FrancophonIA/ELRC3.0 huggingface dataset:
English: Caution should be used when prescribing antimuscarinics to patients with pre-existing cardiac diseases.
Croatian: Potreban je oprez kod propisivanja antimuskarinskih lijekova bolesnicima s već postojećim srčanim bolestima.
English: Darifenacin was not teratogenic in rats and rabbits at doses up to 50 and 30 mg/kg/day, respectively.
Croatian: Darifenacin nije bio teratogen u štakora i kunića pri dozama do 50, odnosno 30 mg/kg/dan.
English: Emselex has been administered in clinical trials at doses up to 75 mg (five times maximum therapeutic dose).
Croatian: Emselex se u kliničkim ispitivanjima primjenjivao u dozama do 75 mg (pet puta većima od najviše terapijske doze).
English: It is used in adults for the treatment of the symptoms of overactive bladder conditions - such as a sudden urge to rush to the toilet, needing to go to the toilet frequently and/or not getting to the toilet in time and wetting yourself (urge incontinence).
Croatian: Koristi se za liječenje simptoma kod stanja prekomjerno aktivnog mokraćnog mjehura - poput iznenadne potrebe za odlaskom na toalet, česte potrebe za odlaskom na toalet i/ili nemogućnosti zadržavanja mokraće do odlaska na toalet te se pomočite mokraćom (nezadrživa potreba za mokrenjem).
English: As with other antimuscarinics, patients should be instructed to discontinue Emselex and seek immediate medical attention if they experience oedema of the tongue or laropharynx, or difficulty breathing (see section 4.8).
Croatian: Kao i s drugim antimuskarinskim lijekovima, bolesnike treba uputiti da prekinu primjenu Emselexa i potraže hitnu medicinsku pomoć ukoliko razviju edem jezika ili laringofarinksa, ili otežano dišu (vidjeti dio 4.8).
English: Eating food has no effect on Emselex.
Croatian: Uzimanje hrane ne utječe na Emselex.
English: Fatigue, accidental injury, facial swelling, high blood pressure, diarrhoea, flatulence, inflammation of the mucous membrane of the mouth, increased liver enzymes, swelling, dizziness, sleeplessness, drowsiness, abnormal thinking, runny nose (rhinitis), cough, shortness of breath, dry skin, itching, rash, sweating, visual disturbance including blurred vision, taste disturbance, urinary tract disorder or infection, impotence, discharge and itching in the vagina, bladder pain, inability to empty your bladder.
Croatian: Manje često (mogu se javiti u do 1 na 100 osoba) Umor, slučajna ozljeda, oticanje lica, povišeni krvni tlak, proljev, vjetrovi, upala sluznice usta, povišene vrijednosti jetrenih enzima, oticanje, omaglica, nesanica, pospanost, poremećaj tijeka misli, curenje iz nosa (rinitis), kašalj, nedostatak zraka, suhoća kože, svrbež, osip, znojenje, poremećaj vida uključujući zamućen vid, poremećaj okusa, poremećaj ili infekcija mokraćnog sustava, impotencija, iscjedak iz rodnice i svrbež rodnice, bol u mokraćnom mjehuru, nemogućnost potpunog pražnjenja mokraćnog mjehura.
English: • if you have myasthenia gravis (a disease marked by abnormal tiredness and weakness of selected muscles).
Croatian: • ako imate miasteniju gravis (bolest obilježena abnormalnim umorom i slabošću određenih mišića).
English: Consistent with the pharmacological profile, the most commonly reported adverse reactions were dry mouth (20.2% and 35% for the 7.5 mg and 15 mg dose, respectively, 18.7% after flexible dose titration, and 8% - 9% for placebo) and constipation (14.8% and 21% for the 7.5 mg and 15 mg dose, respectively, 20.9% after flexible dose titration, and 5.4% - 7.9% for placebo).
Croatian: U skladu s farmakološkim profilom, najčešće prijavljivane nuspojave bile su suha usta (20,2% i 35% pri dozi od 7,5 mg, odnosno 15 mg, 18,7% nakon fleksibilne titracije doze i 8%-9% za placebo) i konstipacija (14,8% i 21% pri dozi od 7,5 mg, odnosno 15 mg, 20,9% nakon fleksibilne titracije doze, i 5,4%-7,9% za placebo).
