FrancophonIA/ELRC3.0 huggingface dataset:
English: • For patients with severe asthma and who are on oral corticosteroids or for patients with severe asthma and co-morbid moderate-to-severe atopic dermatitis, an initial dose of 600 mg (two 300 mg injections), followed by 300 mg every other week administered as subcutaneous injection.
Slovenian: • Za bolnike s hudo astmo in ki prejemajo peroralne kortikosteroide ali za bolnike s hudo astmo in s pridruženim zmernim do hudim atopijskim dermatitisom je začetni odmerek 600 mg (dve 300 mg injekciji) in nato 300 mg v subkutani injekciji vsak drugi teden.
English: Dupilumab is administered by subcutaneous injection into the thigh or abdomen, except for the 5 cm around the navel.
Slovenian: Dupilumab se injicira subkutano v stegno ali trebuh (razen v predelu 5 cm okrog popka).
English: You must not try to give yourself or someone else the injection unless you have received training from your healthcare professional.
Slovenian: Ne poskušajte si sami dati injekcije ali zdravila injicirati komu drugemu, dokler vas tega ne nauči zdravnik.
English: • Do not keep Dupixent at room temperature (< 25°C) for more than 14 days.
Slovenian: • Zdravila Dupixent ne shranjujte na sobni temperaturi (< 25 °C) več kot 14 dni.
English: Number of patients with POEM ≥4 at baseline POEM (≥ 4-point improvement), % responders
Slovenian: Število bolnikov z izhodiščno oceno POEM POEM (izboljšanje za
English: Do not stop or reduce your asthma medicines, unless instructed by your doctor.
Slovenian: Ne prenehajte uporabljati svojih zdravil za astmo in ne zmanjšujte njihovega odmerka, ne da bi vam eno ali drugo naročil zdravnik.
English: • Choose a different injection site for each injection
Slovenian: • Za vsako injiciranje izberite drugo injekcijsko mesto.
English: In all three pivotal studies, the co-primary endpoints were the proportion of patients with IGA 0 or 1 (“clear” or “almost clear”) with a reduction of ≥ 2 points on a 0-4 IGA scale and the proportion of patients with improvement of at least 75 % in EASI (EASI-75) from baseline to week 16.
Slovenian: V vseh treh ključnih študijah sta bila soprimarna opazovana dogodka delež bolnikov z IGA 0 ali 1 ("čisto" ali "skoraj čisto") z zmanjšanjem na lestvici IGA 0-4 za ≥ 2 točki ter delež bolnikov z izboljšanjem EASI za vsaj 75 % (EASI-75) od izhodišča do 16. tedna.
English: Talk to your doctor if you have any new or worsening eye problems, including eye pain or changes in vision.
Slovenian: Težave z očmi (če imate atopijski dermatitis) V primeru novonastalih težav z očmi ali poslabšanja takšnih težav, vključno z bolečinami v očeh in spremembami vida, se posvetujte z zdravnikom.
English: Table 8: Additional secondary endpoint results of dupilumab monotherapy at Week 16
Slovenian: Preglednica 8: Dodatni rezultati sekundarnih opazovanih dogodkov monoterapije z dupilumabom po 16. tednih
English: Dupixent is used to treat adults and adolescents 12 years and older with moderate-to-severe atopic dermatitis, also known as atopic eczema.
Slovenian: Zdravilo Dupixent se uporablja za zdravljenje odraslih in mladostnikov, starih 12 let ali več, z zmernim do hudim atopijskim dermatitisom, znanim tudi kot atopijski ekcem.
English: Do not touch the injection site again or blow on it before the injection.
Slovenian: Pred injiciranjem se mesta injiciranja ne smete več dotakniti in vanj tudi ne smete pihati.
English: Do not use the syringe if it has been dropped on a hard surface or damaged.
Slovenian: Ne uporabite brizge, če je padla na trdo podlago ali je poškodovana.
English: Description of selected adverse reactions in atopic dermatitis and asthma indications
Slovenian: Srbenje na mestu injiciranja Opis izbranih neželenih učinkov pri atopijskem dermatitisu in pri astmi
English: It is recommended that patients should be brought up to date with live and live attenuated immunisations in agreement with current immunisation guidelines prior to treatment with dupilumab.
Slovenian: Priporočljivo je, da bolniki pred zdravljenjem z dupilumabom opravijo vsa cepljenja z živimi in živimi oslabljenimi cepivi v skladu z veljavnimi smernicami za cepljenje.
