FrancophonIA/ELRC3.0 huggingface dataset:
English: 300 mg/2 weeks
Croatian: 300 mg/2 tjedna
English: The main findings found in repeat-dose toxicity studies (rat, dog), in a 2-year rat carcinogenicity study, and in toxicity to reproduction studies (rat, rabbit) were limited to injection site reactions for which no NOAEL could be determined.
Croatian: Najvažniji rezultati utvrđeni u ispitivanjima toksičnosti ponovljenih doza (štakori, psi) u dvogodišnjem ispitivanju kancerogenosti na štakorima i ispitivanjima reproduktivne toksičnosti (štakori, kunići) bili su ograničeni na reakcije na mjestu primjene za koje nije bilo moguće odrediti NOAEL.
English: Age > 75 years and vascular/mixed type dementia were identified as risk factors for CVAE in association with olanzapine treatment.
Croatian: Dob > 75 godina i vaskularna demencija/miješani tip demencije identificirani su kao čimbenici rizika za cerebrovaskularne događaje povezane s primjenom olanzapina.
English: • The use of ZYPADHERA in elderly patients with dementia (confusion and memory loss) is not recommended as it may have serious side effects.
Croatian: • Ne preporučuje se primjena lijeka ZYPADHERA u starijih bolesnika s demencijom (smetenost i gubitak pamćenja) jer može imati ozbiljne nuspojave.
English: If you miss an injection of ZYPADHERA
Croatian: Ako ste propustili injekciju lijeka ZYPADHERA
English: In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki; < 100 nM) for serotonin 5HT2A/2C, 5-HT3, 5-HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α-1 adrenergic; and histamine H1 receptors.
Croatian: U nekliničkim ispitivanjima olanzapin je pokazao afinitet prema brojnim receptorima (Ki < 100 nM) za serotonin 5-HT2A/2C, 5-HT3, 5-HT6; dopamin D1, D2, D3, D4, D5; kolinergičke muskarinske receptore M1-M5; α1 adrenergičke; i histaminske H1 receptore.
English: What ZYPADHERA is and what it is used for
Croatian: Što se nalazi u ovoj uputi Što je ZYPADHERA i za što se koristi
English: ZYPADHERA should only be administered by deep intramuscular gluteal injection by a healthcare professional trained in the appropriate injection technique and in locations where post-injection observation and access to appropriate medical care in the case of overdose can be assured.
Croatian: ZYPADHERA se smije davati samo u obliku duboke glutealne intramuskularne injekcije i to od strane zdravstvenoga radnika obučenoga u korištenju odgovarajućih tehnika davanja injekcija i na mjestima gdje postoji mogućnost promatranja bolesnika nakon injekcije i gdje je moguće osigurati primjerenu medicinsku skrb u slučaju predoziranja.
English: ZYPADHERA has not been systematically studied in elderly patients (> 65 years).
Croatian: Starije osobe ZYPADHERA nije sustavno ispitivana u starijih bolesnika (starijih od 65 godina).
English: • Very rarely, medicines of this type may cause unusual movements mainly of the face or tongue or a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness.
Croatian: • Vrlo rijetko, lijekovi iz ove skupine mogu prouzročiti neuobičajene pokrete (uglavnom lica ili jezika) ili kombinaciju vrućice, ubrzanog disanja, znojenja, mišićne ukočenosti te omamljenosti ili pospanosti.
English: If oral olanzapine supplementation is clinically indicated, then the combined total dose of olanzapine from both formulations should not exceed the corresponding maximum oral olanzapine dose of 20 mg/day.
Croatian: Ako je dodavanje oralnog olanzapina klinički indicirano, ukupna doza oba oblika olanzapina ne smije prelaziti odgovarajuću najveću dopuštenu dozu oralnog olanzapina od 20 mg/dan.
English: Tap the vial firmly and repeatedly on a hard surface until no powder is visible.
