natgillin/translations-raw huggingface dataset:
Amenorrhea Breast enlargement Galactorrhea in females 
amenoreja povećanje dojki galaktoreja u žena ginekomastija/povećanje dojki u muškaraca prijapizam12
HT2A/2C, 5 HT3, 5 HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; 1 
U pretkliničkim ispitivanjima olanzapin je pokazao raspon afiniteta za receptore (Ki < 100 nM) serotonina 5HT2A/2C, 5HT3, 5HT6; dopamina D1, D2, D3, D4, D5; kolinergičke muskarinske receptore M1-M5; α1 adrenergičke; i histaminske H1 receptore.
A greater magnitude of weight gain, lipid and prolactin alterations has been reported in short term studies of adolescent patients than in studies of adult patients (see sections 4.4, 4.8, 5.1 and 5.2). 
U kratkotrajnim ispitivanjima provedenima s adolescentima prijavljeno je veće povećanje tjelesne težine i veće promjene vrijednosti lipida i prolaktina nego u ispitivanjima provedenima na odraslim bolesnicima (vidjeti dijelove 4.4, 4.8, 5.1 i 5.2).
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. 
U ispitivanju istodobne terapije u bolesnika liječenih litijem ili valproatom tijekom najmanje 2 tjedna, dodavanje 10 mg olanzapina (istodobna terapija litijem ili valproatom) rezultiralo je većim smanjenjem simptoma manije nego monoterapija litijem ili
Cold-formed aluminium blisters in cartons of 7, 28 or 56 tablets per carton. 
Hladno formirane aluminijske plikovi u šteka 7, 28 ili 56 tableta po kutiji.
Bradycardia QTc prolongation (see section 4.4) 
epistaksa9 bradikardija produljenje QTc intervala (vidjeti dio 4.4)
Dose escalation, when indicated, should be conservative in such patients. 
Povećanje doze, kada je indicirano, treba biti
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) 
razvoj ili egzacerbacija dijabetesa, ponekad povezana s ketoacidozom ili komom, uključujući i neke slučajeve sa smrtnim ishodom (vidjeti dio 4.4)11
Patients treated with any antipsychotic agents, including Olanzapine Cipla, 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. 
U bolesnika liječenih bilo kojim antipsihotikom, uključujući lijek OLANZAPINE, potrebno je redovito pratiti razinu lipida prema smjernicama za primjenu antipsihotika, na primjer, na početku liječenja, 12 tjedana nakon početka liječenja olanzapinom te svakih 5 godina nakon toga.
Olanzapine also showed a statistically significant advantage over placebo in terms of preventing either recurrence into mania or recurrence into depression. 
Olanzapin je također pokazao statistički značajnu prednost nad placebom u sprječavanju
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 prosječno poluvrijeme eliminacije nešto duže u odnosu na muškarce (36,7 naspram 32,3 sata), a klirens je smanjen (18,9 naspram 27,3 l/h).
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. 
Vrlo česti simptomi predoziranja (incidencija > 10%) obuhvaćaju tahikardiju, agitaciju/agresivnost, dizartriju, različite ekstrapiramidalne simptome te smanjenu razinu svijesti u rasponu od sedacije do kome.
Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists. 
Olanzapin može antagonistički djelovati na učinke izravnih i neizravnih agonista dopamina.
Nervous system disorders 
Opća aktivnost središnjeg živčanog sustava
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); problems with speech; 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 se pojaviti u do 1 na 100 osoba) uključuju preosjetljivost (npr. oticanje u ustima i grlu, svrbež; osip); šećernu bolest ili pogoršanje šećerne bolesti, ponekad povezano s ketoacidozom (ketonima u krvi i mokraći) ili komom; napadaje, obično povezane s napadajima u povijesti bolesti (epilepsija); mišićnu ukočenost ili grč (uključujući pokrete očiju); poteškoće s govorom; usporen rad srca; osjetljivost na sunčevu svjetlost; krvarenje iz nosa; nadimanje trbuha; gubitak pamćenja ili zaboravljivost; nemogućnost zadržavanja mokraće (inkontinencija); nemogućnost mokrenja; ispadanje kose; izostanak ili smanjenje mjesečnice i promjene na grudima u muškaraca i žena, kao što je poremećaj stvaranja majčinog mlijeka ili abnormalan rast.
If this happens after you have been given OLANZAPINE CIPLA tell your doctor. 
Vam se ovo pojavi nakon uzimanja lijeka OLANZAPINE CIPLA, obratite se svom liječniku.
In the offspring of rats given olanzapine, delays in foetal development and transient decreases in offspring activity levels were seen. 
