FrancophonIA/ELRC3.0 huggingface dataset:
English: Tocilizumab-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 kkurati b'tocilizumab irrapportaw titjib fl-effetti kollha rrapportati mill-pazjenti (Indiċi ta' Diżabilità ibbażat fuq Kwestjonarju ta' Valutazzjoni tas-Saħħa - HAQ-DI), Short Form-36 u kwestjonarji tal-Valutazzjoni Funzjonali ta' Terapija għal Mard Kroniku.
English: Patients presenting with symptoms potentially indicative of complicated diverticulitis, such as abdominal pain, haemorrhage and/or unexplained change in bowel habits with fever should be evaluated promptly for early identification of diverticulitis which can be associated with gastrointestinal perforation.
Maltese: Pazjenti li jippreżentaw sintomi li juru potenzjalità ta' kumplikazzjoni ta' divertikulite, bħal uġigħ addominali, emorraġija u/jew bidla mhux spjegata fl-abitudni tal-ippurgar bid-deni għandhom jiġu vvalutati immedjatament għal identifikazzjoni bikrija ta' divertikulite li tista' tkun assoċjata ma' perforazzjoni gastrointestinali.
English: 0.9 mL solution in a pre-filled syringe (type I glass) with a staked-in needle containing 162 mg RoActemra assembled into a pre-filled pen.
Maltese: 0.9 mL ta' soluzzjoni f'siringa mimlija għal lest (ħġieġ tip I) b'labra moħbija li fiha 162 mg RoActemra miġbura f'pinna mimlija għal-lest.
English: 10 mg/kg Q4W below 30 kg
Maltese: 10 mg/kg Q4W taħt it-30 kg
English: Hepatic transaminase elevations
Maltese: Rispons kliniku maġġuri
English: Approximately half of the patients who developed an ANC < 1 x 109/ l did so within 8
Maltese: Meta l-ANC jiżdied għal > 1 x 10
English: Thus, CYP450 expression may be reversed when potent cytokine inhibitory therapy, such as tocilizumab, is introduced.
Maltese: Għaldaqstant, l-espressjoni ta' CYP450 tista' titreġġa' lura meta tinbeda terapija qawwija b'inibitur ta' ċitokin bħal tocilizumab.
English: After IV dosing, approximately 90% of the steady-state was reached by week 8 for both the 12 mg/kg (BW < 30 kg) and 8 mg/kg Q2W (BW ≥ 30 kg) regimens.
Maltese: Wara dożaġġ IV, madwar 90% tal-istat fiss intlaħaq sa ġimgħa 12 għad-doża ta' 10 mg/kg (BW < 30 kg), u sa ġimgħa 16 għad-doża ta' 8 mg/kg (BW ≥ 30 kg).
English: TCZ 8 mg/k g + MT X
Maltese: 8 mg/k g +
English: Significant reduction in DAS28 from baseline (mean improvement) of 3.1-3.4 were observed in RoActemra-treated patients compared to control patients (1.3-2.1).
Maltese: Tnaqqis sinifikanti f'DAS28 mil-linja bażi (titjib medju) ta' 3.1-3.4 kien osservat f'pazjenti ttrattati b'RoActemra meta mqabbel ma' pazjenti ta' kontroll (1.3-2.1).
English: RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids.
Maltese: RoActemra huwa indikat għall-kura ta' artrite idjopatika sistemika attiva fil-minorenni (sJIAsystemic juvenile idiopathic arthritis) f'pazjenti b'età minn sentejn 'l fuq, li jkunu rrispondew b'mod mhux adegwat għal terapija preċedenti b'NSAIDs u kortikosterojdi sistemiċi.
English: Each vial contains 200 mg of tocilizumab* in 10 mL (20 mg/mL).
Maltese: Kull kunjett fih 200 mg ta' tocilizumab* f'10 mL (20 mg/mL).
English: • the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more diseasemodifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.
Maltese: • trattament ta' RA attiva moderata sa severa f'pazjenti adulti li jew ma rrispondewx tajjeb, jew inkella kienu intolleranti, għal terapija preċedenti b'wieħed jew aktar mill-mediċini kontra rrewmatiżmu li jimmodifikaw il-marda (DMARDs - disease-modifying anti-rheumatic drugs) jew antagonisti tal-fattur tan-nekrosi tat-tumur (TNF - tumour necrosis factor).
