FrancophonIA/ELRC3.0 huggingface dataset:
English: Abbreviations: N = number of patients in the intent-to-treat population Note: patients with missing data were counted as non-responders a p < 0.001 compared with placebo b p < 0.001 compared with etanercept c Patients with Itch NRS >= 4 at baseline: placebo N = 158, Taltz 80 mg Q4W N = 313, Taltz 80 mg Q2W N = 320, Etanercept N = 312
Maltese: Nota: pazjenti b'dejta nieqsa ngħaddu bħala pazjenti li ma wiġbux għat-trattament a p < 0.001 imqabbel mal-plaċebo b p < 0.001 imqabbel ma' etanercept c Pazjenti b'NRS ta' Ħakk >= 4 fil-linja bażi: plaċebo N = 158, Taltz 80 mg Q4W N = 313, Taltz 80 mg Q2W N = 320, Etanercept N = 312
English: A significantly greater proportion of patients treated with TALTZ achieved a reduction in the PROs of severity of genital pain, genital itch, impact of genital psoriasis on sexual activity, and Dermatology Quality of Life Index (DLQI).
Maltese: Kwalità tal-Ħajja fir-rigward tad-Dermatoloġija (DLQI - Dermatology Quality of Life Index).
English: Efficacy and safety of ixekizumab was also investigated in a double-blind study compared to ustekinumab with ixekizumab being superior on the primary study objective (PASI 90 response at week 12, Table 6).
Maltese: ustekinumab, b'ixekizumab ikun superjuri fl-għan primarju tal-istudju (ir-rispons PASI 90 f'ġimgħa 12, Tabella 6).
English: Approximately 25 % of patients treated with Taltz achieved a PASI score < 5 by Week 2, more than 55 % achieved the PASI score < 5 by Week 4, and increased to 85 % by Week 12 (compared to 3 %, 14 % and 50 % for etanercept).
Maltese: Madwar 25% tal-pazjenti ttrattati b'Taltz kisbu punteġġ PASI ta' < 5 mal-Ġimgħa 2, aktar minn 55% kisbu l-punteġġ PASI < 5 mal-Ġimgħa 4, u żdiedu għal 85% sal-Ġimgħa 12 (mqabbla ma' 3%, 14% u 50% għal etanercept).
English: Twist-off base cap
Maltese: SD = standard deviation.
English: Thigh
Maltese: Nawsja
English: Injection site reactionsf a Placebo-controlled clinical studies (phase III) in moderate to severe plaque psoriasis patients exposed to ixekizumab 80 mg Q2W, ixekizumab 80 mg Q4W or placebo for up to 12 weeks of treatment duration, or in active psoriatic arthritis patients exposed to ixekizumab 80 mg Q2W, ixekizumab 80 mg Q4W or placebo for up to 24 weeks of treatment duration.
Maltese: III) f'pazjenti bi psorjasi bil-plakka moderata jew severa esposti għal ixekizumab 80 mg Q2W, ixekizumab 80 mg Q4W jew plaċebo għal tul ta' trattament ta' 12-il ġimgħa, jew f'pazjenti b'artrite psorjatika attiva esposti għal ixekizumab 80 mg Q2W, ixekizumab 80 mg Q4W jew plaċebo għal tul ta' trattament ta' 24 ġimgħa b
English: At Week 12, significantly more subjects in the TALTZ group than placebo group achieved a sPGA of Genitalia 0/1 and a sPGA 0/1 independent of baseline BSA (baseline BSA 1% - <10% resp. ≥10%: sPGA of Genitalia ‘'0” or “1”: Taltz 71%, resp. 75%; placebo: 0%, resp. 13%).
Maltese: ≥10%: sPGA tal-Genitalja ‘'0” jew “1”: Taltz 71%, risp. 75%; plaċebo: 0%, risp.
English: In SPIRIT-P1, inhibition of progression of structural damage was assessed radiographically and expressed as the change in modified total Sharp Score (mTSS) and its components, the Erosion Score (ES) and the Joint Space Narrowing score (JSN) at Weeks 24 and 52, compared to baseline.
