natgillin/translations-raw huggingface dataset:
Results were supported by the secondary efficacy endpoints and were in line with the overall population.
Rezultate so podprli sekundarni opazovani dogodki učinkovitosti in so bili skladni s celotno populacijo.
• Serious allergic reactions
• Resne alergijske reakcije
b CI = Confidence interval.
b IZ = interval zaupanja.
These cases resulted in the discontinuation of treatment.
V teh primerih je prišlo do prenehanja zdravljenja.
Patients should be instructed on how to recognise symptoms of serious allergic reactions.
Bolnikom je treba dati navodila za prepoznavanje simptomov resnih alergijskih reakcij.
A decision to continue the therapy should be made at least annually based on disease severity and level of exacerbation control.
Odločitev o nadaljevanju zdravljenja je treba sprejeti vsaj enkrat letno na podlagi resnosti bolezni in ravni nadzora poslabšanja.
The infusion will take about 20 to 50 minutes.
Infuzija bo trajala približno 20 do 50 minut.
Do NOT stop treatment with CINQAERO unless your doctor tells you to, even if you feel better.
NE prenehajte zdravljenja z zdravilom CINQAERO, razen če vam tako naroči zdravnik, tudi če se počutite boljše.
This medicine is NOT intended for use in children and adolescents below the age of 18 years.
To zdravilo NI namenjeno za uporabo pri otrocih in mladostnikih, stari manj kot 18 let.
Patients below 35 kg or above 199 kg
Bolniki pod 35 kg ali nad 199 kg
Subgroup GINA 4 and 5
Podskupina GINA 4 in 5
Any concentrate remaining in the vial must be discarded.
Preostali koncentrat v viali je treba zavreči.
The concentrate does not contain any preservatives.
Koncentrat ne vsebuje konzervansov.
Your doctor will work out the right dose for you.
Zdravnik bo določil za vas primeren odmerek.
The recommended dose is based on patient body weight and should only be adjusted for significant changes in body weight.
Priporočeni odmerek temelji na bolnikovi telesni masi in ga je treba prilagoditi samo za znatne spremembe v telesni masi.
Anaphylactic reaction (see section 4.4) occurred in less than 1% of patients.
Anafilaktična reakcija (glejte poglavje 4.4) se je pojavila pri manj kot 1 % bolnikov.
CINQAERO will be given every 4 weeks.
Zdravilo CINQAERO vam bo dano na vsake 4 tedne.
Over 52 weeks
52. tednu.
Elimination Reslizumab clearance is approximately 7 mL/hour.
Izločanje Očistek reslizumaba je približno 7 ml/uro.
Always follow the instructions exactly as your doctor has told you.
Vedno natančno upoštevajte navodila zdravnika.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden boste dobili to zdravilo.
Possible side effects”).
Možni neželeni učinki").
Maintenance OCS was not allowed.
Vzdrževalni PKS ni bil dovoljen.
The active substance in this medicine may pass into breast milk but only during the first few days after birth.
Učinkovina v tem zdravilu lahko prehaja v materino mleko, vendar le prvih nekaj dni po porodu.
Mean number of exacerbations in previous year
Povprečno število poslabšanj v preteklem letu
Given the small sample size and baseline imbalances resulting from subgroup analysis, no conclusion can be drawn regarding asthma efficacy in the paediatric population.
Zaradi majhne velikosti vzorca in izhodiščnega neravnovesja, ki je bilo posledica analize podskupine, ni mogoče izpeljati zaključkov glede učinkovitosti pri astmi pri pediatrični populaciji.
cohort of 763 patients within Studies I and II met this criterion; the primary efficacy outcome is presented in Table 4.
Kohorta 763 bolnikov v študijah I in II je ta kriterije izpolnjevala in primarni izidi učinkovitosti so predstavljeni v preglednici 4.
There are limited safety data in non-white ethnic populations.
V nebelskih etničnih skupinah so varnostni podatki omejeni.
- if you are allergic to reslizumab or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na reslizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Inter-individual variability in peak and overall exposure is approximately 20-30%
Med posamezniki so razlike največje in celokupne izpostavljenosti približno 20 do 30 %.
Interrupting or stopping treatment with this medicine may cause your asthma symptoms to come back.
Prekinitev ali ustavitev zdravljenja s tem zdravilom lahko povzroči, da se simptomi astme ponovijo.
Overall, 2,195 subjects received at least one dose of reslizumab.
Skupaj je 2.195 oseb prejelo vsaj en odmerek reslizumaba.
In vitro data indicate that IL-5 and reslizumab are unlikely to affect CYP1A2, 3A4 or 2B6 activity.
