natgillin/translations-raw huggingface dataset:
Hyperglycaemia and diabetes 
Hiperglikemija i dijabetes
In postmarketing reports with olanzapine, the event of sudden cardiac death has been reported in patients with olanzapine. 
Nakon stavljanja olanzapina na tržište zabilježen je događaj iznenadne srčane smrti u bolesnika na olanzapinu.
With long-term exposure (at least 24 weeks), 89.4 % gained ≥ 7 %, 55.3 % gained ≥ 15 % and 29.1 % gained ≥ 25%, of their baseline body weight. 
Tijekom dugotrajne izloženosti (najmanje 24 tjedna), u 89,4 % bolesnika povećala se tjelesna težina ≥ 7 %, u 55,3 % ≥ 15 %, a u 29,1 % bolesnika tjelesna težina se povećala ≥ 25 % od njihove tjelesne težine na početku liječenja.
Caution should be exercised in patients with low leukocyte and/or neutrophil counts for any reason, in patients receiving medicines known to cause neutropenia, in patients with a history of drug-induced bone marrow depression/toxicity, in patients with bone marrow depression caused by concomitant illness, radiation therapy or chemotherapy and in patients with hypereosinophilic conditions or with myeloproliferative disease. 
Oprez je potreban u bolesnika s niskim brojem leukocita i/ili neutrofila iz bilo kojeg razloga, u bolesnika koji primaju lijekove za koje se zna da uzrokuju neutropeniju, u bolesnika s anamnezom depresije/toksičnosti koštane srži uzrokovane lijekovima, u bolesnika s depresijom koštane srži uzrokovane komorbiditetnom bolesti, zračenjem ili kemoterapijom te u bolesnika s hipereozinofilnim stanjima ili mijeloproliferativnom bolesti.
Induction of emesis is not recommended. 
Ne preporučuje se izazivanje povraćanja.
Olanzapine Mylan 2.5 mg film-coated tablets Olanzapine Mylan 5 mg film-coated tablets Olanzapine Mylan 7.5 mg film-coated tablets Olanzapine Mylan 10 mg film-coated tablets Olanzapine Mylan 15 mg film-coated tablets Olanzapine Mylan 20 mg film-coated tablets 
Olanzapine Mylan 2,5 mg filmom obložene tablete Olanzapine Mylan 5 mg filmom obložene tablete Olanzapine Mylan 7,5 mg filmom obložene tablete Olanzapine Mylan 10 mg filmom obložene tablete Olanzapine Mylan 15 mg filmom obložene tablete Olanzapine Mylan 20 mg filmom obložene tablete olanzapin
NAME OF THE MARKETING AUTHORISATION HOLDER Mylan S.A.S. 
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Mylan S.A.S.
If you suffer from dementia, you or your carer/relative should tell your doctor if you have ever had a stroke or “mini” stroke. 
Ako bolujete od zaboravljivosti (demencije), a imali ste moždani udar ili „manji” moždani udar, Vi ili Vaš skrbnik/rođak morate o tome obavijestiti liječnika.
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). 
U bolesnika liječenim olanzapinom zabilježen je trostruki porast CV događaja u usporedbi s bolesnicima koji su liječeni placebom (1,3 % u odnosu na 0,4 %).
Pneumonia, increased body temperature, lethargy, erythema, visual hallucinations and urinary incontinence were observed commonly. 
Često su uočeni pneumonija, povišena tjelesna temperatura, letargija, eritem, vizualne halucinacije i urinarna inkotinencija.
Maize starch, pregelatinised Crospovidone (Type A) Magnesium stearate 
Jezgra tablete laktoza hidrat kukuruzni škrob kukuruzni škrob, prethodno geliran krospovidon (tip A) magnezijev stearat
Tardive dyskinesia11 
tardivna diskinezija11
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). 
U drugom 12-mjesečnom ispitivanju prevencije relapsa epizode manije, bolesnici koji su postigli remisiju kombinacijom olanzapina i litija te su potom bili randomizirani u skupinu koja je primala samo olanzapin ili samo litij, olanzapin nije bio statistički inferioran litiju u pogledu primarnog ishoda relapsa bipolarnog poremećaja (olanzapin 30,0 %, litij 38,3 %; p = 0,055).
