FrancophonIA/ELRC3.0 huggingface dataset:
English: GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana, No 90 43056 San Polo di Torrile, Parma Italy
Croatian: GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana, No 90 43056 San Polo di Torrile, Parma Italija ili
English: • Do not use the syringe if dropped onto a hard surface.
Croatian: • Nemojte upotrijebiti štrcaljku ako je pala na tvrdu površinu.
English: Baseline (SD)
Croatian: Početna vrijednost (SD)
English: If you are breast-feeding, you must check with your doctor before you use Nucala.
Croatian: Ako dojite, morate provjeriti sa svojim liječnikom prije nego što primite lijek Nucala.
English: Patients received mepolizumab 100 mg administered subcutaneously, mepolizumab 75 mg administered intravenously or placebo treatment once every 4 weeks over 32 weeks.
Croatian: Bolesnici su primali mepolizumab u dozi od 100 mg primijenjenoj supkutano, mepolizumab u dozi od 75 mg primijenjenoj intravenski ili placebo jedanput svaka 4 tjedna tijekom 32 tjedna.
English: For subcutaneous administration, a 1 mL polypropylene syringe fitted with a disposable needle 21 gauge to 27 gauge x 0.5 inch (13 mm) should preferably be used.
Croatian: Za supkutanu je primjenu poželjno upotrijebiti polipropilensku štrcaljku volumena 1 ml opremljenu iglom za jednokratnu uporabu debljine 21 gauge do 27 gauge x 13 mm.
English: • pharyngitis (sore throat) • nasal congestion (stuffy nose)
Croatian: • faringitis (upala grla) • kongestija nosa (začepljen nos)
English: The long-term efficacy profile of Nucala in severe refractory eosinophilic asthma patients (n=998) treated for a median of 2.8 years (range 4 weeks to 4.5 years) in open-label extension studies MEA115666, MEA115661 and 201312 was generally consistent with the 3 placebo-controlled studies.
Croatian: Dugoročni profil djelotvornosti lijeka Nucala u bolesnika s teškom refraktornom eozinofilnom astmom (n=998) liječenih tijekom medijana od 2,8 godina (raspon od 4 tjedna do 4,5 godina) u otvorenim produžecima ispitivanja MEA115666, MEA115661 i 201312 načelno je odgovarao onome iz 3 placebom kontrolirana ispitivanja.
English: Paediatric pharmacokinetics was largely predictable from adults, after taking into account bodyweight.
Croatian: Farmakokinetika u pedijatrijskoj populaciji mogla se u velikoj mjeri predvidjeti na temelju odrasle populacije, vodeći računa o tjelesnoj težini.
English: • Do not use the pen if it appears damaged.
Croatian: • Nemojte upotrijebiti brizgalicu ako izgleda oštećeno.
English: The table below presents the adverse reactions from the two placebo-controlled studies in patients receiving mepolizumab 100 mg subcutaneously (n=263).
Croatian: Tablica ispod prikazuje nuspojave iz dva placebom kontrolirana ispitivanja u bolesnika koji su primali mepolizumab u dozi od 100 mg supkutano (n=263).
English: If your asthma symptoms get worse while receiving injections of Nucala
Croatian: Ako Vam se simptomi astme pogoršaju dok primate injekcije lijeka Nucala,
English: • Keep out of the sight and reach of children.
Croatian: • Čuvati izvan pogleda i dohvata djece.
English: Examinations for internal or skeletal malformations were not performed.
Croatian: Nisu provedena ispitivanja radi utvrđivanja malformacija unutarnjih organa ili kostura.
English: Additional maintenance treatments included long-acting beta2 -adrenergic agonists (LABA), leukotriene modifiers, long-acting muscarinic antagonists (LAMA), theophylline, and oral corticosteroids (OCS).
Croatian: Dodatna terapija održavanja obuhvaćala je dugodjelujuće agoniste beta2 adrenergičkih receptora (engl. long-acting beta2 agonists, LABA), modifikatore leukotrijena, dugodjelujuće antagoniste muskarinskih receptora
English: Administer the 0.4mL injection (equivalent to 40 mg mepolizumab) subcutaneously into the upper arm, thigh, or abdomen.
Croatian: Injicirajte 0,4 ml otopine (što odgovara 40 mg mepolizumaba) supkutano u nadlakticu, bedro ili abdomen.
