natgillin/translations-raw huggingface dataset:
The malignancies observed in reslizumab-treated patients were diverse in nature and without clustering of any particular tissue type.
Zloćudne bolesti opažene u bolesnika liječenih reslizumabom bile su raznolike prirode i nisu zahvaćale neku određenu vrstu tkiva.
No direct effect of hepatic function on the pharmacokinetics of reslizumab is expected because antibodies are principally cleared by catabolism.
Ne očekuje se nikakav izravni utjecaj funkcije jetre na farmakokinetiku reslizumaba zato što se protutijela u načelu uklanjaju katabolizmom.
In humans, during the first few days after birth antibodies may be transferred to the newborns through milk.
U ljudi se protutijela mogu prenijeti novorođenčadi putem mlijeka tijekom prvih nekoliko dana nakon rođenja.
The recommended dose is 3 mg/kg body weight.
Preporučena doza je 3 mg/kg tjelesne težine.
Following multiple doses, serum concentrations of reslizumab accumulate approximately 1.5- to 1.9-fold.
Nakon višestrukih doza, koncentracija reslizumaba u serumu poveća se približno 1,5-1,9 puta.
No physical or biochemical compatibility studies have been conducted to evaluate the co-administration of reslizumab with other medicinal products.
Nisu provedena ispitivanja fizikalne ili biokemijske kompatibilnosti da bi se procijenila istovremena primjena reslizumaba s drugim lijekovima.
If an anaphylactic reaction occurs, administration of reslizumab should be stopped immediately and appropriate medical treatment should be provided; reslizumab must be discontinued permanently (see section 4.3).
Ako nastane anafilaktička reakcija, primjenu reslizumaba treba odmah prekinuti i osigurati odgovarajuće liječenje; primjena reslizumaba mora se trajno prekinuti (vidjeti dio 4.3).
Reslizumab should not be used to treat acute asthma exacerbations.
Reslizumab se ne smije primjenjivati za liječenje akutnih egzacerbacija astme.
No apparent deviation from dose-proportional reslizumab pharmacokinetics was noted over the dose range of 0.3 mg/kg to 3.0 mg/kg.
Nije bilo zapaženo vidljivo odstupanje od farmakokinetike proporcionalne dozi za reslizumab u rasponu doza od 0,3 mg/kg do 3,0 mg/kg.
Reslizumab binds human IL-5 with picomolar affinity blocking its biological function; consequently survival and activity of eosinophils are reduced.
Reslizumab se veže za ljudski IL-5 pikomolarnim afinitetom blokirajući njegovu biološku funkciju; posljedično, preživljenje i aktivnost eozinofila su smanjeni.
Do not use this medicine after the expiry date which is stated on the outer carton and label after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici iza oznaka "Rok valjanosti" i "EXP".
The pharmacokinetics of reslizumab was similar in adults (18-65 years of age; n=759) and elderly patients (greater than 65 years of age; n=30).
Farmakokinetika reslizumaba bila je slična u odraslih (u dobi od 18 do 65 godina; n=759) i starijih bolesnika (stariji od 65 godina; n=30).
The data did not indicate a difference in the safety profile of reslizumab in paediatric patients compared with that in adult patients.
Podaci nisu pokazivali razliku u sigurnosnom profilu reslizumaba između pedijatrijskih i odraslih bolesnika.
If you stop using CINQAERO
Ako prestanete primjenjivati CINQAERO
Population pharmacokinetic analyses indicated that the pharmacokinetics of reslizumab is not significantly different between ethnic groups (white, black and Asian).
Analize populacijske farmakokinetike pokazale su da nema značajne razlike u farmakokinetici reslizumaba između rasnih skupina (bijela, crna i azijatska).
Patients below 35 kg or above 199 kg
Bolesnici tjelesne težine manje od 35 kg ili veće od 199 kg
Overall, 2,195 subjects received at least one dose of reslizumab.
Tablični popis nuspojava Sveukupno je 2195 ispitanika primilo najmanje jednu dozu reslizumaba.
Uncommon (may affect up to 1 in 100 people) • Muscle pain (myalgia).
Manje često (mogu se javiti u do 1 na 100 osoba) • bol u mišićima (mijalgija).
Overall population
Ukupna populacija
CINQAERO has no or negligible influence on the ability to drive and use machines.
