FrancophonIA/ELRC3.0 huggingface dataset:
English: The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
Croatian: Metabolizam olanzapina može se inducirati pušenjem i primjenom karbamazepina.
English: A decrease in the dose of olanzapine should be considered if treatment with an inhibitor of CYP1A2 is initiated.
Croatian: Isto tako bi se moralo razmotriti smanjivanje doze olanzapina kada se započinje liječenje nekim od inhibitora
English: One carton contains one vial of powder for prolonged release suspension for injection, one vial of 3 ml solvent, one syringe with safety needle, 19 gauge, 38mm, attached and three separate safety needles; one 19 gauge, 38mm needle and two 19 gauge 50mm needles.
Croatian: U jednoj kutiji se nalazi jedna bočica praška za suspenziju za injekciju s produljenim oslobađanjem, jedna bočica s 3 ml otapala, jedna štrcaljka s pričvršćenom zaštićenom iglom veličine 19G i duljine 38 mm i tri zasebne zaštićene igle veličine: jedna 19G i duljine 38 mm, te dvije igle 19G i duljine 50 mm.
English: Figure C: Vigorously shake vial
Croatian: Slika C: Snažno protresite bočicu
English: High creatine phosphokinase11 High Gamma Glutamyltransfera se 10
Croatian: visoka razina gama glutamiltransferaz e10
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 kratkotrajne terapije (medijan trajanja 47 dana), porast tjelesne težine za ≥ 7% u odnosu na početnu tjelesnu težinu bio je vrlo čest (22,2%), za ≥ 15% čest (4,2%), a za ≥ 25% manje čest (0,8%).
English: 15 mg/day
Croatian: 15 mg/dan
English: Only slight to moderate increase in olanzapine clearance has been observed.
Croatian: Primijećen je samo blag do umjeren porast klirensa olanzapina.
English: Use in patients who are in an acutely agitated or severely psychotic state ZYPADHERA should not be used to treat patients with schizophrenia who are in an acutely agitated or severely psychotic state such that immediate symptom control is warranted.
Croatian: ZYPADHERA se ne smije primjenjivati u liječenju bolesnika sa shizofrenijom koji su u stanju akutne agitiranosti ili teške psihoze i kod kojih je potrebna trenutna kontrola simptoma.
English: 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 %).
Croatian: 13 Nakon kratkotrajne terapije (medijan trajanja 22 dana), porast tjelesne težine za ≥ 7% u odnosu na početnu tjelesnu težinu (kg) bio je vrlo čest (40,6%), dok je porast za ≥ 15% i ≥ 25% u odnosu na početnu vrijednost bio čest (7,1% i 2,5%).
English: 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).
Croatian: Na estrusne cikluse utjecale su doze od 1,1 mg/kg (3 puta veća od maksimalne doze u ljudi), a doza od
English: (Fig. 1 and 2) 8.
Croatian: 7. Namjestite zaštitni pokrov igle (Slika 1 i 2) 8.
English: Reproductive toxicity
Croatian: Hematološka toksičnost
English: The plasma concentrations of olanzapine observed across the dose range of 150mg every 4 weeks to 300mg every 2 weeks illustrate increased systemic olanzapine exposure with increased ZYPADHERA doses.
Croatian: 150 mg svaka 4 tjedna do 300 mg svaka 2 tjedna ilustriraju povećanu sistemsku izloženost olanzapinu s povećanjem doza lijeka ZYPADHERA.
English: The side effects listed below have been observed when oral olanzapine has been given but may occur following administration of ZYPADHERA.
Croatian: U daljnjem tekstu navedene nuspojave uočene su kod primjene oralnog oblika olanzapina, ali je njihova pojava moguća i nakon primjene lijeka ZYPADHERA.
English: Signs of oral toxicity in rodents were characteristic of potent antipsychotic compounds: hypoactivity, coma, tremors, clonic convulsions, salivation, and depressed weight gain.
Croatian: Akutna toksičnost (nakon jedne doze) Znakovi oralne toksičnosti u glodavaca odgovarali su onima potentnih antipsihotika: smanjena aktivnost, koma, tremor, klonične konvulzije, salivacija i smanjen porast težine.
English: The solvent ingredients are carmellose sodium, mannitol, polysorbate 80, water for injections, hydrochloric acid and sodium hydroxide.
Croatian: Sastojci otapala su karmelozanatrij, manitol, polisorbat 80, voda za injekcije, kloridna kiselina i natrijev hidroksid.
English: Visually confirm that the needle is fully engaged into the needle protection sheath.