Croatian: Čvrsto i opetovano lupkajte bočicom po tvrdoj površini sve dok više nema vidljivih čestica praška.
English: Vial of suspension after reconstitution: 24 hours.
Croatian: Bočica suspenzije nakon pripreme za primjenu: 24 sata.
English: Patients should be monitored carefully for signs of relapse during the first one to two months of treatment.
Croatian: Bolesnike se mora pažljivo pratiti tijekom prvih jedan do dva mjeseca liječenja kako bi se uočili eventualni znakovi relapsa bolesti.
English: • a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness (the frequency of this side effect cannot be estimated from the available data).
Croatian: • kombinaciju vrućice, ubrzanog disanja, znojenja, ukočenosti mišića te omamljenosti ili pospanosti (učestalost ove nuspojave se ne može procijeniti iz dostupnih podataka).
English: Symptomatic treatment and monitoring of vital organ function should be instituted according to clinical presentation, including treatment of hypotension and circulatory collapse and support of respiratory function.
Croatian: U skladu s kliničkom slikom mora se primijeniti simptomatsko liječenje i nadzor funkcije vitalnih organa, uključujući liječenje hipotenzije i cirkulatornog kolapsa te potpora respiratorne funkcije.
English: • difficulty walking
Croatian: • otežano hodanje
English: Given the primary CNS effects of olanzapine, caution should be used when it is taken in combination with other centrally acting medicines and alcohol.
Croatian: Vezano za primarne učinke olanzapina na SŽS, mora se s oprezom istodobno primjenjivati s drugim lijekovima koji djeluju centralno i s alkoholom.
English: Supplementation with oral olanzapine was not authorised in double-blind clinical studies.
Croatian: Dodavanje oralnog olanzapina nije bilo dopušteno tijekom dvostruko slijepih kliničkih ispitivanja.
English: You should not be given this injection if you are breast-feeding as small amounts of olanzapine can pass into breast milk.
Croatian: Ne smijete primiti injekciju ovog lijeka dok dojite dijete jer se mala količina olanzapina izlučuje u majčino mlijeko.
English: Sedation affected mating performance of male rats.
Croatian: Sedacija je utjecala na funkciju parenja u mužjaka štakora.
English: 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.
Croatian: Pri dugotrajnoj izloženosti (barem 24 tjedna) 89,4% je dobilo ≥ 7%, 55,3% je dobilo ≥ 15% i 29,1% je dobilo ≥ 25% u odnosu na svoju početnu tjelesnu težinu.
English: The following table summarises the adverse reactions reported with a greater frequency in adolescent patients (aged 13-17 years) than in adult patients or adverse reactions only identified during short-term clinical trials in adolescent patients.
Croatian: Sljedeća tablica prikazuje nuspojave prijavljivane češće u adolescentnih bolesnika (u dobi između 13 i 17 godina) nego u odraslih, odnosno nuspojave uočene samo u adolescentnih bolesnika tijekom kratkotrajnih kliničkih ispitivanja.
English: ZYPADHERA is not recommended to be started if you are over 75 years.
Croatian: Ne preporučuje se započinjati liječenje lijekom Zypadhera ako ste stariji od 75 godina.
English: The vial is for single use only.
Croatian: Bočice su za jednokratnu uporabu.
English: Plasma concentrations remain measurable for several months after each ZYPADHERA injection.
Croatian: Koncentracije lijeka ZYPADHERE u plazmi ostaju mjerljive tijekom nekoliko mjeseci nakon svake injekcije.
English: Do not drink any alcohol if you have been given ZYPADHERA as together with alcohol it may make you feel drowsy.
Croatian: ZYPADHERA s alkoholom Ne konzumirajte alkohol ako ste primili lijek ZYPADHERA jer ZYPADHERA u kombinaciji s alkoholom može učiniti da se osjećate omamljeno (pospano).
English: ZYPADHERA belongs to a group of medicines called antipsychotics and is used to treat schizophrenia - a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.
