natgillin/translations-raw huggingface dataset:
Yderligere bivirkninger rapporteret med RISPERDAL CONSTA, men ikke med oral RISPERDAL efter systemorganklasse Undersøgelser Vægttab, stigning i gammaglutamyltransferase, stigning i leverenzymer Hjerte Bradykardi Blod og lymfesystem Neutropeni Nervesystemet Paræstesi, kramper Øjne Blefarospasme Øre og labyrint Vertigo Mave- tarm- kanalen Tandpine, tungespasme Hud og subkutane væv Eksem Knogler, led, muskler og bindevæv Smerter i endeballen Infektioner og parasitære sygdomme Infektion i de nedre luftveje, infektion, gastroenteritis, subkutan absces Traumer, forgiftninger og behandlingskomplikationer Fald Vaskulære sygdomme Hypertension Almene symptomer og reaktioner på administrationsstedet Smerter Psykiske forstyrrelser Depression
Additional Adverse Drug Reactions Reported With RISPERDAL CONSTA but Not With Oral RISPERDAL by System Organ Class Investigations Weight decreased, Gamma-glutamyltransferase increased, Hepatic enzyme increased Cardiac Disorders Bradycardia Blood and Lymphatic Disorders Neutropenia Nervous System Disorders Paresthesia, Convulsion Eye Disorders Blepharospasm Ear and Labyrinth Disorders Vertigo Gastrointestinal Disorders Toothache, Tongue spasm Skin and Subcutaneous Tissue Disorders Eczema Musculoskeletal, Connective Tissue, and Bone Disorders Buttock pain Infections and Infestations Lower respiratory tract infection, Infection, Gastroenteritis, Subcutaneous abscess Injury and Poisoning Fall Vascular Disorders Hypertension General Disorders and Administration Site Conditions Pain Psychiatric Disorders Depression
Klasseeffekter
64 Class effects
Som ved andre antipsykotika er der efter markedsføring rapporteret meget sjældne tilfælde af QT - forlængelse med risperidon.
As with other antipsychotics, very rare cases of QT prolongation have been reported postmarketing with risperidone.
Andre klasserelaterede virkninger på hjertet, som er rapporteret med antipsykotika, der forlænger QT- intervallet, omfatter ventrikulær arytmi, ventrikelflimren, ventrikulær takykardi, pludselig død, hjertestop og torsades de pointes.
Other class-related cardiac effects reported with antipsychotics which prolong QT interval include ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia, sudden death, cardiac arrest and Torsades de Pointes.
Forsøget viste en statistisk signifikant større incidens af vægtøgning for RISPERDAL (18%) end for placebo (9%).
The proportions of RISPERDAL and placebo-treated adult patients with schizophrenia meeting a weight gain criterion of ≥ 7% of body weight were compared in a pool of 6- to 8-week, placebo-controlled trials, revealing a statistically significantly greater incidence of weight gain for RISPERDAL (18%) compared to placebo (9%).
I en pulje af 3- ugers placebokontrollerede forsøg med voksne patienter med akut mani var incidensen af vægtøgning på ≥ 7% ved slutvurderingen sammenlignelig i RISPERDAL- gruppen (2, 5%) og placebogruppen (2, 4%), og den var en smule højere i den aktive kontrolgruppe (3, 5%).
In a pool of placebo-controlled 3-week studies in adult patients with acute mania, the incidence of weight increase of ≥ 7% at endpoint was comparable in the RISPERDAL (2.5%) and placebo (2.4%) groups, and was slightly higher in the active-control group (3.5%).
63 I en population af børn og unge med adfærdsforstyrrelser og anden destruktiv adfærd blev der i langtidsforsøg observeret en vægtøgning på gennemsnitligt 7, 3 kg efter 12 måneders behandling.
In a population of children and adolescents with conduct and other disruptive behaviour disorders, in long- term studies, weight increased by a mean of 7.3 kg after 12 months of treatment.
Den forventede vægtøgning for normale børn i alderen 5- 12 år er 3- 5 kg pr. år.
The expected weight gain for normal children between 5-12 years of age is 3 to 5 kg per year.
5 kg pr. år.
From 12-16 years of age, this magnitude of gaining 3 to 5 kg per year is maintained for girls, while boys gain approximately 5 kg per year.
