natgillin/translations-raw huggingface dataset:
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.
olanzapinom nadaljevati (po potrebi s prilagajanjem odmerka) hkrati z dopolnilno terapijo za zdravljenje simptomov razpolož enja, kot je klinič indicirano. no
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.
2 Med zdravljenjem shizofrenije in manič epizode in med prepreč
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.
Več poveč od priporoč
2 Olanzapine can be given without regards for meals as absorption is not affected by food.
Bolniki lahko jemljejo olanzapin ne glede na obroke, ker hrana ne vpliva na absorpcijo.
Gradual tapering of the dose should be considered when discontinuing olanzapine.
Med ukinjanjem olanzapina je treba odmerek zmanjš evati postopno.
Children and adolescents Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
otrocih in mladostnikih, mlajš od 18 let.
A greater magnitude of weight gain, lipid and prolactin alterations has been reported in short term studies of adolescent patients than in studies of adult patients (see sections 4.4, 4.8, 5.1 and 5.2).
V kratkotrajnih raziskavah na bolnih mladostnikih so ih poroč o več poveč telesne mase in o spremenjenih vrednostih lipidov in prolaktina kot v
Elderly 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 also section 4.4).
etnim odmerkom (5 mg na dan) zdravite bolnike, stare več 65 let, kadar to kot
Renal and/ or hepatic impairment A lower starting dose (5 mg) should be considered for such patients.
Okvarjeno ledvič in/ ali jetrno delovanje no Te bolnike zač zdraviti z manjš odmerki (5 mg).
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.
delovanjem (ciroza, stopnja jetrne okvare Child- Pugh razreda A ali B) zač zdraviti z odmerkom po nite 5 mg in ga previdno poveč ujte
Gender The starting dose and dose range need not be routinely altered for female patients relative to male patients.
Spol Zač odmerek in razpon dajanja odmerkov je enak za bolnice in bolnike. etni
Smokers The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
Kadilci Zač odmerek in razpon dajanja odmerkov je enak za nekadilce in kadilce. etni
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.
Č je prisoten več en dejavnik, ki bi lahko prispeval k poč
Dose escalation, when indicated, should be conservative in such patients.
asnejšpresnovi (ž i enski spol, starostnik,
(See sections 4.5 and 5.2.)
Pri poveč
4.3 Contraindications
evanju odmerka, kadar je to
Hypersensitivity to the active substance or to any of the excipients.
indicirano, bodite pri takih bolnikih previdni.
Patients with known risk for narrow-angle glaucoma.
Preobčutljivost za aktivno uč inkovino ali katerokoli pomož snov. no Bolniki s tveganjem za razvoj glavkoma z zaprtim zakotjem.
During antipsychotic treatment, improvement in the patient's clinical condition may ta ke several days to some weeks.
Med zdravljenjem z antipsihotiki je treba bolnike skrbno opazovati.
Patients should be closely monitored during this period.
Njihovo klinič stanje se lahko no izboljš v nekaj dneh do nekaj tednih. a
Dementia-related psychosis and/ or behavioural disturbances Olanzapine is not approved for the treatment of dementia-related psychosis and/ or behavioural disturbances and is not recommended for use in this particular group of patients because of an increase in mortality and the risk of cerebrovascular accident.
Psihoza, povezana z demenco, in/ ali vedenjske motnje Olanzapin ni odobren za zdravljenje bolnikov s psihozo, povezano z demenco, in/ ali vedenjskimi motnjami in zaradi poveč umrljivosti in tveganja za mož uporabo pri teh bolnikih.
In placebo-controlled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementia-related 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.
tednov), pri starejš bolnikih s psihozo, povezano z demenco, in/ ali vedenjskimi motnjami ih (povpreč starost 78 let), je bilo 2- krat več
1.5%, respectively).
smrtnih primerov med bolniki, zdravljenimi z
The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
olanzapinom, kot med bolniki, zdravljenimi s placebom (3, 5% v primerjavi z 1, 5%).
