FrancophonIA/ELRC3.0 huggingface dataset:
English: Sycrest is not approved for the treatment of elderly patients with dementia and is not recommended for use in this particular group of patients.
Croatian: Sycrest nije odobren za liječenje starijih bolesnika s demencijom i ne preporučuje se za primjenu u toj specifičnoj skupini bolesnika.
English: Appropriate care is advised when prescribing Sycrest for patients who will be experiencing conditions that may contribute to an elevation in core body temperature, e.g. exercising strenuously, exposure to extreme heat, receiving concomitant medicinal products with anticholinergic activity or being subject to dehydration.
Croatian: Preporučuje se odgovarajući nadzor kad se Sycrest propisuje bolesnicima koji će biti izloženi stanjima koja pridonose povišenju bazalne tjelesne temperature, npr. intenzivnom vježbanju, ekstremnim vrućinama, istodobnom uzimanju lijekova s antikolinergičkim djelovanjem ili dehidraciji.
English: Drynam Road, Swords, Co. Dublin Ireland
Croatian: Drynam Road, Swords, Co.
English: Both asenapine doses (5 mg BID and 10 mg BID) were superior to placebo and showed statistically significant improvement in change from baseline in Y-MRS total score at Day 21 compared with placebo.
Croatian: Obje doze asenapina (5 mg dvaput na dan i 10 mg dvaput na dan) bile su superiorne u odnosu na placebo i pokazale su statistički značajno poboljšanje u promjeni ukupnog rezultata na ljestvici Y-MRS od početnog do onog u 21. danu u usporedbi s placebom.
English: Asenapine was excreted in milk of rats during lactation.
Croatian: Asenapin se izlučuje u mlijeko štakorica u laktaciji.
English: The pharmacokinetics of asenapine were similar among subjects with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment and subjects with normal hepatic function.
Croatian: Farmakokinetika asenapina bila je slična u ispitanika s blagim (Child-Pugh stadij A) ili umjerenim (Child-Pugh stadij B) oštećenjem funkcije jetre i ispitanika s normalnom funkcijom jetre.
English: Asenapine may cause sleepiness, sudden drops in blood pressure when you stand up, dizziness and changes in your ability to move and balance, which may lead to falls and, consequently, fractures or other injuries.
Croatian: Asenapin može uzrokovati pospanost, nagli pad krvnog tlaka pri ustajanju, omaglicu i promjene Vaše sposobnosti za kretanje i održavanje ravnoteže, što može dovesti do padova te posljedično prijeloma ili drugih ozljeda.
English: The absolute bioavailability of sublingual asenapine at 5 mg is 35 %.
Croatian: Apsolutna bioraspoloživost sublingvalno primijenjene doze asenapina od 5 mg iznosi 35%.
English: The possibility of elevated asenapine plasma levels cannot be excluded in some patients with moderate hepatic impairment (Child-Pugh B) and caution is advised.
Croatian: Ne može se isključiti mogućnost povišenja razine asenapina u plazmi u nekih bolesnika s umjereno oštećenom funkcijom jetre (Child-Pugh stadij B) te se preporučuje oprez.
English: In a dedicated study, concomitant smoking during administration of a single 5 mg sublingual dose had no effect on the pharmacokinetics of asenapine.
Croatian: U posebnom je ispitivanju ustanovljeno da pušenje tijekom sublingvalne primjene jednokratne doze od 5 mg nije utjecalo na farmakokinetiku asenapina.
English: Sycrest should be used with caution in elderly patients and in patients with known cardiovascular disease (e.g., heart failure, myocardial infarction or ischemia, conduction abnormalities), cerebrovascular disease, or conditions that predispose the patient to hypotension (e.g., dehydration and hypovolemia).
Croatian: Sycrest se mora primjenjivati uz oprez u starijih te u bolesnika s poznatom kardiovaskularnom bolešću (npr. zatajenjem srca, infarktom ili ishemijom miokarda, smetnjama provođenja), cerebrovaskularnom bolešću ili stanjima koja su predispozicija za hipotenziju (npr. dehidracija i hipovolemija).
English: - Do not swallow or chew on the tablet.
