FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients (treated with or without MTX) were randomised (tocilizumab:placebo = 2:1) to one of two treatment groups, 75 patients received tocilizumab infusions every two weeks, either 8 mg/kg for patients ≥ 30 kg or 12 mg/kg for patients < 30 kg and 37 patients were assigned to receiving placebo infusions every two weeks.
Maltese: Pazjenti (kkurati bi jew bla MTX) kienu randomised (tocilizumab: plaċebo = 2:1) għal wieħed miżżewġ gruppi ta' kura, 75 pazjent irċevew infużjonijiet ta' tocilizumab kull ġimagħtejn, 8 mg/kg għallpazjenti ta' ≥ 30 kg jew 12 mg/kg għal pazjenti ta' <30 kg u 37 pazjent kienu assenjati biex jirċievu infużjonijiet ta' plaċebo kull ġimagħtejn.
English: Seventeen (24%) tocilizumab treated patients versus 1 (3%) placebo patient were able to reduce their dose of corticosteroid by at least 20% without experiencing a subsequent JIA ACR30 flare or occurrence of systemic symptoms to week 12 (p=0.028).
Maltese: Sbatax-il pazjent (24%) ikkurati b'tocilizumab kontra pazjent wieħed (3%) fuq il-plaċebo setgħu jnaqqasu ddoża tagħhom ta' kortikosterojdi b'tal-inqas 20% mingħajr ma kellhom esperjenza ta' rkadar JIA ACR30 sussegwenti jew l-okkorrenza ta' sintomi sistemiċi sa ġimgħa 12 (p = 0.028).
English: In the open label extension phase, elevation in ALT or AST ≥ 3 x ULN occurred in 12% and 4% of patients, respectively, in the tocilizumab group.
Maltese: Fil-fażi ta' estensjoni open label, żieda fl-ALT jew l-AST ta' ≥ 3 x ULN seħħet fi 12% u f'4% talpazjenti, rispettivament, fil-grupp ta' tocilizumab.
English: Clinically significant hypersensitivity reactions associated with tocilizumab and requiring treatment discontinuation, were reported in 1 out of 112 patients (< 1%) treated with tocilizumab during the controlled and up to and including the open label clinical trial.
Maltese: Reazzjonijiet ta' sensittività eċċessiva klinikament sinifikanti assoċjati ma' tocilizumab u li kienu jeħtieġu waqfien tal-kura, kienu irrappurtati f'wieħed minn 112-il pazjent (< 1%) ikkurati b'tocilizumab waqt il-fażi kkontrollata u sa u inkluża il-prova klinika open label.
English: In this study, ACR/EULAR remission (Boolean and Index) were also analysed as pre-specified exploratory endpoints, with higher responses observed in the tocilizumab groups.
Maltese: F'dan listudju, remissjoni ACR/EULAR (Boolean u Indiċi) ukoll kienet analizzata bħala punt finali esploratorju speċifikat minn qabel, b'rispons akbar osservat fil-gruppi ta' tocilizumab.
English: For the 162 every other week dose, the predicted mean (±SD) steady-state AUC2week, Cmin, and Cmax of RoActemra were 3430 ± 2660 µg•h/mL, 5.7 ± 6.8 µg/mL, and 13.2 ± 8.8 µg/mL, respectively.
Maltese: Għad-doża ta' 162 kull ġimagħtejn, il-medja mbassra (±SD) tal-AUCġimgħa2 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: Of these 51 patients, 26 (51%) were naive to RoActemra and 25 (49%) had been receiving RoActemra IV and switched to RoActemra SC at baseline.
Maltese: Minn dawn il51 pazjent, 26 (51%) qatt ma kienu ħadu RoActemra qabel u 25 (49%) kienu qed jirċievu RoActemra IV u qalbu għal RoActemra SC fil-linja bażi.
English: RoActemra should be diluted to a final volume of 100 mL with sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection using aseptic technique.
Maltese: RoActemra għandu jiġi dilwit għall-volum finali ta' 100 mL b'soluzzjoni għall-injezzjoni sterili u mhux piroġenika ta' sodium chloride 9 mg/mL (0.9 %) bl-użu ta' teknika asettika.
English: The rate of infection/serious infection events was balanced between the RoActemra weekly group (200.2/9.7 events per 100 patient years) vs. placebo plus 26 weeks prednisone taper (156.0/4.2 events per 100 patient years) and placebo plus 52 weeks taper (210.2/12.5 events per 100 patient years) groups.
