FrancophonIA/ELRC3.0 huggingface dataset:
English: anaphylaxis tumour lysis syndrome, cytokine release syndrome4, serum sickness infusion-relate d acute reversible thrombocytop enia4
Maltese: Disturbi fissistema immuni reazzjonijiet relatati mal infużjoni4, anġjoedima sensittività eċċessiva anafilassi sindrome tallisi tat-tumur, sindrome tarrilaxx taċċitokina4, marda tasserum tromboċito penija akuta riversibbli relatata mal infużjoni4
English: The overall response rate (ORR) in the intent-to-treat (ITT) population was 48 % (CI95% 41% - 56%) with a 6% complete response (CR) and a 42% partial response (PR) rate.
Maltese: 48% (CI95% 41% - 56%) b'rispons komplut (CR) ta' 6% u rata ta' rispons parzjali (PR) ta' 42%.
English: The proportion of patients with a tumour response (CR, CRu, PR) was significantly higher (p< 0.0001 Chi-Square test) in the R-CVP group (80.9%) than the CVP group (57.2%).
Maltese: fil-grupp ta' R-CVP (80.9%) milli fil-grupp ta' CVP (57.2%).
English: IRRs for patients with granulomatosis with polyangiitis and microscopic polyangiitis were similar to those seen for rheumatoid arthritis patients in clinical trials (see section 4.8).
Maltese: IRRs għall-pazjenti bi granulomatosi b'polianġite u polianġite mikroskopika kienu simili għal dawk osservati f'pazjenti b'artrite rewmatika fi provi kliniċi (ara sezzjoni 4.8).
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, il proporzjon 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: Subsequent doses of Rituzena can be infused at an initial rate of 100 mg/h, and increased by 100 mg/h increments at 30 minute intervals, to a maximum of 400 mg/h.
Maltese: Dożi sussegwenti ta' Rituzena jistgħu jiġu infużi b'rata inizjali ta' 100 mg/siegħa, u miżjuda b'żidiet ta' 100 mg/siegħa f'intervalli ta' 30 minuta, sa massimu ta' 400 mg/siegħa.
English: Summary of the Safety Profile (granulomatosis with polyangiitis and microscopic polyangiitis) In the clinical trial in granulomatosis with polyangiitis and microscopic polyangitis, 99 patients were treated with rituximab (375 mg/m2, once weekly for 4 weeks) and glucocorticoids (see section 5.1).
Maltese: Fil-prova klinika dwar granulomatosi b'polianġite u polianġite mikroskopika, 99 pazjent kienu kkurati b'rituximab (375 mg/m2, darba fil-ġimgħa għal 4 ġimgħat) u glukokortikojdi (ara sezzjoni 5.1).
English: Mean pre-therapeutic antibody titres against a panel of antigens (Streptococcus pneumoniae, influenza A, mumps, rubella, varicella) were maintained for at least 6 months after treatment with rituximab.
Maltese: Il-medja tat-titri tal-antikorpi ta' qabel it-terapija kontra sensiela ta' antigens (Streptococcus pneumoniae, influwenza A, ħosba, rubella, varicella) inżammu għal tal-inqas 6 xhur wara kura
English: In all patients subgroups (gender, age, age adjusted IPI, Ann Arbor stage, ECOG, β2
Maltese: aġġustat, skont l-età, stadju ta' Ann Arbor, ECOG, mikroglobulina β2, LDH, albumina, sintomi B,
English: microglobulin, LDH, albumin, B symptoms, bulky disease, extranodal sites, bone marrow involvement), the risk ratios for event-free survival and overall survival (R-CHOP compared with CHOP) were less than 0.83 and 0.95 respectively.
Maltese: bulky disease, siti ekstranodali, involvement tal-mudullun), il-proporzjon tar-riskju għal sopravivenza mingħajr episodji u ta' sopravivenza ġenerali (R-CHOP ikkumparat ma' CHOP) kienu inqas minn 0.83 u 0.95 rispettivament.
