natgillin/translations-raw huggingface dataset:
Hos rygere med let leverfunktionsnedsættelse var den gennemsnitlige eliminationshalveringstid (39, 3 timer) forlænget, og clearance (18, 0 l/ time) reduceret i overensstemmelse med raske ikke- rygende forsøgspersoner (henholdsvis 48, 8 timer og 14, 1 l/ time).
82 In smoking subjects with mild hepatic dysfunction, 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).
Vækstparametre mindskedes ved høje
Growth parameters were decreased at high doses.
Mutagenicitet Olanzapin var ikke mutagen eller clastogen i en række standardtests, der omfattede bakterielle mutationstests og in vitro og in vivo tests på pattedyr.
83 Mutagenicity Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and in vivo mammalian tests.
Hver smeltetablet indeholder 0, 50 mg aspartame.
Each orodispersible tablet contains 0.50 mg aspartame.
Olanzapin kan tages uden hensyntagen til måltider, da absorptionen ikke påvirkes af fødeindtagelse.
86 Olanzapine can be given without regards for meals as absorption is not affected by food.
86 Zalasta smeltetablet bør placeres i munden, hvor den hurtigt vil dispergeres i spyttet, så den let kan synkes.
Zalasta orodispersible tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
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), consider ation should be given to decreasing the starting dose.
I tilfælde, hvor dosisstigninger på 2, 5 mg er nødvendige, bør Zalasta tabletter anvendes.
In cases where dose increments of 2.5 mg are considered necessary, Zalasta tablets should be used.
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.
In placebo-controlled clinical trials (6-12 weeks
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
87 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.
87 placebobehandlede patienter (henholdsvis 3, 5% og 1, 5%).
1.5%, respectively).
Alle de olanzapin - og placebobehandlede patienter, som oplevede en cerebrovaskulær hændels e, havde præeksisterende risikofaktorer.
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
I disse forsøg skulle patienterne initialt være stabiliserede på den lavest effektive dosis af antiparkinsonbehandling (dopaminagonist) og skulle forblive på den samme antiparkinsonbehandling og dosering under hele forsøget.
In these trials, patients wer e initially required to be stable on the lowest effective dose of anti- Parkinsonian medicinal products (dopamine agonist) and to remain on the same anti-Parkinsonian medicinal products and dosages throughout the study.
Yderligere symptomer kan inkludere forhøjet kreatinkinase, myoglobulinuri (rhabdomyolyse) og akut nyresvigt.
Additi onal signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Leverfunktionen Forbigående, asymptomatiske forhøjelser af levertransaminaser, ALAT og ASAT er almindeligt forekommende, især i den tidlige behandling.
88 Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
88 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 medicines.
Neutropeni Forsigtighed bør udvises 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.
89 Postural hypotension observeredes lejlighedsvist hos ældre i kliniske undersøgelser med olanzapin.
89 Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
Aspartam Zalasta smeltetabletter indeholder aspartam, som indeholder phenylalanin.
Aspartame Zalasta orodispersible tablets contain aspartame, a source of phenylalanine.
Terapeutisk monitorering af valproat- plasmaniveauer indikerer ikke, at en justering af valproat- dosis er nødvendig, når olanzapin gives sammen med valproat.
90 Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
Almindelig CNS aktivitet
General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
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 ver y rarely received on tremor, hypertonia, lethargy and sleepiness, in infants born to mothers who had used olanzapine during the 3rd trimester.
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 appet ite, 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.
Allergisk reaktion Metabolisme og ernæring Vægtøgning 1
Blood and the lymphatic system disorders Immune system disorders
Forhøjede kolesterolniveauer2, 3 Forhøjede
Leukopenia Neutropenia
Udvikling eller forværring af diabetes lejlighedsvist sammen
Thrombocytopenia Allergic reaction
91
91 Metabolism and nutrition disorders Weight gain1
glucoseniveauer 4 Forhøjede triglyceridniveauer 2, 5 Glukosuri Øget appetit
Elevated cholesterol levels 2,3 Elevated glucose levels 4 Elevated triglyceride levels 2,5 Glucosuria Increased appetite
Vaskulære sygdomme
6
Bradykardi QT c forlængelse (se pkt.
