FrancophonIA/ELRC3.0 huggingface dataset:
English: In CSU patients, based on population pharmacokinetic simulations, omalizumab serum elimination half-life at steady state averaged 24 days and apparent clearance at steady state for a patient of 80 kg weight was 3.0 ml/kg/day.
Croatian: U bolesnika s KSU-om na temelju simulacija populacijske farmakokinetike poluvijek eliminacije omalizumaba iz seruma u stanju dinamičke ravnoteže u prosjeku je bio 24 dana, a prividni klirens u stanju dinamičke ravnoteže za bolesnika tjelesne težine od 80 kg bio je 3,0 ml/kg/dan.
English: Table 5 includes results in the study 1 population.
Croatian: Tablica 5 uključuje rezultate iz populacije studije 1.
English: Further evaluations which did show statistical significance (p<0.05) in favour of Xolair included reductions in severe exacerbations (where patient's lung function was reduced to below 60% of personal best and requiring systemic corticosteroids) and asthma-related emergency visits (comprised of hospitalisations, emergency room, and unscheduled doctor visits), and improvements in Physician's overall assessment of treatment effectiveness, Asthma-related Quality of Life (AQL), asthma symptoms and lung function.
Croatian: Ostala ispitivanja koja su pokazala statističku značajnost (p<0,05) u korist Xolaira uključivala su smanjenje teških egzacerbacija (kada je funkcija pluća bolesnika bila smanjena na ispod 60% osobne najbolje vrijednosti te je bilo potrebno uvesti sistemske kortikosteroide) te u hitnim prijemima vezanim uz astmu (objedinjuju hospitalizacije, odjel hitne pomoći i neplanirane posjete liječniku), kao i poboljšanje u Ukupnoj liječničkoj procjeni učinkovitosti liječenja, kvaliteti života u odnosu na astmu (Asthma-related Quality of Life, AQL), simptomima astme i funkciji pluća.
English: If you stop treatment with Xolair
Croatian: Ako prestanete primjenjivati Xolair
English: In all these cases, return the entire pack to the pharmacy.
Croatian: U slučaju bilo koje od ovih situacija vratite cijelo pakiranje u ljekarnu.
English: If you are breast-feeding or plan to breast-feed, ask your doctor for advice before using this medicine.
Croatian: Ako dojite ili planirate dojiti, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
English: In a clinical trial where Xolair was co-administered with immunotherapy, the safety and efficacy of Xolair in combination with specific immunotherapy were found to be no different to that of Xolair alone.
Croatian: U kliničkom ispitivanju u kojem je Xolair primijenjen uz imunoterapiju nisu nađene razlike u sigurnosti i djelotvornosti Xolaira u kombinaciji sa specifičnom imunoterapijom u odnosu na primjenu samog Xolaira.
English: Single use
Croatian: Za jednokratnu uporabu
English: Analyses of these limited data suggest that no dose adjustments are necessary for age (6-76 years), race/ethnicity, gender or Body Mass Index (see section 4.2).
Croatian: Analize ovih ograničenih podataka upućuju da nije potrebno prilagođavanje doze glede životne dobi (6-76 godina), rase/etničke pripadnosti, spola ili indeksa tjelesne mase (vidjeti dio 4.2).
English: Replace the 18-gauge needle with a 25-gauge needle for subcutaneous injection.
Croatian: Zamijeniti iglu od 18 G s iglom od 25 G za supkutanu injekciju.
English: CARTON FOR INTERMEDIATE PACK (WITHOUT BLUE BOX) OF MULTIPACKS
Croatian: KARTONSKA KUTIJA ZA MEĐUPAKIRANJE (BEZ PLAVOG OKVIRA) U VIŠESTRUKIM PAKIRANJIMA
English: A clinically significant exacerbation was defined as a worsening of asthma symptoms as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose for at least 3 days and/or treatment with rescue systemic (oral or intravenous) corticosteroids for at least 3 days.
Croatian: Klinički značajna egzacerbacija definirana je kao pogoršanje simptoma astme prema kliničkoj procjeni ispitivača koje zahtijeva udvostručenje doze inhalacijskih kortikosteroida s početka ispitivanja tijekom najmanje 3 dana i/ili liječenje sistemskim (oralnim ili intravenskim) kortikosteroidima za hitne slučajeve tijekom najmanje 3 dana.
