FrancophonIA/ELRC3.0 huggingface dataset:
English: In study WA28119, the SF-36 results were separated into the physical and mental component summary scores (PCS and MCS, respectively).
Maltese: SF-36 kienu separati f'punteġġi ta' sommarju ta' komponent fiżiku u mentali (PCS u MCS - physical component summary and mental component summary,
English: Steady state was reached after 12 weeks for AUC, Cmin, and Cmax.
Maltese: Stat fiss intlaħaq wara 12-il ġimgħa għal AUC, Cmin, u Cmax.
English: The frequency category was estimated as the upper limit of the 95% confidence interval calculated on the basis of the total number of patients exposed to TCZ in clinical trials.
Maltese: Il-kategorija ta' frekwenza kienet stmata bħala l-limitu ta' fuq tal-intervall ta' kunfidenza ta' 95% ikkalkulat abbażi tan-numru totali ta' pazjenti esposti għal TCZ fil-provi kliniċi.
English: Haematological abnormalities
Maltese: Anormalitajiet ematoloġiċi
English: RA and CRS Patients (≥ 30 kg)
Maltese: Pazjenti b'RA u CRS (≥ 30 kg)
English: Reported serious infections, some with fatal outcome, included pneumonia, cellulitis, herpes zoster, gastroenteritis, diverticulitis, sepsis, bacterial arthritis.
Maltese: Infezzjonijiet serji li ġew irrappurtati, uħud b'riżultat fatali, kienu jinkludu pulmonite, ċellulite, herpes zoster, gastroenterite, divertikulite, sepsi u artrite batterika.
English: The safety profile of RoActemra across these indications remains similar and undifferentiated.
Maltese: Il-profil tas-sigurtà ta' RoActemra tul dawn l-indikazzjonijiet jibqa' simili u mhux differenzjat.
English: In the tocilizumab group, the events included, but were not limited to rash, urticaria, diarrhea, epigastric discomfort, arthralgia and headache.
Maltese: Fil-grupp ta' tocilizumab, lavvenimenti inkludew, iżda ma kinux limitati għal raxx, urtikarja, dijarea, skomdu epigastriku, artralġja u uġigħ ta' ras.
English: Primary Endpoint
Maltese: Punt Finali Primarju
English: Neutrophils
Maltese: Newtrofili
English: The study consisted of a 52-week blinded period (Part 1), followed by a 104-week open-label extension (Part 2).
Maltese: L-istudju kien jikkonsisti minn perjodu blinded ta' 52 ġimgħa (Parti 1), segwit minn 104 ġimgħat ta' estensjoni open-label (Parti 2).
English: • The other ingredients are sucrose, polysorbate 80, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate and water for injections.
Maltese: • Is-sustanzi l-oħra huma sucrose, polysorbate 80, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate u ilma għall-injezzjonijiet.
English: The majority (67%) of patients were MTX-naïve.
Maltese: Il-maġġoranza (67 %) ta' pazjenti qatt ma ħadu MTX.
English: Ninety three percent (93%; n=271) of patients had no progression between week 52 and week 104.
Maltese: Tlieta u disgħin fil-mija (93%; n=271) talpazjenti ma kellhom l-ebda progressjoni bejn ġimgħa 52 u ġimgħa 104.
English: The safety profile comes from 4510 patients exposed to RoActemra in clinical trials; the majority of these patients were participating in adult RA studies (n=4009), while the remaining experience comes from GCA (n=149), pJIA (n=240) and sJIA (n=112) studies.
Maltese: Il-profil tas-sigurtà ġej minn 4510 pazjenti esposti għal RoActemra fi provi kliniċi; il-maġġoranza ta' dawn il-pazjenti kienu qed jieħdu sehem fi studji dwar RA fl-adulti (n=4009), filwaqt li l-esperjenza li jifdal ġejja minn studji dwar GCA (n=149), pJIA (n=240) u sJIA (n=112).
English: Excipients with known effects Each 80 mg vial contains 0.10 mmol (2.21 mg) sodium.
Maltese: Kull kunjett ta' 80 mg fih 0.10 mmol (2.21 mg) sodium.
