natgillin/translations-raw huggingface dataset:
< 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki
Dupilumab is expected to degrade to small peptides and individual amino acids.
Pričakovati je, da se dupilumab razgradi v majhne peptide in posamezne aminokisline.
Other medicines and Dupixent
Druga zdravila in zdravilo Dupixent
Efficacy with respect to severe asthma exacerbations and lung function was observed in both adolescents and adults.
Učinkovitost glede poslabšanj hude astme in delovanja pljuč so opažali pri mladostnikih in pri odraslih.
Very Common (may affect more than 1 in 10 people) atopic dermatitis and asthma: • injection site reactions (i.e. redness, swelling, and itching)
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 oseb) pri atopijskem dermatitisu in astmi: • reakcije na mestu injiciranja (npr. pordelost, oteklost in srbenje)
At higher concentrations, dupilumab elimination is primarily through a non-saturable proteolytic pathway, while at lower concentrations, the non-linear saturable IL-4R α target-mediated elimination predominates.
Pri višjih koncentracijah se dupilumab odstranjuje v prvi vrsti po nesaturabilni proteolitični poti, pri nižjih koncentracijah pa prevladuje nelinearno, saturabilno odstranjevanje preko ciljnega IL-4Rα.
Dupixent is not a rescue medicine and should not be used to treat a sudden asthma attack.
Zdravilo Dupixent ni rešilno zdravilo in ga ne smete uporabljati za zdravljenje nenadnega napada astme.
Press the pre-filled pen firmly against your skin until you cannot see the orange needle cover, and hold.
Napolnjeni injekcijski peresnik trdno pritisnite na kožo, dokler ne morete več videti oranžnega pokrovčka igle, in držite.
• Do not get rid of any air bubbles in the syringe.
• Ne odstranjujte morebitnih zračnih mehurčkov v brizgi.
• Ask your healthcare professional how often you will need to inject the medicine.
• Zdravnika vprašajte, kako pogosto si boste morali injicirati zdravilo.
Inject your medicine immediately after removing the needle cap.
Zdravilo injicirajte takoj potem, ko ste odstranili pokrovček igle.
Of these, 2,678 had a history of 1 or more severe exacerbations in the year prior to enrolment despite regular use of medium-to-high dose inhaled corticosteroids plus an additional controller(s) (DRI12544 and QUEST).
Od teh jih je 2.678 imelo anamnezo 1 ali več hudih poslabšanj v letu pred vključitvijo, in sicer kljub redni uporabi srednjih do velikih odmerkov inhalacijskih kortikosteroidov in enega ali več dodatnih zdravil za obvladovanje (DRI12544 in QUEST).
After a single subcutaneous (SC) dose of 75-600 mg dupilumab, median times to maximum concentration in serum (tmax) were 3-7 days.
Po enkratnem subkutanem (s.c.) odmerku od 75 do 600 mg dupilumaba je bil mediani čas do največje koncentracije v serumu (tmax) od 3 do 7 dni.
Quality of Life/Patient-Reported Outcomes in Asthma
Kakovost življenja/izidi po navedbi bolnikov pri astmi
If a systemic hypersensitivity reaction (immediate or delayed) occurs, administration of dupilumab should be discontinued immediately and appropriate therapy initiated.
Če se pojavi sistemska preobčutljivostna reakcija (zgodnja ali pozna), je treba uporabo dupilumaba nemudoma prekiniti in uvesti ustrezno zdravljenje.
Contents of the pack and other information What Dupixent contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Dupixent
What you need to know before you use Dupixent Do not use Dupixent
Kaj morate vedeti, preden boste uporabili zdravilo Dupixent Ne uporabljajte zdravila Dupixent
Of the 1,977 patients with asthma exposed to dupilumab, a total of 240 patients were 65 years or older and 39 patients were 75 years or older.
Od 1.977 bolnikov z astmo, izpostavljenih dupilumabu, je bilo skupno 240 bolnikov starih 65 let ali več in 39 bolnikov je bilo starih 75 let ali več.
Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician.
Če je zmanjšanje odmerka kortikosteroida umestno, mora biti izvedeno postopno in pod neposrednim nadzorstvom zdravnika.
