FrancophonIA/ELRC3.0 huggingface dataset:
English: de la Industria 30, 28108 Alcobendas, Madrid, Spain.
Croatian: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Španjolska.
English: Based on the results of oral studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Croatian: Temeljem rezultata ispitivanja oralnih pripravaka na miševima i štakorima zaključeno je da olanzapin nije kancerogen.
English: • Tell the doctor or nurse if you feel dizzy or faint after the injection.
Croatian: • Obavijestite svog liječnika ili medicinsku sestru ako osjetite omaglicu ili nesvjesticu nakon injekcije.
English: Speech disorder was also reported commonly.
Croatian: Često je bio prijavljen i poremećaj govora.
English: You and your doctor should check your weight regularly.
Croatian: Morate pod nadzorom liječnika redovito kontrolirati tjelesnu težinu.
English: Do not use epinephrine, dopamine, or other sympathomimetic agents with beta-agonist activity since beta stimulation may worsen hypotension.
Croatian: Ne davati epinefrin, dopamin ili druge simpatikomimetike s beta-agonističkom aktivnošću jer beta stimulacija može pogoršati hipotenziju.
English: Tolerance developed to the CNS depression.
Croatian: Na depresiju SŽS-a se razvila tolerancija.
English: Although unlikely, you may get the symptoms more than 3 hours after the injection.
Croatian: Iako je malo vjerojatno, ovi simptomi se mogu pojaviti i nakon više od 3 sata poslije injekcije.
English: Close medical supervision and monitoring should continue until the patient recovers.
Croatian: Pojačan medicinski nadzor i praćenje mora se nastaviti sve dok se bolesnik ne oporavi.
English: The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
Croatian: Viša incidencija smrti nije bila povezana s dozom olanzapina (prosječna dnevna doza 4,4 mg) niti trajanjem liječenja.
English: − Promote awareness of appropriate metabolic monitoring by distributing utilized published antipsychotic guidelines
Croatian: Promicati svjesnost o odgovarajućem metaboličkom nadzoru raspodjelom korištenih objavljenih antipsihotičnih smjernica.
English: Withdraw the pre-determined solvent volume (Step 2) into the syringe.
Croatian: Izvucite prethodno utvrđeni volumen otapala (korak 2) u štrcaljku.
English: The major circulating metabolite is the 10-N-glucuronide.
Croatian: Glavni metabolit u cirkulaciji je 10-N-glukuronid.
English: The mean increase in olanzapine Cmax following fluvoxamine was 54 % in female nonsmokers and 77 % in male smokers.
Croatian: Srednja vrijednost porasta Cmax olanzapina nakon primjene fluvoksamina bila je 54% u žena nepušača i 77% u muškaraca pušača.
English: These symptoms typically resolve within 24 to 72 hours after your injection.
Croatian: Uobičajeno je da se ovi simptomi povuku unutar 24 do 72 sata nakon injekcije.
English: • unusual movement (a common side effect that may affect up to 1 in 10 people) mainly of the face or tongue;
Croatian: • neuobičajene pokrete (česta nuspojava koja može zahvatiti do 1 na 10 osoba) uglavnom lica i jezika;
English: The efficacy of olanzapine was not established in these trials.
Croatian: Djelotvornost olanzapina u ovim ispitivanjima nije ustanovljena.
English: Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with olanzapine.
Croatian: Bolesnice se mora savjetovati da obavijeste svog liječnika ako zatrudne ili namjeravaju zatrudnjeti tijekom liječenja olanzapinom.
English: Select and prepare a site for injection in the gluteal area.
Croatian: 5. Odredite i pripremite mjesto za injekciju u području gluteusa.
English: Patients who have been given too much olanzapine have also experienced the following symptoms:
Croatian: Bolesnici koji su primili previše olanzapina imali su i sljedeće simptome:
English: Although no clinical studies designed to compare adolescents to adults have been conducted, data from the adolescent trials were compared to those of the adult trials.