English: If you have forgotten to inject a dose of Dupixent, talk to your doctor, pharmacist or nurse.
Slovenian: Če ste pozabili uporabiti zdravilo Dupixent Če ste pozabili injicirati odmerek zdravila Dupixent, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: • Do not use the syringe if it has been damaged.
Slovenian: • Ne uporabite brizge, če je poškodovana.
English: Solution for injection (injection) Clear to slightly opalescent, colourless to pale yellow solution, which is free from visible particulates.
Slovenian: Raztopina za injiciranje (injekcija) Bistra do rahlo opalescentna, brezbarvna do bledo rumena raztopina brez vidnih delcev.
English: • a puncture-resistant container* (See Step 12)
Slovenian: • 1 kosem vate ali zloženec gaze* • proti prebadanju odporen vsebnik* (glejte 12. korak)
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.
Slovenian: Povprečna starost je bila 38,4 leta, 38,8 % je bilo žensk, izhodiščna povprečna ocena EASI je bila 33,1, povprečna telesna površina 55,7, izhodiščno tedensko povprečje ocene srbenja NRS 6,4, izhodiščna povprečna ocena SCORAD 67,2 in izhodiščni povprečni DLQI 13,8.
English: The dupilumab group significantly improved patient-reported symptoms, the impact of AD on sleep and health-related quality of life as measured by POEM, SCORAD, and CDLQI scores at 16 weeks compared to placebo.
Slovenian: V skupini z dupilumabom so se po 16 tednih v primerjavi s placebom značilno izboljšali simptomi po navedbi bolnikov, vpliv AD na spanje in zdravstvena kakovost življenja, merjeni z ocenami POEM, SCORAD in CDLQI.
English: • a puncture-resistant container* (See Step D)
Slovenian: • 1 kosem vate ali zloženec gaze* • proti prebadanju odporen vsebnik* (glejte korak D)
English: Other evaluated outcomes included the proportion of patients with improvement of at least 50 % and 90 % in EASI (EASI-50 and EASI-90, respectively), reduction in itch as measured by the peak pruritus Numerical Rating Scale (NRS), and percent change in the SCORing Atopic Dermatitis (SCORAD) scale from baseline to week 16.
Slovenian: Drugi ocenjeni izidi so vključevali delež bolnikov z izboljšanjem EASI za vsaj 50 % in vsaj 90 % (EASI-50 in EASI-90), zmanjšanje srbenja, merjeno z lestvico največjega srbenja NRS (Numerical Rating Scale), in odstotno spremembo na lestvici SCORAD (SCORing Atopic Dermatitis) od izhodišča do 16. tedna.
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
Slovenian: 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: Patients who received rescue treatment were considered non-responders.
Slovenian: Bolniki, ki so prejeli rešilno zdravljenje, so bili ocenjeni kot neodzivni.
English: Patients being treated for asthma may present with serious systemic eosinophilia sometimes presenting with clinical features of eosinophilic pneumonia or vasculitis consistent with eosinophilic granulomatosis with polyangiitis, conditions which are often treated with systemic corticosteroid therapy.
Slovenian: Ta se včasih pokaže s klinično sliko eozinofilne pljučnice ali vaskulitisa, ki ustreza eozinofilni granulomatozi s poliangiitisom, bolezni, ki jih pogosto zdravijo s sistemskimi kortikosteroidi.
English: 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.
Slovenian: 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
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%.
Slovenian: 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
English: • If somebody else gives you the injection, they can also use your upper arm.
Slovenian: • Če vam zdravilo injicira nekdo drug, lahko uporabi tudi zunanji del nadlakta.
English: • Do not use the syringe if the needle cap is missing or not securely attached.
Slovenian: • Ne uporabite brizge, če ji pokrovček igle manjka ali ni trdno nameščen.
English: A caregiver may also give you your Dupixent injection after proper training.
Slovenian: Zdravilo Dupixent vam lahko po ustreznem usposabljanju injicira tudi oseba, ki skrbi za vas
English: Baseline characteristics are presented in Table 5.
Slovenian: Izhodiščne značilnosti so prikazane v Preglednici 5.
English: b Full analysis set (FAS) includes all patients randomized.
Slovenian: b Celotni nabor za analizo (FAS - full analysis set) vključuje vse randomizirane bolnike.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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 %.
