FrancophonIA/ELRC3.0 huggingface dataset:
English: Try to take your tablets at the same time each day.
Slovenian: Tablete poskušajte jemati vsak dan ob isti uri.
English: Some fatal cases have been reported in this particular group of patients.
Slovenian: Poročali so o nekaj smrtnih izidih pri tej skupini bolnikov.
English: Such factors possibly contribute to the higher average exposure observed in adolescents.
Slovenian: Možno je, da taki dejavniki vplivajo na večjo povprečno izpostavljenost, ki so jo opazili pri mladostnikih.
English: Show the doctor your pack of tablets.
Slovenian: Zdravniku pokažite svojo škatlo tablet.
English: Your doctor may suggest you to reduce the dose gradually before stopping treatment.
Slovenian: Vaš zdravnik vam bo morda predlagal postopno zmanjševanje odmerka, preden bo ukinil zdravilo.
English: No studies on the effects on the ability to drive and use machines have been performed.
Slovenian: Raziskave o vplivu na sposobnost za vožnjo in upravljanje strojev niso bile narejene.
English: In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
Slovenian: Pri nekaterih bolnikih so poročali o predhodnem povečanju telesne mase, kar bi lahko bil predisponirajoči dejavnik.
English: Do not stop taking your tablets just because you feel better.
Slovenian: Ne prenehajte jemati tablet, čeprav se počutite bolje.
English: These symptoms can temporally deteriorate or even arise after discontinuation of treatment.
Slovenian: Simptomi se lahko sčasoma poslabšajo, lahko pa se pojavijo celo po prenehanju zdravljenja.
English: Unlike some other antipsychotic agents, olanzapine increases responding in an “anxiolytic” test.
Slovenian: Za razliko od nekaterih drugih antipsihotikov olanzapin poveča odzivanje v "anksiolitičnem" testu.
English: However, olanzapine (5-20 mg) demonstrated a comparable safety profile in female (n=467) as in male patients (n=869).
Slovenian: Vendar je olanzapin (5 do 20 mg) pokazal primerljiv profil varnosti tako pri bolnicah (n=467) kot pri bolnikih (n=869).
English: Olanzapine had no teratogenic effects.
Slovenian: Olanzapin ni povzročal teratogenih učinkov.
English: There are no controlled data on maintenance of effect or long term safety (see sections 4.4 and 4.8).
Slovenian: Nadzorovanih podatkov o vzdrževalnem učinku ali podatkov o dolgoročni varnosti ni (gl. poglavji 4.4 in 4.8).
English: As a routine precaution, if you are over 65 years your blood pressure may be monitored by your doctor.
Slovenian: Če ste stari več kot 65 let, vam lahko vaš osebni zdravnik nadzoruje krvni tlak.
English: It does not matter whether you take them with or without food.
Slovenian: Zaužijete jih lahko s hrano ali brez nje.
English: It is recommended that blood pressure is measured periodically in patients over 65 years.
Slovenian: Pri starejših od 65 let je zato priporočeno redno merjenje krvnega tlaka.
English: Do not use epinephrine, dopamine, or other sympathomimetic agents with betaagonist activity since beta stimulation may worsen hypotension.
Slovenian: Ne uporabljajte adrenalina, dopamina ali drugih simpatikomimetikov z betaagonističnim delovanjem, ker lahko beta stimulacija poslabša hipotenzijo.
English: If you suffer from dementia, you or your carer/relative should tell your doctor if you have ever had a stroke or “mini” stroke.
Slovenian: Če ste bolnik z demenco, morate vi ali vaš skrbnik/sorodnik povedati vašemu zdravniku, če ste kdaj doživeli možgansko kap ali "majhno" možgansko kap.
English: - If you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
Slovenian: - če so vam v preteklosti ugotovili težave z očmi, npr. določeno vrsto glavkoma (zvišan očesni tlak).
English: If you forget to take Zalasta Take your tablets as soon as you remember.
