FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients treated with secukinumab 150 mg also showed statistically significant improvements on exploratory endpoints in physical function as assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI) compared to placebo (-2.15 versus -0.68), and in fatigue as assessed by the Functional Assessment of Chronic Illness TherapyFatigue (FACIT-Fatigue) scale compared to placebo (8.10 versus 3.30).
Maltese: Pazjenti kkurati b'secukinumab 150 mg urew ukoll titjib statistikament sinifikanti fil-punti finali esploratorji fil-funzjoni fiżika kif ivvalutat mill-Indiċi Funzjonali Bath Ankylosing Spondylitis (BASFI - Bath Ankylosing Spondylitis Functional Index) imqabbel ma' plaċebo (-2.15 kontra -0.68), u fl-għeja kif ivvalutat mill-iskala talValutazzjoni Funzjonali ta' Terapija-Għeja ta' Mard Kroniku (FACIT-Għeja - Functional Assessment of Chronic Illness Therapy-Fatigue) imqabbel ma' plaċebo (8.10 kontra 3.30).
English: Of the 100 patients randomised to secukinumab 300 mg, 64, 44 and 24 had an ACR 20/50/70 response, respectively.
Maltese: Mill-100 pazjent randomizzati għal secukinumab 300 mg, 64, 44 u 24 kellhom rispons għal ACR 20/50/70, rispettivament.
English: Over 17,900 patients have been treated with secukinumab in blinded and open-label clinical studies in various indications (plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and other autoimmune conditions), representing 29,978 patient years of exposure.
Maltese: Aktar minn 17,900 pazjent kienu ttrattati b'secukinumab fi studji kliniċi blinded u open-label f'indikazzjonijiet varji (psorjasi tal-plakka, artrite psorjatika, spondilite ankilotika u kondizzjonijiet awtoimmuni oħrajn), li jirrappreżentaw 29,978 sena ta' esponiment ta' pazjenti.
English: In an additional psoriasis study (CLEAR) 676 patients were evaluated.
Maltese: Fi studju ieħor dwar il-psorajsi (CLEAR) 676 pazjent kienu evalwati.
English: PsA study 2 (FUTURE 2) evaluated 397 patients, of whom 46.6% had concomitant MTX.
Maltese: L-istudju 2 tal-PsA (FUTURE 2) evalwa 397 pazjent, li minnhom 46.6% kellhom MTX konkomitanti.
English: Forty percent of the participants in studies 1 and 2 completed the Psoriasis Symptom Diary©.
Maltese: Erbgħin fil-mija tal-parteċipanit fi studji 1 u 2 temmew il-Psoriasis Symptom Diary©.
English: ASAS: Assessment of SpondyloArthritis International Society Criteria; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; hsCRP: high-sensitivity C-reactive protein; ASDAS: Ankylosing Spondylitis Disease Activity Score; BSL: baseline
Maltese: Indiċi talAttività tal-Marda Spondilite Ankilotika Bath; hsCRP: proteina C-reattiva ta' sensittività għolja; ASDAS:
English: Secukinumab is a fully human IgG1/κ monoclonal antibody that selectively binds to and neutralises the proinflammatory cytokine interleukin-17A (IL-17A).
Maltese: IgG1/κ għal kollox uman li jeħel b'mod selettiv ma' u jinnewtralizza ċ-ċitokin proinfjammatorju interleukin-17A (IL-17A).
English: ADRs from clinical studies and post-marketing reports (Table 1) are listed by MedDRA system organ class.
Maltese: L-ADRs minn studji kliniċi u minn rapporti ta' wara t-tqegħid fis-suq (Tabella 1) huma elenkati skont il-klassi tas-sistemi u tal-organi
English: • Ankylosing spondylitis
Maltese: • Spondilite ankilotika
English: Population pharmacokinetic analysis showed that secukinumab was absorbed with an average absolute bioavailability of 73% in patients with plaque psoriasis.
