FrancophonIA/ELRC3.0 huggingface dataset:
English: a 170 (66%) a 178 (71%) 191 (79%)
Maltese: Rispons PASI 75 N (%) 8 (3%) 171 (67%) a 170 (66%) a 178 (71%) 191 (79%)
English: The steady-state trough ustekinumab levels resulting from 90 mg ustekinumab every 8 weeks were associated with higher clinical remission rates as compared to the steady-state trough levels following 90 mg every 12 weeks.
Maltese: L-inqas livelli ta' ustekinumab fi stat fiss li rriżultaw minn ustekinumab 90 mg kull 8 ġimgħat kienu assoċjati ma' rati ogħla ta' remissjoni klinika meta mqabbel mal-inqas livelli fi stat fiss wara 90 mg kull 12-il ġimgħa.
English: Uncommon: Cellulitis, dental infections, herpes zoster, lower respiratory tract infection, viral upper respiratory tract infection, vulvovaginal mycotic infection
Maltese: Mhux komuni: Ċellulite, infezzjonijiet fis-snien, herpes zoster (ħruq ta' Sant'Antnin), infezzjoni fil-parti t'isfel tal-apparat respiratorju, infezzjoni virali fil-parti ta' fuq tal-passaġġ respiratorju, infezzjoni mikotika tal-vulva u l-vaġina
English: Approximately 48% of the patients had failed 1 prior anti-TNF therapy and 52% had failed 2 or 3 prior anti-TNFα therapies.
Maltese: Madwar 48% tal-pazjenti ma rrispondewx għal terapija preċedenti darba kontra TNFα u 52% ma rrispondewx għal 2 jew 3 terapiji preċedenti kontra
English: STELARA 45 mg injection ustekinumab
Maltese: STELARA 45 mg għall-injezzjoni ustekinumab
English: The safety and efficacy of ustekinumab was assessed in two randomized, double-blind, placebocontrolled, multicenter studies in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥ 2).
Maltese: Is-sigurtà u l-effikaċja ta' ustekinumab ġew stmati f'żewġ studji arbitrarji, ikkontrollati bi plaċebo b'ħafna ċentri, fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża f'pazjenti adulti b'kolite ulċerattiva attiva b'mod moderat sa sever (punteġġ Mayo 6 sa 12; sottopunteġġ tal-Endoskopija ≥ 2).
English: Concomitant doses of oral corticosteroids, immunomodulators, aminosalicylates and antibiotics were permitted and 75% of patients continued to receive at least one of these medications.
Maltese: Kienu permessi dożi konkomitanti ta' kortikosterojdi orali, immunomodulaturi, aminosalicylates u antibijotiċi u 75% tal-pazjenti komplew jirċievu mill-inqas waħda minn dawn il-mediċini.
English: Over 70% and 40% of the patients in both studies had enthesitis and dactylitis at baseline, respectively.
Maltese: Iktar minn 70% u 40% tal-pazjenti fiż-żewġ studji kellhom entesite u dactilite fillinja bażi, rispettivament.
English: Following the recommended intravenous induction dose, median peak serum ustekinumab concentration, observed 1 hour after the infusion, was 126.1 μg/mL in patients with Crohn's disease and 127.0 µg/mL in patients with ulcerative colitis.
Maltese: Wara d-doża rrakkomandata ta' induzzjoni fil-vina, il-medjan tal-konċentrazzjoni massima ta' ustekinumab fis-serum, osservat siegħa wara l-infużjoni, kien ta' 126.1 μg/mL f'pazjenti bil-marda ta' Crohn u 127.
English: Plaque psoriasis
Maltese: Psorijasi tal-plakka
English: Approximately 50% of the patients had failed at least 1 prior anti-TNF therapy (of which 48% were primary non-responders) and 17% had failed at least 1 anti-TNFα therapy and vedolizumab.