CINQAERO ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Table 2: Adverse reactions System organ class
Tablica 2: Nuspojave Klasifikacija organskih sustava
Reslizumab binds specifically to IL-5 and interferes with IL-5 binding to its cell-surface receptor.
Reslizumab se veže specifično za IL-5 i ometa vezanje IL-5 za njegove receptore na površini stanice.
Demographics
Demografske značajke
Due to an overlap in signs and symptoms, it was not possible to distinguish between an anaphylactic reaction, another hypersensitivity reaction and an infusion-related reaction in all cases (see section 4.4).
Zbog preklapanja znakova i simptoma nije bilo moguće u svim slučajevima razlikovati anafilaktičku reakciju od neke druge reakcije preosjetljivosti i infuzijske reakcije (vidjeti dio 4.4).
Gently invert the bag to mix the solution.
Nježno okrenite vrećicu naopako da se otopina promiješa.
The primary endpoint was the change from baseline over 16 weeks in FEV1.
Primarna mjera ishoda bila je promjena od početne vrijednosti FEV1 tijekom 16 tjedana.
Based on the characteristics of reslizumab, drug-drug interactions are not expected.
Na temelju značajki reslizumaba, ne očekuju se interakcije s lijekovima.
The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove
In a population pharmacokinetic analysis, patients were classified by baseline liver function levels.
U analizi populacijske farmakokinetike bolesnici su bili klasificirani prema početnoj razini funkcije jetre.
Fertility There are no fertility data in humans.
Nema podataka o plodnosti u ljudi.
The range of systemic exposures in patients from 12 to less than 18 years of age (n=15) overlapped that in the other groups although the median value was slightly lower than in adult patients (18-65 years of age; n=759) and elderly patients (greater than 65 years of age; n=30).
Raspon sistemske izloženosti u bolesnika u dobi od 12 do manje od 18 godina (n=15) preklapao se s onim u drugim skupinama, iako je medijan vrijednosti bio nešto niži nego u odraslih bolesnika (u dobi od 18 do 65 godina; n=759) i starijih bolesnika (stariji od 65 godina; n=30).
Table 5: Treatment difference in mean change from baseline for selected secondary efficacy variables - Integrated data (Studies I and II) for the overall population and subgroup GINA 4 and 5
Tablica 5: Terapijska razlika u srednjoj vrijednosti promjene od početnih vrijednosti u odabranim sekundarnim varijablama djelotvornosti - integrirani podaci (Ispitivanja I i II) za ukupnu populaciju i podskupinu GINA 4 i 5
Mean number of exacerbations in previous year
Srednja vrijednost broja egzacerbacija u prethodnoj godini
Reslizumab has not been studied in patients concurrently taking immunosuppressant medicinal products other than oral corticosteroids (OCS); therefore, the safety and efficacy profile of reslizumab in these patients is unknown.
Reslizumab nije ispitan u bolesnika koji istodobno uzimaju imunosupresivne lijekove koji nisu peroralni kortikosteroidi; stoga profil sigurnosti i djelotvornosti reslizumaba u ovih bolesnika nije poznat.
Manifestations included skin or mucosal involvement, dyspnoea, wheezing, gastrointestinal symptoms and chills.
Manifestacije su uključivale zahvaćenost kože ili sluznica, dispneju, piskanje pri disanju, gastrointestinalne simptome i zimicu.
Improvements were observed as early as 4 weeks following the first dose of reslizumab (AQLQ at 16 weeks) and sustained through week 52.
Poboljšanja su bila opažena već u 4. tjednu (AQLQ u 16. tjednu) nakon prve doze reslizumaba i održala su se tijekom 52 tjedna.
Results of population pharmacokinetic analysis confirm that concomitant use of either leukotriene antagonists or systemic corticosteroids does not affect the pharmacokinetics of reslizumab (see section 5.2).
Rezultati analize populacijske farmakokinetike potvrđuju da istodobna primjena bilo antagonista leukotriena, bilo sistemskih kortikosteroida ne utječe na farmakokinetiku reslizumaba (vidjeti dio 5.2).
Inter-individual variability in peak and overall exposure is approximately 20-30%
Interindividualna varijabilnost vršne i ukupne izloženosti približno je
It is unknown whether reslizumab is excreted in human milk.
Nije poznato izlučuje li se reslizumab u majčino mlijeko.