English: Clinically significant hypersensitivity reactions associated with RoActemra and requiring treatment discontinuation were reported in a total of 56 out of 4,009 patients (1.4%) treated with RoActemra during the controlled and open label clinical studies.
Maltese: Reazzjonijiet ta' sensittività eċċessiva assoċjati ma' RoActemra li kienu klinikament sinifikanti u li kellhom bżonn twaqqif tat-trattament, kienu rrappurtati f'total ta' 56 minn 4,009 pazjenti (1.4%) ittrattati b'RoActemra waqt l-istudji kliniċi kkontrollati u open label.
English: Use in the paediatric population sJIA, pJIA and CRS Patients ≥ 30 kg
Maltese: Pazjenti b'sJIA, pJIA u CRS ≥ 30 kg
English: During routine laboratory monitoring in the intravenous RoActemra study WA19977 3.4% and 10.4% of patients experienced a post-baseline elevation of their LDL-cholesterol value to ≥ 130 mg/dL and total cholesterol value to ≥ 200 mg/dL at any time during the study treatment, respectively.
Maltese: Waqt sorveljanza ta' rutina tal-laboratorju fil-fażi kkontrollata ta' 12-il ġimgħa (studju WA18221), 13.4% u 33.3% tal-pazjenti kellhom żieda wara l-linja bażi fil-valur tal-kolesterol LDL tagħhom għal ≥ 130 mg/dL u fil-valur tal-kolesterol totali għal ≥ 200 mg/dL fi kwalunkwe ħin waqt it-trattament talistudju, rispettivament.
English: Inhibition of joint structural damage was shown with significantly less radiographic progression in patients receiving RoActemra compared to control (Table 6).
Maltese: Inibizzjoni ta' ħsara strutturali fil-ġogi ntweriet permezz ta' progressjoni radjografika sinifikament anqas f'pazjenti li kienu qed jirċievu RoActemra meta mqabbel mal-kontroll (Tabella 6).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE CARTON (WITH BLUE BOX) - Multipack
Maltese: KARTUNA TA' PINNA MIMLIJA GĦAL-LEST (MINGĦAJR KAXXA BLU) - Pakkett multiplu
English: Study WA28119 was a randomized, multi-center, double-blind placebo-controlled Phase III superiority study conducted to assess the efficacy and safety of RoActemra in patients with GCA.
Maltese: Studju WA28119 kien studju dwar superjorità, każwali, multiċentriku, double-blind, bil-plaċebo bħala kontroll, ta' Fażi
English: The mean change in HAQ-DI was maintained at Week 104 in the tocilizumab 8 mg/kg plus MTX group (-0.61).
Maltese: Il-bidla medja f'HAQ-DI inżammet f'Ġimgħa 104 fil-grupp ta' tocilizumab 8 mg/kg flimkien ma' MTX (-0.61).
English: The safety profile of tocilizumab has been studied in 4 placebo-controlled studies (studies II, III, IV and V), 1 MTX-controlled study (study I) and their extension periods (see section 5.1).
Maltese: Il-perjodu double-blind ikkontrollat kien ta' 6 xhur f'erba' studji (studji I, III, IV u V) u kien sa sentejn fi studju wieħed (studju II).
English: The total clearance of RoActemra was concentration-dependent and is the sum of the linear clearance and the nonlinear clearance.
Maltese: Ittneħħija totali ta' RoActemra kienet dipendenti fuq il-konċentrazzjoni u hija s-somma tat-tneħħija lineari u mhux lineari.
English: During the 6-month controlled period, in SC-I, the frequency of injection site reactions was 10.1% (64/631) and 2.4% (15/631) for the subcutaneous RoActemra and the subcutaneous placebo (intravenous group) weekly injections, respectively.
Maltese: 1% (64/631) u 2.4% (15/631) għall-injezzjonijiet ta' kull ġimgħa ta' RoActemra taħt il-ġilda u plaċebo taħt il-ġilda (grupp ta' għoti fil-vina), rispettivament.