Croatian: ZYPADHERA pripada skupini lijekova koji se nazivaju antipsihotici i primjenjuje se u liječenju shizofrenije, bolesti u kojoj se pojavljuju simptomi poput slušnih, vidnih ili osjetilnih doživljaja koji u stvarnosti ne postoje, pogrešnih uvjerenja, neuobičajene sumnjičavosti i povlačenja u sebe.
English: Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
Croatian: Promjene vrijednosti lipida moraju se odgovarajuće klinički zbrinjavati, pogotovo u dislipidemičnih bolesnika i bolesnika s čimbenicima rizika za nastanak poremećaja lipida.
English: ZYPADHERA is intended for adult patients who are sufficiently stabilised during treatment with oral olanzapine.
Croatian: ZYPADHERA je namijenjena odraslim bolesnicima koji su dovoljno stabilizirani tijekom liječenja oralnim olanzapinom.
English: Very rare side effects include serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Croatian: Vrlo rijetke nuspojave uključuju ozbiljne alergijske reakcije poput reakcije na lijek uz eozinofiliju i sistemske simptome (engl. drug reaction with eosinophilia and systemic symptoms, DRESS).
English: • blood clots in the veins (an uncommon side effect that may affect up to 1in 100 people) 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.
Croatian: • krvne ugruške u venama (manje česta nuspojava koja može zahvatiti do 1 na 100 osoba), posebno u nogama (simptomi uključuju oticanje, bol i crvenilo noge), koji mogu putovati kroz krvne žile do pluća uzrokujući bol u prsnom košu i otežano disanje.
English: Antipsychotic supplementation is not required at the initiation of ZYPADHERA treatment (see section 4.2).
Croatian: Nije potrebno dodavanje antipsihotika na početku liječenja lijekom ZYPADHERA (vidjeti dio 4.2).
English: Cytochromes P450-CYP1A2 and P450-CYP2D6 contribute to the formation of the N-desmethyl and 2-hydroxymethyl metabolites; both exhibited significantly less in vivo pharmacological activity than olanzapine in animal studies.
Croatian: Citokromi P450-CYP1A2 i P450-CYP2D6 sudjeluju u stvaranju N-desmetil i 2-hidroksimetil metabolita; oba su u ispitivanjima na životinjama iskazala slabiju farmakološku aktivnost in vivo od olanzapina.
English: Only remove the device with the engaged needle from the syringe when required by a specific medical procedure.
Croatian: Skinite iglu sa zaštitnim pokrovom sa štrcaljke tek onda kada je to potrebno zbog određenog medicinskog postupka.
English: However, since patients with schizophrenia often present with acquired risk factors for venous thromboembolism all possible risk factors of VTE e.g. immobilisation of patients, should be identified and preventive measures undertaken.
Croatian: No, budući da bolesnici sa shizofrenijom često imaju stečene čimbenike rizika za nastanak venske tromboembolije, mora se identificirati sve moguće čimbenike rizika za nastanak VTE, npr. imobilizacija bolesnika, i poduzeti preventivne mjere.
English: Three Hypodermic safety needles.
Croatian: Tri hipodermalne zaštićene igle.
English: Very common: Decreased total bilirubin, increased GGT, elevated plasma prolactin levels16.
Croatian: Vrlo često: snižen ukupan bilirubin, povišen GGT, povišene koncentracije prolaktina u plazmi16.
English: Olanzapine reduced a conditioned avoidance response, a test indicative of antipsychotic activity, at doses below those producing catalepsy, an effect indicative of motor side-effects.
Croatian: Olanzapin je smanjio uvjetovani obrambeni odgovor, koji predstavlja test antipsihotičke aktivnosti, u dozama nižim od onih koje izazivaju katalepsiju, učinak koji ukazuje na motoričke nuspojave.
English: During the initial three months of treatment with ZYPADHERA, accumulation of olanzapine was observed but there was no additional accumulation during long-term use (12 months) in patients who were injected with up to 300 mg every two weeks.
