FrancophonIA/ELRC3.0 huggingface dataset:
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Croatian: Neklinički podaci ne upućuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i kancerogenosti.
English: Entacapone and iron preparations should be taken at least 2-3 hours apart (see section 4.8).
Croatian: Entakapon i preparate željeza treba uzimati odvojeno u vremenskom razmaku od najmanje 2-3 sata (vidjeti dio 4.8).
English: As there is no experience in pregnant women, entacapone should not be used during pregnancy.
Croatian: Budući da ne postoji iskustvo s trudnicama, entakapon se ne smije koristiti tijekom trudnoće.
English: However, in an interaction study with healthy volunteers, entacapone did not change the plasma levels of S-warfarin, while the AUC for R-warfarin increased on average by 18 % [CI90 11-26%].
Croatian: Međutim, u jednom ispitivanju interakcija na zdravim dobrovoljcima, entakapon nije promijenio razine S-varfarina u plazmi, dok je AUC R-varfarina porastao prosječno za 18% [CI90 11-26%].
English: What Entacapone Teva is and what it is used for
Croatian: Što je Entakapon Teva i za što se koristi
English: TEVA Pharmaceutical Works Private Limited Company Pallagi út 13, 4042 Debrecen Hungary
Croatian: TEVA Pharmaceutical Works Private Limited Company Pallagi út 13, 4042 Debrecen
English: Entacapone binds to human albumin binding site II which also binds several other medicinal products, including diazepam and ibuprofen.
Croatian: Entakapon se veže na II. vezno mjesto ljudskog albumina na koje se također veže nekoliko drugih lijekova, uključujući diazepam i ibuprofen.
English: Follow the instructions that your doctor has given you.
Croatian: Pažljivo slijedite upute vašeg liječnika.
English: Insomnia, hallucinations, confusion, paroniria
Croatian: Nesanica, halucinacije, konfuzija, paronirija
English: The post-marketing data include isolated cases of overdose in which the reported highest daily dose of entacapone has been 16,000 mg.
Croatian: Postmarketinški podaci uključuju izolirane slučajeve predoziranja u kojima je najviša prijavljena doza entakapona bila 16 000 mg.
English: Absorption There are large intra- and interindividual variations in the absorption of entacapone.
Croatian: Apsorpcija Postoje velike intra- i interindividualne razlike u apsorpciji entakapona.
English: • if you have ever suffered from a rare muscle disorder called rhabdomyolysis which was not caused by injury.
Croatian: • ako ste ikad patili od rijetkog mišićnog poremećaja zvanog rabdomioliza, koji nije bio uzrokovan ozljedom.
English: Study II: Proportion of daily On time (%) Entacapone (n=103) Placebo (n=102)
Croatian: Ispitivanje II: udio dnevnog trajanja „ON“ faze (%) Entakapon (n=103) Placebo (n=102)
English: The safety and efficacy of Entacapone Teva in children below age 18 have not been established.
Croatian: Sigurnost i djelotvornost Entakapona Teva u djece u dobi do 18 godina nije ustanovljena.
English: Fatigue, sweating increased, fall
Croatian: Umor, pojačano znojenje, pad
English: Do not stop taking Entacapone Teva unless your doctor tells you to.
Croatian: Teva nemojte prestati uzimati, osim ako Vam to ne kaže liječnik.
English: See section 4 Possible side effects for the characteristics of NMS;
Croatian: Pogledajte dio 4. Moguće nuspojave za karakteristike NMS-a;
English: Experience with Entacapone Teva in patients under 18 years is limited.
Croatian: Teva u bolesnika mlađih od 18 godina je ograničeno.
English: Entacapone may be used with selegiline (a selective MAO-B inhibitor), but the daily dose of selegiline should not exceed 10 mg.
Croatian: Entakapon se može koristiti sa selegilinom (selektivni MAO-B inhibitor), ali dnevna doza selegilina ne smije prijeći 10 mg.
English: Patients should be regularly monitored for the development of impulse control disorders.
Croatian: U bolesnika treba redovito pratiti razvoj poremećaja kontrole impulsa.
