FrancophonIA/ELRC3.0 huggingface dataset:
English: The plasma protein binding of risperidone is 90%; that of the active metabolite 9-hydroxy-risperidone is 77%.
Danish: Plasmaproteinbindingen for risperidon er 90 % og 77 % for den aktive metabolit 9-hydroxyrisperidon.
English: • Cimetidie, ranitidine (blockers of the acidity of stomach) If you start or stop taking such medicines you may need a different dose of risperidone
Danish: • Cimetidin, ranitidin (blokerer syreproduktionen i maven) Hvis du begynder eller ophører behandling med disse midler, skal du muligvis have en anden dosis af risperidon.
English: Sweden Janssen-Cilag AB Box 7073
Danish: Janssen-Cilag AB Box 7073
English: The CHMP was also of the opinion that the proposed wording of the SPC gives enough flexibility to the treating physician to start with the dose of 25 mg or higher.
Danish: CHMP var også af den opfattelse, at den foreslåede formulering i produktresuméet giver den behandlende læge tilstrækkelig fleksibilitet til at starte med en dosis på 25 mg eller derover.
English: For those patients on a fixed dose of oral risperidone for two weeks or more, the following conversion scheme should be considered.
Danish: For patienter på en fast dosis oral risperidon i to uger eller derover, bør følgende konverteringsskema overvejes.
English: The CHMP assessed the proposed wording provided by the MAH, and particular attention was given to the following issues:
Danish: CHMP vurderede den foreslåede formulering, der var fremlagt af indehaveren af markedsføringstilladelsen, og der blev lagt særlig vægt på følgende punkter:
English: • You know of any factors which would favour you having a stroke, such as high blood pressure,
Danish: • Hvis du kender til nogle faktorer, som kan gøre dig disponeret for slagtilfælde, f.eks. forhøjet blodtryk,
English: Therapeutic plasma concentrations remain until 4 to 6 weeks after the last RISPERDAL CONSTA injection.
Danish: Terapeutiske plasmakoncentrationer vedbliver med at være til stede indtil 4-6 uger efter sidste injektion af RISPERDAL CONSTA.
English: • Sudden swelling of lips and eyes along with difficulty breathing, allergy
Danish: • Pludselig hævelse af læber og øjne samtidig med åndedrætsbesvær, allergi.
English: Verapamil, an inhibitor of CYP 3A4 and P-gp, increases the plasma concentration of risperidone.
Danish: Verapamil, som er en inhibitor af CYP 3A4 og P-gp, øger plasmakoncentrationen af risperidon.
English: After a single intramuscular injection with RISPERDAL CONSTA, the release profile consists of a small initial release of risperidone (<1% of the dose), followed by a lag time of 3 weeks.
Danish: Efter en enkelt intramuskulær injektion med RISPERDAL CONSTA består afgivelsesprofilen af en lille initial afgivelse af risperidon (< 1 % af dosis), efterfulgt af en latensperiode på 3 uger.
English: • Talk to your doctor before using RISPERDAL CONSTA if you are pregnant, trying to become pregnant or breast-feeding.
Danish: • Tal med lægen, før du bruger RISPERDAL CONSTA, hvis du er gravid eller prøver at blive gravid,
English: The elimination phase is complete approximately 7 to 8 weeks after the last RISPERDAL CONSTA injection.
Danish: Elimineringsfasen er afsluttet ca. 7-8 uger efter sidste injektion af RISPERDAL CONSTA.
English: • Carbamazepine, phenytoin (mdicines for epilepsy)
Danish: • Carbamazepin, fenytoin (midler mod epilepsi)
English: Absorption The absorption of risperidone from RISPERDAL CONSTA is complete.
Danish: Absorption Absorptionen af risperidon fra RISPERDAL CONSTA er fuldstændig.
English: Other dopamine antagonists, when administered to pregnant animals, have caused negative effects on learning and motor development in the offspring.
Danish: Andre dopaminantagonister har ved indgift i drægtige dyr medført negative virkninger på afkommets indlæring og motoriske udvikling.
