FrancophonIA/ELRC3.0 huggingface dataset:
English: Age, gender and ethnicity: Population pharmacokinetic analyses in RA and GCA patients, showed that age, gender and ethnic origin did not affect the pharmacokinetics of RoActemra.
Maltese: Analiżi tal-farmakokinetika tal-popolazzjoni f'pazjenti b'RA u GCA, uriet li l-età, is-sess u l-oriġini etnika ma affettwawx il-farmakokinetika ta' RoActemra.
English: The most common events observed were nasopharyngitis and upper respiratory tract infections.
Maltese: L-aktar avvenimenti komuni osservati kienu nażofarinġite u infezzjonijiet tal-apparat respiratorju ta' fuq.
English: Of the 46 patients (1.6%) who developed anti-tocilizumab antibodies, 6 had an associated medically significant hypersensitivity reaction, of which 5 led to permanent discontinuation of treatment.
Maltese: Minn 46 pazjent (1.6 %) li żviluppaw antikorpi kontra tocilizumab, 6 kellhom reazzjoni ta' sensittività eċċessiva li kienet medikament sinifikanti, u minn dawn 5 waqqfu ilkura b'mod permanenti.
English: A 52-week, open-label, multicenter, PK-PD and safety study was conducted in paediatric patients with pJIA, aged 1 to 17 years old, to determine the appropriate subcutaneous dose of RoActemra that achieved comparable PK/PD and safety profiles to the IV regimen.
Maltese: Studju ta' 52 ġimgħa, open-label, b'aktar minn ċentru wieħed, dwar il-PK-PD u s-sigurtà twettaq f'pazjenti pedjatriċi b'pJIA, b'età minn sena sa 17-il sena, biex tiġi ddeterminata d-doża taħt il-ġilda xierqa ta' RoActemra li kisbet profili PK/PD u tas-sigurtà komparabbli għall-kors IV.
English: Side effects in children and adolescents with sJIA or pJIA
Maltese: Effetti jistgħu jinkludu puplesiji u għama.
English: In 6-month controlled clinical studies, the rate of serious infections with RoActemra 8 mg/kg plus DMARDs was 5.3 events per 100 patient years exposure compared to 3.9 events per 100 patient years exposure in the placebo plus DMARD group.
Maltese: Fl-istudji kliniċi kkontrollati ta' 6 xhur, ir-rata ta' infezzjonijiet serji b'RoActemra 8 mg/kg flimkien ma' DMARDs kienet ta' 5.3 avvenimenti għal kull 100 sena ta' esponiment ta' pazjent meta mqabbla ma' 3.9 avvenimenti għal kull 100 sena ta' esponiment ta' pazjent fil-grupp ta' plaċebo flimkien ma' DMARDs.
English: The control period in 4 of the studies was 6 months and in 1 study was up to 2 years.
Maltese: Il-perjodu ta' kontroll f'4 mill-istudji kien ta' 6 xhur u fi studju wieħed kien sa sentejn.
English: Five patients (0.8%) developed positive anti-RoActemra antibodies; of these, all developed neutralizing anti-RoActemra antibodies.
Maltese: Ħames pazjenti (0.8%) żviluppaw antikorpi pożittivi kontra RoActemra; minn dawn, kollha żviluppaw antikorpi newtralizzanti kontra RoActemra.
English: RoActemra -treated patients reported an improvement in all patient-reported outcomes (Health Assessment Questionnaire Disability Index - HAQ-DI), Short Form-36 and Functional Assessment of Chronic Illness Therapy questionnaires.
Maltese: Pazjenti ttrattati b'RoActemra rrappurtaw titjib fir-riżultati kollha rrappurtati mill-pazjenti (Indiċi ta' Diżabilità ibbażat fuq Kwestjonarju ta' Valutazzjoni tas-Saħħa - HAQ-DI [Health Assessment Questionnaire Disability Index]), Short Form-36 u kwestjonarji tal-Valutazzjoni Funzjonali ta' Terapija għal Mard Kroniku.
English: IL-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T- and B-cells, monocytes and fibroblasts.
