FrancophonIA/ELRC3.0 huggingface dataset:
English: Decreases below 0.5 x 109/ L were reported in 0.3% patients receiving RoActemra8 mg/kg plus DMARDs.
Maltese: 9/ L kienu rrappurtati f'0.3% tal-pazjenti li rċevew RoActemra 8 mg/kg flimkien ma' DMARDs.
English: • Low absolute neutrophil count (ANC)
Maltese: • Għadd assolut ta' newtrofili baxx (ANC - absolute neutrophil count) Valur tal
English: The pharmacokinetics of tocilizumab were determined using a population pharmacokinetic analysis on a database composed of 140 sJIA patients treated with 8 mg/kg IV every 2 weeks (patients with a body weight ≥ 30 kg ) 12 mg/kg IV every 2 weeks (patients with a body weight < 30 kg), 162 mg SC every week (patients weighing ≥ 30 kg), 162 mg SC every 10 days or every 2 weeks (patients weighing below 30 kg).
Maltese: Il-farmakokinetika ta' tocilizumab kienet determinata bl-użu ta' analiżi tal-farmakokinetika talpopolazzjoni fuq dejtabażi komposta minn 140 pazjent b'sJIA kkurati b'8 mg/kg IV kull ġimagħtejn (pazjenti b'piż tal-ġisem ≥ 30 kg ), 12 mg/kg IV kull ġimagħtejn (pazjenti b'piż tal-ġisem < 30 kg), 162 mg SC kull ġimgħa (pazjenti li jiżnu ≥ 30 kg), 162 mg SC kull 10 ijiem jew kull ġimagħtejn (pazjenti li jiżnu inqas minn 30 kg).
English: Radiographic response
Maltese: Rispons radjografiku
English: During routine laboratory monitoring in the RoActemra 12 month controlled clinical trial, one patient (1%, 1/100) in the RoActemra subcutaneous weekly group had a single transient occurence of decrease in platelet count to <100 × 103 / μL without associated bleeding events.
Maltese: Matul monitoraġġ ta' rutina tal-laboratorju fil-prova klinika kkontrollata ta' 12-il xahar ta' RoActemra, pazjent wieħed (1%, 1/100) fil-grupp ta' RoActemra taħt il-ġilda kull ġimgħa kellu okkorrenza waħda temporanja ta' tnaqqis fl-għadd tal-plejtlits għal <100 × 10
English: N/A= Not applicable HR = Hazard Ratio CI = Confidence Interval
Maltese: HR = Proporzjon ta' Periklu
English: Peripheral oedema Hypersensitivity reaction, Injection site reaction
Maltese: Edima periferali, Reazzjoni ta' sensittività eċċessiva, Reazzjoni fis-sit tal-injezzjoni
English: Other medicines and RoActemra
Maltese: Mediċini oħra u RoActemra
English: Continued durable responses were seen for over 3 years in the ongoing open label extension studies I-V.
Maltese: Reazzjonijiet kontinwi li jibqgħu għal tul ta' żmien dehru għal aktar minn 3 snin fl-istudji open label ta' estensjoni I-V.
English: Hypothyroidism
Maltese: Ipertrigliċeridemija
English: In SC-I, 1262 patients were randomized 1:1 to receive RoActemra subcutaneous 162 mg every week or RoActemra intravenous 8 mg/kg every four weeks in combination with non-biologic DMARD(s).
Maltese: F'SC-I, 1,262 pazjent kienu randomized 1:1 biex jirċievu RoActemra taħt il-ġilda 162 mg kull ġimgħa jew RoActemra 8 mg/kg fil-vini kull erba' ġimgħat flimkien ma' DMARD(s) mhux bijoloġiċi.
English: During the double-blind controlled period, the incidence of indirect bilirubin greater than the upper limit of normal, collected as a routine laboratory parameter, is 6.2% in patients treated with 8 mg/kg RoActemra+ DMARD.
Maltese: Waqt il-perjodu double-blind u kkontrollat, l-inċidenza ta' bilirubina indiretta ogħla mil-limitu ta' fuq tan-normal, miġbura bħala parametru ta' rutina tal-laboratorju, kienet ta' 6.2% f'pazjenti ttrattati b'8 mg/kg RoActemra + DMARD.
