FrancophonIA/ELRC3.0 huggingface dataset:
English: In the cancer studies, between 64 and 73% of patients who received Eporatio had an increase in haemoglobin of 2 g/dl compared with between 20 and 26% of patients who were given placebo.
Maltese: Fl-istudji tal-kanċer, bejn 64 u 73% tal-pazjenti li rċevew Eporatio kellhom żieda fl-emoglobina ta' 2 g/dl meta mqabbla ma' bejn 20 u 26% tal-pazjenti li rċevew il-plaċebo.
English: Average weekly increases in haemoglobin were 0.73 and 0.58 g/dl in patients receiving the higher dose of Eporatio compared with 0.20 and 0.26 g/dl in patients receiving the lower dose of Eporatio.
Maltese: Iż-żidiet medji ta' kull ġimgħa fl-emoglobina kienu ta' 0.73 u 0.58 g/dl f'pazjenti li kienu qed jirċievu d-doża l-għolja ta' emoglobina meta mqabbla mal-0.20 u 0.26 g/dl f'pazjenti li kienu qed jirċievu d-doża aktar baxxa ta' Eporatio.
English: What is Eporatio?
Maltese: X'inhu Eporatio?
English: What is the risk associated with Eporatio?
Maltese: X'inhu r-riskju assoċjat ma' Eporatio?
English: Why has Eporatio been approved?
Maltese: Għaliex ġie approvat Eporatio?
English: Eporatio is used to treat anaemia (low levels of red blood cells or haemoglobin) that is causing symptoms.
Maltese: Eporatio jintu¿a biex jikkura l-anemija (livelli baxxi ta' ċelloli ħomor tad-demm jew emoglobina) li tkun qed tikkaw¿a s-sintomi.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Eporatio's benefits are greater than its risks for the treatment of symptomatic anaemia in adults with chronic renal failure and adults with non-myeloid cancers who are receiving chemotherapy.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Eporatio huma akbar mir-riskji tiegħu għat-trattament tal-anemija sintomatika f'adulti b'insuffiċjenza renali kronika u f'adulti b'kanċers mhux majelojdi li jkunu qed jirċievu l-kimoterapija.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Eporatio to ratiopharm GmbH on 29 October 2009.
Maltese: GmbH fid-29 ta' Ottubru 2009.
English: The active substance in Eporatio, epoetin theta, is a copy of a human hormone called erythropoietin that stimulates the production of red blood cells from the bone marrow.
Maltese: Is-sustanza attiva f'Eporatio, epoetin theta, hija kopja tal-ormon uman imsejjaħ erythropoietin li jistimula l-produzzjoni taċ-ċelloli l-ħomor tad-demm mill-mudullun.
English: In the four renal failure studies, patients were given either Eporatio (under the skin or into a vein) or epoetin beta (another erythropoietin-like medicine used for anaemia).
Maltese: Fl-erba' studji tal-insuffiċjenza renali, il-pazjenti ngħataw jew Eporatio (taħt il-ġilda jew ġo vina) jew epoetin beta (mediċina oħra bħall-erythropoietin użata għall-anemija).
English: In the cancer studies, the main measure of effectiveness was the number of patients receiving either Eporatio or placebo (a dummy treatment) with an increase in haemoglobin of 2 g/dl over 12 or 16 weeks.
Maltese: Fl-istudji tal-kanċer, il-kejl ewlieni tal-effikaċja kien in-numru ta' pazjenti li rċevew jew Eporatio jew plaċebo (kura finta) b'żieda fl-emoglobina ta' 2 g/dl fuq 12 jew 16-il ġimgħa.
English: How has Eporatio been studied?
Maltese: Kif ġie studjat Eporatio?
English: The effects of Eporatio were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Eporatio għall-ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: What benefit has Eporatio shown during the studies?
Maltese: Liema benefiċċju wera Eporatio waqt l-istudji?
English: Eporatio is a solution for injection.
Maltese: Eporatio huwa soluzzjoni għall-injezzjoni.
English: In chronic renal failure patients, the correction phase showed that increasing the starting dose of Eporatio leads to improvements in haemoglobin levels.
