FrancophonIA/ELRC3.0 huggingface dataset:
English: QUEST: Blood Eosinophils ≥ 300 cells/mcL
Slovenian: QUEST: Eozinofilci v krvi ≥ 300 celic/mcl
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.
Slovenian: 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.
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.
Slovenian: 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.
English: Hepatic impairment No data are available in patients with hepatic impairment (see section 5.2).
Slovenian: Podatkov o bolnikih z okvaro jeter ni (glejte poglavje 5.2).
English: Dupilumab was administered by subcutaneous (SC) injection.
Slovenian: Dupilumab so uporabljali v subkutanih (s.c.) injekcijah.
English: ≥ 150 cells/mcL ≥ 300 cells/mcL
Slovenian: ≥ 150 celic/mcl ≥ 300 celic/mcl
English: Dupilumab 300 mg Q2W N=57
Slovenian: Dupilumab 300 mg vsak drugi teden N=57
English: Table 4: Efficacy results of dupilumab in the adolescent atopic dermatitis study at Week 16 (FAS)
Slovenian: Preglednica 4: Rezultati o učinkovitosti dupilumaba v študiji pri mladostnikih z atopijskim dermatitisom po 16 tednih (celotni nabor za analizo)
English: N Rate (95% CI)
Slovenian: N Delež (95% IZ)
English: QUEST: Blood Eosinophils ≥ 150 cells/mcL
Slovenian: QUEST: Eozinofilci v krvi ≥ 150 celic/mcl
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)
Slovenian: 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)
English: • Multipack containing 6 (3 packs of 2) pre-filled syringes
Slovenian: • Skupno pakiranje s 6 (3 pakiranja po 2) napolnjenimi injekcijskimi brizgami
English: Gender was not found to be associated with any clinically meaningful impact on the systemic exposure of dupilumab determined by population PK analysis.
Slovenian: Spol ni bil povezan s kakšnim klinično pomembnim vplivom na sistemsko izpostavljenost dupilumabu, ugotovljeno s populacijsko FK analizo.
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.
Slovenian: 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).
English: Dupilumab 300 mg Q2W N=48
Slovenian: Dupilumab 300 mg vsak drugi teden N=48
English: Q4W N=86
Slovenian: vsak 4 teden N = 86
English: Adults with atopic dermatitis
Slovenian: Odrasli z atopijskim dermatitisom
English: Dupixent is a clear to slightly opalescent, colourless to pale yellow solution supplied in a pre-filled syringe.
Slovenian: Zdravilo Dupixent je bistra do rahlo opalescentna, brezbarvna do bledo rumena raztopina v napolnjenem injekcijskem peresniku.
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.
Slovenian: Protitelesa proti dupilumabu so se pojavila pri približno 9 % bolnikov z astmo, ki so 52 tednov prejemali 200 mg dupilumaba vsaka 2 tedna; približno 4 % bolnikov so imeli trajen odziv ADA in približno 4 % so imeli nevtralizacijska protitelesa.
English: Each syringe contains one dose of Dupixent (300 mg).
Slovenian: Ena injekcijska brizga vsebuje en odmerek zdravila Dupixent (300 mg).
English: Adolescents with atopic dermatitis
Slovenian: Mladostniki z atopijskim dermatitisom
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.
Slovenian: Izhodiščna povprečna ocena EASI je bila 33,0, izhodiščna tedensko povprečena ocena srbenja NRS 7,4, izhodiščna povprečna ocena SCORAD 67,8, izhodiščna povprečna ocena POEM 20,5, izhodiščni povprečni DLQI 15,0 in izhodiščna povprečna celotna ocena
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.
Slovenian: 2 tedna 107 ± 51,6 mcg/ml in med uporabo 200 mg na 2 tedna 46,7 ± 26,9 mcg/ml.
