FrancophonIA/ELRC3.0 huggingface dataset:
English: The frequency terms listed are defined as follows: Very common (≥ 1/10), 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).
Slovenian: Našteti izrazi pogostnosti so definirani kot sledi: zelo pogosti (≥ 10 %), pogosti (≥ 1/100 do do < 1/10 ), občasni (≥ 1/1000 do < 1/100 ), redki (≥ 1/10.000do < 1/10.000 ), zelo redki (< 1/10.000 ), ni znano (ocena ni možna iz danih podatkov).
English: Carcinogenicity Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Slovenian: Na podlagi izsledkov študij peroralnega olanzapina na miših in podganah je bilo zaključeno, da olanzapin ni kancerogen.
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 pri akutnih prevelikih odmerjanjih tako nizkih odmerkov, kot je 450 mg, vendar so poročali tudi o preživetju po akutnem prevelikem odmerjanju z odmerkom približno 2 g peroralnega olanzapina.
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 uživajo alkohol ali prejemajo zdravila, ki lahko povzročijo depresijo osrednjega živčevja, je potrebna previdnost.
English: Clinically significant weight gain (≥ 7 %) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
Slovenian: Videti je, da se klinično značilno zvečanje telesne mase (≥ 7 %) pojavlja pogosteje pri populaciji mladostnikov v primerjavi z odraslimi pri primerljivi izpostavljenosti.
English: Olanzapine is an antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacologic profile across a number of receptor systems.
Slovenian: Olanzapin je antipsihotik, antimanik in stabilizator razpoloženja, ki kaže širok farmakološki profil prek številnih receptorskih sistemov.
English: Olanzapine is bound predominantly to albumin and 1-acid-glycoprotein.
Slovenian: Olanzapin se veže predvsem na albumin in α1-kisli glikoprotein.
English: Speech disorder was also reported commonly.
Slovenian: Pogosto so poročali tudi o motnji govora.
English: In a study in breast-feeding, healthy women, olanzapine was excreted in breast milk.
Slovenian: V študiji pri doječih zdravih ženskah se je olanzapin izločal v materino mleko.
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, manične epizode in preprečevanjem ponovnega pojava bipolarne motnje se lahko dnevni odmerek na podlagi individualnega kliničnega stanja kasneje prilagodi v razponu 5 do 20 mg na dan.
English: In clinical studies, the average olanzapine exposure was approximately 27 % higher in adolescents.
Slovenian: V kliničnih študijah je bila povpreča izpostavitev približno 27 % višja pri mladostnikih.
English: Activated charcoal reduces the bioavailability of oral olanzapine by 50 % to 60 % and should be taken at least 2 hours before or after olanzapine.
Slovenian: Aktivno oglje zmanjša biološko uporabnost peroralnega olanzapina za 50 do 60 % in ga je treba zaužiti vsaj 2 uri pred olanzapinom ali vsaj dve uri po njem.
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 študijah, ki so pri miših trajale do 3 mesece, pri podganah in psih pa do 1 leta, so bili prevladujoči učinki depresija osrednjega živčevja, antiholinergični učinki in periferne hematološke motnje.
English: Induction of emesis is not recommended.
Slovenian: Sproženje bruhanja ni priporočeno.
English: Tolerance developed to the CNS depression.
Slovenian: Za depresijo osrednjega živčevja se je razvila toleranca.
English: A lower starting dose (5 mg/day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant (see section 4.4).
Slovenian: Nižji začetni odmerek (5 mg na dan) ni rutinsko priporočen, vendar ga je treba upoštevati pri bolnikih, starih 65 let in več, kadar to upravičujejo klinični dejavniki (glejte poglavje 4.4).
English: After first opening use within 90 days.
Slovenian: Po prvem odprtju uporabite v 90 dneh.
English: The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to
Slovenian: Našteti izrazi pogostnosti so definirani kot sledi: zelo pogosti (≥ 1/10 ), pogosti (≥ 1/100 do < 1/10 ).
English: EXP After first opening use within 90 days.
Slovenian: EXP Po prvem odprtju uporabite v 90 dneh.
English: Controlled efficacy data in adolescents (ages 13 to 17 years) are limited to short term studies in schizophrenia (6 weeks) and mania associated with bipolar I disorder (3 weeks), involving less than 200 adolescents.
