FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence of anti-infliximab antibodies following the subcutaneous infliximab was demonstrated to be not higher than that of the intravenous infliximab and had no significant impact on efficacy (determined by disease activity score in 28 joints [DAS28] and American College of Rheumatology criteria 20 [ACR20]) and the safety profile.
Maltese: Immunoġeniċità L-inċidenza ta' antikorpi kontra infliximab wara infliximab subkutanju intweriet li ma kinitx ogħla minn dik ta' infliximab ġol-vini u ma kellha ebda impatt sinifikanti fuq l-effikaċja (determinata millpunteġġ tal-attività tal-marda fi 28 ġog [DAS28] u mill-kriterju 20 tal-American College of Rheumatology [ACR20]) u l-profil ta' sigurtà.
English: PGA of cleared (0) or minimal (1)
Maltese: PGA ta' pazjenti bid-dwiefer imfejqa (0), minimu (1),
English: a. Leave the syringe at room temperature for 30 minutes to allow it to naturally warm up.
Maltese: Ħalli l-pinna f'temperatura ambjentali għal 30 minuta biex tħalliha tisħon b'mod naturali.
English: 10 mg/kg q 4 wks
Maltese: 10 mg/kg q 4
English: Week 22
Maltese: Ġimgħa 22
English: Proportions of Patients Achieving Clinical Response According to the ACR Criteria ACR20
Maltese: Tabella 6 Proporzjonijiet ta' Pazjenti li Kisbu Rispons Kliniku Skont il-Kriterji tal-ACR ACR20
English: Patients in both studies had plaque psoriasis (Body Surface Area [BSA] ≥10% and Psoriasis Area and Severity Index [PASI] score ≥12).
Maltese: Il-pazjenti fiż-żewġ studji kellhom psorjasi talplakka (Erja tas-Superfiċje tal-Ġisem [BSA] ≥ 10% u punteġġ tal-Indiċi tas-Severità u l-Erja talPsorjasi [PASI] ≥ 12).
English: Localised injection site reactions predominantly of mild to moderate in nature included the following reactions limited to injection site: erythema, pain, pruritus, swelling, induration, haematoma, oedema, bruising, coldness, irritation, paraesthesia, ulcer, urticaria, haemorrhage, rash and scab were reported to be associated with infliximab subcutaneous treatment.
Maltese: Reazzjonijiet lokalizzati fis-sit tal-injezzjoni li huma predominantament ta' natura ħafifa għal moderata inkludew ir-reazzjonijiet li ġejjin limitati għas-sit tal-injezzjoni: eritema, uġigħ, ħakk, nefħa, twebbis, ematoma, edema, tbenġil, kesħa, irritazzjoni, paraesteżija, ulċeri, urtikarja, emorraġija, raxx u qoxra xotta ġew irrapportati li huma assoċjati ma' kura taħt il-ġilda ta' infliximab.
English: Placebo Maintenance
Maltese: Placebo
English: 1 pre-filled syringe with 2 alcohol pads 1 pre-filled syringe with needle guard with 2 alcohol pads 2 pre-filled syringes with 2 alcohol pads 2 pre-filled syringes with needle guard with 2 alcohol pads 4 pre-filled syringes with 4 alcohol pads 4 pre-filled syringes with needle guard with 4 alcohol pads
Maltese: 1 siringa mimlija għal-lest b'2 pads tal-alkoħol 1 siringa mimlija għal-lest bi lqugħ għal-labra b'2 pads tal-alkoħol 2 siringi mimlijin għal-lest b'2 pads tal-alkoħol 2 siringi mimlijin għal-lest bi lqugħ għal-labra b'2 pads tal-alkoħol 4 siringi mimlijin għal-lest b'4 pads tal-alkoħol 4 siringi mimlijin għal-lest bi lqugħ għal-labra b'4 pads tal-alkoħol
English: Intestinal perforation, intestinal stenosis, diverticulitis, pancreatitis, cheilitis
Maltese: Titqib fil-musrana, stenożi fil-musrana, divertikulite, pankreatite, kejlite.
