natgillin/translations-raw huggingface dataset:
Dupilumab, as a monoclonal antibody, is not expected to undergo significant hepatic elimination. 
Ni pričakovati, da bi bil dupilumab, ki je monoklonsko protitelo, podvržen bistvenemu odstranjevanju skozi jetra.
Do not inject into skin that is tender, damaged or has bruises or scars. 
Ne injicirajte v kožo, ki je občutljiva, poškodovana, ima modrice ali je zabrazgotinjena.
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. 
Zdravilo Dupixent je indicirano za dodatno vzdrževalno zdravljenje hude astme z vnetjem tipa 2 z značilno povišanim številom krvnih eozinofilcev in/ali s povišanim deležem izdihanega dušikovega oksida (diNO) (glejte poglavje 5.1) pri odraslih in mladostnikih, starih 12 let ali več, ki bolezni nimajo ustrezno urejene z velikimi odmerki inhalacijskega kortikosteroida (IKS) in še enim zdravilom za vzdrževalno zdravljenje.
Physicians should be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients with eosinophilia. 
Pri bolnikih z eozinofilijo morajo biti zdravniki pozorni na vaskulitičen izpuščaj, poslabšanje pljučnih simptomov, srčne zaplete in ali nevropatijo.
In the pooled analysis of DRI12544 and QUEST, hospitalizations and/or emergency room visits due to severe exacerbations were reduced by 25.5% and 46.9% with dupilumab 200 mg or 300 mg every other week, respectively. 
V združeni analizi študij DRI12544 in QUEST so se ob aplikaciji 200 mg oziroma 300 mg dupilumaba vsak drugi teden hospitalizacije in/ali obiski urgence zaradi hudih poslabšanj zmanjšali za 25,5 % oziroma 46,9 %.
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. 
Študija SOLO 2 je zajela 708 bolnikov (236 na placebu, 233 na dupilumabu 300 mg vsak drugi teden in 239 na dupilumabu 300 mg vsak teden) in je imela 16-tedensko obdobje zdravljenja.
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. 
Slika 3 in slika 4 prikazujeta povprečno odstotno spremembo EASI (slika 3) in povprečno odstotno spremembo NRS (slika 4) od izhodišča do 52. tedna v študiji CHRONOS.
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). 
V post hoc analizi podskupine bolnikov, ki so imeli izhodiščno oceno na podlestvici HADS-anksioznost ali HADSdepresija ≥ 8 (mejna vrednost za anksioznost ali depresijo), je po 52 tednih dosegel oceno HADSanksioznost in HADS-depresija < 8 značilno večji delež bolnikov v skupinah s 300 mg dupilumaba vsak drugi teden + LKS in 300 mg dupilumabavsak teden + LKS kot s placebom + LKS (glejte preglednico 9).
Table 3: List of adverse reactions in asthma MedDRA System 
Preglednica 3: Seznam neželenih učinkov pri astmi
Hold firmly 
C4. Držite trdno
• Do not keep pre-filled pens at room temperature (<25ºC) for more than 14 days. 
• Napolnjenih injekcijskih peresnikov ne shranjujte na sobni temperaturi (< 25 °C) več kot 14
For single use only Subcutaneous use 
Samo za enkratno uporabo.
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. 
Soprimarni opazovani dogodki so bili: razliki odstotne spremembe EASI od izhodišča (0. tedna) do 36. tedna v študijah SOLO 1 in SOLO 2 in odstotek bolnikov z izhodiščnim EASI-75, ki so imeli EASI-75
• Read all of the instructions carefully before using the syringe. 
• Pred uporabo brizge natančno in v celoti preberite navodila za uporabo.
After optimizing the OCS dose during the screening period, patients received 300 mg dupilumab (n=103) or placebo (n=107) once every other week for 24 weeks following an initial dose of 600 mg or placebo. 
Po optimizaciji odmerka peroralnega kortikosteroida med obdobjem presejanja so bolniki po uvodnem odmerku 600 mg dupilumaba ali placeba 24 tednov prejemali 300 mg dupilumaba (n = 103) ali placeba (n = 107) enkrat na dva tedna.
