FrancophonIA/ELRC3.0 huggingface dataset:
English: • Other skin problems such as erythema multiforme, lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes), blisters and peeling skin, or boils (furunculosis)
Maltese: • Problemi oħra fil-ġilda bħal eritema multiforme, reazzjonijiet likenojdi (raxx tal-ġilda ħamrani fil-vjola bil-ħakk u/jew ħjut bojod fil-griż fuq il-membrani mukużi), infafet u ġilda titqaxxar, jew imsiemer (furunkulożi)
English: 10 mg/kg Combined
Maltese: 10 mg/kg
English: Total scored (van der Heijde-modified Sharp score)
Maltese: Punteġġ totalid (punteġġ van der
English: Study 12 evaluated the efficacy of infliximab induction therapy in 249 patients with plaque psoriasis that had previously received PUVA or systemic therapy.
Maltese: Studju 12 evalwa l-effikaċja tat-terapija ta' induzzjoni b'infliximab f'249 pazjent bi psorjasi tal-plakka li qabel kienu rċevew PUVA jew terapija sistemika.
English: Patients received 3 or 6 mg/kg infliximab as a 3dose 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: Dilute the total volume of the reconstituted Zessly solution dose to 250 ml with sodium chloride 9 mg/ml (0.9%) solution for infusion.
Maltese: Madankollu, Zessly jiġi ddilwit f'soluzzjoni għall-infużjoni ta' sodium chloride 9 mg/ml (0.9%).
English: In this study, there were more patients in the 12 to 17 year age group than in the 6 to 11 year age group (45/60 vs.15/60).
Maltese: 6 sa 11-il sena (45/60 vs. 15/60).
English: Each Zessly vial contains 100 mg infliximab.
Maltese: Kull kunjett fih 100 mg ta' infliximab.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing infliximab 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 bil-prodott mediċinali ta' referenza li fih infliximab 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: 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: (N = 60), marda ta' Crohn (N = 112), artrite rewmatojde ġuvenili (N = 117) u l-marda ta' Kawasaki (N = 16) b'medda totali ta' età minn xahrejn sa 17-il sena, indikat espożizzjoni għal infliximab li kienet tiddependi fuq il-piż tal-ġisem b'mod mhux lineari.
English: Neutropenia, leukopenia, anaemia, lymphadenopathy.
Maltese: Komuni: Newtropenija, lewkopenija, anemija, limfadenopatija.
English: Overall, the adverse reactions reported in the paediatric ulcerative colitis trial and adult ulcerative colitis studies were generally consistent.
Maltese: B'mod globali, ir-reazzjonijiet avversi rrappurtati fil-prova dwar kolite bl-ulċeri fit-tfal u fl-istudji dwar kolite bl-ulċeri fl-adulti kienu ġeneralment konsistenti.
English: Table 5 Effects on response and remission rate in patients with moderately to severely active Crohn's disease, data from study 4 (week-2 responders)
Maltese: Tabella 5 Effetti fuq ir-rispons u r-rata ta' tnaqqis f'pazjenti b'marda ta' Crohn attiva b'mod moderat sa sever, dejta minn studju 4 (persuni li rrispondew sa ġimgħa 2) Studju 4 (persuni li rrispondew ta' ġimgħa 2)
English: In the second clinical study, (study 9), 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: 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 study 6 & study 7 data) and week 54 (21.0% vs. 8.9%, p = 0.022, study 6 data).
Maltese: (22.3% vs 7.2%, p < 0.001, dejta ta' studju 6 & studju 7 mgħaqqdin flimkien) u ġimgħa 54 (21.0% vs. 8.9%, p = 0.022, dejta ta' studju 6).
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: • The medicine will be given as an infusion (drip) over a 2 hours into one of your veins,
Maltese: Tliet każijiet ta' pulmonite (1 serju) u 2 każijiet ta'
English: In study 2, more than 90% of patients had at least two evaluable X-rays.
Maltese: Fi studju 2, aktar minn 90% tal-pazjenti kellhom mill-anqas żewġ X-rays li setgħu jkunu evalwati.
English: Your doctor may recommend temporarily stopping Zessly.
Maltese: It-tabib tiegħek jista' jirrikkmandalek li twaqqaf Zessly temporanjament.
English: ** PASI 75 response for study 10 not included due to low N; p < 0.001 for infliximab vs. placebo at week 24 for study 11.