Croatian: Iako nisu dizajnirana klinička ispitivanja koja bi uspoređivala adolescente i odrasle, podaci iz ispitivanja s adolescentima uspoređeni su s onima iz ispitivanja s odraslima.
English: In the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position.
Croatian: U ranim fazama liječenja neki će ljudi možda osjećati omaglicu ili nesvjesticu (uz usporen srčani ritam), osobito kad ustaju iz ležećeg ili sjedećeg položaja.
English: • Reconstitution and Administration card (this leaflet)
Croatian: • Uputu za rekonstituciju i primjenu (ovaj letak)
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 20-25°C.
Croatian: Ako se ne upotrijebi odmah, vrijeme čuvanja i uvjeti čuvanja prije primjene odgovornost su korisnika, te oni ne bi smjeli biti dulji od 24 sata na 20-25°C.
English: When more than one factor is present which might result in slower metabolism (female gender, geriatric age, non-smoking status), consideration should be given to decreasing the dose.
Croatian: Kada je prisutan više nego jedan čimbenik koji može djelovati na usporavanje metabolizma (ženski spol, starija dob, nepušenje), mora se razmotriti snižavanje doze.
English: • an allergy (hypersensitivity) to olanzapine or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični (preosjetljivi) na olanzapin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: The most commonly reported injection site related adverse reaction was pain.
Croatian: Najčešće prijavljivana nuspojava na mjestu primjene injekcije bila je bol.
English: Shake the vial vigorously until the suspension appears smooth and is consistent in color and texture.
Croatian: 11. Snažno protresite bočicu dok suspenzija ne postane homogena i konzistentna po boji i teksturi.
English: If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, all antipsychotic medicines, including olanzapine must be discontinued.
Croatian: Ako bolesnik razvije znakove i simptome koji upućuju na MNS ili dobije visoku vrućicu nejasnog uzroka bez dodatnih kliničkih manifestacija MNS-a, mora se odmah prekinuti primjena svih antipsihotika, uključujući olanzapin.
English: Final volume to inject (ml)
Croatian: Konačni volumen za injiciranje (ml)
English: All 3 ZYPADHERA treatment groups showed statistically significantly greater improvement than placebo beginning by end of Week 1.
Croatian: Sve tri skupine liječene lijekom ZYPADHERA pokazale su statistički značajno veće poboljšanje u odnosu na placebo počevši od kraja prvog tjedna.
English: Tell your doctor immediately if you have:
Croatian: Odmah obavijestite svog liječnika ako primijetite:
English: Nevertheless, because human experience is limited, olanzapine should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Croatian: S obzirom na to da je iskustvo u trudnica ograničeno, olanzapin se u trudnoći smije primjenjivati samo onda kada potencijalna korist opravdava potencijalan rizik za plod.
English: Among all ZYPADHERA treated patients, sedation was reported by 4.7% of patients.
Croatian: Od svih bolesnika liječenih lijekom ZYPADHERA sedacija je prijavljena u njih 4,7%.
English: In a study of oral olanzapine given to Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
Croatian: U ispitivanju oralnog olanzapina u ispitanika bijele rase, Japanaca i Kineza, nije bilo razlika u farmakokinetičkim parametrima među navedenim populacijama.
English: The plasma protein binding of olanzapine is about 93% over the concentration range of 7 to about 1000 ng/mL.
Croatian: Vezanje olanzapina na proteine u plazmi iznosi približno 93% u rasponu koncentracija od 7 do približno 1000 ng/ml.
English: Tell your doctor as soon as possible if any of the following applies to you:
Croatian: Obavijestite svog liječnika što je prije moguće ako se nešto od sljedećeg odnosi na Vas:
English: In 44 patients with schizophrenia >65 years of age, dosing from 5 to 20 mg/day was not associated with any distinguishing profile of adverse events.
