natgillin/translations-raw huggingface dataset:
4. 8 Bivirkninger), 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.
Hensigtsmæssig klinisk 88 monitorering tilrådes særligt hos diabetikere og hos patienter med risikofaktorer for udvikling af diabetes, og det anbefales at foretage regelmæssige blodsukkermålinger hos disse patienter.
88 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.
En gradvis reduktion af dosis bør overvejes ved seponering af olanzapin.
Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
Antikolinerg aktivitet Selvom olanzapin udviste antikolinerg aktivitet in vitro, frembød kliniske forsøg med oral olanzapin en lav forekomst af dertil relaterede hændelser.
Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during oral clinical trials revealed a low incidence of related events.
Hvis hepatitis (inklusiv hepatocellulær, cholestatisk eller blandet leverskade) er diagnosticeret bør olanzapin seponeres.
In cases where hepatitis (including hepatocellular, cholestatic or mixed liver injury) has been diagnosed, olanzapine treatment should be discontinued.
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.
Neutropenia 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.
Neutropeni er almindeligt rapporteret, når olanzapin og valproat anvendes samtidig (se afsnit 4. 8).
Neutropenia has been reported commonly when olanzapine and valproate are used concomitantly (see section 4.8).
Ophør med behandling Ved pludselig seponering af olanzapin er akutte symptomer, såsom svedtendens, søvnløshed, tremor, angstanfald, kvalme og opkastning, meget sjældent rapporteret (< 0, 01%).
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 with oral administration, 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.
Olanzapin blev i kliniske forsøg med ZYPREXA pulver til injektionsvæske, opløsning, ikke forbundet med en vedvarende forlængelse af absolutte QT- intervaller eller af QTc- intervaller.
In clinical trials with ZYPREXA powder for solution for injection, olanzapine was not associated with a persistent increase in absolute QT or in QTc intervals.
Som med andre antipsykotika skal der imidlertid udvises forsigtighed, når olanzapin ordineres sammen med lægemidler, der er kendt for at øge QTc- intervallet, specielt hos ældre personer, 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 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.
Der er ikke blevet konstateret nogen kausal sammenhæng mellem 89 forekomsten af venøse tromboembolier og behandlingen med olanzapin.
A causal relationship between the occurrence of venous thromboembolism and treatment with olanzapine has not been established.
Generel CNS aktivitet Som følge af olanzapins primære effekt på CNS bør der udvises forsigtighed, når stoffet anvendes i kombination med andre centralt virkende lægemidler og alkohol.
89 General CNS activity Given the primary CNS effects of olanzapine, caution should be used when it is taken in combination with other centrally acting medicines and alcohol.
Da olanzapin udviser in vitro dopamin- antagonisme, kan det hæmme effekten af direkte eller indirekte dopaminagonister.
As it exhibits in vitro dopamine antagonism, olanzapine may antagonize the effects of direct and indirect dopamine agonists.
Krampeanfald Olanzapin bør anvendes med forsigtighed hos 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.
Tardiv dyskinesi I sammenlignende undersøgelser af op til 1 års varighed, hvor olanzapin blev administreret oralt, var olanzapin forbundet med en statistisk lavere forekomst af behandlingsrelateret dyskinesi.
Tardive Dyskinesia In comparator oral 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 forsøg med oral olanzapin.
Postural hypotension Postural hypotension was infrequently observed in the elderly in oral olanzapine clinical trials.
Som med andre antipsykotika, anbefales det periodisk at måle blodtryk på patienter over 65 år.
As with other antipsychotics, it is recommended that blood pressure is measured periodically in patients over 65 years.
4. 4).
IM olanzapine has not been studied in patients with alcohol or drug intoxication (see section 4.4).
4. 4).
Caution should be exercised in patients who consume alcohol or receive medicinal products that can induce hypotension, bradycardia, respiratory or central nervous system depression (see section 4.4).
Mulighed for interaktion efter intramuskulær injektion I en enkeltdosis intramuskulær undersøgelse af olanzapin 5 mg, administreret 1 time før intramuskulær lorazepam 2 mg (metaboliseret ved glukuronidering), var farmakokinetikken af begge præparater uændret.
Potential for interaction following intramuscular injection In a single dose intramuscular study of olanzapine 5 mg, administered 1 hour before intramuscular lorazepam 2 mg (metabolised by glucuronidation), the pharmacokinetics of both medicines were unchanged.
Kombinationen øgede imidlertid den somnolens, som ses med hvert præparat alene.
However, the combination added to the somnolence observed with either medicines alone.
4. 4 og 6. 2).
Concomitant injection of olanzapine and parenteral benzodiazepine is not recommended (see sections 4.4 and 6.2).
Den gennemsnitlige øgning af olanzapin AUC var 90 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.