English: This medicine contains 45 mg sorbitol in each 120 mg dose.
Maltese: Din il-mediċina fiha 45 mg sorbitol f'kull doża ta' 120 mg.
English: Remsima is produced in packs of 1, 2, 3, 4 or 5 vials.
Maltese: Remsima jiġi f'pakketti ta' 1, 2, 3, 4 jew 5 kunjetti.
English: Sorbitol content Remsima contains 45 mg sorbitol per 1 mL (in each 120 mg dose).
Maltese: Remsima fih 45 mg sorbitol għal kull 1 mL (f'kull doża ta' 120 mg).
English: Table 5 Effects on response and remission rate, data from ACCENT I (Week-2 responders)
Maltese: Tabella 5 Effetti fuq ir-rispons u r-rata ta' tnaqqis, dejta minn ACCENT I (persuni li rrispondew sa ġimgħa 2) ACCENT I (persuni li rrispondew ta' ġimgħa 2)
English: In this study 150 patients with NYHA Class III-IV CHF (left ventricular ejection fraction ≤35%) were treated with 3 infusions of infliximab 5 mg/kg, 10 mg/kg, or placebo over 6 weeks.
Maltese: III-IV CHF tal-NYHA (frazzjoni tal-volum tal-ventrikulu tax-xellug ppumpjat ≤ 35%) kienu kkurati bi tliet infużjonijiet ta' infliximab ta' 5 mg/kg, 10 mg/kg, jew plaċebo fuq sitt ġimgħat.
English: Name patient:
Maltese: 5 kriterji:
English: Remsima 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: Remsima huwa indikat għall-kura ta' kolite ulċerattiva attiva minn moderata sa severa f'pazjenti adulti li ma kellhomx rispons adegwat għat-terapija konvenzjonali, inkluż kortikosterojdi u 6-mercaptopurine (6-MP) jew azathioprine (AZA), jew li huma intolleranti għal jew għandhom kontra-indikazzjonijiet mediċi għal terapiji bħal dawn.
English: Single intravenous doses up to 20 mg/kg have been administered without toxic effects and repeated doses of Remsima subcutaneous formulation up to 240 mg have been administered without toxic effects.
Maltese: Dożi b'waħdiet ġol-vina sa 20 mg/kg ġew mogħtija mingħajr effetti tossiċi u dożi ripetuti ta' Remsima formulazzjoni taħt il-ġilda sa 240 mg ingħataw mingħajr effetti tossiċi.
English: The most serious ADRs associated with the use of TNF blockers that have been reported for infliximab include HBV reactivation, CHF (congestive heart failure), serious infections (including sepsis, opportunistic infections and TB), serum sickness (delayed hypersensitivity reactions), haematologic reactions, systemic lupus erythematosus/lupus-like syndrome, demyelinating disorders, hepatobiliary events, lymphoma, HSTCL, leukaemia, Merkel cell carcinoma, melanoma, paediatric malignancy, sarcoidosis/sarcoid-like reaction, intestinal or perianal abscess (in Crohn's disease), and serious infusion reactions (see section 4.4).
