FrancophonIA/ELRC3.0 huggingface dataset:
English: Consistent with the potentially immunogenic properties of protein and peptide therapeutics, patients may develop antibodies to mepolizumab following treatment.
Croatian: U skladu s potencijalnim imunogenim svojstvima proteinskih i peptidnih lijekova, bolesnici nakon liječenja mogu razviti protutijela na mepolizumab.
English: After use
Croatian: Nakon uporabe
English: Call your doctor
Croatian: javite se svom liječniku
English: The solution for injection can be stored between 2°C to 30°C for no more than 8 hours.
Croatian: Otopina za injekciju može se čuvati na temperaturi od 2°C do 30°C najdulje 8 sati.
English: The powder should be reconstituted prior to administration and the reconstituted solution should be used immediately.
Croatian: Prašak se prije primjene mora rekonstituirati, a rekonstituirana otopina mora se odmah upotrijebiti.
English: • Insert the entire needle into the pinched skin at a 45° angle, as shown.
Croatian: • Ubodite iglu cijelom dužinom u nabor kože pod kutom od 45°, kao što je prikazano na slici.
English: Dose-ranging efficacy MEA112997 (DREAM) study
Croatian: Ispitivanje djelotvornosti u rasponu doza MEA112997 (DREAM)
English: • Continue to hold the pen down until you hear the 2nd “click”, and the stopper and yellow indicator have stopped moving and fill the inspection window.
Croatian: • Nastavite držati brizgalicu pritisnutom dok ne čujete drugi 'klik' te dok se zaustavnik i žuti indikator ne prestanu pomicati i ne ispune prozorčić za provjeru.
English: There are limited pharmacokinetic data available in elderly patients (≥65 years old) across all clinical studies (N=90).
Croatian: Dostupni su ograničeni farmakokinetički podaci o primjeni u starijih bolesnika (≥ 65 godina) iz svih kliničkih ispitivanja (N=90).
English: This condition is called eosinophilic asthma - the type of asthma Nucala can treat.
Croatian: To stanje se zove eozinofilna astma - ona vrsta astme koju Nucala može liječiti.
English: The reconstituted solution, if not used immediately must be:
Croatian: Ako se ne upotrijebi odmah, rekonstituirana otopina mora se:
English: Ask your doctor or pharmacist for advice if necessary.
Croatian: Po potrebi se obratite liječniku ili ljekarniku za savjet.
English: These medicines (especially ones called corticosteriods) must be stopped gradually, under the direct supervision of your doctor and dependant on your response to Nucala.
Croatian: Ti se lijekovi (osobito oni koji se zovu kortikosteroidi) moraju prestati uzimati postupno, pod izravnim nadzorom liječnika i ovisno o Vašem odgovoru na lijek Nucala.
English: Do not lift the pen until you are sure you have completed your injection.
Croatian: Nemojte podizati brizgalicu dok ne budete sigurni da je injekcija dovršena.
English: These may affect up to 1 in 1,000 people: • Severe allergic reactions (anaphylaxis)
Croatian: Mogu se javiti u do 1 na 1000 osoba: • teške alergijske reakcije (analfilaksija)
English: • Discarded if not used within 8 hours of reconstitution
Croatian: • baciti ako se ne upotrijebi unutar 8 sati nakon rekonstitucije
English: **From spontaneous post marketing reporting.
Croatian: **Iz spontanih prijava nakon stavljanja lijeka u promet.
English: A total of 135 patients were enrolled: mean age was 50 years, 55% were female, and 48% had been receiving oral steroid therapy for at least 5 years.
Croatian: Ukupno je uključeno 135 bolesnika: prosječna dob bila je 50 godina, 55% ih je bilo ženskog spola, a 48% ih je primalo terapiju oralnim steroidima najmanje 5 godina.
English: The need for continued therapy should be considered at least on an annual basis as determined by physician assessment of the patient's disease severity and level of control of exacerbations.
Croatian: Potrebu za nastavkom liječenja treba razmotriti najmanje jednom godišnje na temelju liječnikove ocjene težine bolesti u bolesnika i stupnja kontrole egzacerbacija.
English: Eosinophils are thought to be associated with immune system responses to some parasitic infections.