Maltese: TNF qabel (li minnhom 48% kienu persuni li ma jirrispondux b'mod primarju) u 17% kienu fallew mill-inqas terapija waħda kontra TNFα u vedolizumab.
English: PASI 75 responders PASI 90 responders PASI 100 responders CDLQI
Maltese: Dawk li rrispondew PASI 100 CDLQI
English: • If you weigh more than 100 kg, the recommended dose is 90 mg Stelara.
Maltese: • Jekk inti tiżen aktar minn 100 kg, id-doża rrakkomandata hija 90 mg Stelara.
English: 90mg ustekinumab every 12 Weeks N = 172
Maltese: 90mg ustekinumab kull 12-il Ġimgħa N = 172
English: The container of this medicinal product contains latex rubber.
Maltese: Il-kontenitur ta' dan il-prodott mediċinali fih il-gomma latex.
English: The primary endpoint was change from baseline in Simplified Endoscopic Disease Severity Score for Crohn's Disease (SES-CD), a composite score across 5 ileocolonic segments of presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any other lesions and presence/type of narrowing/strictures.
Maltese: Il-punt finali primarju kien bidla mil-linja bażi fil-Punteġġ Simplifikat tas-Severità Endoskopika tal-Marda għall-Marda ta' Crohn (SES CD - Simplified Endoscopic Disease Severity Score for Crohn's Disease), punteġġ kompost tul 5 segmenti tal-ileu u lkolon ta' preżenza/daqs ta' ulċeri, proporzjon ta' superfiċje tal-mukuża miksi b'ulċeri, proporzjon ta' superfiċje tal-mukuża affettwat b'xi feriti oħrajn u l-preżenza/tip ta' tidjiq/kontrazzjonijiet.
English: In these studies, 2.2% of 785 placebo treated patients and 1.9% of 790 patients treated with the recommended dose of ustekinumab reported adverse events occurring during or within an hour of the infusion.
Maltese: F'dawn l-istudji, 2.2% ta' 785 pazjent ittrattati bil-plaċebo u 1.9% ta' 790 pazjent ittrattati bid-doża rrakkomandata ta' ustekinumab irrappurtaw avvenimenti avversi li seħħew waqt jew fi żmien siegħa mill-infużjoni.
English: The incidence of non-melanoma skin cancer was 0.49 per 100 patient-years of follow-up for ustekinumab-treated patients (56 patients in 11,545 patient-years of follow-up).
Maltese: Linċidenza ta' kanċer tal-ġilda li mhux melanoma kienet ta' 0.49 kull 100 sena ta' sorveljanza talpazjenti wara l-kura għal pazjenti kkurati b'ustekinumab (56 pazjent f'11,545 sena ta' sorveljanza talpazjent wara l-kura).
English: In clinical studies, serious bacterial, fungal, and viral infections have been observed in patients receiving STELARA (see section 4.8).
Maltese: Fi studji kliniċi, infezzjonijiet serji batterjali, fungali, u virali kienu osservati f'pazjenti li kienu qed jingħataw STELARA (ara sezzjoni 4.8).
English: In patients with Crohn's disease, median steady-state trough concentrations ranged from 1.97 μg/mL to 2.24 μg/mL and from 0.61 μg/mL to 0.76 μg/mL for 90 mg ustekinumab every 8 weeks or every 12 weeks respectively.
Maltese: F'pazjenti bil-marda ta' Crohn, il-medjan tal-inqas konċentrazzjonijiet fi stat fiss varja minn 1.97 μg/mL sa 2.24 μg/mL u minn 0.61 μg/mL sa 0.76 μg/mL għal ustekinumab 90 mg kull 8 ġimgħat jew kull 12-il ġimgħa rispettivament.
English: Eight weeks later, 50.5% of the patients achieved clinical response and continued to receive maintenance dosing every 8 weeks; among these patients with continued maintenance dosing, a majority maintained response (68.1%) and achieved remission (50.2%) at week 44, at proportions that were similar to the patients who initially responded to ustekinumab induction.