English: Table 4 Adverse reactions in allergic asthma
Croatian: Tablica 4 Nuspojave kod alergijske astme
English: In clinical studies in CSU, Xolair was used in conjunction with antihistamines (anti-H1, anti-H2) and leukotriene receptor antagonists (LTRAs).
Croatian: U kliničkim ispitivanjima KSU-a, Xolair se primjenjivao zajedno s antihistaminicima (anti-H1, antiH2) i antagonistima leukotrijenskih receptora.
English: Patients received Xolair at 75 mg, 150 mg or 300 mg or placebo by subcutaneous injection every 4 weeks for 24 and 12 weeks in studies 1 and 2, respectively, and 300 mg or placebo by subcutaneous injection every 4 weeks for 24 weeks in study 3.
Croatian: Bolesnici su primali Xolair u dozi od 75 mg, 150 mg ili 300 mg ili placebo supkutanom injekcijom svaka 4 tjedna tijekom 24 tjedna u ispitivanju 1 i tijekom 12 tjedana u ispitivanju 2, te 300 mg ili placebo supkutanom injekcijom svaka 4 tjedna tijekom 24 tjedna u ispitivanju
English: Infections and infestations Upper respiratory tract infection
Croatian: Infekcije i infestacije Infekcija gornjeg dijela dišnog sustava
English: Table 6 includes results in the study 1 population.
Croatian: Tablica 6 uključuje rezultate iz populacije studije 1.
English: A third study (study 3) primarily evaluated the safety of Xolair in patients with CSU who remained symptomatic despite treatment with H1 antihistamines at up to four times the approved dose and H2 antihistamine and/or LTRA treatment.
Croatian: Treće ispitivanje (ispitivanje 3) primarno je ocjenjivalo sigurnost Xolaira u bolesnika s KSU-om koji su i dalje imali simptome unatoč liječenju H1 antihistaminicima u dozi koja je bila do četiri puta veća od odobrene doze i H2 antihistaminikom i/ili terapijom antagonistom leukotrijenskih receptora.
English: In studies 3, 4 and 5 patients treated with Xolair had respective reductions in asthma exacerbation rates of 37.5% (p = 0.027), 40.3% (p<0.001) and 57.6% (p<0.001) compared to placebo.
Croatian: U ispitivanjima 3, 4 i 5 bolesnici liječeni Xolairom imali su smanjenja u stopama egzacerbacija astme od 37,5% (p=0,027), 40,3% (p<0,001), odnosno 57,6% (p<0,001) u usporedbi s placebom.
English: - Store in a refrigerator (2°C - 8°C).
Croatian: - Čuvati u hladnjaku (2°C - 8°C).
English: Therefore for patients with a known history of anaphylaxis, Xolair must be administered by a health care professional, who should always have medicinal products for the treatment of anaphylactic reactions available for immediate use following administration of Xolair.
Croatian: Stoga bolesnicima s anafilaksijom u anamnezi Xolair mora primijeniti zdravstveni radnik koji uvijek treba imati dostupne lijekove za liječenje anafilaktičke reakcije za slučaj da je potrebna njihova hitna primjena nakon davanja Xolaira.
English: Solvent ampoule: Clear, colourless type I glass ampoule containing 2 ml water for injections.
Croatian: Ampula s otapalom: prozirna, bezbojna staklena ampula tip I koja sadrži 2 ml vode za injekcije.
English: Note: Depending on the dose prescribed to you by your doctor, you may need to prepare one or more pre-filled syringes, and inject the contents of them all.
Croatian: Priprema Xolair napunjene štrcaljke za uporabu Napomena: Ovisno o dozi koju Vam je propisao liječnik, možda ćete morati pripremiti jednu ili više napunjenih štrcaljki te ubrizgati sadržaj svake od njih.
English: - Do not use any pack that is damaged or shows signs of tampering.
Croatian: - Nemojte upotrijebiti lijek ako je pakiranje oštećeno ili ako primijetite znakove otvaranja.
English: The efficacy and safety of Xolair were demonstrated in two randomised, placebo-controlled phase III studies (study 1 and 2) in patients with CSU who remained symptomatic despite H1 antihistamine therapy at the approved dose.