English: 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
Slovenian: 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),
English: (> 4-point improvement)
Slovenian: (izboljšanje za
English: Do not use the syringe if the liquid is discoloured or cloudy, or if it contains flakes or particles.
Slovenian: Brizge ne uporabite, če je tekočina spremenjene barve ali motna, ali če vsebuje kosme ali delce.
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]).
Slovenian: 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]).
English: 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.
Slovenian: 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.
English: 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).
Slovenian: Vnaprej določeni opazovani dogodek ACQ-5 in AQLQ(S) in deleže odziva so analizirali po 24 tednih (DRI12544 in VENTURE) oziroma 52 tednih (QUEST).
English: Multipack: 3 (3 packs of 1) pre-filled syringes Multipack: 6 (3 packs of 2) pre-filled syringes
Slovenian: Skupno pakiranje: 3 (3 pakiranja po 1) napolnjene injekcijske brizge Skupno pakiranje: 6 (3 pakiranja po 2) napolnjenih injekcijskih brizg
English: b FAS week 52 includes all patients randomized at least one year before the cutoff date of the primary analysis.
Slovenian: b FAS 52. teden obsega vse bolnike, randomizirana vsaj eno leto pred presečnim datumom primarne analize.
English: Do not touch the needle.
Slovenian: Pazite, da se ne boste dotaknili igle.
English: It is recommended to rotate the injection site with each injection.
Slovenian: Mesto injiciranja je priporočljivo ob vsakem injiciranju krožno menjati.
English: Step 6: Clean
Slovenian: 6. korak: Očistite mesto
English: 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.
Slovenian: 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.
English: Baseline characteristics are presented in Table 11.
Slovenian: Izhodiščne značilnosti so prikazane v Preglednici 11.
English: • Upper Arm If a caregiver gives your dose, they can also use the outer area of the upper arm.
Slovenian: • Nadlaket - če vam odmerek injicira oseba, ki za vas skrbi, lahko uporabi tudi zunanjo stran nadlakti.
English: Patients were enrolled without requiring a minimum baseline blood eosinophil or other type 2 inflammatory biomarker (e.g. FeNO or IgE) level.
Slovenian: 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).
English: 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).
Slovenian: 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).
English: Talk to your doctor before you stop Dupixent or if your asthma remains uncontrolled or worsens during treatment with this medicine.
Slovenian: Preden prenehate uporabljati zdravilo Dupixent ali če astma ni kontrolirana ali se med zdravljenjem s tem zdravilom poslabša, se morate posvetovati z zdravnikom.
English: 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).
Slovenian: 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).
English: DRI12544 study Dupilumab 200 mg
Slovenian: Študija DRI12544 Dupilumab 200 mg vsak drugi teden
English: bFAS week 52 includes all patients randomized at least one year before the cutoff date of the primary analysis.
Slovenian: bFAS 52. teden obsega vse bolnike, randomizirane vsaj eno leto pred presečnim datumom primarne analize.
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
Slovenian: Preglednica 2 navaja neželene učinke, opažene v kliničnih preskušanjih atopijskega dermatitisa, razvrščene po organskih sistemih in pogostnosti, upoštevaje naslednje kategorije: zelo pogosti (≥ 1/10),
English: 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.
Slovenian: 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.
English: ADA responses lasting more than 12 weeks: QW: 0.0%; Q2W: 1.4%; Q4W: 0.0%; Q8W:
Slovenian: 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
English: No dose adjustment is needed in patients with mild or moderate renal impairment.
Slovenian: Bolnikom z blago do zmerno okvaro ledvic odmerka ni treba prilagoditi.
English: Do not use the pre-filled pen if the liquid is discolored or cloudy, or if it contains visible flakes or particles.
Slovenian: Napolnjenega injekcijskega peresnika ne uporabite, če je tekočina spremenjene barve ali motna, ali če vsebuje vidne kosme ali delce.
English: Placebo ap-value <0.0001
Slovenian: Placebo ap-vrednost <0,0001
English: Placebo ap-value < 0.0001
Slovenian: Placebo ap-vrednost < 0,0001
English: Based on the population analysis, commonly co-administered medications had no effect on dupilumab pharmacokinetics on patients with moderate to severe asthma.
Slovenian: Na podlagi populacijske analize pri bolnikih z zmerno do hudo astmo pogosto sočasno uporabljena zdravila niso vplivala na farmakokinetiko dupilumaba.
English: No age-related pharmacokinetic difference was observed in adolescent patients after correction for body weight.