English: pJIA Patients:
Maltese: Pazjenti b'pJIA:
English: Patients should seek immediate medical attention if developing symptoms of serious allergic reactions (see section 4.4).
Maltese: Il-pazjenti għandhom ifittxu attenzjoni medika immedjata jekk jiżviluppaw sintomi ta' reazzjonijiet allerġiċi serji (ara sezzjoni 4.4).
English: HR (99% CI) Time to first GCA flare¹ (Tocilizumab groups vs Placebo+52)
Maltese: Żmien sal-ewwel rikaduta ta' GCA¹ (gruppi ta' Tocilizumab kontra Plaċebo+52)
English: Tocilizumab binds specifically to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R).
Maltese: Tocilizumab jintrabat b'mod speċifiku mar-riċetturi IL-6, kemm dawk li huma solubbli kif ukoll dawk li huma marbutin mal-membrana (sIL-6R u mIL-6R).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled pen contains 162 mg tocilizumab
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Pinna mimlija għal-lest waħda fiha 162 mg tocilizumab
English: RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX.
Maltese: RoActemra flimkien ma' methotrexate (MTX) huwa indikat għall-kura ta' poliartrite idjopatika filminorenni (pJIA; oligoartrite estiża u pożittiva jew negattiva għall-fattur tar-rewmatiżmu) f'pazjenti b'età minn sentejn 'l fuq, li rrispondew b'mod mhux adegwat għal terapija preċedenti b'MTX.
English: In study II, 65% of patients achieved a DAS28 < 2.6 at week 104 compared to 48% at 52 weeks and 33% of patients at week 24.
Maltese: Fi studju II, 65% tal-pazjenti kisbu DAS28 ta' < 2.6 f'ġimgħa 104 imqabbel ma' 48% f'ġimgħa 52 u 33% tal-pazjenti f'ġimgħa 24.
English: This should be a final volume of 50 mL.
Maltese: Dan għandu jkun volum finali ta' 50 mL.
English: ACR responses in placebo-/MTX-/DMARDs-controlled studies (% patients)
Maltese: Risponsi ta' ACR fi studji kkontrollati bi plaċebo/MTX/DMARD (% ta' pazjenti)
English: At body weight ≥ 100 kg, the predicted mean (± SD) steady state AUC, Cmin and Cmax of RoActemra were 50000 ± 16800 μg•h/mL, 24.4 ± 17.5 μg/mL, and 226 ± 50.3 μg/mL, respectively, which are higher than mean exposure values for the patient population (i.e. all body weights) reported above.
Maltese: Għall-piż tal-ġisem ta' ≥ 100 kg, il-medja mbassra (± SD) fi stat fiss tal-AUC, Cmin u Cmax ta' RoActemra kienet ta' 50000 ± 16800 μg•h/mL, 24.4 ± 17.5 μg/mL, u 226 ± 50.3 μg/mL, rispettivament, li huma ogħla mill-valuri medji ta' espożizzjoni għall-popolazzjoni tal-pazjenti (i.e. il-piżijiet tal-ġisem kollha) irrappurtati fuq.
English: 90% of the steady-state was reached by Week 12 for both the 162 mg SC Q2W and Q3W regimens.
Maltese: Wara dożaġġ SC, madwar 90% tal-istat fiss intlaħaq sa Ġimgħa 12 għaż-żewġ korsijiet ta' 162 mg SC, dak Q2W u dak Q3W.
English: RoActemra has not been studied in patients with severe renal impairment (see section 5.2).
Maltese: RoActemra ma kienx studjat f'pazjenti b'indebolimenti tal-kliewi sever (ara sezzjoni 5.2).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial contains 200 mg tocilizumab.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett fih 200 mg ta' tocilizumab.
English: During routine laboratory monitoring in the tocilizumab all exposure population, 1% of patients had a decrease in platelet count to ≤ 50 × 103/µL without associated bleeding events.
