FrancophonIA/ELRC3.0 huggingface dataset:
English: , increased appetite.
Croatian: , pojačan apetit.
English: This medicine has been prescribed for you only.
Croatian: • Ovaj je lijek propisan samo Vama.
English: Speech disorder was also reported commonly.
Croatian: Poremećaj govora također je često prijavljen.
English: Some fatal cases have been reported in this particular group of patients.
Croatian: Prijavljeno je i nekoliko smrtnih slučajeva u ovoj specifičnoj skupini bolesnika.
English: Common: Dry mouth
Croatian: Često: suha usta
English: People with this disease may also feel depressed, anxious or tense.
Croatian: Osobe s tom bolešću mogu se također osjećati depresivno, tjeskobno ili napeto.
English: Place the tablet in your mouth.
Croatian: Stavite tabletu u usta.
English: You and your doctor should check your weight regularly.
Croatian: Sa svojim liječnikom redovito kontrolirajte tjelesnu težinu.
English: Close medical supervision and monitoring should continue until the patient recovers.
Croatian: Pažljiv liječnički nadzor i praćenje treba nastaviti do oporavka bolesnika.
English: In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
Croatian: U nekim je slučajevima prijavljeno prethodno povećanje tjelesne težine što može biti predisponirajući čimbenik.
English: (See sections 4.5 and 5.2)
Croatian: (Vidjeti dijelove 4.5 i 5.2)
English: Dose escalation, when indicated, should be conservative in such patients.
Croatian: Povećanje doze, kada je indicirano, treba biti konzervativno u takvih bolesnika.
English: If you notice any of these symptoms seek medical advice immediately;
Croatian: Ako primijetite bilo koji od ovih simptoma odmah zatražite liječnički savjet;
English: Increased total bilirubin
Croatian: povišen ukupni bilirubin
English: With some drinks, the mixture may change colour and possibly become cloudy.
Croatian: S nekim pićima mješavina može promijeiti boju i može postati zamućena.
English: • If you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
Croatian: • Ako od ranije imate dijagnosticirane tegobe s očima kao što su određene vrste glaukoma (povišeni očni tlak).
English: In particular, tell your doctor if you are taking:
Croatian: Posebno obavijestite svog liječnika ako uzimate:
English: Your doctor will tell you how many Olanzapine Apotex tablets to take and how long you should continue to take them.
Croatian: Liječnik će Vam reći koliko tableta Olanzapine Apotexa trebate uzeti i koliko ćete ih dugo nastaviti uzimati.
English: This leaflet was last revised in {month XXXX}.
Croatian: Ova uputa je zadnji puta revidirana u {mjesec GGGG}.
English: • If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6).
Croatian: • Ako ste alergični (preosjetljivi) na olanzapin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: If your baby develops any of these symptoms you may need to contact your doctor.
Croatian: Ako se u Vašeg djeteta razvije bilo koji od ovih simptoma, možda ćete se trebati obratiti svom liječniku.
English: • Tell the doctor if you or someone else in your family has a history of blood clots, as medicines like these have been associated with the formation of blood clots.
Croatian: • Obavijestite svog liječnika ako ste Vi ili netko drugi u Vašoj obitelji ranije imali krvne ugruške, jer su lijekovi poput ovih povezani sa stvaranjem krvnih ugrušaka.
English: An increase to a dose greater than the recommended starting dose is advised only after appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours.
Croatian: Povećanje doze iznad preporučene početne doze savjetuje se samo nakon odgovarajuće ponovne kliničke procjene i općenito se treba uvoditi u intervalima ne kraćim od 24 sata.
English: Olanzapine Apotex belongs to a group of medicines called antipsychotics and is used to treat the following conditions:
Croatian: Olanzapine Apotex pripada skupini lijekova koji se zovu antipsihotici i koristi se za liječenje sljedećih stanja:
English: In the majority of these patients the elevations were generally mild, and remained below two times the upper limit of normal range.
Croatian: U većine ovih bolesnika povećanja su bila uglavnom blaga i ostala su niža od dvostrukog povećanja gornje granice normalnog raspona.
English: There are no controlled data on maintenance of effect or long term safety (see sections 4.4 and 4.8).
Croatian: Ne postoje podaci o održavanju učinka ni dugotrajnoj sigurnosti iz kontroliranih ispitivanja (vidjeti dijelove 4.4 i 4.8).
