natgillin/translations-raw huggingface dataset:
2 ml solution in a siliconised type-1 clear glass pre-filled syringe with or without needle shield, with a fixed 27 gauge 12.7 mm (½ inch), thin wall stainless steel staked needle.
2 ml raztopine v silikonizirani napolnjeni injekcijski brizgi iz stekla tipa 1 s ščitnikom igle ali brez njega ter s fiksno nameščeno iglo iz nerjavnega jekla s tanko steno, številka 27 dolžine 12,7 mm (½
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%.
randomizirani, dvojno slepi, s placebom nadzorovani študiji (AD-1526) pri 251 mladostnikih z zmernim do hudim atopijskim dermatitisom (AD), starih od 12 do 17 let, ki so imeli oceno IGA (Investigator's Global Assessment) ≥ 3 na celotni oceni lezij AD na lestvici izrazitosti od 0 do 4, oceno prizadetosti ekcemskega predela EASI (Eczema Area and Severity Index) ≥ 16 na lestvici od
• If somebody else gives you the injection, they can also use your upper arm.
• Če vam zdravilo injicira nekdo drug, lahko uporabi tudi zunanji del nadlakta.
• Do not use the syringe if the needle cap is missing or not securely attached.
• Ne uporabite brizge, če ji pokrovček igle manjka ali ni trdno nameščen.
A caregiver may also give you your Dupixent injection after proper training.
Zdravilo Dupixent vam lahko po ustreznem usposabljanju injicira tudi oseba, ki skrbi za vas
Baseline characteristics are presented in Table 5.
Izhodiščne značilnosti so prikazane v Preglednici 5.
b Full analysis set (FAS) includes all patients randomized.
b Celotni nabor za analizo (FAS - full analysis set) vključuje vse randomizirane bolnike.
The ACQ-5 and AQLQ(S) responder rate results in patients with elevated baseline biomarkers of type 2 inflammation in QUEST at week 52 are presented in Table 10.
Rezultati deležev odziva po ACQ-5 in AQLQ(S) pri bolnikih s povišanimi izhodiščnimi vrednostmi bioloških označevalcev vnetja tipa 2 v študiji QUEST po 52. tednih so prikazani v preglednici 10.
In DRI12544 and QUEST studies, the proportion of patients who discontinued treatment due to adverse events was 4.3% of the placebo group, 3.2% of the dupilumab 200 mg Q2W group, and 6.1% of the dupilumab 300 mg Q2W group.
V študijah DRI12544 in QUEST je bil delež bolnikov, ki so prenehali zdravljenje zaradi neželenih učinkov, v skupini s placebom 4,3 %, v skupini z 200 mg dupilumaba vsaka dva tedna 3,2 % in v skupini s 300 mg dupilumaba vsaka dva tedna 6,1 %.
Listed in Table 3 are adverse reactions observed in asthma clinical trials presented by system organ class and frequency, using the following categories: very common (≥ 1/10); common (≥ 1/100 to
V preglednici 3 so navedeni neželeni učinki, opaženi v kliničnih preskušanjih pri astmi; prikazani so po organskih sistemih in skupinah pogostnosti upoštevaje naslednje kategorije: zelo pogosti (≥ 1/10),
(> 4-point improvement)
(izboljšanje za
Do not use the syringe if the liquid is discoloured or cloudy, or if it contains flakes or particles.
Brizge ne uporabite, če je tekočina spremenjene barve ali motna, ali če vsebuje kosme ali delce.
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]).
V tem 24-tedenskem preskušanju je bilo poslabšanj astme (opredeljenih kot prehodno povečanje odmerka peroralnega kortikosteroida za vsaj 3 dni) za 59 % manj med preiskovanci, ki so prejemali dupilumab, kot med tistimi, ki so prejemali placebo (letni delež 0,65 med prvimi in 1,60 med drugimi, razmerje deležev 0,41 [95 % IZ 0,26, 0,63]), izboljšanje FEV1 pred bronhodilatatorjem v primerjavi z izhodiščem pa je bilo po 24 tednih večje med preiskovanci, ki so prejemali dupilumab, kot med tistimi, ki so prejemali placebo (povprečna sprememba po mNK za dupilumab v primerjavi s placebom 0,22 l [95 % IZ: 0,09 do 0,34 l]).
