FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: 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, 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 razina kreatin fosfokinaze i edem.
English: 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.
Croatian: 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 primarnoj mjeri ishoda - relapsu bipolarnog poremećaja.
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).
Croatian: U zdravih starijih ispitanika (65 godina i starijih) u odnosu na mlađe ispitanike srednja vrijednost poluvremena eliminacije bila je produljena (51,8 naspram 33,8 sati), a klirens smanjen (17,5 naspram 18,2 l/h).
English: Olanzapine Apotex 2.5 mg film-coated tablets Olanzapine Apotex 5 mg film-coated tablets Olanzapine Apotex 7.5 mg film-coated tablets Olanzapine Apotex 10 mg film-coated tablets
Croatian: Olanzapine Apotex 2,5 mg filmom obložene tablete Olanzapine Apotex 5 mg filmom obložene tablete Olanzapine Apotex 7,5 mg filmom obložene tablete Olanzapine Apotex 10 mg filmom obložene tablete olanzapin
English: Gradual tapering of the dose should be considered when discontinuing olanzapine.
Croatian: Pri ukidanju liječenja olanzapinom, treba razmotriti postupno smanjivanje doze.
English: Olanzapine orodispersible tablet is bioequivalent to olanzapine film-coated tablets, with a similar rate and extent of absorption.
Croatian: Olanzapin raspadljiva tableta za usta je bioekvivalent filmom obloženim tabletama olanzapina, sa sličnom stopom i opsegom apsorpcije.
English: Only slight to moderate increase in olanzapine clearance has been observed.
Croatian: Uočen je samo blag do umjeren porast klirensa olanzapina.
English: See package leaflet for further information.
Croatian: Vidjeti Uputu o lijeku za detaljnije informacije.
English: NL-2333 CN Leiden Netherlands
Croatian: NL-2333 CN Leiden
English: 9 Adverse event identified from clinical trials in the Olanzapine Integrated Database.
Croatian: 9 Štetan događaj identificiran iz kliničkih ispitivanja u integriranoj bazi podataka za olanzapin.
English: It has the same dosage and frequency of administration as olanzapine filmcoated tablets.
Croatian: Ima isto doziranje i učestalost primjene kao filmom obložene tablete olanzapina.
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 %).
Croatian: 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 %).
English: Thromboembolism (including pulmonary embolism and deep vein thrombosis) (see section 4.4)
Croatian: (uključujući plućnu emboliju i duboku vensku trombozu) (vidjeti dio 4.4)
English: Rare cases reported as NMS have also been received in association with olanzapine.
Croatian: Prijavljeni su i rijetki slučajevi NMS-a povezani s primjenom olanzapina.
English: 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.
Croatian: Manje česte nuspojave (mogu se pojaviti u do 1 na 100 osoba) uključuju preosjetljivosti (npr. oticanje u ustima i grlu, svrbež, osip), dijabetes ili pogoršanje dijabetesa, ponekad povezano s ketoacidozom (ketoni u krvi i mokraći) ili komom, napadaje, obično povezane s napadajima u povijesti bolesti (epilepsija); ukočenost mišića ili grčevi (uključujući pokrete očiju), sindrom nemirnih nogu; problemi s govorom; mucanje; 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 abnormalno stvaranje majčinog mlijeka ili abnormalan rast.
English: As assessed by measured values from clinical trials in the Olanzapine Integrated Database.
Croatian: Procijenjeno na temelju izmjerenih vrijednosti iz kliničkih ispitivanja u integriranoj bazi podataka za olanzapin.
English: Metabolism and nutrition disorders Weight gain
Croatian: Poremećaji metabolizma i prehrane
English: Orodispersible tablet
Croatian: Raspadljiva tableta za usta
English: Lactose monohydrate Microcrystalline cellulose Maize starch
Croatian: Jezgra tablete: laktoza hidrat celuloza, mikrokristalična kukuruzni škrob magnezijev stearat
English: Olanzapine orodispersible tablets may be used as an alternative to olanzapine filmcoated tablets.
Croatian: Raspadljive tablete olanzapina za usta mogu se koristiti kao alternativa filmom obloženim tabletama olanzapina.