Maltese: Waqt sorveljanza ta' rutina tal-laboratorju fil-popolazzjoni kollha ta' esponiment għal tocilizumab, 1% tal-pazjenti kellhom tnaqqis fil-għadd tal-plejtlits għal ≤ 50 × 10
English: For the 162 mg every week dosing regimen, the steady-state Cavg was 51% higher in patients with body weight less than 60 kg compared to patients weighing between 60 to 100 kg. For the 162 mg every other week regimen, the steady-state Cavg was 129% higher in patients with body weight less than 60 kg compared to patients weighing between 60 to 100 kg.
Maltese: Għall-kors ta' 162 mg kull ġimagħtejn, is-Cavg fl-istat fiss kien 129% ogħla f'pazjenti b'piż tal-ġisem ta' inqas minn 60 kg imqabblin ma' pazjenti li jiżnu bejn 60 sa 100 kg.
English: Fatal anaphylaxis has been reported after marketing authorisation during treatment with tocilizumab (see section 4.4).
Maltese: Dawn ir-reazzjonijiet ġeneralment kienu osservati waqt it-tieni sal-ħames infużjoni ta' tocilizumab (ara sezzjoni 4.4).
English: (cells x 109/ L )
Maltese: 109/ L )
English: Each 4 mL vial contains 80 mg tocilizumab (20 mg/mL).
Maltese: Kull kunjett ta' 4 mL fih 80 mg tocilizumab (20 mg/mL).
English: Upper respiratory tract infections
Maltese: Infezzjonijiet flapparat respiratorju ta' fuq
English: sJIA Patients
Maltese: TA' EĊĊIPJENTI
English: RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids.
Maltese: RoActemra huwa indikat għat-trattament ta' artrite idjopatika sistemika fil-minorenni (sJIA - systemic juvenile idiopathic arthritis) attiva f'pazjenti b'età minn sena 'l fuq, li jkunu rrispondew b'mod mhux adegwat għal terapija preċedenti b'NSAIDs u kortikosterojdi sistemiċi.
English: The total patient years duration in the RoActemra all exposure population was 138.5 patient years during the 12 month double blind, placebo controlled phase of the study.
Maltese: It-tul totali ta' snin ta' pazjent fil-popolazzjoni ta' esponiment sħiħ għal RoActemra kien ta' 138.5 snin ta' pazjent matul il-fażi ta' 12-il xahar, double blind u bil-plaċebo bħala kontroll tal-istudju.
English: Dose adjustments due to laboratory abnormalities (see section 4.4).
Maltese: Aġġustament fid-doża minħabba anormalitajiet tal-laboratorju (ara sezzjoni 4.4).
English: Increases in haemoglobin levels were observed, through tocilizumab decreasing the IL-6 driven effects on hepcidin production to increase iron availability.
Maltese: Ġew osservati żidiet fil-livelli ta' emoglobina, minħabba li tocilizumab inaqqas l-effetti kkawżati minn IL-6 fuq il-produzzjoni ta' hepcidin biex tiżdied iddisponibilità tal-ħadid.
English: Key Secondary Endpoints
Maltese: Punti Finali Esploratorji
English: The rate of anaphylactic reactions (occurring in a total of 6/3778patients, 0.2%) was several fold higher with the 4 mg/kg dose, compared to the 8 mg/kg dose.
Maltese: Ir-rata ta' reazzjonijiet anafilattiċi (iseħħu f'total ta' 6/3778 pazjent, 0.2%) kienet diversi drabi ogħla bid-doża ta' 4 mg/kg, meta mqabbla mad-doża ta' 8 mg/kg.
English: Fertility Available non-clinical data do not suggest an effect on fertility under tocilizumab treatment.
Maltese: Fertilità Dejta mhux klinika disponibbli ma tissuġġerixxix effett fuq il-fertilità waqt kura b'tocilizumab.
English: Of the patients who completed the study who were originally randomised to placebo + MTX, 86% received open-label tocilizumab 8 mg/kg in year 2.
Maltese: Mill-pazjenti li temmew l-istudju li oriġinarjament kienu randomised għall-plaċebo + MTX, 86% irċevew open-label tocilizumab 8 mg/kg fit-tieni sena.
