natgillin/translations-raw huggingface dataset:
However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Vendar pa mora imetnik dovoljenja za promet za to zdravilo predložiti redno posodobljena poročila o varnosti zdravila, če je zdravilo vključeno v seznam referenčnih datumov Unije (seznam EURD), opredeljen v členu 107c(7) Direktive 2001/83/ES in objavljen na evropskem spletnem portalu o zdravilih.
Demographic differences between the adolescents and adults include a lower average body weight and fewer adolescents were smokers.
Demografske razlike med mladostniki in odraslimi vključujejo nižjo povprečno telesno maso ter manj mladostnikov je bilo kadilcev.
A lower starting dose (5 mg) should be considered for such patients.
Pri teh bolnikih je treba upoštevati nižji začetni odmerek (5 mg).
These symptoms can temporally deteriorate or even arise after discontinuation of treatment.
Ti simptomi se lahko s časom poslabšajo ali se pojavijo celo po ukinitvi zdravljenja.
In a study of Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
V študiji pri belcih, Japoncih in Kitajcih ni bilo razlik v farmakokinetičnih parametrih med temi tremi populacijami.
Such factors possibly contribute to the higher average exposure observed in adolescents.
Možno je, da taki dejavniki vplivajo na višjo povprečno izpostavitev, ki so jo opazili pri mladostnikih.
Increased total bilirubin
Zvišan celokupni bilirubin
The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
Začetnega odmerka in razpona odmerkov za nekadilce ni treba rutinsko spreminjati glede na kadilce.
Olanzapine had no teratogenic effects.
Olanzapin ni imel teratogenih učinkov.
Decreased libido in males and females
Zmanjšan libido pri moških in ženskah
Do not take a double dose to make up for the forgotten tablet.
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjo tableto.
In particular, tell your doctor if you are taking:
Še zlasti pa povejte zdravniku, če jemljete:
Olanzapine belongs to a group of medicines called antipsychotics and is used to treat the following conditions:
Olanzapin spada v skupino zdravil, imenovanih antipsihotiki in se uporablja za zdravljenje naslednjih bolezni:
Your doctor may suggest you to reduce the dose gradually before stopping treatment.
Zdravnik vam bo morda predlagal postopno nižanje odmerka pred ukinitvijo zdravljenja.
People with this disease may also feel depressed, anxious or tense.
Ljudje s to boleznijo se lahko počutijo tudi depresivno, občutijo tesnobo ali napetost;
Fertility Effects on fertility are unknown (see section 5.3 for preclinical information).
Plodnost Učinki na plodnost niso znani (glejte poglavje 5.3 za predklinične informacije).
This leaflet was last revised in {month YYYY}.
Navodilo je bilo nazadnje revidirano dne {mesec LLLL}.
Date of latest renewal: 22 May 2013
Datum prve odobritve: 7. oktober 2008 Datum zadnjega podaljšanja: 22. Maj 2013
NMS is a potentially life-threatening condition associated with antipsychotic medicinal products.
NMS je potencialno življenje ogrožajoče stanje, povezano z antipsihotiki.
Discontinuation of treatment
Prekinitev zdravljenja
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.
Če ste noseči ali dojite, menite, da bi lahko bili noseči oziroma načrtujete zanositev, se posvetujte z zdravnikom preden vzamete to zdravilo.
Smokers
Kadilci
Your doctor will tell you how many Olanzapine Mylan tablets to take and how long you should continue to take them.
Zdravnik vam bo povedal, koliko Olanzapin Mylan tablet morate vzeti in kako dolgo naj bi jih jemali.
Adolescents (ages 13 to 17 years): The pharmacokinetics of olanzapine are similar between adolescents and adults.
Mladostniki (stari 13 do17 let): Farmakokinetika olanzapina je podobna pri mladostnikih in odraslih.
Photosensitivity reaction
Fotosenzitivnostne reakcije
During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
Med zdravljenjem z antipsihotiki se lahko bolnikovo klinično stanje izboljša v nekaj dneh do nekaj tednih.
The median lethal doses were approximately 210 mg/kg (mice) and 175 mg/kg (rats).
Srednji letalni odmerki so bili približno 210 mg/kg (miši) in 175 mg/kg (podgane).
There are no controlled data on maintenance of effect or long term safety (see sections 4.4 and 4.8).
Nadzorovanih podatkov o vzdrževalnem učinku ali podatkov o dolgoročni varnosti ni (glejte poglavji 4.4 in 4.8).
