FrancophonIA/ELRC3.0 huggingface dataset:
English: During the 6-month controlled trials, increases of lipid parameters such as total cholesterol, triglycerides, LDL cholesterol, and/or HDL cholesterol have been reported commonly.
Maltese: Waqt il-provi kkontrollati ta' 6 xhur ġew irrapportati b'mod komuni żidiet fil-parametri tal-lipidi bħal kolesterol totali, trigliċeridi, kolesterol LDL, u/jew kolesterol HDL.
English: Tocilizumab has been shown to inhibit sIL-6R and mIL-6R-mediated signalling.
Maltese: Instab li tocilizumab jimpedixxi s-sinjalar permezz ta' sIL-6R u mIL-6R.
English: (See Fig. F).
Maltese: Fig. F).
English: In RA clinical studies with RoActemra, rapid decreases in CRP, erythrocyte sedimentation rate (ESR), serum amyloid A (SAA) and fibrinogen were observed.
Maltese: Fi studji klinici b'RoActemra, kien osservat tnaqqis rapidu f'CRP, fir-rata ta' sedimentazzjoni tal eritroċiti (ESR - erythrocyte sedimentation rate), f'amyloid A fis-serum (SAA - serum amyloid A) u fibrinoġen.
English: When clinically indicated, other liver function tests including bilirubin should be considered.
Maltese: Meta klinikament indikat, għandhom jiġu kkunsidrati testijiet oħra tal-funzjoni talfwied inkluż il-bilirubina.
English: Maintain dose.
Maltese: infezzjonijiet serji.
English: Four patients were tested positive for IgE isotype (0.9%).
Maltese: Erba' pazjenti ittestjaw pożittivi għall-isotip IgE (0.9%).
English: Each mL concentrate contains 20 mg tocilizumab*.
Maltese: U KWANTITATTIVA Kull mL ta' konċentrat fih 20 mg tocilizumab*.
English: Infusion related reaction events in sJIA patients included but were not limited to rash, urticaria, diarrhoea, epigastric discomfort, arthralgia and headache pJIA Patients
Maltese: Avvenimenti ta' reazzjoni relatata mal-infużjoni f'pazjenti b'sJIA inkludew iżda ma kinux limitati għal raxx, urtikarja, dijarea, skomdu epigastriku, artralġja u uġigħ ta' ras
English: Dose adjustments due to laboratory abnormalities (sJIA and pJIA)
Maltese: Aġġustamenti fid-doża minħabba anormalitajiet tal-laboratorju (sJIA u pJIA)
English: 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: 3A4, 1A2 jew 2C9 (eż. methylprednisolone, dexamethasone, (bil-possibbiltà ta' sindrome ta' rtirar ta' glukokortikojdi orali), atorvastatin, sustanzi li jibblukkaw il-kanal 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: In study SC-II, inhibition of structural joint damage was assessed radiographically and expressed as a change from baseline in the van der Heijde modified mean total Sharp score (mTSS).
Maltese: Fi studju SC-II, l-inibizzjoni ta' ħsara strutturali fil-ġogi kienet evalwata b'mod radjografiku u mfissra bħala bidla mil-linja bażi fil-punteġġ Sharp totali medju (mTSS - mean total Sharp score) modifikat skont van der Heijde.
English: Clinically significant hypersensitivity reactions associated with tocilizumab and requiring treatment discontinuation were reported in a total of 56 out of 4,009 patients (1.4%) treated with tocilizumab during the controlled and open label clinical studies.
Maltese: Reazzjonijiet ta' sensittività eċċessiva assoċjati ma' tocilizumab li kienu klinikament sinifikanti u li ħtiegu twaqqif tal-kura, ġew irrapportati f'total ta' 56 minn 4,009 pazjent (1.4 %) ikkurat b'tocilizumab matul l-istudji kliniċi kkontrollati u open label.