English: Unlike some other antipsychotic agents, olanzapine increases responding in an “anxiolytic” test.
Croatian: Za razliku od nekih drugih antipsihotika, olanzapin povećava odgovor u “anksiolitičkom” testu.
English: Keep this medicine out of sight and reach of children.
Croatian: Ovaj lijek čuvajte izvan pogleda i dohvata djece.
English: Do not handle the tablets with wet hands as the tablets may break up.
Croatian: Ne uzimajte tablete mokrim rukama jer se tablete mogu prelomiti.
English: • Moderate to severe manic episodes, a condition with symptoms of excitement or euphoria.
Croatian: • umjerenih do teških epizoda manije, stanja sa simptomima uzbuđenja ili euforije.
English: If this happens do not drive or operate any tools or machines.
Croatian: Ako se ovo dogodi, nemojte upravljati vozilima niti rukovati bilo kakvim alatima ili strojevima.
English: In clinical studies, the average olanzapine exposure was approximately 27% higher in adolescents.
Croatian: U kliničkim ispitivanjima prosječna izloženost olanzapinu bila je približno 27 % viša u adolescenata.
English: Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Croatian: Na temelju rezultata ispitivanja u miševa i štakora zaključeno je da olanzapin nije kancerogen.
English: Olanzapine is metabolized in the liver by conjugative and oxidative pathways.
Croatian: Olanzapin se metabolizira u jetri konjugacijskim i oksidacijskim putovima.
English: You can also place the tablet in a full glass or cup of water, orange juice, apple juice, milk or or coffee and stir.
Croatian: Tabletu također možete staviti u čašu punu vode, soka od naranče ili jabuke, mlijeka ili kave i promiješati.
English: Talk to your doctor or pharmacist before taking Olanzapine Apotex.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Olanzapine Apotex.
English: Removal of the intact orodispersible tablet from the mouth is difficult.
Croatian: Vađenje intaktne raspadljive tablete iz usta je teško.
English: Since the orodispersible tablet is fragile, it should be taken immediately on opening the blister.
Croatian: Budući da je raspadljiva tableta za usta krhka, treba ju uzeti odmah nakon otvaranja blistera.
English: The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
Croatian: Veća incidencija smrti nije bila povezana s dozom olanzapina (srednja vrijednost dnevne doze od 4,4 mg) ni s trajanjem liječenja.
English: If you forget to take Olanzapine Apotex Take your tablets as soon as you remember.
Croatian: Ako ste zaboravili uzeti Olanzapine Apotex Uzmite tablete čim se sjetite.
English: Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and in vivo mammalian tests.
Croatian: Olanzapin nije bio ni mutagen ni klastogen u punom rasponu standardnih testova koji su uključivali testove bakterijske mutacije te in vitro i in vivo testove na sisavcima.
English: As a routine precaution, if you are over 65 years your blood pressure may be monitored by your doctor.
Croatian: Ako ste stariji od 65 godina, liječnik će Vam možda kao rutinsku mjeru opreza redovito kontrolirati krvni tlak.
English: Activated charcoal reduces the bioavailability of oral olanzapine by 50 to 60% and should be taken at least 2 hours before or after olanzapine.
Croatian: Aktivni ugljen smanjuje bioraspoloživost oralnog olanzapina za 50 do 60 % te ga treba uzeti najmanje 2 sata prije ili poslije olanzapina.
English: Elevated plasma prolactin levels were reported in 47.4% of adolescent patients.
Croatian: 16 Povišene razine prolaktina u plazmi prijavljene su u 47,4 % adolescentnih bolesnika.
English: Very common: Sedation (including: hypersomnia, lethargy, somnolence).
Croatian: Vrlo često:sedacija (uključujući: hipersomniju, letargiju, somnolenciju).
English: Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.
Croatian: Olanzapin je učinkovit u održavanju kliničkog poboljšanja tijekom nastavka terapije u bolesnika koji su pokazali početni odgovor na liječenje.
English: However, the magnitude of the impact of age, gender, or smoking on olanzapine clearance and half-life is small in comparison to the overall variability between individuals.
Croatian: Međutim, utjecaj dobi, spola ili pušenja na klirens i poluvijek olanzapina malen je u usporedbi s ukupnom varijabilnošću među pojedincima.
English: Alternatively, it may be dispersed in a full glass of water or other suitable beverage (orange juice, apple juice, milk or coffee) immediately before administration.