English: Tell your doctor before you are given Nucala.
Croatian: obavijestite o tome svog liječnika prije nego što primite lijek Nucala.
English: • You can inject Nucala into your thighs or abdomen.
Croatian: • Lijek Nucala možete injicirati u bedro ili trbuh.
English: nucala syringe
Croatian: nucala štrcaljka
English: No dose adjustment is required for elderly patients (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu u starijih bolesnika (vidjeti dio 5.2).
English: • Stored below 30°C, not frozen
Croatian: • zaštititi od sunčeve svjetlosti • čuvati na temperaturi ispod 30°C i ne zamrzavati
English: Common Rare
Croatian: Rijetke nuspojave
English: If appropriate, they will then provide training to show you or your caregiver the correct way to use Nucala.
Croatian: Zatim će sukladno tomu pokazati Vama ili Vašem njegovatelju kako pravilno primjenjivati lijek Nucala.
English: If particulate matter remains in the solution or if the solution appears cloudy or milky, the solution must not be used.
Croatian: Ako u otopini zaostanu čestice ili ako je otopina mutna ili mliječne boje, ne smije se primijeniti.
English: • The yellow indicator will move down through the inspection window as you receive your dose.
Croatian: • Tijekom primjene doze žuti će se indikator spuštati niz prozorčić za provjeru.
English: Other medicines and Nucala
Croatian: Drugi lijekovi i Nucala
English: No decrease in OCS/lack of asthma control/ withdrawal from treatment Odds ratio (95% CI) p-value
Croatian: Bez smanjenja OKS-a / nedostatna kontrola astme / povlačenje iz liječenja
English: Thirty -six paediatric patients (aged 611) received mepolizumab subcutaneously in an open-label study for 12 weeks.
Croatian: Trideset i šest pedijatrijskih bolesnika (u dobi od 6 do 11 godina) primalo je supkutane injekcije mepolizumaba tijekom 12 tjedana u sklopu otvorenog ispitivanja.
English: Open-label extension studies in severe refractory eosinophilic asthma MEA115666 (COLUMBA), MEA115661 (COSMOS) and 201312 (COSMEX)
Croatian: (95% CI) Medijan razlike (95% CI) p-vrijednost Otvoreni produžeci ispitivanja kod teške refraktorne eozinofilne astme MEA115666 (COLUMBA), MEA115661 (COSMOS) i 201312 (COSMEX)
English: Dispose of the used syringe
Croatian: Zbrinite upotrijebljenu štrcaljku
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 100 mg dose, i.e. essentially “sodiumfree”.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi od 100 mg, tj. zanemarive količine natrija
English: • chest infection - symptoms of which may include cough and fever (high temperature)
Croatian: Mogu se javiti u do 1 na 10 osoba: • simptomi infekcije u prsnom košu, koji mogu uključivati kašalj i vrućicu (visoku temperaturu)
English: • Do not use the pen if dropped onto a hard surface.
Croatian: • Nemojte upotrijebiti brizgalicu ako je pala na tvrdu površinu.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded in the patient file.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka potrebno je jasno evidentirati u zdravstvenom kartonu bolesnika.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva ekcem često
English: Powder for solution for injection.
Croatian: Prašak za otopinu za injekciju.
English: The pre-filled syringe is not intended for use in children below 12 years of age.
Croatian: Napunjena brizgalica nije namijenjena za primjenu u djece mlađe od 12 godina.
English: Frequency of exacerbations requiring hospitalisation
Croatian: Učestalost egzacerbacija koje su zahtijevale hospitalizaciju
English: Peel off the plastic cover
Croatian: Skinite plastični pokrov
English: In the placebo-controlled trials, 15/260 (6%) of adults and adolescents treated with 100 mg dose subcutaneously had detectable anti-mepolizumab antibodies after having received at least one dose of mepolizumab.
Croatian: U placebom kontroliranim ispitivanjima, mjerljiva razina protutijela na mepolizumab zabilježena je u 15/260 (6%) odraslih i adolescenata liječenih supkutanom dozom od 100 mg nakon što su primili najmanje jednu dozu mepolizumaba.
English: The recommended dose of mepolizumab is 40 mg administered subcutaneously once every 4 weeks.