English: RESUSPENSION OF RISPERDAL CONSTA WILL BE NECESSARY PRIOR TO ADMINISTRATION AS SETTLING WILL OCCUR OVER TIME ONCE PRODUCT IS RECONSTITUTED.
Danish: RESUSPENSION AF RISPERDAL CONSTA ER NØDVENDIG INDEN INDGIFT, DA BUNDFÆLDELSE VIL FINDE STED, EFTER AT PRODUKTET ER REKONSTITUERET.
English: Children and adolescents RISPERDAL CONSTA is not for people who are under 18 years old.
Danish: Børn og unge RISPERDAL CONSTA må ikke anvendes til personer under 18 år.
English: Some patients may benefit from the higher doses of 37.5 mg or 50 mg.
Danish: Nogle patienter kan have gavn af de højere doser på 37,5 mg eller 50 mg.
English: Tremor includes tremor and parkinsonian rest tremor.
Danish: Tremor omfatter tremor og parkinsons hviletremor.
English: • You have difficulty controlling body temperature or overheating
Danish: • Hvis du har vanskeligt ved at kontrollere legemstemperaturen eller får hedeture.
English: The following are all the ADRs that were reported in clinical trials and postmarketing.
Danish: Nedenfor anføres samtlige bivirkninger, som er rapporteret i kliniske forsøg og efter markedsføringen.
English: Using RISPERDAL CONSTA with food and drink You should avoid drinking alcohol when using RISPERDAL CONSTA.
Danish: Brug af RISPERDAL CONSTA sammen med mad og drikke Drik ikke alkohol, når du tager RISPERDAL CONSTA.
English: Elderly patients with dementia treated with atypical antipsychotics have an increased mortality compared to placebo in a meta-analysis of 17 controlled trials of atypical antipsychotics, including oral RISPERDAL.
Danish: Ældre med demens, som behandles med atypiske antipsykotika, har øget mortalitet sammenlignet med placebo i en metaanalyse af 17 kontrollerede forsøg med atypiske antipsykotika, herunder oral RISPERDAL.
English: The CHMP also assessed the proposed 12.5 mg dosing, in particular with regards to the elderly population, and considered that the 12.5 mg dose of Risperdal Consta would provide additional dosing flexibility but stressed that this dose is intended only as a lower initial dose to establish tolerability, to be used mainly for patients with a higher sensitivity to the effects of the drug, either because of reduced metabolism/excretion, or in patients with an intrinsic lower tolerability to psychotropic medication.
Danish: CHMP vurderede også den foreslåede 12,5 mg dosering, navnlig med hensyn til den ældre population, og var af den opfattelse, at 12,5 mg dosen af Risperdal Consta ville give ekstra doseringsfleksibilitet, men understregede, at denne dosis udelukkende er beregnet som en lavere startdosis til opnåelse af tolerabilitet, og som hovedsageligt bør anvendes til patienter med en højere følsomhed over for lægemidlets virkninger, enten på grund af nedsat metabolisme/udskillelse eller hos patienter med en egentlig lavere tolerabilitet over for psykotrop medicin.
English: For intramuscular use only.
Danish: Kun til intramuskulær brug.
English: Because Risperdal Consta has not been studied in elderly patients with dementia, it is therefore not indicated for use in this group of patients, as stated in Section 4.4 of the proposed SPC and in line with the current CHMP SPC guideline.
Danish: Da Risperdal Consta ikke er undersøgt hos ældre patienter med demens, er det derfor ikke indiceret til brug hos denne patientgruppe som angivet i punkt 4.4 i det foreslåede produktresumé og i overensstemmelse med de gældende CHMP-retningslinjer for produktresuméer.
English: The risk/benefit of further treatment with RISPERDAL CONSTA should be assessed if clinically relevant orthostatic hypotension persists.
Danish: Risici og fordele ved yderligere behandling med RISPERDAL CONSTA bør vurderes, hvis klinisk relevant ortostatisk hypotension vedvarer.
