FrancophonIA/ELRC3.0 huggingface dataset:
English: ANX 2.1 - The MAH commits to conduct a long-term comparative observational safety study.
Croatian: Dodatak 2.1 - Nositelj odobrenja obvezuje se provesti dugoročno usporedno opservacijsko ispitivanje sigurnosti.
English: Food intake does not affect the total PDE4 inhibitory activity, but delays time to maximum concentration (tmax) of roflumilast by one hour and reduces Cmax by approximately 40%.
Croatian: Unos hrane ne utječe na ukupnu inhibicijsku aktivnost PDE4, ali odgađa vrijeme do postizanja maksimalne koncentracije (tmax) roflumilasta za jedan sat i smanjuje Cmax za približno 40%.
English: Daxas is to be used in addition to bronchodilators.
Croatian: Daxas treba koristiti kao dodatak bronhodilatatorima.
English: Daxas has no influence on the ability to drive and use machines.
Croatian: Daxas ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: That patients should tell their doctor if they are taking any other medicines.
Croatian: Da bolesnik mora reći liječniku ako uzima bilo koje druge lijekove.
English: The potential risk of malignant tumours and the lack of experience in patients with past history of cancer.
Croatian: Potencijalni rizik malignih tumora i nedostatak iskustva kod bolesnika s karcinomom u povijesti bolesti.
English: When the activity of this protein is reduced, there is less inflammation in the lungs.
Croatian: Pri smanjenoj aktivnosti tog proteina smanjuje se upala u plućima.
English: Each pack contains 10, 14, 28, 30, 84 , 90 or 98 film-coated tablets.
Croatian: Jedno pakiranje sadrži 10, 14, 28, 30, 84, 90 ili 98 filmom obloženih tableta.
English: There is no relevant use of Daxas in the paediatric population (under 18 years) in the indication COPD.
Croatian: Nema relevantne primjene lijeka Daxas u pedijatrijskoj populaciji (do 18 godina) za indikaciju KOPB-a.
English: The need to inform patients about the risks of Daxas and the precautions for safe use including:
Croatian: Potrebu da se bolesnike upozori na rizike lijeka Daxas i mjere opreza za sigurnu primjenu uključujući:
English: Daxas 500 micrograms may need to be taken for several weeks to achieve its full effect (see sections 5.1 and 5.2).
Croatian: Daxas 500 mikrograma je ponekad potrebno uzimati više tjedana da bi se postigao puni učinak (vidjeti dijelove 5.1 i 5.2).
English: Talk to your doctor if these side effects do not resolve within the first weeks of treatment.
Croatian: Obavijestite svog liječnika ako se ove nuspojave ne povuku tijekom prvih tjedana liječenja.
English: The Marketing Authorisation Holder (MAH) should ensure that all Healthcare Professionals who are expected to prescribe Daxas are provided with an updated Educational pack.
Croatian: Nositelj odobrenja će osigurati da svi zdravstveni djelatnici za koje se očekuje da će propisivati Daxas dobiju obnovljeni edukacijski paket.
English: There is no evidence for an immunotoxic, skin sensitising or phototoxic potential.
Croatian: Nema dokaza o potencijalu za imunotoksičnost, senzibilizaciju kože ili fototoksičnost.
English: If you take more Daxas than you should
Croatian: Ako uzmete više lijeka Daxas nego što ste trebali
English: It is important to continue taking Daxas for as long as prescribed by your doctor, even when you have no symptoms, in order to maintain control of your lung function.
Croatian: Važno je da Daxas uzimate onoliko dugo koliko je preporučio liječnik, čak i kad nemate simptome, jer se samo tako može održati kontrola plućne funkcije.
English: This starting dose is intended to reduce adverse events and patient discontinuation when initiating therapy, but it is a sub-therapeutic dose.
Croatian: Navedena početna doza je namijenjena za smanjenje nuspojava i stope prekida liječenja na početku terapije, ali je supterapijska doza.
English: Allergic reactions may affect the skin and in rare cases cause swelling of the eyelids, face, lips and tongue, possibly leading to difficulties in breathing and/or a drop in blood pressure and accelerated heartbeat.