Maltese: Fi SPIRIT-P1, l-inibizzjoni tal-progrssjoni ta' ħsara strutturali ġiet evalwata b'mod radjografiku u murija bħala il-bidla fil-modified total Sharp Score (mTSS) u l-komponenti tiegħu, fl-Erosion Score (ES) u l-punteġġ tal-Joint Space Narrowing (JSN) fl-24 Ġimgħa u t-52 Ġimgħa, meta mqabbla mal linja bażi.
English: Efficacy results at Week 12 in UNCOVER-1
Maltese: Riżultati ta' effikaċja fil-Ġimgħa 12 f'UNCOVER-1
English: - if you have an infection which your doctor thinks is important (for example, active tuberculosis).
Maltese: - jekk inti għandek infezzjoni li t-tabib tiegħek jaħseb li hija important (per eżempju, tuberkulożi attiva).
English: Ixekizumab modulates biological responses that are induced or regulated by IL-17A.
Maltese: Ixekizumab jirregola r-risponsi bijoloġiċi kkaġunati jew irregolati minn IL-17A.
English: - Cold sores of mouth, skin and mucous membranes (herpes simplex, mucocutaneous)
Maltese: - Ponot tad-deni madwar il-ħalq, fil-ġilda u fir-riti mukożi (herpes simplex, mukokutaneju)
English: points at week 12 (84.6% for Taltz Q2W, 79.2% for Taltz Q4W and 16.5% for placebo) and the benefit was sustained over time up to Week 60 in patients treated with Taltz who were sPGA (0 or 1)
Maltese: Numru sinifikanti akbar ta' pazjenti ttrattati b'Taltz kisbu tnaqqis fl- Itch NRS ≥ 4 punti f'ġimgħa 12 (84.6% għal Taltz Q2W, 79.2% għal Taltz Q4W u 16.5% għal plaċebo) u l benefiċċju nżamm għal tul ta' żmien sa Ġimgħa 60 f'pazjenti ttrattati b'Taltz li kienu rrispondew b'mod pożittiv għall-sPGA (0 jew 1) f'Ġimgħa 12.
English: Pack sizes of 1, 2, 3 pre-filled pens.
Maltese: Daqsijiet tal-pakkett ta' 1, 2, 3 pinen mimlijin għal-lest.
English: (Based on adverse reactions data from 4,204 patients with moderate to severe plaque psoriasis [4,729.7 patient years] and 1,117 patients with active psoriatic arthritis [1,050.6 patient years] who have received at least 1 dose of ixekizumab.)
Maltese: Deskrizzjoni ta' għażla ta' reazzjonijiet avversi (Ibbażati fuq tagħrif ta' reazzjonijiet avversi minn 4,204 pazjenti bi psorjasi tal-plakka moderata għal severa [4,729.7 pazjenti/sena] u 1,117-il pazjent b'artrite psorjatika attiva [1,050.6 pazjenti/sena] li rċevew għall-inqas doża 1 ta' ixekizumab.)
English: EU/1/15/1085/004 1 pre-filled syringe EU/1/15/1085/005 2 pre-filled syringes EU/1/15/1085/006 3 pre-filled syringes
Maltese: EU/1/15/1085/004 siringa 1 mimlija għal-lest EU/1/15/1085/005 2 siringi mimlijin għal-lest EU/1/15/1085/006 3 siringi mimlijin għal-lest
English: The recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg (one injection) at Weeks 2, 4, 6, 8, 10, and 12, then maintenance dosing of 80 mg (one injection) every 4 weeks.
Maltese: 80 mg) f' Ġimgħa 0, segwita minn 80 mg (injezzjoni waħda) fil-Ġimgħat 2, 4, 6, 8, 10, u 12,
English: Taltz was efficacious in the maintenance of response in systemic treatment-naive, biologic-naive, biologic/anti-TNF-exposed and biologic/anti-TNF-failure patients.
Maltese: Taltz kien effikaċi fil-manteniment ta' rispons f'pazjenti li qatt ma kienu ħadu trattament sistemiku qabel, li qatt ma kienu ħadu sustanza bijoloġika qabel, li kienu esposti għal sustanza bijoloġika/antiTNF u li kienu fallew trattament b'sustanza bijoloġika/anti-TNF.
