FrancophonIA/ELRC3.0 huggingface dataset:
English: Anaphylactic reaction has been reported very rarely in the asthma development program (see section 4.4).
Croatian: U razvojnom programu kod astme vrlo je rijetko prijavljena anafilaktička reakcija (vidjeti dio 4.4).
English: Do not use the pre-filled pen if the liquid is discolored or cloudy, or if it contains visible flakes or particles.
Croatian: Nemojte upotrijebiti napunjenu brizgalicu ako je tekućina u njoj promijenila boju ili je zamućena ili ako sadrži vidljive pahuljice ili čestice.
English: • Read all of the instructions carefully before using the pre-filled pen.
Croatian: • Pažljivo pročitajte cijele upute prije nego što upotrijebite napunjenu brizgalicu.
English: Percent Reduction
Croatian: Postotno smanjenje
English: Among asthma patients frequency of conjunctivitis was low and similar between dupilumab and placebo (see section
Croatian: Učestalost konjunktivitisa među bolesnicima s astmom bila je niska te slična uz dupilumab i placebo
English: In the 16-week atopic dermatitis monotherapy clinical studies, serious infections were reported in 1.0 % of patients treated with placebo and 0.5 % of patients treated with dupilumab.
Croatian: U 16-tjednim kliničkim ispitivanjima monoterapije kod atopijskog dermatitisa ozbiljne infekcije prijavljene su u 1,0% bolesnika koji su primali placebo i 0,5% bolesnika liječenih dupilumabom.
English: For adolescents 12 to 17 years of age with atopic dermatitis receiving every other week dosing (Q2W) with either 200 mg (<60 kg) or 300 mg (≥60 kg), the mean ±SD steady state trough concentration of dupilumab was 54.5±27.0 mcg/ml.
Croatian: Kod adolescenata s atopijskim dermatitisom u dobi od 12 do 17 godina koji su svaki drugi tjedan primali doze od 200 mg (<60 kg) ili 300 mg (≥60 kg), srednja vrijednost ± SD najnižih koncentracija dupilumaba u stanju dinamičke ravnoteže iznosila je 54,5 ± 27,0 µg/ml.
English: Multipack: 3 (3 packs of 1) pre-filled syringes Multipack: 6 (3 packs of 2) pre-filled syringes
Croatian: Višestruko pakiranje: 3 (3 pakiranja od 1) napunjene štrcaljke Višestruko pakiranje: 6 (3 pakiranja od 2) napunjenih štrcaljki
English: Dupixent is used to treat adults and adolescents 12 years and older with moderate-to-severe atopic dermatitis, also known as atopic eczema.
Croatian: Dupixent se koristi za liječenje odraslih osoba i adolescenata u dobi od 12 ili više godina s umjerenim do teškim atopijskim dermatitisom, koji se još naziva i atopijskim ekcemom.
English: Marketing Authorisation Holder sanofi-aventis groupe 54, rue La Boétie 75008 Paris France
Croatian: Nositelj odobrenja za stavljanje lijeka u promet sanofi-aventis groupe 54, rue La Boétie 75008 Paris Francuska
English: h p-value = 0.0003
Croatian: h p-vrijednost = 0,0003
English: Check the medicine
Croatian: A4. Pregledajte lijek
English: Do not remove the yellow cap until you are ready to inject.
Croatian: Nemojte skinuti žuti zatvarač dok ne budete spremni injicirati lijek.
English: • Do not touch the plunger rod until you are ready to inject.
Croatian: • Nemojte dirati potisnik klipa dok ne budete spremni injicirati lijek.
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.
Croatian: U 52-tjednom ispitivanju kombinacije dupilumab + TKS kod atopijskog dermatitisa herpetični je ekcem prijavljen u 0,2% bolesnika koji su primali dupilumab + TKS i 1,9% onih koji su primali placebo + TKS.
English: No dose adjustment is recommended for elderly patients (see section 5.2).
Croatian: Stariji bolesnici (≥ 65 godina) Ne preporučuje se prilagođavati dozu u starijih bolesnika (vidjeti dio 5.2).