Croatian: Alergijske reakcije mogu zahvatiti kožu i u rijetkim slučajevima uzrokovati oticanje očnih kapaka, lica, usana i jezika, što može uzrokovati poteškoće s disanjem i/ili pad krvnog tlaka i ubrzanje otkucaja srca.
English: The risk of weight decrease in underweight patients and the need to monitor the body weight at each visit and to stop the treatment in the event of an unexplained and clinically concerning weight decrease.
Croatian: Rizik smanjenja težine kod bolesnika s niskom tjelesnom težinom i potrebu praćenja tjelesne težine pri svakom kontrolnom posjetu te potrebu prekida terapije u slučaju neobjašnjivog i klinički značajnog smanjenja težine.
English: Most relevant findings in safety pharmacology and toxicology studies occurred at higher doses and exposure than that intended for clinical use.
Croatian: Većina značajnih rezultata u ispitivanjima sigurnosne farmakologije i toksičnosti javljala se pri dozama i izloženosti višima od onih koje se očekuju u kliničkoj primjeni.
English: 10 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 84 film-coated tablets 90 film-coated tablets 98 film-coated tablets
Croatian: 10 filmom obloženih tableta 14 filmom obloženih tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 84 filmom obloženih tableta 90 filmom obloženih tableta 98 filmom obloženih tableta
English: Please notify your doctor immediately of any suicidal thoughts you may have.
Croatian: Molimo, odmah obavijestite svog liječnika ako se pojave bilo kakve suicidalne misli.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases, ATC code: R03DX07
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje opstruktivnih bolesti dišnih puteva, ostali sistemski lijekovi za opstruktivne bolesti dišnih puteva, ATK oznaka: R03DX07
English: PVC/PVDC aluminium blisters in packs of 10, 14, 28, 30, 84, 90 or 98 film-coated tablets.
Croatian: PVC/PVDC aluminijski blisteri u pakiranjima s 10, 14, 28, 30, 84, 90 ili 98 filmom obloženih tableta.
English: In the event of an unexplained and clinically concerning weight decrease, the intake of roflumilast should be stopped and body weight should be further followed-up.
Croatian: U slučaju neobjašnjivog i klinički značajnog gubitka tjelesne težine potrebno je prekinuti uzimanje roflumilasta i nastaviti praćenje tjelesne težine.
English: Due to the physico-chemical properties, roflumilast is readily distributed to organs and tissues including fatty tissue of mice, hamster and rat.
Croatian: Zbog fizikalno-kemijskih značajki roflumilast se lako distribuira do organa i tkiva uključujući masno tkivo miševa, hrčaka i štakora.
English: Each film-coated tablet contains 188.72 mg lactose (as monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 188,72 mg laktoze (u obliku hidrata).
English: The potential risk of infections: Daxas should not be initiated, or treatment should be stopped, in patients with severe acute infectious diseases.
Croatian: Potencijalni rizik infekcija: Daxas ne treba uvoditi ili liječenje treba prekinuti kod bolesnika s teškim akutnim infektivnim bolestima.
English: The respective reduction in exacerbations seen in patients without concomitant LABAs was on average 15% (p=0.0387).
Croatian: Odgovarajuće smanjenje egzacerbacija kod bolesnika bez istodobne primjene LABA prosječno je iznosilo 15% (p=0,0387).
English: Roflumilast reduces the activity of phosphodiesterase-4, a protein occurring naturally in body cells.
Croatian: Roflumilast smanjuje aktivnost fosfodiesteraze-4, proteina koji se prirodno javlja u tjelesnim stanicama.
English: No interactions were observed with inhaled salbutamol, formoterol, budesonide and oral montelukast, digoxin, warfarin, sildenafil and midazolam.
Croatian: Nisu zabilježene interakcije s inhalacijskim salbutamolom, formoterolom i budezonidom, kao ni s oralnim montelukastom, digoksinom, varfarinom, sildenafilom i midazolamom.
English: Rescue medicinal products (salbutamol or albuterol) were allowed on an as-needed basis.