Croatian: ZYPADHERA opaženo je nakupljanje olanzapina, ali nije bilo dodatnog nakupljanja tijekom dugotrajne uporabe (12 mjeseci) u bolesnika kojima je ubrizgano do 300 mg svaka dva tjedna.
English: Reconstituted ZYPADHERA remains stable for up to 24 hours in the vial.
Croatian: Rekonstituiran lijek ZYPADHERA je stabilan tijekom 24 sata u bočici.
English: Caution should be exercised in patients who receive medicinal products that can induce hypotension or sedation.
Croatian: Mora se s oprezom postupati u bolesnika koji primaju lijekove koji mogu izazvati hipotenziju ili sedaciju.
English: Loosen the powder by lightly tapping the vial.
Croatian: Rastresite prašak lagano lupkajući bočicu.
English: Post-injection syndrome
Croatian: Postinjekcijski sindrom
English: The effectiveness of ZYPADHERA in the treatment and maintenance treatment of schizophrenia is consistent with the established effectiveness of the oral formulation of olanzapine.
Croatian: Učinkovitost lijeka ZYPADHERA u liječenju i terapiji održavanja shizofrenije je konzistentna s utvrđenom djelotvornošću oralne formulacije olanzapina.
English: New-born infants exposed to antipsychotics (including olanzapine) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
Croatian: Novorođenčad izložena antipsihoticima (uključujući olanzapin) tijekom trećeg tromjesečja trudnoće ima rizik od nastanka nuspojava, uključujući ekstrapiramidne simptome i/ili simptome ustezanja, koji mogu varirati u težini i trajanju nakon poroda.
English: The clinical consequences are likely to be limited, but clinical monitoring is recommended and an increase of olanzapine dose may be considered if necessary (see section 4.2).
Croatian: Kliničke posljedice su vjerojatno ograničene, ali se ipak preporučuje kliničko praćenje, a po potrebi se može razmotriti i povišenje doze olanzapina (vidjeti dio 4.2).
English: Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia).
Croatian: Kliničke manifestacije MNS-a su hiperpireksija, rigidni mišići, promjene mentalnog statusa i znakovi nestabilnosti autonomnog živčanog sustava (nepravilan puls ili krvni tlak, tahikardija, diaforeza i srčana aritmija).
English: These results support efficacy for ZYPADHERA over 8 weeks of treatment and a drug effect that was observed as early as 1 week after starting treatment with ZYPADHERA.
Croatian: Ovi rezultati govore u prilog djelotvornosti lijeka ZYPADHERA tijekom 8 tjedana liječenja i pokazuju nastup učinka lijeka nakon tjedan dana od početka liječenja lijekom ZYPADHERA.
English: Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e.g. 1A2, 2D6, 2C9, 2C19, 3A4).
Croatian: Olanzapin in vitro ne inhibira glavne izoenzime CYP450 (npr. 1A2, 2D6, 2C9, 2C19, 3A4).
English: No new toxic effect resulting from systemic exposure to olanzapine could be identified.
Croatian: Nisu uočeni novi toksični učinci proizašli iz sistemske izloženosti olanzapinu.
English: Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo-controlled clinical trials (see section 4.8).
Croatian: Neželjene promjene vrijednosti lipida primijećene su u bolesnika liječenih olanzapinom u placebom kontroliranim kliničkim ispitivanjima (vidjeti dio 4.8).
English: All oral olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
Croatian: Svi bolesnici liječeni oralnim oblikom olanzapina i oni koji su primali placebo, a koji su razvili cerebrovaskularne događaje, imali su od ranije prisutne čimbenike rizika.