English: Frequency category with preferred term
Maltese: Kategorija ta' frekwenza bit-terminu ppreferut
English: IL-6 is involved in diverse physiological processes such as T-cell activation, induction of immunoglobulin secretion, induction of hepatic acute phase protein synthesis and stimulation of haemopoiesis.
Maltese: IL-6 huwa involut f'diversi proċessi fiżjoloġiċi bħall-attivazzjoni taċ-ċelluli T, stimulazzjoni tas-sekrezzjoni ta' immunoglobulini, stimulazzjoni ta' sintesi ta' proteini tal-fwied f'fażi akuta u stimulazzjoni ta' emopoesi.
English: Pharmacotherapeutic group: Immunosuppressants, Interleukin inhibitors; ATC code: L04AC07.
Maltese: Immunosoppressivi, Inibituri ta' interleukin; Kodiċi ATC:
English: 4 vials of 20 mL
Maltese: 400 mg/20 mL
English: Efficacy results from Study WA28119
Maltese: Riżultati tal-effikaċja minn Studju WA28119
English: Patients in studies I - V had a mean Disease Activity Score (DAS28) of 6.5-6.8 at baseline.
Maltese: Pazjenti fl-studji I - V kellhom Punteġġ tal-Attività tal-Marda (DAS28 - Disease Activity Score) medju ta' 6.5-6.8 fil-linja bażi.
English: An elevation in ALT or AST ≥3 x ULN occurred in 9.6% and 3.8% patients treated with RoActemra SC,
Maltese: Żieda flALT jew l-AST ta' ≥3 x ULN seħħet f'9.6% u 3.8% tal-pazjenti ttrattati b'RoActemra SC, rispettivament.
English: Two subcutaneous doses of RoActemra (162 mg every week and 162 mg every other week) were compared to two different placebo control groups randomised 2:1:1:1.
Maltese: Żewġ dożi taħt il-ġilda ta' RoActemra (162 mg kull ġimgħa u 162 mg kull ġimagħtejn) tqabblu ma' żewġ gruppi differenti ta' plaċebo bħala kontroll magħżula b'mod każwali fi proporzjon ta' 2:1:1:1.
English: The physician's global assessment of disease activity, as measured on a 0-100 mm scale, showed a greater reduction in disease activity for tocilizumab compared to placebo (adjusted mean changes of -45.2 mm vs -35.2 mm, p=0.0031).
Maltese: Il-valutazzjoni globali tat-tabib tal-attività tal-marda kif imkejjla fuq skala ta' 0-100 mm, uriet tnaqqis akbar fl-attività tal-marda għal tocilizumab meta mqabbel mal-plaċebo (bidliet medji aġġustati ta'45.2 mm vs -35.2 mm, p=0.0031).
English: IL-6 has been implicated in the pathogenesis of diseases including inflammatory diseases, osteoporosis and neoplasia.
Maltese: IL-6 kien implikat fil-patoġenesi tal-mard inkluż mard infjammatorju, osteoporożi u neoplażja.
English: RA and CRS adult patients (≥ 30 kg)
Maltese: Pazjenti adulti b'RA u CRS (≥ 30 kg)
English: • abnormal liver function tests (increased transaminases)
Maltese: • testijiet tal-funzjoni tal-fwied mhux normali (żieda fit-transaminases)
English: Concentrate for solution for infusion 80 mg/4 mL
Maltese: Konċentrat għal soluzzjoni għall-infużjoni 80 mg/4 mL
English: For storage conditions of the diluted medicinal product see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna tal-prodott mediċinali dilwit, ara sezzjoni 6.3. 6.5
English: - Joint space narrowing - p≤ 0.0001, TCZ vs. PBO + MTX - p< 0.005, TCZ vs. PBO + MTX
Maltese: - Djuq tal-ispazju tal-ġog - p≤0.0001, TCZ kontra PBO + MTX - p<0.005, TCZ kontra PBO + MTX
English: A higher incidence of infections and infestations was reported in the RoActemra arm (48% vs. 42%), with no difference in the incidence of serious infections (3.1%).
Maltese: Inċidenza ogħla ta' infezzjonijiet u infestazzjonijiet kienet irrappurtata fil-grupp ta' RoActemra (48% kontra 42%), bl-ebda differenza flinċidenza ta' infezzjonijiet serji (3.1%).
