FrancophonIA/ELRC3.0 huggingface dataset:
English: Detailed information on this medicine is available on the European Medicines Agency website: 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: There was a 3-fold increase in CVAE in patients treated with olanzapine compared to patients treated with placebo (1.3 % versus 0.4 %, respectively).
Danish: Der var en tre gange s å høj forekomst af cerebrovaskulære hændelser hos de patienter, som blev behandlet med olanzapin, sammenlignet med patienterne, som blev behandlet med placebo (henholdsvis 1,3 % og 0,4 %).
English: • Slow heart rate.
Danish: • Langsom hjertefrekvens (puls).
English: Olanzapine Glenmark contains aspartame
Danish: Olanzapine Glenmark indeholder aspartam
English: 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.
Danish: Forsigtighed bør udvises og opfølgning organiseres hos patienter med forhøjet ALT og/eller AST, hos patienter med tegn og symptomer på leverfunktionsnedsættelse, hos patienter med tilstande forbundet med begrænset leverfunktionskapacitet og hos patienter i behandling med potentielle hepatotoksiske præparater.
English: Do not drink any alcohol if you have been given Olanzapine Glenmark as together with alcohol it may make you feel drowsy.
Danish: Brug af Olanzapine Glenmark sammen med alkohol Drik ikke nogen form for alkohol, når du får Olanzapine Glenmark, da det sammen med alkohol kan gøre dig døsig.
English: • Sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males.
Danish: • Seksuelle problemer såsom nedsat sexlyst (libido) hos mænd og kvinder eller rejsningsbesvær hos mænd.
English: Contains aspartame.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder aspartam.
English: Warnings and precautions Talk to your doctor or pharmacist before you take Olanzapine Glenmark
Danish: Kontakt lægen eller apoteket, før du tager Olanzapine Glenmark
English: In clinical trials in patients with drug-induced (dopamine agonist) psychosis associated with Parkinson's disease, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo.
Danish: I kliniske forsøg med patienter med lægemiddelinduceret (dopaminagonist) psykose i forbindelse med Parkinsons sygdom, blev der rapporteret forværring af Parkinson-symptomatologi og hallucinationer meget almindeligt og hyppigere end med placebo.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: AF IKKE ANVENDT LÆGEMIDDEL SAMT AFFALD HERAF
English: Olanzapine Glenmark 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg are available in aluminium foil blisters of 28, 56, 70 and 98tablets
Danish: Olanzapine Glenmark 2,5 mg, 5 mg, 7,5 mg, 10 mg, 15 mg findes i aluminium blisterpakninger med 28, 56, 70 og 98 tabletter.
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 antipsychotic and risperidone-responsive patients, while being comparable to clozapine-responsive patients.
Danish: Desuden afslørede en 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.
English: Olanzapine Glenmark 20 mg tablets are available in aluminium foil blisters of 28, 35, 56, 70 and 98 tablets
Danish: Olanzapine Glenmark 20 mg tabletter findes i aluminium blisterpakninger med 28, 35, 56, 70 og 98 tabletter.
English: Transient, asymptomatic elevations of hepatic aminotransferases, alanine transferase (ALT), aspartate transferase (AST) have been seen commonly, especially in early treatment.
Danish: Forbigående, asymptomatiske forhøjelser af leveraminotransferaser, alanintransferase (ALAT) og aspartattransferase (ASAT) er almindeligt forekommende, især initialt i behandlingen.
English: Do not take two doses in one day.
Danish: Tag dine tabletter lige s å snart, du kommer i tanke om det. Du m å ikke tage to doser på en dag.
English: • diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma
Danish: • Sukkersyge eller forværring af sukkersyge, af og til ledsaget af syreforgiftning (ketoacidose - ketonstoffer i blod og urin) eller bevidstløshed
English: • Hypersensitivity (e.g. swelling in the mouth and throat, itching, rash)
Danish: • Overfølsomhed (f.eks. hævelser i mund og hals, kløe, hududslæt).