Slovenian: Če ste tablete pozabili vzeti, jih vzemite takoj, ko se spomnite.
English: Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.
Slovenian: Olanzapin je učinkovit za vzdrževanje kliničnega izboljšanja pri nadaljevanju zdravljenja bolnikov, pri katerih je prišlo do začetnega odziva na zdravljenje.
English: The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
Slovenian: Večja smrtnost ni bila povezana z odmerkom olanzapina (povprečni dnevni odmerek je bil 4,4 mg) ali trajanjem zdravljenja.
English: The pharmacokinetic variability observed in the elderly is within the range for the non-elderly.
Slovenian: Farmakokinetična variabilnost, opažena pri starejših, je v okvirih razpona za mlajše.
English: In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 6 months.
Slovenian: Pri odraslih bolnikih, ki so končali 9- do 12-mesečno zdravljenje, se je povečevanje povprečnih vrednosti glukoze v krvi upočasnilo po približno 6 mesecih.
English: Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Zalasta and regularly during treatment.
Slovenian: Vaš zdravnik mora opraviti krvni test za preiskavo sladkorja v krvi in nivo določenih maščob pred začetkom jemanja zdravila Zalasta in redno tekom zdravljenja.
English: Do not take Zalasta - If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Zalasta: - če ste alergični na olanzapin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: The median lethal doses were approximately 210 mg/kg (mice) and 175 mg/kg (rats).
Slovenian: Srednji letalni odmerki so bili približno 210 mg/kg za miši in 175 mg/kg za podgane.
English: In a study of Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
Slovenian: Raziskava, v kateri so sodelovali belci, Japonci in Kitajci, ni pokazala razlik v farmakokinetičnih parametrih.
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.
Slovenian: Te spremembe je treba klinično ustrezno zdraviti, zlasti pri bolnikih z dislipidemijo in bolnikih z dejavniki tveganja za razvoj motenj lipidov.
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.
Slovenian: Pri 44 bolnikih s shizofrenijo, starejših od 65 let, odmerjanje od 5 do 20 mg/dan ni pokazalo razlike v profilu neželenih učinkov.
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.
Slovenian: Posebnih kliničnih raziskav, v katerih bi primerjali mladostnike in odrasle, niso izvedli, so pa podatke iz preizkušanj na mladostnikih primerjali s podatki iz preizkušanj na odraslih.
English: A mass balance study showed that approximately 57% of radiolabelled olanzapine appeared in urine, principally as metabolites.
Slovenian: Raziskava ravnovesja snovi je pokazala, da se približno 57 % radioaktivno označenega olanzapina pojavi v urinu, predvsem v obliki presnovkov.
English: Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
Slovenian: Pri bolnikih, ki pijejo alkohol ali jemljejo zdravila, ki lahko povzročijo depresijo osrednjega živčevja, je potrebna previdnost.
English: Fatal outcomes have been reported for acute overdoses as low as 450 mg but survival has also been reported following acute overdose of approximately 2 g of oral olanzapine.
Slovenian: Poročali so o smrtnih izidih po akutnih prevelikih odmerjanjih tako majhnih odmerkov, kot je 450 mg, vendar so poročali tudi o preživetju po akutnem prevelikem odmerjanju z odmerkom približno 2 g peroralnega olanzapina.
English: If this has happened to you, tell your doctor.
Slovenian: Če se vam je zgodilo kaj takega, povejte svojemu zdravniku).
English: Elevated plasma prolactin levels were reported in 47.4% of adolescent patients.
Slovenian: O povečanih plazemskih koncentracijah prolaktina so poročali pri 47,4 % mladostnikov.
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 starting dose.
Slovenian: Če je prisoten več kot en dejavnik, ki bi lahko prispeval k počasnejši presnovi (ženski spol, starostnik, nekadilec), pretehtajte, ali je treba zmanjšati začetni odmerek.
English: Aspartame
Slovenian: Aspartam
English: Olanzapine can be given without regards for meals as absorption is not affected by food.