English: High creatine phosphokinase11
Croatian: visoka razina kreatin fosfokinaze11,
English: Since olanzapine is metabolised by CYP1A2, substances that can specifically induce or inhibit this isoenzyme may affect the pharmacokinetics of olanzapine.
Croatian: Potencijalne interakcije koje utječu na olanzapin Budući da se olanzapin metabolizira preko CYP1A2, tvari koje mogu specifično inducirati ili inhibirati taj izoenzim mogu utjecati na farmakokinetiku olanzapina.
English: Gastrointestinal disorders Mild, transient anticholinergic effects including constipation and dry mouth
Croatian: Poremećaji probavnog sustava blagi, prolazni antikolinergički učinci uključujući konstipaciju i suha usta distenzija abdomena pankreatitis
English: Do not take Olanzapine Apotex
Croatian: Nemojte uzimati Olanzapine Apotex
English: Excipient with known effect: Each film-coated tablet contains 189.50 mg lactose.
Croatian: Pomoćna tvar s poznatim učinkom: Svaka filmom obložena tableta sadrži 189,50 mg laktoze.
English: Metabolism and nutrition disorders Weight gain1
Croatian: Poremećaji metabolizma i prehrane povećanje tjelesne težine1
English: Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
Croatian: Akutni simptomi kao što su znojenje, nesanica, tremor, anksioznost, mučnina i povraćanje prijavljeni su prilikom naglog prekida primjene olanzapina.
English: 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.
Croatian: Promjene u vrijednosti triglicerida natašte od početnih graničnih vrijednosti (≥ 1,69 -< 2,26 mmol/l) do visokih vrijednosti (≥ 2,26 mmol/l) bile su vrlo česte.
English: 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.
Croatian: Česte nuspojave (mogu se pojaviti u manje od 1 na 10 osoba) uključuju promjene razina nekih krvnih stanica, cirkulirajućih masnoća u krvi te u ranim fazama liječenja privremen porast razine jetrenih enzima; porast razine šećera u krvi i mokraći; porast razine mokraćne kiseline i kreatin fosfokinaze u krvi; pojačan apetit; omaglicu; nemir; nevoljno drhtanje; neobične pokrete (diskinezije); zatvor; suha usta; osip; slabost; pojačani umor; zadržavanje vode u tijelu koje dovodi do oticanja ruku, zglobova ili stopala; vrućica, bol u zglobovima; te seksualne poremećaje kao što su smanjeni libido u muškaraca i žena ili erektilna disfunkcija u muškaraca.
English: 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.
Croatian: Potreban je oprez i kontrola u bolesnika s povišenim ALT-om i/ili AST-om, u bolesnika sa znakovima i simptomima oštećenja jetre, u bolesnika s prethodno postojećim stanjima povezanima s ograničenom funkcionalnom rezervom jetre te u bolesnika koji se liječe potencijalno hepatotoksičnim lijekovima.
English: PHARMACEUTICAL FORM AND CONTENTS 28 orodispersible tablets
Croatian: OBLIK I SADRŽAJ 28 raspadljivih tableta za usta
English: 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).
Croatian: 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 %).
English: Seizures have been reported to occur uncommonly in patients when treated with olanzapine.
Croatian: Zabilježeno je da se napadaji manje često pojavljuju u bolesnika liječenih olanzapinom.
English: tachycardia/fibrillation, sudden death (see section 4.4)11
Croatian: ventrikularna tahikardija/ fibrilacija, iznenadna smrt (vidjeti dio 4.4)11
English: In female versus male subjects, the mean elimination half-life was somewhat prolonged (36.7 versus 32.3 hrs) and the clearance was reduced (18.9 versus 27.3 l/hr).
Croatian: U žena je srednja vrijednost poluvremena eliminacije nešto veća u odnosu na muškarce (36,7 naspram 32,3 sata), a klirens je smanjen (18,9 naspram 27,3 l/h).
English: High Gamma Glutamyltransferase High uric acid 10
Croatian: visoka razina gama glutamiltransferaz visoka razina mokraćne kiseline10
English: Olanzapine Apotex contains lactose
Croatian: Olanzapine Apotex sadrži laktozu
English: Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported rarely rarely (≥ 0.01% and < 0.1%) when olanzapine is stopped abruptly.
