FrancophonIA/ELRC3.0 huggingface dataset:
English: Approximately 9 % of patients with asthma who received dupilumab 200 mg Q2W for 52 weeks developed antibodies to dupilumab; approximately 4 % exhibited persistent ADA responses and approximately 4 % had neutralizing antibodies.
Croatian: Protutijela na dupilumab razvila su se u približno 9% bolesnika s astmom koji su primali dupilumab u dozi od 200 mg svaka 2 tjedna tijekom 52 tjedna; približno 4% bolesnika pokazivalo je perzistentan odgovor u smislu stvaranja protutijela na lijek, a približno 4% njih imalo je neutralizirajuća protutijela.
English: SOLO 2 enrolled 708 patients (236 to placebo, 233 to dupilumab 300 mg Q2W, and 239 to dupilumab 300 mg QW) and had a treatment period of 16 weeks.
Croatian: U ispitivanju SOLO 2 sudjelovalo je 708 bolesnika (236 primala su placebo, 233 dupilumab 300 mg svaka 2 tjedna, a 239 dupilumab 300 mg svaki tjedan), a razdoblje liječenja trajalo je 16 tjedana.
English: The mean age was 38.4 years, 38.8 % were female, the baseline mean EASI score was 33.1, the mean BSA was 55.7, the baseline weekly average pruritis NRS was 6.4, the baseline mean SCORAD score was 67.2, and the baseline mean DLQI was 13.8.
Croatian: Srednja vrijednost dobi iznosila je 38,4 godine, 38,8% bolesnika bile su žene, početna srednja vrijednost EASI rezultata iznosila je 33,1, srednja vrijednost zahvaćene površine tijela iznosila je 55,7%, početni tjedni prosječni NRS rezultat za pruritus iznosio je 6,4, početna srednja vrijednost SCORAD rezultata 67,2, a početna srednja vrijednost DLQI rezultata 13,8.
English: Hold the syringe in the middle of the syringe body with the needle pointing away from you and pull off the needle cap.
Croatian: Uhvatite štrcaljku za srednji dio tijela, usmjerite iglu od sebe i povucite zatvarač igle da biste ga skinuli.
English: Do not pull off the needle cap until you are ready to inject.
Croatian: Nemojte skinuti zatvarač igle dok ne budete spremni injicirati lijek.
English: Mean ACQ-5 score (± SD)
Croatian: Reverzibilnost, % (± SD) Srednja vrijednost ACQ-5 rezultata (± SD)
English: Adults with atopic dermatitis
Croatian: Odrasli bolesnici s atopijskim dermatitisom
English: No clinical studies have been conducted to evaluate the effect of renal impairment on the pharmacokinetics of dupilumab.
Croatian: Nisu provedena klinička ispitivanja kojima bi se ocijenio učinak oštećenja bubrežne funkcije na farmakokinetiku dupilumaba.
English: Adolescents with atopic dermatitis
Croatian: Adolescenti s atopijskim dermatitisom
English: • Do not use the syringe if it has been damaged.
Croatian: • Nemojte upotrijebiti štrcaljku ako je oštećena.
English: EU/1/17/1229/003 EU/1/17/1229/004 EU/1/17/1229/005 EU/1/17/1229/006 EU/1/17/1229/007 EU/1/17/1229/008
Croatian: EU/1/17/1229/001 EU/1/17/1229/002 EU/1/17/1229/003 EU/1/17/1229/004 EU/1/17/1229/005 EU/1/17/1229/006 EU/1/17/1229/007 EU/1/17/1229/008
English: In this 24-week trial, asthma exacerbations (defined as a temporary increase in oral corticosteroid dose for at least 3 days) were reduced by 59% in subjects receiving dupilumab compared with those receiving placebo (annualized rate 0.65 and 1.60 for the dupilumab and placebo group, respectively; rate ratio 0.41 [95% CI 0.26, 0.63]) and improvement in pre-bronchodilator FEV1 from baseline to week 24 was greater in subjects receiving dupilumab compared with those receiving placebo (LS mean difference for dupilumab versus placebo of 0.22 L [95% CI: 0.09 to 0.34 L]).
Croatian: U tom se 24-tjednom ispitivanju stopa egzacerbacija astme (koje su se definirale kao privremeno povećanje doze oralnih kortikosteroida tijekom najmanje 3 dana) smanjila za 59% u ispitanika koji su primali dupilumab u odnosu na one koji su primali placebo (godišnja stopa iznosila je 0,65 za dupilumab i 1,60 za placebo; omjer stopa: 0,41 [95% CI: 0,26; 0,63]), dok je poboljšanje vrijednosti
English: Lay the syringe on a flat surface for at least 45 minutes and let it get to room temperature naturally.
