FrancophonIA/ELRC3.0 huggingface dataset:
English: For section 4.2, the CHMP discussed the Risperdal Consta starting dose (25 mg, intramuscular, every 2 weeks), considering the data provided by the MAH, and was of the opinion that the recommendation in the SPC that treatment should be started with the dose of 25 mg every two weeks should be maintained.
Danish: For punkt 4.2 drøftede CHMP startdosen af Risperdal Consta (25 mg intramuskulært hver anden uge) under hensyntagen til de data, der var forelagt af indehaveren af markedsføringstilladelsen, og var af den opfattelse, at anbefalingen i produktresuméet om, at behandlingen skal indledes med en dosis på 25 mg hver anden uge, skulle opretholdes.
English: Risperidone plus 9-hydroxy-risperidone form the active antipsychotic fraction.
Danish: Risperidon plus 9-hydroxyrisperidon udgør den aktive antipsykotiske fraktion.
English: Holding the plunger rod down with the thumb, shake the vial vigorously for at least 10 seconds until obtaining a homogeneous suspension.
Danish: Hold stemplet nede med tommelfingeren, og omryst hætteglasset kraftigt i mindst 10 sekunder, indtil suspensionen er ensartet.
English: In this event, all antipsychotics, including RISPERDAL CONSTA, should be discontinued.
Danish: Hvis de nævnte symptomer opstår, skal alle antipsykotika, herunder RISPERDAL CONSTA, seponeres.
English: For instructions on preparation and handling RISPERDAL CONSTA, see section 6.6.
Danish: For instruktioner vedrørende forberedelse og brug af RISPERDAL CONSTA, se pkt.
English: Alternatively, a starting dose of RISPERDAL CONSTA of 12.5 mg may be appropriate.
Danish: Alternativt kan en begyndelsesdosis af RISPERDAL CONSTA på 12,5 mg være passende.
English: Luxembourg:
Danish: Luxemburg:
English: No osteodystrophy was observed in dogs treated for 12 months with RISPERDAL CONSTA up to 20 mg/kg/2 weeks.
Danish: Der blev ikke observeret osteodystrofi i hunde, der blev behandlet i 12 måneder med op til 20 mg/kg/2 uger RISPERDAL CONSTA.
English: The CHMP assessed the MAH responses and the submitted data, noting that Risperdal Consta was developed for the maintenance treatment of schizophrenia and adopting a harmonised wording that conveys the concept of a therapy to be administered after a disease has been brought under control.
Danish: CHMP vurderede svarene fra indehaveren af markedsføringstilladelsen og de forelagte data og bemærkede, at Risperdal Consta var udviklet til vedligeholdelsesbehandling af skizofreni, og man vedtog en harmoniseret formulering, hvoraf det fremgår, at det er en behandling, der skal administreres efter, at en sygdom er bragt under kontrol.
English: • A lower dose of 12.5 mg or a higher dose of 37.5 or 50 mg may also be necessary.
Danish: • Det kan muligvis være nødvendigt at give en lavere dosis på 12,5 mg eller en højere dosis på 37,5 eller 50 mg.
English: RISPERDAL does not show a clinically relevant effect on the pharmacokinetics of lithium, valproate, digoxin or topiramate.
Danish: Risperidon viser ikke en klinisk relevant effekt på lithiums, valproats, digoxins eller topiramats farmakokinetik.
English: RISPERDAL CONSTA can lower blood pressure
Danish: RISPERDAL CONSTA kan forårsage lavt blodtryk.
English: As expected for a potent dopamine D2-antagonist, in oral carcinogenicity studies of risperidone in rats and mice, increases in pituitary gland adenomas (mouse), endocrine pancreas adenomas (rat), and mammary gland adenomas (both species) were seen.
Danish: Som det kunne forventes for en potent dopamin D2-antagonist, blev der i orale carcinogenicitetsforsøg med risperidon til rotter og mus observeret stigninger i hypofyseadenomer (mus), endokrine pankreasadenomer (rotter) og brystkirteladenomer (begge arter).
English: The mechanism underlying the renal tumours in RISPERDAL CONSTA-treated male Wistar (Hannover) rats is unknown.
Danish: Mekanismen bag nyretumorerne i gruppen af Wistar-hanrotter (Hannover), som blev behandlet med RISPERDAL CONSTA, kendes ikke.
