natgillin/translations-raw huggingface dataset:
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
In Studies I and II only, patients were required to have at least one asthma exacerbation requiring systemic corticosteroid use in the year prior to study entry. 
Bolesnici su morali imati najmanje jednu egzacerbaciju astme koja je zahtijevala primjenu sistemskih kortikosteroida u godinu dana prije ulaska u ispitivanje samo u Ispitivanjima
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. 
I i II bila su randomizirana, placebom kontrolirana ispitivanja u trajanju od 52 tjedna u bolesnika s najmanje jednom egzacerbacijom astme koja je zahtijevala primjenu sistemskih kortikosteroida tijekom prethodnih dvanaest mjeseci.
Clear to slightly hazy opalescent, colourless to slightly yellow solution with pH 5.5. 
Bistra do blago zamućena, opalescentna, bezbojna do blago žuta otopina s pH 5,5.
CINQAERO is a clear to slightly hazy opalescent, colourless to slightly yellow concentrate for solution for infusion (sterile concentrate). 
CINQAERO je bistri do blago mutni, opalescentni, bezbojni ili blago žuti koncentrat za otopinu za infuziju (sterilni koncentrat).
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). 
Infuzija se mora odmah prekinuti ako bolesnik razvije reakciju preosjetljivosti na reslizumab ili neku od pomoćnih tvari (vidjeti dio 4.4).
What you need to know before you are given CINQAERO You must not receive CINQAERO: 
Što morate znati prije nego primite CINQAERO
Systemic exposure to reslizumab appears to be unaffected by anti-reslizumab antibodies. 
Čini se da protutijela protiv reslizumaba ne utječu na sistemsku izloženost reslizumabu.
As reslizumab binds to a soluble target, linear non-target-mediated clearance is expected. 
Kako se reslizumab veže za topljivu ciljnu molekulu, očekuje se linearni klirens koji nije posredovan ciljnom molekulom.
There was no prior asthma exacerbation requirement for this study. 
Za ovo ispitivanje prethodna egzacerbacija astme nije bila uvjet.
Investigations 
Ispitivanjima
CINQAERO is provided as a concentrate for solution for infusion in a single-use vial. 
CINQAERO se isporučuje kao koncentrat za otopinu za infuziju u bočici za jednokratnu primjenu.
95% CI a Rate adjusted for stratification factors (baseline usage of OCS and geographical region). 
a Stopa prilagođena za stratifikacijske čimbenike (početna uporaba peroralnih kortikosteroida i geografska regija).
What CINQAERO is used for 
Za što se CINQAERO koristi
ACQ Mean diff (95% CI) (p-value) AQLQ Mean diff (95% CI) (p-value) 
Srednja vrijednost razlike (95 % CI) (p-vrijednost) AQLQ
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. 
Tijekom kontroliranih kliničkih ispitivanja, udio bolesnika koji su prekinuli liječenje zbog nekog štetnog događaja iznosio je 5 % i u skupini koja je primala reslizumab u dozi od 3 mg/kg i u onoj koja je primala placebo.
Numbers of each vial** Vials with 10 mL concentrate (100 mg reslizumab) 
Broj bočica** Bočice s 10 ml koncentrata (100 mg reslizumaba)
Study I (n=489) 
Ispitivanje I (n=489)
No significant difference in the pharmacokinetics of reslizumab was observed across these groups. 
Nije opažena značajna razlika u farmakokinetici reslizumaba između ovih skupina.
CINQAERO is compatible with polyethersulfone (PES), polyvinylidene fluoride (PVDF), nylon, cellulose acetate (CA) low protein binding in-line infusion filters. 
CINQAERO je kompatibilan s ugrađenim infuzijskim filtrima s niskim afinitetom vezanja proteina izrađenima od polietersulfona (PES), poliviniliden fluorida (PVDF), najlona, celulozaacetata (CA).
39 paediatric asthma patients from 12 to 17 years were randomised to reslizumab 0.3 mg/kg, reslizumab 3 mg/kg or placebo as part of two 52-week exacerbation studies (Studies I and II) and one 16-week lung function study (Study III). 
Trideset devet pedijatrijskih bolesnika s astmom u dobi od 12 do 17 godina bilo je randomizirano da prima reslizumab u dozi 0,3 mg/kg, reslizumab u dozi od 3 mg/kg ili placebo u sklopu dva ispitivanja egzacerbacije u trajanju od 52 tjedna (Ispitivanja I i II) i jednog ispitivanja funkcije pluća u trajanju od
Maintenance OCS (up to 10 mg per day prednisone equivalent) were allowed. 
Bila je dopuštena terapija održavanja peroralnim kortikosteroidima (ekvivalent prednizonu u dozi do10 mg na dan).