Croatian: Preporučena doza mepolizumaba je 40 mg, primijenjena supkutano jedanput svaka 4 tjedna.
English: Asthma-related adverse symptoms or exacerbations may occur during treatment.
Croatian: Tijekom liječenja mogu se pojaviti štetni simptomi povezani s astmom ili egzacerbacije astme.
English: In MEA112997, a randomised, double-blind, placebo-controlled, parallel-group, multi-centre study of 52 weeks duration in 616 patients with severe refractory eosinophilic asthma, mepolizumab significantly reduced clinically significant asthma exacerbations (defined as worsening of asthma requiring use of oral/systemic corticosteroids and/or hospitalisation and/or emergency department visits) when administered in doses of 75 mg, 250 mg or 750 mg intravenously compared to placebo (see Table 1).
Croatian: 616 bolesnika s teškom refraktornom eozinofilnom astmom, mepolizumab je u usporedbi s placebom značajno smanjio klinički značajne egzacerbacije astme (definirane kao pogoršanje astme koje je zahtijevalo primjenu oralnih/sistemskih kortikosteroida i/ili hospitalizaciju i/ili posjete hitnoj službi) kada se primjenjivao u intravenskim dozama od 75 mg, 250 mg ili 750 mg (vidjeti Tablicu 1).
English: Instructions for administration of 40 mg dose 1.
Croatian: Upute za primjenu doze od 40 mg
English: This medicine contains less than 1 mmol sodium (23 mg) per 100 mg dose, i.e., it is essentially “sodiumfree”.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi od 100 mg, tj. zanemarive količine natrija.
English: • Continue to hold the pen in place while you count to 5.
Croatian: • Nastavite držati brizgalicu na mjestu dok ne izbrojite do 5, a zatim je podignite s kože.
English: GlaxoSmithKline Trading Services Ltd, Currabinny, Co. Cork, Ireland.
Croatian: GlaxoSmithKline Trading Services Ltd, Currabinny, Co.
English: No formal studies have been conducted to investigate the effect of hepatic impairment on the pharmacokinetics of mepolizumab.
Croatian: Nisu provedena službena ispitivanja učinka oštećenja jetrene funkcije na farmakokinetiku mepolizumaba.
English: After removing the pre-filled pen or pre-filled syringe from the refrigerator, allow the pen or syringe to reach room temperature for at least 30 minutes before injecting Nucala.
Croatian: Nakon što se napunjena brizgalica ili napunjena štrcaljka izvade iz hladnjaka, treba pričekati najmanje 30 minuta prije injiciranja lijeka Nucala da se brizgalica ili štrcaljka ugriju na sobnu temperaturu.
English: It may be injected into the upper arm, thigh, or abdomen.
Croatian: Injekcija se može primijeniti u nadlakticu, bedro ili abdomen.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČI
English: • Do not put the needle cap back onto the syringe.
Croatian: • Nemojte vraćati zatvarač igle na štrcaljku.
English: Instructions for administration of 100 mg dose 1.
Croatian: Upute za primjenu doze od 100 mg
English: Paediatric pharmacokinetics following subcutaneous administration in subjects 6 to 11 years old with severe refractory eosinophilic asthma was investigated in an open label, uncontrolled study of 12-weeks duration.
Croatian: Farmakokinetika u pedijatrijskih bolesnika nakon supkutane primjene lijeka u ispitanika s teškom refraktornom eozinofilnom astmom u dobi od 6 do 11 godina ispitivala se u otvorenom, nekontroliranom ispitivanju u trajanju od 12 tjedana.
English: Subcutaneous use after reconstitution.
Croatian: Za potkožnu primjenu nakon rekonstitucije.
English: What you need to know before you use Nucala 3.
Croatian: Što morate znati prije nego počnete primjenjivati lijek Nucala
English: • Remove the tray from the carton.
Croatian: • Izvadite podložak iz kutije.
English: Alternatively, another person can inject in your upper arm
Croatian: Druga osoba može Vam injicirati lijek i u nadlakticu
English: Local injection site reactions
Croatian: Lokalne reakcije na mjestu injiciranja
English: Comprehensive instructions for subcutaneous administration of Nucala in a pre-filled pen or pre-filled syringe are provided in the instructions for use in the package leaflet.