English: The safety and benefits of Dupixent are not yet known in children with asthma below the age of 12.
Croatian: Sigurnost i koristi lijeka Dupixent u djece s astmom mlađe od 12 godina još nisu poznate.
English: Blocking the IL-4/IL-13 pathway with dupilumab in patients decreases many of the mediators of type 2 inflammation.
Croatian: Dupilumab blokira put IL-4/IL-13 i tako smanjuje razine brojnih posrednika upale tipa 2.
English: Let your skin dry before injecting.
Croatian: Pričekajte da se koža osuši prije nego što injicirajte lijek.
English: Figure 5: Proportion of adolescent patients with ≥4-point improvement on the pruritus NRS in AD-1526 studya (FAS)b a In the primary analyses of the efficacy endpoints, subjects who received rescue treatment or with missing data were considered non-responders.
Croatian: Slika 5: Udio adolescentnih bolesnika u ispitivanju AD-1526a (FAS)b s poboljšanjem NRS rezultata za pruritus za ≥ 4 boda aU primarnoj analizi mjera ishoda djelotvornosti, bolesnici koji su primili liječenje za hitno ublažavanje simptoma ili za koje su nedostajali podaci smatrali su se bolesnicima bez odgovora.
English: It contains 200 mg of Dupixent for injection under the skin (subcutaneous injection).
Croatian: Sadrži 200 mg lijeka Dupixent za injekciju koja se daje pod kožu (supkutana injekcija).
English: g p-value = 0.0015
Croatian: g p-vrijednost = 0,0015
English: The results for VENTURE by baseline biomarkers are presented in the Table 17.
Croatian: Rezultati za ispitivanje VENTURE prema početnim vrijednostima bioloških biljega prikazani su u Tablici 17.
English: 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.
Croatian: b Bolesnik s odgovorom definirao se kao bolesnik s IGA rezultatom 0 ili 1 („čisto“ ili „gotovo čisto“) s postignutim smanjenjem za ≥ 2 boda na IGA ljestvici od 0 do 4 boda.
English: Step 11: Release and Remove
Croatian: 11. korak: Otpustite klip i izvucite iglu
English: • Multipack containing 3 (3 packs of 1) pre-filled syringes
Croatian: • Višestruko pakiranje koje sadrži 3 (3 pakiranja od 1) napunjene štrcaljke
English: Your doctor will decide how much Dupixent you need and for how long.
Croatian: Vaš će liječnik odlučiti koliko lijeka Dupixent
English: • Do not shake the pre-filled pen at any time.
Croatian: • Nemojte tresti napunjenu brizgalicu ni u jednom trenutku.
English: Placebo ap-value <0.0001
Croatian: Placebo ap-vrijednost < 0,0001
English: Table 9: Other secondary endpoint results of dupilumab with concomitant TCS at Week 16 and Week 52 in CHRONOS
Croatian: Tablica 9: Rezultati za ostale sekundarne mjere ishoda uz dupilumab + TKS u 16. tjednu i 52. tjednu ispitivanja CHRONOS
English: Step 12: Dispose
Croatian: 12. korak: Zbrinite pribor
English: The parts of the Dupixent pre-filled syringe with needle shield are shown in this picture.
Croatian: Dijelovi Dupixent napunjene štrcaljke sa zaštitnim pokrovom igle prikazani su na sljedećoj slici.
English: Keep the container out of sight and reach of children.
Croatian: Spremnik treba čuvati izvan pogleda i dohvata djece.
English: It contains 300 mg of Dupixent for injection under the skin (subcutaneous injection).
Croatian: Sadrži 300 mg lijeka Dupixent za injekciju koja se daje pod kožu (supkutana injekcija).
English: Number of patients with baseline pruritus NRS score ≥ 4
Croatian: NRS rezultatom za pruritus ≥ 4
English: Dupixent is also used with other asthma medicines for the maintenance treatment of severe asthma in adults and adolescents (12 years of age and older) whose asthma is not controlled with their current asthma medicines.
