FrancophonIA/ELRC3.0 huggingface dataset:
English: The plasma protein binding of olanzapine was about 93 % over the concentration range of about 7 to about 1000 ng/ml.
Croatian: Vezanje olanzapina na proteine u plazmi bilo je oko 93 % u rasponu koncentracija od približno 7 do približno 1000 ng/ml.
English: Controlled efficacy data in adolescents (ages 13 to 17 years) are limited to short term studies in schizophrenia (6 weeks) and mania associated with bipolar I disorder (3 weeks), involving less than 200 adolescents.
Croatian: Podaci o djelotvornosti iz kontroliranih ispitivanja u adolescenata (u dobi od 13 do 17 godina) ograničeni su na kratkotrajna ispitivanja shizofrenije (6 tjedana) i manije povezane s bipolarnim poremećajem I (3 tjedna), a obuhvatili su manje od 200 adolescenata.
English: The mean increase in olanzapine Cmax following fluvoxamine was 54 % in female non-smokers and 77 % in male smokers.
Croatian: Srednja vrijednost porasta Cmax olanzapina nakon primjene fluvoksamina iznosila je 54 % u žena nepušača i 77 % u muškaraca pušača.
English: However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors.
Croatian: Međutim, incidencija smrti bila je veća u bolesnika liječenih olanzapinom nego u bolesnika koji su primali placebo, neovisno o ovim čimbenicima rizika.
English: Olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/day.
Croatian: Olanzapin se primjenjivao u fleksibilnoj dozi počevši s 2,5 mg dnevno i postupno je povećavana do 20 mg dnevno.
English: Effects on haematology parameters were found in each species, including dose-related reductions in circulating leukocytes in mice and non-specific reductions of circulating leukocytes in rats; however, no evidence of bone marrow cytotoxicity was found.
Croatian: U svakoj su vrsti pronađeni učinci na hematološke parametre uključujući smanjenje broja cirkulirajućih leukocita ovisno o dozi u miševa te nespecifično smanjenje broja cirkulirajućih leukocita u štakora; međutim, nisu nađeni dokazi citotoksičnosti za koštanu srž.
English: Olanzapine is an antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacologic profile across a number of receptor systems.
Croatian: Olanzapin je antipsihotik, lijek za liječenje manije i stabilizaciju raspoloženja, koji pokazuje širok farmakološki profil djelujući preko brojnih receptorskih sustava.
English: However, as clinical experience with olanzapine in patients with concomitant illness is limited, caution is advised when prescribing for patients with prostatic hypertrophy, or paralytic ileus and related conditions.
Croatian: Međutim, kako je kliničko iskustvo s olanzapinom u bolesnika s konkomitantnom bolesti ograničeno, savjetuje se oprez pri propisivanju lijeka bolesnicima s hipertrofijom prostate ili paralitičkim ileusom i povezanim stanjima.
English: If a new manic, mixed, or depressive episode occurs, olanzapine treatment should be continued (with dose optimisation as needed), with supplementary therapy to treat mood symptoms, as clinically indicated.
Croatian: Ako dođe do nove manične, miješane ili depresivne epizode, liječenje olanzapinom treba nastaviti (uz optimizaciju doze prema potrebi), uz dopunsku terapiju za liječenje simptoma poremećaja raspoloženja, sukladno kliničkoj slici.
English: Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia).
Croatian: Kliničke manifestacije NMS-a su hiperpireksija, rigidnost mišića, promijenjen mentalni status te dokaz autonomne nestabilnosti (nepravilan puls ili krvni tlak, tahikardija, dijaforeza i poremećaj srčanog ritma).
English: In 44 patients with schizophrenia > 65 years of age, dosing from 5 to 20 mg/day was not associated with any distinguishing profile of adverse events.
Croatian: U 44 bolesnika sa shizofrenijom u dobi iznad 65 godina doziranje od 5 do 20 mg/dan nije bilo povezano ni sa kakvim razlikovnim profilom nuspojava.
English: Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
Croatian: Promjene lipida treba prikladno klinički liječiti, posebno u bolesnika s dislipidemijom i u bolesnika s čimbenicima rizika za razvoj poremećaja lipida.
English: Age > 75 years and vascular/mixed type dementia were identified as risk factors for CVAE in association with olanzapine treatment.
Croatian: Dob iznad 75 godina i demencija vaskularnog/miješanog tipa bili su prepoznati kao čimbenici rizika za CV štetne događaje povezane s liječenjem olanzapinom.