Croatian: Alternativno se može rastopiti u čaši punoj vode ili drugog pogodnog napitka (soka od naranče ili jabuke, mlijeka ili kave) netom prije primjene.
English: Dogs tolerated single oral doses up to 100 mg/kg without mortality.
Croatian: Psi su podnosili pojedinačne peroralne doze do 100 mg/kg bez smrtnog ishoda.
English: Very rare side effects include serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Croatian: Vrlo rijetke nuspojave uključuju ozbiljne alergijske reakcije kao što je reakcija na lijek s eozinofilijom i sistemskim simptomima (DRESS).
English: If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, all antipsychotic medicines, including olanzapine must be discontinued.
Croatian: Ako se u bolesnika razviju znakovi i simptomi koji upućuju na NMS ili bolesnik dobije neobjašnjivu vrućicu bez dodatnih kliničkih manifestacija NMS-a, potrebno je prekinuti primjenu svih antipsihotika, uključujući olanzapin.
English: Children and adolescents Olanzapine Apotex is not for patients who are under 18 years.
Croatian: Djeca i adolescenti Olanzapine Apotex nije za primjenu u bolesnika mlađih od 18 godina.
English: The following table lists the adverse reactions and laboratory investigations observed from spontaneous reporting and in clinical trials.
Croatian: Sljedeća tablica prikazuje nuspojave i laboratorijske nalaze uočene iz spontanih prijava i u kliničkim ispitivanjima.
English: Patients should be advised not to breast-feed an infant if they are taking olanzapine.
Croatian: Bolesnice treba savjetovati da ne doje dijete ako uzimaju olanzapin.
English: In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 6 months.
Croatian: U odraslih bolesnika koji su nakon 9-12 mjeseci završili liječenje, stopa povećanja srednje vrijednosti glukoze u krvi smanjila se nakon približno 6 mjeseci.
English: The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 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).
Croatian: Učestalost je definirana kako slijedi: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Clinically significant weight gain (≥ 7%) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
Croatian: Čini se da se klinički značajno povećanje tjelesne težine (≥ 7 %) češće javlja u populaciji adolescenata u usporedbi s odraslim osobama s usporedivim izlaganjima lijeku.
English: A lower starting dose (5 mg/day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant (see section 4.4).
Croatian: Niža početna doza (5 mg/dan) nije rutinski indicirana, no treba je razmotriti u osoba u dobi od 65 godina i starijih, kada to opravdavaju klinički čimbenici (vidjeti dio 4.4).
English: Fatal outcomes have been reported for acute overdoses as low as 450 mg but survival has also been reported following acute overdose of approximately 2 g of oral olanzapine.
Croatian: Prijavljeni su i smrtni ishodi kod akutnog predoziranja već pri maloj dozi od 450 mg, ali je opisano i preživljavanje nakon akutnog predoziranja s približno 2 g oralnog olanzapina.
English: The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
Croatian: Metabolizam olanzapina može se inducirati pušenjem i karbamazepinom, što može dovesti do smanjenja koncentracija olanzapina.
English: In patients with Parkinson's disease Olanzapine Apotex may worsen the symptoms.
Croatian: U bolesnika koji boluju od Parkinsonove bolesti, Olanzapine Apotex može pogoršati simptome.
English: Do not use epinephrine, dopamine, or other sympathomimetic agents with beta-agonist activity since beta stimulation may worsen hypotension.
Croatian: Ne koristite epinefrin, dopamin ili druge simpatomimetike s beta-agonističkim djelovanjem, jer beta stimulacija može pogoršati hipotenziju.
English: It is important that you carry on taking Olanzapine Apotex for as long as your doctor tells you.
Croatian: Važno je da nastavite uzimati Olanzapine Apotex onoliko dugo koliko Vam je liječnik rekao.
English: Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with olanzapine.
Croatian: Bolesnice treba savjetovati da obavijeste svog liječnika ako tijekom liječenja olanzapinom zatrudne ili planiraju trudnoću.
English: Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
Croatian: Terapijsko praćenje razina valproata u plazmi nije upućivalo na potrebu za prilagođavanjem doze valproata nakon početka istodobne primjene olanzapina.
English: • carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your Olanzapine Apotex dose.
Croatian: • karbamazepin (antiepileptik i stabilizator raspoloženja), fluvoksamin (antidepresiv) ili ciprofloksacin (antibiotik) - možda će biti potrebno promijeniti dozu Olanzapine Apotexa.
