FrancophonIA/ELRC3.0 huggingface dataset:
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.
Danish: I disse forsøg skulle patienterne initialt være stabiliserede på den lavest effektive dosis af antiparkinsonbehandling (dopaminagonist) og skulle forblive på den samme antiparkinsonbehandling og dosering under hele forsøget.
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.
Danish: Ved behandling af skizofreni, en manisk episode og til forebyggelse af tilbagefald i bipolær lidelse kan den daglige dosering herefter justeres på basis af den individuelle kliniske status indenfor intervallet 5-20 mg/dag.
English: Very common
Danish: Meget almindelig Almindelig
English: Smokers
Danish: Rygere
English: Very common: Weight gain13, elevated triglyceride levels14, increased appetite.
Danish: Meget almindelig: Vægtstigning13, forhøjede triglyceridniveauer14 , øget appetit.
English: 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.
Danish: Dosisøgning udover den anbefalede startdosis kan kun anbefales efter en passende klinisk revurdering og bør generelt foretages med mindst 24 timers interval.
English: If this happens, contact your doctor at once.
Danish: Hvis dette forekommer, skal du omgående kontakte din læge.
English: Carcinogenicity Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Danish: På baggrund af resultater fra studier af mus og rotter blev det konkluderet, at olanzapin ikke er karcinogent.
English: The pharmacokinetic variability observed in the elderly is within the range for the non-elderly.
Danish: Den farmakokinetiske variation hos ældre forsøgspersoner er indenfor variationen hos ikke-ældre.
English: All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
Danish: Alle de olanzapin- og placebobehandlede patienter, som oplevede en cerebrovaskulær hændelse, havde præeksisterende risikofaktorer.
English: In patients with Parkinson's disease Olanzapine Mylan may worsen the symptoms.
Danish: Hos patienter med Parkinsons sygdom kan Olanzapine Mylan forværre symptomerne.
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.
Danish: Dødelig udgang er rapporteret efter akut overdosering med ned til 450 mg, men overlevelse er også rapporteret efter akut overdosering med ca. 2 g olanzapin oralt.
English: In the majority of these patients the elevations were generally mild, and remained below two times the upper limit of normal range.
Danish: Koncentrationsøgningen var generelt lille hos hovedparten af disse patienter, og den forblev under den dobbelte værdi af normalområdets øvre grænse.
English: • if you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
Danish: • hvis du tidligere har fået at vide, at du har en bestemt slags glaukom (grøn stær) med øget tryk i øjet.
English: Very rare side effects include serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Danish: Meget sjældne bivirkninger inkluderer alvorlige allergiske reaktioner såsom lægemiddelfremkaldt reaktion med eosinofili og systemiske symptomer (DRESS).
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).
Danish: Hyppighederne er defineret som følgende: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.
Danish: Olanzapin er effektivt i fastholdelsen af den kliniske bedring ved fortsat behandling af patienter, der har vist initial behandlingsrespons.
English: Bottles:
Danish: Flasker:
English: 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.
Danish: Olanzapin var ikke mutagen eller clastogen i en række standardtests, der omfattede bakterielle mutationstests og in vitro og in vivo tests på pattedyr.
English: Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
Danish: Der skal udvises forsigtighed hos patienter, som indtager alkohol eller får lægemidler, der kan undertrykke centralnervesystemet.
English: Pregnancy, puerperium and perinatal conditions
Danish: Graviditet, puerperium og den perinatale periode
English: The following table lists the adverse reactions and laboratory investigations observed from spontaneous reporting and in clinical trials.
Danish: Følgende tabel viser bivirkninger og laboratorieundersøgelser set i spontane indberetninger og i kliniske forsøg.
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.
Danish: På grund af manglende detaljeret information om tidligere individuelle akutte og tardive ekstrapyramidale bevægelsesforstyrrelser, kan det for nuværende ikke konkluderes, at olanzapin forårsager mindre tardiv dyskinesi og/eller andre tardive ekstrapyramidale syndromer.