Croatian: Smatra se da su eozinofili povezani s odgovorima imunosnog sustava na neke parazitske infekcije.
English: Mepolizumab crosses the placental barrier in monkeys.
Croatian: Mepolizumab prolazi kroz placentalnu barijeru u majmuna.
English: There are limited pharmacokinetic data available in the paediatric population (59 subjects with eosinophilic esophagitis, 55 subjects with severe refractory eosinophilic asthma).
Croatian: Dostupni su ograničeni farmakokinetički podaci o primjeni u pedijatrijskoj populaciji (59 ispitanika s eozinofilnim ezofagitisom, 55 ispitanika s teškom refraktornom eozinofilnom astmom).
English: Lyophilised white powder.
Croatian: Liofilizirani bijeli prašak.
English: Other side effects include: Very common side effects
Croatian: Ostale nuspojave uključuju: Vrlo česte nuspojave
English: In clinical studies in subjects with severe refractory eosinophilic asthma, the most commonly reported adverse reactions during treatment were headache, injection site reactions and back pain.
Croatian: U kliničkim ispitivanjima u ispitanika s teškom refraktornom eozinofilnom astmom, najčešće prijavljene nuspojave tijekom liječenja bile su glavobolja, reakcije na mjestu injiciranja i bol u leđima.
English: • Inject straight after removing the needle cap, and always within 5 minutes.
Croatian: • Injicirajte lijek odmah nakon što skinete zatvarač igle, a svakako unutar 5 minuta.
English: The stream of sterile water should be directed vertically, onto the centre of the lyophilised cake.
Croatian: Mlaz sterilne vode treba usmjeriti okomito, na sredinu liofiliziranog kolačića.
English: Make sure the white plunger is fully down
Croatian: Uvjerite se da je bijeli klip potisnut do kraja
English: Animal toxicology and/or pharmacology
Croatian: Toksikološka i/ili farmakološka ispitivanja na životinjama
English: Press down
Croatian: Pritisnite
English: The baseline mean prednisone equivalent dose was approximately 13 mg per day.
Croatian: Srednja vrijednost početne doze ekvivalenta prednizona iznosila je približno 13 mg na dan.
English: • Slowly push down on the plunger to inject your full dose.
Croatian: • Polagano potiskujte klip kako biste injicirali cijelu dozu.
English: • Use your free hand to pinch the skin around your injection site.
Croatian: • Slobodnom rukom uhvatite nabor kože oko mjesta injiciranja.
English: Nucala has no or negligible influence on the ability to drive and use machines.
Croatian: Nucala ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Table 2: Results of primary and secondary endpoints at week 32 in the intent to treat population (MEA115588)
Croatian: Tablica 2: Rezultati za primarnu i sekundarne mjere ishoda u 32. tjednu u populaciji koju se namjeravalo liječiti (MEA115588)
English: These may affect more than 1 in 10 people: • headache
Croatian: Mogu se javiti u više od 1 na 10 osoba: • glavobolja
English: Animal studies do not indicate reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama ne upućuju na reproduktivnu toksičnost (vidjeti dio 5.3).
English: These patients either remained uncontrolled (at least two severe exacerbations in the previous 12 months) on their current standard of care, including at least high doses of inhaled corticosteroids (ICS) plus an additional maintenance treatment(s), or were dependent on systemic corticosteroids.
Croatian: Ti bolesnici ili i dalje nisu bili kontrolirani (najmanje dvije teške egzacerbacije u proteklih 12 mjeseci) uz trenutnu standardnu terapiju, koja uključuje najmanje visoke doze inhalacijskih kortikosteroida (IKS) plus dodatnu(e) terapiju(e) održavanja, ili su bili ovisni o sistemskim kortikosteroidima.
English: Following subcutaneous administration of mepolizumab the mean terminal half-life (t1/2) ranged from 16 to 22 days.
Croatian: Nakon supkutane primjene mepolizumaba, srednja vrijednost terminalnog poluvijeka (t1/2) kretala se između 16 i 22 dana.
English: Secondary endpoints (weeks 20-24)
Croatian: Sekundarne mjere ishoda (20. - 24. tjedan)
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases, ATC code: R03DX09.
