natgillin/translations-raw huggingface dataset:
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.
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 osebah, starih 65 let in več, kadar to upravičujejo klinični dejavniki (glejte poglavje 4.4).
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.
In these trials, patients were initially required to be stable on the lowest effective dose of anti-Parkinsonian medicinal products (dopamine agonist) and to remain on the same anti-Parkinsonian medicinal products and dosages throughout the study.
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.
Clinically significant weight gain (≥7%) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
(≥ 7 %) pojavlja pogosteje pri populaciji mladostnikov v primerjavi z odraslimi pri primerljivi izpostavljenosti.
- 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.
- 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.
Very common: Elevations of hepatic aminotransferases (ALT/AST; see section 4.4).
Zelo pogosti: Zvišane ravni jetrnih aminotransferaz (ALT/AST; glejte poglavje 4.4)
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.
V retrospektivni opazovalni kohortni študiji so ugotovili, da je bilo tveganje za domnevno nenadno srčno smrt pri bolnikih, ki so se zdravili z olanzepinom, približno dvakrat večje kot pri bolnikih, ki niso jemali antipsihotikov.
55.3%gained ≥15% and 29.1% gained ≥25% of their baseline body weight.
55,3 % ≥ 15 % in 29,1 % ≥ 25 % od njihove osnovne telesne mase.
QT interval In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF]
V kliničnih preskušanjih so bila klinično pomembna podaljšanja QTc (QT korekcija Fridericia
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.
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.
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.
Consult your doctor if your symptoms return but do not stop taking Olanzapine Teva unless your doctor tells you to.
Če se simptomi povrnejo, se posvetujte s svojim zdravnikom, vendar ne prenehajte jemati zdravila Olanzapin Teva, če vam tega ne naroči vaš zdravnik.
It is important that you carry on taking Olanzapine Teva for as long as your doctor tells you.
Pomembno je, da nadaljujete z jemanjem zdravila Olanzapin Teva tako dolgo, kot vam naroči zdravnik.
Olanzapine Teva orodispersible tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
Olanzapin Teva orodisperzibilno tableto naj se položi v usta, kjer se hitro dispergira v slini, tako da jo je mogoče brez težav pogoltniti.
Very common: Sedation (including: hypersomnia, lethargy, somnolence).
Zelo pogosti: Sedacija (vključno s: hipersomnijo, letargijo, zaspanostjo)
Risk Management Plan (RMP) Not applicable.
ZDRAVILA • Načrt za obvladovanje tveganj (RMP)
Alternatively, it may be dispersed in a full glass of water or other suitable beverage (orange juice, apple juice, milk or coffee) immediately before administration.
Drug način uporabe je, da tableto dispergiramo v polnem kozarcu vode ali druge ustrezne pijače (pomarančni sok, jabolčno sok, mleko ali kava) neposredno pred zaužitjem.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Če vam je vaš zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
Olanzapine Teva tablets break easily, so you should handle the tablets carefully.
Olanzapin Teva tablete se zlahka lomijo, zato z njimi ravnajte previdno.
In patients with Parkinson's disease Olanzapine Teva may worsen the symptoms.
Pri bolnikih s Parkinsonovo boleznijo lahko zdravilo Olanzapin Teva poslabša simptome.
The daily dose of Olanzapine Teva is between 5 mg and 20 mg.
Dnevni odmerek zdravila Olanzapin Teva je med 5 mg in 20 mg.
You should not be given this medicine when breast-feeding, as small amounts of Olanzapine Teva can pass into breast milk.
Ko dojite, tega zdravila ne smete jemati, ker lahko majhne količine zdravila Olanzapin Teva prehajajo v materino mleko.
Very rare side effects include serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
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
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The mean increase in olanzapine Cmax following fluvoxamine was 54% in female non-smokers and 77% in male smokers.
Srednje zvišanje Cmax olanzapina po dajanju fluvoksamina je bilo 54 % pri ženskah nekadilkah in
Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olanzapine Teva and regularly during treatment.
Vaš zdravnik mora opraviti krvni test za preiskavo sladkorja v krvi in nivo določenih maščob pred začetkom jemanja zdravila Olanzapin
LIST OF EXCIPIENTS Contains, among others, Lactose monohydrate.