English: RoActemra 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: RoActemra huwa antikorp monoklonali anti-uman, rikombinanti u umanizzat tas-sottoklassi ta' immunoglobulini G1 (IgG1 - immunoglobulin G1) immirat kontra r-riċetturi ta' interleukin 6 li jinħall u li jeħel mal-membrana.
English: uncommon (≥ 1/1,000 to < 1/100) rare, (≥1/10,000 to <1/1,000) or very rare (<1/10,000).
Maltese: (≥1/10,000 sa <1/1,000) jew rari ħafna (<1/10,000).
English: Primary Endpoint ****Sustained remission (Tocilizumab groups vs Placebo+26) Responders at Week 52, n (%)
Maltese: Punt Finali Primarju ****Remissjoni sostnuta (gruppi ta' Tocilizumab kontra Plaċebo+26)
English: Tocilizumab PK Parameter
Maltese: Parametru PK ta' Tocilizumab
English: Elevations of ALT/AST > 5 x ULN were observed in 0.7% of tocilizumab monotherapy patients and 1.4% of tocilizumab plus DMARD patients, the majority of whom were discontinued permanently from tocilizumab treatment.
Maltese: Żidiet ta' ALT/AST > 5 x ULN ġew osservati f'0.7 % talpazjenti b'monoterapija ta' tocilizumab u f'1.4 % tal-pazjenti b'tocilizumab ma' DMARDs, fejn ilmaġġoranza tagħhom twaqqfitilhom il-kura ta' tocilizumab b'mod permanenti.
English: Patients in the adalimumab arm received an adalimumab SC injection (40 mg) q2w plus an IV placebo infusion q4w.
Maltese: Pazjenti fil-grupp ta' adalimumab irċevew injezzjoni SC ta' adalimumab (40 mg) q2w flimkien ma' infużjoni ta' plaċebo IV q4w.
English: Leukopenia, Neutropenia, Hypofibrinogenaem ia
Maltese: Lewkopenja, Newtropenja, Ipofibrinoġenimja
English: Table 7.
Maltese: Tabella 7:
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu/.
English: TCZ 8 mg/k g
Maltese: 8 mg/k g
English: Impaired lung function may increase the risk for developing infections.
Maltese: Indeboliment fil-funzjoni tal-pulmun jista' jżid ir-riskju li jiżviluppaw infezzjonijiet.
English: Patients in study SC-I had a mean Disease Activity Score (DAS28) at baseline of 6.6 and 6.7 on the subcutaneous and intravenous arms, respectively.
Maltese: Pazjenti fl-Istudju SC-I kellhom Punteġg tal-Attività tal-Marda (DAS28) medju fil-linja bażi ta' 6.6 u 6.7 fil-gruppi ta' għoti taħt il-ġilda u fil-vini, rispettivament.
English: Carcinogenicity studies were not performed because IgG1 monoclonal antibodies are not deemed to have intrinsic carcinogenic potential.
Maltese: IgG1 mhux meqjusa li għandhom potenzjal karċinoġeniku intrinsiku.
English: ‡p-value < 0.05 vs.
Maltese: - p< 0.01, TCZ vs.
English: Cholesterol increased sJIA
Maltese: Żieda fil-kolesterol sJIA
English: In RA patients the central volume of distribution was 3.72 L, the peripheral volume of distribution was 3.35 L resulting in a volume of distribution at steady state of 7.07 L.
Maltese: F'pazjenti b'RA, il-volum ta' distribuzzjoni ċentrali kien ta' 3.72 L, il-volum ta' distribuzzjoni periferali kien ta' 3.35 L li rriżulta f'volum ta' distribuzzjoni fi stat fiss ta' 7.07 L.
English: Eligible patients received tocilizumab dosed according to body weight (BW), with patients weighing ≥30 kg (n = 25) dosed with 162 mg of RoActemra every 2 weeks (Q2W) and patients weighing below 30 kg (n = 27) dosed with 162 mg of RoActemra every 3 weeks (Q3W) for 52 weeks.