Croatian: - Nemojte progutati niti žvakati tabletu.
English: The pharmacokinetics of asenapine following a single dose of 5 mg asenapine were similar among subjects with varying degrees of renal impairment and subjects with normal renal function.
Croatian: Farmakokinetika asenapina nakon jedne doze od 5 mg bila je slična u ispitanika s različitim stupnjevima oštećenja funkcije bubrega i ispitanika s normalnom funkcijom bubrega.
English: In the combined short-term and long-term schizophrenia and bipolar mania trials in adults, the mean change in body weight for asenapine was 0.8 kg.
Croatian: U kombiniranim kratkoročnim i dugoročnim ispitivanjima u odraslih bolesnika sa shizofrenijom i manijom u bipolarnom poremećaju, prosječna promjena tjelesne težine u bolesnika liječenih asenapinom iznosila je 0,8 kg.
English: When asenapine was administered intravenously to pregnant rabbits, no signs of embryotoxicity were observed.
Croatian: Kad je asenapin skotnim ženkama kunića primijenjen intravenski, nisu opaženi znakovi embriotoksičnosti.
English: Elderly patients are particularly at risk for experiencing orthostatic hypotension (see section 4.8).
Croatian: Rizik od nastupa ortostatske hipotenzije osobito je izražen u starijih bolesnika (vidjeti dio 4.8).
English: - Do not push the tablet through the blister.
Croatian: - Nemojte protiskivati tabletu kroz blister.
English: Appropriate clinical monitoring is advisable in diabetic patients and in patients with risk factors for the development of diabetes mellitus.
Croatian: Preporučuje se odgovarajući klinički nadzor dijabetičara i bolesnika s čimbenicima rizika za razvoj dijabetesa.
English: Asenapine is a weak inhibitor of CYP2D6.
Croatian: Asenapin je slab inhibitor CYP2D6.
English: If a patient develops signs and symptoms indicative of NMS Sycrest must be discontinued.
Croatian: Ako se u bolesnika pojave znakovi i simptomi koji ukazuju na NMS, primjena lijeka Sycrest mora se prekinuti.
English: Do not use this medicine after the expiry date which is stated on the blister and on the carton.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake "EXP".
English: Paediatric studies with Sycrest were performed using flavoured sublingual tablets.
Croatian: Pedijatrijska ispitivanja lijeka Sycrest provedena su uz primjenu sublingvalnih tableta s okusom.
English: Co-administration of a single 20 mg dose of paroxetine (a CYP2D6 substrate and inhibitor) during treatment with 5 mg asenapine twice daily in 15 healthy male subjects resulted in an almost 2-fold increase in paroxetine exposure.
Croatian: Istodobna primjena jedne doze od 20 mg paroksetina (supstrata i inhibitora CYP2D6) tijekom liječenja asenapinom u dozi od 5 mg dvaput na dan u 15 zdravih muških ispitanika rezultirala je gotovo dvostrukim porastom izloženosti paroksetinu.
English: In adolescents, the 10 mg twice daily dose did not result in increased exposure compared to 5 mg twice daily.
Croatian: U adolescenata doza od 10 mg dvaput na dan nije rezultirala povećanom izloženosti u odnosu na dozu od 5 mg dvaput na dan.
English: The recommended dose is a sublingual tablet of 5 mg or 10 mg two times a day.
Croatian: Preporučena doza je jedna sublingvalna tableta od 5 mg dvaput na dan ili jedna tableta od 10 mg dvaput na dan.
English: All patients met the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnostic criteria for bipolar I disorder, current episode manic (DSM-IV 296.4x), or mixed (DSM-IV 296.6x) and had a Young Mania Rating Scale (Y-MRS) score of ≥ 20 at screening and baseline.
Croatian: Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, DSM-IV) za bipolarni poremećaj tipa I, sadašnju maničnu (DSM-IV 296.4x) ili miješanu epizodu (DSM-IV 296.6x), te su u trenutku probira i na početku ispitivanja imali rezultat ≥ 20 na ljestvici za ocjenu stupnja manije po Youngu (engl.
English: Falls may occur as a result of one or more adverse events such as the following: Somnolence, Orthostatic hypotension, Dizziness, Extrapyramidal symptoms.