Maltese: Ir-rata ta' avvenimenti ta' infezzjoni/infezzjoni serja kienet ibbilanċjata bejn il-grupp ta' RoActemra kull ġimgħa (200.2/9.7 avvenimenti kull 100 sena ta' pazjent) kontra l-gruppi ta' plaċebo flimkien ma' 26 ġimgħa ta' prednisone mnaqqas bil-mod għax-xejn (156.
English: • 1 Alcohol pad
Maltese: • Imselħa tal-alkoħol
English: Patients in the RoActemra arm received an intravenous (IV) infusion of RoActemra (8 mg/kg) every 4 weeks (q4w) and a subcutaneous (SC) placebo injection every 2 weeks (q2w).
Maltese: Pazjenti fil-grupp ta' RoActemra rċevew infużjoni fil-vini (IV - intravenous) ta' RoActemra (8 mg/kg) kull 4 ġimgħat (q4w) u injezzjoni ta' plaċebo taħt il-ġilda (SC - subcutaneous) kull ġimagħtejn (q2w).
English: Number and Proportion of Patients with a JIA ACR30 Flare and Proportion of Patients with JIA ACR30/50/70/90 Responses at Week 40, by Previous Biologic Use (ITT Population - Study Part II)
Maltese: JIA ACR30/50/70/90 f'Ġimgħa 40, skont l-Użu Bijoloġiku Preċedenti (Popolazzjoni ITT
English: Events of diverticular perforations as complications of diverticulitis have been reported uncommonly with RoActemra in RA patients (see section 4.8).
Maltese: Avvenimenti ta' perforazzjonijiet tad-divertikuli bħala komplikazzjonijiet tad-divertikulite kienu rrappurtati b'mod mhux komuni f'pazjenti ttrattati b'RoActemra (ara sezzjoni 4.8).
English: RoActemra contains the active substance tocilizumab, which is a protein made from specific immune cells (monoclonal antibody), that blocks the action of a specific protein (cytokine) called interleukin-6.
Maltese: RoActemra fih is-sustanza attiva tocilizumab, li hija proteina magħmula minn ċelluli immuni speċifiċi (antikorp monoklonali), li timblokka l-azzjoni ta' proteina speċifika (ċitokina) imsejħa interleukin-6.
English: JIA ACR70 Response
Maltese: JIA ACR70 Rispons
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled pen, ACTPen® Multipack: 12 (3 packs of 4) pre-filled pens.
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest, ACTPen® Pakkett multiplu: 12-il (3 pakketti ta' 4) pinna mimlija għal-lest.
English: Decreases in neutrophil and platelet counts have occurred following treatment with RoActemra 8 mg/kg in combination with MTX (see section 4.8).
Maltese: Tnaqqis fl-għadd ta' newtrofili u plejtlits seħħ wara trattament b'RoActemra 8 mg/kg flimkien ma' MTX (ara sezzjoni 4.8).
English: RoActemra, in combination with methotrexate (MTX), is indicated for
Maltese: RoActemra, flimkien ma' methotrexate (MTX), huwa indikat għal
English: In the open label extension phase (study WA18221), 13.2% and 27.7% of patients experienced a post baseline elevation of their LDL-cholesterol value to ≥ 130 mg/dL and total cholesterol value to ≥ 200
Maltese: Fil-fażi ta' estensjoni open label (studju WA18221), 13.2% u 27.7% tal-pazjenti kellhom żieda wara llinja 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 tal-istudju, rispettivament.
English: Diluted product: After dilution, the prepared solution for infusion is physically and chemically stable in sodium chloride 9 mg/mL (0.9%) solution for injection at 30ºC for 24 hours.
Maltese: Prodott dilwit: Wara d-dilwazzjoni, is-soluzzjoni għall-infużjoni lesta hija stabbli fiżikament u kimikament f'soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/mL (0.9 %) f'temperatura ta' 30°C għal 24 siegħa.
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 tocilizumab + DMARD.
Maltese: Waqt il-perijodu kkontrollat u double-blind, l-inċidenza ta' bilirubina indiretta akbar mill-ogħla limitu tan-normal, miġbura bħala parametru ta' rutina tal-laboratorju, hija ta' 6.2% f'pazjenti kkurati b'8 mg/kg tocilizumab + DMARD,.