Croatian: 44 bolesnika sa shizofrenijom starija od 65 godina primjena doze od 5 do 20 mg/dan nije bila povezana s nekim posebnim profilom štetnih događaja.
English: Very common: Sedation (including: hypersomnia, lethargy, somnolence).
Croatian: Vrlo često: sedacija (uključujući hipersomniju, letargiju, somnolenciju).
English: In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 6 months.
Croatian: U odraslih bolesnika koji su liječeni 9-12 mjeseci, stopa povišenja prosječne vrijednosti glukoze u krvi se usporila nakon približno 6 mjeseci.
English: In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects were CNS depression, anticholinergic effects, and peripheral haematological disorders.
Croatian: U ispitivanjima u trajanju do 3 mjeseca na miševima i do jedne godine na štakorima i psima među glavnim učincima su bili depresija SŽS-a, antikolinergički učinci i periferni hematološki poremećaji.
English: Similar pharmacokinetic differences between males and females and smokers and non-smokers were observed in ZYPADHERA clinical trials.
Croatian: Slične farmakokinetičke razlike između muškaraca i žena te pušača i nepušača primijećene su i u kliničkim ispitivanjima lijeka ZYPADHERA.
English: In these trials, patients were initially required to be stable on the lowest effective dose of antiParkinsonian medicinal products (dopamine agonist) and to remain on the same anti-Parkinsonian medicinal products and dosages throughout the study.
Croatian: U navedenim ispitivanjima se zahtijevalo da bolesnici na početku budu stabilni na najnižim učinkovitim dozama lijekova za Parkinsonovu bolest (dopaminski agonisti) te da ostanu na istim antiparkinsonicima i dozama tijekom cijelog trajanja ispitivanja.
English: If you are already taking antidepressants, medicines for anxiety or to help you sleep (tranquillisers), you may feel drowsy if ZYPADHERA is given.
Croatian: Ako već uzimate antidepresive, lijekove za liječenje tjeskobe ili lijekove za pomoć kod uspavljivanja (trankvilizatore), možete se osjećati omamljeno (pospano) nakon primjene lijeka ZYPADHERA.
English: Failure to follow these instructions may result in a needle stick injury.
Croatian: Ako se ne pridržavate ovih uputa, možete se ozlijediti iglom.
English: An education program to the health care professionals (HCP) (doctors-nurses-pharmacist) shall address,
Croatian: Edukacijski program za zdravstvene radnike (liječnike-medicinske sestre-ljekarnike) odnosit će se na, 1)
English: Unlike some other antipsychotic agents, olanzapine increases responding in an “anxiolytic” test.
Croatian: Za razliku od nekih drugih antipsihotika, olanzapin pojačava odgovor na „anksiolitički“
English: Patients should be advised about this potential risk and the need to be observed for 3 hours in a healthcare facility each time ZYPADHERA is administered.
Croatian: Bolesnike se mora upozoriti o tom mogućem riziku i potrebi da budu promatrani u zdravstvenoj ustanovi tijekom 3 sata svaki put nakon primjene lijeka ZYPADHERA.
English: Distribution Oral olanzapine is rapidly distributed.
Croatian: Distribucija oralnog olanzapina je brza.
English: ZYPADHERA has not been studied in the paediatric population.
Croatian: ZYPADHERA nije ispitivana u pedijatrijskoj populaciji.
English: Fertility Effects on fertility are unknown (see section 5.3 for preclinical information)
Croatian: Nisu poznati učinci na plodnost (vidjeti dio 5.3 za pretkliničke podatke).
English: Anticholinergic activity
Croatian: Antikolinergička aktivnost
English: ZYPADHERA comes as a powder which your doctor or nurse will make into a suspension that will then be injected into the muscle in your buttock.
Croatian: ZYPADHERA dolazi u obliku praška od kojeg će Vaš liječnik ili medicinska sestra pripremiti suspenziju koja će Vam se potom injicirati u mišić stražnjice.