English: For the characteristics of NMS see Section 4 Possible side effects.
Croatian: Za karakteristike NMS-a vidjeti Dio 4 Moguće nuspojave.
English: Do not drive or operate machinery if you experience these side effects.
Croatian: Nemojte voziti ili upravljati strojevima ako primjetite ove nuspojave.
English: Entacapone (n=85) Placebo (n=86)
Croatian: Placebo (n=86)
English: The daily dose of levodopa should be reduced by about 10-30% by extending the dosing intervals and/or by reducing the amount of levodopa per dose, according to the clinical condition of the patient.
Croatian: Dnevnu dozu levodope treba smanjiti za oko 10-30%, što se postiže produljenjem intervala doziranja i/ili smanjenjem količine levodope po dozi, u skladu s kliničkim stanjem bolesnika.
English: In the event of prolonged or persistent diarrhoea, the medicinal product should be discontinued and appropriate medical therapy and investigations considered.
Croatian: U slučaju produljenog ili dugotrajnog proljeva, primjenu lijeka treba prekinuti i razmotriti odgovarajuću medicinsku terapiju i pretrage.
English: In single-dose studies in healthy volunteers, no interactions were observed between entacapone and imipramine or between entacapone and moclobemide.
Croatian: U ispitivanjima s jednokratnom dozom na zdravim dobrovoljcima nisu opažene interakcije između entakapona i imipramina ili između entakapona i moklobemida.
English: In the event of an overdose, consult your doctor, pharmacist or the nearest hospital immediately.
Croatian: U slučaju predoziranja, odmah se obratite Vašem liječniku, ljekarniku ili najbližoj bolnici.
English: The total clearance of entacapone is about 800 ml/min.
Croatian: Ukupni klirens entakapona iznosi oko 800 ml/min.
English: After absorption from the gastrointestinal tract, entacapone is rapidly distributed to the peripheral tissues with a distribution volume of 20 litres at steady state (Vdss).
Croatian: Nakon apsorpcije iz gastrointestinalnog trakta entakapon se brzo raspodjeljuje u periferna tkiva s volumenom distribucije od 20 litara u stanju dinamičke ravnoteže (Vdss).
English: Date of first authorisation: 18/02/2011 Date of latest renewal: 19/11/2015
Croatian: Datum posljednje obnove: 19.11.2015.
English: Entacapone showed little or no inhibition of other types of P450 isoenzymes (CYP1A2, CYP2A6, CYP2D6, CYP2E1, CYP3A and CYP2C19) (see section
Croatian: Entakapon je pokazao malo ili nikakvo inhibiranje drugih tipova P450 izoenzima (CYP1A2, CYP2A6, CYP2D6, CYP2E1, CYP3A i CYP2C19) (vidjeti dio 4.5).
English: Because of its mechanism of action, entacapone may interfere with the metabolism of medicinal products containing a catechol group and potentiate their action.
Croatian: Zbog svog mehanizma djelovanja, entakapon može utjecati na metabolizam lijekova koji sadržavaju kateholsku skupinu i pojačati njihovo djelovanje.
English: Tell your doctor if you or your family/carer notices you are developing urges or cravings to behave in ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others.
Croatian: Obavijestite svog liječnika ako Vi ili Vaša obitelj/osoba koja se brine o Vama primijeti da se kod Vas razvijaju porivi ili neobuzdana želja da se ponašate na način koji je neuobičajen za Vas ili da se ne možete oduprijeti porivu, nagonu ili iskušenju da napravite nešto što bi moglo naštetiti Vama ili drugima.
English: (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data, since no valid estimate can be derived from clinical trials or epidemiological studies).
Croatian: rijetko (≥1/10 000, <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka, budući da se iz kliničkih ili epidemioloških ispitivanja ne može izvući valjana procjena).
