FrancophonIA/ELRC3.0 huggingface dataset:
English: 90mg ustekinumab every 8 Weeks N = 176
Maltese: 90mg ustekinumab kull 8 Ġimgħat N = 176
English: The infusion solution is to be composed of the number of vials of STELARA 130 mg as specified in Table 1 (see section 6.6 for preparation).
Maltese: Issoluzzjoni għall-infużjoni għandha tiġi komposta minn numru ta' kunjetti ta' STELARA 130 mg kif speċifikat fit-Tabella 1 (ara sezzjoni 6.6 għall-preparazzjoni).
English: At week 8 of UNIFI-I, patients receiving ustekinumab showed significantly greater and clinically meaningful improvements on IBDQ total score, EQ-5D and EQ-5D VAS, and SF-36 Mental Component Summary Score and SF-36 Physical Component Summary Score when compared to placebo.
Maltese: F'ġimgħa 8 ta' UNIFI-I, pazjenti li kienu qed jirċievu ustekinumab urew titjib b'mod sinifikanti akbar u ta' sinifikat kliniku fuq il-punteġġ totali ta' IBDQ, EQ-5D u EQ-5D VAS, u s-Sommarju tal-Punteġġ tal-Komponent Mentali SF-36 u s-Sommarju tal-Punteġġ tal-Komponent fiżiku SF-36 meta mqabbel mal-plaċebo.
English: STELARA is available in a 1 vial pack.
Maltese: STELARA huwa disponibbli f'pakkett bi fjala waħda.
English: The pharmacokinetics of ustekinumab was not impacted by concomitant use of MTX, NSAIDs, 6-mercaptopurine, azathioprine and oral corticosteroids in patients with psoriatic arthritis, Crohn's disease or ulcerative colitis, or prior exposure to anti-TNFα agents, in patients with psoriatic arthritis or Crohn's disease or by prior exposure to biologics (i.e. anti-TNFα agents and/or vedolizumab) in patients with ulcerative colitis.
Maltese: Il-farmakokinetika ta' ustekinumab ma ġietx affettwata mill-użu fl-istess ħin ta' MTX, NSAIDs, 6-mercaptopurine, azathioprine u kortikosterojdi orali f'pazjenti b'artrite psorjatika, bilmarda ta' Crohn jew b'kolite ulċerattiva, jew esponiment fil-passat għal mediċini kontra TNFα, f'pazjenti b'artrite psorijatika jew bil-marda ta' Crohn jew perezz ta' esponiment fil-passat għal sustanzi bijoloġiċi (i.e sustanzi kontra TNFα u/jew vedolizumab) f'pazjenti b'kolite ulċerattiva.
English: Approximately 50% of patients continued on stable doses of MTX (≤ 25 mg/week).
Maltese: Madwar 50% tal-pazjenti komplew fuq dożi stabbli ta' MTX (≤ 25 mg/ġimgħa).
English: The safety and efficacy of ustekinumab was assessed in 1,996 patients in two randomised, double-blind, placebo-controlled studies in patients with moderate to severe plaque psoriasis and who were candidates for phototherapy or systemic therapy.
Maltese: Is-sigurtà u l-effikaċja ta' ustekinumab kienu stmati f'1,996 pazjent f'żewġ studji, randomizzati, double-blind, ikkontrollati bi plaċebo f'pazjenti bi psorijasi bil-qoxra minn moderata sa qawwija u li kienu kandidati għal fototerapija jew kura sistemika.
English: Improvements in PGA, PASI, CDLQI and PedsQL were maintained through week 52 (Table 7).
Maltese: Titjib f'PGA, PASI, CDLQI u PedsQL inżammu sal-Ġimgħa 52 (Tabella 7).
English: Durable Remission is defined as partial Mayo remission at ≥80% of all visits prior to Week 44 and in partial Mayo remission at last visit (Week 44).
Maltese: Remissjoni li ddum hija ddefinita bħala remissjoni parzjali Mayo f'≥80% tal-visti kollha qabel Ġimgħa 44 u remissjoni parzjali Mayo fl-aħħar vista (Ġimgħa 44).