English: The safety and efficacy of Taltz in children and adolescents aged 2 to less than 18 years in the treatment of psoriatic arthritis (a category of juvenile idiopathic arthritis) have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Taltz fit-tfal u fl-adolexxenti minn età ta' sentejn sa inqas minn 18-il sena fit-trattament ta' artrite psorjatika ( kategorija ta' artrite idjopatika tal-minorenni) ma ġewx determinati s'issa.
English: Patients were stratified at baseline based on concomitant cDMARD use and presence of moderate-to-severe psoriasis (PASI≥12,
Maltese: Il-pazjenti ġew separati fil-linja bażi skont l-użu konkomitanti ta' cDMARD u l-presenza ta' psorjasi moderata għal severa (PASI≥12, BSA≥10 u sPGA≥3).
English: Serious hypersensitivity reactions, including some cases of anaphylaxis, angioedema, urticaria and, rarely, late (10-14 days following injection) serious hypersensitivity reactions including widespread urticaria, dyspnea and high antibody titres have been reported.
Maltese: Ġew irrappurtati reazzjonijiet serji ta' sensittività eċċessiva, inkluż xi każijiet ta' anafilassi, anġjoedima, urtikarja u u b'mod rari reazzjonijiet serji ta' sensittività eċċessiva li joħorġu tard (10 ijiem-14-il jum wara l-injezzjoni) li jinkludu urtikarja mfirxxa ma' kullimkien, qtugħ ta' nifs u livelli għoljin ta' antikorpi.
English: In SPIRIT-P1, efficacy was maintained up to Week 52 as assessed by ACR 20/50/70, MDA, enthesitis resolution, dactylitis resolution, and PASI 75/90/100 response rates.
Maltese: Fi SPIRIT-P1, l-effikaċja nżammet sat-52 Ġimgħa kif evalwat mill-ACR 20/50/70, MDA, entesite li ma dehretx iżjed, daktilite li ma dehretx iżjed u r-rati ta' rispons ta' PASI 75/90/100.
English: The solution/the syringe must not be shaken.
Maltese: Simboli maqfula/mhux maqfula
English: Abbreviations: N = number of patients in the analysis population Note: patients with missing data were counted as non-responders a p < 0.001 compared with placebo
Maltese: Taqsiriet: N = numru ta' pazjenti fil-popolazzjoni ta' analiżi Nota: pazjenti b'dejta nieqsa ngħaddu bħala persuni li ma wiġbux għat-trattament a p < 0.001 imqabbel mal-plaċebo
English: Efficacy results at Week 12 in UNCOVER-3
Maltese: Riżultati ta' effikaċja fil-Ġimgħa 12 f'UNCOVER-3
English: Some side effects are uncommon (may affect up to 1 in 100 people): - oral thrush (oral candidiasis).
Maltese: Xi effetti sekondarji mhumiex komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100): - ħrar (kandidjasi orali). - influwenza.
English: How to store Taltz
Maltese: Taltz kien
English: a p < 0.001 compared with placebo b p < 0.001 compared with etanercept c p < 0.01 compared with placebo d Patients with Itch NRS > = 4 at baseline: placebo N = 135, Taltz 80 mg Q4W N = 293, Taltz 80 mg Q2W N = 303, Etanercept N = 306
Maltese: Nota: pazjenti b'dejta nieqsa ngħaddu bħala pazjenti li ma wiġbux għat-trattament. a p < 0.001 imqabbel ma' plaċebo b p < 0.001 imqabbel ma' etanercept c p < 0.01 imqabbel ma' plaċebo d Pazjenti b'NRS għall-Ħakk > = 4 fl-linja bażi: plaċebo N = 135, Taltz 80 mg Q4W N = 293, Taltz 80 mg Q2W N = 303, Etanercept N = 306
English: Plaque psoriasis - The first dose is 160 mg (two 80 mg injections) by subcutaneous injection.
Maltese: - L-ewwel doża hija 160 mg (żewġ injezzjonijiet ta' 80 mg) permezz ta' injezzjoni taħt il-ġilda.
English: EXPIRY DATE
Maltese: Data ta' skadenza
English: - The other ingredients are sodium citrate; citric acid, anhydrous; sodium chloride; polysorbate 80; water for injections.
Maltese: - Is-sustanzi l-oħra huma sodium citrate; citric acid, anhydrous; sodium chloride; polysorbate 80; ilma għall-injezzjonijiet.
English: (neutropenia).
