FrancophonIA/ELRC3.0 huggingface dataset:
English: LS = least squares; SE = standard error a p-value < 0.0001 b p-value < 0.001 c p-value < 0.05
Croatian: LS (least squares) srednja vrijednost = srednja vrijednost dobivena metodom najmanjih kvadrata; SE = standardna pogreška a p-vrijednost < 0,0001 b p-vrijednost < 0,001 c p-vrijednost < 0,05
English: Do not place the syringe in direct sunlight.
Croatian: Nemojte izlagati štrcaljku izravnoj sunčevoj svjetlosti.
English: Figure 1 and Figure 2 show the mean percent change from baseline in EASI and the mean percent change from baseline in NRS, respectively up to week 16.
Croatian: Slika 1 i Slika 2 prikazuju srednju vrijednost postotne promjene EASI rezultata odnosno NRS rezultata od početka ispitivanja do 16. tjedna.
English: • Do not keep Dupixent at room temperature (< 25°C) for more than 14 days.
Croatian: • Nemojte čuvati Dupixent na sobnoj temperaturi (< 25°C) dulje od 14 dana.
English: • Keep the syringe(s) out of the reach of children.
Croatian: • Štrcaljku/štrcaljke čuvajte izvan dohvata djece.
English: In all three studies, patients received 1) an initial dose of 600 mg dupilumab (two 300 mg injections) on day 1, followed by 300 mg once every two weeks (Q2W); 2) an initial dose of 600 mg dupilumab on day 1, followed by 300 mg once weekly (QW); or 3) matching placebo.
Croatian: U sva su tri ispitivanja bolesnici primili 1) početnu dozu dupilumaba od 600 mg (dvije injekcije od 300 mg) na dan 1, nakon čega je uslijedila primjena doze od 300 mg jedanput svaka dva tjedna; 2)
English: • Do not keep Dupixent at room temperature (< 25ºC) for more than 14 days.
Croatian: • Nemojte čuvati Dupixent na sobnoj temperaturi (< 25ºC) dulje od 14 dana.
English: • 6 pre-filled pens
Croatian: • 6 napunjenih brizgalica
English: For the initial 400 mg dose, two 200 mg injections should be administered consecutively in different injection sites.
Croatian: Za početnu dozu od 400 mg potrebno je primijeniti dvije injekcije lijeka Dupixent od 200 mg zaredom na različitim mjestima.
English: ADA responses lasting more than 12 weeks: QW: 0.0%; Q2W: 1.4%; Q4W: 0.0%; Q8W:
Croatian: Odgovori stvaranjem protutijela na lijek koji su trajali dulje od 12 tjedana: kod primjene svaki tjedan: 0,0%; svaka 2 tjedna: 1,4%; svaka 4 tjedna: 0,0%; svakih 8 tjedana: 2,6%.
English: HADS, LS mean change from baseline (SE)
Croatian: HADS, LS srednja vrijednost promjene od početne vrijednosti (SE)
English: For the initial 600 mg dose, two 300 mg injections should be administered consecutively in different injection sites.
Croatian: Za početnu dozu od 600 mg potrebno je primijeniti dvije injekcije lijeka Dupixent od 300 mg zaredom na različitim mjestima.
English: Recommended dose in adult and adolescent patients with asthma For asthma, the recommended dose of Dupixent for adult and adolescents patients (12 years of age and older) is:
Croatian: Kod astme je preporučena doza lijeka Dupixent za odrasle i adolescente (u dobi od 12 ili više godina)
English: Patients were enrolled without requiring a minimum baseline blood eosinophil or other type 2 inflammatory biomarker (e.g. FeNO or IgE) level.
Croatian: Za uključivanje u ispitivanje bolesnici nisu morali imati određenu minimalnu početnu razinu eozinofila u krvi ili nekog drugog biološkog biljega upale tipa 2 (npr. FeNO ili IgE).