Maltese: Analiżi tal-farmakokinetika tal-popolazzjoni wriet li secukinumab kien assorbit b'bijodisponibbiltà assoluta medja ta' 73% f'pazjenti bi psorjasi tal-plakka.
English: Secukinumab is a monoclonal antibody which belongs to a group of medicines called interleukin (IL) inhibitors.
Maltese: Secukinumab hu antikorp monoklonali li jappartjeni għal grupp ta' mediċini msejħin inibituri tal-interleukin (IL).
English: Of the 72 patients randomised to secukinumab 150 mg, 45 and 35 had an ASAS 20/40 response, respectively.
Maltese: Mit-72 pazjent randomizzati għal secukinumab 150 mg, 45 u 35 kellhom rispons għal ASAS 20/40, rispettivament.
English: Of the 100 patients randomised to secukinumab 150 mg, 64, 39 and 20 had an ACR 20/50/70 response, respectively.
Maltese: Mill-100 pazjent randomizzati għal secukinumab 150 mg, 64, 39 u 20 kellhom rispons għal ACR 20/50/70, rispettivament.
English: PASI 75 response n (%) 0 (0.0%) 41
Maltese: Reazzjoni PASI 75 n (%) 0 (0.0%) 41
English: Serum levels of total IL-17A (free and secukinumab-bound IL-17A) are initially increased in patients receiving secukinumab.
Maltese: Il-livelli tas-serum ta' IL-17A totali (IL-17A liberu u marbut ma' secukinumab) għall-ewwel jiżdiedu f'pazjenti mogħtija secukinumab.
English: ASAS 20 responses were improved at week 16 in both anti-TNFα-naïve patients (68.2% versus 31.1%; p<0.05) and anti-TNFα-IR patients (50.0% versus 24.1%; p<0.05) for secukinumab 150 mg compared with placebo, respectively.
Maltese: Ir-rispons tal-ASAS 20 tjieb fis-16-il ġimgħa kemm fil-pazjenti naivi anti-TNFα (68.2% versus 31.1%; p<0.05) kif ukoll fil-pazjenti IR anti-TNFα (50.0% versus 24.1%; p<0.05) għal secukinumab 150 mg imqabbel ma' plaċebo, rispettivament.
English: Of the 2,403 patients who were included in the placebo-controlled studies, 79% were biologic-naive, 45% were non-biologic failures and 8% were biologic failures (6% were anti-TNF failures, and 2% were anti-p40 failures).
Maltese: Mill-2,403 pazjenti li kienu inklużi fl-istudji kkontrollati bil-plaċebo, 79% kienu pazjenti li qatt ma ngħataw din il-mediċina, 45% kienu fallimenti mhux bijoloġiċi u 8% kienu fallimenti bijoloġiċi (6% kienu fallimenti anti-TNF, u 2% kienu fallimenti anti-p40). Madwar 15 sa 25% tal-pazjenti fi studji ta' fażi
English: AS study 2 (MEASURE 2) evaluated 219 patients, of whom 11.9% and 14.2% used concomitant MTX or sulfasalazine, respectively.
Maltese: L-istudju 2 tal-AS (MEASURE 2) evalwa 219-il pazjent, li minnhom 11.9% u 14.2% użaw MTX konkomitanti jew sulfasalazine, rispettivament.
English: Based on population pharmacokinetic analysis with a limited number of elderly patients (n=71 for age ≥65 years and n=7 for age ≥75 years), clearance in elderly patients and patients less than 65 years of age was similar.
Maltese: Skont analiżi farmakokinetika tal-popolazzjoni b'numru limitat ta' pazjenti anzjani (n=71 għall-età ta' ≥65 sena u n=7 għall-età ta' ≥75 sena), it-tneħħija f'pazjenti anzjani u f'pazjenti iżgħar minn 65 sena kienet simili.
