FrancophonIA/ELRC3.0 huggingface dataset:
English: ZYPREXA VELOTAB 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 ZYPREXA VELOTAB forebygger tilbagefald af disse symptomer ved bipolar lidelse (maniodepressiv sygdom) hos patienter, hvis maniske episode har reageret på olanzapinbehandling.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 3 February 2000
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Tardive dyskinesia11
Danish: Tardiv dyskinesi11 Amnesi9
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 QTc intervallet.
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: ZYPREXA VELOTAB contains the active substance olanzapine.
Danish: ZYPREXA VELOTAB indeholder det aktive stof olanzapin.
English: Тел : + 359 2 491 41 40
Danish: - България тел + 359 2 491 41 40
English: ZYPREXA VELOTAB contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which may cause an allergic reaction in some people.
Danish: ZYPREXA VELOTAB indeholder natriummethylparahydroxybenzoat og natriumpropylparahydroxybenzoat, som kan give en allergisk reaktion hos nogle mennesker.
English: Patients who cannot take mannitol should note that ZYPREXA VELOTAB contains mannitol.
Danish: Patienter, som ikke kan tåle mannitol, bør bemærke, at ZYPREXA VELOTAB også indeholder mannitol.
English: An allergic reaction may be recognised as a rash, itching or shortness of breath.
Danish: En allergisk reaktion kan kendes på et udslæt, kløe eller åndenød.
English: ZYPREXA VELOTAB should be stored in its original pack in order to protect from light and moisture.
Danish: ZYPREXA VELOTAB bør opbevares i den originale yderpakning for at beskytte mod lys og fugt.
English: Neuroleptic malignant syndrome (see section
Danish: Malignt neuroleptikasyndrom (se pkt.
English: Transient, asymptomatic elevations of hepatic aminotransferases, ALT, AST have been seen commonly, especially in early treatment.
Danish: Forbigående, asymptomatiske forhøjelser af leveraminotransferaser (ALAT, ASAT) er almindeligt forekommende, især initialt i behandlingen.
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: Haematologic toxicity: 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, no evidence of bone marrow cytotoxicity was found.
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: Patients who cannot take phenylalanine should note that ZYPREXA VELOTAB contains aspartame, which is a source of phenylalanine.
Danish: Patienter, som ikke kan tåle phenylalanin, bør bemærke, at ZYPREXA VELOTAB indeholder aspartam, som omdannes til phenylalanin.
English: Do not drink any alcohol if you have been given ZYPREXA VELOTAB as together with alcohol it may make you feel drowsy.
Danish: Brug af ZYPREXA VELOTAB sammen med alkohol Drik ikke nogen form for alkohol, når du får ZYPREXA VELOTAB, da det sammen med alkohol kan gøre dig døsig.
English: 28 orodispersible tablets 35 orodispersible tablets 56 orodispersible tablets 70 orodispersible tablets 98 orodispersible tablets
Danish: 28 smeltetabletter 35 smeltetabletter 56 smeltetabletter 70 smeltetabletter 98 smeltetabletter
English: In renally impaired patients (creatinine clearance < 10 ml/min) versus healthy subjects, there was no significant difference in mean elimination half-life (37.7 versus 32.4 hr) or clearance (21.2 versus 25.0 l/hr).
Danish: Hos patienter med nedsat nyrefunktion (kreatinin clearance < 10 ml/min) versus raske forsøgspersoner fandtes ingen signifikant forskel i den gennemsnitlige eliminations halveringstid (37,7 versus 32,4 timer) eller clearance (21,2 versus 25,0 l/time).
English: If you suddenly stop taking ZYPREXA VELOTAB, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur.
Danish: Hvis du pludseligt holder op med at tage ZYPREXA VELOTAB, kan der forekomme symptomer som svedtendens, søvnbesvær, rysten, angst, kvalme og opkastning.
English: Do not take ZYPREXA VELOTAB
Danish: Tag ikke ZYPREXA VELOTAB
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: Separate one blister cell from the strip.
Danish: Adskil en blisterlomme fra blisterkortet.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines
Danish: Fortæl altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: In a single oral dose (10 mg) Positron Emission Tomography (PET) study in healthy volunteers, olanzapine produced a higher 5 HT2A than dopamine D2 receptor occupancy.
Danish: I en enkeltdosis (10 mg) Positron Emission Tomography (PET) undersøgelse hos raske forsøgspersoner bandt olanzapin til flere 5-HT2A end til dopamin D2 receptorer.
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 uger) forebyggende mod tilbagefald hos patienter med bipolær sygdom blev forbundet med en stigning på ≥7 % af baseline legemsvægt hos
English: (including pulmonary embolism and deep vein thrombosis) (see section 4.4)
Danish: Tromboemboli (inklusive lungeemboli og dyb venetrombose) (se pkt.
English: Elevated glucose levels4
Danish: Forhøjede glucoseniveauer4
English: The exact amount is shown on your ZYPREXA VELOTAB pack.
Danish: Den præcise mængde kan ses på din pakning med ZYPREXA VELOTAB smeltetabletter.
English: Do not stop taking your tablets just because you feel better.
Danish: Hvis du holder op med at tage ZYPREXA VELOTAB Du må ikke ophøre med at tage tabletterne, fordi du føler dig bedre tilpas.
English: Carefully peel off the backing.
Danish: Træk forsigtigt bagsiden af.
English: If you take more ZYPREXA VELOTAB than you should Patients who have taken more ZYPREXA VELOTAB than they should have experienced the following symptoms: rapid beating of the heart, agitation/aggressiveness, problems with speech,
Danish: Hvis du har taget for meget ZYPREXA VELOTAB Patienter, som har taget mere ZYPREXA VELOTAB 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: Other ingredients: gelatin, mannitol (E421), aspartame (E951), sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217).
Danish: Andre indholdsstoffer: gelatine, mannitol (E421), aspartam (E951), natriummethylparahydroxybenzoat (E219), natriumpropylparahydroxybenzoat (E217).
English: Mannitol ZYPREXA VELOTAB orodispersible tablet contains mannitol.
Danish: Mannitol ZYPREXA VELOTAB smeltetablet indeholder mannitol.
English: It has the same dosage and frequency of administration as olanzapine coated tablets.
Danish: Der anvendes samme dosis og dosisinterval som for olanzapin overtrukne tabletter.
English: Systemic Symptoms (DRESS)
Danish: Lægemiddelfremkaldt udslæt med eosinofili og systemiske symptomer (DRESS)
English: Ventricular tachycardia/fibrillation, sudden death (see section 4.4)11
Danish: Ventrikulær takykardi/ventrikelflimren, pludselig død (se pkt.
English: ZYPREXA VELOTAB 5 mg orodispersible tablets ZYPREXA VELOTAB 10 mg orodispersible tablets ZYPREXA VELOTAB 15 mg orodispersible tablets ZYPREXA VELOTAB 20 mg orodispersible tablets
Danish: ZYPREXA VELOTAB 5 mg smeltetabletter ZYPREXA VELOTAB 10 mg smeltetabletter ZYPREXA VELOTAB 15 mg smeltetabletter ZYPREXA VELOTAB 20 mg smeltetabletter olanzapin
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/timer).
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 eliminations halveringstid forlænget (51,8 versus 33,8 timer) og clearance var reduceret (17,5 versus 18,2 l/time).
English: Patients treated with any antipsychotic medicines, including ZYPREXA VELOTAB, 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 ZYPREXA VELOTAB bør observeres for tegn og symptomer på hyperglykæmi (som polydipsi, polyuri, polyfagi og svaghed).
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 med gulfarvning af huden og af det hvide i øjnene; muskelsygdom, som viser sig med uforklarlige smerter; forlænget og/eller pinefuld erektion.
English: An updated RMP should be submitted: • At the request of the European Medicines Agency
Danish: En opdateret RMP skal fremsendes:
English: Sodium methyl parahydroxybenzoate (E219) Sodium propyl parahydroxybenzoate (E217)
Danish: Natriummethylparahydroxybenzoat (E219) Natriumpropylparahydroxybenzoat (E217).
English: ZYPREXA VELOTAB orodispersible tablet contains aspartame, which is a source of phenylalanine.
Danish: ZYPREXA VELOTAB smeltetablet indeholder aspartam, som indeholder phenylalanin.
English: What you need to know before you take ZYPREXA VELOTAB
Danish: Det skal du vide, før du begynder at tage ZYPREXA VELOTAB
English: Thromboembolism hypotension10
Danish: Vaskulære sygdomme Ortostatisk hypotension10
English: Gastrointestinal disorders Mild, transient anticholinergic effects including constipation and dry mouth
Danish: Mave-tarmkanalen Lette, forbigående antikolinerge virkninger, herunder
English: EU/1/99/125/006 EU/1/99/125/007 EU/1/99/125/008 EU/1/99/125/009 EU/1/99/125/010 EU/1/99/125/011 EU/1/99/125/012 EU/1/99/125/013 EU/1/99/125/014 EU/1/99/125/015 EU/1/99/125/016 EU/1/99/125/017 EU/1/99/125/018 EU/1/99/125/019 EU/1/99/125/020
Danish: EU/1/99/125/001 EU/1/99/125/002 EU/1/99/125/003 EU/1/99/125/004 EU/1/99/125/005 EU/1/99/125/006 EU/1/99/125/007 EU/1/99/125/008 EU/1/99/125/009 EU/1/99/125/010 EU/1/99/125/011 EU/1/99/125/012 EU/1/99/125/013 EU/1/99/125/014 EU/1/99/125/015 EU/1/99/125/016 EU/1/99/125/017
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: Almindelige bivirkninger (forekommer hos op til 1 ud af 10 patienter) omfatter ændringer i mængden 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; ekstrem træthed; væskeophobning som medfører hævede hænder, ankler eller fødder; feber; ledsmerter og seksuelle problemer såsom nedsat sexlyst (libido) hos mænd og kvinder eller rejsningsbesvær hos mænd.
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 almindelige 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); muslkestivhed eller muskelkramper (herunder øjenbevægelser); restless legs-syndrom (stærk uro i underbenene); problemer med at tale; stammen; langsom hjertefrekvens (puls); følsomhed overfor 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: Sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate Olanzapine orodispersible tablet contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate.
Danish: Natriummethylparahydroxybenzoat og natriumpropylparahydroxybenzoat Olanzapin smeltetablet indeholder natriummethylparahydroxybenzoat og natriumpropylparahydroxybenzoat.
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: Only take other medicines while you are on ZYPREXA VELOTAB if your doctor tells you that you can. You might feel drowsy if ZYPREXA VELOTAB 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 ZYPREXA VELOTAB tages sammen med depressionsmidler eller medicin til behandling af angst eller søvnløshed (sovepiller).
English: ZYPREXA VELOTAB contains aspartame, mannitol and sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate
Danish: ZYPREXA VELOTAB indeholder aspartam, mannitol, natriummethylparahydroxybenzoat og natriumpropylparahydroxybenzoat.
English: Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking ZYPREXA VELOTAB and regularly during treatment.
Danish: Inden du påbegynder behandling med ZYPREXA VELOTAB samt jævnligt i løbet af behandlingen, skal din læge tage blodprøver for at kontrollere indholdet af sukker og fedt i dit blod.
English: Hepatobiliary disorders Transient, asymptomatic elevations of hepatic aminotransferases (ALT, AST), especially in early treatment (see section 4.4)
Danish: forstoppelse og mundtørhed Lever og galdeveje Forbigående, asymptomatisk forhøjede leveraminotransferaser (ALAT, ASAT), særligt initialt i behandlingen (se pkt.
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 studier, er der set uønskede forandringer i lipidniveauer (se pkt.
English: If you forget to take ZYPREXA VELOTAB Take your tablets as soon as you remember.
Danish: Hvis du har glemt at tage ZYPREXA VELOTAB Tag dine tabletter lige så snart, du kommer i tanke om det. Du må ikke tage en dobbeltdosis som erstatning for den glemte.
English: What ZYPREXA VELOTAB looks like and contents of the pack ZYPREXA VELOTAB 5 mg, 10 mg, 15 mg and 20 mg are yellow orodispersible tablets.
Danish: ZYPREXA VELOTAB 5 mg, 10 mg, 15 mg og 20 mg er gule smeltetabletter.
English: (≥ 1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 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: INFORMATION IN BRAILLE ZYPREXA VELOTAB 20 mg
Danish: INFORMATION I BRAILLESKRIFT ZYPREXA VELOTAB 20 mg
English: EU/1/99/125/001 EU/1/99/125/002 EU/1/99/125/003 EU/1/99/125/004 EU/1/99/125/005
Danish: EU/1/99/125/018 EU/1/99/125/019 EU/1/99/125/020
English: However, since patients with schizophrenia often present with acquired risk factors for venous thromboembolism all possible risk factors of VTE e.g. immobilisation of patients, should be identified and preventive measures undertaken.