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje opstruktivnih bolesti dišnih putova, ostali sustavni lijekovi za liječenje opstruktivnih bolesti dišnih puteva, ATK oznaka: R03DX09
English: Nucala should not be used to treat acute asthma exacerbations.
Croatian: Nucala se ne smije koristiti za liječenje akutnih egzacerbacija astme.
English: It is used to treat severe asthma in adults, adolescents and children aged 6 years and older.
Croatian: Koristi se za liječenje teške astme u odraslih, adolescenata i djece u dobi od 6 i više godina.
English: Hypersensitivity reactions (systemic allergic)*
Croatian: Poremećaji imunološkog sustava reakcije preosjetljivosti (sistemske alergijske)* anafilaksija**
English: No additional adverse reactions were identified.
Croatian: Nisu primijećene dodatne nuspojave.
English: For self-administration the recommended injection sites are the abdomen or thigh.
Croatian: Prilikom samostalne primjene, preporučeno mjesto injiciranja je abdomen ili bedro.
English: • Make sure the plunger is pushed all the way down, until the stopper reaches the bottom of the syringe and all of the solution is injected.
Croatian: • Pobrinite se da potisnete klip skroz do kraja, sve dok zaustavnik ne dođe do kraja štrcaljke i dok sva otopina nije injicirana.
English: Pre-bronchodilator FEV1 (mL) at week 32
Croatian: FEV1 prije bronhodilatacije (ml) u 32. tjednu
English: Eosinophils may be involved in the immunological response to some helminth infections.
Croatian: Eozinofili mogu biti uključeni u imunološki odgovor kod nekih helmintijaza.
English: Cytochrome P450 enzymes, efflux pumps and protein-binding mechanisms are not involved in the clearance of mepolizumab.
Croatian: Enzimi citokroma P450, efluksne pumpe i mehanizmi vezivanja na proteine nisu uključeni u klirens mepolizumaba.
English: Based on population pharmacokinetic analyses, no dose adjustment is required in patients with creatinine clearance values between 50-80 mL/min.
Croatian: Na temelju populacijske farmakokinetičke analize, nije potrebno prilagođavati dozu u bolesnika s klirensom kreatinina od 50 - 80 ml/min.
English: * Systemic reactions including hypersensitivity have been reported at an overall incidence comparable to that of placebo.
Croatian: * Ukupna incidencija prijavljenih sistemskih reakcija, uključujući reakcije preosjetljivosti, bila je usporediva s onom kod primjene placeba.
English: Increased levels of pro-inflammatory cytokines (e.g. IL-6), via interaction with their cognate receptors on hepatocytes, have been shown to suppress the formation of CYP450 enzymes and drug transporters, however, elevation of systemic pro-inflammatory markers in severe refractory eosinophilic asthma is minimal and there is no evidence of IL-5 receptor alpha expression on hepatocytes.
Croatian: Pokazalo se da povišene razine proupalnih citokina (npr. IL-6), putem interakcije s odgovarajućim receptorima na hepatocitima, potiskuju stvaranje enzima CYP450 i prijenosnika lijekova; međutim, povišenje vrijednosti sistemskih proupalnih biljega kod teške refraktorne eozinofilne astme je minimalno i nema dokaza ekspresije receptora IL-5 alfa na hepatocitima.
English: Table 2 provides the results of the primary and secondary endpoints for patients treated with subcutaneous mepolizumab or placebo.
Croatian: Tablica 2 prikazuje rezultate primarne i sekundarnih mjera ishoda za bolesnike liječene mepolizumabom primijenjenim supkutano ili placebom.
English: What Nucala is and what it is used for
Croatian: Što je Nucala i za što se koristi
English: • To start your injection, push the pen down all the way and keep it held down against your skin.
Croatian: • Da biste započeli injiciranje, pritisnite brizgalicu do kraja i držite je pritisnutom o kožu.
English: Yellow needle guard (needle inside)
Croatian: Žuti štitnik igle (igla u unutrašnjosti)
English: Abrupt discontinuation of corticosteroids after initiation of Nucala therapy is not recommended.
Croatian: Ne preporučuje se nagli prekid primjene kortikosteroida nakon uvođenja terapije lijekom Nucala.
