FrancophonIA/ELRC3.0 huggingface dataset:
English: Common: Neutropenia, leucopenia, anaemia, lymphadenopathy.
Maltese: Komuni: Newtropenija, lewkopenija, anemija, limfadenopatija.
English: st dose rd dose
Maltese: It-2 doża
English: 3 mg/kg q 8 wks
Maltese: 3 mg/kg q 8 ġimgħat
English: 5 vials 100 mg
Maltese: 5 kunjetti ta' 100 mg
English: Rare: Transverse myelitis, central nervous system demyelinating disorders (multiple sclerosis-like disease and optic neuritis), peripheral demyelinating disorders (such as Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy).
Maltese: Mijelite transversa, disturbi li jneħħu l-majelin tas-sistema nervuża ċentrali (mard li jixbah l-isklerożi multipla u nevrite ottika), disturbi li jneħħu l-majelin tas-sistema periferali (bħal sindrome ta' Guillain-Barré, polinewropatija bit-telf tal-majelin b'infjammazzjoni kronika u newropatija motorjali multifokali).
English: Patients received 3 or 6 mg/kg infliximab as a 3-dose induction regimen (weeks 0, 2, 6 or weeks 14, 16, 20 respectively) followed by maintenance therapy every 8 weeks, in combination with methotrexate.
Maltese: Il-pazjenti rċevew 3 jew 6 mg/kg ta' infliximab bħal kors ta' induzzjoni bi 3 dożi (ġimgħat 0, 2, 6 jew ġimgħat 14, 16, 20 rispettivament) segwiti minn terapija ta' manteniment kull 8 ġimgħat, flimkien ma' methotrexate.
English: The solution may develop a few fine translucent particles, as infliximab is a protein.
Maltese: Issoluzzjoni tista' tifforma ftit frak transluċidu, peress li infliximab huwa proteina.
English: Infliximab (week 24)
Maltese: Infliximab (ġimgħa 24)
English: These medicines may cause side effects.
Maltese: Dawn il-mediċini jistgħu jikkawżaw effetti sekondarji.
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: The ATTRACT study evaluated responses at 30, 54 and 102 weeks in a placebo-controlled study of 428 patients with active rheumatoid arthritis despite treatment with methotrexate.
Maltese: L-istudju ATTRACT evalwa r-risponsi f'ġimgħa 30, 54 u 102 fl-istudju kkontrollat bi plaċebo fuq 428 pazjent b'artrite rewmatojde attiva minkejja l-kura b'methotrexate.
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' emoglobina, meta mqabbel mal-linja bażi.
English: Date of Remicade therapy initiation:
Maltese: Data ta' meta bdiet it-terapija b'Remicade:
English: Infliximab (week 98)
Maltese: Infliximab (ġimgħa 98)
English: In both studies concurrent use of stable doses of folic acid, oral corticosteroids (≤ 10 mg/day) and/or non-steroidal antiinflammatory drugs (NSAIDs) was permitted.
Maltese: Fiż-żewġ studji, l-użu flistess ħin ta' dożi stabbli ta' folic acid, kortikosterojdi orali (≤ 10 mg/jum) u/jew mediċini antiinfjammatorji mhux sterojdi (NSAIDs) ġie permess.
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 kien evalwat 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: 3 mg/kg q 4 wks
Maltese: 3 mg/kg q 4 ġimgħat
English: Adult ulcerative colitis
Maltese: Kolite ulċerattiva fl-adulti
English: p < 0.001, for each infliximab treatment group vs. control.
Maltese: p < 0.001, għal kull grupp li ngħata kura b'infliximab vs. kontroll.
English: Remicade contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Maltese: Remicade fih inqas minn 1 mmol sodium (23 mg) f'kull doża, i.e. huwa essenzjalment ‘ħieles missodium.
English: Infliximab (week 54)
Maltese: Infliximab (ġimgħa 54)
English: There have been reports of pancytopenia, leucopenia, neutropenia, and thrombocytopenia in patients receiving TNF-blockers, including Remicade.