English: Week 12 2 doses (week 0 and week 4)
Maltese: Ġimgħa 12 2 dożi (Ġimgħa 0 u Ġimgħa 4)
English: Systemic and respiratory hypersensitivity reactions
Maltese: Reazzjonijiet sistemiċi u respiratorji ta' sensittività eċċessiva Sistemiċi
English: Patients with PASI ≥ 12, PGA ≥ 3 and BSA involvement of at least 10%, who were candidates for systemic therapy or phototherapy, were eligible for the study.
Maltese: Pazjenti b'PASI ≥ 12, PGA ≥ 3 u involviment ta' BSA ta' mill-inqas 10%, li kienu kandidati għal terapija sistemika jew fototerapija, kienu eliġibbli għall-istudju.
English: p < 0.001 for ustekinumab 45 mg or 90 mg in comparison with etanercept.
Maltese: p < 0.001 għal ustekinumab 45 mg jew 90 mg meta mqabbel ma' etanercept.
English: Table 2 Injection volumes of STELARA for paediatric psoriasis patients < 60 kg Body weight at time of dosing (kg)
Maltese: Tabella 2: Volumi tal-injezzjoni ta' STELARA għal pazjenti pedjatriċi bi psorijasi < 60 kg Piż tal-ġisem fil-ħin tal-għoti tad-doża (kg)
English: Alternatively, 90 mg may be used in patients with a body weight > 100 kg.
Maltese: Alternattivament, doża ta' 90 mg tista' tintuża f'pazjenti li jiżnu > 100 kg.
English: Concentrate for Solution for infusion 130 mg/26 mL
Maltese: Konċentrat għal Soluzzjoni għall-infużjoni 130 mg/26 mL
English: The overall safety profile was similar for patients with psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.
Maltese: Il-profil ta' sigurtà globali kien simili għall-pazjenti bi psorijasi, artrite psorijatika, il-marda ta' Crohn u kolite ulċerattiva.
English: Approximately 43% of the patients had prior exposure to conventional systemic therapy or phototherapy.
Maltese: Madwar 43% tal-pazjenti kellhom esponiment preċedenti għal terapija sistemika konvenzjonali jew fototerapija.
English: Inject the dose:
Maltese: Injetta d-doża:
English: Common: Back pain, myalgia, arthralgia
Maltese: Komuni: Dijarea, dardir, rimettar
English: Immunogenicity
Maltese: Immunoterapija
English: Patients in UNITI-2 had failed at least one conventional therapy, including corticosteroids or immunomodulators, and were either anti-TNF-α naïve (68.6%) or had previously received but not failed anti-TNFα therapy (31.4%).
Maltese: Pazjenti f'UNITI-2 ma rrispondewx għal mill-inqas terapija konvenzjonali waħda, inkluż kortikosterojdi jew immunomodulaturi, u kienu persuni li qatt ma rċevew terapija kontra TNF-α (68.6%) jew kienu rċevew iżda ma rrispondewx għal terapija preċedenti kontra TNF-α (31.4%).
English: Health-related quality of life was assessed by Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36 and EuroQoL-5D (EQ-5D) questionnaires.
Maltese: Il-kwalità tal-ħajja marbuta mas-saħħa ġiet stmata permezz tal-kwestjonarji, Kwestjonarju ta' Mard Infjammatorju tal-Musrana (IBDQ, Inflammatory Bowel Disease Questionnaire), SF-36 u EuroQoL5D (EQ-5D).
English: In PsA Study 2, ACR 20 responses at week 52 were achieved by 47% and 48%, for 45 mg and 90 mg, respectively.
Maltese: Fi Studju 2 ta' PsA, reazzjonijiet favorevoli għal ACR 20 fil-Ġimgħa 52 inkisbu minn 47% u 48%, għal 45 mg u 90 mg, rispettivament.
English: STELARA should only be diluted with sodium chloride 9 mg/mL (0.9%) solution.
Maltese: STELARA għandu jiġi dilwit biss b'soluzzjoni ta' sodium chloride 9 mg/ml (0.9%).