Slovenian: Pri bolnikihmladostnikih po korekciji za telesno maso niso ugotovili s starostjo povezanih razlik v farmakokinetiki.
English: Do not pull off the needle cap until you are ready to inject.
Slovenian: Ne snemite pokrovčka igle, dokler niste povsem pripravljeni za injiciranje.
English: Figure 2: Mean percent change from baseline in NRS in SOLO 1a and SOLO 2a (FAS)b
Slovenian: Slika 2: Povprečna odstotna sprememba ocene NRS v študijah SOLO 1a in SOLO 2a (FAS)b mNK = metoda najmanjših kvadratov.
English: For the initial 400 mg dose, two 200 mg injections should be administered consecutively in different injection sites.
Slovenian: Za uvodni odmerek 400 mg je treba dati dve 200-mg injekciji zapored na dve različni mesti.
English: QUEST: FeNO ≥ 25 ppb
Slovenian: QUEST: diNO ≥ 25 ppb
English: In a subset of patients with HADS-anxiety or HADS-depression subscale scores ≥ 8 at baseline (the cut-off value for anxiety or depression), a larger proportion of patients in the dupilumab groups achieved HADS-anxiety and HADS-depression scores < 8 at week 16 compared to placebo (See Table 8).
Slovenian: 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).
English: D. Dispose
Slovenian: D. Zavrzite
English: 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.
Slovenian: 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.
English: Anaphylactic reaction has been reported very rarely in the asthma development program following the administration of dupilumab (section 4.8).
Slovenian: V programu razvoja pri astmi so po uporabi dupilumaba v zelo redkih primerih poročali o anafilaktični reakciji (poglavje 4.8).
English: Figure 1 and Figure 2 show the mean percent change from baseline in EASI and the mean percent change from baseline in NRS, respectively up to week 16.
Slovenian: Slika 1 in slika 2 prikazujeta povprečno odstotno spremembo EASI (slika 1) in povprečno odstotno spremembo NRS (slika 2) od izhodišča do 16. tedna.
English: Table 16: ACQ-5 and AQLQ(S) Responder Rates at Week 52 in QUEST
Slovenian: Preglednica 16: Deleži odziva po ACQ-5 in AQLQ(S) po 52. tednih zdravljenja v študiji QUEST
English: 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.
Slovenian: Herpetični ekcem (eczema herpeticum) so v 16-tedenskih študijah monoterapije zabeležili pri < 1 % v skupini z dupilumabom in pri < 1 % v skupini s placebom.
English: Dupixent is available as 200 mg pre-filled pens in a pack containing 1, 2, 3, or 6 pre-filled pens.
Slovenian: Zdravilo Dupixent je na voljo kot 200 mg napolnjeni injekcijski peresnik v pakiranjih, ki vsebujejo po 1, 2, 3 ali 6 napolnjenih injekcijskih persnikov.
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.
Slovenian: • Za vse druge bolnike je začetni odmerek 400 mg (dve 200 mg injekciji) in nato 200 mg v subkutani injekciji vsak drugi teden.
English: Choose a different injection site for each Dupixent injection.
Slovenian: Za vsako injiciranje zdravila Dupixent izberite drugo mesto injiciranja.
English: In this subset, the percent change of pruritus NRS from baseline was -51.4 % vs -30.2 % at week 16 and -54.8 % vs -30.9 % at week 52, for the dupilumab 300 mg Q2W and placebo groups respectively.
Slovenian: 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 %.
English: Biomarkers of type 2 inflammation may be suppressed by systemic corticosteroid use.
Slovenian: Uporaba kortikosteroidov lahko deluje zaviralno na biološke označevalce vnetja tipa 2.
English: 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).
Slovenian: Za bolnike z atopijskim dermatitisom, stare od 12 do 17 let, je priporočeni odmerek 200 mg (< 60 kg)
English: 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.
Slovenian: 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.
English: - The other ingredients are arginine hydrochloride, histidine, polysorbate 80, sodium acetate, glacial acetic acid, sucrose, water for injections.
Slovenian: - Druge sestavine so argininijev klorid, histidin, polisorbat 80, natrijev acetat, ledocetna kislina, saharoza in voda za injekcije.
English: 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.
Slovenian: V 52-tedenski študiji dupilumaba + LKS pri atopijskem dermatitisu so herpetični ekcem zabeležili pri 0,2 % v skupini z dupilumabom + LKS in pri