Maltese: Tmien ġimgħat wara, 50.5% tal-pazjenti kisbu rispons kliniku u komplew jirċievu għoti ta' dożi ta' manteniment kull 8 ġimgħat; fost dawn il-pazjenti b'dożaġġ ta' manteniment kontinwu, il-maġġoranza żammew ir-rispons (68.1%) u kisbu remissjoni (50.2%) f'ġimgħa 44, fi proporzjonijiet li kienu simili għall-pazjenti li fil-bidu rrispondew għal induzzjoni b'ustekinumab.
English: • Serious allergic reactions (‘anaphylaxis') are rare in people taking Stelara (may affect up to 1 in 1,000 people).
Maltese: • Reazzjonijiet allerġiċi serji (‘anafilassi') huma rari fin-nies li jieħdu Stelara (jistgħu jaffettwaw sa persuna waħda minn kull 1,000 persuna).
English: In patients who failed biological therapy
Maltese: F'pazjenti li fallew terapija bijoloġika
English: Solution for injection 45 mg/0.5 mL 1 vial
Maltese: Soluzzjoni għall-injezzjoni 45 mg/0.5 mL Fjala 1
English: Serious infections occurred at the rate of 0.03 per patient-year of follow-up in ustekinumab-treated patients (30 serious infections in 930 patient-years of follow-up) and 0.03 in placebo-treated patients (15 serious infections in 434 patient-years of follow-up) (see section 4.4).
Maltese: Infezzjonijiet serji seħħew b'rata ta' 0.03 għal kull sena ta' sorvelajanza wara l-kura ta' pazjent fil-pazjenti kkurati b'ustekinumab (30 infezzjoni serja f'930 sena ta' sorveljanza wara l-kura ta' pazjent) u 0.03 fil-pazjenti kkurati bi plaċebo (15-il infezzjoni serja fi 434 sena ta' sorveljanza wara l-kura ta'pazjent) (ara sezzjoni 4.4).
English: The systemic exposure of ustekinumab (Cmax and AUC) increased in an approximately dose-proportional manner after a single intravenous administration at doses ranging from 0.09 mg/kg to 4.5 mg/kg.
Maltese: L-esponiment sistemiku ta' ustekinumab (Cmax u AUC) żdied bejn wieħed u ieħor b'mod proporzjonali mad-doża wara li ngħatat doża waħda ġol-vina f'dożi fuq medda ta' bejn 0.09 mg/kg u 4.5 mg/kg.
English: Latex sensitivity
Maltese: Sensittività għal-latex
English: In patients who failed biological therapy Symptomatic Remission
Maltese: F'pazjenti li fallew terapija bijoloġika Remissjoni tas-sintomi
English: Each 26 mL vial of STELARA contains 130 mg of ustekinumab.
Maltese: Kull kunjett ta' 26 mL ta' STELARA fih 130 mg ta' ustekinumab.
English: Similar results were obtained from a confirmatory population pharmacokinetic analysis using data from patients with psoriatic arthritis.
Maltese: Riżultati simili nkisbu minn analiżi farmakokinetika konfermatorja talpopolazzjoni bl-użu ta' dejta minn pazjenti b'artrite psorjatika.
English: Clinical remission is defined as CDAI score < 150; Clinical response is defined as reduction in CDAI of at least 100 points or being in clinical remission * The placebo group consisted of patients who were in response to ustekinumab and were randomized to receive placebo at the start of maintenance therapy.
Maltese: Rispons kliniku huwa definit bħala tnaqqis ta' millinqas 100 punt f'CDAI jew li wieħed ikun f'remissjoni klinika * Il-grupp tal-plaċebo kien jikkonsisti minn pazjenti li kienu f'rispons għal ustekinumab u kienu randomised biex jirċievu plaċebo fil-bidu ta' terapija ta' manteniment.