Croatian: Lijekovi za hitno ublažavanje simptoma (salbutamol ili albuterol) mogli su se uzimati prema potrebi.
English: Thus, roflumilast treatment is not recommended in patients receiving strong cytochrome P450 enzyme inducers.
Croatian: Zbog toga, liječenje roflumilastom se ne preporučuje kod bolesnika koji primaju jake induktore enzima citokroma P450.
English: Daxas should not be initiated or should be stopped in patients with cancers (except basal cell carcinoma).
Croatian: Daxas ne treba uvoditi ili terapiju treba prekinuti kod bolesnika s karcinomima (osim bazocelularnog karcinoma).
English: Volume of distribution for single dose of 500 micrograms roflumilast is about 2.9 l/kg.
Croatian: Volumen distribucije jednokratne doze od 500 mikrograma roflumilasta je oko 2,9 l/kg.
English: Roflumilast is extensively metabolised via Phase I (cytochrome P450) and Phase II (conjugation) reactions.
Croatian: Roflumilast se opsežno metabolizira reakcijama faze I (preko citokroma P450) i reakcijama faze II (konjugacijom).
English: Gamma-GT increased Aspartate aminotransferase (AST) increased
Croatian: Poremećaji jetre i žuči povišena gama GT povišena aspartat aminotransferaza (AST)
English: The risk of psychiatric disorders such as insomnia, anxiety, depression in patients receiving Daxas and the potential risk of suicide.
Croatian: Rizik psihijatrijskih poremećaja poput nesanice, tjeskobe, depresije kod bolesnika koji uzimaju Daxas te potencijalni rizik suicida.
English: Inhaled corticosteroids were used in 809 (61%) of the roflumilast treated patients, whereas the use of LABAs and theophylline was prohibited.
Croatian: Inhalacijske kortikosteroide koristilo je 809 (61%) bolesnika liječenih roflumilastom, dok LABA i teofilin nisu bili dopušteni.
English: Daxas may be taken with other medicines used in the treatment of COPD such as inhaled or oral corticosteroids or bronchodilators.
Croatian: Daxas se može uzimati s drugim lijekovima koji se koriste za liječenje KOPB-a, poput inhalacijskih ili oralnih kortikosteroida ili bronhodilatatora.
English: That patients or their caregivers should tell their doctor if the patient develops symptoms indicative of:
Croatian: Da se bolesnici ili osobe koje o njima brinu moraju obratiti liječniku ako se kod bolesnika pojave simptomi koji ukazuju na:
English: The fact that Daxas is not indicated for the treatment of COPD patients outside of the approved indication, nor for use in patients with asthma or alpha-1 antitrypsin deficiency.
Croatian: Činjenicu da Daxas nije indiciran za liječenje bolesnika s KOPB-om koji ne odgovaraju odobrenoj indikaciji, niti za bolesnike s astmom ili deficijencijom alfa-1 antitripsina.
English: The European Medicines Agency has waived the obligation to submit the results of studies with roflumilast in all subsets of the paediatric population in chronic obstructive pulmonary disease (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja roflumilasta u svim podskupinama pedijatrijske populacije za indikaciju kronične opstruktivne bolesti pluća (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: That they should tell their doctor if they have a history of any of the following conditions
Croatian: Da moraju reći liječniku ako u povijesti bolesti imaju bilo koje od sljedećih stanja:
English: Short-acting anticholinergics (SAMAs) were allowed for those patients not taking LABAs.
Croatian: Kratkodjelujući antikolinergici (engl. short-acting anticholinergics, SAMA) bili su dopušteni bolesnicima koji nisu uzimali LABA.
English: Starting dose titration trial
Croatian: Ispitivanje titracije početne doze
English: While adverse reactions like diarrhoea, nausea, abdominal pain and headache mainly occur within the first weeks of therapy and mostly resolve on continued treatment, roflumilast treatment should be reassessed in case of persistent intolerability.
Croatian: Iako se nuspojave poput proljeva, mučnine, abdominalne boli i glavobolje uglavnom javljaju u prvim tjednima liječenja i zatim većinom nestaju, opravdanost liječenja roflumilastom treba revidirati u slučaju trajne nepodnošljivosti.
