FrancophonIA/ELRC3.0 huggingface dataset:
English: GO-AFTER evaluated 445 patients who were previously treated with one or more of the anti-TNF agents adalimumab, etanercept, or infliximab.
Maltese: GO-AFTER evalwa 445 pazjent li qabel kienu ikkurati b'wieħed jew aktar sustanzi kontra t-TNF adalimumab, etanercept jew infliximab.
English: For paediatric patients < 40 kg
Maltese: Għal pazjenti pedjatriċi < 40 kg
English: The active substance is golimumab.
Maltese: Is-sustanza attiva hi golimumab.
English: Table 2 Tabulated list of ARs
Maltese: Tabella 2 Lista tal-ARs f'Tabella
English: Storage information Store in refrigerator at 2° to 8°C.
Maltese: Informazzjoni dwar il-ħażna Aħżen fi friġġ f'temparatura ta' 2° sa 8°C.
English: Defined as 0 or 1 on the endoscopy subscore of the Mayo score.
Maltese: Definit bħala 0 jew 1 fuq is-sottopunteġġ ta' endoskopija tal-punteġġ Mayo.
English: Responders, % of patients ACR 20
Maltese: % tal-pazjenti li kellhom rispons ACR 20
English: Based on the subset of patients with ≥ 3% BSA involvement at baseline, 79 patients (69.9%) in the placebo group and 109 (74.3%) in the Simponi 50 mg group.
Maltese: Ibbażat fuq is-sottogrupp ta' pazjenti b'involviment ta' BSA ta' ≥ 3% mal-linja bażi, 79 pazjent (69.9%) fil-grupp fuq plaċebo u 109 (74.3%) fil-grupp fuq Simponi 50 mg.
English: Table 4 Key efficacy outcomes from the controlled portions of GO-FORWARD, GO-AFTER and GO-BEFORE.
Maltese: Tabella 4 Riżultati ewlenin tal-effikaċja minn porzjonijiet ikkontrollati ta' GO-FORWARD, GO-AFTER u GO-BEFORE.
English: Among those, 85, 66 and 53 patients had ACR 20/50/70 response, respectively, at week 104.
Maltese: Fost dawn, 85, 66 u 53 pazjent kellhom rispons ACR ta' 20/50/70 rispettivament f'ġimgħa 104.
English: No data are available.
Maltese: Data mhux disponibbli.
English: Height (cm)
Maltese: Tul (ċm)
English: This type of cancer has usually resulted in death.
Maltese: Huwa normali li xi mediċina tkun għadha tidher fit-tieqa mnejn tara.
English: Date _______________
Maltese: Data_______________
English: Excipients: sorbitol (E420), histidine, histidine hydrochloride monohydrate, polysorbate 80, water for injections.
Maltese: Eċċipjenti: sorbitol (E420), histidine, histidine hydrochloride monohydrate, polysorbate 80, ilma għall-injezzjonijiet.
English: 125 to < 135
Maltese: 125 sa < 135
English: ACR 50 Week 14 10% 35%*
Maltese: Ġimgħa 14 10% 35%*
English: Lymphoma
Maltese: Limfoma
English: Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis:
Maltese: Artrite rewmatojde, artrite psorijatika, u spondiloartrite tal-assi, inkluż ankylosing spondylitis u spondiloartrite tal-assi mhux radjugrafika:
English: • You will choose from 2 injection methods.
Maltese: • Inti se tagħżel bejn 2 metodi ta' injezzjoni.
English: Cap*
Maltese: Għatu*
English: Children in this study demonstrated ACR Ped 30, 50, 70, and 90 responses from week 4.
Maltese: It-tfal f'dan l-istudju wrew risponsi ACR Ped 30, 50, 70, u 90 minn ġimgħa 4.