Maltese: Kien hemm rapporti ta' panċitopenija, lewkopenija, newtropenija, u tromboċitopenija f'pazjenti li kienu qed jirċievu imblokkaturi ta' TNF, inkluż Remicade.
English: Of these 108 patients, 27 were treated with the recommended dosage of infliximab 5 mg/kg.
Maltese: Minn dawn il108 pazjent, 27 kienu kkurati bid-doża rakkomandata ta' infliximab 5 mg/kg.
English: 10 mg/kg q 4 wks
Maltese: 10 mg/kg q 4 ġimgħat
English: Table 6 Percent of patients achieving corticosteroid-free clinical remission at week 26, SONIC
Maltese: Tabella 6 Perċentwali ta' pazjenti li kisbu nuqqas totali tas-sinjali u s-sintomi kliniċi mingħajr kortikosterojdi f'ġimgħa 26, SONIC
English: Use of concomitant immunosuppressant agents appeared to reduce the frequency of infusion-related reactions.
Maltese: Meta fl-istess ħin intużaw aġenti immunosoppressivi, ġie osservat tnaqqis fil-frekwenza ta' reazzjonijiet relatati mal-infużjoni.
English: There have been reports of active tuberculosis in patients receiving Remicade.
Maltese: Kien hemm rapporti ta' tuberkulożi attiva f'pazjenti li kienu qed jirċievu Remicade.
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 evakwat 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: Paediatric Crohn's disease (6 to 17 years)
Maltese: Marda ta' Crohn (6 sa 17-il sena)
English: Week-14 responders (195/282) were analysed for the primary endpoint, which was time from randomisation to loss of response (see Table 7).
Maltese: Persuni li rrispondew sa Ġimgħa 14 (195/282) kienu analizzati għall-punt aħħari primarju, li kien iżżmien minn meta ntgħażlu b'mod każwali sakemm tilfu r-rispons (ara Tabella 7).
English: In Crohn's disease patients who received maintenance treatment, antibodies to infliximab occurred overall in 3.3% of patients receiving immunosuppressants and in 13.3% of patients not receiving immunosuppressants.
Maltese: Fil-pazjenti bil-marda ta' Crohn li rċevew kura ta' manteniment, antikorpi għal infliximab seħħew f'total ta' 3.3% tal-pazjenti li kienu qed jirċievu immunosoppressanti u fi 13.3% tal-pazjenti li ma kinux qed jirċievu immunosoppressanti.
English: In the first clinical study (IMPACT), efficacy and safety of infliximab were studied in 104 patients with active polyarticular psoriatic arthritis.
Maltese: Fl-ewwel studju kliniku (IMPACT), l-effikaċja u s-sigurtà ta' infliximab kienu studjati f'104 pazjenti b'artrite psorijatika li taffettwa ħafna ġogi.
English: Reports of lupus and lupus-like syndromes, however, remain uncommon (see section 4.4).
Maltese: Rapporti ta' lupus u sindromi bħal dawk tal-lupus, madankollu jibqgħu mhux komuni (ara sezzjoni 4.4).
English: Three cases of pneumonia (1 serious) and 2 cases of herpes zoster (both non-serious) were reported.
Maltese: Tliet każijiet ta' pulmonite (1 serju) u 2 każijiet ta' herpes zoster (it-tnejn mhux serji) kienu rrappurtati.
English: Due to methodological limitations, a negative assay did not exclude the presence of antibodies to infliximab.
Maltese: Minħabba llimitazzjonijiet fil-metodoloġija, assay negattiv ma teskludix il-presenza ta' antikorpi għal infliximab.
English: Uncommon: Pulmonary oedema, bronchospasm, pleurisy, pleural effusion.
Maltese: Mhux komuni: Edema fil-pulmun, bronkospażmu, plewriżi, effużjoni millplewra Rari:
English: Uncommon: Vaginitis.