Podatki in vitro kažejo, da ni verjetno, da bi IL-5 in reslizumab vplivala na aktivnost CYP1A2, 3A4 ali 2B6.
The concentrate must not be used if coloured (except slightly yellow) or if foreign particles are present.
Koncentrata se ne sme uporabiti, če je obarvan (razen rahlo rumen) ali so v njem tujki.
This is particularly important: - if you are receiving other medicines which affect your immune system; - if you have recently received a vaccination or if you are likely to need a vaccination.
- če dobivate druga zdravila, ki vplivajo na vaš imunski sistem; - če ste bili pred kratkim cepljeni ali boste morda potrebovali cepljenje.
Proteinaceous particles might be present.
Prisotni so lahko beljakovinski delci.
The most frequently reported adverse reaction during treatment was increased blood creatine phosphokinase, which occurred in approximately 2% of patients.
Najpogostejši neželeni učinek, o katerem so poročali med zdravljenjem, je bila zvečana vrednost kreatin-fosfokinaze v krvi, ki se je pojavila pri približno 2 % bolnikov.
Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases; ATC code: R03DX08
Farmakoterapevtska skupina: zdravila za obstruktivne pljučne bolezni, druga sistemska zdravila za obstruktivne pljučne bolezni, oznaka ATC: R03DX08
Particles might be present.
Prisotni so lahko delci.
In humans, during the first few days after birth antibodies may be transferred to the newborns through milk.
Pri ljudeh se lahko v prvih dneh po rojstvu protitelesa z mlekom prenesejo na novorojence.
No data are available for children aged up to 11 years.
Podatkov za otroke, stare do 11 let, ni na voljo.
Maintenance OCS (up to 10 mg per day prednisone equivalent) were allowed.
Dovoljeni so bili vzdrževalni PKS (do 10 mg ekvivalenta prednizona na dan).
There are limited data available on the use of reslizumab in patients older than 75 years of age.
Razpoložljivi podatki o uporabi reslizumaba pri bolnikih, starejših od 75 let, so omejeni.
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of reslizumab in pregnant women.
Podatkov o uporabi reslizumaba pri nosečnicah ni oziroma so omejeni (manj kot 300 izpostavljenih nosečnosti).
Reslizumab should not be used to treat acute asthma exacerbations.
Reslizumab se ne sme uporabljati za zdravljenje akutnih poslabšanj astme.
Treatment duration CINQAERO is intended for long-term treatment.
Trajanje zdravljenja Zdravilo CINQAERO je namenjeno dolgotrajnemu zdravljenju.
The safety and efficacy of CINQAERO in children and adolescents aged up to 17 years have not been established for the indication of CINQAERO.
Pediatrična populacija Varnost in učinkovitost zdravila CINQAERO pri otrocih in mladostnikih, starih do 17 let, nista bili dokazani za indikacijo zdravila CINQAERO.
The volume (in mL) required from the vial(s) should be calculated as follows: 0.3 x patient body weight (in kg).
Potrebno količino (v ml) iz vial(e) je treba izračunati kot je navedeno: 0,3 x bolnikova telesna masa (v kg).
The antibodies had no impact on clinical pharmacodynamics, efficacy or safety.
Protitelesa niso vplivala na klinično farmakodinamiko, učinkovitost ali varnost.
There was no prior asthma exacerbation requirement for this study.
Za to študijo ni bilo potrebno predhodno poslabšanje astme.
Improvements were noted in FEV1 at 4 weeks following the first dose of reslizumab.
Izboljšanja so opazili za FEV1 v 4. tednu po prvem odmerku reslizumaba.
** The nominal volume of the vials (10 mL or 2.5 mL for each vial) has to be used.
** Uporabiti je treba nominalen volumen vial (10 ml ali 2,5 ml za eno vialo).
*See subsection “Description of selected adverse reactions” below
*glejte spodnje podpoglavje "Opis izbranih neželenih učinkov"
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 16 hours at 2 °C-8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Če zdravilo ni uporabljeno takoj, so časi in pogoji shranjevanja zdravila pred uporabo odgovornost uporabnika in običajno ne trajajo dlje kot 16 ur pri 2 °C-8 °C razen če je razredčitev potekala v kontroliranih okoliščinah in validiranih aseptičnih pogojih.
Efficacy variablea
Spremenljivka učinkovitostia
* This dosing scheme is based on a maximum dose of 3 mg/kg.
* Ta režim odmerjanja temelji na največjem odmerku 3 mg/kg.
