natgillin/translations-raw huggingface dataset:
CINQAERO is compatible with polyvinylchloride (PVC) or polyolefin (PO) infusion bags. 
Zdravilo CINQAERO je združljivo z infuzijskimi vrečicami iz polivinilklorida (PVC) ali poliolefina (PO).
Contents of the pack and other information What CINQAERO contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo CINQAERO
In a population pharmacokinetic analysis, patients were classified by baseline liver function levels. 
V analizi populacijske farmakokinetike so bili bolniki razvrščeni glede na izhodiščne ravni delovanja jeter.
What CINQAERO is and what it is used for What you need to know before you are given CINQAERO How CINQAERO is given 
Kaj je zdravilo CINQAERO in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo CINQAERO Kako se daje zdravilo CINQAERO
Studies I and II were 52-week, randomised, placebo-controlled studies in patients who had at least one asthma exacerbation requiring systemic corticosteroid use over the past twelve months. 
Študiji I in II sta bili 52-tedenski, randomizirani, s placebom nadzorovani študiji pri bolnikih, ki so imeli v zadnjih dvanajstih mesecih vsaj eno poslabšanje astme, ki je zahtevalo uporabo sistemskega kortikosteroida.
The patient has to be observed over the duration of the infusion and for an appropriate period afterwards. 
Bolnika je treba opazovati v času infundiranja in še ustrezno obdobje potem.
It is recommended that the solution for infusion be administered immediately after preparation. 
Raztopino za infundiranje je priporočljivo dati takoj po pripravi.
[ATS]/European Respiratory Society [ERS] 2000 workshop definition for refractory asthma) from Studies I and II was analysed post hoc. 
Ameriškega torakalnega društva (ATS-American Thoracic Society))/Evropskega združenja za dihanje (ERS-European Respiratory Society)) leta 2000) iz študij I in II je bil analiziran post hoc.
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 
Preglednica 5: Razlika v zdravljenju glede na povprečno spremembo od izhodišča za izbrane spremenljivke sekundarne učinkovitosti - združeni podatki (študiji I in II) za celotno populacijo in podskupino GINA 4 in 5
Improvements were observed as early as 4 weeks following the first dose of reslizumab (AQLQ at 16 weeks) and sustained through week 52. 
Že po 4 tednih od prvega odmerka reslizumaba (AQLQ 16 tednov) so opazili izboljšanje, ki se je ohranjalo vse do konca 52. tedna.
The solution for infusion should be infused intravenously over 20 - 50 minutes. 
Raztopino za infundiranje je treba infundirati intravensko v 20-50 minutah.
- The active substance is reslizumab. 
- Učinkovina je reslizumab.
Reslizumab is a humanised monoclonal antibody produced in mouse myeloma cells (NS0) by recombinant DNA technology. 
Reslizumab je humanizirano monoklonsko protitelo, pridobljeno iz mišjih mielomskih celic (NS0) s tehnologijo rekombinantne DNA.
CINQAERO has no or negligible influence on the ability to drive and use machines. 
Zdravilo CINQAERO nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
No treatment effect on asthma exacerbations was observed for this age group (asthma exacerbation rate ratio [reslizumab/placebo] of 2.09). 
V tej starostni skupini niso opazili učinka zdravljenja na poslabšanje astme (razmerje pogostnosti poslabšanja astme [reslizumab/placebo] 2,09).
For dosing instructions see section 4.2 of Summary of Product Characteristics. 
Za navodila glede odmerjanja glejte poglavje 4.2 Povzetka glavnih značilnosti zdravila.
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%). 
Večina bolnikov je imela normalne teste delovanja jeter (n = 766, približno 95 %) ali blago zvečane teste delovanja jeter (bodisi - v prvem primeru - skupni bilirubin nad zgornjo mejo normalne vrednosti [ULN-upper limit of normal], a enak 1,5-kratni ULN ali nižji, ali - v drugem primeru aspartat-aminotransferazo višjo od ULN in skupni bilirubin enak ULN ali manj; n = 35, približno
Do not use this medicine after the expiry date which is stated on the outer carton and label after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
CINQAERO is for intravenous infusion only. 
