FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety profile of subcutaneous RoActemra was evaluated in 51 paediatric patients (1 to 17 years of age) with sJIA.
Maltese: Il-profil tas-sigurtà ta' RoActemra taħt il-ġilda kien evalwat f'51 pazjent pedjatriku (b'età minn sena sa 17-il sena) b'sJIA.
English: However, doses below 1025 mg of this medicine contain less than 23 mg sodium, so they are virtually sodium free.
Maltese: Madankollu, dożi taħt 1025 mg ta' din il-mediċina fihom inqas minn 23 mg ta' sodium, għalhekk huma virtwalment bla sodium.
English: In SC-I, a total of 625 patients treated with RoActemra 162mg weekly were tested for anti-RoActemra antibodies in the 6 month controlled period.
Maltese: F'SC-I, total ta' 625 pazjent ittrattati b'RoActemra 162 mg kull ġimgħa kienu ttestjati għall-antikorpi kontra RoActemra fil-perjodu kkontrollat ta' 6 xhur.
English: Elevations of ALT/AST > 5 x ULN were observed in 0.7% of RoActemra monotherapy patients and 1.4% of RoActemra plus DMARD patients, the majority of whom were discontinued permanently from tocilizumab treatment.
Maltese: Żidiet ta' ALT/AST ta' > 5 x ULN kienu osservati f'0.7% talpazjenti fuq RoActemra bħala monoterapija u f'1.4% tal-pazjenti fuq RoActemra flimkien ma' DMARD, fejn il-maġġoranza tagħhom twaqqfitilhom il-kura ta' tocilizumab b'mod permanenti.
English: • children and adolescents, aged 1 year and over, with active systemic juvenile idiopathic arthritis (sJIA), an inflammatory disease that causes pain and swelling in one or more joints as well as fever and rash.
Maltese: • tfal u adolexxenti, ta' età minn sena 'l fuq, b'artrite idjopatika sistemika fil-minorenni (sJIA - systemic juvenile idiopathic arthritis) attiva, marda infjammatorja li tikkawża wġigħ u nefħa f'ġog wieħed jew aktar kif ukoll deni u raxx.
English: In Study II, in patients with an inadequate response to MTX, inhibition of structural joint damage was assessed radiographically and expressed as change in modified Sharp score and its components, the erosion score and joint space narrowing score.
Maltese: Fi Studju II, f'pazjenti b'rispons mhux adegwat għal MTX, inibizzjoni ta' ħsara strutturali fil-ġogi kienet evalwata b'mod radjografiku u imfissra bħala bidla fil-punteġġ Sharp immodifikat u lkomponenti tiegħu, il-punteġġ ta' tħaffir u l-punteġġ ta' djuq tal-ispazju tal-ġog.
English: In the open-label extension of Study II the inhibition of progression of structural joint damage in RoActemra plus MTX-treated patients was maintained in the second year of treatment.
Maltese: Fl-estensjoni open-label tal-Istudju II, l-inibizzjoni ta' progressjoni ta' ħsara strutturali fil-ġogi f'pazjenti ttrattati b'RoActemra flimkien ma' MTX inżammet fit-tieni sena ta' trattament.
English: TCZ + Placebo (SC) N = 163 p-value(a) Primary Endpoint - Mean Change from baseline at Week 24 DAS28 (adjusted mean) Difference in adjusted mean (95% CI) Secondary Endpoints - Percentage of Responders at Week 24
Maltese: Differenza fil-medja aġġustata (CI ta' 95%) -1.5 (-1.8, -1.1) Punti Finali Sekondarji - Persentaġġ ta' Dawk li Rrispondew f'Ġimgħa 24
English: In general, side effects in pJIA patients were of a similar type to those in adults with RA.
Maltese: B'mod ġenerali, l-effetti sekondarji f'pazjenti b'pJIA kienu ta' tip simili għal dawk f'adulti b'RA.
