FrancophonIA/ELRC3.0 huggingface dataset:
English: How to store LAVENTAIR ELLIPTA
Danish: Sådan skal du tage Laventair Ellipta
English: If you use more LAVENTAIR ELLIPTA than you should
Danish: Hvis du har taget for meget Laventair Ellipta
English: 30 months
Danish: 30 måned
English: Date of renewal: 22.08.2014
Danish: Dato for seneste fornyelse: 22.08.2014
English: However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Dog skal indehaveren af markedsføringstilladelsen indsende periodiske sikkerhedsopdateringer for dette lægemiddel, hvis produktet indgår på listen over EU-referencedatoer (EURD liste) er omhandlet i artikel 107c (7), i direktiv 2001/83/EF og offentliggjort på Europa webportal om lægemidler
English: Aspartame E 951
Danish: Aspartam E 951
English: You should not be given this medicine when breast-feeding, as small amounts of Olazax can pass into breast milk.
Danish: Du bør ikke få denne medicin, mens du ammer, da små mængder Olazax kan overføres til modermælken.
English: Children and adolescents Olazax is not for patients who are under 18 years
Danish: Børn og unge Olazax er ikke til patienter under 18 år.
English: If you are pregnant or think you might be pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du bruger dette lægemiddel.
English: In patients with Parkinson's disease Olazax may worsen the symptoms
Danish: Hos patienter med Parkinsons sygdom kan Olazax forværre symptomerne.
English: There is a risk of feeling drowsy when you are given Olazax.
Danish: Der er risiko for døsighed, når du får Olazax.
English: You should take your Olazax tablets once a day following the advice of your doctor.
Danish: Du bør tage Olazax tabletter én gang dagligt efter din læges anvisning.
English: Tablet 28 tablets 56 tablets
Danish: Tablet 28 tabletter 56 tabletter
English: • Weight gain has been seen in patients taking Olazax.
Danish: • Vægtøgning er set hos patienter, som tager OLAZAX.
English: • The use of OLAZAX in elderly patients with dementia is not recommended as it may have serious side effects.
Danish: • OLAZAX anbefales ikke til ældre, demente patienter, da det kan have alvorlige bivirkninger
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.emea.europa.eu
Danish: Detaljerede oplyninger om dette produkt forefindes på hjemmesiden for European Medicines Agency http://www.emea.europa.eu
English: It is important that you carry on taking Olazax for as long as your doctor tells you.
Danish: Det er vigtigt, du fortsætter med at tage Olazax, s å længe lægen beder dig om det.
English: Patients who have taken more Olazax than they should, have experienced the following symptoms: rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Danish: Patienter, som har taget mere Olazax 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: • carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your Olazax dose
Danish: • Carbamazepin (mod epilepsi og stemningsforstyrrelser), fluvoxamin (mod depression) eller ciprofloxacin (mod infektion), da det kan blive nødvendigt at ændre din OLAZAX-dosis
English: In a study in breast-feeding, healthy women, olanzapine was excreted in breast milk.
Danish: I et studie af raske, ammende kvinder blev olanzapin udskilt i modermælken.
English: Olazax contains the active substance olanzapine.
Danish: Olazax indeholder det aktive stof olanzapin.
English: Hvězdova 1716/2b, 140 78 Praha 4
Danish: Hvezdova 1716/2b, 140 78 Prag 4 Tjekkiet
English: Adults Schizophrenia: The recommended starting dose for olanzapine is 10 mg/day.
Danish: Skizofreni: Den anbefalede startdosis af olanzapin er 10 mg/dag.
English: Do not take Olazax - 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: The following table summarises the adverse reactions reported with a greater frequency in adolescent patients (aged 13-17 years) than in adult patients or adverse reactions only identified during shortterm clinical trials in adolescent patients.
Danish: Den følgende tabel opsummerer de bivirkninger, som blev rapporteret med større frekvens hos unge patienter (alder 13 - 17 år) end hos voksne patienter, eller bivirkninger som kun blev identificeret i kortvatige kliniske forsøg med unge patienter.
English: You should swallow the Olazax X tablets whole, with water.
Danish: Du bør synke Olazax tabletterne hele med vand.
English: The following symptoms may occur in newborn babies, of mothers that have used OLAZAX in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Danish: Følgende symptomer kan forekomme hos nyfødte af mødre, som har taget OLAZAX i sidste trimester (de sidste tre måneder af graviditeten): rystelser, muskelstivhed og/eller svaghed, søvnighed, ophidselse, vejrtrækningsbesvær og besvær med at indtage føde.
English: Olazax 5 mg tablets Olazax 7.5 mg tablets Olazax 10 mg tablets Olazax 15 mg tablets Olazax 20 mg tablets Olanzapine
Danish: Olazax 5 mg tabletter Olazax 7,5 mg tabletter Olazax 10 mg tabletter Olazax 15 mg tabletter Olazax 20 mg tabletter olanzapin
English: Adults Olanzapine is indicated for the treatment of schizophrenia.