Croatian: Djelotvornost i sigurnost Xolaira bile su dokazane u dva randomizirana, placebom kontrolirana ispitivanja faze III (ispitivanje 1 i 2) u bolesnika s KSU-om koji su i dalje imali simptome unatoč terapiji H1 antihistaminikom u odobrenoj dozi.
English: The apparent volume of distribution in patients following subcutaneous administration was 78 ± 32 ml/kg.
Croatian: Prividni volumen distribucije u bolesnika nakon supkutane primjene iznosio je 78 ± 32 ml/kg.
English: In specifically-designed non-clinical fertility studies in non-human primates, including mating studies, no impairment of male or female fertility was observed following repeated dosing with omalizumab at dose levels up to 75 mg/kg.
Croatian: U specifično dizajniranim nekliničkim ispitivanjima plodnosti u nečovjekolikih primata, koja su uključivala ispitivanja parenja, nije bilo uočeno smanjenje plodnosti u mužjaka i ženki nakon ponavljanih doza omalizumaba pri razinama do 75 mg/kg.
English: Omalizumab has been associated with age-dependent decreases in blood platelets in non-human primates, with a greater relative sensitivity in juvenile animals (see section 5.3).
Croatian: U nehumanih primata omalizumab je povezan sa smanjenjem broja trombocita u krvi ovisnim o dobi, pri čemu su relativno osjetljivije bile mlađe životinje (vidjeti dio 5.3).
English: Chronic spontaneous urticaria (CSU) You will be given two 150 mg injections at a time every four weeks.
Croatian: Kronična spontana urtikarija (KSU) Dobit ćete dvije injekcije od 150 mg svaka četiri tjedna.
English: After discontinuation of Xolair, free IgE levels increased towards pre-treatment levels over a 16-week treatment-free follow-up period.
Croatian: Nakon prekida primjene Xolaira razine slobodnog IgE-a povećale su se prema razinama prije liječenja tijekom 16-tjednog razdoblja praćenja bez terapije.
English: Statistically significant results were further observed in the responder rates for UAS7≤6 (at week 12) which were higher for the 300 mg treatment groups, ranging from 52-66% (p<0.0001) compared to 11-19% for the placebo groups, and complete response (UAS7=0) was achieved by 34-44% (p<0.0001) of patients treated with 300 mg compared to 5-9% of patients in the placebo groups.
Croatian: Statistički značajni rezultati bili su nadalje uočeni u stopama osoba s odgovorom UAS7≤6 (u 12. tjednu) koje su bile više za terapijske skupine koje su primale 300 mg, s rasponom od 52-66% (p<0,0001) u usporedbi s 11-19% za placebo skupine, a kompletan odgovor (UAS7=0) postiglo je 34-44% (p<0,0001) bolesnika liječenih dozom od 300 mg u usporedbi s 5-9% bolesnika u placebo skupinama.
English: - Serum sickness.
Croatian: - Serumska bolest.
English: Store in the refrigerator between 2°C and 8°C.
Croatian: Čuvajte u hladnjaku na temperaturi između 2°C i 8°C.
English: - Systemic lupus erythematosus (SLE).
Croatian: - Sistemski eritemski lupus (SLE).
English: The antibody is an IgG1 kappa that contains human framework regions with the complementary-determining regions of a murine parent antibody that binds to IgE.
Croatian: To je protutijelo IgG1 kappa s humanom osnovom, dok je regija koja određuje komplementarnost, te se veže na IgE, dobivena iz mišjeg matičnog protutijela.
English: Omalizumab studies 1, 2 and 3 Pooled Frequency category Placebo N=242
Croatian: 1. i 3. ispitivanje omalizumaba objedinjeno Kategorija učestalosti Placebo N=163
English: c or use 0.6 ml from a 150 mg vial.
Croatian: c ili primjena 0,6 ml iz bočice sa 150 mg.
English: Clearance of omalizumab involves IgG clearance processes as well as clearance via specific binding and complex formation with its target ligand, IgE.
Croatian: Klirens omalizumaba uključuje procese IgG klirensa, kao i klirens putem specifičnog vezanja i stvaranja kompleksa s njegovim ciljnim ligandom, IgE.