English: Following SC dosing in pJIA patients, the absorption half-life was around 2 days, and the bioavailability for the SC formulation in pJIA patients was 96%.
Maltese: Wara dożaġġ SC f'pazjenti b'pJIA, il-half-life tal-assorbiment kienet ta' madwar jumejn, u l-bijodisponibilità għall-formulazzjoni SC f'pazjenti b'pJIA kienet ta' 96%.
English: One patient in the 10 mg/kg < 30kg group developed positive anti-tocilizumab antibodies without developing a hypersensitivity reaction and subsequently withdrew from the study.
Maltese: Pazjent wieħed fil-grupp ta' 10 mg/kg < 30kg żviluppa antikorpi pożittivi kontra tocilizumab mingħajr l-iżvilupp ta' reazzjoni ta' sensittività eċċessiva u wara dan irtira mill-istudju.
English: Subcutaneous
Maltese: Pożoloġija
English: TCZ 8 mg/kg + MTX
Maltese: TCZ 8 mg/kg + plaċebo
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 RoActemra 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 (avvenimenti magħżula li jseħħu waqt l-infużjoni jew fi żmien 24 siegħa mill-infużjoni) kienu rrappurtati minn 6.9% tal-pazjenti fil-grupp ta' RoActemra 8 mg/kg flimkien ma' DMARD u f'5.1% tal-pazjenti fil-grupp ta' plaċebo flimkien ma' DMARD.
English: Doses of 4 or 8 mg/kg of RoActemraor placebo were given every four weeks as blinded therapy for 52 weeks in combination with stable MTX (10 mg to 25 mg weekly).
Maltese: Dożi ta' 4 jew 8 mg/kg ta' RoActemra jew plaċebo ngħataw kull erba' ġimgħat bħala terapija fl-għama għal 52 ġimgħa flimkien ma' MTX stabbli (10 mg sa 25 mg kull ġimgħa).
English: In all studies, patients treated with tocilizumab 8 mg/kg had statistically significant higher ACR 20, 50, 70 response rates at 6 months compared to control (Table 3).
Maltese: Fl-istudji kollha, pazjenti kkurati b'tocilizumab 8 mg/kg kellhom rati ta' rispons ta' ACR 20, 50, 70 li kienu statistikament ogħla b'mod sinifikanti fis-6 xahar meta mqabbla mal-kontroll (Tabella 3).
English: The pharmacokinetics of RoActemra 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 RoActemra 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' RoActemra 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 RoActemra 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: The safety of subcutaneous RoActemra has been studied in one Phase III study (WA28119) with 251 GCA patients.
Maltese: III (WA28119) b'251 pazjent b'GCA.
English: Doses of 4 or 8 mg/kg of tocilizumab or placebo were given every four weeks as blinded therapy for 52 weeks in combination with stable MTX (10 mg to 25 mg weekly).
Maltese: Dożi ta' 4 jew 8 mg/kg ta' tocilizumab jew plaċebo ngħataw kull erba' ġimgħat bħala terapija fl-għama għal 52 ġimgħa flimkien ma' MTX stabbli (10 mg sa 25 mg kull ġimgħa).
English: As recommended for other biological treatments, RA, sJIA and pJIA patients should be screened for latent tuberculosis (TB) infection prior to starting RoActemra therapy.
Maltese: Kif rakkomandat għal trattamenti bijoloġiċi oħra, il-pazjenti kollha għandhom jiġu eżaminati għal infezzjoni tat-tuberkulosi (TB - tuberculosis) li mhux attiva qabel tinbeda terapija b'RoActemra.
English: Approximately one-third of the patients in the GCA study had moderate renal impairment at baseline (estimated creatinine clearance of 30-59 mL/min).
Maltese: Madwar terz tal-pazjenti fl-istudju dwar GCA kellhom indeboliment moderat tal-kliewi fil-linja bażi (stima tat-tneħħija tal-kreatinina ta' 30-59 mL/min).