Seizures where in most cases a history of
4. 4)
Dyskinesia
4. 4)
for seizures were reported Neuroleptic malignant syndrome (see section 4.4) Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7
Mave- tarmkanalen
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
Musculoskeletal and connective tissue disorders Rhabdomyolysis Renal and urinary disorders Urinary hesitation Reproductive system and breast disorders
92 Undersøgelser Forhøjede plasmaprolaktinniveau er 8 1
92 Priapism General disorders and administration site conditions Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels 8 1
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 ≥
En potentielt medvirkende faktor kunne være høje niveauer af valproat i plasma.
93 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.
94 Meget almindelige symptomer på overdosering (forekomst > 10%) inkluderer takykardi, agitation/ aggressivitet, dysartri, forskellige ekstrapyramidale symptomer og nedsat bevidsthedsniveau, varierende fra sedation til koma.
94 Signs and symptoms Very common symptoms in overdose (> 10% incidence) include tachycardia, agitation/ aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
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 In a multinationational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p=0.001) favouring olanzapine (-6.0) versus haloperidol (-3.1).
96 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).
96 In healthy elderly (65 and over) versus non-elderly subjects, the mean elimination half-life was prolonged (51.8 versus 33.8 hr) and the clearance was reduced (17.5 versus 18.2 l/ hr).
97 Hæmatologisk toksicitet:
97 Haematologic toxicity:
Mannitol Microkrystallinsk cellulose Crospovidon Lavt substitueret hydroxypropylcellulose Aspartam Kalciumsilikat Magnesium stearate
Mannitol Microcrystalline cellulose Crospovidone Low-substituted hydroxypropylcellulose Aspartame Calcium silicate Magnesium stearate
Zalasta smeltetabletter er tilgængelige i æske med 14, 28, 35, 56 eller 70 smeltetabletter i blisterpakker (AI/ OPA/ AI/ PVC).
Zalasta orodispersible tablets are available in boxes of 14, 28, 35, 56 or 70 tablets in blister packs (Al/ OPA/ Al/ PVC).
Ikke alle pakningsstørrelser er nødvendigvis markedsført.
6.6 Special precautions for disposal
6. 6 Regler for destruktion og anden håndtering
Any unused product or waste material should be disposed of in accordance with local requirements.
98 Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinier.
98 7.
Zalasta 7, 5 mg smeltetablet
Zalasta 7.5 mg orodispersible tablets
Hver smeltetablet indeholder 7, 5 mg olanzapin.
Each orodispersible tablet contains 7.5 mg olanzapine.
Hver smeltetablet indeholder 0, 75 mg aspartame.
Each orodispersible tablet contains 0.75 mg aspartame.
Olanzapin kan tages uden hensyntagen til måltider, da absorptionen ikke påvirkes af fødeindtagelse.
100 Olanzapine can be given without regards for meals as absorption is not affected by food.
100 Zalasta smeltetablet bør placeres i munden, hvor den hurtigt vil dispergeres i spyttet, så den let kan synkes.
Zalasta orodispersible tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
Under antipsykotisk behandling kan det tage flere dage eller nogle uger, før patientens kliniske tilstand bedres.
During antipsychotic treatment, improvement in the patient's clinical condition may take severa l days to some weeks.
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
101 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.
101 placebobehandlede patienter (henholdsvis 3, 5% og 1, 5%).
1.5%, respectively).
Risikofaktorer, som kan prædisponer e 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.
Da klinisk erfaring med olanzapin til patienter med samtidige sygdomme er begrænset, tilrådes forsigtighed ved ordination til patienter med prostatahypertrofi eller paralytisk ileus og beslægtede tilstande.
However, as clinical experience with olanzapine in patients with concomitant illness is limited, caution is advised when prescribing for patients with prostatic hypertrophy, or paralytic ileus and relat ed conditions.
Leverfunktionen Forbigående, asymptomatiske forhøjelser af levertransaminaser, ALAT og ASAT er almindeligt forekommende, især i den tidlige behandling.
102 Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
102 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 medicines.
Krampeanfald Olanzapin bør anvendes med forsigtighed til patienter med tidliger e 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.
103 Postural hypotension observeredes lejlighedsvist hos ældre i kliniske undersøgelser med olanzapin.
103 Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
Terapeutisk monitorering af valproat- plasmaniveauer indikerer ikke, at en justering af valproat- dosis er nødvendig, når olanzapin gives sammen med valproat.
