FrancophonIA/ELRC3.0 huggingface dataset:
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 MabThera 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 l-aħħar 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'MabThera flimkien ma' FC.
English: When should I not have MabThera?
Maltese: Meta m'għandix nieħu MabThera?
English: Vascular disorders hypertension, orthostatic hypotension, hypotension vasculitis (predominatel y cutaneous), leukocytoclast ic vasculitis
Maltese: Vaskulite (primarjament fil-ġilda), vaskulite lewkoċitoklast ika
English: Very rare cases of fatal progressive multifocal leukoencephalopathy (PML) have been reported following use of MabThera for the treatment of rheumatoid arthritis and autoimmune diseases including Systemic Lupus Erythematosus (SLE) and vasculitis.
Maltese: Wara l-użu ta' MabThera għall-kura ta' artrite rewmatika u mard awtoimmuni inkluż Lupus Eritematosus Sistemika (SLE) u vaskulite kienu irrappurtati każijiet rari ħafna ta' lewkoenċefalopatija multifokali progressiva (PML) fatali.
English: The recommended dosage of MabThera in combination with chemotherapy for previously untreated and relapsed/refractory patients is: MabThera intravenous formulation 375 mg/m2 body surface area administered on day 0 of the first cycle of treatment followed by MabThera subcutaneous formulation injected at a fixed dose of 1600 mg per cycle, on day 1 of each subsequent cycle (in total: 6 cycles).
Maltese: MabThera formulazzjoni għall-għoti fil-vini 375 mg/m ta' erja tas-superfiċje tal-ġisem mogħti f'jum 0 tal-ewwel ċiklu ta' trattament segwit minn MabThera formulazzjoni għall-għoti taħt il-ġilda injettat b'doża fissa ta' 1600 mg kull ċiklu, f'jum 1 ta' kull ċiklu sussegwenti (b'kollox: 6 ċikli).
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu.
English: What MabThera 1400 mg solution for subcutaneous injection looks like and contents of the pack MabThera is a ready to use, clear to opalescent, colourless to yellowish liquid, supplied as a solution for subcutaneous injection in a colourless glass vial with a butyl rubber stopper with aluminium over seal and a pink plastic flip-off disk.
Maltese: Kif jidher MabThera 1400 mg soluzzjoni għall-injezzjoni taħt il-ġilda u l-kontenut tal-pakkett MabThera huwa likwidu ċar sa jkanġi, bla kulur sa fl-isfar, lest għall-użu, disponibbli bħala soluzzjoni għall-injezzjoni taħt il-ġilda f'kunjett tal-ħġieġ bla kulur b'tapp tal-lasktu butyl b'siġill fuq kollox tal-aluminju u ċirku flip-off tal-plastik ta' lewn roża.
English: MabThera 1400 mg is used to treat Non-Hodgkin's lymphoma in adults.
Maltese: MabThera 1400 mg jintuża biex jikkura limfoma mhux ta' Hodgkin fl-adulti.
English: MabThera subcutaneous
Maltese: MabThera fil-vini
English: MabThera 100 mg concentrate for solution for infusion Clear Type I glass vials with butyl rubber stopper containing 100 mg of rituximab in 10 mL.
Maltese: MabThera 100 mg konċentrat għal soluzzjoni għal infużjoni Kunjetti tal-ħġieġ ta' Tip I ċar b'tapp tal-lastku butyl li fihom100 mg ta' rituximab f'10 mL.
English: Table 3 Adverse drug reactions occurring at 6-months in ≥ 5% of patients receiving MabThera for induction of remission of GPA and MPA, and at a higher frequency than the comparator group.
Maltese: Tabella 3 Reazzjonijiet avversi tal-mediċina li seħħew wara 6 xhur f'≥ 5% tal-pazjenti li rċevew MabThera għall-induzzjoni ta' remissjoni ta' GPA u MPA, u bi frekwenza ogħla mill-grupp ta' paragun.