90 Decreased bioavailability Activated charcoal reduces the bioavailability of oral olanzapine by 50 to 60% and should be taken at least 2 hours before or after olanzapine.
6. 2 Uforligeligheder).
Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists (see section 6.2).
Da olanzapin kan forårsage somnolens og svimmelhed, bør patienter tilrådes forsigtighed ved bilkørsel og maskinbetjening.
Because olanzapine may cause somnolence and dizziness, patients should be cautioned about operating machinery, including motor vehicles.
91 4. 8 Bivirkninger
4.8 Undesirable effects
Somnolens er en almindelig (1- 10%) bivirkning, som i kliniske forsøg blev forbundet med brug af intramuskulær olanzapin.
A common (1-10%) undesirable effect associated with the use of intramuscular olanzapine in clinical trials was somnolence.
4. 4 og 4. 5).
In post marketing reports, temporal association of treatment with IM olanzapine with cases of respiratory depression, hypotension or bradycardia and death have been very rarely reported, mostly in patients who concomitantly received benzodiazepines, and/ or other antipsychotic medicinal products or who were treated in excess of olanzapine recommended daily doses (see sections 4.4 and 4.5).
Følgende tabel er baseret på de bivirkninger og laboratorieundersøgelser som sås i kliniske forsøg med ZYPREXA pulver til injektionsvæske, opløsning fremfor oral ZYPREXA.
91 The following table is based on the undesirable effects and laboratory investigations from clinical trials with ZYPREXA powder for solution for injection rather than oral olanzapine.
Hjerte Almindelige (1- 10%):
Cardiac disorders Common (1-10%):
Bradykardi med eller uden hypotension eller synkope, takykardi Usædvanlige (0, 1- 1%):
Uncommon (0.1-1%):
Sinusarrest Vaskulære sygdomme Almindelige (1- 10%):
Vascular Disorders Common (1-10%):
Postural hypotension, hypotension.
Postural hypotension, hypotension.
Luftveje, thorax og mediastinum Usædvanlige (0, 1- 1%):
Respiratory disorders Uncommon (0.1-1%):
Hypoventilation.
Hypoventilation.
Almene symptomer og reaktioner på administrationsstedet Almindelige (1- 10%):
General disorders and administration site conditions Common (1-10%):
Gener ved injektionsstedet.
Injection site discomfort.
Nedenfor nævnte bivirkninger er observeret efter administration af oral olanzapin, men kan også tænkes at forekomme efter administration af ZYPREXA pulver til injektionsvæske, opløsning.
The undesirable effects listed below have been observed following administration of oral olanzapine, but may also occur following administration of ZYPREXA powder for solution for injection.
Hypotermi
Nervous system disorders Somnolence
92 Nervesystemet Somnolens Hjerte
92
Svimmelhed Akatisi6 Parkinsonisme6 Dyskinesi6
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)
4. 4) Dystoni (inklusive oculogyration) Tardiv dyskinesi Abstinenssymptomer7
Tardive dyskinesia Discontinuation symptoms7 Cardiac disorders Vascular disorders
Knogler, led, muskler og bindevæv Rhabdomyolyse Nyrer og urinveje Vandladningsbesvær Det reproduktive system og mammae Priapismus Almene symptomer og reaktioner på administrationsstedet Asteni Træthed Ødemer Undersøgelser Forhøjede plasmaprolaktin - niveauer8 1
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 Elevated plasma
Høje niveauer af kreatininkinase Forøget total bilirubin 93
phosphokinase Increased total bilirubin
Forøget alkalisk fosfatase
Clinically significant weight gain was observed
Klinisk signifikant vægtøgning blev observeret på tværs af alle baseline bodymassindex (BMI) kategorier.
across all baseline Body Mass
3 Observeret for fastende normalt niveau ved baseline (< 5, 17 mmol/ l), der blev øget til højt niveau (≥ 6, 2 mmol/ l).
93 3 Observed for fasting normal levels at baseline (< 5.17 mmol/ l) which increased to high (≥ 6.2 mmol/ l).
Langvarig eksposition (mindst 48 uger) Andelen af patienter, som fik kritisk, klinisk signifikante ændringer i vægtøgning, glucose, total/ LDL/ HDL- choresterol eller triglycerider, blev forøget over tid.
Long-term exposure (at least 48 weeks) The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/ LDL/ HDL cholesterol or triglycerides increased over time.
Olanzapin administreret sammen med lithium eller valproat resulterede i øgede værdier (≥ 10%) af tremor, mundtørhed, øget appetit og vægtøgning.
Olanzapine administered with lithium or valproate resulted in increased levels (≥ 10%) of tremor, dry mouth, increased appetite, and weight gain.
Taleforstyrrelser blev også
Speech disorder was also reported commonly.