English: 1 pre-filled pen 2 pre-filled pens 3 pre-filled pens 6 pre-filled pens
Slovenian: 1 napolnjen injekcijski peresnik 2 napolnjena injekcijska peresnika 3 napolnjeni injekcijski peresniki 6 napolnjenih injekcijskih peresnikov
English: In the 52-week atopic dermatitis CHRONOS study, serious infections were reported in 0.6 % of patients treated with placebo and 0.2 % of patients treated with dupilumab.
Slovenian: tedenski študiji CHRONOS so o resnih okužbah poročali pri 0,6 % bolnikov, ki so prejemali placebo,
English: Figure 4: Mean percent change from baseline in NRS in CHRONOSa (FAS Week 52)b
Slovenian: Slika 4: Povprečna odstotna sprememba ocene NRS od izhodišča v študiji CHRONOSa (FAS
English: Sanofi Belgium
Slovenian: SANOFI BULGARIA EOOD
English: A reduction of lactate dehydrogenase (LDH), a biomarker associated with AD disease activity and severity, was observed with dupilumab treatment.
Slovenian: biološkega označevalca, povezanega z bolezensko aktivnostjo in izrazitostjo AD.
English: Table 4: Efficacy results of dupilumab monotherapy at week 16 (FAS)
Slovenian: Preglednica 4: Rezultati učinkovitosti monoterapije z dupilumabompo 16 tednih (FAS)
English: Dupixent 300 mg syringe
Slovenian: Dupixent 300 mg brizga
English: • Do not re-use the pre-filled pen.
Slovenian: • Napolnjenega injekcijskega peresnika ne uporabite ponovno.
English: Very rare cases of serum sickness/serum sickness-like reactions have been reported in the atopic dermatitis development program following the administration of dupilumab.
Slovenian: V kliničnih preskušanjih so po uporabi dupilumaba v programu razvoja pri atopijskem dermatitisu poročali o zelo redkih primerih serumske bolezni/serumski bolezni podobne reakcije.
English: • Do not freeze the pre-filled pen.
Slovenian: • Napolnjenega injekcijskega peresnika ne zamrznite.
English: Do not place the syringe in direct sunlight.
Slovenian: Brizge ne izpostavljajte neposredni sončni svetlobi.
English: These reductions in type 2 inflammatory biomarkers were comparable for the 200 mg Q2W and 300 mg Q2W regimens.
Slovenian: Znižanja bioloških označevalcev vnetja tipa 2 so bila s shemama 200 mg vsaka dva tedna in 300 mg vsaka dva tedna primerljiva.
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.
Slovenian: 1,14 ml raztopine v silikonizirani napolnjeni injekcijski brizgi s ščitnikom igle ali napolnjenem injekcijskem peresnikom iz stekla tipa 1 s fiksno nameščeno iglo iz nerjavnega jekla s tanko steno, G
English: Also at baseline the mean Eczema Area and Severity Index (EASI) score was 35.5, the baseline weekly averaged pruritus Numerical Rating Scale (NRS) was 7.6, the baseline mean SCORing Atopic Dermatitis (SCORAD) score was 70.3, the baseline mean Patient Oriented Eczema Measure (POEM) score was 21.0, and the baseline mean Children Dermatology
Slovenian: Poleg tega je bila izhodiščna povprečna ocena EASI (Eczema Area and Severity Index) 35,5 %, izhodiščna tedenska povprečena ocena srbenja NRS (Numerical Rating Scale) 7,6, izhodiščna povprečna ocena SCORAD (SCORing Atopic
English: Dupixent 200 mg solution for injection in pre-filled syringe Dupixent 200 mg solution for injection in pre-filled pen
Slovenian: Dupixent 200 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Dupixent 200 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: EASI-75, % respondersd
Slovenian: EASI-75, % odzivnihd
English: Table 9: Mean Change from Baseline in Pre-Bronchodilator FEV1 at Week 12 and Week 52 in QUEST by Baseline FeNO Subgroups
Slovenian: Preglednica 9: Povprečna sprememba FEV1 pred bronhodilatatorjem po 12. in po 52. tednih v primerjavi z izhodiščem glede na podskupini izhodiščnega diNO v študiji QUEST
English: A total of 107 adolescents aged 12 to 17 years with asthma were enrolled in QUEST study.