English: This syndrome may be associated with some features of tumour lysis syndrome such as hyperuricaemia, hyperkalaemia, hypocalcaemia, hyperphosphaetemia, acute renal failure, elevated lactate dehydrogenase (LDH) and may be associated with acute respiratory failure and death.
Maltese: Din is-sindrome tista' tiġi assoċjata ma' xi karatteristiċi tas-sindrome tal-lisi tat-tumur bħall-iperuriċemija, iperkalimja, ipokalċimja, iperfosfatimja, insuffiċjenza akuta tal-kliewi, lactate dehydrogenase (LDH) elevat u tista' tkun assoċjata ma'kollass respiratorju akut u mewt.
English: Relapsed/Refractory follicular lymphoma
Maltese: Limfoma follikulari li reġgħet tfaċċat/reżistenti
English: Significant benefit from maintenance treatment with MabThera 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'MabThera 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: The pre-specified primary analysis was conducted at a median observation time of 25 months from randomization, maintenance therapy with MabThera resulted in a clinically relevant and statistically significant improvement in the primary endpoint of investigator assessed progression-free survival (PFS) as compared to observation in patients with previously untreated follicular lymphoma (Table 7).
Maltese: L-analiżi primarja speċifikata minn qabel twettqet fi żmien medjan ta' osservazzjoni ta' 25 xahar mir-randomization, f'pazjenti b'limfoma follikulari mhux ikkurati minn qabel, terapija ta' manteniment b'MabThera wasslet għal titjib klinikament rilevanti u statistikament sinifikanti fil-punt finali primarju ta' sopravivenza mingħajr progressjoni (PFS) evalwata mill-investigatur meta mqabbla ma' osservazzjoni (Tabella 7).
English: In contrast, three patients (1.5%) had cerebrovascular events in the CHOP group, all of which occurred during the follow-up period.
Maltese: B'kuntrast, tliet pazjenti (1.5%) fil-grupp ta' CHOP kellhom avvenimenti ċerebrovaskulari li kollha seħħew waqt il-perijodu ta' segwitu.
English: The most frequently reported serious infection in the MabThera group was pneumonia at a frequency of 4%.
Maltese: L-aktar infezzjoni serja irrappurtata b'mod frekwenti fil-grupp ta' MabThera kienet pnewmonja bi frekwenza ta' 4%.
English: Pneumocystis jirovecii pneumonia (PCP) prophylaxis is recommended for patients with GPA/MPA or PV during and following MabThera 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'MabThera, kif xieraq skont il-linji gwida lokali dwar il-prattika klinika.
English: key efficacy results for the pooled analysis of 410 patients in SABRINA stages 1 and 2 are shown in table 2.
Maltese: Ir-riżultati ewlenin tal-effikaċja għall-analiżi miġbura ta' 410 pazjenti f'SABRINA stadji 1 u 2 huma murija f'tabella 2.
English: It is recommended that immunoglobulin levels are determined prior to initiating treatment with MabThera.
Maltese: Huwa rrakkomandat li l-livelli ta' immunoglobulina jiġu determinati qabel ma tinbeda l-kura MabThera.
English: Response rate and CR rates analysed using Chi-squared Test. *: only applicable to patients achieving a CR, nPR, PR;
Maltese: *: japplika biss għall-pazjenti li laħqu CR, nPR, PR;
English: MabThera 100 mg concentrate for solution for infusion Each mL contains 10 mg of rituximab.
Maltese: MabThera 100 mg konċentrat għal soluzzjoni għal infużjoni Kull mL fih 10 mg ta' rituximab.
English: The best responses to MabThera are seen in those who have a positive blood test to rheumatoid factor (RF) and/or anti-Cyclic Citrullinated Peptide (anti-CCP).
Maltese: L-aħjar rispons għal MabThera huwa osservat f'dawk li jkollhom test tad-demm pożittiv għall-fattur rewmatiku (RF) u/jew għall-anti-Cyclic Citrullinated Peptide (anti-CCP).
English: You will be given MabThera 1600 mg with other medicines called “chemotherapy”.