English: What Daxas contains The active substance is roflumilast.
Croatian: Što Daxas sadrži Djelatna tvar je roflumilast.
English: These studies in rats with radiolabelled roflumilast also indicate low penetration across the blood-brain barrier.
Croatian: Ispitivanja na štakorima s radiooznačenim roflumilastom pokazuju slabi prolaz kroz krvno-moždanu barijeru.
English: AstraZeneca (AstraZeneca logo)
Croatian: AstraZeneca (logo društva AstraZeneca)
English: The pharmacokinetics of roflumilast and its N-oxide metabolite are dose-proportional over a range of doses from 250 micrograms to 1,000 micrograms.
Croatian: Farmakokinetike roflumilasta i njegovog N-oksid metabolita proporcionalne su dozi u rasponu doza od 250 mikrograma do 1000 mikrograma.
English: If you have taken more tablets than you should, you may experience the following symptoms: headache, nausea, diarrhoea, dizziness, throbbing of your heart, light-headedness, clamminess and low blood pressure.
Croatian: Ako uzmete više tableta nego što ste trebali, možete osjetiti sljedeće simptome: glavobolju, mučninu, proljev, lupanje srca, ošamućenost, hladan, ljepljivi znoj i nizak krvni tlak.
English: The reduction of moderate or severe exacerbations with roflumilast and LABA compared to placebo and LABA was on average 21% (p=0.0011).
Croatian: Smanjenje umjerenih i teških egzacerbacija s roflumilastom i LABA u usporedbi s placebom i LABA prosječno je iznosilo 21% (p=0,0011).
English: Roflumilast or placebo treatment was added to continuous treatment with a long-acting bronchodilator, in particular salmeterol in Study M2-127 or tiotropium in Study M2-128.
Croatian: Roflumilast ili placebo dodani su kontinuiranoj terapiji dugodjelujućim bronhodilatatorom, odnosno salmeterolu u ispitivanju M2-127 ili tiotropiju u ispitivanju M2-128.
English: This leads to symptoms such as coughing, wheezing, chest tightness or difficulty in breathing.
Croatian: To dovodi do simptoma poput kašlja, piskanja, stezanja u prsima i otežanog disanja.
English: Patients and caregivers should be instructed to notify the prescriber of any suicidal ideation (see also section 4.4).
Croatian: Bolesnike i osobe koje o njima brinu treba uputiti da se obrate liječniku u slučaju bilo kakvih suicidalnih misli (vidjeti također dio 4.4).
English: That Daxas may cause weight loss and patients should weigh themselves regularly and record their weight on the patient card.
Croatian: Da Daxas može izazvati gubitak težine i bolesnici se trebaju redovito vagati i bilježiti težinu na karticu za bolesnike.
English: If on one day you have forgotten to take a tablet of Daxas, just carry on the next day with the next tablet as usual.
Croatian: Ako jedan dan zaboravite uzeti tabletu, sljedeći dan samo nastavite terapiju sa sljedećom tabletom u uobičajeno vrijeme.
English: What you need to know before you take Daxas
Croatian: Što morate znati prije nego počnete uzimati Daxas
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako Vam je dijagnosticirana nepodnošljivost nekih šećera, obratite se liječniku za savjet prije uzimanja ovog lijeka.
English: In this case, roflumilast treatment should be reassessed (see section 4.4).
Croatian: U tom slučaju treba ocijeniti opravdanost liječenja roflumilastom (vidjeti dio 4.4).
English: 250 micrograms once a day is a sub-therapeutic dose, and should be used only as a starting dose for the first 28 days (see sections 4.2 and 5.2).
Croatian: Doza od 250 mikrograma jedanput na dan je supterapijska doza i smije se primjenjivati samo kao početna doza prvih 28 dana (vidjeti dijelove 4.2 i 5.2).
English: The rate of exacerbations (as defined in the protocols) were not significantly reduced by roflumilast in the individual studies (relative risk reduction: 13.5% in Study M2-111 and 6.6% in Study M2-112; p= not significant).
