FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients were randomized to receive a subcutaneous maintenance regimen of either 90 mg ustekinumab every 8 weeks, 90 mg ustekinumab every 12 weeks or placebo for 44 weeks (for recommended maintenance posology, see section 4.2 of the STELARA Solution for injection (vial) and Solution for injection in pre filled syringe SmPC).
Maltese: Il-pazjenti kienu randomised biex jirċievu kors ta' manteniment taħt il-ġilda ta' 90 mg ustekinumab kull 8 ġimgħat, 90 mg ustekinumab kull 12-il ġimgħa jew plaċebo għal 44 ġimgħa (għall-pożoloġija ta' manteniment irrakkomandata, ara sezzjoni 4.2 tal-SmPC ta' STELARA Soluzzjoni għall-injezzjoni (kunjett) u Soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest).
English: Patients in UNITI-1 had failed or were intolerant to prior anti-TNFα therapy.
Maltese: Pazjenti f'UNITI-1 ma rrispondewx jew kienu intolleranti għal terapija preċedenti kontra
English: In patients with Crohn's disease and ulcerative colitis, treatment with ustekinumab resulted in a decrease in inflammatory markers including C-Reactive Protein (CRP) and fecal calprotectin during the induction phase, which were then maintained throughout the maintenance phase.
Maltese: F'pazjenti bil-marda ta' Crohn u f'kolite ulċerattiva, it-trattament b'ustekinumab wassal għal tnaqqis fil-markaturi tal-infjammazzjoni inkluż il-Proteina Riattiva Ċ (CRP - C-Reactive Protein) u calprotectin fl-ippurgar matul il-fażi ta' induzzjoni, imbagħad dawn kienu miżmuma matul il-fażi ta' manteniment.
English: Each vial contains 45 mg ustekinumab in 0.5 mL.
Maltese: Kull fjala fiha 45 mg ustekinumab f'0.5 mL.
English: Median half-life (t1/2) of ustekinumab was approximately 3 weeks in patients with ulcerative colitis, Crohn's disease, psoriasis and/or psoriatic arthritis, ranging from 15 to 32 days across all psoriasis and psoriatic arthritis studies.
Maltese: Il-medjan tal-half-life (t1/2) ta' ustekinumab kien bejn wieħed u ieħor ta' 3 ġimgħat f'pazjenti bil-marda ta' Crohn u kolite ulċerattiva, psorijasi u/jew artrite psorjatika, fuq medda minn 15 sa 32 jum fl-istudji kollha tal-psorijasi u artrite psorjatika.
English: Patients randomised to receive placebo at Weeks 0 and 4 crossed over to receive ustekinumab (either 45 mg or 90 mg) at Weeks 12 and 16.
Maltese: Pazjenti randomized biex jirċievu plaċebo fil-Ġimgħat 0 u 4 qalbu għall-fergħa l-oħra tal-istudju u bdew jirċievu ustekinumab (45 mg jew 90 mg) fil-Ġimgħat 12 u 16.
English: However, abnormal regulation of IL 12 and IL 23 has been associated with immune mediated diseases, such as psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.
Maltese: Madankollu, ir-regolazzjoni anormali ta' IL-12 u IL-23 ġiet assoċjata ma' mard medjat immuni, bħal psorijasi, artrite psorijatika, il-marda ta' Crohn u kolite ulċerattiva.
English: Clinical Remission Clinical Response Corticosteroid-Free Clinical Remission Clinical Remission in patients: in remission at the start of maintenance therapy who entered from study CRD3002 who are Anti-TNFα naïve who entered from study CRD3001
Maltese: Remissjoni Klinika Rispons Kliniku Remissjoni Klinika Mingħajr Kortikosterojdi Remissjoni Klinika f'pazjenti: f'remissjoni fil-bidu ta' terapija ta' manteniment li daħlu minn studju CRD3002 li qatt ma rċevew terapija kontra TNF-α 49% (25/51) 65% (34/52) li daħlu minn studju CRD3001
English: Your doctor will examine you and do a test for tuberculosis, before you have Stelara.