Step 3: Inspect 
3. korak: Preglejte zdravilo
The instructions for the preparation and administration of Dupixent in a pre-filled syringe or in a prefilled pen are given in the package leaflet. 
Navodila za pripravo in dajanje zdravila Dupixent v napolnjeni injekcijski brizgi ali v napolnjenem injekcijskem persniku so navedena v navodilu za uporabo zdravila.
• Do not heat the syringe. 
• Brizge ne segrevajte.
A decision must be made whether to discontinue breast-feeding or to discontinue dupilumab therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. 
Odločiti se je treba ali za prenehanje dojenja ali za prenehanje zdravljenja z dupilumabom,
Solution for injection 1 pre-filled syringe 2 pre-filled syringes 
raztopina za injiciranje 1 napolnjena injekcijska brizga 2 napolnjeni injekcijski brizgi
The efficacy results at week 16 for adolescent atopic dermatitis study are presented in Table 10. 
Rezultati o učinkovitosti v študiji pri mladostnikih z atopijskim dermatitisom po 16 tednih so prikazani v preglednici 10.
• Never pull back on the plunger rod. 
• Bata brizge nikoli ne vlecite ven.
Table 10: ACQ-5 and AQLQ(S) Responder Rates at Week 52 in QUEST 
Preglednica 10: Deleži odziva po ACQ-5 in AQLQ(S) po 52. tednih zdravljenja v študiji QUEST
The efficacy results at week 16 for adolescent atopic dermatitis study are presented in Table 4. 
Rezultati o učinkovitosti v študiji pri mladostnikih z atopijskim dermatitisom po 16 tednih so prikazani v preglednici 4.
b Responder was defined as a subject with IGA 0 or 1 (“clear” or “almost clear”) with a reduction of ≥2 points on a 0-4 IGA scale. 
b Kot odzivni so bili opredeljeni preiskovanci z oceno IGA 0 ali 1 ("čisto" ali "skoraj čisto") z zmanjšanjem na lestvici IGA 0-4 za ≥ 2 točki.
Dupixent contains sodium 
Zdravilo Dupixent vsebuje natrij
Excipients: arginine hydrochloride, histidine, polysorbate 80, sodium acetate, glacial acetic acid, sucrose, water for injections. 
Pomožne snovi: argininijev klorid, histidin, polisorbat 80, natrijev acetat, ledocetna kislina, saharoza, voda za injekcije.
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. 
V kliničnih preskušanjih je bila najnižja koncentracija (povprečje ± standardni odklon) v stanju dinamičnega ravnovesja, med uporabo odmerka 300 mg vsak drugi teden od 60,3±35,1 mcg/ml do 79,9 ± 41,4 mcg/ml, med uporabo odmerka 200 mg vsak drugi teden pa od 29,2±18,7 do 36,5±22,2 mcg/ml Porazdelitev
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. 
ADA so se pojavila pri približno 6 % bolnikov z atopijskim dermatitisom ali astmo, ki so 52 tednov prejemali 300 mg dupilumaba vsaka dva tedna; približno 2 % bolnikov sta imela trajen odziv ADA in približno 2 % sta imela nevtralizacijska protitelesa.
Do not heat the syringe. 
Brizge ne segrevajte.
• eye dryness, redness and itching 
• suhost, pordelost in srbenje oči
No clinical studies have been conducted to evaluate the effect of renal impairment on the pharmacokinetics of dupilumab. 
Kliničnih študij za ovrednotenje vpliva okvare ledvic na farmakokinetiko dupilumaba niso izvedli.
Injection site erythema Injection site oedema Injection site pain Injection site pruritus 
Eritem na mestu injiciranje Edem na mestu injiciranja
Very rare cases of serum sickness/serum sickness-like reactions and anaphylactic reaction have been reported following administration of dupilumab (see section 4.4). 
Po uporabi dupilumaba so poročali o zelo redkih primerih serumske bolezni/serumski bolezni podobnih reakcijah in anafilaktični reakciji (glejte poglavje 4.4).