Croatian: Dupixent se također koristi zajedno s drugim lijekovima za astmu kao terapija održavanja za tešku astmu u odraslih i adolescenata (u dobi od 12 ili više godina) kojima astma nije kontrolirana lijekovima koje trenutno uzimaju.
English: • Do not use the syringe if the needle cap is missing or not securely attached.
Croatian: • Nemojte upotrijebiti štrcaljku ako nedostaje zatvarač igle ili ako on nije čvrsto pričvršćen.
English: Table 1: Dose of dupilumab for subcutaneous administration in adolescent patients 12 years to 17 years of age with atopic dermatitis Body Weight of Patient
Croatian: Tablica 1: Doza dupilumaba za supkutanu primjenu u adolescentnih bolesnika s atopijskim dermatitisom u dobi od 12 do 17 godina
English: c Responder was defined as a patient with IGA 0 or 1 (“clear” or “almost clear”) with a reduction of
Croatian: c Bolesnik s odgovorom definirao se kao bolesnik s IGA rezultatom 0 ili 1 („čisto“ ili „gotovo čisto“)
English: Do not use the syringe if the liquid is discoloured or cloudy, or if it contains flakes or particles.
Croatian: Nemojte upotrijebiti štrcaljku ako je tekućina u njoj promijenila boju ili je zamućena ili ako sadrži pahuljice ili čestice.
English: After use, place the pre-filled syringe into a puncture-resistant container and discard as required by local regulations.
Croatian: Nakon primjene, štrcaljku treba odložiti u neprobojan spremnik i zbrinuti u skladu s nacionalnim propisima.
English: Table 5: Efficacy results of dupilumab with concomitant TCSa at Week 16 and Week 52 in CHRONOS
Croatian: Tablica 5: Rezultati za djelotvornost kombinacije dupilumab + TKSa u 16. tjednu i 52. tjednu u ispitivanju CHRONOS
English: Choose a different injection site for each Dupixent injection.
Croatian: Promijenite mjesto injiciranja kod svake injekcije lijeka Dupixent.
English: • Multipack containing 6 (3 packs of 2) pre-filled syringes
Croatian: • Višestruko pakiranje koje sadrži 6 (3 pakiranja od 2) napunjenih štrcaljki
English: Table 3: List of adverse reactions in asthma MedDRA System
Croatian: Tablica 3: Popis nuspojava kod astme
English: After use, place the pre-filled syringe or the pre-filled pen into a puncture-resistant container and discard as required by local regulations.
Croatian: Nakon primjene, štrcaljku ili brizgalicu treba odložiti u neprobojan spremnik i zbrinuti u skladu s nacionalnim propisima.
English: This device is a single-use pre-filled syringe.
Croatian: Ova brizgalica je napunjena brizgalica za jednokratnu uporabu.
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).
Croatian: U bolesnika s atopijskim dermatitisom u dobi od 12 do 17 godina, preporučena doza iznosi 200 mg (< 60 kg) odnosno 300 mg (≥ 60 kg) svaki drugi tjedan.
English: Do not put the needle cap back on.
Croatian: Nemojte vraćati zatvarač igle na štrcaljku.
English: Patients requiring a third controller were allowed to participate in this trial.
Croatian: U ispitivanju su mogli sudjelovati i bolesnici kojima je bio potreban treći lijek za terapiju održavanja.
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.
Croatian: 2 ml otopine u napunjenoj štrcaljki od silikoniziranog bezbojnog stakla tipa I, sa zaštitnim pokrovom igle ili bez njega, s pričvršćenom iglom tankih stijenki od nehrđajućeg čelika veličine 27 G i duljine
English: Results were evaluated in the overall population (unrestricted by minimum baseline eosinophils or other type 2 inflammatory biomarkers) and subgroups based on baseline blood eosinophils count.
Croatian: Rezultati su se ocjenjivali u cjelokupnoj populaciji (koja nije bila ograničena minimalnom početnom razinom eozinofila ili drugih bioloških biljega upale tipa 2) te u podskupinama prema početnom broju eozinofila u krvi.
English: 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.