Maltese: Inti se tingħata MabThera 1600 mg flimkien ma' mediċini oħra msejħa “kimoterapija”.
English: Three patients in the MabThera subcutaneous NHL formulation trial SABRINA (BO22334) were inadvertently adminstered subcutaneous formulation through the intravenous route up to a maximum rituximab dose of 2780 mg with no untoward effect.
Maltese: Tliet pazjenti fil-prova tal-formulazzjoni għall-għoti taħt il-ġilda ta' MabThera SABRINA (BO22334), involontarjament ingħataw il-formulazzjoni għall-għoti taħt il-ġilda permezz ta' għoti fil-vini sa doża massima ta' rituximab ta' 2780 mg bl-ebda effett mhux mixtieq.
English: As typical for monoclonal antibodies, rituximab PK parameters depended on body size measures.
Maltese: Kif inhu tipiku għall-antikorpi monoklonali, parametri PK ta' rituximab kienu jiddependu mill-kejl tad-daqs tal-ġisem.
English: Nervous system disorders paraesthesia, hypoaesthesia, agitation, insomnia, vasodilatation, dizziness, anxiety dysgeusia peripheral neuropathy, facial nerve palsy5
Maltese: Rimettar , dijarea, uġigħ addominali, disfaġja, stomatite, stitikezza, dispepsja, anoressija, irritazzjoni fil-griżmejn
English: Event-free survival (median)
Maltese: Sopravivenza mingħajr avveniment (medjana)
English: Patients were randomised in a 1:1 ratio to receive either oral cyclophosphamide daily (2mg/kg/day) for 3-6 months or MabThera (375 mg/m2) once weekly for 4 weeks.
Maltese: Il-pazjenti kienu randomised fi proporzjon ta' 1:1 biex jirċievu cyclophosphamide orali kuljum (2 mg/kg/jum) għal 3-6 xhur jew MabThera (375 mg/m2) darba fil-ġimgħa għal 4 ġimgħat.
English: Patients randomised to the MabThera group received an initial 1000 mg IV on Study Day 1 and a second 1000 mg IV on Study Day 15.
Maltese: Il-pazjenti randomised għall-grupp ta' MabThera rċevew 1000 mg IV inizjali fil-Jum 1 tal-Istudju u t-tieni 1000 mg IV fil-Jum 15 talIstudju.
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 MabThera (the last dose of methylprednisolone may be given on the same day as the first infusion of MabThera).
Maltese: F'pazjenti bi granulomatosi b'polianġite (ta' Wegener) jew polianġite mikroskopika, methylprednisolone mogħti fil-vini għal 1 sa 3 ijiem b'doża ta' 1000 mg kuljum huwa rrakkomandat qabel l-ewwel infużjoni ta' MabThera (l-aħħar doża ta' methylprednisolone tista' tingħata fl-istess jum bħall-ewwel infużjoni ta' MabThera).
English: In a non-randomized study, patients with relapsed low-grade NHL who received the MabThera intravenous formulation as 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. 69% when assessed for >2-fold increase in antibody titer).
Maltese: Fi studju mhux randomised, pazjenti b'NHL ta' grad baxx li reġgħet tfaċċat li rċevew il-formulazzjoni għall-għoti fil-vini ta' MabThera bħala monoterapija meta mqabbel ma' kontrolli f'saħħithom mhux ikkurati kellhom rata aktar baxxa ta' rispons għal tilqim bl-antiġen recall tat-tetnu (16% kontra 81%) u n-neoantiġen ta' Keyhole Limpet Haemocyanin (KLH) (4% kontra 69% meta evalwati għal żieda ta' > darbtejn fit-titer tal-antikorpi).
English: The antigen is expressed on >95 % of all B cell non-Hodgkin's lymphomas.
Maltese: L-antiġen huwa espress fuq >95 % tal-limfomi mhux ta' Hodgkin taċ-ċellula B.
English: The recommended dosage of MabThera for the treatment of pemphigus vulgaris is 1000 mg administered as an IV infusion followed two weeks later by a second 1000 mg IV infusion in combination with a tapering course of glucocorticoids.
