FrancophonIA/ELRC3.0 huggingface dataset:
English: • blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 people) especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing.
Danish: • Blodpropper i venerne (en ikke almindelig bivirkning, som forekommer hos op til 1 ud af 100 patienter), særligt i benene (symptomerne omfatter hævelse og smerte i benet samt hudrødme).
English: Common: Elevated cholesterol levels
Danish: Almindelig: Forhøjede kolesterolniveauer
English: Archimedesweg 2, 2333 CN, Leiden, The Netherlands
Danish: Archimedesweg 2, 2333 CN, Leiden, Holland
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,
Danish: De hyppigst rapporterede (set hos ≥ 1 % af patienter) bivirkninger, som var forbundet med anvendelse af olanzapin i kliniske forsøg, var somnolens og vægtøgning, eosinofili, forhøjede niveauer af prolaktin,
English: Do not drink any alcohol if you have been given Olanzapine Apotex as together with alcohol it may make you feel drowsy.
Danish: Brug af Olanzapin Apotex sammen med alkohol Drik ikke nogen form for alkohol, når du får Olanzapin Apotex, da det sammen med alkohol kan gøre dig døsig.
English: (See sections 4.5 and 5.2).
Danish: 4.5 og 5.2).
English: Do not take Olanzapine Apotex
Danish: Tag ikke Olanzapin Apotex
English: LIST OF EXCIPIENTS Contains lactose.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder lactose
English: , elevated triglyceride levels
Danish: , forhøjede triglyceridniveauer
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 hrs) or clearance (21.2 versus 25.0 l/hr).
Danish: Hos patienter med nedsat nyrefunktion (kreatininclearance < 10 ml/min) versus raske forsøgspersoner fandtes ingen signifikant forskel i den gennemsnitlige eliminationshalveringstid (37,7 versus 32,4 timer) eller clearance (21,2 versus 25,0 l/time).
English: Colloidal anhydrous silica
Danish: Kolloid vandfri silica
English: Eosinophil ia and Systemic Symptoms (DRESS)
Danish: Lægemiddel reaktion med eosinofili og systemiske symptomer (DRESS)
English: Increased alkaline phosphatase High creatine phosphokinase11
Danish: Forhøjet alkalisk fosfatase Høje niveauer af kreatinkinase11
English: Elevated triglyceride levels
Danish: Forhøjede triglyceridniveauer
English: In one clinical trial in patients with bipolar mania, valproate combination therapy with olanzapine resulted in an incidence of neutropenia of 4.1%; a potential contributing factor could be high plasma valproate levels.
Danish: I et klinisk forsøg med patienter med bipolær mani resulterede valproat kombinationsterapi med olanzapin i en incidens af neutropeni på 4,1 %.
English: PHARMACEUTICAL FORM AND CONTENTS 28 orodispersible tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 28 smeltetabletter
English: Patients treated with any antipsychotic medicines, including Olanzapine Apotex, 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 Olanzapin Apotex bør observeres for tegn og symptomer på hyperglykæmi (som polydipsi, polyuri, polyfagi og svaghed).
English: 2333 CN, Leiden, The Netherlands
Danish: 2333 CN, Leiden, Holland
English: Olanzapine Apotex film-coated tablets contain lactose.
Danish: Olanzapin Apotex filmovertrukne tabletter indeholder lactose.
English: Amnesia
Danish: Amnesi
English: Olanzapine Apotex 2.5 mg film-coated tablets Olanzapine Apotex 5 mg film-coated tablets Olanzapine Apotex 7.5 mg film-coated tablets Olanzapine Apotex 10 mg film-coated tablets
Danish: Olanzapin Apotex 2,5 mg filmovertrukne tabletter Olanzapin Apotex 5 mg filmovertrukne tabletter Olanzapin Apotex 7,5 mg filmovertrukne tabletter Olanzapin Apotex 10 mg filmovertrukne tabletter
English: In non-smoking versus smoking subjects (males and females), the mean elimination half-life was prolonged (38.6 versus 30.4 hrs) and the clearance was reduced (18.6 versus 27.7 l/hr).
Danish: Hos ikke-rygere versus rygere (mænd og kvinder) var den gennemsnitlige eliminations halveringstid forlænget (38,6 versus 30,4 timer) og clearance reduceret (18,6 versus 27,7 l/time).