English: Worsening asthma
Croatian: Pogoršanje astme
English: Check with your doctor if you think any of these may apply to you.
Croatian: provjerite sa svojim liječnikom ako mislite da se nešto od navedenoga možda odnosi na Vas.
English: Studies conducted in mice treated with anti-IL-5 antibodies or genetically deficient in IL-5 or eosinophils have not shown impaired ability to clear parasitic infections.
Croatian: Ispitivanja provedena na miševima kojima su davana anti-IL-5 protutijela ili koji su imali genetski nedostatak IL-5 ili eozinofila nisu pokazala smanjenu sposobnost suzbijanja parazitske infekcije.
English: Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment.
Croatian: Bolesnike treba uputiti da zatraže savjet liječnika ako se simptomi astme i dalje ne mogu kontrolirati ili se pogoršaju nakon početka liječenja.
English: Do not use Nucala after the expiry date which is stated on the label and carton after EXP.
Croatian: Nucala se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake EXP.
English: Patients continued to receive their existing asthma medicine during the studies.
Croatian: Bolesnici su tijekom ispitivanja nastavili uzimati svoje dotadašnje lijekove za astmu.
English: Reduction in the daily OCS dose to 0 mg/d
Croatian: Smanjenje dnevne doze OKS-a na 0 mg/dan
English: Your doctor or nurse will decide if you or your caregiver can inject Nucala.
Croatian: Vaš liječnik ili medicinska sestra odlučit će možete li Vi ili Vaš njegovatelj sami injicirati lijek Nucala.
English: Anti-mepolizumab antibodies did not discernibly impact the pharmacokinetics and pharmacodynamics of mepolizumab in the majority of patients and there was no evidence of a correlation between antibody titres and change in blood eosinophil level.
Croatian: Protutijela na mepolizumab u većine bolesnika nisu primjetno utjecala na farmakokinetiku i farmakodinamiku mepolizumaba i nije bilo znakova korelacije između titra protutijela i promjene razine eozinofila u krvi.
English: Note: The reconstituted solution must not be shaken during the procedure as this may lead to product foaming or precipitation.
Croatian: Napomena: Rekonstituirana otopina se tijekom ovog postupka ne smije tresti jer to može uzrokovati pjenjenje ili precipitaciju lijeka.
English: Tell your doctor or nurse if your asthma remains uncontrolled, or gets worse, after you start Nucala treatment.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako Vam astma i dalje nije pod kontrolom ili se pogorša nakon započinjanja liječenja lijekom Nucala.
English: Inspection window (medicine inside)
Croatian: Prozorčić za provjeru (lijek u unutrašnjosti)
English: Animal studies showed no adverse effects of anti-IL5 treatment on fertility (see section 5.3).
Croatian: Ispitivanja na životinjama nisu pokazala nikakve štetne učinke liječenja anti-IL5 protutijelima na plodnost (vidjeti dio 5.3).
English: The primary endpoint was the percent reduction in daily OCS dose (weeks 20-24), whilst maintaining asthma control by defined dose reduction categories (see Table 4).
Croatian: Primarna mjera ishoda bio je postotak smanjenja dnevne doze OKS-a (20. - 24. tjedan) uz istodobno održanu kontrolu astme prema definiranim kategorijama smanjenja doze (vidjeti Tablicu 4).
English: Do not touch the needle.
Croatian: Nemojte dodirivati iglu.
English: • eczema (itchy red patches on the skin)
Croatian: • ekcem (crvene mrlje po koži koje svrbe)
English: The proportion of patients on maintenance OCS was 31% and 24%, respectively.
Croatian: Udio bolesnika koji su uzimali OKS kao dio terapije održavanja bio je 31% odnosno 24%.
English: If you already have a parasitic infection; it should be treated before you start treatment with Nucala.
Croatian: Ako već imate parazitsku infekciju, ona se mora liječiti prije nego započnete liječenje lijekom Nucala.
English: Do not touch your injection site again until you have finished your injection.
Croatian: Nemojte ponovno dodirivati mjesto za injiciranje dok ne završite s primjenom lijeka.