Cold-formed aluminium/aluminium perforated unit dose blisters in cartons of 28 x 1, 56 x 1 (7.5 mg only), 98 x 1 (5 mg, 7.5 mg and 10 mg only) and 100 x 1 (7.5 mg only) film-coated tablets. 
Hladno oblikovani aluminij/aluminijski perforirani blisteri djeljivi na jedinične doze u kutijama od 28 × 1, 56 × 1 (samo 7,5 mg), 98 × 1 (samo 5 mg, 7,5 mg i 10 mg) te 100 × 1 (samo 7,5 mg) filmom obloženih tableta.
In an 18-month co-therapy study in manic or mixed episode patients stabilised with olanzapine plus a mood stabiliser (lithium or valproate), long-term olanzapine co-therapy with lithium or valproate was not statistically significantly superior to lithium or valproate alone in delaying bipolar recurrence, defined according to syndromic (diagnostic) criteria. 
U 18-mjesečnom ispitivanju istodobne terapije u bolesnika s maničnim ili miješanim epizodama, koji su stabilizirani olanzapinom i stabilizatorom raspoloženja (litij ili valproat), dugotrajna istodobna terapija olanzapina s litijem ili valproatom nije bila statistički značajno superiorna za litij ili valproat primijenjene u monoterapiji za odgađanje relapsa bipolarnog poremećaja definiranom prema (dijagnostičkim) kriterijima sindroma.
PHARMACEUTICAL FORM AND CONTENTS Multipack 70 (2 packs of 35) film-coated tablets 
Multipakiranje sa 70 (2 pakiranja od 35) filmom obloženih tableta
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 %). 
Nakon kratkotrajnog liječenja (medijan trajanja 47 dana), povećanje tjelesne težine ≥ 7 % od početne tjelesne težine bilo je vrlo često (22,2 %), povećanje ≥ 15 % bilo je često (4,2 %), a ≥ 25 % bilo je manje često (0,8 %).
Only slight to moderate increase in olanzapine clearance has been observed. 
Uočen je samo blagi do umjereni porast klirensa olanzapina.
As it exhibits in vitro dopamine antagonism, olanzapine may antagonise the effects of direct and indirect dopamine agonists. 
S obzirom da olanzapin in vitro pokazuje antagonizam s dopaminom, on može imati antagonističke učinke na izravne ili neizravne agoniste dopamina.
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. 
Rijetke nuspojave (mogu zahvatiti do 1 na 1000 osoba) uključuju snižavanje normalne tjelesne temperature; nenormalni srčani ritam; iznenadnu, neobjašnjivu smrt; upalu gušterače koja uzrokuje jake bolove u trbuhu, vrućicu i osjećaj bolesti; bolest jetre koja se očituje kao žutilo kože i bjeloočnica; bolest mišića koja se očituje kao neobjašnjivi bolovi te produljene i/ili bolne erekcije.
In a 12-month recurrence prevention study in manic episode patients who achieved remission on olanzapine and were then randomised to olanzapine or placebo, olanzapine demonstrated statistically significant superiority over placebo on the primary endpoint of bipolar recurrence. 
U 12-mjesečnom ispitivanju prevencije relapsa u bolesnika s epizodom manije koji su postigli remisiju na olanzapinu, a zatim su randomizirani u skupinu koja je uzimala olanzapin ili placebo, olanzapin je pokazao statistički značajnu prednost nad placebom u primarnom krajnjem ishodu relapsa bipolarnog poremećaja.
Rhabdomyolysis11 
rabdomioliza11
Musculoskeletal and connective tissue disorders Arthralgia9 
Poremećaji mišićno-koštanog sustava i vezivnog tkiva artralgija9
Transient, asymptomatic elevations of hepatic aminotransferases, ALT, AST have been seen commonly, especially in early treatment. 
Često je uočen prolazni asimptomatski porast vrijednosti jetrenih aminotransferaza, ALT i AST, osobito u ranoj fazi liječenja.
Olanzapine is indicated for the treatment of schizophrenia. 
Odrasli Olanzapin je indiciran za liječenje shizofrenije.
The tablet film-coating contains soya lecithin. 
Film kojim su obložene tablete sadrži sojin lecitin.
Olanzapine Mylan 2.5 mg, 5 mg, 7.5 mg, 15 mg and 20 mg is available in packs containing 10, 28, 30, 35, 56, 70 (2 x 35 multipack) and 70 film-coated tablets. 
