natgillin/translations-raw huggingface dataset:
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).
Če se pojavi anafilaktična reakcija, je treba dajanje reslizumaba takoj ustaviti in nuditi ustrezno zdravljenje; zdravljenje z reslizumabom je treba trajno prekiniti (glejte poglavje 4.3).
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.
Zmanjšanje števila eozinofilcev v krvi z reslizumabom, se pri bolnikih, pozitivnih na protitelesa proti reslizumabu, ni razlikovalo od tistega pri bolnikih, ki so bili negativni na protitelesa proti reslizumabu.
If you stop using CINQAERO
Če ste prenehali uporabljati zdravilo CINQAERO
Asthma exacerbation ratea
Stopnja poslabšanja astmea
CINQAERO should be prescribed by physicians experienced in the diagnosis and treatment of the above-mentioned indication (see section 4.1).
Zdravilo CINQAERO mora predpisati zdravnik z izkušnjami v diagnostiki in zdravljenju zgoraj navedene indikacije (glejte poglavje 4.1).
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 je bila pri odraslih (starih 18 do 65 let; n = 759) in starejših bolnikih (starih več kot 65 let; n = 30) podobna.
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 potrjujejo, da sočasna uporaba antagonistov levkotrienskih receptorjev ali sistemskih kortikosteroidov ne vpliva na farmakokinetiko reslizumaba (glejte poglavje 5.2).
The malignancies observed in reslizumab-treated patients were diverse in nature and without clustering of any particular tissue type.
Malignosti, ki so jih opazili pri bolnikih, zdravljenih z reslizumabom, so bile različne in brez kopičenja primerov za določeno tkivo.
CINQAERO must not be administered as a bolus injection or as undiluted concentrate.
CINQAERO se ne sme dati kot bolusna injekcija ali kot nerazredčen koncentrat.
Decreases in blood eosinophils were related to reslizumab levels.
Zmanjšanja eozinofilcev v krvi so bila povezana z ravnmi reslizumaba.
The effect of reslizumab 3 mg/kg administered once every 4 weeks on secondary endpoints, including FEV1, Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Questionnaire (ACQ) and Asthma Symptom Utility Index (ASUI), further supports the efficacy of reslizumab 3 mg/kg compared to placebo.
Učinek reslizumaba 3 mg/kg, danega enkrat na 4 tedne ob sekundarnih opazovanih dogodkih, vključno z FEV1, Vprašalnikom o kakovosti življenja bolnikov z astmo (AQLQ-Asthma Quality of Life Questionnaire), Vprašalnikom o urejenosti astme (ACQ-Asthma Control Questionnaire) in Indeksom uporabnosti pri simptomih astme (ASUI-Asthma Symptom Utility Index) nadalje podpira učinkovitost reslizumaba 3 mg/kg v primerjavi s placebom.
Posology CINQAERO is given as intravenous infusion once every four weeks.
Odmerjanje Zdravilo CINQAERO se daje kot intravenska infuzija enkrat na štiri tedne.
These reactions were observed during or within 20 minutes after completion of the reslizumab infusion and were reported as early as the second dose of reslizumab.
Te reakcije so opazili med infundiranjem reslizumaba ali v 20 minutah po infundiranju, o njih pa so poročali že ob drugem odmerku reslizumaba.
Reslizumab binds human IL-5 with picomolar affinity blocking its biological function; consequently survival and activity of eosinophils are reduced.
Reslizumab veže humani IL-5 s pikomolarno afiniteto in zavre njegovo biološko funkcijo; posledično se zmanjšata preživetje in aktivnost eozinofilcev.
No physical or biochemical compatibility studies have been conducted to evaluate the co-administration of reslizumab with other medicinal products.
Študij fizikalne ali biokemične združljivosti za ocenjevanje sočasne uporabe reslizumaba z drugimi zdravili niso izvedli.
These adverse reactions were observed during or within 20 minutes after completion of the infusion.
Te neželene učinke so opazili med infundiranjem ali v 20 minutah po koncu infundiranja.
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).
Razpon sistemske izpostavljenosti pri bolnikih, starih od 12 do manj kot 18 let (n = 15), se je prekrival s tistim pri drugih skupinah, čeprav je bila mediana vrednosti nekoliko manjša kot pri odraslih bolnikih (starih 18 do 65 let; n = 759) in starejših bolnikih (starih več kot 65 let; n = 30).
Interleukin-5 is a protein your body makes that plays a key role in inflammation in asthma by activating eosinophils.
Interlevkin-5 je beljakovina, ki jo telo proizvaja in ima odločilno vlogo pri astmatskem vnetju z aktiviranjem eozinofilcev.
The solution for infusion should not be infused concomitantly in the same intravenous line with other medicinal products.
Raztopine za infundiranje ne infundirajte sočasno z drugimi zdravili skozi isto intravensko linijo.
CINQAERO is a medicine containing the active substance reslizumab, a monoclonal antibody, a type of protein that recognises and binds to a specific target substance in the body.
Zdravilo CINQAERO vsebuje učinkovino reslizumab, monoklonsko protitelo, ki je vrsta beljakovine, ki v telesu prepoznava specifične ciljne snovi in se nanje veže.
You will be given CINQAERO by a doctor or nurse as an infusion (drip) into a vein.
Zdravilo CINQAERO vam bo dal zdravnik ali medicinska sestra v obliki infuzije (kapanja) v žilo.
Proportions of patients in GINA steps 4 and 5c
Delež bolnikov s 4. in 5. korakom po GINAc
CINQAERO reduces how often you have flare-ups of your asthma, helps you breathe better and decreases your asthma symptoms.
Zdravilo CINQAERO zmanjša pogostnost poslabšanja astme, izboljša dihanje in zmanjša simptome astme.
CINQAERO blocks interleukin-5 activity and reduces the number of eosinophils in your blood and lungs.
Zdravilo CINQAERO zavira aktivnost interlevkina-5 in zmanjša število eozinofilcev v krvi in pljučih.
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)