Zdravilo CINQAERO je samo za intravensko infundiranje.
No apparent deviation from dose-proportional reslizumab pharmacokinetics was noted over the dose range of 0.3 mg/kg to 3.0 mg/kg. 
Očitnega odstopanja od farmakokinetike reslizumaba, sorazmerne z odmerkom, v razponu odmerka od 0,3 mg/kg do 3,0 mg/kg niso opazili.
In Study III, patients receiving reslizumab 3 mg/kg had significantly larger increases in FEV1 from baseline compared to placebo (treatment difference: 160 mL, p=0.0018). 
V študiji III so imeli bolniki, ki so prejemali reslizumab 3 mg/kg, značilno večje zvečanje FEV1 od izhodišča v primerjavi s placebom (razlika v zdravljenju: 160 ml, p = 0,0018).
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'. 
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni „brez natrija“.
CINQAERO is used together with other medicines to treat asthma (inhaled corticosteroids plus other asthma medicines). 
Zdravilo CINQAERO se uporablja skupaj z drugimi zdravili za zdravljenje astme (inhalacijski kortikosteroid in še eno zdravilo za astmo).
Pulmonary function tests 
povprečno v letih Testi pljučne funkcije
Studies I and II 
Študiji I in II
Gently invert the bag to mix the solution. 
Vrečico nežno obrnite, da se raztopina premeša.
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. 
V združenih podatkih je bilo povprečno število eozinofilcev ob izhodišču 655 µl-1 (n = 476) oz. 654 µl-1 (n = 477) za skupino s placebom oz. skupino, zdravljeno z reslizumabom, in 514 µl-1 (n = 405) oz. 61 µl-1 (n = 407) v
Store in a refrigerator (2 °C-8 ºC). 
Shranjujte v hladilniku (2 ºC - 8 ºC).
Table 4: Frequency of asthma exacerbations during the 52-week treatment period - Studies I and II, integrated data (Studies I and II) for the overall population and subgroup GINA 4 and 5 Treatment arms (n) 
Preglednica 4: Pogostnost poslabšanj astme v 52-tedenskem obdobju zdravljenja - študiji I in II, združeni podatki (študiji I in II) za celotno populacijo in podskupino GINA 4 in 5 Kraki zdravljenja (n)
Data by study Study I 
Podatki po študiji Študija I
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 viala z 10 ml EU/1/16/1125/002 - 1 viala z 2,5 ml EU/1/16/1125/003 - 2 viali z 10 ml EU/1/16/1125/004 - 2 viali z 2,5 ml
Serious allergic reactions have occurred in patients receiving this medicine (see section “4. 
so se pojavile resne alergijske reakcije (glejte poglavje "4.
This is not unusual for proteinaceous solutions. 
Za beljakovinske raztopine to ni neobičajno.
The effect of reslizumab in patients with asthma and elevated sputum eosinophil counts (at least 3%) was evaluated in a 15-week, phase 2, randomised, double-blind, placebo-controlled clinical study with reslizumab 3 mg/kg. 
Učinek reslizumaba pri bolnikih z astmo in zvečanim številom eozinofilcev v sputumu (vsaj 3 %) so ocenili v 15-tedenski, randomizirani, dvojno slepi, s placebom nadzorovani klinični študiji 2. faze z reslizumabom 3 mg/kg.
If you miss a scheduled dose of CINQAERO, ask your doctor when to schedule your next treatment. 
Če ste izpustili načrtovani odmerek zdravila CINQAERO Če ste izpustili načrtovani odmerek zdravila CINQAERO, se z zdravnikom dogovorite za naslednji termin zdravljenja.