Med drugim vsebuje laktozo monohidrat.
There were more smokers among subjects with cirrhosis (4/6; 67%) than among subjects with no hepatic dysfunction (0/3; 0%).
Med osebami s cirozo (4/6, 67 %) je bilo več kadilcev kot med osebami brez jetrne okvare (0/3, 0 %).
Contains among others: lactose, sucrose and aspartame (E951).
Med drugim vsebuje: laktozo, saharozo in aspartam (E951).
You should take your Olanzapine Teva tablets once a day following the advice of your doctor.
Olanzapin Teva tablete jemljite enkrat na dan, in sicer upoštevajte nasvet zdravnika.
In cases where dose increments of 2.5 mg are considered necessary, Olanzapine Teva film-coated tablets should be used.
V primerih, kjer so nujna višanja odmerkov po 2,5 mg, je potrebno uporabljati Olanzapin Teva filmsko obložene tablete.
≥25% was common (2.5%).
občasno (2,5 %).
Patients treated with any antipsychotic medicines, including olanzapine, should be monitored regularly for lipids in accordance with utilised antipsychotic guidelines, e.g. at baseline, 12 weeks after starting olanzapine treatment and every 5 years thereafter.
Bolnike, zdravljene s katerimkoli antipsihotikom, vključno z olanzapinom, moramo redno spremljati glede lipidov, v skladu z znanimi priporočili za antipsihotike, npr. na začetku, 12 tednov po začetku jemanja olanzapina in nato vsakih 5 let.
Pharmacotherapeutic group: psycholeptics, diazepines, oxazepines, thiazepines and oxepines.
Farmakoterapevtska skupina: psiholeptiki, diazepini, oksazepini, tiazepini in oksepini.
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 (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), ni znano (ocena ni možna iz danih podatkov).
The frequency terms listed are defined as follows: Very common (≥1/10), common (≥1/100 to <1/10).
Našteti izrazi pogostnosti so definirani kot sledi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10).
Discontinuation symptoms7,12
Odtegnitveni simptomi7, 12
(≥ 1.016 mmol/l-<1.467 mmol/l) to high (≥1.467 mmol/l).
(≥ 1,016 mmol/l - < 1,467 mmol/l) na visoke (≥ 1,467 mmol/l).
Do not stop taking your tablets just because you feel better.
Če ste prenehali jemati zdravilo Olanzapin Teva Ne prenehajte jemati tablet samo zato, ker se počutite bolje.
DRESS appears initially as flu like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia).
Simptomi DRESS so ob nastopu sprva podobni simptomom gripe, z izpuščaji na obrazu, ki se nato razširijo drugam, povišano telesno temperaturo, povečanimi bezgavkami, povišano ravnijo jetrnih encimov ob krvnih preiskavah in povečanjem števila vrste belih krvnih celic (eozinofilija).
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This medicine contains 2.25 mg/4.5 mg/6.75 mg/9 mg aspartame in each 5 mg/10 mg/15 mg/20 mg orodispersible tablet.
To zdravilo vsebuje 2,25 mg/4,5 mg/6,75 mg/9 mg aspartam (E951) v vsaki 5-mg/10-mg/15-mg/20mg orodisperzibilni tableti.
- The use of Olanzapine Teva in elderly patients with dementia is not recommended as it may have serious side effects.
- Uporabe zdravila Olanzapin Teva pri starejših bolnikih z demenco ne priporočamo, ker ima lahko resne neželene učinke.
Do not take Olanzapine Teva: - if you are allergic to olanzapine or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na olanzapin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
- Very rarely, medicines of this type cause a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness.
- Zelo redko tovrstna zdravila povzročijo kombinacijo zvišanja telesne temperature, pospešenega dihanja, znojenja, okorelosti mišic in dremavosti ali zaspanosti.
Other medicines and Olanzapine Teva
Druga zdravila in zdravilo Olanzapin Teva
Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater 5HT than D activity in vivo models.