English: Steady-state was reached following the first administration for Cmax and after 8 and 20 weeks for AUC and Cmin, respectively.
Maltese: Intlaħaq stat fiss wara lewwel teħid għal Cmax u wara 8 u 20 ġimgħa għall-AUC u Cmin, rispettivament.
English: Conjunctivitis
Maltese: RESPONSABBLI
English: Injection Site Reactions (ISRs)
Maltese: Reazzjonijiet fis-Sit tal-Injezzjoni (ISRs - Injection Site Reactions)
English: Reporting suspected adverse reactions after authorization of the medicinal product is important.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: Each 10 mL vial contains 200 mg tocilizumab (20 mg/mL).
Maltese: Kull kunjett ta' 10 mL fih 200 mg tocilizumab (20 mg/mL).
English: At week 12, the proportion of tocilizumab treated patients showing a minimally clinically important improvement in the Childhood Health Assessment Questionnaire - Disability Index (defined as an individual total score decrease of ≥ 0.13) was significantly higher than in placebo treated patients, 77% versus 19% (p<0.0001).
Maltese: F'ġimgħa 12, il-proporzjon ta' pazjenti kkurati b'tocilizumab li wrew titjib minimu ta' importanza klinika fil-Kwestjonarju ta' Valutazzjoni tas-Saħħa tat-Tfal - Indiċi ta' Diżabilità (definit bħala tnaqqis fil-punteġġ individwali totali ta' ≥ 0.13) kien ogħla b'mod sinifikanti minn dak f'pazjenti kkurati bil-plaċebo, 77% kontra 19% (p <0.0001).
English: Steady state was reached after 12 weeks for AUC and Cmin, and after 10 weeks for Cmax.
Maltese: Stat fiss intlaħaq wara 12-il ġimgħa għall-AUC u Cmin, u wara 10 ġimgħat għal Cmax.
English: How to store RoActemra
Maltese: Tużax RoActemra
English: • Physician Information Pack
Maltese: INFORMAZZJONI BIL-BRAILLE
English: Elevations in lipid parameters including total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL) and triglycerides were observed in patients treated with RoActemra (see section 4.8).
Maltese: F'pazjenti kkurati b'RoActemra kienu osservati żidiet fil-parametri tal-lipidi inkluż kolesterol totali, lipoproteina ta' densità baxxa (LDL - low-density lipoprotein), lipoproteina ta' densità għolja (HDLhigh-density lipoprotein) u trigliċeridi (ara sezzjoni 4.8).
English: • Check the expiration date on the RoACTEMRA pre-filled pen (See Figure A).
Maltese: • Iċċekkja d-data ta' skadenza fuq il-pinna mimlija għal-lest ta' RoACTEMRA (Ara Figura A).
English: In the 52-week open-label SC Study (WA28118), 23.4% and 35.4% of patients experienced a post baseline elevation of their LDL-cholesterol value to ≥130 mg/dL and total cholesterol value to ≥200
Maltese: Fl-Istudju SC open-label ta' 52 ġimgħa (WA28118), 23.4% u 35.4% tal-pazjenti kellhom żieda wara llinja 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 tal-istudju, rispettivament.
English: Reports of gastrointestinal perforation on RoActemrawere primarily reported as complications of diverticulitis including generalised purulent peritonitis, lower gastrointestinal perforation, fistulae and abscess.
Maltese: Rapporti ta' perforazzjoni gastro-intestinali dwar RoActemra kienu rrappurtati primarjament bħala komplikazzjonijiet ta' divertikulite inkluż peritonite ġeneralizzata bilmaterja, perforazzjoni gastro-intestinali tal-parti t'isfel, fistla u axxess.
English: In study I, superiority of tocilizumab 8 mg/kg was demonstrated against the active comparator MTX.
Maltese: Fi Studju I, intweriet is-superjorità ta' tocilizumab 8 mg/kg kontra l-komparatur attiv MTX.
English: The safety profile comes from 4158 patients exposed to RoActemra in clinical trials; the majority of these patients were participating in RA studies (n=4009), while the remaining experience comes from GCA (n=149) studies.
Maltese: Il-profil tas-sigurtà ġej minn 4158 pazjent esposti għal RoActemra fi provi kliniċi; il-maġġoranza ta' dawn il-pazjenti kienu qed jieħdu sehem fi studji dwar RA (n=4009), filwaqt li l-esperjenza li jifdal ġejja minn studji dwar GCA (n=149).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial contains 80 mg tocilizumab.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett fih 80 mg ta' tocilizumab.