English: EU/1/10/665/001 - 30 tablets EU/1/10/665/002 - 60 tablets EU/1/10/665/003 - 100 tablets EU/1/10/665/004 - 175 tablets
Croatian: EU/1/10/665/001 - 30 tableta EU/1/10/665/002 - 60 tableta EU/1/10/665/003 - 100 tableta EU/1/10/665/004 - 175 tableta
English: Week 8-24 66.8±14.5
Croatian: Početna vrijednost Tjedan 8-24 66,8±14,5
English: EU/1/10/665/002 - 60 tablets EU/1/10/665/003 - 100 tablets EU/1/10/665/004 - 175 tablets
Croatian: EU/1/10/665/002 - 60 tableta EU/1/10/665/003 - 100 tableta EU/1/10/665/004 - 175 tableta
English: Dyskinesias (27%), nausea (11%), diarrhoea (8%), abdominal pain (7%) and dry mouth (4.2%) were reported significantly more often with entacapone than with placebo in pooled data from clinical studies involving 406 patients taking the medicinal product and 296 patients taking placebo.
Croatian: Diskinezije (27%), mučnina (11%), proljev (8%), bol u trbuhu (7%) i suhoća usta (4,2%) zabilježene su značajno češće s entakaponom nego s placebom u objedinjenim podacima iz kliničkih ispitivanja koja su uključivala 406 bolesnika koji su uzimali lijek i 296 bolesnika koji su uzimali placebo.
English: This leads to a higher levodopa AUC.
Croatian: To dovodi do povećanja AUC levodope.
English: It is a reversible, specific, and mainly peripherally acting COMT inhibitor designed for concomitant administration with levodopa preparations.
Croatian: On je reverzibilan, specifičan i uglavnom periferno aktivan inhibitor COMT namijenjen za istovremenu primjenu s preparatima levodope.
English: Hepatitis with mainly cholestatic features (see section 4.4.)
Croatian: Hepatitis s uglavnom kolestatskim obilježjima (vidjeti dio 4.4)
English: Entacapone is extensively bound to plasma proteins, mainly to albumin.
Croatian: Entakapon se u velikoj mjeri veže na proteine plazme, uglavnom na albumin.
English: How to store Entacapone Teva Contents of the pack and other information
Croatian: Kako čuvati Entakapon Teva Sadržaj pakiranja i druge informacije
English: Due to its affinity to cytochrome P450 2C9 in vitro (see section 5.2), entacapone may potentially interfere with medicinal products with metabolism dependent on this isoenzyme, such as S-warfarin.
Croatian: Zbog svog afiniteta prema citokromu P450 2C9 in vitro (vidjeti dio 5.2), entakapon može potencijalno interferirati s lijekovima čiji metabolizam ovisi o ovom izoenzimu, kao što je S-varfarin.
English: Pharmacotherapeutic group: other dopaminergic agents, ATC code: N04BX02.
Croatian: Farmakoterapijska skupina: ostali dopaminergici, ATK oznaka: N04BX02.
English: Data from in vitro studies using human liver microsomal preparations indicate that entacapone inhibits cytochrome P450 2C9 (IC50 ~4 μM).
Croatian: Podaci iz in vitro ispitivanja uz korištenje humanih jetrenih mikrosomalnih preparata pokazuju da entakapon inhibira citokrom P450 2C9 (IC50 ~ 4 μM).
English: In animal studies entacapone was excreted in milk.
Croatian: U ispitivanjima na životinjama, entakapon se izlučivao mlijekom.
English: Other medicines and Entacapone Teva
Croatian: Drugi lijekovi i Entakapon Teva
English: Weight decrease * Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon
Croatian: * Nuspojave su poredane prema učestalosti, pri čemu se na početku navode najčešće, koristeći sljedeće izraze: vrlo često (≥1/10), često (≥1/100, <1/10), manje često (≥1/1000, <1/100),
English: Entacapone inhibits the COMT enzyme mainly in peripheral tissues.
Croatian: Entakapon inhibira enzim COMT uglavnom u perifernim tkivima.
English: These behaviours are called impulse control disorders and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or a preoccupation with an increase in sexual thoughts or feelings.
Croatian: Ta se ponašanja nazivaju poremećaji kontrole impulsa i mogu uključivati ovisnost o kockanju, pretjerano jedenje ili trošenje, pretjerano pojačan seksualni nagon ili učestala zaokupljenost seksualnim mislima ili osjećajima.