Maltese: IL-6 huwa ċitokin pro-infjammatorju b'aktar minn effett wieħed magħmul minn ħafna tipi ta' ċelluli fosthom ċelluli T u B, monoċiti u fibroblasti.
English: The safety profile of subcutaneous RoActemra was also evaluated in 52 paediatric patients with pJIA.
Maltese: Il-profil tas-sigurtà ta' RoActemra taħt il-ġilda kien evalwat ukoll fi 52 pazjent pedjatriku b'pJIA.
English: The assessment of the time to first GCA flare showed a significantly lower risk of flare for the RoActemra subcutaneous weekly group compared to placebo plus 26 weeks prednisone and placebo plus 52 weeks prednisone taper groups and for the RoActemra subcutaneous every other weekly group compared to placebo plus 26 weeks prednisone (when compared at a 0.01 significance level).
Maltese: Il-valutazzjoni tal-ħin sal-ewwel irkadar ta' GCA wriet riskju ferm aktar baxx ta' rkadar għall-grupp ta' RoActemra taħt il-ġilda kull ġimgħa meta mqabbel mal-gruppi ta' plaċebo flimkien ma' 26 ġimgħa ta' prednisone mnaqqas bil-mod għax-xejn u plaċebo flimkien ma' 52 ġimgħa ta' prednisone mnaqqas bil-mod għax-xejn u għall-grupp ta' RoActemra taħt il-ġilda kull ġimagħtejn meta mqabbel ma' plaċebo flimkien ma' 26 ġimgħa ta' prednisone (meta mqabbel f'livell ta' sinifikanza ta' 0.01).
English: The half life of tocilizumab in sJIA patients is up to 16 days for the two body weight categories (8 mg/kg for body weight ≥ 30 kg or 12 mg/kg for body weight < 30 kg) at week 12.
Maltese: Il-half life ta' tocilizumab f'pazjenti b'sJIA hija sa 16-il ġurnata għaż-żewġ kategoriji ta' piż tal-ġisem (8 mg/kg għall-piż tal-ġisem ≥ 30 kg jew 12-il mg/kg għall-piż tal-ġisem < 30 kg) f'ġimgħa 12.
English: In the monotherapy study the rate of serious infections was 3.6 events per 100 patient years of exposure in the RoActemra group and 1.5 events per 100 patient years of exposure in the MTX group.
Maltese: Fl-istudju ta' monoterapija, ir-rata ta' infezzjonijiet serji kienet ta' 3.6 avvenimenti għal kull 100 sena ta' esponiment ta' pazjent fil-grupp ta' RoActemra u 1.5 avvenimenti għal kull 100 sena ta' esponiment ta' pazjent fil-grupp ta' MTX.
English: In sJIA patients, the central volume of distribution was 1.87 L and the peripheral volume of distribution was 2.14 L resulting in a volume of distribution at a steady state of 4.01 L. The linear clearance estimated as a parameter in the population pharmacokinetic analysis, was 5.7 mL/h.
Maltese: F'pazjenti b'sJIA, il-volum ċentrali ta' distribuzzjoni kien ta' 1.87 L u l-volum periferali ta' distribuzzjoni kien ta' 2.14 L li wassal għall-volum ta' distribuzzjoni fi stat fiss ta' 4.01 L.
English: For MCS, the mean change from baseline to week 52 for both RoActemra weekly and every other weekly dose groups [7.28, 6.12, respectively] were higher than the placebo plus 52 weeks prednisone taper group [2.84] (although the differences were not statistically significant [weekly p=0.0252 for weekly, p=0.1468 for every other weekly]) and similar to the placebo plus 26 weeks prednisone taper group [6.67].
Maltese: Għal MCS, il-bidla medja mil-linja bażi sa ġimgħa 52 kemm għall-grupp ta' doża ta' RoActemra ta' kull ġimgħa kif ukoll ta' kull ġimagħtejn [7.28, 6.12, rispettivament] kienet ogħla mill-grupp ta' plaċebo flimkien ma' 52 ġimgħa ta' prednisone mnaqqas bil-mod għax-xejn [2.84] (għalkemm id-differenzi ma kinux statistikament sinifikanti [p ta' kull ġimgħa=0.0252 għal doża ta' kull ġimgħa, p=0.1468 għal doża ta' kull ġimagħtejn]) u simili għallgrupp ta' plaċebo flimkien ma' 26 ġimgħa ta' prednisone mnaqqas bil-mod għax-xejn [6.67].