English: Serious hypersensitivity reactions have been reported in association with infusion of RoActemra (see section 4.8).
Maltese: Reazzjonijiet serji ta' sensittività eċċessiva ġew irrapportati b'rabta ma' infużjoni ta' RoActemra (ara sezzjoni 4.8).
English: • Dose calculation (RA, sJIA and pJIA patients), preparation of infusion and infusion rate
Maltese: • Kalkulazzjoni tad-doża (pazjenti b'RA, sJIA u pJIA), preparazzjoni tal-infużjoni u r-rata talinfużjoni
English: The pharmacokinetic parameters of RoActemra do not change with time.
Maltese: Il-parametri farmakokinetiċi ta' RoActemra ma nbidlux maż-żmien.
English: After subcutaneous administration, the effective t1/2 of RoActemra in pJIA patients is up to 10 days for patients < 30 kg (162 mg SC Q3W) and up to 7 days for patients >= 30 kg (162 mg SC Q2W) during a dosing interval at steady state.
Maltese: Wara għoti taħt il-ġilda, it-t1/2 effettiva ta' RoActemra f'pazjenti b'pJIA hija sa 10 ijiem għall-pazjenti ta' < 30 kg (162 mg SC Q3W) u sa 7 ijiem għall-pazjenti ta' >= 30 kg (162 mg SC
English: The proportion of patients achieving a DAS28 clinical remission (DAS28 < 2.6) was significantly higher in patients receiving RoActemra (28-34%) compared to 1-12% of control patients at 24 weeks.
Maltese: Ilproporzjon ta' pazjenti li laħqu DAS28 ta' remissjoni klinika (DAS28 < 2.6) kien ogħla b'mod sinifikanti f'pazjenti li rċevew RoActemra (28-34%) meta mqabbel ma 1-12% tal-pazjenti ta' kontroll f'ġimgħa 24.
English: x ULN occurred in 9.8% and 4.0% patients treated with RoActemra SC, respectively.
Maltese: Żieda fl-ALT jew l-AST għal ≥3 x ULN seħħet f'9.8% u 4.0% tal-pazjenti ttrattati b'RoActemra SC, rispettivament.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 162 mg/0.9 mL
Maltese: INDIVIDWALI 162 mg/0.9 mL
English: Store in a refrigerator (2°C-8°C)
Maltese: Aħżen fi friġġ (2°C-8°C)
English: One patient was tested positive for IgE isotype (0.2%).
Maltese: Pazjent wieħed ittestja pożittiv għall-isotip IgE (0.2%).
English: Decreases in neutrophil and platelet counts have occurred following treatment with tocilizumab 8 mg/kg in combination with MTX (see section 4.8).
Maltese: Tnaqqis fl-għadd ta' newtrofili u plejtlits seħħ wara kura b'tocilizumab 8 mg/kg flimkien ma' MTX (ara sezzjoni 4.8).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled pen contains 162 mg of RoActemra (tocilizumab) in 0.9 mL.
Maltese: Kull pinna mimlija għal-lest fiha 162 mg ta' RoActemra (tocilizumab) f'0.9 mL.
English: The following parameters (predicted mean ± SD) were estimated for a dose of 8 mg/kg tocilizumab 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 the accumulation ratios for AUC and Cmax were small, 1.32 and 1.09, respectively.
Maltese: 9 ± 13.1 µg/mL u l-ogħla konċentrazzjoni (Cmax) = 182 ± 50.4 µg/mL u lproporzjonijiet ta' akkumulazzjoni għal AUC u Cmax kienu żgħar, 1.32 u 1.09, rispettivament.
English: After SC dosing, approximately 90% of the steady-state was reached by week 12 for both the 162 mg QW and Q2W regimens.
Maltese: Wara dożaġġ SC, madwar 90% tal-istat fiss intlaħaq sa ġimgħa 12 għaż-żewġ korsijiet ta' 162 mg, dak QW u dak Q2W.