English: RoActemra subcutaneous formulation is not intended to be given to children with sJIA weighing less than 10 kg.
Maltese: RoActemra formulazzjoni għal taħt il-ġilda mhux maħsub biex jingħata lil tfal b'sJIA li jiżnu inqas minn 10 kg.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR
English: The linear clearance was estimated as a parameter in the population pharmacokinetic analysis and was 9.5 mL/h.
Maltese: It-tneħħija lineari kienet stmata bħala parametru fl-analiżi tal-farmakokinetika tal-popolazzjoni u kienet 9.5 mL/siegħa.
English: Each vial contains 400 mg of tocilizumab* in 20 mL (20 mg/mL).
Maltese: Kull kunjett fih 400 mg ta' tocilizumab* f'20 mL (20 mg/mL).
English: Marketing Authorisation Holder Roche Registration GmbH Emil-Barell-Strasse 1
Maltese: Emil-Barell-Strasse 1
English: The rate of serious infections was numerically higher in patients weighing <30 kg treated with 10 mg/kg tocilizumab (12.2 per 100 patient years) compared to patients weighing ≥30 kg, treated with 8 mg/kg tocilizumab (4.0 per 100 patient years).
Maltese: Ir-rata ta' infezzjonijiet serji kienet numerikament ogħla f'pazjenti li jiżnu <30 kg ikkurati b'10 mg/kg tocilizumab (12.2 għal kull 100 sena ta' pazjent) meta mqabbel ma' pazjenti li jiżnu ≥30 kg ikkurati b'8 mg/kg tocilizumab (4.0 għal kull 100 sena ta' pazjent) . Linċidenza ta' infezzjonijiet li jwasslu għal interruzzjonijiet fid-doża ukoll kienet numerikament ogħla f'pazjenti li jiżnu <30 kg kkurati b'10 mg/kg tocilizumab (21.4%) meta mqabbel ma' pazjenti li jiżnu ≥30 kg, ikkurati b'8 mg/kg tocilizumab (7.6%).
English: (fatal)1, 2 ,3
Maltese: Differenza miżgħuna (CI ta'
English: Age, gender and ethnicity: Population pharmacokinetic analyses in RA patients, showed that age, gender and ethnic origin did not affect the pharmacokinetics of tocilizumab.
Maltese: Analiżi tal-farmakokinetika tal-popolazzjoni f'pazjenti b'RA wriet li l-età, is-sess u l-oriġini etnika ma affettwawx il-farmakokinetika ta' tocilizumab.
English: Predicted mean ± SD PK parameters at steady-state after IV dosing in pJIA RoActemra PK Parameter
Maltese: Medja mbassra ± SD tal-parametri PK fi stat fiss wara dożaġġ IV f'pJIA
English: Study VI (WA19924), a 24 week double-blinded study that compared RoActemra monotherapy with adalimumab monotherapy, evaluated 326 patients with RA who were intolerant of MTX or where continued treatment with MTX was considered inappropriate (including MTX inadequate responders).
Maltese: RoActemra kontra adalimumab bħala monoterapija Studju VI (WA19924), studju double-blind ta' 24 ġimgħa li qabbel monoterapija ta' RoActemra ma' monoterapija ta' adalimumab, ivvaluta 326 pazjent b'RA li kienu intolleranti għal MTX jew li għalihom kontinwazzjoni ta' kura b'MTX kienet ikkunsidrata mhux xierqa (inkluż dawk li ma rrispondewx b'mod adegwat għal MTX).
English: In the double-blind controlled studies, 774 patients received tocilizumab 4 mg/kg in combination with MTX, 1870 patients received tocilizumab 8 mg/kg in combination with MTX or other DMARDs and 288 patients received tocilizumab 8 mg/kg monotherapy.
Maltese: Fl-istudji double-blind u kkontrollati, 774 pazjent irċevew tocilizumab 4 mg/kg flimkien ma' MTX, 1870 pazjent irċevew tocilizumab 8 mg/kg flimkien ma' MTX jew DMARDs oħra u 288 pazjent irċevew monoterapija ta' tocilizumab 8 mg/kg.
English: Store vials in a refrigerator (2°C-8°C).