Croatian: Položite štrcaljku na ravnu površinu i pričekajte najmanje 45 minuta da se sama ugrije na sobnu temperaturu.
English: Biomarkers of type 2 inflammation may be suppressed by systemic corticosteroid use.
Croatian: Primjena sistemskih kortikosteroida može suprimirati biološke biljege upale tipa 2.
English: The results for VENTURE by baseline biomarkers are presented in the Table 11.
Croatian: Rezultati za ispitivanje VENTURE prema početnim vrijednostima bioloških biljega prikazani su u Tablici 11.
English: POEM, (≥6-point improvement), % responders a Full Analysis Set (FAS) includes all patients randomised.
Croatian: bolesnika s odgovorom POEM, LS srednja vrijednost promjene od početne vrijednosti (+/- SE) POEM (poboljšanje za ≥6 bodova) % bolesnika s odgovorom a Potpuni skup podataka za analizu (FAS) uključuje sve randomizirane bolesnike.
English: Dispose of the syringe and the needle cap in a puncture-resistant container.
Croatian: Bacite štrcaljku i zatvarač igle u neprobojni spremnik.
English: An effect of dupilumab on the PK of co-administered medications is not expected.
Croatian: Ne očekuje se da će dupilumab utjecati na farmakokinetiku istodobno primijenjenih lijekova.
English: • Do not keep pre-filled pens at room temperature (<25ºC) for more than 14 days.
Croatian: • Nemojte čuvati napunjene brizgalice na sobnoj temperaturi (< 25ºC) dulje od 14 dana.
English: Secondary endpoint (week 24)a Proportion of patients achieving a reduction of OCS dose to <5 mg/day
Croatian: Udio bolesnika kojima je doza OKS-a smanjena na < 5 mg na dan
English: c Patients who received rescue treatment or with missing data were considered as non-responders.
Croatian: c Bolesnici koji su koji su primili terapiju za hitno ublažavanje simptoma ili za koje su nedostajali podaci smatrali su se bolesnicima bez odgovora.
English: Patients were randomised to receive either 200 mg (N=631) or 300 mg (N=633) Dupixent every other week (or matching placebo for either 200 mg (N = 317) or 300 mg (N= 321) every other week) following an initial dose of 400 mg, 600 mg or placebo respectively.
Croatian: Bolesnici su bili randomizirani za primanje lijeka Dupixent u dozi od 200 mg (N=631) ili 300 mg (N=633) svaki drugi tjedan (ili placeba koji je odgovarao dozi od 200 mg [N=317] ili 300 mg [N=321] svaki drugi tjedan) nakon početne doze od 400 mg, 600 mg odnosno placeba.
English: Pre-dose FEV1 (L) at baseline ± SD Mean percent predicted FEV1 at baseline (%)(± SD) % Reversibility (± SD)
Croatian: Srednja vrijednost postotka predviđenog FEV1 na početku ispitivanja (%) (± SD)
English: In this study, 53.1 % of patients had a baseline IGA score of 3 and 46.9 % of patients had a baseline IGA of 4 and 33.6 % of patients received prior systemic immunosuppressants.
Croatian: 53,1% bolesnika imalo početni IGA rezultat 3, 46,9% imalo je početni IGA rezultat 4, a 33,6% bolesnika prethodno je primalo sistemske imunosupresive.
English: How to use Dupixent
Croatian: Kako primjenjivati Dupixent
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.
Croatian: Udio bolesnika koji su prekinuli liječenje zbog štetnih događaja u ispitivanjima monoterapije iznosio je 1,9% u skupini koja je primala placebo, 1,9% u skupini koja je primala dupilumab 300 mg svaka 2 tjedna te 1,5% u skupini koja je primala dupilumab 300 mg svaki tjedan.
English: If the carton needs to be removed permanently from refrigerator,
Croatian: Nakon vađenja iz hladnjaka,
English: Excipients: arginine hydrochloride, histidine, polysorbate 80, sodium acetate, glacial acetic acid, sucrose, water for injections.
Croatian: Pomoćne tvari: argininklorid, histidin, polisorbat 80, natrijev acetat, ledena acetatna kiselina, saharoza, voda za injekcije.