Maltese: F'pazjenti b'insuffiċjenza renali kronika, fil-fażi ta' korrezzjoni, intwera li, li tiżdied id-doża inizjali ta' Eporatio twassal għal titjib fil-livelli tal-emoglobina.
English: Eporatio was effective at treating anaemia in patients with chronic renal failure and patients with nonmyeloid cancer who were receiving chemotherapy.
Maltese: Eporatio kien effettiv fil-kura tal-anemija f'pazjenti b'insuffiċjenza renali kronika u f'pazjenti b'kanċer mhux majelojdi li kienu qed jirċievu l-kimoterapija.
English: How does Eporatio work?
Maltese: Għalxiex jintuża Eporatio?
English: For the full list of all side effects reported with Eporatio, see the Package Leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rappurtati b'Eporatio, ara lFuljett ta' Tagħrif.
English: The weekly dose of Eporatio should not be more than 60,000 IU.
Maltese: Id-doża ta' Eporatio ta' kull ġimgħa m'għandhiex tkun aktar minn 60,000
English: 50 to 100
Maltese: 50 sa 100
English: Important Information:
Maltese: Informazzjoni importanti:
English: Tuberculosis
Maltese: Tuberkulosi
English: Study IV TOWARD
Maltese: Studju IV TOWARD
English: MedDRA SOC Preferrred term (PT)
Maltese: SOC MedDRA Terminu ppreferut (PT
English: Immunoglobulin G
Maltese: Immunoglobulina G
English: (See Fig.
Maltese: (Ara Fig.
English: Date of last renewal: 25 September 2013
Maltese: Data tal-aħħar tiġdid: 25 ta' Settembru 2013
English: p-value(a)
Maltese: Valur p(a)
English: HR (99% CI)
Maltese: HR (CI ta' 99%)
English: - modified Total Sharp Score
Maltese: - Punteġġ Sharp Totali modifikat
English: • Risk of serious infections
Maltese: • Riskju ta' infezzjonijiet serji
English: DAS28 Remission
Maltese: Remissjoni DAS28
English: MedDRA System Organ Class
Maltese: Sistema talklassifika talorgani MedDRA
English: Combination with TNF antagonists
Maltese: Taħlita ma' antagonisti ta' TNF
English: • The injection may take up to 10 seconds.
Maltese: • L-injezzjoni tista' tieħu sa 10 sekondi.
English: respectively.
Maltese: rispettivament).
English: Immunomodulatory medicinal products may increase the risk of malignancy.
Maltese: Prodotti mediċinali immunomodulatorji jistgħu jżidu r-riskju ta' tumuri malinni.
English: 2 See section 4.4
Maltese: 2 Ara sezzjoni 4.4
English: • The active substance is tocilizumab.
Maltese: • Is-sustanza attiva hi tocilizumab.
English: Laboratory Parameters
Maltese: Parametri tal-laboratorju
English: Haemoglobin levels
Maltese: Livelli ta' emoglobina
English: EU/1/08/492/001 EU/1/08/492/002 EU/1/08/492/003 EU/1/08/492/004 EU/1/08/492/005 EU/1/08/492/006
Maltese: EU/1/08/492/001 EU/1/08/492/002 EU/1/08/492/003 EU/1/08/492/004
English: Genentech Inc. One Antibody Way Oceanside CA 92056
Maltese: One Antibody Way Oceanside
English: 24 months.
Maltese: 24 xahar.
English: TCZ = tocilizumab a = Per Protocol Population
Maltese: TCZ = tocilizumab a = Skont il-Popolazzjoni tal-Protokoll
English: * p<0.01, tocilizumab vs. placebo
Maltese: * p<0.01, tocilizumab vs. plaċebo
English: • methylprednisolone, dexamethasone, used to reduce inflammation
Maltese: • methylprednisolone, dexamethasone, użati biex inaqqsu l-infjammazzjoni
English: DAS 28 remission
Maltese: Remissjoni DAS 28
English: Unadjusted difference in proportions (99.5% CI)
Maltese: Differenza mhux aġġustata filproporzjonijiet (CI ta' 99.5%)
English: These proportions were statistically significantly different (p=0.0024).
Maltese: 32) biss wera differenza statistikament sinifikanti (p = 0.0024).