Maltese: Ittabib tiegħek se jeżaminak u jagħmillek test għat-tuberkolożi, qabel ma jagħtik Stelara.
English: Crohn's disease or Ulcerative Colitis
Maltese: Il-Marda ta' Crohn u Kolite Ulċerattiva
English: The median V/F in patients with weight > 100 kg was approximately 37% higher as compared to patients with weight ≤ 100 kg.
Maltese: Il-medjan ta' V/F f'pazjenti b'piż > 100 kg kien bejn wieħed u ieħor 37% ogħla meta mqabbel ma' pazjenti b'piż ta' ≤ 100 kg.
English: PASI 50 response N (%)
Maltese: Rispons ACR 50, N (%)
English: Mucosal Healing
Maltese: Rispons Radjugrafiku
English: 70 point response is defined as reduction in CDAI score by at least 70 points * Anti-TNFα failures ** Conventional therapy failures p < 0.001
Maltese: TNFα ** Ma rrispondewx għal terapija konvenzjonali p < 0.001
English: Histologic healing (defined as neutrophil infiltration in < 5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue) was assessed at week 8 of UNIFI-I and Week 44 of UNIFI-M. At week 8, after a single intravenous induction dose, significantly greater proportions of patients in the recommended dose group achieved histologic healing (36%) compared with patients in the placebo group (22%).
Maltese: Fejqan istoloġiku (ddefinit bħala infiltrazzjoni tan-newtrofili f'< 5% tal-glandoli żgħar, l-ebda distruzzjoni tal-gandoli żgħar, u l-ebda selħiet, ulċeri jew tessut granulari) ġie stmat f'ġimgħa 8 ta' UNIFI-I u Ġimgħa 44 ta' UNIFI-M.
English: STELARA 130 mg concentrate for solution for infusion ustekinumab
Maltese: STELARA 130 mg konċentrat għal soluzzjoni għall-infużjoni Ustekinumab
English: STELARA 130 mg concentrate for solution for infusion Ustekinumab
Maltese: STELARA 130 mg konċentrat għal soluzzjoni għall-infużjoni ustekinumab
English: At week 8, after a single intravenous induction dose, the change in SES-CD score was greater in the ustekinumab group (n = 155, mean change = -2.8) than in the placebo group (n = 97, mean change = -0.7, p = 0.012).
Maltese: F'ġimgħa 8, wara doża waħda ta' induzzjoni fil-vini, il-bidla fil-punteġġ SES-CD kien akbar fil-grupp ta' ustekinumab (n = 155, bidla medja = 2.8) milli fil-grupp tal-plaċebo (n = 97, bidla medja = -0.7, p = 0.
English: Structural damage in both hands and feet was expressed as change in total van der Heijde-Sharp score (vdH-S score), modified for PsA by addition of hand distal interphalangeal joints, compared to baseline.
Maltese: Ħsara strutturali kemm fl-idejn kif ukoll fis-saqajn kienet espressa bħala bidla fil-punteġġ totali van der Heijde-Sharp (punteġġ vdH-S), modifikat għal PsA biż-żieda tal-ġogi interfalanġeali distali tal-id, mqabbla mal-linja bażi.
English: Approximately one third (Psoriasis Study 1) and one quarter (Psoriasis Study 2) of subjects had Psoriatic Arthritis (PsA).
Maltese: Bejn wieħed u ieħor terz (l-Istudju tal-Psorijasi 1) u kwart (l-Istudju tal-Psorijasi 2) tal-individwi kellhom Artrite tal-Psorijasi (PsA).
English: Table 2 provides a list of adverse reactions from adult psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies as well as adverse reactions reported from post-marketing experience.
Maltese: Tabella 2 tagħti lista tar-reazzjonijiet avversi mill-istudji kliniċi tal-psorijasi, artrite psorijatika, ilmarda ta' Crohn u kolite ulċerattiva fl-adulti kif ukoll reazzjonijiet avversi rrappurtati minn esperjenza ta' wara t-tqegħid fis-suq.
