FrancophonIA/ELRC3.0 huggingface dataset:
English: Improvements in the PASI 75 response were seen in both subgroups and the 300 mg dose showed statistically significant benefit in the anti-TNFα-IR patients.
Maltese: Ġie osservat titjib fir-rispons għal PASI 75 fiż-żewġ sottogruppi u d-doża ta' 300 mg uriet benefiċċju statistikament sinifikanti fil-pazjent anti-TNFα-IR.
English: Replace the attached needle with a 27G x ½″ needle.
Maltese: Biddel il-labra mwaħħla ma' labra 27G x ½″.
English: The ASAS 20 and ASAS 40 responses were maintained up to week 156 (69.5% and 47.6% for 150 mg versus 74.8% and 55.6% for 300 mg).
Maltese: 6% għal 150 mg kontra 74.8% u 55.6% għal 300 mg).
English: In PsA study 1, the percentage of patients with no disease progression (defined as a change from baseline in mTSS of ≤0.5) from randomisation to week 24 was 82.3% in secukinumab 10 mg/kg intravenous load - 150 mg subcutaneous maintenance and 75.7% in placebo.
Maltese: Fl-istudju 1 tal-PsA, il-perċentwal ta' pazjenti mingħajr progressjoni tal-marda (definita bħala bidla mil-linja bażi fl-mTSS ta' ≤0.5) minn randomizzazzjoni sal-24 ġimgħa kien 82.3% f'tagħbija ta' secukinumab 10 mg/kg taħt il-ġilda - manutenzjoni ta' 150 mg taħt il-ġilda u 75.7% fi plaċebo.
English: Secukinumab was efficacious in systemic treatment-naive, biologic-naive, biologic/anti-TNF-exposed and biologic/anti-TNF-failure patients.
Maltese: Secukinumab kien effikaċi f'pazjenti li qatt ma ngħataw kura sistemika, li qatt ma ngħataw il-mediċina, esposti għal trattamenti bijoloġiċi/anti-TNF u li ma ħadmux fuqhom trattamenti bioloġiċi/anti-TNF.
English: Secukinumab
Maltese: Tajjeb Ħażin
English: This medicine works by neutralising the activity of a protein called IL-17A, which is present at increased levels in diseases such as psoriasis, psoriatic arthritis and ankylosing spondylitis.
Maltese: Din il-mediċina taħdem billi tinnewtralizza l-attività ta' proteina msejħa IL-17A, li tinsab f'livelli għolja f'mard bħall-psorjasi, artrite psorjatika u spondilite ankilotika.
English: Allow the vial to stand undisturbed at room temperature for approximately 5 minutes.
Maltese: Ħalli l-kunjett wieqaf mingħajr ma toqgħod tmissu f'temperatura tal-kamra għal madwar 5 minuti.
English: Cosentyx can potentially cause serious side effects, including infections and allergic reactions.
Maltese: Oqgħod attent għal infezzjonijiet u reazzjonijiet allerġiċi Cosentyx potenzjalment jista' jikkawża effetti sekondarji serji, inkluż infezzjonijiet u reazzjonijiet allerġiċi.
English: PASI 100 response n (%)
Maltese: Reazzjoni PASI 100 n (%)
English: Week 4
Maltese: Dublin 4
English: • The recommended dose is 150 mg by subcutaneous injection.
Maltese: • Id-doża rakkomandata hija 150 mg permezz ta' injezzjoni taħt il-ġilda.
English: Figure 2 ACR20 response in PsA study 2 over time up to week 52
Maltese: 2 Ir-rispons ta' ACR20 fl-istudju 2 tal-PsA matul iż-żmien sat-52 ġimgħa
English: The single and multiple dose pharmacokinetics of secukinumab in plaque psoriasis patients were determined in several studies with intravenous doses ranging from 1x 0.3 mg/kg to 3x 10 mg/kg and with subcutaneous doses ranging from 1x 25 mg to multiple doses of 300 mg.
Maltese: Il-farmakokinetika ta' doża waħda u dożi multipli ta' secukinumab f'pazjenti bi psorjasi tal-plakka kienet determinata f'bosta studji b'dożi mogħtija fil-vina li jvarjaw minn 1x 0.3 mg/kg għal 3x 10 mg/kg u b'dożi mogħtija taħt il-ġilda li jvarjaw minn 1x 25 mg għal dożi multipli ta' 300 mg.