Slovenian: Bolniki lahko jemljejo olanzapin ne glede na obroke, ker hrana ne vpliva na absorpcijo.
English: Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with olanzapine.
Slovenian: Bolnicam je treba svetovati, naj obvestijo svojega zdravnika, če med zdravljenjem z olanzapinom zanosijo ali če nameravajo zanositi.
English: Induction of CYP1A2
Slovenian: Zaviranje CYP1A2
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.
Slovenian: Psihoza, povezana z demenco, in/ali vedenjske motnje Olanzapin ni priporočljiv za uporabo pri bolnikih s psihozo, povezano z demenco, in/ali vedenjskimi motnjami zaradi povečane umrljivosti in tveganja za možganskožilne dogodke.
English: Równoległa 5, 02-235 Warszawa, Poland TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Slovenian: Równoległa 5, 02-235 Warszawa, Poljska TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Nemčija
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: Demographic differences between the adolescents and adults include a lower average body weight and fewer adolescents were smokers.
Slovenian: Pri mladostnikih je bila povprečna telesna masa manjša, manj mladostnikov je bilo kadilcev.
English: The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
Slovenian: Plazemski očistek olanzapina je bil manjši pri starejših v primerjavi z mlajšimi, pri ženskah v primerjavi z moškimi in pri nekadilcih v primerjavi s kadilci.
English: In cytopenic dogs, there were no adverse effects on progenitor and proliferating cells in the bone marrow.
Slovenian: Pri psih s citopenijo ni bilo neželenih učinkov na progenitorne in proliferirajoče celice v kostnem mozgu.
English: In two of two placebo and two of three comparator controlled trials with over 2,900 schizophrenic patients presenting with both positive and negative symptoms, olanzapine was associated with statistically significantly greater improvements in negative as well as positive symptoms.
Slovenian: Pri dveh od dveh s placebom kontroliranih in dveh od treh primerjalno kontroliranih preizkušanjih na več kot 2900 bolnikih s shizofrenijo, ki so imeli tako pozitivne kot negativne simptome, je olanzapin statistično značilno izboljšal negativne in tudi pozitivne simptome.
English: Neuroleptic malignant syndrome (see section 4.4) Discontinuation symptoms
Slovenian: Nevroleptični maligni sindrom (glejte poglavje 4.4) Odtegnitveni simptomi
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.
Slovenian: Elektrofiziološke raziskave so pokazale, da je olanzapin selektivno zmanjšal proženje mezolimbičnih (A10) dopaminergičnih nevronov, medtem ko je imel majhen učinek na striatne (A9) poti, vpletene v motorično delovanje.
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.
Slovenian: Ker pa so pri bolnikih s shizofrenijo pogosto prisotni pridobljeni dejavniki tveganja za VTE, je treba ugotoviti vse možne dejavnike tveganja za VTE (npr. imobilizacija bolnikov) ter preventivno ukrepati.
English: If a new manic, mixed, or depressive episode occurs, olanzapine treatment should be continued (with dose optimisation as needed), with supplementary therapy to treat mood symptoms, as clinically indicated.
Slovenian: Če se pojavi nova manična, mešana ali depresivna epizoda, je treba zdravljenje z olanzapinom nadaljevati (po potrebi s prilagajanjem odmerka) hkrati z dopolnilno terapijo za zdravljenje simptomov razpoloženja, kot je klinično indicirano.
English: Very rare side effects include serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Slovenian: Zelo redki neželeni učinki vključujejo resne alergijske reakcije, kot je reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms).
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.
Slovenian: Obseg povečanja telesne mase in delež mladostnikov, pri katerih se je telesna masa klinično značilno povečala, sta bila pri dolgotrajni izpostavljenosti (najmanj 24 tednov) večja kot pri kratkotrajni.
English: Urinary incontinence, urinary retention Urinary hesitation
Slovenian: Urinska inkontinenca, zastajanje urina
English: Manic episode: The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section 5.1).