Maltese: Aħżen fi friġġ (2°C-8°C).
English: Corticosteroid tapering was permitted from week six for patients who achieved a JIA ACR70 response.
Maltese: Tnaqqis tal-kortikosterojdi kien permess mis-sitt ġimgħa 'l quddiem għall-pazjenti li kisbu rispons JIA ACR70.
English: Increases in haemoglobin levels were observed, through RoActemra decreasing the IL-6 driven effects on hepcidin production to increase iron availability.
Maltese: Kienu osservati żidiet fil-livelli tal-emoglobina, minħabba li RoActemra inaqqas l-effetti kkawżati minn IL-6 fuq il-produzzjoni ta' hepcidin biex tiżdied id-disponibilità tal-ħadid.
English: The following parameters (predicted mean ± SD) were estimated for a dose of 8 mg/kg RoActemra given every 4 weeks: steady-state area under curve (AUC) = 38000 ± 13000 h•µg/mL, trough concentration (Cmin) = 15.9 ± 13.1 µg/mL and maximum concentration (Cmax) = 182 ± 50.4 µg/mL, and.
Maltese: Il-parametri li ġejjin (medja imbassra ± SD) kienu stmati għal doża ta' 8 mg/kg RoActemra mogħtija kull erba' ġimgħat: l-erja taħt il-kurva (AUC) fi stat fiss = 38000 ± 13000 h µg/mL, l-inqas konċentrazzjoni (Cmin) = 15.
English: In the 6-month controlled trials decreases in platelet counts below 100 x 103/ μL occurred in 1.7% of patients on tocilizumab 8 mg/kg plus DMARDs compared to < 1% on placebo plus DMARDs.
Maltese: Fil-provi kkontrollati ta' 6 xhur tnaqqis fl-għadd ta' newtrofili taħt 1 x 10 fuq tocilizumab 8 mg/kg flimkien ma' DMARDs meta mqabbel ma' <0.1 % tal-pazjenti fuq plaċebo flimkien ma' DMARDs.
English: Week TCZ 8 mg/kg
Maltese: Ġimgħa TCZ 8 mg /kg
English: In the 6-month controlled trials adverse events associated with infusion (selected events occurring during or within 24 hours of infusion) were reported by 6.9% of patients in the tocilizumab 8 mg/kg plus DMARD group and 5.1% of patients in the placebo plus DMARD group.
Maltese: Fil-provi kkontrollati ta' 6 xhur avvenimenti avversi assoċjati mal-infużjoni (ċerti ġrajjiet iseħħu waqt l-infużjoni jew fi żmien 24 siegħa mill-infużjoni) ġew irrapportati minn 6.9 % tal-pazjenti fil-grupp ta' tocilizumab 8 mg/kg flimkien ma' DMARDs u f'5.1 % tal-pazjenti fil-grupp ta' plaċebo ma' DMARDs.
English: > 3 to 5 x ULN Interrupt RoActemra dosing until < 3 x ULN and follow recommendations above for > 1 to 3 x ULN.
Maltese: Waqqaf l-għoti ta' RoActemra sakemm < 3 x ULN u segwi rrakkomandazzjonijiet imniżżla fuq għal > 1 sa 3 x ULN.
English: JIA ACR Response Rates at Week 40 Relative to baseline (Percentage of Patients)
Maltese: JIA ACR f'Ġimgħa 40 Imqabbel mal-linja bażi (Persentaġġ ta' Pazjenti)
English: The pharmacokinetics of tocilizumab were determined using a population pharmacokinetic analysis on a database composed of 3552 RA patients treated with a one-hour infusion of 4 or 8 mg/kg tocilizumab every 4 weeks for 24 weeks or with 162 mg tocilizumab given subcutaneously either once a week or every other week for 24 weeks.
Maltese: Il-farmakokinetika ta' tocilizumab ġiet iddeterminata bl-użu ta' analiżi tal-farmakokinetika talpopolazzjoni minn tagħrif miġbur minn 3552 pazjent b'RA kkurati b'infużjoni ta' siegħa ta' 4 jew 8 mg/kg tocilizumab kull erba' ġimgħat għal 24 ġimgħa jew b'162 mg tocilizumab mogħtija taħt ilġilda darba fil-ġimgħa jew darba kull ġimagħtejn għal 24 ġimgħa.