English: Metabolism and nutrition disorders Weight gain1
Danish: Metabolisme og ernæring Vægtstigning1
English: 4.4)12Discontinuat ion symptoms7, 12
Danish: 4.4)12 Abstinenssymptom er7, 12
English: Dizziness Akathisia6
Danish: Svimmelhed Akatisi6
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Danish: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN Opbevares utilgængeligt for børn.
English: Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater 5 HT2 than D2 activity in vivo, models.
Danish: Olanzapin udviste større affinitet til serotonin 5HT2 end til dopamin D2 receptorerne i in vitro studier og større 5 HT2- end D2- aktivitet i in vivo modeller.
English: Neuroleptic malignant syndrome (see section
Danish: Malignt neuroleptikasyndro m (se pkt.
English: Consider referral to a dietician or help with a diet plan if necessary.
Danish: Du og din læge bør jævnligt kontrollere din vægt Henvisning til en diætist eller hjælp med at lægge en kostplan bør om nødvendigt overvejes..
English: 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: 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: Glenmark Pharmaceuticals B.V. Tél/Tel: + 31 629 62 4818 / +31 40 245 3611
Danish: Tél/Tel: + 31 629 62 4818 / +31 40 245 3611
English: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Danish: Lægemiddelfremk aldt reaktion med eosinofili og systemiske symptomer (DRESS) (hyppighed ikke kendt)
English: 6.4 Special precautions for storage Store below 30C
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares ved temperaturer under 30ºC.
English: 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 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 s å høj forekomst af dødsfald hos de olanzapinbehandlede patienter i forhold til de placebobehandlede patienter (henholdsvis 3,5 % og 1,5 %).
English: See package leaflet for further information
Danish: Se indlægssedlen for yderligere oplysninger.
English: Following short term treatment (median duration 47 days), weight gain ≥ 7 % of baseline body weight was very common (22.2%), ≥ 15% was common (4.2%) and ≥25% was uncommon (0.8%).
Danish: Efter kortvarig behandling (gennemsnitlig varighed 47 dage), var vægtøgning ≥ 7 % af baseline kropsvægt meget almindelig (22,2%), ≥ 15 % var almindelig (4,2%) og ≥ 25% var ikke almindelig (0,8%).
English: Thrombocytopeni
Danish: Trombocytopeni
English: Reproductive system and breast disorders Erectile dysfunction in males
Danish: Det reproduktive system og mammae Erektil dysfunktion hosmænd Nedsat libido hos mænd og kvinder
English: What you need to know before you take Olanzapine Glenmark
Danish: Det skal du vide, før du begynder at tage Olanzapine Glenmark
English: Pharmacotherapeutic group: psycholeptics, diazepines, oxazepines, thiazepines and oxepines, ATC code N05A H03.3
Danish: Farmakoterapeutisk klassifikation: Psykoleptika, diazepiner, oxazepiner, thiazepiner og oxepiner, ATC-kode: N05A H03
English: Dysarthria Stuttering11
Danish: Dysartri Stammen11
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
English: You should not be given this medicine when breast-feeding, as small amounts of Olanzapine Glenmark can pass into breast milk.
Danish: Du bør ikke anvende denne medicin under graviditet, medmindre du har talt med din læge om det. Du bør ikke få denne medicin, mens du ammer, da små mængder Olanzapine Glenmark kan overføres til modermælken.
English: 6.6 Special precautions for disposal No special requirements
Danish: 6.6 Regler for destruktion og anden håndtering Ingen særlige forholdsregler.
English: Abdominal distension9
Danish: Udspilet abdomen9
English: • Weight gain
Danish: • vægtstigning.
English: Signs of oral toxicity in rodents were characteristic of potent neuroleptic compounds: hypoactivity, coma, tremors, clonic convulsions, salivation, and depressed weight gain.
Danish: Den observerede perorale toksicitet hos gnavere er karakteristisk for potente antipsykotiske lægemiddelstoffer: hypoaktivitet, coma, tremor, kloniske kramper, spytsekretion og hæmmet vægtøgning.
