FrancophonIA/ELRC3.0 huggingface dataset:
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 (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, axxess fl-imsaren jew perianali
English: Significant improvements from baseline were demonstrated in DLQI (p<0.001) and the physical and mental component scores of the SF 36 (p<0.001 for each component comparison).
Maltese: Titjib sinifikanti mil-linja bażi ġew osservati fil-DLQI (p < 0.001) u l-punteġġi fiżiċi u mentali talkomponenti tal-SF 36 (p < 0.001 għall-paragun ta' kull komponent).
English: • Inflamed liver caused by a problem with the immune system (autoimmune hepatitis)
Maltese: • Fwied infjammat ikkawżat minn problema bis-sistema immuni (epatite awtoimmuni)
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) b'rispons inadegwat għat-terapiji konvenzjonali [kortikosterojdi orali, aminosalicylates u/jew immunomodulaturi (6-MP, AZA)].
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 titres 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 miċċelluli T.
English: • Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson syndrome and acute generalised exanthematous pustulosis
Maltese: • Problemi serji fil-ġilda bħal nekroliżi tossika tal-epiderme, sindrome ta' Stevens-Johnson u pustullożi ekżantematuża mifruxa akuta
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Rare:
Maltese: Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi) Rari:
English: Psoriatic arthritis, ankylosing spondylitis (Bechterew's disease), psoriasis, ulcerative colitis and Crohn's disease
Maltese: Artrite bi psorjasi, ankylosing spondylitis (Marda ta' Bechterew), psorjasi, kolite ulċerattiva u lmarda ta' Crohn
English: Infliximab b
Maltese: infliximab
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: Proporzjon akbar ta' pazjenti fil-grupp ta' kura b'infliximab kombinat setgħu jwaqqfu lkortikosterojdi fil-waqt li baqgħu bi tnaqqis kliniku meta mqabbla ma' grupp ta' kura bi plaċebo kemm f'ġimgħa 30 (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: Pharmacotherapeutic group: immunosuppressants, tumour necrosis factor alpha (TNFα) inhibitors, ATC code: L04AB02.
Maltese: Immunosoppressanti, inibituri tal-fattur tan-necrożi alfa (TNFα), Kodiċi ATC:
English: Fewer subjects underwent colectomy in the 5 mg/kg infliximab group (28/242 or 11.6% [N.S.]) and the 10 mg/kg infliximab group (18/242 or 7.4% [p=0.011]) than in the placebo group
Maltese: Kien hemm anqas individwi li għamlu kolektomija fil grupp ta' 5 mg/kg infliximab (28/242 jew 11.6% [N.S.]) u l-grupp ta' 10 mg/kg infliximab (18/242 jew 7.4% [p=0.011]) milli fil-grupp talplaċebo (36/244; 14.
English: Approximately 93% of the patients had previously received antibiotic or immunosuppressive therapy.
Maltese: Madwar 93% talpazjenti qabel kienu ngħataw antibijotiċi jew terapija immunosoppressiva.
English: At week 24, the number of ASAS 20 responders was 15/78 (19%) in the placebo group, and 123/201 (61%) in the 5 mg/kg infliximab group (p<0.001).
Maltese: Mal-24 ġimgħa, in-numru ta' persuni li rrispondew għal ASAS 20 kienu 15/78 (19%) fil-grupp tal-plaċebo, u 123/201 (61) fil-grupp fuq 5 mg/kg infliximab (p < 0.001).
English: • treat active Crohn's disease,
Maltese: • tikkura marda ta' Crohn attiva,
English: Pulmonary oedema, bronchospasm, pleurisy, pleural effusion.
Maltese: Edema fil-pulmun, bronkospażmu, plewriżi, effużjoni millplewra.
English: Placebo (Week 16)
Maltese: Plaċebo (ġimgħa 16)
English: Efficacy and safety of infliximab were assessed in two multicentre, double-blind, placebo-controlled studies in patients with active ankylosing spondylitis (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] score ≥ 4 and spinal pain ≥ 4 on a scale of 1-10).
Maltese: L-effikaċja u s-sigurtà ta' infliximab kienu evalwati f'żewġ studji multiċentriċi, double-blind, ikkontrollati bi plaċebo f'pazjenti b'ankylosing spondylitis attiva (Indiċi tal-Marda Ankylosing Spondylitis ta' Bath [BASDAI] punteġġ ≥ 4 u wġigħ fis-sinsla ≥ 4 fuq skala minn 1 - 10).