English: While overdose is less likely with parenteral than oral medicinal products, reference information for oral olanzapine overdose is presented below:
Croatian: Iako je predoziranje manje vjerojatno kod primjene parenteralnog nego oralnog oblika lijeka, u nastavku su prikazane referentne informacije o predoziranju oralnim oblikom olanzapina:
English: Hepatitis (including hepatocellular, cholestatic or mixed liver injury)11
Croatian: (uključujući hepatocelularno, kolestatsko ili miješano oštećenje jetre)11
English: Controlled efficacy data in adolescents (ages 13 to 17 years) are limited to short term oral olanzapine studies in schizophrenia (6 weeks) and mania associated with bipolar I disorder (3 weeks), involving less than 200 adolescents.
Croatian: Podaci o djelotvornosti iz kontroliranih ispitivanja u adolescenata (u dobi od 13 do 17 godina) ograničeni su na ispitivanja kratkotrajne primjene oralnog oblika olanzapina u shizofreniji (6 tjedana) i maniji povezanoj s bipolarnim poremećajem tipa 1 (3 tjedna) u koja je uključeno manje od 200 adolescenata.
English: Immediately prior to leaving the health care facility, it should be confirmed that the patient is alert, oriented, and absent of any signs and symptoms of overdose.
Croatian: Neposredno prije otpusta iz zdravstvene ustanove mora se potvrditi da je bolesnik priseban, orijentiran i da nema znakova ni simptoma predoziranja.
English: Other medically significant sequelae of overdose include delirium, convulsion, coma, possible neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension, cardiac arrhythmias (< 2% of overdose cases) and cardiopulmonary arrest.
Croatian: Ostale medicinski značajne posljedice predoziranja su delirij, konvulzije, koma, mogući maligni neuroleptički sindrom, depresija disanja, aspiracija, hipertenzija ili hipotenzija, srčane aritmije (< 2% slučajeva predoziranja) i kardiopulmonalni arest.
English: After a single IM injection with ZYPADHERA the slow dissolution of the olanzapine pamoate salt in muscle tissue begins immediately and provides a slow continuous release of olanzapine for more than four weeks.
Croatian: Nakon jedne intramuskularne injekcije lijeka ZYPADHERA polagano otapanje soli olanzapin pamoata u mišićnom tkivu započinje odmah i osigurava polagano kontinuirano oslobađanje olanzapina kroz više od 4 tjedna.
English: Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines, e.g. measuring of blood glucose at baseline, 12 weeks after starting olanzapine treatment and annually thereafter.
Croatian: Preporučuje se prikladan klinički nadzor u skladu sa smjernicama za primjenu antipsihotika, npr. mjerenje glukoze u krvi na početku, 12 tjedana nakon početka terapije olanzapinom i nakon toga jednom godišnje.
English: • aggression
Croatian: • agresivnost
English: Olanzapine is metabolised in the liver by conjugative and oxidative pathways.
Croatian: Olanzapin se metabolizira u jetri konjugacijom i oksidacijom.
English: Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Croatian: Olanzapin nije indiciran u liječenju djece i adolescenata mlađih od 18 godina.
English: In most of these cases, a history of seizures or risk factors for seizures were reported.
Croatian: U većini takvih slučajeva su u anamnezi postojali navodi o napadajima ili čimbenicima rizika za njihov nastanak.
English: In a retrospective observational cohort study, the risk of presumed sudden cardiac death in patients treated with olanzapine was approximately twice the risk in patients not using antipsychotics.
Croatian: U retrospektivnom opservacijskom kohortnom ispitivanju pretpostavljeno je da je rizik od iznenadne srčane smrti dvostruko veći u bolesnika liječenih olanzapinom od onog u bolesnika koji nisu liječeni antipsihoticima.
English: Weight should be monitored regularly, e.g. at baseline, 4, 8 and 12 weeks after starting olanzapine treatment and quarterly thereafter.
Croatian: Također se mora redovito kontrolirati tjelesnu težinu, npr. na početku, 4, 8 i 12 tjedana nakon početka terapije olanzapinom, a nakon toga tromjesečno.
English: Warnings and precautions Talk to your doctor or nurse before you are given ZYPADHERA
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije nego primite lijek ZYPADHERA.