U mladunčadi štakora kojima je davan olanzapin primijećeni su zastoj u fetalnom razvoju i
Glucosuria 
BLISTERA
Olanzapine was started at 2.5 mg/day and titrated to a maximum of 15 mg/day based on investigator judgement. 
Početna doza olanzapina bila je 2,5 mg/dan te je potom titrirana do najviše 15 mg/dan na temelju
If you forget to take OLANZAPINE CIPLA Take your tablets as soon as you remember. 
Uzmite tablete čim se sjetite.
Photosensitivity reaction Alopecia 
Poremećaji kože i potkožnog tkiva reakcija fotoosjetljivosti alopecija
Olanzapine Cipla 2.5 mg, 5 mg, 7.5 mg and 15 mg coated tablets are available in 28 and 56 blister packs. 
Olanzapin Cipla 2,5 mg , 5 mg , 7,5 mg i 15 mg obložene tablete su dostupne u 28 i 56 blister omot . Olanzapin Cipla 10 mg obložene tablete su dostupne u 7 , 28 i 56 žulj paketima
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 se pojaviti u do 1 na 10 osoba) uključuju promjene razina nekih krvnih stanica, cirkulirajućih masti u krvi te, u ranim fazama liječenja, privremena povećanja razine jetrenih enzima; povišene razine šećera u krvi i mokraći; povećanje razine mokraćne kiseline i kreatin fosfokinaze u krvi; pojačan apetit; omaglicu; nemir; nevoljno drhtanje; neuobičajene pokrete (diskinezije); zatvor; suha usta; osip; slabost; pojačan umor; zadržavanje vode u tijelu koje dovodi do oticanja ruku, zglobova ili stopala; vrućicu; bol u zglobovima te seksualne poremećaje kao što su smanjeni libido u muškaraca i žena ili erektilna disfunkcija u muškaraca.
In smoking subjects with mild hepatic dysfunction, mean elimination half-life (39.3 hr) was prolonged and clearance (18.0 l/hr) was reduced analogous to non-smoking healthy subjects (48.8 hr and 14.1 l/hr, respectively). 
U ispitanika pušača s blago poremećenom funkcijom jetre prosječno poluvrijeme eliminacije bilo je produljeno (39,3 sata), a klirens (18,0 l/h) smanjen kao i u zdravih ispitanika nepušača (48,8 sati
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. 
Najčešće prijavljene nuspojave (uočene u ≥ 1% bolesnika) povezane s primjenom olanzapina u kliničkim ispitivanjima bile su somnolencija, povećanje tjelesne težine, eozinofilija, povišene vrijednosti prolaktina, kolesterola, glukoze i triglicerida (vidjeti dio 4.4), glikozurija, povećan apetit, omaglica, akatizija, parkinsonizam parkinsonizam, leukopenija, neutropenija (vidjeti dio 4.4), diskinezija, ortostatska hipotenzija, antikolinergički učinci, prolazni asimptomatski porasti vrijednosti jetrenih aminotransferaza (vidjeti dio 4.4), osip, astenija, umor, pireksija, artralgija, povišena razina alkalne fosfataze, visoka razina gama glutamiltransferaze, visoka razina mokraćne kiseline, visoka
CARTON OF COATED TABLETS IN BLISTERS 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU KUTIJA S OBLOŽENIM TABLETAMA U BLISTERIMA
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 olanzapinom s litijem ili valproatom nije bila statistički značajno superiorna u odnosu na litij ili valproat primijenjen u monoterapiji za odgađanje relapsa bipolarnog poremećaja definiranog prema
7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly. 
7 Akutni simptomi kao što su znojenje, nesanica, tremor, anksioznost, mučnina i povraćanje prijavljeni
• High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking OLANZAPINE CIPLA. 
• U bolesnika koji uzimaju lijek OLANZAPINE CIPLA uočena je visoka razina šećera i masnoća u krvi (trigliceridi i kolesterol).
As it exhibits in vitro dopamine antagonism, olanzapine may antagonize 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 i
Coated tablet Blue, elliptical, convex, coated tablets with ‘NEO' debossed on one side and plain on the other side. 