Reslizumab binds specifically to IL-5 and interferes with IL-5 binding to its cell-surface receptor. 
Reslizumab se specifično veže na IL-5 in moti vezavo IL-5 na receptor na površini celice.
In the subset of patients requiring courses of OCS treatment for management of their asthma exacerbation, reslizumab was shown to reduce the frequency of asthma exacerbations by 56% (p<0.0001) and 60% (p<0.0001) in Study I and Study II, respectively. 
V podskupini bolnikov, ki so za obvladovanje poslabšanja astme potrebovali cikle zdravljenja s PKS, se je izkazalo, da reslizumab zmanjšuje pogostnost poslabšanj astme za 56 % (p < 0,0001) v študiji I oz. 60 % (p < 0,0001) v študiji II.
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 viala z 10 ml EU/1/16/1125/002 1 viala z 2,5 ml EU/1/16/1125/003 2 viali z 10 ml EU/1/16/1125/004 2 viali z 2,5 ml
No formal clinical drug interaction studies have been performed with reslizumab. 
Formalnih kliničnih študij medsebojnega delovanja zdravil z reslizumabom niso izvedli.
The primary endpoint was the change from baseline over 16 weeks in FEV1. 
Študija III Primarni opazovani dogodek je bila sprememba FEV1 od izhodišča čez 16 tednov.
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. 
Kemična in fizikalna stabilnost med uporabo sta bili dokazani pri 2 °C - 8 °C in pri 25 °C v raztopini natrijevega klorida 9 ml/ml (0,9 %) za infundiranje, zaščiteno pred svetlobo za obdobje do 16 ur.
The recommended dose is 3 mg/kg body weight. 
Priporočeni odmerek je 3 mg/kg telesne mase.
The proportion of patients who did not experience an asthma exacerbation during the 52-week treatment period was higher in the reslizumab 3 mg/kg group (62% and 75%) compared with the placebo group (46% and 55%), in Studies I and II, respectively. 
Delež bolnikov, pri katerih se astma v 52-tedenskem obdobju zdravljenja ni poslabšala, je bil večji v skupini z reslizumabom 3 mg/kg (62 % oz. 75 %) v primerjavi s skupino s placebom (46 % oz. 55 %) v študijah I oz. II.
Study III (n=315) 
Študija III (n = 315)
Integrated Studies I and II 
Združeni študiji I in II
Intravenous use, after dilution only. 
Intravenska uporaba, samo po redčenju.
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. 
Zdravilo CINQAERO je na voljo v pakiranjih, ki vsebujejo 1 ali 2 viali z 2,5 ml, in v pakiranjih, ki vsebujejo 1 ali 2 viali z 10 ml.
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. 
Učinkovitost reslizumaba pri eozinofilni astmi (eozinofilci v krvi ≥ 400 µl-1) so ocenili v treh randomiziranih, dvojno slepih, s placebom nadzorovanih študijah (študije I do III), ki so trajale od 16 do 52 tednov in vključevale 1.268 bolnikov z zmerno do hudo astmo, ki s srednje visokimi do visokimi odmerki inhaliranih kortikosteroidov (IKS) (vsaj 440 μg flutikazonpropionata ali ustreznega zdravila na dan) z drugimi zdravili za obvladovanje ali brez njih ni bila ustrezno urejena; predhodna stabilna imunoterapija na alergene je bila dovoljena.
Myalgia was reported in 0.97% of patients (10 out of 1,028) in the 3 mg/kg reslizumab group of the placebo-controlled asthma studies compared with 0.55% of patients (4 out of 730) in the placebo group. 
O mialgiji so poročali pri 0,97 % bolnikov (10 od 1.028) v skupini s 3 mg/kg reslizumaba v študijah astme, nadzorovanih s placebom, v primerjavi z 0,55 % bolnikov (4 od 730) v skupini s placebom.