Maltese: Pazjenti eliġibbli rċevew tocilizumab iddożat skont il-piż tal-ġisem (BW - body weight), b'pazjenti li kienu jiżnu ≥30 kg (n = 25) iddożati b'162 mg ta' RoActemra kull ġimagħtejn (Q2W - every 2 weeks) u pazjenti li kienu jiżnu inqas minn 30 kg (n = 27) iddożati b'162 mg ta' RoActemra kull 3 ġimgħat (Q3W - every 3 weeks) għal 52 ġimgħa.
English: The syringe is closed by a rigid needle shield (elastomer seal with a polypropylene shell) and a plunger stopper (butyl rubber with a fluororesin coating).
Maltese: Is-siringa hija magħluqa b'għatu ta' protezzjoni tal-labra riġidu (siġill ta' elastomer b'kisja ta' polypropylene) u b'tapp talplanġer (lasktu butyl b'kisja ta' fluororesin).
English: The mean [SD] change scores were as follows: RoActemra weekly plus 26 weeks 5.61 [10.115], RoActemra every other weekly plus 26 weeks 1.81 [8.836], placebo plus 26 weeks 0.26 [10.702], and placebo plus 52 weeks -1.63 [6.753].
Maltese: Il-punteġġi tal-bidla medja [SD] kienu kif ġej: RoActemra kull ġimgħa flimkien ma' 26 ġimgħa 5.61 [10.115], RoActemra kull ġimagħtejn flimkien ma' 26 ġimgħa 1.81 [8.836], plaċebo flimkien ma' 26 ġimgħa 0.26 [10.702], u plaċebo flimkien ma' 52 ġimgħa -1.63 [6.753].
English: A total of 2,876 patients have been tested for anti-RoActemra antibodies in the 6-month controlled clinical trials.
Maltese: Fil-provi kliniċi kkontrollati ta' sitt xhur total ta' 2,876 pazjent kienu ittestjati għall-antikorpi kontra RoActemra.
English: The efficacy population for the tisagenlecleucel cohort included 28 males and 23 females (total 51 patients) of median age 17 years (range, 3-68 years).
Maltese: Il-popolazzjoni taleffikaċja għall-koorti ta' tisagenlecleucel kien jinkludi 28 raġel u 23 mara (total ta' 51 pazjent) ta' età medjana ta' 17-il sena (firxa, 3-68 sena).
English: Complications of diverticulitis
Maltese: Komplikazzjonijiet ta' divertikulite
English: RA, sJIA, pJIA and CRS Patients ≥ 30 kg
Maltese: Pazjenti b'RA, sJIA, pJIA u CRS ≥ 30 kg
English: RoActemra 162 mg SC every other weekly + 26 weeks prednisone taper N=49
Maltese: RoActemra 162 mg SC kull ġimagħtejn + 26 ġimgħa ta' prednisone mnaqqas bil-mod għaxxejn N=49
English: Mean (SD) * p<0.0001 ** p<0.005 (threshold for significance for primary and key secondary tests of superiority) ***Descriptive p value <0.005 ****Flare: recurrence of GCA signs or symptoms and/or ESR ≥30 mm/h - Increase in the prednisone dose required Remission: absence of flare and normalization of the CRP Sustained remission: remission from week 12 to week 52 -Patients must adhere to the protocol-defined prednisone taper ¹ analysis of the time (in days) between clinical remission and first disease flare 2 p-values are determined using a Van Elteren analysis for non-parametric data § statistical analyses has not been performed
Maltese: Medja (SD) * p< 0.0001 ** p< 0.005 (limitu għal sinifikanza għal testijiet ta' superjorità primarji u sekondarji ewlenin) ***Valur p deskrittiv < 0.005 ****Rikaduta: rikorrenza ta' sinjali jew sintomi ta' GCA u/jew ESR ≥ 30 mm/siegħa - Żieda fid-doża meħtieġa ta' prednisone
English: At steady-state, predicted AUC and Cmin were 3.2 and 30 fold higher at 8 mg/kg as compared to 4 mg/kg, respectively.
