FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Danish: Derfor forventes ingen særlig interaktion, hvilket bekræftes af in vivo studier, hvor der ikke blev fundet inhibition af metaboliseringen af følgende aktive substanser: tricykliske antidepressiva (hovedsageligt CYP2D6), warfarin (CYP2C9), theophyllin (CYP1A2) eller diazepam (CYP3A4 og 2C19).
English: Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported rarely (≥ 0.01 % and < 0.1 %) when olanzapine is stopped abruptly.
Danish: Akutte symptomer såsom perspiration, søvnløshed, rysten, angst, kvalme eller opkastning er rapporteret sjældent (≥ 0,01 % og < 0,1 %) når olanzapin stoppes pludseligt.
English: During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
Danish: Under antipsykotisk behandling kan det tage flere dage eller nogle uger, før patientens kliniske tilstand bedres.
English: • unusual movement (a common side effect that may affect up to 1 in 10 people) mainly of the face or tongue;
Danish: • Unormale bevægelser (en almindelig bivirkning, som forekommer hos op til 1 ud af 10 patienter) særligt i ansigtet eller tungen (grimasser);
English: In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
Danish: I sammenlignende studier af op til 1 års varighed var olanzapin forbundet med en statistisk lavere forekomst af behandlingsrelateret dyskinesi.
English: Olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/day.
Danish: Olanzapin blev brugt i en fleksibel dosis, som begyndte med 2,5 mg, og som gik op til 20 mg daglig.
English: In clinical studies, the average olanzapine exposure was approximately 27 % higher in adolescents.
Danish: Den gennemsnitlige eksponering med olanzapin var i kliniske forsøg ca. 27 % højere hos unge.
English: A lower starting dose (5 mg/day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant (see section 4.4).
Danish: En lavere startdosis (5 mg/dag) er ikke rutinemæssigt indiceret, men bør overvejes til patienter  65 år, dersom det findes klinisk indiceret (se pkt.
English: Talk to your doctor or pharmacist before you take Olanzapine Mylan.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Olanzapine Mylan.
English: You should take your Olanzapine Mylan tablets once a day following the advice of your doctor.
Danish: Du bør tage Olanzapine Mylan tabletter én gang dagligt efter din læges anvisning.
English: Neutropenia has been reported commonly when olanzapine and valproate are used concomitantly (see section 4.8).
Danish: Neutropeni er almindeligt rapporteret, når olanzapin og valproat anvendes samtidig (se pkt.
English: Reproductive toxicity
Danish: Reproduktiv toksicitet
English: Acute (single-dose) toxicity
Danish: Akut (enkelt-dosis) toksicitet
English: Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Danish: Olanzapins potentielle indvirken på andre lægemidler Olanzapin kan antagonisere effekten af direkte og indirekte dopamin agonister.
English: A mass balance study showed that approximately 57 % of radiolabelled olanzapine appeared in urine, principally as metabolites.
Danish: Et studie af den totale omsætning af olanzapin viste imidlertid, at omkring 57 % radioaktivt mærket olanzapin genfandtes i urinen, hovedsageligt som metabolitter.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter faldende grad af alvorlighed.
English: Bottles: After first opening use within 90 days.
Danish: Flasker: Skal anvendes inden for 90 dage efter første åbning.
English: The concomitant administration of activated charcoal was shown to reduce the oral bioavailability of olanzapine by 50 to 60 %.
Danish: Samtidig administration af aktivt kul har vist at nedsætte den perorale biotilgængelighed af olanzapin med 50-60 %.
English: The predominant pharmacologic activity is from the parent olanzapine.
Danish: Den dominerende farmakologiske aktivitet stammer fra det native olanzapin.
English: Restless legs syndrome
Danish: Restless legssyndrom
English: • carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your Olanzapine Mylan dose.
Danish: • Carbamazepin (mod epilepsi og stemningsforstyrrelser), fluvoxamin (mod depression) eller ciprofloxacin (mod infektion), da det kan blive nødvendigt at ændre din Olanzapine Mylandosis
English: In the offspring of rats given olanzapine, delays in foetal development and transient decreases in offspring activity levels were seen.
