natgillin/translations-raw huggingface dataset:
Lay the pre-filled pen on a flat surface and let it naturally warm up at room temperature (less than 25ºC) for at least 30 minutes.
Položite napolnjeni injekcijski peresnik na ravno površino in pustite, da se naravno segreje na sobno temperaturo (manj kot 25 °C); pustite ga vsaj 30 minut.
Patients receiving concomitant oral corticosteroids may reduce their steroid dose once clinical improvement with dupilumab has occurred (see section 5.1).
Bolniki, ki sočasno prejemajo peroralne kortikosteroide, lahko zmanjšajo odmerek steroidov, ko se z dupilumabom pojavi klinično izboljšanje (glejte poglavje 5.1).
Dupixent may be used with eczema medicines that you apply to the skin or it may be used on its own.
Zdravilo Dupixent se lahko uporablja skupaj z zdravili za ekcem, ki jih nanesete na kožo, ali pa se uporablja samo.
Using Dupixent for atopic dermatitis (atopic eczema) can improve the condition of your skin and reduce itching.
Uporaba zdravila Dupixent za atopijski dermatitis (atopijski ekcem) lahko izboljša stanja kože in zmanjša srbenje.
Treatment effects in subgroups (weight, age, gender, race, and background treatment, including immunosuppressants) in CHRONOS were consistent with the results in the overall study population.
Terapevtski učinki so se v podskupinah (telesna masa, starost, spol, rasa in osnovno zdravljenje, vključno z imunosupresivi) v študiji CHRONOS skladali z rezultati v celotni populaciji študije.
Tell your doctor or pharmacist - if you are using, have recently used or might use any other medicines.
- če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
VENTURE evaluated the effect of dupilumab on reducing the use of maintenance oral corticosteroids.
Študija VENTURE je ovrednotila učinek dupilumaba na zmanjšanje uporabe vzdrževalnih peroralnih kortikosteroidov (PKS).
Inject Dupixent yourself only after you have been trained by your doctor or nurse.
Zdravilo Dupixent si smete injicirati sami šele potem, ko sta vas zdravnik ali medicinska sestra tega naučila.
Animal studies showed no impairment of fertility (see section 5.3).
Študije na živalih niso pokazale okvare plodnosti (glejte poglavje 5.3).
A volume of distribution for dupilumab of approximately 4.6 L was estimated by population PK analysis, indicating that dupilumab is distributed primarily in the vascular system.
S populacijsko FK analizo ocenjeni volumen porazdelitve dupilumaba je bil približno 4,6 l; to kaže, da se dupilumab v prvi vrsti porazdeli v ožilju.
Placebo + TCS
Placebo + LKS
Due to nonlinear clearance, dupilumab exposure, as measured by area under the concentration-time curve, increases with dose in a greater than proportional manner following single SC doses from 75600 mg.
Zaradi nelinearnega očistka se izpostavljenost dupilumabu, merjena s površino pod krivuljo koncentracije po času, po enkratnih subkutanih odmerkih od 75 do 600 mg povečuje bolj kot sorazmerno odmerku.
How to store Dupixent 6.
Shranjevanje zdravila Dupixent 6.
The most common adverse reaction was injection site erythema.
Najpogostejši neželeni učinek je bil eritem na mestu injiciranja.
The safety of dupilumab was evaluated in four randomized, double-blind, placebo-controlled studies and one dose-ranging study in patients with moderate-to-severe atopic dermatitis.
Varnost dupilumaba so ocenili v štirih randomiziranih, dvojno slepih, s placebom kontroliranih študijah in v eni študiji razpona odmerkov pri bolnikih z zmernim do hudim atopijskim dermatitisom.
Remove the syringe from the carton by holding the middle of the syringe body.
Vzemite brizgo iz škatle tako, da jo primete na sredi telesa brizge.
The primary endpoint was the percent reduction in oral corticosteroid dose assessed in the overall population, based on a comparison of the oral corticosteroid dose at weeks 20 to 24 that maintained asthma control with the previously optimized (at baseline) oral corticosteroid dose.
Primarni opazovani dogodek je bil odstotek zmanjšanja odmerka peroralnega kortikosteroida, ocenjen v celotni populaciji na podlagi primerjave odmerka peroralnega kortikosteroida od 20. do 24. tedna, ki je ohranjal urejenost astme, s predhodno (izhodiščno) optimiziranim odmerkom peroralnega kortikosteroida.