English: In female versus male subjects the mean elimination half life was somewhat prolonged (36.7 versus 32.3 hrs) and the clearance was reduced (18.9 versus 27.3 l/hr).
Danish: Hos kvinder versus mænd var den gennemsnitlige halveringstid en del forlænget (36,7 versus 32,3 timer) og clearance reduceret (18,9 versus 27,3 l/time).
English: In healthy elderly (65 and over) versus non-elderly subjects, the mean elimination half-life was prolonged (51.8 versus 33.8 hr) and the clearance was reduced (17.5 versus 18.2 l/hr).
Danish: Hos raske ældre ( 65 år) versus ikke-ældre forsøgspersoner var den gennemsnitlige eliminationshalveringstid forlænget (51,8 versus 33,8 timer) og clearance var reduceret (17,5 versus 18,2 l/time).
English: Elevated triglyceride levels2,5
Danish: Forhøjede triglyceridniveauer
English: 14 Observed for fasting normal levels at baseline (< 1.016 mmol/l) which increased to high (≥ 1.467
Danish: 14 Observerede normalniveauer ved faste ved baseline (< 1.016 mmol/l, som steg til (≥ 1.467
English: Clinical monitoring is recommended and an increase of olanzapine dose may be considered if necessary (see section 4.5).
Danish: Klinisk overvågning anbefales og en øget dosis af olanzapin kan overvejes, hvis nødvendigt (se pkt.
English: Decreased libido in males and females
Danish: Erektil dysfunktion hos mænd Nedsat libido hos mænd og kvinder
English: In a single oral dose (10 mg) Positron Emission Tomography (PET) study in healthy volunteers, olanzapine produced a higher 5HT2A than dopamine D2 receptor occupancy.
Danish: I et enkeltdosis (10 mg) Positron Emission Tomography (PET) studie hos raske forsøgspersoner bandt olanzapin til flere 5HT2A end til dopamin D2 receptorer.
English: High Gamma Glutamyltransferase
Danish: Høje niveauer af gammaglutamyltransferase10
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/587/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/09/587/004
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg olanzapine Excipient with known effect: Each tablet contains 0.92 mg of aspartame For the full list of excipients, see section 6.1.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 2,5 mg olanzapin Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 0,23 mg aspartam Alle hjælpestoffer er anført under pkt.6.1
English: Store below 30C.
Danish: Opbevares ved temperaturer under 30ºC.
English: What Olanzapine Glenmark contains - The active substance is olanzapine - Each Olanzapine Glenmark tablet contains 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg olanzapine
Danish: Hver Olanzapine Glenmark tablet indeholder enten 2,5 mg, 5 mg, 7,5 mg, 10 mg, 15 mg eller 20 mg olanzapin.
English: Patients should be advised not to breast- feed an infant if they are taking olanzapine.
Danish: Patienterne bør frarådes at amme, hvis de er i behandling med olanzapin.
English: • restless legs syndrome
Danish: • Restless legs-syndrom (stærk uro i underbenene)
English: 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.
Danish: Derskal dog udvises forsigtighed, når olanzapin ordineres sammen med lægemidler, der vides at øge QTc-intervallet, specielt hos ældre patienter, hos patienter med medfødt langt QT-syndrom, hjerteinsufficiens, hjertehypertrofi, hypokaliæmi eller hypomagnesiæmi.
English: Store below 30C
Danish: Opbevares ved temperaturer under 30º C
English: 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: Olanzapin bør ikke anvendes hos patienter med demensrelateret psykose og/eller adfærdsforstyrrelse på grund af øget mortalitet og risiko for cerebrovaskulære hændelser.
English: Hepatobiliary disorders Transient, asymptomatic elevations of hepatic aminotransferases (ALT, AST), especially in early treatment (see section 4.4)
Danish: Forbigående, asymptomatisk forhøjede leveraminotransfer aser (ALAT, ASAT), særlig initialt i behandlingen (se pkt 4.4)
English: In a second 12-month recurrence prevention study in manic episode patients who achieved remission with a combination of olanzapine and lithium and were then randomised to olanzapine or lithium alone, olanzapine was statistically non-inferior to lithium on the primary endpoint of bipolar recurrence (olanzapine 30.0 %, lithium 38.3 %; p = 0.055).
