FrancophonIA/ELRC3.0 huggingface dataset:
English: Following second infusion, mean Cmax ranged from 183 to 198 μg/mL for the 2 x 500 mg dose and ranged from 355 to 404 μg/mL for the 2 x 1,000 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'
English: Atrial flutter
Maltese: Avveniment avvers
English: Musculoskeletal pain
Maltese: Uġigħ muskolo-skeletriku
English: In rheumatoid arthritis patients, immediate depletion of B cells in the peripheral blood was observed following two infusions of 1,000 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' 1000 mg rituximab separati b'intervall ta' 14-il jum.
English: It is recommended that immunoglobulin levels are determined prior to initiating treatment with Rixathon.
Maltese: immunoglobulina jiġu determinati qabel ma tinbeda l-kura Rixathon.
English: In the relapsed/refractory CLL study grade 3/4 thrombocytopenia was reported in 11% of patients in the R-FC group compared to 9% of patients in the FC group.
Maltese: Fl-istudju dwar CLL li reġgħet tfaċċat/refrattarja, kienet irrappurtata tromboċitopenija ta' grad 3/4 fi 11% tal-pazjenti fil-grupp ta' R-FC meta mqabbel ma' 9% tal-pazjenti fil-grupp ta' FC.
English: • skin rashes, including acne or spots
Maltese: • raxx fil-ġilda, inkluż akne jew ponot
English: When should I not have Rixathon?
Maltese: Meta m'għandix nieħu Rixathon?
English: Using a cox regression analysis, the risk of experiencing progressive disease or death was reduced by 61% with rituximab maintenance treatment when compared to observation (95% CI; 45% - 72%).
Maltese: Bl-użu ta' analiżi tar-rigressjoni cox, ir-riskju li jkunu esperjenzati mard progressiv jew mewt tnaqqas b'61% bil-kura ta' manteniment ta' rituximab meta mqabbel mal-osservazzjoni (CI ta' 95%; 45% - 72%).
English: For the 60 re-treatments on study, the ORR was 38% (CI95% 26% - 51%; CR 10%, PR 28%) 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%; CR 10%, PR 28%) b'TTP medjan ipproġettat għal pazjenti li rrispondew ta' 17.8 xhur (firxa minn 5.4 sa
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%
English: Rixathon in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.
Maltese: Artrite rewmatika Rixathon flimkien ma' methotrexate huwa indikat għall-kura ta' pazjenti adulti b'artrite rewmatika attiva severa li kellhom rispons inadegwat jew intolleranza għal mediċini anti-rewmatiċi oħra li jimmodifikaw il-marda (DMARD) fosthom terapija ta' inibizzjoni waħda jew aktar tal-fattur tannekrosi tat-tumuri (TNF).
English: Depression, anxiety
Maltese: Depressjoni, ansjetà
English: You will always be given Rixathon as a drip (intra-venous infusion).
Maltese: Inti dejjem se tingħata Rixathon bħala dripp (infużjoni fil-vini).
English: Maintenance treatment with rituximab led to a clinically relevant and statistically significant improvement in the primary endpoint, PFS, (time from maintenance randomisation to relapse, disease progression or death) when compared to observation alone (p < 0.0001 log-rank test).The median PFS was 42.2 months in the rituximab maintenance arm compared to 14.3 months in the observation arm.
Maltese: Il-kura ta' manteniment b'rituximab wasslet għal titjib klinikament rilevanti u statistikament sinifikanti fil-punt finali primarju, PFS, (żmien mill-għażla każwali tal-manteniment sar-rikaduta, progressjoni tal-marda jew mewt) meta pparagunata ma' osservazzjoni waħedha (p< 0.0001 log-rank test).
English: ESR
Maltese: SN
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: Renal failure4
Maltese: Insuffiċjenza tal-kliewi4
English: 10 mL vial: Clear Type I glass vials with butyl rubber stopper containing 100 mg of rituximab in 10 mL.
Maltese: Kunjett ta' 10 mL: Kunjetti tal-ħġieġ ta' Tip I ċari b'tapp tal-lastku butyl li fihom 100 mg ta' rituximab f'10 mL.