During controlled clinical studies, the proportion of patients who discontinued due to any adverse event was 5% for both the 3 mg/kg reslizumab and placebo groups. 
Med nadzorovanimi kliničnimi študijami je bil delež bolnikov, ki so zaradi neželenega učinka prenehali sodelovati, 5 % za obe skupini; skupino s 3 mg/kg reslizumaba in skupino s placebom.
FEV1 (mL) Mean diff (95% CIb) (p-value) 
FEV1 (ml) Srednja razlika (95-% IZb) (vrednost p)
Each vial of 10 mL contains 0.20 mmol (4.6 mg) of sodium. 
Ena viala z 10 ml vsebuje 0,20 mmol (4,6 mg) natrija.
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. 
V kliničnih študijah I in II z reslizumabom 3 mg/kg so opazili zmanjšanje števila eozinofilcev v krvi po prvem odmerku in do konca 52. tedna zdravljenja brez znakov tahifilaksije.
Serious allergic reactions can happen uncommonly (may affect up to 1 in 100 people) while receiving CINQAERO or afterwards. 
Resne alergijske reakcije se lahko pojavijo občasno (pojavijo se lahko pri največ 1 od
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. 
Raztopino zdravila CINQAERO, razredčeno v raztopini natrijevega klorida 9 mg/ml (0,9 %) za infundiranje, se lahko shranjuje v hladilniku pri 2 °C - 8 °C (ali do 25 °C, razen če je razredčitev potekala v kontroliranih okoliščinah in validiranih aseptičnih pogojih), zaščiteno pred svetlobo do 16 ur.
What are the benefits of using CINQAERO 
Kakšne so koristi uporabe zdravila CINQAERO
Package leaflet: Information for the patient CINQAERO 10 mg/mL concentrate for solution for infusion reslizumab This medicine is subject to additional monitoring. 
Navodilo za uporabo CINQAERO 10 mg/ml koncentrat za raztopino za infundiranje reslizumab Za to zdravilo se izvaja dodatno spremljanje varnosti.
The medicinal product should be inspected visually before use. 
Pred uporabo je treba zdravilo pregledati s prostim očesom.
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). 
Zdravilo CINQAERO je indicirano kot dodatno zdravljenje pri odraslih bolnikih s hudo eozinofilno astmo, ki kljub uporabi visokih odmerkov inhalacijskih kortikosteroidov z drugim zdravilom za vzdrževalno zdravljenje ni ustrezno urejena (glejte poglavje 5.1).
In Studies I and II, severe eosinophilic asthma is defined as any patients falling into GINA steps 4 and 5 (medium- to high-dose ICS [≥ 440 µg fluticasone propionate] plus another controller, with or without maintenance OCS) with a blood eosinophil count of ≥400 µL-1 at start of treatment. 
V študijah I in II je bila huda eozinofilna astma opredeljena kot vsi bolniki v 4. in 5. koraku po GINA (srednje visok do visok odmerek IKS [≥ 440 µg flutikazonpropionata] in še eno zdravilo za obvladovanje, z vzdrževalni PKS ali brez njega) s številom eozinofilcev v krvi ≥ 400 µl-1 na začetku zdravljenja.
CINQAERO is a clear to slightly hazy opalescent, colourless to slightly yellow concentrate for solution for infusion (sterile concentrate). 
Zdravilo CINQAERO je bister do rahlo moten, opalescenten, brezbarven do rahlo rumen koncentrat za raztopino za infundiranje (sterilni koncentrat).
Remove CINQAERO from the refrigerator. 
Priprava raztopine za infundiranje Zdravilo CINQAERO vzemite iz hladilnika.
Asthma-related symptoms or exacerbations may occur during treatment. 
Med zdravljenjem se lahko pojavijo simptomi, povezani z astmo, ali poslabšanja.