English: Know your dose
Maltese: DATA TA' SKADENZA
English: Pharmacotherapeutic group: Immunosuppressants, tumour necrosis factor alpha (TNF-α) inhibitors, ATC code: L04AB06
Maltese: Immunosoppressanti, inibituri tal-fattur alfa tan-nekrożi tat-tumur (TNF- α), Kodiċi ATC:
English: 135 to < 145
Maltese: 135 sa < 145
English: Common: Leukopenia (including neutropenia), anaemia Uncommon: Thrombocytopenia, pancytopenia Rare: Aplastic anaemia, agranulocytosis
Maltese: Komuni: Lewkopenija (inkluża newtropenija), anemija Mhux komuni: Tromboċitopenija, panċitopenija Rari:
English: The frequency of anti-dsDNA antibodies at 1 year of follow-up in patients anti-dsDNA negative at baseline was 1.1%.
Maltese: Il-frekwenza ta' antikorpi kontra dsDNA wara sena ta' follow-up f'pazjenti negattivi għall-antikorpi kontra dsDNA fil-linja bażi kienet ta' 1.1%.
English: GO-BEFORE evaluated 637 patients with active RA who were MTX-naïve and had not previously been treated with an anti-TNF agent.
Maltese: GO-BEFORE evalwa 637 pazjent b'RA attiva li fil-passat qatt ma ngħataw MTX u li qabel ma kienux ikkurati b'sustanza kontra t-TNF.
English: Polyarticular juvenile idiopathic arthritis (pJIA)
Maltese: Artrite poliartikulari idjopatika tat-tfal u ż-żgħażagħ (pJIA - polyarticular juvenile idiopathic arthritis)
English: Treatment with concomitant immunomodulators (azathioprine, 6-mercaptopurine and MTX) resulted in a lower proportion of patients with antibodies to golimumab than patients receiving golimumab without immunomodulators (1% (4/308) versus 3% (22/638), respectively).
Maltese: Kura flimkien ma' immunomodulaturi (azathioprine, 6-mercaptopurine u MTX) wasslet għal proporzjon inqas ta' pazjenti b'antikorpi għal golimumab minn pazjenti li rċivew golimumab mingħajr immunomodulaturi (1% (4/308) kontra 3% (22/638), rispettivament).
English: Within the designated system organ classes, the ARs are listed under headings of frequency and using 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); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Maltese: Fost il-klassijiet tal-organi tas-sistema allokati, l-ARs huma elenkati taħt titli tal-frekwenza u skont 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); rari ħafna (< 1/10,000); mhux magħruf (ma jistax jiġi stmat mid-dejta disponibbli).
English: Patients were randomised to receive placebo + MTX, Simponi 50 mg + MTX, Simponi 100 mg + MTX or Simponi 100 mg + placebo.
Maltese: Il-pazjenti kienu randomised biex jirċievu plaċebo + MTX, Simponi 50 mg + MTX, Simponi 100 mg + MTX jew Simponi 100 mg + plaċebo.
English: The baseline median number of active joints was 12, and median CRP was 0.17 mg/dL.
Maltese: Fil-linja bażi in-numru medjan ta' ġogi attivi kien ta' 12 u l-medjan ta' CRP kien 0.17 mg/dL.
English: 165 to < 175
Maltese: 165 sa < 175
English: The incidence of serious infections per 100 subject-years of follow-up in the controlled period of RA, PsA, AS, and nr-Axial SpA trials was 7.3; 95% CI: 4.6, 11.1 for the golimumab 100 mg group, 2.9; 95% CI: 1.2, 6.0 for the golimumab 50 mg group and 3.6; 95% CI: 1.5, 7.0 for the placebo group.
Maltese: Fil-perjodu kkontrollat tal-provi ta' RA, PsA, AS, u nr-Axial SpA l-inċidenza ta' infezzjonijiet serji għal kull 100 sena ta' segwitu ta' individwu kienet 7.3; 95% CI: 4.6, 11.1 għall-grupp ta' 100 mg ta' golimumab, 2.9; 95% CI: 1.2, 6.0 għall-grupp ta' 50 mg ta' golimumab u 3.6; 95% CI: 1.5, 7.0 għall-grupp ta' plaċebo.
