FrancophonIA/ELRC3.0 huggingface dataset:
English: You should tell your doctor if you are taking antidepressant medicines (specifically fluvoxamine, paroxetine or fluoxetine), as it may be necessary to change your Sycrest or antidepressant medicine dose.
Croatian: Morate obavijestiti liječnika ako uzimate antidepresive (naročito fluvoksamin, paroksetin ili fluoksetin) jer može biti potrebno promijeniti dozu lijeka Sycrest ili dozu antidepresiva.
English: In addition, histopathological examination of the eyes from dogs treated chronically with asenapine did not reveal any signs of ocular toxicity, demonstrating the absence of a phototoxic hazard.
Croatian: Također, histopatološkim pregledom očiju pasa dugoročno liječenih asenapinom nisu otkriveni znakovi toksičnosti za oči, što ukazuje da nema rizika od fototoksičnosti.
English: Following sublingual administration, asenapine is rapidly absorbed with peak plasma concentrations occurring within 0.5 to 1.5 hours.
Croatian: Nakon sublingvalne primjene asenapin se brzo apsorbira, a vršne koncentracije u plazmi postižu se za 0,5 do 1,5 sati.
English: To ensure optimal absorption, the Sycrest sublingual tablet should be placed under the tongue and allowed to dissolve completely.
Croatian: Radi optimalne apsorpcije Sycrest sublingvalnu tabletu se mora staviti pod jezik i pustiti da se u potpunosti otopi.
English: Patients with rapid cycling were excluded from these studies.
Croatian: Bolesnici s brzom izmjenom ciklusa nisu bili uključeni u ova ispitivanja.
English: If you stop taking Sycrest
Croatian: Ako prestanete uzimati Sycrest
English: If you take more Sycrest than you should
Croatian: Ako uzmete više Sycrest tableta nego što ste trebali
English: However, based on its receptor pharmacology, it is proposed that the efficacy of asenapine is mediated through a combination of antagonist activity at D2 and 5-HT2A receptors.
Croatian: Međutim, na temelju njegove receptorske farmakologije pretpostavlja se da se djelovanje asenapina odvija kombinacijom antagonističkog djelovanja na receptorima D2 i 5-HT2A.
English: Therefore, patients should be cautioned about driving and using machines until they are reasonably certain that Sycrest therapy does not affect them adversely.
Croatian: Stoga se mora upozoriti bolesnike da budu oprezni prilikom upravljanja vozilima i rada sa strojevima dok nisu sigurni da liječenje lijekom Sycrest na njih ne utječe nepovoljno.
English: Given the primary effects of asenapine on the central nervous system (CNS) (see section 4.8), caution should be used when it is taken in combination with other centrally acting medicinal products.
Croatian: S obzirom na to da asenapin primarno djeluje na središnji živčani sustav (SŽS) (vidjeti dio 4.8), potreban je oprez kad se ovaj lijek uzima u kombinaciji s drugim lijekovima s centralnim djelovanjem.
English: Asenapine has anaesthetic properties.
Croatian: Asenapin ima anestetička svojstva.
English: Some medicines may reduceor increasethe effect of Sycrest.
Croatian: Neki lijekovi mogu umanjiti ili povećati učinak lijeka Sycrest.
English: MSD (Norge) AS Tlf: +47 32 20 73 00 msdnorge@msd.no
Croatian: MSD (Norge) AS Tel: +47 32 20 73 00 msdnorge@msd.no
English: Furthermore, prolactin-mediated effects on mammary glands and oestrus cycle disturbances were observed.
Croatian: Nadalje, opaženi su prolaktinom posredovani učinci na mliječne žlijezde i poremećaji spolnog ciklusa.
English: Overall mean (SD) weight gain at study endpoint was 3.5 (5.76) kg.
Croatian: Sveukupna srednja vrijednost (SD) porasta tjelesne težine na kraju ispitivanja bila je 3,5 (5,76) kg.
English: In case of overdose you may feel sleepy or tired, or have abnormal body movements, problems with standing and walking, feel dizzy due to low blood pressure and feel agitated and confused.