Yderligere oplysninger om særlige patientpopulationer
Additional information on special populations
Nedenfor beskrives bivirkninger, som er rapporteret med højere incidens hos ældre med demens eller hos børn i sammenligning med voksne populationer:
Adverse drug reactions that were reported with higher incidence in elderly patients with dementia or paediatric patients than in adult populations are described below:
Transitorisk iskæmisk attak og cerebrovaskulært anfald er bivirkninger, som er rapporteret i kliniske forsøg med en hyppighed på henholdsvis 1, 4% og 1, 5% hos ældre med demens.
Transient ischaemic attack and cerebrovascular accident were ADRs reported in clinical trials with a frequency of 1.4% and 1.5%, respectively, in elderly patients with dementia.
Endvidere er følgende bivirkninger rapporteret med en hyppighed på ≥ 5% hos ældre med demens og med en hyppighed på mindst det dobbelte af den hyppighed, der ses hos andre voksne populationer: urinvejsinfektion, perifert ødem, letargi og hoste.
In addition, the following ADRs were reported with a frequency ≥ 5% in elderly patients with dementia and with at least twice the frequency seen in other adult populations: urinary tract infection, peripheral oedema, lethargy, and cough.
Følgende bivirkninger er rapporteret med en hyppighed på ≥ 5% hos børn og unge (5- 17 år) og med en hyppighed på mindst det dobbelte af den hyppighed, der ses i kliniske forsøg med voksne: somnolens/ sedation, træthed, hovedpine, forhøjet appetit, opkastning, infektioner i de øvre respirationsveje, fortætning i næsen, mavesmerter, svimmelhed, hoste, pyreksi, tremor, diaré og enuresis.
The following ADRs were reported with a frequency ≥ 5% in paediatric patients (5 to 17 years) and with at least twice the frequency seen in clinical trials in adults: somnolence/ sedation, fatigue, headache, increased appetite, vomiting, upper respiratory tract infection, nasal congestion, abdominal pain, dizziness, cough, pyrexia, tremor, diarrhoea, and enuresis.
Generelt svarer de registrede symptomer til en forstærkning af de kendte farmakologiske virkninger af risperidon.
In general, reported signs and symptoms have been those resulting from an exaggeration of the known pharmacological effects of risperidone.
Ved overdosering er der rapporteret QT- forlængelse og krampeanfald.
In overdose, QT-prolongation and convulsions have been reported.
Torsades de pointes er rapporteret i forbindelse med kombineret overdosis af RISPERDAL og paroxetin.
Torsade de Pointes has been reported in association with combined overdose of RISPERDAL and paroxetine.
I tilfælde af akut overdosering bør muligheden for, at patienten har indtaget flere stoffer, tages i betragtning.
In case of acute overdose, the possibility of multiple drug involvement should be considered.
Maveskylning (efter intubation, hvis patienten er bevidstløs) og indgift af aktivt kul sammen med laksantia bør kun overvejes, hvis indtagelsen af lægemidlet er sket inden for en time.
Gastric lavage (after intubation, if the patient is unconscious) and administration of activated charcoal together with a laxative
Derfor bør nødvendig understøttende behandling påbegyndes.
Therefore, appropriate supportive measures should be instituted.
Hypotension og kredsløbskollaps behandles med relevante midler, f. eks. intravenøs væske og/ eller sympatomimetika.
Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluids and/ or sympathomimetic agents.
I tilfælde af svære ekstrapyramidale symptomer bør der indgives et antikolinergikum.
In case of severe extrapyramidal symptoms, an anticholinergic medicinal product should be administered.
Andre antipsykotika, ATC- kode:
Other antipsychotics, ATC code:
Risperidon har høj affinitet over for serotonin 5- HT2 - og dopamin D2- receptorer.
It has a high affinity for serotoninergic 5-HT2 and dopaminergic D2 receptors.
Risperidon bindes også til alfa1- adrenerge receptorer samt med lavere affinitet til histamin H1 - og alfa2- adrenerge receptorer.
Risperidone binds also to alpha1-adrenergic receptors, and, with lower affinity, to H1-histaminergic and alpha2-adrenergic receptors.