English: A risk to the nursing child cannot be excluded.
Croatian: Ne može se isključiti rizik za novorođenče/dojenče.
English: Following administration of an oral dose of 14C-darifenacin solution to healthy volunteers, approximately 60% of the radioactivity was recovered in the urine and 40% in the faeces.
Croatian: Nakon peroralne primjene 14C-darifenacin otopine u zdravih dobrovoljaca, oko 60% radioaktivnosti nađeno je u mokraći, a oko 40% u stolici.
English: Darifenacin should not be used together with potent CYP3A4 inhibitors (see section 4.3) such as protease inhibitors (e.g. ritonavir), ketoconazole and itraconazole.
Croatian: Darifenacin se ne smije primjenjivati istodobno sa snažnim inhibitorima CYP3A4 (vidjeti dio 4.3), kao što su inhibitori proteaze (npr. ritonavir), ketokonazol i itrakonazol.
English: Clear PVC/CTFE/aluminium or PVC/PVDC/aluminium blisters in cartons containing 7, 14, 28, 49, 56 or 98 tablets as unit pack or in multipacks containing 140 (10x14) tablets.
Croatian: Prozirni PVC/CTFE/ aluminij ili PVC/PVDC/ aluminij blisteri u kutijama koje sadrže 7, 14, 28, 49, 56 ili 98 tableta kao pojedinačno pakiranje ili višestruka pakiranja koja sadrže 140 (10x14) tableta.
English: The active substance is darifenacin.
Croatian: Djelatna tvar je darifenacin.
English: PHARMACEUTICAL FORM AND CONTENTS 14 tablets
Croatian: OBLIK I SADRŽAJ 14 tableta
English: • if you have an obstructive gastrointestinal disorder (any obstruction of the passage of intestinal or gastric contents, such as narrowing of the pylorus, the lower part of the stomach) - your doctor will have told you if you have this.
Croatian: • ako imate opstrukcijski poremećaj probavnog sustava (bilo kakvo začepljenje prolaza crijevnog ili želučanog sadržaja, kao što je suženje pilorusa, donjeg dijela želuca) -liječnik će Vas obavijestiti ako to imate.
English: Dyspnoea, cough, rhinitis
Croatian: Dispneja, kašalj, rinitis
English: Grapefruit juice may interact with Emselex.
Croatian: Sok od grejpa može stupiti u interakciju s Emselexom.
English: Safety and efficacy have not yet been established in patients with a neurogenic cause for detrusor over activity.
Croatian: Sigurnost primjene i djelotvornost u bolesnika s neurogenim uzrokom prekomjerne aktivnosti detruzora još nisu utvrđeni.
English: However, caution should be exercised when treating this population (see section 5.2).
Croatian: Ipak, nužan je oprez pri liječenju te populacije (vidjeti dio 5.2).
English: The increase in digoxin exposure could be caused by competition between darifenacin and digoxin for P-glycoprotein.
Croatian: Povećana izloženost digoksinu mogla bi biti posljedica nadmetanja između darifenacina i digoksina za P-glikoprotein.
English: A population pharmacokinetic analysis of patient data indicated a trend for clearance to decrease with age (19% per decade based on Phase III population pharmacokinetic analysis of patients aged 6089 years), see section 4.2.
Croatian: Farmakokinetička analiza u populaciji bolesnika pokazala je trend smanjenja klirensa s povećanjem životne dobi (za 19% na svakih 10 godina, temeljeno na fazi III farmakokinetičke analize u populaciji bolesnika u dobi 60-89 godina), vidjeti dio 4.2.
English: The effect of treatment with 15 mg and 75 mg of darifenacin on QT/QTc interval was evaluated in a study in 179 healthy adults (44% male: 56% females) aged 18 to 65 for 6 days (to steady state).
Croatian: Učinak liječenja darifenacinom u dozama od 15 mg i 75 mg na QT/QTc-interval procijenjen je u ispitivanju provedenom u 179 zdravih odraslih osoba (44% muškaraca: 56% žena) u dobi od 18 do 65 godina, tijekom 6 dana (do stanja dinamičke ravnoteže).