Danish: Hos afkommet af rotter, der havde fået olanzapin, observeredes en forsinket fosterudvikling og et forbigående nedsat aktivitetsniveau hos afkommet.
English: Olanzapine administered with lithium or valproate resulted in increased levels (10 %) of tremor, dry mouth, increased appetite, and weight gain.
Danish: Olanzapin administreret sammen med lithium eller valproat resulterede i øgede værdier (≥ 10 %) af rysten, mundtørhed, øget appetit og øget vægt.
English: 12 Adverse event identified from spontaneous post-marketing reporting with frequency estimated at the upper limit of the 95 % confidence interval utilising the Olanzapine Integrated Database.
Danish: 12 Bivirkning identificeret fra spontane indberetninger efter markedsføring med en hyppighed estimeret ved den øvre grænse af 95% konfidensintervallet ved brug af Den Integrerede Olanzapindatabase.
English: While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Danish: Selvom olanzapin udviste antikolinerg aktivitet in vitro, frembød kliniske studier en lav forekomst af dertil relaterede hændelser.
English: Induction of emesis is not recommended.
Danish: Fremkaldelse af opkastning kan ikke anbefales.
English: Consider referral to a dietician or help with a diet plan if necessary.
Danish: Henvisning til en diætist for hjælp til at lægge en kostplan bør om nødvendigt overvejes.
English: In cases where hepatitis (including hepatocellular, cholestatic or mixed liver injury) has been diagnosed, olanzapine treatment should be discontinued.
Danish: tilfælde, hvor hepatitis (inklusive hepatocellulær, kolestatisk eller blandet leverskade) er diagnosticeret, bør olanzapin seponeres.
English: The clinical consequences are likely to be limited, but clinical monitoring is recommended and an increase of olanzapine dose may be considered if necessary (see section 4.2).
Danish: De kliniske konsekvenser er sandsynligvis begrænsede, men klinisk overvågning anbefales og en øgning af olanzapin dosis bør overvejes, hvis nødvendigt (se pkt.
English: 2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
Danish: 2Gennemsnitlig forøgelse i fastende lipidtal (totalkolesterol, LDL kolesterol og triglycerider) var højere hos patienter uden tegn på lipiddysregulering ved baseline.
English: It is important that you carry on taking Olanzapine Mylan for as long as your doctor tells you.
Danish: Det er vigtigt, du fortsætter med at tage Olanzapine Mylan, så længe lægen beder dig om det.
English: Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section
Danish: Udvikling eller forværring af diabetes lejlighedsvist sammen med ketoacidose eller coma, heriblandt dødelige tilfælde (se pkt.
English: 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).
Danish: Under behandling med olanzapin sammen med lithium eller valproat forekom en stigning på ≥ 7 % af baseline legemsvægt hos 17,4 % af patienterne ved akut behandling (op til 6 uger).
English: 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 cells (eosinophilia).
Danish: DRESS fremtræder indledningsvist som influenzalignende symptomer med udslæt i ansigtet og sidenhen med mere udbredt udslæt, høj temperatur, forstørrede lymfeknuder, forhøjede tal for leverenzymer i blodprøver og et øget antal eosinofile granulocytter (en type hvide blodlegemer).
English: EXP After first opening use within 90 days.
Danish: EXP Skal anvendes inden for 90 dage efter første åbning.
English: Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
Danish: Postural hypotension observeredes lejlighedsvist hos ældre i kliniske studier med olanzapin.
English: Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
Danish: Forandringerne i lipidniveauer skal håndteres i henhold til normal klinisk praksis, specielt hos patienter med dyslipidæmi og hos patienter med risikofaktorer for udvikling af lipidforstyrrelser.
English: Thromboembolism (including pulmonary embolism and deep vein thrombosis) (see section
Danish: Tromboemboli (inklusive lungeemboli og dyb venetrombose) (se pkt.