Selv om risperidon er en potent D2- antagonist, som anses for at bedre de positive symptomer ved skizofreni, forårsager risperidon mindre hæmning af motorisk aktivitet samt færre kataleptiske anfald end de klassiske antipsykotika.
Although risperidone is a potent D2 antagonist, which is considered to improve the positive symptoms of schizophrenia, it causes less depression of motor activity and induction of catalepsy than classical antipsychotics.
Velafbalanceret central serotonin - og dopaminantagonisme kan nedsætte risikoen for ekstrapyramidale symptomer og øge den terapeutiske effekt over for skizofreniens negative og affektive symptomer.
Balanced central serotonin and dopamine antagonism may reduce extrapyramidal side effect liability and extend the therapeutic activity to the negative and affective symptoms of schizophrenia.
Effekten af risperidon til kortvarig behandling af skizofreni blev bestemt i fire forsøg af 4- 8 ugers varighed med over 2. 500 patienter, som opfyldte DSM- IV- kriterierne for skizofreni.
The efficacy of risperidone in the short-term treatment of schizophrenia was established in four studies, 4- to 8-weeks in duration, which enrolled over 2500 patients who met DSM-IV criteria for schizophrenia.
I et 6- ugers placebokontrolleret forsøg med titrering af risperidon i doser op til 10 mg/ dag indgivet to gange dagligt var risperidon bedre end placebo på en samlet BPRS- score (Brief Psychiatric Rating Scale).
In a 6- week, placebo-controlled trial involving titration of risperidone in doses up to 10 mg/ day administered twice daily, risperidone was superior to placebo on the Brief Psychiatric Rating Scale (BPRS) total score.
I et 8- ugers placebokontrolleret forsøg med fire faste risperidondoser (2, 6, 10 og 16 mg/ dag indgivet to gange dagligt) var alle fire risperidongrupper bedre end placebo på en bedre samlet PANSS- score (Positive and Negative Syndrome Scale).
In an 8- week, placebo-controlled trial involving four fixed doses of risperidone (2, 6, 10, and 16 mg/ day, administered twice daily), all four risperidone groups were superior to placebo on the Positive and Negative Syndrome Scale (PANSS) total score.
I et 8- ugers dosissammenligningsforsøg med fem faste risperidondoser (1, 4, 8, 12 og 16 mg/ dag indgivet to gange dagligt) var grupperne med 4, 8 og 16 mg/ dag risperidon bedre end gruppen med 1 mg risperidon på en samlet PANSS- score.
In an 8-week, dose comparison trial involving five fixed doses of risperidone (1, 4, 8, 12, and 16 mg/ day administered twice-daily), the 4, 8, and 16 mg/ day risperidone dose groups were superior to the 1 mg risperidone dose group on PANSS total score.
I et 4- ugers placebokontrolleret dosissammenligningsforsøg med to faste risperidondoser (4 og 8 mg/ dag indgivet én gang dagligt) var begge risperidongrupper bedre end placebo på flere PANSS- mål, bl. a. samlet PANSS- score og et responsmål (> 20% reduktion i samlet PANSS- score).
In a 4-week, placebo- controlled dose comparison trial involving two fixed doses of risperidone (4 and 8 mg/ day administered once daily), both risperidone dose groups were superior to placebo on several PANSS measures, including total PANSS and a response measure (> 20% reduction in PANSS total score).
I et længerevarende forsøg blev voksne ambulante patienter, som overvejende opfyldte DSM- IV- kriterierne for skizofreni, og som havde været klinisk stabile i mindst 4 uger på et antipsykotisk lægemiddel, randomiseret til risperidon 2- 8 mg/ dag eller haloperidol i 1- 2 år med observation for recidiv.
In a longer-term trial, adult outpatients predominantly meeting DSM-IV criteria for schizophrenia and who had been clinically stable for at least 4 weeks on an antipsychotic medicinal product were randomised to risperidone 2 to 8 mg/ day or to haloperidol for 1 to 2 years of observation for relapse.
De patienter, som fik risperidon, oplevede en signifikant længere periode før recidiv i denne tidsperiode end de patienter, som fik haloperidol.
Patients receiving risperidone experienced a significantly longer time to relapse over this time period compared to those receiving haloperidol.