CINQAERO is compatible with polyvinylchloride (PVC) or polyolefin (PO) infusion bags.
CINQAERO je kompatibilan s infuzijskim vrećicama od polivinilklorida (PVC) ili poliolefina
EU/1/16/1125/001 1 vial of 10 mL EU/1/16/1125/002 - 1 vial of 2.5 mL EU/1/16/1125/003 - 2 vials of 10 mL EU/1/16/1125/004 - 2 vials of 2.5 mL
EU/1/16/1125/001 1 bočica od 10 ml EU/1/16/1125/002 - 1 bočica od 2,5 ml EU/1/16/1125/003 - 2 bočice od 10 ml EU/1/16/1125/004 - 2 bočice od 2,5 ml
● Periodic safety update reports (PSURs)
• Periodička izvješća o neškodljivosti lijeka (PSUR-evi)
Most patients had normal liver function tests (n=766, approximately 95%) or mildly increased liver function tests (either, in the first case, total bilirubin above the upper limit of normal [ULN] but less than or equal to 1.5 times the ULN or, in the second case, aspartate aminotransferase greater than the ULN and total bilirubin less than or equal to the ULN; n=35, approximately 4%).
Većina bolesnika imala je normalne rezultate testova funkcije jetre (n=766, približno 95 %) ili blago povišene rezultate testova funkcije jetre (bilo, u prvom slučaju, ukupni bilirubin iznad gornje granice normale [GGN], ali ispod ili jednako 1,5 puta GGN ili, u drugom slučaju, aspartat aminotransferaza iznad GGN i ukupni bilirubin ispod ili jednako GGN; n=35, približno 4 %).
An updated RMP should be submitted: ● At the request of the European Medicines Agency;
• na zahtjev Europske agencije za lijekove;
CINQAERO is available in packs containing 1 or 2 vials with 2.5 mL and in packs containing 1 or 2 vials with 10 mL.
CINQAERO je dostupan u pakiranjima koja sadrže 1 ili 2 bočice s 2,5 ml i u pakiranjima koja sadrže 1 ili 2 bočice s 10 ml.
EU/1/16/1125/001 1 vial of 10 mL EU/1/16/1125/002 1 vial of 2.5 mL EU/1/16/1125/003 2 vials of 10 mL EU/1/16/1125/004 2 vials of 2.5 mL
EU/1/16/1125/001 1 bočica od 10 ml EU/1/16/1125/002 1 bočica od 2,5 ml EU/1/16/1125/003 2 bočice od 10 ml EU/1/16/1125/004 2 bočice od 2,5 ml
The reduction in blood eosinophil counts by reslizumab in anti-reslizumab antibody-positive patients was not different from patients who were anti-reslizumab antibody-negative.
Sniženje broja eozinofila u krvi izazvano reslizumabom u bolesnika s pozitivnim nalazom protutijela protiv reslizumaba nije se razlikovalo od onog u bolesnika s negativnim nalazom protutijela protiv reslizumaba.
The solution for infusion should be infused intravenously over 20 - 50 minutes.
Otopinu za infuziju treba dati kao intravensku infuziju tijekom 20 do 50 minuta.
Reslizumab total dose (mg)
Ukupna doza reslizumaba (mg)
The recommended dose is achieved using the vial-based dosing scheme in Table 1 below.
Preporučena doza postiže se prema shemi doziranja na temelju broja bočica prikazanoj u tablici 1 niže.
(p<0.0001) a The values represent the treatment difference between placebo and reslizumab 3 mg/kg based on adjusted means over the specified time period for each treatment group, except for the change to week 16 for AQLQ, which was the first timepoint where AQLQ was assessed.
Ove vrijednosti predstavljaju terapijsku razliku između placeba i reslizumaba u dozi od 3 mg/kg na temelju prilagođenih srednjih vrijednosti tijekom određenog razdoblja u svakoj terapijskoj skupini, osim promjene do 16. tjedna za AQLQ, što je bila prva vremenska točka u kojoj je bio procijenjen
What CINQAERO is and what it is used for What you need to know before you are given CINQAERO How CINQAERO is given
Što je CINQAERO i za što se koristi Što morate znati prije nego primite CINQAERO
Blood creatine phosphokinase elevations were transient and asymptomatic, and did not lead to treatment discontinuation.