English: In healthy subjects administered RoActemra in doses from 2 to 28 mg/kg intravenously and 81 to 162 mg subcutaneously, absolute neutrophil counts decreased to their lowest 2 to 5 days following administration.
Maltese: F'individwi f'saħħithom li ngħataw RoActemra f'dożi minn 2 sa 28 mg/kg fil-vini u 81 sa 162 mg taħt il-ġilda, l-għadd assolut ta' newtrofili naqas għall-inqas livell jumejn sa ħamest ijiem wara l-għoti.
English: Doses of 4 or 8 mg/kg RoActemra or placebo were given every four weeks in combination with stable MTX (10 mg to 25 mg weekly).
Maltese: Dożi ta' 4 jew 8 mg/kg ta' RoActemra jew plaċebo ngħataw kull erba' ġimgħat, flimkien ma' MTX stabbli (10 mg sa 25 mg kull ġimgħa).
English: pJIA Patients
Maltese: Patients b'RA
English: A total of 2,876 patients have been tested for anti-tocilizumab antibodies in the 6-month controlled clinical trials.
Maltese: Fl-istudji kliniċi kkontrollati ta' sitt xhur kien hemm total ta' 2,876 pazjent li ġew ittestjati għallantikorpi kontra tocilizumab.
English: The safety profile of intravenous RoActemra in pJIA has been studied in 188 patients from 2 to 17 years of age.
Maltese: Il-profil tas-sigurtà ta' RoActemra fil-vini f'pJIA kien studjat f'188 pazjent b'età minn sentejn sa 17-il sena.
English: • In RA, GCA, pJIA and sJIA, ALT/AST should be monitored every 4 to 8 weeks for the first 6 months of treatment followed by every 12 weeks thereafter.
Maltese: • F'RA, GCA, pJIA u sJIA, l-ALT/AST għandhom jiġu mmonitorjati kull 4 sa 8 ġimgħat għall-ewwel 6 xhur ta' trattament, segwit b'monitoraġġ kull 12-il ġimgħa minn hemm 'il quddiem.
English: • RoActemra is used to treat adults and children aged 2 years and over with severe or lifethreatening cytokine release syndrome (CRS), a side-effect in patients treated with chimeric antigen receptor (CAR) T-cell therapies used to treat certain types of cancer.
Maltese: • RoActemra jintuża biex jikkura adulti u tfal ta' età minn sentejn 'il fuq b'sindrome ta' rilaxx ta' ċitokina (CRS - cytokine release syndrome) sever jew ta' periklu għall-ħajja, effett sekondarju f'pazjenti kkurati b'terapiji taċ-ċellula T b'riċettur ta' antiġene kimeriku (CAR - chimeric antigen receptor) użati biex jikkuraw ċerti tipi ta' kanċer.
English: No adverse reactions were observed.
Maltese: Ma ġewx osservati reazzjonijiet avversi.
English: Platelets During routine laboratory monitoring in the 12 week controlled phase, 3% of patients in the placebo group and 1% in the tocilizumab group had a decrease in platelet count to ≤ 100 x 103/µl.
Maltese: Waqt sorveljanza ta' rutina tal-laboratorju fil-fażi kkontrollata ta' 12-il ġimgħa, 3% tal-pazjenti filgrupp tal-plaċebo u 1% fil-grupp ta' tocilizumab kellhom tnaqqis fl-għadd ta' plejtlits għal ≤ 100 x
English: • RoActemra is used to treat children with pJIA.
Maltese: • RoActemra jintuża biex jikkura tfal b'pJIA.
English: In the SC RoActemra study, the rate of infection in pJIA patients treated with SC RoActemra was comparable with pJIA patients treated with IV RoActemra.
Maltese: Fi studji kliniċi b'RoActemra, kienu esklużi pazjenti li kellhom riżultat pożittiv għall-epatite.
English: Doses of 4 or 8 mg/kg tocilizumab or placebo were given every four weeks in combination with stable MTX (10 mg to 25 mg weekly).