Maniske episoder ved bipolar lidelse
Manic episodes in bipolar disorder
820 patienter med bipolar lidelse type I baseret på DSM- IV- kriterierne.
The efficacy of risperidone monotherapy in the acute treatment of manic episodes associated with bipolar I disorder was demonstrated in three double-blind, placebo-controlled monotherapy studies in approximately 820 patients who had bipolar I disorder, based on DSM-IV criteria.
I de tre forsøg var risperidon 1- 6 mg/ dag (startdosis 3 mg i to forsøg og 2 mg i ét forsøg) signifikant bedre end placebo på det forud specificerede primære effektmål, dvs. ændring fra baseline i samlet YMRS- score (Young Mania Rating Scale) i uge 3.
In the three studies, risperidone 1 to 6 mg/ day (starting dose 3 mg in two studies and 2 mg in one study) was shown to be significantly superior to placebo on the pre-specified primary endpoint, i. e., the change from baseline in total Young Mania Rating
Sekundære effektresultater svarede generelt til det primære resultat.
Secondary efficacy outcomes were generally consistent with the primary outcome.
Procenten af patienter med et fald på ≥ 50% i samlet YMRS- score fra baseline til effektmålet i uge 3 var signifikant højere for risperidon end for placebo.
The percentage of patients with a decrease of ≥ 50% in total YMRS score from baseline to the 3-week endpoint was significantly higher for risperidone than for placebo.
Ét af de tre forsøg omfattede en gruppe med haloperidol og en 9- ugers dobbeltblindet vedligeholdelsesfase.
One of the three studies included a haloperidol arm and a 9-week double-blind maintenance phase.
Effekten blev fastholdt i vedligeholdelsesbehandlingsperioden på 9 uger.
Efficacy was maintained throughout the 9-week maintenance treatment period.
Ændring fra baseline i samlet YMRS- score viste fortsat bedring og var i uge 12 sammenlignelig mellem risperidon og haloperidol.
Change from baseline in total YMRS showed continued improvement and was comparable between risperidone and haloperidol at Week 12.
300 patienter, som opfyldte DSM- IV- kriterierne for bipolar lidelse type I.
The efficacy of risperidone in addition to mood stabilisers in the treatment of acute mania was demonstrated in one of two 3-week double-blind studies in approximately 300 patients who met the DSM-IV criteria for bipolar I disorder.
Behandlingen, hvor risperidon blev brugt som supplement, viste sig at være
In one 3-week study, risperidone 1 to 6 mg/ day starting at 2 mg/ day in addition to lithium or valproate was superior to lithium or valproate alone on the pre-specified primary endpoint, i. e., the change from baseline in YMRS total score at Week 3.
I et andet 3- ugers forsøg var risperidon 1- 6 mg/ dag startende med 2 mg/ dag kombineret med litium, valproat eller carbamazepin ikke bedre end litium, valproat eller carbamazepin alene med hensyn til reduktion af samlet YMRS- score.
In a second 3-week study, risperidone 1 to 6 mg/ day starting at 2 mg/ day, combined with lithium, valproate, or carbamazepine was not superior to lithium, valproate, or carbamazepine alone in the reduction of YMRS total score.
En mulig forklaring på behandlingssvigtet i dette forsøg er, at carbamazepin inducerer clearance af risperidon og 9- hydroxyrisperidon, hvilket medfører subterapeutiske niveauer af risperidon og 9- hydroxyrisperidon.
A possible explanation for the failure of this study was induction of risperidone and 9-hydroxy-risperidone clearance by carbamazepine, leading to subtherapeutic levels of risperidone and 9-hydroxy-risperidone.
Da carbamazepingruppen blev udeladt i en post hoc- analyse, var risperidon kombineret med litium eller valproat bedre end litium eller valproat alene med hensyn til reduktion af samlet YMRS- score.
When the carbamazepine group was excluded in a post-hoc analysis, risperidone combined with lithium or valproate was superior to lithium or valproate alone in the reduction of YMRS total score.
Svær aggression ved demens
Persistent aggression in dementia
Effekten af risperidon til behandling af adfærdsmæssige og psykologiske symptomer ved demens, der omfatter adfærdsforstyrrelser som aggression, agitation, psykose, aktivitet og affektive forstyrrelser, blev påvist i tre dobbeltblindede, placebokontrollerede forsøg med 1. 150 ældre med demens.
