FrancophonIA/ELRC3.0 huggingface dataset:
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 or following a single subcutaneous administration at doses ranging from approximately 24 mg to 240 mg in patients with psoriasis.
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, jew wara li ngħatat doża waħda taħt il-ġilda f'dożi fuq medda ta' bejn wieħed u ieħor 24 mg u 240 mg f'pazjenti bil-psorijasi.
English: Similar symptoms sometimes develop as a natural change in the type of psoriasis symptoms (erythrodermic psoriasis)
Maltese: Sintomi simili xi drabi jiżviluppaw bħala bidla naturali fit-tip ta' sintomi tal-psorijasi (psorijasi eritrodermika).
English: Patients with body weight > 100 kg
Maltese: Pazjenti li jiżnu > 100 kg
English: The clinical development program consisted of two 8-week intravenous induction studies (UNITI-1 and UNITI-2) followed by a 44 week subcutaneous randomized withdrawal maintenance study (IM-UNITI) representing 52 weeks of therapy.
Maltese: Il-programm ta' żvilupp kliniku kien jikkonsisti minn żewġ studji ta' 8 ġimgħat ta' induzzjoni fil-vini (UNITI-1 u UNITI-2) segwiti minn studju ta' manteniment ta' 44 ġimgħa randomised, ta' irtirar taħt il-ġilda (IM-UNITI) li jirrappreżentaw 52 ġimgħa ta' terapija.
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 followed by dosing every 12 weeks.
Maltese: Pazjenti randomised biex jirċievu plaċebo fil-Ġimgħat 0 u 4 qalbu għal ustekinumab (45 mg jew 90 mg) fil-Ġimgħat 12 u 16 u komplew bl-istess doża kull 12-il ġimgħa.
English: • the number of pre-filled syringes and strength is correct o If your dose is 45 mg you will get one 45 mg pre-filled syringe of Stelara o If your dose is 90 mg you will get two 45 mg pre-filled syringes of Stelara and you will need to give yourself two injections.
Maltese: • li n-numru ta' fjali huwa tajjeb u li l-qawwa tad-doża hija tajba o Jekk id-doża tiegħek hija ta' 45 mg jew inqas, inti se jkollok fjala waħda ta' 45 mg Stelara o Jekk id-doża tiegħek hija ta' 90 mg inti se jkollok żewġ fjali ta' Stelara ta' 45 mg ilwieħed u inti trid tagħti żewġ injezzjonijiet lilek innifsek.
English: Each vial contains 90 mg ustekinumab in 1 mL.
Maltese: Kull kunjett fih 90 mg ustekinumab f'1 mL.
English: Patients who were not in clinical response to ustekinumab induction at week 8 of the UNITI-1 and UNITI-2 induction studies (476 patients) entered into the non-randomized portion of the maintenance study (IM-UNITI) and received a 90 mg subcutaneous injection of ustekinumab at that time.
Maltese: Pazjenti li ma kinux f'rispons kliniku għal induzzjoni b'ustekinumab f'ġimgħa 8 tal-istudji ta' induzzjoni ta' UNITI-1 u UNITI-2 (476 pazjent) daħlu fil-porzjon mhux randomised tal-istudju ta' manteniment (IM-UNITI) u f'dak il-waqt irċevew injezzjoni ta' 90 mg ustekinumab taħt il-ġilda.
English: PRE-FILLED SYRINGE LABEL TEXT (90 mg)
Maltese: TEST TAT-TIKKETTA TAL-FJALA (90 mg)
English: In patients with psoriasis, exfoliative dermatitis has been reported following ustekinumab treatment (see section 4.8).
Maltese: Jekk tkun ġiet eskluża infezzjoni u tiġi kkonfermata d-dijanjosi, waqqaf ustekinumab u ibda trattament xieraq (ara sezzjoni 4.8).
English: Corticosteroid-free clinical remission is defined as patients in clinical remission and not receiving corticosteroids at Week 44.