Maltese: Id-dożaġġ rakkomandat ta' MabThera għat-trattament ta' pemphigus vulgaris huwa ta' 1000 mg mogħti bħala infużjoni IV segwit ġimagħtejn wara mit-tieni infużjoni IV ta' 1000 mg flimkien ma' kors ta' glukokortikojdi li jitnaqqsu għax-xejn.
English: NAME OF THE MEDICINAL PRODUCT MabThera 500 mg concentrate for solution for infusion Rituximab
Maltese: MabThera 500 mg konċentrat għal soluzzjoni għal infużjoni Rituximab
English: MabThera 1600 mg solution for subcutaneous injection rituximab
Maltese: Mabthera 1600 mg soluzzjoni għall-injezzjoni taħt il-ġilda rituximab
English: Gastrointestin al disorders nausea vomiting , diarrhoea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation abdominal enlargement gastro-intestin al perforation7
Maltese: Tqalligħ Rimettar , dijarea, uġigħ addominali, disfaġja, stomatite, stitikezza, dispepsja, anoressija, irritazzjoni fil-griżmejn
English: In a randomised trial, patients with rheumatoid arthritis treated with MabThera and methotrexate had comparable response rates to tetanus recall antigen (39% vs. 42%), reduced rates to pneumococcal polysaccharide vaccine (43% vs. 82% to at least 2 pneumococcal antibody serotypes), and KLH neoantigen (47% vs. 93%), when given 6 months after MabThera as compared to patients only receiving methotrexate.
Maltese: 82 % għal tal-inqas żewġ serotipi ta' antikorpi pnewmokokkali), u KLH neoantigen (47 % vs. 93 %), meta mogħtija 6 xhur wara MabThera meta mqabbel ma pazjenti li rċevew methotrexate biss.
English: Infusion related adverse reactions of all kinds have been observed in 77% of patients treated with MabThera intravenous formulation (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% tal-pazjenti kkurati b'MabThera (inkluż is-sindrome tar-reħa taċ-ċitokina flimkien ma' pressjoni baxxa u bronkospażmu f'10% tal-pazjenti) ara sezzjoni 4.8.
English: Rate
Maltese: Rata
English: Hepatitis B Infections
Maltese: Infezzjonijiet u infestazzjonijie t
English: NAME OF THE MEDICINAL PRODUCT MabThera 1600 mg solution for subcutaneous injection Rituximab
Maltese: IL-PRODOTT MEDIĊINALI Mabthera 1600 mg soluzzjoni għall-injezzjoni taħt il-ġilda Rituximab
English: ≥ 1.90 m2).
Maltese: < BSA medja < 1.90 m 2; BSA għolja ≥ 1.90 m 2).
English: 3 Reactions occurring during or within 24 hours of infusion.
Maltese: Reazzjonijiet li jseħħu waqt jew sa 24 siegħa wara l-infużjoni.
English: Mean terminal elimination half-life after the second infusion, following the second course, was 19 days for 2 x 500 mg dose and ranged from 21 to 22 days for the 2 x 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 1000 mg.
English: MabThera 1600 mg subcutaneous formulation should be administered as subcutaneous injection only, over approximately 7 minutes.
Maltese: Il-formulazzjoni għall-għoti taħt il-ġilda ta' MabThera 1600 mg għandha tingħata bħala injezzjoni taħt il-ġilda biss, fuq madwar 7 minuti.
English: doses to 203 patients with NHL naive to MabThera, yielded a mean Cmax following the fourth infusion of 486 µg/mL (range, 77.5 to 996.6 µg/mL).
Maltese: MabThera mogħti f'doża ta' 375 mg/m bħala infużjoni fil-vini f'intervalli ta' kull ġimgħa għal 4 dożi lil 203 pazjent b'NHL li qatt ma kienu ħadu MabThera qabel, ipproduċa Cmax medja wara r-raba' infużjoni ta' 486 µg/mL (firxa, 77.5 sa 996.6 µg/mL).
