FrancophonIA/ELRC3.0 huggingface dataset:
English: The long-term efficacy of dupilumab in adolescent patients with moderate-to-severe AD who had participated in previous clinical trials of dupilumab was assessed in open-label extension study (AD1434).
Maltese: L-effikaċja fit-tul ta' dupilumab f'pazjenti adolexxenti b'AD moderata għal severa li kienu pparteċipaw preċedentement f'provi kliniċi ta' dupilumab ġiet evalwata f'studju ta' estensjoni openlabel (AD-1434).
English: • Thigh
Maltese: U L-UŻU
English: Percent of patients whose IGA response at week 36 was maintained within 1 point of baseline in the subset of patients with IGA (0,1) at baseline, n (%) Percent of patients with IGA (0,1) at week 36 in the subset of patients with IGA (0,1) at baseline, n (%) Percent of patients whose peak pruritus
Maltese: Perċentwal ta' pazjenti li r-rispons talIGA tagħhom f'ġimgħa 36 inżamm filfirxa ta' punt wieħed tal-linja bażi fis sottosett ta' pazjenti b'IGA (0,1) fil-linja bażi, n (%) Perċentwali ta' pazjenti b'IGA (0,1)
English: Atopic Dermatitis
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Hepatic impairment No data are available in patients with hepatic impairment (see section 5.2).
Maltese: M'hemmx data disponibbli f'pazjenti b'indeboliment tal-fwied (ara sezzjoni 5.2).
English: Pre-filled syringe with needle shield 300 mg
Maltese: Siringa mimlija għal-lest 300 mg
English: The baseline mean EASI score was 33.0, the baseline weekly averaged pruritus NRS was 7.4, the baseline mean SCORAD score was 67.8, the baseline mean POEM score was 20.5, the baseline mean DLQI was 15.0, and the baseline mean HADS total score was 13.3.
Maltese: Il-punteġġ medju ta' EASI fillinja bażi kien 33.0, il-medja tal-NRS tal-ħakk ta' kull ġimgħa fil-linja bażi kienet 7.4, il-punteġġ medju SCORAD fil-linja bażi kien 67.8, il-punteġġ medju ta' POEM fil-linja bażi kien 20.5, DLQI medju fil-linja bażi kien 15.
English: Cases of eosinophilic pneumonia and cases of vasculitis consistent with eosinophilic granulomatosis with polyangiitis have been reported with dupilumab in adult patients who participated in the asthma development program.
Maltese: Il-profil tal-avvenimenti avversi fl-adolexxenti kien ġeneralment jixbah dak fl-adulti.
English: Step 10: Push
Maltese: Pass 2: Ipprepara
English: Select the injection site.
Maltese: kontrollatur addizzjonali.
English: Antibody responses to both tetanus vaccine and meningococcal polysaccharide vaccine were similar in dupilumab-treated and placebo-treated patients.
Maltese: polisakkarid meningokokkali kienu simili f'pazjenti ttrattati b'dupilumab u f'pazjenti ttrattati bilplaċebo.
English: ≥ 150 cells/mcL
Maltese: ≥150 ċellula/mcL
English: Dupilumab 200 mg solution for injection in pre-filled syringe Each single-use pre-filled syringe contains 200 mg of dupilumab in 1.14 ml solution (175 mg/ml).
Maltese: Kull siringa mimlija għal-lest għall-użu ta' darba fiha 200 mg ta' dupilumab f'soluzzjoni ta' 1.14 ml (175 mg/ml).
English: Listed in Table 3 are adverse reactions observed in asthma clinical trials presented by system organ class and frequency, using the following categories: very common (≥ 1/10); common (≥ 1/100 to
Maltese: Elenkati f'Tabella 3 hemm reazzjonijiet avversi osservati fil-provi kliniċi tal-ażżma ppreżentati skont il-klassi tas-sistemi u tal-organi u l-frekwenza, bl-użu tal-kategoriji li ġejjin: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000).