Maltese: Remissjoni klinika mingħajr kortiikosterojdi hija ddefinta bħala pazjenti b'remissjoni klinika u li ma jkunux qed jirċievu kortikosterojdi f'Ġimgħa 44.
English: By binding the shared p40 subunit of IL-12 and IL-23, ustekinumab may exert its clinical effects in psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis through interruption of the Th1 and Th17 cytokine pathways, which are central to the pathology of these diseases.
Maltese: Billi jwaħħal is-sottounità kondiviża p40 ta' IL-12 u IL-23, ustekinumab jista' jeżerċita l-effetti kliniċi tiegħu fi psorijasi, f'artrite psorjatika, fil-marda ta' Crohn u kolite ulċerattiva permezz ta' interruzzjoni tal-passaġġi Th1 u Th17 cytokine, li huma ċentrali għall-patoloġija ta' dan il-mard.
English: STELARA is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies (see section 5.1).
Maltese: STELARA huwa indikat għat-trattament ta' psorijasi tal-plakka minn moderata sa qawwija f'pazjenti tfal u adolexxenti mill-età ta' 6 snin u aktar, li mhumiex ikkontrollati b'mod xieraq bi, jew huma intolleranti għal, terapiji sistemiċi jew fototerapiji oħra (ara sezzjoni 5.1).
English: Rare side effects (may affect up to 1 in 1000 people)
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000)
English: STELARA 90 mg solution for injection in pre-filled syringe 1 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 90 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest 1mL 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 combined endpoint of histo-endoscopic mucosal healing defined as subjects having both mucosal healing and histologic healing was evaluated at week 8 of UNIFI-I and week 44 of UNIFI-M.
Maltese: Normalizzazzjoni endoskopika ġiet iddefinita bħala sottopunteġġ endoskopiku Mayo ta' 0 u ġie osservat sa minn ġimgħa 8 ta' UNIFI-I.
English: PRE-FILLED SYRINGE LABEL TEXT (45 mg)
Maltese: TEST TAT-TIKKETTA TAL-FJALA (45 mg)
English: VIAL CARTON TEXT (90 mg)
Maltese: TEST TAL-KARTUNA TAL-FJALA VIAL (90 mg)
English: Paediatric plaque psoriasis
Maltese: Psorijasi bil-plakka
English: The safety and efficacy of ustekinumab was assessed in three randomized, double-blind, placebo-controlled, multicenter studies in adult patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index [CDAI] score of ≥ 220 and ≤ 450).
Maltese: Is-sigurtà u l-effikaċja ta' ustekinumab kienet evalwata fi tliet studji randomised, double-blind, ikkontrollati bil-plaċebo, b'aktar minn ċentru wieħed f'pazjenti adulti bil-marda ta' Crohn attiva b'mod moderat sa severa (punteġġ tal-Indiċi tal-Attività tal-Marda ta' Crohn [CDAI - Crohn's Disease Activity Index] ta' ≥ 220 u ≤ 450).
English: Long term treatment with STELARA does not suppress the humoral immune response to pneumococcal polysaccharide or tetanus vaccines (see section 5.1).
Maltese: Kura fit-tul b'STELARA ma jxejjinx ir-rispons immuni umorali għal polysaccharide pnewmokokkali jew għat-tilqim tat-tetnu (ara sezzjoni 5.1).
English: In the controlled and non-controlled periods of psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies, representing 11,561 patient-years of exposure in 6,709 patients, the median follow-up was 1.0 years; 1.1 years for psoriatic disease studies, 0.6 year for Crohn's disease studies and 1.0 years for ulcerative colitis studies.
Maltese: Fil-perijodi kkontrollati u mhux ikkontrollati tal-istudji kliniċi dwar il-psorijasi, artrite psorijatika, ilmarda ta' Crohn u kolite ulċerattiva, li jirrappreżentaw 11,561 sena ta' pazjenti ta' espożizzjoni f'6,709 pazjenti, il-perijodu ta' sorveljanza medjan kien ta' 1.0 sena; 1.1 snin għal studji dwar mard psorjatiku, 0.6 snin għal studji dwar il-marda ta' Crohn u 1.0 sena għal studji dwar kolite ulċerattiva.
