natgillin/translations-raw huggingface dataset:
Den anbefalede startdosis af olanzapin er 10 mg/ dag.
The recommended starting dose for olanzapine is 10 mg/ day.
Manisk episode:
Manic episode:
5. 1).
The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section 5.1).
Den anbefalede startdosis er 10 mg/ dag.
The recommended starting dose is 10 mg/ day.
2 Ved behandling af skizofreni, en manisk episode og til forebyggelse af tilbagefald i bipolær lidelse kan den daglige dosering herefter justeres på basis af den individuelle kliniske status indenfor intervallet 5- 20 mg/ dag.
2 During treatment for schizophrenia, manic episode and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5-20 mg/ day.
Børn og unge Olanzapin bør ikke anvendes til børn og unge under 18 år på grund af manglende dokumentation for sikkerhed og virkning.
Children and adolescents Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
4. 4, 4. 8, 5. 1 og 5. 2).
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).
4. 4).
A lower starting dose (5 mg/ day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant (see section 4.4).
Nedsat nyre - og/ eller leverfunktion En lavere startdosis (5 mg) bør overvejes til sådanne patienter.
A lower starting dose (5 mg) should be considered for such patients.
I tilfælde af moderat leverinsufficiens (cirrhosis, Child- Pugh klasse A eller B) bør startdosis være 5 mg og bør kun øges med forsigtighed.
In cases of moderate hepatic insufficiency (cirrhosis, Child-Pugh Class A or B), the starting dose should be 5 mg and only increased with caution.
Køn Det er ikke nødvendigt rutinemæssigt at ændre startdosis og dosisforløb hos kvinder i forhold til mænd.
The starting dose and dose range need not be routinely altered for female patients relative to male patients.
Rygere Det er ikke nødvendigt rutinemæssigt at ændre startdosis og dosisinterval hos ikke- rygere i forhold til rygere.
The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
Når mere end én parameter, som kan føre til nedsat metabolisering, er til stede (kvinder, ældre, ikke - rygere), bør det overvejes at reducere startdosis.
When more than one factor is present which might result in slower metabolism (female gender, geriatric age, non-smoking status), consideration should be given to decreasing the starting dose.
4. 5 og 5. 2).
(see sections 4.5 and 5.2.)
Overfølsomhed over for det aktive stof, jordnødder (peanut) eller soja eller over for et eller flere af hjælpestofferne.
Hypersensitivity to the active substance, peanut or soya or to any of the excipients.
Demensrelaterede psykoser og/ eller adfærdsforstyrrelser Olanzapin er ikke godkendt til behandling af demensrelateret psykose og/ eller adfærdsforstyrrelse, og bør ikke anvendes hos denne patientgruppe på grund af øget mortalitet og risiko for cerebrovaskulære hændelser.
Dementia-related psychosis and/ or behavioural disturbances Olanzapine is not approved for the treatment of dementia-related psychosis and/ or behavioural disturbances and is not recommended for use in this particular group of patients because of an increase in mortality and the risk of cerebrovascular accident.
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%).
In placebo-controlled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/ or disturbed behaviours, there was a 2-fold increase in the incidence of death in olanzapine-treated patients compared to patients treated with placebo (3.5% vs.
Den højere forekomst af dødsfald var ikke relateret til olanzapindosis (gennemsnitlig daglig dosis, 4, 4 mg) eller behandlingsvarighed.
The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
Risikofaktorer, som kan prædisponere denne patientpopulation til øget mortalitet, inkluderer alder > 65 år, dysfagi, sedation, fejlernæring og dehydrering, pulmonale tilstande (f. eks. pneumoni, med eller uden aspiration) eller samtidig brug af benzodiazepiner.
Risk factors that may predispose this patient population to increased mortality include age > 65 years, dysphagia, sedation, malnutrition and dehydration, pulmonary conditions (e. g., pneumonia, with or without aspiration), or concomitant use of benzodiazepines.
Forekomsten af dødsfald var dog højere 3 hos olanzapin- behandlede patienter end hos patienter, behandlet med placebo, uafhængig af disse risikofaktorer.
However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors.
I de samme kliniske forsøg blev cerebrovaskulære hændelser (f. eks. slagtilfælde, forbigående iskæmiske anfald), inklusive dem med dødelig udgang, rapporteret.
3 In the same clinical trials, cerebrovascular adverse events (CVAE e. g., stroke, transient ischemic attack), including fatalities, were reported.
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%).
0.4%, respectively).
Alle de olanzapin - og placebobehandlede patienter, som oplevede en cerebrovaskulær hændelse, havde præeksisterende risikofaktorer.
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
Alder > 75 år og vaskulær/ blandet demens blev identificeret som risikofaktorer for cerebrovaskulære hændelser i relation til olanzapinbehandling.