English: Approximately 6 % of patients with atopic dermatitis or asthma who received dupilumab 300 mg Q2W for 52 weeks developed ADA to dupilumab; approximately 2 % exhibited persistent ADA responses and approximately 2 % had neutralizing antibodies.
Croatian: Protutijela na dupilumab razvila su se u približno 6% bolesnika s atopijskim dermatitisom ili astmom koji su primali dupilumab u dozi od 300 mg svaka 2 tjedna tijekom 52 tjedna; približno 2% bolesnika pokazivalo je perzistentan odgovor u smislu stvaranja protutijela na lijek, a približno 2% njih imalo je neutralizirajuća protutijela.
English: IGA 0 or 1b, % respondersc
Croatian: IGA 0 ili 1c, % bolesnika s odgovoromd
English: Placebo ap-value < 0.0001
Croatian: Placebo bp-vrijednost < 0,0001
English: Each syringe contains one dose of Dupixent (300 mg).
Croatian: Jedna štrcaljka sadrži jednu dozu lijeka Dupixent (300 mg).
English: Figure 4: Mean percent change from baseline in NRS in CHRONOSa (FAS Week 52)b
Croatian: Slika 4: Srednja vrijednost postotne promjene od početnog NRS rezultata u ispitivanju CHRONOSa (FAS, 52. tjedan)b
English: Additional secondary endpoints included mean change from baseline to week 16 in the POEM and CDLQI scores.
Croatian: Dodatne sekundarne mjere ishoda uključivale su srednju vrijednost promjene POEM i CDLQI rezultata od početka do 16. tjedna ispitivanja.
English: ≥ 8 or HADSdepression ≥ 8 at baseline Patients achieving HADS-anxiety and HADSdepression score
Croatian: HADS rezultatom za depresiju ≥ 8 Bolesnici koji su postigli HADS rezultat za tjeskobu i HADS rezultat za depresiju
English: At baseline 46.2% of patients had a baseline IGA score of 3 (moderate AD), 53.8% of patients had a baseline IGA of 4 (severe AD), the mean BSA involvement was 56.5%, and 42.4 % of patients had received prior systemic immunosuppressants.
Croatian: Na početku ispitivanja 46,2% bolesnika imalo je početni IGA rezultat 3 (umjereni AD), 53,8% imalo je početni IGA rezultat 4 (težak AD), srednja vrijednost zahvaćenosti tjelesne površine iznosila je 56,5 %, a 42,4% bolesnika prethodno je primalo sistemske imunosupresive.
English: d Patients who received rescue treatment or with missing data were considered as non-responders.
Croatian: d Bolesnici koji su primili terapiju za hitno ublažavanje simptoma ili za koje su nedostajali podaci smatrali su se bolesnicima bez odgovora.
English: Very common Injection site reactions
Croatian: Opći poremećaji i reakcije na mjestu primjene vrlo često reakcije na mjestu injiciranja
English: A patient may self-inject dupilumab or the patient's caregiver may administer dupilumab if their healthcare professional determines that this is appropriate.
Croatian: Ako zdravstveni radnik utvrdi da je to prikladno, bolesnik može samostalno injicirati dupilumab ili mu ga može dati skrbnik.
English: Placebo 237 0.22 (14.2) ap-value <0.0001, bp-value = 0.0004, cp-value = 0.0008, dp-value = 0.0063, ep-value <0.0001
Croatian: Placebo ap-vrijednost < 0,0001; bp-vrijednost = 0,0004; cp-vrijednost = 0,0008; dp-vrijednost = 0,0063; ep-vrijednost < 0,0001
English: Table 16: ACQ-5 and AQLQ(S) Responder Rates at Week 52 in QUEST
Croatian: Tablica 16: Stope bolesnika s odgovorom prema upitnicima ACQ-5 i AQLQ(S) u 52. tjednu ispitivanja QUEST
English: Pruritus NRS (>4-point improvement), % respondersc
Croatian: NRS rezultat za pruritus (poboljšanje ≥ 4 boda), % bolesnika s odgovoromd, e
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.
Croatian: Preporučena prva doza kod atopijskog dermatitisa je 600 mg (dvije injekcije od 300 mg), nakon koje slijedi doza od 300 mg svaka dva tjedna supkutanom injekcijom.
English: Population PK analysis did not identify mild or moderate renal impairment as having a clinically meaningful influence on the systemic exposure of dupilumab.
