natgillin/translations-raw huggingface dataset:
LAVENTAIR ELLIPTA is an inhalation powder, pre-dispensed. 
Zdravilo LAVENTAIR ELLIPTA je prašek za inhaliranje, odmerjeni.
LAVENTAIR ELLIPTA is for inhalation use. 
Zdravilo LAVENTAIR ELLIPTA je namenjeno za inhalacijsko uporabo.
FAES FARMA, S.A. Tel: + 34 900 460 153 aweber@faes.es 
FAES FARMA, S.A. Tel: + 34 900 460 153
In addition, LAVENTAIR ELLIPTA demonstrated clinically meaningful and statistically significant improvements in trough FEV1 compared with tiotropium in two of the three 6-month active-comparator studies and numerically greater improvements from tiotropium in the third active-comparator study (see Table 1). 
ELLIPTA v primerjavi s tiotropijem klinično pomembno in statistično značilno izboljšalo najnižji FEV1 v dveh od treh 6-mesečnih študij z aktivno primerjalno učinkovino, v tretji od teh študij pa je doseglo številsko večje izboljšanje kot tiotropij (glejte preglednico 1).
There was no evidence for tachyphylaxis in the effect of LAVENTAIR ELLIPTA over time. 
Znakov postopnega zmanjšanja učinkovitosti (tahifilaksije) zdravila LAVENTAIR ELLIPTA ni bilo.
LAVENTAIR ELLIPTA demonstrated a statistically significant and clinically meaningful reduction in breathlessness as evaluated by an increase in TDI focal score at Week 24 (key secondary end-point) compared with placebo (see Table 1). 
Zdravilo LAVENTAIR ELLIPTA je v primerjavi s placebom statistično značilno in klinično pomembno izboljšalo težko dihanje, ocenjeno s povečanjem fokalnega seštevka TDI po 24 tednih (ključni sekundarni opazovani dogodek) (glejte preglednico 1).
If you are breast-feeding, you must check with your doctor before you use LAVENTAIR ELLIPTA. 
Če dojite, se morate pred uporabo zdravila LAVENTAIR ELLIPTA posvetovati z zdravnikom.
LAVENTAIR ELLIPTA contains lactose 
Zdravilo LAVENTAIR ELLIPTA vsebuje laktozo
LAVENTAIR ELLIPTA 55/22 micrograms improved exercise endurance time compared with placebo, as evaluated with the endurance shuttle walk test (ESWT), in one study but not the second and improved lung volume measures compared with placebo in both studies in adult COPD patients with hyperinflation (functional residual capacity [FRC] >120%). 
Zdravilo LAVENTAIR ELLIPTA 55/22 mikrogramov je v primerjavi s placebom v eni študiji (ne pa tudi v drugi) izboljšalo čas obremenitvene vzdržljivosti ocenjene z vzdržljivostnim krožnim testom hoje (ESWT
The first time you use LAVENTAIR ELLIPTA you do not need to check that the inhaler is working properly; it contains previously measured doses and is ready to use straight away. 
Ko zdravilo LAVENTAIR ELLIPTA uporabite prvič, vam ni treba preverjati, ali inhalator deluje pravilno;
LAVENTAIR ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed 
LAVENTAIR ELLIPTA 55 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni
LAVENTAIR ELLIPTA (N = 207) versus tiotropium 18 mcg (N = 203) (Study DB2113360) 
18 µg tiotropija (N = 203) (študija DB2113360)
- if you have severe liver problems 
- če imate težave z žlezo ščitnico,
LAVENTAIR ELLIPTA (N = 217) versus tiotropium 18 mcg (N = 215) (Study DB2113374) 
18 µg tiotropija (N = 215) (študija DB2113374)
In the first study, LAVENTAIR ELLIPTA 55/22 micrograms demonstrated a statistically significant and clinically relevant improvement (based on a minimal clinically important difference (MCID) between 45 to 85 seconds) over placebo in exercise endurance time (EET) obtained 3 hours after dosing at Week 12 (69.4 seconds [p=0.003]). 
[MCID - minimal clinically important difference] med 45 in 85 sekund) čas obremenitvene vzdržljivosti (EET - exercise endurance time), dosežen 3 ure po uporabi (69,4 sekunde [p = 0,003]).
LAVENTAIR ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed umeclidinium/vilanterol 
LAVENTAIR ELLIPTA 55 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni umeklidinij/vilanterol
In the three 6-month active-comparator-controlled studies, LAVENTAIR ELLIPTA reduced the use of rescue medication with salbutamol compared with tiotropium, with statistically significant reductions observed in two of the studies (see Table 1). 