V pogojih in vitro je olanzapin pokazal večjo afiniteto za serotoninske 5-HT2 kot za dopaminske D2 receptorje in večjo 5-HT kot D aktivnost v modelih in vivo.
What Olanzapine Teva is and what it is used for
Kaj je zdravilo Olanzapin Teva in za kaj ga uporabljamo
Tardive dyskinesia11 Amnesia9
Tardivne diskinezije11 Amnezija9
Olanzapine Teva has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment.
Zdravilo Olanzapin Teva dokazano preprečuje ponoven pojav teh simptomov pri bolnikih z bipolarno motnjo, pri katerih se je manična epizoda po zdravljenju z olanzapinom izboljšala.
A small study of the effect of impaired liver function in 6 subjects with clinically significant (Childs Pugh Classification A (n = 5) and B (n = 1)) cirrhosis revealed little effect on the pharmacokinetics of orally administered olanzapine (2.5 - 7.5 mg single dose): Subjects with mild to moderate hepatic dysfunction had slightly increased systemic clearance and faster elimination half-time compared to subjects with no hepatic dysfunction (n = 3).
Majhna študija učinka okvarjene funkcije jeter pri 6 preiskovancih s klinično značilno cirozo (Childs Pugh klasifikacija A (n = 5) in B (n = 1)) je pokazala majhen učinek na farmakokinetiko peroralno apliciranega olanzapina (2,5-7,5 mg enojni odmerek): osebe z blago do zmerno jetrno okvaro so imele nekoliko povišan sistemski očistek in hitrejši razpolovni čas izločanja v primerjavi s preiskovanci brez jetrne okvare (n = 3).
Caution should be exercised and follow-up organised in patients with elevated ALT and/or AST, in patients with signs and symptoms of hepatic impairment, in patients with pre-existing conditions associated with limited hepatic functional reserve, and in patients who are being treated with potentially hepatotoxic medicines.
Pri bolnikih s zvišano ALT in/ali AST, bolnikih z znaki in simptomi okvarjenega delovanja jeter, bolnikih s prej obstoječimi stanji, povezanimi z omejeno jetrno funkcionalno rezervo, in pri bolnikih, ki se zdravijo s potencialno hepatotoksičnimi zdravili, je potrebna previdnost in nadaljnje spremljanje.
Dystonia (including oculogyration)11
(vključno z okulogiracijo)11
If you take more Olanzapine Teva than you should Patients who have taken more Olanzapine Teva than they should have experienced the following symptoms: rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Bolniki, ki so vzeli večji odmerek zdravila Olanzapin Teva, kot bi smeli, so imeli naslednje simptome: hitro bitje srca, vznemirjenost/nasilnost, težave pri govoru, nenavadne zgibke (posebno v mišicah obraza ali jezika) in zmanjšano stopnjo zavesti.
In addition, the 15 mg strength contains indigo carmine (E132) and the 20 mg strength contains iron oxide red (E172).
15 mg oblika zdravila poleg tega vsebuje še indigo karmin (E132), 20 mg oblika pa rdeč železov oksid (E172)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12.
Datum prve odobritve: 12. december 2007 Datum zadnjega podaljšanja: 12 december 2012
Ventricular tachycardia/fibrill ation, sudden death (see section 4.4)11
Prekatna tahikardija/fibrilacij a, nenadna smrt (glejte poglavje 4.4)11
Children and adolescents Olanzapine Teva is not for patients who are under 18 years.
Zdravilo Olanzapin Teva ni namenjeno bolnikom, mlajšim od 18 let.
It may be harmful for patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Lahko škoduje bolnikom, ki imajo fenilketonurijo, redko genetsko bolezen, pri kateri pride do kopičenja fenilalanina, ker se ne more ustrezno odstranjevati iz telesa.
Patients treated with any antipsychotic medicines, including olanzapine, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
moramo opazovati za znake in simptome hiperglikemije (kot so polidipsija, poliurija, polifagija in šibkost) ter redno spremljati bolnike s sladkorno boleznijo ali dejavniki tveganja za sladkorno bolezen glede poslabšanja nadzora glukoze.
Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
Hepatitis (vključno s hepatocelularno, holestatsko ali mešano okvaro jeter)11
- carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your Olanzapine Teva dose.