Olanzapine Mylan 2,5 mg, 5 mg, 7,5 mg, 15 mg i 20 mg dostupan je u pakiranjima s 10, 28, 30, 35, 56, 70 (2 × 35 multipakiranje) i 70 filmom obloženih tableta.
13 Following short term treatment (median duration 22 days), weight gain ≥ 7 % of baseline body weight (kg) was very common (40.6 %), ≥ 15 % of baseline body weight was common (7.1 %) and ≥ 25 % was common (2.5 %). 
13 Nakon kratkotrajnog liječenja (medijan trajanja 22 dana), povećanje tjelesne težine ≥ 7 % od početne tjelesne težine (kg) bilo je vrlo često (40,6 %), porast ≥ 15 % od početne tjelesne težine bio je čest (7,1 %), a ≥ 25 % bio je čest (2,5 %).
Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine. 
Nije utvrđen značajan utjecaj fluoksetina (inhibitora CYP2D6), jednokratne doze antacida (aluminij, magnezij) ili cimetidina na farmakokinetiku olanzapina.
Olanzapine tablets contain lactose monohydrate. 
Tablete olanzapina sadrže laktozu hidrat.
Do not take Olanzapine Mylan 
Nemojte uzimati Olanzapine Mylan
If you stop taking Olanzapine Mylan 
Ako prestanete uzimati Olanzapine Mylan
Caution should be exercised and follow-up organised in patients with elevated ALT and/or AST, in patients with signs and symptoms of hepatic impairment, in patients with pre-existing conditions associated with limited hepatic functional reserve, and in patients who are being treated with potentially hepatotoxic medicines. 
Povećani oprez i praćenje potrebni su u svih bolesnika s povišenim razinama ALT-a i/ili AST-a, u bolesnika sa znakovima i simptomima oštećenja jetre, u bolesnika s već postojećim stanjima povezanima s ograničenom funkcijom jetre te u bolesnika na terapiji lijekovima potencijalno toksičnima za jetru.
In healthy elderly (65 and over) versus non-elderly subjects, the mean elimination half-life was prolonged (51.8 versus 33.8 hr) and the clearance was reduced (17.5 versus 18.2 l/hr). 
U zdravih starijih ispitanika (65 godina i stariji) u odnosu na mlađe ispitanike srednja vrijednost poluvremena eliminacije bila je produžena (51,8 u odnosu na 33,8 sati), a klirens je bio smanjen (17,5 u odnosu na 18,2 l/sat).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF SINGLE PACK 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA JEDNOSTRUKOG PAKIRANJA
Olanzapine Mylan contains the active substance olanzapine. 
Olanzapine Mylan sadrži djelatnu tvar olanzapin.
If you forget to take Olanzapine Mylan 
Ako ste zaboravili uzeti Olanzapine Mylan
In female versus male subjects the mean elimination half life was somewhat prolonged (36.7 versus 32.3 hr) and the clearance was reduced (18.9 versus 27.3 l/hr). 
U žena je srednja vrijednost poluvremena eliminacije nešto duža u odnosu na muškarce (36,7 u odnosu na 32,3 sata), a klirens je smanjen (18,9 u odnosu na 27,3 l/sat).
11 Adverse event identified from spontaneous post-marketing reporting with frequency determined utilising the Olanzapine Integrated Database. 
11 Štetni događaj identificiran iz spontanih izvješća nakon stavljanja lijeka u promet s učestalošću koja je određena upotrebom integrirane baze podataka za olanzapin.
UK 
Velika Britanija
Lipid alterations 
Promjene vrijednosti lipida
Olanzapine Mylan 10 mg is available in packs containing 7, 10, 28, 30, 35, 56, 70 (2 x 35) (multipack) and 70 film-coated tablets. 
Olanzapine Mylan 10 mg dostupan je u pakiranjima sa 7, 10, 28, 30, 35, 56, 70 (2 × 35) (multipakiranje) i 70 filmom obloženih tableta.
Cold-formed aluminium/aluminium blister in cartons of 7 (10 mg only), 10, 28, 30, 35, 56, 70 and multipacks containing 70 (2 packs of 35) film-coated tablets. 
