FrancophonIA/ELRC3.0 huggingface dataset:
English: Simponi may be stored at temperatures up to a maximum of 25°C for a single period of up to 30 days, but not exceeding the original expiry date printed on the carton.
Maltese: Simponi jista' jinħażen f'temperaturi sa massimu ta' 25°C għal perjodu wieħed sa 30 jum, iżda li ma jkunx jaqbeż id-data oriġinali ta' meta jiskadi stampata fuq il-kartuna.
English: Change from baseline n reflects randomised patients * p = 0.015
Maltese: Bidla mil-linja bażi n tirrifletti pazjenti randomised * p = 0.015
English: Patients were assessed for UC disease activity by partial Mayo score every 4 weeks (loss of response was confirmed by endoscopy).
Maltese: Il-pazjenti kienu evalwati għall-attività tal-marda UC b'punteġġ Mayo parzjali kull 4 ġimgħat (telf ta' rispons kien ikkonfermat permezz ta' endoskopija).
English: Psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis Simponi 50 mg given once a month, on the same date each month.
Maltese: Artrite psorijatika, ankylosing spondylitis, jew spondiloartrite tal-assi mhux radjugrafika Simponi 50 mg mogħti darba f'xahar, fl-istess data kull xahar.
English: Continue to hold until the second ‘click' (see figure 8)
Maltese: Kompli agħfas sakemm terġa tisma' li ‘tfaqqa' għat-tieni darba (ara figura 8)
English: Adult psoriatic arthritis
Maltese: Artrite psorijatika fl-adulti
English: The incidence per 100 subject-years of all serious infections was 4.1; 95% CI: 3.6, 4.5, in patients receiving golimumab 100 mg and 2.5; 95% CI: 2.0, 3.1, in patients receiving golimumab 50 mg.
Maltese: L-inċidenza tal-infezzjonijiet serji kollha għal kull 100 sena ta' individwu kienet 4.1; 95% CI: 3.6, 4.5, f'pazjenti li kienu qed jirċievu 100 mg ta' golimumab u 2.5; 95% CI: 2.0, 3.1, f'pazjenti li kienu qed jirċievu 50 mg ta' golimumab.
English: Following a single subcutaneous injection of 100 mg, the absorption of golimumab was similar in the upper arm, abdomen, and thigh, with a mean absolute bioavailability of 51%.
Maltese: Wara injezzjoni waħda ta' 100 mg taħt il-ġilda, l-assorbiment ta' golimumab kien simili fin-naħa ta' fuq tad-driegħ, fl-addome u fil-koxxa, b'bijodisponibilità assoluta medja ta' 51%.
English: Among the 54% of patients (247/456) who were receiving concomitant corticosteroids at the start of PURSUIT-Maintenance, the proportion of patients who maintained clinical response through week 54 and were not receiving concomitant corticosteroids at week 54 was greater in the 50 mg group (38%, 30/78) and 100 mg group (30%, 25/82) compared with the placebo group (21%, 18/87).
Maltese: Fost l-54% ta' pazjenti (247/456) li kienu qed jirċievu kortikosterojdi fl-istess ħin fil-bidu ta' PURSUIT-Manteniment, il-proporzjon ta' pazjenti li żammew ir-rispons kliniku sa ġimgħa 54 u li ma kinux qed jirċievu kortikosterojdi fl-istess ħin f'ġimgħa 54 kien akbar fil-grupp ta' 50 mg (38%, 30/78) u fil-grupp ta' 100 mg (30%, 25/82) mqabbel mal-grupp tal-plaċebo (21%, 18/87).
English: Subsequent administrations: ______________________________________________
Maltese: L-għoti ta' wara: ______________________________________________
English: Table 8 Improvements from baseline in ACR Ped components at week 16 Median percent improvement Simponi 30 mg/m b = 173
Maltese: Tabella 8 Titjib fil-komponenti ACR Ped mil-linja bażi f'ġimgħa 16 Medjan tal-perċentwal ta' titjib Simponi 30 mg/m b = 173
English: In the controlled and uncontrolled portions of these trials with a median follow-up of up to 3 years, a greater incidence of lymphoma was observed in patients receiving golimumab 100 mg compared with patients receiving golimumab 50 mg. Lymphoma was diagnosed in 11 subjects (1 in the golimumab 50 mg treatment groups and 10 in the golimumab 100 mg treatment groups) with an incidence (95% CI) per 100 subject-years of follow-up of 0.03 (0.00, 0.15) and 0.13 (0.06, 0.24) events for golimumab 50 mg and 100 mg respectively and 0.00 (0.00, 0.57) events for the placebo.