English: At Week 52, the mean change in HAQ-DI was -0.58 in the tocilizumab 8 mg/kg plus MTX group compared with -0.39 in the placebo + MTX group.
Maltese: F'Ġimgħa 52, il-bidla medja f'HAQ-DI kienet ta' -0.58 fil-grupp ta' tocilizumab 8 mg/kg flimkien ma' MTX meta mqabbel ma' -0.
English: Malignancies
Maltese: Plejtlits
English: In SCII, 656 patients were randomized 2:1 to RoActemra subcutaneous 162 mg every other week or placebo, in combination with non-biologic DMARD(s).
Maltese: F'SC-II, 656 pazjent kienu randomised 2:1 għal RoActemra 162 mg taħt il-ġilda kull ġimagħtejn jew plaċebo, flimkien ma' DMARD(s) mhux bijoloġiċi.
English: CLINICAL PARTICULARS
Maltese: Effikaċja Klinika
English: • tiredness,
Maltese: • għeja,
English: In a randomized open-label study, adult RA patients treated with RoActemra and MTX were able to mount an effective response to both the 23-valent pneumococcal polysaccharide and tetanus toxoid vaccines which was comparable to the response seen in patients on MTX only.
Maltese: Fi studju randomised open-label, pazjenti adulti b'RA kkurati b'RoActemra u MTX kienu kapaċi jibnu rispons effettiv kemm għall-vaċċin ta' 23-valent pneumococcal polysaccharide kif ukoll għal dak tat-tossina tat-tetnu u dan kien komparabbli marrispons osservat f'pazjenti fuq MTX biss.
English: > 5x ULN Discontinue RoActemra.
Maltese: X'fih RoActemra
English: Cmax of RoActemra were 3430 ± 2660 µg•h/mL, 5.7 ± 6.8 µg/mL, and 13.2 ± 8.8 µg/mL,
Maltese: Għad-doża ta' 162 kull ġimagħtejn, il-medja mbassra (±SD) tal-AUC ta' ġimgħa 2 fi stat fiss, Cmin u Cmax ta' RoActemra kienu ta' 3430 ± 2660 µg•h/mL, 5.7 ± 6.8 µg/mL, u 13.2 ± 8.8 µg/mL, rispettivament.
English: Fatal anaphylaxis has been reported after marketing authorisation during treatment with intravenous RoActemra (see section 4.4).
Maltese: Kura b'RoActemra m'għandhiex tinbeda f'pazjenti li għandhom infezzjonijiet attivi (ara sezzjoni 4.3).
English: METHOD OF ADMINISTRATION IV infusion
Maltese: Il-grupp komparatur ingħata
English: The mean change in HAQ-DI was maintained at Week 104 in the RoActemra 8 mg/kg plus MTX group (-0.61).
Maltese: Il-bidla medja f'HAQ-DI inżammet f'Ġimgħa 104 fil-grupp ta' RoActemra 8 mg/kg flimkien ma' MTX (-0.61).
English: Four (2.5%) patients in the RoActemra arm and two (1.2%) patients in the adalimumab arm experienced CTC grade 3 or 4 neutrophil count decreases.
Maltese: Erba' (2.5%) pazjenti fil-grupp ta' RoActemra u żewġ (1.2%) pazjenti fil-grupp ta' adalimumab kellhom tnaqqis fl-għadd ta' newtrofili ta' CTC grad 3 jew 4.
English: Interrupt RoActemra dosing until < 3 x ULN and follow recommendations above for > 1 to 3 x ULN
Maltese: Interrompi d-dożaġġ ta' RoActemra sakemm < 3x ULN u segwi ir-rakkomandazzjonijiet ta' fuq għal >1 sa 3x ULN
English: Mild renal impairment
Maltese: Disturbi flgħajnejn
English: This medicine contains 26.55 mg sodium per maximum dose of 1200 mg. Take this into account if you are on a low-sodium diet.
Maltese: 55 mg) ta' sodium f'kull doża massima ta' 1200 mg.