English: Instructions for reconstitution for each vial
Croatian: Upute za rekonstituciju svake bočice
English: Mepolizumab 75 mg IV/100 mg SC N=538
Croatian: Mepolizumab 75 mg i.v./100 mg s.c. N=538
English: In the population pharmacokinetic analysis estimated mepolizumab systemic clearance was 3.1 mL/day/kg.
Croatian: U populacijskoj farmakokinetičkoj analizi, procijenjeni sistemski klirens mepolizumaba iznosio je 3,1 ml/kg na dan.
English: Allow the vial to sit at room temperature during reconstitution, gently swirling the vial for 10 seconds with circular motion at 15-second intervals until the powder is dissolved.
Croatian: Ostavite bočicu na sobnoj temperaturi tijekom rekonstitucije i lagano je okrećite kružnim pokretima tijekom 10 sekundi u razmacima od 15 sekundi dok se prašak ne otopi.
English: Data in cynomolgus monkeys demonstrate that mepolizumab crossed the placenta.
Croatian: Podaci prikupljeni u makaki majmuna pokazuju da je mepolizumab prolazio kroz placentu.
English: There is a limited amount of data (less than 300 pregnancy outcomes) from the use of mepolizumab in pregnant women.
Croatian: Količina podataka o primjeni mepolizumaba u trudnica je ograničena (manje od 300 ishoda trudnoća).
English: • upper abdominal pain (stomach pain or discomfort in the upper area of the stomach)
Croatian: • bol u gornjem dijelu trbuha (bol u trbuhu ili nelagoda u gornjem dijelu trbuha)
English: It is not known whether the ingredients of Nucala can pass into breast milk.
Croatian: Nije poznato mogu li sastojci lijeka Nucala proći u majčino mlijeko.
English: *** The most common manifestations associated with reports of systemic non-allergic administration-related reactions were rash, flushing and myalgia; these manifestations were reported infrequently and in <1% of subjects receiving mepolizumab 100 mg subcutaneously.
Croatian: ***Kod prijava sistemskih nealergijskih reakcija na primjenu lijeka, najčešće su manifestacije bile osip, navale vrućine i mialgija; one su prijavljene manje često i u < 1% ispitanika koji su primali mepolizumab u dozi od 100 mg supkutano.
English: If a mechanical reconstitution device (swirler) is used to reconstitute Nucala, reconstitution can be accomplished by swirling at 450 rpm for no longer than 10 minutes.
Croatian: Ako se za rekonstituciju lijeka Nucala koristi mehaničko pomagalo (swirler), rekonstitucija se može postići vrtnjom pri brzini od 450 okretaja u minuti (rpm) tijekom najviše 10 minuta.
English: There are limited data available in patients with creatinine clearance values <50 mL/min.
Croatian: Dostupni podaci o primjeni u bolesnika s klirensom kreatinina < 50 ml/min su ograničeni.
English: Thirty-seven adolescents (aged 12-17) were enrolled in four placebo-controlled studies (25 mepolizumab treated intravenously or subcutaneously) of 24 to 52 weeks duration.
Croatian: Trideset i sedam adolescenata (u dobi od 12 do 17 godina) bilo je uključeno u četiri placebom kontrolirana ispitivanja (25 ispitanika liječeno je mepolizumabom primijenjenim intravenski ili supkutano) u trajanju od 24 do 52 tjedna.
English: Following subcutaneous dosing in patients with asthma, mepolizumab exhibited approximately doseproportional pharmacokinetics over a dose range of 12.5 mg to 250 mg.
Croatian: Nakon supkutane primjene u bolesnika s astmom, mepolizumab je pokazao farmakokinetiku približno proporcionalnu dozi u rasponu doza od 12,5 mg do 250 mg.
English: Reduction in the daily OCS dose to ≤5mg/day
Croatian: Smanjenje dnevne doze OKS-a na ≤ 5 mg/dan
English: • Move your thumb to the plunger and place your fingers on the white finger grip, as shown.
Croatian: • Stavite palac na klip, a prste na bijelo hvatište za prste, kao što je prikazano na slici.
English: • Hold the pen with its inspection window facing towards you, so you can see it, and with the yellow needle guard facing down.