English: Manic episode: The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section 5.1).
Croatian: Epizoda manije: početna doza je 15 mg primijenjena kao jednokratna dnevna doza u monoterapiji ili 10 mg dnevno u kombinacijskoj terapiji (vidjeti dio 5.1).
English: Given the primary CNS effects of olanzapine, caution should be used when it is taken in combination with other centrally acting medicines and alcohol.
Croatian: S obzirom na primarne učinke olanzapina na središnji živčani sustav, potreban je oprez kod njegove primjene u kombinaciji s drugim centralno djelujućim lijekovima i alkoholom.
English: Olanzapine reduced a conditioned avoidance response, a test indicative of antipsychotic activity, at doses below those producing catalepsy, an effect indicative of motor side-effects.
Croatian: Olanzapin je smanjio uvjetovani odgovor izbjegavanja, test koji ukazuje na antipsihotičko djelovanje u dozama nižim od onih koje uzrokuju katalepsiju, učinak koji ukazuje na motoričke nuspojave.
English: In most of these cases, a history of seizures or risk factors for seizures were reported.
Croatian: U većini ovih slučajeva prijavljeni su napadaji u anamnezi ili čimbenici rizika za nastanak napadaja.
English: What Olanzapine Apotex is and what it is used for
Croatian: Što je Olanzapine Apotex i za što se koristi
English: During treatment with olanzapine in combination with lithium or divalproex, an increase of  7% from baseline body weight occurred in 17.4% of patients during acute treatment (up to 6 weeks).
Croatian: Tijekom liječenja olanzapinom u kombinaciji s litijem ili divalproeksom, porast tjelesne težine  7 % od početne pojavio se u 17,4 % bolesnika tijekom akutnog liječenja (do 6 tjedana).
English: Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels (see sections 4.8 and 5.1).
Croatian: Ispitivanja s bolesnicima u dobi od 13 do 17 godina pokazala su različite nuspojave, uključujući povećanje tjelesne težine, promjene metaboličkih parametara te porast razina prolaktina (vidjeti dijelove 4.8 i 5.1).
English: In the same clinical trials, cerebrovascular adverse events (CVAE e.g., stroke, transient ischemic attack), including fatalities, were reported.
Croatian: U istim kliničkim ispitivanjima zabilježeni su cerebrovaskularni štetni događaji (CV štetni događaji, primjerice moždani udar, prolazni ishemijski napad), uključujući smrtne slučajeve.
English: • blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 people) especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing.
Croatian: • krvne ugruške u venama (manje česta nuspojava koja se može pojaviti u manje od 1 na 100 osoba), posebno u nogama (simptomi uključuju oticanje, bol i crvenilo noge), koji mogu putovati krvnim žilama do pluća uzrokujući bol u prsima i otežano disanje.
English: • Periodic Safety update Reports
Croatian: • Periodička izvješća o neškodljivosti
English: Long-term olanzapine treatment (up to 12 months) for recurrence prevention in patients with bipolar disorder was associated with an increase of 7% from baseline body weight in 39.9% of patients.
Croatian: Dugotrajno liječenje olanzapinom (do 12 mjeseci) radi prevencije relapsa u bolesnika s bipolarnim poremećajem bilo je povezano s povećanjem tjelesne težine  7 % od početne tjelesne težine u 39,9 % bolesnika.
English: • medicines for Parkinson's disease.
Croatian: • lijekove protiv Parkinsonove bolesti
English: Olanzapine is bound predominantly to albumin and 1-acid-glycoprotein.
Croatian: Olanzapin se prvenstveno veže za albumin i 1-kiseli-glikoprotein.
English: The concomitant administration of activated charcoal was shown to reduce the oral bioavailability of olanzapine by 50 to 60%.
Croatian: Pokazalo se da istodobna primjena aktivnog ugljena smanjuje oralnu bioraspoloživost olanzapina za 50 do 60 %.
English: Olanzapine was started at 2.5 mg/day and titrated to a maximum of 15 mg/day based on investigator judgement.
Croatian: Početna doza olanzapina bila je 2,5 mg/dan te je potom titrirana do najviše 15 mg/dan na temelju procjene ispitivača.
English: However, olanzapine (5-20 mg) demonstrated a comparable safety profile in female (n = 467) as in male patients (n = 869).
Croatian: Međutim, sigurnosni profil olanzapina (5-20 mg) u bolesnica (n=467) pokazao se usporedivim s onim u bolesnika (n=869).