Maltese: Fi stat fiss, l-AUC u Cmin imbassra kienu 3.2 u 30 darba ogħla rispettivament bi 8 mg/kg meta mqabbel ma' 4 mg/kg.
English: Of the 4009 patients in this population, 3577 received treatment for at least 6 months, 3296 for at least one year, 2806 received treatment for at least 2 years and 1222 for 3 years.
Maltese: Minn 4009 pazjenti f'din il-popolazzjoni, 3577 irċevew trattament għal mill-inqas 6 xhur, 3296 għal millinqas sena, 2806 irċevew trattament għal mill-inqas sentejn u 1222 għal 3 snin.
English: RoActemra 162mg SC weekly + 26 weeks prednisone taper N=100
Maltese: RoActemra 162 mg SC kull ġimgħa + 26 ġimgħa ta' prednisone mnaqqas bil-mod għax-xejn N=100
English: 4 vials of 4 mL
Maltese: 4 kunjetti ta' 4 mL
English: Of these 52 patients, 37 (71%) were naive to RoActemra and 15 (29%) had been receiving RoActemra IV and switched to RoActemra SC at baseline.
Maltese: Minn dawn it-52 pazjent, 37 (71%) qatt ma kienu ħadu RoActemra qabel u 15 (29%) kienu qed jirċievu RoActemra IV u qalbu għal RoActemra SC fil-linja bażi.
English: • high blood fat (cholesterol) levels.
Maltese: • livelli għoljin ta' xaħam fid-demm (kolesterol).
English: In RA patients the central volume of distribution was 3.72, the peripheral volume of distribution was 3.35 resulting in a volume of distribution at steady state of 7.07.
Maltese: F'pazjenti b'RA, il-volum ta' distribuzzjoni ċentrali kien ta' 3.72, il-volum ta' distribuzzjoni periferali kien ta' 3.35 li rriżulta f'volum ta' distribuzzjoni fi stat fiss ta' 7.07.
English: Time to first GCA flare¹ (Relapsing patients; Tocilizumab groups vs Placebo +26) HR (99% CI) Time to first GCA flare¹ (Relapsing patients; Tocilizumab groups vs Placebo + 52) HR (99% CI) Time to first GCA flare¹ (New-onset patients; Tocilizumab groups vs Placebo +26) HR (99% CI) Time to first GCA flare¹ (New-onset patients; Tocilizumab groups vs Placebo + 52) HR (99% CI)
Maltese: HR (CI ta' 99%) Żmien sal-ewwel rikaduta ta' GCA¹ (Pazjenti li jirkadu; gruppi ta' Tocilizumab kontra Plaċebo + 52) HR (CI ta' 99%) Żmien sal-ewwel rikaduta ta' GCA¹ (Pazjenti b'bidu ġdid; gruppi ta' Tocilizumab kontra Plaċebo +26)
English: In clinical trials, RoActemra has not been studied in patients during an episode of active MAS.
Maltese: Fil-provi kliniċi, RoActemra ma ġiex studjat f'pazjenti waqt episodju ta' MAS attiv.
English: The incidence of anti-tocilizumab antibody formation might be underestimated because of interference of tocilizumab with the assay and higher drug concentration observed in children compared to adults.
Maltese: L-inċidenza ta' formazzjoni ta' antikorpi kontra tocilizumab tista' tkun sottovalutata minħabba l-interferenza ta' tocilizumab mal-analiżi u konċentrazzjoni ogħal tal-mediċina osservata fit-tfal meta mqabbla mal-adulti.
English: Week 24
Maltese: Ġimgħa 24
English: Patients < 30 kg were randomized 1:1 to receive either tocilizumab 8 mg/kg or 10 mg/kg IV every 4 weeks for 4 doses.