Table 9: Other secondary endpoint results of dupilumab with concomitant TCS at Week 16 and Week 52 in CHRONOS 
Preglednica 9: Rezultati drugih sekundarnih opazovanih dogodkov dupilumabaskupaj s sočasnimi LKS po 16. in 52. tednih v študiji CHRONOS Sočasna uporaba LKS
Results were evaluated in the overall population (unrestricted by minimum baseline eosinophils or other type 2 inflammatory biomarkers) and subgroups based on baseline blood eosinophils count. 
Rezultate so ovrednotili v celotni populaciji (ki ni bila omejena z najmanjšo izhodiščno vrednostjo eozinofilcev ali drugih bioloških označevalcev vnetja tipa 2) in v podskupinah glede na izhodiščno število eozinofilcev v krvi.
Do not put the yellow cap back on. 
Rumenega pokrovčka ne nameščajte nazaj na peresnik.
If necessary, pre-filled syringes or pre-filled pens may be kept at room temperature up to 25°C for a maximum of 14 days. 
Če je treba, je mogoče napolnjene injekcijske brizge ali napolnjene injekcijske peresnike shranjevati na sobni temperaturi do 25 °C največ 14 dni.
This device is a single-use pre-filled syringe. 
Ta pripomoček je napolnjena injekcijska brizga za enkratno uporabo.
LS Mean Difference vs. placebo (95% CI) 
LS v primerjavi s placebom (95 % IZ)
Severity Index (EASI) score ≥16, and a minimum body surface area (BSA) involvement of ≥ 10 %. 
Investigator's Global Assessment) ≥ 3, oceno prizadetosti ekcemskega predela (EASI - Eczema Area and Severity Index) ≥ 16 in zajetostjo ≥ 10 % telesne površine.
The instructions for the preparation and administration of Dupixent in a pre-filled syringe are given in the package leaflet. 
Navodila za pripravo in dajanje zdravila Dupixent v napolnjeni injekcijski brizgi so navedena v navodilu za uporabo zdravila.
After the last steady state dose, the median time for dupilumab concentrations to decrease below the lower limit of detection, estimated by population PK analysis, was 9 weeks for the 200 mg Q2W, 1011 weeks for the 300 mg Q2W regimen and 13 weeks for the 300 mg QW regimen. 
Po zadnjem odmerku v stanju dinamičnega ravnovesja je bil s populacijsko FK analizo ocenjeni mediani čas, ko se je koncentracija dupilumaba zmanjšala pod spodnjo mejo zaznavne, je bil 9 tednov ob uporabi odmerka 200 mg vsak drugi teden, 10 -11 tednov ob uporabi odmerka 300 mg vsak drugi teden in 13 tednov po uporabi odmerka 300 mg vsak teden.
• fever 
• Stegno
Clinically significant increases in pre-bronchodilator FEV1 were observed at week 12 for DRI12544 and QUEST. 
Klinično pomembna povišanja FEV1 (FEV1 - Forced expiratory volume in 1 second) pred bronhodilatatorjem so bila opažena po 12. tednih v študijah DRI12544 in QUEST.
Parasitic (intestinal parasites) infection 
Okužbe z zajedavci (črevesnimi zajedavci)
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. 
V študijah monoterapije je bil delež bolnikov, ki so zdravljenje prenehali zaradi neželenih učinkov, v skupini s placebom 1,9 %, skupini s 300 mg dupilumaba vsaka dva tedna 1,9 % in v skupini s 300 mg dupilumaba vsak teden 1,5 %.
Dupilumab, as a monoclonal antibody, is not expected to undergo significant renal elimination. 
Ni pričakovati, da bi bil dupilumab, ki je monoklonsko protitelo, podvržen bistvenemu izločanju skozi ledvice.
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). 
mg vsak drugi teden, so opazili pomembno izboljšanje FEV1 (razlika v povprečju LS od izhodišča do 12. tedna) (0,36 l oziroma 0,27 l).