Croatian: Populacijska farmakokinetička analiza nije pokazala da blago ili umjereno oštećenje bubrežne funkcije klinički značajno utječe na sistemsku izloženost dupilumabu.
English: Dupixent is available as 200 mg pre-filled pens in a pack containing 1, 2, 3, or 6 pre-filled pens.
Croatian: Dupixent je dostupan u pakiranju koje sadrži 1, 2, 3 ili 6 napunjenih brizgalica od 200 mg.
English: Table 10: ACQ-5 and AQLQ(S) Responder Rates at Week 52 in QUEST
Croatian: Tablica 10: Stope bolesnika s odgovorom prema upitnicima ACQ-5 i AQLQ(S) u 52. tjednu ispitivanja QUEST
English: From baseline L (%)
Croatian: l (%)
English: Figure 3: Mean percent change from baseline in EASI in CHRONOSa (FAS Week 52)b
Croatian: Slika 3: Srednja vrijednost postotne promjene od početnog EASI rezultata u ispitivanju CHRONOSa (FAS, 52. tjedan)b
English: Solution for injection (injection) Clear to slightly opalescent, colourless to pale yellow solution, which is free from visible particulates.
Croatian: Bistra do blago opalescentna, bezbojna do blijedožuta otopina, koja ne sadrži vidljive čestice.
English: In SOLO 1 and SOLO 2, from baseline to week 16, a significantly greater proportion of patients randomized to dupilumab achieved an IGA 0 or 1 response, EASI-75, and/or an improvement of > 4 points on the pruritus NRS compared to placebo (see Table 4).
Croatian: U ispitivanjima SOLO 1 i SOLO 2 značajno je veći udio bolesnika randomiziranih za primanje dupilumaba u usporedbi s onima koji su primali placebo postigao odgovor IGA 0 ili 1, EASI-75 i/ili poboljšanje NRS rezultata za pruritus za ≥ 4 boda od početka ispitivanja do 16. tjedna (vidjeti
English: The efficacy results at week 16 for adolescent atopic dermatitis study are presented in Table 10.
Croatian: Rezultati za djelotvornost u 16. tjednu ispitivanja atopijskog dermatitisa u adolescenata prikazani su u Tablici 10.
English: EASI-90, % respondersc
Croatian: EASI-90, % bolesnika s odgovoromd
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.
Croatian: Slika 3 i Slika 4 prikazuju srednju vrijednost postotne promjene EASI rezultata odnosno NRS rezultata od početka ispitivanja do 52. tjedna u ispitivanju CHRONOS.
English: Across clinical trials, the mean ±SD steady-state trough concentrations ranged from 60.3±35.1 mcg/mL to 79.9±41.4 mcg/mL for 300 mg dose and from 29.2±18.7 to 36.5±22.2 mcg/mL for 200 mg dose administered every other week.
Croatian: 79,9 ± 41,4 μg/ml kod primjene doze od 300 mg svaki drugi tjedan te od 29,2 ± 18,7 mg/l do 36,5 ± 22,2 µg/ml kod primjene doze od 200 mg svaki drugi tjedan.
English: • Do not heat the syringe.
Croatian: • Nemojte zagrijavati štrcaljku.
English: Do not put the yellow cap back on.
Croatian: Nemojte vraćati žuti zatvarač na brizgalicu.
English: Step 11: Remove
Croatian: 11. korak: Izvucite iglu
English: Step 5: Choose
Croatian: 5. korak: Odaberite mjesto injiciranja
English: Number of patients with POEM ≥4 at baseline POEM (≥ 4-point improvement), % responders
Croatian: POEM rezultatom ≥ 4 POEM (poboljšanje za ≥ 4 boda), % bolesnika s odgovorom
English: If necessary, pre-filled pens may be kept at room temperature up to 25°C for a maximum of 14 days.
Croatian: Ako je potrebno, napunjene brizgalice mogu se čuvati na sobnoj temperaturi do 25°C tijekom najviše 14 dana.
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.
Croatian: Eozinofilna stanja Kod primjene dupilumaba u odraslih bolesnika koji su sudjelovali u razvojnom programu lijeka kod astme prijavljeni su slučajevi eozinofilne pneumonije i slučajevi vaskulitisa koji su odgovarali eozinofilnoj granulomatozi praćenoj poliangitisom.
English: Dupixent 300 mg injection dupilumab
Croatian: Dupixent 300 mg injekcija dupilumab
English: If necessary, pre-filled syringes may be kept at room temperature up to 25°C for a maximum of 14 days.