If patients become infected while receiving treatment with dupilumab and do not respond to antihelminth treatment, treatment with dupilumab should be discontinued until infection resolves.
Če se bolnik okuži med zdravljenjem z dupilumabom in se ne odzove na zdravljenje z antihelmintiki, je treba zdravljenje z dupilumabom prekiniti, dokler okužba ni odpravljena.
The safety profile of dupilumab in patients followed through week 52 was similar to the safety profile observed at week 16 in AD-1526 study.
Varnostne značilnosti dupilumaba so bile pri bolnikih, ki so jih spremljali do 52. tedna, podobne varnostnim značilnostim, opaženim 16. teden v študiji AD-1526.
Dupixent may also help reduce the amount of another group of medicines you need to control your asthma, called oral corticosteroids, while preventing severe asthma attacks and improving your breathing.
Zdravilo Dupixent lahko tudi pomaga zmanjšati količino druge skupine zdravil, ki jih potrebujete za obvladovanje astme in jih imenujemo peroralni kortikosteroidi, s tem ko preprečuje hude napade astme in vam izboljša dihanje.
• Place the orange needle cover on your skin at approximately a 90-degree angle.
• Položite oranžni pokrovček igle na kožo pod kotom približno 90 stopinj.
Patients with pre-existing helminth infections should be treated before initiating dupilumab.
Bolnike z obstoječimi okužbami s helminti je treba zdraviti pred uvedbo dupilumaba.
Step 4: Wait 30 minutes
4. korak: Počakajte 30 minut
After 12 weeks of dupilumab administration, patients were vaccinated with a Tdap vaccine (T cell-dependent), and a meningococcal polysaccharide vaccine (T cell-independent) and immune responses were assessed 4 weeks later.
Po 12 tednih uporabe dupilumaba so bolnike cepili s cepivom Tdap (odvisnim od celic T) in z meningokoknim polisaharidnim cepivom (neodvisnim od celic T) ter so njihov imunski odziv ocenili 4 tedne pozneje.
For the 200 mg every other week dose, patients had a reduction in the rate of severe exacerbations that was consistent with adults.
Bolniki, ki so prejemali odmerek 200 mg vsak drugi teden, so imeli znižano stopnjo hudih poslabšanj, ki je bila skladna z odraslo populacijo.
Do not store above 25°C.
Ne shranjujte na temperaturi nad 25 °C.
The ACQ-5 and AQLQ(S) were also assessed in VENTURE and showed improvements similar to those in QUEST.
ACQ-5 in AQLQ(S) so ocenjevali tudi v študiji VENTURE in ugotovili podobna izboljšanja kot v študiji QUEST.
Dupilumab elimination is mediated by parallel linear and nonlinear pathways.
Odstranjevanje dupilumaba poteka vzporedno po linearni in nelinearni poti.
Common (may affect up to 1 in 10 people) atopic dermatitis only:
Pogosti (pojavijo se lahko največ 1 od 10 oseb) le pri atopijskem dermatitisu:
Rarely patients taking an asthma medicine may develop inflammation of blood vessels or lungs due to an increase of certain white blood cells (eosinophilia).
Redko se lahko bolnikom, ki uporabljajo zdravila za astmo, pojavi vnetje žil ali pljuč zaradi povečanja števila določenih belih krvnih celic (eozinofilija).
• Check with your healthcare professional how often you will need to inject the medicine.
• Z zdravnikom se pogovorite, kako pogosto si boste morali injicirati zdravilo.
Annualized rate of severe asthma exacerbation events during the 24-week placebo controlled treatment period was also determined.
Določena je bila tudi letna stopnja hudih poslabšanj astme med 24-tedenskim, s placebom nadzorovanim zdravljenjem.
Dupixent may weaken your resistance to infections caused by parasites.
Zdravilo Dupixent lahko poslabša odpornost proti okužbam, ki jih povzročajo paraziti (zajedavci).
Clinical Response in Patients Not Adequately Controlled with, Intolerant to, or for whom Ciclosporin Treatment was Inadvisable (CAFE study)
Klinični odziv pri bolnikih, ki s ciklosporinom niso bili zadostno urejeni, ga niso prenesli ali za katere ni bil priporočljiv (študija CAFE)
If needed to control intolerable symptoms of atopic dermatitis, patients were permitted to receive rescue treatment (which included higher potency topical steroids or systemic immunosuppressants) at the discretion of the investigator.