Croatian: Cjelovite upute za supkutanu primjenu lijeka Nucala u napunjenoj brizgalici ili napunjenoj štrcaljki navedene su u uputama za uporabu koje se nalaze u uputi o lijeku.
English: In patients with severe refractory eosinophilic asthma (adults/adolescents), following a dose of 100 mg administered subcutaneously every 4 weeks for 32 weeks, blood eosinophils were reduced from a geometric mean count at baseline of 290 to 40 cells/μL at week 32 (n=182), a reduction of 84% compared to placebo.
Croatian: U bolesnika s teškom refraktornom eozinofilnom astmom (odrasli/adolescenti), nakon doze od 100 mg primijenjene supkutano svaka 4 tjedna tijekom 32 tjedna, razina eozinofila u krvi smanjila se s početne geometrijske srednje vrijednosti od 290 na 40 stanica/µl u 32. tjednu (n=182), što predstavlja smanjenje od 84% u usporedbi s placebom.
English: • Nucala pre-filled syringe
Croatian: • Nucala napunjena štrcaljka
English: Do not rub your injection site.
Croatian: Nemojte trljati mjesto injiciranja.
English: • Do not rub your injection site.
Croatian: • Nemojte trljati mjesto injiciranja.
English: • Keep your used syringes and needle caps out of the reach of children.
Croatian: • Upotrijebljene brizgalice i zatvarače igle čuvajte izvan dohvata djece.
English: Primary endpoint Percent reduction in OCS from baseline (weeks 20-24)
Croatian: Primarna mjera ishoda Postotak smanjenja primjene OKS-a od početne vrijednosti (20. - 24. tjedan)
English: The solution should be clear to opalescent, and colourless to pale yellow or pale brown, free of visible particles.
Croatian: Otopina mora biti bistra do opalescentna, bezbojna do blijedožuta ili blijedosmeđa i ne smije sadržavati vidljive čestice.
English: Before you use Nucala
Croatian: Prije nego što primijenite lijek Nucala
English: Nucala 100 mg solution for injection in pre-filled pen and Nucala 100 mg solution for injection in pre-filled syringe are not indicated for administration to this population.
Croatian: Nucala 100 mg otopina za injekciju u napunjenoj brizgalici i Nucala 100 mg otopina za injekciju u napunjenoj štrcaljki nisu indicirane za primjenu u ovoj populaciji.
English: Check the expiry date
Croatian: Provjerite rok valjanosti
English: Lower respiratory tract infection Urinary tract infection Pharyngitis
Croatian: Infekcije i infestacije infekcija donjih dišnih putova infekcija mokraćnih putova faringitis često
English: Patients had a blood eosinophil count of ≥150/µL at baseline or a blood eosinophil count of ≥300/µL in the 12 months prior to screening.
Croatian: Bolesnici su imali početnu vrijednost eozinofila u krvi od ≥ 150 stanica/µl ili vrijednost eozinofila u krvi od ≥ 300 stanica/µl u 12 mjeseci prije probira.
English: Single doses of up to 1,500 mg were administered intravenously in a clinical trial to patients with eosinophilic disease without evidence of dose-related toxicities.
Croatian: U jednom su kliničkom ispitivanju bolesnicima s eozinofilnom bolešću intravenski primijenjene pojedinačne doze do 1500 mg i nije bilo znakova toksičnosti povezane s dozom.
English: • nasal congestion (stuffy nose)
Croatian: • kongestija nosa (začepljen nos)
English: Patients were required to have a history of two or more severe asthma exacerbations requiring oral or systemic corticosteroid treatment in the past 12 months and reduced lung function at baseline (pre-bronchodilator FEV1<80% in adults and <90% in adolescents).
Croatian: Bolesnici su u anamnezi morali imati dvije ili više teških egzacerbacija astme koje su zahtijevale liječenje oralnim ili sistemskim kortikosteroidima u proteklih 12 mjeseci te smanjenu plućnu funkciju na početku ispitivanja (FEV1
English: In children aged 6 to 11 years old with severe refractory eosinophilic asthma following either 40 mg subcutaneously (for a weight < 40kg) or 100 mg subcutaneously (for a weight ≥ 40 kg), 2/35 (6%) had detectable anti-mepolizumab antibodies after having received at least one dose of mepolizumab during the initial short phase of the study.