Povišena kreatin fosfokinaza u krvi Povišenja kreatin fosfokinaze u krvi bila su prolazna i asimptomatska te nisu dovela do prekida liječenja.
Eosinophils are white blood cells involved in asthma inflammation.
Eozinofili su bijele krvne stanice uključene u upalu kod astme.
No formal clinical drug interaction studies have been performed with reslizumab.
Nisu provedena službena klinička ispitivanja interakcija reslizumaba.
CINQAERO is used together with other medicines to treat asthma (inhaled corticosteroids plus other asthma medicines).
CINQAERO se primjenjuje zajedno s drugim lijekovima za liječenje astme (inhalacijskim kortikosteroidima u kombinaciji s drugim lijekovima za astmu).
Patients between 35 kg and 199 kg
Bolesnici tjelesne težine između 35 kg i 199 kg
Decreases in blood eosinophils were related to reslizumab levels.
Sniženje broja eozinofila u krvi bilo je povezano s razinom reslizumaba.
CINQAERO reduces how often you have flare-ups of your asthma, helps you breathe better and decreases your asthma symptoms.
CINQAERO smanjuje učestalost pogoršanja astme, pridonosi lakšem disanju i smanjuje simptome astme.
CINQAERO contains sodium
CINQAERO sadrži natrij
Age, mean in years Asthma duration, mean in years
Trajanje astme, srednja vrijednost u godinama
CINQAERO is indicated as add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment (see section 5.1).
CINQAERO je indiciran kao dodatna terapija u odraslih bolesnika s teškom eozinofilnom astmom koja nije odgovarajuće kontrolirana unatoč visokoj dozi inhalacijskih kortikosteroida plus drugi lijek za terapiju održavanja (vidjeti dio 5.1).
Gender The pharmacokinetics of reslizumab was not significantly different between males and females.
Farmakokinetika reslizumaba nije se značajno razlikovala između muškaraca i žena.
If you miss your scheduled dose of CINQAERO
Ako propustite primiti planiranu dozu lijeka CINQAERO
In this study, the percentage of sputum eosinophils was reduced from a mean baseline value of 17.4% (standard deviation: 15.9%) by 82% at end of therapy in the reslizumab group.
U tom ispitivanju, početna srednja vrijednost postotka eozinofila u sputumu od 17,4 % (standardna devijacija: 15,9 %) u skupini koja je primala reslizumab smanjila se do kraja terapije za 82 %.
Table 1: Vial-based dosing scheme* for patients with body weight between 35 kg and 199 kg Body weight (kg)
Tablica 1: Shema doziranja na temelju broja bočica* za bolesnike tjelesne težine između 35 kg i 199 kg
For dosing instructions see section 4.2 of Summary of Product Characteristics.
Za upute o doziranju vidjeti dio 4.2 Sažetka opisa svojstava lijeka.
Solutions of CINQAERO diluted in sodium chloride 9 mg/mL (0.9%) solution for infusion may be stored refrigerated at 2 °C-8 °C (or not above 25 °C if dilution has taken place in controlled and validated aseptic conditions), protected from light for up to 16 hours.
Otopine lijeka CINQAERO razrijeđene u otopini natrijevog klorida za infuziju od 9 mg/ml (0,9 %) mogu se čuvati u hladnjaku na temperaturi od 2 °C do 8 °C (ili ne iznad 25 °C ako se razrjeđivanje provelo u kontroliranim i validiranim aseptičkim uvjetima), zaštićene od svjetlosti do 16 sati.
If patients become infected whilst receiving treatment with reslizumab and do not respond to anti-helminth treatment, temporary discontinuation of therapy should be considered.
Ako se bolesnici inficiraju dok primaju terapiju reslizumabom i ne odgovore na liječenje antihelminticima,
Serum reslizumab concentrations generally decline from peak in a biphasic manner.
Koncentracije reslizumaba u serumu uglavnom opadaju od vršnih vrijednosti na bifazični način.
In clinical Studies I and II with reslizumab 3 mg/kg, decreases in blood eosinophil counts were seen following the first dose and maintained through 52 weeks of treatment with no signs of tachyphylaxis.
I i II s reslizumabom u dozi od 3 mg/kg, nakon prve doze opažena su sniženja broja eozinofila u krvi koja su se održala tijekom 52 tjedna liječenja bez ikakvih znakova tahifilaksije.