The efficacy of risperidone in the treatment of Behavioural and Psychological Symptoms of Dementia (BPSD), which includes behavioural disturbances, such as aggressiveness, agitation, psychosis, activity, and affective disturbances was demonstrated in three double-blind, placebo-controlled studies in 1150 elderly patients with moderate to severe dementia.
Ét forsøg omfattede faste risperidondoser på 0, 5, 1 og 2 mg/ dag.
One study included fixed risperidone doses of 0.5, 1, and 2 mg/ day.
To forsøg med fleksible doser omfattede risperidongrupper med doser på henholdsvis 0, 5- 4 mg/ dag og 0, 5- 2 mg/ dag.
Two flexible-dose studies included risperidone dose groups in the range of 0.5 to 4 mg/ day and 0.5 to 2 mg/ day, respectively.
Risperidon viste statistisk signifikant og klinisk betydningsfuld effekt til behandling af aggression og mindre entydig effekt til behandling af agitation og psykose hos ældre demente patienter (målt på BEHAVE- AD- skalaen (Behavioural Pathology in Alzheimer' s Disease Rating Scale) og CMAI- skalaen (Cohen- Mansfield Agitation Inventory)).
Risperidone showed statistically significant and clinically important effectiveness in treating aggression and less consistently in treating agitation and psychosis in elderly dementia patients (as measured by the Behavioural Pathology in Alzheimer’ s Disease Rating Scale [BEHAVE-AD] and the Cohen-Mansfield Agitation Inventory [CMAI]).
Risperidons behandlingseffekt var uafhængig af MMSE- score (Mini- Mental State Examination) (og følgelig af demensens sværhedsgrad), af risperidons sedative egenskaber, af forekomsten af psykose og af demenstypen, Alzheimers, vaskulær eller blandet.
The treatment effect of risperidone was independent of Mini-Mental State Examination (MMSE) score (and consequently of the severity of dementia); of sedative properties of risperidone; of the presence or absence of psychosis; and of the type of dementia, Alzheimer’ s, vascular, or mixed.
4. 4).
(See also section 4.4)
Adfærdsforstyrelse
Conduct disorder
240 patienter i alderen 5- 12 år med DSM- IV- diagnosen DBD og borderline intellektuel funktion eller mild eller moderat mental retardering/ indlæringsforstyrrelser.
The efficacy of risperidone in the short-term treatment of disruptive behaviours was demonstrated in two double-blind placebo-controlled studies in approximately 240 patients 5 to 12 years of age with a DSM-IV diagnosis of disruptive behaviour disorders (DBD) and borderline intellectual functioning or mild or moderate mental retardation/ learning disorder.
I de to forsøg var risperidon 0, 02- 0, 06 mg/ kg/ dag i uge 6 signifikant bedre end placebo på det forud specificerede primære effektmål, dvs. ændring fra baseline i subskalaen "adfærdsproblem" på N- CBRF- skemaet (Nisonger- Child Behaviour Rating Form).
In the two studies, risperidone 0.02 to 0.06 mg/ kg/ day was significantly superior to placebo on the pre-specified primary endpoint, i. e., the change from baseline in the Conduct Problem subscale of the Nisonger-Child Behaviour Rating Form (N-CBRF) at Week 6.
RISPERDAL smeltetabletter og oral opløsning er bioækvivalente med RISPERDAL filmovertrukne tabletter.
RISPERDAL orodispersible tablets and oral solution are bio-equivalent to RISPERDAL film-coated tablets.
Risperidon metaboliseres til 9- hydroxyrisperidon, som har farmakologisk aktivitet svarende til risperidon (se Biotransformation og eliminering).
Risperidone is metabolised to 9-hydroxy-risperidone, which has a similar pharmacological activity to risperidone (see Biotransformation and Elimination).
Absorption
67 Absorption
Risperidon absorberes fuldstændigt efter peroral indgift og når maksimal plasmakoncentration efter 1- 2 timer.
Risperidone is completely absorbed after oral administration, reaching peak plasma concentrations within 1 to 2 hours.
Risperidons absolutte orale biotilgængelighed er 70% (CV = 25%).