English: Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Danish: Yderligere symptomer kan inkludere forhøjet kreatinfosfokinase, myoglobulinuri (rhabdomyolyse) og akut nyresvigt.
English: Olanzapine also demonstrated comparable efficacy results to haloperidol in terms of the proportion of patients in symptomatic remission from mania and depression at 6 and 12 weeks.
Danish: Olanzapin havde også effekt svarende til haloperidol, udtrykt ved andelen af patienter med symptomatisk remission af mani og depression efter 6 og 12 uger.
English: The following symptoms may occur in newborn babies of mothers that have used Olanzapine Mylan in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Danish: Følgende symptomer kan forekomme hos børn, hvis mødre har taget olanzapin i det sidste trimester (de sidste tre måneder af graviditeten): rysten, muskelstivhed og/eller svaghed, søvnighed, uro, vejrtrækningsproblemer og problemer med at indtage føde.
English: 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.
Danish: Olanzapine Mylan indeholder lactose og sojalecithin Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: Patients gaining ≥ 7 %, ≥ 15 % and ≥ 25 % of their baseline body weight with long-term exposure (at least 48 weeks) were very common (64.4 %, 31.7 % and 12.3 % respectively).
Danish: Patienter med vægtøgning på ≥ 7 %, ≥ 15 % og ≥25 % af baseline kropsvægt ved langvarig eksponering (mindst 48 uger) var meget almindelig (henholdsvis 64,4 %, 31,7 % og 12,3
English: Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines, e.g. measuring of blood glucose at baseline, 12 weeks after starting olanzapine treatment and annually thereafter.
Danish: Passende klinisk monitorering tilrådes i overensstemmelse med anvendte antipsykotiske vejledninger, som f.eks. måling af blodsukker ved baseline, 12 uger efter start på olanzapinbehandling og derefter årligt.
English: Mylan Hrvatska d.o.o.
Danish: Hrvatska Mylan Hrvatska d.o.o.
English: Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e.g. 1A2, 2D6, 2C9, 2C19, 3A4).
Danish: Olanzapin inhiberer ikke de vigtigste CYP-isoenzymer in vitro (f.eks. 1A2, 2D6, 2C9, 2C19, 3A4).
English: Very common symptoms in overdose (> 10 % incidence) include tachycardia, agitation/aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
Danish: Meget almindelige symptomer på overdosering (forekomst > 10 %) inkluderer takykardi, agitation/aggressivitet, dysartri, forskellige ekstrapyramidale symptomer og nedsat bevidsthedsniveau, varierende fra sedation til koma.
English: 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.
Danish: Da klinisk erfaring med olanzapin til patienter med samtidige sygdomme er begrænset, tilrådes forsigtighed ved ordination til patienter med prostatahypertrofi eller paralytisk ileus og beslægtede tilstande.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: In the same clinical trials, cerebrovascular adverse events (CVAE e.g., stroke, transient ischaemic attack), including fatalities, were reported.
Danish: I de samme kliniske forsøg blev cerebrovaskulære hændelser (f.eks. slagtilfælde, forbigående iskæmiske anfald), inklusive dem med dødelig udgang, rapporteret.
English: If you suffer from dementia, you or your carer/relative should tell your doctor if you have ever had a stroke or “mini” stroke.
Danish: Hvis du lider af demens, bør du, din pårørende eller en anden, der hjælper dig, fortælle din læge, hvis du nogensinde har haft et slagtilfælde, også hvis du ikke har nogen følger efter det.
English: If this has happened to you, tell your doctor.
Danish: Hvis du har oplevet dette, skal du fortælle det til lægen.
English: Fertility Effects on fertility are unknown (see section 5.3 for preclinical information).
Danish: Fertilitet Påvirkning af fertiliteten er ukendt (se pkt.
English: 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).
Danish: De kliniske manifestationer af NMS er hyperpyreksi, muskelrigiditet, ændret mental status og tegn på autonom ustabilitet (uregelmæssig puls eller ustabilt blodtryk, takykardi, svedtendens og hjertearytmi).
English: Animal behavioural studies with olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor-binding profile.