Maltese: kellhom ukoll ġilda bi psorjasi fil-linja bażi fi studju 11. ** Rispons PASI 75 għal studju 10 mhux inkluż minħabba N baxx; p < 0.001 għal infliximab vs plaċebo f'ġimgħa 24 għal studju 11.
English: Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 ≤ 400) in a randomised, double blinded, placebo-controlled, dose-response study.
Maltese: (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: • That treatment with Zessly 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'Zessly 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: In a clinical study of patients with Crohn's disease, infusion-related reactions occurred in 16.6% (27/163) of patients receiving infliximab monotherapy, 5% (9/179) of patients receiving infliximab in combination with AZA, and 5.6% (9/161) of patients receiving AZA monotherapy.
Maltese: (27/163) tal-pazjenti li kienu qed jirċievu terapija b'infliximab waħdu, f'5% (9/179) tal-pazjenti li kienu qed jirċievu infliximab flimkien ma' AZA, u f'5.6% (9/161) tal-pazjenti li kienu qed jirċievu terapija b'AZA waħdu.
English: Vaginitis.
Maltese: funzjonali.
English: Efficacy and safety of infliximab were assessed in two multicenter, double-blind, placebocontrolled studies 8 and 9 in patients with active ankylosing spondylitis (Bath Ankylosing
Maltese: L-effikaja u s-sigurtà ta' infliximab kienu evalwati f'żewġ studji, 8 u 9, 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: infliximab (week 24)
Maltese: terapija b'infliximab waħdu (30.
English: Paediatric population
Maltese: Popolazzjoni pedjatrika Infezzjonijiet
English: a Week 98 data for study 10 includes combined placebo crossover and infliximab patients who entered the open-label extension.
Maltese: Dejta ta' Ġimgħa 98 għal studju 10 jinkludi plaċebo kombinat crossover u pazjenti fuq infliximab li daħlu għall-estensjoni open-label.
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: Ir-rikonoxximent 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: 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: 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: optic neuritis and Guillain-Barré syndrome
Maltese: • Jonqsu s-sinjali u s-sintomi tal-marda tiegħek
English: Chemical and physical in use stability of the reconstituted solution has been demonstrated for 24 hours at 2 °C - 30 °C.
Maltese: L-istabilità kimika u fiżika waqt l-użu tas-soluzzjoni rikostitwita f'temperatura ta' 2°C - 30°C kienet aċċertata għal 24 siegħa.
English: In both studies concurrent use of stable doses of folic acid, oral corticosteroids (≤ 10 mg/day) and/or non-steroidal anti-inflammatory drugs (NSAIDs) was permitted.
Maltese: Fiż-żewġ studji, l-użu fl-istess ħin ta' dożi stabbli ta' folic acid, kortikosterojdi orali (≤ 10 mg/jum) u/jew mediċini antiinfjammatorji mhux sterojdi (NSAIDs) ġie permess.
English: Table 7 Effects on response rate in patients with fistulising Crohn's disease, data from study 5 (week14 responders)
Maltese: Tabella 7 Effetti fuq ir-rata ta' rispons f'pazjenti bil-marda ta' Crohn fistulizzanti, dejta minn studju 5
English: Combined data from studies infliximab
Maltese: Fil-grupp fuq infliximab,
English: Table 4 Effects on ACRn, Structural Joint Damage and Physical Function at week 54, study 2
Maltese: Effetti fuq l-ACRn, Ħsara Strutturali fuq il-Ġogi u Funzjoni Fiżika f'ġimgħa 54, studju 2 Plaċebo
English: Of these 108 patients, 27 were treated with the recommended dosage of infliximab 5 mg/kg.
Maltese: Minn dawn il-108 pazjent, 27 kienu kkurati bid-doża rakkomandata ta' infliximab 5 mg/kg.
English: The primary endpoints were the reduction of signs and symptoms as assessed by the American College of Rheumatology criteria (ACR20 for study 1 (described below), landmark ACR-N for study 2 (described below)), 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 (ACR 20 għal studju 1 (deskritt hawn taħt), landmark ACR-N għal studju 2
English: However,studies from the published literature in variousindications (e.g. rheumatoid arthritis, psoriasis, Crohn's disease) suggestthat non-live vaccinations received during treatment with anti-TNF therapies, including infliximab, may elicit a lower immune response than in patients not receiving anti-TNF therapy."