English: PK differences are not accompanied by marked differences in PD parameters and so the clinical relevance is unknown.
Maltese: Differenzi fil-PK mhumiex akkumpanjati minn differenzi notevoli fil-parametri ta' PD u għalhekk ir-rilevanza klinika mhix magħrufa.
English: The t1/2 of tocilizumab was concentration-dependent.
Maltese: It-t1/2 ta' tocilizumab kienet dipendenti fuq il-konċentrazzjoni.
English: RoActemra PK Parameter
Maltese: Parametru PK ta' RoActemra
English: • Stevens-Johnson syndrome (skin rash, which may lead to severe blistering and peeling of the skin)
Maltese: • sindrome ta' Stevens-Johnson (raxx tal-ġilda, li jista' jwassal għal infafet u tqaxxir severi tal ġilda)
English: RA and GCA Dose adjustments due to laboratory abnormalities (see section 4.4).
Maltese: RA u GCA Aġġustamenti fid-doża minħabba anormalitajiet tal-laboratorju (ara sezzjoni 4.4).
English: DAS28 ≤ 3.2, n (%) ACR20 response, n (%) ACR50 response, n (%) ACR70 response, n (%)
Maltese: Ġimgħa 24 ACR20, n (%) ACR50, n (%)
English: Eighty five percent (64/75) of tocilizumab treated patients and 24.3% (9/37) of placebo treated patients achieved this endpoint.
Maltese: Ħamsa u tmenin fil-mija (64/75) ta' pazjenti kkurati b'tocilizumab u 24.3% (9/37) ta' pazjenti kkurati bi plaċebo laħqu din il-mira.
English: In study SC-II, at week 24 there was ACR20 of 60.9%, ACR50 of 39.8% and ACR70 of 19.7% for patients treated with RoActemra subcutaneous every other week versus placebo ACR20 of 31.5%, ACR50 of 12.3% and ACR70 of 5.0%.
Maltese: Fi studju SC-II, f'ġimgħa 24 kien hemm ACR20 ta' 60.9%, ACR50 ta' 39.8% u ACR70 ta' 19.7% għall-pazjenti kkurati b'RoActemra taħt il-ġilda kull ġimagħtejn kontra ACR20 ta' 31.5%, ACR50 ta' 12.3% u ACR70 ta' 5.0% ta' plaċebo.
English: The expression of hepatic CYP450 enzymes is suppressed by cytokines, such as IL-6, that stimulate chronic inflammation.
Maltese: L-espressjoni tal-enzimi CYP450 tal-fwied hija soppressa minn ċitokini, bħal IL-6, li jistimulaw infjammazzjoni kronika.
English: Hepatic transaminases increased pJIA
Maltese: Żieda fit-transaminases tal-fwied pJIA
English: Step 6.
Maltese: Pass 6.
English: Hepatic transaminase elevations During routine laboratory monitoring in the RoActemra 6-month controlled clinical trial SC-I,
Maltese: Waqt il-monitoraġġ ta' rutina tal-laboratorju fil-prova klinika kkontrollata ta' 6 xhur ta' RoActemra,
English: In GCA patients, the central volume of distribution was 4.09 L, the peripheral volume of distribution was 3.37 L, resulting in a volume of distribution at steady state of 7.46 L.
Maltese: F'pazjenti b'GCA, il-volum ċentrali ta' distribuzzjoni kien ta' 4.09 L, il-volum periferali ta' distribuzzjoni kien ta' 3.37 L, li jwassal għal volum ta' distribuzzjoni fi stat fiss ta' 7.46 L.
English: In a pooled analysis of studies II, III and IV, the proportion of patients achieving an ACR 20, 50 and 70 response was significantly higher (59% vs. 50%, 37% vs. 27%, 18% vs. 11%, respectively) in the tocilizumab 8 mg/kg plus DMARD vs. the tocilizumab 4 mg/kg plus DMARD group (p< 0.03).
Maltese: II, III u IV, il-proporzjon ta' pazjenti li kisbu rispons ta' ACR 20, 50 u 70 kien ogħla b'mod sinifikanti (59% kontra 50%, 37% kontra 27%, 18% kontra 11%, rispettivament) filgrupp ta' tocilizumab 8 mg/kg flimkien ma' DMARD kontra l-grupp ta' tocilizumab 4 mg/kg flimkien ma' DMARD (p<0.03).