English: Secondary Endpoints
Maltese: Punti Finali Sekondarji
English: > 3 to 5 x ULN (confirmed by repeat testing, see section 4.4).
Maltese: > 3 sa 5 x ULN (ikkonfermat minn ittestjar ripetut, ara sezzjoni 4.4).
English: At the conclusion of Part I, JIA ACR 30/50/70/90 responses were 89.4%, 83.0%, 62.2%, and 26.1%, respectively.
Maltese: JIA ACR 30/50/70/90 kienu ta' 89.4%, 83.0%, 62.2%, u 26.
English: TCZ SC 162 mg every week + DMARD N=558
Maltese: TCZ SC 162 mg kull ġimgħa + DMARD N=558
English: Lipid parameters
Maltese: Parametri ta' lipidi
English: Placebo N=81
Maltese: Plaċebo N=81
English: No (N = 55)
Maltese: Le (N = 55)
English: No data are available
Maltese: M'hemm l-ebda data disponibbli.
English: No (N = 58)
Maltese: Le (N = 58)
English: Frequency categories with preferred terms
Maltese: Kategoriji ta' frekwenza bit-termini ppreferuti
English: Placebo + MTX N=287
Maltese: Plaċebo + MTX N=287
English: Reporting of suspected adverse reactions
Maltese: Rapportar ta' reazzjonijiet avversi suspettati
English: • Preparation of injection/infusion
Maltese: • Preparazzjoni ta' l-injezzjoni/infużjoni
English: A total of 28.8% (15/52) pJIA patients experienced ISRs to RoActemra SC.
Maltese: Total ta' 28.8% (15/52) tal-pazjenti b'pJIA kellhom ISRs għal RoActemra SC.
English: The bioavailability for the subcutaneous formulation was 79%.
Maltese: Il-bijodisponibilità għall-formulazzjoni SC kienet ta' 79%.
English: Very rare side effects:
Maltese: Effetti sekondarji rari:
English: Cellulitis, Pneumonia, Oral herpes simplex, Herpes zoster
Maltese: Ċellulite, Pulmonite, Herpes simplex talħalq, Herpes zoster
English: • lung infection (pneumonia)
Maltese: • infezzjoni fil-pulmun (pnewmonja)
English: Component of a multipack, can't be sold separately.
Maltese: Komponent ta' pakkett multiplu, ma jistgħax jinbiegħ separatament.
English: Manufacturer Roche Pharma AG Emil-Barell-Str. 1
Maltese: Roche Pharma AG Emil-Barell-Str.
English: Diarrhea pJIA, sJIA
Maltese: Dijarea pJIA, sJIA
English: There is limited data for patients above 100 kg (n=7).
Maltese: Hemm data limitata għal pazjenti li jiżnu iktar minn 100 kg (n=7).
English: (See Fig. B)
Maltese: (Ara Fig. B)
English: Endocrine disorders
Maltese: Disturbi fissistema endokrinarja
English: Polysorbate 80, sucrose, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate and water for injections.
Maltese: Polysorbate 80, sucrose, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate u ilma għall-injezzjonijiet.
English: • abdominal pain,
Maltese: • uġigħ addominali,
English: Rash, Pruritus, Urticaria
Maltese: Raxx, Ħakk, Urtikarja
English: ***p≤0.0001; **p<0.001; *p<0.05;
Maltese: 001; *p<0.05; ‡valur p < 0.05 vs.
English: Disodium phosphate dodecahydrate Sodium dihydrogen phosphate dihydrate Water for injections
Maltese: Sodium dihydrogen phosphate dihydrate
English: (See Fig. E).
Maltese: (Ara Fig. E).
English: Thirty-nine patients (76.5%; 95% CI: 62.5%-87.2%) achieved a response.
Maltese: Disgħa u tletin pazjent (76.5%; CI ta' 95%: 62.5%-87.
English: The total patient exposure was 184.4 patient years.
Maltese: L-esponiment totali tal-pazjenti kien ta' 184.4 snin ta' pazjent.
English: • cold sores (oral herpes simplex), blisters
Maltese: • ponot tad-deni (herpes simplex orali), infafet
English: In the SC Study (WA28118), a total of 41.2% (21/51) sJIA patients experienced ISRs to RoActemra SC.