English: Clinical Remission, week 8
Maltese: Rispons Kliniku (100 punt), ġimgħa 8
English: CorticosteroidFree Clinical Remission Durable Remission
Maltese: Remissjoni Klinika Mingħajr Kortikosterojdi
English: Efficacy (defined as PGA 0 or 1) was observed as early as the first post-baseline visit at week 4 and the proportion of subjects who achieved a PGA score of 0 or 1 increased through week 16 and then remained relatively stable through week 52.
Maltese: Effikaċja (ddefinita bħala PGA 0 jew 1) ġiet osservata anke mal-ewwel vista wata l-linja bażi f'ġimgħa 4 u l-proporzjon ta' individwi li kisbu punteġġ ta' PGA ta' 0 jew 1 żdied sa ġimgħa 16 imbagħad baqa' relattivament stabbli sa ġimgħa 52.
English: Ustekinumab has been shown to improve signs and symptoms, physical function and health-related quality of life, and reduce the rate of progression of peripheral joint damage in adult patients with active PsA.
Maltese: Intwera li ustekinumab itejjeb is-sinjali u s-sintomi, il-funzjoni fiżika u l-kwalità tal-ħajja relatata massaħħa, u jnaqqas ir-rata ta' progressjoni ta' ħsara fil-ġogi periferali f'pazjenti adulti b'PsA attiva.
English: Ustekinumab has been shown to improve signs and symptoms, and health related quality of life in paediatric patients 6 years and older with plaque psoriasis.
Maltese: Ustekinumab intwera li jtejjeb sinjali u sintomi, u kwalità tal-ħajja marbuta mas-saħħa f'pazjenti pedjatriċi ta' 6 snin u aktar bi psorijasi tal-plakka.
English: Patients randomised to ustekinumab received 45 mg or 90 mg doses at Weeks 0 and 4 followed by an additional dose at 16 weeks.
Maltese: Pazjenti randomised għal ustekinumab ingħataw dożi ta' 45 mg jew 90 mg fil-Ġimgħat 0 u 4 segwiti minn doża addizzjonali fis-16-il ġimgħa.
English: Patients receiving ustekinumab at the recommended dose showed significant improvements on the histo endoscopic mucosal healing endpoint at week 8 in the ustekinumab group (18%) as compared to theplacebo group (9%).
Maltese: Il-pazjenti li kienu qed jirċievu d-doża rrakkomandata urew titjib sinifikanti fl-iskop finali ta' fejqan istoendoskopiku tal-mukuża f'ġimgħa 8 fil-grupp ta' ustekinumab (18%) meta mqabbel mal-grupp tal-plaċebo(9%).
English: Number of patients randomised PASI 50 response N (%) PASI 75 response N (%) PASI 90 response N (%) PGA of cleared or minimal N (%) Number of patients ≤ 100 kg
Maltese: Rispons PASI 90 N (%) PGA ta' psorijasi li fieqet jew hija minima N (%) Numru ta' pazjenti ≤ 100 kg Rispons PASI 75 N (%) Numru ta' pazjenti > 100 kg Rispons PASI 75 N (%)
English: In these patients, clinical remission was achieved in 41.4% of patients 16 weeks after dose adjustment.
Maltese: F'dawn il-pazjenti, remissjoni klinika inkisbet f'41.4% tal-pazjenti 16-il ġimgħa wara aġġustament fid-doża.
English: The median CL/F in patients with weight > 100 kg was approximately 55% higher compared to patients with weight ≤ 100 kg.
Maltese: Il-medjan ta' CL/F f'pazjenti b'piż > 100 kg kien bejn wieħed u ieħor 55% ogħla meta mqabbel ma' pazjenti b'piż ta' ≤ 100 kg.
English: In this study, 29.1% of the patients had an inadequate initial response (primary non-responders), 69.4% responded but lost response (secondary non-responders), and 36.4% were intolerant to antiTNFα therapies.