English: Following 1 year of treatment with RoActemra plus MTX, 85% of patients(n=348) had no progression of structural joint damage, as defined by a change in the Total Sharp Score of zero or less, compared with 67% of placebo plus MTX-treated patients(n=290) (p ≤ 0.001).
Maltese: Wara sena ta' trattament b'RoActemra flimkien ma' MTX, 85% tal-pazjenti (n=348) ma kellhom lebda progressjoni fil-ħsara strutturali fil-ġogi, kif definit minn bidla ta' żero jew inqas fil-Punteġġ Sharp Totali, meta mqabbel ma' 67% tal-pazjenti ttrattati bi plaċebo flimkien ma' MTX (n=290) (p ≤ 0.001).
English: • adults with severe, active and progressive rheumatoid arthritis (RA), who have not had previous treatment with methotrexate.
Maltese: • adulti b'artrite rewmatojde (RA - rheumatoid arthritis) severa, attiva u progressiva, li ma kinux ittrattati qabel b'methotrexate.
English: Peripheral oedema, Hypersensitivity reactions
Maltese: Edima periferali, Reazzjonijiet ta' sensittività eċċessiva
English: Doses of 8 mg/kg of tocilizumab were given every four weeks as monotherapy.
Maltese: Dożi ta' 8 mg/kg ta' tocilizumab ingħataw kull erba' ġimgħat bħala monoterapija.
English: sJIA,pJIA and CRS Patients < 30 kg
Maltese: Pazjenti b'sJIA, pJIA u CRS < 30 kg
English: Reports of gastrointestinal perforation on tocilizumab were primarily reported as complications of diverticulitis including generalised purulent peritonitis, lower gastrointestinal perforation, fistulae and abscess.
Maltese: Rapporti ta' perforazzjoni gastro-intestinali dwar tocilizumab kienu rrappurtati primarjament bħala kumplikazzjonijiet ta' divertikulite inkluż peritonite ġeneralizzata bilmaterja, perforazzjoni gastro-intestinali tal-parti t'isfel, fistla u axxess.
English: Given its long elimination half-life (t1/2), the effect of RoActemra on CYP450 enzyme activity may persist for several weeks after stopping therapy.
Maltese: Minħabba l-half-life (t1/2) tal-eliminazzjoni twila tiegħu, l-effett ta' RoActemra fuq l-attività tal-enzima CYP450 jista' jippersisti għal ħafna ġimgħat wara li titwaqqaf it-terapija.
English: Of the patients who completed the study who were originally randomised to placebo + MTX, 86% received open-label RoActemra 8 mg/kg in year 2.
Maltese: Mill-pazjenti li temmew l-istudju li oriġinarjament kienu randomised għall-plaċebo + MTX, 86% irċivew open-label RoActemra 8 mg/kg fit-tieni sena.
English: Headache, Dizziness
Maltese: DATA TA' SKADENZA
English: After 2 years of treatment with RoActemra plus MTX, 14% of patients achieved a major clinical response (maintenance of an ACR70 response for 24 weeks or more).
Maltese: Wara sentejn ta' trattament b'RoActemra flimkien ma' MTX, 14% tal-pazjenti kisbu rispons kliniku maġġuri (manteniment ta' rispons ta' ACR70 għal 24 ġimgħa jew aktar).
English: Interrupt RoActemra dosing.
Maltese: Tużax RoActemra.
English: In the open-label extension of Study II the inhibition of progression of structural joint damage in tocilizumab plus MTX-treated patients was maintained in the second year of treatment.
Maltese: Fl-estensjoni open-label ta' Studju II, l-inibizzjoni ta' progressjoni ta' ħsara strutturali fil-ġogi f'pazjenti kkurati b'tocilizumab flimkien ma' MTX inżammet fit-tieni sena ta' kura.