English: The mean LDL increase from baseline was 0.64 mmol/L (25 mg/dL) for patients in the RoActemra arm and 0.19 mmol/L (7 mg/dL) for patients in the adalimumab arm.
Maltese: Iż-żieda medja fil-livell ta' LDL mil-linja bażi kienet ta' 0.64 mmol/L (25 mg/dL) għall-pazjenti fil-grupp ta' RoActemra u ta' 0.19 mmol/L (7 mg/dL) għall-pazjenti fil-grupp ta' adalimumab.
English: Significant reduction in DAS28 from baseline (mean improvement) of 3.1-3.4 were observed in tocilizumab-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 kkurati b'tocilizumab meta mqabbel mal-pazjenti ta' kontroll (1.3-2.1).
English: • If you have persistent headaches.
Maltese: • Jekk għandek uġigħ ta' ras persistenti.
English: RoActemra is supplied as vials containing 4 mL, 10 mL and 20 mL concentrate for solution for infusion.
Maltese: RoActemra huwa fornut bħala kunjetti li fihom 4 mL, 10 mL u 20 mL ta' konċentrat għall-soluzzjoni għall-infużjoni.
English: Both considerably lower than in the placebo plus 26 weeks and the placebo plus 52 weeks prednisone taper groups, 4023.5 mg and 5389.5 mg respectively.
Maltese: It-tnejn ferm aktar baxxi minn dawk fil-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, ta' 4023.5 mg u 5389.5 mg rispettivament.
English: The proportion of patients achieving a clinically relevant improvement in HAQ-DI at week 24 (change from baseline of ≥ 0.3 units) was also comparable on the subcutaneous (65.2%) versus intravenous (67.4%) arms, with a weighted difference in proportions of - 2.3% (95% CI - 8.1, 3.4).
Maltese: Il-proporzjon ta' pazjenti li kisbu titjib klinikament rilevanti f'HAQ-DI f'ġimgħa 24 (bidla mil-linja bażi ta' ≥ 0.3 unità) kien ukoll komparabbli fil-gruppi ta' għoti taħt il-ġilda (65.2%) kontra għoti fil-vini (67.4%), b'differenza miżgħuna fi proporzjonijiet ta' - 2.3% (CI ta' 95% - 8.1, 3.4).
English: The rate of anaphylactic reactions (occurring in a total of 8/4,009 patients, 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' 8/4,009 pazjenti, 0.2%) kienet diversi drabi ogħla bid-doża ta' 4 mg/kg, meta mqabbla mad-doża ta' 8 mg/kg.
English: Similarly the proportion of patients achieving a DAS28 remission (DAS28 < 2.6) was significantly higher (31% vs. 16% respectively) in patients receiving tocilizumab 8 mg/kg plus DMARD than in patients receiving tocilizumab 4 mg/kg plus DMARD (p< 0.0001).
Maltese: B'mod simili, il-proporzjon ta' pazjenti li kisbu DAS28 ta' remissjoni (DAS28 <2.6) kien ogħla b'mod sinifikanti (31 % vs. 16 % rispettivament) f'pazjenti li rċevew tocilizumab 8 mg/kg flimkien ma' DMARD mill-pazjenti li rċevew tocilizumab 4 mg/kg flimkien ma' DMARD (p< 0.0001).
English: RoActemra should be diluted to a final volume of 50 mL with sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection using aseptic technique.
Maltese: RoActemra għandhu jiġi dilwit għall-volum finali ta' 50 mL b'soluzzjoni għall-injezzjoni sterili u mhux piroġenika ta' sodium chloride 9 mg/mL (0.9%) bl-użu ta' teknika asettika.
English: Patients in the tocilizumab arm received an intravenous (IV) infusion of tocilizumab (8 mg/kg) every 4 weeks (q4w) and a subcutaneous (SC) placebo injection every 2 weeks (q2w).
Maltese: Pazjenti fil-grupp ta' tocilizumab irċevew infużjoni fil-vini (IV) ta' tocilizumab (8 mg/kg) kull 4 ġimgħat (q4w) u injezzjoni ta' plaċebo taħt il-ġilda (SC) kull ġimagħtejn (q2w).
English: Similarly the proportion of patients achieving a DAS 28 remission (DAS28 < 2.6) was significantly higher (31% vs. 16% respectively) in patients receiving RoActemra 8 mg/kg plus DMARD than in patients receiving RoActemra 4 mg/kg plus DMARD (p< 0.0001).