Hladno oblikovani aluminij/aluminijski blister u kutijama od 7 (samo 10 mg), 10, 28, 30, 35, 56 i 70 filmom obloženih tableta te multipakiranja od 70 (2 pakiranja s 35) filmom obloženih tableta.
Olanzapine Mylan 10 mg is available in packs containing 100 and 500 film-coated tablets. 
Olanzapine Mylan 10 mg dostupan je u pakiranjima sa 100 i 500 filmom obloženih tableta.
Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling in the mouth and throat, itching, rash); diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; problems with speech; stuttering; slow heart rate; sensitivity to sunlight; bleeding from the nose; abdominal distension; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods; and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth. 
Manje česte nuspojave (mogu zahvatiti do 1 na 100 osoba) uključuju preosjetljivost (primjerice oticanje usta i grla, svrbež i osip); dijabetes ili pogoršanje dijabetesa povremeno povezano s ketoacidozom (ketoni u krvi ili mokraći) ili komom; napadaje, obično povezane s anamnezom napadaja (epilepsije); ukočenost mišića ili spazme (uključujući pokrete očiju); sindrom nemirnih nogu; probleme s govorom; mucanje; usporene srčane otkucaje; osjetljivost na sunčevu svjetlost; krvarenje iz nosa; abdominalnu distenziju; gubitak pamćenja ili zaboravljivost; mokraćnu inkontinenciju; nedostatak sposobnosti mokrenja; gubitak kose; izostanak ili slabljenje menstrualnog ciklusa te promjene na dojkama kod muškaraca i žena poput nenormalnog stvaranja mlijeka ili nenormalnog rasta dojki.
The metabolism of olanzapine may be induced by smoking. 
Pušenje može inducirati metabolizam olanzapina.
Olanzapine Mylan 2.5 mg and 5.0 mg is available in packs containing 250 and 500 film-coated tablets. 
Olanzapine Mylan 2,5 mg i 5,0 mg dostupan je u pakiranjima s 250 i 500 filmom obloženih tableta.
Urinary incontinence, urinary retention Urinary hesitation11 
Poremećaji bubrega i mokraćnog sustava urinarna inkontinencija, urinarna retencija otežano mokrenje11
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. 
Česte nuspojave (mogu zahvatiti do 1 na 10 osoba) uključuju promjene u razinama nekih krvnih stanica, masnoća u krvotoku te u ranoj fazi liječenja i privremeni porast razine jetrenih enzima; porast razina šećera u krvi i mokraći; porast razina mokraćne kiseline i kreatin fosfokinaze u krvi; osjećaj povećane gladi; omaglicu; nemir; tremor; neuobičajene pokrete (diskineziju); konstipaciju; suha usta; osip; gubitak snage; umor u ekstremitetima; retenciju vode koja uzrokuje oticanje šaka, gležnjeva ili stopala; vrućicu; bol u zglobovima te poremećaje seksualne funkcije poput smanjenog libida u muškaraca ili žena ili erektilnu disfunkciju u muškaraca.
While taking olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, a rise in body temperature, redness of the skin and have trouble walking. 
Tijekom liječenja olanzapinom u starijih bolesnika s demencijom (zaboravljivošću) mogu nastati moždani udar, upala pluća, inkontinencija mokraće, padanje, izraziti umor, vidna priviđanja, povišenje tjelesne temperature, crvenilo kože i teškoće pri hodu.
Bradycardia QTc prolongation (see section 4.4) 
Srčani poremećaji bradikardija produljenje QTc intervala (vidjeti dio 4.4)
Consider referral to a dietician or help with a diet plan if necessary. 
Po potrebi razmotrite da Vas liječnik uputi nutricionistu ili zatražite pomoć oko planiranja prehrane.
After oral administration, the mean terminal elimination half-life of olanzapine in healthy subjects varied on the basis of age and gender. 
Srednja vrijednost poluvremena eliminacije olanzapina u zdravih ispitanika nakon peroralne primjene varira ovisno o dobi i spolu.
Olanzapine Mylan 7.5 mg is available in packs containing 28 x 1, 56 x 1, 98 x and 100 x 1 filmcoated tablets. 
Olanzapine Mylan 7,5 mg dostupan je u pakiranjima s 28 × 1, 56 × 1, 98 x 1 i 100 × 1 filmom obloženih tableta.
Oestrous 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). 