Croatian: U slučaju predoziranja možete biti pospani ili umorni, ili imati nekontrolirane pokrete tijela, poteškoće pri stajanju i hodanju, osjećati omaglicu zbog niskog krvnog tlaka i biti vidno uznemireni i smeteni.
English: Tell your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth and face.
Croatian: Odmah obavijestite liječnika ako osjetite: - nevoljne ritmične pokrete jezika, usta i lica.
English: Parkinson's disease and dementia with Lewy bodies Physicians should weigh the risks versus the benefits when prescribing Sycrest to patients with Parkinson's disease or dementia with Lewy Bodies (DLB) since both groups may be at increased risk of neuroleptic malignant syndrome as well as having an increased sensitivity to antipsychotics.
Croatian: Parkinsonova bolest i demencija s Lewyjevim tjelešcima Liječnici moraju procijeniti rizike i koristi pri propisivanju lijeka Sycrest bolesnicima s Parkinsonovom bolešću ili demencijom s Lewyjevim tjelešcima jer obje skupine mogu imati povećan rizik za neuroleptički maligni sindrom kao i povećanu osjetljivost na antipsihotike.
English: A pharmacokinetic study and a short term efficacy and safety study were performed in a paediatric population (ages 10-17 years) with manic or mixed episodes associated with bipolar I disorder.
Croatian: Ispitivanje farmakokinetike i ispitivanje kratkoročne djelotvornosti i sigurnosti primjene provedeno je u pedijatrijskoj populaciji (u dobi od 10 do 17 godina) s maničnim ili miješanim epizodama povezanima s bipolarnim poremećajem tipa I.
English: It is not known whether asenapine or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se asenapin ili njegovi metaboliti u majčino mlijeko.
English: Sycrest should be used with care in the elderly.
Croatian: Sycrest se u starijih osoba mora primjenjivati uz oprez.
English: Long term safety in this population was explored in a 50-week, open-label, uncontrolled extension study.
Croatian: Dugoročna sigurnost primjene u ovoj populaciji ispitana je u 50-tjednom otvorenom, nekontroliranom nastavku ispitivanja.
English: Therefore, Sycrest is not recommended in such patients.
Croatian: Stoga se takvim bolesnicima Sycrest ne preporučuje.
English: Increasing the dose from 5 to 10 mg twice daily (a two-fold increase) results in less than linear (1.7 times) increases in both the extent of exposure and maximum concentration.
Croatian: Povišenje doze s 5 mg na 10 mg dvaput na dan (tj. udvostručenje) rezultira manje nego linearnim povećanjem (1,7 puta) kako stupnja izloženosti tako i najveće koncentracije.
English: Based on a small pharmacokinetic study, paediatric patients appeared to be more sensitive to dystonia with initial dosing with asenapine when a gradual up-titration schedule was not followed (see section 5.2).
Croatian: Na temelju ispitivanja farmakokinetike malog opsega, čini se da su pedijatrijski bolesnici osjetljiviji na distoniju pri početnom doziranju asenapina kada se nije slijedio režim postupnog povećanja doze (vidjeti dio 5.2).
English: There are no adequate data from the use of Sycrest in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni lijeka Sycrest u trudnica.
English: NL- 5349 AB Oss The Netherlands
Croatian: NL- 5349 AB Oss Nizozemska
English: Fertility No impairment of fertility has been observed in nonclinical studies (see section 5.3).
Croatian: U nekliničkim ispitivanjima nije opažen poremećaj plodnosti (vidjeti dio 5.3).
English: Increased neonatal mortality was observed among the offspring of female rats treated during gestation and lactation.
Croatian: Opažen je povećan neonatalni mortalitet potomaka štakorica koje su dobivale lijek tijekom gestacije i laktacije.
English: In in vitro assays asenapine acts as an antagonist at these receptors.
Croatian: U testovima in vitro asenapin djeluje kao antagonist navedenih receptora.
English: Asenapine may antagonise the effect of levodopa and dopamine agonists.
Croatian: Asenapin može antagonizirati učinak levodope i agonista dopamina.
English: Asenapine may induce orthostatic hypotension and syncope, especially early in treatment, probably reflecting its α1-adrenergic antagonist properties.