English: ≥ 150 cells/mcL ≥ 300 cells/mcL
Croatian: ≥ 150 stanica/μl ≥ 300 stanica/μl
English: Step 1: Remove
Croatian: 7. korak: Skinite zatvarač
English: Number of patients with DLQI ≥4 at baseline DLQI (≥ 4-point improvement), % responders
Croatian: rezultatom ≥ 4 DLQI (poboljšanje za ≥ 4 boda), % bolesnika s odgovorom
English: Step 7: Pull
Croatian: 1. korak: Izvadite štrcaljku
English: Other evaluated outcomes included the proportion of patients with improvement of at least 50 % and 90 % in EASI (EASI-50 and EASI-90, respectively), reduction in itch as measured by the peak pruritus Numerical Rating Scale (NRS), and percent change in the SCORing Atopic Dermatitis (SCORAD) scale from baseline to week 16.
Croatian: Ostali ocjenjivani ishodi uključivali su udio bolesnika s poboljšanjem EASI rezultata za najmanje 50% te 90% (EASI-50 odnosno EASI-90), ublažavanje svrbeža mjereno vršnim rezultatom za pruritus na brojčanoj ocjenskoj ljestvici (engl.
English: - Each pre-filled syringe contains 300 mg of dupilumab in 2 ml solution for injection (injection).
Croatian: Jedna napunjena štrcaljka sadrži 300 mg dupilumaba u 2 ml otopine za injekciju (injekcija).
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Dupixent Lijek čuvajte izvan pogleda i dohvata djece.
English: Read the “Instructions for Use” for the pre-filled syringe carefully before using Dupixent.
Croatian: Pažljivo pročitajte ‘Upute za uporabu' napunjene štrcaljke prije nego što primijenite Dupixent.
English: POEM, LS mean change from baseline (SE)
Croatian: POEM, LS srednja vrijednost promjene od početne vrijednosti (SE)
English: Patients who received rescue treatment were considered non-responders.
Croatian: Bolesnici koji su primili terapiju za hitno ublažavanje simptoma smatrali su se bolesnicima bez odgovora.
English: EU/1/17/1229/003 3 pre-filled syringes (3 packs of 1) EU/1/17/1229/004 6 pre-filled syringes (3 packs of 2)
Croatian: EU/1/17/1229/003 3 napunjene štrcaljke (3 pakiranja od 1) EU/1/17/1229/004 6 napunjenih štrcaljki (3 pakiranja od 2)
English: Do not heat the syringe.
Croatian: Nemojte zagrijavati štrcaljku.
English: Pre-filled syringe 300 mg - Multipack (without Blue Box)
Croatian: Napunjena štrcaljka od 300 mg - višestruko pakiranje (bez plavog okvira)
English: Duration of Asthma (years), mean ± SD Never smoked, (%)
Croatian: Trajanje astme (godine), srednja vrijednost ± SD
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
Croatian: EU/1/17/1229/013 1 napunjena brizgalica EU/1/17/1229/014 2 napunjene brizgalice EU/1/17/1229/015 3 napunjene brizgalice EU/1/17/1229/016 6 napunjenih brizgalica
English: A total of 107 adolescents aged 12 to 17 years with asthma were enrolled in the 52 week QUEST study.
Croatian: U 52-tjedno ispitivanje QUEST ukupno je bilo uključeno 107 adolescenata s astmom u dobi od 12 do 17 godina.
English: LS mean change (SE) between baseline and week 36 in percent change in EASI Score from Parent Study baseline Percent of patients with EASI-75 at week 36 for patients with EASI-75 at baseline, n (%)
Croatian: između početka ispitivanja i 36. tjedna u postotnoj promjeni EASI rezultata u odnosu na početnu vrijednost u osnovnom ispitivanju Postotak bolesnika s rezultatom EASI-75 u 36. tjednu među bolesnicima koji su imali rezultat
English: Placebo Dupilumab 300 mg Q2W + TCS
Croatian: Placebo Dupilumab 300 mg svaka 2 tjedna + TKS
English: Dupilumab, as a monoclonal antibody, is not expected to undergo significant renal elimination.