English: In conclusion, the CHMP was not in favour of restricting the use of long-acting risperidone for patients who were administered with 6 mg risperidone per day.
Danish: CHMP gik derfor ikke ind for at begrænse brugen af langtidsvirkende risperidon til patienter, der fik 6 mg risperidon dagligt.
English: In plasma, risperidone is bound to albumin and alpha-1-acid glycoprotein.
Danish: I plasma bindes risperidon til albumin og alfa-1-glykoproteinsyre.
English: Smartinska cesta 53, 1000 Ljubljana, Slovenia
Danish: Smartinska cesta 53, 1000
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉER, ETIKETTERING OG INDLÆGSSEDDEL FREMLAGT AF EMEA
English: RISPERDAL CONSTA taken by itself or with furosemide, may have an increased risk of stroke or death in elderly people with dementia.
Danish: RISPERDAL CONSTA indgivet alene eller sammen med furosemid kan øge risikoen for slagtilfælde eller død hos ældre med demens.
English: Tap the syringe gently to make any air bubbles rise to the top.
Danish: Bank let på sprøjten for at få eventuelle luftbobler til at stige op til toppen.
English: The need for increased patient monitoring during the switch period was discussed and the CHMP considered that the data provided showed no worsening in clinical symptoms after the therapy with long-acting risperidone was initiated.
Danish: Behovet for øget patientovervågning i overgangsperioden blev drøftet, og CHMP mente, at de fremlagte data ikke viste nogen forværring af de kliniske symptomer efter indledningen af behandlingen med langtidsvirkende risperidon.
English: • Two Hypoint 20G 2” TW needles for reconstitution
Danish: • To Hypoint 20G 2" TW-kanyler til rekonstitution
English: No accumulation of risperidone was observed during long term use (12 months) in patients who were injected with 25-50 mg every two weeks.
Danish: Der blev ikke observeret akkumulering af risperidon ved langvarig brug (12 måneder) hos patienter, der fik injiceret 25-50 mg hver anden uge.
English: Although risperidone is a potent D2 antagonist, that is considered to improve the positive symptoms of schizophrenia, it causes less depression of motor activity and induction of catalepsy than classical antipsychotics.
Danish: 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.
English: Interaction studies were performed with oral RISPERDAL.
Danish: Der er udført interaktionsundersøgelser med oral RISPERDAL.
English: Both groups may be at increased risk of Neuroleptic Malignant Syndrome as well as having an increased sensitivity to antipsychotic medicinal products; these patients were excluded from clinical trials.
Danish: Begge patientgrupper har forhøjet risiko for at udvikle malignt neuroleptikasyndrom samt har øget sensitivitet for antipsykotika; disse patienter var udelukket fra kliniske forsøg.
English: 02130 Espoo Finland suspension for injection
Danish: 02130 Espoo Finland suspension
English: • fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called “neuroleptic malignant syndrome).
Danish: • Feber, alvorlig muskelstivhed, svedudbrud eller nedsat bevidsthed (en tilstand kaldet malignt neuroleptikasyndrom).
English: Do not drive or use any tools or machines without talking to your doctor first.
Danish: Du må ikke køre bil, motorcykel eller cykle og heller ikke arbejde med værktøj eller maskiner, før du har talt med lægen.
English: In urine, risperidone plus 9-hydroxy-risperidone represent 35-45% of the orally administered dose.
Danish: I urin udgør risperidon plus 9-hydroxyrisperidon 35-45 % af den peroralt indgivne dosis.
English: • Trouble breathing during sleep
Danish: • Åndedrætsbesvær i søvne.
English: These tumours observed upon oral and intramuscular dosing can be related to prolonged dopamine D2 antagonism and hyperprolactinaemia.
Danish: Disse tumorer, som er observeret ved oral og intramuskulær administration kan relateres til langvarig dopamin D2-antagonisme og hyperprolactinæmi.
English: • Sexual dysfunction, enlargement of breast in men, decreased sexual drive
Danish: • Seksuelle funktionsforstyrrelser, forstørrelse af brysterne hos mænd, nedsat seksualdrift.