Slovenian: Manična epizoda: Začetni odmerek je 15 mg v enkratnem dnevnem odmerku pri monoterapiji ali 10 mg na dan pri kombiniranem zdravljenju (gl. poglavje 5.1).
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.
Slovenian: V raziskavah, ki so pri miših trajale do tri mesece, pri podganah in psih pa do eno leto, so prevladovali depresija osrednjega živčevja, antiholinergični učinki in periferne hematološke motnje.
English: During treatment for schizophrenia, manic episode and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5-20 mg/day.
Slovenian: Med zdravljenjem shizofrenije in manične epizode in med preprečevanjem ponovitve bipolarne motnje lahko dnevni odmerek glede na individualno klinično stanje kasneje povečujete po 5 do 20 mg na dan.
English: The efficacy of olanzapine was not established in these trials.
Slovenian: V teh preizkušanjih niso ugotavljali učinkovitosti olanzapina.
English: Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
Slovenian: Terapevtsko spremljanje plazemskih koncentracij valproata ni pokazalo, da bi bilo treba po uvedbi sočasnega zdravljenja z olanzapinom prilagoditi odmerek valproata.
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.
Slovenian: Zaradi pomanjkanja podrobnih anamnestičnih podatkov o preteklih posameznih akutnih in poznih ekstrapiramidnih motnjah gibanja trenutno ni možno sklepati, da povzroča olanzapin manj tardivnih diskinezij in/ali drugih zapoznelih ekstrapiramidnih sindromov.
English: Dose escalation, when indicated, should be conservative in such patients.
Slovenian: Pri povečevanju odmerka, kadar je to indicirano, bodite pri takih bolnikih previdni.
English: The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
Slovenian: Začetni odmerek in razpon dajanja odmerkov je enak za nekadilce in kadilce.
English: In the offspring of rats given olanzapine, delays in foetal development and transient decreases in offspring activity levels were seen.
Slovenian: Pri potomcih podgan, ki so dobivale olanzapin, so opazili zastoje v razvoju zarodka in prehodna zmanjšana aktivnost potomcev.
English: This medicine should be used with caution in patients with phenylketonuria.
Slovenian: To zdravilo je treba uporabljati previdno pri ljudeh s fenilketonurijo.
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.
Slovenian: Če se pri bolniku pojavijo znaki in simptomi, ki kažejo na nevroleptični maligni sindrom, ali če ima nerazložljivo visoko telesno temperaturo brez dodatnih kliničnih manifestacij, je treba prekiniti zdravljenje z vsemi antipsihotiki, vključno z olanzapinom.
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.
Slovenian: Dolgotrajno zdravljenje z olanzapinom (do 12 mesecev) za preprečevanje ponovnega pojava bolezni pri bolnikih z bipolarno motnjo je bilo povezano s povečanjem telesne mase za ≥ 7 % z osnovne pri 39,9 % bolnikov.
English: The major circulating metabolite is the 10-N-glucuronide, which does not pass the blood brain barrier.
Slovenian: V krvi je glavni presnovek 10-N-glukuronid, ki ne prehaja skozi krvnomožgansko pregrado.
English: The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
Slovenian: Presnovo olanzapina lahko pospešita kajenje in karbamazepin, kar lahko povzroči znižanje koncentracije olanzapina.
English: Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
Slovenian: Klinično pomembno povečanje telesne mase so opazili pri vseh izhodiščnih indeksih telesne mase (ITM).
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).
Slovenian: - kombinacijo zvišane telesne temperature, pospešenega dihanja, znojenja, mišične okorelosti in dremavosti ali zaspanosti (pogostnosti tega neželenega učinka iz razpoložljivih podatkov ni mogoče oceniti).
English: What Zalasta is and what it is used for
Slovenian: Kaj je zdravilo Zalasta in za kaj ga uporabljamo
English: All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
Slovenian: Vsi bolniki, ki so jemali olanzapin ali placebo in so doživeli možganskožilni dogodek, so bili prisotni dejavniki tveganja.