Croatian: Padovi mogu nastupiti kao posljedica jednog ili više štetnih događaja kao što su: somnolencija, ortostatska hipotenzija, omaglica, ekstrapiramidalni simptomi.
English: In this short-term, fixed-dose controlled trial there was no evidence of added benefit with a 10 mg twice daily dose compared to 5 mg twice daily.
Croatian: U ovom kratkoročnom kontroliranom ispitivanju fiksne doze nije bilo dokaza o dodatnoj koristi doze od 10 mg dvaput na dan u usporedbi s dozom od 5 mg dvaput na dan.
English: Gelatin Mannitol (E421)
Croatian: 6.1 Popis pomoćnih tvari želatina manitol (E421)
English: The following symptoms may occur in newborn babies, of mothers that have used Sycrest in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Croatian: U novorođenčadi čije su majke uzimale Sycrest u zadnjem tromjesečju trudnoće (u posljednja tri mjeseca trudnoće) opaženi su sljedeći simptomi: tresavica, ukočenost i/ili slabost mišića, pospanost, uznemirenost, problemi s disanjem i poteškoće pri hranjenju.
English: When used in combination with other medicinal products, Sycrest should be taken last.
Croatian: Kad se Sycrest koristi u kombinaciji s drugim lijekovima, mora se uzeti zadnji.
English: tongue, or jaw, slow or sustained muscle contractions, muscle spasms, tremor (shaking),
Croatian: jezika ili čeljusti, usporeno ili dugotrajno stezanje mišića, grčeve u mišićima, tresenje (tremor),
English: Alanine aminotransferas e increased
Croatian: Poremećaji jetre i žuči povišena razina alanin aminotransferaze
English: The onset of extrapyramidal symptoms is a risk factor for tardive dyskinesia.
Croatian: Nastup ekstrapiramidalnih simptoma predstavlja čimbenik rizika za tardivnu diskineziju.
English: In a population pharmacokinetic analysis, no clinical relevant effects of race on the pharmacokinetics of asenapine were found.
Croatian: U analizi populacijske farmakokinetike nisu ustanovljeni klinički relevantni učinci rase na farmakokinetiku asenapina.
English: Serious side effects have been reported with this medicine.
Croatian: Ozbiljne nuspojave bile su prijavljene tijekom primjene ovog lijeka.
English: Sycrest activity is primarily due to the parent compound.
Croatian: Djelovanje lijeka Sycrest je prije svega posljedica djelovanja osnovnog spoja.
English: Asenapine is a high clearance compound, with a clearance after intravenous administration of 52 L/h.
Croatian: Asenapin je spoj visokog klirensa, koji nakon intravenske primjene iznosi 52 l/h.
English: The most common adverse reactions (proportion of patients  5 % and at least twice placebo) reported in paediatric patients with schizophrenia were somnolence, sedation, akathisia, dizziness, and hypoaesthesia oral.
Croatian: Najčešće nuspojave (udio bolesnika od ≥ 5% i najmanje dvostruko u odnosu na placebo) prijavljene u pedijatrijskih bolesnika sa shizofrenijom bile su somnolencija, sedacija, akatizija, omaglica i oralna hipoestezija.
English: Patients with severe hepatic impairment
Croatian: Bolesnici s teškim oštećenjem funkcije jetre
English: Sycrest is not approved for the treatment of patients with dementia-related psychosis and is not recommended for use in this particular group of patients.
Croatian: Sycrest nije odobren za liječenje starijih bolesnika s psihozom povezanom s demencijom i ne preporučuje se za primjenu u toj određenoj skupini bolesnika.
English: Manic episodes associated with bipolar I disorder is a condition with symptoms such as feeling “high”, having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.
Croatian: I su bolest koju prate simptomi poput osjećaja ushićenja, prekomjerne količine energije, puno manje potrebe za snom nego je uobičajeno, vrlo brzog govora s ubrzanim tijekom misli te ponekad jake razdražljivosti.