Neuroleptic Malignant Syndrome (NMS)
Nevroleptični maligni sindrom (NMS)
However, olanzapine (5-20 mg) demonstrated a comparable safety profile in female (n=467) as in male patients (n=869).
Vendar pa je olanzapin (520 mg) pokazal primerljiv profil varnosti tako pri bolnikih ženskega (n = 467) kot moškega spola (n = 869).
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.
Čeprav niso opravili kliničnih študij z namenom primerjave mladostnikov z odraslimi, so podatke iz preskušanj pri mladostnikih primerjali s tistimi iz preskušanj pri odraslih.
The mean increase in olanzapine AUC was 52 % and 108 % respectively.
Srednje povečanje AUC olanzapina je bilo 52 % oziroma 108 %.
The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
Večja incidenca smrtnosti ni bila povezana z odmerkom olanzapina (povprečni dnevni odmerek 4,4 mg) ali trajanjem zdravljenja.
Olanzapine can be given without regards for meals as absorption is not affected by food.
Olanzapin se lahko daje ne glede na obroke, ker hrana ne vpliva na absorpcijo.
The mean increase in olanzapine Cmax following fluvoxamine was 54 % in female nonsmokers and 77 % in male smokers.
Srednje zvišanje Cmax olanzapina po dajanju fluvoksamina je bilo 54 % pri ženskah nekadilkah in 77 % pri moških kadilcih.
• Prostate problems
• težave s prostato
Unlike some other antipsychotic agents, olanzapine increases responding in an “anxiolytic” test.
Za razliko od nekaterih drugih antipsihotikov olanzapin poveča odzivanje v »anksiolitičnem« testu.
• if you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
- če so vam v preteklosti ugotovili težave z očmi, kot je določena vrsta glavkoma (povišan tlak v očesu).
Nevertheless, because human experience is limited, olanzapine should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Ker pa so izkušnje pri človeku omejene, naj se olanzapin v nosečnosti uporablja samo, če možna korist upraviči možno tveganje za plod.
Consider referral to a dietician or help with a diet plan if necessary.
Razmislite o napotnici za dietetika ali pomoči pri prehranskem načrtu, če jo potrebujete.
Do not use epinephrine, dopamine, or other sympathomimetic agents with beta agonist activity since beta stimulation may worsen hypotension.
Ne uporabljajte adrenalina, dopamina ali drugih simpatikomimetikov z beta-agonističnim delovanjem, ker lahko beta stimulacija poslabša hipotenzijo.
In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 6 months.
Pri odraslih bolnikih, ki so zaključili 9 - 12 mesecev terapije, se je razmerje zvišanja povprečne glukoze v krvi upočasnilo po približno 6 mesecih.
However, the magnitude of the impact of age, gender, or smoking on olanzapine clearance and half-life is small in comparison to the overall variability between individuals.
Vendar pa je vpliv starosti, spola ali kajenja na očistek in razpolovni čas olanzapina majhen v primerjavi s povprečno variabilnostjo med posamezniki.
A mass balance study showed that approximately 57 % of radiolabelled olanzapine appeared in urine, principally as metabolites.
Študija bilance snovi je pokazala, da se približno 57 % radioaktivno označenega olanzapina pojavi v urinu, predvsem v obliki metabolitov.
The absorption is not affected by food.
Hrana na absorpcijo ne vpliva.
If you suffer from dementia, you or your carer/relative should tell your doctor if you have ever had a stroke or “mini” stroke.
Če ste bolnik z demenco, morate vi ali vaš skrbnik/sorodnik povedati zdravniku, če ste kdaj doživeli možgansko kap ali »majhno« možgansko kap.
Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.
Olanzapin je učinkovit za vzdrževanje kliničnega izboljšanja pri nadaljevanju zdravljenja bolnikov, ki so pokazali začetni odziv na terapijo.
• Medicines of this type may cause unusual movements mainly of the face or tongue.
- Tovrstna zdravila lahko povzročijo nenavadne zgibke predvsem mišic obraza ali jezika.
Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and in vivo mammalian tests.
Olanzapin ni bil mutagen ali klastogen v širokem razponu standardnih testov, ki je vključeval teste mutiranja bakterij ter in vitro in in vivo teste na sesalcih.
Olanzapine Mylan contains lactose and soya lecithin If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Zdravilo Olanzapin Mylan vsebuje laktozo in sojin lecitin Če vam je vaš zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred jemanjem tega zdravila posvetujte s svojim zdravnikom.