English: Infections and infestations Uncommon
Croatian: Infekcije i infestacije Manje često
English: Emselex is not recommended during pregnancy.
Croatian: Emselex se ne preporučuje u trudnoći.
English: However, the patient discontinuation rates due to these adverse reactions were low (dry mouth: 0%0.9% and constipation: 0.6% - 2.2% for darifenacin, depending on the dose; and 0% and 0.3% for placebo, for dry mouth and constipation, respectively).
Croatian: Međutim, stope prekida liječenja bolesnika zbog tih nuspojava bile su niske (suha usta: 0%-0,9% i konstipacija: 0,6%-2,2% za darifenacin, ovisno o dozi; 0% za suha usta i 0,3% za konstipaciju za placebo).
English: For both doses of 7.5 mg and 15 mg, the percentage median reduction from baseline in the number of incontinence episodes per week was similar between males and females.
Croatian: Za obje doze od 7,5 mg i 15 mg medijan postotka smanjenja broja epizoda inkontinencije na tjedan bio je sličan u muškaraca i žena.
English: Therapeutic and supra-therapeutic doses of darifenacin resulted in no increase in QT/QTc interval prolongation from baseline compared to placebo at maximum darifenacin exposure.
Croatian: Terapijske i supraterapijske doze darifenacina nisu rezultirale produženjem QT/QTc-intervala u odnosu na početno stanje, pri najvećoj izloženosti darifenacinu u usporedbi s placebom.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Merus Labs Netherlands B.V.,
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Merus Labs Netherlands B.V.,
English: However, overdose with darifenacin can potentially lead to severe anticholinergic effects and should be treated accordingly.
Croatian: Predoziranje darifenacinom može, međutim, dovesti do jakih antikolinergičkih učinaka, koje treba i primjereno liječiti.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: U svakoj su kategoriji nuspojave predstavljene redoslijedom prema sve manjoj ozbiljnosti.
English: There are limited amount of data from the use of darifenacin in pregnant women.
Croatian: Ograničeni su podaci o primjeni darifenacina u trudnica.
English: Special patient population
Croatian: Posebne populacije bolesnika
English: The interaction with midazolam lacks clinical relevance, and therefore no dose adjustment is needed for CYP3A4 substrates.
Croatian: Interakcija s midazolamom nije klinički značajna te stoga nije potrebno prilagođavanje doze za CYP3A4 supstrate.
English: Concomitant treatment with potent CYP2D6 inhibitors results in an increase in exposure (e.g. of 33% with 20 mg paroxetine at the 30 mg dose of darifenacin).
Croatian: Istodobno liječenje snažnim inhibitorima CYP2D6 rezultira povećanjem izloženosti (npr. za 33% pri dozi od 30 mg darifenacina uz 20 mg paroksetina).
English: Talk to your doctor before taking Emselex
Croatian: Obratite se svom liječniku prije nego uzmete Emselex
English: If you have not noticed any effect by then, discuss it with your doctor.
Croatian: Ako dotad ne uočite nikakvu promjenu, pitajte svog liječnika.
English: Emselex is contraindicated in patients with severe hepatic impairment (Child Pugh C) (see section 4.3).
Croatian: Emselex je kontraindiciran u bolesnika s teškim oštećenjem jetre (Child Pugh C) (vidjeti dio 4.3).
English: 26-28, rue Edward Steichen L-2540 Luxembourg
Croatian: 26-28, rue Edward Steichen L-2540 Luksemburg
English: Flatulence, diarrhoea, mouth ulceration
Croatian: Flatulencija, proljev, ulceracija usta
English: • certain anticonvulsants (carbamazepine, barbiturates),
Croatian: • neki antikonvulzivi (karbamazepin, barbiturati),
English: The information below applies to subjects who have normal CYP2D6 activity (extensive metabolisers) unless otherwise stated.
Croatian: Niže navedeni podaci odnose se na osobe s normalnom aktivnošću CYP2D6 (osobe koje opsežno metaboliziraju lijek), osim ako nije drugačije navedeno.
English: Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome.
Croatian: Simptomatsko liječenje urgentne inkontinencije i/ili učestalog mokrenja ili hitnosti za mokrenjem, koji se mogu javiti u odraslih bolesnika sa sindromom prekomjerno aktivnog mokraćnog mjehura.