English: Maintenance dose after 2 months of ZYPADHERA treatment
Croatian: Doza održavanja nakon 2 mjeseca liječenja lijekom ZYPADHERA
English: • been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
Croatian: • ako od ranije imate dijagnosticirane tegobe s očima kao što su određeni oblici glaukoma (povišenog očnog tlaka).
English: These signs and symptoms can sometimes occur as a result of ZYPADHERA entering the bloodstream too quickly (a common side effect that may affect up to1 in10 people);
Croatian: Ovi znakovi i simptomi se ponekad mogu javiti kao rezultat prebrzog ulaska lijeka ZYPADHERA u krvotok (česta nuspojava koja može zahvatiti do 1 na 10 osoba);
English: There are no controlled data on maintenance of effect or long term safety (see sections 4.4 and 4.8).
Croatian: Nema podataka iz kontroliranih ispitivanja o održavanju učinka niti o sigurnosti tijekom dugotrajne primjene (vidjeti dijelove 4.4 i
English: In the majority of these patients the elevations were generally mild, and remained below two times the upper limit of normal range.
Croatian: U većine ovih bolesnika povišenja su uglavnom bila blaga te nisu prelazila dvostruku vrijednost gornje granice normalnog raspona.
English: As olanzapine may cause somnolence and dizziness, patients should be cautioned about operating machinery, including motor vehicles.
Croatian: Budući da olanzapin može izazvati somnolenciju i omaglicu, bolesnike se mora upozoriti na oprez prilikom rada sa strojevima, uključujući upravljanje vozilima.
English: After reconstitution in the vial: 24 hours.
Croatian: Nakon rekonstitucije u bočici: 24 sata.
English: In a review of safety data from clinical trials and spontaneous postmarketing reports, injection site abscess was rarely (≥ 1/10,000 to < 1/1,000) reported.
Croatian: U analizi podataka o sigurnosti lijeka iz kliničkih ispitivanja te spontanih prijava nakon stavljanja lijeka u promet, apsces na mjestu injekcije prijavljen je rijetko (≥ 1/10 000 i < 1/1000).
English: It is recommended that gloves are used as ZYPADHERA may irritate the skin.
Croatian: Preporučuje se koristiti rukavice jer ZYPADHERA može uzrokovati nadražaj kože.
English: • Hypodermic Device Safety Information and Instructions for Use leaflet
Croatian: • Sigurnosne informacije i upute za uporabu hipodermalne naprave
English: In cases of moderate hepatic insufficiency (cirrhosis, Child-Pugh Class A or B), the starting dose should be 150 mg every 4 weeks and only increased with caution.
Croatian: U slučajevima umjerene jetrene insuficijencije (ciroza, Child-Pugh stupanj A ili B) početna doza mora biti 150 mg svaka 4 tjedna, a povisiti se smije samo uz oprez.
English: Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and oral in vivo mammalian tests.
Croatian: Olanzapin nije pokazao mutagenost niti klastogenost u cijelom rasponu standardnih testova, koji su uključivali testove bakterijskih mutacija te in vitro i in vivo testove oralno primijenjenog olanzapina na sisavcima.
English: During treatment with oral olanzapine, adolescents gained significantly more weight compared with adults.
Croatian: Tijekom liječenja oralnim oblikom olanzapina adolescenti su dobili na težini značajno više nego odrasli.
English: Electrophysiological studies demonstrated that olanzapine selectively reduced the firing of mesolimbic (A10) dopaminergic neurons, while having little effect on the striatal (A9) pathways involved in motor function.
Croatian: Elektrofiziološka ispitivanja pokazala su da olanzapin selektivno smanjuje izbijanje mezolimbičkih (A10) dopaminergičkih neurona, uz vrlo mali učinak na strijatalne putove (A9) uključene u motoričku funkciju.
English: It is important that you carry on receiving ZYPADHERA for as long as your doctor has told you to.