English: Table 3 Effects on ACR20, Structural Joint Damage and Physical Function at week 54, ATTRACT Infliximab b
Maltese: Tabella 3 Effetti fuq ACR20, Ħsara Strutturali fil-Ġogi u Funzjoni Fiżika fil-ġimgħa 54, ATTRACT
English: • Inflectra will be given to you by your doctor or nurse, in a hospital or clinic.
Maltese: • Inflectra ser jiġi mogħti lilek mit-tabib tiegħek jew infermier, fi sptar jew klinika.
English: In clinical studies with infliximab in which 5,780 patients were treated, representing 5,494 patient years, 5 cases of lymphomas and 26 non-lymphoma malignancies were detected as compared with no lymphomas and 1 non-lymphoma malignancy in 1,600 placebo-treated patients representing 941 patient years.
Maltese: Fi studji kliniċi b'infliximab fejn kienu kkurati 5,780 pazjent, li jirrappreżentaw 5,494 sena ta' pazjenti, 5 każijiet ta' limfomi u 26 tumur malinni mhux limfomi nstabu meta mqabbla mal-ebda każ ta' limfoma u każ wieħed ta' tumur malinn mhux limfoma f'1,600 pazjent ikkurati bi plaċebo li jirrapreżentaw 941 sena ta' pazjenti.
English: a a p <0.001, for each infliximab treatment group vs. placebo.
Maltese: a p < 0.001, għal kull grupp ta' infliximab vs. plaċebo.
English: Inflectra is indicated for:
Maltese: Inflectra huwa indikat għal:
English: Tuberculosis, fungal infections (e.g. candidiasis, onychomycosis).
Maltese: Tuberkulożi, infezzjonijiet ikkawżati minn moffa (eż. kandidijażi, onikomikożi).
English: Week 30 Clinical Response a
Maltese: Rispons kliniku f'ġimgħa 30
English: • The other ingredients are sucrose, polysorbate 80, sodium dihydrogen phosphate monohydrate and disodium phosphate dihydrate.
Maltese: • Is-sustanzi mhux attivi l-oħra huma sucrose, polysorbate 80, sodium dihydrogen phosphate monohydrate u disodium phosphate dihydrate.
English: Decreases in parameters of peripheral activity characteristic of psoriatic arthritis (such as number of swollen joints, number of painful/tender joints, dactylitis and presence of enthesopathy) were seen in the infliximab-treated patients.
Maltese: Tnaqqis fil-parametri ta' attività periferali karatteristika ta' artrite psorijatika (bħannumru ta' ġogi minfuħin, numru ta' ġogi bl-uġigħ/teneri, daktilite u preżenza ta' entesopatija) ġew osservati f'pazjenti kkurati b'infliximab.
English: Thrombocytopenia, lymphopenia, lymphocytosis.
Maltese: Tromboċitopenija, limfopenija, limfoċitożi.
English: ACR 20 response* ACR 50 response* ACR 70 response* PASI response (% of patients)b
Maltese: ACR 70 rispons* Rispons PASI (% ta' pazjenti)
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: Fit-tieni studju kliniku (ASSERT), 279 pazjent intgħażlu b'mod każwali sabiex jirċievu jew plaċebo (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: EXPRESS Placebo → Infliximab 5 mg/kg (at week 24)
Maltese: Plaċebo → Infliximab 5 mg/kg (f'ġimgħa 24)
English: Inflectra belongs to a group of medicines called ‘TNF blockers'.
Maltese: Inflectra jagħmel parti minn grupp ta' mediċini magħrufa bħala ‘imblokkaturi TNF'.
English: The primary endpoints were the reduction of signs and symptoms as assessed by the American College of Rheumatology 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-American College of Rheumatology (ACR20 għal ATTRACT, landmark ACR-N għal ASPIRE), il-prevenzjoni ta' ħsara strutturali fil-ġogi, u t-titjib fil-funzjoni fiżika.
English: scores were 4.6 and 4.3 in infliximab and placebo group.
Maltese: Punteġġi medji fil-linja bażi kienu 4.6 u 4.3 fil-grupp fuq infliximab u fuq il-plaċebo.
English: Inflectra 100 mg powder for concentrate for solution for infusion infliximab
Maltese: Inflectra 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni infliximab
English: At week 12, the number of BASDAI 50 responders were 3/35 (9%) in the placebo group, and 20/35 (57%) in the 5 mg/kg group (p<0.01).