English: Tell your doctor right away if you have: - signs of increased blood sugar levels such as excessive thirst, hunger or urination, weakness or onset of worsening of diabetes - worm-like movements of the tongue, or other uncontrolled movements of the tongue, mouth,
Croatian: Odmah obavijestite svog liječnika ukoliko imate: - znakove povećane razine šećera u krvi kao što su izrazita žeđ, glad ili učestalo mokrenje, slabost ili pojava, odnosno pogoršanje šećerne bolesti - crvoliki pokreti jezika ili drugi nekontrolirani pokreti jezika, usta, obraza ili vilice koji se mogu proširiti na ruke i noge
English: NL-5349 AB Oss The Netherlands
Croatian: NL-5349 AB Oss
English: Asenapine exhibits high affinity for serotonin 5-HT1A, 5-HT1B, 5-HT2A, 5-HT2B, 5-HT2C, 5-HT5, 5-HT6, and 5-HT7 receptors, dopamine D2, D3, D4, and D1 receptors, α1 and α2-adrenergic receptors, and histamine H1 receptors, and moderate affinity for H2 receptors.
Croatian: Asenapin pokazuje visok afinitet za 5-HT1A, 5-HT1B, 5-HT2A, 5-HT2B, 5-HT2C, 5-HT5, 5-HT6 i 5-HT7 receptore serotonina, D2, D3, D4 i D1 receptore dopamina, α1 i α2-adrenergičke receptore i H1 receptore histamina, te umjeren afinitet za H2 receptore.
English: Newborn infants exposed to antipsychotics (including Sycrest) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
Croatian: Postoji rizik da u novorođenčadi izloženoj antipsihoticima (uključujući Sycrest) u trećem tromjesečju trudnoće nakon rođenja nastupe nuspojave, uključujući ekstrapiramidalne i/ili simptome ustezanja različite težine i trajanja.
English: There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder in newborn infants.
Croatian: U novorođenčadi su prijavljeni agitacija, hipertonija, hipotonija, tremor, somnolencija, respiratorni distres ili poremećaj hranjenja.
English: In a separate study, co-administration of a single 75 mg dose of imipramine with a single 5 mg dose of asenapine did not affect the plasma concentrations of the metabolite desipramine (a CYP2D6 substrate).
Croatian: U drugom ispitivanju istodobna primjena jedne doze imipramina od 75 mg i jedne doze asenapina od 5 mg nije utjecala na koncentraciju metabolita dezipramina (supstrata CYP2D6) u plazmi.
English: Within each frequency grouping, ADRs are presented in order of decreasing seriousness.
Croatian: Unutar iste skupine učestalosti nuspojave su navedene u padajućem nizu prema ozbiljnosti.
English: Therefore, Sycrest should be co-administered cautiously with medicinal products that are both substrates and inhibitors for CYP2D6.
Croatian: Stoga se Sycrest moraprimjenjivati uz oprez istodobno s lijekovima koji su ujedno supstrati i inhibitori CYP2D6.
English: Treatment-related adverse reactions included agitation and confusion, akathisia, orofacial dystonia, sedation, and asymptomatic ECG findings (bradycardia, supraventricular complexes, intraventricular conduction delay).
Croatian: Nuspojave povezane s liječenjem obuhvaćale su agitaciju i konfuziju, akatiziju, orofacijalnu distoniju, sedaciju i asimptomatske promjene na EKG-u (bradikardiju, supraventrikularne komplekse, kašnjenje intraventrikularnog provođenja).
English: During combined administration with a single dose of asenapine 5 mg, fluvoxamine 25 mg twice daily resulted in a 29 % increase in asenapine AUC.
Croatian: Pri istodobnoj primjeni s jednom dozom asenapina od 5 mg, fluvoksamin u dozi od 25 mg dvaput na dan povećao je AUC asenapina za 29%.
English: In a PK study using unflavoured sublingual tablets, at the 5 mg twice daily dose level, asenapine pharmacokinetics in adolescent patients (12 to 17 years of age, inclusive) are similar to those observed in adults.
Croatian: U ispitivanju farmakokinetike uz primjenu sublingvalnih tableta bez okusa, pri razini doze od 5 mg dvaput na dan, farmakokinetika asenapina u bolesnika adolescentske dobi (12 do uključivo 17 godina) slična je onoj opaženoj u odraslih.