Na cikluse estrusa u štakora utjecale su doze od 1,1 mg/kg (3 puta veća doza od maksimalne doze u ljudi),
Changes in fasting triglycerides from borderline at baseline (≥ 1.69 mmol/l-< 2.26 mmol/l) to high (≥ 2.26 mmol/l) were very common. 
Promjene vrijednosti triglicerida natašte od početnih graničnih vrijednosti (≥ 1,69< 2,26 mmol/l) do visokih vrijednosti (≥ 2,26 mmol/l) bile su vrlo česte.
Seizures have been reported to occur uncommonly in patients when treated with olanzapine. 
Zabilježeno je da se napadaji pojavljuju manje često u bolesnika liječenih olanzapinom.
Nervous system disorders Somnolence Dizziness Akathisia6 
Poremećaji živčanog sustava somnolencij a omaglica akatizija6 parkinsonizam6 diskinezija6
Blood and lymphatic system disorders Eosinophilia 
Poremećaji krvi i limfnog sustava eozinofilija leukopenija10 neutropenija10
Patients gaining ≥ 7 %, ≥ 15 % and ≥ 25 % of their baseline body weight with long-term exposure (at least 48 weeks) were very common (64.4 %, 31.7 % and 12.3 % respectively). 
Tijekom dugotrajne izloženosti lijeku (najmanje 48 tjedana), povećanje tjelesne težine ≥ 7 %, ≥ 15 % i ≥ 25 % od početne bilo je vrlo često (64,4 %, 31,7 %, odnosno 12,3 %).
Tolerance developed to the CNS depression. 
Na depresiju središnjeg živčanog sustava razvila se podnošljivost.
If you are allergic to peanut or soya do not take these tablets. 
Ove tablete ne smiju uzimati bolesnici alergični na kikiriki ili soju.
In non-smoking versus smoking subjects (males and females) the mean elimination half-life was prolonged (38.6 versus 30.4 hr) and the clearance was reduced (18.6 versus 27.7 l/hr). 
Srednja vrijednost poluvremena eliminacije u ispitanika nepušača (muškarci i žene) bila je duža nego u ispitanika pušača (38,6 u odnosu na 30,4 sata), a klirens je bio manji (18,6 u odnosu na 27,7 l/sat).
Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17-< 6.2 mmol) to high (≥ 6.2 mmol) were very common. 
Promjene ukupnog kolesterola natašte od početnih graničnih vrijednosti (≥ 5,17< 6,2 mmol) do visokih vrijednosti (≥ 6,2 mmol) bile su vrlo česte.
How to store Olanzapine Mylan 
Kako čuvati Olanzapine Mylan
Rare cases reported as NMS have also been received in association with olanzapine. 
Rijetki su slučajevi zabilježili da je NMS povezan uz primjenu olanzapina.
Cardiac disorders 
Tardivna diskinezija
Vascular disorders Orthostatic hypotension10 
Krvožilni poremećaji ortostatska hipotenzija10
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. 
• 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 nogu), koji može putovati krvnim žilama do pluća uzrokujući bol u prsima i otežano disanje.
Hepatic function 
Funkcija jetre
How to take Olanzapine Mylan 
Kako uzimati Olanzapine Mylan
Also contains lactose monohydrate and soya lecithin. 
POPIS POMOĆNIH TVARI Sadrži i laktozu monohidrat te sojin lecitin.
• High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Olanzapine Mylan. 
• U bolesnika koji uzimaju Olanzapine Mylan uočena je visoka razina šećera i masnoća u krvi (trigliceridi i kolesterol).
Respiratory, thoracic and mediastinal disorders Epistaxis9 
Poremećaji dišnog sustava, prsišta i sredoprsja epistaksa9
Olanzapine Mylan 7.5 mg, 15 mg and 20 mg is available in packs containing 100 film-coated tablets. 
Olanzapine Mylan 7,5 mg, 15 mg i 20 mg dostupan je u pakiranjima sa 100 filmom obloženih tableta.
15 Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/l) to high (≥ 5.17 mmol/l) were observed commonly. 
15 Često su uočene promjene ukupnog kolesterola natašte od normalnih početnih vrijednosti (< 4,39 mmol/l) do visokih vrijednosti (≥ 5,17 mmol/l).
Olanzapine Mylan 5 mg and 10 mg is available in packs containing 28 x 1 and 98 x 1 film-coated tablets. 