Under behandling med olanzapin i kombination med lithium eller valproat forekom er stigning på ≥7% af baseline legemsvægt hos 17, 4% af patienterne i akut behandling (op til 6 uger).
During treatment with olanzapine in combination with lithium or divalproex, an increase of ≥ 7% from baseline body weight occurred in 17.4% of patients during acute treatment (up to 6 weeks).
Andre medicinsk signifikante følger efter overdosering inkluderer delirium, kramper, koma, muligt malignt neuroleptikasyndrom, respirationsbesvær, aspiration, hypertension eller hypotension, hjertearytmi (< 2% af overdoseringstilfældene) og kardiopulmonært ophør.
94 Other medically significant sequelae of overdose include delirium, convulsion, coma, possible neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension, cardiac arrhythmias (< 2% of overdose cases) and cardiopulmonary arrest.
I prækliniske undersøgeler udviste olanzapin affinitet (Ki; < 100 nM) til serotonin 5- HT2A/ 2C, 5- HT3, 5- HT6; dopamin D1, D2, D3, D4, D5; kolinerge muskarine receptorer m1- m5, α1- adrenerge og histamin H1- receptorer.
In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki; < 100 nM) for serotonin 5-HT2A/ 2C, 5-HT3, 5-HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors m1-m5; α -1 adrenergic; and histamine H1 receptors.
Dyreadfærdsundersøgelser af olanzapin indikerede 5- HT, dopamin og kolinerg antagonisme i overensstemmelse med receptorbindingsprofilen.
Animal behavioural studies with olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor-binding profile.
Olanzapin udviste større affinitet til serotonin 5- HT2 - end til dopamin D2- receptorer i in vitro undersøgelser og større 5- HT2 - end D2 - aktivitet i in vivo modeller.
Olanzapine demonstrated a greater in-vitro affinity for serotonin 5-HT2 than dopamine D2 receptors and greater 5- HT2 than D2 activity in vivo, models.
I en enkeltdosis (10 mg) Positron Emissions Tomografi (PET) undersøgelse hos raske forsøgspersoner bandt olanzapin til flere 5- HT2A - end til dopamin D2- receptorer.
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.
Desuden afslørede en SPECT undersøgelse af skizofrene patienter, at olanzapin- responderende patienter havde en lavere striatal D2 - 95 binding end visse andre antipsykotika - og risperidon- responderende patienter, hvorimod det var sammenligneligt med clozapin- responderende patienter.
In addition, a 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.
I to ud af to placebo - og to ud af tre komparatorkontrollerede forsøg af mere end 2. 900 skizofrene patienter med både positive og negative symptomer, hvor olanzapin blev administreret oralt, blev olanzapin forbundet med statistisk signifikante større forbedringer af negative såvel som af positive symptomer.
In two of two placebo and two of three comparator controlled trials with oral olanzapine in over 2,900 schizophrenic patients presenting with both positive and negative symptoms, olanzapine was associated with statistically significantly greater improvements in negative as well as positive symptoms.
Undersøgelsen omfattede 1481 patienter med varierende grad af hertil forbundne depressive symptomer (middelværdi før behandling lig 16, 6 ved Montgomery- Asberg Depression Rating Scale).
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
Undersøgelsen 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).
95 analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p=0.001) favouring oral olanzapine (-6.0) versus haloperidol (-3.1).
Hos patienter med maniske eller blandede episoder af maniodepressiv sygdom havde olanzapin, administreret oralt, overlegen effekt i reduktion af maniske symptomer over 3 uger i forhold til placebo og valproat.
In patients with manic or mixed episode of bipolar disorder, oral olanzapine demonstrated superior efficacy to placebo and valproate semisodium (divalproex) in reduction of manic symptoms over 3 weeks.
Oral olanzapin havde også effekt svarende til haloperidol, udtrykt ved andelen af patienter med symptomatisk remission af mani og depression efter 6 og 12 uger.
Oral olanzapine also demonstrated comparable efficacy results to haloperidol in terms of the proportion of patients in symptomatic remission from mania and depression at 6 and 12 weeks.
I en undersøgelse af patienter i behandling med lithium eller valproat i minimum 2 uger medførte samtidig behandling med oral olanzapin 10 mg (kombinationsterapi med lithium eller valproat) en større reduktion af symptomerne på mani efter 6 uger end ved lithium - eller valproat- monoterapi.
In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition of oral 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.
5 gange højere end den, som sås efter den samme dosis olanzapin administreret oralt.
In a pharmacokinetic study in healthy volunteers, a dose of 5 mg of ZYPREXA powder for solution for injection produced a maximum plasma concentration (Cmax) approximately 5 times higher than that seen with the same dose of olanzapine administered orally.