The plasma protein binding of olanzapine was about 93 % over the concentration range of about 7 to about 1000 ng/ml.
Vezava olanzapina na plazemske beljakovine je bila okoli 93 % v razponu koncentracij od približno 7 do približno 1000 ng/ml.
• If you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets)
• če veste, da imate morda pomanjkanje soli zaradi dolgotrajne hude driske in bruhanja ali uporabe diuretikov (tablet za odvajanje vode)
Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olanzapine Mylan and regularly during treatment.
Zdravnik mora opraviti krvni test za preiskavo sladkorja v krvi in ravni določenih maščob pred začetkom jemanja zdravila Olanzapin Mylan in redno med zdravljenjem.
As a routine precaution, if you are over 65 years your blood pressure may be monitored by your doctor.
Kot običajen previdnostni ukrep vam lahko zdravnik nadzoruje krvni tlak, če ste stari več kot 65 let.
The following table lists the adverse reactions and laboratory investigations observed from spontaneous reporting and in clinical trials.
V naslednji tabeli so našteti neželeni učinki in laboratorijske preiskave, ki so jih opazili iz spontanega poročanja in kliničnih preskušanj.
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.
Pri 44 bolnikih s shizofrenijo, starejših od 65 let, odmerjanje od 5 do 20 mg/dan ni bilo povezano s kakim razločevalnim profilom neželenih učinkov.
Contents of the pack and other information
Vsebina pakiranja in dodatne informacija
Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
Klinično značilno zvečanje telesne mase so opažali preko celotne osnove kategorij Indeksa telesne mase (BMI, Body Mass Index).
Preventing recurrence in bipolar disorder: The recommended starting dose is 10 mg/day.
Preprečevanje ponovnega pojava bolezni pri bipolarni motnji: Priporočeni začetni odmerek je 10 mg na dan.
Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
Na spremembe lipidov se je potrebno odzvati kot je klinično primerno, zlasti pri bolnikih z dislipidemijo in bolnikih z dejavniki tveganja za razvoj motenj lipidov.
16 Elevated plasma prolactin levels were reported in 47.4 % of adolescent patients.
16 O zvišanih plazemskih koncentracijah prolaktina so poročali pri 47,4 % mladostnikov.
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.
Če bolnik razvije znake in simptome, ki kažejo na NMS, ali ima nerazložljivo visoko telesno temperaturo brez dodatnih kliničnih manifestacij NMS, je treba prekiniti zdravljenje z vsemi antipsihotiki, vključno z olanzapinom.
Tell your doctor immediately if you have:
Takoj obvestite svojega zdravnika, če opazite:
Because olanzapine may cause somnolence and dizziness, patients should be cautioned about operating machinery, including motor vehicles.
Ker olanzapin lahko povzroči zaspanost in omotičnost, je treba bolnike opozoriti na previdnost glede upravljanja strojev, vključno z motornimi vozili.
An increase to a dose greater than the recommended starting dose is advised only after appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours.
Zvišanje odmerka na več kot priporočeni začetni odmerek je priporočljivo le po ustrezni ponovni klinični oceni, odmerki naj se v splošnem višajo po preteku vsaj 24-urnega časovnega intervala.
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.
Ob navzočnosti več kot enega dejavnika, ki bi lahko prispeval k počasnejši presnovi (ženski spol, starostnik, nekadilec), je treba pretehtati znižanje začetnega odmerka.
Bradycardia QTc prolongation (see section 4.4)
Bradikardija Podaljšanje QTc (glejte poglavje 4.4)
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).
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).
Carcinogenicity Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Na podlagi izsledkov študij peroralnega olanzapina na miših in podganah je bilo zaključeno, da olanzapin ni kancerogen.
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.
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.
Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
Pri bolnikih, ki uživajo alkohol ali prejemajo zdravila, ki lahko povzročijo depresijo osrednjega živčevja, je potrebna previdnost.
Clinically significant weight gain (≥ 7 %) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
Videti je, da se klinično značilno zvečanje telesne mase (≥ 7 %) pojavlja pogosteje pri populaciji mladostnikov v primerjavi z odraslimi pri primerljivi izpostavljenosti.
Olanzapine is an antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacologic profile across a number of receptor systems.
Olanzapin je antipsihotik, antimanik in stabilizator razpoloženja, ki kaže širok farmakološki profil prek številnih receptorskih sistemov.