English: Adverse event identified from spontaneous post-marketing reporting with frequency determined utilising the Olanzapine Integrated Database.
Danish: Bivirkning identificeret fra spontane indberetninger efter markedsføring med en hyppighed bestemt ved brug af Den Integrerede Olanzapindatabase.
English: High Gamma Glutamyltransferase High uric acid 10
Danish: Høje niveauer af gammaglutamyltransferase Høje niveauer af urinsyre10
English: What you need to know before you take Olanzapine Apotex
Danish: Det skal du vide, før du begynder at tage Olanzapin Apotex
English: Olanzapine Apotex 5 mg orodispersible tablets Olanzapine Apotex 10 mg orodispersible tablets Olanzapine Apotex 15 mg orodispersible tablets Olanzapine Apotex 20 mg orodispersible tablets
Danish: Olanzapin Apotex 5 mg smeltetabletter Olanzapin Apotex 10 mg smeltetabletter Olanzapin Apotex 15 mg smeltetabletter Olanzapin Apotex 20 mg smeltetabletter
English: Temporal association of olanzapine treatment and venous thromboembolism has been reported uncommonly (≥ 0.1% and < 1%).
Danish: En tidsmæssig sammenhæng mellem behandling med olanzapin og venøs tromboembolisme er meget sjældent (< 0,01 %) rapporteret.
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,
Danish: De hyppigst rapporterede (set hos ≥ 1 % af patienter) bivirkninger, som var forbundet med anvendelse af olanzapin i kliniske forsøg, var somnolens og vægtøgning, eosinofili, forhøjede niveauer af prolaktin, kolesterol, glucose og triglycerider (se pkt.
English: If you have any further questions, ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet.
English: Excipient with known effect: Each film-coated tablet contains 189.50 mg lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver filmovertrukken tablet indeholder 189,50 mg lactose.
English: Seizures where in most cases a history of seizures or risk factors for seizures were reported
Danish: Krampeanfald, hvor der i de fleste tilfælde var rapporteret krampeanfald i anamnesen eller risikofaktorer for kramper
English: A greater magnitude of weight gain, lipid and prolactin alterations has been reported in short term studies of adolescent patients than in studies of adult patients (see sections 4.4, 4.8, 5.1 and 5.2).
Danish: Der er rapporteret vægtøgning og lipid- og prolaktinforandringer i en større mængde i kortvarige studier med unge patienter end i studier med voksne patienter (se pkt.
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 maniodepressiv sygdom havde olanzapin overlegen effekt i reduktion af maniske symptomer over 3 uger i forhold til placebo og valproat.
English: Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
Danish: Akutte symptomer såsom svedtendens, søvnløshed, tremor, angstanfald, kvalme og opkastning er rapporteret ved pludselig seponering af 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: As it exhibits in vitro dopamine antagonism, olanzapine may antagonize the effects of direct and indirect dopamine agonists.
Danish: Da olanzapin udviser in vitro antagonisme, kan det hæmme effekten af direkte eller indirekte dopaminagomisme.
English: Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo controlled clinical trials (see section 4.8).
Danish: Hos olanzapinbehandlede patienter i placebo-kontrollerede kliniske undersøgelser er der set uønskede forandringer i lipidniveauer (se pkt.
English: Lactose monohydrate Microcrystalline cellulose Maize starch
Danish: Lactosemonohydrat Mikrokrystallinsk cellulose Majsstivelse
English: Seizures where in most cases a history of seizures or risk factors for seizures were reported 11
Danish: Krampeanfald, hvor der i de fleste tilfælde var rapporteret krampeanfald i anamnesen eller risikofaktorer for kramper11
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: 9 Adverse event identified from clinical trials in the Olanzapine Integrated Database.
Danish: Bivirkning identificeret fra kliniske studier i Den Integrerede Olanzapindatabase.
English: If you forget to take Olanzapine Apotex Take your tablets as soon as you remember.
Danish: Hvis du har glemt at tage Olanzapin Apotex Tag dine tabletter lige så snart, du kommer i tanke om det. Du må ikke tage to doser på en dag.