English: • medicines for Parkinson's disease.
Danish: • Medicin mod Parkinsons sygdom.
English: In the study, the risk of olanzapine was comparable to the risk of atypical antipsychotics included in a pooled analysis.
Danish: Risikoen forbundet med olanzapin var i studiet sammenlignelig med risikoen forbundet med de atypiske antipsykotika, som var inkluderet i en pooled analyse.
English: Olanzapine was started at 2.5 mg/day and titrated to a maximum of 15 mg/day based on investigator judgement.
Danish: Olanzapin blev initieret på 2,5 mg/dag og titreret til maksimalt 15 mg/dag, baseret på lægens vurdering.
English: Olanzapine showed no interaction when co-administered with lithium or biperiden.
Danish: Olanzapin viste ingen interaktioner, når det blev administreret samtidig med lithium eller biperiden.
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.
Danish: I begyndelsen af behandlingen kan nogle patienter føle svimmelhed eller svaghed (med langsom puls), særligt når de rejser sig fra liggende eller siddende stilling.
English: Children and adolescents Olanzapine Mylan is not for patients who are under 18 years.
Danish: Børn og unge Olanzapine Mylan er ikke beregnet til patienter under 18 år.
English: Olanzapine is bound predominantly to albumin and 1-acid-glycoprotein.
Danish: Olanzapin er overvejende bundet til albumin og surt 1-glykoprotein.
English: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Danish: Lægemiddelfremkaldt reaktion med eosinofili og systemiske symptomer (DRESS)
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.
Danish: I 2 ud af 2 placebo- og 2 ud af 3 komparatorkontrollerede studier af mere end 2.900 skizofrene patienter med både positive og negative symptomer blev olanzapin forbundet med statistisk signifikante større forbedringer af negative såvel som af positive symptomer.
English: Neuroleptic Malignant Syndrome (NMS)
Danish: Malignt neuroleptikasyndrom (NMS)
English: Olanzapine is indicated for the treatment of schizophrenia.
Danish: Olanzapin er indiceret til behandling af skizofreni.
English: In cytopenic dogs, there were no adverse effects on progenitor and proliferating cells in the bone marrow.
Danish: Hos cytopeniske hunde var der ingen bivirkninger på stamceller og prolifererende celler i knoglemarven.
English: 3 years.
Danish: Flaske: 3 år.
English: 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.
Danish: Betydningen af forskellene i olanzapins clearance og halveringstid grundet alder, køn eller rygning er imidlertid lille i forhold til den generelle variation fra person til person.
English: Olanzapine also showed a statistically significant advantage over placebo in terms of preventing either recurrence into mania or recurrence into depression.
Danish: Olanzapin viste også en statistisk signifikant fordel overfor placebo i form af forebyggelse af enten tilbagefald til mani eller tilbagefald til depression.
English: Bradycardia QTc prolongation (see section 4.4)
Danish: Bradykardi QTc -forlængelse (se pkt.
English: Elevated triglyceride levels2,5
Danish: Forhøjede triglyceridniveauer2,5
English: In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 6 months.
Danish: Hos voksne patienter, som fuldførte 9-12 måneders behandling, aftog hyppigheden i stigning af middelblodglucose efter ca. 6 måneder.
English: Very common: Decreased total bilirubin, increased GGT, elevated plasma prolactin levels16.
Danish: Meget almindelig: Nedsat total-bilirubin, forhøjet GGT, forhøjet plasma-prolaktin16.
English: Symptomatic treatment and monitoring of vital organ function should be instituted according to clinical presentation, including treatment of hypotension and circulatory collapse and support of respiratory function.
Danish: Symptomatisk behandling og overvågning af de vitale organers funktion bør indledes afhængig af den kliniske tilstand, inklusiv behandling af hypotension og kredsløbssvigt samt understøtning af den respiratoriske funktion.