Croatian: • Držite brizgalicu tako da je prozorčić za provjeru okrenut prema Vama i da ga možete vidjeti te da je žuti štitnik igle usmjeren prema dolje.
English: Of these 34 subjects: 12 received placebo, 9 received mepolizumab 75 mg intravenously, and 13 received 100 mg subcutaneously.
Croatian: Od ta 34 ispitanika: 12 ih je primalo placebo, 9 je primalo mepolizumab u dozi od 75 mg intravenski, a 13 mepolizumab u dozi od 100 mg supkutano.
English: • Do not remove the needle cap until just before your injection.
Croatian: • Nemojte skinuti zatvarač igle do neposredno prije primjene injekcije.
English: Reduction in corticosteroid doses, if required, should be gradual and performed under the supervision of a physician.
Croatian: Ako je potrebno smanjenje doze kortikosteroida, ono se mora provoditi postupno i pod liječničkim nadzorom.
English: Table 4: Results of the primary and secondary endpoints in MEA115575
Croatian: Tablica 4: Rezultati za primarnu i sekundarne mjere ishoda u ispitivanju MEA115575
English: The primary endpoint was the frequency of clinically significant exacerbations of asthma and the reductions for both mepolizumab treatment arms compared to placebo were statistically significant (p<0.001).
Croatian: Primarna mjera ishoda bila je učestalost klinički značajnih egzacerbacija astme i smanjenja su u obje skupine liječene mepolizumabom bila statistički značajna u odnosu na placebo (p<0,001).
English: The active substance is mepolizumab.
Croatian: Djelatna tvar je mepolizumab.
English: • Clean your injection site by wiping the skin with an alcohol wipe and allowing the skin to air dry.
Croatian: • Očistite mjesto za injiciranje tako da kožu obrišete tupferom natopljenim alkoholom te pričekate da se osuši na zraku.
English: For the oral corticosteroid-sparing study MEA115575, a total of 135 patients were enrolled (55% were female; mean age of 50 years) who were being treated daily with OCS (5-35 mg per day), and high-dose ICS plus an additional maintenance medicine.
Croatian: U ispitivanje smanjenja primjene oralnih kortikosteroida, pod nazivom MEA115575, uključeno je ukupno 135 bolesnika (55% njih ženskog spola, prosječne dobi: 50 godina) koji su svakodnevno liječeni OKS-om (5-35 mg na dan) i visokim dozama IKS-a, uz još jedan lijek za terapiju održavanja.
English: Patients were administered mepolizumab or placebo treatment once every 4 weeks over the treatment period.
Croatian: Bolesnici su primali liječenje mepolizumabom ili placebo jedanput svaka 4 tjedna tijekom razdoblja liječenja.
English: However, in the population pharmacokinetic analysis, there were no indications of an effect of age on the pharmacokinetics of mepolizumab over the age range of 12 to 82 years.
Croatian: Međutim, populacijska farmakokinetička analiza nije pokazala utjecaj dobi na farmakokinetiku mepolizumaba u dobnom rasponu od 12 do 82 godine.
English: The two exacerbations studies MEA112997 and MEA115588 enrolled a total of 1192 patients, 60% females, with a mean age of 49 years (range 12- 82).
Croatian: U dva ispitivanja egzacerbacija, MEA112997 i MEA115588, uključena su ukupno 1192 bolesnika, 60% njih ženskog spola, prosječne dobi od 49 godina (raspon: 12 - 82).
English: Following administration of a single 100 mg subcutaneous dose in healthy subjects, mepolizumab systemic exposure was comparable between formulations.
Croatian: Nakon supkutane primjene jednokratne doze od 100 mg u zdravih ispitanika, sistemska izloženost mepolizumabu bila je usporediva između farmaceutskih oblika.
English: In MEA115588 and in the double-blind placebo-controlled study 200862, there were 34 adolescents (12 to 17 years old).
Croatian: U ispitivanje MEA115588 i dvostruko slijepo, placebom kontrolirano ispitivanje 200862 uključena su 34 adolescenta (u dobi od 12 do 17 godina).
English: • Do not share your Nucala pre-filled syringe with another person.
Croatian: • Nemojte dijeliti svoju Nucala napunjenu brizgalicu s drugom osobom.