Do not rub your skin after the injection.
Ne drgnite kože po injiciranju.
A. Check expiration date
A. Preverite datum izteka roka uporabnosti
Of the 1,472 patients with atopic dermatitis exposed to dupilumab in a phase 2 dose-ranging study or phase 3 placebo-controlled studies, a total of 67 were 65 years or older.
Od 1.472 bolnikov z atopijskim dermatitisom, ki so bili dupilumabu izpostavljeni v študiji 2. faze razpona odmerkov ali v študijah 3. faze, kontroliranih s placebom, je bilo skupno 67 bolnikov starih 65 let ali več.
In this study, the mean age was 14.5 years, the median weight was 59.4 kg, 41.0 % were female, 62.5% were White, 15.1% were Asian, and 12.0% were Black.
V tej študiji je bila povprečna starost 14,5 leta, mediana telesna masa 59,4 kg, 41 % oseb je bilo ženskega spola, 62,5 % belcev, 15,1 % Azijcev in 12,0 % črncev.
If you have asthma and are taking asthma medicines, do not change or stop your asthma medicine without talking to your doctor.
Če imate astmo in uporabljate zdravila za astmo, zdravil za astmo ne spreminjajte in jih ne prenehajte uporabljati, ne da bi se posvetovali z zdravnikom.
Do not put the needle cap back on.
Ne nameščajte pokrovčka igle nazaj nanjo.
Treatment effects in subgroups (weight, age, gender, race, and background treatment, including immunosuppressants) in SOLO 1 and SOLO 2 were consistent with the results in the overall study population.
Terapevtski učinki so se v podskupinah (telesna masa, starost, spol, rasa in osnovno zdravljenje, vključno z imunosupresivi) v študijah SOLO 1 in SOLO 2 skladali z rezultati v celotni populaciji študij.
Dupilumab should not be used to treat acute asthma symptoms or acute exacerbations.
Dupilumaba se ne sme uporabljati za zdravljenje akutnih simptomov astme ali akutnih poslabšanj astme.
Do not use the pre-filled pen if the expiration date has passed.
Ne uporabite napolnjenega injekcijskega peresnika, če je ta datum že potekel.
Effects on lung function, on oral steroid and exacerbation reduction were similar irrespective of baseline levels of type 2 inflammatory biomarkers (e.g. blood eosinophils, FeNO).
Učinki na delovanje pljuč, peroralni steroid in zmanjšanje poslabšanj so bili podobni ne glede na izhodiščno raven bioloških označevalcev vnetja tipa 2 (npr. eozinofilcev v krvi,
Always keep the container out of the reach of children.
Vsebnik vedno shranjujte nedosegljiv otrokom.
Table 7: Results of the primary and secondary endpoints in SOLO CONTINUE study Placebo
Preglednica 7: Rezultati primarnih in sekundarnih opazovanih dogodkov v študiji SOLO CONTINUE
Asthma treatment guidelines define type 2 inflammation as eosinophilia ≥ 150 cells/mcL and/or FeNO ≥ 20 ppb.
Smernice za zdravljenje astme opredeljujejo vnetje tipa 2 kot eozinofilijo ≥ 150 celic/mcl in/ali diNO ≥ 20 ppb.
All Severe Exacerbations DRI12544 study Dupilumab
Vsa huda poslabšanja Študija DRI12544 Dupilumab2
You and your doctor should decide if you will breast-feed or use Dupixent.
Skupaj z zdravnikom se morate odločiti, ali boste dojili ali boste uporabljali zdravilo Dupixent.
Very common Injection site reactions
Zelo pogosti reakcije na mestu injiciranja
Patients received dupilumab or placebo with concomitant use of TCS starting at baseline using a standardized regimen.
Prejemanje dupilumaba ali placeba s sočasnim LKS se je začelo ob izhodišču z uporabo standardizirane sheme.
If you need to permanently remove the carton from the refrigerator, write down the date of removal in the space provided on the outer carton, and use Dupixent within 14 days.
Če morate škatlo za stalno vzeti iz hladilnika, zapišite datum, ko ste jo vzeli iz hladilnika, na temu namenjen prostor na škatli ter zdravilo Dupixent porabite v 14 dneh.
After removing the 300 mg pre-filled syringe from the refrigerator, it should be allowed to reach room temperature by waiting for 45 min before injecting Dupixent.