Croatian: Budući da je dupilumab monoklonsko protutijelo, ne očekuje se da će se značajno eliminirati putem bubrega.
English: Each pre-filled syringe contains one dose of Dupixent (200 mg).
Croatian: Jedna napunjena brizgalica sadrži jednu dozu lijeka Dupixent (200 mg).
English: Patients randomised
Croatian: Randomizirani bolesnici
English: Dupixent 200 mg solution for injection in pre-filled syringe Dupixent 200 mg solution for injection in pre-filled pen
Croatian: Dupixent 200 mg otopina za injekciju u napunjenoj štrcaljki Dupixent 200 mg otopina za injekciju u napunjenoj brizgalici
English: • eye dryness, redness and itching
Croatian: • suhoća, crvenilo i svrbež oka • suhoća, crvenilo i oticanje očne vjeđe
English: LS = least squares; SE = standard error a p-value < 0.0001 b p-value < 0.001
Croatian: LS (least squares) srednja vrijednost = srednja vrijednost dobivena metodom najmanjih kvadrata; SE = standardna pogreška a p-vrijednost < 0,0001 b p-vrijednost < 0,001
English: DRI12544 study Dupilumab 200 mg
Croatian: Ispitivanje DRI12544 Dupilumab
English: QUEST: Blood Eosinophils ≥ 150 cells/mcL
Croatian: QUEST: Broj eozinofila u krvi ≥ 150 stanica/μl
English: • Do not use the pre-filled pen if it has been damaged.
Croatian: • Nemojte upotrijebiti napunjenu brizgalicu ako je oštećena.
English: Rate Ratio (95%CI)
Croatian: Stopa (95% CI)
English: In this subset, the percent change of pruritus NRS from baseline was -51.4 % vs -30.2 % at week 16 and -54.8 % vs -30.9 % at week 52, for the dupilumab 300 mg Q2W and placebo groups respectively.
Croatian: U toj je podskupini postotna promjena početnog NRS rezultata za pruritus u bolesnika liječenih dupilumabom 300 mg svaka 2 tjedna i onih koji su primali placebo iznosila -51,4% odnosno -30,2% u 16. tjednu te -54,8% odnosno -30,9% u 52. tjednu.
English: Very rare cases of serum sickness/serum sickness-like reactions and anaphylactic reaction have been reported following administration of dupilumab (see section 4.4).
Croatian: Nakon primjene dupilumaba prijavljeni su vrlo rijetki slučajevi serumske bolesti/reakcija nalik na serumsku bolest i anafilaktičke reakcije (vidjeti dio 4.4).
English: QUEST: Blood Eosinophils ≥ 300 cells/mcL
Croatian: QUEST: Broj eozinofila u krvi ≥ 300 stanica/μl
English: Patients who continued on the same dose regimen received in the SOLO 1 and SOLO 2 studies (300 mg Q2W or 300 mg QW) showed the optimal effect in maintaining clinical response while efficacy for other dose regimens diminished in a dose-dependent manner.
Croatian: (300 mg svaka 2 tjedna ili 300 mg svaki tjedan) zabilježen je optimalan učinak na održavanje kliničkog odgovora, dok se djelotvornost kod drugih režima liječenja smanjivala ovisno o dozi.
English: EASI-50, % respondersc
Croatian: EASI-50, % bolesnika s odgovoromd
English: These reductions in type 2 inflammatory biomarkers were comparable for the 200 mg Q2W and 300 mg Q2W regimens.
Croatian: Ta smanjenja razina bioloških biljega upale tipa 2 bila su usporediva uz režim liječenja dozom od 200 mg svaka 2 tjedna i režim liječenja dozom od 300 mg svaka 2 tjedna.