English: Fatal outcomes have been reported for acute oral overdoses as low as 450 mg but survival has also been reported following acute overdose of approximately 2 g of oral olanzapine.
Croatian: Smrtni ishodi kod akutnog oralnog predoziranja bilježe se već pri dozama od 450 mg, međutim bilo je slučajeva preživljavanja i kod akutnog predoziranja dozama od približno 2 g oralnog olanzapina.
English: During treatment with olanzapine in combination with lithium or divalproex, an increase of ≥ 7% from baseline body weight occurred in 17.4% of patients during acute treatment (up to 6 weeks).
Croatian: Tijekom liječenja olanzapinom u kombinaciji s litijem ili divalproeksom primijećen je porast tjelesne težine za ≥ 7% u odnosu na početnu tjelesnu težinu u 17,4% bolesnika tijekom akutnog liječenja (do 6 tjedana).
English: In monkeys, single oral doses up to 100 mg/kg resulted in prostration and, at higher doses, semi-consciousness.
Croatian: U majmuna je primjena jednokratne oralne doze do 100 mg/kg rezultirala prostracijom, a pri višim dozama djelomičnim gubitkom svijesti.
English: If signs and symptoms of overdose consistent with post injection syndrome are observed, appropriate supportive measures should be taken (see section 4.4).
Croatian: Ako se uoče znakovi i simptomi predoziranja koji odgovaraju postinjekcijskom sindromu, moraju se poduzeti odgovarajuće suportivne mjere (vidjeti dio 4.4).
English: Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Croatian: Mogućnost utjecaja olanzapina na druge lijekove Olanzapin može antagonizirati učinke direktnih i indirektnih agonista dopamina.
English: Long-term olanzapine treatment (up to 12 months) for recurrence prevention in patients with bipolar disorder was associated with an increase of ≥7% from baseline body weight in 39.9% of patients.
Croatian: Dugotrajno liječenje olanzapinom (do 12 mjeseci) u svrhu prevencije rekurentnih epizoda u bolesnika s bipolarnim poremećajem bilo je povezano s porastom tjelesne težine za ≥ 7% u odnosu na početnu tjelesnu težinu u 39,9% bolesnika.
English: Seat the needle firmly on the device with a push and a clockwise twist, then pull the needle cap straight away from the needle.
Croatian: Namjestite iglu čvrsto na štrcaljku pritišćući je i okrećući u smjeru kazaljke na satu, a zatim povlačenjem ravno skinite kapicu s igle.
English: Reactions occurred rarely (<1 in 1,000 injections) between 1 and 3 hours, and very rarely (<1 in 10,000 injections) after 3 hours.
Croatian: Nuspojave su se javljale rijetko (< 1 na 1000 injekcija) unutar 1-3 sata, a vrlo rijetko (< 1 na
English: Clinically significant weight gain (≥ 7%) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
Croatian: Izgleda da se klinički značajan porast tjelesne težine (≥ 7%) javlja češće u adolescenata nego u odraslih približno podjednako izloženih lijeku.
English: Dementia-related psychosis and/or behavioural disturbances Olanzapine is not recommended for use in patients with dementia-related psychosis and/or behavioural disturbances because of an increase in mortality and the risk of cerebrovascular accident.
Croatian: Primjena olanzapina ne preporučuje se u bolesnika s psihozom povezanom s demencijom i/ili poremećajima ponašanja zbog povećane smrtnosti i rizika od cerebrovaskularnog incidenta.
English: In one clinical trial in patients with bipolar mania, valproate combination therapy with olanzapine resulted in an incidence of neutropenia of 4.1%; a potential contributing factor could be high plasma valproate levels.
Croatian: U jednom kliničkom ispitivanju u koje su bili uključeni bolesnici s bipolarnom manijom kombinacija valproata s olanzapinom rezultirala je incidencijom neutropenije od 4,1%; čimbenik koji je potencijalno mogao tome doprinijeti bila je visoka koncentracija valproata u plazmi.