English: You should swallow the Olanzapine Mylan tablets whole with water.
Danish: Du bør synke Olanzapine Mylan tabletterne hele med vand.
English: Do not use this medicine after the expiry date, which is stated on the carton or label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen eller etiketten, efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Olanzapine is an antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacologic profile across a number of receptor systems.
Danish: Olanzapin er et antipsykotisk, antimanisk og stemningsstabiliserende lægemiddelstof med en bred farmakologisk profil omfattende adskillige receptorsystemer.
English: Inhibition of CYP1A2
Danish: Inhibition af CYP1A2
English: Olanzapine is indicated for the treatment of moderate to severe manic episode.
Danish: Olanzapin er indiceret til behandling af moderat til svær manisk episode.
English: Patients with known risk of narrow-angle glaucoma.
Danish: Patienter med kendt risiko for snævervinklet glaukom.
English: Very common: Sedation (including: hypersomnia, lethargy, somnolence).
Danish: Meget almindelig: Sedation (inklusive: hypersomni, letargi, døsighed).
English: In 44 patients with schizophrenia > 65 years of age, dosing from 5 to 20 mg/day was not associated with any distinguishing profile of adverse events.
Danish: Hos 44 patienter > 65 år med skizofreni gav dosering med 5-20 mg/dag ingen udsving i bivirkningsprofilen.
English: The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to
Danish: Hyppighederne er defineret som følgende: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10).
English: Reproductive system and breast disorders Erectile dysfunction in males
Danish: Det reproduktive system og mammae Erektil dysfunktion hos mænd
English: In a study in breast-feeding, healthy women, olanzapine was excreted in breast milk.
Danish: I et studie af raske, ammende kvinder blev olanzapin udskilt i mælken.
English: The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
Danish: Olanzapins metabolisering kan induceres ved rygning eller af carbamazepin, hvilket kan medføre reducerede olanzapin koncentrationer.
English: A decrease in the dose of olanzapine should be considered if treatment with an inhibitor of CYP1A2 is initiated.
Danish: En nedsat dosis af olanzapin bør overvejes, hvis behandling med en inhibitor af CYP1A2 initieres.
English: 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.
Danish: Olanzapin bør ikke anvendes til børn og unge under 18 år på grund af manglende dokumentation for sikkerhed og virkning.
English: Standard procedures for management of overdose may be indicated (i.e. gastric lavage, administration of activated charcoal).
Danish: Standard procedurer til behandling af overdosering kan være indiceret (fx ventrikelskylning, administration af aktivt kul).
English: Pharmacotherapeutic group: psycholeptics, diazepines, oxazepines, thiazepines and oxepines, ATC code: N05AH03.
Danish: Farmakoterapeutisk klassifikation: Psykoleptika, diazepiner, oxazepiner, thiazepiner og oxepiner, ATC-kode: N05A H03
English: General CNS activity
Danish: Almindelig CNS aktivitet
English: Olanzapine reduced a conditioned avoidance response, a test indicative of antipsychotic activity, at doses below those producing catalepsy, an effect indicative of motor side-effects.
Danish: Olanzapin hæmmede et klassisk betinget respons (conditioned avoidance response), en test der indikerer antipsykotisk aktivitet, ved lavere doser end de, der frembringer katalepsi, en effekt der indikerer motoriske bivirkninger.
English: Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
Danish: Der skal udvises forsigtighed, hvis olanzapin administreres samtidig med lægemidler, som øger QTcintervallet (se pkt 4.4).
English: The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
Danish: Olanzapins plasmaclearance er lavere hos: ældre end hos yngre personer, kvinder end hos mænd og ikke-rygere end hos rygere.
English: A lower starting dose of olanzapine should be considered in patients who are using fluvoxamine or any other CYP1A2 inhibitors, such as ciprofloxacin.