Danish: Olanzapin er indiceret til behandling af skizofreni.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Aluminium blisters
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Aluminium blisterpakninger
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Dette gælder også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel.Du ellerdine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Do not drink any alcohol if you have been given Olazax as together with alcohol it may make you feel drowsy.
Danish: Brug af Olazax sammen med alkohol Drik ikke nogen form for alkohol, når du får Olazax, da det sammen med alkohol kan gøre dig døsig.
English: 1 Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
Danish: 1 Klinisk signifikant vægtøgning blev observeret på tværs af alle baseline bodymassindex (BMI) kategorier.
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) undersøgelse 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: • Very rarely, medicines of this type cause a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness.
Danish: • Yderst sjældent forårsager denne slags medicin en kombination af feber, hurtigere vejrtrækning, svedtendens, muskel¬stivhed og døsighed/søvnighed.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11.12.2009
Danish: Dato for første markedsføringstilladelse: 11.12.2009
English: 16 Elevated plasma prolactin levels were reported in 47.4% of adolescent patients.
Danish: 16 Forhøjede plasma-prolaktinniveauer blev rapporteret hos 47,4 % af de unge patienter.
English: If you stop taking Olazax
Danish: Hvis du holder op med at tage Olazax
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 % versus 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: • High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Olazax.
Danish: • Højt sukker- og fedtindhold (triglycerider og kolesterol) i blodet er set hos patienter, som tager ZYPREXA.
English: Dystonia (including oculogyration) 11 Tardive dyskinesia11
Danish: Dystoni (inklusive okulogyration)11 Tardiv dyskinesi11 Amnesi9
English: Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels.
Danish: Forsøg med patienter i alderen 13 - 17 år gav forskellige bivirkninger, inklusive vægtøgning, ændringer i metaboliske parametre og stigning i prolaktinværdier (se pkt.
English: Olazax 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 forebygger tilbagefald af disse symptomer ved bipolar lidelse (maniodepressiv sygdom) hos patienter, hvis maniske episode har reageret på olanzapinbehandling.
English: (see sections 4.8 and 5.1).
Danish: 4.8 og 5.1).
English: This leaflet was last revised in {month/YYYY}.
Danish: Denne indlægsseddel blev sidst ændret (MM/YYYY)
English: Weight should be monitored regularly e.g. at baseline, 4, 8 and 12 weeks after starting olanzapine treatment and quarterly thereafter.
Danish: Vægten bør kontrolleres regelmæssigt, f.eks. ved baseline, 4, 8 og 12 uger efter start på olanzapinbehandling, og derefter kvartalsvist.
English: Olazax belongs to a group of medicines called antipsychotics and is used to treat the following conditions:
Danish: Olazax tilhører en gruppe af lægemidler, der kaldes antipsykotika.
English: In the offspring of rats given olanzapine, delays in foetall development and transient decreases in offspring activity levels were seen.
Danish: Hos afkommet af rotter, der havde fået olanzapin, observeredes en forsinket fosterudvikling og et forbigående nedsat aktivitetsniveau hos afkommet.
English: Olazax, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg are available in aluminium foil blisters of 28 or 56 tablets
Danish: Olazax 5 mg, 7,5 mg, 10 mg, 15 mg, 20 mg findes i aluminium blisterpakninger med 28, 56 tabletter.
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: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller på apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Reversible neutropenia, thrombocytopenia, or anaemiaa developed in a few dogs treated with 8 or 10 mg/kg/day (total olanzapine exposure [AUC] is 12- to 15-fold greater than that of a man given a 12-mg dose).
Danish: Reversibel neutropeni, trombocytopeni eller anæmi udvikledes hos enkelte hunde, som blev behandlet med 8 eller 10 mg/kg/dag (total olanzapin dosis (AUC) var 12-15 gange højere end human dosis på 12 mg).
English: Caution should be exercised in patients with low leukocyte and/or neutrophil counts for any reason, in patients receiving medicines known to cause neutropenia, in patients with a history of drug-induced bone marrow depression/toxicity, in patients with bone marrow depression caused by concomitant illness, radiation therapy or chemotherapy and in patients with hypereosinophilic conditions or with myeloproliferative disease.
Danish: Der bør udvises forsigtighed hos patienter med lavt leukocyt- og/eller neutrofiltal uanset årsag, hos patienter, som får medicin, der er kendt for at medføre neutropeni, hos patienter med tidligere medicininduceret knoglemarvsdepression, hos patienter med knoglemarvsdepression forårsaget af samtidig sygdom, strålebehandling eller kemoterapi og hos patienter med hypereosinofile tilstande eller myeloproliferativ sygdom.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Liste over hjælpestoffer
English: Talk to your doctor or pharmacist before you take OLAZAX.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager OLAZAX.
