FrancophonIA/ELRC3.0 huggingface dataset:
English: Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines, e.g. measuring of blood glucose at baseline, 12 weeks after starting olanzapine treatment and annually thereafter.
Slovenian: Priporoča se ustrezno klinično spremljanje v skladu z znanimi priporočili za antipsihotike, npr. merjenje glukoze v krvi na začetku, 12 tednov po začetku jemanja olanzeapina in nato enkrat na leto.
English: NL-2333 CN Leiden Netherlands
Slovenian: NL-2333 CN Leiden Nizozemska
English: Very common: Decreased total bilirubin, increased GGT, elevated plasma prolactin levels16.
Slovenian: Zelo pogosti: nizek celokupni bilirubin, visok GGT, zvišane plazemske koncentracije prolaktina16
English: Olanzapine is metabolized in the liver by conjugative and oxidative pathways.
Slovenian: Olanzapin se presnavlja v jetrih s potmi konjugacije in oksidacije.
English: Hepatitis (including hepatocellular, cholestatic or mixed liver injury) 11
Slovenian: hepatitis (vključno s hepatocelularno, holestatsko ali mešano okvaro jeter)11
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.
Slovenian: Pri novorojenčkih, ki so bili med tretjim trimesečjem nosečnosti izpostavljeni antipsihotikom (vključno z olanzapinom), obstaja tveganje za pojav neželenih učinkov, vključno z ekstrapiramidnimi in/ali odtegnitvenimi simptomi, katerih jakost in čas trajanja po porodu sta lahko različna.
English: Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Slovenian: Olanzapin ni indiciran za zdravljenje otrok in mladostnikov mlajših od 18 let.
English: In addition, a Single Photon Emission Computed Tomography (SPECT) imaging study in schizophrenic patients revealed that olanzapine-responsive patients had lower striatal D2 occupancy than some other antipsychotic- and risperidone-responsive patients, while being comparable to clozapineresponsive patients.
Slovenian: Dodatno je slikovna študija s fotonsko emisijsko računalniško tomografijo (Single Photon Emission Computed Tomography - SPECT) pri bolnikih s shizofrenijo razkrila, da so imeli bolniki, ki so se odzivali na olanzapin, nižjo zasedenost striatnih D2 receptorjev kot bolniki, ki so se odzivali na nekatere druge antipsihotike in risperidon, medtem ko je bila primerljiva z bolniki, ki so se odzivali na klozapin.
English: Cytochromes P450CYP1A2 and P450-CYP2D6 contribute to the formation of the N-desmethyl and 2-hydroxymethyl metabolites; both exhibited significantly less in vivo pharmacological activity than olanzapine in animal studies.
Slovenian: Citokroma P450-CYP1A2 in P450-CYP2D6 prispevata k tvorbi N-demetilnih in 2-hidroksimetilnih metabolitov, oboji so v študijah na živalih pokazali pomembno manj farmakološke aktivnosti in vivo kot olanzapin.
English: Animal behavioural studies with olanzapine indicated 5 HT, dopamine, and cholinergic antagonism, consistent with the receptorbinding profile.
Slovenian: Vedenjske študije z olanzapinom na živalih so kazale na 5HT, dopaminski in holinergični antagonizem v skladu s profilom vezave na receptorje.
English: The daily dose of Olanzapine Apotex is between 5 mg and 20 mg.
Slovenian: Dnevni odmerek zdravila Olanzapin Apotex je med 5 mg in 20 mg.
English: Patients treated with any antipsychotic medicines, including Olanzapine Apotex, should be monitored regularly for lipids in accordance with utilised antipsychotic guidelines, e.g. at baseline, 12 weeks after starting olanzapine treatment and every 5 years thereafter.
Slovenian: Bolnike, zdravljene s katerimkoli antipsihotikom, vključno z zdravilom Olanzapin Apotex, moramo redno spremljati glede lipidov, v skladu z znanimi priporočili za antipsihotike, npr. na začetku, 12 tednov po začetku jemanja olanzapina in nato vsakih 5 let.