Croatian: Ako je potrebno, napunjene štrcaljke mogu se čuvati na sobnoj temperaturi do 25°C tijekom najviše 14 dana.
English: The efficacy and safety of dupilumab monotherapy in adolescent patients was evaluated in a multicentre, randomised, double-blind, placebo-controlled study (AD-1526) in 251 adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis (AD) defined by Investigator's Global Assessment (IGA) score ≥3 in the overall assessment of AD lesions on a severity scale of 0 to 4, an Eczema Area and Severity Index (EASI) score ≥16 on a scale of 0 to 72, and a minimum body surface area (BSA) involvement of ≥10%.
Croatian: Djelotvornost i sigurnost dupilumaba kao monoterapije u adolescenata bila je ispitivana u multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju (AD1526) u 251 adolescentna bolesnika u dobi od 12 do 17 godina s umjerenim do teškim atopijskim dermatitisom (AD) koji se definirao kao rezultat ≥ 3 prema općoj ocjeni AD lezija od strane ispitivača
English: • 1 alcohol wipe*
Croatian: • Dupixent napunjenu brizgalicu • 1 vaticu natopljenu alkoholom*
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.
Croatian: EASI rezultata iznosila je 33,0, početni tjedni prosječni NRS rezultat za pruritus bio je 7,4, početna srednja vrijednost SCORAD rezultata iznosila je 67,8, početna srednja vrijednost POEM rezultata 20,5, početna srednja vrijednost DLQI rezultata 15,0, a početna srednja vrijednost ukupnog
English: Dupilumab, as a monoclonal antibody, is not expected to undergo significant hepatic elimination.
Croatian: Budući da je dupilumab monoklonsko protutijelo, ne očekuje se da će se značajno eliminirati putem jetre.
English: EASI-75, % respondersc
Croatian: EASI-75, % bolesnika s odgovoromd
English: Name and address of the manufacturer(s) of the biological active substance(s) REGENERON PHARMACEUTICALS INC.
Croatian: Naziv(i) i adresa(e) proizvođača biološke(ih) djelatne(ih) tvari
English: Dupixent 200 mg injection dupilumab
Croatian: Dupixent 200 mg injekcija dupilumab
English: In CHRONOS, a significantly greater proportion of patients randomized to dupilumab 300 mg Q2W + TCS achieved an IGA 0 or 1 response, EASI-75, and/or an improvement of > 4 points on the pruritis NRS from baseline to week 16 and week 52 compared to placebo + TCS (see Table 5).
Croatian: U ispitivanju CHRONOS značajno je veći udio bolesnika randomiziranih za primanje kombinacije dupilumab 300 mg svaka 2 tjedna + TKS u usporedbi s onima koji su primali placebo + TKS postigao odgovor IGA 0 ili 1, EASI-75 i/ili poboljšanje NRS rezultata za pruritus za ≥ 4 boda od početka ispitivanja do 16. tjedna i 52. tjedna (vidjeti Tablicu 5).
English: No age-related pharmacokinetic difference was observed in adolescent patients after correction for body weight.
Croatian: Nakon korekcije za tjelesnu težinu u adolescentnih bolesnika nije opažena nikakva razlika u farmakokinetici povezana s dobi.
English: The efficacy results at week 16 for adolescent atopic dermatitis study are presented in Table 4.
Croatian: Rezultati za djelotvornost u 16. tjednu ispitivanja atopijskog dermatitisa u adolescenata prikazani su u Tablici 4.
English: A total of 107 adolescents aged 12 to 17 years with moderate to severe asthma were enrolled in QUEST study and received either 200 mg (N=21) or 300 mg (N=18) dupilumab (or matching placebo either 200 mg [N=34] or 300 mg [N=34]) every other week.
Croatian: U ispitivanje QUEST bilo je uključeno ukupno 107 adolescenata u dobi od 12 do 17 godina s umjerenom do teškom astmom koji su primali 200 mg (N=21) ili 300 mg (N=18) dupilumaba (ili odgovarajuću dozu placeba, tj. 200 mg [N=34] ili 300 mg [N=34]) svaki drugi tjedan.