Maltese: Limfoma kienet iddijanjostikata fi 11-il individwu (1 fil-gruppi ta' kura b'50 mg ta' golimumab u 10 fil-gruppi ta' kura b'100 mg ta' golimumab ) b'inċidenza (95% CI) għal kull 100 sena ta' individwu li matulhom il-pazjenti ġew segwiti ta' 0.03 (0.00, 0.15) u 0.13 (0.06, 0.24) każijiet għal 50 mg u 100 mg ta' golimumab rispettivament u 0.00 (0.00, 0.57) każijiet għall-plaċebo.
English: Common: Depression, insomnia Nervous system disorders Common: Dizziness, headache, paraesthesia Uncommon: Balance disorders Rare: Demyelinating disorders (central and peripheral), dysguesia
Maltese: Komuni: Depressjoni, insomnja Disturbi fis-sistema nervuża Komuni: Sturdament, uġigħ ta' ras, paresteżija Mhux komuni: Disturbi fil-bilanċ Rari:
English: • 1 Sharps container (See Step 3)
Maltese: • Kontenitur għal oġġetti li jaqtgħu jew bil-ponta 1 (Ara Pass 3)
English: In the controlled period of RA and PsA pivotal trials, mild ALT elevations (> 1 and < 3 x upper limit of normal (ULN)) occurred in similar proportions of golimumab and control patients in the RA and PsA studies (22.1% to 27.4% of patients); in the AS and nr-Axial SpA studies, more golimumab-treated patients (26.9%) than control patients (10.6%) had mild ALT elevations.
Maltese: Fil-perjodu kontrollat tal-provi pivitali ta' RA u PsA, żidiet żgħar fl-ALT (> 1 u < 3 x l-ogħla limitu tan-normali (ULN) seħħew f'proporzjonijiet simili fil-pazjenti fuq golimumab u l-kontroll fl-istudji RA u PsA (22.1% sa 27.4% tal-pazjenti); fl-istudji dwar AS u nr-Axial SpA, aktar pazjenti ikkurati b'golimumab (26.9%) minn dawk fuq kontroll (10.
English: Subject/parent global assessment of overall well-being (VAS 0-10 cm) Number of active joints Number of joints with limited range of motion Physical function by CHAQ ESR (mm/h)
Maltese: Numru ta' ġogi b'firxa ta' moviment limitat Funzjoni fiżika skont CHAQ ESR (mm/siegħa)
English: EXP EXP, if stored at room temperature___________________
Maltese: JIS JIS, jekk jinħażen f'temperatura ambjentali___________________
English: Uncommon: Constipation, gastro-oesophageal reflux disease
Maltese: Mhux komuni: Marda tal-interstizju tal-pulmun Disturbi gastro-intestinali
English: Psoriatic arthritis
Maltese: Artrite psorijatika
English: One 0.45 mL pre-filled pen contains 45 mg golimumab 1 mL contains 100 mg golimumab.
Maltese: Pinna waħda tal-0.45 mL mimlija għal-lest fiha 45 mg golimumab 1 mL fih 100 mg golimumab.
English: There was a trend toward higher apparent clearance of golimumab with increasing weight (see section 4.2).
Maltese: Kien hemm tendenza li t-tneħħija apparenti ta' golimumab tiżdied b'żieda fil-piż (ara sezzjoni 4.2).
English: In nr-Axial SpA, antibodies to golimumab were detected in 7% (14/193) of golimumab treated patients through week 52 by the EIA method.
Maltese: F'nr-Axial SpA, sa ġimgħa 52 instabu antikorpi għal golimumab bil-metodu EIA f'7% (14/193) talpazjenti ttrattati b'golimumab.