Danish: En lavere startdosis af olanzapin bør overvejes hos patienter, som anvender fluvoxamin eller andre CYP1A2 inhibitorer, såsom ciprofloxacin.
English: Marketing Authorisation Holder Mylan S.A.S., 117 Allée des Parcs, 69800 Saint-Priest, France.
Danish: Indehaver af markedsføringstilladelsen Mylan S.A.S., 117 Allée des Parcs, 69800 Saint-Priest, Frankrig.
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.
Danish: Elektrofysiologiske undersøgelser viste, at olanzapin selektivt reducerede "firing" ved de mesolimbiske (A10) dopaminerge neuroner, hvorimod det kun havde lille påvirkning af de striatale (A9) baner for motorisk funktion.
English: The metabolism of olanzapine may be induced by smoking.
Danish: Metaboliseringen af olanzapin kan induceres ved rygning.
English: Schizophrenia: The recommended starting dose for olanzapine is 10 mg/day.
Danish: Skizofreni: Den anbefalede startdosis af olanzapin er 10 mg/dag.
English: 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.
Danish: Risikofaktorer, som kan prædisponere denne patientpopulation til øget mortalitet, inkluderer alder >65 år, dysfagi, sedation, fejlernæring og dehydrering, pulmonale tilstande (f.eks. pneumoni, med eller uden aspiration) eller samtidig brug af benzodiazepiner.
English: Age >75 years and vascular/mixed type dementia were identified as risk factors for CVAE in association with olanzapine treatment.
Danish: Alder >75 år og vaskulær/blandet demens blev identificeret som risikofaktorer for cerebrovaskulære hændelser i relation til olanzapinbehandling.
English: You should not be given this medicine when breast-feeding, as small amounts of olanzapine can pass into breast milk.
Danish: Du bør ikke få denne medicin, mens du ammer, da små mængder Olanzapine Mylan kan overføres til modermælken.
English: 117 Allée des Parcs 69800 Saint-Priest France
Danish: 117 Allée des Parcs 69800 Saint-Priest Frankrig
English: Hepatitis (including hepatocellular, cholestatic or mixed liver injury)11
Danish: Hepatitis (inklusive hepatocellulær kolestatisk eller blandet leverskade)11
English: Induction of CYP1A2
Danish: Induktion af CYP1A2
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.
Danish: Som følge af olanzapins primære effekt på centralnervesystemet bør der udvises forsigtighed, når stoffet anvendes i kombination med andre centralt virkende lægemidler og alkohol.
English: The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/LDL/HDL cholesterol or triglycerides increased over time.
Danish: Andelen af patienter, som fik kritisk, klinisk signifikante ændringer i vægtøgning, glucose, total/LDL/HDL-cholesterol eller triglycerider, blev forøget over tid.
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.
Danish: Demensrelaterede psykoser og/eller adfærdsforstyrrelser Olanzapin bør ikke anvendes hos patienter med demensrelateret psykose og/eller adfærdsforstyrrelse på grund af øget mortalitet og risiko for cerebrovaskulære hændelser.
English: • The use of Olanzapine Mylan in elderly patients with dementia is not recommended as it may have serious side effects.
Danish: • Olanzapine Mylan anbefales ikke til ældre, demente patienter, da det kan have alvorlige bivirkninger.
English: Mean infant exposure (mg/kg) at steady state was estimated to be 1.8 % of the maternal olanzapine dose (mg/kg).
Danish: Den gennemsnitlige dosis, som barnet blev udsat for (mg/kg), blev ved steady state bestemt til at være 1,8 % af moderens olanzapindosis (mg/kg).
English: • A blocked intestine (Paralytic ileus)
Danish: • Tarmslyng (paralytisk ileus)
English: Oestrous cycles were affected at doses of 1.1 mg/kg (3 times the maximum human dose) and reproduction parameters were influenced in rats given 3 mg/kg (9 times the maximum human dose).