Maltese: F'ġimgħa 12, in-numru ta' dawk li kellhom rispons BASDAI 50 kienu 3/35 (9%) fil-grupp tal-plaċebo, u 20/35 (57%) fil-grupp tal-5 mg/kg (p < 0.01).
English: ACR response (% of patients) N
Maltese: ACR rispons (% ta' pazjenti)
English: Table 1 Adverse reactions in clinical studies and from post-marketing experience Infections and infestations Very common:
Maltese: Tabella 1 Reazzjonijiet avversi fi studji kliniċi u mill-esperjenza ta' wara t-tqegħid fis-suq Infezzjonijiet u infestazzjonijiet Komuni ħafna:
English: After 54 weeks of treatment, both doses of infliximab + methotrexate resulted in statistically significantly greater improvement in signs and symptoms compared to methotrexate alone as measured by the proportion of patients achieving ACR20, 50 and 70 responses.
Maltese: Wara 54 ġimgħa ta' kura, iż-żewġ dożi ta' infliximab + methotrexate irriżultaw f'aktar titjib statistikament sinifikanti fis-sinjali u s-sintomi mqabbla ma' methotrexate waħdu kif imkejjel millproporzjon ta' nies li kisbu rispons ACR20, 50 u 70.
English: Other medicines and Inflectra
Maltese: Mediċini oħra u Inflectra
English: Mean ± SDd a p <0.001, for each infliximab treatment group vs control.
Maltese: Ġimgħa 50 a p < 0.001, għal kull grupp ta' kura b'infliximab vs il-kontroll.
English: Storage beyond 24 hours at 2 °C - 8 °C applies to preparation of Inflectra in the infusion bag only.
Maltese: Ħażna għal aktar minn 24 siegħa f'temperatura ta' 2 °C - 8 °C tapplika biss għal Inflectra ippreparat fil-borża tal-infużjoni.
English: Due to methodological limitations, a negative assay did not exclude the presence of antibodies to infliximab.
Maltese: Minħabba l-limitazzjonijiet fil-metodoloġija, assay negattiv ma teskludix ilpresenza ta' antikorpi għal infliximab.
English: 3 mg/kg 6 mg/kg Combined
Maltese: 6 mg/kg
English: In C0168T72, the most common adverse reactions were upper respiratory tract infection, pharyngitis, abdominal pain, fever,
Maltese: F'C0168T72, l-aktar reazzjonijiet avversi komuni kienu infezzjoni fil-parti ta' fuq tal-apparat respiratorju, farinġite, uġigħ addominali, deni u wġigħ ta' ras.
English: Clinical remission and mucosal healing occurred in a greater proportion of patients in the combined infliximab treatment group compared to the placebo treatment group at week 54 (34.6% vs. 16.5%, p<0.001 and 46.1% vs. 18.2%, p<0.001, respectively).
Maltese: Tnaqqis kliniku u fejqan tal-mukuża seħħew fi proporzjon akbar ta' pazjenti fil-grupp ta' kura li kienu fuq infliximab kombinat meta mqabbla mal-grupp ta' kura fuq il-plaċebo f'ġimgħa 54 (34.6% vs 16.5%, p < 0.001 u 46.1% vs 18.2%, p < 0.001, rispettivament).
English: For volumes greater than 250 mL, either use a larger infusion bag (e.g. 500 mL, 1000 mL) or use multiple 250 mL infusion bags to ensure that the concentration of the infusion solution does not exceed 4 mg/mL.
Maltese: Għal volumi akbar minn 250 mL, uża borża talinfużjoni akbar (eż. 500 mL, 1000 mL) jew uża boroż tal-infużjoni ta' 250 mL multipli biex tkun ċert li l-konċentrazzjoni tas-soluzzjoni għall-infużjoni ma tkunx aktar minn 4 mg/mL.
English: Ankylosing spondylitis Psoriatic arthritis Plaque psoriasis
Maltese: Artrite idjopatika ġuvenili, artrite psorijatika u ankylosing spondylitis
English: • Abnormal values of a blood protein called ‘complement factor' which is part of the immune system.
Maltese: • Valuri mhux normali ta' proteina fid-demm imsejħa “complement factor” li hija parti mis sistema immuni
English: • If your doctor feels that you are at risk for TB, you may be treated with medicines for TB before you are given Inflectra.
Maltese: • Jekk it-tabib tiegħek iħoss li għandek riskju li jkollok TB, tista' tingħata kura b'mediċini kontra t-TB qabel tingħata Inflectra.