Maltese: 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: During the 24-week double blind phase, patients received either 5 mg/kg infliximab or placebo at weeks 0, 2, 6, 14, and 22
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: • treat active Crohn's disease
Maltese: • tikkura marda ta' Crohn attiva
English: Vascular disorders Common:
Maltese: Mhux komuni: Fejqan indebolit.
English: Maintenance treatment in fistulising active Crohn's disease
Maltese: Kura ta' manteniment fil-marda ta' Crohn fistulizzanti attiva
English: Investigations Uncommon:
Maltese: Komuni ħafna:
English: In the Phase IIIb trial in Crohn's disease, placebo patients received AZA 2.5 mg/kg/day as active control in addition to placebo infliximab infusions.
Maltese: IIIb fil-marda ta' Crohn, pazjenti tal-plaċebo rċivew 2.5 mg/kg/kuljum ta' AZA bħala kontroll attiv flimkien ma' infużjonijiet ta' infliximab bħala plaċebo.
English: • Swollen lymph nodes
Maltese: Dwiefer kollha fiequc
English: The potential risk with the combination of AZA or 6-MP and Zessly should be carefully considered.
Maltese: Ir-riskju li jista' jkun hemm bil-kombinazzjoni ta' AZA jew 6-MP u Zessly għandu jiġi kkunsidrat bir-reqqa.
English: Zessly contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially ‘sodium-free'.
Maltese: Zessly fih anqas minn 1 mmol sodium (23 mg) f'kull doża, li tista' tgħid huwa essenzjalment ‘ħieles mis-sodium'.
English: In the paediatric Crohn's disease study, infections were reported in 56.3% of randomised subjects treated with infliximab.
Maltese: Infezzjonijiet Fl-istudju dwar il-marda ta' Crohn fit-tfal, infezzjonijiet kienu rrappurtati f'56.3% tal-individwi li ntgħażlu b'mod każwali kkurati b'infliximab.
English: • Signs of infection (including TB) such as fever, feeling tired, cough which may be persistent, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, collection of pus in the gut or around the anus (abscess), dental problems or burning sensation when urinating.
Maltese: • Sinjali ta' infezzjoni (inkluża TB) bħal deni, tħossok għajjien, sogħla li tista' tkun persistenti, qtugħ ta' nifs, sintomi bħal tal-influwenza, telf tal-piż, issir għarqan/a bil-lejl, dijarea, ġrieħi,
English: Zessly over 1 hour.
Maltese: 60 minuta jew anqas.
English: In rheumatoid arthritis, psoriatic arthritis and Crohn's disease patients, there are indications that concomitant use of methotrexate and other immunomodulators reduces the formation of antibodies against infliximab and increases the plasma concentrations of infliximab.
Maltese: F'pazjenti b'sintomi ta' artrite rewmatojde, artrite psorijatika u l-marda ta' Crohn, hemm indikazzjonijiet li meta jingħataw methotrexate u immunomodulaturi oħra fl-istess ħin, dan inaqqas il-formazzjoni ta' antikorpi kontra infliximab u jżid il-konċentrazzjonijiet ta' infliximab fil-plażma.
English: Mucosal healing at week 8a
Maltese: Rispons kliniku f'ġimgħa 30a
English: How to store Zessly
Maltese: X'fih Zessly
English: 3 mg/kg q 8 wks
Maltese: 3 mg/kg q 8 ġim għat
English: In one of the study arms (group 2, n = 329), patients with an inadequate response were allowed to dose titrate with 1.5 mg/kg increments from 3 up to 9 mg/kg.
Maltese: F'wieħed mill-partijiet tal-istudji (grupp 2, n = 329), pazjenti li ma kellhomx rispons adegwat kellhom id-dożi ttitrati b'inkrementi ta' 1.5 mg/kg minn 3 sa 9 mg/kg.
English: All infliximabb
Maltese: Kollha infliximabb
English: Sustained Steroid-Free Remissionb a
Maltese: Rispons Fistula (%) a
English: Change from baseline (Mean ± SDc) Median (Interquartile range)
Maltese: Bdil mil-linja bażi (Medja ± SDc)
English: In study 10 and study 11 in patients with active psoriatic arthritis, clinical responses were observed as early as week 2 and were maintained through week 98 and week 54 respectively.