English: Patients treated with ustekinumab received 45 mg or 90 mg at weeks 0 and 4, then every 12 weeks until week 52 (dosed by weight as per approved posology) ** p values versus ustekinumab: p<0.0001 for primary endpoint of PASI 90 at week 16 and secondary endpoint of PASI 75 at week 4 *** p values versus ustekinumab: p=0.0001 for secondary endpoint of PASI 90 at week 52
Maltese: Pazjenti ttrattati b'ustekinumab ngħataw 45 mg jew 90 mg f'ġimgħat 0 u 4, u wara kull 12-il ġimgħa sat-52 ġimgħa (dożi skont il-piż fid-dawl tal-pożoloġija approvata) ** valuri p kontra ustekinumab: p<0.0001 għall-endpoint primarju ta' PASI 90 fis-16-il ġimgħa u għall-endpoint sekondarju ta' PASI 75 fir-4 ġimgħa *** il-valuri-p kontra ustekinumab: p=0.0001 għall-endpoint sekondarju ta' PASI 90 fit-52 ġimgħa
English: Cosentyx is supplied in a pre-filled 1 ml glass syringe with a silicone-coated bromobutyl rubber plunger stopper, staked 27G x ½″ needle and rigid needle shield of styrene butadiene rubber assembled in a passive safety device of polycarbonate.
Maltese: Cosentyx huwa disponibbli f'siringa tal-ħġieġ ta' 1 ml mimlija għal-lest b'tapp tal-planġer tal-lastiku bromobutyl miksi bis-silicone, b'labra mwaħħla miegħu ta' 27G x ½″ u b'tokka riġida tal-labra magħmula minn lastku styrene butadiene immuntata f'tagħmir sigur passiv tal-polycarbonate.
English: In clinical studies, infections have been observed in patients receiving secukinumab (see section 4.8).
Maltese: Fi studji kliniċi, kienu osservati infezzjonijiet f'pazjenti mogħtija secukinumab (ara sezzjoni 4.8).
English: • if you have ulcerative colitis.
Maltese: • jekk għandek kolite ulċerattiva.
English: Also contains: Sucrose, histidine, histidine hydrochloride monohydrate, polysorbate 80.
Maltese: Fih ukoll: Sucrose, histidine, histidine hydrochloride monohydrate, polysorbate 80.
English: In psoriasis, psoriatic arthritis and ankylosing spondylitis clinical studies, less than 1% of patients treated with secukinumab developed antibodies to secukinumab up to 52 weeks of treatment.
Maltese: Fi studji kliniċi dwar psorjasi, artrite psorjatika u spondilite ankilotika, inqas minn 1% tal-pazjenti ttrattati b'secukinumab żviluppaw antikorpi għal secukinumab tul it-52 ġimgħa ta' trattament.
English: IGA mod 2011 “clear” or “almost clear” response n (%)
Maltese: IGA mod 2011 “ċar” jew “kważi ċar” n (%)
English: Number of patients PASI 75 response n (%) PASI 90 response n (%) PASI 100 response n (%) IGA mod 2011 “clear” or “almost clear” response n (%)
Maltese: Numru ta' pazjenti 334 rispons PASI 75 n (%) rispons PASI 90 n (%) rispons PASI 100 n (%) rispons
English: • if you are receiving any other treatment for psoriasis, such as another immunosuppressant or phototherapy with ultraviolet (UV) light.
Maltese: • jekk qed tingħata xi trattament ieħor għall-psorjasi, bħal immunosuppressant ieħor jew fototerapija b'raġġi ultravjola (UV - ultraviolet).
English: In psoriasis studies, the safety and efficacy of secukinumab in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.
Maltese: Fi studji dwar psorjasi, is-sigurtà u l-effikaċja ta' secukinumab flimkien ma' immunosoppressanti, inkluż bijoloġiċi, jew fototerapija ma ġewx evalwati.