Croatian: Koprimarne mjere ishoda bile su razlika između početka (0. tjedna) i 36. tjedna u postotnoj promjeni EASI rezultata u odnosu na početnu vrijednost u ispitivanjima SOLO 1 i SOLO 2 te postotak bolesnika s rezultatom EASI-75 u 36. tjednu među bolesnicima koji su imali rezultat EASI-75 na početku ispitivanja.
English: • Do not re-use the syringe.
Croatian: • Nemojte ponovno upotrijebiti istu štrcaljku.
English: 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).
Croatian: Među njima je 2678 bolesnika u anamnezi imalo 1 ili više teških egzacerbacija unutar godinu dana prije uključivanja u ispitivanje unatoč redovitoj primjeni umjerenih do visokih doza inhalacijskih kortikosteroida i jednog ili više dodatnih lijekova za terapiju održavanja
English: Serum sickness/serum sickness-like reactions
Croatian: Poremećaji imunološkog sustava vrlo rijetko serumska bolest/reakcije nalik serumskoj bolesti
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).
Croatian: Značajna poboljšanja vrijednosti FEV1 opažena su već u 2. tjednu nakon prve doze dupilumaba i uz dozu od 200 mg i uz dozu od 300 mg, a održala su se do 24. tjedna u ispitivanju DRI12544 te do 52. tjedna u ispitivanju QUEST (vidjeti Sliku 6).
English: *Items not included in the carton
Croatian: *Nije uključeno u pakiranje lijeka
English: Table 10: Efficacy results of dupilumab in the adolescent atopic dermatitis study at Week 16 (FAS)
Croatian: Tablica 10: Rezultati za djelotvornost dupilumaba u ispitivanju atopijskog dermatitisa u adolescenata u 16. tjednu (FAS)
English: Dupixent is used with other asthma medicines for the maintenance treatment of severe asthma in adults and adolescents (12 years of age and older) whose asthma is not controlled with their current asthma medicines.
Croatian: Dupixent se koristi zajedno s drugim lijekovima za astmu kao terapija održavanja za tešku astmu u odraslih i adolescenata (u dobi od 12 ili više godina) kojima astma nije kontrolirana lijekovima koje trenutno uzimaju.
English: If somebody else administers the injection, the upper arm can also be used.
Croatian: Ako bolesniku injekciju daje netko drugi, može se primijeniti i u nadlakticu.
English: The long-term safety profile of dupilumab observed in adolescents was consistent with that seen in adults with atopic dermatitis.
Croatian: Dugoročni sigurnosni profil dupilumaba opažen u adolescenata bio je u skladu s onim primijećenim u odraslih bolesnika s atopijskim dermatitisom.
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).
Croatian: Značajna poboljšanja vrijednosti FEV1 opažena su već u 2. tjednu nakon prve doze dupilumaba i uz dozu od 200 mg i uz dozu od 300 mg, a održala su se do 24. tjedna u ispitivanju DRI12544 te do 52. tjedna u ispitivanju QUEST (vidjeti Sliku 2).
English: Table 13.
Croatian: Tablici 1.
English: 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.
Croatian: Nakon optimizacije doze OKS-a tijekom razdoblja probira bolesnici su nakon početne doze od 600 mg dupilumaba ili placeba primali 300 mg dupilumaba (n=103) ili placebo (n=107) jedanput svaki drugi tjedan tijekom 24 tjedna.
English: Asthma treatment guidelines define type 2 inflammation as eosinophilia ≥ 150 cells/mcL and/or FeNO ≥ 20 ppb.
Croatian: smjernicama za liječenje astme upala tipa 2 definira se kao razina eozinofila ≥ 150 stanica/μl i/ili
English: Q4W N=86
Croatian: svaka 4 tjedna N=86
English: Step 10: Push
Croatian: 10. korak: Pritisnite potisnik klipa
English: The safety and benefits of Dupixent are not yet known in children and adolescents with atopic dermatitis below the age of 12.
Croatian: Sigurnost i koristi lijeka Dupixent u djece i adolescenata s atopijskim dermatitisom mlađih od 12 godina još nisu poznate.