Results for FEV1, ACQ and AQLQ are shown in Table 5 below for the overall population, and subgroup GINA 4 and 5.
Rezultati za FEV1, ACQ in AQLQ so prikazani v spodnji preglednici 5 za celotno populacijo in za podskupino GINA 4 in 5.
Afterwards, CINQAERO could be used during breast-feeding if appropriate.
Kasneje se zdravilo CINQAERO med dojenjem lahko uporablja, če je primerno.
Sputum eosinophils were measured in a subset of 38 adult patients at the end of therapy.
Eozinofilce v sputum so izmerili v podskupini 38-ih odraslih bolnikov ob koncu zdravljenja.
It is unknown whether reslizumab is excreted in human milk.
Ni znano, ali se reslizumab izloča v materino mleko.
Your doctor or nurse will watch you closely for signs of a reaction.
Vaš zdravnik ali medicinska sestra vas bosta natančno spremljala za pojav znakov reakcije.
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
● Načrt za obvladovanje tveganj (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
CI = Confidence interval
b IZ = interval zaupanja
Infusion time may vary depending on the total volume to be infused.
Čas infundiranja se lahko razlikuje glede na skupno količino, ki jo je treba infundirati.
In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse effects and given appropriate symptomatic treatment.
V primeru prevelikega odmerjanja se priporoča spremljanje bolnika zaradi pojava znakov ali simptomov neželenih učinkov ter ustrezno simptomatsko zdravljenje.
The solution for infusion is intended only for intravenous use after dilution and should be prepared using aseptic technique as follows:
Raztopina za infundiranje se uporablja samo intravensko po razredčitvi in jo je treba pripraviti z uporabo aseptične tehnike kot sledi:
Available pharmacodynamic/toxicological data in animals have shown excretion of reslizumab in milk.
Razpoložljivi farmakodinamični/toksikološki podatki pri živalih kažejo na izločanje reslizumaba v mleko.
Asthma exacerbations were evaluated only in the exacerbation studies (Studies I and II: reslizumab
Poslabšanja astme so ocenili samo v študijah poslabšanja (študiji I in II: reslizumab
Eosinophils began to return towards baseline in those reslizumab patients completing a 90-day follow-up assessment (394 µL-1, n=36).
Eozinofilci so se začeli vračati proti izhodišču pri tistih bolnikih na reslizumabu, ki so končali oceno po 90-dnevnem spremljanju (394 µl-1, n = 36).
The data did not indicate a difference in the safety profile of reslizumab in paediatric patients compared with that in adult patients.
Podatki ne kažejo na razliko v varnostnem profilu reslizumaba pri pediatričnih bolnikih v primerjavi z odraslimi bolniki.
No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving reslizumab or the response to new immunisations in patients receiving reslizumab.
Podatki o sekundarnem prenosu okužb z oseb, ki so bile cepljene z živimi cepivi, na bolnike, ki prejemajo reslizumab, ali o odzivu na novo imunizacijo pri bolnikih, ki prejemajo reslizumab, niso na voljo.
Table 1: Vial-based dosing scheme* for patients with body weight between 35 kg and 199 kg Body weight (kg)
Preglednica 1: Režim odmerjanja na osnovi vial* za bolnike s telesno maso med 35 kg in 199 kg Telesna masa (kg)
Study III was a 16-week, randomised, placebo-controlled study.
Študija III je bila 16-tedenska, randomizirana, s placebom nadzorovana študija.
Proteinaceous particles may be present in the concentrate that appear as translucent to white, amorphous particles, some of which may look fibrous.
V koncentratu so lahko prisotni beljakovinski delci, ki se lahko pojavijo kot prosojni do beli, amorfni delci, med katerimi so lahko nekateri videti vlaknati.
The European Medicines Agency has deferred the obligation to submit the results of studies with CINQAERO in one or more subsets of the paediatric population in asthma (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom CINQAERO za eno ali več podskupin pediatrične populacije z astmo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The highest single dose administered intravenously was reported at 12.1 mg/kg and had no clinical consequences for the patient.
Poročali so, da je bil največji intravenski enkratni odmerek 12,1 mg/kg in za bolnika ni imel kliničnih posledic.
Blood creatine phosphokinase elevations were transient and asymptomatic, and did not lead to treatment discontinuation.
Zvečanja vrednosti kreatin fosfokinaze so bila prehodna in asimptomatska ter niso vodila v prekinitev zdravljenja.
If the solution for infusion has been stored in a refrigerator, allow it to reach room temperature (15 °C-25 °C).
Če je bila raztopina za infundiranje shranjena v hladilniku, počakajte, da se ogreje na sobno temperaturo (15 °C - 25 °C).