English: Simponi belongs to a group of medicines called ‘TNF blockers'.
Maltese: Simponi jgħamel parti minn grupp ta' mediċini li jissejħu ‘imblukkaturi tat-TNF'.
English: When you are treated with Simponi, you might get infections more easily.
Maltese: Meta tkun qed tingħata kura b'Simponi, jistgħu jaqbduk infezzjonijiet aktar b'mod aktar faċili.
English: • Stomach pain
Maltese: • Ponot tad-deni
English: Excipient with known effect Each pre-filled pen contains 18.45 mg sorbitol (E420) per 45 mg dose.
Maltese: Eċċipjent b'effett magħruf Kull pinna mimlija għal-lest fiha 18.45 mg sorbitol (E420) għal kull doża ta' 45 mg.
English: Across the Phase III RA, PsA and AS studies through week 52, antibodies to golimumab were detected by the enzyme immunoassay (EIA) method in 5% (105/2062) of golimumab treated patients and, where tested, nearly all antibodies were neutralising in vitro.
Maltese: III sa' ġimgħa 52, l-antikorpi għal golimumab, instabu bilmetodu ta' immunoanaliżi tal-enzimi (EIA - enzyme immunoassay) f'5% (105/2062) tal-pazjenti ikkurati b'golimumab u, meta kienu ttestjati, kważi l-antikorpi kollha kienu newtralizzanti in vitro.
English: • Sinus infection
Maltese: • Infezzjoni tas-sinus
English: The pharmacokinetics of golimumab were determined in 173 children with pJIA with an age range from 2 to 17 years of age.
Maltese: Il-farmakokinetika ta' golimumab ġiet determinata f'173 tifel u tifla b'pJIA b'firxa ta' etajiet minn sentejn sa 17-il sena.
English: • If you received Simponi during your pregnancy, your baby may have a higher risk for getting an infection.
Maltese: • Jekk irċevejt Simponi waqt it-tqala, it-tarbija tiegħek jista' jkollha riskju akbar li tieħu infezzjoni.
English: • Merkel cell carcinoma (a type of skin cancer)
Maltese: • Karċinoma taċ-ċellula ta' Merkel (tip ta' kanċer tal-ġilda)
English: Treatment with 50 mg or 100 mg golimumab subcutaneous every 4 weeks during maintenance resulted in a mean steady-state trough serum concentration of approximately 0.9 ± 0.5 g/mL and 1.8 ± 1.1 g/mL, respectively.
Maltese: Kura b'50 mg jew 100 mg golimumab taħt il-ġilda kull 4 ġimgħat matul ilmanteniment wasslet għall-konċentrazzjoni minima medja fi stat fiss fis-serum ta' madwar 0.9 ± 0.5 g/mL u 1.8 ± 1.1 g/mL, rispettivament.
English: Table 3 Improvements from baseline in ACR Ped components at week 16 Median percent improvement Simponi 30 mg/m b = 173
Maltese: Tabella 3 Titjib fil-komponenti ACR Ped mil-linja bażi f'ġimgħa 16 Medjan tal-perċentwal ta' titjib Simponi 30 mg/m b = 173
English: Patients in clinical remission at week 6
Maltese: Pazjenti b'remissjoni klinika f'ġimgħa 6
English: Similar rates were shown across rheumatologic indications.
Maltese: Rati simili intwerew fost l-indikazzjonijiet rewmatoloġiċi.
English: Patients were allowed to continue concomitant DMARD therapy with MTX, sulfasalazine (SSZ), and/or hydroxychloroquine (HCQ) during the study.
Maltese: Il-pazjenti tħallew ikomplu terapija b'DMARD fl-istess ħin b'MTX, sulfasalazine (SSZ), u/jew hydroxychloroquine (HCQ) waqt l-istudju.
English: Table 4 Key efficacy outcomes from GO-REVEAL
Maltese: Tabella 4 Riżultati ewlenin dwar l-effikaċja minn GO-REVEAL
English: In patients with rare hereditary problems of fructose intolerance, the additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account (see section 2).