Maltese: (minumu)
English: In all three studies, the co-primary endpoints were the proportion of patients who achieved a PASI 75 response (Psoriasis Area and Severity Index) and an sPGA of 0 (“clear”) or 1 (“minimal”) response at Week 12 versus placebo.
Maltese: Fit-tliet studji, il-lott tal-iskopijiet primarji kienu l-proporzjon ta' pazjenti li kisbu rispons PASI 75 (Indiċi tas-Severità u l-Erja tal-Psorjasi -Psoriasis Area and Severity Index) u rispons sPGA ta' 0 (“ċar”) jew 1 (“minimu”) f'Ġimgħa 12 versus plaċebo.
English: Difference from Placebo in Response Rate (95% CI)
Maltese: Differenza mill-Plaċebo firRata ta' Rispons (95% CI)
English: Needle
Maltese: Dunderrow
English: Thumb pad Green plunger rod
Maltese: Fi psorjasi bil-plakka, tliet studji ta' fażi
English: EU/1/15/1085/001 1 pre-filled pen EU/1/15/1085/002 2 pre-filled pens EU/1/15/1085/003 3 pre-filled pens
Maltese: EU/1/15/1085/001 pinna 1 mimlija għal-lest EU/1/15/1085/002 2 pinen mimlijin għal-lest EU/1/15/1085/003 3 pinen mimlijin għal-lest
English: Placebo (N = 168)
Maltese: (N = 168)
English: Taltz is injected under the skin (subcutaneous injection).
Maltese: Taltz jiġi injettat taħt il-ġilda (injezzjoni subkutaneja).
English: Each pen contains one dose of Taltz (80 mg).
Maltese: Kull pinna fiha doża waħda ta' Taltz (80 mg).
English: Efficacy results at Week 12 in UNCOVER-2
Maltese: Riżultati ta' effikaċja fil-Ġimgħa 12 f'UNCOVER-2
English: Taltz should be used with caution in patients with clinically important chronic infection.
Maltese: Taltz għandu jintuża b'kawtela f'pazjenti b'infezzjoni kronika li hija klinikament importanti.
English: Each pre-filled syringe contains 80 mg of ixekizumab in 1 ml solution.
Maltese: Kull siringa mimlija għal-lest fiha 80 mg ta' ixekizumab f'1 ml ta' soluzzjoni.
English: As a precautionary measure, it is preferable to avoid the use of Taltz during pregnancy.
Maltese: Bћala prekawzjoni huwa preferribli li jiġi evitat l-użu ta' Taltz matul it-tqala.
English: Based on psoriatic skin biopsy data from a phase I study, there was a dose-related trend towards decreased epidermal thickness, number of proliferating keratinocytes, T cells, and dendritic cells, as well as reductions in local inflammatory markers from baseline to day 43.
Maltese: Abbażi ta' dejta minn bijopsija ta' ġilda psorjatika minn studju ta' fażi I, kien hemm tendenza marbuta mad-doża lejn tnaqqis fil-ħxuna tal-epidermide, fin-numru ta' keratinoċiti, ċelluli T, u ċelluli dentritiċi li jkunu qed joktru, kif ukoll tnaqqis fil-markaturi lokali ta' infjammazzjoni mil-linja bażi sa jum 43.
English: If a serious hypersensitivity reaction occurs, administration of Taltz should be discontinued immediately and appropriate therapy initiated.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIRRIGWARD TAL-UŻU SIGUR U EFFETTIV TAL-PRODOTT
English: The average bioavailability of ixekizumab after subcutaneous administration was 54 % to 90 % across analyses.
Maltese: Il-bijodisponibbiltà medja ta' ixekizumab wara għoti taħt il-ġilda kienet 54% sa 90% fl-analiżi kollha.
English: Anaphylaxish
Maltese: - Raxx
English: The efficacy and safety of Taltz was demonstrated regardless of age, gender, race, body weight, PASI baseline severity, plaques location, concurrent psoriatic arthritis, and previous treatment with a biologic.
Maltese: L-effikaċja u s-sigurtà ta' Taltz intwerew irrispettivament mill-età, is-sess tal-persuna, ir-razza, il-piż tal-ġisem, is-severità PASI fil-linja bażi, il-post tal-plakek, artrite psorjatika fl-istess waqt, u trattament qabel b'sustanza bijoloġika.