English: You should not be given this medicine when breast-feeding, as small amounts of OlanzapineApotex can pass into breast milk
Croatian: Ne biste smjeli uzimati ovaj lijek dok dojite, jer se male količine Olanzapin Apotexa mogu izlučiti u majčino mlijeko.
English: Symptomatic treatment and monitoring of vital organ function should be instituted according to clinical presentation, including treatment of hypotension and circulatory collapse and support of respiratory function.
Croatian: Simptomatsko liječenje i praćenje funkcije vitalnih organa treba započeti prema kliničkoj slici, uključujući liječenje hipotenzije i cirkulatornog kolapsa te potporu respiratorne funkcije.
English: • Stroke or “mini” stroke (temporary symptoms of stroke)
Croatian: • moždani udar ili “mali” moždani udar (kratkotrajni simptomi moždanog udara)
English: The magnitude of weight gain and the proportion of adolescent patients who had clinically significant weight gain were greater with long-term exposure (at least 24 weeks) than with short-term exposure.
Croatian: Povećanje tjelesne težine i udio adolescentnih bolesnika koji su imali klinički značajno povećanje tjelesne težine bili su veći tijekom dugotrajnog izlaganja (najmanje 24 tjedna) nego tijekom kratkotrajnog izlaganja lijeku.
English: You should take your Olanzapine Apotex tablets once a day following the advice of your doctor.
Croatian: Olanzapine Apotex tablete morate uzimati jednom dnevno pridržavajući se savjeta svog liječnika.
English: • a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness (the frequency of this side effect cannot be estimated from the available data).
Croatian: • kombinaciju vrućice, ubrzanog disanja, znojenja, ukočenosti mišića te omamljenosti ili pospanosti (učestalost ove nuspojave ne može se procijeniti iz dostupnih podataka).
English: If you take more Olanzapine Apotex than you should Patients who have taken more Olanzapine Apotex than they should have experienced the following symptoms: rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Croatian: Ako uzmete više Olanzapine Apotexa nego što ste trebali Bolesnici koji su uzeli više Olanzapine Apotexa nego što su trebali imali su sljedeće simptome: ubrzan rad srca, uznemirenost/agresivnost, poteškoće s govorom, neuobičajene pokrete (osobito lica ili jezika) i sniženu razinu svijesti.
English: What Olanzapine Apotex is and what it is used for What you need to know before you take Olanzapine Apotex How to take Olanzapine Apotex Possible side effects
Croatian: Što je Olanzapine Apotex i za što se koristi Što morate znati prije nego počnete uzimati Olanzapine Apotex Kako uzimati Olanzapine Apotex Moguće nuspojave
English: Consult your doctor if your symptoms return but do not stop taking Olanzapine Apotex unless your doctor tells you to.
Croatian: Ako Vam se simptomi vrate, posavjetujte se sa svojim liječnikom, ali nemojte prestati uzimati Olanzapine Apotex dok Vam liječnik to ne kaže.
English: Electrophysiological studies demonstrated that olanzapine selectively reduced the firing of mesolimbic (A10) dopaminergic neurons, while having little effect on the striatal (A9) pathways involved in motor function.
Croatian: Elektrofiziološka ispitivanja pokazala su da olanzapin selektivno smanjuje izbijanje mezolimbičkih (A10) dopaminergičkih neurona, a nema većeg učinka na strijatalne (A9) putove uključene u motoričku funkciju.
English: The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to
Croatian: Navedene učestalosti definirane su kako slijedi: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10).
English: Olanzapine should be used cautiously in patients who have a history of seizures or are subject to factors which may lower the seizure threshold.
Croatian: Olanzapin treba oprezno primjenjivati u bolesnika koji imaju napadaje u anamnezi ili su izloženi čimbenicima koji mogu sniziti prag za napadaje.
English: In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects were CNS depression, anticholinergic effects, and peripheral haematological disorders.
Croatian: U ispitivanjima u trajanju do 3 mjeseca na miševima te do godine dana na štakorima i psima prevladavajući učinci bili su depresija središnjeg živčanog sustava, antikolinergički učinci i periferni hematološki poremećaji.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON BOX
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA
English: However the risk of tardive dyskinesia increases with long term exposure, and therefore if signs or symptoms of tardive dyskinesia appear in a patient on olanzapine, a dose reduction or discontinuation should be considered.