Risk factors that may predispose this patient population to increased mortality include age > 65 years, dysphagia, sedation, malnutrition and dehydration, pulmonary conditions (e. g., pneumonia, with or without aspiration), or concomitant use of benzodiazepines.
Dejavniki tveganja, ki pri tej skupini bolnikov lahko vplivajo na več umrljivost, so jo starost več 65 let, tež s pož
However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors.
iranjem, sedacija, nezadostna prehrana ali dehidracija, pljuč
In the same clinical trials, cerebrovascular adverse events (CVAE e. g., stroke, transient ischemic attack), including fatalities, were reported.
obolenja (npr. pljuč z aspiracijo ali brez nje) ali soč
There was a 3-fold increase in CVAE in patients treated
Vendar je bila
3 with olanzapine compared to patients treated with placebo (1.3% vs.
3 smrtnost, neodvisno od omenjenih dejavnikov tveganja, več pri bolnikih, zdravljenih z olanzapinom, ja kot pri bolnikih, zdravljenih s placebom.
0.4%, respectively).
Pri bolnikih, zdravljenih z olanzapinom, je
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
Vsi kot bolniki, ki so jemali olanzapin ali placebo in so dož mož
Age > 75 years and vascular/ mixed type dementia were identified as risk factors for CVAE in association with olanzapine treatment.
Starost več 75 let in vaskularna/ meš demenca sta bili določ kot
The efficacy of olanzapine was not established in these trials.
povezane z dopaminskimi agonisti, pri bolnikih s
Parkinson's disease The use of olanzapine in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease is not recommended.
halucinacijah poroč zelo pogosto in pogosteje ali zdravljenju psihotič simptomov ni bil uč
In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo (see section 4.8), and olanzapine was not more effective than placebo in the treatment of psychotic symptoms.
treba najprej ustaliti ob prejemanju najmanjš uč ega inkovitega odmerka antiparkinsonskih zdravil (dopaminskih agonistov).
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.
Zač odmerek olanzapina je bil 2, 5 mg na dan, nato pa so ga na podlagi presoje etni preiskovalca postopoma poveč
Olanzapine was started at 2.5 mg/ day and titrated to a maximum of 15 mg/ day based on investigator judgement.
evali do največ odmerka, ki je znaš 15 mg na dan. jega al
Neuroleptic Malignant Syndrome (NMS) NMS is a potentially life-threatening condition associated with antipsychotic medicinal product.
Nevroleptič maligni sindrom (NMS) je stanje, ki je povezano z jemanjem antipsihotikov in lahko ni ogrož ž a ivljenje.
Rare cases reported as NMS have also been received in association with olanzapine.
O redkih primerih tega sindroma so poroč tudi v povezavi z jemanjem olanzapina. ali Klinič manifestacije so zviš telesna temperatura, miš na okorelost, motnje zavesti in znaki
Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia).
avtonomne nestabilnosti (nepravilen srč utrip ali neurejen krvni tlak, tahikardija, č
Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Č se pri bolniku pojavijo znaki in simptomi, ki kaž na
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.
klinič manifestacij, je treba prekiniti zdravljenje z vsemi antipsihotiki, vključ z olanzapinom.
Hyperglycaemia and diabetes Hyperglycaemia and/ or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported rarely, including some fatal cases (see section 4.8).
Hiperglikemija in diabetes Redko so poroč o hiperglikemiji in/ ali razvoju ali poslabš sladkorne bolezni, vključ z nekaj
In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
Zlasti
Appropriate clinical monitoring is advisable particularly in diabetic patients and in patients with risk factors for the development of diabetes mellitus for which regular glucose control is recommended.
sladkorne bolnike in bolnike z dejavniki tveganja za razvoj sladkorne bolezni, za katere je priporoč en reden nadzor glukoze, je treba klinič spremljati. no
Lipid alterations Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo- controlled clinical trials (see section 4.8).
anjih, nadzorovanih s placebom, so pri bolnikih, ki so jemali olanzapin, opazili
Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
Te spremembe je treba klinič ustrezno no zdraviti, zlasti pri bolnikih z dislipidemijo in bolnikih z dejavniki tveganja za razvoj motenj lipidov.
Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Antiholinergič delovanje no Medtem ko je olanzapin v pogojih in vitro deloval antiholinergič so klinič preizkuš razkrila
However, as clinical experience with olanzapine in patients with concomitant illness is limited, caution is advised when prescribing for patients with prostatic hypertrophy, or paralytic ileus and related conditions.
Pri etku bolnikih z zviš vrednostjo ALT in/ ali AST, bolnikih z znaki in simptomi okvarjenega delovanja ano jeter, bolnikih s stanji, povezanimi z zmanjš rezervo v jetrnem delovanju, in pri bolnikih, ki se ano nimi zdravili, je potrebna previdnost.
Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
4 odmerek olanzapina.
Caution should be exercised 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.
Bolnike, pri katerih je ugotovljen hepatitis (vključ s hepatocelularno, no holestatsko ali meš jetrno okvaro), je treba prenehati zdraviti z olanzapinom. ano
In the event of elevated ALT and/ or AST during treatment, follow- up should be organised and dose reduction should be considered.
Nevtropenija Previdnost je potrebna tudi pri bolnikih, ki imajo iz kateregakoli vzroka nizko koncentracijo levkocitov in/ ali nevtrofilcev, in pri bolnikih, ki jemljejo zdravila, za katera je znano, da povzroč ajo nevtropenijo.
In cases where hepatitis (including hepatocellular, cholestatic or mixed liver injury) has been diagnosed, olanzapine treatment should be discontinued.
Previdnost je prav tako potrebna pri bolnikih, ki so imeli v preteklosti tež zaradi ave zavrtega delovanja kostnega mozga, ki so ga povzroč zdravila, toksič za kostni mozeg, pri
4 Neutropenia Caution should be exercised in patients with low leukocyte and/ or neutrophil counts for any reason, in patients receiving medicines known to cause neutropenia, in patients with a history of drug-induced bone marrow depression/ toxicity, in patients with bone marrow depression caused by concomitant illness, radiation therapy or chemotherapy and in patients with hypereosinophilic conditions or with myeloproliferative disease.
bolnikih z zavrtim delovanjem kostnega mozga zaradi soč bolezni, obsevanja ali kemoterapije in asne pri bolnikih s hipereozinofilnimi stanji ali z mieloproliferativno boleznijo.
Neutropenia has been reported commonly when olanzapine and valproate are used concomitantly (see section 4.8).
Ob soč olanzapina in valproata so pogosto poroč o nevtropeniji (gl. poglavje 4. 8). ali
Discontinuation of treatment Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported very rarely (< 0.01%) when olanzapine is stopped abruptly.
Zelo redko (< 0, 01%) so pri nenadni prekinitvi zdravljenja z olanzapinom poroč o akutnih ali simptomih, kot so znojenje, nespečnost, tresenje, obč tesnobe, slabost ali bruhanje. utek
QT interval In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 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.
popravljen po Fridericiju / Friderici QT correction, QTcF /, ≥500 milisekund / ms / kadarkoli nad osnovno vrednostjo pri bolnikih z osnovno vrednostjo QTcF < 500 ms) pri bolnikih, zdravljenih z olanzapinom, redka (od 0, 1% do 1%) in brez pomembnih razlik v spremljajoč srč dogodkih v ih nih primerjavi z bolniki, zdravljenimi s placebom.
However, as with other antipsychotics, caution should be exercised when olanzapine is prescribed with medicines known to increase QTc interval, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia.
intervala QT, kongestivnim srč popušanjem, srč hipertrofijo, hipokaliemijo ali hipomagneziemijo.
Thromboembolism Temporal association of olanzapine treatment and venous thromboembolism has very rarely (< 0.01%) been reported.