Maltese: Mhux komuni: Pajilonefrite.
English: Week 98 data for IMPACT includes combined placebo crossover and infliximab patients who entered the open-label extension.
Maltese: Dejta ta' Ġimgħa 98 għal IMPACT jinkludi plaċebo kombinat crossover u pazjenti fuq infliximab li daħlu għallestensjoni open-label.
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: ≥ 50% improvement
Maltese: Titjib ta' ≥ 50%
English: or boils (furunculosis)
Maltese: jew imsiemer (furunkulożi)
English: • Severe allergic reactions (e.g. anaphylaxis), an immune system disorder called lupus, allergic reactions to foreign proteins
Maltese: • Reazzjonijiet allerġiċi severi (eż. anafilassi), disturb tas-sistema immuni li jissejjaħ lupus,
English: • Lung problems (such as oedema)
Maltese: • Problemi tal-pulmun (bħal edima)
English: • Treat active Crohn's disease
Maltese: • Tikkura marda ta' Crohn attiva
English: Low blood counts
Maltese: Health) Limited
English: There were 53 subjects who continued on 5 mg/kg every 6 weeks.
Maltese: Kien hemm 53 individwu li komplew fuq 5 mg/kg kull 6 ġimgħat.
English: Common: New onset or worsening psoriasis including pustular psoriasis (primarily palm & soles), urticaria, rash, pruritus, hyperhidrosis, dry skin, fungal dermatitis, eczema, alopecia.
Maltese: Bidu ġdid ta' psorjasi jew taggrava inkluż psorjasi bl-imsiemer (l-aktar fil-pala tal-idejn u s-saqajn), urtikarja, raxx, ħakk, iperidrożi, ġilda xotta, dermatite fungali, ekżema, alopeċja.
English: Efficacy and safety were assessed in two multicenter, double-blind, placebo-controlled studies in patients with active psoriatic arthritis.
Maltese: L-effikaċja u s-sigurtà kienu evalwati f'żewġ studji multiċentriċi, double-blind, ikkontrollati bi plaċebo f'pazjenti b'artrite psorijatika attiva.
English: This should be taken into consideration for patients on a controlled sodium diet (see section 6.6).
Maltese: Dan għandu jitqies għall-pazjenti li qegħdin fuq dieta b'ammont ikkontrollat ta' sodium (ara sezzjoni 6.6).
English: A ≥ 50% reduction from baseline in the number of draining fistulas over a period of ≥ 4 weeks.
Maltese: Tnaqqis ta' ≥ 50% mill-linja bażi fin-numru ta' fistuli li kienu qed inixxu fuq perjodu ta' ≥ 4 ġimgħat.
English: Dilute the total volume of the reconstituted Remicade solution dose to 250 ml with sodium chloride 9 mg/ml (0.9%) solution for infusion.
Maltese: Iddilwixxi l-volum totali tad-doża tas-soluzzjoni rikostitwita Remicade għal 250 ml b'soluzzjoni għall-infużjoni ta' sodium chloride 9 mg/ml (0.9%).
English: Particular attention regarding the risk for infection should be paid when treating the elderly (see section 4.8).
Maltese: Attenzjoni partikolari dwar ir-riskju għal infezzjoni għandha tingħata meta tkun qed tingħata kura lill-anzjani (ara sezzjoni 4.8).
English: The overall incidence of infections in C0168T72 was 13/22 (59%) in the every 8 week maintenance treatment group and 14/23 (60.9%) in the every 12 week maintenance treatment group.
Maltese: L-inċidenza globali ta' infezzjonijiet f'C0168T72 kienet ta' 13/22 (59%) fil-grupp ta' kura ta' manteniment ta' kull 8 ġimgħat u ta' 14/23 (60.9%) fil-grupp ta' kura ta' manteniment ta' kull 12-il ġimgħa.