Maltese: L-aktar ADRs serji assoċjati ma' użu ta' imblokkaturi ta' TNF li kienu rrappurtati għal infliximab jinkludu attivazzjoni mill-ġdid ta' HBV, CHF (congestive heart failure, insuffiċjenza konġestiva tal-qalb), infezzjonijiet serji (li jinkludu sepsis, infezzjonijiet opportunistiċi u TB), mard tas-serum (reazzjonijiet ta' sensittività eċċessiva li jdumu biex iseħħu), reazzjonijiet ematoloġiċi, lupus erythematosus sistemiku/sindrome jixbah il-lupus, disturbi ta' demijelinazzjoni, avvenimenti tal-fwied u tal-marrara, limfoma, HSTCL, lewkimja, karċinoma taċ ċellula ta' Merkel, melanoma, tumuri malinni fit-tfal, sarkojdosi/ reazzjoni li tixbah lil sarkojdosi,
English: Clinical Responsea
Maltese: KLINIKU
English: • Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson syndrome and acute generalised exanthematous pustulosis
Maltese: • Nuqqas ta' interess jew emozzjoni • Problemi serji fil-ġilda bħal nekroliżi tossika tal-epiderme, Sindrome ta' Stevens-Johnson u pustullożi ekżantematuża mifruxa akuta
English: About the Remsima pen Parts of the pen (see Figure A):
Maltese: Dwar ir-Remsima pinna Partijiet tal-pinna (ara l-Figura A):
English: The safety and efficacy of infliximab were assessed in two (ACT 1 and ACT 2) randomised, double-blind, placebo-controlled clinical studies in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥2) with an inadequate response to conventional therapies [oral corticosteroids, aminosalicylates and/or immunomodulators (6-MP, AZA)].
Maltese: Is-sigurtà u l-effikaċja ta' infliximab kienu evalwati f'żewġ studji kliniċi (ACT 1 u ACT 2) li fihom ilparteċipanti ntgħażlu b'mod każwali, double blind, ikkontrollati bi plaċebo f'pazjenti adulti b'kolite ulċerattiva attiva b'mod moderat sa sever (Punteġġ Mayo 6 sa 12; Sottopunteġġ tal-endoskopija ≥ 2)
English: Concurrent use of stable doses of oral corticosteroids (≤10 mg/day) and/or NSAIDs was permitted, and folate supplementation was given.
Maltese: Użu fl-istess ħin ta' kortikosterojdi orali (≤ 10 mg/kuljum) u/jew NSAIDs ġie permess, u ngħataw supplementi ta' folate.
English: ≥50% improvement
Maltese: Titjib ta' ≥ 50%
English: Week 50 a p <0.001, for each infliximab treatment group vs. control.
Maltese: Medja ± SDd a p < 0.001, għal kull grupp li ngħata kura b'infliximab vs. kontroll.
English: Infections were reported in 31 (51.7%) of 60 treated patients in C0168T72 and 22 (36.7%) required oral or parenteral antimicrobial treatment.
Maltese: Infezzjonijiet Infezzjonijiet kienu rrappurtati f'31 (51.7%) minn 60 pazjent ikkurat f'C0168T72 u 22 (36.7%)
English: Week 54 125 (71.8%)a 132 (80.0%) 101 (58.0%)a 108 (65.5%) 68 (39.1%)a a Remsima IV was switched to Remsima SC at Week 30
Maltese: 0%) 101 (58.0%)a 108 (65.5%) 68 (39.1%)a 77 (46.7%)
English: Remsima belongs to a group of medicines called ‘TNF blockers'.
Maltese: Remsima jagħmel parti minn grupp ta' mediċini magħrufa bħala ‘imblokkaturi TNF'.
English: • If your doctor feels that you are at risk for TB, you may be treated with medicines for TB before you are given Remsima.
Maltese: • Jekk it-tabib tiegħek iħoss li għandek riskju li jkollok TB, tista' tingħata kura b'mediċini kontra t-TB qabel tingħata Remsima.
English: In the second clinical study (ASSERT), 279 patients were randomised to receive either placebo (Group 1, n=78) or 5 mg/kg infliximab (Group 2, n=201) at 0, 2 and 6 weeks and every 6 weeks to week 24.
Maltese: (Grupp 1, n=78) jew 5 mg/kg infliximab (Grupp 2, n=201) f'ġimgħa 0, 2 u 6 u kull 6 ġimgħat sa ġimgħa 24.
English: Anaphylactic shock, vasculitis, sarcoid-like reaction
Maltese: Xokk anafilattiku, vaskulite, reazzjoni tat-tip sarkojd.
English: Also at week 4, 13/27 (48%) of infliximab-treated patients achieved a clinical remission (CDAI <150) vs. 1/25 (4%) of placebo-treated patients.
