FrancophonIA/ELRC3.0 huggingface dataset:
English: +left ventricular failure, +supraventricular tachycardia, +ventricular tachycardia, +angina, +myocardial ischaemia, bradycardia severe cardiac disorders4 and 6
Maltese: +insuffiċjenza ventrikulari tax-xellug, +takikardja supraventrikula ri, +takikardja ventrikulari, +anġina, +iskemija mijokardijaka, bradikardja disturbi kardijaċi severi 4 u 6
English: Infections and infestations upper respiratory tract infection, urinary tract infections bronchitis, sinusitis, gastroenteritis, tinea pedis
Maltese: Infezzjonijiet u infestazzjonijiet infezzjoni flapparat respiratorju ta' fuq, infezzjonijiet flapparat urinarju bronkite, sinożite, gastro-enterite, tinea pedis
English: Blitzima may be used for the treatment of several different conditions in adults.
Maltese: Blitzima jista' jintuża għall-kura ta' diversi kundizzjonijiet differenti fl-adulti.
English: Subsequent doses of Blitzima 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' Blitzima 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: 3 patients (8%) in the rituximab group experienced a total of 5 serious infections (Pneumocystis jirovecii pneumonia, infective thrombosis, intervertebral discitis, lung infection, Staphylococcal sepsis) and one patient (3%) in the standard-dose prednisone group experienced a serious infection (Pneumocystis jirovecii pneumonia).
Maltese: Tliet pazjenti (8%) fil-grupp ta' rituximab kellhom total ta' 5 infezzjonijiet serji (pnewmonja kkawżata minn Pneumocystis jirovecii, trombożi infettiva, infezzjoni fl-ispazju bejn id-diski vertebrali, infezzjoni fil-pulmun u sepsis ikkawżata minn Staphylococcus) u pazjent wieħed (3%) fil-grupp b'doża standard ta' prednisone kellu infezzjoni serja (pnewmonja kkawżata minn Pneumocystis jirovecii).
English: Table 14 Physical function and quality of life outcomes at week 24 in Trial 1
Maltese: Tabella 14 Funzjoni fiżika u riżultati tal-kwalità tal-ħajja f'ġimgħa 24 fi prova 1 Riżultat†
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), vaskulite lewkoċitokl astika
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' 19.2-il ġurnata.
English: Influenza-like illness Oedema peripheral
Maltese: Deni Marda tixbah lill-influwenza Edima periferali
English: s r.o Tel: +420 227 129 111
Maltese: Česká republika EGIS Praha, spol. s r.o Tel: +420 227 129 111
English: In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis in disease remission or pemphigus vulgaris, premedication with 100 mg intravenous methylprednisolone should be completed 30 minutes prior to Blitzima infusions to decrease the incidence and severity of infusion related reactions (IRRs).
Maltese: F'pazjenti b' granulomatosi b'polianġite (ta' Wegener) jew polianġite mikroskopika f'remissjoni talmarda jew pemphigus vulgaris, medikazzjoni minn qabel b'100 mg methylprednisolone fil-vini għandha tiġi kompluta 30 minuta qabel infużjonijiet ta' Blitzima biex titnaqqas l-inċidenza u s-severità ta' reazzjonijiet relatati mal-infuzjoni (IRRs - infusion related reactions).
English: All patients were followed until month 28 (10 or 6 months, respectively, after the last rituximab infusion or azathioprine dose).
Maltese: Il-pazjenti kollha kienu segwiti sa xahar 28 (10 jew 6 xhur, rispettivament, wara l-aħħar infużjoni ta' rituximab jew doża ta' azathioprine).
English: +myocardial infarction4 and 6, arrhythmia, +atrial fibrillation, tachycardia, +cardiac disorder
Maltese: 6, arritmija, +fibrillazjoni atrijali, takikardja, +disturb fil-qalb
English: Posology
Maltese: radjugrafika
English: Blitzima is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
Maltese: Blitzima huwa indikat għat-trattament ta' pazjenti b'pemphigus vulgaris (PV) moderat sa sever.
English: Outcome†
Maltese: ANNESS I
English: The ORR was 36% (CI95% 21% - 51%; CR 3%, PR 33%) with a median TTP for responding patients of 9.6 months (range 4.5 to 26.8 months).