- zdravila za Parkinsonovo bolezen, - karbamazepin (antiepileptik in stabilizator razpoloženja), fluvoksamin (antidepresiv) ali ciprofloksacin (antibiotik) - morda bo treba spremeniti vaš odmerek zdravila Olanzapin Teva.
Development or exacerbation of
Razvoj ali poslabšanje sladkorne bolezni,
≥500 milliseconds [msec] at any time post baseline in patients with baseline QTcF <500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
[QTcF] ≥ 500 milisekund [msek] kadarkoli nad osnovno vrednostjo pri bolnikih z osnovno vrednostjo QTcF < 500 msek) pri bolnikih, zdravljenih z olanzapinom, redka (od 0,1 % do 1 %), brez pomembnih razlik v spremljajočih srčnih dogodkih v primerjavi z bolniki, zdravljenimi s placebom.
Olanzapine Teva film-coated tablets contain lactose.
Olanzapin Teva filmsko obložene tablete vsebujejo laktozo.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu<, and on the website of {name of MS Agency (link)}>.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu< in na spletni strani {ime agencije v državi članici (povezava)}>.
6 weeks).
65 let.
Olanzapine Teva with alcohol
Jemanje zdravila Olanzapin Teva skupaj z alkoholom
8 In clinical trials of up to 12 weeks, plasma prolactin concentrations exceeded the upper limit of normal range in approximately 30% of olanzapine treated patients with normal baseline prolactin value.
8 V kliničnih preskušanjih, ki so trajala do 12 tednov, so pri 30 % bolnikov z normalno začetno vrednostjo prolaktina, ki so se zdravili z olanzepinom, ugotovili zvišanje plazemske koncentracije prolaktina nad zgornjo mejo normalne vrednosti.
You should swallow the Olanzapine Teva tablets whole with water.
Olanzapin Teva tablete pogoltnite cele z vodo.
During treatment with olanzapine in combination with lithium or divalproex, an increase of ≥7% from baseline body weight occurred in 17.4% of patients during acute treatment (up to 6 weeks).
Med zdravljenjem z olanzapinom v kombinaciji z litijem ali divalproeksom se je pri 17,4 % bolnikov med akutnim zdravljenjem (do 6 tednov) pojavilo povečanje telesne mase za
In female versus male subjects the mean elimination half-life was somewhat prolonged (36.7 versus 32.3 hr) and the clearance was reduced (18.9 versus 27.3 l/hr).
Pri ženskah v primerjavi z moškimi je bil srednji razpolovni čas izločanja nekoliko podaljšan (36,7 v primerjavi z 32,3 ure) in očistek zmanjšan (18,9 v primerjavi s 27,3 l/h).
What Olanzapine Teva looks like and contents of the pack
Izgled zdravila Olanzapin Teva in vsebina pakiranja
5HT2A/2C, 5HT3, 5HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1 M5; α1 adrenergic; and histamine H1 receptors.
V predkliničnih študijah je olanzapin pokazal razpon afinitet do receptorjev (Ki; < 100 nM) za serotonin 5-HT2A/2C, 5-HT3, 5-HT6; dopamin D1, D2, D3, D4, D5; holinergičnih muskarinskih receptorjev M1 M5; adrenergičnih α1; in histaminskih H1 receptorjev.
There is a risk of feeling drowsy when you are given Olanzapine Teva.
Obstaja tveganje, da se boste po tem, ko ste dobili zdravilo Olanzapin Teva, počutili zaspane.
In postmarketing reports with olanzapine, the event of sudden cardiac death has been reported in patients with olanzapine.
V postmarketinških poročilih so pri bolnikih, ki so se zdravili z olanzepinom, poročali o primerih nenadne srčne smrti.
Do not drink any alcohol if you have been given Olanzapine Teva as together with alcohol it may make you feel drowsy.
Če ste dobili zdravilo Olanzapin Teva, ne pijte nobenega alkohola, saj lahko zdravilo Olanzapin Teva in alkohol skupaj povzročita občutek zaspanosti.
Olanzapine Teva contains lactose, sucrose and aspartame This medicine contains lactose and sucrose.