Blood creatine phosphokinase increased* 
Pretrage često povišena kreatin fosfokinaza u krvi*
Vials with 2.5 mL concentrate (25 mg reslizumab) 
Bočice s 2,5 ml koncentrata (25 mg reslizumaba)
CINQAERO 10 mg/mL sterile concentrate reslizumab 
CINQAERO 10 mg/ml sterilni koncentrat reslizumab
Patients with refractory asthmad 
Bolesnici s refrakternom astmom d
Asthma-related symptoms or exacerbations may occur during treatment. 
Tijekom liječenja mogu nastupiti simptomi vezani uz astmu ili egzacerbacije astme.
The appropriate volume of CINQAERO should be dispensed into an infusion bag containing 50 mL sodium chloride 9 mg/mL (0.9%) solution for infusion. 
Odgovarajući volumen lijeka CINQAERO treba dodati u infuzijsku vrećicu koja sadrži 50 ml otopine natrijevog klorida za infuziju od 9 mg/ml (0,9 %).
Excipients: sodium acetate trihydrate, acetic acid glacial, sucrose, water for injections. 
POPIS POMOĆNIH TVARI Pomoćne tvari: natrijev acetat trihidrat, ledena acetatna kiselina, saharoza, voda za injekcije.
Common (may affect up to 1 in 10 people) • Increase of an enzyme in your blood (blood creatine phosphokinase). 
• povišenje jednog enzima u krvi (kreatin fosfokinaze u krvi)
GINA step 5 patients received in addition, as an add-on, maintenance OCS. 
Bolesnici u koraku 5 prema klasifikaciji GINA dodatno su primili, kao dodatnu terapiju, peroralne kortikosteroide kao terapiju održavanja.
How CINQAERO works 
Kako CINQUAERO djeluje
Serious allergic reactions can happen uncommonly (may affect up to 1 in 100 people) while receiving CINQAERO or afterwards. 
Dok primate CINQAERO ili nakon toga, manje često (mogu se javiti u do 1 na 100 osoba) mogu nastupiti ozbiljne alergijske reakcije.
Table 3: Demographics and baseline characteristics of asthma studies I - III Demographic or baseline characteristic 
Tablica 3: Demografske i početne značajke Ispitivanja astme
In phase 3 placebo-controlled studies with a duration of 16 to 52 weeks, low-titre, frequently transient anti-reslizumab antibodies were detected in 53 out of 983 asthma patients (5%) receiving reslizumab at 3 mg/kg. 
U placebom kontroliranim ispitivanjima faze 3 u trajanju od 16 do 52 tjedna, u 53 od 983 bolesnika s astmom (5 %) koji su primali reslizumab u dozi od 3 mg/kg otkriven je niski titar često prolaznih protutijela protiv reslizumaba.
CINQAERO should be administered by a healthcare professional prepared to manage hypersensitivity reactions including anaphylaxis (see section 4.4). 
CINQAERO treba primjenjivati zdravstveni radnik pripremljen za liječenje reakcija preosjetljivosti uključujući anafilaksiju (vidjeti dio 4.4).
Each vial of 2.5 mL contains 25 mg of reslizumab and each vial of 10 mL contains 100 mg of reslizumab. 
Jedna bočica od 2,5 ml sadrži 25 mg reslizumaba, a jedna bočica od 10 ml sadrži 100 mg reslizumaba.
Reslizumab has not been studied in patients with severe renal impairment or end stage renal disease. 
Reslizumab nije ispitan u bolesnika s teškim oštećenjem funkcije bubrega i završnim stadijem bolesti bubrega.
The antibodies had no impact on clinical pharmacodynamics, efficacy or safety. 
Ta protutijela nisu utjecala na kliničku farmakodinamiku,
How to store CINQAERO 
Kako čuvati CINQAERO
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. 
U placebom kontroliranim ispitivanjima astme, mijalgija je bila zabilježena u 0,97 % bolesnika (10 od 1028) u skupini koja je primala reslizumab u dozi od 3 mg/kg u usporedbi s 0,55 % bolesnika (4 od 730) u skupini koja je primala placebo.
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. 
I i II, udio bolesnika koji nisu imali egzacerbaciju astme tijekom 52 tjedna liječenja bio je veći u skupini koja je primala reslizumab u dozi od 3 mg/kg (62 % odnosno 75 %) nego u skupini koja je primala placebo (46 % odnosno 55 %).
Slowly dispense the contents of the syringe(s) into an infusion bag containing 50 mL of sodium chloride 9 mg/mL (0.9%) solution for infusion. 
Polako ubrizgajte sadržaj štrcaljke(i) u infuzijsku vrećicu koja sadrži 50 ml otopine natrijevog klorida za infuziju od 9 mg/ml (0,9 %).
CINQAERO should be administered by a healthcare professional prepared to manage hypersensitivity reactions including anaphylaxis (see section 4.4 of Summary of Product Characteristics). 
CINQAERO treba primjenjivati zdravstveni radnik pripremljen za liječenje reakcija preosjetljivosti uključujući anafilaksiju (vidjeti dio 4.4 Sažetak opisa svojstava lijeka).