English: • ciclosporin, used to suppress your immune system during organ transplants
Maltese: • ciclosporin, użat biex irażżan s-sistema immuni tiegħek waqt trapjanti ta' organi
English: Chugai Pharma Europe Zweigniederlassung Deutschland Tel: +49 (0) 69 663000 0
Maltese: Zweigniederlassung Deutschland Tel: +49 (0) 69 663000 0
English: Table 5.
Maltese: Tabella 5:
English: Laboratory Abnormalities
Maltese: Anormalitajiet tal-Laboratorju
English: At week 24, inhibition of structural damage was shown, with significantly less radiographic progression in patients receiving RoActemra subcutaneous compared to placebo (mean mTSS of 0.62 vs. 1.23, p=0.0149 (van Elteren).
Maltese: F'ġimgħa 24, intweriet inibizzjoni ta' ħsara strutturali, bi progressjoni radjografika inqas b'mod sinifikanti f'pazjenti li kienu qed jirċievu RoActemra taħt il-ġilda meta mqabbel mal-plaċebo (mTSS medju ta' 0.62 kontra 1.23, p=0.0149 (van Elteren).
English: The total patient exposure to RoActemra in the pJIA all exposure population was 184.4 patient years for IV and 50.4 patient years for SC tocilizumab.
Maltese: Lesponiment totali tal-pazjent għal RoActemra fil-popolazzjoni b'pJIA ta' esponiment sħiħ kien ta' 184.4 snin ta' pazjent għal tocilizumab IV u 50.4 snin ta' pazjent għal tocilizumab SC.
English: TCZ IV 8 mg/kg + DMARD
Maltese: IV 8 mg/kg + DMARD
English: Interrupt RoActemra dosing
Maltese: Interrompi d-dożaġġ ta' RoActemra
English: Change in EQ5D scores from baseline to week 52 were RoActemra weekly plus 26 weeks 0.10 [0.198], RoActemra every other weekly plus 26 weeks 0.05 [0.215], placebo plus 26 weeks 0.07 [0.293], and placebo plus 52 weeks -0.02 [0.159].
Maltese: Il-bidla fil-punteġġi EQ5D mil-linja bażi sa ġimgħa 52 kienet RoActemra kull ġimgħa flimkien ma' 26 ġimgħa 0.10 [0.198], RoActemra kull ġimagħtejn flimkien ma' 26 ġimgħa 0.05 [0.215], plaċebo flimkien ma' 26 ġimgħa 0.07 [0.293], u plaċebo flimkien ma' 52 ġimgħa -0.02 [0.159].
English: • calcium channel blockers (e.g. amlodipine), used to treat raised blood pressure
Maltese: • imblokkaturi tal-kanali tal-kalċju (eż. amlodipine), użati għat-trattament ta' pressjoni għolja
English: • theophylline, used to treat asthma
Maltese: • theophylline, użat għat-trattament tal-ażżma
English: When starting or stopping therapy with tocilizumab, patients taking medicinal products which are individually adjusted and are metabolised via CYP450 3A4, 1A2 or 2C9 (e.g. methylprednisolone, dexamethasone, (with the possibility for oral glucocorticoid withdrawal syndrome), atorvastatin, calcium channel blockers, theophylline, warfarin, phenprocoumon, phenytoin, ciclosporin, or benzodiazepines) should be monitored as doses may need to be increased to maintain therapeutic effect.
Maltese: Meta tinbeda jew titwaqqaf terapija b'RoActemra, pazjenti li jieħdu prodotti mediċinali li huma aġġustati individwalment u huma metabolizzati permezz ta' CYP450 3A4, 1A2 jew 2C9 (eż. methylprednisolone, dexamethasone, (bil-possibbiltà ta' sindrome ta' rtirar ta' glukokortikojdi orali), atorvastatin, imblokkaturi tal-kanali tal-kalċju, theophylline, warfarin, phenprocoumon, phenytoin, ciclosporin, jew benzodiazepines) għandhom jiġu immonitorjati peress li d-dożi jista' jkollhom bżonn li jiżdiedu biex jinżamm l-effett terapewtiku.