Maltese: F'dan l-istudju, 29.1% tal-pazjenti kellhom rispons inizjali inadegwat (ma rrispondewx b'mod primarju), 69.4% irrispondew iżda tilfu r-rispons (ma rrispondewx b'mod sekondarju), u 36.4% kienu intolleranti għal terapiji kontra
English: Patients were randomised to receive a single intravenous administration of either the recommended tiered dose of approximately 6 mg/kg (see Table 1, section 4.2), a fixed dose of 130 mg ustekinumab, or placebo at week 0.
Maltese: Fiż-żewġ studji, il-pazjenti kienu randomised biex jirċievu għoti darba fil-vini tad-doża tiered irrakkomandata ta' madwar 6 mg/kg (ara Tabella 1, sezzjoni 4.2), doża fissa ta' 130 mg ustekinumab, jew plaċebo f'ġimgħa 0.
English: In the controlled and non-controlled periods of psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies, representing 11,581 patient-years of exposure in 6,709 patients, the median follow up was 1.0 years; 1.1 years for psoriatic disease studies, 0.6 year for Crohn's disease studies, and 1.0 years for ulcerative colitis studies.
Maltese: Fil-porzjonijiet tal-istudji kliniċi tal-psorijasi, artrite psorijatika, il-marda ta' Crohn u kolite ulċerattiva kkontrollati u mhux ikkontrollati, li jirrappreżentaw 11,581 sena ta' pazjenti ta' espożizzjoni f'6,709 pazjenti, il-follow up medjan kien ta' 1.0 sena; 1.1 snin għal studji dwar il-mard psorjatiku, 0.6 snin għal studji dwar il-marda ta' Crohn u 1.0 sena għal studji dwar kolite ulċerattiva.
English: • Sinus infection
Maltese: Infezzjonijiet u infestazzjonijiet
English: The efficacy of ustekinumab was studied in 110 paediatric patients aged 12 to 17 years with moderate to severe plaque psoriasis in a multicenter, phase 3, randomised, double blind, placebo controlled study (CADMUS).
Maltese: L-effikaċja ta' ustekinumab ġiet studjata f'110 pazjenti pedjatriċi b'età minn 12 sa 17-il sena bi psorijasi tal-plakka minn moderata sa severa fi studju (CADMUS) b'ħafna ċentri, ta' fażi 3, ikkontrollat bi plaċebo, fejn la l-pazjenti li ntgħażlu b'mod każwali u lanqas l-investigaturi ma kienu jafu liema mediċina qed tintuża.
English: During the placebo controlled period through week 12, the efficacy of both the recommended and half of the recommended dose groups were generally comparable at the primary endpoint (69.4% and 67.6% respectively) although there was evidence of a dose response for higher level efficacy criteria (e.g. PGA of cleared (0), PASI 90).
Maltese: Waqt il-perijodu kkontrollat bi plaċebo sa Ġimgħa 12, l-effikaċja kemm fil-gruppi tad-doża rrakkomandata kif ukoll ta' nofs id-doża rrakkomandata kienu b'mod ġenerali kumparabbli fl-iskop finali primarju (69.4% u 67.6% rispettivament) għalkemm kien hemm xhieda ta' rispons għad-doża għal kriterji ta' effikaċja ta' livell ogħla (eż. PGA li fieqet (0), PASI 90).
English: Of these 51 patients, 70.6% achieved clinical response and 39.2% percent achieved clinical remission 16 weeks after receiving the first subcutaneous dose of ustekinumab.
Maltese: Minn dawn il-51 pazjent, 70.6% kisbu rispons kliniku u 39.2% fil-mija kisbu remissjoni klinika 16-il ġimgħa wara li rċevew lewwel doża taħt il-ġilda ta' ustekinumab.
English: For the posology of the intravenous dosing regimen, see section 4.2 of the STELARA 130 mg Concentrate for solution for infusion SmPC.