Olanzapine Mylan 5 mg i 10 mg dostupan je u pakiranjima s 28 × 1 i 98 x 1 filmom obloženih tableta.
INFORMATION IN BRAILLE Olanzapine 20 mg 
PISMU Olanzapin 20 mg
Gradual tapering of the dose should be considered when discontinuing olanzapine. 
U slučaju prestanka liječenja olanzapinom, treba razmotriti postupno smanjivanje doze.
INFORMATION IN BRAILLE Olanzapine 7.5 mg 
PISMU Olanzapin 7,5 mg
Repeated-dose toxicity 
Toskičnost ponavljane doze
The mean increase in olanzapine AUC was 52 % and 108 % respectively. 
Srednja vrijednost porasta AUC olanzapina iznosila je 52 % u žena nepušača, odnosno 108 % u muškaraca pušača.
6.3 Shelf life Blisters 3 years. 
6.3 Rok valjanosti
4 Observed for fasting normal levels at baseline (< 5.56 mmol/l) which increased to high (≥ 7 mmol/l). 
4 Uočeno za početne normalne razine natašte (< 5,56 mmol/l) koje su porasle na visoke razine (≥ 7 mmol/l).
Changes in fasting glucose from borderline at baseline (≥ 5.56-< 7 mmol/l) to high (≥ 7 mmol/l) were very common. 
Promjene vrijednosti glukoze natašte od početnih graničnih vrijednosti (≥ 5,56< 7 mmol/l) do visokih vrijednosti (≥ 7 mmol/l) bile su vrlo česte.
EU/1/08/475/014 EU/1/08/475/015 EU/1/08/475/016 EU/1/08/475/017 EU/1/08/475/018 EU/1/08/475/019 EU/1/08/475/020 EU/1/08/475/021 EU/1/08/475/022 EU/1/08/475/023 EU/1/08/475/024 EU/1/08/475/025 EU/1/08/475/026 EU/1/08/475/027 EU/1/08/475/028 EU/1/08/475/029 EU/1/08/475/030 EU/1/08/475/031 EU/1/08/475/032 EU/1/08/475/033 EU/1/08/475/034 EU/1/08/475/035 EU/1/08/475/036 EU/1/08/475/037 EU/1/08/475/038 EU/1/08/475/039 EU/1/08/475/040 EU/1/08/475/041 EU/1/08/475/042 EU/1/08/475/043 EU/1/08/475/044 EU/1/08/475/045 EU/1/08/475/046 EU/1/08/475/047 EU/1/08/475/048 EU/1/08/475/049 EU/1/08/475/050 EU/1/08/475/051 EU/1/08/475/052 EU/1/08/475/053 EU/1/08/475/054 EU/1/08/475/055 EU/1/08/475/056 EU/1/08/475/057 EU/1/08/475/058 EU/1/08/475/059 EU/1/08/475/060 EU/1/08/475/061 EU/1/08/475/062 EU/1/08/475/063 
EU/1/08/475/001 EU/1/08/475/002 EU/1/08/475/003 EU/1/08/475/004 EU/1/08/475/005 EU/1/08/475/006 EU/1/08/475/007 EU/1/08/475/008 EU/1/08/475/009 EU/1/08/475/010 EU/1/08/475/011 EU/1/08/475/012 EU/1/08/475/013 EU/1/08/475/014 EU/1/08/475/015 EU/1/08/475/016 EU/1/08/475/017 EU/1/08/475/018 EU/1/08/475/019 EU/1/08/475/020 EU/1/08/475/021 EU/1/08/475/022 EU/1/08/475/023 EU/1/08/475/024 EU/1/08/475/025 EU/1/08/475/026 EU/1/08/475/027 EU/1/08/475/028 EU/1/08/475/029 EU/1/08/475/030 EU/1/08/475/031 EU/1/08/475/032 EU/1/08/475/033 EU/1/08/475/034 EU/1/08/475/035 EU/1/08/475/036 EU/1/08/475/037 EU/1/08/475/038 EU/1/08/475/039 EU/1/08/475/040
In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder (see section 5.1). 
Olanzapin je indiciran za prevenciju relapsa u bolesnika s bipolarnim poremećajem čije su manične epizode reagirale na liječenje olanzapinom (vidjeti dio 5.1).