Maltese: Pazjenti ta' < 30 kg kienu randomised 1:1 biex jirċievu tocilizumab 8 mg/kg jew 10 mg/kg IV kull 4 ġimgħat għal 4 dożi.
English: The corresponding frequency category is based on the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) rare (≥1/10,000 to <1/1,000) or very rare (<1/10,000).
Maltese: Ilkategorija ta' frekwenza korrispondenti hija bbażata fuq il-konvenzjoni li ġejja: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa <1/1,000) jew rari ħafna (<1/10,000).
English: Study I AMBITION
Maltese: AMBITION
English: In the tocilizumab all exposure population, 11 patients (5.9%) experienced infusion reactions during the infusion and 38 patients (20.2%) experienced an event within 24 hours of an infusion.
Maltese: Fil-popolazzjoni kollha ta' esponiment għal tocilizumab, 11-il pazjent (5.9%) kellhom esperjenza ta' reazzjonijiet għall-infużjoni waqt l-infużjoni u 38 pazjent (20.2%) kellhom esperjenza ta' avveniment fi żmien 24 siegħa wara infużjoni.
English: This should be a final volume of 100 mL.
Maltese: Dan għandu jkun volum finali ta' 100 mL.
English: For persistent increases > 3 x ULN (confirmed by repeat testing, see 4.4.
Maltese: Għal żidiet persistenti ta' > 3 x ULN, (ikkonfermati minn ittestjar ripetut, ara sezzjoni 4.4), waqqaf RoActemra.
English: Other Secondary Endpoints Time to first GCA flare¹ (Tocilizumab groups vs Placebo+26)
Maltese: Punti Finali Sekondarji Oħrajn Żmien sal-ewwel rikaduta ta' GCA¹ (gruppi ta' Tocilizumab kontra Plaċebo+26)
English: At week 24, a significant reduction in DAS28 from baseline (mean improvement) of 3.5 was observed on both treatment arms, and a comparable proportion of patients had achieved DAS28 clinical remission (DAS28 < 2.6) on the subcutaneous (38.4%) and IV (36.9%) arms.
Maltese: F'ġimgħa 24, kien osservat tnaqqis sinifikanti f'DAS28 mil-linja bażi (titjib medju) ta' 3.5 fiż-żewġ gruppi ta' trattament, u proporzjon komparabbli ta' pazjenti kienu kisbu DAS28 ta' remissjoni klinika (DAS28 < 2.6) fil-gruppi ta' għoti taħt il-ġilda (38.4%) u fil-vini (36.9%).
English: The types of adverse drug reactions in the tocilizumab arm were consistent with the known safety profile of tocilizumab 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' tocilizumab kienu konsistenti mal-profil tas-sigurtà magħruf ta' tocilizumab u r-reazzjonijiet avversi kienu rrappurtati bi frekwenza simili meta mqabbla ma' Tabella 1.
English: When starting or stopping therapy with RoActemra, 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,
Maltese: Meta tinbeda jew titwaqqaf terapija b'tocilizumab, 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,
English: • Nurse Information Pack
Maltese: • Pakkett ta' Informazzjoni għall-infermier
English: In paediatric patients with sJIA, the central volume of distribution was 1.87 L, the peripheral volume of distribution was 2.14 L resulting in a volume of distribution at steady state of 4.01 L
Maltese: F'pazjenti pedjatriċi b'sJIA, il-volum ta' distribuzzjoni ċentrali kien ta' 1.87 L, il-volum ta' distribuzzjoni periferali kien ta' 2.14 L li rriżulta f'volum ta' distribuzzjoni fi stat fiss ta' 4.01 L.
English: This study evaluated the efficacy of IV tocilizumab 4 or 8 mg/kg every 4 weeks/MTX combination therapy, IV tocilizumab 8 mg/kg monotherapy and MTX monotherapy in reducing the signs and symptoms and rate of progression of joint damage for 104 weeks.