English: Remove the needle cover (see Figure 3):
Maltese: Neħħi t-tokka tal-labra (ara Figura 3):
English: a 311 (76%) a 276 (70%) 314 (79%)
Maltese: Rispons PASI 75 N (%) 15 (4%) 273 (67%) a 311 (76%) a 276 (70%) 314 (79%)
English: The absolute bioavailability of ustekinumab following a single subcutaneous administration was estimated to be 57.2% in patients with psoriasis.
Maltese: Il-bijodisponibbiltà assoluta ta' ustekinumab wara doża waħda mogħtija taħt il-ġilda ġiet stmata li kienet 57.2% f'pazjenti bil-psorijasi.
English: STELARA 45 mg solution for injection in pre-filled syringe 0.5 mL solution in a type I glass 1 mL syringe with a fixed stainless steel needle and a needle cover containing dry natural rubber (a derivative of latex).
Maltese: STELARA 45 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest 0.5 mL ta' soluzzjoni f'siringa tal-ħġieġ tat-tip I ta' 1 ml b'labra mwaħħla tal-azzar li ma jissaddadx u għatu tal-labra li fih lastku naturali niexef (derivattiv ta' latex).
English: A higher proportion of patients treated with ustekinumab who had spondylitis with peripheral arthritis as their primary presentation, demonstrated 50 and 70 percent improvement in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores compared with placebo at week 24.
Maltese: Proporzjon ogħla ta' pazjenti kkurati b'ustekinumab li kellhom spondilite b'artrite periferali bħala l-preżentazzjoni primarja tagħhom, wera 50 u 70 fil-mija titjib fil-punteġġi Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) meta mqabbel malplaċebo f'Ġimgħa 24.
English: Hospitalizations and ulcerative colitis (UC) related surgeries Through week 8 of UNIFI-I, the proportions of subjects with UC disease related hospitalizations were significantly lower for subjects in the ustekinumab recommended dose group (1.6%, 5/322) compared with subjects in the placebo group (4.4%, 14/319) and no subjects underwent UC disease related surgeries in subjects receiving ustekinumab at the recommended induction dose compared to 0.6% (2/319) subjects in the placebo group.
Maltese: Sa ġimgħa 8 ta' UNIFI-I, il-proporzjonijiet tal-indvidwi b'rikoverar l-isptar kawża ta' mard UC kienu b'mod sinifikanti aktar baxxi għal individwi fil-grupp tad-doża rrakkomandata ta' ustekinumab (1.6%, 5/322) meta mqabbla ma' individwi fil-grupp ta' plaċebo (4.4%, 14/319) u l-ebda individwi ma sarulhom operazzjonijiet marbuta mal-marda ta' UC f'individwi li kienu qed jirċievu d-doża rrakkomandata ta' induzzjoni meta mqabbla ma' 0.6% (2/319) tal-individwi fil-grupp tal-plaċebo.
English: * Clinical remission is defined as Mayo score ≤2 points, with no individual subscore > 1.
Maltese: * Remissjoni klinika hija ddefinta bħala punteġġ Mayo ≤ 2 punti, mingħajr l-ebda sottopunteġġ individwali > 1.
English: At 3 years (week 148), 82% of patients re-randomised to maintenance treatment were PASI 75 responders.
Maltese: Mat-3 snin (Ġimgħa 148), 82% tal-pazjenti randomised mill-ġdid għall-kura ta' manteniment kienu dawk li kisbu rispons ta' PASI 75.
English: STELARA, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).
Maltese: STELARA, waħdu jew flimkien ma' MTX, hu indikat għall-kura ta' artrite psorjatika attiva f'pazjenti adulti meta r-rispons għal terapija fil-passat b'mediċina kontra r-rewmatiżmu li timmodifika mard mhux bijoloġiku (DMARD - non-biological disease-modifying anti-rheumatic drug) ma kinitx adegwata (ara sezzjoni 5.1).
English: The first study was in 110 patients from 12 to 17 years of age treated for up to 60 weeks and the second study was in 44 patients from 6 to 11 years of age treated for up to 56 weeks.