SOLO 1 enrolled 671 patients (224 to placebo, 224 to dupilumab 300 mg Q2W, and 223 to dupilumab 300 mg QW) and had a treatment period of 16 weeks.
Študija SOLO 1 je zajela 671 bolnikov (224 na placebu, 224 na dupilumabu 300 mg vsak drugi teden in 223 na dupilumabu 300 mg vsak teden) in je imela 16-tedensko obdobje zdravljenja.
Pre-specified secondary endpoint of ACQ-5 and AQLQ(S) responder rates were analysed at 24 weeks (DRI12544 and VENTURE) and at 52 weeks (QUEST).
Vnaprej določeni opazovani dogodek ACQ-5 in AQLQ(S) in deleže odziva so analizirali po 24 tednih (DRI12544 in VENTURE) oziroma 52 tednih (QUEST).
Multipack: 3 (3 packs of 1) pre-filled syringes Multipack: 6 (3 packs of 2) pre-filled syringes
Skupno pakiranje: 3 (3 pakiranja po 1) napolnjene injekcijske brizge Skupno pakiranje: 6 (3 pakiranja po 2) napolnjenih injekcijskih brizg
b FAS week 52 includes all patients randomized at least one year before the cutoff date of the primary analysis.
b FAS 52. teden obsega vse bolnike, randomizirana vsaj eno leto pred presečnim datumom primarne analize.
Do not touch the needle.
Pazite, da se ne boste dotaknili igle.
It is recommended to rotate the injection site with each injection.
Mesto injiciranja je priporočljivo ob vsakem injiciranju krožno menjati.
Step 6: Clean
6. korak: Očistite mesto
The co-primary endpoint was the proportion of patients with IGA 0 or 1 (“clear” or “almost clear”) least a 2-point improvement and the proportion of patients with EASI-75 (improvement of at least 75% in EASI), from baseline to week 16.
Soprimarni opazovani dogodek je bil delež bolnikov z IGA 0 ali 1 ("čisto" ali "skoraj čisto") izboljšanje za vsaj 2 točki in delež bolnikov z EASI-75 (izboljšanje EASI za vsaj 75 %) od izhodišča do 16. tedna.
Baseline characteristics are presented in Table 11.
Izhodiščne značilnosti so prikazane v Preglednici 11.
• Upper Arm If a caregiver gives your dose, they can also use the outer area of the upper arm.
• Nadlaket - če vam odmerek injicira oseba, ki za vas skrbi, lahko uporabi tudi zunanjo stran nadlakti.
Patients were enrolled without requiring a minimum baseline blood eosinophil or other type 2 inflammatory biomarker (e.g. FeNO or IgE) level.
Bolniki so bili vključeni, ne da bi bila zahtevana najmanjša izhodiščna raven eozinofilcev v krvi ali drugih bioloških označevalcev vnetja tipa 2 (npr. diNO ali IgE).
Significant improvements in FEV1 were observed as early as week 2 following the first dose of dupilumab for both the 200 mg and 300 mg dose strengths and were maintained through week 24 (DRI12544) and week 52 in QUEST (see Figure 2).
Značilna izboljšanja FEV1 so opažali že v 2. tednu po prvem odmerku dupilumaba, tako z jakostjo 200 mg kot 300 mg, in so se ohranila do 24. tedna (DRI12544) in 52. tedna v QUEST (glejte sliko 2).
Talk to your doctor before you stop Dupixent or if your asthma remains uncontrolled or worsens during treatment with this medicine.
Preden prenehate uporabljati zdravilo Dupixent ali če astma ni kontrolirana ali se med zdravljenjem s tem zdravilom poslabša, se morate posvetovati z zdravnikom.
Significant improvements in FEV1 were observed as early as week 2 following the first dose of dupilumab for both the 200 mg and 300 mg dose strengths and were maintained through week 24 (DRI12544) and week 52 in QUEST (see Figure 6).
Značilna izboljšanja FEV1 so opažali že v 2. tednu po prvem odmerku dupilumaba, tako z jakostjo 200 mg kot 300 mg, in so se ohranila do 24. tedna (DRI12544) in 52. tedna v QUEST (glejte sliko 6).