English: During routine laboratory monitoring in the RoActemra 12 month controlled clinical trial, 34% of patients experienced sustained elevations in total cholesterol > 6.2 mmol/L (240 mg/dL), with 15% experiencing a sustained increase in LDL to ≥ 4.1 mmol/L (160 mg/dL) in the RoActemra subcutaneous weekly group.
Maltese: Matul monitoraġġ ta' rutina tal-laboratorju fil-prova klinika kkontrollata ta' 12-il xahar ta' RoActemra, 34% tal-pazjenti kellhom żidiet sostnuti fil-kolesterol totali ta' > 6.2 mmol/L (240 mg/dL), bi 15% li kellhom żieda sostnuta f'LDL għal ≥ 4.1 mmol/L (160 mg/dL) fil-grupp ta' RoActemra taħt il-ġilda kull ġimgħa.
English: Of the 46 patients (1.6%) who developed anti-RoActemra 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 RoActemra, 6 kellhom reazzjoni ta' sensittività eċċessiva li kienet medikament sinifikanti, u minn dawn 5 waqqfu it-trattament b'mod permanenti.
English: Renal impairment:
Maltese: Rari ħafna:
English: Signs of serious infections
Maltese: Sinjali ta' infezzjonijiet serji
English: Clinical response
Maltese: KLINIKU
English: • adults with moderate to severe active rheumatoid arthritis (RA), an autoimmune disease, if previous therapies did not work well enough.
Maltese: • adulti b'artrite rewmatojde (RA - rheumatoid arthritis), attiva, moderata sa severa, marda awtoimmuni, jekk terapiji preċedenti ma ħadmux tajjeb biżżejjed.
English: At week 52 and week 104 the co-primary endpoints were prevention of joint damage and improvement in physical function.
Maltese: F'ġimgħa 52 u f'ġimgħa 104 il-punti finali ko-primarji kienu l-prevenzjoni ta' ħsara fil-ġogi u t-titjib fil-funzjoni fiżika.
English: During the 6-month controlled trials transient elevations in ALT/AST > 3 x ULN were observed in 2.1% of patients on RoActemra 8 mg/kg compared to 4.9% of patients on MTX and in 6.5% of patients who received 8 mg/kg RoActemra plus DMARDs compared to 1.5% of patients on placebo plus DMARDs.
Maltese: Waqt il-provi kkontrollati ta' 6 xhur żidiet temporanji fl-ALT/AST ta' > 3 x ULN kienu osservati f'2.1% tal-pazjenti fuq RoActemra 8 mg/kg meta mqabbla ma' 4.9% tal-pazjenti fuq MTX u f'6.5% tal-pazjenti li rċevew 8 mg/kg RoActemra flimkien ma' DMARDs meta mqabbla ma' 1.5% talpazjenti fuq plaċebo flimkien ma' DMARDs.
English: Mild renal impairment (estimated creatinine clearance based on Cockcroft-Gault formula) did not impact the pharmacokinetics of RoActemra.
Maltese: Indeboliment tal-kliewi ħafif (stima tat-tneħħija tal-kreatinina bbażata fuq il-formula CockcroftGault) ma kellux effett kbir fuq il-farmakokinetika ta' RoActemra.
English: * Includes elevations collected as part of routine laboratory monitoring (see text below) 1 See section 4.3
Maltese: * Jinkludu żidiet miġbura bħala parti minn monitoraġġ ta' rutina tal-laboratorju (ara l-kitba taħt) Ara sezzjoni 4.3 Ara sezzjoni 4.4
English: In patients treated with tocilizumab 8 mg/kg, significant improvements were noted on all individual components of the ACR response including: tender and swollen joint counts; patients and physician global assessment; disability index scores; pain assessment and CRP compared to patients receiving placebo plus MTX or other DMARDs in all studies.
Maltese: F'pazjenti kkurati b'tocilizumab 8 mg/kg, ġie nnutat titjib sinifikanti fil-komponenti individwali kollha tar-rispons ta' ACR fosthom: għadd tal-ġogi muġugħin u minfuħin; assessjar globali tal-pazjenti u tat-tobba; punteġġi tal-indiċi ta' diżabilità; valutazzjoni tal-uġigħ u CRP meta mqabbla ma' pazjenti li rċevew plaċebo ma' MTX jew DMARDs oħra fl-istudji kollha.