English: Secukinumab 300 mg met the primary and secondary endpoints by showing superiority to ustekinumab based on PASI 90 response at week 16 (primary endpoint), speed of onset of PASI 75 response at week 4, and long-term PASI 90 response at week 52.
Maltese: Secukinumab 300 mg laħqu lendpoints primarji u sekondarji billi ntweriet superjorità għal ustekinumab skont ir-rispons PASI 90 fis-16-il ġimgħa (endpoint primarju), l-ħeffa tar-rispons PASI 75 fir-4 ġimgħa, u skont ir-rispons PASI 90 fit-tul fit-52 ġimgħa.
English: In AS study 1 and study 2, patients treated with secukinumab 150 mg showed improvements in healthrelated quality of life as measured by AS Quality of Life Questionnaire (ASQoL) (p=0.001) and SF-36 Physical Component Summary (SF-36PCS) (p<0.001).
Maltese: Il-funzjoni fiżika u l-kwalità tal-ħajja relatata mas-saħħa Fl-istudju 1 u fl-istudju 2 tal-AS, il-pazjenti kkurati b'secukinumab 150 mg urew titjib fil-kwalità talħajja relatata mas-saħħa kif imkejla permezz tal-Kwestjonarju dwar il-Kwalità tal-Ħajja tal-AS (ASQoL - AS Quality of Life Questionnaire) (p=0.001) u s-Sommarju tal-Komponent Fiżiku SF-36 (SF-36 PCS - SF-36 Physical Component Summary) (p<0.001).
English: Blood and lymphatic system disorders
Maltese: Sistema protettiva tas-siringa
English: In a study in subjects with plaque psoriasis, no interaction was observed between secukinumab and midazolam (CYP3A4 substrate).
Maltese: Fi studju fost suġġetti bi psorajsi tal-plakka, ma dehret l-ebda interazzjoni bejn secukinumab u midazolam (sottostrat ta' CYP3A4).
English: Week 24 *p<0.05 based on nominal, but non adjusted, p-value 1secukinumab 150 mg or 300 mg s.c. at weeks 0, 1, 2, 3, and 4 followed by the same dose every month 10 mg/kg at weeks 0, 2 and 4 followed by subcutaneous doses of 75 mg or 150 mg
Maltese: 24 Ġimgħa *p<0.05 abbażi ta' valur p nominali, iżda mhux aġġustat 1150 mg jew 300 mg secukinumab s.c. fil-ġimgħat 0, 1, 2, 3 u 4 segwiti bl-istess doża kull xahar 10 mg/kg fil-ġimgħat 0, 2 u 4 segwiti b'dożi taħt il-ġilda ta' 75 mg jew 150 mg
English: PASI 90 response n (%)
Maltese: Reazzjoni PASI 90 n (%)
English: For storage conditions after reconstitution of the medicinal product, see section 6.3
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: Cosentyx is used to treat a condition called “ankylosing spondylitis”.
Maltese: Cosentyx jintuża biex jikkura kondizzjoni msejħa “spondilite ankilotika”.
English: The onset of action of secukinumab 150 mg occurred as early as week 1 for ASAS 20 and week 2 for ASAS 40 (superior to placebo) in AS study 2.
Maltese: L-azzjoni ta' secukinumab 150 mg bdiet sa minn kmieni fl-1 ġimgħa għal ASAS 20 u ġimgħa 2 għal ASAS 40 (superjuri għal plaċebo) fl-istudju 2 tal-AS.
English: Multipack containing 6 (3 x 2) pre-filled syringes
Maltese: Pakkett multiplu li fih 6 (3 x 2) siringi mimlija għal-lest
English: • Each 300 mg dose is given as two injections of 150 mg.
Maltese: • Kull doża ta' 300 mg tingħata bħala żewġ injezzjonijiet ta' 150 mg.