Maltese: Fir-raba' ġimgħa wkoll, 13/27 (48%) tal-pazjenti li ngħataw infliximab kellhom fejqan kliniku mill-marda (CDAI < 150) kontra 1/25 (4%) tal-pazjenti li ngħataw plaċebo.
English: a Week 98 data for IMPACT includes combined placebo crossover and infliximab patients who entered the open-label extension.
Maltese: a Dejta ta' Ġimgħa 98 għal IMPACT jinkludi plaċebo kombinat crossover u pazjenti fuq infliximab li daħlu għall-estensjoni open-label.
English: Nine of these patients developed malignancies, including 1 lymphoma.
Maltese: Disgħa minn dawn il pazjenti żviluppaw tumuri malinni, inkluża limfoma.
English: Based on an observational study from Northern Europe, an increased risk (OR, 95% CI; p-value) for C-section (1.50, 1.14-1.96; p = 0.0032), preterm birth (1.48, 1.05-2.09; p = 0.024), small for gestational age (2.79, 1.54-5.04; p = 0.0007), and low birth weight (2.03, 1.41-2.94; p = 0.0002) was observed in women exposed during pregnancy to infliximab (with or without immunomodulators/corticosteroids, 270 pregnancies) as compared to women exposed to immunomodulators and/or corticosteroids only (6,460 pregnancies).
Maltese: p = 0.024), tarbija żgħira għall-età tat-tqala (2.79, 1.54-5.04; p = 0.0007), u piż tat-twelid baxx (2.03, 1.41-2.94; p = 0.0002) f'nisa esposti għal infliximab matul it-tqala (flimkien ma'
English: Pregnancy, breast-feeding and fertility
Maltese: Tqala, treddigħ, u fertilità
English: Give the injection (see Figure F).
Maltese: Agħti l-injezzjoni (ara l-Figura F).
English: Other medicines and Remsima
Maltese: Mediċini oħra u Remsima
English: Population pharmacokinetic analysis based on data obtained from patients with ulcerative colitis (N=60), Crohn's disease (N=112), juvenile rheumatoid arthritis (N=117) and Kawasaki disease (N=16) with an overall age range from 2 months to 17 years indicated that exposure to infliximab was dependent on body weight in a non-linear way.
Maltese: Analiżi farmakokinetika tal-popolazzjoni bbażata fuq dejta miksuba minn pazjenti b'kolite ulċerattiva (N=60), marda ta' Crohn (N=112), artrite rewmatojde ġuvenili (N=117) u l-marda ta' Kawasaki
English: Use of concomitant immunosuppressant agents appeared to reduce the frequency of infusion-related reactions.
Maltese: ġie osservat tnaqqis fil-frekwenza ta' reazzjonijiet relatati mal-infużjoni.
English: The ASPIRE study evaluated responses at 54 weeks in 1,004 methotrexate naive patients with early (≤3 years disease duration, median 0.6 years) active rheumatoid arthritis (median swollen and tender joint count of 19 and 31, respectively).
Maltese: L-istudju ASPIRE evalwa ir-rispons mal-ġimgħa 54 f'1,004 pazjenti li qatt ma ngħataw methotrexate (marda tkun ilha ≤ 3 snin, medjan 0.6 sena) b'artrite rewmatojde attiva li tkun feġġet kmieni (l-għadd medjan tal-ġogi minfuħin u teneri ta' 19 u 31 rispettivament).
English: Table 1 Adverse reactions in clinical studies and from post-marketing experience
Maltese: Tabella 1 Reazzjonijiet avversi fi studji kliniċi u mill-esperjenza ta' wara t-tqegħid fis-suq
English: Remsima contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Maltese: Remsima fih inqas minn 1 mmol sodium (23 mg) f'kull doża, i.e. huwa essenzjalment ‘ħieles missodium.
English: After infliximab treatment, patients exhibited decreased levels of serum interleukin 6 (IL-6) and C-reactive protein (CRP), and increased haemoglobin levels in rheumatoid arthritis patients with reduced haemoglobin levels, compared with baseline.