Danish: Olanzapin viste sig ikke ringere end lithium på det primære slutpunkt for bipolære tilbagefald (olanzapin 30,0 %, lithium 38,3 %; p = 0,055)
English: High uric acid 10
Danish: Høje niveauer af urinsyre10
English: 13 Following short term treatment (median duration 22 days), weight gain ≥ 7 % of baseline body weight (kg) was very common (40.6 %), ≥ 15 %of baseline body weight was common (7.1 %) and ≥ 25 % was common (2.5 %).
Danish: 13 Efter kortvarig behandling (gennemsnitlig varighed 22 dage), var øget vægt ≥ 7 % af baseline legemsvægt (kg) meget almindelig (40,6%), ≥ 15 % af baseline legemsvægt var almindelig (7,1%) og ≥ 25% var almindelig (2,5%).
English: Olanzapine Glenmark is used to treat the following conditions:
Danish: Olanzapine Glenmark indeholder:
English: Dementia-related psychosis and/or behavioural disturbances Olanzapine is not recommended for use 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 patienter med demensrelateret psykose og/eller adfærdsforstyrrelse på grund af øget mortalitet og risiko for cerebrovaskulære hændelser.
English: Gastrointestinal disorders Mild, transient anticholinergic effects including
Danish: Mave-tarm-kanalen Lette forbigående antikolinerge virkninger, herunder forstoppelse og
English: 13 Following short term treatment (median duration 22 days), weight gain ≥ 7 % of baseline body weight (kg) was very common (40.6 %), ≥ 15 %of baseline body weight was common (7.1 %) and ≥
Danish: 13 Efter kortvarig behandling (gennemsnitlig varighed 22 dage), var øget vægt ≥ 7 % af baseline legemsvægt (kg) meget almindelig (40,6%), ≥ 15 % af baseline legemsvægt var almindelig (7,1%)
English: Changes in fasting triglycerides from borderline at baseline (≥ 1.69 mmol/l - < 2.26 mmol/l) to high (≥ 2.26 mmol/l) were very common.
Danish: Ændring i fastende triglyceridniveau fra let forhøjet niveau ved baseline (≥ 1,69 - < 2,26 mmol/l) til højt niveau (≥ 2,26 mmol/l) var meget almindeligt.
English: 4 Observed for fasting normal levels at baseline (< 5.56 mmol/l) which increased to high (≥ 7 mmol/l).
Danish: 4Observeret for fastende normalt niveau ved baseline (< 5,56 mmol/l), der blev øget til højt niveau (≥ 7 mmol/l).
English: General disorders and administration site conditions Asthenia
Danish: Almene symptomer og reaktioner på administrationsstedet
English: How to take Olanzapine Glenmark
Danish: Sådan skal du tage Olanzapine Glenmark
English: Very common side effects (may affect more than 1 in 10 people) include:
Danish: Meget almindelige bivirkninger (forekommer hos flere end 1 ud af 10 patienter) omfatter
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 (≥1/1.000til < 1/100), sjælden (≥1/10.000til 1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Discontinuation symptoms7, 12
Danish: Abstinenssymptom er7, 12
English: Only take other medicines while you are on Olanzapine Glenmark if your doctor tells you that you can. You might feel drowsy if Olanzapine Glenmark is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
Danish: Du kan komme til at føle dig døsig, hvis Olanzapine Glenmark tages sammen med depressionsmidler eller medicin til behandling af angst eller søvnløshed (sovepiller).
English: 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.
Danish: QTc-forlængelse blev defineret som Fridericia korrigeret QT (QTcF) 500 millisekunder (msek) på et hvilket som helst tidspunkt post-baseline hos patienter med baseline QTcF <500 msek.
English: Do not stop taking your tablets just because you feel better.