Če je bilo zaradi neznosnih simptomov atopijskega dermatitisa potrebno, so bolniki smeli po raziskovalčevi presoji dobiti rešilno zdravljenje (ki je vključevalo močnejše lokalne steroide ali sistemske imunosupresive).
What Dupixent is and what it is used for 2.
Kaj je zdravilo Dupixent in za kaj ga uporabljamo 2.
In SOLO CONTINUE, a trend for increased treatment-emergent ADA positivity with increased dosing intervals was observed.
V študiji SOLO CONTINUE so opazili trend k večanju pozitivnih izvidov med zdravljenjem nastalih protiteles proti zdravilu (ADA) z naraščajočimi odmernimi intervali.
The pre-filled syringe should not be exposed to heat or direct sunlight and should not be shaken.
Napolnjene injekcijske brizge se ne sme izpostavljati vročini ali neposredni sončni svetlobi in se je ne sme pretresati.
Do not stop using Dupixent without speaking to your doctor first.
Ne prenehajte uporabljati zdravila Dupixent, ne da bi se prej posvetovali z zdravnikom.
Week 16 (FAS)b
16. teden (FAS)b
• After you have completed your injection pull straight up to remove pre-filled pen from the skin.
• Ko ste injiciranje dokončali, potegnite naravnost navzgor, da boste napolnjeni injekcijski peresnik odstranili s kože.
Primary and secondary endpoints for the 16 week CAFE study are summarized in table 6.
Primarni in sekundarni opazovani dogodki 16-tedenske študije CAFE so povzeti v preglednici 6.
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Če ste noseči, menite, da ste noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden uporabite to zdravilo.
You and your doctor or nurse should decide if you should inject Dupixent yourself.
Skupaj z zdravnikom ali medicinsko sestro se morate odločiti, ali si boste zdravilo Dupixent injicirali sami.
After removal from the refrigerator, Dupixent must be used within 14 days or discarded.
Ko je zdravilo Dupixent vzeto iz hladilnika, ga je treba uporabiti v 14 dneh ali ga zavreči.
In addition, anxiety and depression symptoms as measured by the HADS total score were significantly reduced in the dupilumab groups compared to placebo at 16 weeks.
Poleg tega so se simptomi anksioznosti in depresija, merjeni s celotno oceno HADS, v skupinah z dupilumabompo 16 tednih značilno zmanjšali v primerjavi s placebom.
Anti-Drug-Antibodies (ADA) responses were not generally associated with impact on dupilumab exposure, safety, or efficacy.
Odzivi na protitelesa proti dupilumabu (ADA, Anti-Drug-Antibodies) na splošno niso vplivali na izpostavljenost dupilumabu, njegovo varnost ali učinkovitost.
If you develop an allergic reaction, stop using Dupixent and talk to your doctor right away.
Če se vam pojavi alergijska reakcija, nehajte uporabljati zdravilo Dupixent in se takoj posvetujte z zdravnikom.
• Clean the injection site with an alcohol wipe.
• Očistite mesto injiciranja z alkoholnim zložencem.
Pull the needle out of the skin at the same angle it was inserted.
Izvlecite iglo iz kože pod istim kotom, kot ste jo vanjo zabodli.
The baseline mean oral corticosteroid use was 11.75 mg in the placebo group and 10.75 mg in the group receiving dupilumab.
Povprečna izhodiščna uporaba peroralnega kortikosteroida je bila v skupini s placebom 11,75 mg in v skupini z dupilumabom 10,75 mg.
At Week 12
12. teden
Dupilumab has no or negligible influence on the ability to drive or operate machinery.
Dupilumab nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
• When placing the orange needle cover on your skin, hold the pre-filled pen so that you can see the window.
• Ko nameščate oranžni pokrovček igle na kožo, držite napolnjeni injekcijski peresnik tako, da boste videli okence.
Safety and efficacy in paediatric patients (< 12 years of age) with severe asthma have not been established.
Varnost in učinkovitost pri pediatričnih bolnikih (v starosti < 12 let) s hudo astmo nista ugotovljeni.