English: Q8W N=84
Croatian: svakih 8 tjedana N=84
English: Listed in Table 2 are adverse reactions observed in atopic dermatitis clinical trials presented by system organ class and frequency, using the following categories: very common (≥ 1/10); common (≥ 1/100 to
Croatian: Tablici 2 navode se nuspojave primijećene u kliničkim ispitivanjima kod atopijskog dermatitisa, prikazane prema organskim sustavima i učestalosti, sukladno sljedećim kategorijama: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/1000).
English: How to Store Dupixent
Croatian: Kako čuvati Dupixent
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.
Croatian: • za sve ostale bolesnike, početna doza od 400 mg (dvije injekcije od 200 mg), nakon koje slijedi doza od 200 mg svaki drugi tjedan supkutanom injekcijom.
English: Table 15: Mean Change from Baseline in Pre-Bronchodilator FEV1 at Week 12 and Week 52 in QUEST by Baseline FeNO Subgroups
Croatian: Tablica 15: Srednja vrijednost promjene FEV1 prije primjene bronhodilatatora od početka ispitivanja do 12. tjedna i 52. tjedna ispitivanja QUEST u podskupinama prema početnoj razini FeNO
English: Table 9: Mean Change from Baseline in Pre-Bronchodilator FEV1 at Week 12 and Week 52 in QUEST by Baseline FeNO Subgroups
Croatian: Tablica 9: Srednja vrijednost promjene FEV1 prije primjene bronhodilatatora od početka ispitivanja do 12. tjedna i 52. tjedna ispitivanja QUEST u podskupinama prema početnoj razini FeNO
English: Do not heat the pre-filled pen.
Croatian: Nemojte zagrijavati napunjenu brizgalicu.
English: Read the “Instructions for Use” for the syringe carefully before using Dupixent.
Croatian: Pažljivo pročitajte ‘Upute za uporabu' štrcaljke prije nego što primijenite Dupixent.
English: The parts of the Dupixent pre-filled pen are shown in this picture.
Croatian: Dijelovi Dupixent napunjene brizgalice prikazani su na sljedećoj slici.
English: Table 8: Additional secondary endpoint results of dupilumab monotherapy at Week 16
Croatian: Tablica 8: Rezultati za dodatne sekundarne mjere ishoda u 16. tjednu kod monoterapije dupilumabom
English: • Do not freeze the pre-filled pen.
Croatian: • Nemojte zamrzavati napunjenu brizgalicu.
English: Specific metabolism studies were not conducted because dupilumab is a protein.
Croatian: Budući da je dupilumab protein, nisu provedena specifična ispitivanja metabolizma.
English: • An initial dose of 400 mg (two 200 mg injections), followed by 200 mg given every other week administered as subcutaneous injection.
Croatian: • početna doza od 400 mg (dvije injekcije od 200 mg), nakon koje slijedi doza od 200 mg svaki drugi tjedan supkutanom injekcijom.
English: A significantly larger proportion of patients administered dupilumab groups had clinically meaningful reductions in POEM and DLQI total score (each defined as ≥ 4 points improvement) from baseline to week 16 compared to placebo group.
Croatian: značajno je veći udio bolesnika koji su primali dupilumab ostvario klinički važna smanjenja ukupnog POEM i DLQI rezultata (oba definirana kao poboljšanja za ≥ 4 boda) od početka ispitivanja do 16. tjedna.
English: LS = least squares aIn the primary analyses of the efficacy endpoints, patients who received rescue treatment or with missing data were considered non-responders.
Croatian: LS = metoda najmanjih kvadrata a U primarnim analizama mjera ishoda za djelotvornost, bolesnici koji su primili terapiju za hitno ublažavanje simptoma ili za koje su nedostajali podaci smatrali su se bolesnicima bez odgovora.
English: The baseline mean EASI score was 32.5, the baseline weekly pruritus NRS was 7.3, the baseline mean SCORAD score was 66.4, the baseline mean POEM score was 20.1, the baseline mean DLQI was 14.5, and the baseline mean HADS total score was 12.7.
Croatian: Početna srednja vrijednost EASI rezultata iznosila je 32,5, početni tjedni NRS rezultat za pruritus bio je 7,3, početna srednja vrijednost SCORAD rezultata iznosila je 66,4, početna srednja vrijednost POEM rezultata 20,1, početna srednja vrijednost DLQI rezultata 14,5, a početna srednja vrijednost ukupnog
English: Read the “Instructions for Use” for the pre-filled pen carefully before using Dupixent.
Croatian: Pažljivo pročitajte ‘Upute za uporabu' napunjene brizgalice prije nego što primijenite Dupixent.