English: • Heart disease
Croatian: • srčana bolest
English: Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo controlled clinical trials (see section 4.8).
Croatian: Neželjene promjene vrijednosti lipida uočene su u bolesnika liječenih olanzapinom u placebom kontroliranim kliničkim ispitivanjima (vidjeti dio 4.8).
English: In these trials, patients were initially required to be stable on the lowest effective dose of anti- Parkinsonian medicinal products (dopamine agonist) and to remain on the same anti-Parkinsonian medicinal products and dosages throughout the study.
Croatian: Na početku ovih ispitivanja bolesnici su morali biti stabilni na najnižoj učinkovitoj dozi antiparkinsonika (agonisti dopamina) te su na istom antiparkinsoniku i pri istoj dozi morali ostati tijekom cijelog ispitivanja.
English: How to store Olanzapine Apotex Contents of the pack and other information
Croatian: Kako čuvati Olanzapine Apotex Sadržaj pakiranja i druge informacije
English: Very common: Elevations of hepatic aminotransferases (ALT/AST; see section 4.4).
Croatian: Vrlo često: povišene razine jetrenih aminotransferaza (ALT/AST; vidjeti dio 4.4).
English: Very common adverse reactions associated with the use of olanzapine in this patient group were abnormal gait and falls.
Croatian: Vrlo česte nuspojave povezane s primjenom olanzapina u ovoj skupini bolesnika bile su neuobičajen hod i padanje.
English: The following symptoms may occur in newborn babies, of mothers that have used Olanzapine Apotex 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: Sljedeći simptomi mogu se pojaviti u novorođenčadi majki koje su koristile Olanzapine Apotex u posljednjem tromjesečju (zadnja tri mjeseca trudnoće): drhtanje, ukočenost mišića i/ili slabost, pospanost, uznemirenost, tegobe s disanjem te poteškoće u hranjenju.
English: Neutropenia has been reported commonly when olanzapine and valproate are used concomitantly (see section 4.8).
Croatian: Neutropenija je često prijavljivana kod istodobne primjene olanzapina i valproata (vidjeti dio 4.8).
English: Olanzapine Apotex has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment.
Croatian: Pokazalo se da Olanzapine Apotex sprječava ponavljanje tih simptoma u bolesnika s bipolarnim poremećajem u kojih je epizoda manije reagirala na liječenje olanzapinom.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujte se s liječnikom prije uzimanja ovog lijeka.
English: Risk factors that may predispose this patient population to increased mortality include age > 65 years, dysphagia, sedation, malnutrition and dehydration, pulmonary conditions (e.g., pneumonia, with or without aspiration), or concomitant use of benzodiazepines.
Croatian: Čimbenici rizika koji mogu pogodovati povećanom mortalitetu u ovoj populaciji bolesnika uključuju dob iznad 65 godina, disfagiju, sedaciju, malnutriciju i dehidraciju, bolesti pluća (npr. upala pluća sa ili bez aspiracije) ili istodobnu primjenu benzodiazepina.
English: A mass balance study showed that approximately 57% of radiolabelled olanzapine appeared in urine, principally as metabolites.
Croatian: Ispitivanje masene bilance pokazalo je da se približno 57 % olanzapina označenog radioizotopom pojavljuje u mokraći, uglavnom u obliku metabolita.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake grupe učestalosti nuspojave su prikazane u nizu od ozbiljnijih prema manje ozbiljnima.
English: Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
Croatian: Potreban je oprez ako se olanzapin primjenjuje istodobno s lijekovima za koje se zna da produljuju QTc interval (vidjeti dio 4.4).
English: Patients treated with any antipsychotic medicines, including Olanzapine Apotex, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
Croatian: U bolesnika liječenih bilo kojim antipsihotikom, uključujući Olanzapine Apotexom, treba pratiti pojavu znakova i simptoma hiperglikemije (kao što su polidipsija, poliurija, polifagija i slabost), a bolesnike s diabetes mellitusom ili čimbenicima rizika za razvoj diabetes mellitusa treba redovito pratiti zbog mogućeg pogoršanja glikemije.
English: The concomitant use of olanzapine with anti-Parkinsonian medicinal products in patients with Parkinson's disease and dementia is not recommended (see section 4.4).
Croatian: Ne preporučuje se istodobna primjena olanzapina s antiparkinsonicima u bolesnika s Parkinsonovom bolešću i demencijom (vidjeti dio 4.4).