English: Pharmacotherapeutic group: Urologicals, drugs for urinary frequency and incontinence; ATC code: G04BD10.
Croatian: Farmakoterapijska skupina: Urološki lijekovi, lijekovi za smanjenje učestalosti mokrenja i liječenje inkontinencije; ATK oznaka: G04BD10.
English: • Do not use this medicine after the expiry date which is stated on the carton and blister.
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „Rok valjanosti“ ili „EXP“.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 October 2004
Croatian: Datum prvog odobrenja: 22. listopada 2004.
English: • if you have heartburn and belching.
Croatian: • ako imate žgaravicu i podrigujete.
English: What Emselex is and what it is used for 2.
Croatian: Što je Emselex i za što se koristi 2.
English: As with any other antimuscarinic agents, concomitant use of medicinal products that possess antimuscarinic properties, such as oxybutynin, tolterodine and flavoxate, may result in more pronounced therapeutic and side effects.
Croatian: Kao i s bilo kojim antimuskarinskim agensima, tako i istodobna primjena s lijekovima koji posjeduju antimuskarinska svojstva, poput oksibutinina, tolterodina i flavoksata, može rezultirati izraženijim terapijskim učinkom, ali i nuspojavama.
English: Potent P-glycoprotein inhibitors such as ciclosporin and verapamil should also be avoided.
Croatian: Snažne inhibitore Pglikoproteina, poput ciklosporina i verapamila, također treba izbjegavati.
English: The M3 receptor is the major subtype that controls urinary bladder muscle contraction.
Croatian: Receptor M3 je glavna podvrsta tog receptora, koji kontrolira kontrakcije mišića mokraćnog mjehura.
English: Paediatric patients The pharmacokinetics of darifenacin have not been established in the paediatric population.
Croatian: Pedijatrijski bolesnici Farmakokinetika darifenacina u pedijatrijskoj populaciji nije utvrđena.
English: Maximum plasma levels are reached approximately 7 hours after administration of the prolonged-release tablets and steady-state plasma levels are achieved by the sixth day of administration.
Croatian: Maksimalne razine u plazmi postižu se oko 7 sati nakon primjene tableta s produljenim oslobađanjem, a ravnotežne razine u plazmi postižu se do šestog dana nakon primjene.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: S preosjetljivosti na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: However, there is a risk of increased exposure in this population (see section 5.2).
Croatian: Kod te populacije ipak postoji rizik od povećane izloženosti (vidjeti dio 5.2).
English: The three main metabolic routes are as follows: monohydroxylation in the dihydrobenzofuran ring;
Croatian: Postoje tri glavna metabolička puta: monohidroksilacija u dihidrobenzofuranskom prstenu;
English: Rash, dry skin, pruritus, hyperhidrosis
Croatian: Osip, suha koža, pruritus, hiperhidroza
English: • if you suffer from uncontrolled narrow-angle glaucoma (high pressure in the eyes with loss of eyesight that is not being adequately treated).
Croatian: • ako imate nekontrolirani glaukom uskog kuta (visok očni tlak praćen gubitkom vida, koji se ne liječi na primjereni način).
English: Food had no effect on darifenacin pharmacokinetics during multiple-dose administration of prolonged-release tablets.
Croatian: Hrana nema učinka na farmakokinetiku darifenacina kod primjene višestrukih doza tableta s produljenim oslobađanjem.
English: However, no studies involving the interaction with antiparkinson agents and tricyclic antidepressants have been performed.
Croatian: Ispitivanja interakcija s lijekovima protiv parkinsonizma i tricikličkim antidepresivima nisu, međutim, provedena.
English: • if you are receiving treatment for narrow-angle glaucoma.
Croatian: • ako uzimate lijekove protiv glaukoma uskog kuta.
English: Darifenacin pharmacokinetics were investigated in subjects with mild (Child Pugh A) or moderate (Child Pugh B) impairment of hepatic function given darifenacin 15 mg once daily to steady state.
Croatian: Farmakokinetika darifenacina ispitana je u ispitanika s blagim (Child Pugh A) ili umjerenim (Child Pugh B) oštećenjem funkcije jetre, koji su uzimali 15 mg darifenacina jednom na dan do postizanja stanja dinamičke ravnoteže.