Slovenian: V študijo QUEST je bilo vključenih skupno 107 mladostnikov, starih od 12 do 17 let, z zmerno do hudo astmo.
English: - Each pre-filled syringe contains 300 mg of dupilumab in 2 ml solution for injection (injection).
Slovenian: - Ena napolnjena injekcijska brizga vsebuje 300 mg dupilumaba v 2 ml raztopine za injiciranje (injekciji).
English: Table 15: Mean Change from Baseline in Pre-Bronchodilator FEV1 at Week 12 and Week 52 in QUEST by Baseline FeNO Subgroups
Slovenian: Preglednica 15: Povprečna sprememba FEV1 pred bronhodilatatorjem po 12. in po 52. tednih v primerjavi z izhodiščem glede na podskupini izhodiščnega diNO v študiji QUEST
English: Read the “Instructions for Use” for the syringe carefully before using Dupixent.
Slovenian: Pred uporabo zdravila Dupixent natančno preberite "Navodila za uporabo" injekcijske brizge.
English: For adolescents 12 to 17 years of age with atopic dermatitis receiving every other week dosing (Q2W) with either 200 mg (<60 kg) or 300 mg (≥60 kg), the mean ±SD steady state trough concentration of dupilumab was 54.5±27.0 mcg/ml.
Slovenian: 60 kg) ali 300 mg (≥ 60 kg) vsak drugi teden, je bila povprečna najnižja koncentracija dupilumaba v stanju dinamičnega ravnovesja (± standardni odklon) 54,5 ± 27,0 mcg/ml.
English: A total of 107 adolescents aged 12 to 17 years with asthma were enrolled in the 52 week QUEST study.
Slovenian: V 52-tedensko študijo QUEST je bilo skupno vključenih 107 mladostnikov z astmo, starih od 12 do 17 let.
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).
Slovenian: Večje zmanjšanje poslabšanj je bilo pri preiskovancih, ki so imeli višje izhodiščne ravni vnetnih bioloških označevalcev kot so eozinofilci v krvi ali diNO (preglednica 6 in preglednica 7).
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.
Slovenian: Pri atopijskem dermatitisu je priporočeni prvi odmerek 600 mg (dve 300-mg injekciji), nato pa 300 mg v podkožni injekciji na dva tedna.
English: Q2W/QW N=169
Slovenian: vsak 2 teden/vsak tedenVT N = 169
English: Talk to your doctor, pharmacist or nurse before using Dupixent:
Slovenian: Pred začetkom uporabe zdravila Dupixent se posvetujte z zdravnikom, farmacevtom ali z medicinsko sestro:
English: If the carton needs to be removed permanently from refrigerator,
Slovenian: Če morate škatlo za stalno vzeti iz hladilnika, zapišite datum, ko ste jo vzeli iz hladilnika,
English: Dupixent contains the active substance dupilumab.
Slovenian: Zdravilo Dupixent vsebuje zdravilno učinkovino dupilumab.
English: A total of 2,888 adult and adolescent patients with moderate-to-severe asthma were evaluated in 3 randomised, placebo-controlled, multicentre trials of 24 to 52 weeks duration (DRI12544, QUEST, and VENTURE).
Slovenian: Program razvoja pri astmi je obsegal tri randomizirane, dvojno slepe, s placebom kontrolirane multicentrične študije vzporednih skupin (DRI12544, QUEST in VENTURE).
English: Table 7: Rate of Severe Exacerbations in QUEST Defined by Baseline FeNO Subgroups
Slovenian: Preglednica 13: Delež hudih poslabšanj v QUEST, opredeljeno po podskupinah izhodiščnega deleža izdihanega dušikovega oksida (diNO)
English: • Do not place the pre-filled pen into direct sunlight.