English: How to store Inflectra
Maltese: X'fih Inflectra
English: Inflectra 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: Inflectra 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: b CDAI < 150 at both week 30 and 54 and not receiving corticosteroids in the 3 months prior to week 54
Maltese: b CDAI< 150 kemm f'ġimgħa 30 kif ukoll f'54 u mhux jirċievu kortikosterojdi fit-3 xhur qabel ġimgħa 54
English: Inflectra.
Maltese: Tilqim
English: In clinical studies using single and multiple infliximab doses ranging from 1 to 20 mg/kg, antibodies to infliximab were detected in 14% of patients with any immunosuppressant therapy, and in 24% of patients without immunosuppressant therapy.
Maltese: Fi studji kliniċi fejn intużat doża waħda jew ħafna dożi ta' infliximab li varjaw minn 1 sa 20 mg/kg, instabu antikorpi għal infliximab f'14% tal-pazjenti fuq xi terapija immunosoppressiva, u f'24% talpazjenti mingħajr terapija immunosoppressiva.
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: Significantly fewer colectomies occurred within 3 months of study infusion in patients who received a single dose of 5 mg/kg infliximab compared to patients who received placebo (29.2% vs. 66.7% respectively, p=0.017).
Maltese: Kien hemm numru anqas b'mod sinifikanti ta' kolektomiji fit-3 xhur tal-istudju f'pazjenti li rċevew doża waħda ta' 5 mg/kg infliximab meta mqabbla ma' pazjenti li rċevew plaċebo (29.2% kontra 66.7% rispettivament, p=0.017).
English: • That treatment with Inflectra may increase the risks of serious infections/sepsis, opportunistic infections, tuberculosis, hepatitis B reactivation, and BCG breakthrough in infants with in utero exposure to infliximab, and when to seek attention from a HCP
Maltese: • Li t-trattament b'Inflectra jista' jżid ir-riskji ta' infezzjonijiet serji/sepsis, infezzjonijiet opportunistiċi, tuberkulożi, riattivazzjoni tal-epatite B, u ifiġġ BCG fi trabi b'esponiment għal infliximab in utero u meta għandek tfittex għajnuna minn HCP
English: Infliximab (Week 16)
Maltese: Infliximab (ġimgħa 16)
English: Bacterial infections (e.g. sepsis, cellulitis, abscess).
Maltese: Infezzjonijiet batterjali (eż. sepsis, ċellulite, axxess).
English: The proportions of patients in sustained response and sustained remission at week 54 were greater in the combined infliximab treatment group than in the placebo treatment group (37.9% vs. 14.0%, p<0.001; and 20.2% vs. 6.6%, p<0.001, respectively).
Maltese: Il-proporzjonijiet tal-pazjenti b'rispons sostnut u tnaqqis sostnut f'ġimgħa 54 kien akbar fil-grupp ta' kura b'infliximab milli fil-grupp ta' kura bil-plaċebo (37.9% vs. 14.0%, p < 0.001, u 20.2% vs 6.6%, p < 0.001, rispettivament).
English: At 54 weeks, 44.9% of patients in the combined infliximab treatment group were in clinical response compared to 19.8% in the placebo treatment group (p<0.001).
Maltese: Wara ġimgħa 54, 44.9% tal-pazjenti fil-grupp ta' kura b'infliximab kombinat kellhom rispons kliniku meta mqabbla ma' 19.8% fil-grupp ta' plaċebo (p < 0.001).
English: Dizziness may occur following administration of infliximab (see section 4.8).
Maltese: Jista' jkun hemm sturdamenti wara l-għoti ta' infliximab (ara sezzjoni 4.8).
English: Table 4 Effects on ACRn, Structural Joint Damage and Physical Function at week 54, ASPIRE Infliximab + MTX
Maltese: Tabella 4 Effetti fuq l-ACRn, Ħsara Strutturali fuq il-Ġogi u Funzjoni Fiżika f'ġimgħa 54, ASPIRE
English: In long-term safety follow-up of clinical studies with infliximab of up to 5 years, representing 6,234 patients-years (3,210 patients), 5 cases of lymphoma and 38 cases of non-lymphoma malignancies were reported.
Maltese: Fi studji kliniċi follow-up dwar is-sigurtà fit-tul b'infliximab li ħadu sa 5 snin, li jirrappreżentaw 6,234 snin ta' pazjenti (3,210 pazjenti), 5 każijiet ta' limfomi u 38 każ ta' tumuri malinni mhux limfomi kienu rrappurtati.