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: Barra r-reazzjonijiet avversi osservati fil-provi kliniċi b'RA għal rituximab, waqt l-esperjenza ta' wara t-tqegħid fis-suq kienu rrappurtati lewkoenċefalopatija multifokali progressiva (PML) (ara sezzjoni 4.4) u reazzjoni li tixbah lill-marda tas-serum.
English: Based on a population pharmacokinetic analysis in 298 NHL patients who received single or multiple infusions of rituximab as a single agent or in combination with CHOP therapy (applied rituximab doses ranged from 100 to 500 mg/m2), the typical population estimates of nonspecific clearance (CL1), specific clearance (CL2) likely contributed by B cells or tumour burden, and central compartment volume of distribution (V1) were 0.14 L/day, 0.59 L/day, and 2.7 L, respectively.
Maltese: rituximab applikati varjaw minn 100 sa 500 mg/m2), l-estimi tipiċi tal-popolazzjoni tat-tneħħija mhux speċifika (CL1), tat-tneħħija speċifika (CL2) probabbli kkontribwita minn ċelluli B jew mill-massa tat tumur, u tal-volum ta' distribuzzjoni fil-kompartiment ċentrali (V1) kienu ta' 0.14
English: Table 5 Adverse drugs reactions for rituximab-treated pemphigus vulgaris patients in the clinical study up to month 24
Maltese: Reazzjonijiet avversi tal-mediċina għal pazjenti b'pemphigus vulgaris ittrattati b'rituximab fl-istudju kliniku sa xahar 24
English: TNLT (median) log-rank p value hazard ratio (95% CI) risk reduction
Maltese: TNLT (medjan) valur p log-rank proporzjon ta' periklu (CI ta' 95%) tnaqqis tar-riskju
English: The safety profile of rituximab in combination with short-term, low-dose glucocorticoids in the treatment of patients with pemphigus vulgaris was studied in a Phase 3, randomised, controlled, multicenter, open-label study in pemphigus patients that included 38 pemphigus vulgaris (PV) patients randomised to the rituximab group.
Maltese: b'aktar minn ċentru wieħed, open-label f'pazjenti b'pemphigus li kien jinkludi 38 pazjent b'pemphigus vulgaris (PV) randomised għall-grupp ta' rituximab.
English: The majority of patients (81%) showed signs of B cell return, with counts > 10 cells/μL by month 12, increasing to 87% of patients by month 18.
Maltese: Il-maġġoranza tal-pazjenti (81%) urew sinjali ta' ritorn taċ ċelluli B, b'għadd ta' > 10 ċelluli/μL wara 12-il xahar, li żdiedu sa 87% tal-pazjenti wara 18-il xahar.
English: TNCT (median) log-rank p value hazard ratio (95% CI) risk reduction
Maltese: TNCT (medjan) valur p log-rank proporzjon ta' periklu (CI ta' 95%) tnaqqis tar-riskju
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 1 x 109/L between day 24 and 42 after the last dose) or occurred with a late onset (defined as neutrophil count below 1 x 109/L later than 42 days after last dose in patients with no previous prolonged neutropenia or who recovered prior to day 42) following treatment with rituximab plus FC.
Maltese: Studji dwar CLL mhux ikkurata minn qabel u li reġgħet tfaċċat/refrattarja stabbilew li f'sa 25% tal-pazjenti kkurati b'R-FC innewtropenija kienet imtawwla (definita bħala għadd ta' newtrofili li baqa taħt 1 x 109/L bejn jum 24 u jum 42 wara l-aħħar doża) jew seħħet b'bidu ttardjat (definita bħala għadd ta' newtrofili taħt 1 x 109/L
English: collapse
Maltese: KLIEM
English: Infusionrelated acute reversible thrombocytop enia4
Maltese: Tromboċitope nija akuta riversibbli relatata mal infużjoni4
English: Dizziness may occur following administration of rituximab (see section 4.8).
Maltese: naqset b'korsijiet sussegwenti (ara sezzjoni 4.8).
English: This medicinal product contains 11.5 mmol (263.2 mg) sodium per 50 mL vial.
Maltese: Dan ilprodott mediċinal fih 11.5 mmol (263.2 mg) ta' sodium f'kull kunjett ta' 50 mL.