English: NL-2333 CN Leiden Netherlands
Danish: Archimedesweg 2 NL-2333 CN Leiden Holland
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: Discontinuation symptoms7, 12
Danish: 4.4) Abstinenssymptomer7,12
English: In healthy elderly (65 and over) versus non-elderly subjects, the mean elimination half-life was prolonged (51.8 versus 33.8 hrs) and the clearance was reduced (17.5 versus 18.2 l/hr).
Danish: Hos raske ældre forsøgspersoner (> 65 år) var den gennemsnitlige eliminationshalveringstid forlænget (51,8 versus 33,8 timer) og clearance var reduceret (17,5 versus 18,2 l/time).
English: Only take other medicines while you are on Olanzapine Apotex if your doctor tells you that you can. You might feel drowsy if Olanzapine Apotex 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 Olanzapin Apotex tages sammen med depressionsmidler eller medicin til behandling af angst eller søvnløshed (sovepiller).
English: Excipient with known effect: Each film-coated tablet contains 126.34 mg lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver filmovertrukken tablet indeholder 126,34 mg lactose.
English: Neutropenia10
Danish: Leukopeni10
English: 3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high
Danish: 3 Observeret for fastende normalt niveau ved baseline (< 5,17 mmol/l), der blev øget til højt niveau
English: Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported rarely 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: Observed for fasting normal levels at baseline (< 1.69 mmol/l) which increased to high (≥ 2.26 mmol/l).
Danish: Observeret for fastende normalt niveau ved baseline (< 1,69 mmol/l), der blev øget til højt niveau (≥ 2,26 mmol/l).
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; øget niveau af 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 hænder, ankler eller fødder; feber; ledsmerter og seksuelle problemer såsom nedsat sexlyst (libido) hos mænd og kvinder eller rejsningsbesvær hos mænd.
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: Aluminium/aluminium blister strips in cartons of 28 film-coated tablets per carton.
Danish: Aluminium/aluminium blisterkort i kartoner á 28 filmovertrukne tabletter pr. karton.
English: Excipient with known effect: Each film-coated tablet contains 63.17 mg lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver filmovertrukken tablet indeholder 63,17 mg lactose.
English: General disorders and administration site conditions
Danish: Almene symptomer og reaktioner på administrationsstedet Asteni
English: Olanzapine Apotex contains lactose
Danish: Olanzapin Apotex indeholder lactose.
English: Nervous system disorders Somnolence Dizziness Akathisia
Danish: Nervesystemet Døsighed Svimmelhed Akatisi
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: What Olanzapine Apotex contains
Danish: Olanzapin Apotex indeholder:
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: 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); muskelstivhed eller muskelkramper (herunder øjenbevægelser); restless legs-syndrom (stærk uro i underbenene); problemer med at tale; langsom hjertefrekvens; 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: Hepatobiliary disorders Transient, asymptomatic elevations of hepatic aminotransferases (ALT, AST), especially in early treatment (see section 4.4)
Danish: Lever og galdeveje Forbigående, asymptomatisk forhøjede leveraminotransfera ser (ALAT, ASAT), særlig i den tidlige behandling (se pkt.
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 foranstaltninger iværksættes, da patienter, som lider af skizofreni, ofte har sygdomsbetingede risikofaktorer for venøse tromboembolier.
English: Apotex Nederland B.V. Archimedesweg 2
Danish: Apotex Nederland B.V.
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: Aluminium/aluminium blister strips in cartons of 28, 56 and 98 film-coated tablets per carton.
Danish: Aluminium/aluminium blisterkort i kartoner á 28, 56 og 98 filmovertrukne tabletter pr. karton.
English: Excipient with known effect: Each film-coated tablet contains 252.70 mg lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver filmovertrukken tablet indeholder 257,70 mg lactose.
English: Olanzapine orodispersible tablet is bioequivalent to olanzapine film-coated tablets, with a similar rate and extent of absorption.
Danish: Olanzepin smeltetablet er bioækvivalent med olanzepin filmovertrukne tabletter med lignende absorptionshastighed og -grad. Der anvendes samme dosis og hyppighed som for indgivelse af olanzapin filmovertrukne tabletter.
English: Tardive dyskinesia11 Amnesia 9
Danish: Tardiv dyskinesi11
English: Do not stop taking your tablets just because you feel better.
Danish: Hvis du holder op med at tage Olanzapin Apotex Du må ikke holde op med at tage tabletterne, fordi du har fået det bedre.