Plavi, eliptična, konveksna, obložene tablete s "NEO" debossed na jednoj strani i ravni na drugoj
4 Observed for fasting normal levels at baseline (< 5.56 mmol/l) which increased to high (≥ 7 mmol/l). 
3 Uočeno za početne normalne razine natašte (< 5,17 mmol/l) koje su porasle na visoke razine (≥ 6,2 mmol/l).
Musculoskeletal and connective tissue disorders Arthralgia9 
Poremećaji mišićno-koštanog sustava i vezivnog tkiva rabdomioliza11
Hypersensitivity11 
preosjetljivost11
Opadry II White containing: Hypromellose (E464) Titanium dioxide (E171) Lactose monohydrate Polyethylene glycol 3000 Glycerol triacetate 
: Opadry bijeli sadrži hipromeloze ( E464 ) , titan dioksid ( E171 ) , laktoza monohidrat , polietilen glikol 3000 i glicerola triacetatna - 15 mg tablete
Name and address of the manufacturer(s) responsible for batch release 
PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornih za puštanje serije lijeka u promet Obložene tablete:
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/. 
Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove
Children and adolescents OLANZAPINE CIPLA is not for patients who are under 18 years. 
OLANZAPINE CIPLA nije za primjenu u bolesnika mlađih od 18 godina.
Medicinal product subject to medical prescription. 
Vidjeti Uputu o lijeku za dodatne informacije.
After oral administration, the mean terminal elimination half-life of olanzapine in healthy subjects varied on the basis of age and gender. 
Prosječno poluvrijeme eliminacije olanzapina u zdravih ispitanika nakon peroralne primjene varira
Immune system disorders 
Poremećaji imunološkog sustava preosjetljivost11
Olanzapine Cipla 7.5 mg coated tablets 
NAZIV GOTOVOG LIJEKA OLANZAPINE CIPLA 7,5 mg obložene tablete
The concomitant administration of activated charcoal was shown to reduce the oral bioavailability of olanzapine by 50 to 60%. 
Pokazalo se da istodobna primjena aktivnog ugljena smanjuje oralnu bioraspoloživost
Olanzapine Cipla 7.5 mg coated tablets are white, round, biconvex, coated tablets with ‘OLZ 7.5' debossed on one side and ‘NEO' on the other. 
Olanzapin Cipla 7,5 mg obložene tablete su bijele , okrugle, bikonveksne , obložene tablete s ' OLZ 7.5 ' debossed s jedne strane i " NEO " s druge strane.
Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking OLANZAPINE CIPLA and regularly during treatment. 
Prije početka uzimanja lijeka OLANZAPINE CIPLA te redovito tijekom liječenja, liječnik bi Vam trebao obaviti krvne pretrage kako bi provjerio razinu šećera i
COLD-FORMED ALUMINIUM BLISTER STRIPS 
TABLETE: OZNAČAVANJE NA FOLIJI BLISTERA
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
OSTALI UVJETI I ZAHTJEVI ZA STAVLJANJE GOTOVOG LIJEKA U
Seizures 
Predoziranje
Tablet coat 
OLANZAPINE CIPLA tablete morate
Each coated tablet contains 7.5 mg olanzapine. 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna obložena tableta sadrži 7,5 mg olanzapina.
What Olanzapine Cipla contains 
Što OLANZAPINE CIPLA sadrži
OLANZAPINE CIPLA coated tablets are for oral use. 
OLANZAPINE CIPLA obložene tablete uzimaju se kroz usta.
In most of these cases, a history of seizures or risk factors for seizures were reported. 
U većini ovih slučajeva prijavljeni su napadaji u anamnezi ili
3 years 6.4 Special precautions for storage 
6.3 Rok valjanosti
Olanzapine Cipla 10 mg coated tablets are white, round, biconvex, coated tablets with ‘OLZ 10' debossed on one side and ‘NEO' on the other. 
Olanzapin Cipla 10 mg obložene tablete su bijele , okrugle, bikonveksne , obložene tablete s ' OLZ 10 ' debossed s jedne strane i " NEO " s druge strane.
Pneumonia, increased body temperature, lethargy, erythema, visual hallucinations and urinary incontinence were observed commonly. 
Često su uočeni upala pluća, povišena tjelesna temperatura, letargija, eritem, vizualne
Only take other medicines while you are on OLANZAPINE CIPLA if your doctor tells you that you can. You might feel drowsy if OLANZAPINE CIPLA is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers). 
Ako uzimate lijek OLANZAPINE CIPLA u kombinaciji s antidepresivima, lijekovima za tjeskobu ili lijekovima koji Vam pomažu zaspati (trankvilizeri), možete se osjećati omamljeno.