Age > 75 years and vascular/ mixed type dementia were identified as risk factors for CVAE in association with olanzapine treatment.
Parkinsons sygdom Anvendelse af olanzapin til behandling af dopaminagonist- relateret psykose hos patienter med Parkinsons sygdom kan ikke anbefales.
Parkinson's disease The use of olanzapine in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease is not recommended.
4. 8), og olanzapin var ikke mere effektivt end placebo til behandling af psykotiske symptomer.
In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo (see section 4.8), and olanzapine was not more effective than placebo in the treatment of psychotic symptoms.
Olanzapin blev initieret på 2, 5 mg/ dag og titreret til maksimalt 15 mg/ dag, baseret på lægens vurdering.
Olanzapine was started at 2.5 mg/ day and titrated to a maximum of 15 mg/ day based on investigator judgment.
Malignt neuroleptikasyndrom (NMS) NMS er en potentielt livstruende tilstand, som er forbundet med antipsykotisk behandling.
Neuroleptic Malignant Syndrome (NMS) NMS is a potentially life-threatening condition associated with antipsychotic medicinal product.
Yderligere symptomer kan inkludere forhøjet kreatinkinase, myoglobulinuri (rhabdomyolyse) og akut nyresvigt.
Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
4. 8).
Hyperglycaemia and diabetes Hyperglycaemia and/ or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported very rarely, including some fatal cases (see section 4.8).
Hensigtsmæssig klinisk monitorering tilrådes særligt hos diabetikere og hos patienter med risikofaktorer for udvikling af diabetes, og det anbefales at foretage regelmæssige blodsukkermålinger hos disse patienter.
Appropriate clinical monitoring is advisable particularly in diabetic patients and in patients with risk factors for the development of diabetes mellitus for which regular glucose control is recommended.
Lipidforandringer Hos olanzapinbehandlede patienter i placebo- kontrollerede kliniske undersøgelser, er der set uønskede forandringer i lipidniveauer (se pkt.
Lipid alterations Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo- controlled clinical trials (see section 4.8).
Antikolinerg aktivitet Selvom olanzapin udviste antikolinerg aktivitet in vitro, frembød kliniske undersøgelser en lav forekomst af dertil relaterede hændelser.
Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Leverfunktionen Forbigående, asymptomatiske forhøjelser af levertransaminaser, ALAT og ASAT er almindeligt forekommende, især i den tidlige behandling.
Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
Forsigtighed bør udvises 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.
Caution should be exercised 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 medicinal products.
I tilfælde af forhøjet ALAT og/ eller ASAT 4 under behandlingen bør der foretages opfølgning af patienten, og dosisreduktion bør overvejes.
In the event of elevated ALT and/ or AST during treatment, follow-up should be organised and dose reduction should be considered.
Neutropeni 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 medicin- induceret knoglemarvsdepression, hos patienter med knoglemarvsdepression forårsaget af samtidig sygdom, strålebehandling eller kemoterapi og hos patienter med hypereosinofile tilstande eller myeloproliferativ sygdom.
4 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.
4. 8).
Neutropenia has been reported commonly when olanzapine and valproate are used concomitantly (see section 4.8).
Ophør med behandling Akutte symptomer såsom perspiration, søvnløshed, rysten, angst, kvalme eller opkastning er rapporteret meget sjældent (< 0, 01%) når olanzapin stoppes pludseligt.
Discontinuation of treatment Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported very rarely (< 0.01%) when olanzapine is stopped abruptly.
I forhold til placebo var der ingen signifikante forskelle i hjertelidelser, som var relaterede til QTc- forlængelse.
QT interval 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.
Som med ethvert andet antipsykotisk middel skal der udvises forsigtighed, når olanzapin ordineres sammen med lægemidler, der er kendt for at øge QTc- intervallet, specielt hos ældre patienter, hos patienter hvor syndrom med lang QT er medfødt, hjerteinsufficiens, hjertehypertrofi, hypokaliæmi eller hypomagnesiæmi.
However, as with other antipsychotics, caution should be exercised when olanzapine is prescribed with medicinal products known to increase QTc interval, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia.
Tromboemboli En tidsmæssig sammenhæng mellem behandling med olanzapin og venøs tromboembolisme er meget sjældent (< 0, 01%) rapporteret.
Thromboembolism Temporal association of olanzapine treatment and venous thromboembolism has very rarely (< 0.01%) been reported.
På trods af dette bør alle mulige risikofaktorer for venøse tromboembolier identificeres og forebyggende foranstaltninger, f. eks. immobilisering af patienter, iværksættes, da patienter, som lider af skizofreni, ofte har sygdomsbetingede risikofaktorer for venøse tromboembolier.
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.