Hos ikke- rygere versus rygere (mænd og kvinder), som fik intramuskulær olanzapin, var den gennemsnitlige eliminationshalveringstid forlænget (38, 6 versus 30, 4 timer) og clearance reduceret (18, 6 versus 27, 7 l/ time).
In non-smoking versus smoking subjects (males and females) administered olanzapine intramuscularly the mean elimination half-life was prolonged (38.6 versus 30.4 hr) and the clearance was reduced (18.6 versus 27.7 l/ hr).
96 Olanzapin metaboliseres i leveren via konjugering og oxidation.
Olanzapine is metabolised in the liver by conjugative and oxidative pathways.
Hos raske ældre forsøgspersoner (≥ 65 år), som fik oral olanzapin, var den gennemsnitlige eliminationshalveringstid forlænget (51, 8 versus 33, 8 timer) og clearance var reduceret (17, 5 versus 18, 2 l/ time).
In healthy elderly (65 and over) versus non-elderly subjects administered oral olanzapine, 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).
Den farmakokinetiske variation hos ældre er indenfor variationen hos ikke- ældre.
The pharmacokinetic variability observed in the elderly is within the range for the non- elderly.
Hos 44 patienter > 65 år med skizofreni gav dosering med 5 til 20 mg/ dag ingen udsving i bivirkningsprofilen.
In 44 patients with schizophrenia > 65 years of age, dosing from 5 to 20 mg/ day was not associated with any distinguishing profile of adverse events.
Hos kvindelige versus mandlige forsøgspersoner, som fik oral olanzapin, var den gennemsnitlige eliminationshalveringstid noget forlænget (36, 7 versus 32, 3 timer) og clearance reduceret (18, 9 versus 27, 3 l/ time).
96 In female versus male subjects administered oral olanzapine 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).
Hos patienter med nedsat nyrefunktion (kreatinin clearance < 10 ml/ min) versus raske forsøgspersoner, som fik oral olanzapin, fandtes ingen signifikant forskel i den gennemsnitlige eliminationshalveringstid (37, 7 versus 32, 4 timer) eller clearance (21, 2 versus 25, 0 l/ time).
In renally impaired patients (creatinine clearance < 10 ml/ min) versus healthy subjects administered oral olanzapine, 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).
57% radioaktivt mærket olanzapin genfandtes i urinen, hovedsageligt som metabolitter.
A mass balance study showed that approximately 57% of radiolabelled olanzapine appeared in urine, principally as metabolites.
Hos rygere med let leverfunktionsnedsættelse, som fik oral olanzapin, var den gennemsnitlige eliminationshalveringstid (39, 3 timer) forlænget, og clearance (18, 0 l/ time) reduceret svarende til raske ikke- rygende forsøgspersoner (henholdsvis 48, 8 timer og 14, 1 l/ time).
In smoking subjects with mild hepatic dysfunction administered olanzapine orally, mean elimination half-life (39.3 hr) was prolonged and clearance (18.0 l/ hr) was reduced analogous to non-smoking healthy subjects (48.8 hr and 14.1 l/ hr, respectively).
I en undersøgelse af kaukasiske, japanske og kinesiske forsøgspersoner fandtes ingen forskelle i de farmakokinetiske parametre i de tre populationsgrupper.
In a study of Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
Akut (enkeltdosis) toksicitet Den observerede orale toksicitet hos gnavere er karakteristisk for potente antipsykotiske lægemiddelstoffer: hypoaktivitet, coma, tremor, kloniske kramper, spytsekretion og hæmmet vægtøgning.
Acute (single-dose) toxicity Signs of oral toxicity in rodents were characteristic of potent antipsychotic compounds: hypoactivity, coma, tremors, clonic convulsions, salivation, and depressed weight gain.
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 en human dosis på 12 mg).
Reversible neutropenia, thrombocytopenia, or anaemia 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).
Mutagenicitet Olanzapin var ikke mutagent eller clastogent i en række standardtests, der omfattede bakterielle mutationstests og in vitro og in vivo tests med oral administration hos pattedyr.
97 Mutagenicity Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and oral in vivo mammalian tests.
Karcinogenicitet På baggrund af resultater fra undersøgelser med oral administration hos mus og rotter blev det konkluderet, at olanzapin ikke er karcinogent.
Carcinogenicity Based on the results of oral studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
• Lactosemonohydrat • Vinsyre, E334 • Saltsyre • Natriumhydroxid
• Lactose monohydrate • Tartaric acid, E334 • Hydrochloric acid. • Sodium hydroxide.
Opløsning (efter rekonstitution):
Solution (after reconstitution):
1 time.
1 hour.
98 6. 4 Særlige opbevaringsforhold
6.4 Special precautions for storage
Må ikke opbevares over 25°C.
Do not store above 25º C.