Maltese: Fl-Istudju SC (WA28118), total ta' 41.2% (21/51) tal-pazjenti b'sJIA kellhom ISRs għal RoActemra SC.
English: > 3 x ULN to 5x ULN
Maltese: > 3 x ULN sa 5x ULN
English: Multiplicity controlled using Bonferroni-Holm Procedure
Maltese: Multipliċità ikkontrollata bl-użu tal-Proċedura Bonferroni-Holm
English: Active, severe infections (see section 4.4).
Maltese: Infezzjonijiet attivi severi (ara sezzjoni 4.4).
English: Each 400 mg vial contains 0.39 mmol (8.85 mg) sodium.
Maltese: Kull kunjett ta' 400 mg fih 0.39 mmol (8.85 mg) sodium.
English: Hepatic transaminases increased, Weight increased, Total bilirubin increased*
Maltese: Żieda ta' transaminases epatiċi, Żieda fil-piż, Żieda fil-bilirubina totali*
English: The efficacy of tocilizumab was assessed in a three-part study WA19977 including an open-label extension in children with active pJIA.
Maltese: L-effikaċja ta' tocilizumab kienet evalwata fi studju ta' tliet partijiet WA19977 li inkluda estensjoni open-label fi tfal b'pJIA attiva.
English: In GCA clinical study WA28119, similar rapid decreases in CRP and ESR were observed along with slight increases in mean corpuscular haemoglobin concentration.
Maltese: Fl-istudju kliniku dwar GCA WA28119, kien osservat tnaqqis rapidu simili f'CRP u ESR flimkien ma' żidiet żgħar fil-konċentrazzjoni medja ta' emoglobina korpuskulari.
English: This remained consistent following 2 years of treatment (83%; n=353).
Maltese: Dan baqa' konsistenti wara sentejn ta' trattament (83%; n=353).
English: Tocilizumab versus adalimumab in monotherapy
Maltese: Tocilizumab kontra adalimumab bħala monoterapija
English: Stevens-JohnsonSyndrome3
Maltese: Sindrome ta' Stevens-Johnson
English: • if you have an active, severe infection.
Maltese: • jekk għandek infezzjoni attiva severa.
English: ANC > 1 Maintain dose ANC 0.5 to
Maltese: ANC > 1 Żomm id-doża ANC 0.5 sa
English: Haematological abnormalities:
Maltese: Anormalitajiet ematoloġiċi:
English: Adult patients with RA
Maltese: Pazjenti adulti b'RA
English: I)
Maltese: (a)
English: 1p<0.0001, tocilizumab vs. placebo
Maltese: 1p<0.0001, tocilizumab kontra placebo
English: Viral reactivation
Maltese: Riattivazzjoni virali
English: The Patient's Global Assessment of disease activity was assessed on a 0-100mm Visual Analogue Scale (VAS).
Maltese: Il-Valutazzjoni Globali tal-attività tal-marda tal-Pazjent ġiet evalwata fuq Skala Analoga Viżwali (VAS - Visual Analogue Scale) ta' 0-100mm.
English: • benzodiazepines (e.g. temazepam), used to relieve anxiety.
Maltese: • benzodiazepines (e.ż. temazepam), użati biex itaffu l-ansjetà.
English: ADA + Placebo (IV) N = 162
Maltese: ADA + Plaċebo (IV)
English: JIA ACR 30 JIA ACR 50 JIA ACR 70 JIA ACR 90
Maltese: JIA ACR 70 JIA ACR 90
English: Study II LITHE
Maltese: Studju II
English: There are limited data available on overdose with RoActemra.
Maltese: Hemm dejta limitata disponibbli dwar doża eċċessiva ta' RoActemra.
English: Exploratory Endpoints Week 24: ACR/EULAR Boolean Remission, n (%) ACR/EULAR Index Remission, n (%) Week 52: ACR/EULAR Boolean Remission, n (%) ACR/EULAR Index Remission, n (%)
Maltese: Remissjoni Boolean ACR/EULAR, n (%) Indiċi ta' Remissjoni ACR/EULAR, n (%)
English: ANC 0.5 to 1
Maltese: ANC 0.5 sa 1
English: The bioavailability for the SC formulation was 0.8.