English: Each 20 mL vial contains 400 mg tocilizumab (20 mg/mL).
Maltese: Kull kunjett ta' 20 mL fih 400 mg tocilizumab (20 mg/mL).
English: • Low platelet count Laboratory Value (cells x 103/µL)
Maltese: • Għadd ta' plejtlits baxx Valur talLaboratorju (ċelluli x 103/µl)
English: Total Sharp-Genant score Erosion score JSN score
Maltese: Kif tipprepara għall-injezzjoni ta' RoACTEMRA
English: The PCS mean change from baseline to week 52 was higher (showing more improvement) in the RoActemra weekly and every other weekly dose groups [4.10, 2.76, respectively] than in the two placebo groups [placebo plus 26 weeks; -0.28, placebo plus 52 weeks; -1.49], although only the comparison between RoActemra weekly plus 26 weeks prednisone taper group and placebo plus 52 weeks prednisone taper group (5.59, 99% CI: 8.6, 10.32) showed a statistically significant difference (p=0.0024).
Maltese: Il-bidla medja f'PCS mil-linja bażi sa ġimgħa 52 kienet ogħla (li turi aktar titjib) filgruppi ta' doża ta' RoActemra kull ġimgħa u kull ġimagħtejn [4.10, 2.76, rispettivament] milli fiżżewġ gruppi tal-plaċebo [plaċebo flimkien ma' 26 ġimgħa; -0.28, plaċebo flimkien ma' 52 ġimgħa; -1.49], għalkemm il-paragun bejn il-grupp ta' RoActemra kull ġimgħa flimkien ma' 26 ġimgħa ta' prednisone mnaqqas bil-mod għax-xejn u l-grupp ta' plaċebo flimkien ma' 52 ġimgħa ta' prednisone mnaqqas bil-mod għax-xejn (5.59, CI ta' 99%: 8.6, 10.
English: Given its long elimination half-life (t1/2), the effect of tocilizumab 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' tocilizumab fuq l-attività tal-enzima CYP450 jista' jippersisti għal ħafna ġimgħat wara li titwaqqaf it-terapija.
English: Exploratory efficacy results showed that RoActemra SC improved median Juvenile Arthritis Disease Activity Score (JADAS)-71 for RoActemra naïve patients and maintained the median JADAS-71 for patients who switched from IV to SC RoActemra treatment over the entire course of the study for patients in both body weight groups (below 30 kg and ≥ 30 kg).
Maltese: Riżultati esploratorji tal-effikaċja wrew li RoActemra SC tejjeb il-parametri esploratorji kollha taleffikaċja li kienu jinkludu l-Punteġġ tal-Attività tal-Marda ta' Artrite fil-Minorenni (JADAS - Juvenile Arthritis Disease Activity Score)-71, għall-pazjenti li qatt ma ħadu TCZ qabel u żamm il-parametri esploratorji kollha tal-effikaċja għall-pazjenti li qalbu minn trattament b'RoActemra IV għal RoActemra SC matul il-kors kollu tal-istudju għall-pazjenti fiż-żewġ gruppi ta' piż tal-ġisem (inqas minn 30 kg u ≥30 kg).
English: After IV dosing, approximately 90% of the steady-state was reached by week 12 for the 10 mg/kg (BW < 30 kg), and by week 16 for the 8 mg/kg (BW ≥ 30 kg) dose.
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: Duration of Corticosteroid Therapy During Screening in Study WA28119
Maltese: Riżultati tal-effikaċja mill-Istudju WA28119
English: The types of adverse drug reactions in the RoActemra arm were consistent with the known safety profile of RoActemra and adverse drug reactions were reported at a similar frequency compared with Table 1.
Maltese: It-tipi ta' reazzjonijiet avversi tal-mediċina fil-grupp ta' RoActemra kienu konsistenti mal-profil tas-sigurtà magħruf ta' RoActemra u r-reazzjonijiet avversi kienu rrappurtati bi frekwenza simili meta mqabbla ma' Tabella 1.