Maltese: LORR kienet ta' 36% (CI95% 21% - 51%; CR 3%, PR 33%) b'TTP medjan għal pazjenti li rrispondew ta' 9.6 xhur (firxa minn 4.5 sa 26.
English: Table 10b First-line treatment of chronic lymphocytic leukaemia Hazard ratios of progression-free survival according to Binet stage (ITT) - 48.1 months median observation time
Maltese: Tabella 10b Kura preferita ta' lewkimja limfoċitika kronika Proporzjonijiet ta' periklu ta' sopravivenza mingħajr progressjoni skont l istadju Binet (ITT) - perjodu medjan ta' osservazzjoni ta' 48.1 xaharSopravivenza Mingħajr Progressjoni (PFS)
English: Bronchitis Rhinitis
Maltese: Tnaqqis tarriskju
English: 3infusion-related reactions (hypertension, nausea, rash, pyrexia, pruritus, urticaria, throat irritation, hot flush, hypotension, rhinitis, rigors, tachycardia, fatigue, oropharyngeal pain, peripheral oedema, erythma)
Maltese: 3reazzjonijiet relatati malinfużjoni (presjoni għolja, tqalligħ, raxx, deni, ħakk, urtikarja, irritazzjoni filgriżmejn, fwawar pressjoni baxxa, rinite, tertir, takikardija, għeja, uġigħ orofarinġali, edima periferali, eritema)
English: Subgroup analysis PFS
Maltese: Analiżi tas-sottogruppi
English: Aseptically withdraw the necessary amount of Blitzima, 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: Neħħi b'mod assetiku l-ammont neċessarju ta' Blitzima, 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' klorur tas-sodju 9 mg/mL (0.9%) jew 5% D-Glucose fl-ilma.
English: 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: Immune system disorders infusion-relate d reactions4, angioedema hypersensitivity anaphylaxis tumour lysis syndrome, cytokine release syndrome4, serum sickness infusion-relate d acute reversible thrombocytop enia4
Maltese: Disturbi fissistema immuni reazzjonijiet relatati malinfużjoni4, anġjoedima sensittività eċċessiva anafilassi sindrome tallisi tat-tumur, sindrome tarrilaxx taċċitokina4, marda tasserum tromboċito penija akuta riversibbli relatata malinfużjoni4
English: Binet stage A Binet stage B Binet stage C CI: Confidence Interval 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, test log-rank).
English: Blitzima 500 mg concentrate for solution for infusion Rituximab
Maltese: Blitzima 500 mg konċentrat għal soluzzjoni għal infużjoni Rituximab
English: In the maintenance therapy clinical trial, the incidence of all-grade neutropenia was 0% for rituximab-treated patients vs. 5% for azathioprine treated patients.
Maltese: Fil-prova klinika dwar terapija ta' manteniment, l-inċidenza ta' newtropenija ta' kull grad kienet ta' 0% għall-pazjenti ttrattati b'rituximab vs 5% għall-pazjenti ttrattati b'azathioprine.
English: Table 13 Radiographic outcomes at 1 year (mITT population) Placebo+MTX Rituximab +MTX 2 × 1000 mg
Maltese: Tabella 13 Riżultati radjugrafiċi wara sena (popolazzjoni mITT) Plaċebo+MTX
English: Blood and lymphatic system neutropenia1
Maltese: Disturbi tad-demm u tas-sistema limfatika newtropenija1
English: Blitzima 100 mg concentrate for solution for infusion Rituximab
Maltese: Blitzima 100 mg konċentrat għal soluzzjoni għal infużjoni Rituximab
English: Overall, 4% of patients in the rituximab arm experienced adverse events leading to discontinuation.
Maltese: B'mod globali, 4% tal-pazjenti filgrupp ta' rituximab kellhom avvenimenti avversi li wasslu għal waqfien.
English: Gastrointesti nal disorders nausea vomiting , diarrhoea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation abdominal enlargement gastro-intestin al perforation7
Maltese: Disturbi gastrointestin ali tqalligħ rimettar, dijarea, uġigħ addominali, disfaġja, stomatite, stitikezza, dispepsja, anoressija, irritazzjoni filgriżmejn tkabbir taladdome perforazzjoni gastro-intest inali7
English: EFS - Event Free Survival TTP - Time to progression or death PFS - Progression-Free Survival TTF - Time to Treatment Failure OS rates - survival rates at the time of the analyses
Maltese: TTP - Żmien sal-progressjoni jew sal-mewt PFS - Sopravivenza Mingħajr Progressjoni TTF - Żmien sal-Falliment tal-Kura
English: Metabolism and nutritional disorders hypercholesterolemia
Maltese: Disturbi filmetaboliżmu u nnutrizzjoni iperkolesterolimja
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 flapparat tal-awrina, infezzjoni fungali u konġuntivite.