Maltese: Ilbijodisponibilità għall-formulazzjoni SC kienet ta' 0.8.
English: SF-36 (mean change in mental and physical component scores) was significantly greater with RoActemra subcutaneous group (6.5 and 5.3) versus placebo (3.8 and 2.9).
Maltese: SF-36 (bidla medja fil-punteġġi tal-komponent mentali u fiżiku) kien ogħla b'mod sinifikanti bilgrupp ta' RoActemra taħt il-ġilda (6.5 u 5.3) kontra plaċebo (3.8 u 2.9).
English: Cases of opportunistic infections have been reported.
Maltese: Ġew irrapportati każijiet ta' infezzjonijiet opportunistiċi.
English: • children and adolescents, aged 2 years and over, with active polyarticular juvenile idiopathic arthritis (pJIA).
Maltese: • tfal u adolexxenti, ta' età minn sentejn 'il fuq, b'artrite idjopatika poliartikolari filminorenni (pJIA - polyarticular juvenile idiopathic arthritis) attiva.
English: Step 5.
Maltese: Pass 5.
English: Each 200 mg vial contains 0.20 mmol (4.43 mg) sodium.
Maltese: Kull kunjett ta' 200 mg fih 0.20 mmol (4.43 mg) sodium.
English: Diverticulitis
Maltese: Divertikulite
English: The percent of patients achieving JIA ACR 30, 50, 70 and 90 responses are shown in Table 7.
Maltese: Il-persentaġġ ta' pazjenti li laħqu risponsi JIA ACR 30, 50, 70 u 90 huma murija f'Tabella 7.
English: DMARD - Disease modifying anti-rheumatic drug - p< 0.01, TCZ vs. PBO + MTX/DMARD - p< 0.0001, TCZ vs. PBO + MTX/DMARD
Maltese: DMARD - Mediċina kontra r-rewmatiżmu li timmodifika l-marda (Disease modifying anti-rheumatic drug) - p< 0.01, TCZ kontra PBO + MTX/DMARD - p< 0.0001, TCZ kontra PBO + MTX/DMARD
English: In an independent cohort of 15 patients (range: 9-75 years old) with axicabtagene ciloleucel-induced CRS, 53% responded.
Maltese: F'koorti indipendenti ta' 15-il pazjent (firxa: 9-75 sena) b'CRS indott minn axicabtagene ciloleucel, irrispondew 53%.
English: RoActemra is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients.
Maltese: RoActemra huwa indikat għat-trattament ta' Artrite taċ-Ċelluli Ġganti (GCA - Giant Cell Arteritis) f'pazjenti adulti.
English: Discontinue RoActemra
Maltese: Waqqaf RoActemra
English: Skin Reactions Rare reports of Stevens-Johnson Syndrome have occurred in the post marketing setting.
Maltese: Fl-ambjent ta' wara t-tqegħid fis-suq kien hemm rapporti rari tas-Sindrome ta' Stevens-Johnson.
English: Figure L
Maltese: Figura L
English: L-Histidine, L-Histidine monohydrochloride monohydrate, L-Arginine, L-Arginine hydrochloride, LMethionine, Polysorbate 80, Water for injections.
Maltese: L-Histidine, L-Histidine monohydrochloride monohydrate, L-Arginine, L-Arginine hydrochloride, LMethionine, Polysorbate 80, Ilma għall-injezzjonijiet.
English: Stomatitis, Gastric ulcer
Maltese: Stomatite, Ulċera flistonku
English: The accumulation ratios for AUC, Cmin, and Cmax were 6.32, 6.30, and 5.27, respectively.
Maltese: Il-proporzjonijiet ta' akkumulazzjoni għall-AUC, Cmin, u Cmax kienu ta' 6.32, 6.30, u 5.27, rispettivament.
English: Cumulative glucocorticoid dose (mg) median at Week 52 (Tocilizumab groups vs Placebo+262) median at Week 52 (Tocilizumab groups vs Placebo +522)
Maltese: Doża kumulattiva ta' glukokortikojdi (mg) medjan f'Ġimgħa 52 (gruppi ta' Tocilizumab kontra Plaċebo+262) medjan f'Ġimgħa 52 (gruppi ta' Tocilizumab kontra Plaċebo +522)
English: RoActemra, in combination with methotrexate (MTX), is indicated for:
Maltese: RoActemra, f'taħlita ma' methotrexate (MTX), huwa indikat għal:
English: The overall safety profile observed in the RoActemra treatment groups was consistent with the known safety profile of RoActemra (see Table 1).