English: The safety profile observed in patients with psoriatic arthritis treated with Taltz is consistent with the safety profile in plaque psoriasis with the exception of the frequencies of the adverse reactions of influenza and conjunctivitis which were common in patients with psoriatic arthritis.
Maltese: Il-profil ta' sigurtà osservat f'pazjenti b'artrite psorjatika ttrattati b'Taltz huwa konsistenti mal-profil ta' sigurtà f'psorjasi bil-plakka bl-eċċezzjoni tal-frekwenzi tarreazzjonijiet avversi tal-influwenza u l-konġuntivite li kienu komuni fil-pazjenti b'artrite psorjatika.
English: 0.1% of patients receiving Taltz developed a neutrophil count <1000 cells/mm3.
Maltese: Fil-parti l-kbira tal-każijiet, l-għadd ta' newtrofili fid-demm kien ta' ≥1,000 celluli/mm3.
English: Over the entire treatment period infections were reported in 52.8 % of patients treated with Taltz (46.9 per 100 patient years).
Maltese: Matul il-perjodu kollu ta' trattament, infezzjonijiet ġew irrapportati f'52.8% mill-pazjenti ttrattati b'Taltz (46.9 minn kull 100 pazjent kull sena ).
English: • 1 alcohol wipe
Maltese: 1 BIEX TIBDA
English: Taltz was efficacious in systemic treatment-naive, biologic-naive, biologic/anti-TNFexposed and biologic/anti-TNF-failure patients.
Maltese: Taltz kien effikaċi f'pazjenti li qatt ma kienu ħadu trattament sistemiku qabel, li qatt ma kienu ħadu sustanza bijoloġika qabel, li kienu esposti għal sustanza bijoloġika/antiTNF u li kienu fallew trattament b'sustanza bijoloġika/anti-TNF.
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Maltese: Studji f'annimali ma jurux effetti ħżiena diretti jew indiretti fuq il-fertilità (ara sezzjoni 5.3).
English: Elderly (≥ 65 years) No dose adjustment is required (see section 5.2).
Maltese: Anzjani (≥ 65 sena) Ma huwa meħtieġ l-ebda aġġustament fid-doża (ara sezzjoni 5.2).
English: The pharmacokinetic properties of Taltz observed in psoriatic arthritis patients were similar to those displayed in plaque psoriasis patients.
Maltese: It-tagħrif farmakokinetiku ta' Taltz li ġie osservat f'pazjenti b'artrite psorjatika kien simili għal dak muri f'pazjenti bi psorjasi bil-plakka.
English: Randomised patients also had current plaque psoriasis skin lesions (94.0%) or a documented history of plaque psoriasis, with 12.1% of patients with moderate to severe plaque psoriasis at baseline.
Maltese: Pazjenti li ntgħażlu b'mod arbitrarju kellhom ukoll fl-istess ħin leżjonijiet fil-ġilda ta' psorjasi bil-plakka (94.0%) jew passat mediku ddokumentat ta' psorjasi bil-plakka, b'12.1% tal pazjenti li fil-linja bażi kellhom psorjasi bil-plakka li kienet moderata għal severa.
English: List of adverse reactions in clinical studiesa and postmarketing reports System Organ Class
Maltese: Lista ta' reazzjonijiet avversi fl-istudji kliniċi a u minn rapporti wara t-tqegħid fis-suq
English: Q4W(p=0.026), 95.8% for adalimumab (p<0.001), all compared to 77.4% for placebo.
Maltese: 001), kollha mqabbla ma' 77.4% għal plaċebo.
English: Physical function and health-related quality of life In both SPIRIT-P1 and SPIRIT-P2, patients treated with Taltz Q2W (p<0.001) and Q4W (p<0.001) showed significant improvement in physical function compared to patients treated with placebo as assessed by Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24, and maintained at Week 52 in SPIRIT-P1.
Maltese: (p<0.001) wrew titjib sinifikanti fil-funzjoni fiżika meta mqabbla ma' plaċebo skont kif evalwati mill-Kwestjonarju ta' Evalwazzjoni tas-Saħħa -Indiċi ta' Diżabilità (Health Assessment Questionnaire-Disability Index (HAQ-DI)) fl-24 Ġimgħa u li nżamm sat-52 Ġimgħa fi SPIRIT-P1.