Maltese: Dan l-istudju evalwa l-effikaċja ta' tocilizumab IV 4 jew 8 mg/kg kull 4 ġimgħat/terapija kombinata ta' MTX, monoterapija ta' tocilizumab IV 8 mg/kg u monoterapija ta' MTX li jnaqqsu ssinjali u s-sintomi u r-rata ta' progressjoni ta' ħsara fil-ġogi għal 104 ġimgħat.
English: Anaphylaxis (fatal)1,
Maltese: Anafilassi (fatali)
English: • stomach ache
Maltese: • deni u sirdat
English: Seven patients (1.6%) developed positive anti-RoActemra antibodies; of these, six (1.4%) developed neutralizing anti-RoActemra antibodies.
Maltese: Seba' pazjenti (1.6%) żviluppaw antikorpi pożittivi kontra RoActemra; minn dawn, sitta (1.4%) żviluppaw antikorpi newtralizzanti kontra RoActemra.
English: Abdominal pain, Mouth ulceration, Gastritis
Maltese: Uġigħ addominali, Ulċeri fil-ħalq, Gastrite
English: OTHER
Maltese: or
English: The efficacy of tocilizumab in alleviating the signs and symptoms of RA was assessed in five randomised, double-blind, multi-centre studies.
Maltese: L-effikaċja ta' tocilizumab li ttaffi s-sinjali u s-sintomi ta' RA ġiet evalwata f'ħames studji randomised, double-blind u multi-ċentri.
English: The results from study SC-I is shown in Table 2.
Maltese: Irriżultati minn studju SC-I huma murija f'Tabella 2.
English: RoActemra is supplied as a 0.9 mL pre-filled syringe containing 162 mg tocilizumab solution for injection.
Maltese: RoActemra huwa fornut bħala siringa mimlija għal-lest ta' 0.9 mL li fiha soluzzjoni għall-injezzjoni ta' 162 mg tocilizumab.
English: Dispose of the pre-filled pen
Maltese: Disturbi filfwied u fil marrara
English: • Prevention of medical errors and injection/infusion reactions
Maltese: • Prevenzjoni ta' żbalji mediċi u reazzjonijiet għall-injezzjoni/infużjoni
English: Numerically greater responses compared with MTX alone were observed in the tocilizumab 8 mg/kg monotherapy group in all secondary endpoints, including radiographic endpoints.
Maltese: Rispons numerikament akbar meta mqabbel ma' MTX waħdu kien osservati fil-grupp ta' monoterapija b'tocilizumab 8 mg/kg fil-punti finali sekondarji kollha, inkluż punti finali radjografiċi.
English: Tocilizumab normalises expression of these enzymes.
Maltese: Tocilizumab jinnormalizza l-espressjoni ta' dawn l-enżimi.
English: Allow the syringe to adjust to room temperature
Maltese: Ħalli s-siringa tilħaq temperatura tal-kamra
English: Peripheral oedema Hypersensitivity reaction,
Maltese: Edima periferali, Reazzjoni ta' sensittività eċċessiva,
English: Predicted mean ± SD PK parameters at steady-state after SC dosing in pJIA RoActemra PK Parameter
Maltese: Medja mbassra ± SD tal-parametri PK fi stat fiss wara dożaġġ SC f'pJIA Parametru PK ta' RoActemra
English: RoActemra 20 mg/mL concentrate for solution for infusion Tocilizumab
Maltese: RoActemra, 20 mg/mL, konċentrat għal soluzzjoni għall-infużjoni Tocilizumab
English: RA and GCA
Maltese: RA u GCA
English: For the 162 mg every week dose, the predicted mean (±SD) steady-state AUC1week, Cmin and Cmax of RoActemra were 7970 ± 3432 µg•h/mL, 43.0 ± 19.8 µg/mL, and 49.8 ± 21.0 µg/mL, respectively.
Maltese: Għad-doża ta' 162 mg kull ġimgħa, il-medja mbassra (±SD) tal-AUCġimgħa1 fi stat fiss, Cmin u Cmax ta' RoActemra kienu ta' 7970 ± 3432 µg•h/mL, 43.0 ± 19.8 µg/mL, u 49.8 ± 21.0 µg/mL, rispettivament .