EU/1/07/426/007 - Olanzapine Cipla - 10 mg - coated tablets - 7 tablets per box EU/1/07/426/008 - Olanzapine Cipla - 10 mg - coated tablets - 28 tablets per box EU/1/07/426/009 - Olanzapine Cipla - 10 mg - coated tablets - 56 tablets per box 
ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/07/426/007 - Olanzapin Cipla - 10 mg - obložene tablete - 7 tableta po kutiji EU/1/07/426/008 - Olanzapin Cipla - 10 mg - obložene tablete - 28 tableta po kutiji EU/1/07/426/009 - Olanzapin Cipla - 10 mg - obložene tablete - 56 tableta po kutiji
Olanzapine Cipla 10 mg coated tablets 
NAZIV GOTOVOG LIJEKA OLANZAPINE CIPLA 10 mg obložene tablete
- Tablet coat: - 2.5 mg, 5 mg, 7.5 mg and 10 mg tablets: Opadry white containing hypromellose (E464), titanium dioxide (E171), lactose monohydrate, polyethylene glycol 3000 and glycerol triacetate - 15 mg tablets: Opadry Blue containing hypromellose (E464), titanium dioxide (E171), polyethylene glycol 6000, indigo carmine aluminium lake (E132), brilliant blue FCF aluminium lake (E133) and iron oxide black (E172) 
: Opadry Blue sadrže hipromeloze ( E464 ) , titan dioksid ( E171 ) , polietilen glikol 6000 , indigo karmina aluminija jezero ( E132 ) , briljantne plavo FCF aluminija jezero ( E133 ) i
Neutropenia10 
pankreatitis11
Olanzapine Cipla 5 mg coated tablets are white, round, biconvex, coated tablets with ‘OLZ 5' debossed on one side and ‘NEO' on the other. 
Olanzapin Cipla 5 mg obložene tablete su bijele , okrugle, bikonveksne , obložene tablete s ' OLZ 5 ' debossed s jedne strane i " NEO " s druge strane.
Abdominal distension9 Pancreatitis11 
konstipaciju i suha usta distenzija abdomena9
Each coated tablet contains 2.5 mg olanzapine. 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna obložena tableta sadrži 2,5 mg olanzapina.
Each coated tablet contains 10 mg olanzapine. 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna obložena tableta sadrži 10 mg olanzapina.
Coated tablet White, round, biconvex, coated tablets with ‘2.5' debossing on one side and ‘OLZ' on the other. 
Bijela, okrugli, bikonveksne, obložene tablete s 2,5 debossing na jednu stranu i 'OLZ' na druge.
Cytochromes P450 
Polietilen glikol 3000
Coated tablet White, round, biconvex, coated tablets with ‘OLZ 7.5' debossing on one side and ‘NEO' on the other. 
Bijela, okrugli, bikonveksne, obložene tablete s 'OLZ 7.5' debossing na jednoj strani i 'NEO' na druge.
Olanzapine Cipla 2.5 mg coated tablets 
NAZIV GOTOVOG LIJEKA OLANZAPINE CIPLA 2,5 mg obložene tablete
Olanzapine Cipla 15 mg coated tablets 
NAZIV GOTOVOG LIJEKA OLANZAPINE CIPLA 15 mg obložene tablete
Coated tablet White, round, biconvex, coated tablets with ‘OLZ 10' debossing on one side and ‘NEO' on the other. 
Bijela, okrugli, bikonveksne, obložene tablete s 'OLZ 10' debossing na jednu stranu i 'NEO' na druge.
Olanzapine Cipla 5 mg coated tablets 
NAZIV GOTOVOG LIJEKA OLANZAPINE CIPLA 5 mg obložene tablete
Each coated tablet contains 5 mg olanzapine. 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna obložena tableta sadrži 5 mg olanzapina.
3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high 
4 Uočeno za početne normalne razine natašte (< 5,56 mmol/l) koje su porasle na visoke razine
Coated tablet White, round, biconvex, coated tablets with ‘OLZ 5' debossing on one side and ‘NEO' on the other. 
Bijela, okrugli, bikonveksne, obložene tablete s 'OLZ 5' debossing na jednoj strani i 'NEO' na druge.
Each coated tablet contains 15 mg olanzapine. 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna obložena tableta sadrži 15 mg olanzapina.
OTHER SPECIAL WARNING(S), IF NECESSARY 
OD LIJEKA, KADA JE POTREBNO
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). 
Ne preporučuje se istodobna primjena olanzapina s antiparkinsonicima u bolesnika s Parkinsonovom
Excipient with known effect: Each coated tablet contains 161.3 mg lactose monohydrate For the full list of excipients, see section 6.1. 
Jedna obložena tableta sadrži 161.3 mg laktoze hidrata.
Excipient with known effect: Each coated tablet contains 322.6 mg lactose monohydrate For the full list of excipients, see section 6.1. 