Croatian: Asenapin može izazvati ortostatsku hipotenziju i sinkopu, osobito u ranoj fazi liječenja, što je vjerojatno odraz njegovih svojstava kao antagonista α1-adrenergičkih receptora.
English: What Sycrest contains - The active substance is asenapine.
Croatian: Što Sycrest sadrži - Djelatna tvar je asenapin.
English: Treatment with Sycrest is not advised in patients who are unable to comply with this method of administration, as the bioavailability of asenapine when swallowed is low (< 2 % with an oral tablet formulation).
Croatian: Liječenje lijekom Sycrest ne preporučuje se za bolesnike koji se ne mogu pridržavati ovog načina primjene jer je bioraspoloživost asenapina mala kad se proguta (< 2% kod tablete za peroralnu primjenu).
English: Asenapine has no appreciable affinity for muscarinic cholinergic receptors.
Croatian: Asenapin nema značajan afinitet za muskarinske kolinergičke receptore.
English: In the same study, treatment with paroxetine 20 mg daily decreased the DX/DM ratio to 0.032.
Croatian: U istom je ispitivanju liječenje paroksetinom u dozi od 20 mg na dan smanjilo omjer DX/DM na 0,032.
English: If you do, you should not take Sycrest if you have difficulty controlling core body temperature if you have thoughts of suicide if you have abnormally high levels of prolactin in the blood (hyperprolactinaemia)
Croatian: U tom slučaju ne smijete uzimati Sycrest, - ako imate poteškoća s reguliranjem bazalne tjelesne temperature, - ako razmišljate o samoubojstvu, - ako imate neuobičajeno visoke razine prolaktina u krvi (hiperprolaktinemija).
English: If you forget to take Sycrest
Croatian: Ako ste zaboravili uzeti Sycrest
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Croatian: U nekliničkim ispitivanjima zapaženi su učinci samo pri razinama izloženosti koje su znatno veće od maksimalno dozvoljenih u ljudi, što ukazuje na njihov mali značaj za kliničku primjenu.
English: The potential effects of inhibitors and an inducer of several of these enzyme pathways on asenapine pharmacokinetics were studied, specifically fluvoxamine (CYP1A2 inhibitor), paroxetine (CYP2D6 inhibitor), imipramine (CYP1A2/2C19/3A4 inhibitor), cimetidine (CYP3A4/2D6/1A2 inhibitor), carbamazepine (CYP3A4/1A2 inducer) and valproate (UGT inhibitor).
Croatian: Ispitivani su mogući učinci više inhibitora i jednog induktora nekolicine spomenutih enzimskih putova na farmakokinetiku asenapina, i to fluvoksamina (inhibitor CYP1A2), paroksetina (inhibitor CYP2D6), imipramina (inhibitor CYP1A2/2C19/3A4), cimetidina (inhibitor CYP3A4/2D6/1A2), karbamazepina (induktor CYP3A4/1A2) i valproata (inhibitor UGT).
English: In rats, embryofoetal toxicity (increased post-implantation loss, decreased foetal weights, and delayed ossification) was observed following oral or intravenous administration during organogenesis or throughout gestation.
Croatian: U štakora je embriofetalna toksičnost (povećan gubitak ploda nakon implantacije, smanjena tjelesna masa ploda i zastoj u osifikaciji) opažena nakon peroralne ili intravenske primjene tijekom organogeneze i tijekom cijelog razdoblja gestacije.
English: Do not cut or tear the blister.
Croatian: Nemojte rezati niti trgati blister.
English: Depending on the clinical response and tolerability in the individual patient, the dose can be increased to 10 mg twice daily.
Croatian: Ovisno o kliničkom odgovoru i podnošljivosti u pojedinog bolesnika, doza se može povećati na 10 mg dvaput na dan.
English: Since Sycrest works primarily in the brain, interference from other medicines(or alcohol) that work in the brain could occur due to an additive effect on brain function.
Croatian: Sycrest primarno djeluje na mozak te drugi lijekovi (ili alkohol) koji djeluju na mozak mogu omesti njegovo djelovanje uslijed zbirnog učinka na rad mozga.