English: In a post-hoc analysis in a subset of patients with HADS-anxiety or HADS-depression subscale scores ≥8 at baseline (the cut-off value for anxiety or depression), a larger proportion of patients in the dupilumab 300 mg Q2W + TCS and 300 mg QW + TCS groups achieved HADS-anxiety and HADS-depression scores < 8 at week 52 compared to placebo + TCS (See Table 9).
Maltese: kisbu punteġġi ta' ansjetà ta' HADS u ta' depressjoni ta' HADS ta' < 8 f'ġimgħa 52 meta mqabbel mal-plaċebo + TCS (Ara Tabella 9).
English: VENTURE evaluated the effect of dupilumab on reducing the use of maintenance oral corticosteroids.
Maltese: Dawn l-effetti nżammu matul it-trattament kollu.
English: POEM, (≥6-point improvement), % responders a Full Analysis Set (FAS) includes all patients randomised.
Maltese: POEM, (≥6- punti ta' titjib), % li rrispondew a Sett sħiħ ta' Analiżi-(FAS-Full Analysis Set) jinkludi l-pazjenti kollha li ntgħażlu b'mod arbitrarju.
English: LS = least squares; SE = standard error a All patients were on background topical corticosteroids therapy and patients were permitted to use topical calcineurin inhibitors.
Maltese: SE = standard error a Il-pazjenti kollha kienu qed jirċievu wkoll terapija ta' kortikosterojdi topiċi u l-pazjenti kienu permessi jużaw inibituri topiċi ta' calcineurin.
English: From baseline L
Maltese: It-titjib fl
English: In addition, dupilumab 300 mg Q2W + TCS and 300 mg QW + TCS reduced anxiety and depression as measured by the HADS total score at 52 weeks compared to placebo + TCS.
Maltese: Barra dan, dupilumab 300 mg Q2W + TCS u 300 mg QW + TCS naqqsu lansjetà u d-depressjoni kif imkejla mill-punteġġ totali ta' HADS f'ġimgħa 52 meta mqabbel ma'
English: b Full analysis set (FAS) includes all patients randomized.
Maltese: b Sett ta' Analiżi Kompluta (FAS - full analysis set) jinkludi l-pazjenti kollha randomised.
English: Table 15: Mean Change from Baseline in Pre-Bronchodilator FEV1 at Week 12 and Week 52 in QUEST by Baseline FeNO Subgroups
Maltese: Bidla Medja mil-Linja Bażi fl-FEV1 ta' qabel il-bronkodilatatur f'Ġimgħa 12 u Ġimgħa 52 fi QUEST skont is-Sottogruppi ta' FeNO fil-Linja bażi
English: Number of patients with HADS-anxiety ≥ 8 or HADSdepression ≥ 8 at baseline Patients achieving HADS-anxiety and HADSdepression < 8,
Maltese: ansjetà ta' HADS u ta' depressjoni ta' HADS ta' < 8,
English: • eyelid itching, redness and swelling
Maltese: • It-tieqa se tibda ssir safra.
English: The pharmacokinetics of dupilumab is similar in patients with atopic dermatitis and asthma.
Maltese: Il-farmakokinetika ta' dupilumab tixxiebah f'pazjenit b'dermatite atopika u bl-ażżma.
English: Significant improvements in FEV1 were observed as early as week 2 following the first dose of dupilumab for both the 200 mg and 300 mg dose strengths and were maintained through week 24 (DRI12544) and week 52 in QUEST (see Figure 6).
Maltese: Titjib sinifikanti fl-FEV1 ġie osservat sa minn ġimgħa 2 wara l-ewwel doża ta' dupilumab kemm għall-qawwiet tad-doża ta' 200 mg u 300 mg u nżammu sa ġimgħa 24 (DRI12544) u ġimgħa 52 fi
English: • For all other patients, an initial dose of 400 mg (two 200 mg injections), followed by 200 mg every other week administered as subcutaneous injection.
Maltese: • Għall-pazjenti l-oħra kollha, doża fil-bidu ta' 400 mg (żewġ injezzjonijiet ta' 200 mg), segwita minn 200 mg ġimgħa iva u ġimgħa le li tingħata bħala injezzjoni subkutaneja.