English: In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF < 500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
Slovenian: V kliničnih preskušanjih so bila klinično pomembna podaljšanja QTc (QT korekcija Fridericia [QTcF] ≥ 500 milisekund [msek] kadarkoli nad osnovno vrednostjo pri bolnikih z osnovno vrednostjo QTcF < 500 msek) pri bolnikih, zdravljenih z olanzapinom, občasna (od 0,1 % do 1 %), brez pomembnih razlik v spremljajočih srčnih dogodkih v primerjavi z bolniki, zdravljenimi s placebom.
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).
Slovenian: Med zdravljenjem z olanzapinom v kombinaciji z litijem ali divalproeksom se je pri 17,4 % bolnikov med akutnim zdravljenjem ( do 6 tednov) pojavilo povečanje telesne mase za > 7 % od osnovne.
English: Very common: Sedation (including: hypersomnia, lethargy, somnolence).
Slovenian: Zelo pogosti: sedacija (vključno s: hipersomnijo, letargijo, zaspanostjo) Bolezni prebavil
English: Gastrointestinal disorders Mild, transient anticholinergic effects including constipation and dry mouth
Slovenian: Bolezni prebavil blagi prehodni antiholinergični učinki, vključno z zaprtjem in suhimi usti
English: What Olanzapine Apotex is and what it is used for
Slovenian: Kaj je zdravilo Olanzapin Apotex in za kaj ga uporabljamo
English: The other ingredients are mannitol (E421), microcrystalline cellulose, carmellose calcium, sucralose, magnesium stearate and colloidal anhydrous silica.
Slovenian: Druge sestavine zdravila so manitol (E421), mikrokristalna celuloza, kalcijev karmelozat, sukraloza, magnezijev stearat in brezvoden koloidni silicijev dioksid.
English: There have been reports of agitation, hypertonia, hypotonis, tremor, somnolence, respiratory distress, or feeding disorder.
Slovenian: Poročali so o agitaciji, hipertoniji, hipotoniji, tremorju, somnolenci, respiratorni stiski in motnjah hranjenja.
English: Olanzapine Apotex tablets break easily, so you should handle the tablets carefully.
Slovenian: Tablete Olanzapin Apotex se hitro zlomijo, zato z njimi ravnajte previdno.
English: Metabolism and nutrition disorders Very common: Weight gain13, elevated triglyceride levels14, increased appetite.
Slovenian: Presnovne in prehranske motnje Zelo pogosti: povečanje telesne mase13, zvišane ravni trigliceridov14, povečan apetit
English: Adults Schizophrenia: The recommended starting dose for olanzapine is 10 mg/day.
Slovenian: Odrasli Shizofrenija: Priporočeni začetni odmerek olanzapina je 10 mg na dan.
English: The other ingredients are (tablet core) lactose monohydrate, microcrystalline cellulose, maize starch, magnesium stearate, (tablet coat) hypromellose, hydroxypropylcellulose, macrogol 8000, titanium dioxide (E171).
Slovenian: Druge sestavine zdravila so (jedro tablete) laktoza monohidrat, mikrokristalna celuloza, korizni škrob, magnezijev stearat, (obloga tablete) hipromeloza, hidroksipropilceluloza, makrogol 8000, titanov dioksid (E171).
English: Blood and lymphatic system disorders Eosinophilia
Slovenian: Bolezni krvi in limfatičnega sistema eozinofilija
English: Bradycardia QTc prolongation (see section 4.4)
Slovenian: Srčne bolezni bradikardija podaljšanje QTc (glejte poglavje 4.4)
English: (≥ 1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/l< 1.467 mmol/l) to high (≥ 1.467 mmol/l).
Slovenian: (≥ 1,467 mmol/l) in spremembe v ravneh trigliceridov na tešče z mejnih osnovnih vrednosti (≥ 1,016 mmol/l - < 1,467 mmol/l) na visoke (≥ 1,467 mmol/l).