English: The primary endpoint was the proportion of patients who achieved a PGA score of cleared (0) or minimal (1) at week 12.
Maltese: L-iskop primarju kien il-proporzjon ta' pazjenti li kisbu punteġġ PGA ta' fieqet (0) jew hija minima (1) f'ġimgħa 12.
English: Each vial contains130 mg ustekinumab in 26 mL.
Maltese: Kull fjala fiha 130 mg ustekinumab f'26 mL.
English: • Inflammation of tissue under the skin (‘cellulitis') is uncommon (may affect up to 1 in 100 people)
Maltese: • Infjammazzjoni tat-tessut taħt il-ġilda (‘ċellulite') mhijiex komuni (tista' taffettwa sa persuna waħda minn kull 100)
English: Uncommon: Pustular psoriasis, skin exfoliation, acne Rare: Exfoliative dermatitis
Maltese: Rikoverar l-isptar u operazzjonijiet marbuta mal-kolite ulċerattiva (UC - kolite ulċerattiva)
English: Table 3 provides a list of adverse reactions from adult psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies as well as adverse reactions reported from post-marketing experience.
Maltese: Tabella 3 tagħti lista tar-reazzjonijiet avversi mill-istudji kliniċi tal-psorijasi, artrite psorijatika, ilmarda ta' Crohn u kolite ulċerattiva fl-adulti kif ukoll reazzjonijiet avversi rrappurtati minn esperjenza ta' wara t-tqegħid fis-suq.
English: In ulcerative colitis, population PK model based simulations demonstrated that adjusting dosing from 90 mg every 12 weeks to every 8 weeks would be expected to result in a 3-fold increase in steady-state trough ustekinumab concentrations.
Maltese: F'kolite ulċerattiva, simulazzjonijiet mudelli PK ta' popolazzjoni urew li l-aġġustament tad-doża minn 90 mg kull 12-il ġimgħa għal kull 8 ġimgħat ikun mistenni jwassal għal żidea ta' 3 darbiet aktar fl-inqas konċentrazzjonijiet ta' ustekinumab fl-istat fiss.
English: STELARA is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.
Maltese: STELARA huwa indikat għat-trattament ta' pazjenti adulti bil-marda ta' Crohn attiva b'mod moderat sa sever li kellhom rispons mhux adegwat, ma baqgħux jirrispondu, jew kienu intolleranti għal terapija konvenzjonali jew għal antagonist ta' TNFα jew għandhom kontraindikazzjonijiet mediċi għal terapiji bħal dawn.
English: Treatment of latent tuberculosis infection should be initiated prior to administering STELARA.
Maltese: Kura tal-infezzjoni tat-tuberkulosi rieqda għandha tinbeda qabel ma jingħata STELARA.
English: Pregnancy
Maltese: Ustekinumab
English: Solution for injection in pre-filled syringe 45 mg/0.5 mL
Maltese: Soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest 45 mg/0.5 mL
English: The efficacy of ustekinumab was studied in 44 paediatric patients aged 6 to 11 years with moderate to severe plaque psoriasis in an open label, single-arm, multicenter, phase 3, study (CADMUS Jr.).
Maltese: L-effikacja ta' ustekinumab ġiet studjata f'44 pazjent pedjatriku b'età minn 6 snin sa 11-il sena bi psorijasi tal-plakka moderata sa severa fi studju ta' fażi 3, bi grupp wieħed, b'ħafna ċentri, fejn kemm l-investigaturi kif ukoll l-individwi kienu jafu liema sustanza qed tintuża (CADMUS Jr.).
English: How to store Stelara
Maltese: X'fih Stelara
English: In both UNITI-1 and UNITI-2, a significantly greater proportion of patients were in clinical response and remission in the ustekinumab treated group compared to placebo (Table 9).