Potem, ko je 300 mg napolnjena injekcijska brizga vzeta iz hladilnika, je treba pustiti, da doseže sobno temperaturo, in sicer tako, da se jo pusti na sobni temperaturi 45 minut pred injiciranjem zdravila Dupixent.
• general ill feeling
• splošno slabo počutje
Eligible patients enrolled into the three studies had previous inadequate response to topical medication.
Primerni bolniki, vključeni v omenjene tri študije, se predhodno niso zadostno odzvali na lokalna zdravila.
Population PK analysis did not identify mild or moderate renal impairment as having a clinically meaningful influence on the systemic exposure of dupilumab.
Populacijska FK analiza ni ugotovila, da bi blaga ali zmerna okvara ledvic klinično pomembno vplivala na sistemsko izpostavljenost dupilumabu.
The safety and benefits of Dupixent are not yet known in children with asthma below the age of 12.
Varnost in koristi zdravila Dupixent še niso znane pri otrocih z astmo, mlajših od 12 let.
The demographics and baseline characteristics of these 3 studies are provided in Table 5 below.
Demografske in izhodiščne značilnosti vseh treh študij so prikazane spodaj v preglednici 5.
Treatment-emergent eosinophilia (≥ 5,000 cells/mcL) was reported in < 2 % of dupilumab-treated patients and < 0.5 % in placebo-treated patients.
Med zdravljenjem nastalo eozinofilijo (≥ 5.000 celic/mcl) so zabeležili pri < 2 % bolnikov, zdravljenih z dupilumabom, in pri < 0,5 % bolnikov, ki so prejemali placebo.
Less than 0.4 % of patients exhibited high titer ADA responses associated with reduced exposure and efficacy.
Odziv z visokim titrom ADA, povezan z zmanjšanjem izpostavljenosti in učinkovitosti, je imelo manj kot 0,4 % bolnikov.
The safety and benefits of Dupixent are not yet known in children and adolescents with atopic dermatitis below the age of 12.
Varnost in koristi zdravila Dupixent še niso znane pri otrocih in mladostnikih z atopijskim dermatitisom, mlajših od 12 let.
400 mg (two 200 mg injections)
400 mg (dve 200-mg injekciji)
The pharmacokinetics of dupilumab in paediatric patients (< 12 years of age) with atopic dermatitis has not been studied.
Pediatrični bolniki Farmakokinetika dupilumaba pri pediatričnih bolnikih (mlajših od 12 let) z atopijskim dermatitisom ni bila raziskana.
What Dupixent is and what it is used for
Kaj je zdravilo Dupixent in za kaj ga uporabljamo
Patients randomized IGA 0 or 1c, % respondersd
Randomizirani bolniki IGA 0 ali 1c, % odzivnihd
The pharmacokinetics of dupilumab is similar in patients with atopic dermatitis and asthma.
Farmakokinetila dupilumaba je podobna tako pri bolnikih z atopijskim dermatitisom kot pri bolnikih z astmo.
A total of 325 patients were enrolled, with 210 patients who were previously exposed to ciclosporin and 115 patients who have never been exposed to ciclosporin because ciclosporin treatment was medically inadvisable.
Vključenih je bilo skupno 325 bolnikov; 210 bolnikov je predhodno že prejemalo ciklosporin, 115
CDLQI, (≥6-point improvement), % responders POEM, LS mean change from baseline (+/- SE)
CDLQI, (izboljšanje za ≥ 6 točk), % odzivnih POEM, povprečna % sprememba od izhodišča po mNK (+- SN)
Patients treated with dupilumab who develop conjunctivitis that does not resolve following standard treatment should undergo ophthalmological examination (section 4.8).
Bolniki, zdravljeni z dupilumabom, ki se jim pojavi konjunktivitis in jim ne izgine po običajnem zdravljenju, morajo opraviti pregled pri oftalmologu (poglavje 4.8).
Immune responses to TdaP vaccine and meningococcal polysaccharide vaccine were assessed, see section 4.5.
Imunske odzive na cepivo proti davici, tetanusu in oslovskemu kašlju (brezcelično) ter na meningokokno polisaharidno cepivo so ocenili, glejte poglavje 4.5.
In a clinical study of AD patients, the effects of dupilumab on the pharmacokinetics (PK) of CYP substrates were evaluated.