ELLIPTA zmanjšalo uporabo rešilnega zdravila s salbutamolom v primerjavi s tiotropijem; v dveh od teh treh študij je bilo zmanjšanje statistično značilno (glejte preglednico 1).
How to use LAVENTAIR ELLIPTA 
Kako uporabljati zdravilo LAVENTAIR ELLIPTA
In a 24-week placebo-controlled study in patients with symptomatic COPD, LAVENTAIR ELLIPTA reduced the risk of a moderate/severe COPD exacerbation by 50% compared with placebo (based on analysis of time to first exacerbation: Hazard Ratio (HR) 0.5; 95% CI: 0.3, 0.8; p=0.004*); by 20% compared with umeclidinium (HR 0.8; 95% CI: 0.5, 1.3; p=0.391); and by 30% compared with vilanterol (HR 0.7; 95% CI: 0.4, 1.1; p=0.121). 
V 24-tedenski s placebom kontrolirani študiji pri bolnikih s simptomatsko KOPB je zdravilo LAVENTAIR ELLIPTA v primerjavi s placebom zmanjšalo tveganje za zmerno/hudo poslabšanje KOPB za 50 % (na podlagi analize časa do prvega poslabšanja: Razmerje ogroženosti (ROg) 0,5; 95 % IZ: 0,3; 0,8, p=0.004*);
Renal impairment No dose adjustment is required in patients with renal impairment. 
Okvara ledvic Bolnikom z okvaro ledvic odmerka ni treba prilagoditi.
If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your LAVENTAIR ELLIPTA inhaler: 
Če se vam takoj po uporabi inhalatorja LAVENTAIR ELLIPTA pojavi tiščanje v prsih, kašelj, piskajoče dihanje ali težko dihanje:
- if you have diabetes 
- če imate sladkorno bolezen, - če imate hudo okvaro jeter.
LAVENTAIR ELLIPTA 55/22 mcg inhalation powder umeclidinium/vilanterol 
LAVENTAIR ELLIPTA 55/22 µg prašek za inhaliranje umeklidinij/vilanterol
In the second study, LAVENTAIR ELLIPTA 55/22 micrograms showed improvements compared with placebo in change from baseline in lung volume measures at trough and at 3 hours post dose at Week 12 (inspiratory capacity: 198 ml and 238 ml respectively, residual volume: -295 ml and -351 ml respectively and functional residual capacity: -238 ml and -302 ml respectively); all p<0.001∗). 
(inspiratorna kapaciteta: 198 ml oziroma 238 ml, rezidualni volumen: -259 ml oziroma -351 ml in funkcionalna rezidualna kapaciteta: -238 ml oziroma -302 ml, vse p < 0,001∗).
The “Discard by” date should be written on the inhaler label in the space provided. 
V predvideni prostor na nalepki inhalatorja je potrebno vpisati datum “Zavrzite do“.
LAVENTAIR ELLIPTA has also shown an improvement in health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ) as indicated by a reduction in SGRQ total score at Week 24 compared with placebo and each monotherapy component (see Table 1). 
Zdravilo LAVENTAIR ELLIPTA je izboljšalo tudi kakovost življenja povezano z zdravjem, merjeno z vprašalnikom SGRQ (St. George's Respiratory Questionnaire).
4) Close the inhaler 
Zaprite pokrovček inhalatorja
If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes during treatment with LAVENTAIR ELLIPTA: 
Če se vam med zdravljenjem z zdravilom LAVENTAIR ELLIPTA pojavijo bolečine ali neugodje v očesu,
Your LAVENTAIR ELLIPTA inhaler carton contains 
Škatla vašega zdravila LAVENTAIR ELLIPTA vsebuje
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate). 
Z enim vdihom dobite odmerek (odmerek, ki pride iz ustnika) 55 mikrogramov umeklidinija (to ustreza 65 mikrogramom umeklidinijevega bromida) in 22 mikrogramov vilanterola (v obliki trifenatata).
The results were similar to 
Med takimi so:
Oropharyngeal pain Dysphonia 
PODATKI NA ZUNANJI OVOJNINI
How to store LAVENTAIR ELLIPTA 
Shranjevanje zdravila LAVENTAIR ELLIPTA
Rare side effects (may affect up to 1 in 1,000 people): 
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): • otekanje, včasih obraza ali ust (angioedem),
LAVENTAIR ELLIPTA demonstrated improvements in lung function (as defined by change from baseline in trough FEV1) in several studies. 