ICS = inhaled corticosteroid; FEV1 = Forced expiratory volume in 1 second; ACQ-5 = Asthma Control Questionnaire-5; AQLQ = Asthma Quality of Life Questionnaire; AD = atopic dermatitis; NP = nasal polyposis; AR = allergic rhinitis; FeNO = fraction of exhaled nitric oxide; EOS = blood eosinophil aThe population in dupilumab asthma trials included patients on medium and high dose ICS.
IKS = inhalacijski kortikosteroid, FEV1 = forsirani ekspiracijski volumen v 1 sekundi, ACQ5 = vprašalnik Asthma Control Questionnaire-5, AQLQ = vprašalnik Asthma Quality of Life Questionnaire, AD = atopijski dermatitis, NP = nosna polipoza, AR = alergijski rinitis, diNO = delež izdihanega dušikovega oksida; EOS = eozinofilci v krvi a Populacija v preskušanjih dupilumaba pri astmi je obsegala bolnike na srednjem in velikem odmerku IKS.
- The active substance is dupilumab.
- Zdravilna učinkovina je dupilumab.
• There will be a “click” when the injection starts.
• Ko se bo injiciranje začelo, boste slišali "klik".
• You can inject into your thigh or belly (stomach), except for the 5 cm around your navel.
• Injicirate lahko v stegno ali v trebuh; izjema je le predel 5 cm okrog popka.
Clean the injection site with an alcohol wipe.
Očistite mesto injiciranja z alkoholnim zložencem.
Fertility studies conducted in male and female mice using a surrogate antibody against IL-4Rα showed no impairment of fertility (see section 4.6).
Študije plodnosti, izvedene pri mišjih samcih in samicah z uporabo nadomestnega protitelesa proti IL-4Rα, niso pokazale okvare plodnosti (glejte poglavje 4.6).
If you stop using Dupixent
Če ste prenehali uporabljati zdravilo Dupixent
Do not keep Dupixent at room temperature for more than 14 days.
Zdravila Dupixent ne shranjujte na sobni temperaturi več kot 14 dni.
POEM, (≥6-point improvement), % responders a Full Analysis Set (FAS) includes all patients randomised.
POEM, (izboljšanje za ≥ 6 točk), % odzivnih a Celotni nabor za analizo (FAS - Full Analysis Set) obsega vse randomizirane bolnike.
In these 5 trials, 1,689 subjects were treated with subcutaneous injections of dupilumab, with or without concomitant topical corticosteroids (TCS).
V teh 5 preskušanjih so 1689 preiskovancev zdravili s subkutanimi injekcijami dupilumaba, s sočasnimi lokalnimi kortikosteroidi (LKS) ali brez njih.
Serum sickness/serum sickness-like reactions
Zelo redki serumska bolezen/serumski bolezni podobne reakcije
Both play a major role in causing the signs and symptoms of atopic dermatitis and asthma.
Ti dve imata pomembno vlogo pri nastanku znakov in simptomov atopijskega dermatitisa in astme.
Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of conditions for which dupilumab is indicated (see section 4.1).
Zdravljenje mora vpeljati zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem atopijskega dermatitisa, za katerega je indiciran dupilumab (glejte poglavje 4.1).
Overall, 92.0% of patients had at least one co-morbid allergic condition; 65.6% had allergic rhinitis, 53.6% had asthma, and 60.8% had food allergies.
Skupaj je imelo 92,0 % bolnikov vsaj eno sočasno alergijsko stanje; 65,6 % jih je imelo alergijski rinitis, 53,6 % astmo in 60,8 % prehranske alergije.
Dupixent helps prevent severe asthma attacks (exacerbations) and can improve your breathing.
Zdravilo Dupixent pomaga preprečevati hude napade astme (poslabšanja) in lahko izboljša dihanje.
There is no specific treatment for dupilumab overdose.
Za preveliko odmerjanje dupilumaba ni specifičnega zdravljenja.
Dupilumab 200 mg (<60 kg) and
Dupilumab 200 mg (< 60 kg) in
c Patients who received rescue treatment or with missing data were considered as non-responders (58.8% and 20.7% in the placebo and dupilumab arms, respectively).
c Bolniki, ki so prejeli rešilno zdravljenje, in bolniki z manjkajočimi podatki so bili ocenjeni kot neodzivni (v skupini s placebom je bilo takšnih 58,8 % in v skupini z dupilumabom 20,7 %).