Maltese: Wara kura b'infliximab, il-pazjenti wrew tnaqqis fil-livelli ta' interleukin 6 (IL-6) fis-serum u proteina reattiva-Ċ (CRP), u żieda fil-livelli ta' emoglobina f'pazjenti b'artrite rewmatojde b'livelli aktar baxxi ta'
English: Remsima IV 3 mg/kgb (N=174)
Maltese: Remsima IV 3 mg/kgb
English: Single subcutaneous injections of 120, 180 and 240 mg of infliximab yielded approximately dose proportional increases in the maximum serum concentration (Cmax) and area under the concentrationtime curve (AUC).
Maltese: Injezzjonijiet taħt il-ġilda ta' darba ta' 120, 180 u 240 mg ta' infliximab taw bejn wieħed u ieħor żidiet proporzjonali għad-dożi tal-konċentrazzjoni massima fis-serum (Cmax) u fl-erja taħt il-kurva talkonċentrazzjoni mal-ħin (AUC).
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 ilmembrani mukużi).
English: The incidence of systemic injection reactions (e.g. rash, pruritus, flushing and oedema) was 1.2 per 100 patient-years in the Remsima subcutaneous group (from Week 6) and 2.1 per 100 patient-years in the Remsima intravenous group who switched to Remsima subcutaneous administration (from Week 30).
Maltese: L-inċidenza tar-reazzjonijiet għall-injezzjoni sistemika (eż. raxx, prurite, ħmura fil-wiċċ u edema) kienet 1.2 għal kull 100 sena ta' pazjent fil-grupp ta' Remsima subkutanju (minn Ġimgħa 6) u 2.1 għal kull 100 sena ta' pazjent fil-grupp ta' Remsima intravenuż li qelbu għal għoti subkutanju ta' Remsima (minn Ġimgħa 30).
English: 3 mg/kg q 4 wks
Maltese: 3 mg/kg q 4 ġimg ħat
English: Appropriate screening tests, (e.g. tuberculin skin test, chest X-ray, and/or Interferon Gamma Release Assay), should be performed in all patients (local recommendations may apply).
Maltese: Screening tests adattati (eż. test tal ġilda bit-tuberkulin, X-ray tas-sider u/jew Assaġġ tar-Rilaxx tal-Interferon Gamma) għandhom isiru fuq il-pazjenti kollha (rakkomandazzjonijiet lokali jistgħu jkunu applikati).
English: Some of these infections have been fatal; the most frequently reported opportunistic infections with a mortality rate of >5% include pneumocystosis, candidiasis, listeriosis and aspergillosis (see section 4.4).
Maltese: > 5% jinkludu pnewmoċistożi, kandidijażi, listerjożi u asperġillożi (ara sezzjoni 4.4).
English: A reduction in signs and symptoms was defined to be at least a 20% improvement (ACR20) in both tender and swollen joint counts, and in 3 of the following 5 criteria: (1) evaluator's global assessment, (2) patient's global assessment, (3) functional/disability measure, (4) visual analogue pain scale and (5) erythrocyte sedimentation rate or C-reactive protein.
Maltese: (1) l-evalwazzjoni globali tal-evalwatur, (2) l-evalwazzjoni globali tal-pazjent, (3) kejl tal funzjonalità/diżabiltà, (4) skala viżwali analoga tal-uġigħ u (5) rata ta' sedimentazzjoni tal-eritroċiti jew proteina reattiva-Ċ.
English: It is recommended that therapeutic infectious agents not be given concurrently with infliximab (see section 4.4).
Maltese: Huwa rrakkomandat li sustanzi terapewtiċi infettivi ma jingħatawx flimkien ma' infliximab (ara sezzjoni 4.4).
English: The mean scores for DAS28 (CRP) and DAS28 (ESR) gradually decreased from baseline at each time point until Week 54 in each treatment arm (see Table 5 and Table 6, respectively).