English: ACR: American College of Rheumatology; PASI: Psoriasis Area and Severity Index; DAS: Disease Activity Score; BSA: Body Surface Area
Maltese: ACR: American College of Rheumatology;
English: In clinical studies, urticaria and rare cases of anaphylactic reaction to secukinumab were observed (see also section 4.4).
Maltese: Fi studji kliniċi, kien hemm urtikarja u każijiet rari ta' reazzjoni anafilattika b'secukinumab (ara wkoll sezzjoni 4.4).
English: Mean decreases (improvements) in DLQI from baseline ranged from -10.4 to -11.6 with secukinumab 300 mg, from -7.7 to -10.1 with secukinumab 150 mg, versus -1.1 to -1.9 for placebo at week 12.
Maltese: 1 b'secukinumab 150 mg, kontra -1.1 għal -1.9 bil-plaċebo f'ġimgħa 12.
English: A placebo-controlled study evaluated 102 patients with moderate to severe scalp psoriasis, defined as having a Psoriasis Scalp Severity Index (PSSI) score of ≥12, an IGA mod 2011 scalp only score of 3 or greater and at least 30% of the scalp surface area affected.
Maltese: Studju kkontrollat bil-plaċebo evalwa 102 pazjenti bi psorajsi tal-qurriegħa, definiti bħala li għandhom punteġġ tal-Indiċi ta' Psorajrsi tal-Qurriegħa Severa (PSSI) ta' ≥12, il-punteġġ tal-qurriegħa biss ta' 3 skont IGA mod 2011 jew aktar u mill-inqas 30% tal-area tas-superfiċi affettwata.
English: Secukinumab-treated patients without concomitant MTX use had a higher ACR 20 response (53.6% and 53.6% for 150 mg and 300 mg, respectively, compared to placebo 10.4%) and ACR 50 response (37.5% and 32.1% for 150 mg and 300 mg, respectively, compared to placebo 6.3%).
Maltese: Il-pazjenti kkurati b'secukinumab mingħajr użu minn MTX konkomitanti kellhom rispons ogħla għal ACR 20 (53.6% u 53.6% għal 150 mg u 300 mg, rispettivament, imqabbla ma' plaċebo 10.
English: Mean systemic clearance (CL) following a single intravenous administration to patients with plaque psoriasis ranged from 0.13 to 0.36 l/day.
Maltese: Il-medja tat-tneħħija (CL - clearance) sistemika wara l-għoti ta' darba tal-mediċina fil-vina lil pazjenti bi psorjasi tal-plakka kienet bejn 0.13 u 0.36 l/jum.
English: Multipack containing 6 (3 x 2) pre-filled pens
Maltese: Pakkett multiplu li fih 6 (3 x 2) pinen mimlija għal-lest
English: This medicine is for single use only.
Maltese: L-effetti ta' din il-mediċina f'nisa tqal mhux magħruf.
English: Secukinumab works by targeting IL-17A and inhibiting its interaction with the IL-17 receptor, which is expressed on various cell types including keratinocytes.
Maltese: Secukinumab jaħdem billi jimmira IL-17A u jinibixxi l-interazzjoni tiegħu mar-riċettur IL-17, li jidher fuq tipi varji ta' ċelluli inkluż il-keratinoċiti.
English: For Psoriatic Arthritis study 3 (PsA study 3), the primary endpoint was at week 16 with the key secondary endpoint, the change from baseline in modified Total Sharp Score (mTSS), at week 24.
Maltese: Għallistudju 3 dwar l-Artrite Psorjatika (studju 3 tal-PsA), l-endpoint primarju kien fis-16-il ġimgħa blendpoint sekondarju ewlieni, il-bidla mil-linja bażi fil-Punteġġ Sharp Totali modifikat (mTSS), fl24 ġimgħa.
English: Lower respiratory tract infections Not known Mucosal and cutaneous candidiasis (including oesophageal candidiasis)
Maltese: • infezzjonijiet fungali tal-ġilda u tal-membrani mukużi (inkluż kandidjażi tal-esofagu)
English: Over 61% and 42% of the PsA patients had enthesitis and dactylitis at baseline, respectively.
Maltese: Aktar minn 61% u 42% tal-pazjenti b'PsA kellhom entesite u dattilite fillinja bażi, rispettivament.
English: Non-responder imputation used for missing binary endpoint.