V klinični študiji bolnikov z AD so ocenili učinke dupilumaba na farmakokinetiko (FK) substratov CYP.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients arginine hydrochloride histidine polysorbate 80 sodium acetate trihydrate glacial acetic acid sucrose water for injections
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi argininijev klorid histidin polisorbat 80 natrijev acetat trihidrat ledocetna kislina saharoza voda za injekcije
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity (including safety pharmacology endpoints) and toxicity to reproduction and development.
Predklinični podatki na osnovi običajnih študij toksičnosti ponavljajočih se odmerkov (vključno z opazovanimi dogodki varnostne farmakologije) in toksičnosti za reprodukcijo in razvoj ne kažejo posebnega tveganja za človeka.
• Do not press or touch the orange needle cover with your fingers.
• Ne pritiskajte in ne dotikajte se s prsti oranžnega pokrovčka igle.
The pre-filled syringe or the pre-filled pen should not be exposed to heat or direct sunlight and should not be shaken.
Napolnjene injekcijske brizge ali napolnjenega injekcijskega peresnika se ne sme izpostavljati vročini ali neposredni sončni svetlobi in se je ne sme pretresati.
600 mg (two 300 mg injections)
600 mg (dve 300-mg injekciji)
SANOFI WINTHROP INDUSTRIE 1051 Boulevard Industriel, 76580 LE TRAIT, FRANCE
SANOFI WINTHROP INDUSTRIE 1051 Boulevard Industriel, 76580 LE TRAIT, FRANCIJA
Prepare the injection site
Pripravite mesto injiciranja.
Step 2: Prepare
2. korak: Pripravite vse potrebno
Conjunctivitis related events
S konjunktivitisom povezani dogodki
Do not press or touch the orange needle cover with your fingers.
Ne pritiskajte in ne dotikajte se s prsti oranžnega pokrovčka igle.
Check with your doctor if you have diarrhea, gas, upset stomach, greasy stools, and dehydration which could be a sign of a parasitic infection.
Posvetujte se z zdravnikom, če imate drisko, vetrove, razdražen želodec, mastno blato ali dehidracijo (ste izsušeni): to so lahko znaki okužbe z zajedavci.
In atopic dermatitis clinical trials, treatment with dupilumab was associated with decreases from baseline in concentrations of type 2 immunity biomarkers, such as thymus and activation-regulated chemokine (TARC/CCL17), total serum IgE and allergen-specific IgE in serum.
V kliničnih preskušanjih pri atopijskem dermatitisu je zdravljenje z dupilumabom v primerjavi z izhodiščem zmanjšalo koncentracijo bioloških označevalcev imunosti tipa 2, kot npr. timusni in z aktivacijo regulirani kemokin (TARC/CCL17), celokupne IgE v serumu in za alergen specifične IgE v serumu.
Very rarely, Dupixent can cause serious side effects, including allergic (hypersensitivity) reactions and anaphylactic reaction.
Zelo redko lahko zdravilo Dupixent povzroči resne neželene učinke, vključno z alergijskimi (preobčutljivostnimi) reakcijami ter anafilaktično reakcijo.
• Dispose of the pre-filled pens, (needle inside), and yellow caps in a puncture resistant container right away after use.
• Napolnjene injekcijske peresnike (z iglo v njih) in rumene pokrovčke tako po uporabi zavrzite v vsebnik, odporen proti prebadanju.
What Dupixent looks like and contents of the pack
Izgled zdravila Dupixent in vsebina pakiranja
The recommended dose of dupilumab for adults and adolescents (12 years of age and older) is:
Začetni odmerek dupilumaba za odrasle in mladostnike (stare 12 let in več) je:
The demographics and baseline characteristics of these 3 studies are provided in Table 11 below.
Demografske in izhodiščne značilnosti vseh treh študij so prikazane spodaj v preglednici 11.
To evaluate maintenance and durability of response, subjects treated with dupilumab for 16 weeks in SOLO 1 and SOLO 2 studies who achieved IGA 0 or 1 or EASI-75 were re-randomized in SOLO CONTINUE study to an additional 36-week treatment of dupilumab or placebo, for a cumulative 52week study treatment.
Za oceno vzdrževanja in trajnosti odziva so preiskovance, ki so bili v študijah SOLO 1 in SOLO 2 16 tednov zdravljeni z dupilumabomin so dosegli IGA 0 ali 1 ali EASI-75, v študiji SOLO CONTINUE ponovno randomizirali na dodatnih 36 tednov prejemanja dupilumaba ali placeba, tako da je raziskovano zdravljenje kumulativno trajalo 52 tednov.