Almindelig CNS aktivitet Som følge af olanzapins primære effekt på centralnervesystemet bør der udvises forsigtighed, når stoffet anvendes i kombination med andre centralt virkende lægemidler og alkohol.
General CNS activity Given the primary CNS effects of olanzapine, caution should be used when it is taken in combination with other centrally acting medicinal products and alcohol.
Krampeanfald Olanzapin bør anvendes med forsigtighed til patienter med tidligere krampeanfald, eller som er udsat for faktorer, som kan nedsætte krampetærsklen.
Seizures Olanzapine should be used cautiously in patients who have a history of seizures or are subject to factors which may lower the seizure threshold.
Krampeanfald kan i sjældne tilfælde forekomme hos patienter i behandling med olanzapin.
Seizures have been reported to occur rarely in patients when treated with olanzapine.
Tardiv dyskinesi I sammenlignende undersøgelser af op til 1 års varighed var olanzapin forbundet med en statistisk lavere forekomst af behandlingsrelateret dyskinesi.
Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
Postural hypotension Postural hypotension observeredes lejlighedsvist hos ældre i kliniske undersøgelser med olanzapin.
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
5 Brug til børn og unge under 18 år Olanzapin er ikke godkendt til behandling af børn og unge under 18 år.
Use in children and adolescents under 18 years of age Olanzapine is not indicated for use in the treatment of children and adolescents.
4. 5 og 5. 1).
Lactose
Lactose OLANZAPIN MYLAN- tabletter indeholder lactose.
5 Olanzapine tablets contain lactose monohydrate.
Tabletterne bør ikke anvendes til patienter med følgende lidelser: arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/ galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Induktion af CYP1A2 Olanzapins metabolisering kan induceres ved rygning eller af carbamazepin, hvilket kan medføre reducerede olanzapin koncentrationer.
The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
4. 2).
The clinical consequences are likely to be limited, but clinical monitoring is recommended and an increase of olanzapine dose may be considered if necessary (see section 4.2).
Inhibition af CYP1A2 Fluvoxamin, en specifik CYP1A2 inhibitor, er vist signifikant at hæmme metaboliseringen af olanzapin.
Fluvoxamine, a specific CYP1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
Den gennemsnitlige øgning af olanzapin Cmax efter fluvoxamin var 54% hos kvindelige ikke- rygere og 77% hos mandlige rygere.
The mean increase in olanzapine Cmax following fluvoxamine was 54% in female nonsmokers and 77% male smokers.
Den gennemsnitlige øgning af olanzapin AUC var henholdsvis 52% og 108%.
The mean increase in olanzapine AUC was 52% and 108% respectively.
Nedsat biotilgængelighed Aktivt kul reducerer biotilgængeligheden af oral olanzapin med 50 til 60% og bør tages mindst 2 timer før eller efter olanzapin.
Activated charcoal reduces the bioavailability of oral olanzapine by 50% to 60% and should be taken at least 2 hours before or after olanzapine.
Olanzapin inhiberer ikke de vigtigste CYP450 isoenzymer in vitro (f. eks.
Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e. g.
Terapeutisk monitorering af valproat- plasmaniveauer indikerer ikke, at en justering af valproatdosis er nødvendig, når olanzapin gives sammen med valproat.
Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
6 Almindelig CNS aktivitet Der skal udvises forsigtighed hos patienter, som indtager alkohol eller får lægemidler, der kan undertrykke centralnervesystemet.
General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
4. 4).
The concomitant use of olanzapine with anti-Parkinsonian medicinal products in patients with Parkinson's disease and dementia is not recommended (see section 4.4).
QTc- interval Der skal udvises forsigtighed, hvis olanzapin administreres samtidig med lægemidler, som øger QTc - intervallet.
QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
Spontane indberetninger af tremor, hypertoni, letargi og søvnighed hos børn af mødre, som har taget olanzapin under tredje trimester, er meget sjældent modtaget.
Spontaneous reports have been very rarely received on tremor, hypertonia, lethargy and sleepiness, in infants born to mothers who had used olanzapine during the 3rd trimester.
Den gennemsnitlige dosis, som barnet blev udsat for (mg/ kg), blev ved steady state bestemt til at være 1, 8% af moderens olanzapindosis (mg/ kg).
Mean infant exposure (mg/ kg) at steady state was estimated to be 1.8% of the maternal olanzapine dose (mg/ kg).
4. 4), hududslæt, asteni, træthed og ødemer.
Adults 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 (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic transaminases (see section 4.4), rash, asthenia, fatigue and oedema.