Slovenian: • Ne izpostavljajte napolnjenega injekcijskega peresnika neposredni sončni svetlobi.
English: Dispose of the syringe and the needle cap in a puncture-resistant container.
Slovenian: Brizgo in pokrovček igle varno zavrzite v vsebnik, odporen proti prebadanju.
English: Do not put the pre-filled pen into direct sunlight.
Slovenian: Ne polagajte napolnjenega injekcijskega peresnika na neposredno sončno svetlobo.
English: Solution for injection 1 pre-filled syringe with needle shield 2 pre-filled syringes with needle shield
Slovenian: raztopina za injiciranje 1 napolnjena injekcijska brizga s ščitnikom igle
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).
Slovenian: Večje zmanjšanje poslabšanj je bilo pri preiskovancih, ki so imeli višje izhodiščne ravni vnetnih bioloških označevalcev kot so eozinofilci v krvi ali diNO (preglednica 12 in preglednica 13).
English: All p-values <0.0001
Slovenian: Vse vrednosti p so < 0,0001.
English: Adverse Reaction
Slovenian: odzivnih
English: Each pre-filled syringe contains 300 mg of dupilumab in 2 ml solution (150 mg/ml).
Slovenian: Ena napolnjena injekcijska brizga vsebuje 300 mg dupilumaba v 2 ml raztopine (150 mg/ml).
English: Q8W N=84
Slovenian: vsak 8 teden N = 84
English: Figure 3: Mean percent change from baseline in EASI in CHRONOSa (FAS Week 52)b
Slovenian: Slika 3: Povprečna odstotna sprememba ocene EASI od izhodišča v študiji CHRONOSa (FAS
English: How to store Dupixent
Slovenian: Shranjevanje zdravila Dupixent
English: Dupilumab was administered by subcutaneous (SC) injection in all studies.
Slovenian: Dupilumab so v vseh študijah uporabljali v subkutanih
English: Pre-filled syringe with needle shield 200 mg
Slovenian: Napolnjena injekcijska brizga s ščitnikom igle 200 mg
English: C. Give injection C1.
Slovenian: (s.c.) injekcijah.
English: Pre-filled syringe 300 mg
Slovenian: Napolnjena injekcijska brizga 300 mg
English: Age was not found to be associated with any clinically meaningful impact on the systemic exposure of dupilumab determined by population PK analysis.
Slovenian: Starost ni bila povezana s kakšnim klinično pomembnim vplivom na sistemsko izpostavljenost dupilumabu, ugotovljeno s populacijsko FK analizo.
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.
Slovenian: Pri odraslih bolnikih, ki so sodelovali v programu razvoja pri astmi, so poročali o primerih eozinofilne pljučnice in primerih vaskulitisa, ki so ustrezali eozinofilni granulomatozi s poliangiitisom.
English: The efficacy and safety of dupilumab as monotherapy and with concomitant topical corticosteroids were evaluated in three pivotal randomised, double-blind, placebo-controlled studies (SOLO 1, SOLO 2, and CHRONOS) in 2,119 patients 18 years of age and older with moderate to severe atopic dermatitis (AD) defined by Investigator's Global Assessment (IGA) score ≥ 3, an Eczema Area and
Slovenian: Učinkovitost in varnost dupilumaba kot monoterapije in med sočasno uporabo lokalnih kortikosteroidov so ocenili v treh ključnih randomiziranih, dvojno slepih, s placebom kontroliranih študijah (SOLO 1, SOLO 2 in CHRONOS).