Maltese: B'mod simili, il-proporzjon ta' pazjenti li kisbu DAS28 ta' remissjoni (DAS28 < 2.6) kien ogħla b'mod sinifikanti (31% kontra 16% rispettivament) f'pazjenti li rċevew RoActemra 8 mg/kg flimkien ma' DMARD milli f'pazjenti li rċevew RoActemra 4 mg/kg flimkien ma' DMARD (p< 0.0001).
English: In the 52-week open-label SC Study (WA28118), neutrophil count decrease to below 1 × 109/L occurred in 23.5% of patients treated with RoActemra SC. Decreases in platelet counts to below 100 ×
Maltese: Fl-Istudju SC open-label ta' 52 ġimgħa (WA28118), seħħ tnaqqis fl-għadd ta' newtrofili għal taħt 9/L fi 23.5% tal-pazjenti ttrattati b'RoActemra SC.
English: Prescribers are reminded of the risk of false negative tuberculin skin and interferon-gamma TB blood test results, especially in patients who are severely ill or immunocompromised.
Maltese: Dawk li jippreskrivu huma mfakkra dwar ir-riskju ta' riżultati negattivi foloz ta' testijiet ta' tuberculin tal-ġilda u testijiet tad-demm ta' interferon-gamma tat-TB, speċjalment f'pazjenti li huma morda ħafna jew immunokompromessi.
English: During the 6-month controlled trials transient elevations in ALT/AST > 3 x ULN were observed in 2.1% of patients on tocilizumab 8 mg/kg compared to 4.9% of patients on MTX and in 6.5% of patients who received 8 mg/kg tocilizumab plus DMARDs compared to 1.5% of patients on placebo plus DMARDs.
Maltese: Fil-provi kkontrollati ta' 6 xhur żidiet temporanji fil-livelli ta' ALT/AST ta' > 3 x ULN ġew osservati f'2.1 % tal-pazjenti fuq tocilizumab 8 mg/kg meta mqabbla ma' 4.9 % tal-pazjenti fuq MTX u f'6.5 % tal-pazjenti li rċevew 8 mg/kg tocilizumab ma' DMARDs meta mqabbla ma' 1.5 % tal-pazjenti fuq plaċebo ma' DMARDs.
English: At body weight ≥ 100 kg, the predicted mean (± SD) steadystate AUC, Cmin and Cmax of tocilizumab 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' tocilizumab 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: sJIA and CRS patients < 30 kg
Maltese: Pazjenti b'sJIA u CRS < 30 kg
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial contains 400 mg tocilizumab.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett fih 400 mg ta' tocilizumab.
English: The mean LDL increase from baseline was 0.64 mmol/L (25 mg/dL) for patients in the tocilizumab arm and 0.19 mmol/L (7 mg/dL) for patients in the adalimumab arm.
Maltese: Iż-żieda medja fil-livell ta' LDL mil-linja bażi kienet ta' 0.64 mmol/L (25 mg/dL) għall-pazjenti fil-grupp ta' tocilizumab u ta' 0.19 mmol/L (7 mg/dL) għall-pazjenti fil-grupp ta' adalimumab.
English: Study VI (WA19924), a 24 week double-blinded study that compared tocilizumab 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: Studju VI (WA19924), studju double-blind ta' 24 ġimgħa li qabbel monoterapija ta' tocilizumab ma' monoterapija ta' adalimumab, evalwa 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: Table 2: List of ADRs occurring in clinical trial patients with sJIA or pJIA receiving tocilizumab as monotherapy or in combination with MTX.
Maltese: Tabella 2: Lista tal-ADRs li jseħħu f'pazjenti tal-prova klinika b'sJIA jew pJIA li jkunu qed jirċievu tocilizumab bħala monoterapija jew flimkien ma' MTX.
English: A significantly higher proportion of patients in the tocilizumab 8 mg/kg + MTX and tocilizumab monotherapy groups met the primary endpoint compared with MTX alone.
Maltese: Proporzjon ogħla b'mod sinifikanti ta' pazjenti fil-grupp ta' tocilizumab 8 mg/kg + MTX u f'dak ta' monoterapija ta' tocilizumab laħqu l-punt finali primarju meta mqabbla ma' MTX waħdu.
English: The most serious ADRs were serious infections, complications of diverticulitis, and hypersensitivity reactions.