Slovenian: Nadzorovani podatki o učinkovitosti pri mladostnikih (starih 13 do 17 let) so omejeni na kratkoročne študije pri shizofreniji (6 tednov) in maniji povezani z bipolarno I motnjo (3 tedni), ki vključujejo manj kot 200 mladostnikov.
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 nestarejše.
English: All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
Slovenian: Vsi bolniki, ki so prejemali olanzapin ali placebo in so doživeli cerebrovaskularni dogodek, so imeli prej obstoječe dejavnike tveganja.
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 cerebrovaskularne dogodke.
English: Children and adolescents Olanzapine Mylan is not for patients who are under 18 years.
Slovenian: Otroci in mladostniki Zdravilo Olanzapin Mylan ni namenjeno bolnikom, mlajšim od 18 let.
English: In the majority of these patients the elevations were generally mild, and remained below two times the upper limit of normal range.
Slovenian: Pri večini teh bolnikov je bilo povišanje navadno blago in ni preseglo dvakratne koncentracije zgornje meje normalne vrednosti.
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.
Slovenian: Glede na primarne učinke olanzapina na osrednje živčevje je potrebna previdnost, kadar se ga jemlje v kombinaciji z drugimi osrednje delujočimi zdravili in alkoholom.
English: Age >75 years and vascular/mixed type dementia were identified as risk factors for CVAE in association with olanzapine treatment.
Slovenian: Starost > 75 let in vaskularna/mešana demenca sta bili določeni kot dejavnika, ki prispevata k tveganju za CVAE v povezavi z zdravljenjem z olanzapinom.
English: Olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/day.
Slovenian: Olanzapin so uporabljali kot prilagodljiv odmerek, ki so ga začeli z 2,5 mg in zviševali do 20 mg/dan.
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 zaključiti, da olanzapin povzroča manj tardivnih diskinezij in/ali drugih zapoznelih ekstrapiramidnih sindromov.
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 študije 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: Polyvinyl alcohol Titanium dioxide (E171) Talc (E553b) Soya lecithin (E322) Xanthan gum (E415)
Slovenian: Obloga tablete polivinilalkohol titanov dioksid (E171) smukec (E553b) sojin lecitin (E322) ksantanski gumi (E415)
English: You should not be given this medicine when breast-feeding, as small amounts of olanzapine can pass into breast milk.
Slovenian: Ko dojite, tega zdravila ne smete jemati, ker lahko majhne količine zdravila Olanzapin Mylan prehajajo v materino mleko.
English: Mean infant exposure (mg/kg) at steady state was estimated to be 1.8 % of the maternal olanzapine dose (mg/kg).
Slovenian: Srednjo izpostavitev dojenčka (mg/kg) v stanju dinamičnega ravnovesja so ocenili na 1,8 % materinega odmerka olanzapina (mg/kg).
English: During treatment with olanzapine, adolescents gained significantly more weight compared with adults.
Slovenian: Med zdravljenjem z olanzapinom so mladostniki povečali signifikantno več telesne mase v primerjavi z odraslimi.
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 prejemale olanzapin, so opazili zastoje v fetalnem razvoju in prehodna znižanja v ravneh aktivnosti potomcev.
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: Vendar, ker imajo bolniki s shizofrenijo pogosto prisotne pridobljene dejavnike tveganja za vensko tromboembolijo, je treba ugotoviti vse možne dejavnike tveganja za VTE, kot npr. imobilizacija bolnikov ter izvesti preventivne ukrepe.
English: • Moderate to severe manic episodes, a condition with symptoms of excitement or euphoria.
Slovenian: • zmernih do resnejših maničnih epizod, bolezni s simptomi razburjenja ali evforije.
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.
Slovenian: V teh preskušanjih je bilo potrebno, da se je zdravstveno stanje bolnikov najprej ustalilo ob prejemanju najnižjega učinkovitega odmerka antiparkinsonskih zdravil (dopaminskih agonistov) ter da so ves čas študije prejemali ista antiparkinsonska zdravila v enakih odmerkih.
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 preskušanjih pri več kot 2900 bolnikih s shizofrenijo, ki so kazali tako pozitivne kot negativne simptome, je bil olanzapin povezan s statistično značilnim večjim izboljšanjem negativnih in tudi pozitivnih simptomov.
English: In cases of moderate hepatic insufficiency (cirrhosis, Child-Pugh Class A or B), the starting dose should be 5 mg and only increased with caution.