English: crospovidone, magnesium stearate
Danish: crospovidon, magnesiumstearat.
English: Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) 11
Danish: Udvikling eller forværring af diabetes lejlighedsvist sammen med ketoacidose eller koma, heriblandt dødelige tilfælde (se pkt.
English: What you need to know before you take Olazax
Danish: Det skal du vide, før du begynder at tage OLAZAX
English: Olazax tablet contains aspartame, which is a source of phenylalanine.
Danish: Olazax tabletter indeholder aspartam, der er en phenylalaninkilde.
English: Other medicines and Olazax
Danish: Brug af anden medicin sammen med OLAZAX
English: If you suddenly stop taking Olazax, 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, kan der forekomme symptomer som svedtendens, søvnbesvær, rysten, angst, kvalme og opkastning.
English: SPECIAL STORAGE CONDITIONS Store below 30°C
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares ved temperaturer under 30ºC.
English: Caution should be exercised and follow-up organized 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 ALAT og/eller ASAT, 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: Store below 30°C.
Danish: Opbevares ved under 30ºC.
English: Dysarthria Stuttering Restless legs syndrome
Danish: Restless legs-syndrom
English: Phenylalanine Olazax tablet contains aspartame, which is a source of phenylalanine.
Danish: Olanzapin Glenmark tabletter indeholder aspartam, der er en phenylalaninkilde.
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 en enkeltdosis (10 mg) Positron Emission Tomography (PET) undersøgelse hos raske forsøgspersoner bandt olanzapin til flere 5HT2A end til dopamin D2 receptorer.
English: 6.6 Special precautions for disposal No special requirements
Danish: 6.6 Regler for bortskaffelse og anden håndtering Ingen særlige forholdsregler.
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 et studie 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 valproatmonoterapi.
English: There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder.
Danish: Der er blevet rapporteret om agitation, hypertoni, hypotoni, tremor, døsighed,, akut respirationsbesvær eller besvær ved fødeindtagelse.
English: Very common: Elevations of hepatic aminotransferases (ALT/AST; see section 4.4).
Danish: Meget almindelig: Forhøjede leveraminotransferaser(ALAT/ASAT; se pkt.
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: Hepatitis (including hepatocellular, cholestatic or mixed liver injury) 11
Danish: Hepatitis (inklusive hepatocellulær kolestatisk eller blandet leverskade) 11
English: 6.5 Nature and contents of container Aluminium/aluminium blisters in cartons of 28, 56 tablets per carton.
Danish: Aluminium/aluminium blisterkort i kartoner á 28, 56 tabletter pr. karton.
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: Dysarthria Stuttering11Restle
Danish: Dysartri Stammen11
English: Only take other medicines while you are on Olazax if your doctor tells you that you can. You might feel drowsy if Olazax 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 tages sammen med depressionsmidler eller medicin til behandling af angst eller søvnløshed (sovepiller).
English: Olazax 7.5 mg tablets
Danish: Olazax 7,5 mg tabletter
English: Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olazax and regularly during treatment.
Danish: Inden du påbegynder behandling med OLAZAX samt jævnligt i løbet af behandlingen skal din læge tage blodprøver for at kontrollere indholdet af sukker og fedt i dit blod.
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; 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: PHARMACEUTICAL FORM AND CONTENTS Tablet
Danish: LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE)
English: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Danish: Lægemidde lfremkaldt reaktion med eosinofili og systemiske symptomer (DRESS)
English: How to take Olazax
Danish: Sådan skal du tage OLAZAX
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: Transient, asymptomatic elevations of hepatic aminotransferases, alanine transferase (ALT), aspartatetransferase (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: Olazax 20 mg tablets
Danish: Olazax 20 mg tabletter
English: 5 Observed for fasting normal levels at baseline (< 1.69 mmol/l) which increased to high (≥ 2.26 mmol/l).
Danish: 5 Observeret for fastende normalt niveau ved baseline (< 1,69 mmol/l), der blev øget til højt niveau (≥ 2,26 mmol/l).
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 sindslidelse sygdom havde 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 dog 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: Each tablet contains 7.5 mg olanzapine.
Danish: Hver tablet indeholder 5 mg olanzapin
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: Er du i tvivl, s å spørg lægen eller apotekspersonalet.
English: Olazax 15 mg tablets
Danish: Olazax 15 mg tabletter
English: 3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high (≥ 6.2 mmol/l).
Danish: 3 Observeret for fastende normalt niveau ved baseline (< 5,17 mmol/l), der blev øget til højt niveau(≥ 6,2 mmol/l).
English: Rhabdomyolysis11
Danish: Rabdomy olyse11