English: There have been post-marketing reports of serious hypersensitivity reactions in patients treated with asenapine, including anaphylactic/anaphylactoid reactions, angioedema, swollen tongue and swollen throat (pharyngeal oedema).
Croatian: Nakon stavljanja lijeka u promet prijavljene su ozbiljne reakcije preosjetljivosti u bolesnika liječenih asenapinom, uključujući anafilaktičke/anafilaktoidne reakcije, angioedem, oticanje jezika i grla (faringealni edem).
English: You should avoid drinking alcohol when taking this medicine.
Croatian: Kad uzimate ovaj lijek, morate izbjegavati pijenje alkohola.
English: Therefore, make sure your concentration and alertness are not affected before you drive or operate machinery.
Croatian: Stoga nemojte voziti ili upravljati strojevima prije nego se uvjerite da Vaša koncentracija i budnost nisu ometene.
English: The efficacy of asenapine in the treatment of a DSM-IV manic or mixed episode of bipolar I disorder with or without psychotic features was evaluated in two similarly designed 3-week, randomized, double-blind, flexible-dose, placebo- and active controlled (olanzapine) monotherapy trials involving 488 and 489 patients, respectively.
Croatian: I Djelotvornost asenapina u liječenju maničnih ili miješanih epizoda u bipolarnom poremećaju tipa I (prema DSM-IV) s psihotičnim značajkama ili bez njih ocijenjena je u dva trotjedna randomizirana, dvostruko slijepa ispitivanja s promjenjivom dozom u monoterapiji, koja su bila slično osmišljena te kontrolirana placebom (488 bolesnika), odnosno aktivnim lijekom (olanzapinom) (489 bolesnika).
English: The possibility of a suicide attempt is inherent in psychotic illnesses and bipolar disorder and close supervision of high-risk patients should accompany treatment.
Croatian: Mogućnost pokušaja samoubojstva nije rijetkost u osoba s psihičkim bolestima i bipolarnim poremećajem; stoga je tijekom liječenja potreban strogi nadzor visokorizičnih bolesnika.
English: Do not crush, chew or swallow.
Croatian: Nemojte drobiti, žvakati niti progutati.
English: Thus, Sycrest is not recommended in patients with severe hepatic impairment.
Croatian: Stoga se Sycrest ne preporučuje u bolesnika s teškim oštećenjem funkcije jetre.
English: Asenapine may cause adverse effects such as somnolence, orthostatic hypotension, dizziness and extrapyramidal symptoms, which may lead to falls and, consequently, fractures or other injuries.
Croatian: Asenapin može uzrokovati nuspojave kao što su somnolencija, ortostatska hipotenzija, omaglica i ekstrapiramidalni simptomi, što može dovesti do padova te posljedično prijeloma ili drugih ozljeda.
English: How to store Sycrest
Croatian: Kako čuvati Sycrest
English: From the short-term (6 weeks) schizophrenia trials there appears to be a dose-response relationship for akathisia in patients treated with asenapine, and for parkinsonism there was an increasing trend with higher doses.
Croatian: Rezultati kratkoročnih (šestotjednih) ispitivanja u bolesnika sa shizofrenijom ukazuju da u bolesnika liječenih asenapinom postoji povezanost između doze i odgovora kod akatizije, dok je kod parkinsonizma uočen trend povećanja pri većim dozama.
English: H. Lundbeck AB Tel: + 46 40 699 82 00
Croatian: Lundbeck AB Tel: + 46 40 699 82 00
English: Following co-administration of dextromethorphan and asenapine in healthy subjects, the ratio of dextrorphan/dextromethorphan (DX/DM) as a marker of CYP2D6 activity was measured.
Croatian: Nakon istodobne primjene dekstrometorfana i asenapina zdravim ispitanicima mjeren je omjer dekstrorfana i dekstrometorfana (DX/DM) kao biljeg aktivnosti CYP2D6.