English: • Let your skin dry before injecting.
Croatian: • Pričekajte da se koža osuši prije nego što injicirajte lijek.
English: In a clinical study of AD patients, the effects of dupilumab on the pharmacokinetics (PK) of CYP substrates were evaluated.
Croatian: U kliničkom ispitivanju provedenom u bolesnika s atopijskim dermatitisom ocjenjivali su se učinci dupilumaba na farmakokinetiku supstrata izoenzima CYP.
English: Other evaluated outcomes included the proportion of subjects with EASI-50 or EASI-90 (improvement of at least 50% or 90% in EASI from baseline respectively), reduction in itch as measured by the peak pruritus NRS, and percent change in the SCORAD scale from baseline to week 16.
Croatian: Ostali ocjenjivani ishodi uključivali su udio bolesnika s EASI-50 ili EASI-90 rezultatom (poboljšanje EASI rezultata za najmanje 50% ili 90%), ublažavanje svrbeža mjereno vršnim NRS rezultatom za pruritus te postotna promjena SCORAD rezultata od početka ispitivanja do 16. tjedna.
English: The absolute bioavailability of dupilumab following a SC dose is similar between AD and asthma patients, ranging between 61% and 64 %, as determined by a population pharmacokinetics (PK) analysis.
Croatian: apsolutna bioraspoloživost dupilumaba nakon s.c. doze slična je u bolesnika s atopijskim dermatitisom i onih s astmom, a kreće se u rasponu od 61% do 64%.
English: Figure 1: Proportion of adolescent patients with ≥4-point improvement on the pruritus NRS in AD-1526 studya (FAS)b a In the primary analyses of the efficacy endpoints, subjects who received rescue treatment or with missing data were considered non-responders.
Croatian: Slika 1: Udio adolescentnih bolesnika u ispitivanju AD-1526a (FAS)b s poboljšanjem NRS rezultata za pruritus za ≥ 4 boda aU primarnoj analizi mjera ishoda djelotvornosti, bolesnici koji su primili liječenje za hitno ublažavanje simptoma ili za koje su nedostajali podaci smatrali su se bolesnicima bez odgovora.
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.
Croatian: U ispitivanju SOLO 1 sudjelovao je 671 bolesnik (224 primala su placebo, 224 dupilumab 300 mg svaka 2 tjedna, a 223 dupilumab 300 mg svaki tjedan), a razdoblje liječenja trajalo je 16 tjedana.
English: Do not inject into skin that is tender, damaged, bruised or scarred.
Croatian: Nemojte injicirati lijek u kožu koja je osjetljiva na dodir, oštećena ili prekrivena modricama ili ožiljcima.
English: Eosinophilic conditions
Croatian: Eozinofilna stanja
English: Check if the liquid is clear and colourless to pale yellow.
Croatian: Provjerite je li otopina bistra te bezbojna do blijedožuta.
English: No clinical studies have been conducted to evaluate the effect of hepatic impairment on the pharmacokinetics of dupilumab.
Croatian: Nisu provedena klinička ispitivanja kojima bi se ocijenio učinak oštećenja jetrene funkcije na farmakokinetiku dupilumaba.
English: Patients randomized DLQI, LS mean change from baseline (SE)
Croatian: Randomizirani bolesnici DLQI, LS srednja vrijednost promjene od početne vrijednosti (SE)
English: The instructions for the preparation and administration of Dupixent in a pre-filled syringe are given in the package leaflet.
Croatian: Upute za pripremu i primjenu lijeka Dupixent u napunjenoj štrcaljki navedene su u uputi o lijeku.
English: i p-value = 0.0005
Croatian: i p-vrijednost = 0,0005
English: Hepatic impairment No data are available in patients with hepatic impairment (see section 5.2).
Croatian: Nema dostupnih podataka o primjeni u bolesnika s oštećenjem funkcije jetre (vidjeti dio 5.2).
English: 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.
Croatian: A5: Pričekajte 30 minuta Položite napunjenu brizgalicu na ravnu površinu i pričekajte najmanje 30 minuta da se sama ugrije na sobnu temperaturu (ispod 25ºC).