English: Step 6: Clean
Maltese: Tabella 6:
English: B. Choose your injection site B1.
Maltese: B2.Aħsel idejk.
English: Number of patients with DLQI ≥4 at baseline DLQI (≥ 4-point improvement), % responders
Maltese: DLQI (titjib ta' ≥ 4 punti), % ta' persuni li rrispondew
English: EU/1/17/1229/009 EU/1/17/1229/010 EU/1/17/1229/011 EU/1/17/1229/012 EU/1/17/1229/013 EU/1/17/1229/014 EU/1/17/1229/015 EU/1/17/1229/016
Maltese: EU/1/17/1229/012 EU/1/17/1229/013 EU/1/17/1229/014
English: Dupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised FeNO (see section 5.1), who are inadequately controlled with high dose ICS plus another medicinal product for maintenance treatment.
Maltese: Dupixent huwa indikat fl-adulti u fl-adolexxenti li għandhom 12-il sena u aktar bħala trattament ta' manteniment miżjud għal ażżma severa b'infjammazzjoni tat-tip 2 karatterizzata minn żieda fl eosinofili fid-demm u/jew żieda fl-FeNO (ara sezzjoni 5.1), li mhumiex ikkontrollati b'mod adegwat b'doża għolja ta' ICS flimkien ma' prodott mediċinali ieħor għat-trattament ta'manteniment.
English: There were greater reductions in exacerbations in subjects with higher baseline levels of type 2 inflammatory biomarkers such as blood eosinophils or FeNO (Table 6 and Table 7).
Maltese: Kien hemm tnaqqis akbar fit-taħrix f'individwi b'livelli ogħla ta' bijomarkaturi infjammatorji tat-tip 2 fil-linja bażi bħal eosinofili fid-demm jew FeNO (Tabella 6 u Tabella 7).
English: There were greater reductions in exacerbations in subjects with higher baseline levels of type 2 inflammatory biomarkers such as blood eosinophils or FeNO (Table 12 and Table 13).
Maltese: Kien hemm tnaqqis akbar fit-taħrix f'individwi b'livelli ogħla ta' bijomarkaturi infjammatorji tat-tip 2 fil-linja bażi bħal eosinofili fid-demm jew FeNO (Tabella 12 u Tabella 13).
English: • Multipack containing 3 (3 packs of 1) pre-filled syringes
Maltese: • Pakkett multiplu li fih 3 (3 pakketti ta' 1) siringi mimlija għal-lest
English: • skin rash
Maltese: • raxx tal-ġilda
English: Less than 0.4 % of patients exhibited high titer ADA responses associated with reduced exposure and efficacy.
Maltese: Inqas minn 0.4 % tal-pazjenti urew risponsi ta' ADA ta' titer għoli assoċjati ma' esponiment u effikaċja imnaqqsa.
English: Pre-filled syringe with needle shield 200 mg - Multipack (contains Blue Box)
Maltese: Siringa mimlija għal-lest bi protezzjoni tal-labra 200 mg - Pakkett Multiplu (mingħajr Kaxxa Blu)
English: In the concomitant TCS study, the proportion of patients who discontinued treatment due to adverse events was 7.6 % of the placebo + TCS group, 1.8 % of the dupilumab 300 mg Q2W + TCS group, and 2.9 % of the dupilumab 300 mg QW + TCS group.
Maltese: tal-grupp ta' dupilumab 300 mg Q2W + TCS, u 2.9 % tal-grupp ta' dupilumab 300 mg QW + TCS.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 200 mg dose, i.e. essentially “sodium-free”.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol sodium (23 mg) f'kull doża ta' 200 mg, jiġifieri essenzjalment “ħieles mis-sodium”.
English: Figure 4: Mean percent change from baseline in NRS in CHRONOSa (FAS Week 52)b
Maltese: Figura 4: Bidla perċentwali medja mil-linja bażi fl-NRS fi CHRONOSa (FAS ta' Ġimgħa 52)b
English: The mean ±SD steady-state trough concentrations of dupilumab were 107±51.6 mcg/mL and 46.7±26.9 mcg/mL, respectively, for 300 mg or 200 mg administered every other week.