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: Amnesia Dysarthria Stuttering11
Danish: Dysartri Stammen11
English: Respiratory, thoracic and mediastinal disorders Epistaxis
Danish: Luftveje, thorax og mediastinum
English: • Each Olanzapine Apotex 7.5 mg film-coated tablet contains 7.5 mg olanzapine.
Danish: • Hver Olanzapin Apotex 7,5 mg filmovertrukken tablet indeholder 7,5 mg olanzapin.
English: 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: 4.4), hududslæt, asteni, træthed, pyreksi, artralgi, forhøjet alkalisk fosfatase, høje niveauer af gammaglutamyltransferase, af urinsyre og af kreatinkinase samt ødemer.
English: Marketing Authorisation Holder Apotex Europe B.V.
Danish: Indehaver af markedsføringstilladelsen Apotex Europe B.V.
English: Hepatic function
Danish: Leverfunktionen
English: Observed for fasting normal levels at baseline (< 5.56 mmol/l) which increased to high (≥ 7 mmol/l).
Danish: Observeret for fastende normalt niveau ved baseline (< 5,56 mmol/l), der blev øget til højt niveau (≥ 7 mmol/l).
English: • Olanzapine Apotex 20 mg orodispersible tablets are available in blister packs of 28 and 56 tablets.
Danish: • Olanzapin Apotex 20 mg smeltetabletter fås i blisterpakninger med 28 og 56 tabletter.
English: Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high (≥ 6.2 mmol/l).
Danish: Observeret for fastende normalt niveau ved baseline (< 5,17 mmol/l), der blev øget til højt niveau (≥ 6,2 mmol/l).
English: • Olanzapine Apotex 7.5 mg film-coated tablets are available in blisters packs of 28 and 56 tablets.
Danish: • Olanzapin Apotex 7,5 mg filmovertrukne tabletter fås i blisterpakninger med 28 og 56 tabletter.
English: Keep this medicine out of sight and reach of children.
Danish: Opbevar lægemidlet utilgængeligt for børn.
English: • Each Olanzapine Apotex 20 mg orodispersible tablet contains 20 mg olanzapine.
Danish: • Hver Olanzapin Apotex 20 mg smeltetablet indeholder 20 mg olanzapin.
English: What Olanzapine Apotex is and what it is used for What you need to know before you take Olanzapine Apotex How to take Olanzapine Apotex Possible side effects
Danish: Det skal du vide, før du begynder at tage Olanzapin Apotex Sådan skal du tage Olanzapin Apotex Bivirkninger
English: • Olanzapine Apotex 15 mg orodispersible tablets are available in blisters packs of 28 tablets.
Danish: • Olanzapin Apotex 15 mg smeltetabletter fås i blisterpakninger med 28 tabletter.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/635/004-005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/10/635/004-005
English: • Olanzapine Apotex 2.5 mg film-coated tablets are available in blisters packs of 28 tablets.
Danish: • Olanzapin Apotex 2,5 mg filmovertrukne tabletter fås i blisterpakninger med 28 tabletter.
English: Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olanzapine Apotex and regularly during treatment.
Danish: Inden du påbegynder behandling med Olanzapin Apotex samt jævnligt i løbet af behandlingen skal din læge tage blodprøver for at kontrollere indholdet af sukker og fedt i dit blod,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/635/013-014
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/10/635/013-014
English: Aluminium/aluminium blister strips in cartons of 28 and 56 film-coated tablets per carton.
Danish: Aluminium/aluminium blisterkort i kartoner á 28 eller 56 filmovertrukne tabletter pr. karton.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Apotex Europe B.V.
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Apotex Europe B.V.
English: • Olanzapine Apotex 5 mg and 10 mg film- coated tablets are available in blister packs of 28, 56
Danish: • Olanzapin Apotex 5 mg og 10 mg filmovertrukne tabletter fås i blisterpakninger med 28, 56 og
English: • Each Olanzapine Apotex 2.5 mg film-coated tablet contains 2.5 mg olanzapine.
Danish: • Hver Olanzapin Apotex 2,5 mg filmovertrukken tablet indeholder 2,5 mg olanzapin.
English: If you stop taking Olanzapine Apotex
Danish: Hvis du har taget for meget Olanzapin Apotex