English: Figure 9
Maltese: Figura 9
English: • Balance disorders
Maltese: • Disturbi tal-bilanċ
English: • Leukaemia
Maltese: • Lewkimja
English: Of these 70 patients, 64, 46 and 31 patients had an ACR 20/50/70 response, respectively.
Maltese: Minn dawn is-70 pazjent, 64, 46 u 31 pazjent kellhom rispons ACR 20/50/70, rispettivament.
English: Dose Lines
Maltese: Linji tadDoża Lines
English: Ankylosing Spondylitis Disease Activity Score C-Reactive Protein (AT-Placebo, N = 90; AT-Simponi 50 mg, N = 88; OSI-Placebo, N = 71; OSI-Simponi 50 mg, N = 71) n reflects number of patients with baseline and week 16 MRI data SPARCC (Spondyloarthritis Research Consortium of Canada) ** p < 0.0001 for Simponi vs placebo comparisons * p < 0.05 for Simponi vs placebo comparisons
Maltese: AT-Simponi 50 mg, N = 88; OSI-Plaċebo, N = 71; OSI-Simponi 50 mg, N = 71) n jirrifletti n-numru ta' pazjenti b'dejta mill-MRI fil-linja bażi u f'ġimgħa 16
English: In GO-FORWARD and GO-AFTER, statistically significant improvements were observed in fatigue as measured by functional assessment of chronic illness therapy-fatigue scale (FACIT-F).
Maltese: F'GO-FORWARD u GO-AFTER, titjib statistikament sinifikanti dehru fl'għeja hekk kif imkejla mill-evalwazzjoni funzjonali tal-iskala tat-terapija tal-għeja minn mard kroniku (FACIT-F).
English: The proportion of patients who eliminated corticosteroids by week 54 was greater in the 50 mg group (41%, 32/78) and 100 mg group (33%, 27/82) compared with the placebo group (22%, 19/87).
Maltese: Ilproporzjon ta' pazjenti li eliminaw il-kortikosterojdi sa ġimgħa 54 kien akbar fil-grupp ta' 50 mg (41%, 32/78) u fil-grupp ta' 100 mg (33%, 27/82) meta mqabbel mal-grupp tal-plaċebo (22%, 19/87).
English: Lymphoma and leukaemia
Maltese: Limfoma u lewkimja
English: 155 to < 165
Maltese: 155 sa < 165
English: • Psoriatic arthritis
Maltese: • Artrite psorijatika
English: 50 mg) + MTX or placebo + MTX every 4 weeks.
Maltese: 50 mg) + MTX.
English: At week 104, X-ray data were available for 114 patients, and 77% showed no progression from baseline.
Maltese: F'ġimgħa 104, dejta minn X-ray kienet disponibbli għal 114-il pazjent, u 77% ma wrew l-ebda progressjoni mil-linja bażi.
English: In the controlled period of pivotal trials, infections were observed in 23.0% of golimumab-treated patients (incidence per 100 subject-years: 132.0; 95% CI: 123.3, 141.1) compared with 20.2% of control patients (incidence per 100 subject-years: 122.3; 95% CI: 109.5, 136.2).
Maltese: Fil-perjodu kkontrollat tal-provi pivitali, infezzjonijiet ġew osservati fi 23.0% tal-pazjenti kkurati b'golimumab (inċidenza għal kull 100 sena ta' individwu: 132.0; 95% CI: 123.3, 141.1) mqabbla ma' 20.2% tal-pazjenti ta' kontroll (inċidenza għal kull 100 sena ta' individwu: 122.3; 95% CI: 109.5, 136.2).
English: Among those, 40, 33 and 24 patients had ACR 20/50/70 response, respectively at week 104.
Maltese: Fost dawk, 40,33 u 24 pazjent kellhom rispons ACR ta' 20/50/70, rispettivament f'ġimgħa 104.
English: 145 to < 155
Maltese: 145 sa < 155
English: Pre-specified subgroup analyses of the primary endpoint by baseline CRP (≥ 1 mg/dL vs < 1 mg/dL) demonstrated higher flare rates in placebo + MTX vs Simponi + MTX treated subjects among subjects with baseline CRP ≥ 1 mg/dL (87% vs 40% p = 0.0068).