English: Patient subpopulations - rituximab combination therapy Elderly patients (≥ 65 years)
Maltese: Sottopopolazzjonijiet ta' pazjenti - monoterapija ta' rituximab Pazjenti anzjani (≥ 65 sena):
English: Rituzena 500 mg concentrate for solution for infusion Rituximab
Maltese: Rituzena 500 mg konċentrat għal soluzzjoni għal infużjoni rituximab
English: Rituzena is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine,
Maltese: Rituzena huwa indikat għall-kura ta' pazjenti b'limfoma mhux ta' Hodgkin ta ċ-ċellula B kbira mifruxa pożittiva għal CD20 flimkien ma' kimoterapija CHOP (cyclophosphamide, doxorubicin,
English: Kaplan-Meier estimate of median time to event (months)
Maltese: Estimu Kaplan-Meier ta' żmien medjan sal avveniment (xhur)
English: PML, reactivation of hepatitis B late neutropenia2 serum sicknesslike reaction
Maltese: PML, attivazzjoni mill-ġdid talepatite B
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%) talpazjenti li kellhom IRR wara l-ewwel infużjoni tal-ewwel esponiment għal rituximab.
English: Rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis
Maltese: Artrite rewmatika, granulomatosi b'polianġite u polianġite mikroskopika
English: The alert card contains important safety information for patients regarding potential increased risk of infections, including PML.
Maltese: Il-kartuna ta' twissija fiha tagħrif importanti dwar is-sigurtà għall-pazjenti dwar il-potenzjal ta' riskju akbar ta' infezzjonijiet, inkluża PML.
English: Currently, there are limited data on possible medicinal product interactions with rituximab.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Attwalment, teżisti informazzjoni limitata dwar l-interazzjonijiet possibbli ta' prodotti mediċinali oħra ma' rituximab.
English: Serious infections, including fatalities, can occur during therapy with rituximab (see section 4.8).
Maltese: Waqt terapija bi rituximab jista' jkun hemm infezzjonijiet serji, inkluż fatalitajiet (ara sezzjoni 4.8).
English: Rituzena 100 mg concentrate for solution for infusion Rituximab
Maltese: Rituzena 100 mg konċentrat għal soluzzjoni għal infużjoni rituximab
English: Aseptically withdraw the necessary amount of Rituzena, and dilute to a calculated concentration of 1 to 4 mg/mL rituximab into an infusion bag containing sterile, pyrogen-free sodium chloride9 mg/mL (0.9%) solution for injection or 5 % D-Glucose in water.
Maltese: Neħħi b'mod assetiku l-ammont neċessarju ta' Rituzena, u iddilwa għal konċentrazzjoni kkalkulata ta' minn 1 sa 4 mg/mL ta' rituximab f'borża tal-infużjoni li jkun fiha, soluzzjoni għall-injezzjoni sterili u mingħajr piroġeni ta' sodium chloride 9 mg/mL (0.9%) jew 5% D-Glucose fl-ilma.
English: Name and address of the manufacturer of the biological active substance CELLTRION Inc.,
Maltese: Isem u indirizz tal-manifattur tas-sustanza bioloġika attiva
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
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 l kura ta' induzzjoni kemm fil-grupp ta' osservazzjoni kif ukoll f'dak ta' rituximab.
English: ORR in patients previously treated with autologous bone marrow transplant (ABMT) was 78% versus 43% in patients with no ABMT.
Maltese: ORR f'pazjenti trattati preċedentement bi trapjant awtologu tal-mudullun (ABMT) kienet ta' 78% kontra 43% f'pazjenti mingħajr ABMT. L
English: Rituzena may be used for the treatment of several different conditions in adults.
Maltese: Rituzena jista' jintuża għall-kura ta' diversi kundizzjonijiet differenti fl-adulti.
English: Repeated treatment courses
Maltese: TAL-PRODOTT MEDIĊINALI
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'
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: Toxic Epidermal Necrolysis (Lyell 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: Following second infusion, mean Cmax ranged from 183 to 198 µg/mL for the2 x 500 mg dose and ranged from 355 to 404 µg/mL for the 2 x 1000 mg dose.