DRI12544 study Dupilumab 200 mg
Študija DRI12544 Dupilumab 200 mg vsak drugi teden
bFAS week 52 includes all patients randomized at least one year before the cutoff date of the primary analysis.
bFAS 52. teden obsega vse bolnike, randomizirane vsaj eno leto pred presečnim datumom primarne analize.
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
Preglednica 2 navaja neželene učinke, opažene v kliničnih preskušanjih atopijskega dermatitisa, razvrščene po organskih sistemih in pogostnosti, upoštevaje naslednje kategorije: zelo pogosti (≥ 1/10),
The recommended dose of dupilumab for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week administered as subcutaneous injection.
Priporočeni odmerek dupilumaba za odrasle bolnike je začetni odmerek 600 mg (dve 300-mg injekciji), ki mu sledi 300 mg v subkutani injekciji vsak drugi teden.
ADA responses lasting more than 12 weeks: QW: 0.0%; Q2W: 1.4%; Q4W: 0.0%; Q8W:
Več kot 12 tednov trajajoči odzivi ADA: vsak teden: 0,0 %, vsak 2. teden: 1,4 %, vsak 4. teden: 0,0 %, vsak 8. teden: 2,6
No dose adjustment is needed in patients with mild or moderate renal impairment.
Bolnikom z blago do zmerno okvaro ledvic odmerka ni treba prilagoditi.
Do not use the pre-filled pen if the liquid is discolored or cloudy, or if it contains visible flakes or particles.
Napolnjenega injekcijskega peresnika ne uporabite, če je tekočina spremenjene barve ali motna, ali če vsebuje vidne kosme ali delce.
Placebo ap-value <0.0001
Placebo ap-vrednost <0,0001
Placebo ap-value < 0.0001
Placebo ap-vrednost < 0,0001
Based on the population analysis, commonly co-administered medications had no effect on dupilumab pharmacokinetics on patients with moderate to severe asthma.
Na podlagi populacijske analize pri bolnikih z zmerno do hudo astmo pogosto sočasno uporabljena zdravila niso vplivala na farmakokinetiko dupilumaba.
No age-related pharmacokinetic difference was observed in adolescent patients after correction for body weight.
Pri bolnikihmladostnikih po korekciji za telesno maso niso ugotovili s starostjo povezanih razlik v farmakokinetiki.
Do not pull off the needle cap until you are ready to inject.
Ne snemite pokrovčka igle, dokler niste povsem pripravljeni za injiciranje.
Figure 2: Mean percent change from baseline in NRS in SOLO 1a and SOLO 2a (FAS)b
Slika 2: Povprečna odstotna sprememba ocene NRS v študijah SOLO 1a in SOLO 2a (FAS)b mNK = metoda najmanjših kvadratov.
For the initial 400 mg dose, two 200 mg injections should be administered consecutively in different injection sites.
Za uvodni odmerek 400 mg je treba dati dve 200-mg injekciji zapored na dve različni mesti.
QUEST: FeNO ≥ 25 ppb
QUEST: diNO ≥ 25 ppb
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).
V podskupini bolnikov, ki so imeli izhodiščno oceno na podlestvici HADS-anksioznost ali HADS-depresija ≥ 8 (mejna vrednost za anksioznost ali depresijo), je po 16 tednih dosegel oceno HADS-anksioznost ali HADS-depresija < 8 značilno večji delež bolnikov v skupinah z dupilumabomkot s placebom (glejte preglednico 8).
D. Dispose
D. Zavrzite
Dupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.
Zdravilo Dupixent je indicirano za zdravljenje zmernega do hudega atopijskega dermatitisa pri odraslih in mladostnikih, starih 12 let ali več, ki so kandidati za sistemsko zdravljenje.
Anaphylactic reaction has been reported very rarely in the asthma development program following the administration of dupilumab (section 4.8).
V programu razvoja pri astmi so po uporabi dupilumaba v zelo redkih primerih poročali o anafilaktični reakciji (poglavje 4.8).
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.
Slika 1 in slika 2 prikazujeta povprečno odstotno spremembo EASI (slika 1) in povprečno odstotno spremembo NRS (slika 2) od izhodišča do 16. tedna.