Maltese: 46.7±26.9 mcg/mL, rispettivament, għal 300 mg jew 200 mg mogħtija darba kull ġimagħtejn.
English: Multipack: 3 (3 packs of 1) pre-filled syringes Multipack: 6 (3 packs of 2) pre-filled syringes
Maltese: Pakkett Multiplu: 3 (3 pakketti ta' 1) siringi mimlija għal-lest bi protezzjoni tal-labra
English: LS = least squares a In the primary analyses of the efficacy endpoints, patients who received rescue treatment or with missing data were considered non-responders b Full analysis set (FAS) includes all patients randomized.
Maltese: LS = least squares a Fl-analiżi primarja tal-punti finali tal-effikaċja, il-pazjenti li rċevew trattament ta' salvataġġ jew b'data nieqsa kienu kkunsidrati bħala li ma rrispondewx.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 300 mg dose, i.e. essentially “sodium-free”.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol sodium (23 mg) f'kull doża ta' 300 mg, jiġifieri essenzjalment “ħieles mis-sodium”.
English: A volume of distribution for dupilumab of approximately 4.6 L was estimated by population PK analysis, indicating that dupilumab is distributed primarily in the vascular system.
Maltese: Volum ta' distribuzzjoni għal dupilumab ta' madwar 4.6 L ġie stmat permezz ta' analiżi tal-PK tal popolazzjoni, li jindika li dupilumab huwa primarjament distribwit fis-sistema vaskulari.
English: Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00
Maltese: France sanofi-aventis france Tél: 0 800 222 555
English: EU/1/17/1229/013 1 pre-filled pen EU/1/17/1229/014 2 pre-filled pens EU/1/17/1229/015 3 pre-filled pens EU/1/17/1229/016 6 pre-filled pens
Maltese: 2 pinen mimlijin għal-lest EU/1/17/1229/015 3 pinen mimlijin għal-lest EU/1/17/1229/016 6 pinen mimlijin għal-lest
English: The baseline mean oral corticosteroid use was 11.75 mg in the placebo group and 10.75 mg in the group receiving dupilumab.
Maltese: Il-medja tal-użu talkortikosterojd mill-ħalq fil-linja bażi kien 11.75 mg fil-grupp tal-plaċebo u 10.
English: i p-value = 0.0005
Maltese: 0001 dvalur p =0.
English: In both monotherapy studies (SOLO 1 and SOLO 2), both dupilumab 300 mg Q2W and 300 mg QW groups significantly improved patient-reported symptoms and the impact of AD on sleep and healthrelated quality of life as measured by POEM and DLQI total scores, respectively, at 16 weeks compared to placebo.
Maltese: Fiż-żewġ studji ta' monoterapija (SOLO 1 u SOLO 2), kemm il-grupp ta' dupilumab 300 mg Q2W kif ukoll dak ta' 300 mg QW tejbu b'mod sinifikanti is-sintomi rrappurtati mill-pazjenti u l-impatt ta' AD fuq l-irqad u l-kwalità tal-ħajja relatata mas-saħħa kif imkejla mill-punteġġi totali ta' POEM u DLQI,
English: Dupixent is available as 200 mg pre-filled syringes in a pack containing 1 or 2 pre-filled syringes or in a pack containing 3 (3 packs of 1) or 6 (3 packs of 2) pre-filled syringes.
Maltese: Dupixent huwa disponibbli bħala siringi mimlijin għal-lest ta' 200 mg f'pakkett li fih siringa waħda jew 2 siringi mimlijin għal-lest jew f'pakkett li fih 3 (3 pakketti ta' 1) jew 6 (3 pakketti ta' 2) siringi mimlijin għal-lest.
English: Table 8: Mean Change from Baseline in Pre-Bronchodilator FEV1 at Week 12 in DRI12544 and
Maltese: Tabella 8: Bidla Medja mil-Linja Bażi fl-FEV1 ta' qabel il-bronkodilatatur f'Ġimgħa 12 f'DRI12544 u QUEST (Livelli tal-Eosinofili fid-Demm fil-Linja Bażi ≥ 150 u ≥ 300 ċellula/mcL)
English: Each pre-filled syringe contains 200 mg of dupilumab in 1.14 ml solution (175 mg/ml).