Maltese: L-ewwel studju sar f'110 pazjent b'età minn 12 sa 17-il sena trattati sa 60 ġimgħa u t-tieni studju sar f'44 pazjent b'età minn 6 snin sa 11-il sena trattati sa 56 ġimgħa.
English: Uncommon side effects (may affect up to 1 in 100 people):
Maltese: Effetti skondarji mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100 persuna):
English: Of those patients, 9% of patients who were initially randomized to the recommended induction dose achieved clinical remission and 58% achieved clinical response at Week 16.
Maltese: Minn dawk il-pazjenti, 9% tal-pazjenti li fil-bidu kienu ntagħżlu b'mod arbitrarju għad-doża rrakkomandata ta' induzzjoni kisbu remissjoni klinika u 58% kisbu rispons kliniku f'Ġimgħa 16.
English: 26 mL solution in a type I glass 30 mL vial closed with a coated butyl rubber stopper.
Maltese: 26 mL soluzzjoni fi fjala ta' 30 mL tal-ħġieġ tat-tip I magħluq b'tapp tal-lastku butyl miksi.
English: Only use complete vials of STELARA.
Maltese: Uża biss kunjetti kompluti ta' STELARA.
English: Health-related quality of life
Maltese: GĦAMLA KWALITATTIVA
English: d.o.o.
Maltese: Tħawwdux.
English: Single doses up to 6 mg/kg have been administered intravenously in clinical studies without dose-limiting toxicity.
Maltese: Dożi waħdiet sa 6 mg/kg ingħataw ġol-vina fi studji kliniċi mingħajr tossiċità li tillimita d-doża.
English: Patients were treated with the recommended dose of ustekinumab (see section 4.2; n = 44) by subcutaneous injection at weeks 0 and 4 followed by every 12 week (q12w) dosing.
Maltese: Il-pazjenti ġew trattati bid-doża rrakkomandata ta' ustekinumab (ara sezzjoni 4.2; n = 44) permezz ta' injezzjoni taħt il-ġilda fil-ġimgħat 0 u 4 segwiti minn għoti ta' doża kull 12-il ġimgħa (q12w).
English: Number of patients ≤ 100 kg ACR 20 response, N (%)
Maltese: Rispons kombinat PASI 75 u ACR 20, N (%)
English: In Study 2, the majority of patients (58%, n = 180) had been previously treated with one or more anti-TNFα agent(s), of whom over 70% had discontinued their anti-TNFα treatment for lack of efficacy or intolerance at any time.
Maltese: Fi Studju 2, il-maġġoranza (58%, n = 180) tal-pazjenti kienu kkurati fil-passat b'sustanza waħda jew aktar kontra TNFα, li minnhom iktar minn 70% ma kinux komplew il-kura tagħhom kontra TNFα minħabba nuqqas ta' effikaċja jew intolleranza fi kwalunkwe ħin.
English: Look out for serious side effects
Maltese: Oqgħod attent għal effetti sekondarji serji
English: Maintenance of Clinical Remission through week 44
Maltese: Manteniment tar-Remissjoni Klinika sa ġimgħa 44
English: Patients were randomised to receive either placebo (n = 37), or the recommended dose of ustekinumab (see section 4.2; n = 36) or half of the recommended dose of ustekinumab (n = 37) by subcutaneous injection at Weeks 0 and 4 followed by every 12 week (q12w) dosing.
Maltese: Il-pazjenti ntgħażlu b'mod każwali biex jirċievu plaċebo (n = 37), jew id-doża rrakkomandata ta' ustekinumab (ara sezzjoni 4.2; n = 36) jew nofs id-doża rrakkomandata ta' ustekinumab (n = 37) permezz ta' għoti tad-dożi b'injezzjoni taħt il-ġilda f'Ġimgħa 0 u 4 segwita minn kull 12-il ġimgħa (q12w - every 12 weeks).