Maltese: Imputazzjoni għal dawk li ma rrispondewx użata għal endpoint binarju nieqes.
English: In PsA study 2, at week 24, secukinumabtreated patients with concomitant MTX use had a higher ACR 20 response (47.7% and 54.4% for 150 mg and 300 mg, respectively, compared to placebo 20.0%) and ACR 50 response (31.8% and 38.6% for 150 mg and 300 mg, respectively, compared to placebo 8.0%).
Maltese: Fl-istudju 2 tal-PsA, fl24 ġimgħa, il-pazjenti kkurati b'secukinumab li kienu qed jagħmlu użu minn MTX konkomitanti kellhom rispons ogħla għal ACR 20 (47.7% u 54.4% għal 150 mg u 300 mg, rispettivament, imqabbla ma' plaċebo 20.
English: The percentage of patients achieving ACR 20 response by visit is shown in Figure 2.
Maltese: Il-perċentwal tal-pazjenti li kisbu rispons ta' ACR 20 permezz ta' żjara huwa muri fil-Figura 2.
English: PsA study 2
Maltese: ANNESS II
English: After reconstitution, 1 ml of solution contains 150 mg secukinumab.
Maltese: Wara r-rikostituzzjoni, 1 ml ta' soluzzjoni fiha 150 mg secukinumab.
English: Table 4 Summary of clinical response on CLEAR study
Maltese: Tabella 4 Sommarju tar-rispons kliniku fl-istudju CLEAR
English: - The other ingredients are sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 80.
Maltese: - Is-sustanzi l-oħra huma sucrose, histidine, histidine monohydrochloride monohydrate u polysorbate 80.
English: In PsA study 3, inhibition of progression of structural damage was assessed radiographically and expressed by the modified Total Sharp Score (mTSS) and its components, the Erosion Score (ES) and the Joint Space Narrowing Score (JSN).
Maltese: Fl-istudju 3 tal-PsA, kienet evalwata b'mod radjografiku l-inibizzjoni ta' progressjoni tal-ħsara strutturali u kienet espressa permezz tal-Punteġġ Sharp Totali modifikat (mTSS) u l-komponenti tiegħu, il-Punteġġ ta' Erożjoni (ES) u t-Tidjiq tal-Ispazju bejn il-Ġogi (JSN).
English: Over the entire treatment period (a total of 3,430 patients treated with secukinumab for up to 52 weeks for the majority of patients), infections were reported in 47.5% of patients treated with secukinumab (0.9 per patient-year of follow-up).
Maltese: Matul il-perjodu sħiħ ta' trattament (total ta' 3,430 pazjent ittrattati b'secukinumab għal sa 52 ġimgħa fil-biċċa l-kbira tal-pazjenti), kienu rrappurtati infezzjonijiet f'47.5% tal-pazjenti ttrattati b'secukinumab (0.9 għal kull sena ta' pazjent li matulhom il-pazjent baqa' jiġi segwit).
English: Included in the carton:
Maltese: Inkluż fil-pakkett:
English: The safety profile of secukinumab is consistent across all indications.
Maltese: Il-profil tas-sigurtà ta' secukinumab huwa konsistenti fl-indikazzjonijiet kollha.
English: Number of patients randomised
Maltese: Numru ta' pazjenti randomizzati
English: Cosentyx is for long-term treatment.
Maltese: Cosentyx hu għal trattament fit-tul.
English: • severe allergic reaction with shock (anaphylactic reaction)
Maltese: • Reazzjoni allerġika severa flimkien ma xokk (reazzjoni anafilattika)
English: • itchy rash (urticaria)
Maltese: • raxx bil-ħakk (urtikarja)
English: In AS study 2, among 72 patients initially randomised to secukinumab 150 mg, 61 (84.7%) patients were still on treatment at week 52.
Maltese: Fl-istudju 2 tal-AS, fost 72 pazjent inizjalment randomizzati għal secukinumab 150 mg, 61 (84.7%) pazjent kienu għadhom qed jingħataw kura fit-52 ġimgħa.
English: Cosentyx is supplied in a colourless glass vial with a grey coated rubber stopper and aluminium cap with a white flip-off component containing 150 mg of secukinumab.