English: Similar effects may be observed with e.g. rifampicin, phenytoin and phenobarbital which also induce CYP 3A4 hepatic enzyme as well as P-glycoprotein.
Danish: Lignende effekt kan observeres med andre stoffer, f.eks. rifampicin, phenytoin og phenobarbital, som også inducerer leverenzymet CYP 3A4 såvel som P-glykoprotein.
English: It was considered shown that it is not mandatory for patients to have been stabilised on oral medications, and even preferable that patients be switched to the long-acting injectable Risperdal Consta treatment, to increase adherence to the treatment.
Danish: Det ansås for påvist, at det ikke er obligatorisk for patienterne at være stabiliseret på oral medicin, og at det tilmed er at fortrække, at patienterne skifter til langtidsvirkende injicérbar Risperdal Consta for at forbedre overholdelsen af behandlingen.
English: According to postmarketing data reversible extrapyramidal symptoms in the neonate were observed following the use of risperidone during the last trimester of pregnancy.
Danish: Ifølge data fra efter markedsføringen er der observeret reversible ekstrapyramidale symptomer hos neonatale, når risperidon har været brugt i det sidste trimester af graviditeten.
English: The long-term (50 weeks) safety and efficacy of RISPERDAL CONSTA was also evaluated in an open-label trial of stable psychotic inpatients and outpatients who met the DSM-IV criteria for schizophrenia or schizoaffective disorder.
Danish: Langtidssikkerheden og -effekten (50 uger) af RISPERDAL CONSTA blev også evalueret i et åbent forsøg med stabile psykotiske indlagte og ambulante patienter, som opfyldte DSM-IV-kriterierne for skizofreni eller skizoaffektiv lidelse.
English: There was no increased incidence of mortality among patients taking other diuretics as concomitant treatment with risperidone.
Danish: Der var ikke øget mortalitetsincidens blandt patienter, som blev behandlet med andre diuretika samtidig med risperidon.
English: According to various treatment guidelines of schizophrenia, the switch of antipsychotic treatment in patients with schizophrenia requires “per se” the increased monitoring of therapy by qualified physicians and the CHMP was therefore of the opinion that due to nature of the illness and long-term experience with treatment of schizophrenia by atypical antipsychotics, proper monitoring of therapy after switching antipsychotic treatment can be expected, without being explicitly mentioned in the SPC.
Danish: I henhold til forskellige behandlingsvejledninger for skizofreni kræver skift af behandling med psykofarmaka hos patienter med skizofreni “per se” øget overvågning af behandlingen ved kvalificerede læger, og CHMP var derfor af den opfattelse, at på grund af sygdommens karakter og langtidserfaring med behandling af skizofreni med atypiske psykofarmaka kan korrekt overvågning af behandlingen efter skift af psykofarmakabehandling forventes, uden at det eksplicit nævnes i produktresuméet.
English: JANSSEN CILAG, SA Paseo de las 12 estrellas, 5-7 Madrid, Spain
Danish: Spanien JANSSEN CILAG, SA Paseo de las 12 estrellas, 5-7
English: In general, reported signs and symptoms have been those resulting from an exaggeration of the known pharmacological effects of risperidone.
Danish: Generelt svarer de registrerede symptomer til en forstærkning af de kendte farmakologiske virkninger af risperidon.
English: No additional benefit was observed with 75 mg in clinical trials.
Danish: I kliniske forsøg er der ikke observeret nogen ekstra fordel ved 75 mg.
English: RESUSPEND THE MICROSPHERES IN THE SYRINGE BY SHAKING VIGOROUSLY.
Danish: RESUSPENDER MIKROSFÆRERNE I SPRØJTEN VED AT OMRYSTE KRAFTIGT.
English: If you start or stop taking such medicines you may need a different dose of risperidone
Danish: Hvis du begynder eller ophører behandling med disse midler, skal du muligvis have en anden dosis af risperidon.
