FrancophonIA/ELRC3.0 huggingface dataset:
English: In Study RO-2455-404-RD when compared with the overall population, the total PDE4 inhibitory activity determined from ex vivo unbound fractions was found to be 15% higher in patients ≥75 years of age, and 11% higher in patients with baseline body weight <60 kg (refer to section 4.4).
Croatian: U ispitivanju RO-2455-404-RD, inhibicijska aktivnost PDE4 određena na temelju ex vivo nevezane frakcije bila je, u usporedbi s cjelokupnom populacijom, 15% viša u bolesnika u dobi od ≥75 godina, te 11% viša u bolesnika s početnom tjelesnom težinom < 60 kg (vidjeti dio 4.4).
English: Two six-month supportive studies (M2-127 and M2-128) included patients with a history of COPD for at least 12 months prior to baseline.
Croatian: Dva šetomjesečna suportivna ispitivanja (M2-127 i M2-128) uključila su bolesnike s dijagnozom KOPB-a postavljenom barem 12 mjeseci prije uključivanja u ispitivanje.
English: Inhibition of PDE4 leads to elevated intracellular cAMP levels and mitigates COPD-related malfunctions of leukocytes, airway and pulmonary vascular smooth muscle cells, endothelial and airway epithelial cells and fibroblasts in experimental models.
Croatian: Inhibicija PDE4 dovodi do povišene razine staničnog cAMP i u eksperimentalnim modelima ublažava KOPB-om uzrokovane poremećaje leukocita, glatkih mišića u dišnim putovima i plućnim žilama, endotela i epitelnih stanica dišnih puteva te fibroblasta.
English: How to take Daxas
Croatian: Kako uzimati Daxas
English: In two confirmative replicate one-year studies (M2-124 and M2-125) and two supplementary six-month studies (M2-127 and M2-128), a total number of 4,768 patients were randomised and treated, of whom 2,374 were treated with roflumilast.
Croatian: U dva jednaka potvrdna jednogodišnja ispitivanja (M2-124 i M2-125) i dva dodatna šestomjesečna ispitivanja (M2-127 i M2-128) ukupno je randomizirano 4768 bolesnika, od kojih je 2374 liječeno roflumilastom.
English: In an interaction study with an oral contraceptive containing gestodene and ethinyl oestradiol, the total PDE4 inhibitory activity was increased by 17%.
Croatian: U ispitivanjima interakcija s oralnim kontraceptivom koji sadrži gestoden i etinilestradiol ukupna inhibicijska aktivnost PDE4 povećala se za 17%.
English: Plasma protein binding of roflumilast and its N-oxide metabolite is approximately 99% and 97%, respectively.
Croatian: Vezanje za proteine plazme roflumilasta je oko 99%, a njegovog N-oksid metabolita 97%.
English: No dose adjustment is necessary.
Croatian: Prilagodba doze nije potrebna.
English: Study RO-2455-404-RD was a one year study in COPD patients with a baseline (pre-bronchodilator) FEV1 <50% of predicted normal and a history of frequent exacerbations.
Croatian: Ispitivanje RO-2455-404-RD bilo je jednogodišnje ispitivanje u bolesnika s KOPB-om s početnim (predbronhodilatacijski) FEV1 <50% od predviđene normalne vrijednosti i učestalim egzacerbacijama u anamnezi.
English: Roflumilast 500 micrograms once daily significantly improved lung function compared to placebo, on average by 51 ml (pre-bronchodilator FEV1, p<0.0001), and by 53 ml (post-bronchodilator FEV1, p<0.0001).
Croatian: Roflumilast od 500 mikrograma jedanput na dan značajno je poboljšao plućnu funkciju u odnosu na placebo, prosječno za 51 ml (predbronhodilatacijski FEV1, p<0,0001), te za 53 ml (postbronhodilatacijski FEV1, p<0,0001).
English: Roflumilast is a PDE4 inhibitor, a non-steroid, anti-inflammatory active substance designed to target both the systemic and pulmonary inflammation associated with COPD.
Croatian: Roflumilast je inhibitor PDE4, nesteroidna protuupalna djelatna tvar dizajnirana da djeluje i na sistemsku i na plućnu upalu povezanu s KOPB-om.
English: • After 28 days - the recommended maintenance dose is one 500 micrograms tablet once daily.