English: 1 pre-filled SensoReady pen 2 pre-filled SensoReady pens
Maltese: Pinna SensoReady mimlija għal-lest waħda 2 pinen SensoReady mimlija għal-lest
English: Weeks of treatment n = number of patients evaluable secukinumab 150 mg (n=243)
Maltese: Ġimgħat ta' trattament n = numru ta' pazjenti li setgħu jiġu evalwati secukinumab 150 mg (n=243)
English: In Ankylosing Spondylitis study 1 (AS study 1), Ankylosing Spondylitis study 2 (AS study 2), and Ankylosing Spondylitis study 3 (AS study 3), 27.0%, 38.8%, and 23.5% 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 dwar l-Ispondilite Ankilotika (studju 1 tal-AS), fl-istudju 2 dwar l-Ispondilite Ankilotika (studju 2 tal-AS), u fl-istudju 3 dwar l-Ispondilite Ankilotika (studju 3 tal-AS), 27.0%, 38.8%, u 23.5% 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: Also contains: Trehalose dihydrate, histidine, histidine hydrochloride monohydrate, methionine, polysorbate 80, water for injections.
Maltese: Fih ukoll: Trehalose dihydrate, histidine, histidine hydrochloride monohydrate, methionine, polysorbate 80, ilma għall-injezzjonijiet.
English: Cosentyx is not recommended for children and adolescents (under 18 years of age) because it has not been studied in this age group.
Maltese: Cosentyx mhuwiex irrakkomandat għal tfal u adolexxenti (taħt it-18-il sena) minħabba li ma ġiex studjat f'dan il-grupp ta' età.
English: In PsA study 2, both anti-TNFα-naive and anti-TNFα-IR secukinumab-treated patients had a significantly higher ACR 20 response compared to placebo at week 24, with a slightly higher response in the anti-TNFα-naive group (anti-TNFα-naive: 64% and 58% for 150 mg and 300 mg, respectively, compared to placebo 15.9%; anti-TNFα-IR: 30% and 46% for 150 mg and 300 mg, respectively, compared to placebo 14.3%).
Maltese: Fl-istudju 2 tal-PsA, kemm il-pazjenti kkurati b'secukinumab naivi anti-TNFα u dawk b'IR anti-TNFα kellhom rispons ferm ogħla għal ACR 20 meta mqabbla ma' plaċebo fl-24 ġimgħa, b'rispons kemmxejn ogħla fil-grupp ta' pazjenti naivi anti-TNFα (naivi anti-TNFα: 64% u 58% għal 150 mg u 300 mg, rispettivament, imqabbla ma' plaċebo 15.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2ºC to 8ºC.
Maltese: Stabbiltà kimika u fiżika waqt l-użu intweriet għal 24 siegħa f'temperatura ta' bejn 2°C u 8°C.
English: Exfoliative dermatitis Placebo-controlled clinical studies (phase III) in plaque psoriasis, PsA and AS patients exposed to 300 mg, 150 mg, 75 mg or placebo up to 12 weeks (psoriasis) or 16 weeks (PsA and AS) treatment duration Cases were reported in patients with psoriasis diagnosis
Maltese: Dermatite esfoljattiva Studji kliniċi kkontrollati bil-plaċebo (fażi III) fost pazjenti bi psorjasi tal-plakka, PsA u AS esposti għal 300 mg, 150 mg, 75 mg jew plaċebo sa 12-il ġimgħa (psorjasi) jew 16-il ġimgħa (PsA u AS) li matulhom dam għaddej it-trattament Kienu rrappurtati każijiet f'pazjenti b'dijanjożi ta' psorijasi
English: A new and unused Cosentyx SensoReady pen (2 pens are needed for a 300 mg dose).
Maltese: Pinna Cosentyx SensoReady ġdida u mhux użata (huma meħtieġa 2 pinen għal doża ta' 300 mg).
English: Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).
Maltese: Cosentyx, waħdu jew flimkien ma' methotrexate (MTX), hu indikat għat-trattament ta' artrite psorjatika attiva f'pazjenti adulti meta r-rispons għat-terapija preċedenti b'mediċina antirewmatika li timmodifika l-marda (DMARD) ikun inadegwat (ara sezzjoni 5.1).
English: PASI 75 response n (%) 11
Maltese: Reazzjoni PASI 75 n (%) 11
English: In the placebo-controlled period of clinical studies in plaque psoriasis (a total of 1,382 patients treated with secukinumab and 694 patients treated with placebo for up to 12 weeks), infections were reported in 28.7% of patients treated with secukinumab compared with 18.9% of patients treated with placebo.