Table 11: Demographics and Baseline Characteristics of Asthma Trials
Preglednica 11: Demografske in izhodiščne značilnosti v preskušanjih pri astmi
If the solution is cloudy, discoloured or contains visible particulate matter, the solution should not be used.
Če je raztopina motna, spremenjene barve ali vsebuje vidne delce, se je ne sme uporabiti.
Very common Common
Zelo pogosti Pogosti
Do not dispose of (throw away) pre-filled pens (needle inside), and yellow caps in your household trash.
Napolnjenih injekcijskih peresnikov (z iglo v njih) in rumenih pokrovčkov ne smete zavreči med gospodinjske odpadke.
Do not give yourself a second dose without speaking to your healthcare provider.
Ne dajte si še drugega odmerka, ne da bi se pogovorili z zdravnikom.
Look at the medicine through the viewing window on the syringe:
Skozi okence za ogled v brizgi preglejte zdravilo:
Patients who continued on the same dose regimen received in the SOLO 1 and SOLO 2 studies (300 mg Q2W or 300 mg QW) showed the optimal effect in maintaining clinical response while efficacy for other dose regimens diminished in a dose-dependent manner.
Bolniki, ki so uporabljali enako odmerno shemo kot v študijah SOLO 1 in SOLO 2 (300 mg vsak drugi teden ali 300 mg vsak teden), so glede vzdrževanja kliničnega odziva dosegli najboljši učinek; učinkovitost drugih odmernih shem se je zmanjševala od odmerka odvisno.
Table 5: Demographics and Baseline Characteristics of Asthma Trials
Preglednica 5: Demografske in izhodiščne značilnosti v preskušanjih pri astmi
• Stomach except for the 5 cm around your belly button (navel).
• Trebuh - razen 5 cm okrog popka.
Patients requiring a third controller were allowed to participate in this trial.
V tem preskušanju so lahko sodelovali tudi bolniki, ki so potrebovali še tretje zdravilo za obvladovanje.
This should be taken into consideration to determine type 2 status in patients taking oral corticosteroids (see section
To je treba upoštevati pri določanju statusa tipa 2 pri bolnikih, ki uporabljajo peroralne kortikosteroide (glejte poglavje 5.1).
% patients with EOS
% bolnikov z diNO
Conjunctivitis occurred more frequently in atopic dermatitis patients who received dupilumab.
Konjunktivitis je bil pri bolnikih z atopijskim dermatitisom, ki so prejemali dupilumab, pogostejši.
Carcinogenicity studies have not been conducted with dupilumab.
Študij kancerogenosti z dupilumabom niso izvedli.
Remove
Odstranite
Pharmacotherapeutic group: Other dermatological preparations, agents for dermatitis, excluding corticosteroids, ATC code: D11AH05
5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: Druga zdravila za bolezni kože in podkožnega tkiva, učinkovine za zdravljenje dermatitisa, razen kortikosteroidov Oznaka ATC: D11AH05
If the carton needs to be removed permanently from refrigerator, the date of removal may be recorded on the outer carton.
Če je treba škatlo trajno vzeti iz hladilnika, je mogoče datum, ko je bila vzeta iz hladilnika, zabeležiti na zunanji ovojnini.
The recommended dose of dupilumab for adolescent patients 12 to 17 years of age is specified in Table 1.
Priporočeni odmerek dupilumaba za mladostnike od 12. do 17. leta starosti je prikazan v preglednici 1.
Among asthma patients frequency of conjunctivitis was low and similar between dupilumab and placebo (see section
Pri bolnikih z astmo je bila pogostnost konjunktivitisa majhna ter pri dupilumabu in placebu podobna (glejte poglavje 4.4).
Patients randomised IGA 0 or 1b, % respondersc
Randomizirani bolniki IGA 0 ali 1b, % odzivnihc
• Keep unused syringes in the original carton and store in the refrigerator between 2ºC and 8ºC.
• Neuporabljene napolnjene injekcijske peresnike shranjujte v originalni škatli in v hladilniku na temperaturi od 2 do 8 °C.
Placebo 237 0.22 (14.2) ap-value <0.0001, bp-value = 0.0004, cp-value = 0.0008, dp-value = 0.0063, ep-value <0.0001
Placebo 237 0,22 (14,2) ap-vrednost <0,0001, bp-vrednost = 0,0004, cp-vrednost = 0,0008, dp-vrednost = 0,0063, ep-vrednost <0,0001
The primary endpoint was change from baseline to week 12 in FEV1 (L).