Slovenian: V primerih zmerno okvarjenega delovanja jeter (ciroza, Child-Pugh razreda A ali B) mora biti začetni odmerek 5 mg in se lahko zvišuje le previdno.
English: If you suffer from any of the following illnesses tell your doctor as soon as possible:
Slovenian: Če imate katero od spodaj naštetih bolezni, čimprej povejte zdravniku:
English: Dose escalation, when indicated, should be conservative in such patients (see sections 4.5 and 5.2).
Slovenian: Višanje odmerka, kadar je to indicirano, naj bo pri takih bolnikih previdno (glejte poglavji 4.5 in 5.2).
English: If this happens after you have been given Olanzapine Mylan tell your doctor.
Slovenian: Če se vam to zgodi po tem, ko ste prejeli zdravilo Olanzapin Mylan, povejte zdravniku.
English: Dogs tolerated single oral doses up to 100 mg/kg without mortality.
Slovenian: Psi so prenesli enkratne peroralne odmerke do 100 mg/kg brez smrtnega izida.
English: Hyperglycaemia and diabetes
Slovenian: Hiperglikemija in diabetes
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 jih poročali z višjo pogostnostjo pri mladostnikih (starih 13 - 17 let) kot pri odraslih bolnikih ali neželene učinke, ki so jih ugotovili samo v kratkoročnih kliničnih preskušanjih pri mladostnikih.
English: Elevated triglyceride levels2,5
Slovenian: Zvišane ravni trigliceridov2,5
English: In patients with Parkinson's disease Olanzapine Mylan may worsen the symptoms.
Slovenian: Pri bolnikih s Parkinsonovo boleznijo lahko zdravilo Olanzapin Mylan poslabša simptome.
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 manjši pri starejših v primerjavi z mlajšimi, pri ženskah v primerjavi z moškimi in pri nekadilcih v primerjavi s kadilci.
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 ter razmerje mladostnikov, ki so imeli klinično značilno zvečanje telesne mase, sta bila višja pri dolgoročni izpostavljenosti (najmanj 24 tednov) kot pri kratkoročni izpostavljenosti.
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) z dopolnilno terapijo za zdravljenje simptomov razpoloženja, kot je klinično indicirano.
English: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Slovenian: Reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS)
English: There is no specific antidote for olanzapine.
Slovenian: Za olanzapin ni specifičnega antidota.
English: You should take your Olanzapine Mylan tablets once a day following the advice of your doctor.
Slovenian: Olanzapin Mylan tablete jemljite enkrat na dan, in sicer upoštevajte nasvet zdravnika.
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.
Slovenian: V retrospektivni opazovalni kohortni študiji so ugotovili, da je bilo tveganje za domnevno nenadno srčno smrt pri bolnikih, ki so se zdravili z olanzapinom, približno dvakrat večje kot pri bolnikih, ki niso jemali antipsihotikov.
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.
Slovenian: Nekateri ljudje imajo lahko v začetnih obdobjih zdravljenja občutek omotice ali oslabelosti (z upočasnjenim srčnim utripom), zlasti pri vstajanju iz ležečega ali sedečega položaja, ki običajno spontano izzveni.
English: After oral administration, the mean terminal elimination half-life of olanzapine in healthy subjects varied on the basis of age and gender.
Slovenian: Po peroralnem dajanju se je srednji končni razpolovni čas izločanja olanzapina pri zdravih osebah razlikoval glede na starost in spol.
English: • carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your Olanzapine Mylan dose.
Slovenian: • karbamazepin (antiepileptik in stabilizator razpoloženja), fluvoksamin (antidepresiv) ali ciprofloksacin (antibiotik) - morda bo potrebno spremeniti vaš odmerek zdravila Olanzapin
English: Olanzapine also demonstrated comparable efficacy results to haloperidol in terms of the proportion of patients in symptomatic remission from mania and depression at 6 and 12 weeks.
Slovenian: Olanzapin je prav tako pokazal rezultate učinkovitosti, primerljive s haloperidolom, glede na delež bolnikov v simptomatski remisiji manije in depresije po 6 in 12 tednih.
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 znižane koncentracije olanzapina.
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: Dolgoročno 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 osnove pri 39,9 % bolnikov.
English: Olanzapine also showed a statistically significant advantage over placebo in terms of preventing either recurrence into mania or recurrence into depression.
Slovenian: Olanzapin je pokazal tudi statistično značilno prednost pred placebom glede preprečevanja ponovnega pojava ali manije ali depresije.