Danish: Østralperioder blev påvirket ved doser på 1,1 mg/kg (3 gange maksimal human dosis), og reproduktionsparametre påvirkedes hos rotter, der fik 3 mg/kg (9 gange maksimal human dosis).
English: Very common adverse reactions associated with the use of olanzapine in this patient group were abnormal gait and falls.
Danish: Meget almindelige bivirkninger i forbindelse med brugen af olanzapin til denne patientgruppe var unormal gang og fald.
English: However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors.
Danish: Forekomsten af dødsfald var dog højere hos olanzapin-behandlede patienter end hos patienter, behandlet med placebo, uafhængig af disse risikofaktorer.
English: There were more smokers among subjects with cirrhosis (4/6; 67 %) than among subjects with no hepatic dysfunction (0/3; 0 %).
Danish: Der var flere rygere blandt forsøgspersoner med cirrose (4/6; 67 %) end blandt forsøgspersoner uden nedsat leverfunktion (0/3; 0
English: Do not take a double dose to make up for the forgotten tablet.
Danish: Tag dine tabletter lige så snart, du kommer i tanke om det. Du må ikke tage dobbelt dosis for at udligne den glemte tablet.
English: METHOD AND ROUTE OF ADMINISTRATION Oral use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ Til oral anvendelse.
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.
Danish: Langvarig olanzapinbehandling (op til 12 måneder) forebyggende mod tilbagefald hos patienter med bipolær sygdom blev forbundet med en stigning på ≥7 % af baseline legemsvægt hos 39,9 % af patienterne.
English: PC: {number} SN: {number} NN: {number}
Danish: SN: {nummer} NN: {nummer}
English: Hypothermia12
Danish: Hypotermi12
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.
Danish: Den følgende tabel opsummerer de bivirkninger, som blev rapporteret med større frekvens hos unge patienter (alder 13 - 17 år) end hos voksne patienter, eller bivirkninger som kun blev identificeret i kortvatige kliniske forsøg med unge patienter.
English: Since olanzapine is metabolised by CYP1A2, substances that can specifically induce or inhibit this isoenzyme may affect the pharmacokinetics of olanzapine.
Danish: Da olanzapin metaboliseres af CYP1A2, kan substanser, som specifikt inducerer eller inhiberer dette isoenzym, påvirke farmakokinetikken af olanzapin.
English: The use of olanzapine in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease is not recommended.
Danish: Anvendelse af olanzapin til behandling af dopaminagonist-relateret psykose hos patienter med Parkinsons sygdom kan ikke anbefales.
English: Patients who have taken more olanzapine 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.
Danish: Patienter, som har taget mere Olanzapine Mylan end de burde, har oplevet følgende symptomer: Hurtig hjerterytme, ophidselse/aggression, problemer med at tale, usædvanlige bevægelser (især af ansigt eller tunge) eller nedsat bevidsthedsniveau (døsighed).
English: Cytochromes P450CYP1A2 and P450-CYP2D6 contribute to the formation of the N-desmethyl and 2-hydroxymethyl metabolites, both exhibited significantly less in vivo pharmacological activity than olanzapine in animal studies.
Danish: Cytochrom P450-CYP1A2 og P450-CYP2D6 bidrager til dannelsen af N-desmethyl og 2-hydroxymethyl metabolitterne, der udviser signifikant mindre in vivo farmakologisk aktivitet end olanzapin i dyrestudier.
English: In addition, a Single Photon Emission Computed Tomography (SPECT) imaging study in schizophrenic patients revealed that olanzapine-responsive patients had lower striatal D2 occupancy than some other antipsychoticand risperidone-responsive patients, while being comparable to clozapine-responsive patients.
Danish: Desuden afslørede et Single Photon Emission Computed Tomography (SPECT) studie af skizofrene patienter, at olanzapin-responderende patienter havde en lavere striatal D2-binding end visse andre antipsykotika- og risperidon-responderende patienter, hvorimod det var sammenligneligt med clozapin-responderende patienter.