English: Cardiovascular monitoring is necessary to detect possible arrhythmias and management of overdose should concentrate on supportive therapy, maintaining an adequate airway oxygenation and ventilation, and management of symptoms.
Croatian: Neophodan je nadzor kardiovaskularnog sustava kako bi se uočile moguće aritmije, a liječenje predoziranja mora se usredotočiti na potpornu terapiju, održavanje odgovarajuće oksigenacije i ventilacije dišnih putova te liječenje simptoma.
English: Clinical efficacy in bipolar I disorder
Croatian: Klinička djelotvornost u bipolarnom poremećaju tipa
English: Weight increase
Croatian: Porast tjelesne težine
English: Elderly patients with dementia-related psychosis Elderly patients with dementia-related psychosis treated with antipsychotic substances are at an increased risk of death.
Croatian: Stariji bolesnici s psihozom povezanom s demencijom Stariji bolesnici s psihozom povezanom s demencijom koji se liječe antipsihoticima imaju povećan rizik od smrti.
English: Sycrest has not been studied in elderly patients with dementia.
Croatian: Sycrest nije ispitivan u starijih bolesnika s demencijom.
English: If you are taking other medicines, Sycrest should be taken last.
Croatian: Ako uzimate i druge lijekove, Sycrest morate uzeti zadnji.
English: In dogs high oral doses resulted in hepatotoxicity that was not observed after chronic intravenous administration.
Croatian: U pasa je peroralna primjena visokih doza dovela do hepatotoksičnosti koja nije opažena nakon dugoročne intravenske primjene.
English: Additional clinical signs may include myoglobinuria (rhabdomyolysis) and acute renal failure.
Croatian: Dodatni klinički znakovi mogu biti mioglobinurija (rabdomioliza) i akutno zatajenje bubrega.
English: Transient, asymptomatic elevations of hepatic transaminases, alanine transferase (ALT), aspartate transferase (AST) have been seen commonly, especially in early treatment.
Croatian: Često su zabilježena prolazna asimptomatska povišenja vrijednosti jetrenih transaminaza, alanin transferaze (ALT) i asparat transferaze (AST), osobito u ranoj fazi liječenja.
English: Asenapine was not teratogenic in animal studies.
Croatian: Asenapin nije bio teratogen u ispitivanjimana životinjama.
English: Asenapine is extensively metabolized.
Croatian: Asenapin se opsežno metabolizira.
English: Sycrest may cause sleepiness or sedation.
Croatian: Sycrest može uzrokovati pospanost ili sedaciju.
English: Maintenance of effect during the episode after 12 weeks of randomised treatment was demonstrated in this trial.
Croatian: To je ispitivanje pokazalo da je održan učinak tijekom epizode nakon 12 tjedana randomiziranog liječenja.
English: Clinical drug interaction studies investigating the effects of CYP2D6 inhibition by asenapine showed the following results:
Croatian: U kliničkim ispitivanjima interakcije lijekova u kojima su se ispitivali učinci inhibicije CYP2D6 asenapinom zabilježeni su sljedeći rezultati:
English: Patients at risk for fall should be evaluated prior to prescribing asenapine.
Croatian: Potrebno je procijeniti bolesnike koji su pod rizikom od pada prije propisivanja asenapina.
English: The intake of water several (2 or 5) minutes after asenapine administration resulted in decreased (19 % and 10 %, respectively) asenapine exposure.
Croatian: Uzimanje vode nekoliko (2 odnosno 5) minuta nakon primjene asenapina dovelo je do smanjenja izloženosti asenapinu (za 19% odnosno 10%).
English: The absolute bioavailability of asenapine when swallowed is low (< 2 % with an oral tablet formulation).
Croatian: Apsolutna bioraspoloživost asenapina kad se proguta je mala (< 2% kod tablete za peroralnu primjenu).
English: If signs and symptoms of tardive dyskinesia appear in a patient on Sycrest, discontinuation of treatment should be considered.
Croatian: Ako se pojave znakovi i simptomi tardivne diskinezije u bolesnika koji uzima Sycrest, mora se razmotriti prekid primjene ovog lijeka.