Maltese: Dożi ta' 4 jew 8 mg/kg ta' tocilizumab jew plaċebo ngħataw kull erba' ġimgħat, flimkien ma' MTX stabbli (10 mg sa 25 mg kull ġimgħa).
English: • The purple indicator will move along the Window area during the injection (See Figure K).
Maltese: • L-indikatur vjola se jimxi tul iż-żona tat-Tieqa waqt l-injezzjoni (Ara Figura K).
English: • RoActemra is used to treat adults with moderate to severe active rheumatoid arthritis (RA), an autoimmune disease, if previous therapies did not work well enough.
Maltese: • RoActemra jintuża biex jikkura adulti b'artrite rewmatojde (RA - rheumatoid arthritis), marda awtoimmuni, attiva, moderata sa severa, jekk terapiji ta' qabel ma ħadmux tajjeb biżżejjed.
English: 12 mg/kg Q2W below 30 kg
Maltese: 12 mg/kg Q2W taħt it-30 kg
English: Eleven (6.8%) patients in the tocilizumab arm and five (3.1%) patients in the adalimumab arm experienced ALT increases of CTC grade 2 or higher.
Maltese: Ħdax-il pazjent (6.8%) fil-grupp ta' tocilizumab u ħames (3.1%) pazjenti fil-grupp ta' adalimumab kellhom esperjenza ta' żidiet fil-livell ta' ALT ta' CTC grad 2 jew ogħla.
English: Forty eight percent (48.1%, 39/81) of the patients treated with placebo flared compared with 25.6% (21/82) of tocilizumab treated patients.
Maltese: 6% (21/82) tal-pazjenti kkurati b'tocilizumab.
English: Statistically significant improvements in haemoglobin levels were observed with tocilizumab compared with DMARDs (p< 0.0001) at week 24.
Maltese: Titjib statistikament sinifikanti fil-livelli ta' emoglobina ġew osservati b'tocilizumab meta mqabbel ma' DMARDs (p<0.
English: 3 This adverse reaction was identified through post marketing surveillance but not observed in controlled clinical trials.
Maltese: Din ir-reazzjoni avversa ġiet identifikata permezz ta' sorveljanza ta' wara t-tqegħid fis-suq iżda ma ġietx osservata fi provi kliniċi kkontrollati.
English: RoActemra is supplied in a vial (type I glass) with a stopper (butyl rubber) containing 4 mL, 10 mL or 20 mL concentrate.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih RoActemra huwa disponibbli f'kunjett (ħġieġ tat-tip I) b'tapp (tal-lastku butyl) li fih 4 mL, 10 mL jew 20 mL ta' konċentrat.
English: Four (2.5%) patients in the tocilizumab 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' tocilizumab u żewġ (1.2%) pazjenti fil-grupp ta' adalimumab kellhom esperjenza ta' tnaqqis fl-għadd ta' newtrofili ta' CTC grad 3 jew 4.
English: Doses above 1.2 g have not been evaluated in clinical studies (see section 5.1).
Maltese: Dożi 'l fuq minn 1.2 g ma ġewx ivvalutati fl-istudji kliniċi (ara sezzjoni 5.1).
English: Eleven (6.8%) patients in the RoActemra arm and five (3.1%) patients in the adalimumab arm experienced ALT increases of CTC grade 2 or higher.
Maltese: Ħdax-il pazjent (6.8%) fil-grupp ta' RoActemra u ħames (3.1%) pazjenti fil-grupp ta' adalimumab kellhom żidiet fil-livell ta' ALT ta' CTC grad 2 jew ogħla.
English: Patients with latent TB should be treated with standard anti-mycobacterial therapy before initiating RoActemra.
Maltese: Pazjenti b'TB li mhux attiva għandhom jiġu ttrattati b'terapija standard kontra l-mikobatterja qabel jinbeda RoActemra.