Danish: Dyreadfærdsstudier af olanzapin indikerede 5-HT, dopamin og kolinerg antagonisme i overensstemmelse med receptorbindingsprofilen.
English: Reversible effects consistent with elevated prolactin in rats included decreased weights of ovaries and uterus and morphologic changes in vaginal epithelium and in mammary gland.
Danish: Reversible virkninger, som var i overensstemmelse med forhøjet prolaktin hos rotter, omfattede nedsat vægt af ovarier og uterus og morfologiske forandringer i det vaginale epitel og i mælkekirtler.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Mylan S.A.S.
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Mylan S.A.S.
English: Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
Danish: Terapeutisk monitorering af valproat-plasmaniveauer indikerer ikke, at en justering af valproatdosis er nødvendig, når olanzapin gives sammen med valproat.
English: Portugal Mylan, Lda.
Danish: Mylan, Lda.
English: Clinical signs included sedation, ataxia, tremors, increased heart rate, laboured respiration, miosis, and anorexia.
Danish: Kliniske tegn omfattede sedation, ataksi, tremor, øget hjertefrekvens, anstrengt respiration, miosis og anoreksi.
English: • Very rarely, medicines of this type cause a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness.
Danish: • Yderst sjældent forårsager denne slags medicin en kombination af feber, hurtigere vejrtrækning, svedtendens, muskelstivhed og døsighed/søvnighed.
English: Reversible neutropenia, thrombocytopenia, or anaemia developed in a few dogs treated with 8 or 10 mg/kg/day (total olanzapine exposure [AUC] is 12- to 15-fold greater than that of a man given a 12 mg dose).
Danish: Reversibel neutropeni, trombocytopeni eller anæmi udvikledes hos enkelte hunde, som blev behandlet med 8 eller 10 mg/kg/dag (total olanzapin dosis (AUC) var 12-15 gange højere end human dosis på 12 mg).
English: Thrombocytopenia11
Danish: Trombocytopeni11
English: • Liver or kidney disease
Danish: • Lever- eller nyresygdom
English: • High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Olanzapine Mylan.
Danish: • Højt sukker- og fedtindhold (triglycerider og kolesterol) i blodet er set hos patienter, som tager Olanzapine Mylan.
English: In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki < 100 nM) for serotonin 5 HT2A/2C, 5 HT3, 5 HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α1 adrenergic; and histamine H1 receptors.
Danish: I prækliniske studier udviste olanzapin affinitet (Ki < 100 nM) til serotonin 5-HT2A/2C, 5-HT3, 5-HT6, dopamin D1, D2, D3, D4, D5, kolinerge muskarine receptorer M1-M5, 1-adrenerge og histamin H1receptorer.
English: 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).
Danish: I placebokontrollerede kliniske forsøg (af 6-12 ugers varighed) med ældre patienter (gennemsnitlig alder 78 år) med demensrelateret psykose og/eller adfærdsforstyrrelse var der en dobbelt så høj forekomst af dødsfald hos de olanzapinbehandlede patienter i forhold til de placebobehandlede patienter (henholdsvis 3,5 % og 1,5 %).
English: Very common side effects (may affect more than 1 in 10 people) include weight gain; sleepiness; and increases in levels of prolactin in the blood.
Danish: Meget almindelige bivirkninger (forekommer hos flere end 1 ud af 10 patienter) omfatter vægtstigning, søvnighed samt forhøjede niveauer af prolaktin i blodet.
English: If a new manic, mixed, or depressive episode occurs, olanzapine treatment should be continued (with dose optimisation as needed), with supplementary therapy to treat mood symptoms, as clinically indicated.
Danish: I tilfælde af nyopstået manisk, blandet eller depressiv episode bør olanzapinbehandlingen fortsættes (med dosisoptimering efter behov), med klinisk indiceret supplerende terapi til behandling af stemningssymptomer.
English: • Parkinson's disease
Danish: • Parkinsons sygdom
English: 14 Observed for fasting normal levels at baseline (< 1.016 mmol/l) which increased to high (≥ 1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/l< 1.467 mmol/l) to high (≥ 1.467 mmol/l).