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-ray tas-sider u/jew Assaġġ tar-Rilaxx tal-Interferon Gamma) għandhom isiru fuq il-pazjenti kollha (rakkomandazzjonijiet lokali jistgħu jkunu applikati).
English: Single doses up to 20 mg/kg have been administered without toxic effects.
Maltese: Dożi b'waħdiet sa 20 mg/kg ġew mogħtija mingħajr effetti tossiċi.
English: Common: Gastrointestinal haemorrhage, diarrhoea, dyspepsia, gastroesophageal reflux, constipation.
Maltese: Komuni ħafna: Uġigħ fl-addome, nawseja Komuni: Emorraġija gastrointestinali, dijarea, dispepsja, rifluss gastroesofagali, stitikezza.
English: In ACT 1 and ACT 2, infliximab improved quality of life, confirmed by statistically significant improvement in both a disease specific measure, IBDQ, and by improvement in the generic 36-item short form survey SF-36.
Maltese: F'ACT 1 u ACT 2, infliximab tejjeb il-kwalità tal-ħajja, u dan ġie kkonfermat b'titjib statistikament sinifikanti kemm f'kejl speċifiku għall-marda, IBDQ, kif ukoll f'titjib fi stħarriġ qasir ġeneriku SF-36 b'36 mistoqsija.
English: Tuberculosis, bacterial infections, including sepsis and pneumonia, invasive fungal, viral, and other opportunistic infections have been observed in patients receiving Remicade.
Maltese: Tuberkulożi, infezzjonijiet batteriċi, inkluża sepsis u pulmonite, infezzjonijiet invażivi fungali, virali, u infezzjonijiet opportunistiċi oħra, ġew osservati f'pazjenti li kienu qed jirċievu Remicade.
English: By week 26, twenty weeks after the last induction dose, 30% of patients in the 5 mg/kg group and 13.8% of patients in the 3 mg/kg group were PASI 75 responders.
Maltese: F'ġimgħa 26, għoxrin ġimgħa wara l-aħħar doża ta' induzzjoni, 30% tal-pazjenti fil-grupp fuq 5 mg/kg u 13.8% fil-grupp fuq 3 mg/kg urew rispons skont PASI 75.
English: Uncommon: Pyelonephritis.
Maltese: Popolazzjoni pedjatrika
English: In the Phase IIIb trial in Crohn's disease, SONIC, placebo patients received AZA 2.5 mg/kg/day as active control in addition to placebo infliximab infusions.
Maltese: IIIb fil-marda ta' Crohn, SONIC, pazjenti tal-plaċebo rċivew 2.5 mg/kg/kuljum ta' AZA bħala kontroll attiv flimkien ma' infużjonijiet ta' infliximab bħala plaċebo.
English: Remicade is indicated for treatment of severe, active Crohn's disease, in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies.
Maltese: Remicade jintuża għal kura tal-marda ta' Crohn attiva, severa, fi tfal u adoloxxenti ta' etajiet bejn 6 sa 17-il sena, li ma kellhomx rispons għat-terapija konvenzjonali inklużi kortikosterojd, immunomodulatur u terapija ta' nutrizzjoni primarja, jew li huma intolleranti jew għandhom kontraindikazzjonijiet għal dawn it-tipi ta' terapiji.
English: At week 4, following administration of a single dose, 22/27 (81%) of infliximab-treated patients receiving a 5 mg/kg dose achieved a clinical response vs. 4/25 (16%) of the placebo-treated patients (p < 0.001).
Maltese: Fir-4 ġimgħa, wara l-għoti ta' doża waħda tal-mediċina studjata, 22/27 (81%) tal-pazjenti kkurati b'infliximab li ngħataw doża ta' 5 mg/kg kellhom rispons kliniku kontra 4/25 (16%) tal-pazjenti li ngħataw plaċebo (p < 0.001).
English: In ASPIRE, more than 90% of patients had at least two evaluable X-rays.