English: MabThera is used for the treatment of patients with moderate to severe pemphigus vulgaris.
Maltese: MabThera jintuża għat-trattament ta' pazjenti b'pemphigus vulgaris moderat sa sever.
English: Cytokine release syndrome may be clinically indistinguishable from acute hypersensitivity reactions.
Maltese: Sindrome tar-reħa ta' ċitokina jista' ma jingħarafx klinikament minn reazzjonijiet ta' sensittività eċċessiva akuti.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/067/004
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/98/067/004
English: The pre-specified primary analysis was conducted at a median observation time of 25 months from randomization, maintenance therapy with MabThera resulted in a clinically relevant and statistically significant improvement in the primary endpoint of investigator assessed progression-free survival (PFS) as compared to observation in patients with previously untreated follicular lymphoma (Table 4).
Maltese: L-analiżi primarja speċifikata minn qabel twettqet fi żmien medjan ta' osservazzjoni ta' 25 xahar wara r-randomization, f'pazjenti b'limfoma follikulari mhux ikkurati minn qabel, terapija ta' manteniment b'MabThera wasslet għal titjib klinikament rilevanti u statistikament sinifikanti fil-punt finali primarju ta' sopravivenza mingħajr progressjoni (PFS - progression-free survival) evalwata mill-investigatur meta mqabbla ma' osservazzjoni (Tabella 4).
English: Common side effects (may affect up to 1 in 10 people): • Infections such as bronchial tube inflammation (bronchitis)
Maltese: • Infezzjonijet bħal infjammazzjoni tat-tubu tal-bronki (bronkite)
English: MabThera at a fixed dose of 1600 mg was administered for 5 cycles subcutaneously at 4-weekly intervals, following the first cycle of MabThera intravenous formulation, in previously untreated CLL patients in combination with chemotherapy (fludarabine and cyclophosphamide (FC).
Maltese: MabThera bħala doża fissa ta' 1600 mg ingħata għal 5 ċikli taħt il-ġilda f'intervalli ta' 4 ġimgħat, wara l-ewwel ċiklu tal-formulazzjoni għall-għoti fil-vini ta' MabThera, f'pazjenti b'CLL mhux ittrattati minn qabel flimkien ma' kimoterapija (fludarabine u cyclophosphamide (FC).
English: Blood and lymphatic system disorders neutropenia, leucopenia, +febrile neutropenia, +thrombocyt openia anaemia, +pancytopenia, +granulocytopeni a coagulation disorders, aplastic anaemia, haemolytic anaemia, lymphadenopa thy transient increase in serum IgM levels3
Maltese: Dawn is-sintomi normalment huma riversibbli bl-interruzzjoni tal-infużjoni ta' MabThera u l-għoti ta' mediċina kontra d-deni, antistamina, u xi kultant, ossiġnu, soluzzjoni ta' melħ fil-vini jew bronkodilaturi, u glukokortikojdi jekk meħtieġ.
English: MabThera 1400 mg solution for subcutaneous injection rituximab
Maltese: MabThera 1400 mg soluzzjoni għall-injezzjoni taħt il-ġilda Rituximab
English: The analysis of overall survival showed a significant benefit of R-FC treatment over FC chemotherapy alone (p = 0.0319, log-rank test) (Table 10a).
Maltese: Analiżi tas-sopravivenza globali kkonfermat il-benefiċċju sinifikanti ta' manteniment b'MabThera fuq l-osservazzjoni (p=0.0039 test log-rank).
English: Patients treated with MabThera in combination with methotrexate had a significantly greater reduction in disease activity score (DAS28) than patients treated with methotrexate alone (Table 12).
Maltese: Il-pazjenti kkurati b'MabThera flimkien ma' methotrexate kellhom tnaqqis sinifikanti akbar fil-punteġġ tal-attività tal-marda (DAS28) mill-pazjenti kkurati b'methotrexate waħdu (Tabella 12).
English: 150 patients originally randomised to placebo + MTX in Trial 1 received at least one course of RTX + MTX by one year * p <0.05, ** p < 0.001.