English: Percent reduction from baseline
Slovenian: Odstotek zmanjšanja PKS od izhodišča
English: Secondary endpoint (week 24)a Proportion of patients achieving a reduction of OCS dose to <5 mg/day
Slovenian: Brez zmanjšanja, kakršno koli povečanje odmerka PKS ali bolnik, izpadel iz študije Sekundarni opazovani dogodek (24. teden)a Delež bolnikov, ki so dosegli zmanjšanje odmerka PKS na < 5 mg/dan
English: Dupixent 200 mg pen
Slovenian: Dupixent 200 mg brizga
English: EU/1/17/1229/001 1 pre-filled syringe EU/1/17/1229/002 2 pre-filled syringes
Slovenian: EU/1/17/1229/001 1 napolnjena injekcijska brizga EU/1/17/1229/002 2 napolnjeni injekcijski brizgi
English: 2 pre-filled syringes
Slovenian: 2 napolnjeni injekcijski brizgi
English: EASI-90, % respondersc
Slovenian: EASI-90, % odzivnihc
English: EASI-50, % respondersd
Slovenian: EASI-50, % odzivnihd
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.
Slovenian: V študiji sočasne uporabe z LKS (CHRONOS) je tako 300 mg dupilumaba vsak drugi teden + LKS kot 300 mg dupilumaba vsak teden + LKS v primerjavi s placebom + LKS po 52 tednih značilno izboljšalo simptome in vpliv AD na spanje in zdravstveno kakovost življenja (merjeno s celotno oceno
English: Pre-filled syringe with needle shield 300 mg
Slovenian: Napolnjena injekcijska brizga s ščitnikom igle 300 mg
English: Table 12: Rate of Severe Exacerbations in DRI12544 and QUEST (Baseline Blood Eosinophil
Slovenian: Preglednica 12: Delež hudih poslabšanj v DRI12544 in QUEST (Število izhodiščnih eozinofilcev v krvi ≥ 150 ter ≥ 300 celic/mcl )
English: Table 6: Rate of Severe Exacerbations in DRI12544 and QUEST (Baseline Blood Eosinophil
Slovenian: Preglednica 6: Delež hudih poslabšanj v DRI12544 in QUEST (število izhodiščnih eozinofilcev v krvi ≥ 150 ter ≥ 300 celic/mcl)
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)
Slovenian: EU/1/17/1229/007 3 napolnjene injekcijske brizge s ščitnikom igle (3 pakiranja po 1) EU/1/17/1229/008 6 napolnjenih injekcijskih brizg s ščitnikom igle (3 pakiranja po 2)
English: Table 17: Effect of dupilumab on OCS dose reduction, VENTURE (Baseline Blood Eosinophil Levels
Slovenian: Preglednica 17: Učinek dupilumaba na zmanjšanje odmerka PKS, študija VENTURE (izhodiščna vrednost eozinofilcev v krvi ≥ 150 in ≥ 300 celic/mcl in diNO ≥ 25 ppb)
English: Package leaflet: Information for the user Dupixent 300 mg solution for injection in pre-filled syringe dupilumab This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Dupixent 300 mg raztopina za injiciranje v napolnjeni injekcijski brizgi dupilumab Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Headache
Slovenian: Brizga
English: AQLQ(S) Dupilumab 200 mg Q2W Placebo
Slovenian: AQLQ(S) Dupilumab 39
English: For the initial 600 mg dose, two 300 mg injections should be administered consecutively in different injection sites.
Slovenian: Za uvodni odmerek 600 mg je treba dati dve 300-mg injekciji zdravila Dupixent zapored na dve različni mesti.
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.
Slovenian: Prejemali so ali 200 mg (N = 21) ali 300 mg (N = 18) dupilumaba (ali ujemajočega se placeba 200 mg [N = 34] ali 300 mg [N = 34]) vsak drugi teden.
English: Step 8: Pinch
Slovenian: 8. korak: Stisnite kožo
English: EASI-75, % respondersc
Slovenian: EASI-75, % odzivnihc
English: Race was not found to be associated with any clinically meaningful impact on the systemic exposure of dupilumab by population PK analysis.