English: STELARA 45 mg solution for injection STELARA 90 mg solution for injection STELARA 45 mg solution for injection in pre-filled syringe STELARA 90 mg solution for injection in pre-filled syringe
Maltese: STELARA 45 mg soluzzjoni għall-injezzjoni STELARA 90 mg soluzzjoni għall-injezzjoni STELARA 45 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest STELARA 90 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest
English: In PsA Study 2 there was a significant improvement in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scores in the ustekinumab groups when compared with placebo at week 24.
Maltese: F'PsA Studju 2 kien hemm titjib sinifikanti fil-punteġġi tal-Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fil-gruppi ta' ustekinumab meta mqabbla mal-plaċebo f'Ġimgħa 24.
English: A numerically lower number of subjects in the ustekinumab group (0.6%, 2/348) underwent UC disease related surgeries compared with subjects in the placebo group (1.7%, 3/175) through week 44.
Maltese: Numru numerikament inqas ta' individwi fl-grupp ta' ustekinumab (0.6%, 2/348) sarulhom operazzjonijiet marbuta mal-marda UC meta mqabbla ma' individwi fil-grupp talplaċebo (1.7%, 3/175) sa ġimgħa 44.
English: The adverse reactions are classified by System Organ Class and frequency, using the following convention: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Komuni ħafna (≥ 1/10), Komuni (≥ 1/100 sa < 1/10), Mhux komuni (≥ 1/1,000 sa < 1/100), Rari (≥ 1/10,000 sa < 1/1,000), Rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: 80, sucrose and water for injections.
Maltese: polysorbate 80 sucrose, u ilma għall-injezzjonijiet.
English: ACR 20, 50 and 70 responses continued to improve or were maintained through week 52 (PsA Study 1 and 2) and week 100 (PsA Study 1).
Maltese: Reazzjonijiet favorevoli għal ACR 20, 50 u 70 komplew jitjiebu jew inżammu sal-Ġimgħa 52 (Studji 1 u 2 ta' PsA) u Ġimgħa 100 (Studju 1 ta' PsA).
English: Patients previously treated with anti-TNFα agents who received ustekinumab achieved a greater response at week 24 than patients receiving placebo (ACR 20 response at week 24 for 45 mg and 90 mg was 37% and 34%, respectively, compared with placebo 15%; p < 0.05), and responses were maintained through week 52.
Maltese: Pazjenti kkurati fil-passat b'mediċini kontra TNFα li rċivew ustekinumab, kisbu rispons ikbar f'Ġimgħa 24 minn pazjenti li rċivew plaċebo (ACR 20 rispons f'Ġimgħa 24 għal 45 mg u 90 mg kien ta' 37% u 34%, rispettivament, meta mqabbla ma' plaċebo 15%; p < 0.05), u r-risponsi nżammu sal-Ġimgħa 52.
English: This will let the liquid come to a comfortable temperature for injection (room temperature).
Maltese: Dan iġiegħel illikwidu jilħaq temperatura komda għall-injezzjoni (temperatura tal-kamra).
English: Table 4: Maintenance of Clinical Response and Remission in IM-UNITI (week 44; 52 weeks from initiation of the induction dose)
Maltese: Tabella 4: Manteniment ta' Rispons u Remissjoni Kliniċi f'IM-UNITI (ġimgħa 44; 52 ġimgħa millbidu tad-doża ta' induzzjoni)
English: Withdraw and then discard a volume of the sodium chloride 9 mg/mL (0.9%) solution from the 250 mL infusion bag equal to the volume of STELARA to be added (discard 26 mL sodium chloride for each vial of STELARA needed, for 2 vials- discard 52 mL, for 3 vials discard 78 mL, for 4 vials- discard 104 mL).
Maltese: Iġbed u imbagħad armi volum mis-soluzzjoni ta' sodium chloride 9 mg/ml (0.9%) mill-borża tal-infużjoni ta' 250 mL daqs il-volum ta' STELARA li għandu jiġi miżjud (armi 26 mL ta' sodium chloride għal kull kunjett ta' STELARA meħtieġ, għal 2 kunjetti armi 52 mL, għal 3 kunjetti armi 78 mL, għal 4 kunjetti armi 104 mL) Iġbed 26 mL ta' STELARA minn kull kunjett meħtieġ u żidhom mal-borża tal-infużjoni ta' 250 mL.