English: Each RISPERDAL CONSTA powder and solvent for prolonged-release suspension for injection contains either 12.5 mg, 25 mg, 37.5 mg or 50 mg of risperidone.
Danish: Hver RISPERDAL CONSTA pulver og solvens til depotinjektionsvæske, suspension til intramuskulær injektion indeholder enten 12,5 mg, 25 mg, 37,5 mg eller 50 mg risperidon.
English: 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.
Danish: 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.
English: The CHMP predominantly agreed to the proposed grouping of terms of adverse events, but nevertheless considered that “bundle branch block left” should not be separated from “bundle block right” as the different clinical management is not essential.
Danish: For punkt 4.8 vurderede CHMP formuleringen og harmoniserede den. CHMP var overvejende enig i den foreslåede gruppering af bivirkningerne, men mente dog, at “venstresidigt grenblok” ikke burde adskilles fra “højresidigt grenblok”, da forskellen i den kliniske behandling ikke er væsentlig.
English: Gender, race and smoking habits
Danish: Køn, race og rygevaner
English: The CHMP assessed the data provided on the use of Risperdal Consta in elderly patients and was of the opinion that no significant trend of increased adverse events according to the age of patients or dose of Risperdal Consta were identified.
Danish: CHMP vurderede de fremlagte data vedrørende brugen af Risperdal Consta til ældre patienter og var af den opfattelse, at der ikke var påvist nogen signifikante tendenser til øgede bivirkninger i forhold til patienternes alder eller dosis af Risperdal Consta.
English: Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin.
Danish: Studier i vævskulturer tyder på, at cellevækst i humane brysttumorer muligvis stimuleres af prolactin.
English: Physicians should weigh the risks versus the benefits when prescribing antipsychotics, including RISPERDAL CONSTA, to patients with Parkinson's Disease or Dementia with Lewy Bodies (DLB).
Danish: Risici og fordele bør afvejes nøje ved ordination af antipsykotika, herunder RISPERDAL CONSTA, til patienter med Parkinsons sygdom eller Lewy-body-demens.
English: • Inappropriate secretion of a hormone that controls urine volume
Danish: • Utilstrækkelig produktion af det hormon, som styrer urinudskillelsen.
English: There are no data available on adverse effects in breast-feeding infants.
Danish: Der er ingen tilgængelige data vedrørende bivirkninger hos ammede spædbørn.
English: UAB Johnson&Johnson, Šeimyniškiu g.1A, Vilnius, Lithuania
Danish: Letland UAB Johnson&Johnson, Šeimyniškiu g.1A, Vilnius, Litauen
English: Your doctor will decide on the dose of RISPERDAL CONSTA that is right for you.
Danish: Lægen afgør, hvilken dosis af RISPERDAL CONSTA, der er den bedste for dig.
English: What RISPERDAL CONSTA is and what it is used for Before you use RISPERDAL CONSTA How to use RISPERDAL CONSTA Possible side effects
Danish: RISPERDAL CONSTAS virkning og hvad du skal bruge det til Det skal du vide, før du begynder at tage RISPERDAL CONSTA Sådan skal du tage RISPERDAL CONSTA Bivirkninger
English: If your daily dose of oral (e.g. tablets) risperidone was 4 mg or less for the last two weeks, your starting dose should be 25 mg RISPERDAL CONSTA.
Danish: Hvis din daglige dosis oral risperidon (f.eks. tabletter) har været 4 mg eller mindre de sidste to uger, bør din startdosis være 25 mg RISPERDAL CONSTA.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton (Pack with ALARIS and separate storage for solvent)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton (pakning med Alaris og separat opbevaring til solvens)
English: Do not take RISPERDAL CONSTA
Danish: Tag ikke RISPERDAL CONSTA
English: Risperidone should be used with caution in combination with other centrally-acting substances notably including alcohol, opiates, antihistamines and benzodiazepines due to the increased risk of sedation.
Danish: Risperidon skal på grund af øget risiko for sedation anvendes med forsigtighed i kombination med andre centralt virkende stoffer, særligt alkohol, opioider, antihistaminer og benzodiazepiner.
English: Although oral risperidone has been studied, RISPERDAL CONSTA has not been studied in patients with renal or liver insufficiency.
Danish: Selv om oral risperidon er blevet undersøgt, er RISPERDAL CONSTA ikke undersøgt til patienter med nyre- eller leverinsufficiens.