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.
Croatian: Srednja vrijednost ± SD najnižih koncentracija dupilumaba u stanju dinamičke ravnoteže iznosila je 107 ± 51,6 μg/ml uz dozu od 300 mg svaki drugi tjedan te 46,7 ± 26,9 μg/ml uz dozu od 200 mg svaki drugi tjedan.
English: Steady-state concentrations were achieved by week 16 following the administration of 600 mg starting dose and 300 mg dose every other week.
Croatian: Koncentracije u stanju dinamičke ravnoteže nakon primjene početne doze od 600 mg i doze od 300 mg svaki drugi tjedan postignute su do 16. tjedna.
English: Solution for injection 1 pre-filled syringe with needle shield 2 pre-filled syringes with needle shield
Croatian: 1 napunjena štrcaljka sa zaštitnim pokrovom igle 2 napunjene štrcaljke sa zaštitnim pokrovom igle
English: In addition, anxiety and depression symptoms as measured by the HADS total score were significantly reduced in the dupilumab groups compared to placebo at 16 weeks.
Croatian: Osim toga, u bolesnika liječenih dupilumabom u 16. je tjednu zabilježeno značajno smanjenje simptoma tjeskobe i depresije u odnosu na placebo, mjereno ukupnim HADS rezultatom.
English: Lightly press a cotton ball or gauze on the injection site if you see any blood.
Croatian: Ako vidite krv, pritisnite komad pamučne vate ili gaze na mjesto injiciranja.
English: In the concomitant TCS study (CHRONOS), dupilumab 300 mg Q2W + TCS and dupilumab 300 mg QW + TCS improved patient-reported symptoms and the impact of AD on sleep and health-related quality of life as measured by POEM and DLQI total scores, respectively, at 52 weeks compared to placebo + TCS.
Croatian: U ispitivanju istodobne primjene s topikalnim kortikosteroidima (CHRONOS), liječenje kombinacijom dupilumab 300 mg svaka 2 tjedna + TKS i kombinacijom dupilumab 300 mg svaki tjedan + TKS je u usporedbi s kombinacijom placebo + TKS poboljšalo simptome koje prijavljuju bolesnici i utjecaj atopijskog dermatitisa na san i kvalitetu života vezanu uz zdravlje u 52. tjednu, što se mjerilo ukupnim POEM odnosno DLQI rezultatom.
English: Additional secondary endpoints included mean change from baseline to week 16 in the Patient Oriented Eczema Measure (POEM), Dermatology Life Quality Index (DLQI), and Hospital Anxiety and Depression Scale (HADS) scores.
Croatian: Patient Oriented Eczema Measure, POEM), indeksa kvalitete života kod dermatoloških bolesti (engl.
English: Each pre-filled syringe contains 300 mg of dupilumab in 2 ml solution (150 mg/ml).
Croatian: Jedna napunjena štrcaljka sadrži 300 mg dupilumaba u 2 ml otopine (150 mg/ml).
English: 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 groups achieved HADS-anxiety and HADS-depression scores < 8 at week 16 compared to placebo (See Table 8).
Croatian: HADS rezultat za depresiju < 8 u 16. tjednu postigao je veći udio bolesnika liječenih dupilumabom nego onih koji su primali placebo (vidjeti Tablicu 8).
English: A reduction of lactate dehydrogenase (LDH), a biomarker associated with AD disease activity and severity, was observed with dupilumab treatment.
Croatian: Kod liječenja dupilumabom primijećen je i pad vrijednosti laktatne dehidrogenaze (LDH), biološkog biljega povezanog s aktivnošću i težinom atopijskog dermatitisa.
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.
Croatian: u bolesnika liječenih kombinacijom dupilumab 300 mg svaka 2 tjedna + TKS i dupilumab 300 mg svaki tjedan + TKS zabilježeno je smanjenje tjeskobe i depresije, mjereno ukupnim HADS rezultatom u 52. tjednu, u odnosu na placebo + TKS.