English: Psoriasis Study 3 (ACCEPT) evaluated 903 patients with moderate to severe psoriasis who inadequately responded to, were intolerant to, or had a contraindication to other systemic therapy and compared the efficacy of ustekinumab to etanercept and evaluated the safety of ustekinumab and etanercept.
Maltese: L-Istudju tal-Psorijasi 3 (ACCEPT) evalwa 903 pazjenti bi psorijasi minn moderata sa qawwija li ma rrispondewx b'mod xieraq, kienu intolleranti, jew kellhom kontraindikazzjoni għal terapija sistemika oħra, u ikkumpara l-effikaċja ta' ustekinumab ma' etanercept u evalwa s-sigurtà ta' ustekinumab u etanercept.
English: Approximately 6 mg/kg
Maltese: Madwar 6 mg/kg
English: Ustekinumab-treated patients showed significant improvement in physical function as assessed by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at week 24.
Maltese: Funzjoni fiżika u kwalità tal-ħajja assoċjata mas-saħħa Pazjenti kkurati b'ustekinumab urew titjib sinifikanti fil-funzjoni fiżika kif evalwat mid-Disability Index of the Health Assessment Questionnaire (HAQ-DI) f'Ġimgħa 24.
English: STELARA is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) (see section 5.1).
Maltese: STELARA hu indikat għall-kura ta' psorijasi bil-plakka moderata sa qawwija fl-adulti li ma kellhomx rispons għal, jew li għandhom kontraindikazzjoni għal, jew li ma jittollerawx terapiji sistemiċi oħra, li jinkludu ciclosporin, methotrexate (MTX) jew PUVA (psoralen u ultraviolet A) (ara sezzjoni 5.1).
English: The expiry date refers to the last day of that month.
Maltese: Agħti s-soluzzjoni dilwita fuq perijodu ta' mill-inqas siegħa.
English: Withdraw and discard a volume of the sodium chloride 9 mg/mL (0.9%) solution from the 250 mL infusion bag equal to the volume of STELARA to be added.
Maltese: Iġbed u armi volum mis-soluzzjoni ta' sodium chloride 9 mg/ml (0.9%) mill-borża tal-infużjoni ta' 250 mL daqs il-volum ta' STELARA li għandu jiġi miżjud.
English: • Moderate to severe Crohn's disease - in adults
Maltese: • Marda moderata sa severa ta' Crohn - fl-adulti
English: During the long term extension of Psoriasis Study 2 (PHOENIX 2), adult patients treated with STELARA for at least 3.5 years mounted similar antibody responses to both pneumococcal polysaccharide and tetanus vaccines as a non-systemically treated psoriasis control group.
Maltese: Matul l-estensjoni fit-tul tal-Istudju Psorijasi 2 (PHOENIX 2), pazjenti adulti kkurati b'STELARA għal mill-inqas 3.5 snin urew rispons ta' antikorpi kemm għal polysaccharide pnewmokokkali kif ukoll għat-tilqim tat-tetnu simili għal grupp psorijatiku ta' kontroll mhux ittrattat sistemikament.
English: In patients who failed biological therapy In patients who failed both a TNF and vedolizumab 28% (13/47) Mucosal Healing
Maltese: F'pazjenti li fallew terapija bijoloġika F'pazjenti li fallew kemm TNF kif ukoll vedolizumab 28% (13/47) Fejqan tal-Mukuża
English: The safety data described below reflect exposure in adults to ustekinumab in 14 phase 2 and phase 3 studies in 6,709 patients (4,135 with psoriasis and/or psoriatic arthritis, 1,749 with Crohn's disease and 825 patients with ulcerative colitis).
Maltese: It-tagħrif ta' sigurtà deskritt hawn taħt jirrifletti esponiment għal ustekinumab fl-adulti fi 14-il studju kkontrollat ta' fażi 2 u fażi 3 ta'6,709 pazjent (4,135 bi psorijasi u/jew artrite psorjatika, 1,749 bilmarda ta' Crohn u 825 pazjent b'kolite ulċerattiva).