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/m 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: Blood and lymphatic system disorders neutropenia, leucopenia, +febrile neutropenia, +thrombocytope nia anaemia, +pancytopenia, +granulocytope nia coagulation disorders, aplastic anaemia, haemolytic anaemia, lymphadenopa thy transient increase in serum IgM levels3
Maltese: Disturbi taddemm u tassistema limfatika newtropenija, lewkopenija, +newtropenija bid-deni, +tromboċitope nija anemija, +panċitopenija, +granuloċitopeni ja disturbi fil-koagulazzjo ni, anemija aplastika, anemija emolitika, limfadenopatija żieda temporanja fil-livelli ta' IgM fis-serum3
English: Other medicines and Blitzima
Maltese: Mediċini oħra u Blitzima
English: Nervous system disorders headache paraesthesia, migraine, dizziness, sciatica
Maltese: Disturbi fis-sistema nervuża uġigħ ta' ras parasteżija, emigranja, sturdament, xjatika
English: Efficacy in autoantibody (RF and or anti-CCP) seropositive patients Patients seropositive to Rheumatoid Factor (RF) and/or anti-Cyclic Citrullinated Peptide (antiCCP) who were treated with rituximab in combination with methotrexate showed an enhanced response compared to patients negative to both.
Maltese: Pazjenti seropożittivi għall-Fattur Rewmatiku (RF) u/jew għall-anti-Cyclic Citrullinated Peptide (antiCCP) li kienu kkurati b'rituximab flimkien ma' methotrexate urew rispons mtejjeb meta mqabbel ma' pazjenti negattivi għat-tnejn.
English: CD20 does not circulate in the plasma as a free antigen and, thus, does not compete for antibody binding.
Maltese: CD20 ma jiċċirkolax filplażma bħala antiġen liberu u, għaldaqstant, ma jikkompetix għall-irbit tal-antikorp.
English: Cases of posterior reversible encephalopathy syndrome (PRES)/reversible posterior leukoencephalopathy syndrome (RPLS) have been reported.
Maltese: 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: 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: Upon administration of rituximab at a dose of 375 mg/m2 as an intravenous infusion at weekly intervals for 8 doses to 37 patients with NHL, the mean Cmax increased with each successive infusion, spanning from a mean of 243 µg/mL (range, 16 - 582 µg/mL) after the first infusion to 550 µg/mL (range, 171 - 1177 µg/mL) after the eighth infusion.
Maltese: Mal-għoti ta' rituximab f'doża ta' 375 mg/m bħala infużjoni fil-vini f'intervalli ta' kull ġimgħa għal 8 dożi lil 37 pazjent b'NHL, Cmax medja żdiedet ma' kull infużjoni ta' wara, varjat minn medja ta' 243 µg/mL (firxa, 16-582 µg/mL) wara l-ewwel infużjoni għal 550 µg/mL (firxa, 171-1177 µg/mL) wara t-tmin infużjoni.
English: Rarely Blitzima can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML.
Maltese: B'mod rari Blitzima jista' jikkawża infezzjoni serja fil-moħħ, imsejħa “lewkoenċefalopatija multifokali progressiva” jew PML.
English: In a randomised, open-label trial, a total of 399 previously untreated elderly patients (age 60 to 80 years) with diffuse large B cell lymphoma received standard CHOP chemotherapy (cyclophosphamide 750 mg/m2, doxorubicin 50 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 eight cycles, or rituximab 375 mg/m2 plus CHOP (R-CHOP).
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/m sa massimu ta' 2 mg fl-ewwel jum, u prednisolone 40 mg/m 2/jum mill-ewwel sal-ħames jum) kull 3 ġimgħat għal 8 ċikli jew rituximab 375 mg/m flimkien ma' CVP (R-CVP).
English: Progression‐free survival (PFS)
Maltese: Sopravivenza mingħajr progressjoni (PFS)
English: You will always be given Blitzima as a drip (intravenous infusion).
Maltese: Inti dejjem se tingħata Blitzima bħala dripp (infużjoni fil-vini).