English: Because of the viscosity of the reconstituted medicinal product care must be taken to withdraw all of the medicinal product from the vial before expelling any air or excess solution from the syringe in order to obtain the 1.2 ml.
Croatian: Zbog viskoznosti rekonstituiranog lijeka potrebno je osigurati da se izvuče sav lijek iz bočice prije istiskivanja zraka ili suviška otopine iz štrcaljke, kako bi se dobilo 1,2 ml.
English: The population pharmacokinetics of omalizumab were analysed to evaluate the effects of demographic characteristics.
Croatian: Populacijska farmakokinetika omalizumaba analizirana je radi procjene učinaka demografskih karakteristika.
English: Xolair is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment.
Croatian: Xolair je indiciran kao dodatna terapija za liječenje kronične spontane urtikarije u odraslih i adolescenata (u dobi od 12 i više godina) s neodgovarajućim odgovorom na liječenje antagonistima H1 histaminskih receptora.
English: If it has expired, return the entire pack to the pharmacy.
Croatian: Ako je rok istekao, vratite cijelo pakiranje u ljekarnu.
English: The majority of severe allergic reactions occur within the first 3 doses of Xolair.
Croatian: Većina teških alergijskih reakcija javlja se uz prve 3 doze Xolaira.
English: During the 52-week double-blind treatment period (including the 24-week fixed-dose steroid phase and the 28-week steroid adjustment phase) the difference in rates between treatment groups represented a 50% (rate ratio 0.504, p<0.001) relative decrease in exacerbations for omalizumab patients.
Croatian: Tijekom 52-tjednog razdoblja dvostruko slijepe terapije (uključujući 24-tjednu fazu primjene steroida u fiksnoj dozi i 28-tjednu fazu prilagođavanja doze steroida) razlika u stopama između terapijskih skupina bila je 50%-tno (omjer stopa 0,504, p<0,001) relativno smanjenje egzacerbacija kod bolesnika liječenih omalizumabom.
English: Parasitic (helminth) infections
Croatian: Parazitske infekcije (helmintima)
English: Xolair works by blocking a substance called immunoglobulin E (IgE), which is produced by the body.
Croatian: Xolair djeluje tako što blokira tvar imunoglobulin E (IgE), koja se stvara u Vašem organizmu.
English: However, no apparent toxicity, such as immune complex-mediated disease or complement-dependent cytotoxicity, was seen.
Croatian: Očigledna toksičnost, poput bolesti posredovane imunokompleksima ili citotoksičnosti ovisne o komplementu nije, međutim, uočena.
English: Because of the viscosity of the reconstituted medicinal product care must be taken to withdraw all of the medicinal product from the vial before expelling any air or excess solution from the syringe in order to obtain the 0.6 ml.
Croatian: Zbog viskoznosti rekonstituiranog lijeka potrebno je osigurati da se izvuče sav lijek iz bočice prije istiskivanja zraka ili suviška otopine iz štrcaljke, kako bi se dobilo 0,6 ml.
English: Prior to administration of the initial dose, patients should have their IgE level determined by any commercial serum total IgE assay for their dose assignment.
Croatian: Bolesnicima treba, prije primjene inicijalne doze, odrediti razinu IgE pomoću bilo kojeg komercijalnog testa za ukupni IgE u serumu kako bi im se utvrdila doza.
English: Omalizumab binds to IgE and lowers free IgE levels.
Croatian: Omalizumab se veže za IgE i smanjuje razine slobodnog IgE-a.
English: Quality of life scores were measured using the Juniper Asthma-related Quality of Life Questionnaire.
Croatian: Upitnik Juniper Asthma-related Quality of Life korišten je za mjerenje bodova kvalitete života.
English: In these patients in study 1 Xolair reduced the rate of asthma exacerbations by 40% (p = 0.002).
Croatian: Xolair je kod tih bolesnika u studiji 1 smanjio stopu egzacerbacija astme za 40% (p=0,002).
English: Disposal instructions
Croatian: Upute za odlaganje
English: The efficacy and safety of Xolair were demonstrated in a 28-week double-blind placebo-controlled study (study 1) involving 419 severe allergic asthmatics, ages 12-79 years, who had reduced lung function (FEV1 40-80% predicted) and poor asthma symptom control despite receiving high dose inhaled corticosteroids and a long-acting beta2-agonist.