English: Efficacy and safety of Taltz was investigated in a multicenter, randomized, open-label, rater-blinded, parallel-group study (SPIRIT-H2H) compared to adalimumab (ADA) in 566 patients with PsA who were naïve to biologic disease-modifying anti-rheumatic drugs (bDMARD).
Maltese: L-effikaċja u s-sigurtà ta' Taltz ġew investigati f'studju ta' grupp paralleli, multiċentriku, magħmul b'mod arbitrarju, open-label u rater-blinded (SPIRIT-H2H) u mqabbel ma' adalimumab (ADA)
English: Consider anti-TB therapy prior to initiation of Taltz in patients with latent TB.
Maltese: Qis terapija kontra t-TB qabel ma tibda Taltz f'pazjenti b'TB inattiva.
English: Packs of 1, 2 , or 3 pre-filled pens.
Maltese: Pakketti ta' 1, 2 , jew 3 pinen mimlijin għal-lest.
English: Concomitant cDMARDs included MTX, leflunomide and sulfasalazine.
Maltese: cDMARDs li ttieħdu fl-istess ħin kienu jinkludu MTX, leflunomide u sulfasalazine. a p<0.05;
English: Itch NRS
Maltese: TAGĦRIF
English: Each syringe contains one dose of Taltz (80 mg).
Maltese: Kull siringa fiha doża waħda ta' Taltz (80 mg).
English: Renal elimination of intact ixekizumab, an IgG MAb, is expected to be low and of minor importance; similarly, IgG MAbs are mainly eliminated via intracellular catabolism and hepatic impairment is not expected to influence clearance of ixekizumab.
Maltese: MAb, mhux mibdul, hija mistennija li tkun ftit u ta' importanza żgħira; b'mod simili, IgG MAbs ilbiċċa l-kbira jitneħħew permezz ta' kataboliżmu intraċellulari u indeboliment tal-fwied mhuwiex mistenni li jaffettwa t-tneħħija ta' ixekizumab.
English: Table 7 Efficacy Results at Week 12 in Adults with Genital Psoriasis in Trial IXORA-Q; NRI a Endpoints
Maltese: Riżultati ta' Effikaċja f'Ġimgħa 12 f'Adulti bi Psorjasi Ġenitali fil-Prova IXORA-Q;
English: Push in the plunger.
Maltese: Mhux applikabbli.
English: Taltz has been shown to lower (within 1 week of treatment) levels of C-reactive protein, which is a marker of inflammation.
Maltese: Ġie muri li Taltz ibaxxi (fi żmien ġimgħa mill-bidu tat-trattament) il-livelli tal-proteina C-reactive, li huwa marker ta' infjammazzjoni.
English: However, ixekizumab is excreted at low levels in the milk of cynomolgus monkeys.
Maltese: Madankollu, ixekizumab jiġi eliminat f'livelli baxxi filħalib tax-xadini cynomolgus.
English: Each pre-filled syringe contains 80 mg ixekizumab in 1 ml.
Maltese: Kull siringa mimlija għal-lest fiha 80 mg ixekizumab f'1 ml.
English: Significantly greater improvements at Week 12 from baseline compared to placebo and etanercept were demonstrated in nail psoriasis (as measured by the Nail Psoriasis Severity Index [NAPSI]), in scalp psoriasis (as measured by Psoriasis Scalp Severity Index [PSSI]) and in palmoplantar psoriasis (as measured by Psoriasis Palmoplantar Severity Index [PPASI]).
Maltese: F'Ġimgħa 12 intwera aktar titjib b'mod sinifikanti mil-linja bażi meta mqabbel mal-plaċebo u etanercept fi psorjasi tad-dwiefer (kif imkejjel skont L-Indiċi ta' Severità ta' Psorjasi tad-Dwiefer [NAPSI - Nail Psoriasis Severity Index]), fi psorjasi tal-qurriegħa (kif imkejjel skont L-Indiċi ta' Severità ta' Psorjasi tal-Qurriegħa [PSSI - Psoriasis Scalp Severity Index]) u fi psorjasi tal-keff tal-id u l-qiegħ tas-sieq (kif imkejjel skont L-Indiċi ta' Severità ta' Psorjasi tal-Keff tal-Id u l-Qiegħ tas-Sieq [PPASI - Psoriasis Palmoplantar Severity Index]).