Croatian: • Nakon 28 dana - preporučena doza održavanja je jedna tableta od 500 mikrograma jedanput na dan
English: These adverse reactions mainly occurred within the first weeks of therapy and mostly resolved on continued treatment.
Croatian: Uglavnom su se javljale u prvim tjednima liječenja i pretežno su se povlačile u nastavku liječenja.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially the following: - a medicine containing theophylline (a medicine to treat respiratory diseases), or - a medicine used for treatment of immunological diseases, such as methotrexate, azathioprine, infliximab, etanercept, or oral corticosteroids to be taken long-term.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, a naročito sljedeće: - lijekove koji sadrže teofilin (lijek za liječenje dišnih bolesti), ili - lijekove koji se koriste za liječenje imunoloških bolesti, poput metotreksata, azatioprina, infliksimaba, etanercepta ili oralnih kortikosteroida u dugotrajnoj terapiji, ili - lijekove koji sadrže fluvoksamin (lijek za liječenje tjeskobe i depresije), enoksacin (lijek za liječenje bakterijskih infekcija) ili cimetidin (lijek za liječenje ulkusa želuca i žgaravice).
English: Roflumilast is not recommended during pregnancy.
Croatian: Ne preporučuje se koristiti roflumilast tijekom trudnoće.
English: In patients with COPD, roflumilast reduced sputum neutrophils.
Croatian: Kod bolesnika s KOPB-om roflumilast je smanjio broj neutrofila u sputumu.
English: Interaction studies with CYP1A2/3A4 inhibitor enoxacin and the CYP1A2/2C19/3A4 inhibitors cimetidine and fluvoxamine, resulted in increases of the total PDE4 inhibitory activity of 25%, 47% and 59%, respectively.
Croatian: Ispitivanja interakcija s inhibitorom CYP1A2/3A4 enoksacinom i inhibitorima CYP1A2/2C19/3A4 cimetidinom i fluvoksaminom rezultirala su porastom ukupne inhibicijske aktivnosti PDE4 za 25% s enoksacinom, 47% sa cimetidinom i 59% s fluvoksaminom.
English: In 1-year studies (M2-124, M2-125), a decrease of body weight occurred more frequently in patients treated with roflumilast compared to placebo-treated patients.
Croatian: U jednogodišnjim ispitivanjima (M2-124, M2-125) kod bolesnika liječenih roflumilastom češće je primijećen gubitak tjelesne težine u odnosu na one koji su uzimali placebo.
English: Respiratory tract infections (excluding Pneumonia)
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja infekcije dišnog sustava (osim pneumonije)
English: Furthermore, roflumilast attenuated influx of neutrophils and eosinophils into the airways of endotoxin challenged healthy volunteers.
Croatian: Nadalje, kod zdravih dobrovoljaca roflumilast je smanjio priljev neutrofila i eozinofila u dišne putove nakon primjene endotoksina.
English: Clinical interaction studies with CYP3A4 inhibitors erythromycin and ketoconazole showed increases of 9% of the total PDE4 inhibitory activity.
Croatian: Klinička ispitivanja interakcija s CYP3A4 inhibitorima eritromicinom i ketokonazolom pokazala su povećanje ukupne inhibicijske aktivnosti PDE4 za 9%.
English: You or your caregiver should also immediately inform your doctor of any changes in behaviour or mood and of any suicidal thoughts you may have.
Croatian: Vi ili osoba koja o vama brine morate odmah obavijestiti liječnika o svim promjenama ponašanja ili raspoloženja te o bilo kakvim suicidalnim mislima ako se pojave.
English: In clinical COPD studies, approximately 16% of patients experienced adverse reactions with roflumilast (compared to 5% in placebo).
Croatian: U kliničkim ispitivanjima kod bolesnika s KOPB-om, približno 16% bolesnika liječenih lijekom Daxas imalo je nuspojave (u usporedbi s 5% na placebu).
English: Rodent-specific toxicity in the nasal mucosa was observed in repeat-dose toxicity and carcinogenicity studies.
Croatian: Toksično djelovanje na sluznicu nosa specifično za glodavce opaženo je u ispitivanjima toksičnosti uzastopnih doza i kancerogenosti.