95% CI a Rate adjusted for stratification factors (baseline usage of OCS and geographical region). 
a Stopnja, prilagojena za stratifikacijska dejavnika (izhodiščna uporaba PKS in zemljepisna regija)
The overall reduction was 54%. 
Celotno zmanjšanje je bilo
This medicinal product must not be mixed with other medicinal products except sodium chloride 9 mg/mL (0.9%) solution for infusion. 
Tega zdravila se ne sme mešati z drugimi zdravili, razen z raztopino natrijevega klorida 9 mg/ml (0,9 %) za infundiranje.
The patients received either four doses of placebo or reslizumab 0.3 mg/kg or 3 mg/kg administered once every 4 weeks. 
Bolniki so prejemali bodisi štiri odmerke placeba ali reslizumaba 0,3 mg/kg ali 3 mg/kg enkrat na 4 tedne.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC, ODGOVOREN ZA
Each vial of 2.5 mL contains 0.05 mmol (1.15 mg) of sodium. 
Ena viala z 2,5 ml vsebuje 0,05 mmol (1,15 mg) natrija.
Adverse reactions are listed below in Table 2 by system organ class and frequency (frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known 
Neželeni učinki so našteti spodaj v preglednici 2 po organskih sistemih in pogostnosti (pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10);
Study I (n=489) 
Študija I (n = 489)
Numbers of each vial** Vials with 10 mL concentrate (100 mg reslizumab) 
Število posameznih vial** Viale z 10 ml koncentrata (100 mg reslizumaba)
The patients received either 13 doses of placebo or reslizumab 3 mg/kg administered once every 4 weeks. 
Bolniki so prejemali bodisi 13 odmerkov placeba ali reslizumaba 3 mg/kg enkrat na 4 tedne.
In common with other monoclonal antibodies, reslizumab is believed to be degraded by enzymatic proteolysis into small peptides and amino acids. 
Biotransformacija Kot za druga monoklonska protitelesa prevladuje mnenje tudi za reslizumab, da se z encimsko proteolizo razgrajuje v majhne peptide in aminokisline.
Each mL of concentrate contains 10 mg of reslizumab (10 mg/mL). 
En ml koncentrata vsebuje 10 mg reslizumaba (10 mg/ml).
Excipients: sodium acetate trihydrate, acetic acid glacial, sucrose, water for injections. 
Pomožne snovi: natrijev acetat trihidrat, ledocet, saharoza, voda za injekcije.
d The percentage of patients with refractory asthma (based on the American Thoracic Society 
d Odstotek bolnikov z neodzivno astmo (na podlagi opredelitve neodzivne astme delavnice
- The other excipients are sodium acetate, acetic acid glacial, sucrose and water for injections. 
- Druge sestavine zdravila so natrijev acetat, ledocet, saharoza in voda za injekcije.
CINQAERO is supplied in glass vials containing 2.5 mL or 10 mL. 
Zdravilo CINQAERO je na voljo v steklenih vialah, ki vsebujejo 2,5 ml ali 10 ml.
Reslizumab has a long half-life (see section 5.2). 
Reslizumab ima dolg razpolovni čas (glejte poglavje 5.2).
Reslizumab total dose (mg) 
Celotni odmerek reslizumaba (mg)
Based on population pharmacokinetic analysis, systemic exposure to reslizumab appears to be unaffected by circulating anti-reslizumab antibodies. 
Na podlagi analize populacijske farmakokinetike kaže, da protitelesa proti reslizumabu v obtoku ne vplivajo na sistemsko izpostavljenost reslizumabu.
CINQAERO is provided as a concentrate for solution for infusion in a single-use vial. 
Zdravilo CINQAERO je na voljo kot koncentrat za raztopino za infundiranje v viali za enkratno uporabo.
Systemic exposure to reslizumab appears to be unaffected by anti-reslizumab antibodies. 
Kaže, da protitelesa proti reslizumabu ne vplivajo na sistemsko izpostavljenost reslizumabu.