English: Blitzima 500 mg concentrate for solution for infusion
Maltese: Blitzima 500 mg konċentrat għal soluzzjoni għal infużjoni
English: Initial treatment, in combination with chemotherapy 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 (R-CVP).
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/m vincristine 1.4 mg/m sa massimu ta' 2 mg fl-ewwel jum, u prednisolone 40 mg/m 2/jum mill-ewwel sal-ħames jum) kull 3 ġimgħat għal 8 ċikli jew rituximab 375 mg/m2 flimkien ma' CVP (R-CVP).
English: The pre-specified primary analysis was conducted at a median observation time of 25 months from randomisation, maintenance therapy with rituximab resulted in a clinically relevant and statistically significant improvement in the primary endpoint of investigator assessed progressionfree 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' mantenimentb'rituximab 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: 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 flinċidenza ta' avvenimenti kardijaċi oħra ta' grad 3 u 4 inkluż insuffiċjenza tal-qalb, mard mijokardijaku u manifestazzjonijiet tal-marda tal-arterji koronarji.
English: Musculoskelet al, connective tissue and bone disorders hypertonia, myalgia, arthralgia, back pain, neck pain, pain
Maltese: Disturbi muskolu-skeltr ali u tattessut konnettiv ipertonja, mijalġja, artralġja, uġigħ fid-dahar, uġigħ fl-għonq, uġigħ
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: fi 11% tal-pazjenti fil-grupp ta' R-FC meta mqabbel ma' 9% tal-pazjenti fil-grupp ta' FC.
English: Of the patients originally receiving methotrexate alone, 81% received rituximab either as rescue between weeks 16-24 or in the extension trial, before week 56.
Maltese: Mill-pazjenti li oriġinarjament kienu qegħdin jirċievu methotrexate waħdu, 81% rċevew rituximab jew bħala salvataġġ bejn ġimgħa 16-24 jew fil-prova ta' estensjoni, qabel ġimgħa 56.
English: How to store Blitzima
Maltese: Tiħux Blitzima jekk:
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: Il-profil ta' sigurtà ta' rituximab flimkien ma' doża baxxa ta' glukokortikojdi għal perjodu qasir fittrattament ta' pazjenti b'pemphigus vulgaris ġie studjat fi studju ta' Fażi 3, randomizzata, ikkontrollat, b'aktar minn ċentru wieħed, open-label f'pazjenti b'pemphigus li kien jinkludi 38 pazjent b'pemphigus vulgaris (PV) mħalltin għall-grupp ta' rituximab.
English: Blitzima is provided in sterile, preservative-free, non-pyrogenic, single use vials.
Maltese: Blitzima jiġi fornut f'kunjetti sterili, mingħajr preservattivi, mhux piroġeniċi, li jintużaw darba biss.
English: 95% CIb
Maltese: CI ta' 95%
English: Do not have Blitzima if you have an active infection or a serious problem with your immune system.
Maltese: Tiħux Blitzima jekk ikollok infezzjoni attiva jew problema serja bis-sistema immuni tiegħek.
English: The Physician information about Blitzima should contain the following key elements:
Maltese: Informazzjoni għall-pazjent dwar Blitzima għandha tinkludi l-punti essenzjali li ġejjin:
English: Exacerbations of pre-existing cardiac conditions such as angina pectoris or congestive heart failure or severe cardiac disorders (heart failure, myocardial infarction, atrial fibrillation), pulmonary oedema, multi-organ failure, tumour lysis syndrome, cytokine release syndrome, renal failure, and respiratory failure were reported at lower or unknown frequencies.
Maltese: Rkadar ta' kondizzjonijiet kardijaċi eżistenti minn qabel bħal anġina pectoris jew insuffiċjenza tal-qalb konġestiva jew disturbi kardijaċi severi (insuffiċjenza talqalb, infart mijokardijaku, fibrillazzjoni atrijali), edima pulmonari, insuffiċjenza ta' ħafna organi, sindrome tal-lisi tat-tumur, sindrome tar-reħa ta' cytokine, insuffiċjenza tal-kliewi, u insuffiċjenza respiratorja kienu rrappurtati bi frekwenza aktar baxxa jew bi frekwenza mhux magħrufa.