Maltese: Waqt il-perjodu kkontrollat bil-plaċebo tal-istudji kliniċi fost pazjenti bi psorjasi tal-plakka (total ta' 1,382 pazjent ittrattati b'secukinumab u 694 pazjent ittrattati bi plaċebo sa 12-il ġimgħa), infezzjonijiet kienu rrappurtati fi 28.7% tal-pazjenti ttrattati b'secukinumab imqabbel ma' 18.9% tal-pazjenti ttrattati bi plaċebo.
English: PASI % change from baseline
Maltese: Bidla % f'PASI mil-linja bażi
English: PsA study 1
Maltese: ANNESS 1
English: PASI 90 response n (%) 3 (1.2%) 95
Maltese: Reazzjoni PASI 90 n (%) 3 (1.2%) 95 Reazzjoni PASI 100 n
English: AS study 3 (MEASURE 3) evaluated 226 patients, of whom 13.3% and 23.5% used concomitant MTX or sulfasalazine, respectively.
Maltese: L-istudju 3 tal-AS (MEASURE 3) evalwa 226 pazjent, li minnhom 13.3% u 23.5% użaw MTX konkomitanti jew sulfasalazine, rispettivament.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti għas-sottomissjoni tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornamenti sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Take the box containing the syringe out of the refrigerator and leave it unopened for about 15-30 minutes so that it reaches room temperature.
Maltese: Oħroġ il-kaxxa li fiha s-siringa mill-friġġ u ħalliha toqgħod magħluqa għal madwar 15-30 minuta sakemm tilħaq it-temperatura tal-kamra.
English: Improvements in HAQ-DI scores were seen regardless of previous anti-TNFα exposure.
Maltese: Ġie osservat titjib fil-punteġġi talHAQ-DI, irrispettivament mill-esponiment anti-TNFα preċedenti.
English: Across studies, absolute bioavailabilities in the range between 60 and 77% were calculated.
Maltese: Mill-istudji kollha, kienu kkalkulati bijodisponibbiltajiet assoluti fuq medda ta' bejn 60 u 77%.
English: Related to the mechanism of action of secukinumab, non-serious mucocutaneous candida infections were more frequently reported for secukinumab than placebo in the psoriasis clinical studies (3.55 per 100 patient years for secukinumab 300 mg versus 1.00 per 100 patient years for placebo) (see section 4.8).
Maltese: Relatat mal-mekkaniżmu ta' azzjoni ta' secukinumab, infezzjonijiet mukokutanji mhux serji kkawżati minn candida kienu irrappurtati aktar ta' spiss għal secukinumab milli għal plaċebo fl-istudji kliniċi dwar psorjasi (3.55 għal kull 100 sena ta' pazjent għal secukinumab 300 mg kontra 1.00 għal kull 100 sena ta' pazjent għall-plaċebo) (ara sezzjoni 4.8).
English: Rhinorrhoea
Maltese: Rinorea
English: There were also statistically significant improvements demonstrated in exploratory endpoints assessed by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scores for 150 mg and 300 mg compared to placebo (7.97, 5.97 versus 1.63, respectively) and these improvements were maintained up to week 104 in PsA study 2.
Maltese: Kien hemm ukoll titjib statistikament sinifikanti li ntwera f'punti finali esploratorji stmati permezz tal-punteġġi tal-Valutazzjoni Funzjonali tat-Terapija għal Mard Kroniku - Għeja (FACIT-F), għal 150 mg u 300 mg imqabbel ma' plaċebo (7.97, 5.97 kontra 1.63, rispettivament) u dan it-titjib inżamm sal-104 ġimgħa fl-istudju 2 tal-PsA.
English: In the anti-TNFα-IR patients subgroup, only the 300 mg dose showed significantly higher response rate for ACR 20 compared to placebo (p<0.05) and demonstrated clinical meaningful benefit over 150 mg on multiple secondary endpoints.