English: The half life of tocilizumab in pJIA patients is up to 16 days for the two body weight categories (8 mg/kg for body weight ≥ 30 kg or 10 mg/kg for body weight < 30 kg) during a dosing interval at steady state.
Maltese: Il-half life ta' tocilizumab f'pazjenti b'pJIA hija sa 16-il ġurnata għaż-żewġ kategoriji ta' piż tal-ġisem (8 mg/kg għall-piż tal-ġisem ≥ 30 kg jew 10 mg/kg għall-piż tal-ġisem < 30 kg) waqt intervall ta' dożaġġ fi stat fiss.
English: Cough, Dyspnoea
Maltese: TCZ Kollha
English: • Pre-filled Syringe
Maltese: Armi s-siringa
English: Doses of 8 mg/kg of RoActemra were given every four weeks as monotherapy.
Maltese: Dożi ta' 8 mg/kg ta' RoActemra ngħataw kull erba' ġimgħat bħala monoterapija.
English: During routine laboratory monitoring in the RoActemra 6 month controlled clinical trial SC-I, 19% of patients experienced sustained elevations in total cholesterol > 6.2 mmol/L (240 mg/dl), with 9% experiencing a sustained increase in LDL to ≥ 4.1 mmol/L(160 mg/dL) on the subcutaneous weekly dose.
Maltese: Waqt monitoraġġ ta' rutina tal-laboratorju fil-prova klinika kkontrollata ta' 6 xhur ta' RoActemra, SCI, 19% tal-pazjenti kellhom elevazzjonijiet sostnuti fil-kolesterol totali ta' > 6.2 mmol/L (240 mg/dL), b'9% kellhom żieda sostnuta fl-LDL għal ≥ 4.1 mmol/L (160 mg/dL) fuq id-doża taħt il-ġilda ta' kull ġimgħa.
English: For instructions on dilution of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq dilwizzjoni tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6.
English: • Liver enzyme abnormalities Laboratory Value
Maltese: • Anormalitajiet fl-enzimi tal-fwied Valur tal
English: The linear clearance was estimated as a parameter in the population pharmacokinetic analysis and was 6.25 mL/h.
Maltese: It-tneħħija lineari kienet stmata bħala parametru fl-analiżi tal-farmakokinetika tal-popolazzjoni u kienet ta' 6.25 mL/siegħa.
English: This medicinal product contains 1.17 mmol (or 26.55 mg) sodium per maximum dose of 1200 mg. To be taken into consideration by patients on a controlled sodium diet. Doses below 1025 mg of this medicinal product contain less than 1 mmol sodium (23 mg), i.e. essentially ‘sodium free'.
Maltese: Dożi taħt 1025 mg ta' dan il-prodott mediċinali fihom inqas minn 1 mmol ta' sodium (23 mg), i.e. essenzjalment ‘bla sodium'.
English: Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents including RoActemra (see section 4.8, undesirable effects).
Maltese: Kienu rrappurtati infezzjonijiet serji u xi kultant fatali f'pazjenti li kienu qed jirċievu sustanzi immunosoppressivi inkluż RoActemra (ara sezzjoni 4.8, Effetti mhux mixtieqa).
English: Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents including RoActemra (see section 4.8, Undesirable effects).
Maltese: Kienu rrappurtati infezzjonijiet serji u xi kultant fatali f'pazjenti li kienu qed jirċievu sustanzi immunosoppressivi inkluż RoActemra (ara sezzjoni 4.8, effetti mhux mixtieqa).
English: In Part 1, eligible patients ≥ 30 kg received tocilizumab at 8 mg/kg IV every 4 weeks for 4 doses.
Maltese: F'Parti I, pazjenti eliġibbli ta' ≥ 30 kg irċevew tocilizumab f'doża ta' 8 mg/kg IV kull 4 ġimgħat għal 4 dożi.
English: • Low platelet count Laboratory Value (cells x 103/ μL)
Maltese: • Għadd baxx ta' plejtlits Valur talLaboratorju (ċelluli x 103/µl)
English: In SC-II, a total of 434 patients treated with RoActemra 162mg every other week were tested for antiRoActemra antibodies in the 6 month controlled period.