English: Blitzima contains sodium
Maltese: Id-dehra ta' Blitzima u l-kontenuti tal-pakkett
English: Table 4 Adverse drug reactions occurring in ≥ 5% of patients receiving rituximab for maintenance treatment of GPA and MPA, and at a higher frequency than the comparator group
Maltese: Tabella 4 Reazzjonijiet avversi tal-mediċina li seħħew f'≥ 5% tal-pazjenti li rċevew rituximab għal trattament ta' manteniment ta' GPA u MPA, u bi frekwenza ogħla mill-grupp ta' paragun
English: Skin and Subcutaneou s tissue disorders pruritus, rash, +alopecia urticaria, sweating, night sweats, +skin disorder severe bullous skin reactions, StevensJohnson syndrome, toxic epidermal necrolysis (Lyell's syndrome)7
Maltese: Disturbi filġilda u fittessuti ta' taħt il-ġilda ħakk, raxx , +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: Mean terminal elimination half-life ranged from 15 to 16 days for the 2 × 500 mg dose group and 17 to 21 days for the 2 × 1000 mg dose group.
Maltese: Ilhalf-life medja tat-tneħħija terminali varjat minn 15 sa 16-il ġurnata għall-grupp tad-doża ta' 2 x 500 mg u minn 17 sa 21 ġurnata għall-grupp tad-doża ta' 2 × 1,000 mg. Cmax medja kienet 16 sa 19% ogħla wara t-tieni infużjoni meta mqabbel mal-ewwel infużjoni għaż-żewġ dożi.
English: Respiratory, thoracic and mediastinal disorders bronchospasm4, respiratory disease, chest pain, dyspnoea, increased cough, rhinitis asthma, bronchiolitis obliterans, lung disorder, hypoxia interstitial lung disease7
Maltese: Disturbi respiratorji, toraċiċi u medjastinali bronkospażmu4, marda respiratorja, uġigħ fis-sider, qtugħ ta' nifs, żieda fis-sogħla, rinite ażżma, bronkolite obliterans, disturb filpulmun, ipoxja marda talinterstizju talpulmun7
English: Date of first authorisation: 13 July 2017 Date of latest renewal:
Maltese: Data tal-ewwel awtorizzazzjoni: 13 ta 'Lulju, 2017
English: Peripheral oedema
Maltese: Effikaċja sekondarja
English: Musculoskeletal and Connective Tissue Disorders
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Spażmi fil-muskoli
English: Patients randomised to the rituximab group received an initial intravenous infusion of 1000 mg rituximab on Study Day 1 in combination with 0.5 mg/kg/day oral prednisone tapered off over 3 months if they had moderate disease or 1 mg/kg/day oral prednisone tapered off over 6 months if they had severe disease, and a second intravenous infusion of 1000 mg on Study Day 15.
Maltese: Il-pazjenti randomised għall-grupp ta' rituximab rċevew infużjoni inizjali fil-vini ta' 1,000 mg rituximab fil-Jum 1 tal-Istudju flimkien ma' 0.5 mg/kg/jum ta' prednisone mill-ħalq li tnaqqas għax-xejn fuq perjodu ta' 3 xhur jekk kellhom marda moderata jew 1 mg/kg/jum ta' prednisone millħalq li tnaqqas għax-xejn fuq perjodu ta' 6 xhur jekk kellhom marda severa, u t-tieni infużjoni fil-vini ta' 1,000 mg fil-Jum 15 tal-Istudju.
English: Gastrointestinal disorders dyspepsia, diarrhoea, gastro-oesophageal reflux, mouth ulceration, upper abdominal pain
Maltese: Disturbi gastrointestinali dispepsja, dijarea, rifluss gastroesofagali, ulċeri filħalq, uġigħ fil-parti ta' fuq tal-addome
English: 7 includes fatal cases
Maltese: reazzjonijiet relatati mal-infużjoni 7 inkluż każijiet fatali
English: EGIS Praha, spol.
Maltese: Likwidu ċar, mingħajr kulur.
English: Response rate and CR rates analysed using Chi-squared Test. NR: not reached; N/A: not applicable *: only applicable to patients achieving a CR, nPR, PR; **: only applicable to patients achieving a CR;
Maltese: NR: ma ntlaħaqx n.a. ma japplikax *: japplika biss għall-pazjenti li laħqu CR, nPR, PR; **: japplika biss għall-pazjenti li laħqu CR;
English: 4.06 years
Maltese: 4.06 snin 10.