English: Hypotension and circulatory collapse should be treated with appropriate measures, such as intravenous fluids and/or sympathomimetic agents (epinephrine and dopamine should not be used, since beta stimulations may worsen hypotension in the setting of Sycrest-induced alpha blockade).
Croatian: Hipotenziju i cirkulacijski kolaps se mora liječiti odgovarajućim mjerama kao što je primjena intravenskih tekućina i/ili simpatomimetika (ne smiju se koristiti adrenalin i dopamin jer stimulacija beta receptora može pogoršati hipotenziju u uvjetima blokade alfa receptora lijekom Sycrest).
English: Close medical supervision and monitoring should continue until the patient recovers.
Croatian: Bolesnika se mora strogo nadzirati i pratiti sve do oporavka.
English: During twice-daily dosing, steady-state is attained within 3 days.
Croatian: Kod doziranja dvaput na dan stanje dinamičke ravnoteže postiže se za 3 dana.
English: 20 sublingual tablets 60 sublingual tablets 100 sublingual tablets
Croatian: 20 sublingvalnih tableta 60 sublingvalnih tableta 100 sublingvalnih tableta
English: Medicinal products with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterised by rhythmical, involuntary movements, predominantly of the tongue and/or face.
Croatian: Lijekovi koji imaju svojstva antagonista dopaminskih receptora povezani su s izazivanjem tardivne diskinezije koju obilježavaju ritmični nevoljni pokreti pretežno jezika i/ili lica.
English: Co-administration of asenapine with known inhibitors, inducers or substrates of these metabolic pathways has been studied in a number of drug-drug interaction studies (see section 4.5).
Croatian: Istodobna primjena asenapina s poznatim inhibitorima, induktorima ili supstratima tih metaboličkih putova ispitana je u nizu ispitivanja interakcija između lijekova (vidjeti dio 4.5).
English: No specific information is available on the treatment of overdose with Sycrest.
Croatian: Nisu dostupne specifične informacije o liječenju predoziranja lijekom Sycrest.
English: The less than proportional increase of Cmax and AUC with dose may be attributed to limitations in the absorption capacity from the oral mucosa following sublingual administration.
Croatian: Porast Cmax i AUC-a koji je manje nego proporcionalan dozi može se pripisati ograničenom kapacitetu apsorpcije iz sluznice usta nakon sublingvalne primjene.
English: Illnesses that affect the brain, such as bipolar I disorder, may be due to certain chemicals in the brain, such as dopamine and serotonin, being out of balance and these imbalances may cause some of the symptoms you may be experiencing.
Croatian: Bolesti koje zahvaćaju mozak, poput bipolarnog poremećaja tipa I, mogu nastati zbog poremećaja ravnoteže nekih tvari u mozgu, primjerice dopamina i serotonina, a ta neravnoteža može izazvati neke simptome koje možda osjećate.
English: However, adverse effects of treatment on weight gain and on plasma lipid profile appeared to be greater than effects observed in the adult trials.
Croatian: Međutim, čini se kako su štetni učinci liječenja na porast tjelesne težine i profil lipida u plazmi značajniji od onih opaženih u ispitivanjima u odraslih bolesnika.
English: A population pharmacokinetic analysis indicated that there is no evidence of gender-related differences in the pharmacokinetics of asenapine.
Croatian: Analiza populacijske farmakokinetike ukazala je da nema dokaza o spolno uvjetovanim razlikama u farmakokinetici asenapina.
English: Danmark MSD Danmark ApS Tlf: + 45 4482 4000 dkmail@merck.com
Croatian: MSD Danmark ApS Tel: + 45 4482 4000 dkmail@merck.com
English: Oral hypoaesthesia and oral paraesthesia may occur directly after administration and usually resolves within 1 hour.
Croatian: Neposredno nakon primjene mogu nastupiti oralna hipoestezija i oralna parestezija, koje se obično povlače unutar sat vremena.
English: if you have a heart disease or a treatment for heart disease that makes you prone to low blood pressure if you are diabetic or prone to diabetes if you have Parkinson's disease or dementia if you have epilepsy (seizures) if you experience any difficulty in swallowing (dysphagia) if you have severe liver problems.