English: Absolute oral bioavailability relative to intravenous administration has not been determined.
Croatian: Apsolutna bioraspoloživost peroralno primijenjenog lijeka u odnosu na intravensku primjenu nije ustanovljena.
English: Pharmacotherapeutic group: psycholeptics, diazepines, oxazepines, thiazepines and oxepines, ATC code N05A H03.
Croatian: Farmakoterapijska skupina: psiholeptici, diazepini, oksazepini, tiazepini i oksepini, ATK oznaka: N05A H03
English: Newborn infants exposed to antipsychotics (including olanzapine) 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: U novorođenčadi izloženoj antipsihoticima (uključujući olanzapin) tijekom trećeg tromjesečja trudnoće postoji rizik od nastanka nuspojava, uključujući ekstrapiramidalne simptome i/ili simptome ustezanja koji nakon poroda mogu varirati po težini i trajanju.
English: Olanzapine also demonstrated comparable efficacy results to haloperidol in terms of the proportion of patients in symptomatic remission from mania and depression at 6 and 12 weeks.
Croatian: Olanzapin je također pokazao usporedive rezultate djelotvornosti u odnosu na haloperidol u smislu udjela bolesnika koji su u 6. i 12. tjednu liječenja pokazali simptomatsku remisiju manije i depresije.
English: Adults Olanzapine is indicated for the treatment of schizophrenia.
Croatian: Odrasli Olanzapin je indiciran za liječenje shizofrenije.
English: Very common symptoms in overdose (> 10% incidence) include tachycardia, agitation/aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
Croatian: Vrlo česti simptomi predoziranja (incidencija > 10 %) obuhvaćaju tahikardiju, agitaciju/agresivnost, dizartriju, različite ekstrapiramidalne simptome te smanjenu razinu svijesti u rasponu od sedacije do kome.
English: There have been reports of agitation, hypertonia, hypotonis, tremor, somnolence, respiratory distress, or feeding disorder.
Croatian: Postoje izvješća o agitaciji, hipertoniji, hipotoniji, tremoru, somnolenciji, respiratornom distresu ili poremećaju hranjenja.
English: Fluvoxamine, a specific CYP1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
Croatian: Dokazano je da fluvoksamin, specifičan inhibitor CYP1A2, značajno inhibira metabolizam olanzapina.
English: Very common: Decreased total bilirubin, increased GGT, elevated plasma prolactin levels
Croatian: Vrlo često: snižena razina ukupnog bilirubina, povišena razina GGT, povišene razine prolaktina u plazmi
English: In the study, the risk of olanzapine was comparable to the risk of atypical antipsychotics included in a pooled analysis.
Croatian: U ispitivanju je rizik kod olanzapina bio usporediv s rizikom povezanim s atipičnim antipsihoticima uključenima u objedinjenu analizu.
English: The use of olanzapine in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease is not recommended.
Croatian: Primjena olanzapina u liječenju psihoze povezane s dopaminskim agonistima u bolesnika s Parkinsonovom bolešću se ne preporučuje.
English: In cytopenic dogs, there were no adverse effects on progenitor and proliferating cells in the bone marrow.
Croatian: U pasa s citopenijom nije bilo štetnih učinaka na matične i proliferacijske stanice koštane srži.
English: In placebo-controlled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/or disturbed behaviours, there was a 2-fold increase in the incidence of death in olanzapine-treated patients compared to patients treated with placebo (3.5% vs. 1.5%, respectively).
Croatian: U placebom kontroliranim kliničkim ispitivanjima (trajanja od 6 do 12 tjedana) starijih bolesnika (srednja vrijednost dobi 78 godina) s psihozom i/ili poremećajima ponašanja uzrokovanima demencijom zabilježeno je dvostruko povećanje incidencije smrti u bolesnika liječenih olanzapinom u usporedbi s bolesnicima koji su primali placebo (3,5 % naspram 1,5 %).
English: The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/LDL/HDL cholesterol or triglycerides increased over time.
Croatian: Udio bolesnika koji su imali klinički značajne nuspojave, poput povećanja tjelesne težine, porasta vrijednosti glukoze, ukupnog/LDL/HDL kolesterola ili triglicerida, porastao je s vremenom.
English: Olanzapine Apotex with alcohol
Croatian: Olanzapine Apotex s alkoholom
English: • The use of Olanzapine Apotex in elderly patients with dementia is not recommended as it may have serious side effects.