Maltese: Analiżi ta' sottogrupp speċifikata minn qabel tal-iskop finali primarju skont is-CRP fil-linja bażi (≥ 1 mg/dL vs < 1 mg/dL) uriet rati ogħla ta' marda li marret għall-agħar f'individwi ttrattati bi plaċebo + MTX vs Simponi + MTX fost individwi b'CRP ≥ 1 mg/dL (87% vs 40% p = 0.0068) fillinja bażi.
English: The stated reasons for discontinuation of prior anti TNF therapies were lack of efficacy (58%), intolerance (13%), and/or reasons other than safety or efficacy (29%, mostly for financial reasons).
Maltese: Ir-raġunijiet li ssemmew għattwaqqif minn qabel ta' terapiji kontra t-TNF kienu nuqqas ta' effikaċja (58%), intolleranza (13%), u/jew raġunijiet apparti s-sigurtà jew l-effikaċja (29%, l-aktar minħabba raġunijiet finanżjarji).
English: It may harm them,
Maltese: Sintomi ta' insuffiċjenza tal-qalb jinkludu qtugħ ta' nifs jew jintefħulek saqajk.
English: • Chronic inflammatory condition of the lungs
Maltese: • Kondizzjoni infjammatorja kronika tal-pulmun
English: • Inflamed eye (conjunctivitis)
Maltese: • Għajn infjammata (konġuntivite)
English: Simponi 100 mg injection golimumab SC
Maltese: Simponi 100 mg injezzjoni golimumab SC
English: • Improve your physical function.
Maltese: • Ittejjeb il-funzjoni fiżika tiegħek.
English: Simponi 45 mg/0.45 mL injection golimumab
Maltese: Simponi 45 mg/0.45 mL mg injezzjoni golimumab
English: Figure 10
Maltese: Figura 10
English: • Axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis
Maltese: • Spondiloartrite tal-assi, inkluż ankylosing spondylitis u spondiloartrite tal-assi mhux radjugrafika
English: This appearance is not unusual for solutions containing protein.
Maltese: Din id-dehra mhux rari għal soluzzjonijiet li jkun fihom il-proteina.
English: Total Score Baseline
Maltese: Punteġġ Totali Linja bażi
English: Among 159 subjects randomised to Simponi 50 mg + MTX, 96 were still on this treatment at week 104.
Maltese: Fost 159 individwu randomised għal Simponi 50 mg + MTX, 96 kienu għadhom fuq il-kura sa ġimgħa 104.
English: The efficacy of Simponi was evaluated in two randomised, double-blind, placebo-controlled clinical studies in adult patients.
Maltese: L-effikaċja ta' Simponi kienet evalwata f'żewġ studji kliniċi, randomised, double-blind u kkontrollati bil-plaċebo f'pazjenti adulti.
English: Simponi 50 mg injection golimumab SC
Maltese: Simponi 50 mg injezzjoni golimumab SC
English: At week 48, 53% and 55% of children in the Simponi + MTX group and placebo + MTX group, respectively, were ACR Ped 30 responders, and 40% and 28% of children in the Simponi + MTX group and placebo + MTX group, respectively, achieved inactive disease.
Maltese: F'ġimgħa 48, 53% u 55% tat-tfal fil-grupp ta' Simponi + MTX u l-grupp ta' plaċebo + MTX, rispettivament, kellhom rispons ACR Ped 30, u 40% u 28% tat-tfal fil-grupp ta' Simponi + MTX u lgrupp ta' plaċebo + MTX, rispettivament, kisbu marda mhux attiva.
English: Golimumab should be used with caution in subjects with impaired hepatic function (see section 4.2).
Maltese: Golimumab għandu jintuża b'attenzjoni f'individwi b'funzjoni epatika indebolita (ara sezzjoni 4.2).
English: Simponi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Maltese: Simponi huwa indikat għall-kura ta' kolite ulċerattiva attiva b'mod moderat sa sever f'pazjenti adulti li kellhom rispons mhux adegwat għal terapija konvenzjonali inkluż kortikosterojdi u 6mercaptopurine (6-MP) jew azathioprine (AZA), jew li huma intolleranti għal jew għandhom kontraindikazzjonijiet mediċi għal terapiji bħal dawn.