Croatian: Akutni simptomi kao što su znojenje, nesanica, tremor, anksioznost, mučnina ili povraćanje rijetko su prijavljivani (≥ 0,01 % i < 0,1 %) nakon naglog prekida uzimanja olanzapina.
English: Olanzapine Apotex film-coated tablets contain lactose.
Croatian: Olanzapine Apotex filmom obložene tablete sadrže laktozu.
English: 3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high
Croatian: 3 Uočeno za početne normalne razine natašte (< 5,17 mmol/l) koje su porasle na visoke razine
English: Vascular disorders Orthostatic hypotension10
Croatian: Krvožilni poremećaji ortostatska tromboembolija hipotenzija10
English: Titanium dioxide (E171)
Croatian: Ovojnica tablete: hipromeloza hidroksipropilceluloza makrogol 8000 titanijev dioksid (E171)
English: Tel: (34) 91.486.15.65
Croatian: Apotex ESPAÑA S.L. Tel: (34) 91.486.15.65
English: Excipient with known effect: Each film-coated tablet contains 126.34 mg lactose.
Croatian: Pomoćna tvar s poznatim učinkom: Svaka filmom obložena tableta sadrži 126,34 mg laktoze.
English: Excipient with known effect: Each film-coated tablet contains 252.70 mg lactose.
Croatian: Pomoćna tvar s poznatim učinkom: Svaka filmom obložena tableta sadrži 252,70 mg laktoze.
English: Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4)
Croatian: glikozurija, pojačan apetit razvoj ili egzacerbacija dijabetesa ponekad povezana s ketoacidozom ili komom, uključujući i neke slučajeve sa smrtnim ishodom (vidjeti dio 4.4)
English: In non-smoking versus smoking subjects (males and females), the mean elimination half-life was prolonged (38.6 versus 30.4 hrs) and the clearance was reduced (18.6 versus 27.7 l/hr).
Croatian: Srednja vrijednost poluvremena eliminacije u ispitanika nepušača (muškarci i žene) bila je veća nego u ispitanika pušača (38,6 naspram 30,4 sata), a klirens je bio manji (18,6 naspram 27,7 l/h).
English: 28 orodispersible tablets 56 orodispersible tablets
Croatian: 56 raspadljivih tableta za usta
English: • Diabetes
Croatian: • šećerna bolest
English: Changes in fasting glucose from borderline at baseline (≥ 5.56 - < 7 mmol/l) to high (≥ 7 mmol/l) were very common.
Croatian: Promjene u vrijednosti glukoze natašte od početnih graničnih vrijednosti (≥ 5,56-< 7 mmol/l) do visokih vrijednosti (≥ 7 mmol/l) bile su vrlo česte.
English: Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/l) to high (≥ 5.17 mmol/l) were observed commonly.
Croatian: Često su uočene promjene ukupnog kolesterola natašte od normalnih početnih vrijednosti (< 4,39 mmol/l) do visokih vrijednosti (≥ 5,17 mmol/l).
English: Excipient with known effect: Each film-coated tablet contains 63.17 mg lactose.
Croatian: Pomoćna tvar s poznatim učinkom: Svaka filmom obložena tableta sadrži 63,17 mg laktoze.
English: Only take other medicines while you are on Olanzapine Apotex if your doctor tells you that you can. You might feel drowsy if Olanzapine Apotex is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
Croatian: Ako uzimate Olanzapine Apotex u kombinaciji s antidepresivima, lijekovima za tjeskobu ili lijekovima koji Vam pomažu zaspati (trankvilizatori), možete se osjećati omamljeno.
English: High Gamma Glutamyltransfera se10
Croatian: visoka razina gama glutamiltransferaz e10,
English: Adverse event identified from spontaneous post-marketing reporting with frequency determined utilising the Olanzapine Integrated Database.
Croatian: Štetan događaj identificiran iz spontanih prijava nakon stavljanja lijeka u promet, a učestalost je određena uz pomoć integrirane baze podataka za olanzapin.
English: Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17< 6.2 mmol/l) to high (≥ 6.2 mmol/l) were very common.
Croatian: Promjene ukupnog kolesterola natašte od početnih graničnih vrijednosti (≥ 5,17-< 6,2 mmol/l) do visokih vrijednosti (≥ 6,2 mmol/l) bile su vrlo česte.