Croatian: Vizualno provjerite da je igla potpuno uglavljena u zaštitni pokrov.
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 putem CYP1A2, tvari koje specifično induciraju ili inhibiraju ovaj izoenzim mogu utjecati na farmakokinetiku olanzapina.
English: Olanzapine should be used cautiously in patients who have a history of seizures or are subject to factors which may lower the seizure threshold.
Croatian: Napadaji Olanzapin se mora s oprezom primjenjivati u bolesnika s anamnezom napadaja i u bolesnika koji su pod utjecajem čimbenika koji mogu sniziti prag nastanka napadaja.
English: Other 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: 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); sindrom nemirnih nogu; tegobe s govorom; mucanje; usporeni srčani ritam; osjetljivost na sunčevu svjetlost; krvarenje iz nosa; nadimanje trbuha; gubitak pamćenja ili zaboravljivost; mokraćnu inkontinenciju (nemogućnost kontroliranja mokrenja); nedostatak sposobnosti mokrenja; gubitak kose; izostanak ili smanjenje menstrualnog krvarenja; i promjene u grudima kod muškaraca i žena kao što su abnormalna proizvodnja mlijeka ili abnormalan rast.
English: Unsuspended powder appears as yellow, dry clumps clinging to the vial.
Croatian: Nesuspendirani prašak stvara svijetložute, suhe grudice zalijepljene za stijenke bočice.
English: In a study of oral olanzapine in breast-feeding, healthy women, olanzapine was excreted in breast milk.
Croatian: U ispitivanju oralnog olanzapina u zdravih dojilja utvrđeno je da se olanzapin izlučuje u majčino mlijeko.
English: Switching to other antipsychotic medicinal products There are no systematically collected data to specifically address switching patients from ZYPADHERA to other antipsychotic medicinal products.
Croatian: Nema sustavno prikupljenih podataka koji bi posebno opisivali način prijelaza bolesnika s lijeka
English: Once the suspension has been removed from the vial, it should be injected immediately.
Croatian: Kada se suspenzija navuče iz bočice, mora se odmah injicirati.
English: Peel blister pouch and remove device.
Croatian: Otvorite blister vrećicu i izvadite pribor.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial Label
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Naljepnica bočice
English: One carton contains one vial of powder and one vial of solvent, one Hypodermic 3ml syringe with preattached 19-gauge, 38 mm safety needle, one 19-gauge, 38 mm Hypodermic safety needle and two 19gauge, 50 mm Hypodermic safety needles.
Croatian: Jedno pakiranje sadrži jednu bočicu praška i jednu bočicu otapala, jednu hipodermalnu štrcaljku od 3 ml s pričvršćenom zaštićenom iglom od 19G i duljine 38 mm, jednu hipodermalnu zaštićenu iglu od
English: The solvent excipients are carmellose sodium, mannitol, polysorbate 80, water for injections, hydrochloric acid, sodium hydroxide.
Croatian: Pomoćne tvari u otapalu su karmelozanatrij, manitol, polisorbat 80, voda za injekcije, kloridna kiselina, natrijev hidroksid.
English: 20 mg/day
Croatian: 20 mg/dan
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati lijek ZYPADHERA Lijek čuvajte izvan pogleda i dohvata djece.
English: Additional signs may include elevated creatine phosphokinase, myoglobinuria
Croatian: Od dodatnih znakova mogu se javiti povišena vrijednost kreatin fosfokinaze, mioglobinurija (rabdomioliza) i akutno zatajenje bubrega.
English: Gastrointestinal disorders Mild, transient anticholinergic effects including constipation and dry mouth
Croatian: Poremećaji probavnog sustava blagi, prolazni antikolinergički učinci koji uključuju konstipaciju i suha usta distenzija abdomena9
English: < 2.26 mmol/l) to high (≥ 2.26 mmol/l) were very common.
Croatian: (≥ 1,69 mmol/l - < 2,26 mmol/l) do visokih (≥ 2,26 mmol/l) bile su vrlo česte.
English: • Liver or kidney disease
Croatian: • imate bolest jetre ili bubrega
English: Olanzapine plasma clearance after oral olanzapine is lower in females (18.9 l/hr) versus males (27.3 l/hr), and in non-smokers (18.6 l/hr) versus smokers (27.7 l/hr).
Croatian: (27,3 l/h) i u nepušača (18,6 l/h) u odnosu na pušače (27,7 l/h).