Maltese: F'ASPIRE, aktar minn 90% tal-pazjenti kellhom mill-anqas żewġ X-rays li setgħu jkunu evalwati.
English: Infliximab is a monoclonal antibody - a type of protein that attaches to a specific target in the body called TNF (tumour necrosis factor) alpha.
Maltese: Infliximab huwa antikorp monoklonali - tip ta' proteina li teħel ma' mira speċifika fil-ġisem imsejħa TNF (fattur tan-nekrosi tat-tumur - tumour necrosis factor) alfa.
English: Peripheral blood mononuclear cells (PBMC) from infliximab-treated patients showed undiminished proliferative responsiveness to stimuli compared with untreated patients, and no substantial changes in cytokine production by stimulated PBMC were observed following treatment with infliximab.
Maltese: Ċelluli mononukleari periferiċi tad-demm (PBMC) meħuda minn pazjenti li ngħataw infliximab ma wrew l-ebda tnaqqis fir-rispons proliferattiv għal stimuli meta mqabbla ma' pazjenti mhux fuq kura, u ma kinux osservati bidliet sostanzjali fil-produzzjoni ta' ċitokini minn PBMC stimulati wara kura b'infliximab.
English: 2 vials 100 mg
Maltese: 2 kunjetti ta' 100 mg
English: During the 24-week double-blind phase, patients received either 5 mg/kg infliximab or placebo at weeks 0, 2, 6, 14, and 22 (100 patients in each group).
Maltese: Waqt l-24-ġimgħa tal-fażi double-blind, pazjenti rċevew 5 mg/kg infliximab jew placebo f'ġimgħa 0, 2, 6, 14 u 22 (100 pazjent f'kull grupp).
English: The efficacy of infliximab was assessed in two multicentre, randomised, double-blind, pivotal clinical studies: ATTRACT and ASPIRE.
Maltese: L-effikaċja ta' infliximab kienet evalwata f'żewġ studji importanti ħafna multiċentriċi, li fihom ilparteċipanti ntgħażlu b'mod każwali, double-blind: ATTRACT u ASPIRE.
English: • That treatment with Remicade 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'Remicade jista' jżid ir-riskji ta' infezzjonijiet serji/sepsi, infezzjonijiet opprotunistiċi, tuberkulożi, riattivazzjoni tal-epatite B, u ifiġġ BCG fi trabi b'esponiment għal infliximab in utero, u meta għandek tfittex għajnuna mingħand HCP
English: Tumour necrosis factor alpha (TNF) mediates inflammation and modulates cellular immune responses.
Maltese: Fattur alfa tan-necrożi tat-tumur (TNF) jikkontrolla l-infjammazzjoni u jimmodula ir-rispons immuni taċ-ċelluli.
English: Sixty eight percent (21/31) of infliximab-treated patients receiving a 5 mg/kg dose regimen achieved a clinical response vs. 26% (8/31) placebo-treated patients (p = 0.002).
Maltese: Tmienja u sittin fil-mija (21/31) tal-pazjenti li ngħataw infliximab b'kors b'doża ta' 5 mg/kg kellhom reazzjoni klinika kontra 26% (8/31) tal-pazjenti li ngħataw plaċebo (p = 0.002).
English: Remicade is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Maltese: Remicade huwa indikat għall-kura ta' ankylosing spondylitis attiva, severa, f'pazjenti adulti li ma kellhomx rispons adegwat għal terapija konvenzjonali.
English: Among patients classified as non-responders at week 2, 32% (26/81) in the placebo maintenance group and 42% (68/163) in the infliximab group achieved clinical response by week 6.