English: Invasive fungal infections
Maltese: Sustanzi terapewtiċi infettivi
English: There is limited safety experience of golimumab treatment in patients who have undergone surgical procedures, including arthroplasty.
Maltese: Hemm esperjenza limitata tal-kura b'golimumab f'pazjenti li kellhom proċeduri kirurġiċi, inkluż artroplasti.
English: Latex sensitivity
Maltese: Sensittività għall-latex
English: At week 52, 15% of patients in the Simponi 50 mg + MTX group achieved a major clinical response compared with 7% of patients in the placebo + MTX group (p = 0.018).
Maltese: F'ġimgħa 52, 15% tal-pazjenti fil-grupp ta' Simponi 50 mg + MTX kisbu rispons kliniku maġġuri meta mqabbla ma' 7% tal-pazjenti fil-grupp tal-plaċebo + MTX (p = 0.018).
English: The most serious ARs that have been reported for golimumab include serious infections (including sepsis, pneumonia, TB, invasive fungal and opportunistic infections), demyelinating disorders, HBV reactivation, CHF, autoimmune processes (lupus-like syndrome), haematologic reactions, serious systemic hypersensitivity (including anaphylactic reaction), vasculitis, lymphoma and leukaemia (see section 4.4).
Maltese: L-aktar ARs serji li kienu rrappurtati għal golinumab kienu jinkludu infezzjonijiet serji (inkluż sepsi, pnewmonja, TB, infezzjonijiet ikkawżati minn fungi invażivi u infezzjonijiet opportunistiċi), disturbi li jneħħu lmajelin, attivazzjoni mill-ġdid tal-HBV, CHF, proċessi awto-immuni (sindrome bħal tal-lupus), reazzjonijiet ematoloġiċi, sensittività eċċessiva sistemika serja (inkluż reazzjoni anafilattika), vaskulite, limfoma u lewkimja (ara sezzjoni 4.4).
English: • Fever
Maltese: • Fwawar
English: Non-radiographic axial spondyloarthritis (nr-Axial SpA) Simponi is indicated for the treatment of adults with severe, active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).
Maltese: Spondiloartrite tal-assi mhux radjugrafika (nr-Axial SpA - non-radiographic axial spondyloarthritis) Simponi huwa indikat għat-trattament ta' adulti bi spondiloartrite tal-assi mhux radjugrafika attiva, severa b'sinjali oġġettivi ta' infjammazzjoni kif indikat minn livell għoli tal-proteina C reattiva (CRP - C-reactive protein ) u/jew evidenza ta' xbihat bir-reżonanza manjetika (MRI - magnetic resonance imaging), li kellhom ripons mhux adegwat jew li huma intolleranti għall-mediċini antiinfjammatorji mhux sterojdi (NSAIDs - nonsteroidal anti-inflammatory drugs).
English: • Inflammation of blood vessels in internal organs
Maltese: • Infjammazzjoni tal-arterji u tal-vini f'organi interni
English: In vitro, TNF-induced secretion of interleukin (IL)-6, IL-8 and granulocyte-macrophage colony stimulating factor (GM-CSF) by human endothelial cells was also inhibited by golimumab.
Maltese: In vitro, is-sekrezzjoni li timbeda mit-TNF ta' interleukin (IL)-6, IL-8 u l-fatturli jistimula l-kolonja tal-garnuloċiti-makrofaġi (GM-CSF) miċ-ċelluli tal-endotilju kienet ukoll inibita minn golimumab.
English: • 1 Alcohol swab
Maltese: • Imselħa bl-alkoħol 1
English: Table 6 Key efficacy outcomes from GO-AHEAD at week 16 Improvements in signs and symptoms
Maltese: Tabella 6 Riżultati importanti ta' effikaċja minn GO-AHEAD f'ġimgħa 16 Titjib fis-sinjali u s-sintomi
English: The relative deficiency of TNF caused by anti-TNF therapy may result in the initiation of an autoimmune process.