Maltese: Il-punteġġi medji għal DAS28 (CRP) u DAS28 (ESR) naqsu gradwalment millinja bażi f'kull punt ta' żmien sal-Ġimgħa 54 f'kull fergħa tal-kura (ara t-Tabella 5 u t-Tabella 6,
English: The medicinal product may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Maltese: Il-prodott mediċinali jista' jinħażen f'temperaturi sa massimu ta' 25°C għal perjodu ta' massimu ta' 14-il jum.
English: Post-marketing spontaneous serious adverse reactions with infliximab in the paediatric population have included malignancies including hepatosplenic T-cell lymphomas, transient hepatic enzyme abnormalities, lupus-like syndromes, and positive auto-antibodies (see sections 4.4 and 4.8).
Maltese: Esperjenza ta' wara t-tqegħid fis-suq Reazzjonijiet avversi serji spontanji ta' wara t-tqegħid fis-suq b'infliximab fil-popolazzjoni pedjatrika kienu jinkludu tumuri malinni inklużi limfomi taċ-ċelluli T, anormalijiet temporanji fl-enzimi epatiċi, sindromi li jixbhu l-lupus, u awtoantikorpi pożittivi (ara sezzjonijiet 4.4 u 4.8).
English: Fistula Response (%)a
Maltese: 0%) a
English: Hepatosplenic T-cell lymphoma (primarily in adolescents and young adult males with Crohn's disease and ulcerative colitis), Merkel cell carcinoma.
Maltese: Limfoma fil-fwied u fil-marrara taċ-ċelluli T (l-aktar f'adolexxenti u rġiel adulti żgħar bil-marda ta' Crohn u kolite ulċerattiva), karċinoma taċ-ċellula ta' Merkel.
English: Remsima 120 mg solution for injection in pre-filled syringe Remsima 120 mg solution for injection in single-use pre-filled syringe (type I glass) with a plunger stopper (flurotec-coated elastomer) and needle with a rigid needle shield.
Maltese: Remsima 120 mg soluzzjoni għal injezzjoni ġo siringa mimlija għal-lest Remsima 120 mg soluzzjoni għal injezzjoni ġo siringa mimlija għal-lest li tintuża darba (ħġieġ tip I) bi stopper tal-planġer (elastomer miksi bi flurotec) u labra bi lqugħ riġidu għal-labra.
English: Date of Remsima therapy initiation:
Maltese: Data tal-ewwel awtorizzazzjoni:
English: Infliximab (Week 24)
Maltese: terapija b'infliximab waħdu (30.
English: Remsima is indicated for:
Maltese: Mhux magħruf:
English: • The other ingredients are acetic acid, sodium acetate trihydrate, sorbitol, polysorbate 80 and water for injections.
Maltese: • Is-sustanzi l-oħra huma acetic acid, sodium acetate trihydrate, sorbitol, polysorbate 80, u ilma għall-injezzjonijiet.
English: Remsima is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Maltese: Remsima huwa indikat għall-kura ta' ankylosing spondylitis attiva, severa, f'pazjenti adulti li ma kellhomx rispons adegwat għal terapija konvenzjonali.
English: At 38 weeks, 9 of 101 patients treated with infliximab (2 at 5 mg/kg and 7 at 10 mg/kg) died compared to one death among the 49 patients on placebo.
Maltese: 38 ġimgħa, 9 minn 101 pazjent li ngħataw infliximab (2 b'5 mg/kg u 7 b'10 mg/kg) mietu meta mqabbel ma' mewt waħda fost id-49 pazjent fuq plaċebo.
English: Finish the injection (see Figure G).
Maltese: Temm l-injezzjoni (ara l-Figura G).
English: In a subset of 90 adult patients with rheumatoid arthritis from the ASPIRE study a similar proportion of patients in each treatment group (methotrexate plus: placebo [n = 17], 3 mg/kg [n = 27] or 6 mg/kg infliximab [n = 46]) mounted an effective two-fold increase in titers to a polyvalent pneumococcal vaccine, indicating that infliximab did not interfere with T-cell independent humoral immune responses.