The primary efficacy measure for both Studies I and II was the frequency of asthma exacerbations for each patient during the 52-week treatment period.
Primarno merilo učinkovitosti za študiji I in II je bila pogostnost poslabšanja astme za vsakega bolnika v 52-tedenskem obdobju zdravljenja.
Experience in paediatric patients is limited (see section 5.1).
Izkušnje pri pediatričnih bolnikih so omejene (glejte poglavje 5.1).
Peak serum concentrations of approximately 80 µg/mL are typically observed at the end of the infusion.
Največje koncentracije v serumu približno 80 µg/ml so običajno opazili ob koncu infundiranja.
If patients become infected whilst receiving treatment with reslizumab and do not respond to anti-helminth treatment, temporary discontinuation of therapy should be considered.
Če se bolniki okužijo med zdravljenjem z reslizumabom in se ne odzovejo na zdravljenje z antihelmintiki, je treba razmisliti o začasnem prenehanju zdravljenja.
Currently available data in adolescents from 12 to 17 years are described in sections 4.8, 5.1 and 5.2, but no recommendation on a posology can be made.
Trenutno razpoložljivi podatki za mladostnike, stare od 12 do 17 let, so opisani v poglavjih 4.8, 5.1 in 5.2,
Reslizumab is an antibody with a molecular mass of 147 kDaltons and is therefore not expected to be excreted in urine.
Reslizumab je protitelo z molekulsko maso 147 kDa, zato se ne pričakuje, da bi se izločal z urinom.
3 mg/kg [n=14] and placebo [n=11]).
3 mg/kg [n = 14] in placebo [n = 11]).
As a precautionary measure, it is preferable to avoid the use of CINQAERO during pregnancy.
Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila CINQAERO bolje izogibati.
Age, mean in years Asthma duration, mean in years
Starost, povprečna v letih Trajanje astme,
Based on the similar reslizumab exposure observed in patients older than 65 years of age as compared to patients 18 to <65 years of age, no dose adjustment is recommended (see section 5.2).
Na podlagi podobne izpostavljenosti reslizumabu, ki so jo opazili pri bolnikih, starejših od 65 let, v primerjavi z bolniki, starimi 18 do < 65 let, se prilagajanje odmerka ne priporoča (glejte poglavje 5.2).
Reslizumab is a humanised monoclonal antibody (IgG4, κ) against the human interleukin-5 (IL-5).
Reslizumab je humanizirano monoklonsko protitelo (IgG4, κ) proti humanemu interlevkinu-5 (IL-5).
No direct effect of hepatic function on the pharmacokinetics of reslizumab is expected because antibodies are principally cleared by catabolism.
Neposredni učinek delovanja jeter na farmakokinetiko reslizumaba se ne pričakuje, saj se protitelesa izločajo v glavnem s katabolizmom.
IL-5 is a key cytokine responsible for the differentiation, maturation, recruitment and activation of human eosinophils.
IL-5 je ključni citokin, odgovoren za diferenciacijo, dozorevanje, novačenje in aktiviranje humanih eozinofilcev.
Overall population
Celotna populacija
Following multiple doses, serum concentrations of reslizumab accumulate approximately 1.5- to 1.9-fold.
Po večkratnih odmerkih se serumske koncentracije reslizumaba kopičijo približno 1,5- do 1,9-kratno.
Table 3 presents the demographics and baseline characteristics of Studies I, II and III.
V preglednici 3 so predstavljene demografske in izhodiščne lastnosti za študije I, II in III.
As reslizumab binds to a soluble target, linear non-target-mediated clearance is expected.
Ker se reslizumab veže na topno tarčo, se pričakuje linearen netarčno posredovani očistek.
Eosinophils may be involved in the immunological response to some helminth infections.
Infestacije s paraziti (helminti) Eozinofilci so lahko vpleteni v imunski odziv na nekatere infestacije s helminti.
A double dose must not be administered to make up for a missed dose.
Ni dovoljeno uporabiti dvojnega odmerka, da se nadomesti izpuščeni odmerek.
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.
Le v študijah I in II se je od bolnikov zahtevalo vsaj eno poslabšanje astme, ki je zahtevalo uporabo sistemskega kortikosteroida, v letu pred vstopom v študijo.
What you need to know before you are given CINQAERO You must not receive CINQAERO:
Kaj morate vedeti, preden boste dobili zdravilo CINQAERO Zdravila CINQAERO ne smete prejeti:
(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.