It is unknown whether dupilumab is excreted in human milk or absorbed systemically after ingestion.
Ni znano, ali se dupilumab pri človeku izloča v materinem mleku in ali se po zaužitju sistemsko absorbira.
Tell your doctor immediately if you develop a combination of symptoms such as a flu-like illness, pins and needles or numbness of arms or legs, worsening of pulmonary symptoms, and/or rash.
Nemudoma obvestite zdravnika, če se vam pojavi kombinacija simptomov, npr. gripi podobna bolezen, mravljinčenje ali omrtvičenost rok ali nog, poslabšanje pljučnih simptomov in/ali izpuščaj.
Pull the yellow cap straight off.
Odstranite rumeni pokrovček Potegnite rumeni pokrovček naravnost dol.
Dupilumab trough concentrations were lower in subjects with higher body weight with no meaningful impact on efficacy.
Najnižja koncentracija dupilumaba je bila pri preiskovancih z večjo telesno maso nižja, vendar to ni pomembno vplivalo na učinkovitost.
Time out of refrigeration should not exceed a maximum of 14 days at temperature below 25 °C.
Čas, ko je zdravilo zunaj hladilnika, ne sme biti daljši od 14 dni pri temperaturi do 25 °C.
Median % reduction in daily OCS dose from baseline
Mediani % zmanjšanja dnevnega odmerka PKS od izhodišča
respondersc, d
% odzivnihc, d
Dupilumab should not be used to treat acute bronchospasm or status asthmaticus.
Dupilumaba se ne sme uporabljati za zdravljenje akutnega bronhospazma ali astmatičnega statusa.
N Responder rate %
N Delež odziva %
SOLO 2 at Week 16
SOLO 2 po 16 tednih
In CHRONOS, efficacy was also evaluated at week 52.
V študiji CHRONOS so učinkovitost ocenili tudi po
Dupixent is unlikely to influence your ability to drive and use machines.
Ni verjetno, da bi zdravilo Dupixent vplivalo na vašo sposobnost upravljanja vozil in strojev.
Lift your thumb to release the plunger rod until the needle is covered by the needle shield and then remove the syringe from the injection site.
Dvignite palec, da boste sprostili bat, dokler igla ni pokrita s ščitnikom igle, nato brizgo odstranite z mesta injiciranja.
A patient may self-inject dupilumab or the patient's caregiver may administer dupilumab if their healthcare professional determines that this is appropriate.
Bolnik si lahko sam injicira dupilumab, ali mu ga injicira njegov negovalec, če zdravnik presodi, da je to primerno.
Eosinophil counts declined to near baseline levels during study treatment.
Število eozinofilcev se je med raziskovanim zdravljenjem zmanjšalo na skoraj izhodiščno raven.
Topical calcineurin inhibitors may be used, but should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas.
Uporabiti je mogoče lokalne zaviralce kalcinevrina, ki pa morajo biti pridržani za težavne predele, kot so obraz, vrat, intertriginozni predeli in predel spolovil.
Proper training should be provided to patients and/or caregivers on the preparation and administration of dupilumab prior to use according to the Instructions for Use (IFU) section in the package leaflet.
Bolnikom in/ali negovalcem je treba pred uporabo zagotoviti ustrezno usposabljanje o pripravi in dajanju dupilumaba v skladu s poglavjem "Navodila za uporabo" v navodilu za uporabo zdravila.
Patients continued to receive their existing asthma medicine during the study; however their OCS dose was reduced every 4 weeks during the OCS reduction phase (week 4-20), as long as asthma control was maintained.
Bolniki so med študijo še naprej uporabljali svoje siceršnje zdravilo za astmo, toda odmerek PKS so jim med obdobjem zmanjševanja PKS (od 4. do 20. tedna) zmanjševali na 4 tedne, dokler je ostajala astma urejena.
The primary endpoint was the proportion of patients with EASI-75 at week 16.
Primarni opazovani dogodek je bil delež bolnikov z EASI-75 16. teden.
Clinical efficacy and safety in atopic dermatitis
Klinična učinkovitost in varnost pri atopijskem dermatitisu
No adverse interactions between either of the non-live vaccines and dupilumab were noted in the study.