Croatian: Djelotvornost i sigurnost Xolaira dokazani su u 28-tjednom dvostruko slijepom, placebo kontroliranom ispitivanju (studija 1) koje je uključivalo 419 bolesnika s teškom alergijskom astmom, starosti 12-79 godina, koji su imali smanjenu funkciju pluća (FEV1 40-80% predviđenoga) i slabu kontrolu simptoma astme usprkos primanju visokih doza inhalacijskih kortikosteroida i dugodjelujućih beta2-agonista.
English: Symptoms may include one or more of the following: swelling, pain or rash around blood or lymph vessels, high level of a specific type of white blood cells (marked eosinophilia), worsening problems with breathing, nasal congestion, heart problems, pain, numbness, tingling in the arms and legs.
Croatian: Simptomi mogu uključivati jedno ili više od sljedećeg: oticanje, bol ili osip oko krvnih ili limfnih žila, visoka razina određene vrste bijelih krvnih stanica (značajna eozinofilija), pogoršanje problema s disanjem, začepljenje nosa, problemi sa srcem, bol, utrnulost, trnci u rukama i nogama.
English: What Xolair is and what it is used for What you need to know before you use Xolair How to use Xolair
Croatian: Što se nalazi u ovoj uputi Što je Xolair i za što se koristi Što morate znati prije nego primite Xolair Kako primjenjivati Xolair Moguće nuspojave
English: All studies had a 16-week treatment-free follow-up period.
Croatian: 3. Sva su ispitivanja imala 16-tjedno razdoblje naknadnog praćenja bez liječenja.
English: In a separate analysis of pooled clinical trials, which included all randomised double-blind, placebo-controlled clinical trials lasting 8 or more weeks, the rate of ATE per 1,000 patient years was 2.69 (5/1,856 patient years) for Xolair-treated patients and 2.38 (4/1,680 patient years) for placebo patients (rate ratio 1.13, 95% confidence interval 0.24-5.71).
Croatian: U odvojenim analizama objedinjenih kliničkih ispitivanja, koja su uključivala sva randomizirana, dvostruko slijepa, placebom kontrolirana klinička ispitivanja koja su trajala 8 ili više tjedana, stopa ATE-a na 1000 bolesnik-godina bila je 2,69 (5/1856 bolesnik-godina) za bolesnike liječene Xolairom te 2,38 (4/1680 bolesnik-godina) za bolesnike koji su dobivali placebo (omjer stopa 1,13, 95%-tni interval pouzdanosti 0,24-5,71).
English: In the specific subgroup of patients on high dose inhaled corticosteroids, the omalizumab group had a statistically significantly lower rate of clinically significant asthma exacerbations than the placebo group.
Croatian: U specifičnoj podskupini bolesnika na visokim dozama inhalacijskih kortikosteroida skupina liječena omalizumabom imala je statistički značajno nižu stopu klinički značajnih egzacerbacija astme u odnosu na placebo skupinu.
English: Prescribing physicians should ensure that adult and adolescent patients with IgE below 76 IU/ml and children (6 to < 12 years of age) with IgE below 200 IU/ml have unequivocal in vitro reactivity (RAST) to a perennial allergen before starting therapy.
Croatian: Kod odraslih bolesnika i adolescenata s IgE nižim od 76 IU/ml te kod djece (6 do <12 godina starosti) s IgE nižim od 200 IU/ml liječnici propisivači moraju nedvojbeno utvrditi in vitro reaktivnost (RAST) na cjelogodišnji alergen prije početka terapije.
English: This will depend on your child's weight and the results of a blood test carried out before the start of the treatment to measure the amount of IgE in his/her blood.
Croatian: To će ovisiti o tjelesnoj težini djeteta te o rezultatima krvne pretrage kojom se mjeri količina IgE u njegovoj/njezinoj krvi a koja se izvodi prije početka liječenja.
English: Dispose of the used syringe immediately after use in a sharps container.
Croatian: Odložite iskorištenu štrcaljku odmah nakon uporabe u spremnik za oštre predmete.
English: Its colour may vary from colourless to pale brownish-yellow.