English: General CNS activity
Croatian: Opća aktivnost SŽS-a
English: ZYPADHERA 210 mg, 300 mg or 405 mg powder and solvent for prolonged release suspension for injection must not be confused with olanzapine 10 mg powder for solution for injection.
Croatian: ZYPADHERA 210 mg, 300 mg ili 405 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem ne smije se zamijeniti s olanzapin 10 mg praškom za otopinu za injekciju.
English: After reconstitution each ml of suspension contains 150 mg olanzapine.
Croatian: Nakon rekonstitucije jedan ml suspenzije sadrži 150 mg olanzapina.
English: The 3-hour observation period should be extended as clinically appropriate for patients who exhibit any signs or symptoms consistent with olanzapine overdose.
Croatian: Trosatno razdoblje promatranja treba produljiti prema kliničkoj potrebi u onih bolesnika koji pokazuju bilo kakve znakove ili simptome koji odgovaraju predoziranju olanzapinom.
English: No information on the use of ZYPADHERA in patients >75 years is available.
Croatian: Primjena u starijih osoba (>75 godina) Nisu dostupne informacije o primjeni lijeka ZYPADHERA u bolesnika starijih od 75 godina.
English: Thromboembolis m (including pulmonary embolism and deep vein thrombosis) (see section 4.4)
Croatian: (uključujući plućnu emboliju i duboku vensku trombozu) (vidjeti dio 4.4)
English: DO NOT ADMINISTER INTRAVENOUSLY OR SUBCUTANEOUSLY (See section 4.4)
Croatian: INTRAVENSKI NITI SUPKUTANO (Vidjeti dio 4.4).
English: Water for injections Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
Croatian: Otapalo karmelozanatrij manitol polisorbat 80 voda za injekcije kloridna kiselina (za podešavanje pH) natrijev hidroksid (za podešavanje pH)
English: During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
Croatian: Tijekom liječenja psihoze potrebno je pričekati nekoliko dana do nekoliko tjedana od početka liječenja da bi došlo do poboljšanja kliničkog stanja bolesnika.
English: Hepatobiliary disorders Transient, asymptomatic elevations of hepatic aminotransferases (ALT, AST), especially in early treatment (see section 4.4)
Croatian: Poremećaji jetre i žuči prolazna, asimptomatska povišenja jetrenih aminotransferaza (ALT, AST), posebice na početku liječenja
English: If the medicine is not used right away, it should be shaken vigorously to re-suspend.
Croatian: Ako se lijek ne iskoristi odmah, potrebno ga je kasnije snažno protresti da se resuspendira.
English: ZYPADHERA is a powder and solvent for prolonged release suspension for injection.
Croatian: ZYPADHERA je prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem.
English: In clinical trials with olanzapine powder for solution for injection or ZYPADHERA, olanzapine was not associated with a persistent increase in absolute QT or in QTc intervals.
Croatian: ZYPADHERA, nije uočena povezanost olanzapina s perzistentnim povećanjem apsolutnog QT ili QTc-intervala.
English: After each injection, patients should be observed in a healthcare facility by appropriately qualified personnel for at least 3 hours for signs and symptoms consistent with olanzapine overdose.
Croatian: Nakon svake injekcije bolesnika mora promatrati odgovarajuće osposobljeno osoblje u zdravstvenoj ustanovi tijekom najmanje 3 sata kako bi se uočila eventualna pojava znakova i simptoma koji odgovaraju predoziranju olanzapinom.
English: • excessive sleepiness, dizziness, confusion, disorientation, difficulty talking, difficulty walking, muscle stiffness or shaking, weakness, irritability, aggression, anxiety, increase in blood pressure, or convulsions and can lead to unconsciousness.
Croatian: ukočenost mišića ili trzaje (drhtanje), slabost, razdražljivost, agresiju, tjeskobu, povećanje krvnog tlaka ili konvulzije te mogu dovesti do nesvijesti.
English: Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking ZYPADHERA and regularly during treatment.
Croatian: Prije nego počnete uzimati lijek ZYPADHERA, a i redovito tijekom liječenja, Vaš liječnik mora Vam napraviti pretrage krvi kako bi provjerio razinu šećera i određenih masnoća u krvi.
English: 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: (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: 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.
Croatian: Stariji bolesnici s demencijom mogu razviti odnosno doživjeti moždani udar, upalu pluća, mokraćnu inkontinenciju (nemogućnost kontroliranja mokrenja), padove, ekstreman umor, vidne halucinacije, povišenje tjelesne temperature, crvenilo kože te mogu imati teškoće pri hodanju dok uzimaju olanzapin.
English: If foam forms, let vial stand to allow foam to dissipate.