V študiji niso ugotovili neželenega medsebojnega delovanja med nobenim od obeh neživih cepiv in dupilumabom.
Keep holding the pre-filled pen firmly against your skin.
Še naprej držite napolnjeni injekcijski peresnik trdno na koži.
SOLO 1 at Week 16
SOLO 1 po 16 tednih
Dupilumab inhibits IL-4 signaling via the Type I receptor (IL-4Rα/γc), and both IL-4 and IL-13 signaling through the Type II receptor (IL-4Rα/IL-13Rα).
Dupilumab zavira signalizacijo z IL-4 preko receptorjev tipa I (IL-4Rα/γc), signalizacijo tako z IL-4 kot z IL-13 pa preko receptorjev tipa II (IL-4Rα/IL-13Rα).
Dupilumab is a monoclonal antibody (a type of specialised protein) that blocks the action of proteins called IL-4 and IL-13.
Dupilumab je monoklonsko protitelo (vrsta specializiranih beljakovin), ki preprečuje delovanje beljakovin IL-4 in IL-13.
Dupixent has also been shown to improve symptoms of pain, anxiety, and depression associated with atopic dermatitis.
Dokazano je, da zdravilo Dupixent izboljša tudi bolečine, tesnobnost (anksioznost) in depresijo, povezane z atopijskim dermatitisom.
Key Secondary Endpoints
Ključni sekundarni opazovani dogodki
If you already have a parasitic infection it should be treated before you start treatment with Dupixent.
Če že imate kakšno zajedavsko okužbo, jo je treba zdraviti, preden začnete zdravljenje z zdravilom Dupixent.
The European Medicines Agency has deferred the obligation to submit the results of studies with dupilumab in one or more subset of the paediatric population in atopic dermatitis and asthma (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z dupilumabom pri atopijskem dermatitisu in astmi za eno ali več podskupin pediatrične populacije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
You must look out for signs of these conditions (i.e. breathing problems, swelling of the face, mouth, and tongue, fainting, dizziness, feeling lightheaded (low blood pressure), fever, general ill feeling, swollen lymph nodes, hives, itching, joint pain, skin rash) while you are taking Dupixent.
Med uporabo zdravila Dupixent morate biti pozorni na znake takšnih reakcij (npr. na težave z dihanjem, otekanje obraza, ust in jezika, omedlevico, omotico, občutek vrtoglavosti (nizek krvni pritisk) zvišano telesno temperaturo, splošno slabo počutje, otekle bezgavke, koprivnico (urtikarijo), srbenje, bolečine v sklepih, izpuščaj na koži).
Check if the liquid is clear and colourless to pale yellow.
Preverite, da je tekočina bistra in brezbarvna do bledo rumena.
Dupilumab may influence the immune response against helminth infections by inhibiting IL-4/IL-13 signaling.
Dupilumab lahko vpliva na imunski odziv proti okužbam s helminti, ker zavira signalizacijo IL-4/IL-13.
In addition, there was one patient with serum sickness and one with serum sickness-like reaction (< 0.1 %) associated with high ADA titers (see section 4.4).
Poleg tega je imel v povezavi z visokim titrom ADA en bolnik serumsko bolezen in en bolnik serumski bolezni podobno reakcijo (< 0,1 %) (glejte poglavje 4.4).
Placebo 127 0.09 (4.36) QUEST study
Placebo 127 0,09 (4,36) Študija QUEST Dupilumab
Very limited data are available in patients with severe renal impairment.
Podatkov o bolnikih s hudo okvaro ledvic je zelo malo.
Primary and secondary endpoints for the 52 week SOLO CONTINUE study are summarized in table 7.
Primarni in sekundarni opazovani dogodki 52-tedenske študije SOLO CONTINUE so povzeti v preglednici 7.
The long-term efficacy of dupilumab in adolescent patients with moderate-to-severe AD who had participated in previous clinical trials of dupilumab was assessed in open-label extension study (AD1434).
Dolgoročno učinkovitost dupilumaba pri mladostnikih z zmernim do hudim AD, ki so sodelovali v predhodnih kliničnih preskušanjih dupilumaba, so ocenili v odprti podaljšani študiji (AD-1434).