English: abnormal movements of the eyes, involuntary muscle contractions, slow movements, or restlessness - unpleasant sensations in the legs (also called restless legs syndrome) - speech problems - abnormal slow or fast heartbeat - middle heart block - abnormal electrocardiogram (prolongation of the QT interval) - low blood pressure upon standing - low blood pressure - tingling of the tongue or in the mouth - swollen or painful tongue - difficulty in swallowing - ulcers, soreness, redness, swelling, and blisters within the mouth - sexual dysfunction - lack of regular menstrual periods
Croatian: neuobičajene pokrete očiju, nevoljno stezanje mišića, usporene pokrete ili nemir - neugodni osjeti u nogama (nazivaju se i sindrom nemirnih nogu) - smetnje govora - neuobičajeno spori ili brzi otkucaji srca - blok provodnog sustava srca - odstupanja u nalazu elektrokardiograma (produljenje QT-intervala) - niski krvni tlak pri ustajanju - niski krvni tlak - trnci po jeziku ili u ustima - otečen ili bolan jezik - poteškoće s gutanjem - vrijedovi, afte, crvenilo, oticanje i mjehurići u ustima - poremećaj spolne funkcije - neredoviti mjesečni ciklusi
English: Sycrest is for sublingual use.
Croatian: Sycrest se primjenjuje sublingvalno.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Sycrest in one or more subsets of the paediatric population in bipolar I disorder (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka Sycrest u jednoj ili više podskupina pedijatrijske populacije u bipolarnom poremećaju tipa
English: Breast-feeding should be discontinued during treatment with Sycrest.
Croatian: Tijekom liječenja lijekom Sycrest mora se prekinuti s dojenjem.
English: The proportion of subjects with clinically significant weight gain (≥ 7 % weight gain from baseline at Day 21) was 14.1 % for asenapine 2.5 mg twice daily, 8.9 % for asenapine 5 mg twice daily, and 9.2 % for asenapine 10 mg twice daily, compared to 1.1 % for placebo.
Croatian: Udio ispitanika s klinički značajnim porastom tjelesne težine (≥ 7%-tni porast od početne vrijednosti 21. dana ispitivanja) bio je 14,1% za asenapin 2,5 mg dvaput na dan, 8,9% za asenapin 5 mg dvaput na dan i 9,2% za asenapin 10 mg dvaput na dan u odnosu na 1,1% za placebo.
English: Asenapine is cleared primarily through direct glucuronidation by UGT1A4 and oxidative metabolism by cytochrome P450 isoenzymes (predominantly CYP1A2).
Croatian: Asenapin se primarno metabolizira neposrednom glukuronidacijom pomoću UGT1A4 te oksidativnim metabolizmom posredovanim izoenzimima citokroma P450 (pretežno CYP1A2).
English: Rare side effects (may affect up to 1 in 1,000 people) - changes in the levels of white blood cells - difficulties in focusing with the eyes - blood clots in blood vessels to the lungs causing chest pain and difficulty in breathing - muscle disease presenting as unexplained aches and pains - male breast enlargement - leakage of milk or fluid from the breast
Croatian: Rijetke nuspojave (mogu se javiti u najviše 1 na 1000 osoba) - promjene broja bijelih krvnih stanica - poteškoće pri izoštravanju vida - krvni ugrušci u krvnim žilama koje vode do pluća, koji uzrokuju bol u prsima i otežano disanje - mišićna bolest sa simptomima nerazjašnjenih bolova - povećanje dojki u muškaraca - curenje mlijeka ili tekućine iz dojki
English: - Peel back the coloured tab (Figure 1).
Croatian: - Odlijepite obojanu naljepnicu (Slika 1).
English: From a cross-fostering study it was concluded that asenapine induced peri- and postnatal losses are caused by impairment of the pups rather than altered nursing behaviour of the dams.
Croatian: Iz rezultata ispitivanja u kojem su potomci unakrsno razdijeljeni majkama zaključeno je da je asenapinom uzrokovana smrtnost u perinatalnom i postnatalnom razdoblju posljedica poremećaja u mladunčadi, a ne promijenjenog ponašanja ženki u laktaciji.
English: In subjects with severe hepatic impairment (Child-Pugh C), a 7-fold increase in asenapine exposure was observed (see section 4.2).
Croatian: U bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C) opažen je sedmerostruki porast ekspozicije asenapinu (vidjeti dio 4.2).