English: The rate of severe exacerbations was reduced in the overall patient group (rate ratio: 0.76; 95% CI: 0.60 to 0.95) with a rate of 0.24 per patient/year compared to a rate of 0.32 per patient/year in patients treated with placebo.
Croatian: Stopa teških egzacerbacija bila je niža u cjelokupnoj skupini bolesnika (omjer stope: 0,76; 95% CI: 0,60 do 0,95) sa stopom od 0,24 po bolesniku/godini u usporedbi sa stopom od 0,32 po bolesniku/godini u bolesnika koji su uzimali placebo.
English: Child-Pugh A patients (see section 4.2).
Croatian: Kod bolesnika s Child-Pugh A potreban je oprez (vidjeti dio 4.2).
English: Patients with moderate or severe hepatic impairment classified as Child-Pugh B or C should not take roflumilast (see section 4.3).
Croatian: Bolesnici s umjerenim i teškim oštećenjem jetre klasificiranim kao Child-Pugh B ili C ne smiju uzimati roflumilast (vidjeti dio 4.3).
English: COPD is a chronic disease of the lungs that results in tightening of the airways (obstruction) and swelling and irritation of the walls of the small air passages (inflammation).
Croatian: KOPB je kronična plućna bolest čije su posljedice stezanje dišnih putova (opstrukcija), te oticanje i nadražaj stijenki malih dišnih puteva (upala).
English: More patients in the roflumilast group (27.6%) than placebo (19.8%) withdrew study medication due to any reason (risk ratio: 1.40; 95% CI: 1.19 to 1.65).
Croatian: Od uzimanja ispitivanog lijeka je iz bilo kojeg razloga odustao veći udio bolesnika na roflumilastu (27,6%) nego na placebu (19,8%) (omjer rizika: 1,40; 95% CI: 1,19 do 1,65).
English: If patients suffered from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt is identified, it is recommended to discontinue treatment with roflumilast.
Croatian: Ako dođe do pojave novih ili pogoršanja postojećih psihijatrijskih simptoma ili ako se prepoznaju suicidalne misli ili ponašanje, preporučuje se prekinuti liječenje roflumilastom.
English: In addition, in vitro studies demonstrated no induction of the CYP1A2, 2A6, 2C9, 2C19, or 3A4/5 and only a weak induction of CYP2B6 by roflumilast.
Croatian: Uz to, in vitro ispitivanja pokazala su da roflumilast ne inducira CYP1A2, 2A6, 2C9, 2C19 i 3A4/5, te tek slabo inducira CYP2B6.
English: Co-administration with theophylline resulted in an increase of 8% of the total PDE4 inhibitory activity (see section 4.4).
Croatian: Pri istodobnoj primjeni s teofilinom ukupna inhibicijska aktivnost PDE4 povećala se za 8% (vidjeti dio 4.4).
English: • For the first 28 days - the recommended starting dose is one 250 micrograms tablet once daily.
Croatian: • Tijekom prvih 28 dana - preporučena početna doza je jedna tableta od 250 mikrograma jedanput na dan.
English: Rare side effects (may affect up to 1 in 1,000 people) - male breast enlargement - decreased sense of taste - respiratory tract infections (excluding pneumonia) - bloody stools, constipation - elevation of liver or muscle enzymes (seen in blood tests) - wheals (urticaria).
Croatian: Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba) - povećanje dojki kod muškaraca - smanjenje osjeta okusa - infekcije dišnog sustava (osim upale pluća) - krv u stolici, zatvor - povećanje jetrenih ili mišićnih enzima (vidljivo iz krvnih testova) - koprivnjača (urtikarija).
English: The rate (per patient per year) of moderate exacerbations (requiring intervention with systemic glucocorticosteroids) or severe exacerbations (resulting in hospitalisation and/or leading to death) after 1 year was 1.142 with roflumilast and 1.374 with placebo corresponding to a relative risk reduction of 16.9% (95% CI: 8.2% to 24.8%) (primary endpoint, p=0.0003).
Croatian: Stopa (po bolesniku po godini) umjerenih egzacerbacija (koje zahtijevaju uvođenje sistemskih glukokortikoida) ili teških egzacerbacija (koje dovode do hospitalizacije i/ili smrti) bila je nakon godine dana 1,142 uz roflumilast i 1,374 uz placebo, što odgovara relativnom smanjenju rizika od 16,9% (95% CI: 8,2% do 24,8%) (primarni ishod p=0,0003).