English: Study SC-II evaluated patients with moderate to severe active RA who had an inadequate clinical response to their existing rheumatologic therapy, including one or more DMARD(s) where approximately 20% had a history of inadequate response to at least one TNF inhibitor.
Maltese: Studju SC-II ivvaluta pazjenti b'RA attiva moderata sa severa li kellhom rispons kliniku inadegwat għat-terapija rewmatoloġika eżistenti tagħhom, inkluż DMARD(s) wieħed jew aktar fejn madwar 20% kellhom storja ta' rispons inadegwat għal mill-inqas inibitur ta' TNF wieħed.
English: The rate of infections in the tocilizumab all exposure population was 163.7 per 100 patient years.
Maltese: Ir-rata ta' infezzjonijiet fil-popolazzjoni kollha ta' esponiment għal tocilizumab kienet ta' 163.7 għal kull 100 sena ta' pazjent.
English: The safety of subcutaneous RoActemra in RA includes a double-blind, controlled, multicenter study, SC-I. SC-I was a non-inferiority study that compared the efficacy and safety of RoActemra 162 mg administered every week versus 8 mg/kg intravenous in 1262 patients with RA.
Maltese: SC-I kien studju ta' nuqqas ta' inferjorità li qabbel l-effikaċja u s-sigurtà ta' RoActemra 162 mg mogħti kull ġimgħa kontra 8 mg/kg fil-vini f'1262 pazjent b'RA.
English: The linear clearance was estimated as a parameter in the population pharmacokinetic analysis and was 6.7 mL/h in GCA patients,
Maltese: It-tneħħija lineari kienet stmata bħala parametru fl-analiżi talfarmakokinetika tal-popolazzjoni u kienet 6.7 mL/siegħa f'pazjenti b'GCA,
English: The pharmacokinetics of RoActemra in pJIA patients was characterized by a population pharmacokinetic analysis which included 237 patients who were treated with 8 mg/kg IV every 4 weeks (patients weighing ≥ 30 kg), 10 mg/kg IV every 4 weeks (patients weighing below 30 kg), 162
Maltese: Il-farmakokinetika ta' RoActemra f'pazjenti b'pJIA kienet ikkaratterizzata minn analiżi talfarmakokinetika tal-popolazzjoni li kienet tinkludi 237 pazjent li kienu ttrattati bi 8 mg/kg IV kull 4 ġimgħat (pazjenti li kienu jiżnu ≥ 30 kg), 10 mg/kg IV kull 4 ġimgħat (pazjenti li kienu jiżnu inqas minn 30 kg), 162 mg SC kull ġimagħtejn (pazjenti li kienu jiżnu ≥ 30 kg), jew 162 mg SC kull 3 ġimgħat (pazjenti li kienu jiżnu inqas minn 30 kg).
English: With routine laboratory monitoring it was seen that approximately 24% of patients receiving RoActemra in clinical trials experienced sustained elevations in total cholesterol ≥ 6.2 mmol/ l, with 15% experiencing a sustained increase in LDL to ≥ 4.1 mmol/ l. Elevations in lipid parameters responded to treatment with lipid-lowering agents.
Maltese: B'monitoraġġ regolari tallaboratorju kien osservat li madwar 24 % tal-pazjenti li kienu qed jirċievu RoActemra fil-provi kliniċi kellhom esperjenza ta' żidiet sostenuti fil-kolesterol totali ta' ≥ 6.2 mmol/ l, bi 15 % li kellhom żjieda sostenuta f'LDL għal ≥ 4.1 mmol/ l. Żidiet fil-parametri tal-lipidi rrispondew għall-kura b'sustanzi li jnaqqsu l-lipidi.