Zdravilo Olanzapin Teva vsebuje laktozo, saharozo in aspartam
Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo-controlled clinical trials (see section 4.8).
V kliničnih preskušanjih, kontroliranih s placebom, so pri bolnikih, zdravljenih z olanzapinom, opažali neželene spremembe lipidov (glejte poglavje 4.8).
In placebocontrolled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementiarelated psychosis and/or disturbed behaviours, there was a 2-fold increase in the incidence of death in olanzapine treated patients compared to patients treated with placebo (3.5% vs. 1.5%, respectively).
povezano z demenco in/ali vedenjskimi motnjami (povprečna starost 78 let), je bilo 2-kratno povečanje incidence smrti pri bolnikih, zdravljenih z olanzapinom, v primerjavi z bolniki, zdravljenimi s placebom (3,5 % v primerjavi z 1,5 %).
Urinary incontinence Urinary retention Urinary hesitation11
Urinska inkontinenca Zastajanje urina Težave z začetkom mokrenja11
SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Shranjujtepri temperaturi do 25 °C.
Excipient with known effect Each film-coated tablet contains 275.5 mg lactose.
Pomožna snov z znanim učinkom Ena filmsko obložena tableta vsebuje 275,5 mg laktoze.
Lemon flavour [flavouring preparation(s), maltodextrin, sucrose, gum arabic (E414), glyceryl triacetate (E1518) and alpha-Tocopherol (E307)]
saharoza, arabski gumi (E414), gliceriltriacetat (E1518) in α-tokoferol (E307)].
Lactose monohydrate Hydroxypropylcellulose Crospovidone type A Silica colloidal anhydrous Microcrystalline cellulose Magnesium stearate
Jedro tablete laktoza monohidrat hidroksipropilceluloza krospovidon (vrsta A) brezvodni koloidni silicijev dioksid, mikrokristalna celuloza magnezijev stearat
Olanzapine Teva contains the active substance olanzapine.
Zdravilo Olanzapin Teva vsebuje učinkovino olanzapin.
How to take Olanzapine Teva
Kako jemati zdravilo Olanzapin Teva
If you notice any of these symptoms seek medical advice immediately; - 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).
- kombinacijo zvišane telesne temperature, pospešenega dihanja, znojenja, mišične okorelosti in dremavosti ali zaspanosti (pogostnosti tega neželenega učinka iz razpoložljivih podatkov ni mogoče oceniti).
Olanzapine Teva 2.5 mg/5 mg/7.5 mg/10 mg film-coated tablets Colour mixture white (polydextrose, hypromellose, glycerol triacetate, macrogol 8000, titanium dioxide E171)
Olanzapin Teva 2,5 mg/5 mg/7,5 mg/10 mg filmsko obložene tablete bela barvna mešanica (polidekstroza, hipromeloza, triacetin, makrogol 8000, titanov dioksid E171) Olanzapin Teva 15 mg filmsko obložene tablete modra barvna mešanica (polidekstroza, hipromeloza, triacetin, makrogol 8000, titanov dioksid E171, indigo karmin E132)
In renally impaired patients (creatinine clearance <10 ml/min) versus healthy subjects, there was no significant difference in mean elimination half-life (37.7 versus 32.4 hr) or clearance (21.2 versus 25.0 l/hr).
Okvarjeno delovanje ledvic Pri bolnikih z okvarjenim delovanjem ledvic (očistek kreatinina < 10 ml/min) v primerjavi z zdravimi osebami ni bilo značilne razlike v srednjem razpolovnem času izločanja (37,7 v primerjavi z 32,4 ure)
Investigations Elevated plasma prolactin levels8
Zvišane plazemske koncentracije prolaktina8
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4)11
občasno povezane s ketoacidozo ali komo, vključno z nekaj smrtnimi primeri (glejte poglavje 4.4)
If you stop taking Olanzapine Teva
Če ste pozabili vzeti zdravilo Olanzapin Teva
A mass balance study showed that approximately 57% of radiolabelled olanzapine appeared in urine, principally as metabolites.
radioaktivno označenega olanzapina pojavi v urinu, predvsem v obliki metabolitov.