Croatian: Važno je primati lijek ZYPADHERA onoliko dugo koliko Vaš liječnik odredi.
English: Due to the slow dissolution of the olanzapine pamoate salt which provides a slow continuous release of olanzapine that is complete approximately six to eight months after the last injection, supervision by a clinician, especially during the first 2 months after discontinuation of ZYPADHERA, is needed when switching to another antipsychotic product and is considered medically appropriate.
Croatian: Zbog sporijeg otapanja soli olanzapin pamoata, koje osigurava polagano kontinuirano oslobađanje olanzapina tijekom približno šest do osam mjeseci nakon posljednje injekcije, potreban je nadzor kliničara pri prelasku na drugi antipsihotik i smatra se medicinski prikladnim, posebice tijekom prva 2 mjeseca nakon prekida primjene lijeka ZYPADHERA.
English: The magnitude of weight gain and the proportion of adolescent patients who had clinically significant weight gain were greater with long-term exposure (at least 24 weeks) than with short-term exposure.
Croatian: Raspon porasta tjelesne težine i udio adolescentnih bolesnika s klinički značajnim porastom tjelesne težine bili su veći kod dugotrajne izloženosti lijeku (barem 24 tjedna), nego kod kratkotrajne izloženosti.
English: No oral antipsychotic supplementation was allowed.
Croatian: Nije bilo dopušteno dodavanje oralnih antipsihotika.
English: While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Croatian: Iako je olanzapin iskazao antikolinergičku aktivnost in vitro, iskustvo tijekom kliničkih ispitivanja pokazalo je nisku incidenciju takvih događaja.
English: If this happens after you have been given ZYPADHERA, tell your doctor or nurse immediately.
Croatian: Ako se to dogodi nakon što ste primili lijek ZYPADHERA, odmah o tome izvijestite svog liječnika ili medicinsku sestru.
English: unstable angina or low blood pressure
Croatian: (abnormalni srčani ritmovi), nestabilnu anginu ili niski krvni tlak
English: Because of this risk, do not drive or operate machinery for the remainder of the day after each injection.
Croatian: Zbog rizika od nastanka ovih simptoma nemojte voziti niti upravljati strojevima tijekom ostatka dana nakon svake injekcije.
English: In cases where hepatitis (including hepatocellular, cholestatic or mixed liver injury) has been diagnosed, olanzapine treatment should be discontinued.
Croatian: U slučajevima dijagnosticiranog hepatitisa (uključujući hepatocelularno, kolestatsko ili miješano oštećenje jetre) mora se prekinuti liječenje olanzapinom.
English: When indicated, dose escalation should be performed with caution in these patients.
Croatian: U slučaju indiciranosti, u ovih bolesnika mora se s oprezom povisivati dozu.
English: Very common: Elevations of hepatic aminotransferases (ALT/AST; see section 4.4).
Croatian: Vrlo često: povišenja jetrenih aminotransferaza (ALT/AST; vidjeti dio 4.4).
English: Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
Croatian: Terapijsko praćenje koncentracije valproata u plazmi nije ukazivalo na potrebu prilagodbe doze valproata nakon uvođenja istodobne primjene olanzapina.
English: Exacerbation was measured by worsening of items on the PANSS derived BPRS Positive scale and hospitalization due to worsening of positive psychotic symptoms.
Croatian: Egzacerbacija je mjerena tako da se određivalo pogoršanje pojedinih stavki na BPRS pozitivnoj ljestvici utemeljenoj na PANSS-u i broju hospitalizacija zbog pogoršanja pozitivnih psihotičnih simptoma.
English: Patients with known risk of narrow-angle glaucoma.
Croatian: Bolesnici s poznatim rizikom od glaukoma uskog kuta.
English: What you need to know before you are given ZYPADHERA
Croatian: Što morate znati prije nego počnete primati lijek ZYPADHERA
English: In patients with Parkinson's disease oral olanzapine may worsen the symptoms.