Maltese: In-nuqqas relattiv ta' TNF minħabba t-terapija anti-TNF jista' jwassal għall-bidu ta' proċess awtoimmuni.
English: In the controlled period of RA, PsA, AS, and nr-Axial SpA trials, serious infections were observed in 1.2% of golimumab-treated patients and 1.2% of control-treated patients.
Maltese: Fil-perjodu kkontrollat tal-provi ta' RA, PsA, AS, u nr-Axial SpA, infezzjonijiet serji ġew osservati f'1.2% tal-pazjenti kkurati b'golimumab u f'1.2% tal-pazjenti kkurati b'kontroll.
English: Paediatric malignancy
Maltese: Popolazzjoni pedjatrika
English: The safety and efficacy of Simponi were evaluated in a multi-centre, randomised, double-blind, placebo-controlled study (GO-REVEAL) in 405 adult patients with active PsA (≥ 3 swollen joints and ≥ 3 tender joints) despite non-steroidal anti-inflammatory (NSAID) or DMARD therapy.
Maltese: Is-sigurtà u l-effikaċja ta' Simponi kienu evalwati fi studju kontrollat bi plaċebo, double-blind, randomised, multi-ċentrali (GO-REVEAL) f'405 pazjent adult bi PsA attiva (≥ 3 ġogi minfuħin u ≥ 3 ġogi teneri) minkejja terapija b'anti-infjammatatorju mhux sterojde (NSAID) jew DMARD.
English: In nr-Axial SpA, antibodies to golimumab were detected in 7% (14/193) of golimumab treated patients through week 52.
Maltese: F'nr-Axial SpA, sa ġimgħa 52 antikorpi għal golimumab ġew innutati f'7% (14/193) tal-pazjenti ttrattati b'golimumab.
English: • cancer of the lymph nodes (lymphoma) (rare).
Maltese: • kanċer tal-glandoli tal-limfa (limfoma) (rari).
English: Colon dysplasia/carcinoma
Maltese: Displasja/karċinoma tal-kolon
English: There have been reports of pancytopenia, leukopenia, neutropenia, agranulocytosis, aplastic anaemia, and thrombocytopenia in patients receiving TNF-blockers, including golimumab.
Maltese: Kien hemm rapporti wara t-tqegħid fis-suq ta' panċitopenija, lewkopenija, newtropenija, agranuloċitożi, anemija aplastika u tromboċitopenja f'pazjenti li kienu qed jirċievu imblokkaturi tatTNF, inkluż golimumab.
English: The safety and efficacy of Simponi were evaluated in a multi-centre, randomised, double-blind, placebo-controlled study (GO-RAISE) in 356 adult patients with active ankylosing spondylitis (defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4 and a VAS for total back pain of ≥ 4, on a scale of 0 to 10 cm).
Maltese: Is-sigurtà u l-effikaċja ta' Simponi kienu evalwati fi studju kontrollat bi plaċebo, double-blind, randomised, multi-ċentrali (GO-RAISE) f'356 pazjent f'ankylosing spondylitis attiva (definita blIndiċi tal-Attività tal-Marda tal-Ankylosing Spondylitis ta' Bath (BASDAI) ≥ 4 u VAS tal-uġigħ taddahar totali ta' ≥ 4, fuq skala minn 0 sa 10 cm).
English: Table 1: Simponi dose in millilitres (mL) by height and weight of patients with pJIA Total Body Weight (kg)
Maltese: Tabella 1: Doża ta' Simponi f'millilitri (mL) skont it-tul u l-piż tal-pazjenti b'pJIA Piż Totali tal-Ġisem (kg)
English: In the Phase III studies in RA, PsA, AS, and UC, no overall differences in adverse events (AEs), serious adverse events (SAEs), and serious infections in patients age 65 or older who received golimumab were observed compared with younger patients.