English: The CHMP considered the MAH responses and agreed that although data may suggest that prolactin is involved in breast cancer etiology, further studies are required to establish a formal link, and therefore adopted the following wording, addressing the potential risks of hyperprolactinaemia, although without specific inclusion of prolactinoma and breast cancer:
Danish: CHMP overvejede svarene fra indehaveren af markedsføringstilladelsen og erklærede sig enig i, at selv om data kan tyde på, at prolaktin har indflydelse på brystcancerætiologi, kræves der yderligere undersøgelser for at konstatere en formel sammenhæng, og udvalget godkendte således følgende formulering for de potentielle risici for hyperprolaktinæmi, dog uden specifikt at medtage prolaktinom og brystcancer:
English: The most frequently reported adverse drug reactions (ADRs) (incidence ≥ 1/10) are: Insomnia, anxiety, headache, upper respiratory tract infection, parkinsonism, depression, and akathisia.
Danish: De hyppigst forekommende bivirkninger (incidens ≥ 1/10) er: Søvnløshed, angst, hovedpine, infektion i de øvre luftveje, parkinsonisme, depression og akatisi.
English: • Medicines that cause a slow heart beat
Danish: • Medicin, som sænker hjerterytmen
English: A population pharmacokinetic analysis revealed no apparent effect of gender, race or smoking habits on the pharmacokinetics of risperidone or the active antipsychotic fraction.
Danish: En farmakokinetisk populationsanalyse viste ingen tydelig effekt af køn, race eller rygevaner på risperidons farmakokinetik eller den aktive antipsykotiske fraktion.
English: Orthostatic hypotension General disorders and administration site conditions Common
Danish: Ikke almindelig Ortostatisk hypotension Almene symptomer og reaktioner på administrationsstedet Almindelig
English: Jaundice Reproductive system and breast disorders Common
Danish: Det reproduktive system og mammae Almindelig
English: • You have liver problems
Danish: • Hvis du har leverproblemer.
English: RISPERDAL CONSTA may cause you to gain weight.
Danish: RISPERDAL CONSTA kan forårsage vægtøgning.
English: Where patients are not currently taking oral risperidone, the oral pre-treatment dosage should be considered when choosing the i.m.
Danish: For patienter, som ikke aktuelt tager oral risperidon bør der tages hensyn til den orale dosering inden behandlingen, når der vælges i.m.
English: In placebo-controlled trials in elderly patients with dementia there was a significantly higher incidence (approximately 3-fold increased) of CVAEs, such as stroke (including fatalities) and transient ischaemic attack in patients treated with RISPERDAL compared with patients treated with placebo (mean age 85 years; range 73 to 97).
Danish: I placebokontrollerede forsøg med ældre med demens var der en signifikant højere incidens (cirka 3 gange så mange) af uønskede cerebrovaskulære hændelser som apopleksitilfælde (herunder dødsfald) og transitorisk iskæmisk attak hos patienter, som blev behandlet med RISPERDAL CONSTA, end hos patienter, som blev behandlet med placebo (gennemsnitsalder 85 år, spændvidde 73-97).
English: Appropriate care is advised when prescribing RISPERDAL CONSTA to patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant treatment with anticholinergic activity, or being subject to dehydration.
Danish: Der bør udvises forsigtighed ved ordination af RISPERDAL CONSTA til patienter, som skal udsættes for forhold, der kan bidrage til forhøjelse af kroppens kernetemperatur, f.eks. kraftig motion, eksponering for ekstrem varme, samtidig behandling med antikolinerg aktivitet eller ved udsættelse for dehydrering.
English: Risperidone has no affinity for cholinergic receptors.
Danish: Risperidon har ingen affinitet over for kolinerge receptorer.
English: • People who have been given more RISPERDAL CONSTA than they should have experienced the following symptoms: sleepiness, tiredness, abnormal body movements, problems with standing and walking, dizziness from low blood pressure, and abnormal heart beats.
Danish: • Personer, som har fået for meget RISPERDAL CONSTA, har fået følgende symptomer: døsighed, træthed, unormale kropsbevægelser, problemer med at stå og gå, svimmelhed på grund af lavt blodtryk og unormalt hjerteslag.