English: In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition of olanzapine 10 mg (co-therapy with lithium or valproate) resulted in a greater reduction in symptoms of mania than lithium or valproate monotherapy after 6 weeks.
Slovenian: V študiji sočasnega zdravljenja bolnikov z litijem ali valproatom vsaj 2 tedna je dodatek 10 mg olanzapina (sočasno zdravljenje z litijem ali valproatom) povzročil večje zmanjšanje simptomov manije kot po 6 tednih pri monoterapiji z litijem ali valproatom.
English: Do not stop taking your tablets just because you feel better.
Slovenian: Če ste prenehali jemati zdravilo Olanzapin Apotex Ne prenehajte jemati tablet samo zato, ker se počutite bolje.
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.
Slovenian: Izgled zdravila Olanzapin Apotex in vsebina pakiranja Orodisperzibilna tableta je tehničen izraz za tableto, ki se razpusti v ustih zaradi lažjega zaužitja.
English: As it exhibits in vitro dopamine antagonism, olanzapine may antagonize the effects of direct and indirect dopamine agonists.
Slovenian: Ker v pogojih in vitro kaže dopaminski antagonizem, olanzapin lahko nasprotuje učinkom direktnih in indirektnih dopaminskih agonistov.
English: Hypothermia12
Slovenian: hipotermija12
English: There was a 3-fold increase in CVAE in patients treated with olanzapine compared to patients treated with placebo (1.3% vs. 0.4%, respectively).
Slovenian: Pri bolnikih, zdravljenih z olanzapinom, je bila 3-krat večja pojavnost CVAE v primerjavi z bolniki, ki so prejemali placebo (1,3 % v primerjavi z 0,4 %).
English: Olanzapine demonstrated a greater in vitro affinity for serotonin 5 HT2 than dopamine D2 receptors and greater 5 HT2 than D2 activity in vivo models.
Slovenian: V pogojih in vitro je olanzapin pokazal večjo afiniteto za serotoninske 5-HT2 kot za dopaminske D2 receptorje in večjo 5-HT2 kot D2 aktivnost v modelih in vivo.
English: What you need to know before you take Olanzapine Apotex
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Olanzapin Apotex
English: In a multinational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p= 0.001) favouring olanzapine (-6.0) versus haloperidol (-3.1).
Slovenian: V dvojno slepi primerjalni študiji shizofrenije, shizoafektivnih in sorodnih motenj, v kateri je sodelovalo več držav in je vključevala 1481 bolnikov z različnimi stopnjami pridruženih depresivnih simptomov (izhodiščna srednja vrednost 16,6 na Montgomery-Asbergovi lestvici ocenjevanja depresije), je prospektivna sekundarna analiza spremembe od izhodiščne do končne ocene razpoloženja pokazala statistično značilno izboljšanje (p = 0,001) v korist olanzapina (-6,0) v primerjavi s haloperidolom (-3,1).
English: In cases where dose increments of 2.5 mg are considered necessary, Olanzapine Apotex film-coated tablets should be used.
Slovenian: V primerih, kjer je treba odmerek višati v korakih po 2,5 mg, se uporabi zdravilo Olanzapin Apotex filmsko obložene tablete.
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.
Slovenian: Druge zdravstveno pomembne posledice prevelikega odmerjanja vključujejo delirij, konvulzije, komo, možen nevroleptični maligni sindrom, depresijo dihanja, aspiracijo, hipertenzijo ali hipotenzijo, motnje srčnega ritma (< 2 % primerov prevelikega odmerjanja) in kardiopulmonalni zastoj.
English: 12 Adverse event identified from spontaneous post-marketing reporting with frequency estimated at the upper limit of the 95% confidence interval utilising the Olanzapine Integrated Database.
Slovenian: 12 Neželeni učinki, ugotovljeni pri spontanem poročanju v obdobju trženja s pogostostjo, ocenjeno na zgornjo mejo 95 % intervala zaupanja, določeno z uporabo integrirane baze podatkov za olanzapin.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Slovenian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ POGLEDA IN DOSEGA OTROK Zdravilo shranjujte nedosegljivo otrokom!