Maltese: III f'RA, PsA, AS, u UC, ma dehrux differenzi b'mod globali fil-każijiet avversi (AEs), każijiet avversi serji (SAE's), u infezzjonijiet serji f'pazjenti ta' 65 sena jew akbar li rċivew golimumab meta mqabbla ma' pazjenti aktar żgħażagħ.
English: In GO-FORWARD and GO-AFTER, clinically meaningful and statistically significant responses in Disease Activity Scale (DAS)28 were observed at each prespecified time point, at week 14 and at week 24 (p ≤ 0.001).
Maltese: F'GO-FORWARD u GO-AFTER, risponsi ta' sinifikat kliniku u statistikament sinifikanti fl-Iskala tal-Attività tal-Marda (DAS)28 ġew osservati f'kull punt tal-ħin li kien speċifikat minn qabel, f'ġimgħa 14 u f'ġimgħa 24 (p ≤ 0.001).
English: • Tell your doctor if you have an infection.
Maltese: • Ċertu tilqim jista' jikkawża infezzjonijiet.
English: Distribution Following a single IV administration, the mean volume of distribution was 115  19 mL/kg.
Maltese: Distribuzzjoni Wara doża waħda fil-vini, il-medja tal-volum ta' distribuzzjoni kienet ta' 115 ± 19 mL/kg.
English: Check expiry date
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Patients were randomly assigned to placebo, Simponi 50 mg and Simponi 100 mg and were allowed to continue concomitant DMARD therapy (MTX, SSZ and/or HCQ).
Maltese: Pazjenti kienu imqassma b'mod każwali għal plaċebo, Simponi 50 mg u Simponi 100 mg u tħallew ikomplu terapija DMARD fl-istess ħin (MTX, SSZ u/jew HCQ).
English: For more information on sorbitol (E420), see Section 2.
Maltese: Għal aktar informazzjoni dwar sorbitol (E420), ara Sezzjoni 2.
English: Dose selections: 0.1 mL
Maltese: Għażla ta' dożi: 0.1 mL
English: There have been reports of tuberculosis in patients receiving golimumab.
Maltese: Kien hemm rapporti ta' tuberkulożi attiva f'pazjenti li kienu qed jirċievu golimumab.
English: • the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate.
Maltese: • kura ta' artrite rewmatojde attiva moderata sa severa f'adulti meta r-rispons għat-terapija b'mediċina kontra r-rewmatiżmu li tibdel il-marda (DMARD) inkluż MTX ma kienx adegwat.
English: In the controlled period of the UC pivotal trials of golimumab induction, mild ALT elevations (> 1 and < 3 x ULN) occurred in similar proportions of golimumab-treated and control patients (8.0% to 6.9%, respectively).
Maltese: Fil-perjodu kkontrollat tal-provi pivitali b'UC, ta' induzzjoni b'golimumab, żidiet żgħar fl-ALT (> 1 u < 3 x ULN) seħħew fi proporzjonijiet simili ta' pazjenti kkurati b'golimumab u bil-kontroll (8.0% sa 6.9%, rispettivament).
English: What Simponi contains The active substance is golimumab.
Maltese: Simponi fih sustanza attiva li tissejjaħ golimumab.
English: Objective signs of inflammation population (OSI) Placebo Simponi 50 mg Placebo Simponi 50 mg
Maltese: Plaċebo Simponi 50 mg Plaċebo Simponi 50 mg a 100
English: In GO-BEFORE, major clinical response, defined as the maintenance of an ACR 70 response over a continuous 6-month period, was measured.
Maltese: F'GO-BEFORE, rispons kliniku maġġuri, definit bħala ż-żamma ta' rispons ACR 70 fuq perijodu kontinwu ta' 6 xhur, kien imkejjel.
English: GO-FORWARD evaluated 444 patients who had active RA despite a stable dose of at least 15 mg/week of MTX and who had not been previously treated with an anti-TNF agent.
Maltese: GO-FORWARD evalwa 444 pazjent li kellhom RA attiva minkejja doża stabbli ta' mill-anqas 15 mg/ġimgħa ta' MTX u li ma kienux ikkurati qabel b'sustanza kontra t-TNF.