Maltese: Il-profil ta' sigurtà globali osservat fil-gruppi ta' trattament ta' RoActemra kien konsistenti mal-profil ta' sigurtà magħruf ta' RoActemra (ara Tabella 1).
English: • phenytoin, used to treat convulsions
Maltese: • phenytoin, użat għat-trattament ta' konvulżjonijiet
English: The potential risk for humans is unknown.
Maltese: Ir-riskju potenzjali għallbnedmin mhux magħruf.
English: • allergic (hypersensitivity) reactions
Maltese: • reazzjonijiet allerġiċi (sensittività eċċessiva)
English: For persistent increases > 3 x ULN, discontinue RoActemra
Maltese: Għal żidiet persistenti ta' > 3 x ULN, waqqaf RoActemra
English: INFORMATION IN BRAILLE roactemra 162 mg
Maltese: pinna roactemra 162 mg
English: Tel: +385 1 47 22 333 Ireland
Maltese: Tel: +385 1 47 22 333
English: - Placebo
Maltese: - Plaċebo
English: Step 1.
Maltese: Pass 1.
English: Yes (N = 27)
Maltese: Iva (N = 27)
English: • simvastatin or atorvastatin, used to reduce cholesterol levels
Maltese: • simvastatin jew atorvastatin, użati biex inaqqsu l-livelli tal-kolesterol
English: In the open label extension phase (Part II), the overall rate of infections remained similar at 306.6 per 100 patient years.
Maltese: Fil-fażi ta' estensjoni open label (Parti II), ir-rata globali ta' infezzjonijiet baqgħet simili bi 306.6 għal kull 100 sena ta' pazjent.
English: • Reference to the Summary of Product Characteristics (e.g., link to EMA website)
Maltese: • Referenza għas-Sommarju tal-Karatteristiċi tal-Prodott (eż., link għas-sit elettroniku tal-EMA)
English: RoActemra contains sodium
Maltese: RoActemra fih sodium
English: Side effects could occur 3 months or more after your last dose of RoActemra.
Maltese: Effetti sekondarja jistgħu jseħħu tal-inqas sa 3 xhur wara l-aħħar doża ta' RoActemra.
English: Discontinue RoActemra.
Maltese: Waqqaf RoActemra.
English: Step 2.
Maltese: Pass 2.
English: • shingles (herpes zoster)
Maltese: • ħruq ta' Sant'Antnin (herpes zoster)
English: In vitro studies with cultured human hepatocytes demonstrated that IL-6 caused a reduction in CYP1A2, CYP2C9, CYP2C19 and CYP3A4 enzyme expression.
Maltese: Studji in vitro b'epatoċiti umani kkolturati wrew li IL-6 ikkawża tnaqqis fl-espressjoni tal-enzimi CYP1A2, CYP2C9, CYP2C19 u CYP3A4.
English: Signs of serious infections:
Maltese: Sinjali ta' infezzjonijiet serji:
English: The overall clinical adverse event profile was similar between RoActemra and adalimumab.
Maltese: Il-profil globali ta' avvenimenti avversi kliniċi kien simili bejn RoActemra u adalimumab.
English: A total of 5.8% of patients experienced an elevation of indirect bilirubin of > 1 to 2 x ULN and 0.4% had an elevation of > 2 x ULN.
Maltese: Total ta' 5.8% tal-pazjenti kellhom żieda ta' bilirubina indiretta ta' > 1 sa 2 x ULN u 0.4% kellhom żieda ta' > 2 x ULN.
English: The tocilizumab 8 mg/kg + MTX group also showed statistically significant results across the key secondary endpoints.
Maltese: Il-grupp ta' tocilizumab 8 mg/kg + MTX wera wkoll riżultati statistikament sinifikanti fil-punti finali sekondarji ewlenin.
English: JIA ACR90 Response
Maltese: JIA ACR90
English: Viral reactivation (e.g. hepatitis B virus) has been reported with biologic therapies for RA.