English: AQLQ(S) Dupilumab 200 mg Q2W Placebo
Croatian: AQLQ(S) Dupilumab 200 mg svaka 2 tj.
English: Systemic, topical, or inhaled corticosteroids should not be discontinued abruptly upon initiation of therapy with dupilumab.
Croatian: Pri uvođenju terapije dupilumabom ne smije se naglo prekinuti primjena sistemskih, topikalnih ili inhalacijskih kortikosteroida.
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).
Croatian: Dupilumab 200 mg otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka za jednokratnu uporabu sadrži 200 mg dupilumaba u 1,14 ml otopine (175 mg/ml).
English: Lay the syringe on a flat surface for at least 30 minutes and let it get to room temperature naturally.
Croatian: 4. korak: Pričekajte 30 minuta Položite štrcaljku na ravnu površinu i pričekajte najmanje 30 minuta da se sama ugrije na sobnu temperaturu.
English: CDLQI, (≥6-point improvement), % responders POEM, LS mean change from baseline (+/- SE)
Croatian: CDLQI, LS srednja vrijednost promjene od početne vrijednosti (+/- SE) CLDQI, (poboljšanje za ≥ 6 bodova), %
English: Treatment-emergent ADA: QW: 1.2%; Q2W: 4.3%; Q4W: 6.0%; Q8W:
Croatian: Protutijela na lijek koja su nastala tijekom liječenja: kod primjene svaki tjedan: 1,2%; svaka 2 tjedna: 4,3%; svaka 4 tjedna: 6,0%; svakih 8 tjedana: 11,7%.
English: 1.14 ml solution in a siliconised type-1 clear glass pre-filled syringe with needle shield or pre-filled pen, with a fixed 27 gauge 12.7 mm (½ inch), thin wall stainless steel staked needle.
Croatian: I sa zaštitnim pokrovom igle ili u napunjenoj brizgalici, s pričvršćenom iglom tankih stijenki od nehrđajućeg čelika veličine 27 G i duljine 12,7 mm.
English: • Do not place the syringe into direct sunlight.
Croatian: • Nemojte izlagati štrcaljku izravnoj sunčevoj svjetlosti.
English: All p -values <0.0001
Croatian: Sve p-vrijednosti bile su <0,0001
English: ACQ-5 Dupilumab 200 mg Q2W Placebo
Croatian: ACQ-5 Dupilumab 200 mg svaka 2 tj.
English: Q2W/QW N=169
Croatian: svaka 2 tjedna/ svaki tjedan N=169
English: - Each pre-filled syringe contains 200 mg of dupilumab in 1.14 ml solution for injection (injection).
Croatian: Jedna napunjena brizgalica sadrži 200 mg dupilumaba u 1,14 ml otopine za injekciju (injekcija).
English: Dupixent 200 mg pen
Croatian: Dupixent 200 mg brizgalica
English: respondersd, e
Croatian: Osim toga,
English: Very rare cases of serum sickness/serum sickness-like reactions have been reported in the atopic dermatitis development program (see section 4.4).
Croatian: U razvojnom programu kod atopijskog dermatitisa prijavljeni su vrlo rijetki slučajevi serumske bolesti/reakcija nalik na serumsku bolest (vidjeti dio 4.4).
English: Percent reduction from baseline
Croatian: Broj egzacerbacija na godinu % smanjenja
English: • Do not heat the pre-filled pen.
Croatian: • Nemojte zagrijavati napunjenu brizgalicu.
English: EU/1/17/1229/001 1 pre-filled syringe EU/1/17/1229/002 2 pre-filled syringes
Croatian: EU/1/17/1229/001 1 napunjena štrcaljka EU/1/17/1229/002 2 napunjene štrcaljke
English: • Do not re-use the pre-filled pen.