Slovenian: Rasa ni bila povezana s kakšnim klinično pomembnim vplivom na sistemsko izpostavljenost dupilumabu, ugotovljeno s populacijsko FK analizo.
English: Stop using Dupixent and tell your doctor or get medical help immediately if you notice any signs of an allergic reaction.
Slovenian: Če opazite kakršne koli znake alergijske reakcije, prenehajte uporabljati zdravilo Dupixent in se takoj posvetujte z zdravnikom oziroma takoj poiščite zdravniško pomoč.
English: Placebo Dupilumab 300 mg Q2W + TCS
Slovenian: Placebo Dupilumab 300 mg vsak drugi teden + LKS
English: This device is a single-use pre-filled pen.
Slovenian: Ta pripomoček je napolnjen injekcijski peresnik za enkratno uporabo.
English: - if you think you may be allergic, or you are not sure, ask your doctor, pharmacist or nurse for advice before using Dupixent.
Slovenian: - če menite, da bi lahko bili alergični, ali če ste negotovi, se pred začetkom uporabe zdravila
English: Step 1: Remove
Slovenian: 1. korak: Vzemite brizgo
English: QUEST study Dupilumab 200 mg Q2W
Slovenian: Študija QUEST Dupilumab2
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).
Slovenian: 52-tedenska študija s sočasnimi LKS (CHRONOS) V študiji CHRONOS je od izhodišča do 16. tedna in 52. tedna doseglo odziv IGA 0 ali 1, EASI-75 in/ali izboljšanje ocene srbenja NRS za > 4 točke značilno več bolnikov, ki so prejemali 300 mg dupilumaba vsak drugi teden + LKS, kot tistih, ki so prejemali placebo + LKS (glejte preglednico 5).
English: EOS ≥ 150 cells/mcL
Slovenian: EOS ≥150 celic/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).
Slovenian: Dupilumab 200 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga za enkratno uporabo vsebuje 200 mg dupilumaba v 1,14 ml raztopine (175 mg/ml).
English: - Each pre-filled syringe contains 200 mg of dupilumab in 1.14 ml solution for injection (injection).
Slovenian: - Ena napolnjena injekcijska brizga vsebuje 200 mg dupilumaba v 1,14 ml raztopine za injiciranje (injekciji).
English: The safety profile observed in adolescents aged 12 to 17 years in atopic dermatitis clinical trials was similar to that seen in adults.
Slovenian: Pediatrična populacija Varnostne značilnosti v kliničnih preskušanjih atopijskega dermatitisa pri mladostnikih od 12. do 17.
English: FeNO ≥ 25 ppb
Slovenian: diNO ≥ 25 ppb
English: Do not shake the syringe.
Slovenian: • Brizge ne zamrzujte.
English: Each pre-filled syringe contains one dose of Dupixent (200 mg).
Slovenian: En injekcijski peresnik vsebuje en odmerek zdravila Dupixent (200 mg).
English: Keep the container out of sight and reach of children.
Slovenian: Vsebnik shranjujte nedosegljiv otrokom!
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.
Slovenian: Celotna ocena POEM in DLQI sta se od izhodišča do 16. tedna v primerjavi s placebom klinično pomembno zmanjšali (pri obeh je bilo to opredeljeno kot izboljšanje za ≥ 4 točke) pri značilno večjem deležu bolnikov v skupinah z dupilumabom.
English: Package leaflet: Information for the user Dupixent 200 mg solution for injection in pre-filled syringe dupilumab This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Dupixent 200 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku dupilumab Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Systemic, topical, or inhaled corticosteroids should not be discontinued abruptly upon initiation of therapy with dupilumab.
Slovenian: Po uvedbi dupilumaba se uporabe sistemskih, lokalnih ali inhalacijskih kortikosteroidov ne sme prekiniti nenadoma.
English: Exacerbations
Slovenian: Izboljšanja