English: Relatively constant dose-response after Risperdal Consta treatment using doses from 25 to 75 mg is considered to be established and the CHMP agreed that good medical practice would be to start patients at the lowest effective dose and to increase the dose only if the response is insufficient.
Danish: Relativt konstant dosisrespons efter Risperdal Consta-behandling med doser fra 25 til 75 mg betragtes som påvist, og i CHMP var der enighed om, at god medicinsk praksis ville være, at patienterne starter med den lavest effektive dosis, og at dosis kun øges, hvis responsen er utilstrækkelig.
English: • Your doctor may prescribe oral RISPERDAL for the first three weeks following your first injection.
Danish: • Lægen kan ordinere RISPERDAL til indtagelse gennem munden (oral indtagelse) i de første 3 uger efter den første injektion.
English: In placebo-controlled trials with oral RISPERDAL in this population, the incidence of mortality was 4.0% for RISPERDAL-treated patients compared to 3.1% for placebotreated patients.
Danish: I placebokontrollerede forsøg med oral RISPERDAL til denne population var mortalitetsincidensen 4,0 % for RISPERDAL-behandlede patienter sammenlignet med 3,1 % for placebobehandlede patienter.
English: In rat reproduction studies with risperidone, adverse effects were seen on mating behaviour of the parents, and on birth weight and survival of the offspring.
Danish: I reproduktionsforsøg med risperidon i rotter blev der set negative virkninger på forældrenes parringsadfærd og på afkommets fødselsvægt og afkommets overlevelse.
English: Šmartinska 53, Ljubljana, Slovenia powder and solvent for suspension for injection
Danish: Šmartinska 53, Ljubljana, Slovenien pulver og solvens til suspension
English: Torsade de Pointes has been reported in association with combined overdose of oral RISPERDAL and paroxetine.
Danish: Torsades de pointes er rapporteret i forbindelse med kombineret overdosis af oral RISPERDAL og paroxetin.
English: It is expected that other CYP 2D6 inhibitors, such as quinidine, may affect the plasma concentrations of risperidone in a similar way.
Danish: Det forventes, at andre CYP 2D6-inhibitorer som kinidin kan påvirke plasmakoncentrationen af risperidon tilsvarende.
English: There was no relationship between the plasma concentrations of the active antipsychotic fraction and the change in total PANSS (Positive And Negative Syndrome Scale) and total ESRS (Extrapyramidal Symptom Rating Scale) scores across the assessment visits in any of the phase-III trials where efficacy and safety was examined.
Danish: Sammenhæng mellem farmakokinetik/farmakodynamik Der var ingen sammenhæng mellem plasmakoncentrationen af den aktive antipsykotiske fraktion og ændringen i samlet PANSS-score (Positive And Negative Syndrome Scale) og samlet ESRS-score (Extrapyramidal Symptom Rating Scale) på tværs af vurderingsbesøgene i nogen af de fase III-forsøg, hvor effekt og sikkerhed blev undersøgt.
English: Johnson & Johnson UAB Sheimynishkiu 1A 09312 Vilnius Lithuania
Danish: Johnson & Johnson UAB Sheimynishkiu 1A 09312 Vilnius Litauen
English: Manifestation of this increased sensitivity can include confusion, obtundation, postural instability with frequent falls, in addition to extrapyramidal symptoms.
Danish: Denne øgede sensitivitet kan bl.a. manifestere sig ved konfusion, bevidsthedssvækkelse og postural ustabilitet med hyppige fald samt ekstrapyramidale symptomer.
English: • Attempt to straighten the needle or engage the Needle-Pro device if the needle is bent or damaged
Danish: • At forsøge at rette kanylen ud eller bruge Needle-Pro-udstyret, hvis kanylen er bukket eller beskadiget
English: Inject the entire contents of the syringe intramuscularly into the buttock of the patient.
Danish: Injicer hele sprøjtens indhold intramuskulært i patientens balle.
English: As with other antipsychotics, very rare cases of QT prolongation have been reported postmarketing with risperidone.
Danish: Som ved andre antipsykotika er der efter markedsføringen rapporteret meget sjældne tilfælde af QTforlængelse med risperidon.