B. Choose your injection site B1. 
B. Izberite mesto injiciranja
Dupilumab 300 mg Q2W N=81 
Dupilumab 300 mg vsak drugi teden N=81
VENTURE was a 24-week oral corticosteroid-reduction study in 210 patients with asthma unrestricted by baseline type 2 biomarker levels who required daily oral corticosteroids in addition to regular use of high dose inhaled corticosteroids plus an additional controller. 
bolnikih z astmo (brez omejitev glede izhodiščne ravni bioloških označevalcev tipa 2), ki so morali dnevno uporabljati peroralne kortikosteroide poleg redne uporabe velikega odmerka inhalacijskih kortikosteroidov in še nekega dodatnega zdravila za obvladovanje.
The solution should be clear to slightly opalescent, colourless to pale yellow. 
Raztopina mora biti bistra do rahlo opalescentna, brezbarvna ali bledo rumena.
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. 
Zdravilo Dupixent, ki je na voljo v pakiranjih, ki vsebujejo po 1 ali po 2 napolnjeni 300 mg injekcijski brizgi, ali v pakiranjih, ki vsebujejo 3 (3 pakiranja po 1) ali 6 (3 pakiranja po 2) napolnjenih injekcijskih brizg.
Mean exacerbations in previous year ± SD 2.17 (2.14) High dose ICS use (%)a 
Povprečno število poslabšanj v prejšnjem letu ± std. odklon Uporaba visokoodmernih IKS (%)a
In the concomitant TCS study (CHRONOS), across all treatment groups, the mean age was 37.1, the mean weight was 74.5 kg, 39.7 % were female, 66.2 % were white, 27.2 % were Asian, and 4.6 % were black. 
37,1 leta, povprečna telesna masa 74,5 kg, 39,7 % je bilo žensk, 66,2 % je bilo belcev, 27,2 % Azijcev in 4,6 % črncev.
Results were evaluated in the overall population (unrestricted by minimum baseline eosinophils or other type 2 inflammatory biomarkers) and subgroups based on baseline blood eosinophil count. 
Rezultate so ovrednotili v celotni populaciji (ki ni bila omejena z najmanjšo izhodiščno vrednostjo eozinofilcev ali drugih bioloških označevalcev vnetja tipa 2) in v podskupinah glede na izhodiščno število eozinofilcev v krvi .
Very rare cases of serum sickness/serum sickness-like reactions have been reported in the atopic dermatitis development program (see section 4.4). 
V programu razvoja pri atopijskem dermatitisu so v zelo redkih primerih poročali o serumski bolezni/serumski bolezni podobnih reakcijah (glejte poglavje 4.4).
• An initial dose of 400 mg (two 200 mg injections), followed by 200 mg given every other week administered as subcutaneous injection. 
• Začetni odmerek 400 mg (dve 200-mg injekciji) in nato 200 mg v subkutani injekciji vsak drugi teden.
In the overall population in DRI12544 and QUEST subjects receiving either dupilumab 200 mg or 300 mg every other week had significant reductions in the rate of severe asthma exacerbations compared to placebo. 
QUEST, ki so prejemali ali 200 mg ali 300 mg dupilumaba vsak drugi teden, značilno zmanjšal v primerjavi s placebom.
Relax the pinch. 
Izpustite gubo.
Marketing Authorisation Holder sanofi-aventis groupe 54, rue La Boétie 75008 Paris France 
Imetnik dovoljenja za promet sanofi-aventis groupe 54, rue La Boétie 75008 Pariz Francija
d Patients who received rescue treatment or with missing data were considered as non-responders. 
d Bolniki, ki so prejeli rešilno zdravljenje, in bolniki z manjkajočimi podatki so bili ocenjeni kot neodzivni.
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. 
Eczema Measure), indeksa DLQI (Dermatology Life Quality Index) in ocene HADS (Hospital Anxiety and Depression Scale) od izhodišča do 16. tedna.
If needed to control intolerable symptoms, patients were permitted to receive rescue treatment at the discretion of the investigator. 
Bolniki so smeli po raziskovalčevi presoji dobiti rešilno zdravljenje, če je bilo to potrebno za obvladanje neznosnih simptomov.
No dose adjustment for body weight is recommended for patients with asthma 12 years of age and older or in adults with atopic dermatitis (see section 5.2). 
Bolnikom z astmo, starim 12 let ali več, in odraslim z atopijskim dermatitisom odmerka ni treba prilagoditi glede na telesno maso (glejte poglavje 5.2).
• Do not place the syringe into direct sunlight. 
• Brizge ne izpostavljajte neposredni sončni svetlobi.
LS = least squares; SE = standard error a All patients were on background topical corticosteroids therapy and patients were permitted to use topical calcineurin inhibitors. 
a Vsi bolniki so prejemali osnovno zdravljenje z lokalnimi kortikosteroidi in bolniki so smeli uporabljati lokalne zaviralce kalcinevrina.
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). 
V študijah SOLO 1 in SOLO 2 je od izhodišča do 16. tedna doseglo odziv IGA 0 ali 1, EASI-75 in/ali izboljšanje ocene srbenja NRS za ≥ 4 točke značilno več bolnikov, ki so prejemali dupilumab, kot tistih, ki so prejemali placebo (glejte preglednico 4).
Table 10: Efficacy results of dupilumab in the adolescent atopic dermatitis study at Week 16 (FAS) 
Preglednica 10: Rezultati o učinkovitosti dupilumaba v študiji pri mladostnikih z atopijskim dermatitisom po 16 tednih (celotni nabor za analizo)
Patients received 1) an initial dose of 400 mg dupilumab (two 200 mg injections) on day 1, followed by 200 mg once every other week (Q2W) for patients with baseline weight of <60 kg or an initial dose of 600 mg dupilumab (two 300 mg injections) on day 1, followed by 300 mg Q2W for patients with baseline weight of ≥ 60 kg; 2) an initial dose of 600 mg dupilumab (two 300 mg injections) on day 1, followed by 300 mg every 4 weeks (Q4W) regardless of baseline body weight; or 3) matching placebo. 
200 mg vsaka dva tedna v primeru izhodiščne telesne mase < 60 kg, ali začetni odmerek 600 mg dupilumaba (dve 300-mg injekciji) 1. dan in nato 300 mg vsaka 2 tedna v primeru izhodiščne telesne mase ≥ 60 kg, ali (2) začetni odmerek 600 mg dupilumaba (dve 300-mg injekciji) 1. dan in nato 300 mg vsake 4 tedne ne glede na izhodiščno telesno maso, ali (3) ujemajoč se placebo.
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. 
Izhodiščna povprečna ocena EASI je bila 32,5, izhodiščna tedenska ocena srbenja NRS 7,3, izhodiščna povprečna ocena SCORAD 66,4, izhodiščna povprečna ocena POEM 20,1, izhodiščni povprečni DLQI 14,5 in izhodiščna povprečna celotna ocena HADS 12,7.
• Then lift the pen up off the skin, your injection is complete. 
• Nato dvignite peresnik navzgor s kože.
Patients randomised 
Randomizirani bolniki
If necessary, pre-filled syringes may be kept at room temperature up to 25°C for a maximum of 14 days. 
Če je treba, je mogoče napolnjene injekcijske brizge shranjevati na sobni temperaturi do 25 °C največ 14 dni.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA
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. 
V študiji s sočasno uporabo LKS je bil delež bolnikov, ki so zdravljenje prenehali zaradi neželenih učinkov, v skupini s placebom + LKS 7,6 %, skupini s 300 mg dupilumaba vsaka dva tedna + LKS 1,8 % in v skupini s 300 mg dupilumaba vsak teden + LKS 2,9 %.
• Multipack containing 3 (3 packs of 1) pre-filled syringes 
• Skupno pakiranje s 3 (3 pakiranja po 1) napolnjenimi injekcijskimi brizgami
An effect of dupilumab on the PK of co-administered medications is not expected. 
Ni pričakovati, da bi dupilumab vplival na farmakokinetiko sočasno uporabljenih zdravil.
Dupixent is given by injection under the skin (subcutaneous injection). 
Zdravilo Dupixent se daje z injekcijo pod kožo (subkutana injekcija).
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 
7 po NRS, n (%) †p < 0,05, *p < 0,01, **p < 0,001, ***p ≤ 0,0001
Mean age (years) (SD) % Female % White 
% žensk % belcev
EASI-90, % respondersd 
EASI-90, % odzivnihd
If necessary, pre-filled pens may be kept at room temperature up to 25°C for a maximum of 14 days. 
Če je treba, je mogoče napolnjene injekcijske peresnike shranjevati na sobni temperaturi do 25 °C največ 14 dni.
Figure 1: Mean percent change from baseline in EASI in SOLO 1a and SOLO 2a (FAS)b 
Slika 1: Povprečna odstotna sprememba ocene EASI v študijah SOLO 1a in SOLO 2a (FAS)b mNK = metoda najmanjših kvadratov.
QUEST: Blood Eosinophils ≥ 300 cells/mcL 
QUEST: Eozinofilci v krvi ≥ 300 celic/mcl
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. 
Izhodiščno je imelo izhodiščno oceno IGA 3 (zmeren AD) 46,2 % bolnikov in izhodiščno oceno IGA 4 (hud AD) 53,8 % bolnikov, povprečna zajetost telesne površine je bila 56,5 % in 42,4 % bolnikov je predhodno prejemalo sistemske imunosupresive.
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. 
Poleg tega je zdravljenje s 300 mg dupilumaba vsak drugi teden + LKS in s 300 mg dupilumaba vsak teden + LKS po 52 tednih v primerjavi s placebom + LKS zmanjšalo anksioznost in depresijo, merjeni s celotno oceno HADS.
Hepatic impairment No data are available in patients with hepatic impairment (see section 5.2). 
Podatkov o bolnikih z okvaro jeter ni (glejte poglavje 5.2).
Dupilumab was administered by subcutaneous (SC) injection. 
Dupilumab so uporabljali v subkutanih (s.c.) injekcijah.
≥ 150 cells/mcL ≥ 300 cells/mcL 
≥ 150 celic/mcl ≥ 300 celic/mcl
Dupilumab 300 mg Q2W N=57 
Dupilumab 300 mg vsak drugi teden N=57
Table 4: Efficacy results of dupilumab in the adolescent atopic dermatitis study at Week 16 (FAS) 
Preglednica 4: Rezultati o učinkovitosti dupilumaba v študiji pri mladostnikih z atopijskim dermatitisom po 16 tednih (celotni nabor za analizo)
N Rate (95% CI) 
N Delež (95% IZ)
QUEST: Blood Eosinophils ≥ 150 cells/mcL 
QUEST: Eozinofilci v krvi ≥ 150 celic/mcl
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) 
EU/1/17/1229/003 3 napolnjene injekcijske brizge (3 pakiranja po 1) EU/1/17/1229/004 6 napolnjenih injekcijskih brizg (3 pakiranja po 2)
• Multipack containing 6 (3 packs of 2) pre-filled syringes 
• Skupno pakiranje s 6 (3 pakiranja po 2) napolnjenimi injekcijskimi brizgami
Gender was not found to be associated with any clinically meaningful impact on the systemic exposure of dupilumab determined by population PK analysis. 
Spol ni bil povezan s kakšnim klinično pomembnim vplivom na sistemsko izpostavljenost dupilumabu, ugotovljeno s populacijsko FK analizo.
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. 
Po začetnem odmerku 400 mg ali 600 mg zdravila Dupixent oziroma ustreznega placeba so bili bolniki randomizirani na prejemanje zdravila Dupixent v odmerku bodisi 200 mg (N=631) bodisi 300 mg (N=633) vsak drugi teden (oziroma placeba v odmerku 200 mg (N=317) ali 300 mg (N=321) vsak drugi teden).
Dupilumab 300 mg Q2W N=48 
Dupilumab 300 mg vsak drugi teden N=48