English: The following side effects have been observed with Inflectra:
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni ħafna:
English: Additionally, closure of all fistulae was achieved in 55% of infliximab-treated patients compared with 13% of placebo-treated patients (p=0.001).
Maltese: Barra dan, kien hemm għeluq tal-fistuli kollha f'55% tal-pazjenti li ngħataw infliximab meta mqabbel ma' 13% tal-pazjenti li ngħataw plaċebo (p=0.001).
English: This should be taken into consideration for patients on a controlled sodium diet (see section 6.6).
Maltese: Dan għandu jiġi kkunsidrat għal pazjenti fuq dieta b'sodium ikkontrollat (ara sezzjoni 6.6).
English: 3 mg/kg q 4 wks
Maltese: 3 mg/kg q 4 ġimgħ at
English: 10 mg/kg q 8 wks
Maltese: 10 mg/kg q 8 ġimgħ at
English: Infliximab (Week 24)
Maltese: Infliximab (ġimgħa 24)
English: The number of ulcerative colitis-related surgical procedures was also lower in the 5 and 10 mg/kg infliximab treatment groups than in the placebo group (mean number of surgical procedures per 100 subject-years: 22 and 19 vs. 34; p=0.145 and p=0.022, respectively).
Maltese: In-numru ta' operazzjonijiet kiruġiċi relatati mal-kolite ulċerattiva kien ukoll aktar baxx fil-gruppi ikkurati b'5 u 10 mg/kg infliximab milli fil-grupp tal-plaċebo (il-medja tannumru ta' dawk li kellhom operazzjonijiet kirurġiċi għal kull 100 sena ta' individwu: 22 u 19 kontra 34; p=0.145 u p=0.022, rispettivament).
English: Therapeutic infectious agents
Maltese: Sustanzi terapewtiċi infettivi
English: Infliximab (Week 98)
Maltese: Infliximab (ġimgħa 98)
English: Infliximab (Week 54)
Maltese: Infliximab (ġimgħa 54)
English: Induction treatment in moderately to severely active Crohn's disease The efficacy of a single dose treatment with infliximab was assessed in 108 patients with active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 ≤ 400) in a randomised, double-blinded, placebo-controlled, dose-response study.
Maltese: Kura ta' induzzjoni fil-marda ta' Crohn attiva b'mod moderat sa qawwi L-effikaċja ta' kura b'doża waħda ta' infliximab kienet evalwata f'108 pazjenti bil-marda ta' Crohn attiva (Indiċi ta' Attività tal-marda ta' Crohn (CDAI) ≥ 220 ≤ 400) fi studju li fih il-parteċipanti ntgħażlu b'mod każwali, double-blinded, ikkontrollat bi plaċebo u li juri rispons għad-doża.
English: ≥ 50% improvement PGA of cleared (0) or minimal (1)
Maltese: PGA ta' pazjenti bid-dwiefer imfejqa (0) jew minimu (1)
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 talġilda bit-tuberkulin, X-rays tas-sider u/jew Assaġġ tar-Rilaxx tal-Interferon Gamma) għandhom isiru fuq il-pazjenti kollha (rakkomandazzjonijiet lokali jistgħu jkunu applikati).
English: Change from baseline in total van der Heijde-modified Sharp score b
Maltese: Bidla mil-linja bażi fit-total tal-punteġġ van der Heijde modifikat Sharp Medja ± SD
English: The proportions of patients with mucosal healing at week 26 were significantly greater in the infliximab plus AZA combination (43.9%, p<0.001) and infliximab monotherapy groups (30.1%, p=0.023) compared to the AZA monotherapy group (16.5%).
Maltese: Il-proporzjonijiet ta' pazjenti b'fejqan tal-membrana mukuża f'ġimgħa 26 kienu ogħla b'mod sinifikanti fil-gruppi tal-kombinazzjoni ta' infliximab flimkien ma' AZA (43.9%, p < 0.001) u ta' terapija b'infliximab waħdu (30.1%, p=0.023) meta mqbbla mal-grupp ta' terapija b'AZA waħdu
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 10 Summary of PASI response, PGA response and percent of patients with all nails cleared at Weeks 10, 24 and 50.
Maltese: Tabella 10 Sommarju tar-rispons PASI, rispons PGA u perċentwali tal-pazjenti li fiqulhom difrejhom kollha f'ġimgħat 10, 24 u 50.
English: Headache.
Maltese: Vaġinite.
English: Date of Inflectra therapy initiation:
Maltese: Data ta' meta bdiet it-terapija b'Inflectra: