FrancophonIA/ELRC3.0 huggingface dataset:
English: Effects on haematology parameters were found in each species, including dose-related reductions in circulating leukocytes in mice and non-specific reductions of circulating leukocytes in rats; however,
Danish: Der blev observeret påvirkning af de hæmatologiske parametre i hver dyreart, herunder dosisafhængig reduktion af cirkulerende leukocytter hos mus og ikke-specifik reduktion af cirkulerende leukocytter hos rotter.
English: 56 orodispersible tablets
Danish: 56 Orodispergible tabletter
English: A. LABELLING
Danish: ETIKETTERING
English: Olazax Disperzi has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment.
Danish: Det er vist, at Olazax Disperzi forebygger tilbagefald af disse symptomer ved bipolar lidelse (maniodepressiv sygdom) hos patienter, hvis maniske episode har reageret på olanzapinbehandling.
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: Do not take Olazax Disperzi - If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk (overfølsom) over for olanzapin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Olazax Disperzi with alcohol
Danish: Brug af Olazax Disperzi sammen med alkohol
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: 8 In clinical trials of up to 12 weeks, plasma prolactin concentrations exceeded the upper limit of normal range in approximately 30% of olanzapine treated patients with normal baseline prolactin value.
Danish: 8 I kliniske forsøg af op til 12 ugers varighed oversteg plasma-prolaktinkoncentrationen den øvre normalgrænseværdi hos ca. 30 % af de olanzapinbehandlede patienter med en normal baseline prolaktinværdi.
English: Leukopenia10
Danish: Leukopeni10
English: Olazax Disperzi belongs to a group of medicines called antipsychotics and is used to treat the following conditions:
Danish: Olazax Disperzi tilhører en gruppe af lægemidler, der kaldes antipsykotika.
English: no evidence of bone marrow cytotoxicity was found.
Danish: Der sås imidlertid ingen tegn på knoglemarvscytotoksicitet.
English: There is a risk of feeling drowsy when you are given Olazax Disperzi.
Danish: Der er risiko for døsighed, når du får Olazax Disperzi.
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 eksponeretfor antipsykotika (inklusive olanzapin) under tredje trimester af graviditeten, er i risiko for bivirkninger inkluderende ekstrapyramidale og/eller abstinenssymptomer, som kan variere i sværhedsgrad og varighed efter fødslen.
English: Olazax Disperzi 5mg, 7.5 mg, 10 mg, 15 mg, 20 mg are available in aluminium foil blisters of 28, 56 orodispersible tablets
Danish: Olazax Disperzi 5 mg, 7,5 mg, 10 mg, 15 mg og 20 mg findes i aluminium blisterpakninger med 28 eller 56 orodispergible tabletter.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ALUMINIUM BLISTERS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Aluminium blisterpakninger
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: Startdosis er 15 mg, som administreres som en enkelt daglig dosis ved monoterapi, eller 10 mg daglig ved kombinationsterapi (se pkt.
English: Olazax Disperzi 5 mg orodispersible tablets Olazax Disperzi 7.5 mg orodispersible tablets Olazax Disperzi 10 mg orodispersible tablets Olazax Disperzi 15 mg orodispersible tablets Olazax Disperzi 20 mg orodispersible tablets Olanzapine
Danish: Olazax Disperzi 5 mg orodispergible tabletter Olazax Disperzi 7,5 mg orodispergible tabletter Olazax Disperzi 10 mg orodispergible tabletter Olazax Disperzi 15 mg orodispergible tabletter Olazax Disperzi 20 mg orodispergible tabletter olanzapin
English: Mannitol (E 421) Microcrystalline cellulose Aspartame (E 951) Crospovidone Magnesium stearate
Danish: Mannitol (E 421) Mikrokrystallinsk cellulose Aspartam (E 951) Crospovidon
English: If you suddenly stop taking Olazax Disperzi, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur.
Danish: Hvis du pludseligt holder op med at tage Olazax Disperzi, kan der forekomme symptomer som svedtendens, søvnbesvær, rysten, angst, kvalme og opkastning.
English: Dizziness Akathisia 6
Danish: Svimmelhed Akatisi6
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 % vrs 1.5 %,
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: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis De oplever bivirkninger, bør Du tale med Din læge, sygeplejerske eller apoteket.