English: During routine laboratory monitoring in the tocilizumab all exposure population, elevation in ALT or AST ≥ 3xULN occurred in 3.7% and <1% of patients, respectively.
Maltese: Waqt sorveljanza ta' rutina tal-laboratorju fil-popolazzjoni kollha ta' esponiment għal tocilizumab, żieda fl-ALT jew l-AST ta' ≥ 3xULN seħħet fi 3.7% u f'<1% tal-pazjenti, rispettivament.
English: TCZ + Placebo (SC) N = 163
Maltese: TCZ + Plaċebo (SC)
English: During the 6-month controlled clinical trials, the overall rate of gastrointestinal perforation was 0.26 events per 100 patient years with tocilizumab 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' pazjenti b'terapija b'tocilizumab.
English: All efficacy comparisons vs Placebo + MTX.
Maltese: 39 fil-grupp ta' plaċebo + MTX.
English: Cardiovascular risk
Maltese: Riskju kardjovaskulari
English: • The other ingredients are L-Histidine, L-Histidine monohydrochloride monohydrate, LArginine, L-Arginine hydrochloride, L-Methionine, Polysorbate 80 and Water for injections.
Maltese: • Is-sustanzi l-oħra huma L-Histidine, L-Histidine monohydrochloride monohydrate, L-Arginine, L-Arginine hydrochloride, L-Methionine, Polysorbate 80 u Ilma għall-injezzjonijiet.
English: Always store the syringe in a refrigerator at a temperature of 2°C - 8°C.
Maltese: Dejjem aħżen is-siringa fi friġġ f'temperatura ta' 2°C - 8°C.
English: Tocilizumab is a recombinant humanized, anti-human monoclonal antibody of the immunoglobulin G1 (IgG1) sub-class directed against soluble and membrane-bound interleukin 6 receptors.
Maltese: Tocilizumab huwa antikorp monoklonali anti-uman, rikombinanti u umanizzat tas-sottoklassi ta' immunoglobulini G1 (IgG1) immirat kontra r-riċetturi ta' interleukin- 6 li jinħall u li jeħel malmembrana.
English: RoActemra has not been studied in patients with moderate to severe renal impairment (see section 5.2).
Maltese: RoActemra ma kienx studjat f'pazjenti b'indebolimenti tal-kliewi moderat sa sever (ara sezzjoni 5.2).
English: In a pooled analysis of studies II, III and IV, the proportion of patients achieving an ACR 20, 50 and 70 response was significantly higher (59% vs. 50%, 37% vs. 27%, 18% vs. 11%, respectively) in the RoActemra 8 mg/kg plus DMARD vs. the RoActemra 4 mg/kg plus DMARD group (p< 0.03).
Maltese: II, III u IV, il-proporzjon ta' pazjenti li kisbu rispons ta' ACR 20, 50 u 70 kien ogħla b'mod sinifikanti (59% kontra 50%, 37% kontra 27%, 18% kontra 11%, rispettivament) filgrupp ta' RoActemra 8 mg/kg flimkien ma' DMARD kontra l-grupp ta' RoActemra 4 mg/kg flimkien ma' DMARD (p< 0.03).
English: Table 5: Efficacy Results for Study VI (WA19924)
Maltese: Riżultati ta' Effikaċja għall-Istudju VI (WA19924)
English: ACR responses in study SC-I (% patients) at Week 24 SC-Ia
Maltese: Risponsi ta' ACR fi Studju SC-I (% ta' pazjenti) f'Ġimgħa 24
English: Anaphylaxis
Maltese: Infezzjonijiet
English: Part I consisted of a 16-week active tocilizumab treatment lead-in period (n=188) followed by Part II, a 24-week randomized double-blind placebo-controlled withdrawal period (n=163), followed by Part III, a 64-week open-label period.
Maltese: Parti I kienet tikkonsisti f'perjodu ta' inizjazzjoni ta' kura attiva b'tocilizumab ta' 16-il ġimgħa (n=188) segwit minn Parti II, perjodu ta' rtirar ta' 24 ġimgħa, randomised, double blind u kkontrollat bil-plaċebo (n=163), segwit minn Parti III, perjodu open-label ta' 64 ġimgħa.