Croatian: Kod bolesnika koji boluju od Parkinsonove bolesti oralni olanzapin može dovesti do pogoršanja simptoma.
English: • carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your ZYPADHERA dose.
Croatian: - karbamazepin (antiepileptik i stabilizator raspoloženja), fluvoksamin (antidepresiv) ili ciprofloksacin (antibiotik) - jer će možda biti potrebno promijeniti dozu lijeka ZYPADHERA.
English: Remove by grasping the Luer hub of the needle protection device with thumb and forefinger, keeping the free fingers clear of the end of the device containing the needle point (Fig. 3).
Croatian: Uklonite iglu sa zaštitnim pokrovom stišćući Luer kapu palcem i kažiprstom, držeći slobodne prste podalje od onog kraja pribora na kojem se nalazi vrh igle (Slika 3).
English: Mean infant exposure (mg/kg) at steady state was estimated to be 1.8% of the maternal olanzapine dose (mg/kg).
Croatian: Procijenjeno je da bi prosječna izloženost dojenčadi (mg/kg) u stanju dinamičke ravnoteže iznosila 1,8% doze olanzapina majke (mg/kg).
English: common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the data available).
Croatian: manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The first, an 8-week, placebo controlled trial conducted in adult patients (n=404) who were experiencing acute psychotic symptoms.
Croatian: Prvo, u trajanju od 8 tjedana, je placebom kontrolirano ispitivanje na odraslim bolesnicima (n=404) sa simptomima akutne psihoze.
English: The following table lists the adverse reactions and laboratory investigations observed from spontaneous reporting and in clinical trials.
Croatian: Sljedeća tablica prikazuje nuspojave i laboratorijske nalaze prikupljene spontanim prijavljivanjem ili iz kliničkih ispitivanja.
English: The safety and efficacy of ZYPADHERA in children and adolescents below 18 years has not been established.
Croatian: Pedijatrijska populacija Sigurnost i djelotvornost lijeka ZYPADHERA u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: In plasma, olanzapine is bound to albumin and α1-acid glycoprotein.
Croatian: Olanzapin se u plazmi veže na albumin i na α1kiseli-glikoprotein.
English: However the risk of tardive dyskinesia increases with long term exposure, and therefore if signs or symptoms of tardive dyskinesia appear in a patient on olanzapine, a dose reduction or discontinuation should be considered.
Croatian: Ipak, rizik od nastanka tardivne diskinezije povećava se s dugotrajnom izloženošću lijeku i zbog toga se, u slučaju pojave znakova ili simptoma tardivne diskinezije u bolesnika na olanzapinu, mora razmisliti o sniženju doze ili prekidu liječenja.
English: In the absence of detailed information on the pre-existing history of individual acute and tardive extrapyramidal movement disorders, it cannot be concluded at present that olanzapine produces less tardive dyskinesia and/or other tardive extrapyramidal syndromes.
Croatian: U nedostatku detaljnijih informacija o ranije postojećim akutnim i tardivnim ekstrapiramidnim poremećajima u pojedinih bolesnika za sada se ne može zaključiti da olanzapin uzrokuje manje tardivnih diskinezija i/ili drugih tardivnih ekstrapiramidnih sindroma.
English: In cytopenic dogs, there were no undesirable effects on progenitor and proliferating cells in the bone marrow.
Croatian: U citopeničnih pasa nije bilo štetnih učinaka na matične i proliferirajuće stanice u koštanoj srži.
English: If this happens, contact your doctor or nurse immediately.
Croatian: Ako se to dogodi, odmah kontaktirajte svog liječnika ili medicinsku sestru.
English: Discard the vials, syringe, used needles, extra needle and any unused solvent in accordance with appropriate clinical procedures.
Croatian: Uklonite bočicu, štrcaljku, iskorištene igle, dodatnu iglu i neiskorišteno otapalo u skladu s primjerenim kliničkim postupcima.