Zdravilo LAVENTAIR ELLIPTA je izboljšalo pljučno funkcijo (opredeljeno kot spremembo najnižjega
These may affect up to 1 in 1,000 people: 
Pojavijo se lahko pri največ 1 od 1.000 bolnikov: • zamegljen vid,
What LAVENTAIR ELLIPTA is used for 
Za kaj uporabljamo zdravilo LAVENTAIR ELLIPTA
- if you have an eye problem called narrow-angle glaucoma 
- če imate očesno bolezen, imenovano glavkom z ozkim zakotjem,
In one 6-month Phase III study, LAVENTAIR ELLIPTA demonstrated statistically significant improvements in trough FEV1 (primary endpoint) at Week 24 compared with placebo and each monotherapy component treatment arm. 
ELLIPTA v primerjavi s placebom in vsako od obeh sestavin v monoterapiji po 24 tednih statistično značilno izboljšalo najnižji FEV1 (primarni opazovani dogodek).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL LAMINATE TRAY LID 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Hvězdova 1716/2b, 140 78 Praha 4 
Hvězdova 1716/2b, 140 78 Praha 4 Češka
Your doctor will tell you how many Olazax tablets to take and how long you should continue to take them. 
Zdravnik vam bo povedal, koliko Olazax tablet morate vzeti in kako dolgo naj bi jih jemali.
(see sections 4.8 and 5.1). 
(Glejte poglavji 4.5 in 5.2.)
If you are pregnant or think you might be pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. 
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom, preden vzamete to zdravilo.
- If you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye). 
- če so vam v preteklosti ugotovili težave z očmi kot je določena vrsta glavkoma (povišan tlak v očesu).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11.12.2009 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 11.12. 2009
You should not be given this medicine when breast-feeding, as small amounts of Olazax can pass into breast milk. 
Ko dojite, tega zdravila ne smete jemati, ker lahko majhne količine zdravila Olazax prehajajo v materino mleko.
You should take your Olazax tablets once a day following the advice of your doctor. 
Olazax tablete jemljite enkrat na dan, in sicer upoštevajte nasvet zdravnika.
(see section 4.4)11 
(glejte poglavje 4.4)12O
cardiac arrhythmias (< 2 % of overdose cases) and cardiopulmonary arrest. 
motnje srčnega ritma (< 2 % primerov prevelikega odmerjanja) in kardiopulmonalni zastoj.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.emea.europa.eu 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu/.
What Olazax is and what it is used for What you need to know before you take Olazax How to take Olazax 
Kaj je zdravilo Olazax in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Olazax Kako jemati zdravilo Olazax
Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olazax and regularly during treatment. 
Vaš zdravnik mora opraviti krvni test za preiskavo sladkorja v krvi in nivo določenih maščob pred začetkom jemanja zdravila OLANZAPINE in redno tekom zdravljenja.
It is important that you carry on taking Olazax for as long as your doctor tells you. 
Pomembno je, da nadaljujete z jemanjem zdravila Olazax tako dolgo, kot vam naroči zdravnik.
In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 
V kliničnih preskušanjih so bila klinično pomembna podaljšanja QTc (QT korekcija Fridericia
Consult your doctor if your symptoms return but do not stop taking Olazax unless your doctor tells you to. 
Če se simptomi povrnejo, se posvetujte s svojim zdravnikom, vendar ne prenehajte jemati zdravila Olazax, če vam tega ne naroči vaš zdravnik.
Other medicines and Olazax 
Druga zdravila in zdravilo Olazax
What OLAZAX is and what it is used for 
Kaj je zdravilo Olazax in za kaj ga uporabljamo
• carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your Olazax dose 
• karbamazepin (antiepileptik in stabilizator razpoloženja), fluvoksamin (antidepresiv) ali ciprofloksacin (antibiotik) - morda bo treba spremeniti vaš odmerek zdravila Olazax.
Potential for olanzapine to affect other medicinal products 
Zmožnost vplivanja olanzapina na druga zdravila
The following table summarises the adverse reactions reported with a greater frequency in adolescent patients (aged 13-17 years) than in adult patients or adverse reactions only identified during shortterm clinical trials in adolescent patients. 
Naslednja tabela vključuje neželene učinke, ki so jih poročali z višjo pogostnostjo pri mladostnikih (starih 13-17 let) kot pri odraslih bolnikih ali neželene učinke, ki so jih ugotovili samo v kratkoročnih kliničnih preskušanjih pri mladostnikih.
