakokinetika ta' rituximab.
English: This medicinal product contains 52.6 mg sodium per 10 mL vial, equivalent to 2.6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.For the full list of excipients, see section 6.1.
Maltese: Dan il-prodott mediċinali fih 52,6 mg sodium f'kull kunjett ta '10 mL, ekwivalenti għal 2,6% talammont massimu rakkomandat mill-WHO ta 2 g sodium li għandu jittieħed kuljum minn adult.
English: serious viral infection2 pneumocystis jirovecii
Maltese: Pneumocystis jirovecii
English: Alopecia Pruritus
Maltese: Effikaċja primarja
English: • respiratory failure
Maltese: Disturbi respiratorji,
English: Contraindications for use in rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis and pemphigus vulgaris
Maltese: Kontraindikazzjonijiet għall-użu f'artrite rewmatika, granulomatosi b'polianġite, polianġite mikroskopika u pemphigus vulgaris
English: 99 patients were treated for induction of remission of GPA and MPA in a clinical trial with rituximab (375 mg/m2, once weekly for 4 weeks) and glucocorticoids (see section 5.1).
Maltese: Disgħa u disgħin pazjent kienu ttrattati għall-induzzjoni ta' remissjoni ta' GPA u MPA fi prova klinika b'rituximab (375 mg/m2, darba fil-ġimgħa għal 4 ġimgħat) u glukokortikojdi (ara sezzjoni 5.1).
English: • Information on the Patient Alert Card
Maltese: • Informazzjoni dwar il-Kartuna ta' Twissija għall-pazjent
English: In the first-line study, after a median observation time of 48.1 months, the median PFS was 55 months in the R-FC group and 33 months in the FC group (p < 0.0001, log-rank test).
Maltese: Fl-istudju primarju, wara żmien ta' osservazzjoni medjan ta' 48.1 xhur, il-PFS medjana kienet ta' 55 xahar fil-grupp ta' R-FC u ta' 33 xahar fil-grupp ta' FC (p < 0.0001, test log-rank).
English: Skin and subcutaneous tissue disorders alopecia toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome5
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt ilġilda alopeċja nekrolisi tossika talepidermide (sindrome ta' Lyell), sindrome ta' Stevens-Johnson5
English: Treatment with R-CVP significantly prolonged the time to disease progression or death compared to CVP, 33.6 months and 14.7 months, respectively (p < 0.0001, log-rank test).
Maltese: Kura b'R-CVP tawwlet b'mod sinifikanti iż-żmien sal-progressjoni tal-marda jew sal-mewt meta mqabbel ma' CVP, 33.6 xhur u 14.7 xhur, rispettivament (p < 0.0001, test log-rank).
English: Read the leaflet for further information.
Maltese: Sorsi oħra ta' informazzjoni