English: Neutropenia10
Danish: Neutropeni10
English: Restless legs syndrome symptoms7, 12
Danish: Restless legssyndrom symptomer7,12
English: Hvězdova 1716/2b, 140 78 Praha 4 Czech Republic
Danish: Hvezdova 1716/2b, 140 78 Prag 4 Tjekkiet
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: 15 Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/l) to high
Danish: 15 Ændringer i de totale kolesterolniveauer ved faste fra normale ved baseline (< 4,39 mmol/l) op til
English: Metabolism and nutrition disorders Weight gain 1
Danish: Metabolisme og ernæring Vægtstigning1
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) ANSVARLIG(E)FOR BATCHFRIGIVELSE
English: There was a 3-fold increase in CVAE in patients treated with olanzapine compared to patients treated with placebo (1.3 % vrs 0.4 %, respectively).
Danish: Der var en tre gange så 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: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i punkt.
English: Elevated cholesterol levels 2,3
Danish: Forhøjede kolesterolniveauer2,3
English: Elevated glucose levels 4
Danish: Forhøjede glucoseniveauer 4
English: 6.4 Special precautions for storage Store below 30 C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares ved temperaturer under 30ºC.
English: PHARMACEUTICAL FORM AND CONTENTS Orodispersible Tablet 28 orodispersible tablets 56 orodispersible tablets METHOD AND ROUTE(S) OF ADMINISTRATION The tablet should be dissolved in the mouth or in a drink.
Danish: Se indlægssedlen for yderligere oplysninger LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) 28 Orodispergible tablette 56 Orodispergible tabletter ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Tabletten bør opløses i munden eller i en drikkevare.
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller apotekspersonalet, hvis der er noget, du er i tvivl om .
English: Thrombocytope nia11
Danish: Trombocytope ni11
English: Hvězdova 1716/2b, 140 78 Praha 4
Danish: Hvezdova 1716/2b, 140 78 Prag 4
English: Stuttering11Restless legs syndrome
Danish: Stammen11 Restless legs-syndrom
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 koma, heriblandt dødelige tilfælde (se pkt.
English: Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
Danish: Postural hypotension observeredes lejlighedsvist hos ældre i kliniske studiermed olanzapin.
English: Hepatitis (including hepatocellular, cholestatic or mixed liver injury)11
Danish: Hepatitis (inklusive hepatocellulær kolestatisk eller blandet leverskade) 11
English: Gastrointestinal disorders Mild, transient anticholinergic effects including constipation and dry mouth
Danish: Mave-tarm-kanalen Lette forbigående antikolinerge virkninger herunder forstoppelse og mundtørhed
English: SPECIAL STORAGE CONDITIONS Store below 30C
Danish: Opbevares ved under 30º C
English: What Olazax Disperzi contains - The active substance is olanzapine - Each tablet contains 5 mg, 7.5 mg, 10 mg, 15 mg, or 20 mg olanzapine
Danish: Hver Olazax Disperzi orodispergible tablet indeholder enten 5 mg, 7,5 mg, 10 mg, 15 mg eller 20 mg olanzapin.
English: If you stop taking Olazax Disperzi
Danish: Hvis du holder op med at tage Olazax Disperzi
English: In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition of olanzapine 10 mg (co-therapy with lithium or valproate) resulted in a greater reduction in symptoms of mania than lithium or valproate monotherapy after 6 weeks.
Danish: I en studiestudie af patienter i behandling med lithium eller valproat i minimum 2 uger medførte samtidig behandling med olanzapin 10 mg (kombinationsterapi med lithium eller valproat) en større reduktion af symptomerne på mani efter 6 uger end ved lithium- eller valproat-monoterapi.
English: Rare side effects (may affect up to 1 in 1000 people) include lowering of normal body temperature; abnormal rhythms of the heart; sudden unexplained death;; inflammation of the pancreas causing severe stomach pain, fever and sickness; liver disease appearing as yellowing of the skin and white parts of the eyes; muscle disease presenting as unexplained aches and pains and prolonged and/or painful erection.
Danish: Sjældne bivirkninger (forekommer hos op til 1 ud af 1.000 patienter) omfatter nedsat kropstemperatur; unormal hjerterytme; pludselig uforklarlig død; betændelse i bugspytkirtlen, som forårsager voldsomme mavesmerter, feber og utilpashed; leversygdom, som viser sig ved gulfarvning af huden og af det hvide i øjnene; muskelsygdom, som viser sig med uforklarlige smerter; forlænget og/eller pinefuld erektion.
English: Thrombocyto penia11
Danish: Trombocyto peni11
English: The following symptoms may occur in newborn babies, of mothers that have used Olazax Disperzi in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness,
Danish: Følgende symptomer kan forekomme hos nyfødte af mødre, som har taget ZYPREXA i sidste trimester (de sidste tre måneder af graviditeten): rystelser, muskelstivhed og/eller svaghed, søvnighed, ophidselse, vejrtrækningsbesvær og besvær med at indtage føde.
English: Pharmacotherapeutic group: psycholeptics, diazepines, oxazepines, thiazepines and oxepines, ATC code N05A H03.
Danish: Farmakoterapeutisk klassifikation:Psykoleptika, diazepiner, oxazepiner, og thiazepiner og oxepiner , ATC-kode: N05A H03
English: Patients who cannot take phenylalanine should note that Olazax Disperzi contains aspartmae, which is a source of phenylalanine.
Danish: Olazax Disperzi orodispergible tabletter indeholder aspartamPatienter, som ikke kan tåle phenylalanin, bør bemærke, at Olazax Disperzi indeholder aspartam, som omdannes til phenylalanin.
English: What you need to know before you take Olazax Disperzi
Danish: Det skal du vide, før du begynder at tage OLAZAX DISPERZI
English: There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder.
Danish: Der er blevet rapporteret omagitation, hypertoni, hypotoni, tremor, døsighed , akut respirationsbesvær eller besvær ved fødeindtagelse.
English: (≥ 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: 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: Thrombocytopenia1
Danish: Trombocytopeni11
English: Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating fats and early in treatment, temporary increases in liver enzymes; increases in the level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in the blood; feeling more hungry; dizziness; restlessness; tremor; unusual movements(dyskinesias); constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet; fever; joint pain and sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males.
Danish: Almindelig bivirkninger (forekommer hos op til 1 ud af 10 patienter) omfatter ændringer i mængderne af visse blodceller, cirkulerende fedtstoffer i blodet; samt forbigående forhøjede leverenzymer tidligt i behandlingen; forhøjet sukker i blodet og urinen; forhøjet urinsyre og kreatinkinase i blodet; øget sultfornemmelse; svimmelhed; rastløshed; rysten; unormale bevægelser (dyskinesi); forstoppelse; mundtørhed; hududslæt; tab af styrke; udpræget træthed; Væskeophobning som medfører hævede af hænder, arme eller fødder; feber; ledsmerter og seksuelle problemer såsom nedsat sexlyst (libido) hos mænd og kvinder eller rejsningsbesvær hos mænd.
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: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Glenmark Pharmaceuticals s.r.o.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Glenmark Pharmaceuticals s.r.o.
English: Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling in the mouth and throat, itching, rash); diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; problems with speech; stuttering, slow heart rate; sensitivity to sunlight; bleeding from the nose; abdominal distension; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.
Danish: Ikke almindelig bivirkninger (forekommer hos op til 1 ud af 100 patienter) omfatter overfølsomhed (f.eks. hævelser i mund og hals, kløe, hududslæt); sukkersyge eller forværring af sukkersyge, af og til ledsaget af syreforgiftning (ketoacidose - ketonstoffer i blod og urin) eller bevidstløshed; krampeanfald, sædvanligvis hos patienter med tidligere krampeanfald (epilepsi); muskelstivhed eller muskelkramper (herunder øjenbevægelser); restless legs-syndrom; problemer med at tale; stammen; langsom hjertefrekvens (puls); følsomhed over for sollys; næseblod; udspilet mave; hukommelsestab eller glemsomhed; ufrivillig vandladning (urininkontinens); vandladningsbesvær; hårtab; manglende menstruation eller længere intervaller mellem menstruationerne ; brystforandringer hos mænd og kvinder, såsom unormal produktion af brystmælk eller unormal vækst.
English: Elevated triglyceride levels
Danish: Forhøjede triglyceridniveauer2
English: Restless legs syndrome
Danish: Restless legs-syndrom pkt.
English: Do not take two doses in one day.
Danish: Tag dine tabletter lige så snart, du kommer i tanke om det. Du m å ikke tage to doser på en dag.
English: Neuroleptic malignant syndrome (see section
Danish: Malignt neuroleptika syndrom (se
English: males and females females Gynaecomastia/breast enlargement in males General disorders and administration site conditions Asthenia Fatigue Oedema Pyrexia10
Danish: Brystforstørrelse Galaktorré hos kvinder Gynækomasti/brystfo r-størrelse hos mænd Almene symptomer og reaktioner på administrationsstedet Asteni Træthed Ødemer Pyreksi10
English: 5 Observed for fasting normal levels at baseline (< 1.69 mmol/l) which increased to high
Danish: 5 Observeret for fastende normalt niveau ved baseline (< 1,69 mmol/l), der blev øget til højt niveau
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: There are no controlled data on maintenance of effect or long term safety (see sections 4.4 and 4.8).
Danish: Der findes ingen kontrollerede data vedrørende virkning ved vedligeholdelsesbehandling og begrænsede data for langvarig eller sikkerheden ved langvarig brug (se pkt.
English: Very common: Weight gain 13, elevated triglyceride levels 14, increased appetite.
Danish: Meget almindelig: Vægtstigning13, forhøjede triglyceridniveauer14 , øget appetit.
English: Only take other medicines while you are on Olazax Disperzi if your doctor tells you that you can. You might feel drowsy if Olazax Disperzi 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 Olazax Disperzi tages sammen med depressionsmidler eller medicin til behandling af angst eller søvnløshed (sovepiller).
English: 4 Observed for fasting normal levels at baseline (< 5.56 mmol/l) which increased to high (≥ 7 mmol/l).
Danish: 4 Observeret for fastende normalt niveau ved baseline (< 5,56 mmol/l), der blev øget til højt niveau (≥ 7 mmol/l).
English: You can also place the tablet in a full glass or cup of water orange juice, apple juice, milk or coffee, and stir.
Danish: Den vil blive opløst med det samme i munden, så du let kan synke den. Du kan også lægge tabletten i et glas vand, appelsinjuice, æblejuice eller mælk eller i en kop kaffe.
English: In patients with a manic or mixed episode of bipolar disorder, olanzapine demonstrated superior efficacy to placebo and valproate semisodium (divalproex) in reduction of manic symptoms over 3 weeks.
Danish: Hos patienter med maniske eller blandede episoder af bipolar sindslidelsehavde olanzapin overlegen effekt i reduktion af maniske symptomer over 3 uger i forhold til placebo og valproat.
English: However, 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: Der skal drog udvises forsigtighed, når olanzapin ordineres sammen med lægemidler, der vides at øge QTc-intervallet, specielt hos ældre patienter, hos patienter med medfødthvor syndrom med langt QT-syndrom er medfødt, hjerteinsufficiens, hjertehypertrofi, hypokaliæmi eller hypomagnesiæmi..
English: Very common: Weight gain13, elevated triglyceride levels 14, increased appetite.
Danish: Meget almindelig: Vægt13, forhøjede triglyceridniveauer14 , øget appetit.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Glenmark Pharmaceuticals s.r.o.
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Glenmark Pharmaceuticals s.r.o.
English: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Danish: Lægemiddelf remkaldt reaktion med eosinofili og systemiske symptomer (DRESS)
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: Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebocontrolled clinical trials (see section 4.8).
Danish: Hos olanzapinbehandlede patienter i placebo-kontrollerede kliniske studierer der set uønskede forandringer i lipidniveauer (se pkt.
English: PHARMACEUTICAL FORM AND CONTENTS Orodispersible Tablet
Danish: LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) 28 Orodispergible tablette
English: Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olazax Disperzi and regularly during treatment.
Danish: Inden du påbegynder behandling med Olazax Disperzi samt jævnligt i løbet af behandlingen skal din læge tage blodprøver for at kontrollere indholdet af sukker og fedt i dit blod.
English: Controlled efficacy data in adolescents (ages 13 to 17 years)are limited to short term studies in schizophrenia (6 weeks) and mania associated with bipolar I disorder (3 weeks), involving less than 200 adolescents.
Danish: Kontrollerede effektdata medhos unge (alder 133 -- 17 år) omfatter mindre end 200 unge og er begrænset til kortvarige effektdata studier vedhos patienter med skizofreni (6 uger) og mani i forbindelse med bipolar I-sygdom (3 uger).
English: Patients treated with any antipsychotic medicines, including olanzapine, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
Danish: Patienter i behandling med antipsykotika herunder olanzapine bør observeres for tegn og symptomer på hyperglykæmi (som polydipsi, polyuri, polyfagi og svaghed).
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: Store below 30 C.
Danish: Opbevares ved temperaturer under 30ºC.