Maltese: F'SC-II, kienu ttestjati total ta' 434 pazjent ittrattati b'RoActemra 162 mg kull ġimagħtejn għallantikorpi kontra RoActemra fil-perjodu kkontrollat ta' 6 xhur.
English: Rare side effects:
Maltese: Effetti sekondarji rari ħafna:
English: *humanised IgG1 monoclonal antibody against the human interleukin-6 (IL-6) receptor produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Maltese: IgG1 umanizzat kontra r-riċettur ta' interleukin-6 (IL-6) uman magħmul f'ċelluli tal-ovarji tal-ħamster Ċiniż (CHO) permezz ta' teknoloġija rikombinanti tad-DNA. Eċċipjenti b'effett magħruf:
English: Table 6: Efficacy Results for Study VII (WA19926) on MTX-naïve, early RA patients
Maltese: Tabella 6: Riżultati tal-effikaċja għal Study VII (WA19926) dwar pazjenti b'RA bikrija li qatt ma ħadu MTX qabel
English: During the withdrawal phase (Part II), the percentage of patients achieving JIA ACR 30, 50, and 70 responses at Week 40 relative to baseline are shown in Table 8.
Maltese: Matul il-fażi ta' rtirar (Parti II), il-persentaġġ ta' pazjenti li laħqu risponsi JIA ACR 30,50, u 70 f'Ġimgħa 40 imqabbel mal-linja bażi huma murija f'Tabella 8.
English: After 2 years of treatment with tocilizumab plus MTX, 14% of patients achieved a major clinical response (maintenance of an ACR70 response for 24 weeks or more).
Maltese: Wara sentejn ta' kura b'tocilizumab flimkien ma' MTX, 14% tal-pazjenti laħqu rispons kliniku maġġuri (manteniment ta' rispons ACR70 għal 24 ġimgħa jew aktar).
English: The PK of RoActemra in GCA patients were determined using a population PK model from an analysis dataset composed of 149 GCA patients treated with 162 mg subcutaneous every week or 162 mg subcutaneous every other week.
Maltese: Il-PK ta' RoActemra f'pazjenti b'GCA kienet determinata bl-użu ta' mudell tal-PK tal-popolazzjoni minn sett ta' dejta kompost minn 149 pazjent b'GCA ttrattati b'162 mg taħt il-ġilda kull ġimgħa jew 162 mg taħt il-ġilda kull ġimagħtejn.
English: Week 24 ACR20, n (%) ACR50, n (%) 165 (56.9)** 139 (47.6) ACR70, n (%) 112 (38.6)** Week 52 ACR20, n (%) ACR50, n (%) 162 (55.9)** 144 (49.3) ACR70, n (%) 125 (43.1)** 105 (36.0) HAQ-DI (adjusted mean change from baseline) Week 52
Maltese: Fl-Istudju SC-II, f'ġimgħa 24 kien hemm ACR20 ta' 60.9%, ACR50 ta' 39.8% u ACR70 ta' 19.7% għall-pazjenti ttrattati b'RoActemra taħt il-ġilda kull ġimagħtejn kontra ACR20 ta' 31.5%, ACR50 ta' 12.3% u ACR70 ta' 5.0% ta' plaċebo.
English: Fifty out of seventy five (67%) tocilizumab treated patients had a haemoglobin < LLN at baseline.
Maltese: Ħamsin minn ħamsa u sebgħin (67%) pazjent ikkurati b'tocilizumab kellhom emoglobina < LLN fillinja bażi.
English: Children with pJIA (aged 2 and over)
Maltese: Tfal b'pJIA (b'età minn sentejn 'il fuq)
English: Resolution of CRS was defined as lack of fever and off vasopressors for at least 24 hours.
Maltese: CRS li għadda ġie ddefinit bħala nuqqas ta' deni u twaqqif ta' vasopressuri għal mill-inqas 24 siegħa.