English: No epididymal toxicity or changes in semen parameters were present in any other rodent or non-rodent species including monkeys in spite of higher exposures.
Croatian: Kod drugih vrsta glodavaca, ali i drugih vrsta ne-glodavaca poput majmuna, nisu zabilježeni znakovi toksičnog djelovanja na epididimis ili promjene osobina sjemena unatoč višim izloženostima.
English: Lactose monohydrate Maize starch Povidone
Croatian: Jezgra laktoza hidrat kukuruzni škrob povidon magnezijev stearat
English: Yellow, D-shaped film-coated tablet of 9 mm, embossed with “D” on one side.
Croatian: Žuta, filmom obložena tableta u obliku slova D od 9 mm, s utisnutim „D“ s jedne strane.
English: If patients suffer from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt, it is recommended to discontinue treatment with Daxas.
Croatian: Ako dođe do pojave novih ili pogoršanja postojećih psihijatrijskih simptoma ili ako se prepoznaju suicidalne misli ili ponašanje, preporučuje se prekinuti liječenje lijekom Daxas.
English: Patients with moderate or severe hepatic impairment classified as Child-Pugh B or C must not take Daxas (see section 4.3).
Croatian: Bolesnici s umjerenim i teškim oštećenjem jetre klasificiranim kao Child-Pugh B ili C ne smiju uzimati Daxas (vidjeti dio 4.3).
English: Concomitant treatment with long acting muscarinic antagonists (LAMA) A higher incidence of weight decrease, decreased appetite, headache and depression was observed during Study RO-2455-404-RD in patients receiving concomitant roflumilast and long-acting muscarinic antagonists (LAMA) plus concomitant inhaled corticosteroids (ICS) and long acting B2 agonists (LABA) compared to those treated only with concomitant roflumilast, ICS and LABA.
Croatian: U ispitivanju RO-2455-404-RD je u bolesnika koji su istodobno uzimali roflumilast i dugodjelujuće muskarinske antagoniste (engl. long acting muscarinic antagonists, LAMA) uz inhalacijske kortikosteroide (engl. inhaled corticosteroids, ICS) i dugodjelujuće β2 agoniste (engl. long acting B2 agonists, LABA) zabilježena veća incidencija smanjenja težine, smanjenog apetita, glavobolje i depresije u usporedbi s onima koji su istodobno uzimali samo roflumilast, ICS i LABA.
English: Common side effects (may affect up to 1 in 10 people) - diarrhoea, nausea, stomach ache - weight decrease, decreased appetite - headache
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba) - proljev, mučnina, bol u trbuhu - gubitak tjelesne težine, smanjenje teka - glavobolja
English: A slight reduction in male fertility was seen in conjunction with epididymal toxicity in rats.
Croatian: Kod štakora je uočeno blago smanjenje plodnosti mužjaka povezano s toksičnim djelovanjem na epididimis.
English: In the two six-month studies, pre-bronchodilator FEV1 was significantly improved by 49 ml (primary endpoint, p<0.0001) beyond the bronchodilator effect of concomitant treatment with salmeterol in Study M2-127 and by 80 ml (primary endpoint, p<0.0001) incremental to concomitant treatment with tiotropium in Study M2-128.
Croatian: U dva šestomjesečna ispitivanja predbronhodilatacijski FEV1 značajno je povećan za 49 ml (primarni ishod, p<0,0001) povrh bronhodilatacijskog učinka istodobnog liječenja salmeterolom u ispitivanju M2-127, te za 80 ml (primarni ishod, p<0,0001) dodatno na istodobno liječenje tiotropijem u ispitivanju M2-128.
English: Suicidal ideation and behaviour* Depression Nervousness Panic attack
Croatian: Psihijatrijski poremećaji nesanica anksioznost suicidalne misli i ponašanje* depresija nervoza napadaj panike
English: White to off-white, round tablet, 5 mm in diameter, embossed with “D” on one side and “250” on the other side.
Croatian: Bijela do bjelkasta okrugla tableta, promjera 5 mm, s utisnutim „D“ s jedne strane i „250“ s druge strane.
English: Thus, the N-oxide metabolite is considered to be the main contributor to the total PDE4 inhibitory activity in vivo.