• 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) 
• krče • če veste, da imate morda pomanjkanje soli zaradi dolgotrajne hude driske in bruhanja ali uporabe diuretikov (tablet za odvajanje vode)
In patients with Parkinson's disease Olazax may worsen the symptoms 
Pri bolnikih s Parkinsonovo boleznijo lahko zdravilo Olazax poslabša simptome.
• The use of OLAZAX in elderly patients with dementia is not recommended as it may have serious side effects. 
• Uporaba zdravila OLANZAPINE ni priporočljiva pri starejših bolnikih z demenco, saj lahko povzroči resne neželene učinke.
If this happens after you have been given Olazax, tell your doctor. 
Če se vam to zgodi po tem, ko ste prejeli zdravilo OLANZAPINE , povejte svojemu zdravniku.
If you take more Olazax than you should 
Če ste vzeli večji odmerek zdravila Olazax, kot bi smeli
Olazax tablets are for oral use. 
Olazax obložene tablete so za peroralno uporabo.
Do not take Olazax - If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6). 
- če ste alergični na (preobčutljivi za) olanzapin ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
The daily dose of Olazax is between 5 mg and 20 mg. 
Dnevni odmerek zdravila Olazax je med 5 mg in 20 mg.
1 Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories. 
Klinično značilno zvečanje telesne mase so opažali preko celotne osnove kategorij Indeksa telesne mase (BMI, Body Mass Index).
Patients who have taken more Olazax 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. 
Bolniki, ki so vzeli večji odmerek zdravila Olazax, kot bi smeli, so imeli naslednje simptome: hitro bitje srca, vznemirjenost/nasilnost, težave pri govoru, nenavadne zgibke (posebno v mišicah obraza ali jezika) in zmanjšano stopnjo zavesti.
Date of renewal: 22.08.2014 
Datum zadnjega podaljšanja: 11.12.2014
PHARMACEUTICAL FORM AND CONTENTS Tablet 
FARMACEVTSKA OBLIKA IN VSEBINA tableta
If you stop taking Olazax 
Če ste prenehali jemati zdravilo Olazax
Olazax belongs to a group of medicines called antipsychotics and is used to treat the following conditions: 
imenovanih antipsihotiki in se uporablja za zdravljenje naslednjih bolezni:
Olanzapine may antagonise the effects of direct and indirect dopamine agonists. 
Olanzapin lahko nasprotuje učinkom direktnih in indirektnih dopaminskih agonistov.
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Oral use. 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo.
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; α 1 adrenergic; and histamine H1 receptors. 
V predkliničnih študijah je olanzapin pokazal razpon afinitet do receptorjev (Ki; < 100 nM) za serotonin 5-HT2A/2C, 5-HT3, 5-HT6; dopamin D1, D2, D3, D4, D5; holinergičnih muskarinskih receptorjev M1-M5; adrenergičnih α1; in histaminskih H1 receptorjev.
Olazax has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment. 
Zdravilo OLAZAX dokazano preprečuje ponoven pojav teh simptomov pri bolnikih z bipolarno motnjo, pri katerih se je manična epizoda po zdravljenju z olanzapinom izboljšala.
6.4 Special precautions for storage Store below 30ºC 
6.4 Posebna navodila za shranjevanje Shranjujte pri temperaturi do 30 °C.
Children and adolescents Olazax is not for patients who are under 18 years 
Zdravilo Olazax ni namenjeno bolnikom, mlajšim od 18 let.
SPECIAL STORAGE CONDITIONS Store below 30°C 
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 30 °C.
The frequency terms listed are defined as follows: Very common (≥1/10), common (≥1/100 to 
Našteti izrazi pogostnosti so definirani kot sledi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do
Olazax, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg are available in aluminium foil blisters of 28 or 56 tablets 
Olazax 5 mg, 7,5 mg, 10 mg, 15 mg, 20 mg tablete so na voljo v aluminijastih pretisnih omotih po 28 & 56 tablet.
Phenylalanine Olazax tablet contains aspartame, which is a source of phenylalanine. 
Zdravilo Olanzapin Glenmark tablete vsebuje aspartam, ki je vir fenilalanina.
Do not drink any alcohol if you have been given Olazax as together with alcohol it may make you feel drowsy. 
Jemanje zdravila Olazax skupaj z alkoholom Če ste dobili zdravilo Olazax, ne pijte nobenega alkohola, saj lahko zdravilo Olazax in alkohol skupaj povzročita občutek zaspanosti.
Ventricular tachycardia/fibri llation, sudden death (see section 4.4)11 
Prekatna tahikardija/fibril acija, nenadna smrt (glejte poglavje 4.4)11
There is a risk of feeling drowsy when you are given Olazax. 