Hyppighederne er defineret som følgende:
The frequency terms listed are defined as follows:
Meget almindelig (≥ 10%), almindelig (≥ 1% og < 10%), ikke almindelig (≥ 0, 1% og < 1%), sjælden (≥ 0, 01% og 0, 1%), meget sjælden (< 0, 01%), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Very common (≥ 10%), common (≥ 1% and < 10%), uncommon (≥ 0.1% and < 1%), rare (≥ 0.01% and < 0.1%), very rare (< 0.01%), not known (cannot be estimated from the data available).
Meget almindelig Blod og lymfesystem
Very common
Immunsystemet
Eosinophilia
Eosinofili
Leucopenia Neutropenia
Trombocytopeni Allergisk reaktion
Thrombocytopenia
Metabolisme og ernæring
Immune system disorders Allergic reaction Metabolism and nutrition disorders Weight gain1
Forhøjede kolesterolniveauer2, 3 Forhøjede glucoseniveauer 4 Forhøjede triglyceridniveauer2, 5 Glukosuri Øget appetit
Elevated cholesterol levels2,3 Elevated glucose levels4 Elevated triglyceride levels2,5 Glucosuria Increased appetite
Hypotermi
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) Hypothermia
Somnolens Hjerte
Nervous system disorders 7 Somnolence Cardiac disorders
4. 4) Dystoni (inklusive oculogyration) Tardiv dyskinesi Abstinenssymptomer7
Seizures where in most cases a history of seizures or risk factors for seizures were reported Neuroleptic malignant syndrome (see section 4.4) Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7
4. 4)
Bradycardia QTc prolongation (see section 4.4)
4. 4)
Ventricular tachycardia/ fibrillation, sudden death (see section 4.4)
Tromboemboli (inklusive lungeemboli og dyb venetrombose)
Thromboembolism (including pulmonary embolism and deep vein thrombosis)
4. 4)
Transient, asymptomatic elevations of hepatic transaminases (ALT, AST), especially in early treatment (see section 4.4)
Knogler, led, muskler Nyrer og urinveje
Skin and subcutaneous tissue disorders
og bindevæv
Rash
Rhabdomyolyse Vandladningsbesvær
Photosensitivity reaction Alopecia
8
Musculoskeletal and connective tissue disorders Rhabdomyolysis Renal and urinary disorders Urinary hesitation Reproductive system and breast disorders Priapism General disorders and administration site conditions Asthenia Fatigue Oedema Investigations 1
Det reproduktive system og mammae Priapismus Almene symptomer og reaktioner på administrationsstedet Asteni Træthed Ødemer Undersøgelser Forhøjede plasmaprolaktinniveau er8 1
Elevated plasma prolactin levels8
Høje niveauer af kreatininkinase Forøget total bilirubin
High creatine phosphokinase Increased total bilirubin
Forøget alkalisk fosfatase
Increased alkaine phosphatase
Vægtøgning ≥ 7% af baseline kropsvægt var meget almindeligt og vægtøgning ≥ 15% af baseline kropsvægt var almindeligt.
Weight gain ≥ 7% of baseline body weight was very common and ≥ 15% of baseline
Patienter, som fik vægtøgning på ≥25% af baseline kropsvægt ved langvarig eksposition, var meget almindeligt.
Patients gaining ≥ 25% of their baseline body weight with long-term exposure were very common.
3 Observeret for fastende normalt niveau ved baseline (< 5, 17 mmol/ l), der blev øget til højt niveau (≥ 6, 2 mmol/ l).
3 Observed for fasting normal levels at baseline (< 5.17 mmol/ l) which increased to high (≥ 6.2 mmol/ l).
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.
Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17- < 6.2 mmol) to high (≥ 6.2 mmol) were very common.
4 Observeret for fastende normalt niveau ved baseline (< 5, 56 mmol/ l), der blev øget til højt niveau (≥ 7 mmol/ l).
4 Observed for fasting normal levels at baseline (< 5.56 mmol/ l) which increased to high (≥ 7 mmol/ l).
Ændring i fastende glucoseniveau fra let forhøjet niveau ved baseline (≥ 5, 56 - < 7 mmol/ l) til højt niveau (≥ 7 mmol/ l) var meget almindeligt.
Changes in fasting glucose from borderline at baseline (≥ 5.56- < 7 mmol/ l) to high (≥ 7 mmol/ l) were very common.
5 Observeret for fastende normalt niveau ved baseline (< 1, 69 mmol/ l), der blev øget til højt niveau (≥ 2, 26 mmol/ l).
5 Observed for fasting normal levels at baseline (< 1.69 mmol/ l) which increased to high (≥ 2.26 mmol/ l).
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.
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.
6 I kliniske forsøg var forekomsten af parkinsonisme og dystoni hos olanzapinbehandlede patienter numerisk højere men ikke statistisk signifikant forskellig fra placebo.
6 In clinical trials, the incidence of parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.