Croatian: Stoga se smatra da N-oksid ima ključnu ulogu u ukupnoj inhibicijskoj aktivnosti PDE4 in vivo.
English: Therefore, following administration of roflumilast, the total PDE4 inhibition is considered to be the combined effect of both roflumilast and roflumilast N-oxide.
Croatian: Stoga se smatra da je nakon primjene roflumilasta ukupna inhibicija PDE4 posljedica zajedničkog djelovanja i roflumilasta i roflumilast N-oksida.
English: In the subgroup of patients with history of frequent exacerbations (at least 2 exacerbations during the last year), the rate of exacerbations was 1.526 with roflumilast and 1.941 with placebo corresponding to a relative risk reduction of 21.3% (95% CI: 7.5% to 33.1%).
Croatian: U podskupini bolesnika s anamnezom učestalih egzacerbacija (barem 2 egzacerbacije u posljednjih godinu dana) stopa egzacerbacija bila je 1,526 s roflumilastom i 1,941 s placebom, što odgovara relativnom smanjenju rizika od 21,3% (95% CI: 7,5% do 33,1%).
English: In order to relieve a sudden attack of breathlessness it is very important that your doctor provides you with another medicine to be available to you at all times that can cope with such an attack.
Croatian: Za ublažavanje naglih napada nedostatka zraka morate u svakom trenutku imati pri ruci drugi lijek koji
English: Daxas is not recommended if you have one or more of the following diseases: - severe immunological diseases such as HIV infection, multiple sclerosis (MS), lupus erythematosus (LE) or progressive multifocal leukoencephalopathy (PML) - severe acute infectious diseases such as tuberculosis, or acute hepatitis - cancer (except basal-cell carcinoma, a slow-growing type of skin cancer) - or severe impairment of the heart function
Croatian: Daxas se ne preporučuje ako imate jednu ili više sljedećih bolesti: - tešku imunološku bolest poput HIV-infekcije, multiple skleroze (MS), eritemskog lupusa (LE) ili progresivne multifokalne leukoencefalopatije (PML) - tešku akutnu infektivnu bolest poput tuberkuloze ili akutnog hepatitisa, - karcinom (osim bazocelularnog karcinoma, vrste sporo napredujućeg karcinoma kože) - ili teško oštećenje funkcije srca Ne postoje primjereni podaci o primjeni lijeka Daxas u takvim okolnostima.
English: Uncommon side effects (may affect up to 1 in 100 people) - trembling, sensation of spinning head (vertigo), dizziness - sensation of rapid or irregular heartbeat (palpitations) - gastritis, vomiting - reflux of stomach acid to the gullet (acid regurgitations), indigestion - rash - muscle pain, muscle weakness or cramps - back pain - feeling of weakness or tiredness, feeling unwell.
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba) - drhtanje, vrtoglavica, omaglica - osjećaj ubrzanog ili nepravilnog rada srca (palpitacije) - gastritis, povraćanje - vraćanje želučane kiseline u jednjak (regurgitacija kiseline), probavne tegobe - osip - bol u mišićima, mišićna slabost ili grčevi - bol u leđima - osjećaj slabosti ili umora, općenito loše osjećanje.
English: Seventeen (1.8%) patients in the roflumilast group and 18 (1.9%) patients in the placebo group died during the double-blind treatment period due to any reason and 7 (0.7%) patients in each group due to a COPD exacerbation.
Croatian: Tijekom dvostruko-slijepog razdoblja liječenja zbog bilo kojeg razloga je umrlo 17 (1,8%) bolesnika iz skupine koja je uzimala roflumilast i 18 (1.9%) bolesnika u skupini koja je uzimala placebo, a 7 (0,7%) iz svake skupine umrlo je zbog egzacerbacije KOPB-a.
English: The tested dose of fluvoxamine was 50 mg. A combination of roflumilast with these active substances might lead to an increase of exposure and persistent intolerability.
Croatian: Istodobno uzimanje roflumilasta s tim djelatnim tvarima može dovesti do povećane izloženosti lijeku i trajne nepodnošljivosti.
English: The lack of experience in patients with HIV infection or active hepatitis, with severe immunological diseases (e.g.multiple sclerosis, lupus erythematosus, multifocal leukoencephalopathy) or treated with immunosuppressive therapy (other than short-term systemic corticosteroids) and that Daxas should not be initiated or should be stopped in these patients.