Danish: På trods af dette bør alle mulige risikofaktorer for venøse tromboembolier identificeres, f.eks. immobilisation, og forebyggende foranstaltningeriværksættes, da patienter, som lider af skizofreni, ofte har sygdomsbetingede risikofaktorer for venøse tromboembolier.
English: INFORMATION IN BRAILLE ZYPREXA VELOTAB 15 mg
Danish: INFORMATION I BRAILLESKRIFT ZYPREXA VELOTAB 15 mg
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: Syndrome
Danish: Bivirkninger
English: Excipients with known effect: Each orodispersible tablet contains 1.20 mg aspartame,
Danish: Hjælpestoffer som behandleren skal være opmærksom på: Hver smeltetablet indeholder 1,20 mg aspartam
English: ZYPREXA VELOTAB 20 mg orodispersible tablets
Danish: ZYPREXA VELOTAB 20 mg smeltetablet
English: Excipients with known effect: Each orodispersible tablet contains 0.80 mg aspartame,
Danish: Hjælpestoffer som behandleren skal være opmærksom på: Hver smeltetablet indeholder 0,80 mg aspartam
English: Each orodispersible tablet contains 20 mg olanzapine.
Danish: Hver smeltetablet indeholder 20 mg olanzapin.
English: 0.15 mg sodium methyl parahydroxybenzoate, 0.05 mg sodium propyl parahydroxybenzoate.
Danish: 0,15 mg natriummethylparahydroxybenzoat 0,05 mg natriumpropylparahydroxybenzoat
English: Changes in fasting glucose from borderline at baseline (≥ 5.56 - < 7 mmol/l) to high (≥ 7 mmol/l)
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: Excipients with known effect: Each orodispersible tablet contains 1.60 mg aspartame,
Danish: Hjælpestoffer som behandleren skal være opmærksom på: Hver smeltetablet indeholder 1,60 mg aspartam
English: Excipients with known effect: Each orodispersible tablet contains 0.60 mg aspartame,
Danish: Hjælpestoffer som behandleren skal være opmærksom på: Hver smeltetablet indeholder 0,60 mg aspartam
English: 0.30 mg sodium methyl parahydroxybenzoate, 0.10 mg sodium propyl parahydroxybenzoate.
Danish: 0,30 mg natriummethylparahydroxybenzoat 0,10 mg natriumpropylparahydroxybenzoat
English: Each orodispersible tablet contains 15 mg olanzapine.
Danish: Hver smeltetablet indeholder 15 mg olanzapin.
English: Each orodispersible tablet contains 5 mg olanzapine.
Danish: Hver smeltetablet indeholder 5 mg olanzapin.
English: In a multinational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p= 0.001) favouring olanzapine (-6.0) versus haloperidol (-3.1).
Danish: Studiet viste en prospektiv sekundær analyse af ændring i stemningslejeniveauet fra før behandling til endt behandling en statistisk signifikant forbedring (p=0,001) til fordel for patienter behandlet med olanzapin (-6,0) i forhold til patienter behandlet med haloperidol (-3,1).
English: 3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high
Danish: 3Observeret for fastende normalt niveau ved baseline (< 5,17 mmol/l), der blev øget til højt niveau (≥ 6,2 mmol/l).
English: NAME OF THE MEDICINAL PRODUCT ZYPREXA VELOTAB 20 mg orodispersible tablets Olanzapine
Danish: LÆGEMIDLETS NAVN ZYPREXA VELOTAB 20 mg smeltetabletter Olanzapin
English: Consult your doctor if your symptoms return but do not stop taking ZYPREXA VELOTAB unless your doctor tells you to.
Danish: Din læge vil fortælle dig, hvor mange ZYPREXA VELOTAB tabletter, du skal tage og i hvor lang tid, du skal tage dem. Dagsdosis for ZYPREXA VELOTAB er mellem 5 mg og 20 mg. Konsulter din læge, hvis dine symptomer vender tilbage, men stop ikke med at tage ZYPREXA VELOTAB, medmindre din læge siger det.