Maltese: Cosentyx huwa disponibbli f'kunjett tal-ħġieġ bla kulur b'tapp miksi b'lastku griż u b'għatu tal-aluminju b'komponent abjad flip-off li fih 150 mg ta' secukinumab.
English: In PsA study 1, PsA study 2 and PsA study 3, 29%, 35% and 30% of patients, respectively, were previously treated with an anti-TNFα agent and discontinued the anti-TNFα agent for either lack of efficacy or intolerance (anti-TNFα-IR patients).
Maltese: Fl-istudju 1 tal-PsA, l-istudju 2 tal-PsA u fl-istudju 3 tal-PsA, 29%, 35% u 30% tal-pazjenti, rispettivament, kienu kkurati preċedentement b'aġent anti-TNFα u kellhom iwaqqfu l-aġent anti-TNFα minħabba nuqqas ta' effikaċja jew minħabba intolleranza (pazjenti b'IR anti-TNFα).
English: In PsA study 2 and PsA study 3, patients treated with secukinumab 150 mg (p=0.0555 and p<0.0001) and 300 mg (p=0.0040 and p<0.0001) showed improvement in physical function compared to patients treated with placebo as assessed by Health Assessment Questionnaire-Disability Index (HAQ-DI) at week 24 and week 16, respectively.
Maltese: Il-funzjoni fiżika u l-kwalità tal-ħajja relatata mas-saħħa Fl-istudju 2 tal-PsA u fl-istudju 3 tal-PsA, il-pazjenti kkurati b'secukinumab 150 mg (p=0.0555 u p<0.0001) u 300 mg (p=0.0040 u p<0.0001) urew titjib fil-funzjoni fiżika mqabbla mal-pazjenti kkurati bi plaċebo kif ivvalutati mill-Indiċi ta' Diżabilità tal-Kwestjonarju dwar il-Valutazzjoni tasSaħħa (HAQ-DI) fl-24 ġimgħa u s-16-il ġimgħa, rispettivament.
English: During the blinded period, the ASAS 20 and ASAS 40 responses were 69.7% and 47.6% for 150 mg and 74.3% and 57.4% for 300 mg at week 52, respectively.
Maltese: 6% għal 150 mg u 74.3% u 57.4% għal 300 mg fit52 ġimgħa, rispettivament.
English: This is followed by a slow decrease due to reduced clearance of secukinumab-bound IL-17A, indicating that secukinumab selectively captures free IL-17A, which plays a key role in the pathogenesis of plaque psoriasis.
Maltese: Wara jkun hemm tnaqqis bil-mod minħabba tnaqqis fit-tneħħija ta' IL-17A marbut ma' secukinumab, li juri li secukinumab jaħtaf b'mod selettiv IL-17A liberu, li għandu sehem ewlieni fil-patoġeneżi tal-psorjasi tal-plakka.
English: In the GESTURE study, secukinumab was superior to placebo at week 16 (33.3% for 300 mg, 22.1% for 150 mg, and 1.5% for placebo) as assessed by significant improvement of ppIGA 0 or 1 response (“clear” or “almost clear”) for patients with moderate to severe palmoplantar plaque psoriasis.
Maltese: Fl-istudju GESTURE, secukinumab kien superjuri għall-plaċebo fis-16-il ġimgħa (33.3% għal 300 mg, 22.1% għal 150 mg u 1.5% għall-plaċebo) kif evalwat skont titjib qawwi b'rispons ppIGA 0 jew 1 (“ċar” jew “kważi ċar”) għal pazjenti bi psorajsi tal-plakka palmoplantar minn moderata sa gravi.
English: Syringe guard
Maltese: Ġwienaħ protettivi tas-siringa
English: The safety and efficacy of secukinumab were assessed in 816 patients in three randomised, double-blind, placebo-controlled phase III studies in patients with active ankylosing spondylitis (AS) with a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4 despite non-steroidal anti-inflammatory drug (NSAID), corticosteroid or disease-modifying anti-rheumatic drug (DMARD) therapy.