Maltese: Għall-pożoloġija tal-kors ta' għoti ta' dożi fil-vini, ara sezzjoni 4.2 tal-SmPC ta' STELARA 130 mg Konċentrat għal soluzzjoni għall-infużjoni.
English: Number of patients ≤ 100 kg PASI 75 response N (%) 6 (4%) 124 (74%) 107 (65%) 130 (79%) 124 (81%) Number of patients > 100 kg PASI 75 response N (%) 2 (2%) 47 (54%) 63 (68%) 48 (56%) 67 (74%)
Maltese: L-Istudju tal-Psorijasi 2 Numru ta' pazjenti randomised Rispons PASI 50 N (%) 41 (10%) 342 (84%) a 367 (89%) a 369 (93%) 380 (95%)
English: Responses observed in the ustekinumab treated groups were similar in patients receiving and not receiving concomitant MTX, and were maintained through weeks 52 and 100.
Maltese: Risponsi osservati fil-gruppi kkurati b'ustekinumab kienu simili f'pazjenti li qed jirċievu u ma kinux qed jirċievu MTX fl-istess ħin, u nżammu sal-Ġimgħat 52 u 100.
English: • If you weigh less than 60 kg, the recommended dose is 0.75 mg of Stelara per kg body weight.
Maltese: • Jekk inti tiżen inqas minn 60 kg, id-doża rrakkomandata hija 0.75 mg ta' Stelara għall kull kg ta' piż tal-ġisem.
English: PRE-FILLED SYRINGE CARTON TEXT (90 mg)
Maltese: TEST TAL-KARTUNA TAS-SIRINGA MIMLIJA GĦAL-LEST (90 mg)
English: Common: Fatigue, injection site erythema, injection site pain Uncommon: Injection site reactions (including haemorrhage, haematoma, induration, swelling and pruritus), asthenia
Maltese: Mhux komuni: Reazzjonijiet fis-sit ta' l-injezzjoni (li jinkludi emorraġija, ematoma, ebusija, nefħa u ħakk), astenja
English: At 18 months (week 76), 84% of patients re-randomised to maintenance treatment were PASI 75 responders compared with 19% of patients re-randomised to placebo (treatment withdrawal).
Maltese: Mat-18-il xahar (Ġimgħa 76), 84% tal-pazjenti randomised mill-ġdid għall-kura ta' manteniment kienu dawk li kisbu rispons ta' PASI 75 meta mqabbla ma' 19% tal-pazjenti randomised mill-ġdid għall-plaċebo (twaqqif tal-kura).
English: In patients with ulcerative colitis, median steady-state trough concentrations ranged from 2.69 μg/mL to 3.09 μg/mL and from 0.92 μg/mL to 1.19 μg/mL for 90 mg ustekinumab every 8 weeks or every 12 weeks.
Maltese: F'pazjenti b'kolite ulċerattiva, il-medjan tal-inqas konċentrazzjonijiet fi stat fiss varja minn 2.69 μg/mL sa 3.09 μg/mL u minn 0.
English: STELARA 90 mg solution for injection 1 mL solution in a type I glass 2 mL vial closed with a coated butyl rubber stopper.
Maltese: STELARA 90 mg soluzzjoni għall-injezzjoni 1 mL ta' soluzzjoni f'kunjett tal-ħġieġ tat-tip I ta' 2 mL magħluq b'tapp tal-lastku butyl miksi.
English: • Drooping eyelid and sagging muscles on one side of the face (‘facial palsy' or ‘Bell's palsy'), which is usually temporary
Maltese: • Tebqet il-għajn imdendla jew muskoli mitluqin fuq naħa waħda tal-wiċċ (‘paraliżi tal wiċċ' jew ‘paraliżi ta' Bell'), li ġeneralment huwa temporanju.
English: CDLQI: The CDLQI is a dermatology instrument to assess the effect of a skin problem on the health-related quality of life in the paediatric population.