What CINQAERO looks like and contents of the pack 
Izgled zdravila CINQAERO in vsebina pakiranja
The maximum dose is 3 mg per kg of body weight. 
Največji priporočeni odmerek je 3 mg na kg telesne mase.
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. 
V kliničnih študijah, nadzorovanih s placebom, so pri 6 od 1.028 bolnikov (0,6 %), ki so prejemali 3 mg/kg reslizumaba, poročali o vsaj eni maligni novotvorbi, v primerjavi z 2 od 730 bolnikov (0,3 %)
What CINQAERO is and what it is used for What CINQAERO is 
Kaj je zdravilo CINQAERO in za kaj ga uporabljamo Kaj je zdravilo CINQAERO
Study II (n=464) 
Študija II (n = 464)
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) z astmo povezano nujno zdravljenje, vključno z vsaj nečim od naslednjega: nenačrtovanim obiskom zdravstvenega delavca, usposobljenega za zdravljenje z nebulatorjem; drugim nujnim zdravljenjem za preprečitev poslabšanja simptomov astme; obiskom oddelka za nujno medicinsko pomoč za zdravljenje, povezano z astmo; ali zdravljenjem v bolnišnici zaradi astme.
A suitable injection syringe should be used to withdraw the needed amount of the concentrate from the vial(s) (see section 4.2). 
Za izvlek potrebne količine koncentrata iz vial(e) je treba uporabiti primerno injekcijsko brizgo (glejte poglavje 4.2).
In integrated Studies I and II, patients receiving reslizumab 3 mg/kg had significant reductions in asthma exacerbations (56% for subgroup GINA 4 and 5) compared to placebo. 
V združenih študijah I in II so imeli bolniki, ki so prejemali reslizumab 3 mg/kg, značilno zmanjšanje poslabšanj astme (56 % za podskupini GINA 4 in 5) v primerjavi s placebom.
The infusion must be discontinued immediately if the patient experiences a hypersensitivity reaction to reslizumab or to any of the excipients (see section 4.4). 
Z infundiranjem je treba takoj prenehati, če bolnik doživi preobčutljivostno reakcijo na reslizumab ali katero koli pomožno snov (glejte poglavje 4.4).
1 vial of 2.5 mL 2 vials of 2.5 mL 1 vial of 10 mL 2 vials of 10 mL 
Velikosti pakiranja: 1 viala z 2,5 ml 2 viali z 2,5 ml 1 viala z 10 ml 2 viali z 10 ml
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). 
Razredčeno zdravilo je treba potem dati v obliki 20- do 50-minutne intravenske infuzije preko sterilnega, apirogenega filtra z majhno vezavo beljakovin (0,2 µm), za enkratno uporabo.
NAb a FEV1=forced expiratory volume in 1 second b NA=not available c The GINA classification is based on the Global Initiative for Asthma (GINA) definition: 
Bolniki z neodzivno astmod n/rb a FEV1 = forsirani ekspiratorni volumen v 1 sekundi b n/r = ni razpoložljivo c Klasifikacija GINA temelji na opredelitvi Globalne iniciative za astmo (GINA-Global Initiative for Asthma): Bolniki s 4. korakom po GINA so prejeli srednje visok do visok odmerek IKS skupaj z drugim zdravilom za obvladovanje.
Blood creatine phosphokinase increased 
Zvečana vrednost kreatin fosfokinaze v krvi
2.5 mL of concentrate in a clear type I glass vial closed by a poly(ethylene-co-tetrafluoroethylene)-coated butyl rubber stopper covered with a crimped-on aluminium ring and a white plastic flip-off cap. 
2,5 ml koncentrata v viali iz prozornega stekla tipa I, zaprti z zamaškom iz butilne gume, prevlečena s poli(etilen-ko-tetrafluoroetilenom) in zapečatena z aluminijastim obročkom in belo plastično snemljivo zaporko.