English: The comparator group was weekly MTX (dose titrated from 7.5 mg to a maximum of 20 mg weekly over an eight week period).
Maltese: MTX darba fil-ġimgħa (dożi miżjuda minn 7.5 mg sa massimu ta' 20 mg fil-ġimgħa fuq perijodu ta' tmien ġimgħat).
English: The recommended dose modifications, including tocilizumab discontinuation, based on transaminases levels, in line with SmPC section 4.2.
Maltese: Il-modifiki fid-doża rakkomandati, inkluż it-twaqqif ta' tocilizumab, ibbażati fuq il-livelli ta' tansaminases, skont is-sezzjoni 4.2 tal-SmPC.
English: Cumulative glucocorticoid dose
Maltese: Disodium phosphate dodecahydrate
English: • If you have moderate to severe kidney function problems, your doctor will monitor you.
Maltese: • Jekk għandek problemi moderati sa severi fil-funzjoni tal-kliewi, it-tabib tiegħek se jissorveljak.
English: In the 6-month controlled studies the rate of all infections reported with tocilizumab 8 mg/kg plus DMARD treatment was 127 events per 100 patient years compared to 112 events per 100 patient years in the placebo plus DMARD group.
Maltese: Fl-istudji kkontrollati ta' 6 xhur, ir-rata tal-infezzjonijiet kollha rrappurtati b'RoActemra 8 mg/kg flimkien ma' kura b'DMARDs kienet ta' 127 avveniment għal kull 100 sena ta' pazjent meta mqabbla ma' 112-il avveniment għal kull 100 sena ta' pazjent fil-grupp ta' plaċebo flimkien ma' DMARDs.
English: It is important to remain under your healthcare provider's care while using RoActemra.
Maltese: Huwa importanti li tibqa' taħt is-sorveljanza tal-fornitur tal-kura tas-saħħa tiegħek waqt li tkun qed tuża RoActemra.
English: Transient or intermittent mild and moderate elevations of hepatic transaminases have been reported commonly with RoActemra treatment (see section 4.8).
Maltese: Ġew irrappurtati b'mod komuni żidiet temporanji jew intermittenti ħfief u moderati fil-livelli ta' transaminases tal-fwied ikkawżati minn trattament b'RoActemra (ara sezzjoni 4.8).
English: Macrophage activation syndrome (MAS) is a serious life-threatening disorder that may develop in sJIA patients.
Maltese: Sindrome ta' attivazzjoni tal-makrofagi (MAS - macrophage activation syndrome) huwa disturb serju ta' periklu għall-ħajja li jista' jiżviluppa f'pazjenti b'sJIA.
English: Each patient continued in Part II of the study until Week 40 or until the patient satisfied JIA ACR30 flare criteria (relative to Week 16) and qualified for escape to tocilizumab therapy (same dose received in Part I).
Maltese: Kull pazjent kompla f'Parti II tal-istudju sa Ġimgħa 40 jew sakemm il-pazjent issodisfa l-kriterji ta' rkadar JIA ACR30 (imqabbel ma' Ġimgħa 16) u kkwalifika għall-ħruġ biex jirċievi terapija b'tocilizumab (l-istess doża li ngħatat f'parti I).
English: All 112 patients were tested for anti-tocilizumab antibodies at baseline.
Maltese: Il-112-il pazjent kollha kienu ttestjati għall-antikorpi kontra tocilizumab fil-linja bażi.
English: However, a slight increase in abortion/embryonal-foetal death was observed with high systemic exposure (> 100 x human exposure) in the 50 mg/kg/day high-dose group compared to placebo and other low-dose groups.
Maltese: Madankollu, ġiet osservata żjieda żgħira fl-abort/mewt tal-embriju-fetu b'espożizzjoni sistemika għolja (> 100 x l-espożizzjoni umana) fil-grupp ta' doża għolja ta' 50 mg/kg/jum meta mqabbel ma' plaċebo u gruppi oħra ta' doża baxxa.
English: Each pre-filled syringe contains 162 mg tocilizumab in 0.9 mL.
Maltese: Kull siringa mimlija għal-lest fiha 162 mg tocilizumab f'0.9 mL.