English: Ustekinumab is a fully human IgG1κ monoclonal antibody to interleukin (IL)-12/23 produced in a murine myeloma cell line using recombinant DNA technology.
Maltese: IgG1κ kollu kemm hu uman għal interleukin (IL)-12/23 magħmul f'linja ta' ċelloli ta' mijeloma murine bl-użu tat-teknoloġija rikombinanti tad-DNA.
English: To calculate the volume of injection (mL) for patients < 60 kg, use the following formula: body weight (kg) x 0.0083 (mL/kg) or see Table 2.
Maltese: Biex tikkalkula l-volum tal-injezzjoni (mL) għall-pazjenti < 60 kg, uża l-formula li ġejja: piż talġisem (kg) x 0.0083 (mL/kg) jew ara Tabella 2.
English: During the controlled periods of the psoriasis and psoriatic arthritis clinical studies of ustekinumab, rash and urticaria have each been observed in < 1% of patients (see section 4.4).
Maltese: Matul il-perijodi kkontrollati tal-istudji kliniċi dwar il-psorijasi u u artrite psorjatika ta' ustekinumab, kemm raxx u kemm urtikarja kienu osservati f'< 1% tal-pazjenti (ara sezzjoni 4.4).
English: Mucosal healing is defined as a Mayo endoscopic sub-score of 0 or 1.
Maltese: Fejqan tal-mukuża huwa ddefinit bħala sottopunteġġ endoskopiku Mayo ta' 0 jew 1.
English: Endoscopic appearance of the mucosa was evaluated in 252 patients with eligible baseline endoscopic disease activity in a substudy.
Maltese: Id-dehra endoskopika tal-mukuża ġiet evalwata f'252 pazjent b'attività endoskopika tal-marda eliġibbli fil-linja bażi f'sottostudju.
English: Combined symptomatic remission and mucosal healing is defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1. p<0.001 p<0.05
Maltese: Remissjoni tas-sintomi flimkien ma' fejqan etal-mukuża huwa ddefinit bħala sottopunteġġ tal-frekwenza tal-ippurgar ta' 0 jew 1, sottopunteġġ tal-ħruġ ta' demm mir-rektum ta' 0, u sottopunteġġ tal-endoskopija ta' 0 jew 1. p<0.001 p<0.05
English: Table 5: Summary of Key Efficacy Outcomes in UNIFI-I (Week 8) Placebo
Maltese: Sommarju tar-Riżultati l-Aktar Importanti ta' Effikaċja f'UNIFI-I (Ġimgħa 8) Plaċebo
English: In PsA Study 1, ACR 20 responses at week 100 were achieved by 57% and 64%, for 45 mg and 90 mg, respectively.
Maltese: Fi Studju 1 ta' PsA, reazzjonijiet favorevoli għal ACR 20 fil-Ġimgħa 100 inkisbu minn 57% u 64%, għal 45 mg u 90 mg, rispettivament.
English: Through week 44 of UNIFI-M, a significantly lower number of UC-related hospitalizations was observed in subjects in the combined ustekinumab group (2.0%, 7/348) as compared with subjects in the placebo group (5.7%, 10/175).
Maltese: Sa ġimgħa 44 ta' UNIFI-M, ġie osservat numru b'mod sinifikanti inqas ta' rikoverar l-isptar marbut ma' UC fil-grupp ta' ustekinumab kombinat (2.0%, 7/348) meta mqabbel ma' individwi fil-grupp talplaċebo (5.7%, 10/175).
English: OUTER CARTON (130 mg)
Maltese: KARTUNA TA' BARRA (130 mg)
English: At 1 year (week 52), 89% of patients re-randomised to maintenance treatment were PASI 75 responders compared with 63% of patients re-randomised to placebo (treatment withdrawal) (p < 0.001).
Maltese: Mas-sena (Ġimgħa 52), 89% tal-pazjenti randomised mill-ġdid għal kura ta' manteniment kienu dawk li kisbu rispons PASI 75 meta mqabbla ma' 63% tal-pazjenti li kienu randomised mill-ġdid għall-plaċebo (twaqqif tal-kura) (p < 0.001).