Maltese: III f'pazjenti bi spondilite ankilotika (AS) attiva b'Indiċi tal-Attività tal-Marda Spondilite Ankilotika Bath (BASDAI) ≥4 minkejja t-terapija b'mediċina anti-infjammatorja nonsterojdali (NSAID), kortikosterojdi jew mediċina antirewmatika li timmodifika l-marda (DMARD).
English: In PsA study 2, among 200 patients initially randomised to secukinumab 150 mg and 300 mg, 178 (89%) patients were still on treatment at week 52.
Maltese: Fl-istudju 2 tal-PsA, fost 200 pazjent li fil-bidu kienu randomizzati għal secukinumab 150 mg u 300 mg, 178 (89%) pazjent kienu għadhom qed jieħdu l-kura fit-52 ġimgħa.
English: • if you have ever had an allergic reaction to latex.
Maltese: • jekk qatt kellek reazzjoni allerġika għal-latex.
English: The mean elimination half-life, as estimated from population pharmacokinetic analysis, was 27 days in plaque psoriasis patients, ranging from 18 to 46 days across psoriasis studies with intravenous administration.
Maltese: Il-medja tal-half-life tal-eliminazzjoni, skont kif stmata mill-analiżi farmakokinetika tal-popolazzjoni, kienet ta' 27 jum f'pazjenti bi psorjasi tal-plakka, li tvarja minn 18 sa 46 jum fost l-istudji dwar il-psorjasi bil-mediċina mogħtija fil-vina.
English: The preparation time from piercing the stopper until end of reconstitution takes 20 minutes on average and should not exceed 90 minutes.
Maltese: Minn meta jittaqqab it-tapp sakemm tintemm ir-rikostituzzjoni il-ħin ta' preparazzjoni jieħu bejn wieħed u ieħor 20 minuta u m'għandux jaqbeż id-90 minuta.
English: Secukinumab-treated patients reported significant improvements in health-related quality of life as measured by the Short Form-36 Health Survey Physical Component Summary (SF-36 PCS) score (p<0.001).
Maltese: Pazjenti kkurati b'secukinumab irrapportaw titjib sinjifikanti fil-kwalità tal-ħajja relatata mas-saħħa kif imkejla mill-punteġġ (p<0.001) tal-Formola Qasira-36 tas-Sommarju dwar il-Komponent Fiżiku (SF-36 PCS) tal-Istħarriġ tas-Saħħa.
English: The powder is a white solid lyophilisate.
Maltese: Tista' tilmaħ qatra likwidu fit-tarf tal-labra.
English: Because of the potential for adverse reactions in nursing infants from secukinumab, a decision on whether to discontinue breast-feeding during treatment and up to 20 weeks after treatment or to discontinue therapy with Cosentyx must be made taking into account the benefit of breast-feeding to the child and the benefit of therapy to the woman.
Maltese: Minħabba l-potenzjal ta' reazzjonijiet avversi kkawżati minn secukinumab fi trabi li qegћdin jiġu mreddgћin, gћandha tittieћed deċiżjoni jekk jitwaqqafx it-treddigћ waqt it-trattament u sa 20 ġimgħa wara t-trattament jew titwaqqafx it-terapija b'Cosentyx, wara li jiġi kkunsidrat il-benefiċċju tat-treddigћ gћat-tarbija u l-benefiċċju ta' terapija gћall-mara.
English: Cosentyx is available in packs containing one vial.
Maltese: Cosentyx hu disponibbli f'pakketti li fihom kunjett wieħed.
English: From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Maltese: Minn perspettiva mikrobijolġika, sakemm il-metodu ta' rikostituzzjoni ma jipprekludix ir-riskju ta' kontaminazzjoni mikrobjali, il-prodott għandu jintuża minnufih.
English: • if you are taking, have recently taken or might take any other medicines.
Maltese: • Iċċekkja li l-indikatur l-aħdar mela t-tieqa u waqaf jiċċaqlaq.
English: In a study, after meningococcal and inactivated influenza vaccinations, a similar proportion of healthy volunteers treated with 150 mg of secukinumab and those treated with placebo were able to mount an adequate immune response of at least a 4-fold increase in antibody titres to meningococcal and influenza vaccines.