Zelo redko (< 0, 01%) so poroč o pojavu venske trombembolije (VTE) med zdravljenjem z ali olanzapinom, vendar vzroč povezave niso ugotovili.
A causal relationship between the occurrence of venous thromboembolism and treatment with olanzapine has not been established.
Ker pa so pri bolnikih s shizofrenijo pogosto ne prisotni pridobljeni dejavniki tveganja za VTE, je treba ugotoviti vse mož dejavnike tveganja za ne VTE (npr. imobilizacija bolnikov) ter preventivno ukrepati.
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.
inkov olanzapina na osrednje ž evje je potrebna previdnost, kadar se ga jemlje v Zaradi primarnih uč
General CNS activity Given the primary CNS effects of olanzapine, caution should be used when it is taken in combination with other centrally acting medicines and alcohol.
kombinaciji z drugimi zdravili, ki delujejo na osrednje ž evje, in z alkoholom.
As it exhibits in vitro dopamine antagonism, olanzapine may antagonize the effects of direct and indirect dopamine agonists.
V pogojih in vitro ivč deluje olanzapin kot antagonist dopamina, zato lahko zavira posredne in neposredne učinke dopaminskih agonistov.
Seizures Olanzapine should be used cautiously in patients who have a history of seizures or are subject to factors which may lower the seizure threshold.
Olanzapin dajemo previdno bolnikom, ki so imeli v preteklosti epileptič napade ali so podvrž
Seizures have been reported to occur rarely in patients when treated with olanzapine.
Več teh bolnikov je imela napade ž v
In most of these cases, a history of seizures or risk factors for seizures was reported.
preteklosti ali pa so bili pri njih prisotni dejavniki tveganja za epileptič napad. ni
Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
Ker pa tveganje za tardivne
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.
diskinezije naraša s trajanjem zdravljenja, je treba ob simptomih ali znakih tardivne diskinezije pri bolniku, ki jemlje olanzapin, razmisliti o zmanjš odmerka ali ukinitvi zdravila.
These symptoms can temporally deteriorate or even arise after discontinuation of treatment.
Simptomi se lahko anju sčasoma poslabš lahko pa se pojavijo celo po prenehanju zdravljenja. ajo,
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
anjih z olanzapinom so pri starejš bolnikih redko poroč o posturalni ih ali
As with other antipsychotics, it is recommended that blood pressure is measured periodically in patients over 65 years.
Pri starejš od 65 let je zato priporoč redno merjenje krvnega tlaka, tako kot pri
Use in children and adolescents under 18 years of age Olanzapine is not indicated for use in the treatment of children and adolescents.
Uporaba pri otrocih in mladostniki, h mlajš od 18 let ih
Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels.
V raziskavah na bolnikih, starih od 13 do 17 let, so ugotovili različ než
Long-term outcomes associated with these events have not been studied and remain unknown (see sections 4.8 and 5.1).
prouč evali in ostajajo neznani (gl. poglavji 4. 8 in 5. 1).
5 Lactose Zalasta tablets contain lactose.
Laktoza Zalasta vsebuje laktozo.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjš ane aktivnosti laktaze ali malabsorpcijo glukoze/ galaktoze ne smejo jemati tega zdravila.
Potential interactions affecting olanzapine Since olanzapine is metabolised by CYP1A2, substances that can specifically induce or inhibit this isoenzyme may affect the pharmacokinetics of olanzapine.
Mož medsebojna delovanja, ki vplivajo na olanzapin na Olanzapin se presnavlja z izoencimom 1A2 citokroma P450 (CYP1A2), zato lahko snovi, ki specifič poveč ali zavirajo delovanje tega izoencima, vplivajo na farmakokinetiko olanzapina.
Induction of CYP1A2 The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
Poveč delovanje CYP1A2 ano Presnovo olanzapina lahko pospeš kajenje in karbamazepin, kar lahko povzročzniž
Only slight to moderate increase in olanzapine clearance has been observed.