Maltese: F'pazjenti bi problemi ereditarji rari ta' intolleranza għall-fructose, għandu jitqies l-effett addittiv meta prodotti li fihom sorbitol (jew fructose) jingħataw flimkien malprodott u t-teħid ta' sorbitol (jew fructose) mid-dieta (ara sezzjoni 2).
English: Each pre-filled pen can deliver 0.1 mL to 0.45 mL (corresponding to 10 mg to 45 mg golimumab) in increments of 0.05 mL.
Maltese: Kull pinna mimlija għal-lest tista' tforni 0.1 mL sa 0.45 mL (li jaqblu ma' 10 mg sa 45 mg golimumab) b'żidiet ta' 0.05 mL.
English: Bacterial (including sepsis and pneumonia), mycobacterial (including TB), invasive fungal and opportunistic infections, including fatalities, have been reported in patients receiving golimumab.
Maltese: Infezzjonijiet ikkawżati minn batterja (inkluż sepsi u pnewmonja), mikobatterja (inkluż TB), fungi invażivi u infezzjonijiet opportunistiċi, inklużi imwiet, kienu rrappurtati f'pazjenti li kienu qed jirċievu golimumab.
English: Do not return this medicine to refrigerator if it has reached room temperature.
Maltese: Terġax tpoġġi l-mediċina lura fil-friġġ jekk tkun laħqet temperatura ambjentali.
English: Simponi given as an initial dose of 200 mg, followed by 100 mg at week 2.
Maltese: Simponi jingħata bħala doża inizjali ta' 200 mg, segwita minn 100 mg f'ġimgħa 2.
English: Use of TNF-blocking agents, including golimumab, has been associated with cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis and peripheral demyelinating disorders.
Maltese: L-użu ta' sustanzi li jimblukkaw it-TNF inkluż golimumab, kien assoċjat mal-iżvilupp ta' każijiet ġodda jew aggravar ta' sintomi kliniċi u/jew evidenza radjugrafika ta' disturbi li jinvolvu t-therrija talmajelin tas-sistem nervuża ċentrali, inkluż sklerożi multipla u disturbi periferali li jneħħu l-majelin.
English: Table 6 Key efficacy outcomes from GO-REVEAL
Maltese: Tabella 6 Riżultati ewlenin dwar l-effikaċja minn GO-REVEAL
English: Nervous system disorders
Maltese: Disturbi fis-sistema endokrinarja Komuni:
English: In the controlled period of UC trials of golimumab induction, serious infections were observed in 0.8% of golimumab-treated patients compared with 1.5% of control-treated patients.
Maltese: Fil-perjodu kkontrollat tal-provi b'UC, ta' induzzjoni b'golimumab, kienu osservati infezzjonijiet serji f'0.8% tal-pazjenti kkurati b'golimumab meta mqabbla ma' 1.5% tal-pazjenti kkurati bil-kontroll.
English: • Lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes)
Maltese: • Reazzjonijiet likenojdi (raxx tal-ġilda ħamrani fil-vjola bil-ħakk u/jew ħjut bojod fil-griż fuq il membrani mukużi)
English: Common: Allergic reactions (bronchospasm, hypersensitivity, urticaria), autoantibody positive Rare: Serious systemic hypersensitivity reactions (including anaphylactic reaction), vasculitis (systemic), sarcoidosis
Maltese: Reazzjonijiet serji sistemiċi ta' sensittività eċċessiva (inkluż reazzjoni anafilattika), vaskulite (sistemika), sarkojdożi
English: Remove the cap (figure 4)
Maltese: Neħħi t-tokka (figura 4)
English: More Simponi-treated patients demonstrated sustained mucosal healing (patients with mucosal healing at both week 30 and week 54) in the 50 mg group (42%, nominal p < 0.05) and 100 mg group (42%, p < 0.005) compared with patients in the placebo group (27%).
Maltese: Aktar pazjenti kkurati b'Simponi wrew fejqan sostnut tal-mukuża (pazjenti b'fejqan tal-mukuża kemm f'ġimgħa 30 kif ukoll f'ġimgħa 54) fil-grupp ta' 50 mg (42%, p nominali < 0.05) u fil-grupp ta' 100 mg (42%, p < 0.005) mqabbel ma' pazjenti fil-grupp tal-plaċebo (27%).