Maltese: 150 pazjent oriġinarjament randomised għal plaċebo + MTX fi Prova 1 irċevew tal-inqas kors wieħed ta' RTX + MTX wara sena
English: Sodium MabThera 1600 mg contains less than 1 mmol sodium per dose, i.e. it is essentially sodium-free.
Maltese: MabThera 1600 mg fih inqas minn 1 mmol ta' sodium f'kull doża, jiġifieri huwa essenzjalment mingħajr sodium.
English: The benefit of MabThera maintenance treatment was confirmed in all subgroups analysed, regardless of induction regimen (CHOP or R-CHOP) or quality of response to induction treatment (CR or PR) (table 6).
Maltese: Il-benefiċċju ta' kura ta' manteniment b'MabThera kien ikkonfermat fis-sottogruppi kollha analizzati, irrispettivament mill-kors ta' induzzjoni (CHOP jew R-CHOP) jew il-kwalità tar-rispons għall-kura ta' induzzjoni (CR jew PR) (tabella 6).
English: InSABRINA, severe administration-related reactions (grade≥3) were reported in two patients (2%) following administration of MabThera subcutaneous formulation.
Maltese: F'SABRINA, reazzjonijiet severi relatati mal-għoti (grad≥3) kienu rrappurtati f'żewġ pazjenti (2%) wara l-għoti tal-formulazzjoni għall-għoti taħt il-ġilda ta' MabThera.
English: The proportion of patients with IgG levels below the LLN was about 60% in the MabThera group throughout the 2 year treatment period, while it decreased in the observation group (36% after 2 years).
Maltese: Il-proporzjon ta' pazjenti b'livelli ta' IgG taħt l-LLN kien madwar 60% fil-grupp ta' MabThera tul il-perijodu ta' kura ta' sentejn, filwaqt li naqas fil-grupp ta' osservazzjoni (36% wara sentejn).
English: Muscle weakness
Maltese: Uġigħ muskolo-skeletriku
English: For CLL patients whose lymphocyte counts are > 25 x 109/L it is recommended to administer prednisone/prednisolone 100 mg intravenous shortly before infusion with MabThera to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome.
Maltese: Għall-pazjenti b'CLL li għandhom għadd ta' limfoċiti ta' > 25 x 109/L, huwa rakkomandat li jingħata prednisone/prednisolone 100 mg fil-vini eżatt qabel l-għoti ta' MabThera biex titnaqqas ir-rata u s-severità ta' reazzjonijiet akuti għall-infużjoni u/jew sindrome tar-reħa ta' cytokine.
English: Neutropenia was not associated with an observed increase in serious infection in MabThera-treated patients.
Maltese: In-newtropenija ma kinitx assoċjata ma' żieda osservata ta' infezzjoni serja f'pazjenti kkurati b'MabThera.
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: Hepatitis B virus (HBV) screening should be performed in all patients before initiation of treatment with MabThera.
Maltese: Ittestjar għall-virus tal-epatite B (HBV - Hepatitis B virus) għandu jsir fil-pazjenti kollha qabel ma tinbeda l-kura b'MabThera.
English: Adverse reactions reported in MabThera subcutaneous formulation usage
Maltese: Ismijiet u indirizzi tal-manifatturi tas-sustanza bijoloġika attiva
English: Investigations decreased IgM levels4
Maltese: EFS - Sopravivenza Mingħajr Avveniment
English: PFSb
Maltese: PHS
English: • lower immunity - because of lower levels of anti-bodies called “immunoglobulins” (IgG) in the blood which help protect against infection.
Maltese: (IgG - immunoglobulins) fid-demm li jgħinu jipproteġu kontra l-infezzjonijiet.
English: Based on the population pharmacokinetic analysis of data in 97 patients with granulomatosis with polyangiitis and microscopic polyangiitis who received 375 mg/m2 MabThera 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' data minn 97 pazjent bi granulomatosi b'polianġite u polianġite mikroskopika li rċevew 375 mg/m