English: For further instructions on preparation and special precautions for handling, see section 6.6.
Maltese: Għal aktar informazzjoni dwar il-preparazzjoni u prekawzjonijiet speċjali li għandhom jittieħdu għallimmaniġġar, ara sezzjoni 6.6.
English: Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometer).
Maltese: Uża biss sett tal-infużjoni b'filtru fil-pajp, sterili, mhux piroġeniku, li ftit li xejn jorbot proteini (daqs tal-pori ta' 0.2 mikrometri).
English: In psoriasis studies, the safety and efficacy of STELARA in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.
Maltese: Fi studji dwar il-psorijasi, is-sigurtà u l-effikaċja ta' STELARA flimkien ma' immunosoppressanti, inklużi prodotti bijoloġiċi, jew fototerapija ma ġewx evalwati.
English: PGA of Cleared (0) PASI
Maltese: PGA li fieqet (0) PASI
English: The effect is considered demonstrated irrespective of concomitant MTX use, and was maintained through Weeks 52 (integrated analysis) and 100 (PsA Study 1).
Maltese: L-effett huwa meqjus li ntwera irrispettivament mill-użu konkomittanti ta' MTX, u nżamm sal-Ġimgħat 52 (analiżi integrata) u 100 (Studju 1 ta' PsA).
English: Disposal:
Maltese: Eċċipjenti:
English: Week 16 Responders to Ustekinumab Induction Ustekinumab treated patients who were not in response at week 8 of UNIFI-I received an administration of 90 mg SC ustekinumab at week 8 (36% of patients).
Maltese: Ġimgħa 16 Persuni li Rrispondew għall-Induzzjoni b'Ustekinumab Pazjenti ttrattati b'ustekinumab li ma kellhomx rispons f'ġimgħa 8 ta' UNIFI-I irċivew għoti ta' 90 mg ustekinumab SC f'ġimgħa 8 (36% tal-pazjenti).
English: • The other ingredients are EDTA disodium salt dihydrate, L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 80, sucrose and water for injection.
Maltese: • Is-sustanzi l-oħra huma EDTA disodium salt dihydrate, L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 80, sucrose, u ilma għall injezzjoni.
English: Carcinogenicity studies were not performed with ustekinumab due to the lack of appropriate models for an antibody with no cross-reactivity to rodent IL-12/23 p40.
Maltese: Ma sarux studji ta' karċinoġeniċità b'ustekinumab minħabba n-nuqqas ta' mudelli xierqa għal antikorp li ma kellux cross-reactivity għall-IL-12/23 p40 ta' l-annimali gerriema.
English: • The other ingredients are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate
Maltese: • Is-sustanzi l-oħra huma L-histidine, L-histidine monohydrochloride monohydrate,
English: Median half-life (t1/2) of ustekinumab was approximately 3 weeks in patients with psoriasis, psoriatic arthritis, Crohn's disease or ulcerative colitis, 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-psorijasi, artrite psorjatika, il-marda ta' Crohn jew kolite ulċerattiva, fuq medda minn 15 sa 32 jum fl-istudji kollha tal-psorijasi u artrite psorjatika.
English: Stelara contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Maltese: Stelara fih inqas minn mmol 1 sodium (23 mg) f'kull doża, li tista' tgħid huwa essenzjalment ‘bla sodium'.
English: Median systemic clearance (CL) following a single intravenous administration to patients with psoriasis ranged from 1.99 to 2.34 mL/day/kg.
Maltese: Il-medjan tat-tneħħija sistemika (CL) wara doża waħda mogħtija fil-vina lill-pazjenti bi psorijasi kien f'medda bejn 1.99 u 2.34 mL/jum/kg.
English: STELARA 45 mg solution for injection 0.5 mL solution in a type I glass 2 mL vial closed with a coated butyl rubber stopper.