Croatian: Mjerljiva razina protutijela na mepolizumab zabilježena je u 2/35 (6%) djece s teškom refraktornom eozinofilnom astmom u dobi od 6 do 11 godina koja su liječena supkutanom dozom od 40 mg (za tjelesnu težinu < 40 kg) ili 100 mg (za tjelesnu težinu ≥ 40 kg) nakon što su primili najmanje jednu dozu mepolizumaba tijekom početne kratkotrajne faze ispitivanja.
English: The following information is intended for healthcare professionals only: Step-by-step instructions for use and handling, reconstitution, and administration
Croatian: Upute korak po korak za uporabu, rukovanje, rekonstituciju i primjenu
English: 1 ml solution in a Type 1 glass syringe with a fixed needle (stainless steel) and passive safety needle guard.
Croatian: Nucala 100 mg otopina za injekciju u napunjenoj štrcaljki 1 ml otopine u staklenoj štrcaljki (staklo tipa I) s pričvršćenom iglom (nehrđajući čelik) i pasivnim sigurnosnim štitnikom igle.
English: Nucala is provided as a lyophilised, white powder in a single-use vial for subcutaneous injection only.
Croatian: Nucala se isporučuje u obliku liofiliziranog bijelog praška u bočici za jednokratnu uporabu, a namijenjena je isključivo za supkutanu injekciju.
English: You should also receive training on how to use the pre-filled syringe.
Croatian: Osim toga, morate proći i obuku o tome kako koristiti napunjenu brizgalicu.
English: Severe refractory eosinophilic asthma
Croatian: Teška refraktorna eozinofilna astma
English: No dose adjustment is required in patients with renal or hepatic impairment (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu u bolesnika s oštećenjem bubrežne ili jetrene funkcije (vidjeti dio 5.2).
English: Nucala is a lyophilised white powder supplied in a clear, colourless glass vial with a rubber stopper.
Croatian: Nucala je liofilizirani bijeli prašak koji dolazi u prozirnoj, bezbojnoj staklenoj bočici s gumenim čepom.
English: Press a cotton wool ball or gauze on the area for a few moments if necessary.
Croatian: Po potrebi kratko pritisnite to područje pamučnom vatom ili gazom.
English: Nucala 100 mg injection mepolizumab SC
Croatian: Nucala 100 mg injekcija mepolizumab s.c.
English: Component of a multipack, can't be sold separately.
Croatian: Ne može se prodavati zasebno.
English: Eczema
Croatian: FARMACEUTSKI
English: Administer the 1 mL injection (equivalent to 100 mg mepolizumab) subcutaneously into the upper arm, thigh, or abdomen.
Croatian: Injicirajte 1 ml otopine (što odgovara 100 mg mepolizumaba) supkutano u nadlakticu, bedro ili abdomen.
English: Instructions for using the pre-filled syringe are given on the other side of this leaflet.
Croatian: Upute za uporabu napunjene brizgalice nalaze se na poleđini ove upute.
English: 1 pre-filled syringe.
Croatian: 1 napunjena brizgalica.
English: If you (or your child) may have had a similar reaction to any injection or medicine: Tell your doctor before you are given Nucala.
Croatian: Ako ste Vi (ili Vaše dijete) možda imali sličnu reakciju na bilo koju injekciju ili lijek, obavijestite o tome svog liječnika prije nego što primite lijek Nucala
English: Adults and adolescents aged 12 years and older The recommended dose of mepolizumab is 100 mg administered subcutaneously once every 4 weeks.
Croatian: Odrasli i adolescenti u dobi od 12 i više godina Preporučena doza mepolizumaba je 100 mg, primijenjena supkutano jedanput svaka 4 tjedna.
English: Hold the pen in place to complete your injection
Croatian: Nastavite držati brizgalicu pritisnutom kako biste dovršili injekciju
English: Mepolizumab inhibits the bioactivity of IL-5 with nanomolar potency by blocking the binding of IL-5 to the alpha chain of the IL-5 receptor complex expressed on the eosinophil cell surface, thereby inhibiting IL-5 signalling and reducing the production and survival of eosinophils.