Maltese: Riattivazzjoni virali (eż. virus tal-epatite B) kienet irrappurtata b'terapiji bijoloġiċi għall-RA.
English: • Risk of gastrointestinal perforations especially in patients with history of diverticulitis or intestinal ulcerations
Maltese: • Riskju ta' perforazzjoni gastro-intestinali speċjalment f'pazjenti b'passat ta' divertikulite jew ulċerazzjoni intestinali
English: > 1 to 3 x Upper Limit of Normal (ULN)
Maltese: (ULN - Upper Limit of Normal)
English: RoActemra normalises expression of these enzymes.
Maltese: RoActemra jinnormalizza l-espressjoni ta' dawn l-enzimi.
English: The accumulation ratios for AUC, Cmin, and Cmax were 2.67, 6.02, and 2.12, respectively.
Maltese: Il-proporzjonijiet ta' akkumulazzjoni għall-AUC, Cmin, u Cmax kienu ta' 2.67, 6.02 , u 2.12, rispettivament.
English: The pharmacokinetics of RoActemra is characterized by nonlinear elimination which is a combination of linear clearance and Michaelis-Menten elimination.
Maltese: Il-farmakokinetika ta' RoActemra hija kkaratterizzata minn eliminazzjoni mhux lineari li hija taħlita ta' tneħħija lineari u eliminazzjoni Michaelis-Menten.
English: pJIA Patients < 30 kg
Maltese: Pazjenti b'pJIA < 30 kg
English: • benzodiazepines (e.g. temazepam), used to relieve anxiety
Maltese: • benzodiazepines (eż. temazepam), użati biex itaffu l-ansjetà
English: Figure C
Maltese: Figura C
English: In the SC Study 5.8% [3/52] developed positive neutralizing anti-tocilizumab antibodies without developing a serious or clinically significant hypersensitivity reaction.
Maltese: Fl-Istudju SC 5.8% [3/52] żviluppaw antikorpi pożittivi newtralizzanti kontra tocilizumab mingħajr ma żviluppaw reazzjoni ta' sensittività eċċessiva serja jew klinikament sinifikanti.
English: Yes (N = 23)
Maltese: Iva (N = 23)
English: • Fatal Allergic Reactions (Anaphylaxis [fatal])
Maltese: • Reazzjonijiet Allerġiċi Fatali (Anafilassi [fatali])
English: Placebo + 52 weeks prednisone taper N=51
Maltese: Plaċebo + 52 ġimgħa ta' prednisone mnaqqas bil-mod għax-xejn N=51
English: The adjusted mean change in the pain VAS after 40 weeks of tocilizumab treatment was 32.4 mm on a 0-100 mm scale compared to a reduction of 22.3 mm for placebo patients (highly statistically significant; p=0.0076).
Maltese: Il-bidla medja aġġustata fil-VAS tal-uġigħ wara 40 ġimgħa ta' kura b'tocilizumab kienet ta' 32.4 mm fuq skala ta' 0-100 mm meta mqabbel ma' tnaqqis ta' 22.3 mm għall-pazjenti fuq plaċebo (statistikament sinifikanti ħafna; p=0.0076).
English: Laboratory Value (cells x 109/ l )
Maltese: Valur talLaboratorju (ċelluli x 10 9/ l)
English: The overall clinical adverse event profile was similar between tocilizumab and adalimumab.
Maltese: Il-profil ġenerali ta' avvenimenti avversi kliniċi kien simili bejn tocilizumab u adalimumab.
English: Patients achieving a JIA ACR70 response were permitted corticosteroid dose reduction.
Maltese: Pazjenti li laħqu rispons JIA ACR70 kienu permessi tnaqqis fid-doża tal-kortikosterojdi.
English: Step 4.
Maltese: Pass 4.
English: (See Fig. H)
Maltese: (Ara Fig. H)
English: Step 7.
Maltese: Pass 7.
English: Common Uncommon
Maltese: Komuni Ħafna
English: DATE OF FIRST AUTHORISATION/DATE OF LATEST RENEWAL Date of first authorisation: 16 January 2009
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/DATA TAL-AĦĦAR TIĠDID Data tal-ewwel awtorizzazzjoni:16 ta' Jannar 2009