104 Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
105
105 Metabolism and nutrition disorders Weight gain1
106 Undersøgelser Forhøjede plasmaprolaktinniveau er 8 1
106 Priapism General disorders and administration site conditions Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels 8 1
En potentielt medvirkende faktor kunne være høje niveauer af valproat i plasma.
107 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.
108 Meget almindelige symptomer på overdosering (forekomst > 10%) inkluderer takykardi, agitation/ aggressivitet, dysartri, forskellige ekstrapyramidale symptomer og nedsat bevidsthedsniveau, varierende fra sedation til koma.
108 Signs and symptoms Very common symptoms in overdose (> 10% incidence) include tachycardia, agitation/ aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
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).
109 In a multinationational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p=0.001) favouring olanzapine (-6.0) versus haloperidol (-3.1).
110 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).
110 In healthy elderly (65 and over) versus non-elderly subjects, the mean elimination half-life was prolonged (51.8 versus 33.8 hr) and the clearance was reduced (17.5 versus 18.2 l/ hr).
111 Hæmatologisk toksicitet:
111 Haematologic toxicity:
112 Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinier.
112 7.
Hver smeltetablet indeholder 1, 00 mg aspartame.
Each orodispersible tablet contains 1.00 mg aspartame.
114 Zalasta smeltetablet bør placeres i munden, hvor den hurtigt vil dispergeres i spyttet, så den let kan synkes.
114 Zalasta orodispersible tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
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
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
115 placebobehandlede patienter (henholdsvis 3, 5% og 1, 5%).
115 compared to patients treated with placebo (3.5% vs.
Leverfunktionen Forbigående, asymptomatiske forhøjelser af levertransaminaser, ALAT og ASAT er almindeligt forekommende, især i den tidlige behandling.
116 Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
116 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 medicines.
117 Postural hypotension observeredes lejlighedsvist hos ældre i kliniske undersøgelser med olanzapin.
117 Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
118 Der skal udvises forsigtighed hos patienter, som indtager alkohol eller får lægemidler, der kan undertrykke centralnervesystemet.
118 General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
glucoseniveauer 4 Forhøjede triglyceridniveauer 2, 5 Glukosuri Øget appetit
levels 2,3 Elevated glucose levels 4 Elevated triglyceride levels 2,5 Glucosuria Increased appetite
Hypotermi
exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) Hypothermia
Somnolens Hjerte
Nervous system disorders
Svimmelhed Akatisi 6 Parkinsonisme 6 Dyskinesi6
Somnolence Cardiac disorders
Vaskulære sygdomme
Dizziness Akathisia6 Parkinsonism6 Dyskinesia 6
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
Musculoskeletal and connective tissue disorders Rhabdomyolysis Renal and urinary disorders Urinary hesitation Reproductive system and breast disorders Priapism General disorders and administration site conditions
120 Undersøgelser Forhøjede plasmaprolaktinniveau er 8 1
120 Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels 8 1
121 I et klinisk forsøg med patienter med bipolær mani resulterede valproat kombinationsterapi med olanzapin i en incidens af neutropeni på 4, 1%.
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
En potentielt medvirkende faktor kunne være høje niveauer af valproat i plasma.
121 valproate levels.
122 Meget almindelige symptomer på overdosering (forekomst > 10%) inkluderer takykardi, agitation/ aggressivitet, dysartri, forskellige ekstrapyramidale symptomer og nedsat bevidsthedsniveau, varierende fra sedation til koma.
122 Very common symptoms in overdose (> 10% incidence) include tachycardia, agitation/ aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
Undersøgelsen omfattede 1481 patienter med varierende grad af hertil
In a multinationational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms
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).
123 (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p=0.001) favouring olanzapine (-6.0) versus haloperidol (-3.1).
124 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).
In healthy elderly (65 and over) versus non-elderly subjects, the mean elimination half-life was prolonged (51.8 versus 33.8 hr) and the clearance was reduced (17.5 versus 18.2 l/ hr).
Den farmakokinetiske variation hos ældre forsøgspersoner er indenfor variationen hos ikke- ældre.
In 44
Hos 44 patienter > 65 år med skizofreni gav dosering med 5- 20 mg/ dag ingen udsving i bivirkningsprofilen.
124 patients with schizophrenia 65 years of age, dosing from 5 to 20 mg/ day was not associated with any distinguishing profile of adverse events.
125 Hæmatologisk toksicitet:
Haematologic toxicity:
Der sås imidlertid ingen tegn på knoglemarvscytotoksicitet.
Reversible