English: The treatment effect was similar in patients independent of rheumatoid factor status, age, gender, race, number of prior treatments or disease status.
Maltese: L-effett tat-trattament kien simili fil-pazjenti indipendenti mill-istat tal-fattur rewmatiku, l-età, is-sess, ir-razza, in-numru ta' trattamenti preċedenti jew l-istat tal-marda.
English: The clinical data are insufficient to assess the potential incidence of malignancy following exposure to RoActemra.
Maltese: M'hemmx biżżejjed dejta klinika biex tiġi stmata l-inċidenza potenzjali ta' tumuri malinni wara esponiment għal RoActemra.
English: Each vial contains 80 mg of tocilizumab* in 4 mL (20 mg/mL).
Maltese: Kull kunjett fih 80 mg ta' tocilizumab* f'4 mL (20 mg/mL).
English: Evaluable patients had been treated with tocilizumab 8 mg/kg (12 mg/kg for patients < 30 kg) with or without additional high-dose corticosteroids for severe or life-threatening CRS; only the first episode of CRS was included in the analysis.
Maltese: Pazjenti li setgħu jiġu evalwati kienu kkurati b'tocilizumab 8 mg/kg (12-il mg/kg għallpazjenti ta' < 30 kg) b'kortikosterojdi ta' doża għolja addizzjonali jew mingħajrhom għal CRS sever jew ta' periklu għall-ħajja; l-ewwel episodju ta' CRS biss ġie inkluż fl-analiżi.
English: Study IV evaluated 1,220 patients who had an inadequate response to their existing rheumatologic therapy, including one or more DMARDs.
Maltese: Studju IV ivvaluta 1,220 pazjent li kellhom rispons mhux adegwat għat-terapija rewmatoloġika li kienu qed jieħdu, inkluż DMARD wieħed jew aktar.
English: Children with pJIA
Maltese: Pazjenti b'pJIA
English: Both study treatments induced the same pattern of changes in laboratory safety parameters (decreases in neutrophil and platelet counts, increases in ALT, AST and lipids), however, the magnitude of change and the frequency of marked abnormalities was higher with tocilizumab compared with adalimumab.
Maltese: Iż-żewġ kuri tal-istudju induċew l-istess modi ta' bidliet filparametri ta' sigurtà tal-laboratorju (tnaqqis fl-għadd ta' newtrofili u plejtlits, żidiet fil-livell ta' ALT, AST u lipidi), madankollu, id-daqs tal-bidla u l-frekwenza ta' anormalitajiet sostanzjali kienu ogħla b'tocilizumab meta mqabbla ma' adalimumab.
English: Parts of your RoACTEMRA pre-filled pen (See Figure A).
Maltese: Tippruvax tuża l-parti ta' fuq tad-driegħ waħdek (Ara Figura D).
English: Nasopharyngitis pJIA, sJIA
Maltese: Tqalligħ pJIA
English: In the double-blind controlled studies, 774 patients received RoActemra 4 mg/kg in combination with MTX, 1870 patients received RoActemra 8 mg/kg in combination with MTX or other DMARDs and 288 patients received RoActemra 8 mg/kg monotherapy.
Maltese: Fl-istudji double-blind u kkontrollat, 774 pazjent irċevew RoActemra 4 mg/kg flimkien ma' MTX, 1870 pazjent irċevew RoActemra 8 mg/kg flimkien ma' MTX jew DMARDs oħra u 288 pazjent irċevew monoterapija ta' RoActemra 8 mg/kg.
English: RoActemra is usually given in combination with methotrexate.
Maltese: RoActemra normalment jingħata flimkien ma' methotrexate.
English: Corticosteroid Tapering
Maltese: Iperkolesterolimja
English: Children with sJIA
Maltese: 1, sJIA
English: The corresponding frequency category for each ADR is based on the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10) or uncommon (≥ 1/1,000
Maltese: Ilkategorija ta' frekwenza korrispondenti għal kull ADR hija bbażata fuq il-konvenzjoni li ġejja: komuni ħafna (≥ 1/10), komuni (> 1/100 sa < 1/10), mhux komuni (> 1/1,000 sa < 1/100), rari,