English: For placebo subjects, the incidence (95% CI) per 100 subject-years of follow-up of these malignancies was 0.00 (0.00, 2.94).
Maltese: Għal individwi fuq plaċebo, l-inċidenza (95% CI) għal kull 100 sena ta' individwu ta' follow-up ta' dawn it-tumuri malinni kienet 0.00 (0.00, 2.94).
English: Eight malignancies in the combined golimumab treatment group (n = 230) and none in the placebo treatment group (n = 79) were reported.
Maltese: Kienu rrappurtati tmien tumuri malinni fil-grupp kombinat ta' kura b'golimumab (n = 230) u ma kien irrappurtat l-ebda wieħed fil-grupp ta' kura fuq plaċebo (n = 79).
English: • If your doctor feels that you are at risk of TB, you may be treated with medicines for TB before you begin using Simponi.
Maltese: • Jekk it-tabib tiegħek iħoss li għandek riskju ta' TB, tista' tiġi ikkurat b'mediċini ghat-TB qabel tibda tuża Simponi.
English: The combination of golimumab and abatacept is not recommended.
Maltese: Il-kombinazzjoni ta' golimumab u abatacept mhix rakkomandata.
English: Concomitant stable doses of oral aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted.
Maltese: Dożi stabbli fl-istess ħin ta' aminosalicylates orali, kortikosterojdi, u/jew sustanzi immunomodulatorji kienu permessi.
English: Simponi works by blocking the action of a protein called ‘tumour necrosis factor alpha' (TNF-α).
Maltese: Simponi jaħdem billi jimblokka l-azzjoni ta' proteina li tissejjaħ ‘fattur alfa tan-nekrożi tat-tumur' (TNF-α).
English: b < 1.3 BASDAI 50 Inhibition of inflammation in sacroiliac (SI) joints as measured by MRI Placebo Simponi 50 mg Placebo Simponi 50 mg
Maltese: Inibizzjoni ta' infjammazzjoni fil-ġogi bejn l-ossu sagru u l-ilju (SI - sacroiliac) kif imkejjel b'MRI Plaċebo Simponi 50 mg Plaċebo Simponi 50 mg n
English: • Reduce the signs and symptoms of your disease.
Maltese: • Tnaqqas is-sinjali u s-sintomi tal-marda tiegħek.
English: Use of live vaccines could result in clinical infections, including disseminated infections.
Maltese: L-użu ta' tilqim ħaj jista' jwassal għal infezzjonijiet kliniċi, inkluż infezzjonijiet mifruxa.
English: In the Phase II and III UC studies through week 54, antibodies to golimumab were detected in 3% (26/946) of golimumab treated patients.
Maltese: II u III sa ġimgħa 54, instabu antikorpi għal golimumab fi 3% (26/946) talpazjenti kkurati b'golimumab.
English: ASAS Partial Remission ASDAS-C
Maltese: ISTRUZZJONIJIET DWAR L-UŻU
English: In the controlled portions of the Simponi Phase IIb and Phase III clinical trials in RA, PsA, AS, and ulcerative colitis (UC), the incidence of non-lymphoma malignancies (excluding non-melanoma skin cancer) was similar between the golimumab and the control groups.
Maltese: III f'RA, PsA, AS u kolite ulċerattiva (UC - ulcerative colitis), il-frekwenza ta' tumuri malinni li ma kienux limfoma (minbarra kanċer tal-ġilda li mhux melanoma) kien simili bejn Simponi u l-gruppi tal-kontroll.
English: Axial spondyloarthritis
Maltese: • Ġebel fil-marrara
English: During the Simponi Phase IIb and Phase III clinical trials in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS), the incidence of lymphoma in golimumab-treated patients was higher than expected in the general population.
Maltese: III f'artrite rewmatojde (RA - rheumatoid arthritis), artrite psorjatika (PsA - psoriatic arthritis) u ankylosing spondylitis (AS), limfoma seħħet aktar ta' spiss f'pazjenti fuq kura b'golimumab minn dak mistenni filpopolazzjoni ġenerali.