English: Do not use this medicine after the expiry date which is stated on the carton and tablet container label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i na naljepnici spremnika za tablete iza oznake EXP.
English: No overt teratogenic or primary foetotoxic effects were observed in animal studies in which the exposure levels of entacapone were markedly higher than the therapeutic exposure levels.
Croatian: Nisu opaženi očiti teratogeni niti primarni fetotoksični učinci u ispitivanjima na životinjama, u kojima su razine izloženosti entakaponu bile značajno više od terapijskih razina izloženosti.
English: Only traces of entacapone are found unchanged in urine.
Croatian: U mokraći su nađeni samo tragovi nepromijenjenog entakapona.
English: • if you have ever suffered from a rare reaction to antipsychotic medicines called neuroleptic malignant syndrome (NMS).
Croatian: • ako ste ikad imali rijetku reakciju na antipsihotike zvanu neuroleptički maligni sindrom
English: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
Croatian: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, Ujedinjeno Kraljevstvo
English: Mogilska 80, 31-546, Krakow Poland
Croatian: Mogilska 80, 31-546, Krakow Poljska
English: Clinical interaction studies with diazepam and non-steroidal antiinflammatory medicinal products have not been carried out.
Croatian: Klinička ispitivanja interakcija s diazepamom i nesteroidnim protuupalnim lijekovima nisu provedena.
English: However, for patients who are receiving dialysis therapy, a longer dosing interval may be considered (see section 5.2).
Croatian: Međutim, u bolesnika na dijalizi može se razmotriti mogućnost produljenja intervala doziranja (vidjeti dio 5.2).
English: COMT inhibition in red blood cells closely follows the plasma concentrations of entacapone, thus clearly indicating the reversible nature of COMT inhibition.
Croatian: Inhibicija COMT u eritrocitima vjerno prati koncentracije entakapona u plazmi, što jasno upućuje na reverzibilnu prirodu inhibicije COMT.
English: Mogilska 80, 31-546, Krakow, Poland
Croatian: Mogilska 80, 31-546, Krakow, Poljska
English: If you are receiving dialysis for renal insufficiency, your doctor may tell you to increase the time between doses.
Croatian: Ako zbog zatajenja bubrega idete na dijalizu, liječnik Vam može reći da povećate vremenski razmak između doza.
English: Prolonged or persistent diarrhoea appearing during use of entacapone may be a sign of colitis.
Croatian: Produljeni ili dugotrajni proljev koji se javlja tijekom primjene entakapona može biti znak kolitisa.
English: - Phaeochromocytoma.
Croatian: - Feokromocitom.
English: Entacapone is indicated as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Croatian: Entakapon je indiciran kao dodatak standardnim preparatima levodope/benzerazida ili levodope/karbidope, za primjenu u odraslih bolesnika s Parkinsonovom bolešću i motoričkim fluktuacijama pri kraju doze koji se ne mogu stabilizirati tim kombinacijama.
English: The acute symptoms and signs in these cases of overdose included confusion, decreased activity, somnolence, hypotonia, skin discolouration and urticaria.
Croatian: Akutni simptomi i znakovi u ovim su slučajevima predoziranja uključivali konfuziju, smanjenu aktivnost, somnolenciju, hipotoniju, promjene boje kože i urtikariju.
English: Week 8-24 10.7±2.2
Croatian: Početna vrijednost Tjedan 8-24 10,7±2,2
English: if you experience increasing loss of appetite, weakness, exhaustion and weight loss within a relatively short period of time, a general medical evaluation including liver function should be considered.
Croatian: • ako imate povećani gubitak apetita, slabost, iscrpljenost i gubitak tjelesne težine unutar relativno kratkog vremenskog perioda, potrebno je razmisliti o općem liječničkom pregledu, uključujući pretragu jetrene funkcije.
English: In human plasma the unbound fraction is about 2.0% in the therapeutic concentration range.
Croatian: Udio nevezanog lijeka u ljudskoj plazmi iznosi oko 2% u rasponu terapijskih koncentracija.