Croatian: - ako bolujete od srčane bolesti ili uzimate lijekove za srce zbog kojih ste skloni niskom tlaku, - ako imate šećernu bolest ili sklonost za šećernu bolest, - ako bolujete od Parkinsonove bolesti ili demencije, - ako imate epilepsiju (epileptičke napadaje), - ako imate poteškoća s gutanjem (disfagija), - ako imate ozbiljnih tegoba s jetrom.
English: Except for fluvoxamine, none of the interacting medicinal products resulted in clinically relevant alterations in asenapine pharmacokinetics.
Croatian: Osim fluvoksamina, niti jedan od lijekova koji ulazi u interakcije nije izazvao klinički značajne promjene u farmakokinetici asenapina.
English: At this dose foetal body weight decreased.
Croatian: Pri toj se dozi smanjila tjelesna masa ploda.
English: The most frequently reported adverse drug reactions (ADRs) associated with the use of asenapine in clinical trials were somnolence and anxiety.
Croatian: Najčešće prijavljene nuspojave povezane s primjenom asenapina u kliničkim ispitivanjima bile su somnolencija i anksioznost.
English: Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia or bipolar disorder and the increasing incidence of diabetes mellitus in the general population.
Croatian: Procjenu povezanosti primjene atipičnih antipsihotika s poremećajima glukoze otežava mogući povećan osnovni rizik za razvoj šećerne bolesti u bolesnika sa shizofrenijom ili bipolarnim poremećajem kao i povećana incidencija šećerne bolesti u općoj populaciji.
English: Because of its α1-adrenergic antagonism with potential for inducing orthostatic hypotension (see section 4.4), Sycrest may enhance the effects of certain antihypertensive agents.
Croatian: Potencijal lijeka Sycrest da djeluje na druge lijekove S obzirom da zbog antagonističnog djelovanja na α1-adrenergičke receptore ima potencijal izazvati ortostatsku hipotenziju (vidjeti dio 4.4), Sycrest može pojačati učinke nekih antihipertenziva.
English: A population pharmacokinetic analysis indicated that smoking, which induces CYP1A2, has no effect on the clearance of asenapine.
Croatian: Analiza populacijske farmakokinetike ukazala je da pušenje, koje inducira enzim CYP1A2, ne utječe na klirens asenapina.
English: In clinical trials, the incidence of extrapyramidal symptoms in asenapine-treated patients was higher than placebo (15.4 % vs 11.0 %).
Croatian: U kliničkim je ispitivanjima incidencija ekstrapiramidalnih simptoma u bolesnika liječenih asenapinom bila veća nego u skupini koja je primala placebo (15,4% naspram 11,0%).
English: In the long-term extension trial (50 weeks), a total of 34.8 % of subjects experienced clinically significant weight increase (i.e., ≥ 7 % increase in body weight at endpoint).
Croatian: U dugoročnom nastavku ispitivanja (50 tjedana), u ukupno 34,8% ispitanika došlo je do porasta tjelesne težine koji je bio klinički značajan (tj.
English: Study results showed statistically significant superiority for all three Sycrest doses in improving the Young Mania Rating Scale (YMRS) total score as measured by the change from baseline to Day 21, as compared with placebo.
Croatian: Rezultati ispitivanja pokazali su statistički značajnu superiornost svih triju doza lijeka Sycrest u poboljšanju ukupnog rezultata na ljestvici za ocjenu stupnja manije po Youngu (YMRS), mjereno promjenom od početne vrijednosti do 21. dana, u usporedbi s placebom.
English: Children and adolescents Sycrest is not recommended for use in patients below the age of 18 years.
Croatian: Ne preporučuje se primjena lijeka Sycrest u bolesnika mlađih od 18 godina.
English: The mechanism of action of asenapine is not fully understood.
Croatian: Mehanizam djelovanja asenapina nije u potpunosti razjašnjen.
English: How to take Sycrest
Croatian: Kako uzimati Sycrest
English: The coloured tab should be peeled back and the tablet should be removed gently.
Croatian: Obojenu naljepnicu se mora odlijepiti i pažljivo izvaditi tabletu.