English: During maintenance treatment, the incidence of grade 3/4 cardiac disorders was comparable between patients treated with rituximab and observation.
Maltese: disturbi kardijaċi ta' grad 3/4 kienet komparabbli bejn pazjenti kkurati b'rituximab u l-osservazzjoni.
English: Mild or moderate infusion-related reactions (IRR) (section 4.8) usually respond to a reduction in the rate of infusion.
Maltese: Reazzjonijiet ħfief jew moderati relatati mal-infużjoni (IRR) (sezzjoni 4.8) ġeneralment jirrispondu għal tnaqqis fir-rata tal-infużjoni.
English: Infusionrelated reactions3 (generalised oedema, bronchospas m, wheezing, laryngeal oedema, angioneuroti c oedema, generalised pruritus, anaphylaxis, anaphylactoi d reaction)
Maltese: Reazzjonijiet relatati mal infużjoni3 (presjoni għolja, tqalligħ, raxx, deni, ħakk,
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 x 1,000 mg dose group.
Maltese: Il-half-life medja tat-tneħħija terminali varjat minn 15 sa 16-il ġurnata għall-grupp tad doża ta' 2 × 500 mg u minn 17 sa 21 ġurnata għall-grupp tad-doża ta' 2 × 1000 mg. Cmax medja kienet
English: • allergic reactions that are most likely to occur during an infusion, but can occur up to 24 hours after infusion
Maltese: • Reazzjonijiet allerġiċi li x'aktarx iseħħu waqt infużjoni, iżda jistgħu jseħħu sa 24 siegħa wara infużjoni
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 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: A total of 19/34 (56%) patients with PV, who were treated with rituximab, tested positive for ADA antibodies by 18 months.
Maltese: Total ta' 19/34 (56%) pazjent b'PV, li kienu ttrattati b'rituximab, kellhom test pożittiv għal antikorpi
English: Vasculitis (predomin ately cutaneous), leukocytoc lastic vasculitis
Maltese: Reazzjonijiet relatati mal-infużjoni* Disturbi fil-Ġilda u fit-Tessuti ta' taħt il-Ġilda Alopeċja
English: • unusual feelings of the skin - such as numbness, tingling, pricking, burning, a creeping skin feeling, reduced sense of touch
Maltese: • sensazzjonijiet mhux tas-soltu fil-ġilda - bħal tnemnim, tingiż, qris, ħruq, tħoss bħal dud miexi fuq il-ġilda, sensazzjoni għall-mess imnaqqsa.
English: In a non-randomised study, patients with relapsed low-grade NHL who received rituximab 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' rituximab meta mqabbel ma' kontrolli f'saħħithom mhux ikkurati kellhom rata ta' rispons aktar baxxa għal tilqim b'tetanus recall antigen (16% vs. 81%) u b'Keyhole Limpet Haemocyanin (KLH)
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: Name and address of the manufacturer(s) of the biological active substance(s)
Maltese: MANIFATTUR(I) TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: The most frequent adverse reactions considered due to receipt of rituximab IRRs.
Maltese: L-aktar reazzjonijiet avversi frekwenti kkunsidrati bħala dovuti għar-riċeviment ta' rituximab kienu IRRs.
English: In the clinical trial on induction of remission, which included 99 rituximab-treated patients, the overall rate of infection was approximately 237 per 100 patient years (95% CI 197 - 285) at the 6-month primary endpoint.
Maltese: Fil-prova klinika dwar l-induzzjoni ta' remissjoni, li kienet tinkludi 99 pazjent ittrattati b'rituximab, irrata globali ta' infezzjoni kienet ta' madwar 237 għal kull 100 sena ta' pazjent (CI ta' 95% 197-285)
English: Hypertonia, myalgia, arthralgia, back pain, neck pain, pain
Maltese: mijalġja, artralġja, uġigħ fid dahar, uġigħ fl-għonq,
English: There was no apparent negative impact of the presence of ADA on safety or efficacy in the maintenance therapy clinical trial.
Maltese: Ma kienx hemm impatt negattiv evidenti tal-preżenza ta' ADA fuq is-sigurtà jew leffikaċja fil-prova klinika dwar terapija ta' manteniment.