Vpliv na sposobnost upravljanja vozil in strojev Obstaja tveganje, da se boste po tem, ko ste dobili zdravilo Olazax, počutili zaspane.
Photosensitivity reaction 
Fotosenzitivnostn e reakcije
Dystonia (including oculogyration)11 Tardive dyskinesia11 
(vključno z okulogiracijo)11 Tardivne diskinezije11
Patients treated with any antipsychotic medicines, including olanzapine, 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. 
OLANZAPINE , moramo opazovati za znake in simptome hiperglikemije (kot so polidipsija, poliurija, polifagija in šibkost) ter redno spremljati bolnike s sladkorno boleznijo ali dejavniki tveganja za sladkorno bolezen glede poslabšanja nadzora glukoze.
How to take Olazax 
Kako jemati zdravilo Olazax
Other medically significant sequelae of overdose include delirium, convulsion, coma, possible neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension, 
Druge zdravstveno pomembne posledice prevelikega odmerjanja vključujejo delirij, konvulzije, komo, možen nevroleptični maligni sindrom, depresijo dihanja, aspiracijo, hipertenzijo ali hipotenzijo,
What Olazax looks like and contents of the pack 
Izgled zdravila Olazax in vsebina pakiranja
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 . 
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.
The following symptoms may occur in newborn babies, of mothers that have used OLAZAX in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. 
Pri novorojenčkih mater, ki so v zadnjih treh mesecih nosečnosti uporabljale zdravilo Olazax, se lahko pojavijo naslednji simptomi: tresenje, okornost ali šibkost mišic, zaspanost, nemir, težave z dihanjem in motnje hranjenja.
(at least 48 weeks) were very common (64.4 %, 31.7 % and 12.3 % respectively). 
64,4 %, 31,7 % in 12,3 %).
If you forget to take Olazax Take your tablets as soon as you remember. 
Vzemite tablete, kakor hitro se spomnite.
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. 
[QTcF] ≥ 500 milisekund [msek] kadarkoli nad osnovno vrednostjo pri bolnikih z osnovno vrednostjo QTcF < 500 msek) pri bolnikih, zdravljenih z olanzapinom, redka (od 0,1 % do 1 %), brez pomembnih razlik v spremljajočih srčnih dogodkih v primerjavi z bolniki, zdravljenimi s placebom.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients Mannitol E 421 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol E 421 mikrokristalna celuloza aspartam E 951 krospovidon magnezijev stearat
You should swallow the Olazax X tablets whole, with water. 
Olazax tablete pogoltnite cele z vodo.
(≥ 1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/l 
(≥ 1,467 mmol/l) in spremembe v ravneh trigliceridov na tešče z mejnih osnovnih vrednosti
Transient, asymptomatic elevations of hepatic aminotransferases, ALT, AST have been seen commonly, especially in early treatment. 
Jetrno delovanje Pogosto so opažali prehodna, asimptomatska zvišanja jetrnih aminotransferaz, ALT, AST, posebno na začetku zdravljenja.
Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating fats and early in treatment, temporary increases in liver enzymes; increases in the level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in the blood; feeling more hungry; dizziness; restlessness; tremor; unusual movements(dyskinesias); constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet; fever; joint pain; and sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males. 
Pogosti neželeni učinki (lahko prizadenejo do 1 od 10 bolnikov) vključujejo spremembe v ravneh nekaterih krvnih celic, maščob v krvnem obtoku in v začetnih obdobjih zdravljenja, začasno povišanje jetrnih encimov, zvišanja v ravni sladkorjev v krvi in urinu, zvišanja v ravni sečne kisline in kreatin fosfokinaze v krvi, večji občutek lakote, omotico, nemirnost, tresenje, nenavadne gibe (diskinezijo), zaprtje, suha usta, izpuščaj, izgubo moči, hudo utrujenost, zadrževanje vode, ki vodi v otekanje rok, gležnjev ali nog, vročino, bolečine v sklepih ter spolne disfunkcije, kot na primer zmanjšan libido pri moških in ženskah ter erektilna disfunkcija pri moških.
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 (< 01/10,000), not known (cannot be estimated from the data available). 
< 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), ni znano (ocena ni možna iz danih podatkov).
Olazax contains the active substance olanzapine. 
Zdravilo Olazax vsebuje zdravilno učinkovino olanzapin.
• High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Olazax. 
• Pri bolnikih, ki so jemali zdravilo OLANZAPINE , so opazili visok nivo sladkorja v krvi in visok nivo maščob (trigliceridov in holesterola).