English: Absolute oral bioavailability relative to intravenous administration has not been determined.
Slovenian: Absolutna peroralna biološka uporabnost glede na intravensko dajanje ni bila določena.
English: It is important that you carry on taking Olanzapine Mylan for as long as your doctor tells you.
Slovenian: Pomembno je, da nadaljujete z jemanjem zdravila Olanzapin Mylan tako dolgo, kot vam naroči zdravnik.
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 imeli vi ali kdo v vaši družini v preteklosti pojav krvnih strdkov, morate o tem obvestiti zdravnika, saj lahko zdravila, kot je to, povzročijo nastanek krvnih strdkov.
English: In cases where hepatitis (including hepatocellular, cholestatic or mixed liver injury) has been diagnosed, olanzapine treatment should be discontinued.
Slovenian: V primerih, kjer je ugotovljen hepatitis (vključno s hepatocelularno, holestatsko ali mešano okvaro jeter), je treba zdravljenje z olanzapinom prekiniti.
English: Sudden cardiac death
Slovenian: Nenadna srčna smrt
English: The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/LDL/HDL cholesterol or triglycerides increased over time.
Slovenian: Delež bolnikov, ki so imeli neželene, klinično značilne spremembe telesne mase, glukoze, celokupnega/LDL/HDL holesterola ali trigliceridov se je s časom povečal.
English: The magnitude of changes in fasting total cholesterol, LDL cholesterol, triglycerides, and prolactin (see sections 4.4 and 4.8) were greater in adolescents than in adults.
Slovenian: Obseg sprememb v celokupnem holesterolu na tešče, LDL holesterolu, trigliceridih in prolaktinu (glejte poglavji 4.4 in 4.8) je bil večji pri mladostnikih kot pri odraslih.
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 bila potrebna prilagoditev odmerka valproata po uvedbi sočasnega zdravljenja z olanzapinom.
English: Ventricular tachycardia/fibrillation , sudden death (see section 4.4)11
Slovenian: Prekatna tahikardija/fibrilacija , nenadna smrt (glejte poglavje 4.4)11
English: Very common adverse reactions associated with the use of olanzapine in this patient group were abnormal gait and falls.
Slovenian: Zelo pogosta neželena učinka povezana z uporabo olanzapina v tej skupini bolnikov sta bila neobičajna hoja in padci.
English: 117 Allée des Parcs 69800 Saint-Priest France
Slovenian: 117 Allée des Parcs 69800 Saint-Priest Francija
English: Very common: Decreased total bilirubin, increased GGT, elevated plasma prolactin levels16.
Slovenian: Zelo pogosti: Nizek celokupni bilirubin, visok GGT, zvišane plazemske koncentracije prolaktina16
English: Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: The efficacy of olanzapine was not established in these trials.
Slovenian: V teh preskušanjih niso ugotavljali učinkovitosti olanzapina.
English: In the study, the risk of olanzapine was comparable to the risk of atypical antipsychotics included in a pooled analysis.
Slovenian: Študija je pokazala, da je bilo tveganje pri olanzapinu primerljivo s tveganjem pri atipičnih antipsihotikih, vključenih v skupno analizo.
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: If this has happened to you, tell your doctor.
Slovenian: Če se to pojavi pri vas, obvestite zdravnika.
English: If this happens, contact your doctor at once.
Slovenian: Če se zgodi kaj takega, se nemudoma obrnite na zdravnika.
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.
Slovenian: Vendar pa tveganje za tardivne diskinezije narašča s trajanjem zdravljenja in je zato ob pojavu znakov ali simptomov tardivnih diskinezij pri bolniku, ki prejema olanzapin, treba razmisliti o znižanju odmerka ali ukinitvi zdravila.
English: Portugal Mylan, Lda.
Slovenian: Mylan, Lda.
English: Olanzapine is not indicated for use in the treatment of children and adolescents.
Slovenian: Olanzapin ni indiciran za uporabo pri zdravljenju otrok in mladostnikov.
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, vendar je priporočeno spremljanje kliničnega stanja in zvišanje odmerka olanzapina, če je potrebno (glejte poglavje 4.2).
English: What Olanzapine Mylan is and what it is used for What you need to know before you take Olanzapine Mylan How to take Olanzapine Mylan Possible side effects
Slovenian: Kaj je zdravilo Olanzapin Mylan in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Olanzapin Mylan Kako jemati zdravilo Olanzapin Mylan Možni neželeni učinki