English: Adverse event identified from spontaneous post-marketing reporting with frequency estimated at the upper limit of the 95% confidence interval utilising the Olanzapine Integrated Database.
Slovenian: Neželeni učinki, ugotovljeni pri spontanem poročanju v obdobju trženja s pogostostjo, ocenjeno na zgornjo mejo 95 % intervala zaupanja, določeno z uporabo integrirane baze podatkov za olanzapin.
English: ─ Tell the doctor if you or someone else in your family has a history of blood clots, as medicines like these have been associated with the formation of blood clots.
Slovenian: - Če ste vi ali kdo iz vaše družine v preteklosti imeli krvne strdke, morate o tem obvestiti svojega zdravnika, saj lahko zdravila, kot je to, povzročijo nastanek krvnih strdkov.
English: Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section
Slovenian: Razvoj ali poslabšanje sladkorne bolezni, občasno povezane s ketoacidozo ali komo, vključno z nekaj smrtnimi primeri (glejte poglavje 4.4)
English: Sedation affected mating performance of male rats.
Slovenian: Sedacija je vplivala na uspešnost parjenja podganjih samcev.
English: Only slight to moderate increase in olanzapine clearance has been observed.
Slovenian: Ugotovili so le blago do zmerno povečanje očistka olanzapina.
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.
Slovenian: Naslednja tabela vključuje neželene učinke, ki so bili pogostejši pri mladostnikih (starih od 13 do 17 let) kot pri odraslih bolnikih, in neželene učinke, ki so jih ugotovili samo v kratkotrajnih kliničnih preizkušanjih na mladostnikih.
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.
Slovenian: Pri dolgotrajni izpostavljenosti (najmanj 24 tednov) je 89,4 % pridobilo ≥ 7 %, 55,3 % ≥ 15 % in 29,1 % ≥ 25 % od izhodiščne telesne mase.
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).
Slovenian: Klinične posledice so verjetno omejene, kljub vsemu je priporočeno spremljati klinično stanje in povečati odmerek olanzapina, če je potrebno (gl. poglavje 4.2).
English: Standard procedures for management of overdose may be indicated (i.e. gastric lavage, administration of activated charcoal).
Slovenian: Lahko so indicirani standardni postopki za zdravljenje prevelikega odmerka (tj. izpiranje želodca, dajanje aktivnega oglja).
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.
Slovenian: Priporoča se ustrezno klinično spremljanje v skladu z znanimi priporočili za antipsihotike, npr. merjenje glukoze v krvi na začetku, 12 tednov po začetku jemanja olanzapina in nato enkrat na leto.
English: Olanzapine is indicated for the treatment of moderate to severe manic episode.
Slovenian: Olanzapin je indiciran za zdravljenje zmerne do hude manične epizode.
English: Children and adolescents Zalasta is not for patients who are under 18 years.
Slovenian: Otroci in mladostniki Zdravilo Zalasta ni namenjeno bolnikom, mlajšim od 18 let.
English: Olanzapine also showed a statistically significant advantage over placebo in terms of preventing either recurrence into mania or recurrence into depression.
Slovenian: Statistično značilno prednost pred placebom je dosegel tudi pri preprečevanju ponovnega pojava manije ali depresije.
English: A decrease in the dose of olanzapine should be considered if treatment with an inhibitor of CYP 1A2 is initiated.
Slovenian: Odmerek olanzapina je treba zmanjšati, če se uvede zdravljenje z zaviralcem CYP1A2.
English: In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
Slovenian: V primerjalnih raziskavah, ki so trajale eno leto ali manj, so olanzapin povezovali s statistično značilno manjšo incidenco diskinezij, ki se pojavijo med zdravljenjem.
English: Cardiovascular monitoring is necessary to detect possible arrhythmias.
Slovenian: Za odkritje možnih aritmij je nujno spremljati delovanje srčno-žilnega sistema.