English: - Concomitant use of a selective MAO-A inhibitor plus a selective MAO-B inhibitor and entacapone (see section 4.5).
Croatian: - Istovremena primjena selektivnog MAO-A inhibitora i selektivnog MAO-B inhibitora s entakaponom (vidjeti dio 4.5).
English: Entacapone should be given cautiously to patients who are taking other medicinal products which may cause orthostatic hypotension.
Croatian: Entakapon treba davati s oprezom bolesnicima koji uzimaju druge lijekove koji mogu izazvati ortostatsku hipotenziju.
English: Pharmacokinetic interaction with benserazide has not been studied.
Croatian: Farmakokinetska interakcija s benzerazidom nije ispitivana.
English: Caution should be exercised when these medicinal products are used concomitantly with entacapone (see also sections 4.3 and 4.4).
Croatian: Kada se ovi lijekovi koriste istovremeno s entakaponom potreban je oprez (vidjeti također dijelove 4.3 and 4.4).
English: To reduce levodopa-related dopaminergic adverse reactions, it is often necessary to adjust levodopa dosage within the first days to first weeks after initiating entacapone treatment, according to the clinical condition of the patient (see sections 4.2 and 4.8).
Croatian: Da bi se smanjile dopaminergičke nuspojave povezane s levodopom, često je potrebno prilagoditi doziranje levodope tijekom prvih dana ili prvih tjedana od početka liječenja entakaponom, u skladu s kliničkim stanjem bolesnika (vidjeti dijelove 4.2 i 4.8).
English: The following adverse reactions, listed below in Table 1, have been accumulated both from clinical studies with entacapone and since the introduction of entacapone into the market.
Croatian: Sljedeće nuspojave, niže navedene u Tablici 1, prikupljene su i iz kliničkih ispitivanja entakapona i nakon stavljanja entakapona na tržište.
English: Rhabdomyolysis secondary to severe dyskinesias or neuroleptic malignant syndrome (NMS) has been observed rarely in patients with Parkinson's disease.
Croatian: Rabdomioliza kao posljedica teških diskinezija ili neuroleptičkog malignog sindroma (NMS) rijetko je opažena u bolesnika s Parkinsonovom bolešću.
English: Hence, patients who are taking standard levodopa/benserazide preparations may need a larger reduction of levodopa dose when entacapone is initiated.
Croatian: Stoga bolesnici koji uzimaju standardne preparate levodope/benzerazida mogu imati potrebu za većim smanjenjem doze levodope pri uvođenju entakapona.
English: Management of acute overdose is symptomatic.
Croatian: Akutno predoziranje liječi se simptomatski.
English: Entacapone Teva has no effect on relieving the symptoms of Parkinson´s disease unless taken with levodopa.
Croatian: Entakapon Teva nema učinak na ublažavanje simptoma Parkinsonove bolesti ako nije uzet s levodopom.
English: General characteristics of the active substance
Croatian: Opća svojstva djelatne tvari
English: According to in vitro studies, significant displacement is not anticipated at therapeutic concentrations of the medicinal products.
Croatian: Prema in vitro ispitivanjima, ne očekuje se značajnije istiskivanje u terapijskim koncentracijama lijekova.
English: In two phase III double-blind studies in a total of 376 patients with Parkinson's disease and end-ofdose motor fluctuations, entacapone or placebo was given with each levodopa/dopa decarboxylase inhibitor dose.
Croatian: U fazi III dvaju dvostruko slijepih ispitivanja s ukupno 376 bolesnika s Parkinsonovom bolešću i motoričkim fluktuacijama pri kraju doze davani su entakapon ili placebo sa svakom dozom levodope/
English: When considered necessary, withdrawal of entacapone and other dopaminergic treatment should proceed slowly, and if signs and/or symptoms occur despite a slow withdrawal of entacapone, an increase in levodopa dosage may be necessary.
Croatian: Kad se pokaže potrebnim, liječenje entakaponom i drugim dopaminergičkim lijekovima treba ukidati polako, a ako se usprkos polaganom ukidanju entakapona pojave znakovi i/ili simptomi, može biti potrebno povećanje doziranja levodope.