English: In a second 12-month recurrence prevention study in manic episode patients who achieved remission with a combination of olanzapine and lithium and were then randomised to olanzapine or lithium alone, olanzapine was statistically non-inferior to lithium on the primary endpoint of bipolar recurrence (olanzapine 30.0%, lithium 38.3%; p = 0.055).
Slovenian: V drugi 12-mesečni študiji preprečevanja ponovitve bolezni pri bolnikih z manično epizodo, ki so z zdravljenjem s kombinacijo olanzapina in litija dosegli remisijo in so jim nato naključno dodelili prejemanje samo olanzapina ali samo litija, ni bil olanzapin statistično značilno nič slabši kot litij ob primarni končni točki ponovitve bipolarne motnje (olanzapin 30,0 %, litij 38,3 %; p = 0,055).
English: As assessed by measured values from clinical trials in the Olanzapine Integrated Database.
Slovenian: 10 Kot je bilo ocenjeno na podlagi meritev v kliničnih študijah v integrirani bazi podatkov za olanzapin.
English: Seizures where in most cases a history of seizures or risk factors for seizures were reported 11
Slovenian: Epileptični napadi, pri katerih so jih v večini primerov imeli že kdaj prej ali so poročali o dejavnikih tveganja za epileptične napade11
English: If you suddenly stop taking Olanzapine Apotex, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur.
Slovenian: Če nenadno prenehate jemati zdravilo Olanzapin Apotex, se lahko pojavijo simptomi, kot so znojenje, nespečnost, tresenje, občutek tesnobe ali slabost in bruhanje.
English: Neuroleptic malignant syndrome (see section 4.4)12
Slovenian: Sindrom nemirnih nog nevroleptični maligni sindrom (glejte poglavje 4.4)12
English: Do not drink any alcohol if you have been given Olanzapine Apotex as together with alcohol it may make you feel drowsy.
Slovenian: Zdravilo Olanzapin Apotex skupaj z alkoholom Če ste dobili zdravilo Olanzapin Apotex, ne pijte nobenega alkohola, saj lahko to zdravilo skupaj z alkoholom povzroči občutek zaspanosti.
English: Weight should be monitored regularly, e.g. at baseline, 4, 8 and 12 weeks after starting olanzapine treatment and quarterly thereafter.
Slovenian: Redno moramo spremljati telesno maso, npr. na začetku, 4, 8 in 12 tednov po začetku jemanja olanzapina in nato enkrat na tri mesece.
English: • Liver or kidney disease
Slovenian: • obolenje jeter ali ledvic
English: It has the same dosage and frequency of administration as olanzapine filmcoated tablets.
Slovenian: Odmerek in pogostnost dajanja sta enaka kot pri filmsko obloženih tabletah olanzapin.
English: Lactose monohydrate Microcrystalline cellulose Maize starch
Slovenian: Jedro tablete laktoza monohidrat mikrokristalna celuloza koruzni škrob magnezijev stearat
English: Increased alkaline phosphatase10
Slovenian: Zvišana alkalna fosfataza10
English: In clinical trials in elderly patients with dementia, olanzapine treatment was associated with a higher incidence of death and cerebrovascular adverse reactions compared to placebo (see section 4.4).
Slovenian: Dodatne informacije glede posebnih skupin bolnikov V kliničnih preskušanjih pri starejših bolnikih z demenco je bilo zdravljenje z olanzapinom povezano z višjo incidenco smrti in cerebrovaskularnih neželenih učinkov v primerjavi s placebom (glejte poglavje 4.4).
English: Olanzapine orodispersible tablets may be used as an alternative to olanzapine filmcoated tablets.
Slovenian: Orodisperzibilne tablete olanzapina se lahko uporabijo kot alternativa za filmsko obložene tablet olanzapina.
English: Hyperglycaemia and/or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported uncommonly, including some fatal cases (see section 4.8).