English: A higher incidence of infections and infestations was reported in the tocilizumab arm (48% vs. 42%), with no difference in the incidence of serious infections (3.1%).
Maltese: Inċidenza ogħla ta' infezzjonijiet u infestazzjonijiet kienet irrappurtata fil-grupp ta' tocilizumab (48% kontra 42%), bl-ebda differenza flinċidenza ta' infezzjonijiet serji (3.1%).
English: • inflammation of the liver (hepatitis), jaundice
Maltese: • infjammazzjoni tal-fwied (epatite), suffejra
English: Patients with CRS
Maltese: Pazjenti b'CRS
English: mTSS Erosion Score JSN 0.03 Radiographic Non-Progression n (%) (change from baseline in mTSS of ≤0)
Maltese: Nuqqas ta' progressjoni Radjografika n (%) (bidla mil-linja bażi f'mTSS ta' ≤0)
English: Key Secondary Endpoint
Maltese: Punti Finali Sekondarji Ewlenin
English: The primary endpoint was the proportion of patients achieving DAS28 remission (DAS28 < 2.6) at week 24.
Maltese: Il-punt finali primarju kien il-proporzjon ta' pazjenti li kisbu remissjoni DAS28 (DAS28 < 2.6) f'ġimgħa 24.
English: Mild renal impairment (creatinine clearance based on Cockcroft-Gault < 80 mL/min and ≥ 50 mL/min) did not impact the pharmacokinetics of tocilizumab.
Maltese: L-indeboliment tal-kliewi ħafif (tneħħija ta' krejatinina bbażata fuq Cockcroft-Gault < 80 mL/min u ≥ 50 mL/min) ma ħalliex effett kbir fuq il-farmakokinetika ta' tocilizumab.
English: Study III OPTION
Maltese: Studju III
English: The t1/2 of RoActemra was concentration-dependent.
Maltese: It-t1/2 ta' RoActemra kienet dipendenti fuq ilkonċentrazzjoni.
English: In clinical studies with tocilizumab, rapid decreases in CRP, erythrocyte sedimentation rate (ESR), serum amyloid A (SAA) and fibrinogen were observed.
Maltese: Fi studji klinici b'tocilizumab, ġie osservat tnaqqis rapidu f'CRP, fir-rata ta' sedimentazzjoni ta' eritroċiti (ESR), amyloid A fis-serum (SAA) u fibrinoġen.
English: The primary endpoint was the proportion of patients with at least 30% improvement in the JIA ACR core set (JIA ACR30 response) at week 12 and absence of fever (no temperature recording ≥ 37.5°C in the preceding 7 days).
Maltese: Il-mira primarja kienet il-proporzjon ta' pazjenti b'titjib ta' mill-inqas 30% fil-core set JIA ACR (rispons JIA ACR30) f'ġimgħa 12 u nuqqas ta' deni (l-ebda rrekordjar ta' temperatura ta' ≥ 37.5°C fis-7t ijiem ta' qabel).
English: • low fibrinogen levels in the blood (a protein involved in blood clotting).
Maltese: • livelli baxxi ta' fibrinoġen fid-demm (proteina involuta fit-tagħqid tad-demm).
English: • the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX.
Maltese: • trattament ta' artrite rewmatojde (RA - rheumatoid arthritis) severa, attiva u progressiva f'adulti li ma kinux ittrattati qabel b'MTX.
English: In the open label extension phase, decreases in neutrophil counts below 1 x 109/l, occurred in 15% of the tocilizumab group.
Maltese: Fil-fażi ta' estensjoni open label, tnaqqis fl-għadd ta' newtrofili taħt 1 x 10 9/l, seħħ fi 15% tal-grupp ta' tocilizumab.
English: There have been postmarketing reports of interstitial lung disease (including pneumonitis and pulmonary fibrosis), some of which had fatal outcomes.
Maltese: Wara t-tqegħid fis-suq kien hemm rapporti ta' mard tal-interstizju tal-pulmun (inkluż pulmonite u fibrożi pulmonari), li wħud minnhom kellhom riżultati fatali.