Croatian: • Nemojte ponovno upotrijebiti istu brizgalicu.
English: Dupixent is a clear to slightly opalescent, colourless to pale yellow solution supplied in a pre-filled syringe.
Croatian: Dupixent je bistra do blago opalescentna te bezbojna do blijedožuta otopina koja dolazi u napunjenoj štrcaljki.
English: SCORAD, LS mean % change from baseline (+/- SE)
Croatian: SCORAD, LS srednja vrijednost % promjene od početne vrijednosti (+/- SE)
English: Do not use the syringe if the expiry date has passed.
Croatian: Nemojte upotrijebiti štrcaljku ako joj je istekao rok valjanosti.
English: Pre-filled syringe 300 mg
Croatian: Napunjena štrcaljka od 300 mg
English: Table 17: Effect of dupilumab on OCS dose reduction, VENTURE (Baseline Blood Eosinophil Levels
Croatian: Tablica 17: Učinak dupilumaba na smanjenje doze OKS-a u ispitivanju VENTURE (početni broj eozinofila u krvi ≥ 150 i ≥ 300 stanica/μl i FeNO > 25 ppb)
English: • 2 pre-filled syringes
Croatian: • 2 napunjene brizgalice
English: Table 12: Rate of Severe Exacerbations in DRI12544 and QUEST (Baseline Blood Eosinophil
Croatian: Tablica 12: Stopa teških egzacerbacija u ispitivanjima DRI12544 i QUEST (podskupine prema početnom broju eozinofila u krvi od ≥ 150 ili ≥ 300 stanica/μl)
English: Table 6: Rate of Severe Exacerbations in DRI12544 and QUEST (Baseline Blood Eosinophil
Croatian: Tablica 6: Stopa teških egzacerbacija u ispitivanjima DRI12544 i QUEST (podskupine prema početnom broju eozinofila u krvi od ≥ 150 ili ≥ 300 stanica/μl)
English: Dupixent 300 mg syringe
Croatian: Dupixent 300 mg štrcaljka
English: ≥150 cells/mcL
Croatian: ≥ 150 stanica/μl
English: EU/1/17/1229/011 3 pre-filled syringes with needle shield (3 packs of 1) EU/1/17/1229/012 6 pre-filled syringes with needle shield (3 packs of 2)
Croatian: EU/1/17/1229/011 3 napunjene štrcaljke sa zaštitnim pokrovom igle (3 pakiranja od 1) EU/1/17/1229/012 6 napunjenih štrcaljki sa zaštitnim pokrovom igle (3 pakiranja od 2)
English: Mean FeNO ppb (± SD) % patients with FeNO ppb
Croatian: Atopija u anamnezi, ukupni % (AD %, NP %, AR %) Srednja vrijednost FeNO, ppb (± SD) % bolesnika kojima je FeNO iznosio ≥ 25 ppb ≥ 50 ppb
English: Table 11: Effect of dupilumab on OCS dose reduction, VENTURE (Baseline Blood Eosinophil Levels
Croatian: Tablica 11: Učinak dupilumaba na smanjenje doze OKS-a u ispitivanju VENTURE (početni broj eozinofila u krvi ≥ 150 i ≥ 300 stanica/μl i FeNO > 25 ppb)
English: Each pre-filled syringe contains 200 mg of dupilumab in 1.14 ml solution (175 mg/ml).
Croatian: Jedna napunjena štrcaljka sadrži 200 mg dupilumaba u 1,14 ml otopine (175 mg/ml).
English: Dupilumab 200 mg solution for injection in pre-filled pen Each single-use pre-filled pen contains 200 mg of dupilumab in 1.14 ml solution (175 mg/ml).
Croatian: Dupilumab 200 mg otopina za injekciju u napunjenoj brizgalici Jedna napunjena brizgalica za jednokratnu uporabu sadrži 200 mg dupilumaba u 1,14 ml otopine (175 mg/ml).