Slovenian: Občasno so poročali o hiperglikemiji in/ali razvoju ali poslabšanju sladkorne bolezni, občasno povezanih s ketoacidozo ali komo, vključujoč nekaj primerov s smrtnim izidom (glejte poglavje 4.4).
English: 14 Observed for fasting normal levels at baseline (< 1.016 mmol/l) which increased to high
Slovenian: 14 Opazovano pri osnovnih normalnih ravneh na tešče (< 1,016 mmol/l), ki so se povišale na visoke
English: Hepatobiliary disorders Transient, asymptomatic elevations of hepatic aminotransferases (ALT, AST), especially in early treatment (see section 4.4)
Slovenian: Bolezni jeter, žolčnika in žolčevodov prehodna asimptomatska zvišanja jetrnih aminotransferaz (ALT, AST), posebno na začetku zdravljenja (glejte poglavje 4.4)
English: Common: Elevated cholesterol levels
Slovenian: Pogosti: zvišane ravni holesterola15
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.
Slovenian: Pri novorojenčkih mater, ki so v zadnjih treh mesecih nosečnosti uporabljale zdravilo Olanzapin Apotex, se lahko pojavijo naslednji simptomi: tresenje, okornost ali šibkost mišic, zaspanost, nemir, težave z dihanjem in motnje hranjenja.
English: In postmarketing reports with olanzapine, the event of sudden cardiac death has been reported in patients with olanzapine.
Slovenian: V postmarketinških poročilih so pri bolnikih, ki so se zdravili z olanzapinom, poročali o primerih nenadne srčne smrti.
English: Olanzapine orodispersible tablet is bioequivalent to olanzapine film-coated tablets, with a similar rate and extent of absorption.
Slovenian: Olanzapin orodisperzibilne tablete so bioekvivalenten filmsko obloženim tabletam olanzapina, s podobno stopnjo in obsegom absorpcije.
English: Orodispersible tablet
Slovenian: Orodisperzibilna tableta.
English: Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo controlled clinical trials (see section 4.8).
Slovenian: V kliničnih preskušanjih, kontroliranih s placebom, so pri bolnikih zdravljenih z olanzapinom opažali neželene spremembe lipidov (glejte poglavje 4.8).
English: tachycardia/fibrillation, sudden death (see section 4.4)11
Slovenian: prekatna tahikardija/fibrilacij a, nenadna smrt (glejte poglavje 4.4)11
English: Olanzapine Apotex orodispersible tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
Slovenian: Zdravilo Olanzapin Apotex orodisperzibilne tablete položite v usta, kjer se v slini hitro razpustijo za lažje požiranj.
English: In renally impaired patients (creatinine clearance <10 ml/min) versus healthy subjects, there was no significant difference in mean elimination half-life (37.7 versus 32.4 hrs) or clearance (21.2 versus 25.0 l/hr).
Slovenian: Pri bolnikih z okvarjenim delovanjem ledvic (očistek kreatinina < 10 ml/min) v primerjavi z zdravimi osebami ni bilo značilne razlike v srednjem razpolovnem času izločanja (37,7 v primerjavi z 32,4 ure) ali očistku (21,2 v primerjavi s 25,0 l/h).
English: In healthy elderly (65 and over) versus non-elderly subjects, the mean elimination half-life was prolonged (51.8 versus 33.8 hrs) and the clearance was reduced (17.5 versus 18.2 l/hr).
Slovenian: Pri zdravih starejših osebah (65 let in več) v primerjavi z nestarejšimi je bil srednji razpolovni čas izločanja podaljšan (51,8 v primerjavi s 33,8 ure) in očistek zmanjšan (17,5 v primerjavi z 18,2 l/h).
English: Other medicines and Olanzapine Apotex
Slovenian: Druga zdravila in zdravilo Olanzapin Apotex
English: Rhabdomyolysis11
Slovenian: rabdomioliza11
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako
English: The most frequently (seen in ≥ 1% of patients) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism, leukopenia, neutropenia (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic aminotransferases (see section 4.4), rash, asthenia, fatigue, pyrexia, arthralgia, increased alkaline phosphatase, high gamma glutamyltransferase, high uric acid, high creatine phosphokinase and oedema.