English: In 6-month controlled clinical studies, the rate of serious infections with tocilizumab 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'tocilizumab 8 mg/kg flimkien ma' DMARDs kienet ta' 5.3 ġrajjiet għal kull 100 sena ta' espożizzjoni ta' pazjenti meta mqabbla ma' 3.9 ġrajjiet għal kull 100 sena ta' espożizzjoni ta' pazjenti fil-grupp ta' plaċebo ma' DMARDs.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 80 mg/4 mL
Maltese: INDIVIDWALI 80 mg/4 mL
English: The median time from start of CRS to first dose of tocilizumab was 3 days (range, 0-18 days).
Maltese: Iż-żmien medjan mill-bidu ta' CRS sal-ewwel doża ta' tocilizumab kien ta' 3 ijiem (firxa, 0-18-il jum).
English: In the 12 week double-blind, controlled phase, 75 patients received treatment with tocilizumab (8 mg/kg or 12 mg/kg based upon body weight).
Maltese: Fil-fażi double-blind u kkontrollata ta' 12-il ġimgħa, 75 pazjent irċevew kura b'tocilizumab (8 mg/kg jew 12 mg/kg ibbażat fuq il-piż tal-ġisem).
English: Following subcutaneous dosing in GCA patients, the absorption t½ was around 4 days.
Maltese: • Jekk kellek tuberkulosi, għid lit-tabib tiegħek.
English: Action
Maltese: OPTION
English: sJIA and pJIA Patients
Maltese: Pazjenti b'sJIA u pJIA
English: There may be an increased risk of neutropenia in patients who have previously been treated with a TNF antagonist.
Maltese: Jista' jkun hemm żieda fir-riskju ta' newtropenija f'pazjenti li qabel kienu ttrattati b'antagonist ta' TNF.
English: JIA ACR response rates at week 12 (% patients)
Maltese: Tabella 7 Rati ta' rispons JIA ACR f'ġimgħa12 (% ta' pazjenti) Rata ta' Rispons
English: In the long-term exposure population, the overall rate of infections with RoActemra was 108 events per 100 patient years exposure.
Maltese: Fil-popolazzjoni ta' esponiment fit-tul, ir-rata globali ta' infezzjonijiet b'RoActemra kienet ta' 108 avveniment għal kull 100 sena ta' esponiment ta' pazjent.
English: Dose interruptions of tocilizumab for the following laboratory abnormalities are recommended in pJIA patients in the tables below.
Maltese: Interruzzjonijiet fid-doża ta' tocilizumab minħabba l-anormalitajiet tal-laboratorju li ġejjin huma rrakkomandati f'pazjenti b'pJIA fit-tabelli hawn isfel.
English: The results from study VII are shown in Table 6.
Maltese: Ir-riżultati minn studju VII huma murija fit-Tabella 6.
English: The most commonly reported Adverse Drug Reactions (ADRs) were upper respiratory tract infections, nasopharyngitis, headache, hypertension and increased ALT.
Maltese: L-aktar Reazzjonijiet Avversi tal-Mediċina (ADRs - Adverse Drug Reactions) irrappurtati b'mod komuni kienu infezzjonijiet fl-apparat respiratorju ta' fuq, nażofarinġite, uġigħ ta' ras, pressjoni għolja u żieda ta' ALT.
English: In sJIA and pJIA patients, neutrophils and platelets should be monitored at the time of the second administration and thereafter according to good clinical practice (see section 4.2).
Maltese: F'pazjenti b'sJIA u pJIA, newtrofili u plejtlits għandhom jiġu mmonitorjati fil-ħin tat-tieni għoti u wara dan skont prattika klinika tajba (ara sezzjoni 4.2).
English: Mean haemoglobin levels increased by week 2 and remained within normal range through to week 24.
Maltese: Il-livelli medji tal-emoglobina żdiedu ma' ġimgħa 2 u baqgħu fil-firxa normali sa ġimgħa 24.
English: The pharmacokinetics of RoActemra were determined using a population pharmacokinetic analysis on a database composed of 3552 RA patients treated with 162 mg subcutaneous every week, 162 mg subcutaneous every other week, and or 4 or 8 mg/kg intravenous every 4 weeks for 24 weeks.