The absolute oral bioavailability of risperidone is 70% (CV=25%).
Risperidons relative orale biotilgængelighed fra en tablet er 94% (CV = 10%) sammenlignet med en opløsning.
The relative oral bioavailability of risperidone from a tablet is 94% (CV=10%) compared with a solution.
Absorptionen påvirkes ikke af fødeindtagelse, og risperidon kan derfor indtages med eller uden måltider.
The absorption is not affected by food and thus risperidone can be given with or without meals.
Steady state for risperidon nås inden for 1 dag hos de fleste patienter.
Steady-state of risperidone is reached within 1 day in most patients.
Steady state for 9- hydroxyrisperidon nås efter 4- 5 dages dosering.
Steady-state of 9-hydroxy-risperidone is reached within 4-5 days of dosing.
Fordelingsvolumenet er 1- 2 l/ kg.
The volume of distribution is 1-2 l/ kg.
I plasma bindes risperidon til albumin og alfa1- glykoproteinsyre.
In plasma, risperidone is bound to albumin and alpha1-acid glycoprotein.
Plasmaproteinbindingen for risperidon er 90% og 77% for 9- hydroxyrisperidon.
The plasma protein binding of risperidone is 90%, that of 9-hydroxy- risperidone is 77%.
Risperidon metaboliseres af CYP 2D6 til 9- hydroxyrisperidon, som har farmakologisk aktivitet svarende til risperidon.
Risperidone is metabolised by CYP 2D6 to 9-hydroxy-risperidone, which has a similar pharmacological activity as risperidone.
Risperidon plus 9- hydroxyrisperidon udgør den aktive antipsykotiske fraktion.
Risperidone plus 9-hydroxy-risperidone form the active antipsychotic fraction.
CYP 2D6
CYP 2D6 is subject to genetic polymorphism.
Personer med en hurtig CYP 2D6- funktion omdanner hurtigt risperidon til 9- hydroxyrisperidon, hvorimod personer med en langsom CYP 2D6- funktion omdanner det meget langsommere.
Extensive CYP 2D6 metabolisers convert risperidone rapidly into 9-hydroxy-risperidone, whereas poor CYP 2D6 metabolisers convert it much more slowly.
Dette ses efter enkelt - og flerdosisindtag.
Although extensive metabolisers have lower risperidone and higher 9-hydroxy-risperidone concentrations than poor metabolisers, the pharmacokinetics of risperidone and 9-hydroxy-risperidone combined (i. e., the active antipsychotic fraction), after single and multiple doses, are similar in extensive and poor metabolisers of CYP 2D6.
En anden metaboliseringsvej for risperidon er N- dealkylering.
Another metabolic pathway of risperidone is N-dealkylation.
CYP 1A2, CYP 2A6, CYP 2C8/ 9/ 10, CYP 2D6, CYP 2E1, CYP 3A4 og CYP 3A5.
In vitro studies in human liver microsomes showed that risperidone at clinically relevant concentration does not substantially inhibit the metabolism of medicines metabolised by cytochrome P450 isozymes, including CYP 1A2, CYP 2A6, CYP 2C8/ 9/ 10, CYP 2D6, CYP 2E1, CYP 3A4, and CYP 3A5.
1 uge efter indgift udskilles 70% af dosis med urin og 14% med fæces.
One week after administration, 70% of the dose is excreted in the urine and 14% in the faeces.
I urin udgør risperidon plus 9- hydroxyrisperidon 35- 45% af dosis.
In urine, risperidone plus 9-hydroxy-risperidone represent 35-45% of the dose.
3 timer.
After oral administration to psychotic patients, risperidone is eliminated with a half-life of about 3 hours.
Elimineringshalveringstiden for 9- hydroxyrisperidon og den aktive antipsykotiske fraktion er 24 timer.
The elimination half-life of 9-hydroxy-risperidone and of the active antipsychotic fraction is 24 hours.
Plasmakoncentrationerne af risperidon er dosisproportionale inden for det terapeutiske doseringsinterval.
Risperidone plasma concentrations are dose-proportional within the therapeutic dose-range.
Ældre samt patienter med lever - og nyreinsufficiens
Elderly, hepatic and renal impairment