Danish: 14 Observerede normalniveauer ved faste ved baseline (< 1,016 mmol/l, som steg til (≥ 1,467 mmol/l) og ændringer i triglycerider ved faste fra grænser ved baseline (≥ 1,016 mmol/l - < 1,467 mmol/l) op til (≥ 1,467 mmol/l).
English: Olanzapine should be used cautiously in patients who have a history of seizures or are subject to factors which may lower the seizure threshold.
Danish: Olanzapin bør anvendes med forsigtighed til patienter med tidligere krampeanfald, eller som er udsat for faktorer, som kan nedsætte krampetærsklen.
English: With long-term exposure (at least 24 weeks), 89.4 % gained ≥ 7 %, 55.3 % gained ≥ 15 % and 29.1 % gained ≥ 25%, of their baseline body weight.
Danish: Ved langvarig eksponering (mindst 24 uger), tog 89,4 % ≥ 7 % på i vægt, 55,3 % tog ≥ 15 % på i vægt og 29,1 % tog ≥ 25 % af deres baseline kropsvægt på.
English: If this happens after you have been given Olanzapine Mylan tell your doctor.
Danish: Hvis dette forekommer, når du har taget Olanzapine Mylan, skal du fortælle det til lægen.
English: Parkinson's disease
Danish: Parkinsons sygdom
English: Manic episode: The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section 5.1).
Danish: Manisk episode: Startdosis er 15 mg, som administreres som en enkelt daglig dosis ved monoterapi, eller 10 mg daglig ved kombinationsterapi (se pkt.
English: In a retrospective observational cohort study, the risk of presumed sudden cardiac death in patients treated with olanzapine was approximately twice the risk in patients not using antipsychotics.
Danish: I et retrospektivt observationskohortestudie var risikoen for formodet pludselig, uventet hjertedød blandt patienter behandlet med olanzapin dobbelt så stor som hos patienter, der ikke blev behandlet med antipsykotika.
English: There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder.
Danish: Der har været rapporter om agitation, hypertoni, hypotonis, tremor, døsighed, vejrtrækningsbesvær eller problemer med at indtage næring.
English: Because olanzapine may cause somnolence and dizziness, patients should be cautioned about operating machinery, including motor vehicles.
Danish: Da olanzapin kan forårsage døsighed og svimmelhed, bør patienterne tilrådes forsigtighed ved bilkørsel og maskinbetjening.
English: There is a risk of feeling drowsy when you are given Olanzapine Mylan.
Danish: Der er risiko for døsighed, når du får Olanzapine Mylan.
English: 6 In clinical trials, the incidence of Parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
Danish: 6I kliniske forsøg var forekomsten af parkinsonisme og dystoni hos olanzapinbehandlede patienter numerisk højere men ikke statistisk signifikant forskellig fra placebo.
English: Priapism12
Danish: Priapisme12
English: For patients who have been receiving olanzapine for treatment of manic episode, continue therapy for preventing recurrence at the same dose.
Danish: Patienter, som har fået olanzapin til behandling af maniske episoder fortsættes i terapi med samme dosis for forebyggelse af tilbagefald.
English: New born infants exposed to antipsychotics (including olanzapine) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
Danish: Nyfødte, der har været eksponeret for antipsykotika (herunder olanzapin) i tredje trimester af graviditeten, har risiko for at få bivirkninger såsom ekstrapyramidale bivirkninger og/eller seponeringssymptomer efter fødslen.
English: However the risk of tardive dyskinesia increases with long term exposure, and therefore if signs or symptoms of tardive dyskinesia appear in a patient on olanzapine, a dose reduction or discontinuation should be considered.
Danish: Risikoen for tardiv dyskinesi øges imidlertid ved længerevarende behandling, hvorfor reduktion af dosis eller seponering bør overvejes, hvis der forekommer tegn eller symptomer på tardiv dyskinesi hos en patient i behandling med olanzapin.