Maltese: Wara t-tieni infużjoni, Cmax medja varjat minn 183 sa 198 μg/mL għad-doża ta' 2 x 500 mg u varjat minn 355 sa 404 μg/mL għad-doża ta' 2 x 1,000 mg.
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: 55 xahar fil-grupp ta' R-FC u ta' 33 xahar fil-grupp ta' FC (p < 0.0001, test log-rank).
English: Rituximab mean clearance and volume of distribution were 0.313 L/day (range, 0.116 to 0.726 L/day) and 4.50 L (range 2.25 to 7.39 L) respectively.
Maltese: L/jum) u 4.50 L (firxa 2.25 sa 7.39 L) rispettivament.
English: The antigen is expressed on >95 % of
Maltese: L-antiġen huwa espress fuq > 95% tal-limfomi mhux ta' Hodgkin
English: Cases of hepatitis B reactivation, including those with a fatal outcome, have been reported in rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis patients receiving
Maltese: Każijiet ta' attivazzjoni mill-ġdid tal-epatite B, inkluż dawk b'riżultat fatali, kienu rrappurtati f'pazjenti b'artrite rewmatika, granulomatosi b'polianġite u polianġite mikroskopika li kienu qed jirċievu rituximab.
English: In placebo-controlled periods of clinical trials, 0.94% (13/1382) of rituximab treated patients and
Maltese: F'perijodi kkontrollati bil-plaċebo tal-provi kliniċi, 0.94% (13/1382) tal-pazjenti kkurati b'rituximab u 0.27% (2/731) tal-pazjenti ttrattati bil-plaċebo żviluppaw newtropenija severa.
English: Patient subpopulations - rituximab monotherapy
Maltese: Sottopopolazzjonijiet ta' pazjenti - rituximab bħala terapija kombinata
English: Key results from all four studies are summarised in table 4.
Maltese: studji kollha huma mqassra f'tabella 4.
English: In addition to adverse reactions seen in RA clinical trials for rituximab, progressive multifocal leukoencephalopathy (PML) (see section 4.4) and serum sickness-like reaction have been reported during post marketing experience.
Maltese: għal rituximab, waqt l-esperjenza ta' wara t-tqegħid fis-suq kienu rrapportati lewkoenċefalopatija multifokali progressiva (PML) (ara sezzjoni 4.4) u reazzjoni li tixbaħ lill-marda tas-serum.
English: In the active-controlled, randomised, double-blind, multicentre, non-inferiority trial of rituximab in granulomatosis with polyangiitis and microscopic polyangiitis, 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 kkontrollata b'attiv, randomised, double-blind, b'aktar minn ċentru wieħed, dwar nuqqas ta' inferjorità ta' rituximab fi granulomatosi b'polianġite u polianġite mikroskopika, 24% tal-pazjenti filgrupp ta' rituximab (kors wieħed) u 23% tal-pazjenti fil-grupp ta' cyclophosphamide żviluppaw newtropenija ta' CTC grad 3 jew aktar.
English: Rituzena 500 mg concentrate for solution for infusion
Maltese: Rituzena 500 mg konċentrat għal soluzzjoni għal infużjoni
English: Serious infections, including fatalities, can occur during therapy with rituximab (see section 4.8).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: heart failure4
Maltese: insuffiċjenza tal-kliewi4
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 (RCVP).
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: Hazard ratio (95% CI)
Maltese: 95.1%b CI
English: Cardiac events occurred at a rate of approximately 273 per 100 patient years (95% CI 149-470) at the 6-month primary endpoint.
Maltese: pazjent (CI ta' 95% 197-285) fil-punt finali primarju ta' 6 xhur.
English: Table 3 Adverse drug reactions occurring at 6-months in ≥ 5% of patients receiving rituximab, and at a higher frequency than the comparator group, in the
Maltese: Tabella 3 Reazzjonijiet avversi tal-mediċina li seħħew wara 6 xhur f'≥ 5% tal-pazjenti li rċevew rituximab, u bi frekwenza ogħla mill-grupp ta' paragun, fl-istudju
English: The ADRs listed in Table 3 were all adverse events which occurred at an incidence of ≥ 5% in the
Maltese: L-ADRs elenkati f'Tabella 3 kienu l-avvenimenti avversi kollha li seħħew b'inċidenza ta' ≥ 5% fil
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħżin wara dilwizzjoni tal-prodott mediċinali, ara t-taqsima 6.3. 6.5
English: 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: Rituzena is provided in sterile, preservative-free, non-pyrogenic, single use vials.