Maltese: F'sottosett ta' 90 pazjent adult b'artrite rewmatojde mill-istudju ASPIRE proporzjon simili ta' pazjenti f'kull grupp ta' trattament (methotrexate flimkien ma': plaċebo [n = 17], 3 mg/kg [n = 27] jew 6 mg/kg infliximab [n = 46]) kellhom żieda effettiva doppja fit-titri għal vaċċin pnewmokokkali polivalenti, li jindika li infliximab ma nterferixxiex mar-risponsi immuni tal-umuri indipendenti miċ ċelluli T. Madankollu, studji mil-letteratura ppubblikata f'diversi indikazzjonijiet (eż. artrite rewmatika, psorjasi, marda ta' Crohn) jissuġġerixxu li tilqim mhux ħaj li wieħed jirċievi waqt trattament b'terapiji kontra TNF, inkluż infliximab, jistgħu jisiltu rispons immuni aktar baxx milli f'pazjenti li ma jkunux qed jirċievu terapija kontra TNF.
English: The primary endpoint of the study was the treatment difference of the change from baseline of DAS28 (CRP) at Week 22.
Maltese: Il-punt ta' tmiem primarju tal-istudju kien id-differenza fil-kura tal-bidla mil-linja bażi ta' DAS28 (CRP) fil-Ġimgħa 22.
English: The required volume of the reconstituted Remsima solution should be diluted to 250 mL with sodium chloride 9 mg/mL (0.9%) solution for infusion.
Maltese: Il-volum meħtieġ tad-doża tas-soluzzjoni rikostitwita Remsima għandu jiġi dilwit għal 250 mL b'soluzzjoni għall-infużjoni ta' sodium chloride 9 mg/mL (0.9%).
English: The primary endpoints were the reduction of signs and symptoms as assessed by the ACR criteria (ACR20 for ATTRACT, landmark ACR-N for ASPIRE), the prevention of structural joint damage, and the improvement in physical function.
Maltese: Il-punti aħħarin ewlenin kienu t-tnaqqis fis-sinjali u s-sintomi kif imkejla skont il-kriterji tal-ACR (ACR20 għal ATTRACT, landmark ACR-N għal ASPIRE), il-prevenzjoni ta' ħsara strutturali fil ġogi, u t-titjib fil-funzjoni fiżika.
English: Early recognition of atypical clinical presentations of serious infections and of typical clinical presentation of rare and unusual infections is critical in order to minimise delays in diagnosis and treatment.
Maltese: Irrikonoxximent minn kmieni ta' preżentazzjonijiet kliniċi mhux tipiċi ta' infezzjonijiet serji u ta' preżentazjoni klinika tipika ta' infezzjonijiet rari u mhux tas-soltu huwa kritiku sabiex jitnaqqsu d dewmien tad-dijanjosi u l-kura.
English: For more information about the safety of infliximab in elderly patients, see sections 4.4 and 4.8.
Maltese: infliximab f'pazjenti anzjani, ara sezzjonijiet 4.4 u 4.8.
English: For storage conditions up to 25°C before reconstitution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna sa 25°C qabel ir-rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: A greater proportion of patients in the combined infliximab treatment group were able to discontinue corticosteroids while remaining in clinical remission compared to the placebo treatment group at both week 30 (22.3% vs. 7.2%, p <0.001, pooled ACT 1 & ACT 2 data) and week 54 (21.0% vs. 8.9%, p=0.022, ACT 1 data).
Maltese: (22.3% vs 7.2%, p < 0.001, dejta ACT 1 u ACT 2 mgħaqqdin flimkien) u ġimgħa 54 (21.0% vs. 8.9%, p=0.022, dejta ACT 1).
English: Table 6 Percent of patients achieving corticosteroid-free clinical remission at Week 26, SONIC
Maltese: Perċentwali ta' pazjenti li kisbu nuqqas totali tas-sinjali u s-sintomi kliniċi mingħajr kortikosterojdi f'ġimgħa 26, SONIC
English: • Rheumatoid arthritis.
Maltese: • Artrite rewmatojde.