Maltese: Fis-sottogrupp ta' pazjenti b'IR anti-TNFα, kienet biss id-doża ta' 300 mg li wriet rata ta' rispons ferm ogħla għal ACR 20 imqabbla ma' plaċebo (p<0.05) u li wriet benefiċċju kliniku sinjifikanti fuq 150 mg fuq endpoints sekondarji multipli.
English: Table 1 List of adverse reactions in clinical studies and post-marketing experience
Maltese: Tabella 1 Lista ta' reazzjonijiet avversi waqt studji kliniċi u mill-esperjenza wara t-tqegħid fis-suq
English: In PsA study 2, the proportion of patients achieving a modified PsA Response Criteria (PsARC) response was greater in the secukinumab-treated patients (59.0% and 61.0% for 150 mg and 300 mg, respectively) compared to placebo (26.5%) at week 24.
Maltese: Fl-istudju 2 tal-PsA, il-proporzjon ta' pazjenti li kisbu rispons ta' Kriterji ta' Rispons PsA (PsARC) modifikat kien akbar fil-pazjenti kkurati b'secukinumab (59.0% u 61.0% għal 150 mg u 300 mg, rispettivament) imqabbla ma' plaċebo (26.5%) fl-24 ġimgħa.
English: PASI 90 response n (%) 0 (0.0%) 27
Maltese: Reazzjoni PASI 90 n (%) 0 (0.0%) 27
English: • if you have an active infection which your doctor thinks is important.
Maltese: • jekk għandek infezzjoni attiva li t-tabib tiegħek jaħseb li hija importanti.
English: What Cosentyx contains - The active substance is secukinumab.
Maltese: X'fih Cosentyx - Is-sustanza attiva hi secukinumab.
English: No interaction was seen when secukinumab was administered concomitantly with methotrexate (MTX) and/or corticosteroids in arthritis studies (including in patients with psoriatic arthritis and ankylosing spondylitis).
Maltese: Ma ġiet osservata l-ebda interazzjoni meta secukinumab ingħata fl-istess ħin ma' methotrexate (MTX) u/jew kortikosterojdi fi studji dwar l-artrite (inkluż f'pazjenti b'artrite psorjatika u spondilite ankilotika).
English: Store in the refrigerator between 2°C and 8°C.
Maltese: Aħżen fil-friġġ f'temperatura bejn 2°C u 8°C.
English: PASI 90 response n (%) 0 (0.0%) 24
Maltese: Reazzjoni PASI 90 n (%) 0 (0.0%) 24
English: Statistically significant improvements in patient-reported signs and symptoms of itching, pain and scaling at week 16 and week 52 (CLEAR) were demonstrated in the Psoriasis Symptom Diary©
Maltese: Kien hemm titjib qawwi statistikament f'sinjali rrappurtati mill-pazjenti u fis-sintomi tal-ħakk, uġigħ u qxur fis-16-il ġimgħa u t-52 ġimgħa (CLEAR) skont il-Psoriasis Symptom Diary©
English: Serious infections were reported in 1.2% of patients treated with secukinumab (0.015 per patient-year of follow-up).
Maltese: Kienu rrappurtati infezzjonijiet serji f'1.2% tal-pazjenti ttrattati b'secukinumab (0.015 għal kull sena ta pazjent li matulhom il-pazjent baqa' jiġi segwit).
English: No pharmacokinetic data are available in patients with renal or hepatic impairment.
Maltese: Ma teżistix dejta farmakokinetika disponibbli f'pazjenti b'indeboliment renali jew epatiku.
English: In a population pharmacokinetic analysis, the mean systemic clearance (CL) was 0.19 l/day in plaque psoriasis patients.
Maltese: Skont analiżi tal-farmakokinetika tal-popolazzjoni, il-medja tat-tneħħija (CL) sistemika kienet ta' 0.19 l/jum f'pazjenti bi psorjasi tal-plakka.