Primarni opazovani dogodek je bila sprememba FEV1 (l) od izhodišča do 12. tedna.
Gather supplies
Zberite pribor
Eligible patients enrolled into this study had previous inadequate response to topical medication.
Primerni bolniki, vključeni v to študijo, se predhodno niso zadostno odzvali na lokalna zdravila.
No dose adjustment is recommended for elderly patients (see section 5.2).
Starejšim bolnikom odmerka ni treba prilagoditi (glejte poglavje 5.2).
Body Weight of Patient
Bolnikova telesna masa
• Ask your healthcare professional to show you the right way to use the syringe before you inject for the first time.
• Preden si prvič injicirate zdravilo, zdravnika prosite, naj vam pokaže, kako pravilno uporabljati brizgo.
PRO Treatment
PRO Zdravljenje
In adolescents 12 years and older, it is recommended that Dupixent be administered by or under supervision of an adult.
Priporočljivo je, da mladostnikom, starim 12 let ali več, zdravilo Dupixent injicira odrasla oseba oziroma da uporaba zdravila poteka pod nadzorstvom odrasle osebe.
After removing the 200 mg pre-filled syringe or pre-filled pen from the refrigerator, it should be allowed to reach room temperature by waiting for 30 min before injecting Dupixent.
Potem, ko je 200 mg napolnjena injekcijska brizga ali napolnjeni injekcijski peresnik vzet iz hladilnika, je treba pustiti, da doseže sobno temperaturo, in sicer tako, da se jo pusti na sobni temperaturi 30 minut pred injiciranjem zdravila Dupixent.
Number of patients with HADS-anxiety ≥ 8 or HADSdepression ≥ 8 at baseline Patients achieving HADS-anxiety and HADSdepression < 8,
odzivnih Število bolnikov z izhodiščno oceno HADSanksioznost ≥ 8 ali HADSdepresija ≥ 8 Bolniki, ki so dosegli oceno HADSanksioznost in HADSdepresija < 8,
Dupilumab is a recombinant human IgG4 monoclonal antibody that inhibits interleukin-4 and interleukin-13 signaling.
Dupilumab je rekombinantno človeško monoklonsko protitelo IgG4, ki zavira signalizacijo z interlevkinom-4 in interlevkinom -13.
Dupilumab should not be injected into skin that is tender, damaged or has bruises or scars.
Dupilumaba se ne sme injicirati v kožo, ki je občutljiva, poškodovana, ima modrice ali je zabrazgotinjena.
Do not use the syringe if it has been damaged.
Ne uporabite brizge, če je poškodovana.
Insert the needle into the fold of skin at roughly a 45º angle.
Zabodite iglo do konca v kožno gubo pod kotom približno 45 stopinj.
If you use more Dupixent than you should or the dose has been given too early, talk to your doctor, pharmacist or nurse.
Če ste uporabili večji odmerek zdravila Dupixent, kot bi smeli Če uporabite večji odmerek zdravila Dupixent, kot bi smeli, ali če odmerek uporabite prezgodaj, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Dupilumab compared with placebo was evaluated in 107 adolescent and 1,795 adult patients with persistent asthma on a medium-to-high dose inhaled corticosteroid (ICS) and a second controller medication.
Dupilumab so v primerjavi s placebom ocenili pri 107 mladostnikih in 1.795 odraslih s persistentno astmo, ki so prejemali srednje velik ali velik odmerek inhalacijskega kortikosteroida (IKS) še eno zdravilo za obvladovanje.
Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Zmanjšanje odmerka kortikosteroida lahko spremljajo sistemski odtegnitveni simptomi oziroma lahko takšno zmanjšanje razkrije bolezni, ki jih zdravljenje s sistemskimi kortikosteroidi pred tem zaviralo.
In DRI12544 and QUEST, the pre-specified subgroup analyses included blood eosinophils ≥ 150 and ≥ 300 cells/mcL, FeNO ≥ 25 and ≥ 50 ppb.
V študijah DRI12544 in QUEST so vnaprej določene analize podskupin obsegale eozinofilce v krvi ≥ 150 in ≥ 300 celic/mcl ter diNO ≥ 25 in ≥ 50 ppb.