(p < 0,0001) a Vrednosti predstavljajo razliko v zdravljenju med placebom in reslizumabom 3 mg/kg na podlagi prilagojenih povprečij v določenem časovnem obdobju za vsako skupino zdravljenja, razen za spremembo glede na 16. teden za AQLQ, ki je bila prva časovna točka za oceno AQLQ.
Patients with pre-existing helminth infections should be treated before starting reslizumab therapy.
Bolnike z obstoječimi infestacijami s helminti je treba zdraviti pred uvedbo zdravljenja z reslizumabom.
Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment.
Bolnikom je treba naročiti, naj takoj poiščejo zdravniško pomoč, če astma po uvedbi zdravljenja ostane neurejena ali se poslabša.
Other medicines and CINQAERO
Druga zdravila in zdravilo CINQAERO
Reslizumab has a volume of distribution of approximately 5 L, suggesting minimal distribution to the extravascular tissues.
Reslizumab ima volumen porazdelitve približno 5 l, kar kaže na minimalno porazdelitev v ekstravaskularna tkiva.
Talk to your doctor or nurse before you are given CINQAERO: - if you have a parasitic infection or if you live in an area where parasitic infections are common or if you are travelling to such a region, as this medicine may weaken your body's ability to fight certain types of parasitic infections.
- če imate okužbo s paraziti ali živite v območju, kjer so okužbe s paraziti pogoste, ali če na tako področje potujete, saj lahko to zdravilo oslabi sposobnost telesa, da se bori proti nekaterim vrstam okužb s paraziti.
It may take more than one dose before your asthma symptoms improve.
Morda bo za izboljšanje simptomov astme potreben več kot en odmerek.
If a reslizumab infusion is missed on the planned date, dosing should resume as soon as possible on the indicated dose and regimen.
Izpuščeni odmerek Če je na načrtovani dan infuzija reslizumaba izpuščena, je treba z odmerjanjem nadaljevati čim prej z navedenim odmerkom in režimom.
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).
Zaradi prekrivanja znakov in simptomov v vseh primerih ni bilo možno razločevati med anafilaktično reakcijo, drugo preobčutljivostno reakcijo in reakcijo, povezano z infuzijo (glejte poglavje 4.4).
Reslizumab has not been studied in patients receiving live vaccines.
Reslizumaba niso preučili pri bolnikih, ki so prejeli živa cepiva.
Reslizumab has a half-life of about 24 days.
Reslizumab ima razpolovni čas približno 24 dni.
Tell your doctor or nurse straight away if you have any of the symptoms of an allergic reaction (e.g. itching, trouble breathing, wheezing, fever, shivering, dizziness, headache, nausea, vomiting, abdominal discomfort, skin rash, redness or swelling).
Zdravniku ali medicinski sestri takoj povejte, če imate katerega od simptomov alergijske reakcije (npr. srbenje, težave z dihanjem, sopenje, zvišana telesna temperatura, tresenje, omotica, glavobol, siljenje na bruhanje, bruhanje, nelagodje v trebuhu, kožni izpuščaj, rdečina ali oteklost).
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.
V tej študiji se je odstotek eozinofilcev v sputumu zmanjšal od povprečne izhodiščne vrednosti 17,4 % (standardni odklon: 15,9 %) za 82 % ob koncu zdravljenja v skupini z reslizumabom.
Your doctor or nurse will watch you closely during and after your infusion for signs of an allergic reaction.
Vaš zdravnik ali medicinska sestra vas bosta med infundiranjem in po njem skrbno spremljala zaradi pojava znakov alergijske reakcije.
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.
Reslizumaba niso preučili pri bolnikih, ki sočasno jemljejo imunosupresivna zdravila, razen peroralnih kortikosteroidov (PKS), zato je profil varnosti in učinkovitosti reslizumaba pri teh bolnikih neznan.
It must not be administered by the subcutaneous, oral or intramuscular route.
Ne sme se uporabljati subkutano, peroralno ali intramuskularno.
Eosinophils are white blood cells involved in asthma inflammation.
Eozinofilci so bele krvne celice, ki so vpletene v astmatsko vnetje.
Based on the characteristics of reslizumab, drug-drug interactions are not expected.
Na podlagi značilnosti reslizumaba se medsebojno delovanje z zdravili ne pričakuje.
It is unlikely that CINQAERO will affect your ability to drive and use machines.
Ni verjetno, da bi zdravilo CINQAERO vplivalo na vašo sposobnost vožnje ali upravljanja strojev.
Uncommon (may affect up to 1 in 100 people) • Muscle pain (myalgia).
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) • bolečine v mišicah (mialgija)