Croatian: Nedostatak iskustva kod bolesnika s HIV-infekcijom ili aktivnim hepatitisom, s teškim imunološkim bolestima (npr. multipla skleroza, eritemski lupus, multifokalna leukoencefalopatija) ili koji se liječe imunosupresivnom terapijom (osim kratkotrajne terapije sistemskim kortikosteroidima).Kod takvih bolesnika Daxas ne treba uvoditi ili terapiju treba prekinuti.
English: Rare instances of suicidal ideation and behaviour, including suicide, have been observed in patients with or without history of depression, usually within the first weeks of treatment (see section 4.8).
Croatian: Kod bolesnika sa ili bez prethodne depresije su, najčešće u prvim tjednima liječenja, zabilježeni rijetki primjeri suicidalnih misli i ponašanja uključujući i suicid (vidjeti dio 4.8).
English: Daxas 250 micrograms tablets are white to off-white, embossed with ‘D' on one side and ‘250' on the other side.
Croatian: Daxas 250 mikrograma tablete su bijele do bjelkaste tablete s utisnutim „D“ s jedne strane i „250“ s druge strane.
English: These findings consisted mainly of gastrointestinal findings (i.e. vomiting, increased gastric secretion, gastric erosions, intestine inflammation) and cardiac findings (i.e. focal haemorrhages, haemosiderin deposits and lympho-histiocytic cell infiltration in the right atria in dogs, and decreased blood pressure and increased heart rate in rats, guinea pigs and dogs).
Croatian: Uglavnom se radilo o gastrointestinalnoj nepodnošljivosti (npr. povraćanje, pojačano lučenje želučane kiseline, želučane erozije, upale crijeva) i srčanim nalazima (npr. fokalna krvarenja, odlaganje hemosiderina i infiltracije limfohistiocitnih stanica u desnom atriju pasa te smanjenje krvnog tlaka i porast frekvencije srca kod štakora, zamoraca i pasa).
English: In older people, females and in non-Caucasians, total PDE4 inhibitory activity was increased.
Croatian: Kod starijih osoba, žena i pripadnika rasa drugačijih od bijele, ukupna inhibicijska aktivnost PDE4 je povećana.
English: In a pooled analysis of the one-year studies M2-124 and M2-125, roflumilast 500 micrograms once daily significantly improved lung function compared to placebo, on average by 48 ml (pre-bronchodilator FEV1, primary endpoint, p<0.0001), and by 55 ml (post-bronchodilator FEV1, p<0.0001).
Croatian: U objedinjenoj analizi jednogodišnjih ispitivanja M2-124 i M2-125 roflumilast od 500 mikrograma jedanput na dan značajno je poboljšao plućnu funkciju u usporedbi s placebom, prosječno za 48 ml (predbronhodilatacijski FEV1, primarni ishod, p<0,0001), te za 55 ml (postbronhodilatacijski FEV1, p<0,0001).
English: Experience in patients with latent infections such as tuberculosis, viral hepatitis, herpes viral infection and herpes zoster is limited.
Croatian: Iskustva kod bolesnika s latentnim infekcijama poput tuberkuloze, virusnog hepatitisa, infekcije herpes virusom ili herpes zosterom su ograničena.
English: The proportion of patients who experienced at least 1 adverse event during the double-blind treatment period were 648 (66.9%) patients and 572 (59.2%) patients in the roflumilast and placebo groups, respectively.
Croatian: Udio bolesnika koji su imali barem jedan štetan učinak tijekom razdoblja liječenja iznosio je 648 (66,9%) u skupini na roflumilastu, te 572 (59,2%) u skupini na placebu.
English: Daxas 500 micrograms film-coated tablets are yellow, D-shaped film-coated tablets, embossed with 'D' on one side.
Croatian: Daxas 500 mikrograma filmom obložene tablete su žute filmom obložene tablete u obliku slova D, s utisnutim “D” s jedne strane.
English: Patients with congestive heart failure (NYHA grades 3 and 4) have not been studied and therefore treatment of these patients is not recommended.
Croatian: Primjena lijeka Daxas kod bolesnika s kongestivnim zatajenjem srca (NYHA stupnjevi 3 i 4) nije ispitana te se liječenje takvih bolesnika ne preporučuje.