Croatian: • Primjena Olanzapine Apotexa u starijih bolesnika s demencijom (zaboravljivošću) se ne preporučuje jer mogu nastati teške nuspojave.
English: Weight should be monitored regularly, e.g. at baseline, 4, 8 and 12 weeks after starting olanzapine treatment and quarterly thereafter.
Croatian: Redovito treba pratiti tjelesnu težinu, npr. na početku, te nakon 4, 8 i 12 tjedana od početka liječenja olanzapinom te svaka 3 mjeseca nakon toga.
English: Standard procedures for management of overdose may be indicated (i.e. gastric lavage, administration of activated charcoal).
Croatian: Mogu biti indicirani standardni postupci za liječenje predoziranja (npr. ispiranje želuca, primjena aktivnog ugljena).
English: Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
Croatian: hepatitis (uključujući hepatocelularno, kolestatsko ili mješovito oštećenje jetre)
English: • Weight gain has been seen in patients taking Olanzapine Apotex.
Croatian: • Zapaženo je povećanje tjelesne težine u bolesnika koji uzimaju Olanzapine Apotex.
English: Other medically significant sequelae of overdose include delirium, convulsion, coma, possible neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension, cardiac arrhythmias (< 2% of overdose cases) and cardiopulmonary arrest.
Croatian: Druge medicinski značajne posljedice predoziranja obuhvaćaju delirij, konvulzije, komu, mogući neuroleptički maligni sindrom, respiratornu depresiju, aspiraciju, hipertenziju ili hipotenziju, srčane aritmije (< 2 % slučajeva predoziranja) i kardiopulmonalni arest.
English: In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo (see section 4.8), and olanzapine was not more effective than placebo in the treatment of psychotic symptoms.
Croatian: U kliničkim su ispitivanjima pogoršanje simptoma parkinsonizma i halucinacije prijavljivani vrlo često te češće u odnosu na placebo (vidjeti dio 4.8), a olanzapin nije bio učinkovitiji od placeba u liječenju psihotičkih simptoma.
English: In postmarketing reports with olanzapine, the event of sudden cardiac death has been reported in patients with olanzapine.
Croatian: U izvješćima o olanzapinu nakon stavljanja lijeka u promet prijavljen je događaj iznenadne srčane smrti u bolesnika na olanzapinu.
English: In one clinical trial in patients with bipolar mania, valproate combination therapy with olanzapine resulted in an incidence of neutropenia of 4.1%; a potential contributing factor could be high plasma valproate levels.
Croatian: U jednom kliničkom ispitivanju u bolesnika s bipolarnom manijom, kombinacijska terapija valproatom i olanzapinom uzrokovala je incidenciju neutropenije od 4,1 %; faktor koji je tome pridonio mogle su biti visoke razine valproata u plazmi.
English: The magnitude of changes in fasting total cholesterol, LDL cholesterol, triglycerides, and prolactin (see sections 4.4 and 4.8) were greater in adolescents than in adults.
Croatian: Promjene vrijednosti ukupnog kolesterola natašte, LDL kolesterola, triglicerida i prolaktina bile su veće u adolescenata nego u odraslih (vidjeti dijelove 4.4 i 4.8).
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom 18. JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM PC: {broj}
English: However, caution should be exercised when olanzapine is prescribed with medicines known to increase QTc interval, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia.
Croatian: Međutim, potreban je oprez prilikom propisivanja olanzapina s lijekovima za koje se zna da produljuju QTcinterval, osobito u starijih osoba, u bolesnika s prirođenim sindromom dugog QT-intervala, kongestivnim zatajenjem srca, hipertrofijom srca, hipokalijemijom ili hipomagnezijemijom.
English: What you need to know before you take Olanzapine Apotex
Croatian: Što morate znati prije nego počnete uzimati Olanzapine Apotex
English: • Liver or kidney disease
Croatian: • bolest jetre ili bubrega
English: Acute (single-dose) toxicity
Croatian: Akutna toksičnost (nakon jedne doze)
English: Dystonia (including oculogyration) 11
Croatian: distonija (uključujući okulogiraciju)11,
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza „Rok valjanosti“.
English: During treatment with olanzapine, adolescents gained significantly more weight compared with adults.
Croatian: Tijekom liječenja olanzapinom u adolescenata je primijećen značajno veći porast tjelesne težine u usporedbi s odraslim osobama.