Patients should be monitored during and for an appropriate time after administration of reslizumab.
Bolesnike treba nadzirati tijekom primjene i tijekom odgovarajućeg razdoblja nakon primjene reslizumaba.
Reslizumab has not been studied in patients receiving live vaccines.
Reslizumab nije ispitan u bolesnika koji primaju živa cjepiva.
Each vial of 10 mL contains 0.20 mmol (4.6 mg) of sodium.
Jedna bočica od 10 ml sadrži 0,20 mmol (4,6 mg) natrija.
Pre-bronchodilator FEV1a, mean % predicted
FEV1a prije bronhodilatatora, srednja vrijednost %
Study III (n=315)
Ispitivanje III (n=315)
A reduction in asthma exacerbations resulting in hospitalisation or an emergency room visit was observed with reslizumab 3 mg/kg that was not statistically significant (34% [p=0.2572] and 31% [p=0.4020] in Study I and Study II, respectively).
Uz reslizumab u dozi od 3 mg/kg bilo je opaženo smanjenje egzacerbacija astme koje rezultiraju hospitalizacijom ili odlaskom na hitnu pomoć, a koje nije bilo statistički značajno (34 % [p=0,2572] u Ispitivanju I i 31 % [p=0,4020] u Ispitivanju II).
Serious allergic reactions have occurred in patients receiving this medicine (see section “4.
U bolesnika koji su primali ovaj lijek nastale su ozbiljne alergijske reakcije (pogledajte dio "4.
In placebo-controlled clinical studies, 6 out of 1,028 patients (0.6%) receiving 3 mg/kg reslizumab had at least one malignant neoplasm reported compared to 2 out of 730 patients (0.3%) in the placebo group.
U placebom kontroliranim kliničkim ispitivanjima, 6 od 1028 bolesnika (0,6 %) koji su primali reslizumab u dozi od 3 mg/kg imalo je barem jednu prijavljenu zloćudnu novotvorinu u usporedbi s 2 od 730 bolesnika (0,3 %) u skupini koja je primala placebo.
What CINQAERO is and what it is used for What CINQAERO is
Što je CINQAERO i za što se koristi Što je CINQAERO
Study III
Ispitivanje III
Each mL of concentrate contains 10 mg of reslizumab (10 mg/mL).
Jedan ml koncentrata sadrži 10 mg reslizumaba (10 mg/ml).
d The percentage of patients with refractory asthma (based on the American Thoracic Society
d Postotak bolesnika s refrakternom astmom (na temelju definicije refrakterne astme s radionice Američkog torakalnog društva [engl.
The patients received either 13 doses of placebo or reslizumab 3 mg/kg administered once every 4 weeks.
Bolesnici su primili ili 13 doza placeba ili reslizumaba u dozi od 3 mg/kg koje su se davale jedanput svaka 4 tjedna.
Study II (n=464)
Ispitivanje II (n=464)
Eosinophils may be involved in the immunological response to some helminth infections.
U imunološkom odgovoru na neke infekcije helmintima mogu biti sudjelovati eozinofili.
Each vial of 2.5 mL contains 0.05 mmol (1.15 mg) of sodium.
Jedna bočica od 2,5 ml sadrži 0,05 mmol (1,15 mg) natrija.
- The other excipients are sodium acetate, acetic acid glacial, sucrose and water for injections.
- Druge pomoćne tvari su natrijev acetat, ledena acetatna kiselina, saharoza i voda za injekcije.
Chemical and physical in-use stability has been demonstrated at 2 °C-8 °C and at 25 °C in sodium chloride 9 mg/mL (0.9%) solution for infusion protected from light for up to 16 hours.
Dokazana je kemijska i fizikalna stabilnost lijeka u primjeni na temperaturi od 2 °C do 8 °C i na 25 °C u otopini natrijevog klorida za infuziju od 9 mg/ml (0,9%) zaštićenoj od svjetlosti do 16 sati.
In pooled data, mean eosinophil counts were 655 µL-1 (n=476) and 654 µL-1 (n=477) for the placebo and reslizumab treatment groups at baseline and were 514 µL-1 (n=405) and 61 µL-1 (n=407) at week 52.
(n=476) u skupini koja je primala placebo i 654 µl-1 (n=477) u terapijskoj skupini koja je primala reslizumab te 514 µl-1 (n=405) odnosno 61 µl-1 (n=407) u 52. tjednu.