Croatian: Stopa egzacerbacija (definiranih po protokolu) nije se u pojedinačnim ispitivanjima na roflumilastu značajno smanjila (relativno smanjenje rizika 13,5% u ispitivanju M2-111 i 6,6% u ispitivanju M2-112; p=nije značajno).
English: Talk to your doctor if, while taking this medicine, you observe an unintentional loss of body weight (not related to a diet or exercise programme).
Croatian: Obratite se liječniku ako za vrijeme terapije lijekom Daxas primijetite nenamjerni gubitak težine (koji nije povezan s prehranom ili tjelesnom aktivnošću).
English: The N-oxide metabolite is the major metabolite observed in the plasma of humans.
Croatian: Metabolit N-oksid je glavni metabolit nađen u ljudskoj plazmi.
English: There are no clinical data to support the concomitant treatment with theophylline for maintenance therapy.
Croatian: Nema kliničkih podataka koji podržavaju istodobno liječenje teofilinom u terapiji održavanja.
English: AstraZeneca Pharma Poland Sp. z o.o.
Croatian: Polska AstraZeneca Pharma Poland Sp. z o.o.
English: The observed adverse reactions for roflumilast in Study RO-2455404-RD were in line with those already included in section 4.8.
Croatian: Nuspojave zabilježene u ispitivanju RO-2455-404-RD bile su u skladu s onima već zabilježenim u dijelu 4.8.
English: Available pharmacokinetic data in animals have shown excretion of roflumilast or its metabolites in milk.
Croatian: Dostupni farmakokinetički podaci u životinja pokazuju da se roflumilast i njegovi metaboliti izlučuju u mlijeku.
English: Daxas is used for maintenance treatment of severe COPD in adults who in the past had frequent worsening of their COPD symptoms (so-called exacerbations) and who have chronic bronchitis.
Croatian: Daxas se koristi za terapiju održavanja teškog KOPB-a kod odraslih koji su u prošlosti imali često pogoršanje simptoma KOPB-a (takozvane egzacerbacije) i koji imaju kronični bronhitis.
English: Each tablet contains 49.7 mg lactose (as monohydrate).
Croatian: Jedna tableta sadrži 49,7 mg laktoze (u obliku hidrata).
English: Other side effects include the following:
Croatian: Ostale nuspojave uključuju kako slijedi:
English: Change
Croatian: Promjena
English: Therefore, there is a low probability of relevant interactions with substances metabolised by these P450 enzymes.
Croatian: Stoga je mala vjerojatnost klinički značajnih interakcija s lijekovima koji se metaboliziraju tim P450 izoenzimima.
English: The plasma clearance after short-term intravenous infusion of roflumilast is about 9.6 l/h.
Croatian: Klirens plazme nakon kratkotrajne intravenozne infuzije roflumilasta iznosi oko 9,6 l/h.
English: The patient card should include an area where patients can record their weight and the date they weighed themselves and they should be asked to bring the patient card with them at each visit.
Croatian: Kartica za bolesnike mora uključivati dio gdje bolesnici mogu bilježiti težinu i datum vaganja te treba navesti da karticu za bolesnike ponesu sa sobom na svaki pregled.
English: Therefore, the 250-micrograms dose should be used only as a starting dose (see sections 5.1 and 5.2).
Croatian: Stoga, doza od 250 mikrograma smije se primjenjivati samo kao početna doza (vidjeti dijelove 5.1 i 5.2).
English: This study should be appropriate to compare the incidences of all-cause mortality, major cardiovascular events, new diagnosis of cancer, all-cause hospitalisation, hospitalisation related to respiratory disease, suicide or hospitalisation for suicide attempt, and new diagnosis of depression, tuberculosis or viral hepatitis B or C in roflumilast treated COPD patients compared with COPD patients not treated with roflumilast.