English: How to take Olanzapine Apotex
Croatian: Kako uzimati Olanzapine Apotex
English: Blood and lymphatic system disorders Eosinophilia
Croatian: Poremećaji krvi i limfnog sustava eozinofilija, leukopenija neutropenija trombocitopenija11
English: Olanzapine Apotex contains the active substance olanzapine.
Croatian: Olanzapine Apotex sadrži djelatnu tvar olanzapin.
English: • High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Olanzapine Apotex.
Croatian: • U bolesnika koji uzimaju Olanzapine Apotex uočena je visoka razina šećera i masnoća u krvi (trigliceridi i kolesterol).
English: Bradycardia QTc prolongation (see section 4.4)
Croatian: Srčani poremećaji bradikardija, produljenje QTc intervala (vidjeti dio 4.4)
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
Croatian: Apotex 10 mg raspadljive tablete za usta Olanzapine Apotex 15 mg raspadljive tablete za usta Olanzapine Apotex 20 mg raspadljive tablete za usta olanzapin
English: Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high (≥ 6.2 mmol/l).
Croatian: Uočeno za početne normalne razine natašte (< 5,17 mmol/l) koje su porasle na visoke razine (≥ 6,2 mmol/l).
English: Archimedesweg 2, 2333 CN, Leiden, The Netherlands
Croatian: Archimedesweg 2 2333 CN Leiden Nizozemska
English: Manufacturer Apotex Nederland B.V. Archimedesweg 2
Croatian: Proizvođač Apotex Nederland B.V.
English: Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olanzapine Apotex and regularly during treatment.
Croatian: Prije početka uzimanja Olanzapine Apotexa te redovito tijekom liječenja, liječnik bi Vam trebao obaviti krvne pretrage kako bi provjerio razinu šećera i određenih masnoća u krvi.
English: Observed for fasting normal levels at baseline (< 5.56 mmol/l) which increased to high (≥ 7 mmol/l).
Croatian: Uočeno za početne normalne razine natašte (< 5,56 mmol/l) koje su porasle na visoke razine (≥ 7 mmol/l).
English: • Each Olanzapine Apotex 7.5 mg film-coated tablet contains 7.5 mg olanzapine.
Croatian: • Svaka Olanzapine Apotex 7,5 mg filmom obložena tableta sadrži 7,5 mg olanzapina.
English: Very common
Croatian: Manje često
English: How to store Olanzapine Apotex
Croatian: Kako čuvati Olanzapine Apotex
English: Tel: (48) 22.311.20.00
Croatian: Apotex Polska Sp. z o.o. Tel: (48) 22.311.20.00
English: and 98 tablets.
Croatian: 98 filmom obloženih tableta
English: Elevated cholesterol levels Elevated glucose levels4
Croatian: povišene razine kolesterola povišene razine glukoze4, povišene razine triglicerida2,5,
English: Apotex Nederland B.V. Archimedesweg 2
Croatian: Apotex Nederland B.V.
English: High uric acid 10
Croatian: visoka razina mokraćne kiseline10
English: Aluminium/aluminium blister strips in cartons of 28 film-coated tablets per carton.
Croatian: Aluminij/aluminij blisteri u kutijama s 28 filmom obloženih tableta po kutiji.
English: • Each Olanzapine Apotex 20 mg orodispersible tablet contains 20 mg olanzapine.
Croatian: • Svaka Olanzapine Apotex 20 mg raspadljiva tableta za usta sadrži 20 mg olanzapina.
English: • Olanzapine Apotex 7.5 mg film-coated tablets are available in blisters packs of 28 and 56 tablets.
Croatian: • Olanzapine Apotex 7,5 mg filmom obložene tablete dostupne su u blister pakiranjima od 28 i 56 tableta.
English: • Olanzapine Apotex 2.5 mg film-coated tablets are available in blisters packs of 28 tablets.
Croatian: • Olanzapine Apotex 2,5 mg filmom obložene tablete dostupne su u blister pakiranjima od 28 tableta.
English: PHARMACEUTICAL FORM AND CONTENTS 28 film-coated tablets 56 film-coated tablets 98 film-coated tablets METHOD AND ROUTE(S) OF ADMINISTRATION Oral use Read the package leaflet before use.