English: If you cannot keep your appointment, be sure to contact your doctor right away to discuss another date when you can come in for your injection.
Danish: Kontakt straks lægen, hvis du er forhindret i at møde til den aftalte tid, så I kan finde en anden tid, hvor du kan få din injektion.
English: The following medicines may reduce the effect of risperidone
Danish: Følgende medicin kan øge virkningen af risperidon
English: • One Alaris SmartSite needle-free vial access device for reconstitution
Danish: • Ét Alaris SmartSite nålefrit hætteglasadgangsudstyr til rekonstitution
English: The odds ratio (95% exact confidence interval) was 2.96 (1.34, 7.50).
Danish: Oddsratio (95 % konfidensinterval) var 2,96 (1,34; 7,50).
English: • Change in consciousness with increased body temperature and twitching of muscles
Danish: • Bevidsthedsændringer med forhøjet legemstemperatur og muskeltrækninger.
English: Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents.
Danish: Hypotension og kredsløbskollaps behandles med relevante midler, f.eks. intravenøs væske og/eller sympatomimetika.
English: Risperidone binds also to alpha1-adrenergic receptors, and, with lower affinity, to H1-histaminergic and alpha2-adrenergic receptors.
Danish: Risperidon bindes også til alfa-1-adrenerge receptorer samt med lavere affinitet til histamin H1- og alfa-2-adrenerge receptorer.
English: Lithuania UAB ,,Johnson & Johnson“, Šeimyniškių g. 1A, LT-09312
Danish: Litauen UAB ,,Johnson & Johnson“, Šeimyniškių g. 1A, LT-09312
English: These include drowsiness and sedation, tachycardia and hypotension, and extrapyramidal symptoms.
Danish: Disse omfatter døsighed og sedation, takykardi og hypotension samt ekstrapyramidale symptomer.
English: In case of severe extrapyramidal symptoms, anticholinergic medicinal product should be administered.
Danish: I tilfælde af svære ekstrapyramidale symptomer bør der indgives antikolinergika.
English: After repeated intramuscular injections with 25 or 50 mg RISPERDAL CONSTA every two weeks, median trough and peak plasma concentrations of the active antipsychotic fraction fluctuated between 9.9-19.2 ng/ml and 17.9-45.5 ng/ml respectively.
Danish: Efter gentagne intramuskulære injektioner af 25 eller 50 mg RISPERDAL CONSTA hver anden uge svingede median minimum- og maksimumplasmakoncentrationer af den aktive antipsykotiske fraktion mellem henholdsvis 9,9-19,2 ng/ml og 17,9-45,5 ng/ml.
English: The MAH presented a table summarising the results of total PANSS score from RIS-INT-61, broken down by dose level for the dose groups 25 mg, 50 mg and 75 mg. Two additional tables provided data showing that treatment is non-inferior to risperidone oral treatment for the changes in positive and negative symptoms subscales of PANSS.
Danish: Indehaveren af markedsføringstilladelsen fremlagde en tabel, som opsummerer resultaterne af fuldstændig PANSS-score fra RIS-INT-61, opdelt efter dosisniveau for dosisgrupperne 25 mg, 50 mg og 75 mg. To yderligere tabeller indeholdt data, der viste at behandlingen ikke står tilbage for risperidon oral behandling med hensyn til ændringerne i positive og negative symptomunderskalaer af PANSS.
English: Risperdal Consta (risperidone) is a benzisoxazole derivative with potent combined serotonin 5HT2A and dopamine D2 receptor-blocking properties.
Danish: Risperdal Consta (risperidon) er et benzisoxazolderivat med stærke kombinerede serotonin 5HT2A og dopamin D2 receptor-blokerende egenskaber.
English: Priapism may occur with RISPERDAL CONSTA treatment due to its alpha-adrenergic blocking effects.
Danish: Priapisme kan forekomme ved behandling med RISPERDAL CONSTA på grund af lægemidlets alfaadrenergt blokerende virkninger.