Croatian: Ovo ispitivanje mora omogućiti usporedbu incidencije smrtnosti od svih uzroka, značajnih kardiovaskularnih događaja, novodijagnosticiranih karcinoma, hospitalizacija od svih uzroka, hospitalizacija povezanih s respiratornim bolestima, suicida ili hospitalizacija zbog pokušaja suicida, novodijagnosticirane depresije, tuberkuloze ili virusnog hepatitisa B ili C kod bolesnika s KOPB-omliječenih roflumilastom u usporedbi s bolesnicima s KOPB-om koji nisu liječeni roflumilastom.
English: Sudden attack of breathlessness
Croatian: Iznenadni napad nedostatka zraka
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom Lapp laktaze ili malapsorpcijom glukoze i galaktoze ne bi trebali uzimati ovaj lijek.
English: Daxas is not intended for the treatment of a sudden attack of breathlessness (acute bronchospasms).
Croatian: Daxas nije namijenjen liječenju iznenadnih napada nedostatka zraka (akutni bronhospazam).
English: Roflumilast is not recommended in women of childbearing potential not using contraception.
Croatian: Roflumilast se ne preporučuje ženama u reproduktivnoj dobi koje ne koriste kontracepciju.
English: Treatment with roflumilast may lead to a higher risk of sleep disorders (mainly insomnia) in patients with a baseline body weight of <60 kg, due to a higher total PDE4 inhibitory activity found in these patients (see section 4.8).
Croatian: Liječenje roflumilastom može povećati rizik za poremećaje spavanja (uglavnom nesanice) u bolesnika s početnom tjelesnom težinom <60 kg, zbog povećane ukupne inhibicijske aktivnosti PDE4 koja je zabilježena u tih bolesnika (vidjeti dio 4.8).
English: EU/1/10/636/008 28 tablets
Croatian: EU/1/10/636/008 28 tableta
English: The primary endpoint was reduction in rate of moderate or severe COPD exacerbations per patient per year.
Croatian: Primarni ishod je bio smanjenje stope umjerenih ili teških egzacerbacija KOPB-a po bolesniku po godini.
English: You should talk to your doctor, if you are diagnosed with any of these diseases.
Croatian: Obratite se liječniku ako Vam je dijagnosticirana bilo koja od tih bolesti.
English: Daxas contains lactose
Croatian: Daxas sadrži laktozu
English: Clinical data are considered insufficient to recommend dose adjustment and caution should be observed in patients with mild liver impairment (Child-Pugh A).
Croatian: Klinički podaci se smatraju nedovoljnima da se preporuči smanjenje doze te je potreban oprez kod bolesnika s blagim zatajenjem jetre (Child Pugh A).
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake kategorije učestalosti nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: Roflumilast did not significantly reduce the rate of exacerbations compared with placebo in the subgroup of patients with moderate COPD.
Croatian: Roflumilast nije značajno smanjio stopu egzacerbacija u odnosu na placebo u podskupini bolesnika s umjerenim KOPB-om.
English: The use of inhaled corticosteroids and theophylline was prohibited during the studies.
Croatian: Primjena inhalacijskih kortikosteroida i teofilina tijekom ispitivanja nije bila dopuštena.
English: Therefore, the concomitant treatment with theophylline is not recommended.
Croatian: Stoga se istodobna primjena s teofilinom ne preporučuje.
English: Long-acting beta-agonists (LABAs) were allowed in the studies and were used in approximately 50% of the study population.
Croatian: U ispitivanju je bila dopuštena primjena dugodjelujućih beta-agonista (engl. long-acting beta-agonists, LABA) i koristilo ih je oko 50% ispitanika.
English: The effect of Daxas may be reduced if taken together with rifampicin (an antibiotic medicine) or with phenobarbital, carbamazepine or phenytoin (medicines usually prescribed for the treatment of epilepsy).
Croatian: Djelovanje lijeka Daxas može se smanjiti ako se uzima zajedno s rifampicinom (antibiotski lijek) ili fenobarbitalom, karbamazepinom ili fenitoinom (lijekovi koji se propisuju za liječenje epilepsije).
English: Roflumilast targets the PDE4A, 4B and 4D splicing variants with similar potency in the nanomolar range.
Croatian: Roflumilast podjednako snažno inhibira PDE4A, 4B i 4D varijante u nanomolarnom rasponu.