Maltese: Kull pinna mimlija għal-lest fiha 200 mg ta' dupilumab f'1.14 ml ta' soluzzjoni (175 mg/ml).
English: Pre-filled syringe with needle shield 300 mg - Multipack (contains Blue Box)
Maltese: Siringa mimlija għal-lest bi protezzjoni tal-labra 300 mg - Pakkett Multiplu (mingħajr Kaxxa Blu)
English: The safety of dupilumab was evaluated in four randomized, double-blind, placebo-controlled studies and one dose-ranging study in patients with moderate-to-severe atopic dermatitis.
Maltese: Is-sigurtà ta' dupilumab kienet evalwata f'erba' studji randomised, double-blind, ikkontrollati bilplaċebo u fi studju wieħed b'firxa ta' dożi f'pazjenti b'dermatite atopika moderata sa severa.
English: Injection site erythema Injection site oedema Injection site pain Injection site pruritus
Maltese: Dawn is-sinjali huma elenkati taħt “Effetti sekondarji serji”
English: Anaphylactic reaction has been reported very rarely in the asthma development program following the administration of dupilumab (section 4.8).
Maltese: Reazzjoni anafilattika ġiet tirrappurtata b'mod rari ħafna fl-iżvilupp ta' programm għall-ażżma wara l-għoti ta' dupilumab (sezzjoni 4.8).
English: Pre-filled syringe with needle shield 200 mg
Maltese: TIKKETTA Siringa mimlija għal-lest bi protezzjoni tal-labra 200 mg
English: • itching
Maltese: Ltd.
English: Patients who received rescue treatment were considered non-responders.
Maltese: Il-pazjenti li rċevew trattament ta' salvataġġ kienu kkunsidrati bħala li ma rrispondewx.
English: A larger proportion of patients administered dupilumab 300 mg Q2W + TCS and 300 mg QW + TCS had clinically meaningful reductions in POEM and DLQI total score (each defined as ≥ 4-point improvement) from baseline to week 52 compared to the placebo + TCS.
Maltese: Proporzjon akbar ta' pazjenti li ngħataw dupilumab 300 mg Q2W + TCS u 300 mg QW + TCS kellhom tnaqqis klinikament sinifikanti fil-punteġġ totali ta' POEM u
English: Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of conditions for which dupilumab is indicated (see section 4.1).
Maltese: It-trattament għandu jinbeda minn professjonisti tal-kura tas-saħħa b'esperjenza fid-dijanjosi u t trattament ta' kondizzjonijiet li huwa indikat għalihom dupilumab (ara sezzjoni 4.1).
English: Patients receiving concomitant oral corticosteroids may reduce their steroid dose once clinical improvement with dupilumab has occurred (see section 5.1).
Maltese: Indeboliment tal-fwied M'hemmx data disponibbli f'pazjenti b'indeboliment tal-fwied (ara sezzjoni 5.2).
English: Conjunctivitis allergic Eye pruritus Blepharitis
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: For both the 200 mg and 300 mg every other week doses, significant improvements in FEV1 (LS mean change from baseline at eek 12) were observed (0.36 L and 0.27 L, respectively).
Maltese: Kemm għad-doża ta' 200 mg kif ukoll għad-doża ta' 300 mg darba kull ġimagħtejn, ġie osservat titjib sinifikanti fl-FEV1 (bidla medja ta' LS mil-linja bażi f'ġimgħa 12) (0.36 L u 0.27 L, rispettivament).
English: In the monotherapy studies, the proportion of patients who discontinued treatment due to adverse events was 1.9 % of the placebo group, 1.9 % of the dupilumab 300 mg Q2W group, 1.5 % of the dupilumab 300 mg QW group.