English: Dizziness, dysgeusia, somnolence
Croatian: Omaglica, disgeuzija, somnolencija
English: Cystometric studies performed with darifenacin in patients with involuntary bladder contractions showed increased bladder capacity, increased volume threshold for unstable contractions and diminished frequency of unstable detrusor contractions.
Croatian: Cistometrijska ispitivanja darifenacina u bolesnika s nevoljnim kontrakcijama mokraćnog mjehura pokazala su povećanje kapaciteta mjehura, povišenje volumnog praga pri nestabilnim kontrakcijama i smanjenje učestalosti nestabilnih kontrakcija detruzora.
English: However the data available do not indicate that darifenacin changes either midazolam clearance or bioavailability.
Croatian: Dostupni podaci, međutim, ne ukazuju da darifenacin mijenja klirens niti bioraspoloživost midazolama.
English: Treatment with Emselex administered at dosages of 7.5 mg and 15 mg daily has been investigated in four double-blind, Phase III, randomised, controlled clinical studies in male and female patients with symptoms of overactive bladder.
Croatian: Liječenje Emselexom u dozama od 7,5 mg i 15 mg na dan ispitano je u četiri dvostruko slijepa, randomizirana, kontrolirana klinička ispitivanja faze III u muškaraca i žena sa simptomima prekomjerno aktivnog mokraćnog mjehura.
English: After 2 weeks of starting therapy, patients should be reassessed for efficacy and safety.
Croatian: Dva tjedna nakon početka liječenja, kod bolesnika treba provjeriti djelotvornost i sigurnost primjene lijeka.
English: The effect of warfarin on prothrombin time was not altered when co-administered with darifenacin.
Croatian: Učinak varfarina na protrombinsko vrijeme se nije promijenio pri istodobnoj primjeni s darifenacinom.
English: Darifenacin 30 mg once daily (two times greater than the recommended daily dose) co-administered with digoxin at steady state resulted in a small increase in digoxin exposure (AUC: 16% and Cmax: 20%).
Croatian: Darifenacin u dozi od 30 mg jednom na dan (dvostruko veća doza od preporučene dnevne), primijenjen istodobno s digoksinom, u stanju dinamičke ravnoteže je malo povećao izloženost digoksinu (AUC: 16% i Cmax: 20%).
English: Merus Labs Netherlands B.V., Alexander Battalaan 37
Croatian: Merus Labs Netherlands B.V., Alexander Battalaan 37 6221 CB Maastricht Nizozemska
English: A small study of subjects (n=24) with varying degrees of renal impairment (creatinine clearance between 10 ml/min and 136 ml/min) given darifenacin 15 mg once daily to steady state demonstrated no relationship between renal function and darifenacin clearance (see section 4.2).
Croatian: Ispitivanje s malim brojem ispitanika (n=24) s različitim stupnjevima oštećenja bubrega (klirens kreatinina od 10 ml/min do 136 ml/min), koji su uzimali 15 mg darifenacina jednom na dan do postizanja stanja dinamičke ravnoteže, pokazalo je da nema povezanosti između klirensa darifenacina i funkcije bubrega (vidjeti dio 4.2).
English: As with other antimuscarinic agents, Emselex may produce effects such as dizziness, blurred vision, insomnia and somnolence.
Croatian: Kao i s ostalim antimuskarinskim agensima, Emselex može izazvati učinke poput omaglice, zamućenog vida, nesanice i pospanosti.
English: The potentiation of anticholinergic effects with antiparkinson agents and tricyclic antidepressants may also occur if antimuscarinic agents are used concurrently with such medicinal products.
Croatian: Mogu se pojačati i antikolinergički učinci s lijekovima protiv parkinsonizma i tricikličkim antidepresivima, ako se ti lijekovi primjenjuju istodobno s antimuskarinskim agensima.
English: Concomitant treatment with potent CYP3A4 inhibitors (see section 4.5).
Croatian: Koji se istodobno liječe snažnim inhibitorima CYP3A4 (vidjeti dio 4.5).
English: • if you have gastric retention (problems emptying the contents of the stomach).
Croatian: • ako patite od zadržavanja sadržaja želuca (problemi s pražnjenjem sadržaja želuca).