Maltese: Fi studju 10 u studju 11 f'pazjent b'artrite psorjatika attiva, rispons kliniċi kienu diġà bdew jidhru mat2 ġimgħa u baqgħu sa ġimgħa 98 u ġimgħa 54 rispettivament.
English: 3 mg/kg q 4 wks
Maltese: 3 mg/kg q 4 ġim għat
English: The combination of Zessly and abatacept is not recommended.
Maltese: Il-kombinazzjoni ta' Zessly ma' abatacept mhux rakkomandata.
English: • If you received Zessly during your pregnancy, your baby may have a higher risk for getting an infection.
Maltese: • Jekk irċevejt Zessly waqt it-tqala, it-tarbija tiegħek jista' jkollha riskju akbar li tieħu infezzjoni.
English: • Periodic safety update reports (PSUR)
Maltese: • Rapporti perjodiċi aġġornati dwar is-sigurtà (PSURs)
English: Hepatosplenic T-cell lymphoma (primarily in adolescents and young adult males with Crohn's disease and ulcerative colitis), Merkel cell carcinoma.
Maltese: Mhux magħruf: 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: Zessly is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Maltese: Zessly huwa indikat għall-kura ta' ankylosing spondylitis attiva, severa, f'pazjenti adulti li ma kellhomx rispons adegwat għal terapija konvenzjonali.
English: Patients randomised 52
Maltese: Tnaqqis Mingħajr Sterojdi Ġimgħa 54
English: Table 8 Effects on clinical response in adult patients with moderately to severely active ulcerative colitis, clinical remission and mucosal healing at weeks 8 and 30.
Maltese: Effetti fuq ir-rispons kliniku f'pazjenti adulti b'kolite ulċerattiva attiva b'mod moderat sa sever,
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 iż-żmien minn meta ntgħażlu b'mod każwali sakemm tilfu r-rispons (ara Tabella 7).
English: Gently mix.
Maltese: MTX.
English: The dilution can be accomplished by withdrawing a volume of the sodium chloride 9 mg/ml (0.9%) solution for infusion from the 250-ml glass bottle or infusion bag equal to the volume of reconstituted Zessly.
Maltese: Id-dilwizzjoni tista' ssir billi jinġibed volum tas-soluzzjoni għall-infużjoni ta' sodium chloride 9 mg/ml (0.9%) mil-flixkun tal-ħġieġ jew borża tal-infużjoni ta' 250 ml li jkun daqs il-volum ta' Zessly rikostitwit.
English: HAQ = Health Assessment Questionnaire; greater values indicate less disability.
Maltese: e HAQ =Kwestjonarju Dwar l-Evalwazzjoni tas-Saħħa; valuri ikbar jindikaw inqas diżabilità.
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: induzzjoni, 30% tal-pazjenti fil-grupp fuq 5 mg/kg u 13.8% fil-grupp fuq 3 mg/kg urew rispons skont
English: Following administration of 5 mg/kg infliximab every 8 weeks, the predicted median steady-state infliximab exposure (area under concentrationtime curve at steady state, AUCss) in paediatric patients aged 6 years to 17 years was approximately 20% lower than the predicted median steady-state drug exposure in adults.
Maltese: 8 ġimgħat, il-medjan imbassar tal-esponiment fi stat fiss ta' infliximab (żona taħt il-kurva konċentrazzjoni-ħin fi stat fiss, AUCss ) f'pazjenti pedjatriċi li kellhom minn 6 snin sa 17-il sena kien madwar 20% iktar baxx mill-medjan imbassar tal-espożizzjoni tal-mediċina fi stat fiss f'persuni adulti.
English: The efficacy of repeated infusions with infliximab in patients with fistulising Crohn's disease was studied in a 1-year clinical study (clinical Study 5).
Maltese: L-effikaċja ta' infużjonijiet ripetuti ta' infliximab f'pazjenti bil-marda ta' Crohn fistulizzanti kienet studjati fi studju kliniku ta' sena (Studju kliniku 5).
English: Zessly 100 mg powder for concentrate for solution for infusion infliximab
Maltese: Zessly 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni infliximab
English: Subjects randomised Percentage ACR improvement Mean ± SDa
Maltese: Pazjenti b'reazzjoni ACR 20 / Pazjenti evalwati (%)
English: In an exploratory clinical study involving patients with moderate to severe COPD who were either current smokers or ex-smokers, 157 adult patients were treated with infliximab at doses similar to those used in rheumatoid arthritis and Crohn's disease.