Maltese: L-aktar ADRs serji kienu infezzjonijiet serji, komplikazzjonijiet tad-divertikulite, u reazzjonijiet ta' sensittività eċċessiva.
English: 4 vials of 10 mL
Maltese: 200 mg/10 mL
English: Clinically significant hypersensitivity reactions associated with RoActemra and requiring treatment discontinuation were reported in a total of 13 out of 3778 patients (0.3%) 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 tal-kura, kienu rrappurtati f'total ta' 13 minn 3778 pazjent (0.3%) ikkurat b'RoActemra waqt l-istudji kliniċi kkontrollati u open label.
English: In the long-term exposure population the overall rate of gastrointestinal perforation was 0.28 events per 100 patient years.
Maltese: Fil-popolazzjoni ta' esponiment fit-tul ir-rata globali ta' perforazzjoni gastro-intestinali kienet ta' 0.28 avveniment għal kull 100 sena ta' pazjent.
English: ADRs in the pJIA and sJIA patients treated with tocilizumab are listed in the Table 2 and presented by MedDRA system organ class.
Maltese: ADRs f'pazjenti b'pJIA u sJIA kkurati b'tocilizumab huma elenkati f'Tabella 2 u huma ppreżentati skont is-sistema tal-klassifika tal-organi MedDRA.
English: *τ = 4 weeks for IV regimens
Maltese: *τ = 4 ġimgħat għall-korsijiet IV
English: During the 6-month controlled clinical trials, the overall rate of gastrointestinal perforation was 0.26 events per 100 patient years with RoActemra therapy.
Maltese: Waqt il-provi kliniċi kkontrollati ta' 6 xhur, ir-rata globali ta' perforazzjoni gastro-intestinali kienet ta' 0.26 avveniment għal kull 100 sena ta' pazjent b'terapija ta' RoActemra.
English: JIA ACR30 Flare
Maltese: Irkadar JIA ACR30 Rispons
English: Children and adolescents with pJIA (aged 2 and over)
Maltese: Tfal u adolexxenti b'pJIA (ta' età minn sentejn 'il fuq)
English: The number of active joints was significantly reduced compared to baseline in patients receiving tocilizumab compared to placebo (adjusted mean changes of -14.3 vs -11.4, p=0.0435).
Maltese: In-numru ta' ġogi attivi kien imnaqqas b'mod sinifikanti meta mqabbel mal-linja bażi f'pazjenti li rċevew tocilizumab meta mqabbel mal-plaċebo (bidliet medji aġġustati ta' -14.3 vs -11.4, p=0.
English: Effects on endocrine active and reproductive system organs were not observed in a chronic cynomolgus monkey toxicity study and reproductive performance was not affected in IL-6 deficient mice.
Maltese: Ma kinux osservati effetti fuq l-organi tas-sistema riproduttiva u fuq dawk b'attività endokrinarja fi studju ta' tossiċità kronika f'xadini tat-tip cynomolgus u l-kapaċità riproduttiva ma ġietx affettwata fi ġrieden mingħajr IL-6.
English: A statistically significant superior treatment effect was seen in favour of RoActemra over adalimumab in control of disease activity from baseline to week 24 for the primary endpoint of change in DAS28 and for all secondary endpoints (Table 7).
Maltese: Kien osservat effett tattrattament superjuri b'mod statistikament sinifikanti favur RoActemra imqabbel ma' adalimumab filkontroll tal-attività tal-marda mil-linja bażi sa ġimgħa 24 għall-punt finali primarju ta' bidla f'DAS28 u għall-punti finali sekondarji kollha (Tabella 7).
English: The adjusted mean change in the pain VAS after 12 weeks of tocilizumab treatment was a reduction of 41 points on a scale of 0 - 100 compared to a reduction of 1 for placebo patients (p<0.0001).
Maltese: Il-bidla medja aġġustata fil-VAS tal-uġigħ wara 12-il ġimgħa ta' kura b'tocilizumab kienet tnaqqis ta' 41 punt fuq skala ta' 0 - 100 meta mqabbla ma' tnaqqis ta' 1 għal pazjenti fuq plaċebo (p <0.
English: The safety of RoActemra has been studied in 5 Phase III, double-blind controlled trials and their extension periods.
Maltese: Is-sigurtà ta' RoActemra kienet studjata f'5 provi kkontrollati double-blind ta' Fażi