English: • warfarin or phenprocoumon, used as a blood thinning agents
Maltese: • warfarin jew phenprocoumon, użati bħala sustanzi li jraqqu d-demm
English: The total clearance of tocilizumab was concentration-dependent and is the sum of the linear and non-linear clearance.
Maltese: Ittneħħija totali ta' tocilizumab kienet dipendenti fuq il-konċentrazzjoni u hija s-somma tat-tneħħija lineari u mhux lineari.
English: For ALT or AST elevations > 3-5 x ULN, confirmed by repeat testing, RoActemra treatment should be interrupted.
Maltese: Għal żidiet ta' ALT jew AST ta' > 3-5 x ULN, ikkonfermati minn ittestjar ripetut, kura b'RoActemra għandha titwaqqaf.
English: The proportion of patients achieving a DAS28 clinical remission (DAS28 < 2.6) was significantly higher in patients receiving tocilizumab (28-34%) compared to 1-12% of control patients at 24 weeks.
Maltese: Il-proporzjon ta' pazjenti li laħqu DAS28 ta' remissjoni klinika (DAS28 < 2.6) kienet ogħla b'mod sinifikanti f'pazjenti li rċevew tocilizumab (28-34 %) meta mqabbel ma 1-12 % tal-pazjenti ta' kontroll f'ġimgħa 24.
English: In RA and GCA patients, assessment of lipid parameters should be performed 4 to 8 weeks following initiation of RoActemra therapy.
Maltese: Fil-pazjenti kollha, il-parametri tal-lipidi għandhom jiġu stmati 4 sa 8 gimgħat wara li tinbeda tterapija b'RoActemra.
English: ACR 30 ACR 50 ACR 70
Maltese: JIA ACR 30 JIA ACR 50
English: Hypertriglyceridae mia
Maltese: Ipertrigliċeridemij a
English: In all studies, patients treated with RoActemra 8 mg/kg had statistically significant higher ACR 20, 50, 70 response rates at 6 months compared to control (Table 5).
Maltese: Fl-istudji kollha, pazjenti ttrattati b'RoActemra 8 mg/kg kellhom rati ta' rispons ta' ACR 20, 50, u 70 li kienu statistikament ogħla b'mod sinifikanti fis-6 xahar meta mqabbla mal-kontroll (Tabella 5).
English: Radiographic Endpoints (mean change from baseline)
Maltese: Punti Finali Radjografiċi (bidla medja mil-linja bażi)
English: The safety of tocilizumab in CRS has been evaluated in a retrospective analysis of data from clinical trials, where 51 patients were treated with intravenous tocilizumab 8 mg/kg (12 mg/kg for patients less than 30 kg) with or without additional high-dose corticosteroids for severe or life-threatening CAR Tcell-induced CRS.
Maltese: Is-sigurtà ta' tocilizumab f'CRS ġiet evalwata f'analiżi ta' data retrospettiva minn provi kliniċi, fejn 51 pazjent kienu kkurati b'tocilizumab 8 mg/kg (12-il mg/kg għall-pazjenti li jiżnu inqas minn 30 kg) fil-vini b'kortikosterojdi ta' doża għolja addizzjonali jew mingħajrhom għal CRS indott minn ċellula T CAR sever jew ta' periklu għall-ħajja.
English: Pre-filled Syringe parts
Maltese: Iċċekkja s-siringa viżwalment
English: Rheumatoid arthritis patients demonstrated a similar pattern of absolute neutrophil counts following tocilizumab administration (see section 4.8).
Maltese: Pazjenti b'artrite rewmatojde wrew tendenza simili ta' għadd assolut ta' newtrofili wara l-għoti ta' tocilizumab (ara sezzjoni 4.8).
English: RoActemra is supplied as a 0.9 mL pre-filled pen containing 162 mg tocilizumab solution for injection.
Maltese: RoActemra huwa fornut bħala pinna mimlija għal-lest ta' 0.9 mL li fiha soluzzjoni għall-inezzjoni ta' 162 mg tocilizumab.