Maltese: Rituzena jiġi fornut f'kunjetti sterili, mingħajr preservattivi, mhux piroġeniċi, li jintużaw darba biss.
English: The benefit in terms of PFS was consistently observed in most patient subgroups analysed according to disease risk at baseline (i.e. Binet stages A-C) (Table 5b).
Maltese: Il-benefiċċju f'termini ta' PFS kien osservat b'mod konsistenti fil-biċċa l-kbira tas-sottogruppi ta' pazjenti analizzati skont ir-riskju tal-marda fil-linja bażi (i.e. stadji
English: Patients with human anti-mouse antibody or human anti-chimeric antibody (HAMA/HACA) titres may have allergic or hypersensitivity reactions when treated with other diagnostic or therapeutic monoclonal antibodies.
Maltese: Pazjenti b'titres ta' antikorpi umani ta' kontra l-ġrieden jew antikorpi anti-kimeriċi umani (HAMA/HACA) jista' jkollhom reazzjonijiet allerġiċi jew ta' sensittività eċċessiva meta trattati b'antikorpi monoklonali dijanjostiċi jew terapewtiċi oħrajn.
English: Malignancies
Maltese: MANIFATTURI
English: The ORR was 57% (95% Confidence interval (CI); 41% - 73%; CR 14%, PR 43%) with a projected median TTP for responding patients of 19.4 months (range 5.3 to 38.9 months).
Maltese: 41% - 73%; CR 14%, RP 43%) TTP medjan ipproġettat għal pazjenti li rrispondew ta' 19.4 xhur
English: Table 5b First-line treatment of chronic lymphocytic leukaemia Hazard ratios of progression-free survival according to Binet stage (ITT) - 48.1 months median observation time Number of patients
Maltese: Proporzjonijiet ta' periklu ta' sopravivenza mingħajr progressjoni skont l istadju Binet (ITT) - perjodu medjan ta' osservazzjoni ta' 48.1 xahar Sopravivenza Mingħajr Progressjoni (PFS)
English: Cases of posterior reversible encephalopathy syndrome (PRES) reversible posterior leukoencephalopathy syndrome (RPLS) have been reported.
Maltese: Avvenimenti newroloġiċi F'kondizzjonijiet awtoimmuni kienu rrappurtati każijiet ta' sindrome ta' enċefalopatija posterjuri riversibbli (PRES - posterior reversible encephalopathy syndrome) sindrome ta' lewkoenċefalopatija riversibbli posterjuri (RPLS - reversible posterior leukoencephalopathy).
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: The risk of disease progression was reduced by 46 % and the risk of relapse by
Maltese: Ir-riskju ta' progressjoni fil-mard kien imnaqqas b'46% u r-riskju li terġa' titfaċċa b'51%.
English: Risk reduction
Maltese: Tnaqqis ta' riskju
English: The pharmacokinetics of rituximab were assessed following two intravenous (IV) doses of 500 mg and 1000 mg on Days 1 and 15 in four studies.
Maltese: Il-farmakokinetika ta' rituximab kienet evalwata wara żewġ dożi fil-vini (IV) ta' 500 mg u 1,000 mg fi
English: In the relapsed/refractory CLL study grade ¾ thrombocytopenia was reported in 11% of patients in the R-FC group compared to 9% of patients in
Maltese: Fl-istudju dwar CLL li reġgħet tfaċċat/refrattarja, kienet irrappurtata tromboċitopenija ta' grad ¾ fi 11% tal-pazjenti fil-grupp ta' R-FC meta mqabbel ma' 9% tal-pazjenti fil-grupp ta' FC.