Maltese: Fl-istudji b'monoterapija, il-proporzjon ta' pazjenti li ma komplewx it-trattament minħabba avvenimenti avversi kien 1.9 % tal-grupp tal-plaċebo, 1.9 % tal-grupp ta' dupilumab 300 mg Q2W, 1.5 % tal-grupp ta' dupilumab 300 mg QW. Fl-istudju b'TCS fl-istess waqt, il-proporzjon ta' pazjenti li waqqfu t-trattament minħabba avvenimenti avversi kien 7.6 % tal-grupp tal-plaċebo + TCS, 1.8 %
English: NRS increased by ≥ 3 points from baseline to week 35 in the subset of patients with peak pruritus NRS ≤ 7 at baseline, n (%) †P< 0.05, *P< 0.01, **P< 0.001, ***P≤ 0.0001
Maltese: †P< 0.05, *P< 0.01, **P< 0.001, ***P≤ 0.0001
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali ma jurux effetti ħżiena diretti jew indiretti rigward l-effett tossiku fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: Place
Maltese: MAIN
English: Figure 3 and Figure 4 show the mean percent change from baseline in EASI and the mean percent change from baseline in NRS, respectively, up to week 52 in CHRONOS.
Maltese: Figura 3 u Figura 4 juru l-bidla perċentwali medja mil-linja bażi f'EASI u l-bidla perċentwali medja mil-linja bażi f'NRS, rispettivament, sa ġimgħa 52 fi CHRONOS.
English: Recommended dose in adults with atopic dermatitis In atopic dermatitis, the recommended first dose is 600 mg (two 300 mg injections), followed by 300 mg given every two weeks by subcutaneous injection.
Maltese: F'dermatite atopika, l-ewwel doża rrakkomandata hija ta' 600 mg (żewġ injezzjonijiet ta' 300 mg),
English: Hold firmly
Maltese: Konġuntivite
English: CAFE study evaluated the efficacy of dupilumab compared to placebo during a 16-week treatment period, administered with concomitant TCS, in adult patients with AD who are not adequately controlled with, or are intolerant to, oral ciclosporin, or when this treatment is currently contraindicated or not medically advisable.
Maltese: 16-il ġimgħa, mogħti flimkien ma' TCS konkomitanti, f'pazjenti adulti b'AD li ma kinux ikkontrollati b'mod adegwat bi, jew li kienu intolleranti għal ciclosporin orali, jew meta dan it-trattament kien kontraindikat f'dak il-waqt jew ma kienx rakkomandat b'mod mediku.
English: • Stomach except for the 5 cm around your belly button (navel).
Maltese: • L-istonku, ħlief fil-parti ta' 5 cm madwar iż-żokra tiegħek.
English: The primary endpoints were the annualized rate of severe exacerbation events during the 52-week placebo controlled period and change from baseline in pre-bronchodilator FEV1 at week 12 in the overall population (unrestricted by minimum baseline eosinophils or other type 2 inflammatory biomarkers) and subgroups based on baseline blood eosinophils count and FeNO.
Maltese: L-iskopijiet finali primarji kienu r-rata annwalizzata ta' avvenimenti ta' taħrix sever matul il-perjodu ta' 52 ġimgħa ikkontrollat bil-plaċebo u bidla mil-linja bażi fl-FEV1 ta' qabel il bronkodilatatur f'ġimgħa 12 fil-popolazzjoni totali (mhux ristretta mill-eosinofili jew bijomarkaturi infjammatorji oħra tat-tip 2 minimi fil-linja bażi) u sottogruppi abbażi tal-eosinofili fid-demm u l
English: Dupilumab compared with placebo was evaluated in adult patients with moderate to severe asthma on a medium-to-high dose inhaled corticosteroid and a long acting beta agonist.
Maltese: Dupilumab mqabbel ma plaċebo ġie evalwat f'pazjenti adulti b'ażżma minn moderata sa severa fuq kortikosterojdi li jinġibdu man-nifs b'doża medja sa għolja u agonist beta li jaħdem fit-tul.
English: Table 5: Demographics and Baseline Characteristics of Asthma Trials
Maltese: Id-Demografiċi u l-Karatteristiċi fil-Linja Bażi tal-Provi tal-Ażżma
English: There were greater improvements in FEV1 in the subjects with higher baseline levels of type 2 inflammatory biomarkers such as blood eosinophils or FeNO (Table 14 and Table 15).