English: The mean change in Patient's global VAS from baseline at week 52 was lower (showing greater improvement) in the RoActemra weekly and every other weekly dose groups [-19.0, -25.3, respectively] than in both placebo groups [placebo plus 26 weeks -3.4, placebo plus 52 weeks -7.2], although only the RoActemra every other weekly plus 26 weeks prednisone taper group showed a statistically significant difference compared to placebo [placebo plus 26 weeks taper p=0.0059, and placebo plus 52 weeks taper p=0.0081].
Maltese: 3, rispettivament] milli fiż-żewġ gruppi tal-plaċebo [plaċebo flimkien ma' 26 ġimgħa -3.4, plaċebo flimkien ma' 52 ġimgħa -7.2], għalkemm fil-grupp ta' RoActemra kull ġimagħtejn flimkien ma' 26 ġimgħa ta' prednisone mnaqqas bil-mod għax-xejn biss uriet differenza statistikament sinifikanti meta mqabbel mal-plaċebo [plaċebo flimkien ma' 26 ġimgħa ta' tnaqqis bil-mod għax-xejn p=0.0059, u plaċebo flimkien ma' 52 ġimgħa ta' tnaqqis bil-mod għaxxejn p=0.0081].
English: All TCZ
Maltese: MTX TCZ
English: Population pharmacokinetic analyses did not detect any effect of MTX, non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids on RoActemra clearance in RA patients.
Maltese: Analiżi tal-farmakokinetika tal-popolazzjoni ma sabet l-ebda effett ta' MTX, mediċini antiinfjammatorji mhux sterojdi (NSAIDs - non-steroidal anti-inflammatory drugs) jew kortikosterojdi fuq it-tneħħija ta' RoActemra f'pazjenti b'RA.
English: Serious drug-induced liver injury, including acute liver failure, hepatitis and jaundice, have been observed with RoActemra (see section 4.8).
Maltese: Ħsara serja fil-fwied ikkawżata mill-mediċina, inklużi insuffiċjenza akuta tal-fwied, epatite u suffejra, ġew osservati b'RoActemra (ara sezzjoni 4.8).
English: In the double-blind controlled studies 774 patients received RoActemra 4 mg/kg in combination with MTX, 1870 patients received tocilizumab 8 mg/kg in combination with MTX/other DMARDs and 288 patients received tocilizumab 8 mg/kg monotherapy.
Maltese: Fl-istudji double-blind ikkontrollati, 774 pazjent irċevew RoActemra 4 mg/kg flimkien ma' MTX, 1870 pazjent irċevew tocilizumab 8 mg/kg flimkien ma' MTX/DMARDs oħrajn u 288 pazjent irċevew monoterapija b'tocilizumab 8 mg/kg.
English: RoActemra 162 mg solution for injection in pre-filled syringe Tocilizumab
Maltese: RoActemra 162 mg, soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Tocilizumab
English: Following 1 year of treatment with tocilizumab plus MTX, 85% of patients (n=348) had no progression of structural joint damage, as defined by a change in the Total Sharp Score of zero or less, compared with 67% of placebo plus MTX-treated patients (n=290) (p ≤ 0.001).
Maltese: Wara sena ta' kura b'tocilizumab flimkien ma' MTX, 85% tal-pazjenti (n=348) ma kellhom l-ebda progressjoni fil-ħsara strutturali fil-ġogi, kif definit minn bidla ta' żero jew inqas fil-Punteġġ Sharp Totali, meta mqabbel ma' 67% tal-pazjenti kkurati bi plaċebo flimkien ma' MTX (n=290) (p ≤ 0.001).
English: PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate).
Maltese: GĦAMLA FARMAĊEWTIKA Konċentrat għal soluzzjoni għall-infużjoni (konċentrat sterili).
English: Systemic Effects In the tocilizumab treated patients, 85% who had fever due to sJIA at baseline were free of fever (no temperature recording ≥ 37.5°C in the preceding 14 days) at week 12 versus 21% of placebo patients
Maltese: Fil-pazjenti kkurati b'tocilizumab, 85% li kellhom deni kkawżat minn sJIA fil-linja bażi kienu ħielsa mid-deni (l-ebda temperatura ta' ≥ 37.5°C irrekordjata fl-14-il jum ta' qabel) f'ġimgħa 12 meta mqabbla ma' 21% tal-pazjenti bil-plaċebo (p <0.