Maltese: Il-farmakokinetika ta' RoActemra kienet determinata bl-użu ta' analiżi tal-farmakokinetika talpopolazzjoni ta' tagħrif miġbur minn 3552 pazjent b'RA ttrattati b'162 mg taħt il-ġilda kull ġimgħa, 162 mg taħt il-ġilda kull ġimagħtejn, u 4 jew 8 mg/kg fil-vini kull 4 ġimgħat għal 24 ġimgħa.
English: Clinical Efficacy
Maltese: Effetti sistemiċi
English: In tocilizumab-treated patients, decreases in the levels of CRP to within normal ranges were seen as early as week 2, with decreases maintained while on treatment.
Maltese: F'pazjenti kkurati b'RoActemra, tnaqqis fil-livelli ta' CRP għall-firxa normali kien osservat mit-2 ġimgħa, bit-tnaqqis miżmum waqt ilkura.
English: No patient developed positive antitocilizumab antibodies post baseline.
Maltese: L-ebda pazjent ma żviluppa antikorpi pożittivi kontra tocilizumab wara l-linja bażi.
English: Cytokine Release Syndrome (CRS) (adults and paediatrics) The recommended posology for treatment of CRS given as a 60-minute intravenous infusion is 8 mg/kg in patients weighing greater than or equal to 30 kg or 12 mg/kg in patients weighing less than 30 kg. RoActemra can be given alone or in combination with corticosteroids.
Maltese: Il-pożoloġija rakkomandata għall-kura ta' CRS mogħtija bħala infużjoni fil-vini fuq medda ta' siegħa hija ta' 8 mg/kg f'pazjenti li jiżnu 30 kg jew aktar jew ta' 12-il mg/kg f'pazjenti li jiżnu inqas minn 30 kg.
English: Thirty patients (1.1%) developed neutralising antibodies.
Maltese: Tletin pazjent (1.1%) żviluppaw antikorpi li jinnewtralizzaw.
English: • kidney stones
Maltese: • uġigħ ta' stonku
English: During the double-blind controlled period and with long-term exposure, the pattern and incidence of elevation in ALT/AST remained consistent with what was seen in the 6-month controlled clinical trials.
Maltese: Waqt il-perjodu double-blind ikkontrollat u b'esponiment fit-tul, it-tendenza u l-inċidenza ta' tnaqqis fl-għadd ta' newtrofili baqgħu konsistenti ma' dak li kien osservat fil-provi kliniċi kkontrollati ta' 6 xhur.
English: Predicted mean ± SD PK parameters at steady-state after SC dosing in sJIA
Maltese: Medja mbassra ± SD tal-parametri PK fi stat fiss wara dożaġġ SC f'sJIA
English: If you develop symptoms such as, but not limited to skin rash, itching, chills, swelling of face, lips, tongue or throat, chest pain, wheezing, difficulty breathing or swallowing or feeling dizzy or faint at any time while not at the clinic during or following an RoACTEMRA injection you should seek emergency care immediately.
Maltese: Kien osservat li RoActemra mogħti lil xadini tat-tip cynomolgus waqt tqala bikrija ma kellu l-ebda effett detrimentali, la dirett u lanqas indirett, fuq it-tqala jew fuq l-iżvilupp tal-embriju u tal-fetu.
English: • Risk of Hepatotoxicity
Maltese: • Riskju ta' Tossiċità fil-fwied
English: Study I evaluated 673 patients who had not been treated with MTX within six months prior to randomisation and who had not discontinued previous MTX treatment as a result of clinically important toxic effects or lack of response.
Maltese: Studju I ivvaluta 673 pazjent li ma kienx ikkurat b'MTX fi żmien sitt xhur qabel ir-randomizzazzjoni u li ma kienux waqqfu kura preċedenti ta' MTX minħabba effetti tossiċi klinikament importanti jew nuqqas ta' rispons.