English: Table 2 Summary of PASI 50/75/90/100 & IGA mod 2011 “clear” or “almost clear” clinical response in psoriasis studies 1, 3 and 4 (ERASURE, FEATURE and JUNCTURE)
Maltese: IGA mod 2011 “ċara” jew “kważi ċara” fi Studji 1, 3 u 4 dwar psorjasi (ERASURE, FEATURE u JUNCTURE)
English: • runny nose (rhinorrhoea)
Maltese: • flissjoni (rinorrea)
English: • The recommended dose is 300 mg by subcutaneous injection.
Maltese: • Id-doża rakkomandata hija 300 mg permezz ta' injezzjoni taħt il-ġilda.
English: The mean volume of distribution during the terminal phase (Vz) following single intravenous administration ranged from 7.10 to 8.60 litres in plaque psoriasis patients, suggesting that secukinumab undergoes limited distribution to peripheral compartments.
Maltese: Il-volum medju tad-distribuzzjoni matul il-fażi terminali (Vz) wara l-għoti ta' darba tal-mediċina fil-vina kien bejn 7.10 u 8.60 litri f'pazjenti bi psorjasi tal-plakka, li jissuġġerixxi li secukinumab jgħaddi minn distribuzzjoni limitata għall-kompartimenti periferali.
English: An effect of inhibition of structural damage was observed in anti-TNFα-naïve and anti-TNFα-IR patients and in patients treated with and without concomitant MTX.
Maltese: Effett tal-inibizzjoni tal-ħsara strutturali kien osservat f'pazjenti anti-TNFα-naïve u anti-TNFα-IR u f'pazjenti ttrattati b'MTX konkomitanti jew mingħajr.
English: Clinically relevant levels of secukinumab reach the skin and reduce local inflammatory markers.
Maltese: Livelli ta' secukinumab relevanti klinikament jilħqu l-ġilda u jnaqqsu l-markaturi infjammatorji lokali.
English: On the basis of simulated data, peak concentrations at steady-state (Cmax,ss) following subcutaneous administration of 150 mg or 300 mg were 27.6 µg/ml and 55.2 µg/ml, respectively.
Maltese: Ibbażat fuq dejta simulata, l-ogħla konċentrazzjonijiet fi stat fiss (Cmax,ss) wara l-għoti ta' 150 mg jew 300 mg taħt il-ġilda kienu ta' 27.6 µg/ml u 55.2 µg/ml, rispettivament.
English: The co-primary endpoints in the placebo and active-controlled studies were the proportion of patients who achieved a PASI 75 response and IGA mod 2011 “clear” or “almost clear” response versus placebo at week 12 (see Tables 2 and 3).
Maltese: Il-punti finali koprimarji fl-istudji kkontrollati bil-plaċebo u bl-attiv kienu l-proporzjon ta' pazjenti li kisbu reazzjoni PASI 75 u IGA mod 2011 “ċara” jew reazzjoni “kważi ċara” kontra l-plaċebo f'ġimgħa 12 (ara Tabelli 2 u 3).
English: In clinical studies, rare cases of anaphylactic reactions have been observed in patients receiving secukinumab.
Maltese: Fi studji kliniċi, ġew osservati każijiet rari ta' reazzjonijiet anafilattiċi f'pazjenti li ngħataw secukinumab.
English: Withdraw slightly more than 1.0 ml sterile water for injections into a 1 ml graduated disposable syringe and adjust to 1.0 ml.
Maltese: Iġbed ħarira aktar minn 1.0 ml ilma sterili għall-injezzjonijiet f'siringa ta' 1 ml li tintuża darba biss u bi gradwazzjoni filwaqt li tirranġaha għal 1.0 ml.
English: AS study 1 (MEASURE 1) evaluated 371 patients, of whom 14.8% and 33.4% used concomitant MTX or sulfasalazine, respectively.
Maltese: L-istudju 1 tal-AS (MEASURE 1) evalwa 371 pazjent, li minnhom 14.8% u 33.4% użaw MTX konkomitanti jew sulfasalazine, rispettivament.