Croatian: Mepolizumab inhibira biološku aktivnost IL-5 s nanomolarnom potentnosti, tako što blokira vezivanje IL-5 za alfa lanac kompleksa
English: mg (for a weight < 40kg) or 100 mg (for a weight ≥ 40 kg) was 1.32 and 1.97 times of that observed in adults at 100 mg.
Croatian: Izloženost nakon supkutane primjene doze od 40 mg (za tjelesnu težinu < 40 kg) odnosno 100 mg (za tjelesnu težinu ≥ 40 kg) bila je 1,32 odnosno
English: Once reconstituted, Nucala will contain a concentration of 100 mg/mL mepolizumab.
Croatian: Nakon rekonstitucije, Nucala će sadržavati mepolizumab u koncentraciji od 100 mg/ml.
English: Children aged 6 to 11 years old The recommended dose of mepolizumab is 40 mg administered subcutaneously once every 4 weeks.
Croatian: Djeca u dobi od 6 do 11 godina Preporučena doza mepolizumaba je 40 mg, primijenjena supkutano jedanput svaka 4 tjedna.
English: How to use Nucala
Croatian: Kako primjenjivati lijek Nucala
English: Take the syringe out of the tray
Croatian: Izvadite štrcaljku iz podloška
English: Powder for solution for injection Multipack: 3 (3 packs of 1) vials
Croatian: Prašak za otopinu za injekciju Višestruko pakiranje: 3 (3 pakiranja od 1) bočice
English: White finger grip
Croatian: Bijelo hvatište za prste
English: Intravenous mepolizumab pharmacokinetics was evaluated by population pharmacokinetic analysis in a paediatric study conducted in subjects aged 2-17 years old with eosinophilic esophagitis.
Croatian: Farmakokinetika intravenski primijenjenog mepolizumaba ocijenjena je u populacijskoj farmakokinetičkoj analizi u pedijatrijskom ispitivanju provedenom s ispitanicima u dobi od
English: Follow these instructions on how to use the pre-filled syringe.
Croatian: Slijedite ove upute za uporabu napunjene brizgalice.
English: • Do not shake the pen.
Croatian: • Nemojte tresti brizgalicu.
English: Dispose of the remaining solution.
Croatian: Ostatak otopine bacite.
English: Some people get asthma-related side effects, or their asthma may become worse, during treatment with Nucala.
Croatian: Tijekom liječenja lijekom Nucala neke će osobe dobiti nuspojave povezane s astmom ili im se astma može pogoršati.
English: White plunge
Croatian: Bijeli klip
English: • Keep in the carton to protect from light.
Croatian: • Čuvati u kutiji radi zaštite od svjetlosti.
English: The rate of exacerbations in the placebo arm increased with increasing baseline blood eosinophil count.
Croatian: Stopa egzacerbacija u skupini koja je primala placebo povećavala se s povećanjem početne vrijednosti eozinofila u krvi.
English: In children aged 6 to 11 years old with severe refractory eosinophilic asthma administered mepolizumab subcutaneously every 4 weeks for 52 weeks, blood eosinophils were reduced from a geometric mean count at baseline to week 52 of 306 (n=16) to 48 (n=15) following 40 mg (for a weight < 40kg) and 331 to
Croatian: U djece s teškom refraktornom eozinofilnom astmom u dobi od 6 do 11 godina koji su primali mepolizumab supkutano svaka 4 tjedna tijekom 52 tjedna, razina eozinofila u krvi smanjila se s početne geometrijske srednje vrijednosti od 306 (n=16) na 48 stanica/µl (n=15) u 52. tjednu nakon primjene doze od 40 mg (za tjelesnu težinu < 40 kg) odnosno s 331 na 44 stanice/µl (n=10) nakon primjene doze od 100 mg (za tjelesnu težinu ≥ 40 kg), što predstavlja smanjenje za 85% odnosno 87%
English: Also contains: sucrose, sodium phosphate dibasic heptahydrate, citric acid monohydrate, polysorbate 80, EDTA disodium dihydrate, water for injections.
Croatian: Također sadrži: saharozu, natrijev hidrogenfosfat heptahidrat, citratnu kiselinu hidrat, polisorbat 80, dinatrijev edetat dihidrat i vodu za injekcije.
English: The powder for solution for injection presentation is appropriate for administration to this population.
Croatian: Prikladna formulacija za ovu populaciju je prašak za otopinu za injekciju.