Jedna obložena tableta sadrži 322.6 mg laktoze hidrata.
EU/1/07/426/010 - Olanzapine Cipla - 15 mg - coated tablets - 28 tablets per box EU/1/07/426/011 - Olanzapine Cipla - 15 mg - coated tablets - 56 tablets per box 
ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/07/426/010 - Olanzapin Cipla - 15 mg - obložene tablete - 28 tableta po kutiji EU/1/07/426/011 - Olanzapin Cipla - 15 mg - obložene tablete - 56 tableta po kutiji
EU/1/07/426/003 - Olanzapine Cipla - 5 mg - coated tablets - 28 tablets per box EU/1/07/426/004 - Olanzapine Cipla - 5 mg - coated tablets - 56 tablets per box 
ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/07/426/003 - Olanzapin Cipla - 5 mg - obložene tablete - 28 tableta po kutiji EU/1/07/426/004 - Olanzapin Cipla - 5 mg - obložene tablete - 56 tableta po kutiji
5.2 Pharmacokinetic properties 
Pharmadox Zdravstvo ograničenom
EU/1/07/426/005 - Olanzapine Cipla - 7.5 mg - coated tablets - 28 tablets per box EU/1/07/426/006 - Olanzapine Cipla - 7.5 mg - coated tablets - 56 tablets per box 
ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/07/426/005 - Olanzapin Cipla - 7,5 mg - obložene tablete - 28 tableta po kutiji EU/1/07/426/006 - Olanzapin Cipla - 7,5 mg - obložene tablete - 56 tableta po kutiji
EU/1/07/426/001 - Olanzapine Cipla - 2.5 mg - coated tablets - 28 tablets per box EU/1/07/426/002 - Olanzapine Cipla - 2.5 mg - coated tablets - 56 tablets per box 
ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/07/426/001 - Olanzapin Cipla - 2,5 mg - obložene tablete - 28 tableta po kutiji EU/1/07/426/002 - Olanzapin Cipla - 2,5 mg - obložene tablete - 56 tableta po kutiji
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
POSEBNE MJERE ČUVANJA Čuvati u originalnom pakiranju.
There is a risk of feeling drowsy when you are given OLANZAPINE CIPLA. 
Kad uzimate lijek OLANZAPINE CIPLA postoji rizik da se osjećate omamljeno.
Gastrointestinal disorders Mild, transient anticholinergic effects including constipation and dry mouth 
antikolinergički učinci uključujući konstipaciju i suhoću usta distenzija abdomena9
Olanzapine Cipla 15 mg coated tablets olanzapine 
Olanzapin Cipla 15 mg obložene tablete su plave , eliptična
Elevated glucose levels4 
Polietilen glikol 3000 glicerol triacetatna
Common 
Ako
Packaging Content Package size 
Put primjene Ambalaža Sadržaj Veličina pakiranja
The tablet can be divided into equal halves. 
Tableta se može podijeliti u jednake polovice.
A clinical response is normally seen within 3-4 days. 
Klinički odgovor obično se vidi za 3-4 dana.
The active substance in Metacam is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010: 
Djelatna tvar u Metacamu je dozvoljena tvar kako je navedeno u tablici 1. Priloga Uredbi Komisije (EU) br. 37/2010:
EXP {month/year} 3 ml: 
EXP {mjesec/godina} 3 ml:
Can Parellada Industrial 08228 Terrassa, Barcelona SPAIN 
Can Parellada Industrial 08228 Terrassa, Barcelona ŠPANJOLSKA
7 tablets 84 tablets 252 tablets 
7 tableta 84 tablete 252 tablete
21 % of the recovered dose is eliminated in urine (2 % as unchanged meloxicam, 19 % as metabolites) and 79 % in the faeces (49 % as unchanged meloxicam, 30 % as metabolites). 
Od izlučene doze 21% eliminira se u mokraću (2% kao nepromijenjen meloksikam, 19% kao metaboliti), a 79% izmetom (49% kao nepromijenjen meloksikam, 30% kao metaboliti).
The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required, or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product. 
Pomoćne tvari navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1. Priloga Uredbi Komisije (EU) br. 37/2010 navedeno da određivanje MRL nije nužno ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EZ) br. 470/2009 kada se primjenjuju u tim veterinarsko-medicinskim proizvodima.
When the product is used according to the recommended dosage regime the oral bioavailability is approximately 98 %. 
Kada se proizvod primjenjuje u skladu s preporučenim režimom doziranja, oralna bioraspoloživost iznosi približno 98%.