Croatian: Ako se stvori pjena, ostavite bočicu da miruje dok se pjena ne slegne.
English: 15 Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/l) to high (≥ 5.17 mmol/l) were observed commonly.
Croatian: 15 Promjena ukupnog kolesterola natašte od normalnih vrijednosti na početku (< 4,39 mmol/l) do visokih (≥ 5,17 mmol/l) bila je česta.
English: Solvent: clear, colourless to slightly yellow solution.
Croatian: Prašak: žuta krutina Otapalo: bistra, bezbojna do svijetložuta otopina.
English: Olanzapine showed no interaction when co-administered with lithium or biperiden.
Croatian: Interakcije olanzapina nisu uočene niti kod istodobne primjene olanzapina s litijem ili biperidenom.
English: Rare cases reported as NMS have also been received in association with oral olanzapine.
Croatian: Navode se i rijetke prijave MNS-a povezanog s uzimanjem oralnog oblika olanzapina.
English: • Two 19-gauge, 50 mm Hypodermic safety needles
Croatian: • Dvije hipodermalne zaštićene igle od 19G i duljine 50 mm
English: Hepatic function
Croatian: hepatitis
English: • A blocked intestine (Paralytic ileus)
Croatian: • bolujete od prestanka rada crijeva (paralitički ileus)
English: The frequency terms listed are defined as follows: Very common (≥ 1/10),
Croatian: Učestalost je definirana kako slijedi: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10),
English: 10 mg/day
Croatian: 10 mg/dan
English: Solvent for ZYPADHERA
Croatian: Otapalo za lijek ZYPADHERA
English: Seizures where in most cases a history of seizures or risk factors for seizures were reported11
Croatian: napadaji, uglavnom u bolesnika s anamnezom napadaja ili čimbenika rizika za njihov nastanak11 distonija
English: Patients should be treated initially with oral olanzapine before administering ZYPADHERA, to establish tolerability and response.
Croatian: U početnoj fazi prije primjene lijeka ZYPADHERA bolesnike se mora liječiti oralnim olanzapinom kako bi se utvrdila podnošljivost i postojanje odgovora na liječenje.
English: During pre-marketing clinical studies, reactions that presented with signs and symptoms consistent with olanzapine overdose, were reported in patients following an injection of ZYPADHERA.
Croatian: Tijekom kliničkih ispitivanja prije puštanja lijeka u promet nakon injekcije lijeka ZYPADHERA u bolesnika su prijavljene nuspojave karakterizirane znakovima i simptomima koji odgovaraju onima koji se javljaju kod predoziranja olanzapinom.
English: Olanzapine demonstrated a greater in vitro affinity for serotonin 5-HT2 than dopamine D2 receptors and greater 5HT2 than D2 activity in vivo, models.
Croatian: D2 dopaminske receptore i veću aktivnost na 5-HT2 nego na D2 receptorima u in vivo modelima.
English: • confusion
Croatian: • konfuzija
English: 3 ml solvent: Type I glass vial.
Croatian: 3 ml otapala: bočica od stakla tipa I.
English: ZYPADHERA is not recommended for treatment in the elderly population unless a well-tolerated and effective dose regimen using oral olanzapine has been established.
Croatian: ZYPADHERA se ne preporučuje u liječenju starije populacije, osim u slučajevima kada je primjenom oralnog oblika olanzapina postignut dobro podnošljiv i učinkovit režim doziranja.
English: Total Positive and Negative Symptom Scores (PANSS) showed significant improvement from baseline (baseline mean Total PANSS Score 101) to endpoint (mean changes -22.57, -26.32, -22.49 respectively) with each dose of ZYPADHERA (405 mg every 4 weeks, 300 mg every 2 weeks, and 210 mg every 2 weeks) as compared to placebo (mean change -8.51).
Croatian: odnosno -22,49) u odnosu na početne vrijednosti (srednja vrijednost početne PANSS ocjene 101) kod svake doze lijeka ZYPADHERA (405 mg svaka 4 tjedna, 300 mg svaka 2 tjedna, 210 mg svaka 2 tjedna) u usporedbi s placebom (srednja vrijednost promjene -8,51).
English: Changes in fasting glucose from borderline at baseline (≥ 5.56 - < 7 mmol/l) to high (≥ 7 mmol/l) were very common.
Croatian: Promjene GUK-a natašte od graničnih vrijednosti na početku (≥ 5,56 - < 7 mmol/l) do visokih (≥ 7 mmol/l) bile su vrlo česte.