English: Placebo + 26 weeks prednisone taper N=50
Maltese: Plaċebo + 26 ġimgħa ta' prednisone mnaqqas bilmod għax-xejn N=50
English: The efficacy of tocilizumab for the treatment of active sJIA was assessed in a 12 week randomised, double blind, placebo-controlled, parallel group, two arm study.
Maltese: L-effikaċja ta' tocilizumab għall-kura ta' sJIA attiva kienet evalwata fi studju b'żewġ gruppi, randomised, double blind, ikkontrollat bil-plaċebo u bi grupp parallel li dam 12-il ġimgħa.
English: The TNF antagonist therapy was discontinued prior to randomisation.
Maltese: It-terapija antagonista għal TNF ġiet imwaqqfa qabel ma beda l-istudju.
English: In GCA patients, at steady state, the effective t ½ of RoActemra varied between 18.3 and 18.9 days for 162 mg weekly regimen, and between 4.2 and 7.9 days for 162 mg every other weekly regimen.
Maltese: F'pazjenti b'GCA, fi stat fiss, it-t½ effettiva ta' RoActemra varjat bejn 18.3 u 18.9 ijiem għall-kors ta' 162 mg kull ġimgħa, u bejn 4.2 u 7.9 ijiem għall-kors ta' 162 mg kull ġimagħtejn.
English: • diverticulitis (fever, nausea, diarrhoea, constipation, stomach pain)
Maltese: • divertikulite (deni, tqalligħ, dijarea, stitikezza, uġigħ fl-istonku)
English: RoActemra 162 mg solution for injection in pre-filled pen (ACTPen®) Tocilizumab
Maltese: RoActemra 162 mg, soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest (ACTPen®) Tocilizumab
English: A 52-week, open-label, multi-centre, PK/PD and safety study (WA28118) was conducted in paediatric patients with sJIA, aged 1 to 17 years, to determine the appropriate SC dose of RoActemra that achieved comparable PK/PD and safety profiles to the IV regimen.
Maltese: Studju ta' 52 ġimgħa, open-label, b'aktar minn ċentru wieħed, dwar il-PK/PD u s-sigurtà (WA28118) twettaq f'pazjenti pedjatriċi b'sJIA, b'età minn sena sa 17-il sena, biex tiġi ddeterminata d-doża SC xierqa ta' RoActemra li kisbet profili PK/PD u tas-sigurtà komparabbli għall-kors IV.
English: The proportion of patients with serious adverse events was balanced between the treatment groups (RoActemra 11.7% vs. adalimumab 9.9%).
Maltese: Ilproporzjon ta' pazjenti b'avvenimenti avversi serji kien ibbilanċjat bejn il-gruppi ta' trattament (RoActemra 11.7% kontra adalimumab 9.9%).
English: In paediatric patients with pJIA, the central volume of distribution was 1.97 L, the peripheral volume of distribution was 2.03 L, resulting in a volume of distribution at steady state of 4.0 L.
Maltese: F'pazjenti pedjatriċi b'pJIA, il-volum ta' distribuzzjoni ċentrali kien ta' 1.97 L, il-volum ta' distribuzzjoni periferali kien ta' 2.03 L, li rriżulta f'volum ta' distribuzzjoni fi stat fiss ta' 4.0 L.
English: The linear clearance was estimated as a parameter in the population pharmacokinetic analysis and was 5.7 mL/h in paediatric patients with systemic juvenile idiopathic arthritis.
Maltese: It-tneħħija lineari kienet stmata bħala parametru fl-analiżi talfarmakokinetika tal-popolazzjoni u kienet ta' 5.7 mL/siegħa f'pazjenti pedjatriċi b'artrite idjopatika sistemika fil-minorenni.
English: The duration of glucocorticoid therapy during screening and before RoActemra (or placebo) was initiated, was similar in all 4 treatment groups (see Table 3).
Maltese: It-tul tat-terapija bi glukokortikojdi matul l-iskrinjar u qabel ma nbeda RoActemra (jew plaċebo), kien simili fl-4 gruppi ta' trattament kollha (ara Tabella 3).
English: Nervous system disorders Headache pJIA
Maltese: Disturbi fis-sistema nervuża Uġigħ ta' ras pJIA