English: Treatment with Emselex may possibly mask symptoms associated with gallbladder disease.
Croatian: Liječenje Emselexom može potencijalno prikriti simptome povezane s bolešću žučnog mjehura.
English: The recommended starting dose, including for patients aged over 65 years, is 7.5 mg daily.
Croatian: Preporučena početna doza, i za bolesnike starije od 65 godina, iznosi 7,5 mg na dan.
English: Table 2: Pooled analysis of data from three Phase III clinical studies assessing fixed doses of 7.5 mg and 15 mg Emselex
Croatian: Tablica 2: Zajednička analiza rezultata triju kliničkih ispitivanja faze III koja su procjenjivala fiksne doze od 7,5 mg i 15 mg Emselexa
English: • if you suffer from urinary retention (inability to empty your bladder).
Croatian: • ako patite od zadržavanja mokraće (nemogućnost potpunog pražnjenja mokraćnog mjehura).
English: What Emselex is and what it is used for
Croatian: Što je Emselex i za što se koristi
English: At steady state, peak-to-trough fluctuations in darifenacin concentrations are small (PTF: 0.87 for 7.5 mg and 0.76 for 15 mg), thereby maintaining therapeutic plasma levels over the dosing interval.
Croatian: U stanju dinamičke ravnoteže kolebanja između vršne i najniže koncentracije (PTF - peak-to-trough fluctuations) su mala (PTF: 0,87 za 7,5 mg i 0,76 za 15 mg), zbog čega se terapijske razine u plazmi održavaju tijekom intervala doziranja.
English: 1 Hodges Lehmann estimate: median difference from placebo in change from baseline
Croatian: 1 Procjena prema Hodges-Lehmannu: medijan promjene u odnosu na početnu vrijednost, prema placebu
English: For those patients who have an acceptable tolerability profile but require greater symptom relief, the dose may be increased to 15 mg daily, based on individual response (see section 5.2).
Croatian: Bolesnicima koji imaju prihvatljiv profil podnošljivosti, a potrebno im je izrazitije ublažavanje simptoma, doza se može povećati na 15 mg dnevno, ovisno o individualnom odgovoru (vidjeti dio 5.2).
English: A few percent of the population have increased CYP2D6 enzyme levels (ultrafast metabolisers).
Croatian: U nekoliko postotaka populacije razina enzima CYP2D6 je povišena (osobe s ultrabrzim metabolizmom lijeka).
English: However, a population pharmacokinetic analyses of Phase III data indicated that on average steady-state exposure is 66% higher in poor metabolisers than in extensive metabolisers.
Croatian: Farmakokinetička analiza faze III ispitivanja u populaciji pokazala je, međutim, da je izloženost u stanju dinamičke ravnoteže u osoba koje slabo metaboliziraju lijek u prosjeku 66% veća od one u osoba s opsežnim metabolizmom.
English: • certain medicines used to treat heart problems (e.g. flecainide, verapamil and digoxin),
Croatian: • neki lijekovi za liječenje srčanih tegoba (npr. flekainid, verapamil i digoksin),
English: There was considerable overlap between the ranges of exposures seen in these two populations (see section 4.2).
Croatian: Rasponi izloženosti tih dviju populacija znatno su se prekrivali (vidjeti dio 4.2).
English: What you need to know before you take Emselex 3.
Croatian: Što morate znati prije nego počnete uzimati Emselex 3.
English: • certain antibiotics (e.g. erythromycin, clarithromycin and rifampicin),
Croatian: • neki antibiotici (npr. eritromicin, klaritromicin i rifampicin),
English: dihydrobenzofuran ring opening and N-dealkylation of the pyrrolidine nitrogen.
Croatian: otvaranje dihidrobenzofuranskog prstena, i N-dealkilacija pirolidinskog dušika.
English: Due to a greater contribution of CYP3A4 after higher darifenacin doses, the magnitude of the effect is expected to be even more pronounced when combining ketoconazole with darifenacin 15 mg.
Croatian: Zbog izrazitijeg učinka CYP3A4 pri višim dozama darifenacina, taj učinak može biti i izraženiji ako se ketokonazol kombinira s 15 mg darifenacina.