Maltese: CDLQI huwa strument tad-dermatoloġija li jivvaluta l-effett ta' problema tal-ġilda fuq il-kwalità tal-ħajja marbuta mas-saħħa fil-popolazzjoni pedjatrika.
English: Stelara is used in adults with moderate to severe plaque psoriasis, who cannot use ciclosporin, methotrexate or phototherapy, or where these treatments did not work.
Maltese: Stelara jintuża f'adulti bi psorijasi bil-qoxra minn moderata sa qawwija, li ma jistgħux jużaw ciclosporin, methotrexate jew fototerapija, jew meta dawn it-trattamenti ma ħadmux.
English: These include:
Maltese: Tel.:
English: Clinical remission is defined as CDAI score < 150; Clinical response is defined as reduction in CDAI score by at least 100 points or being in clinical remission
Maltese: Rispons kliniku huwa definit bħala tnaqqis ta' millinqas 100 punt fil-punteġġ ta' CDAI jew li wieħed ikun f'remissjoni klinika Rispons ta' 70 punt huwa definit bħala tnaqqis ta' mill-inqas 70 punt fil-punteġġ ta' CDAI * Ma rrispondewx għal terapija kontra
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
Maltese: Remissjoni tas-sintomi flimkien ma' fejqan tal-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
English: The primary endpoint for both induction studies was the proportion of subjects in clinical response (defined as a reduction in CDAI score of ≥ 100 points) at week 6.
Maltese: Il-punt finali primarju għaż-żewġ studji ta' induzzjoni kien il-proporzjon ta' individwi f'rispons kliniku (definit bħala tnaqqis fil-punteġġ ta' CDAI ta' ≥ 100 punt) f'ġimgħa 6.
English: In Study 1 previous treatment with anti-tumour necrosis factor (TNF)α agent was not allowed.
Maltese: Fi Studju 1, kura fil-passat b'mediċina ta' fattur tan-nekrożi kontra t-tumur (TNF)α ma kinitx permessa.
English: Baseline disease characteristics were generally consistent across all treatment groups in Psoriasis Studies 1 and 2 with a median baseline PASI score from 17 to 18, median baseline Body Surface Area (BSA) ≥ 20, and median Dermatology Life Quality Index (DLQI) range from 10 to 12.
Maltese: Il-karatteristiċi tal-marda fil-linja bażi kienu b'mod ġenerali konsistenti f'kull grupp ta' kura fl-Istudji tal-Psorijasi 1 u 2 b'linja bażi medjana tal-punteġġ PASI minn 17 sa 18, linja bażi medjana tal-Erja tas-Superfiċje tal-Ġisem (BSA) ≥ 20, u medjan ta' l-Indiċi Dermatoloġiċi dwar il-Kwalità tal-Ħajja (DLQI) f'medda minn 10 sa 12.
English: Stelara is used in children and adolescents aged 6 years and older with moderate to severe plaque psoriasis who are unable to tolerate phototherapy or other systemic therapies or where these treatments did not work.
Maltese: Stelara jintuża fi tfal u adolexxenti b'età ta' 6 snin u aktar bi psorijasi tal-plakka minn moderata sa severa li ma jistgħux jittolleraw fototerapija jew terapiji sistemiċi oħra, jew fejn dawn it-trattamenti ma ħadmux.
English: • Feeling dizzy
Maltese: • Ġilda titqaxxar
English: The proportion of patients with a PGA score of cleared (0) or minimal (1) and the proportion achieving PASI 75 showed separation between the ustekinumab treated group and placebo at the first post-baseline visit at week 4, reaching a maximum by week 12.
Maltese: Il-proporzjon ta' pazjenti b'punteġġ PGA li fiequ (0) jew hija minima (1) u l-proporzjon li kisbu PASI 75 urew separazzjoni bejn il-grupp ttrattat b'ustekinumab u l-plaċebo fl-ewwel vista ta' wara llinja bażi f'Ġimgħa 4, u laħqu l-massimu f'Ġimgħa 12.