English: The peak concentration (Cmax) in plasma is usually reached about one hour after ingestion of a 200 mg entacapone tablet.
Croatian: Vršna koncentracija (Cmax) u plazmi postiže se obično oko jedan sat nakon uzimanja tablete od
English: At therapeutic concentrations, entacapone does not displace other extensively bound substances (e.g. warfarin, salicylic acid, phenylbutazone, or diazepam), nor is it displaced to any significant extent by any of these substances at therapeutic or higher concentrations.
Croatian: U terapijskim koncentracijama entakapon ne istiskuje druge, snažno vezane lijekove (npr. varfarin, salicilnu kiselinu, fenilbutazon ili diazepam) niti ga bilo koji od ovih lijekova može značajnije istisnuti u terapijskim ili višim koncentracijama.
English: The elimination of entacapone occurs mainly by non-renal metabolic routes.
Croatian: Eliminacija entakapona odvija se uglavnom metaboličkim putevima mimo bubrega.
English: Therefore, do not take Entacapone Teva and iron supplements at the same time.
Croatian: Entakapon Teva i preparate željeza u isto vrijeme.
English: Entacapone in association with levodopa has been associated with isolated cases of excessive daytime somnolence and sudden sleep onset episodes.
Croatian: Entakapon udružen s levodopom bio je povezan s izoliranim slučajevima pretjerane pospanosti tijekom dana i epizodama iznenadnog nastupa sna.
English: A small amount of entacapone, the (E)-isomer, is converted to its (Z)-isomer.
Croatian: Mala količina entakapona, (E)-izomer, pretvara se u njegov (Z)-izomer. (E)-izomer čini 95% AUC
English: Very rare (may affect up to 1 in 10,000 people): - Agitation; - decreased appetite, weight loss; - hives.
Croatian: Vrlo rijetko (mogu se javiti u do 1 na 10 000 osoba): - uznemirenost; - smanjeni apetit, gubitak tjelesne težine;
English: Consequently, adverse dopaminergic reactions may be more frequent when entacapone is added to levodopa/benserazide treatment (see also section 4.8).
Croatian: Posljedično, neželjeni dopaminergički učinci mogli bi biti češći nakon dodatka entakapona liječenju levodopom/benzerazidom (vidjeti također dio 4.8).
English: Entacapone decreases the metabolic loss of levodopa to 3O-methyldopa (3-OMD) by inhibiting the COMT enzyme.
Croatian: Entakapon smanjuje metaboličku pretvorbu levodope u 3-Ometildopu (3-OMD) inhibirajući enzim COMT.
English: Entacapone enhances the effects of levodopa.
Croatian: Entakapon pojačava učinke levodope.
English: In clinical studies the most common adverse reactions leading to discontinuation of entacapone treatment have been gastrointestinal symptoms (e.g. diarrhoea, 2.5%) and increased dopaminergic adverse reactions of levodopa (e.g. dyskinesias, 1.7%).
Croatian: Najčešće nuspojave u kliničkim ispitivanjima, koje su zahtijevale prekid liječenja entakaponom, bile su gastrointestinalni simptomi (npr. proljev, 2,5%) i povećane dopaminergičke nuspojave levodope (npr. diskinezije, 1,7%).
English: Entacapone Teva in association with levodopa may have major influence on the ability to drive and use machines.
Croatian: Teva udružen s levodopom može imati velik utjecaj na sposobnost upravljanja vozilima i strojevima.
English: Some of the side effects are often caused by the increased effects of levodopa therapy and are most common at the start of treatment.
Croatian: Nuspojave su često izazvane pojačanim učinkom terapije levodopom i najčešće su na početku liječenja.
English: You may also use other medicines to treat Parkinson's disease at the same time.
Croatian: Istovremeno smijete uzimati i druge lijekove za terapiju Parkinsonove bolesti.
English: Thus, control of INR is recommended when entacapone treatment is initiated for patients receiving warfarin.
Croatian: Zbog toga se preporučuje kontroliranje INR-a kada se entakapon počinje primjenjivati bolesnicima koji primaju varfarin.