English: • Place the syringe on a clean flat surface and allow the syringe to come to room temperature (18°C - 28°C) for about 25-30 minutes to warm up.
Maltese: • Poġġi s-siringa fuq wiċċ ċatt u nadif u ħalli s-siringa tilħaq temperatura tal-kamra (18°C - 28°C) għal madwar 25-30 minuta biex tisħon.
English: At one year in the open label extension phase the overall rate of serious infections remained stable at 11.3 per 100 patient years.
Maltese: Wara sena fil-fażi ta' estensjoni open label ir-rata globali ta' infezzjonijiet serji baqgħet stabbli bi 11.3 għal kull 100 sena ta' pazjent.
English: The proportion of patients with serious adverse events was balanced between the treatment groups (tocilizumab 11.7% vs. adalimumab 9.9%).
Maltese: Ilproporzjon ta' pazjenti b'avvenimenti avversi serji kien ibbilanċjat bejn il-gruppi ta' kura (tocilizumab 11.7% kontra adalimumab 9.9%).
English: The double-blind controlled period was 6 months in four studies (studies I, III, IV and V) and was up to 2 years in one study (study II).
Maltese: Il-perijodu double-blind ikkontollat kien ta' 6 xhur f'erba' studji (studji I, III, IV u V) u kien sa sentejn fi studju wieħed (studju II).
English: IgG levels decrease during therapy.
Maltese: Livelli ta' IgG jonqsu waqt it-terapija.
English: Missed dose
Maltese: Żomm id-doża
English: Elevations in lipid parameters including total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL) and triglycerides were observed in patients treated with tocilizumab (see section 4.8).
Maltese: F'pazjenti kkurati b'tocilizumab ġew osservati żidiet fil-parametri tal-lipidi inkluż kolesterol totali, lipoproteina ta' densità baxxa (LDL), lipoproteina ta' densità għolja (HDL) u trigliċeridi (ara sezzjoni 4.8).
English: Upper Respiratory Tract Infections pJIA, sJIA
Maltese: Infezzjonijiet fl-Apparat Respiratorju ta' Fuq pJIA, sJIA
English: Placebo + MTX, but endpoint was exploratory (not included in the hierarchy of statistical testing and has therefore not been controlled for multiplicity)
Maltese: Plaċebo + MTX, iżda l-punt finali kien esploratorju (mhux inkluż fil-ġerarkija ta' ttestjar statistiku u għalhekk ma kienx ikkontrollat għall-multipliċità)
English: The efficacy of RoActemra for the treatment of CRS was assessed in a retrospective analysis of data from clinical trials of CAR T-cell therapies (tisagenlecleucel and axicabtagene ciloleucel) for hematological malignancies.
Maltese: L-effikaċja ta' RoActemra għall-kura ta' CRS ġiet evalwata f'analiżi ta' data retrospettiva minn provi kliniċi ta' terapiji taċ-ċellula T CAR (tisagenlecleucel u axicabtagene ciloleucel) għal tumuri malinni ematoloġiċi.
English: In clinical trials, tocilizumab has not been studied in patients during an episode of active MAS.
Maltese: Fil-provi kliniċi, tocilizumab ma ġiex studjat f'pazjenti waqt episodju ta' MAS attiva.
English: Serious hypersensitivity reactions, including anaphylaxis have been reported in association with RoActemra (see section 4.8).
Maltese: Reazzjonijiet serji ta' sensittività eċċessiva, inkluż anafilassi ġew irrappurtati b'rabta ma' RoActemra (ara sezzjoni 4.8).
English: In study I, superiority of RoActemra 8 mg/kg was demonstrated against the active comparator MTX.
Maltese: Fi Studju I, intweriet is-superjorità ta' RoActemra 8 mg/kg kontra l-komparatur attiv MTX.