English: Table 3 Adverse drug reactions occurring at 6-months in ≥ 5% of patients receiving rituximab for induction of remission of GPA and MPA, and at a higher frequency than the comparator group.
Maltese: Tabella 3 Reazzjonijiet avversi tal-mediċina li seħħew wara 6 xhur f'≥ 5% tal-pazjenti li rċevew rituximab għall-induzzjoni ta' remissjoni ta' GPA u MPA, u bi frekwenza ogħla mill-grupp ta' paragun.
English: In a prospective, open label, international, multi-centre, phase III trial, 465 patients with relapsed/refractory follicular lymphoma were randomised in a first step to induction therapy with either CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone; n=231) or rituximab plus CHOP (R-CHOP, n=234).
Maltese: 465 pazjent b'limfoma follikulari li reġgħet tfaċċat/refrattarja ntgħażlu b'mod każwali fl-ewwel pass għal terapija ta' induzzjoni b'CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone;
English: The most frequently reported serious infection in the rituximab group was pneumonia at a frequency of 4%.
Maltese: Laktar infezzjoni serja rrappurtata b'mod frekwenti fil-grupp ta' rituximab kienet pnewmonja bi frekwenza ta' 4%.
English: In the induction of remission clinical trial, 24% of patients in the rituximab group (single course) and 23% of patients in the cyclophosphamide group developed CTC grade 3 or greater neutropenia.
Maltese: Fil-prova klinika dwar l-induzzjoni ta' remissjoni, 24% tal-pazjenti fil-grupp ta' rituximab (kors wieħed) u 23% tal-pazjenti fil-grupp ta' cyclophosphamide żviluppaw newtropenija ta' CTC grad 3
English: • Inflammation, irritation and / or tightness of the lungs, and throat, coughing
Maltese: • Infjammazzjoni, irritazzjoni u/jew tgħafis fil-pulmun, u ġriżmejn, sogħla
English: Rixathon should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3).
Maltese: Rixathon m'għandux jingħata lill-pazjenti b'infezzjoni attiva, severa (eż. tuberkulosi, sepsi u infezzjonijiet opportunistiċi, ara sezzjoni 4.3).
English: Rarely fatal cases reported 5 signs and symptoms of cranial neuropathy.
Maltese: 5 sinjali u sintomi ta' newropatija kranjali.
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: (TNLT), żmien sal-kimoterapija li jmiss (TNCT) u rata ta' rispons globali (ORR) fl-analiżi primarja (Tabella 7).
English: In these patients the rate of clinically relevant infection while on rituximab was 6.01 per 100 patient years compared to 4.97 per 100 patient years following treatment with the biologic DMARD.
Maltese: F'dawn il-pazjenti r-rata ta' infezzjoni ta' rilevanza klinika waqt terapija b'rituximab kienet ta' 6.01 għal kull 100 sena tal-pazjent meta mqabbel ma 4.97 għal kull 100 sena tal-pazjent wara kura b'DMARD bijoloġiku.
English: Musculoskelet al and connective tissue disorders
Maltese: Akne Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: Rarely Rixathon can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML.
Maltese: B'mod rari Rixathon jista' jikkawża infezzjoni serja fil-moħħ, imsejħa “lewkoenċefalopatija multifokali progressiva” jew PML.
English: Initiate at a rate of 250 mg/hour for the first 30 minutes and then 600 mg/hour for the next 90 minutes.
Maltese: Ibda b'rata ta' 250 mg/siegħa għall-ewwel 30 minuta u wara 600 mg/siegħa għad-90 minuta ta' wara.
English: • you are allergic to rituximab, other proteins which are like rituximab, or any of the other ingredients of this medicine (listed in section 6).
Maltese: • inti allerġiku għal rituximab, proteini oħrajn li huma simili għal rituximab, jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6).
English: In the relapsed/refractory study, the median progression-free survival (primary endpoint) was 30.6 months in the R-FC group and 20.6 months in the FC group (p=0.0002, log-rank test).