Maltese: Kien hemm titjib akbar fl-FEV1 f'individwi b'livelli ogħla ta' bijomarkaturi ta' infjammazzjoni tat-tip 2 fil-linja bażi bħal eosinofili fid-demm jew FeNO (Tabella 14 u Tabella 15).
English: Dupilumab is expected to degrade to small peptides and individual amino acids.
Maltese: Dupilumab huwa mistenni li jiddegrada għal peptidi żgħar u aċidi amminiċi individwali.
English: Ballycummin
Maltese: Il-ĠERMANJA
English: Atopic dermatitis patients with comorbid asthma
Maltese: Pazjenti b'dermatite atopika flimkien mal-ażżma
English: Clinical Response in Patients Not Adequately Controlled with, Intolerant to, or for whom Ciclosporin Treatment was Inadvisable (CAFE study)
Maltese: Rispons Kliniku f'Pazjenti Mhux Ikkontrollati b'Mod Adegwat bi, Intolleranti għal, jew li għalihom Trattament b'Ciclosporin ma kienx Rakkomandat (studju CAFE)
English: The co-primary endpoints were the difference between baseline (week 0) and week 36 in percent change in EASI from SOLO 1 and SOLO 2 studies baseline and percentage of patients with EASI-75 at week 36 in patients with EASI-75 at baseline.
Maltese: Il-punti finali ko-primarji kienu d-differenza bejn il-linja bażi (ġimgħa 0) u ġimgħa 36 fil-bidla perċentwali f'EASI mil-linja bażi tal-istudji SOLO 1 u SOLO 2 u l-perċentwal ta' pazjenti b'EASI-75
English: Helminth infection
Maltese: Infezzjoni mill-elminti
English: • For patients with severe asthma and who are on oral corticosteroids or for patients with severe asthma and co-morbid moderate-to-severe atopic dermatitis, an initial dose of 600 mg (two 300 mg injections), followed by 300 mg every other week administered as subcutaneous injection.
Maltese: • Għall-pazjenti b'ażżma severa li qegħdin fuq kortikosterojdi mill-ħalq jew għall-pazjenti b'ażżma severa u flimkien magħha dermatite atopika minn moderata sa severa, doża inizjali ta' 600 mg (żewġ injezzjonijiet ta' 300 mg), segwiti minn 300 mg darba kull ġimagħtejn mogħtija bħala injezzjoni taħt il-ġilda.
English: c Responder was defined as a patient with IGA 0 or 1 (“clear” or “almost clear”) with a reduction of
Maltese: b Li rrispondew kienu definiti bħala suġġetti b'IGA 0 jew 1 (“imfejqa” jew “kważi imfejqa”) b'tnaqqis ta' ≥2
English: • Multipack containing 6 (3 packs of 2) pre-filled syringes
Maltese: • Pakkett multiplu li fih 6 (3 pakketti ta' 2) siringi mimlija għal-lest
English: Efficacy data from this study suggests that clinical benefit provided at week 16 was sustained through week 52.
Maltese: Dejta ta' effikaċja minn dan l-istudju jissuġġerixxi li l-benefiċċju kliniku pprovdut f'ġimgħa 16 kien sostnut sa ġimgħa 52.
English: Do not stop using Dupixent without speaking to your doctor first.
Maltese: Mhux magħruf jekk din hijiex ikkawżata minn Dupixent.
English: Dupixent is available as 300 mg pre-filled syringes in a pack containing 1 or 2 pre-filled syringes or in a pack containing 3 (3 packs of 1) or 6 (3 packs of 2) pre-filled syringes.
Maltese: Dupixent huwa disponibbli bħala siringi mimlijin għal-lest ta' 300 mg f'pakkett li fih siringa waħda jew 2 siringi mimlijin għal-lest jew f'pakkett li fih 3 (3 pakketti ta' 1) jew 6 (3 pakketti ta' 2) siringi mimlijin għal-lest.