Croatian: Međutim, rizik od pojave tardivne diskinezije povećava se s dugotrajnom izloženošću te u slučaju pojave znakova ili simptoma tardivne diskinezije u bolesnika na olanzapinu treba razmotriti snižavanje doze ili prekid liječenja.
English: Mean infant exposure (mg/kg) at steady state was estimated to be 1.8% of the maternal olanzapine dose (mg/kg).
Croatian: Srednja vrijednost izloženosti novorođenčeta (mg/kg) u stanju dinamičke ravnoteže procijenjena je na 1,8 % majčine doze olanzapina (mg/kg).
English: In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki < 100 nM) for serotonin 5 HT2A/2C, 5 HT3, 5 HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α1 adrenergic; and histamine H1 receptors.
Croatian: U pretkliničkim ispitivanjima olanzapin je pokazao raspon afiniteta za receptore (Ki < 100 nM) serotonina 5 HT2A/2C, 5 HT3, 5 HT6; dopamina D1, D2, D3, D4, D5; kolinergičke muskarinske receptore M1-M5; α1 adrenergičke; i histaminske H1 receptore.
English: • Schizophrenia, a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.
Croatian: • shizofrenije, bolesti sa simptomima kao što su slušna, vidna ili osjetilna priviđenja stvari koje nisu prisutne, iluzije, neuobičajena sumnjičavost i povučenost.
English: Olanzapine administered with lithium or valproate resulted in increased levels (10%) of tremor, dry mouth, increased appetite, and weight gain.
Croatian: Olanzapin primijenjen s litijem ili valproatom rezultirao je povećanim razinama ( 10 %) tremora, suhoće usta, povećanjem apetita i povećanjem tjelesne težine.
English: In monkeys, single oral doses up to 100 mg/kg resulted in prostration and, at higher doses, semi-consciousness.
Croatian: U majmuna su pojedinačne peroralne doze do 100 mg/kg dovodile do prostracije, a u većim dozama do polusvjesnog stanja.
English: • Blood disorders
Croatian: • poremećaji krvi
English: However, since patients with schizophrenia often present with acquired risk factors for venous thromboembolism all possible risk factors of VTE e.g. immobilisation of patients, should be identified and preventive measures undertaken.
Croatian: Međutim, budući da bolesnici sa shizofrenijom često imaju stečene čimbenike rizika za vensku tromboemboliju, sve moguće čimbenike rizika za VTE npr. imobilizacija bolesnika, treba identificirati te poduzeti preventivne mjere.
English: Do not drink any alcohol if you have been given Olanzapine Apotex as together with alcohol it may make you feel drowsy.
Croatian: Nemojte piti alkohol ako uzimate Olanzapine Apotex, jer u kombinaciji s alkoholom može izazvati omamljenost.
English: The daily dose of Olanzapine Apotex is between 5 mg and 20 mg.
Croatian: Dnevna doza Olanzapine Apotexa iznosi između 5 mg i 20 mg.
English: DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia).
Croatian: DRESS se u početku ispoljava kao simptomi slični gripi praćeni osipom na licu, a zatim proširenim osipom, visokom temperaturom, povećanim limfnim čvorovima, povaćanjem razina jetrenih enzima u analizama krvi i povećanjem jedne vrste bijelih krvnih stanica (eozinofilija).
English: What Olanzapine Apotex looks like and contents of the pack Orodispersible tablet is the technical name for a tablet which dissolves directly in your mouth, so that it can be easily swallowed.
Croatian: Kako Olanzapine Apotex izgleda i sadržaj pakiranja Raspadljiva tableta za usta tehnički je naziv za tabletu koja se otapa izravno u ustima, tako da se može lako progutati.
English: • If you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets)
Croatian: • ako znate da možda imate nedovoljno soli u organizmu kao posljedicu dugotrajnog teškog proljeva i povraćanja ili zbog uzimanja diuretika (tableta za izlučivanje vode iz organizma).
English: Estrous cycles were affected at doses of 1.1 mg/kg (3 times the maximum human dose) and reproduction parameters were influenced in rats given 3 mg/kg (9 times the maximum human dose).
Croatian: Na estrusne cikluse u štakora utjecale su doze od 1,1 mg/kg (3 puta veća doza od maksimalne doze u ljudi), a na parametre reprodukcije utjecala je doza od 3 mg/kg (9 puta veća doza od maksimalne doze u ljudi).