Croatian: Boja joj može varirati od bezbojne do blijedo smećkasto-žute.
English: Analyses of these limited data suggest that no dose adjustments are necessary in patients with asthma for age (6-76 years), race/ethnicity, gender or body mass index (see section 4.2).
Croatian: Analize ovih ograničenih podataka upućuju da nije potrebno prilagođavanje doze u bolesnika s astmom glede životne dobi (6-76 godina), rase/etničke pripadnosti, spola ili indeksa tjelesne mase (vidjeti dio 4.2).
English: In addition more patients had clinically meaningful responses in the total IgE ≥76 IU/ml population across the Xolair severe asthma programme.
Croatian: Osim toga, u populaciji s ukupnim IgE ≥76 IU/ml više bolesnika je imalo klinički značajne odgovore u cijelom Xolair programu ispitivanja teške astme.
English: To prepare Xolair 75 mg vials for subcutaneous administration, please adhere to the following instructions:
Croatian: Za pripremu bočice sa 75 mg Xolaira za supkutanu primjenu molimo slijedite navedene upute:
English: Xolair treatment should be initiated by physicians experienced in the diagnosis and treatment of severe persistent asthma.
Croatian: Liječenje Xolairom treba započeti liječnik s iskustvom u dijagnosticiranju i liječenju teške perzistentne astme.
English: The injection site
Croatian: Mjesto primjene injekcije
English: At 16 weeks after commencing Xolair therapy patients should be assessed by their physician for treatment effectiveness before further injections are administered.
Croatian: U 16. tjednu nakon uvođenja terapije Xolairom, a prije nastavka primjene injekcija, učinkovitost liječenja bolesnika treba procijeniti njegov liječnik.
English: Using a new 3-ml syringe equipped with a large-bore, 18-gauge needle, insert the needle into the inverted vial.
Croatian: Koristeći novu štrcaljku od 3 ml opremljenu s iglom velikog promjera od 18 G, uvesti iglu u preokrenutu bočicu.
English: To prepare Xolair 150 mg vials for subcutaneous administration, please adhere to the following instructions:
Croatian: Za pripremu bočice sa 150 mg Xolaira za supkutanu primjenu molimo slijedite navedene upute:
English: Omalizumab binds to IgE and prevents binding of IgE to FcRI (high-affinity IgE receptor), thereby reducing the amount of free IgE that is available to trigger the allergic cascade.
Croatian: Omalizumab se veže na IgE i sprječava vezanje IgE na FcεRI (IgE receptor visokog afiniteta), smanjujući pri tome količinu slobodnog IgE koji je na raspolaganju za pokretanje alergijske kaskade.
English: Do not use Xolair: - if you are allergic to omalizumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: Ne primjenjujte Xolair - ako ste alergični na omalizumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Eligible patients had experienced multiple asthma exacerbations requiring systemic corticosteroid treatment or had been hospitalised or attended an emergency room due to a severe asthma exacerbation in the past year despite continuous treatment with high-dose inhaled corticosteroids and a long-acting beta2-agonist.
Croatian: Prikladni bolesnici imali su višestruke egzacerbacije astme koje su zahtijevale liječenje sistemskim kortikosteroidima, ili su bili hospitalizirani, ili primljeni na odjel hitne pomoći zbog teške egzacerbacije astme u prošloj godini, usprkos kontinuiranom liječenju visokim dozama inhalacijskih kortikosteroida i dugodjelujućim beta2-agonistom.
English: In clinical trials in children 6 to <12 years of age, the most commonly reported adverse reactions were headache, pyrexia and upper abdominal pain.
Croatian: U kliničkim ispitivanjima u djece od 6 do <12 godina starosti najčešće zabilježene nuspojave bile su glavobolja, vrućica i bol u gornjem dijelu abdomena.
English: Common (may affect up to 1 in 10 people) - reactions at the injection site including pain, swelling, itching and redness - pain in the upper part of the tummy (in children) - headache (very common in children)
Croatian: Često (mogu se javiti u manje od 1 na 10 ljudi) - reakcije na mjestu primjene injekcije, uključujući bol, oticanje, svrbež i crvenilo - bol u gornjem dijelu trbuha (u djece) - glavobolju (vrlo često u djece)