English: In the 52-week atopic dermatitis CHRONOS study, serious infections were reported in 0.6 % of patients treated with placebo and 0.2 % of patients treated with dupilumab.
Croatian: U 52-tjednom ispitivanju primjene kod atopijskog dermatitisa pod nazivom CHRONOS ozbiljne infekcije prijavljene su u 0,6% bolesnika koji su primali placebo i 0,2% bolesnika liječenih dupilumabom.
English: Table 4: Efficacy results of dupilumab in the adolescent atopic dermatitis study at Week 16 (FAS)
Croatian: Tablica 4: Rezultati za djelotvornost dupilumaba u ispitivanju atopijskog dermatitisa u adolescenata u 16. tjednu (FAS)
English: Percent of patients whose IGA response at week 36 was maintained within 1 point of baseline in the subset of patients with IGA (0,1) at baseline, n (%) Percent of patients with IGA (0,1) at week 36 in the subset of patients with IGA (0,1) at baseline, n (%) Percent of patients whose peak pruritus
Croatian: Postotak bolesnika s odgovorom IGA (0, 1) u 36. tjednu u podskupini bolesnika koji su na početku ispitivanja imali IGA (0, 1), n (%) Postotak bolesnika kojima se vršni
English: These medicines (especially ones called corticosteroids) must be stopped gradually, under the direct supervision of your doctor and dependent on your response to Dupixent.
Croatian: Primjena tih lijekova (osobito onih koji se zovu kortikosteroidi) mora se prekidati postupno,
English: Dupixent is available as 300 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.
Croatian: Dupixent je dostupan u pakiranju koje sadrži 1 ili 2 napunjene štrcaljke od 300 mg ili pakiranju koje sadrži 3 (3 pakiranja od 1) ili 6 (3 pakiranja od 2) napunjenih štrcaljki od 300 mg.
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.
Croatian: U sva su tri pivotalna ispitivanja koprimarne mjere ishoda bile udio bolesnika s IGA rezultatom 0 ili 1 („čisto“ ili „gotovo čisto“) postignutim smanjenjem za ≥ 2 boda na IGA ljestvici od 0 do 4 boda te udio bolesnika s poboljšanjem EASI rezultata za najmanje 75% (EASI-75) od početka ispitivanja do
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.
Croatian: Dupixent je dostupan u pakiranju koje sadrži 1 ili 2 napunjene štrcaljke od 200 mg ili pakiranju koje sadrži 3 (3 pakiranja od 1) ili 6 (3 pakiranja od 2) napunjenih štrcaljki od 200 mg.
English: Multipack: 3 (3 packs of 1) pre-filled syringes with needle shield Multipack: 6 (3 packs of 2) pre-filled syringes with needle shield
Croatian: Višestruko pakiranje: 3 (3 pakiranja od 1) napunjene štrcaljke sa zaštitnim pokrovom igle Višestruko pakiranje: 6 (3 pakiranja od 2) napunjenih štrcaljki sa zaštitnim pokrovom igle
English: VENTURE was a 24-week oral corticosteroid-reduction study in 210 patients with asthma unrestricted by baseline type 2 biomarker levels who required daily oral corticosteroids in addition to regular use of high dose inhaled corticosteroids plus an additional controller.
Croatian: provedeno u 210 bolesnika s astmom, bez ograničenja u smislu početne vrijednosti bioloških biljega upale tipa 2, kojima je bila potrebna svakodnevna primjena oralnih kortikosteroida (OKS) uz redovitu primjenu visokih doza inhalacijskih kortikosteroida i dodatnog lijeka za terapiju održavanja.
English: N Rate (95% CI)
Croatian: N Stopa (95% CI)
English: - The other ingredients are arginine hydrochloride, histidine, polysorbate 80, sodium acetate, glacial acetic acid, sucrose, water for injections.
Croatian: - Drugi sastojci su argininklorid, histidin, polisorbat 80, natrijev acetat, ledena acetatna kiselina, saharoza, voda za injekcije.