English: PRE-FILLED SYRINGE CARTON TEXT (45 mg)
Maltese: TEST TAL-KARTUNA TAS-SIRINGA MIMLIJA GĦAL-LEST (45 mg)
English: Ustekinumab cannot bind to IL-12 or IL-23 that is already bound to IL-12R1 cell surface receptors.
Maltese: Ustekinumab ma jistax jeħel mal-IL-12 jew IL-23 li huma diġà marbutin mar-riċetturi IL-12Rβ fuq il-wiċċ taċ-ċellola.
English: Ustekinumab inhibits the bioactivity of human IL-12 and IL-23 by preventing p40 from binding to the IL-12R1 receptor protein expressed on the surface of immune cells.
Maltese: Ustekinumab jimpedixxi l-bijoattività tal-IL-12 u IL-23 umani billi ma jħallix p40 jeħlu mal-proteina riċettur IL-12Rβ1 espress fuq il-wiċċ taċ-ċelloli immuni.
English: Symptomatic Remission Combined Symptomatic Remission and Mucosal Healing
Maltese: Remissjoni tas-Sintomi Remissjoni tas-Sintomi flimkien ma' Fejqan tal-Mukuża
English: During the 12-week active-controlled portion of the study, patients were randomised to receive etanercept (50 mg twice a week), ustekinumab 45 mg at Weeks 0 and 4, or ustekinumab 90 mg at Weeks 0 and 4.
Maltese: Waqt il-fażi ta' 12-il ġimgħa tal-istudju kkontrollata b'mod attiv, il-pazjenti kienu randomised biex jirċievu etanercept (50 mg darbtejn fil-ġimgħa), ustekinumab 45 mg fil-Ġimgħat 0 u 4, jew ustekinumab 90 mg fil-Ġimgħat 0 u 4.
English: b 60 (28.7%) 116 (55.5%) Clinical Response (100 point), week 8 50 (20.2%) 94 (37.8%)
Maltese: Rispons ta' 70 Punt, ġimgħa 3 67 (27.1%) 101 (40.6%) Rispons ta' 70 Punt, ġimgħa 6 75 (30.4%) 109 (43.8%)
English: In Psoriasis Study 1 maintenance of PASI 75 was significantly superior with continuous treatment compared with treatment withdrawal (p < 0.001).
Maltese: Fl-Istudju tal-Psorijasi 1 il-manteniment ta' PASI 75 kien sinifikament superjuri b'kura kontinwa meta mqabbel ma' kura li ma tkomplietx (p < 0.001).
English: Median volume of distribution during the terminal phase (Vz) following a single intravenous administration to patients with psoriasis ranged from 57 to 83 mL/kg.
Maltese: Il-medjan tal-volum ta' distribuzzjoni waqt l-aħħar fażi (Vz) wara doża waħda mogħtija fil-vina lillpazjenti bil-psorijasi kien f'medda bejn 57 u 83 mL/kg.
English: Table 5 Summary of clinical response at week 12 in Psoriasis Study 3 (ACCEPT) Psoriasis Study 3
Maltese: Sommarju tar-rispons kliniku fit-12-il Ġimgħa tal-Istudju tal-Psorijasi 3 (ACCEPT)
English: The beneficial effect of ustekinumab on clinical response, mucosal healing and clinical remission was observed in induction and in maintenance both in patients who failed conventional therapy but not a biologic therapy, as well as in those who had failed at least one prior TNFα antagonist therapy including in patients with a primary non-response to TNFα antagonist therapy.
Maltese: L-effett vantaġġjuż ta' ustekinumab fuq ir-rispons kliniku, il-fejqan tal-mukuża u r-remissjoni klinika ġie osservat fl-induzzjoni u fil-manteniment kemm f'pazjenti li fallew terapija konvenzjonali iżda mhux terapija bijoloġika, kif ukoll f'dawk li fallew mill-inqas terapija preċedenti b'antagonist wieħed ta' TNFα inklużi pazjenti b'nuqqas ta' rispons primarju għal terapija b'antagonist ta' TNFα.