Maltese: Kemm f'UNITI-1 kif ukoll f'UNITI-2, proporzjon akbar b'mod sinifikanti ta' pazjenti kellhom rispons kliniku u kienu f'remissjoni klinika fil-grupp ittrattat b'ustekinumab meta mqabbla malplaċebo (Tabella 9).
English: Patients were randomised to receive treatment with ustekinumab 45 mg, 90 mg, or placebo subcutaneously at Weeks 0 and 4 followed by every 12 weeks (q12w) dosing.
Maltese: Pazjenti randomised għal ustekinumab ingħataw dożi ta' 45 mg jew 90 mg fil-Ġimgħat 0 u 4 u komplew bl-istess doża kull 12-il ġimgħa.
English: STELARA has not been evaluated in patients who have undergone allergy immunotherapy.
Maltese: STELARA ma kienx evalwat f'pazjenti li ħadu immunoterapija għal allerġija.
English: In patients with Crohn's disease and ulcerative colitis, following an intravenous dose of ~6 mg/kg, starting at week 8, subcutaneous maintenance dosing of 90 mg ustekinumab was administered every 8 or 12 weeks.
Maltese: F'pazjenti bil-marda ta' Crohn u kolite ulċerattiva, wara doża fil-vini ta' ~6 mg/kg, b'bidu f'ġimgħa 8, għoti ta' dożi ta' manteniment taħt il-ġilda ta' ustekinumab 90 mg ingħata kull 8 jew 12-il ġimgħa.
English: No overall differences in efficacy or safety in patients age 65 and older who received STELARA were observed compared to younger patients in clinical studies in approved indications, however the number of patients aged 65 and older is not sufficient to determine whether they respond differently from younger patients.
Maltese: Ġeneralment, ebda differenzi fl-effikaċja jew fis-sigurtà ma ġew osservati f'pazjenti ta' 65 sena jew iktar li ngħataw STELARA meta mqabbla ma' pazjenti iżgħar fi studji kliniċi għall-indikazzjonijiet approvati, madankollu n-numru ta' pazjenti li għandhom 65 sena jew aktar mhuwiex biżżejjed biex jiġi stabbilit jekk jirrispondux b'mod differenti minn pazjenti iżgħar.
English: See ‘Look out for serious side effects' in section 4 for the signs of an allergic reaction.
Maltese: Ara ‘Oqgħod attent għal effetti sekondarji serji' fittaqsima 4 għal lista sħiħa reazzjonijiet allerġiċi.
English: • Common signs of an allergic reaction include skin rash and hives (these may affect up to 1 in 100 people).
Maltese: • Sinjali komuni ta' reazzjoni allerġika jinkludu raxx u urtikarja (dawn jistgħu jaffettwaw sa persuna waħda minn kull 100).
English: Number of 130 mg STELARA Vials
Maltese: Kif taħżen Stelara
English: STELARA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies (see section 5.1).
Maltese: STELARA huwa indikat għat-trattament ta' pazjenti adulti b'kolite ulċerattiva attiva b'mod moderat sa sever li kellhom rispons mhux adegwat, ma baqgħux jirrispondu, jew kienu intolleranti għal terapija konvenzjonali jew sustanza bijoloġika jew għandhom kontraindikazzjonijiet mediċi għal dawn itterapiji (ara sezzjoni 5.1).
English: The incidence of non-melanoma skin cancer was 0.43 per 100 patient-years of follow-up for ustekinumab-treated patients (4 patients in 929 patient-years of follow-up) compared to 0.46 for placebo-treated patients (2 patients in 433 patient-years of follow-up).
Maltese: Linċidenza ta' kanċer tal-ġilda li mhux melanoma kien ta' 0.43 għal kull 100 sena ta' pazjent għal pazjenti kkurati b'ustekinumab (4 pazjenti fi 929 sena ta' sorveljanza wara l-kura ta' pazjent) meta mqabbla ma' 0.46 għal pazjenti kkurati bi plaċebo (2 pazjenti fi 433 sena ta' sorveljanza wara l-kura ta' pazjent).