Maltese: fil-grupp ta' manteniment fuq plaċebo u 42% (68/163) fil-grupp fuq infliximab kisbu rispons kliniku sas-6 ġimgħa.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Remicade in all subsets of the paediatric population in rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis and Crohn's disease (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini irrinunzjat għall-obbligu li jiġu ppreżentati r-riżultati tal-istudji b'Remicade f'kull sett tal-popolazzjoni pedjatrika fl-artrite rewmatojde, artrite idjopatika taż-żgħar, artrite psorjatika, ankylosing spondylitis, psorjasi u l-marda ta' Crohn (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: All patients received methotrexate (optimised to 20 mg/wk by week 8) and either placebo, 3 mg/kg or 6 mg/kg infliximab at weeks 0, 2, and 6 and every 8 weeks thereafter.
Maltese: Il-pazjenti kollha rċevew methotrexate (ottimizzati għal 20 mg/kg mat-8 ġimgħa) u jew plaċebo, 3 mg/kg jew 6 mg/kg infliximab f'ġimgħat 0,2, u 6 u kull 8 ġimgħat minn hemm 'il quddiem.
English: Uncommon: Tuberculosis, fungal infections (e.g. candidiasis, onychomycosis).
Maltese: Mhux komuni: Tuberkulożi, infezzjonijiet ikkawżati minn moffa (eż. kandidijażi, onikomikożi).
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) levalwazzjoni 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: 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: • Collections of immune cells resulting from an inflammatory response (granulomatous lesions)
Maltese: • Ġabriet ta' ċelluli immuni kawża ta' rispons infjammatorju (leżjonijiet granulomatużi)
English: Live vaccines/therapeutic infectious agents
Maltese: Tilqim ħaj/sustanzi terapewtiċi infettivi
English: Chemical and physical in use stability of the diluted solution has been demonstrated for up to 28 days at 2 °C to 8 °C and for an additional 24 hours at 25 °C after removal from refrigeration.
Maltese: L-istabilità kimika u fiżika waqt l-użu tas-soluzzjoni ddilwita intweriet sa 28 jum f'temperatura bejn 2 °C u 8 °C u għal 24 siegħa addizzjonali f'temperatura ta' 25 °C wara li titneħħa mill-friġġ.
English: • Do not use this medicine after the expiry date which is stated on the label and the carton after “EXP”.
Maltese: • Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta u l-kartuna wara “JIS”.
English: AZA Monotherapy
Maltese: Proċessi awtoimmuni
English: Maintenance treatment in fistulising active Crohn's disease The efficacy of repeated infusions with infliximab in patients with fistulising Crohn's disease was studied in a 1-year clinical study (ACCENT II).
Maltese: L-effikaċja ta' infużjonijiet ripetuti ta' infliximab f'pazjenti bil-marda ta' Crohn fistulizzanti kienet studjati fi studju kliniku ta' sena (ACCENT II).
English: At week 16, 47 placebo patients with < 10% improvement from baseline in both swollen and tender joint counts were switched to infliximab induction (early escape).
Maltese: F'ġimgħa 16, 47 pazjent fuq plaċebo b'< 10% titjib mil-linja bażi kemm fl-għadd ta' dawk b'ġogi minfuħin kif ukoll b'dawk teneri inqalbu għall-induzzjoni fuq infliximab (early escape).
English: 4 vials 100 mg
Maltese: 4 kunjetti ta' 100 mg
English: Rare: Circulatory failure, petechia, vasospasm.
Maltese: Insuffiċjenza ċirkolatorja, petekje, vażospażmu.
English: Remicade and Kineret should not be used together.
Maltese: Il-kombinazzjoni ta' Remicade ma' abatacept mhux rakkomandata.
English: • treatment of fistulising, active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).
Maltese: • kura tal-marda ta' Crohn attiva fistulizzanti, f'pazjenti adulti li ma kellhomx rispons minkejja kors sħiħ u adegwat ta' terapija b'kura konvenzjonali (li tinkludi antibijotiċi, tneħħija ta' likwidu u terapija immunosoppressiva).
English: • Infection due to a live vaccine because of a weakened immune system.
Maltese: • Infezzjoni minn tilqima ħajja minħabba sistema immuni mdgħajfa.