Slovenian: Najpogosteje poročani (opaženi pri  1 % bolnikov) neželeni učinki, povezani z uporabo olanzapina v kliničnih preskušanjih, so bili zaspanost, povečanje telesne mase, eozinofilija, zvišane ravni prolaktina, holesterola, glukoze in trigliceridov (glejte poglavje 4.4), glikozurija, povečan apetit, omotica, akatizija, parkinsonizem, levkopenija, nevtropenija (glejte poglavje 4.4), diskinezija, ortostatska hipotenzija, antiholinergični učinki, prehodna asimptomatska zvišanja jetrnih aminotransferaz (glejte poglave 4.4), izpuščaj, astenija, utrujenost, pireksija, artralgija, zvišana alkalna fosfataza, visoka raven gama-glutamiltransferaze, visoka raven sečne kisline, visoka raven kreatinfosfokinaze in edem.
English: Transient, asymptomatic elevations of hepatic aminotransferases, alanine transferase (ALT), aspartate transferase (AST) have been seen commonly, especially in early treatment.
Slovenian: Pogosto so opažali prehodna, asimptomatska zvišanja jetrnih aminotransferaz, alanin transferaze (ALT), aspartat transferaze (AST), posebno na začetku zdravljenja.
English: Clinical signs included sedation, ataxia, tremors, increased heart rate, labored respiration, miosis, and anorexia.
Slovenian: Klinični znaki so vključevali sedacijo, ataksijo, tresenje, zvišano srčno frekvenco, težko dihanje, miozo in izgubo apetita.
English: Following short term treatment (median duration 47 days), weight gain ≥ 7% of baseline body weight was very common (22.2 %), ≥ 15 % was common (4.2 %) and ≥ 25 % was uncommon (0.8 %).
Slovenian: S kratkoročnim zdravljenjem (srednje trajanje 47 dni) povezano zvečanje telesne mase za ≥ 7 % od osnovne telesne mase je bilo zelo pogosto (22,2 %), ≥ 15 % pogosto (4,2 %) in ≥ 25 % občasno (0,8 %).
English: Excipient with known effect: Each film-coated tablet contains 189.50 mg lactose.
Slovenian: Pomožna snov z znanim učinkom: Vsaka filmsko obložena tableta vsebuje 189,50 mg laktoze.
English: PHARMACEUTICAL FORM AND CONTENTS 28 orodispersible tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 28 orodisperzibilnih tablet
English: Rare side effects (may affect up to 1 in 1000 people) include lowering of normal body temperature; abnormal rhythms of the heart; sudden unexplained death; inflammation of the pancreas causing severe stomach pain, fever and sickness; liver disease appearing as yellowing of the skin and white parts of the eyes; muscle disease presenting as unexplained aches and pains; and prolonged and/or painful erection.
Slovenian: Redki neželeni učinki (lahko prizadenejo do 1 od 1.000 bolnikov) vključujejo znižanje normalne telesne temperature, motnje srčnega ritma, nenadno nerazložljivo smrt, vnetje trebušne slinavke, ki povzroča hude bolečine v predelu želodca, zvišano telesno temperaturo in slabost, obolenje jeter, ki se kaže kot obarvanje kože in beločnic na rumeno, mišične bolezni, ki se kažejo kot nerazložljive bolečinske težave in bolečine, podaljšano in/ali bolečo erekcijo.
English: Olanzapine Apotex 5 mg orodispersible tablets Olanzapine Apotex 10 mg orodispersible tablets Olanzapine Apotex 15 mg orodispersible tablets Olanzapine Apotex 20 mg orodispersible tablets
Slovenian: Olanzapin Apotex 5 mg orodisperzibilne tablete Olanzapin Apotex 10 mg orodisperzibilne tablete Olanzapin Apotex 15 mg orodisperzibilne tablete Olanzapin Apotex 20 mg orodisperzibilne tablete olanzapin