Croatian: OBLIK I SADRŽAJ 28 filmom obloženih tableta 56 filmom obloženih tableta 98 filmom obloženih tableta
English: Changes in total fasting cholesterol levels from borderline at baseline (≥ 4.39 - < 5.17 mmol/l) to high (≥ 5.17 mmol/l) were very common.
Croatian: Vrlo česte su bile promjene ukupnih razina kolesterola natašte od graničnih početnih vrijednosti (≥ 4,39-< 5,17 mmol/l) do visokih vrijednosti (≥ 5,17 mmol/l).
English: • Each Olanzapine Apotex 2.5 mg film-coated tablet contains 2.5 mg olanzapine.
Croatian: • Svaka Olanzapine Apotex 2,5 mg filmom obložena tableta sadrži 2,5 mg olanzapina.
English: Aluminium/aluminium blister strips in cartons of 28, 56 and 98 film-coated tablets per carton.
Croatian: Aluminij/aluminij blisteri u kutijama s 28, 56 ili 98 filmom obloženih tableta po kutiji.
English: Dysarthria
Croatian: hipotermija
English: Macrogol 8000
Croatian: 4.8 Nuspojave
English: Musculoskeletal and connective tissue disorders Arthralgia
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva artralgija rabdomioliza
English: • Each Olanzapine Apotex 10 mg film-coated tablet contains 10 mg olanzapine.
Croatian: • Svaka Olanzapine Apotex 10 mg filmom obložena tableta sadrži 10 mg olanzapina.
English: • Olanzapine Apotex 15 mg orodispersible tablets are available in blisters packs of 28 tablets.
Croatian: • Olanzapine Apotex raspadljive tablete za usta od 15 mg dostupne su u blister pakiranjima od 28 tableta.
English: Urinary incontinence, urinary retention
Croatian: Poremećaji bubrega i mokraćnog sustava urinarna inkontinencija, urinarna retencija, otežano mokrenje11
English: • Olanzapine Apotex 20 mg orodispersible tablets are available in blister packs of 28 and 56 tablets.
Croatian: • Olanzapine Apotex raspadljive tablete za usta od 20 mg dostupne su u blister pakiranjima od 28 i 56 tableta.
English: If you get any side effects, talk to your doctor or nurse.
Croatian: Ako imate bilo koji od navedenih simptoma, odmah se obratite svom liječniku ili bolnici.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 7.5 mg film-coated tablets
Croatian: NAZIV LIJEKA Olanzapine Apotex 7,5 mg filmom obložene tablete
English: Marketing Authorisation Holder Apotex Europe B.V.
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Apotex Europe B.V.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 7.5 mg olanzapine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka filmom obložena tableta sadrži 7,5 mg olanzapina.
English: • Olanzapine Apotex 7.5 mg are white, round biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘7.5' on the other side.
Croatian: • Olanzapine Apotex tablete od 7,5 mg su bijele, okrugle, bikonveksne filmom obložene tablete s utisnutim »APO« na jednoj strani i »OLA« iznad »7,5« na drugoj.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/635/013-014
Croatian: 12. BROJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/635/013-014
English: Aluminium/aluminium blister strips in cartons of 28 and 56 film-coated tablets per carton.
Croatian: Aluminij/aluminij blisteri u kutijama s 28 i 56 filmom obloženih tableta po kutiji.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/635/004-005
Croatian: 12. BROJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/635/004-005
English: Investigations Elevated plasma prolactin levels
Croatian: Pretrage povišene razine prolaktina u plazmi povišena razina alkalne fosfataze10,
English: 14 Observed for fasting normal levels at baseline (< 1.016 mmol/l) which increased to high
Croatian: Uočeno za početne normalne razine natašte (< 1,69 mmol/l) koje su porasle na visoke razine
English: • Each Olanzapine Apotex 5 mg film-coated tablet contains 5 mg olanzapine.
Croatian: • Svaka Olanzapine Apotex 5 mg filmom obložena tableta sadrži 5 mg olanzapina.
English: Respiratory, thoracic and mediastinal disorders Epistaxis
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja epistaksa