Danish: Hvis du holder op med at tage Olanzapine Glenmark Du må ikke holde op med at tage tabletterne, fordi du har fået det bedre.
English: 15 Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/l) to high (≥ 5.17 mmol/l) were observed commonly.
Danish: 15 Ændringer i de totale kolesterolniveauer ved faste fra normale ved baseline (< 4.39 mmol/l) op til (≥ 5.17 mmol/l) blev observeret almindeligt.
English: 6.6 Special precautions for disposal
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: Er du i tvivl, s å spørg lægen eller på apoteket.
English: Changes in fasting glucose from borderline at baseline (≥ 5.56 - < 7 mmol/l) to high (≥ 7 mmol/l) were very common.
Danish: Ændring i fastende glucoseniveau fra let forhøjet niveau ved baseline (≥ 5,56 - < 7 mmol/l) til højt niveau (≥ 7 mmol/l) var meget almindeligt.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 03 December 2009
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første tilladelse: 03 December 2009 Dato for seneste fornyelse: 19 August 2014
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, á1 -adrenerge og histamin H1 receptorer.
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; α 1 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, á1 -adrenerge og histamin H1 receptorer.
English: What Olanzapine Glenmark is and what it is used for What you need to know before you take Olanzapine Glenmark How to take Olanzapine Glenmark Possible side effects
Danish: Det skal du vide, før du begynder at tage Olanzapine Glenmark Sådan skal du tage Olanzapine Glenmark Bivirkninger
English: The most frequently (seen in ≥ 1 % of patients) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism, leukopenia, neutropenia (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic aminotransferases (see section 4.4), rash, asthenia, fatigue, pyrexia, arthralgia, increased alkaline phosphatase, high gamma glutamyltransferase, high uric acid, high creatine phosphokinase and oedema.
Danish: De hyppigst rapporterede (set hos ≥ 1 % af patienter) bivirkninger, som blev set i forbindelse med anvendelse af olanzapin i kliniske forsøg, var døsighed og vægtøgning, eosinofili, forhøjede niveauer af prolaktin, kolesterol, glucose og triglycerider (se pkt.
English: The pharmacokinetics of olanzapine are similar between adolescents and adults.
Danish: Unge (alder 13 - 17 år): Farmakokinetikken af olanzapin er den samme hos unge og voksne.
English: Very rare side effects (may affect up to 1 in 10,000) include:
Danish: Meget sjældne bivirkninger kan påvirke op til 1 ud af 10.000 patienter) omfatter:
English: Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17- < 6.2 mmol/l) to high (≥ 6.2 mmol/l) were very common.
Danish: Ændring i total fastende kolesterolniveau fra let forhøjet niveau ved baseline (≥ 5,17< 6,2 mmol/l) til højt niveau (≥ 6,2 mmol/l) var meget almindeligt.
English: • Fever
Danish: • feber; ledsmerter
English: • Restlessness.
Danish: • Rastløshed.
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: MARKETING AUTHORISATION HOLDER Glenmark Arzneimittel GmbH Industriestr.
Danish: Indehaver af markedsføringstilladelsen Glenmark Arzneimittel GmbH Industriestr.
English: Rare side effects (may affect up to 1 in 1000 people) include:
Danish: Sjældne bivirkninger (forekommer hos op til 1 ud af 1.000 patienter) omfatter
English: 5 Observed for fasting normal levels at baseline (< 1.69 mmol/l) which increased to high (≥ 2.26
Danish: 5Observeret for fastende normalt niveau ved baseline (< 1,69 mmol/l), der blev øget til højt niveau (≥ 2,26 mmol/l).
English: Changes in total fasting cholesterol levels from borderline at baseline (≥ 4.39 - < 5.17 mmol/l) to high (≥ 5.17 mmol/l) were very common.
Danish: Ændringer i de totale kolesterolniveauer ved faste fra grænser ved baseline (≥ 4.39 - < 5.17 mmol/l) op til (≥ 5.17 mmol/l) var meget almindeligt.
English: Elevated cholesterol levels2,3
Danish: Forhøjede kolesterolniveauer2,