English: It is recommended that live viral or live bacterial vaccines (such as Bacillus of Calmette and Guérin (BCG)) should not be given concurrently with STELARA.
Maltese: Huwa rrakkomadat li tilqim virali ħaj jew batterjali ħaj (bħal Bacillus ta' Calmette u Guérin (BCG)) ma jingħatax fl-istess ħin ma' STELARA.
English: This includes a syringe, needle, antiseptic wipes, a cotton ball or gauze, and a sharps container (see Figure 1).
Maltese: Dan jinkludi siringa, labra, garżiet imxarrbin b'antisettiku, tajjara jew garża, u kontenitur fejn jintremew l-affarijiet bix-xifer jew bil-ponta (ara Figura 1).
English: Patients were randomized to receive a subcutaneous maintenance regimen of either 90 mg ustekinumab every 8 weeks, 90 mg ustekinumab every 12 weeks or placebo for 44 weeks (for recommended maintenance posology, see section 4.2).
Maltese: Il-pazjenti kienu randomised biex jirċievu kors ta' manteniment taħt il-ġilda ta' 90 mg ustekinumab kull 8 ġimgħat, 90 mg ustekinumab kull 12-il ġimgħa jew plaċebo għal 44 ġimgħa (għall-pożoloġija ta' manteniment rakkomandata, ara sezzjoni 4.2).
English: Monoclonal antibodies are proteins that recognise and bind specifically to certain proteins in the body.
Maltese: Antikorpi monoklonali huma proteini li jagħrfu u jeħlu speċifikament ma' ċerti proteini fil-ġisem.
English: STELARA 45 mg solution for injection in pre-filled syringe EU/1/08/494/003
Maltese: STELARA 45 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest EU/1/08/494/003
English: In both UNITI-1 and UNITI-2, a significantly greater proportion of patients were in clinical response and remission in the ustekinumab treated group compared to placebo (Table 3).
Maltese: Kemm f'UNITI-1 kif ukoll f'UNITI-2, proporzjon akbar b'mod sinifikanti ta' pazjenti kellhom rispons kliniku u kienu f'remissjoni klinika fil-grupp ittrattat b'ustekinumab meta mqabbla malplaċebo (Tabella 3).
English: Table 12: Summary of Key Efficacy Measures in UNIFI-M (week 44; 52 weeks from initiation of the induction dose)
Maltese: Tabella 12: Sommarju tar-Riżultati l-Aktar Importanti ta' Effikaċja f'UNIFI-M (ġimgħa 44; 52 ġimgħa mill-bidu tad-doża ta' induzzjoni) Plaċebo* N = 175
English: Additionally in Crohn's disease, clearance was affected by C-reactive protein, TNF antagonist failure status and race (Asian versus non-Asian).
Maltese: Barra dan, fil-marda ta' Crohn, it-tneħħija kienet affettwata mill-proteina reattiva C, l-istat ta' falliment tal-antagonist TNF u rrazza (Asjatika kontra mhux Asjatika).
English: In the placebo-controlled period of these clinical studies, the rate of infection was 1.36 per patient-year of follow-up in ustekinumab-treated patients, and 1.34 in placebo-treated patients.
Maltese: Fil-perjodu kkontrollat bi plaċebo ta' dawn l-istudji kliniċi, ir-rata ta' infezzjoni kienet ta' 1.36 għal kull sena ta' sorveljanza wara l-kura ta' pazjent fil-pazjenti kkurati b'ustekinumab u 1.34 fil-pazjenti kkurati bi plaċebo.
English: Uncommon: Hypersensitivity reactions (including rash, urticaria) Rare: Serious hypersensitivity reactions (including anaphylaxis, angioedema)
Maltese: Disturbi fis-sistema immuni Mhux komuni: Reazzjonijiet ta' sensittività eċċessiva (li jinkludu raxx, urtikarja)
English: STELARA 45 mg solution for injection ustekinumab
Maltese: STELARA 45 mg soluzzjoni għall-injezzjoni
English: In PsA Study 2 significant improvement in enthesitis score and numerical improvement (not statistically significant) in dactylitis score was observed in the ustekinumab 90 mg group compared with placebo at week 24.