English: 1 pre-filled syringe of 1 ml solution 2 pre-filled syringes of 1 ml solution 3 pre-filled syringes of 1 ml solution
Maltese: 1 ml ta' soluzzjoni f'siringa tal-ħġieġ ċar tat-tip I. Daqsijiet tal-pakkett ta' 1, 2, jew 3 siringi mimlijin għal-lest.
English: In a study in healthy subjects, no safety concerns were identified of two inactivated vaccines (tetanus and pneumococcal), received after two doses of ixekizumab (160 mg followed by a second dose of 80 mg two weeks later).
Maltese: F'studju f'suġġetti b'saħħithom, ma ġew identifikati ebda problemi ta' sigurtà meta żewġ vaċċini inattivati (tetnu u pnewmokokkali) ngħataw wara żewġ dożi ta' ixekizumab (160 mg segwit minn tieni doża ta' 80 mg ġimgħatejn wara).
English: Efficacy in Genital Psoriasis A randomized, double-blind, placebo-controlled study (IXORA-Q) was conducted in 149 adult subjects (24% females) with moderate to severe genital psoriasis (sPGA of Genitalia score of ≥3), a minimum body surface area (BSA) involvement of 1% (60.4% had a BSA ≥ 10%) and previous failure of or intolerance to at least one topical therapy for genital psoriasis.
Maltese: Madwar 9-17% tal-pazjenti bi psorjasi bil-plakka ttrattati b'Taltz bl-iskeda ta' għoti tad-dożi rrakkomandati żviluppaw antikorpi kontra l-mediċina, li l-maġġoranza tagħhom kienu titri baxxi u ma kinux assoċjati ma' tnaqqis fir-rispons kliniku sa 60 ġimgħa ta' trattament.
English: Syringe body with medicine
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Abbreviations: N = number of patients in the intent-to-treat population Note: patients with missing data were counted as non-responders.
Maltese: Taqsiriet: N = numru ta' pazjenti fil-popolazzjoni bl-intenzjoni li tiġi ttrattata Nota: pazjenti b'dejta nieqsa ngħaddu bħala pazjenti li ma wiġbux għat-trattament.
English: Abbreviations: ACR 20/50/70 = American College of Rheumatology 20%/50%/70% response rate; ADA = adalimumab; BSA = body surface area; CI = confidence interval; Q4W = Taltz 80 mg every 4 weeks; Q2W = Taltz 80 mg every 2 weeks; N = number of patients in the analysis population; n = number of patients in the specified category; NRI = non-responder imputation; PASI 100 = psoriasis area and severity index 100% improvement; PBO = placebo.
Maltese: ACR 20/50/70 = American College of Rheumatology rata ta' rispons 20%/50%/70% ; ADA = adalimumab;
English: Inflammatory Bowel Disease
Maltese: GĦAMLA KWALITATTIVA
English: Patients were randomised (1:2:2:2) to receive either placebo, or Taltz (80 mg every two or four weeks [Q2W or Q4W] following a 160 mg starting dose) or etanercept 50 mg twice weekly for 12 weeks.
Maltese: Il-pazjenti ntgħażlu b'mod arbitrarju (1:2:2:2) biex jew jirċievu plaċebo, jew Taltz (80 mg kull ġimagħtejn jew erba' ġimgħat [Q2W jew Q4W] wara doża tal bidu ta' 160 mg) jew etanercept 50 mg darbtejn kuljum għal 12-il ġimgħa.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: medja (SD)
English: Clear base
Maltese: Skopijiet Finali
English: No dose adjustment is required (see section 5.2).
Maltese: Ma huwa meħtieġ l-ebda aġġustament fid-doża (ara sezzjoni 5.2).
English: Patients were randomised to subcutaneous injections of placebo, Taltz 80 mg once every 2 weeks (Q2W), or 80 mg once every 4 weeks (Q4W).
Maltese: adalimumab 40 mg darba kull ġimagħtejn (fergħa ta' referenza għall-kontroll attiv), Taltz 80 mg darba kull ġimagħtejn (Q2W), jew 80 mg darba kull 4 ġimgħat (Q4W).