English: *CHOKING HAZARD!
Maltese: *PERIKLU TA' FGAR!
English: Simponi is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.
Maltese: Simponi huwa indikat għall-kura ta' ankylosing spondylitis severa u attiva f'adulti li ma kellhomx rispons adegwat għat-terapija konvenzjonali.
English: In the Phase III pJIA study through week 48, antibodies to golimumab were detected by the drug-tolerant EIA method in 40% (69/172) of golimumab treated children of which a majority had a titre lower than 1:1000.
Maltese: III dwar pJIA sat-48 ġimgħa, permezz tal-metodu ta' EIA li jittollera l-mediċina instabu antikorpi għal golimumab f'40% (69/172) tat-tfal ittrattati b'golimumab li l-maġġoranza tagħhom kellhom titre inqas minn 1:1000.
English: CARTON FOR MULTIPACK COMPRISING 3 PACKS (INCLUDING BLUE BOX)
Maltese: KARTUNA GĦALL-PAKKETT B'ĦAFNA LI FIH 3 PAKKETTI (INKLUŻ
English: Golimumab should be used with caution in patients with mild heart failure (NYHA class I/II).
Maltese: Golimumab għandu jintuża b'attenzjoni f'pazjenti b'CHF ħafifa (klassi NYHA I/II).
English: Simponi 50 mg treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment at week 24 as measured by change from baseline in total modified vdH-S Score (mean ± SD score was 0.27 ± 1.3 in the placebo group compared with -0.16 ± 1.3 in the Simponi group; p = 0.011).
Maltese: Il-kura b'Simponi 50 mg naqqset ir-rata ta' progressjoni ta' ħsara fil-ġogi periferali meta mqabbla ma' kura bi plaċebo f'ġimgħa 24 kif imkejla bil-bidla mil-linja bażi fil-Punteġġ totali modifikat vdH-S (medja ± SD tal-punteġġ kien 0.27 ± 1.3 fil-grupp ta' plaċebo meta mqabbel ma' -0.
English: • Check the expiration date printed or written on the carton.
Maltese: • Iċċekkja d-data ta' skadenza stampata jew miktuba fuq il-kartuna.
English: Treatment with concomitant MTX resulted in a lower proportion of patients with antibodies to golimumab than patients receiving golimumab without MTX (approximately 3% [41/1235] versus 8% [64/827], respectively).
Maltese: Kura fl-istess ħin b'MTX irriżultat f'proporzjon iżgħar ta' pazjenti b'antikorpi għal golimumab milli pazjenti li kienu qed jirċievu golimumab mingħajr MTX (madwar 3% [41/1235] kontra 8% [64/827], rispettivament).
English: Among the children who tested positive for antibodies to golimumab, 39% (25/65) had neutralising antibodies.
Maltese: Fost it-tfal li kellhom riżultat pożittiv għat-test ta' antikorpi għal golimumab, 39% (25/65) kellhom antikorpi li jinnewtralizzaw.
English: In the controlled period of pivotal trials, upper respiratory tract infection was the most common adverse reaction reported in 12.6% of golimumab-treated patients (incidence per 100 subject-years: 60.8; 95% CI: 55.0, 67.1) compared with 11.0% of control patients (incidence per 100 subject-years: 54.5; 95% CI: 46.1, 64.0).
Maltese: Fil-perjodu kkontrollat tal-provi pivitali, infezzjoni fil-passaġġ respiratorju fil-parti ta' fuq kienet l-aktar reazzjoni avversa komuni irrappurtata fi 12.6% tal-pazjenti kkurati b'golimumab (inċidenza għal kull 100 sena ta' individwu: 60.8; 95% CI: 55.0, 67.1) meta mqabbla ma' 11.0% tal-pazjenti ta' kontroll (inċidenza għal kull 100 sena ta' individwu: 54
English: In the Phase II and III UC studies through week 54, antibodies to golimumab were detected by the EIA method in 3% (26/946) of golimumab treated patients.