English: PASI 90 response N (%)
Maltese: Rispons PASI 90, N (%)
English: This includes exposure to STELARA in the controlled and non-controlled periods of the clinical studies for at least 6 months or 1 year (4,577 and 3,253 patients respectively with psoriasis, psoriatic arthritis, Crohn's disease or ulcerative colitis) and exposure for at least 4 or 5 years (1,482 and 838 patients with psoriasis respectively).
Maltese: Dan jinkludi esponiment għal STELARA filperijodi kkontrollati u mhux ikkontrollati tal-istudji kliniċi għal mill-inqas 6 xhur jew sena (4,577 u 3,253 pazjent rispettivament bi psorijasi, artrite psorjatika, il-marda ta' Crohn jew kolite ulċerattiva) u esponiment għal mill-anqas 4 jew 5 snin (1,482 u 838 pazjent bi psorijasi rispettivament).
English: STELARA 90 mg solution for injection EU/1/08/494/002
Maltese: STELARA 90 mg soluzzjoni għall-injezzjoni EU/1/08/494/002
English: STELARA contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Maltese: STELARA fih inqas minn mmol 1 ta' sodium (23 mg) f'kull doża, i.e. huwa essenzjalment ‘mingħajr sodium'.
English: Improvements in PGA, PASI, and CDLQI were maintained through week 52 (Table 8).
Maltese: Titjib f'PGA, PASI, u CDLQI inżamm sa ġimgħa 52 (Tabella 8).
English: Do not shake.
Maltese: jekk ikun hemm bżonn.
English: STELARA 90 mg injection ustekinumab
Maltese: STELARA 90 mg għall-injezzjoni ustekinumab
English: Recommended dose of ustekinumab N = 322
Maltese: Doża rrakkomandata ta' ustekinumab N =322
English: STELARA 45 mg solution for injection EU/1/08/494/001
Maltese: STELARA 45 mg soluzzjoni għall-injezzjoni EU/1/08/494/001
English: Solution for injection in pre-filled syringe 90 mg/1 mL
Maltese: Soluzzjoni għall-injezzjoni 90 mg/1 mL
English: Mucosal healing is defined as a Mayo endoscopic subscore of 0 or 1.
Maltese: Fejqan tal-mukuża huwa ddefinit bħala sottopunteġġ endoskopiku Mayo ta' 0 jew1.
English: 90 mg ustekinumab every 8 weeks
Maltese: 90 mg ustekinumab kull 8 ġimgħat
English: In a subgroup of patients with draining fistulas at baseline (8.8%; n = 26), 12/15 (80%) of ustekinumab-treated patients achieved a fistula response over 44 weeks (defined as ≥ 50% reduction from baseline of the induction study in the number of draining fistulas) compared to 5/11 (45.5%) exposed to placebo.
Maltese: F'sottogrupp ta' pazjenti b'fistuli li jnixxu fil-linja bażi (8.8%; n = 26), 12/15 (80%) tal-pazjenti ttrattati b'ustekinumab kisbu rispons tal-fistla matul 44 ġimgħa (definit bħala tnaqqis ta' ≥ 50% millinja bażi tal-istudju ta' induzzjoni fl-għadd ta' fistli li jnixxu) meta mqabbla ma' 5/11 (45.
English: Cases of allergic alveolitis, eosinophilic pneumonia, and non-infectious organising pneumonia have been reported during post-approval use of ustekinumab.
Maltese: Kienu rrappurtati każijiet ta' alveolite allerġika u pulmonite eosinofilika, u pulmonite sistematizzata mhux infettiva waqt l-użu ta' ustekinumab wara l-approvazzjoni.
English: No adverse effects on female fertility indices were observed using an analogous antibody to IL-12/23 in mice.
Maltese: L-ebda effetti avversi fuq l-indiċi tal-fertilità fin-nisa ma kienu osservati bl-użu ta' antikorpi analogi għall-IL-12/23 filġrieden.