Based on population pharmacokinetic analysis, systemic exposure to reslizumab appears to be unaffected by circulating anti-reslizumab antibodies.
Na temelju analize populacijske farmakokinetike čini se da protutijela protiv reslizumaba u cirkulaciji ne utječu na sistemsku izloženost reslizumabu.
Study III was a 16-week, randomised, placebo-controlled study.
Ispitivanje III bilo je randomizirano, placebom kontrolirano ispitivanje u trajanju od 16 tjedana.
CINQAERO is supplied in glass vials containing 2.5 mL or 10 mL.
CINQAERO dolazi u staklenim bočicama koje sadrže 2,5 ml ili 10 ml.
This medicinal product must not be mixed with other medicinal products except sodium chloride 9 mg/mL (0.9%) solution for infusion.
Ovaj lijek ne smije se miješati s drugim lijekovima osim otopine natrijevog klorida za infuziju od 9 mg/ml (0,9 %).
The diluted medicinal product should then be administered as a 20 - 50-minute intravenous infusion through a sterile, non-pyrogenic infusion, single-use, low protein binding filter (0.2 µm).
Razrijeđeni lijek potom treba primijeniti kao intravensku infuziju u trajanju od 20 do 50 minuta kroz sterilni, nepirogeni, infuzijski filtar s niskim afinitetom vezanja proteina (pora veličine 0,2 µm), za jednokratnu uporabu.
Upon completion of the infusion, flush the infusion set with sterile sodium chloride 9 mg/mL (0.9%) solution for infusion to ensure that all of the CINQAERO solution for infusion has been administered.
Po završetku infuzije, isperite infuzijski set sterilnom otopinom natrijevog klorida za infuziju od 9 mg/ml (0,9 %) kako biste osigurali da je primijenjena sva CINQAERO otopina za infuziju.
In an open-label phase 3 extension study, low-titre, frequently transient anti-reslizumab antibodies were detected in 49 out of 1,014 asthma patients (5%) who received 3 mg/kg reslizumab for up to 36 months.
U otvorenom nastavku ispitivanja faze 3, niski titar često prolaznih protutijela protiv reslizumaba otkriven je u 49 od 1014 bolesnika s astmom (5 %) koji su primali reslizumab u dozi od 3 mg/kg do 36 mjeseci.
Reslizumab is a humanised monoclonal antibody produced in mouse myeloma cells (NS0) by recombinant DNA technology.
Reslizumab je humanizirano monoklonsko protutijelo proizvedeno u stanicama mijeloma miša (NS0)
In both studies, an asthma exacerbation was defined as a worsening of asthma that required the following medical intervention: 1) use of systemic corticosteroids or an increase in the use of ICS treatment for 3 or more days, and/or 2) asthma-related emergency treatment including at least one of the following: an unscheduled visit to their healthcare professional for nebuliser treatment or other urgent treatment to prevent worsening of asthma symptoms; a visit to the emergency room for asthma-related treatment; or asthma-related hospitalisation.
2) hitno liječenje zbog astme koje je uključivalo najmanje jedno od sljedećeg: neplanirani posjet zdravstvenom radniku zbog liječenja pomoću atomizatora ili drugog hitnog liječenja radi sprječavanja pogoršanja simptoma astme; odlazak na hitnu pomoć radi liječenja astme; ili hospitalizacija zbog astme.
Overview of clinical efficacy The efficacy of reslizumab in eosinophilic asthma (blood eosinophils ≥400 µL-1) was evaluated in three randomised, double-blind, placebo-controlled studies (Studies I to III) from 16 to 52 weeks' duration involving 1268 patients with moderate to severe asthma inadequately controlled on mediumto high-dose inhaled corticosteroids (ICS) (at least 440 μg of fluticasone propionate daily or equivalent) with or without other controllers; prior stable allergen immunotherapy was allowed.
Djelotvornost reslizumaba kod eozinofilne astme (eozinofili u krvi ≥400 µl-1) bila je procijenjena u tri randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja (Ispitivanja I do III) u trajanju od 16 do 52 tjedna, koja su uključila 1268 bolesnika s umjerenom do teškom astmom koja nije bila odgovarajuće kontrolirana pomoću srednjih do visokih doza inhalacijskih kortikosteroida (najmanje