Olanzapine is bound predominantly to albumin and 1-acid-glycoprotein.
Olanzapin se veže predvsem na albumin in α1-kisli glikoprotein.
Speech disorder was also reported commonly.
Pogosto so poročali tudi o motnji govora.
In a study in breast-feeding, healthy women, olanzapine was excreted in breast milk.
V študiji pri doječih zdravih ženskah se je olanzapin izločal v materino mleko.
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.
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.
In clinical studies, the average olanzapine exposure was approximately 27 % higher in adolescents.
V kliničnih študijah je bila povpreča izpostavitev približno 27 % višja pri mladostnikih.
Activated charcoal reduces the bioavailability of oral olanzapine by 50 % to 60 % and should be taken at least 2 hours before or after olanzapine.
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.
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.
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.
Induction of emesis is not recommended.
Sproženje bruhanja ni priporočeno.
Tolerance developed to the CNS depression.
Za depresijo osrednjega živčevja se je razvila toleranca.
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).
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).
After first opening use within 90 days.
Po prvem odprtju uporabite v 90 dneh.
The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to
Našteti izrazi pogostnosti so definirani kot sledi: zelo pogosti (≥ 1/10 ), pogosti (≥ 1/100 do < 1/10 ).
EXP After first opening use within 90 days.
EXP Po prvem odprtju uporabite v 90 dneh.
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.
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.
The pharmacokinetic variability observed in the elderly is within the range for the non-elderly.
Farmakokinetična variabilnost, opažena pri starejših, je v okvirih razpona za nestarejše.
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
Vsi bolniki, ki so prejemali olanzapin ali placebo in so doživeli cerebrovaskularni dogodek, so imeli prej obstoječe dejavnike tveganja.
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.
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.
Children and adolescents Olanzapine Mylan is not for patients who are under 18 years.
Otroci in mladostniki Zdravilo Olanzapin Mylan ni namenjeno bolnikom, mlajšim od 18 let.
In the majority of these patients the elevations were generally mild, and remained below two times the upper limit of normal range.
Pri večini teh bolnikov je bilo povišanje navadno blago in ni preseglo dvakratne koncentracije zgornje meje normalne vrednosti.
Given the primary CNS effects of olanzapine, caution should be used when it is taken in combination with other centrally acting medicines and alcohol.
Glede na primarne učinke olanzapina na osrednje živčevje je potrebna previdnost, kadar se ga jemlje v kombinaciji z drugimi osrednje delujočimi zdravili in alkoholom.
Age >75 years and vascular/mixed type dementia were identified as risk factors for CVAE in association with olanzapine treatment.
Starost > 75 let in vaskularna/mešana demenca sta bili določeni kot dejavnika, ki prispevata k tveganju za CVAE v povezavi z zdravljenjem z olanzapinom.
Olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/day.
Olanzapin so uporabljali kot prilagodljiv odmerek, ki so ga začeli z 2,5 mg in zviševali do 20 mg/dan.
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.
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.
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.
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.
Polyvinyl alcohol Titanium dioxide (E171) Talc (E553b) Soya lecithin (E322) Xanthan gum (E415)
Obloga tablete polivinilalkohol titanov dioksid (E171) smukec (E553b) sojin lecitin (E322) ksantanski gumi (E415)
You should not be given this medicine when breast-feeding, as small amounts of olanzapine can pass into breast milk.
Ko dojite, tega zdravila ne smete jemati, ker lahko majhne količine zdravila Olanzapin Mylan prehajajo v materino mleko.
Mean infant exposure (mg/kg) at steady state was estimated to be 1.8 % of the maternal olanzapine dose (mg/kg).
Srednjo izpostavitev dojenčka (mg/kg) v stanju dinamičnega ravnovesja so ocenili na 1,8 % materinega odmerka olanzapina (mg/kg).
During treatment with olanzapine, adolescents gained significantly more weight compared with adults.
Med zdravljenjem z olanzapinom so mladostniki povečali signifikantno več telesne mase v primerjavi z odraslimi.
In the offspring of rats given olanzapine, delays in foetal development and transient decreases in offspring activity levels were seen.
Pri potomcih podgan, ki so prejemale olanzapin, so opazili zastoje v fetalnem razvoju in prehodna znižanja v ravneh aktivnosti potomcev.
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.
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.
• Moderate to severe manic episodes, a condition with symptoms of excitement or euphoria.
• zmernih do resnejših maničnih epizod, bolezni s simptomi razburjenja ali evforije.