Ugotovili so le blago do zmerno poveč oč anje istka olanzapina.
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).
Klinične posledice so verjetno omejene, kljub vsemu je priporoč spremljati klinič stanje in poveč odmerek olanzapina, č je potrebno (gl. poglavje 4. 2). e
Inhibition of CYP1A2 Fluvoxamine, a specific CYP 1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
pri kadilcih pa 77- odstotno, srednje poveč obsega absorpcije olanzapina pa je bilo 52 - oziroma anje 108- odstotno.
The mean increase in olanzapine Cmax following fluvoxamine was 54% in female non- smokers and 77% male smokers.
Pri bolnikih, ki jemljejo fluvoksamin ali druge zaviralce CYP1A2, npr. ciprofloksacin, je treba razmisliti o manjš zač
The mean increase in olanzapine AUC was 52% and 108% respectively.
etnem odmerku olanzapina.
A lower starting dose of olanzapine should be considered in patients who are using fluvoxamine or any other CYP1A2 inhibitors, such as ciprofloxacin.
Odmerek olanzapina je treba zmanjš č se uvede zdravljenje z zaviralcem CYP1A2. ati, e
A decrease in the dose of olanzapine should be considered if treatment with an inhibitor of CYP 1A2 is initiated.
Zauž ga je treba
Decreased bioavailability Activated charcoal reduces the bioavailability of oral olanzapine by 50 to 60% and should be taken at least 2 hours before or after olanzapine.
vsaj dve uri pred olanzapinom ali vsaj dve uri po njem.
Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
Za fluoksetin (zaviralec CYP2D6) in posamezne odmerke antacida (aluminij, magnezij) ali cimetidina niso ugotovili, da bi znač vplivali na farmakokinetiko olanzapina. ilno
Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Zmož vpliva olanzapina na druga zdravila nost Olanzapin lahko zmanjš uč neposrednih in posrednih dopaminskih agonistov. a inek
Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e. g.
Olanzapin v pogojih in vitro ne zavira delovanja glavnih izoencimov citokroma P450 (npr.
Thus no particular interaction is expected as verified through in vivo studies where no inhibition of metabolism of the following active substances was found: tricyclic antidepressant (representing mostly CYP2D6 pathway), warfarin (CYP2C9), theophylline (CYP1A2) or diazepam (CYP3A4 and 2C19).
To so potrdile tudi raziskave in vivo, v katerih niso ugotovili nobenega zaviranja presnove triciklič antidepresivov (ki se presnavljajo s CYP2D6), varfarina (CYP2C9), teofilina nih (CYP1A2) ali diazepama (CYP3A4 in 2C19).
Olanzapine showed no interaction when co-administered with lithium or biperiden.
Olanzapin ni kazal interakcij ob soč asnem dajanju z litijem ali biperidenom.
General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
Pri bolnikih, ki pijejo alkohol ali jemljejo zdravila, ki lahko povzroč depresijo osrednjega ž evja, je potrebna previdnost.
The concomitant use of olanzapine with anti-Parkinsonian medicinal products in patients with Parkinson's disease and dementia is not recommended (see section 4.4).
eno asno jemanje olanzapina in antiparkinsonskih zdravil (gl. poglavje 4. 4).
QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
6 Interval QTc Č predpisujemo olanzapin soč e asno z zdravili, za katera je znano, da podaljš ujejo interval QTc, je potreba previdnost (gl. poglavje 4. 4).
6 4.6 Pregnancy and lactation
4. 6 Noseč in dojenje nost
Pregnancy:
Noseč nost:
There are no adequate and well-controlled studies in pregnant women.
Pri noseč nicah niso bile opravljene dovolj dobro kontrolirane raziskave.
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with olanzapine.
Zaradi omejenih izkuš je
Nevertheless, because human experience is limited, olanzapine should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
upravič samo, č je predvidena korist za plod več od morebitnega tveganja.