Maltese: Fi Studju 2 ta' PsA, titjib sinifikanti fil-punteġġ tal-entesite u t-titjib numeriku (mhux sinifikanti b'mod statistiku) fil-punteġġ ta' daktilite ġie osservat fil-grupp ta' ustekinumab 90 mg meta mqabbel mal-plaċebo f'Ġimgħa 24.
English: The median trough serum concentrations of ustekinumab in patients with higher weight (> 100 kg) in the 90 mg group were comparable to those in patients with lower weight (≤ 100 kg) in the 45 mg group.
Maltese: Il-medjan tal-konċentrazzjonijiet minimi ta' ustekinumab fisserum f'pazjenti b'piż akbar (> 100 kg) fil-grupp ta' 90 mg kien jixbah dak f'pazjenti b'piż anqas (≤ 100 kg) fil-grupp ta' 45 mg.
English: STELARA 45 mg solution for injection Each vial contains 45 mg ustekinumab in 0.5 mL.
Maltese: Kull fjala fiha 45 mg ustekinumab f'0.5 mL ta' soluzzjoni għall-injezzjoni.
English: VIAL LABEL TEXT (130 mg)
Maltese: TEST TAT-TIKKETTA TAL-KUNJETT (130 mg)
English: Clinical response is defined as a decrease from baseline in the Mayo score by ≥30% and ≥3 points, with either a decrease from baseline in the rectal bleeding subscore ≥1 or a rectal bleeding subscore of 0 or 1.
Maltese: Rispons kliniku huwa ddefinit bħala tnaqqis mil-linja bażi fil-punteġġ kliniku Mayo bi ≥ 30% u ≥ 3 punti, jew bi tnaqqis ≥ 1 mil-linja bażi fis-sottopunteġġ ta' ħrug ta' demm mir-rektum jew inkella sottopunteġġ ta' 0 jew 1 għal ħruġ ta' demm mir-rektum.
English: Table 6: Summary of Key Efficacy Measures in UNIFI-M (week 44; 52 weeks from initiation of the induction dose)
Maltese: Tabella 6: Sommarju tar-Riżultati l-Aktar Importanti ta' Effikaċja f'UNIFI-M (ġimgħa 44; 52 ġimgħa mill-bidu tad-doża ta' induzzjoni) Plaċebo* N = 175
English: In UNIFI-I a significantly greater proportion of patients were in clinical remission in the ustekinumab treated group compared to placebo at week 8 (Table 11).
Maltese: F'UNIFI-I proporzjon b'mod sinifikanti akbar ta' pazjenti kienu f'remissjoni klinika fil-grupp ittrattat b'ustekinumab meta mqabbel mal-plaċebo f'ġimgħa 8 (Tabella 11).
English: A pre-specified integrated analysis combining data from 927 subjects in both PsA Study 1 and 2 was performed.
Maltese: Saret analiżi integrata speċifikata minn qabel li għaqqdet id-dejta minn 927 individwu kemm fi Studju 1 kif ukoll 2 ta' PsA.
English: • Do not shake Stelara pre-filled syringes.
Maltese: • Jekk is-sigill ikun imkisser.
English: • Feeling weak
Maltese: • Tħossok debboli
English: Hypersensitivity and infusion reactions
Maltese: Reazzjonijiet ta' sensittività eċċessiva
English: Endoscopic normalization was defined as a Mayo endoscopic subscore of 0 and was observed as early as week 8 of UNIFI-I. At week 44 of UNIFI-M, it was achieved in 24% and 29% of patients treated with ustekinumab every 12 or 8weeks, respectively,as compared to18% of patients in the placebo group.