Maltese: STELARA 45 mg soluzzjoni għall-injezzjoni 0.5 mL soluzzjoni sterili fi fjala ta' 2 mL tal-ħġieġ tat-tip I magħluq b'tapp tal-lastku butyl miksi.
English: Malignancies excluding non-melanoma skin cancers were reported in 62 patients in 11,561 patient-years of follow-up (incidence of 0.54 per 100 patientyears of follow-up for ustekinumab-treated patients).
Maltese: Tumuri malinni li ma jinkludux kanċer tal-ġilda li mhux melanoma ġew irrappurtati f'62 pazjent f'11,561 sena ta' pazjenti ssorveljati wara l-kura (inċidenza ta' 0.54 kull 100 sena ta' sorveljanza ta' pazjent wara l-kura għal dawk il-pazjenti kkurati b'ustekinumab).
English: VIAL LABEL TEXT (45 mg)
Maltese: TEST TAL-KARTUNA TAL-FJALA (45 mg)
English: The most common adverse reactions (> 5%) in controlled periods of the adult psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies with ustekinumab were nasopharyngitis and headache.
Maltese: L-iktar reazzjonijiet avversi komuni (> 5%) f'perijodi kkontrollati tal-istudji kliniċi dwar il-psorijasi, lartrite psorjatika, il-marda ta' Crohn u kolite ulċerattiva fl-adulti b'ustekinumab kienu nażofarinġite u uġigħ ta' ras.
English: In the placebo-controlled period of the psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies, the incidence of malignancies excluding non-melanoma skin cancer was 0.11 per 100 patient-years of follow-up for ustekinumab-treated patients (1 patient in 929 patient-years of follow-up) compared with 0.23 for placebo-treated patients (1 patient in 434 patient-years of follow-up).
Maltese: Fil-perijodu kkontrollat bi plaċebo tal-istudji kliniċi tal-psorijasi, artrite psorijatika, il-marda ta' Crohn u kolite ulċerattiva, l-inċidenza ta' tumuri malinni minbarra kanċer tal-ġilda li mhux melanoma, kienet ta' 0.11 għal kull 100 sena ta' sorveljanza wara l-kura ta' pazjent għall-pazjenti kkurati b'ustekinumab (pazjent wieħed f'929 snin ta' sorveljanza wara l-kura ta' pazjenti) meta mqabbla ma' 0.23 għallpazjenti kkurati bi plaċebo (pazjent wieħed fi 385 sena ta' sorveljanza wara l-kura ta' pazjent).
English: Of 131 patients who responded to ustekinumab induction, and were randomized to the placebo group at the start of the maintenance study, 51 subsequently lost response and received 90 mg ustekinumab subcutaneously every 8 weeks.
Maltese: Minn 131 pazjent li rrispondew għal induzzjoni b'ustekinumab, u kienu randomized għall-grupp talplaċebo fil-bidu tal-istudju ta' manteniment, 51 sussegwentement tilfu r-rispons u rċevew 90 mg ustekinumab taħt il-ġilda kull 8 ġimgħat.
English: Name and address of the manufacturers of the biological active substance
Maltese: Manifattur tas-sustanza bijoloġika attiva
English: At week 8, patients receiving ustekinumab showed statistically significantly greater and clinically meaningful improvements on IBDQ total score and SF-36 Mental Component Summary Score in both UNITI-1 and UNITI-2, and SF-36 Physical Component Summary Score in UNITI-2, when compared to placebo.
Maltese: F'ġimgħa 8, pazjenti li kienu qed jirċievu ustekinumab urew titjib statistikament sinifikanti akbar u ta' sinifikanza klinika fuq il-punteġġ totali ta' IBDQ u fuq il-punteġġ tas-Sommarju tal-Komponent Mentali ta' SF-36 kemm f'UNITI-1 kif ukoll f'UNITI-2, u fuq il-punteġġ tas-Sommarju talKomponent Fiżiku ta' SF-36 f'UNITI-2, meta mqabbel mal-plaċebo.