Maltese: II u III sa ġimgħa 54, instabu antikorpi għal golimumab bil-metodu EIA fi 3% (26/946) tal-pazjenti kkurati b'golimumab.
English: Key ACR results for the Simponi 50 mg dose at weeks 14, 24 and 52 for GO-FORWARD, GO-AFTER and GO-BEFORE are shown in Table 4 and are described below.
Maltese: Ir-riżultati ewlenin ACR għad-doża ta' Simponi 50 mg f'ġimgħa 14, 24 u 52 għal GO-FORWARD, GO-AFTER u GO-BEFORE qed jidhru f'Tabella 4 u qed jiġu deskritti hawn taħt.
English: Vaccinations/therapeutic infectious agents
Maltese: Tilqim/sustanzi terapewtiċi infettivi
English: In an exploratory clinical study, patients with severe persistent asthma received a golimumab loading dose (150% of the assigned treatment dose) subcutaneously at week 0 followed by golimumab 200 mg, golimumab 100 mg or golimumab 50 mg every 4 weeks subcutaneously through week 52.
Maltese: Fi studju kliniku esploratorju, pazjenti b'ażma severa u persistenti irċievew doża għolja tal-bidu ta' golimumab (150% tad-doża li tkun allokata) minn taħt il-ġilda f'ġimgħa 0 segwita b'golimumab 200 mg, golimumab 100 mg jew golimumab 50 mg kull 4 ġimgħat minn taħt il-ġilda sa' ġimgħa 52.
English: Rare: Bladder disorders, renal disorders Reproductive system and breast disorders
Maltese: Disturbi fil-bużżieqa tal-awrina, disturbi renali Disturbi fis-sistema riproduttiva u fis-sider
English: In the controlled period of the pivotal trials in RA, PsA, AS, nr-Axial SpA, and UC, upper respiratory tract infection was the most common adverse reaction (AR) reported in 12.6% of golimumab-treated patients compared with 11.0% of control patients.
Maltese: Fil-perjodu kkontrollat tal-provi pivitali f'RA, PsA, AS, nr-Axial SpA, u UC, infezzjoni tal-passaġġ respiratorju fil-parti ta' fuq kienet l-aktar reazzjoni avversa (AR) komuni rrappurtata fi 12.6% talpazjenti ikkurati b'golinumab mqabbla ma' 11.0% tal-pazjenti fuq il-kontroll.
English: Key ACR results for the Simponi 50 mg dose at weeks 14, 24 and 52 for GO-FORWARD, GO-AFTER and GO-BEFORE are shown in Table 2 and are described below.
Maltese: Ir-riżultati ewlenin ACR għad-doża ta' Simponi 50 mg f'ġimgħa 14, 24 u 52 għal GO-FORWARD, GO-AFTER u GO-BEFORE qed jidhru f'Tabella 2 u qed jiġu deskritti hawn taħt.
English: During the placebo-controlled portion of the study, the incidence (95% CI) of all malignancies per 100 subject-years of follow-up was 3.19 (1.38, 6.28) in the golimumab group.
Maltese: Waqt il-parti tal-istudju ikkontrollata bi plaċebo, l-inċidenza (95% CI) tat-tumuri malinni kollha għal kull 100 sena ta' individwu ta' follow-up kienet 3.19 (1.38, 6.28) fil-grupp ta' golimumab.
English: Other medicines and Simponi
Maltese: Mediċini oħra u Simponi
English: Table 3 Radiographic mean (SD) changes from baseline in total vdH-S score at week 52 in the overall population of GO-BEFORE Placebo + MTX Simponi 50 mg + MTX
Maltese: Tabella 3 Medja radjugrafika (SD) tal-bidliet mil-linja bażi f'punteġġ totali vdH-S f'ġimgħa 52 filpopolazzjoni globali ta' GO-BEFORE Plaċebo + MTX Simponi 50 mg + MTX
English: Concomitant stable doses of oral aminosalicylates, and/or immunomodulatory agents were permitted.
Maltese: Dożi stabbli fl-istess ħin ta' aminosalicylates orali, u/jew sustanzi immunomodulatorji kienu permessi.