English: All patients received background glucocorticoid (prednisone) therapy.
Maltese: Il-pazjenti kollha rċevew terapija bi glukokortikojdi (prednisone) fl-isfond.
English: Malignancy
Maltese: Medjan
English: Each pre-filled pen contains 162 mg tocilizumab in 0.9 mL.
Maltese: Kull pinna mimlija għal-lest fiha 162 mg tocilizumab f'0.9 mL.
English: At week 24, a significant reduction in DAS28 from baseline of 3.1 was observed on subcutaneous and 1.7 on placebo arm, and for DAS28 < 2.6, 32.0% was observed on subcutaneous and 4.0% on placebo arm.
Maltese: F'ġimgħa 24, kien osservat tnaqqis sinifikanti f'DAS28 mil-linja bażi ta' 3.1 fil-grupp ta' għoti taħt il-ġilda u ta' 1.7 fil-grupp tal-plaċebo, u għal DAS28 ta' < 2.6, 32.0% kienu osservati fil-grupp ta' għoti taħt il-ġilda u 4.0% fil-grupp tal-plaċebo.
English: Inhibition of joint structural damage was shown with significantly less radiographic progression in patients receiving tocilizumab compared to control (Table 4).
Maltese: L-impediment ta' ħsara strutturali fil-ġog intwera bi progressjoni radjografika sinifikament anqas f'pazjenti li rċevew tocilizumab meta mqabbel mal-kontroll (Tabella 4).
English: A statistically significant superior treatment effect was seen in favour of RoActemra over placebo in achieving steroid-free sustained remission at week 52 on RoActemra plus 26 weeks prednisone taper compared with placebo plus 26 weeks prednisone taper and with placebo plus 52 weeks prednisone taper.
Maltese: Kien osservat effett superjuri statistikament sinifikanti tat-trattament favur RoActemra fuq il-plaċebo fil-kisba ta' remissjoni sostnuta ħielsa minn sterojdi f'ġimgħa 52 fuq RoActemra flimkien ma' 26 ġimgħa ta' prednisone mnaqqas bil-mod għax-xejn meta mqabbel ma' plaċebo flimkien ma' 26 ġimgħa ta' prednisone mnaqqas bil-mod għax-xejn u ma' plaċebo flimkien ma' 52 ġimgħa ta' prednisone mnaqqas bil-mod għax-xejn.
English: Wee k
Maltese: Valur p
English: NAME OF THE MEDICINAL PRODUCT RoActemra 20 mg/mL concentrate for solution for infusion.
Maltese: RoActemra, 20 mg/mL, konċentrat għal soluzzjoni għall-infużjoni.
English: ADRs from clinical trials and/or post marketing experience with RoActemra based on spontaneous case reports, literature cases and cases from non-interventional study programs are listed in Table 1 and are presented by MedDRA system organ class.
Maltese: ADRs minn provi kliniċi u/jew esperjenza ta' wara t-tqegħid fis-suq b'RoActemra bbażati fuq rapporti ta' każijiet spontanji, każijiet mil-letteratura u każijiet minn programmi ta' studju mingħajr intervent huma elenkati f'Tabella 1 u huma ppreżentati skont is-sistema tal-klassifika tal-organi MedDRA.
English: • If you weigh less than 30 kg: the dose is 10mg for every kilogram of body weight
Maltese: • Jekk tiżen inqas minn 30 kg: id-doża hija 10 mg għal kull kilogramma ta' piż tal-ġisem
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 162 mg tocilizumab
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Siringa mimlija għal-lest waħda fiha 162 mg tocilizumab
English: Nephrolithiasis
Maltese: Nefrolitjasi
English: Population pharmacokinetic analyses did not detect any effect of MTX, non-steroidal antiinflammatory drugs (NSAIDs) or corticosteroids on tocilizumab clearance.
Maltese: Analiżi tal-farmakokinetika tal-popolazzjoni ma sabet l-ebda effett ta' MTX, mediċini antiinfjammatorji mhux sterojdi (NSAIDs) jew kortikosterojdi fuq it-tneħħija ta' tocilizumab.