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,
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: EXP
Maltese: FC
English: Retreatment with rituximab
Maltese: Meta tinkiseb remissjoni b'rituximab,
English: Gastrointestinal
Maltese: Newtropenija
English: 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: • Detailed information on the risk of PML, the need for timely diagnosis of 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: The final analysis confirmed that RCHOP treatment was associated with a clinically relevant and statistically significant improvement in the duration of event-free survival (the primary efficacy parameter; where events were death, relapse or progression of lymphoma, or institution of a new anti-lymphoma treatment) (p = 0.0001).
Maltese: R-CHOP kienet assoċjata ma' titjib klinikament rilevanti u statistikament sinifikanti fit-tul ta' żmien ta' sopravivenza mingħajr episodji (il-parametru primarju tal-effikaċja; fejn l-episodji kienu l-mewt, l-esperjenza ta' limfoma mill-ġdid jew il-progressjoni tagħha, jew il-bidu ta' kura ġdida kontra l-limfoma) (p = 0.0001).
English: Pack of 2
Maltese: Tabella 6
English: Clinical experience in granulomatosis with polyangiitis (Wegener's) and microscopic polyangiitis A total of 197 patients aged 15 years or older with severely, active granulomatosis with polyangiitis
Maltese: Esperjenza klinika fi granulomatosi b'polianġite (ta' Wegener) u polianġite mikroskopika Total ta' 197 pazjent b'età minn 15-il sena 'l fuq bi granulomatosi b'polianġite attiva b'mod sever (75%) u polianġite mikroskopika (24%) kienu rreġistrati u kkurati fi prova b'paragun attiv,
English: Kern Pharma, S.L.
Maltese: Orion Pharma A/S
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: 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 to 49 days).
Maltese: Ibbażat fuq l-analiżi farmakokinetika tal-popolazzjoni ta' dejta minn 97 pazjent bi granulomatosi b'polianġite u polianġite mikroskopika li rċevew 375 mg/m2 rituximab darba fil-ġimgħa għal erba' dożi, il-half-life medjana tal-eliminazzjoni terminali stmata kienet ta' 23 ġurnata (firxa, 9 sa 49 ġurnata).
English: This can be fatal.
Maltese: Din tista' tkun fatali.
English: This should be followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day, and tapered as rapidly as possible based on clinical need)
Maltese: segwit minn prednisone orali (1 mg/kg/jum, sa massimu ta' 80 mg/jum).
English: c) Granulomatosis with polyangiitis or microscopic polyangiitis
Maltese: ċ) Granulomatosi b'polianġite jew polianġite mikroskopika
English: Infections were predominately mild to moderate and consisted mostly of upper respiratory tract infections, herpes zoster and urinary tract infections.
Maltese: Infezzjonijiet u infestazzjonijiet infezzjoni flapparat respiratorju ta' fuq, infezzjonijiet flapparat urinarju bronkite, sinożite,
English: Neutropenia can occur several months after the administration of rituximab (see section 4.4).
Maltese: rituximab (ara sezzjoni 4.4).
English: severe bullous skin reactions, Stevens-Johns on Syndrome toxic epidermal necrolysis (Lyell's Syndrome)7,
Maltese: +alopeċja urtikarja, għaraq, għaraq bil-lejl, +disturb fil-ġilda reazzjonijiet bl-imsiemer severi filġilda, sindrome ta' Stevens-Joh nson, nekrolisi tossika talepidermi de (sindrome ta' Lyell)7
English: In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis, methylprednisolone given intravenously for 1 to 3 days at a dose of 1000 mg per day is recommended prior to the first infusion of Rituzena (the last dose of methylprednisolone may be given on the same day as the first infusion of Rituzena).
Maltese: F'pazjenti bi granulomatosi b'polianġite (ta' Wegener) jew polianġite mikroskopika, methylprednisolone mogħti fil-vini għal 1 sa 3 ijiem b'doża ta' 1,000 mg kuljum huwa rakkomandat qabel l-ewwel infużjoni ta' Rituzena (l-aħħar doża ta' methylprednisolone tista' tingħata fl-istess jum bħall-ewwel infużjoni ta' Rituzena).