Maltese: Fi studju, wara li ngħata tilqim kontra l-meningococci u tilqim inattivat kontra l-influwenza, proporzjon simili ta' voluntiera f'saħħithom ittrattati b'150 mg ta' secukinumab u dawk ittrattati bil-plaċebo kienu kapaċi jżidu b'mod xieraq ir-reazzjoni immuni tal-konċentrazzjoni tal-antikorpi fit-tilqimiet kontra l-meningococci u l-influwenza għal mill-i,nqas 4 darbiet.
English: In PsA study 3, the percentage of patients with no disease progression (defined as a change from baseline in mTSS of ≤0.5) from randomisation to week 24 was 80.3%, 88.5% and 73.6% for secukinumab 150 mg, 300 mg and placebo, respectively.
Maltese: 3%, 88.5% u 73.6% għal secukinumab 150 mg, 300 mg u plaċebo, rispettivament.
English: In AS study 3, patients treated with secukinumab (150 mg and 300 mg) demonstrated improved signs and symptoms, and had comparable efficacy responses regardless of dose that were superior to placebo at week 16 for the primary endpoint (ASAS 20).
Maltese: Fi studju 3 tal-AS, il-pazjenti ttrattati b'secukinumab (150 mg u 300 mg) urew sinjali u sintomi ta' titjib, u kellhom rispons ta' effikaċja komparabbli indipendentament mid-doża li kien superjuri għallplaċebo fis-16-il ġimgħa għall-endpoint primarju (ASAS 20).
English: Caution should be exercised when prescribing secukinumab to patients with inflammatory bowel disease, including Crohn's disease and ulcerative colitis.
Maltese: Wieħed għandu joqgħod attent meta jagħti secukinumab lil pazjenti bil-marda infjammatorja tal-musrana, inkluż il-marda ta' Crohn u l-kolite ulċerattiva.
English: Greater efficacy of secukinumab compared to ustekinumab for the endpoints PASI 75/90/100 and IGA mod 2011 0 or 1 response (“clear” or “almost clear”) was observed early and continued through to week 52.
Maltese: Kienu osservati, imma aktar kmieni, l-effikaċja akbar ta' secukinumab imqabbel ma' ustekinumab għall-endpoints b'rispons PASI 75/90/100 u IGA mod 2011 0 jew 1 (“ċar” jew “kważi ċar”) u dawn komplew sat-52 ġimgħa.
English: Following a single subcutaneous dose of 300 mg as a liquid formulation in healthy volunteers, secukinumab reached peak serum concentrations of 43.2±10.4 μg/ml between 2 and 14 days post dose.
Maltese: Wara doża waħda taħt il-ġilda ta' 300 mg bħala formulazzjoni likwidu f'individwi f'saħħithom, secukinumab laħaq konċentrazzjonijiet massimi fis-serum ta' 43.2±10.4 μg/ml bejn jumejn u 14-il jum wara d-doża.
English: The data suggest that secukinumab does not suppress the humoral immune response to the meningococcal or influenza vaccines.
Maltese: Id-dejta tissuġġerixxi li secukinumab ma jrażżanx ir-reazzjoni immuni umorali għat-tilqim kontra l-meningococci jew l-influwenza.
English: B. PACKAGE LEAFLET
Maltese: BSL: linja bażi
English: Similar responses were seen in PsA study 1 and efficacy was maintained up to week 52.
Maltese: Risponsi simili kienu osservati fi studju 1 tal-PsA u l-effikaċja nżammet sat-52 ġimgħa.
English: ASDAS-CRP major improvement * p<0.05, ** p<0.01, *** p<0.001; versus placebo All p-values adjusted for multiplicity of testing based on pre-defined hierarchy, except BASDAI 50 and ASDAS-CRP
Maltese: ASAS 5/6, % Remissjoni parzjali tal-ASAS, % BASDAI 50, % Titjib maġġuri tal-ASDAS-CRP * p<0.05, ** p<0.01, *** p<0.001; versus plaċebo Il-valuri p kollha aġġustati għall-multipliċità tal-ittestjar abbażi ta' ġerarkija definita minn qabel, għajr BASDAI 50 u ASDAS-CRP Imputazzjoni għal dawk li ma rrispondewx għat-terapija użata għal endpoint binarju nieqes.