Maltese: Fi studju kliniku esploratorju li kien jinvolvi pazjenti b'COPD moderat sa sever li kienu jew ipejpu fil-preżent jew kienu jpejpu fil-passat, 157 pazjent adult kienu kkurati b'infliximab b'dożi simili għal dawk użati f'artrite rewmatojde u l-marda ta' Crohn.
English: Pharmacotherapeutic group: Immunosuppressants, tumour necrosis factor alpha (TNFα) inhibitors, ATC code: L04AB02.
Maltese: Immunosoppressanti, inibituri tal-fattur tan-nekrożi alfa (TNFα),
English: The safety and efficacy of infliximab were assessed in a multicenter, randomised, open-label, parallel-group clinical study 15 in 60 paediatric patients aged 6 through 17 years (median age 14.5 years) with moderately to severely active ulcerative colitis (Mayo score of 6 to 12; endoscopic subscore ≥ 2) with an inadequate response to conventional therapies.
Maltese: Is-sigurtà u l-effikaċja ta' infliximab kienu evalwati fi studju kliniku, b'aktar minn ċentru wieħed, li fih il-parteċipanti ntgħażlu b'mod każwali, open label u bi grupp parallel 15 f'60 pazjent pedjatriku b'età minn 6 sa 17-il sena (età medjana ta' 14.5 snin) b'kolite bl-ulċeri attiva b'mod moderat sa sever
English: • More children taking infliximab developed infections as compared to adults.
Maltese: • Aktar tfal li jkunu qed jieħdu infliximab żviluppaw infezzjonijiet meta mqabbla ma' persuni adulti.
English: Clinical remission at week 8a Clinical remission at week 30a Sustained remission (in remission at both week 8 and week 30)a
Maltese: (rispons kliniku f'ġimgħa 8 kif ukoll f'ġimgħa 30)a
English: Patients with ACR20 response/
Maltese: ACR 50 rispons*
English: In the first clinical study, (study 10), efficacy and safety of infliximab were studied in 104 patients with active polyarticular psoriatic arthritis.
Maltese: Fl-ewwel studju kliniku (studju 10), l-effikaċja u s-sigurtà ta' infliximab kienu studjati f'104 pazjenti b'artrite psorijatika li taffettwa ħafna ġogi.
English: In Phase III clinical studies, 18% of infliximabtreated patients compared with 5% of placebo-treated patients experienced an infusion-related reaction.
Maltese: III, 18% tal-pazjenti kkurati b'infliximab kellhom reazzjoni marbuta mal-infużjoni meta mqabbel ma' 5% tal-pazjenti kkurati bi plaċebo.
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: u 123/201 (61) fil-grupp fuq 5 mg/kg infliximab (p < 0.001).
English: Use only an infusion set with an in-line, sterile, nonpyrogenic, low protein-binding filter (pore size 1.2 micrometre or less).
Maltese: Uża biss sett tal-infużjoni li jkollu filtru fil-pajp, sterili, li ma jikkawżax id-deni, u li jeħel miegħu livell baxx ta' proteini (daqs tal-pori 1.2 mikrometru jew inqas).
English: This includes multiple sclerosis, Guillain-Barré syndrome, if you have fits or have been diagnosed with ‘optic neuritis'.
Maltese: Dan jinkludi sklerożi multipla, sindrome Guillain-Barré, jekk ituk aċċessjonijiet jew ġejt dijanjostikat li tbati b''nevrite ottika'.
English: Zessly should be administered
Maltese: Twissijiet u prekawzjonijiet
English: Zessly is indicated for treatment of severely active ulcerative colitis, in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.
Maltese: Zessly huwa indikat għall-kura ta' kolite ulċerattiva attiva ħafna, fi tfal u adolexxenti li għandhom minn 6 sa 17-il sena, li kellhom rispons mhux adegwat għal terapija konvenzjonali inkluż kortikosterojdi u 6-MP jew AZA, jew li huma intolleranti għal jew għandhom kontra-indikazzjonijiet mediċi għal terapiji bħal dawn.
English: Dosing continued for all patients through week 46.
Maltese: infezzjonijiet b'tilqim ħaj għal perjodu sa 6 xhur wara t-twelid.