Maltese: F'ġimgħa 44 ta' UNIFI-M, hija nkisbet f'24% u 29% talpazjenti ttrattati b'ustekinumab kull 12-il ġimgħa jew 8 ġimgħat, rispettivament, meta mqabbla ma' 18% tal-pazjenti fil-grupp tal-plaċebo.
English: Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC05.
Maltese: Tużax il-mediċina jekk kienet imħawda bil-qawwa.
English: STELARA 90 mg solution for injection Ustekinumab
Maltese: STELARA 90 mg soluzzjoni għall-injezzjoni
English: STELARA 90 mg solution for injection Each vial contains 90 mg ustekinumab in 1 mL.
Maltese: Kull siringa mimlija għal-lest fiha 90 mg ustekinumab f'1 mL ta' soluzzjoni għall-injezzjoni.
English: Health-related quality of life was assessed by Inflammatory Bowel Disease Questionnaire (IBDQ) and SF-36 questionnaires.
Maltese: Il-kwalità tal-ħajja relatata mas-saħħa kienet evalwata permezz tal-Kwestjonarju dwar Mard Infjammatorju tal-Musrana (IBDQ - Inflammatory Bowel Disease Questionnaire) u l-kwestjonarju SF36.
English: At Week 44 maintenance of this effect was observed with significantly more patients in histologic healing in the every 12 week (54%) and every 8 week (59%) ustekinumab groups as compared to placebo (33%).
Maltese: F'Ġimgħa 44 manteniment ta' dan l-effett ġie osservat b'mod sinifikanti f'aktar pazjenti b'fejqan istoloġiku fil-gruppi ta' ustekinumab ta' kull 12-il ġimgħa (54%) u kull 8 ġimgħat (59%) meta mqabbla mal-plaċebo (33%).
English: • If you have ever had an allergic reaction to latex or Stelara injection - the container of this medicinal product contains latex rubber, which may cause severe allergic reactions in people who are sensitive to latex.
Maltese: • Jekk qatt kellek reazzjoni allerġika għal-latex jew injezzjoni Stelara - Il-kontenitur ta' dan il-prodott mediċinali fih il-gomma latex.
English: The ratio of patients with basal versus squamous cell skin cancers (3:1) is comparable with the ratio expected in the general population (see section 4.4).
Maltese: Il-proporzjon ta' pazjenti b'kanċer tal-ġilda taċ-ċelluli bażali kontra taċ-ċelluli skwamużi (3:1) hu komparabbli mal-proporzjon mistenni fil-popolazzjoni in ġenerali (ara sezzjoni 4.4).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with ustekinumab in one or more subsets of the paediatric population in Crohn's Disease and ulcerative colitis (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddiferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'ustekinumab f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika fil-Marda ta' Crohn, u kolite ulċerattiva (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: • Vaginal yeast infection
Maltese: Ilma għall-injezzjonijiet
English: STELARA 90 mg solution for injection in pre-filled syringe EU/1/08/494/004
Maltese: STELARA 90 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest EU/1/08/494/004
English: It is supplied as a carton pack containing 1 single-dose, glass 30 mL vial.
Maltese: Huwa fornut f'pakkett tal-kartun li fih fjala tal-ħġieġ ta' 30 mL b'doża waħda.
English: • It is preferable to avoid the use of Stelara in pregnancy.
Maltese: • Hu preferribli li tevita l-użu ta' Stelara waqt it-tqala.
English: In both studies, patients were randomised to receive a single intravenous administration of either the recommended tiered dose of approximately 6 mg/kg (see section 4.2 of the STELARA 130 mg Concentrate for solution for infusion SmPC), a fixed dose of 130 mg ustekinumab, or placebo at week 0.
Maltese: Fiż-żewġ studji, il-pazjenti kienu randomised biex jirċievu għoti waħda fil-vini tad-doża tiered rakkomandata ta' madwar 6 mg/kg (ara sezzjoni 4.2 talSmPC ta' STELARA 130 mg Konċentrat għal soluzzjoni għall-infużjoni), doża fissa ta' 130 mg ustekinumab, jew plaċebo f'ġimgħa 0.