Table 16: ACQ-5 and AQLQ(S) Responder Rates at Week 52 in QUEST
Preglednica 16: Deleži odziva po ACQ-5 in AQLQ(S) po 52. tednih zdravljenja v študiji QUEST
Eczema herpeticum was reported in < 1 % of the dupilumab groups and in < 1 % of the placebo group in the 16-week atopic dermatitis monotherapy studies.
Herpetični ekcem (eczema herpeticum) so v 16-tedenskih študijah monoterapije zabeležili pri < 1 % v skupini z dupilumabom in pri < 1 % v skupini s placebom.
Dupixent is available as 200 mg pre-filled pens in a pack containing 1, 2, 3, or 6 pre-filled pens.
Zdravilo Dupixent je na voljo kot 200 mg napolnjeni injekcijski peresnik v pakiranjih, ki vsebujejo po 1, 2, 3 ali 6 napolnjenih injekcijskih persnikov.
• 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.
• Za vse druge bolnike je začetni odmerek 400 mg (dve 200 mg injekciji) in nato 200 mg v subkutani injekciji vsak drugi teden.
Choose a different injection site for each Dupixent injection.
Za vsako injiciranje zdravila Dupixent izberite drugo mesto injiciranja.
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.
V tej podskupini je bila odstotna sprememba ocene srbenja NRS od izhodišča po 16 tednih s 300 mg dupilumaba-51,4 % in s placebom -30,2 %, po 52 tednih pa s 300 mg dupilumaba-54,8 % in s placebom -30,9 %.
Biomarkers of type 2 inflammation may be suppressed by systemic corticosteroid use.
Uporaba kortikosteroidov lahko deluje zaviralno na biološke označevalce vnetja tipa 2.
For patients 12 to 17 years of age with atopic dermatitis, the recommended every other week dose is 200 mg (< 60 kg) or 300 mg (≥ 60 kg).
Za bolnike z atopijskim dermatitisom, stare od 12 do 17 let, je priporočeni odmerek 200 mg (< 60 kg)
Dupixent is available as 200 mg pre-filled syringes in a pack containing 1 or 2 pre-filled syringes or in a pack containing 3 (3 packs of 1) or 6 (3 packs of 2) pre-filled syringes.
Zdravilo Dupixent, je na voljo kot 200 mg napolnjena injekcijska brizga v pakiranjih, ki vsebujejo po 1 ali po 2 napolnjeni injekcijski brizgi, ali v pakiranjih, ki vsebujejo 3 (3 pakiranja po 1) ali 6 (3 pakiranja po 2) napolnjenih injekcijskih brizg.
- The other ingredients are arginine hydrochloride, histidine, polysorbate 80, sodium acetate, glacial acetic acid, sucrose, water for injections.
- Druge sestavine so argininijev klorid, histidin, polisorbat 80, natrijev acetat, ledocetna kislina, saharoza in voda za injekcije.
In the 52-week atopic dermatitis dupilumab + TCS study, eczema herpeticum was reported in 0.2 % of the dupilumab + TCS group and 1.9 % of the placebo + TCS group.
V 52-tedenski študiji dupilumaba + LKS pri atopijskem dermatitisu so herpetični ekcem zabeležili pri 0,2 % v skupini z dupilumabom + LKS in pri
FAS week 52 includes all patients randomized at least one year before the cutoff date of the primary analysis.
FAS 52. teden obsega vse bolnike, randomizirane vsaj eno leto pred presečnim datumom primarne analize.
Dupixent can cause serious side effects, including very rare allergic (hypersensitivity) reactions, including anaphylactic reaction; the signs of allergic reaction or anaphylactic reaction may include:
Zdravilo Dupixent lahko povzroči resne neželene učinke, vključno z zelo redkimi primeri alergijskih (preobčutljivostnih) reakcij, vključno z anafilaktično reakcijo.
c Patients who received rescue treatment or with missing data were considered as non-responders.
c Bolniki, ki so prejeli rešilno zdravljenje, in bolniki z manjkajočimi podatki so bili ocenjeni kot neodzivni.
b Responder was defined as a patient 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 bolniki z oceno IGA 0 ali 1 ("čisto" ali "skoraj čisto") z zmanjšanjem na lestvici IGA 0-4 za > 2 točki.
Step 12: Dispose
12. korak: Zavrzite
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