Maltese: Fl-istudju dwar CLL li reġgħet tfaċċat/refrattarja, s-sopravivenza mingħajr progressjoni (punt finali primarju) medjana kienet ta' 30.6 xhur fil-grupp ta' R-FC u 20.6 xhur fil-grupp ta' FC (p = 0.0002,
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: Chronic lymphocytic leukaemia (CLL) is the most common form of adult leukaemia.
Maltese: Lewkimja limfoċitika kronika (CLL) hija l-aktar forma komuni ta' lewkimja fl-adulti.
English: • Additional risk minimisation measures For the indications non-Hodgkin´s lymphoma (NHL) and Chronic lymphocytic leukaemia
Maltese: Għall-indikazzjonijiet għal limfoma mhux ta' Hodgkin (NHL) u Lewkimja limfoċitika kronika (CLL):
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: Rituximab maintenance treatment significantly prolonged median PFS in patients responding to CHOP induction therapy (median PFS 37.5 months vs. 11.6 months, p < 0.0001) as well as in those responding to R-CHOP induction (median PFS 51.9 months vs. 22.1 months, p=0.0071).
Maltese: 11.6 xhur, p< 0.0001) kif ukoll f'dawk li rrispondew għall-induzzjoni b'R-CHOP (PFS medjana 51.9 xhur vs 22.1 xahar, p = 0.0071).
English: • severe skin problems causing blisters that can be life-threatening.
Maltese: • problemi severi fil-ġilda li jikkawżaw infafet li jistgħu jkunu ta' periklu għal ħajja.
English: The pharmacokinetic (PK) parameters in the anti-TNF inadequate responder population, following the same dosage regimen (2 x 1,000 mg, intravenous, 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 × 1000 mg, IV, ġimagħtejn 'il bogħod minn xulxin),
English: Investigations Decreased
Maltese: Investigazzjonijiet Emoglobina imnaqqsa
English: Depending on the severity of the IRR and the required interventions, temporarily or permanently discontinue Rixathon.
Maltese: Skont is-severità tal-IRR u l-interventi meħtieġa, waqqaf Rixathon temporanjament jew b'mod permanenti.
English: Adverse drug reaction rituximab + low-dose prednisone (n = 38)
Maltese: Sistema tal-Klassifika tal-Organi Reazzjoni avversa tal-mediċina rituximab + doża baxxa ta' prednisone
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: Jekk waqt terapija b'rituximab hemm il-ħtieġa ta' tilqim mhux ħaj, dawn għandhom jitkomplew tal-inqas 4 ġimgħat qabel il-bidu tal kors li jmiss ta' rituximab 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: Pneumocystis jirovecii pneumonia (PCP) prophylaxis is recommended for patients with GPA/MPA or PV during and following Rixathon 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'Rixathon, kif xieraq skont il-linji gwida lokali dwar il-prattika klinika.
English: OTHER
Maltese: Na
English: − * Worst case imputation a Non-inferiority was demonstrated since the lower bound (− 3.2%) was higher than the predetermined 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: Rituximab induces B-cell depletion in about 70-80% of patients, but was associated with decreased serum immunoglobulins only in a minority of patients.
Maltese: Rituximab jikkaġuna tnaqqis taċ-ċellula B f'madwar 70-80% tal-pazjenti, iżda kien assoċjat ma'
English: Minor relapses (not life threatening and not involving major organ damage) occurred in seven patients in the rituximab group (12%) and eight patients in the azathioprine group (14%).
Maltese: Irkadar minuri (mhux ta' periklu għall-ħajja u li ma jinvolvix ħsara f'organi prinċipali) seħħ f'seba' pazjenti fil-grupp ta' rituximab (12%) u fi tmien pazjenti fil-grupp ta' azathioprine (14%).
English: The best responses to Rixathon 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 Rixathon huwa osservat f'dawk li jkollhom test tad-demm pożittiv għall-fattur rewmatiku (RF) u/jew għall-anti-Cyclic Citrullinated Peptide (anti-CCP).
English: The recommended dosage of Rixathon 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' Rixathon 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: Clinical experience in Non-Hodgkin's lymphoma and in chronic lymphocytic leukaemia
Maltese: Esperjenza minn limfoma mhux ta' Hodgkin u lewkimja limfoċitika kronika