English: 3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high (≥ 6.2 mmol/l).
Croatian: 3 Opažena kod normalnih vrijednosti natašte na početku (< 5,17 mmol/l) koje su porasle do visokih (≥ 6,2 mmol/l).
English: Although patients with renal impairment were not studied with ZYPADHERA, it is recommended that a well-tolerated and effective dosage regimen using oral olanzapine is established in patients with renal impairment before treatment with ZYPADHERA is initiated (see section 4.2).
Croatian: Iako nisu provedena ispitivanja lijeka ZYPADHERA u bolesnika s oštećenom funkcijom bubrega, preporučuje se prije početka primjene lijeka ZYPADHERA postići učinkovit i dobro podnošljiv režim doziranja primjenom oralnog oblika olanzapina u bolesnika s oštećenjem funkcije bubrega (vidjeti dio 4.2).
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: Promjene ukupnog kolesterola natašte od graničnih vrijednosti na početku (≥ 4,39 - < 5,17 mmol/l) do visokih (≥ 5,17 mmol/l) bile su vrlo česte.
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: porast tjelesne težine u odnosu na početnu vrijednost tjelesne težine za ≥ 7%, ≥ 5% odnosno ≥ 25% bio je vrlo čest (64,4%, 31,7% odnosno 12,3%).
English: ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection ZYPADHERA 300 mg powder and solvent for prolonged release suspension for injection ZYPADHERA 405 mg powder and solvent for prolonged release suspension for injection
Croatian: ZYPADHERA 210 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem ZYPADHERA 300 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem ZYPADHERA 405 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem
English: • An uncommon but serious reaction might occur after you receive each injection.
Croatian: • Nakon svake injekcije može doći do pojave manje čestih, ali zato ozbiljnih nuspojava.
English: If this has happened to you, tell your nurse or doctor.
Croatian: Ako kod Vas dođe do njihove pojave, izvijestite o tome svoju medicinsku sestru ili liječnika.
English: In clinical trials with ZYPADHERA, the only adverse reaction reported at a statistically significantly higher rate in the ZYPADHERA group than in the placebo group was sedation (ZYPADHERA 8.2%, placebo 2.0%).
Croatian: U kliničkim ispitivanjima lijeka ZYPADHERA jedina nuspojava koja se javljala statistički značajno češće u skupini ispitanika koji su primali lijek ZYPADHERA u odnosu na skupinu koja je primala placebo bila je sedacija
English: Seizures have been reported to occur uncommonly in patients when treated with olanzapine.
Croatian: Napadaji su prijavljeni manje često u bolesnika liječenih olanzapinom.
English: In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo (see section 4.8), and oral olanzapine was not more effective than placebo in the treatment of psychotic symptoms.
Croatian: U kliničkim ispitivanjima su pogoršanje simptoma Parkinsonove bolesti i halucinacije prijavljivane kao vrlo česte i zabilježene su puno češće nego u bolesnika koji su primali placebo (vidjeti dio 4.8).
English: What ZYPADHERA looks like and contents of the pack ZYPADHERA powder for prolonged release suspension for injection comes as a yellow powder in a clear glass vial.
Croatian: ZYPADHERA prašak za suspenziju za injekciju s produljenim oslobađanjem je žuti prašak u bočici od prozirnog stakla.
English: Although patients with hepatic impairment were not studied with ZYPADHERA, it is recommended that a well-tolerated and effective dosage regimen using oral olanzapine is established in patients with hepatic impairment before treatment with ZYPADHERA is initiated (see section 4.2).
Croatian: Iako nisu provedena ispitivanja lijeka ZYPADHERA u bolesnika s oštećenjem funkcije jetre, preporučuje se prije početka primjene lijeka ZYPADHERA postići učinkovit i dobro podnošljiv režim doziranja primjenom oralnog oblika olanzapina u bolesnika s oštećenjem funkcije jetre (vidjeti dio 4.2).
English: After reconstitution: 1ml suspension contains 150 mg/ml olanzapine.
Croatian: Nakon pripreme za primjenu: 1 ml suspenzije sadrži 150 mg/ml olanzapina.
English: Glucosuria
Croatian: GLUTEUSA
English: As it exhibits in vitro dopamine antagonism, olanzapine may antagonize the effects of direct and indirect dopamine agonists.
Croatian: olanzapin može antagonizirati učinke direktnih i indirektnih dopaminskih agonista.
English: One vial of powder for prolonged release suspension for injection.
Croatian: Jedna bočica praška za suspenziju za injekciju s produljenim oslobađanjem.