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).
Croatian: Veća poboljšanja FEV1 zabilježena su u ispitanika s višim početnim vrijednostima bioloških biljega upale tipa 2, kao što su eozinofili u krvi ili FeNO (Tablica 14 i Tablica 15).
English: Do not use the pre-filled pen if the expiration date has passed.
Croatian: Nemojte upotrijebiti napunjenu brizgalicu ako joj je istekao rok valjanosti.
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 8 and Table 9).
Croatian: Veća poboljšanja FEV1 zabilježena su u ispitanika s višim početnim vrijednostima bioloških biljega upale tipa 2, kao što su eozinofili u krvi ili FeNO (Tablica 8 i Tablica 9).
English: Number of patients with HADS-anxiety
Croatian: Broj bolesnika s početnim DLQI
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.
Croatian: 300 mg svaka 2 tjedna i liječenje lijekom Dupixent 300 mg svaki tjedan značajno poboljšalo simptome koje prijavljuju bolesnici i utjecaj atopijskog dermatitisa na san i kvalitetu života vezanu uz zdravlje u 16. tjednu, što se mjerilo ukupnim POEM odnosno DLQI rezultatom.
English: Pre-filled syringe 300 mg - Multipack (contains Blue Box)
Croatian: Napunjena štrcaljka od 300 mg - višestruko pakiranje (sadrži plavi okvir)
English: The solution should be clear to slightly opalescent, colourless to pale yellow.
Croatian: Otopina treba biti bistra do blago opalescentna te bezbojna do blijedožuta.
English: Dupixent is a clear to slightly opalescent, colourless to pale yellow solution supplied in a pre-filled pen.
Croatian: Dupixent je bistra do blago opalescentna te bezbojna do blijedožuta otopina koja dolazi u napunjenoj brizgalici.
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).
Croatian: Značajna poboljšanja FEV1 (srednja vrijednost promjene prema metodi najmanjih kvadrata od početka ispitivanja do 12. tjedna) opažena su i uz dozu od 200 mg i uz dozu od 300 mg svaki drugi tjedan (0,36 l odnosno 0,27 l).
English: SCORAD, LS mean % change from baseline (+/SE)
Croatian: SCORAD, LS srednja vrijednost % promjene od početne vrijednosti (+/-SE)
English: EU/1/17/1229/007 3 pre-filled syringes with needle shield (3 packs of 1) EU/1/17/1229/008 6 pre-filled syringes with needle shield (3 packs of 2)
Croatian: EU/1/17/1229/007 3 napunjene štrcaljke sa zaštitnim pokrovom igle (3 pakiranja od 1) EU/1/17/1229/008 6 napunjenih štrcaljki sa zaštitnim pokrovom igle (3 pakiranja od 2)
English: Each pre-filled pen contains 200 mg of dupilumab in 1.14 ml solution (175 mg/ml).
Croatian: Jedna napunjena brizgalica sadrži 200 mg dupilumaba u 1,14 ml otopine (175 mg/ml).
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.
Croatian: (TKS) iznosio je 7,6% u skupini koja je primala placebo + TKS, 1,8% u skupini koja je primala dupilumab 300 mg svaka 2 tjedna + TKS te 2,9 % u skupini koja je primala dupilumab 300 mg svaki tjedan + TKS.
English: Pruritus NRS, LS mean % change from baseline (+/- SE)
Croatian: NRS rezultat za pruritus, LS srednja vrijednost % promjene od početne vrijednosti (+/-SE)
English: Do not twist the yellow cap off.
Croatian: Nemojte zakretati žuti zatvarač da biste ga skinuli.
English: • 1 pre-filled syringe
Croatian: • 1 napunjena štrcaljka
English: Dupixent 200 mg syringe
Croatian: Dupixent 200 mg štrcaljka
English: Exacerbations
Croatian: Poboljšanje