English: • Moderate to severe ulcerative colitis - in adults
Maltese: • Kolite ulċerattiva minn moderata sa severa - fl-adulti
English: The safety and efficacy of ustekinumab was assessed in 927 patients in two randomised, double-blind, placebo-controlled studies in patients with active PsA (≥ 5 swollen joints and ≥ 5 tender joints) despite non-steroidal anti-inflammatory (NSAID) or disease modifying antirheumatic (DMARD) therapy.
Maltese: Is-sigurtà u l-effikaċja ta' ustekinumab ġew evalwati f'927 pazjent f'żewġ studji, li fihom ilparteċipanti ntgħażlu b'mod każwali, double-blind, kkontrollati bi plaċebo, f'pazjenti b'PsA attiva (≥ 5 ġogi minfuħin u ≥ 5 ġogi sensittivi) minkejja terapija mhux sterojde antiinfjammatorja (NSAID) jew terapija b'mediċina antirewmatika li timmodifika l-marda (DMARD).
English: 90 mg ustekinumab every 12 weeks N = 129
Maltese: 90 mg ustekinumab kull 12-il ġimgħa N = 129
English: The primary endpoint was the percentage of patients who achieved American College of Rheumatology (ACR) 20 response at week 24.
Maltese: Il-punt aħħari primarju kien il-perċentwali ta' pazjenti li kisbu rispons talKulleġġ Amerikan tar-Rewmatoloġija (ACR - American College of Rheumatology) ta' 20 f'Ġimgħa 24.
English: Secondary endpoints included PASI 75, PASI 90, change from baseline in Children's Dermatology Life Quality Index (CDLQI), change from baseline in the total scale score of PedsQL (Paediatric Quality of Life Inventory) at week 12.
Maltese: Skopijiet finali sekondarji kienu jinkludu PASI 75, PASI 90, bidla mil-linja bażi fl-Indiċi Dermatoloġiċi dwar il-Kwalità tal-Ħajja tat-Tfal (CDLQI - Children's Dermatology Life Quality Index), bidla mil-linja bażi fil-punteġġ tal-iskala totali ta' PedsQL (Inventarju tal-Kwalità talĦajja Pedjatrika - Paediatric Quality of Life Inventory) f'Ġimgħa 12.
English: Excipients: EDTA disodium salt dihydrate, L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 80, sucrose, water for injection.
Maltese: EDTA disodium salt dihydrate, L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 80, sucrose, ilma għall-injezzjoni.
English: At 5 years (week 244), 80% of patients re-randomised to maintenance treatment were PASI 75 responders.
Maltese: Wara 5 snin (Ġimgħa 244), 80% ta' pazjenti li ġew randomizzati mill-ġdid għal trattament ta' manteniment kienu dawk li kisbu rispons ta' PASI 75.
English: Excipients: Sucrose, L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, water for injections.
Maltese: Eċċipjenti: Sucrose, L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, ilma għall-injezzjonijiet.
English: Secondary endpoints included PASI 75, PASI 90, and change from baseline in Children's Dermatology Life Quality Index (CDLQI) at week 12.
Maltese: Skopijiet sekondarji kienu jinkludu PASI 75, PASI 90, u bidla mil-linja bażi fl-Indiċi Dermatoloġiċi dwar il-Kwalità tal-Ħajja tat-Tfal (CDLQI, Children's Dermatology Life Quality Index) f'ġimgħa 12.
English: p < 0.001 for ustekinumab 45 mg or 90 mg in comparison with placebo (PBO).
Maltese: p < 0.001 għal 45 mg jew 90 mg ustekinumab meta mqabbel ma' plaċebo (PBO). PGA = (Physician Global Assessment) Stima Globali tat-Tabib
English: Approximately 60% of the patients had prior exposure to conventional systemic therapy or phototherapy.
Maltese: Madwar 60% tal-pazjenti kellhom esponiment qabel għal terapija sistemika konvenzjonali jew fototerapija.
English: STELARA is however, diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion.
Maltese: Madankollu STELARA jiġi, ddilwit f'soluzzjoni għall-infużjoni ta' 9 mg/ml (0.9%) sodium chloride.