English: Atrioventricular block, Tachycardia
Danish: AV-blok, takykardi
English: The CHMP further assessed data from patients switched to Risperdal Consta without stabilisation on oral risperidone, and concluded that sufficient antipsychotic coverage should be ensured during a lag period following the first Risperdal Consta injection.
Danish: CHMP vurderede desuden data for patienter, der havde skiftet til Risperdal Consta uden stabilisering på oral risperidon, og konkluderede, at tilstrækkelig antipsykotisk dækning skal sikres under en latensperiode efter den første injektion med Risperdal Consta.
English: Hyperprolactinaemia
Danish: Hyperprolactinæmi
English: In animal studies, risperidone and 9-hydroxy-risperidone are excreted in the milk.
Danish: I dyreforsøg udskilles risperidon og 9-hydroxyrisperidon i modermælk.
English: Phenothiazines, tricyclic antidepressants, and some beta-blockers may increase the plasma concentrations of risperidone but not those of the active antipsychotic fraction.
Danish: Phenothiaziner, tricykliske antidepressiva og visse betablokkere kan øge plasmakoncentrationen af risperidon, men ikke af den aktive antipsykotiske fraktion.
English: RISPERDAL CONSTA administration to male and female rats for 12 and 24 months produced osteodystrophy at a dose of 40 mg/kg/2 weeks.
Danish: Indgift af RISPERDAL CONSTA i rotter af begge køn i 12 og 24 måneder medførte osteodystrofi ved en dosis på 40 mg/kg/2 uger.
English: • Headache, nose and throat infection
Danish: • Hovedpine, infektion i næse og hals.
English: “Risperdal Consta is indicated for the maintenance treatment of schizophrenia in patients currently stabilised with oral antipsychotics”.
Danish: “Risperdal Consta er indiceret til vedligeholdelsesbehandling af skizofreni hos patienter, som for øjeblikket er stabiliseret med orale psykofarmaka”.
English: If your daily dose of oral (e.g. tablets) risperidone was more than 4 mg for the last two weeks, you may be given 37.5 mg RISPERDAL CONSTA as a starting dose.
Danish: Hvis din daglige dosis oral risperidon (f.eks. tabletter) har været over 4 mg de sidste to uger, kan du få 37,5 mg RISPERDAL CONSTA som startdosis.
English: When carbamazepine or other CYP 3A4 hepatic enzyme/P-glycoprotein (P-gp) inducers are initiated or discontinued, the physician should re-evaluate the dosing of RISPERDAL CONSTA.
Danish: Ved initiering eller seponering af carbamazepin eller andre andre stoffer, som inducerer leverenzymet CYP 3A4/P-glykoprotein (P-gp), bør doseringen af RISPERDAL CONSTA reevalueres.
English: In rats, intrauterine exposure to risperidone was associated with cognitive deficits in adulthood.
Danish: I rotter blev intrauterin eksponering for risperidon forbundet med kognitive forstyrrelser (mangler) i voksne dyr.
English: RISPERDAL® CONSTA Sweden: RISPERDAL® CONSTA® United Kingdom: RISPERDAL® CONSTA®
Danish: RISPERDAL® CONSTA® Storbritannien: RISPERDAL
English: In the 1-year, open-label study of RISPERDAL CONSTA, changes in body weight in individual patients were generally within ±7% from baseline; 25% of patients had an increase in body weight of ≥ 7%.
Danish: I et 1-årigt åbent forsøg med RISPERDAL CONSTA lå ændringerne i legemsvægt for individuelle patienter generelt inden for ±7 % fra baseline.
English: The following is a list of additional ADRs associated with risperidone that have been identified as ADRs during clinical trials investigating the oral risperidone formulation (RISPERDAL) but were not determined to be ADRs in the clinical trials investigating RISPERDAL CONSTA.
Danish: Nedenfor følger en oversigt over yderligere bivirkninger, som er associeret med risperidon, og som er identificeret som bivirkninger i kliniske forsøg med den orale risperidonformulering (RISPERDAL), men som ikke er fastslået som bivirkninger i de kliniske forsøg med RISPERDAL CONSTA.
English: See section 4.4 regarding increased mortality in elderly patients with dementia concomitantly receiving furosemide.
Danish: 4.4 vedrørende øget mortalitet hos ældre med demens, som samtidig modtager furosemid og oral RISPERDAL.
English: Carbamazepine has been shown to decrease the plasma concentrations of the active antipsychotic fraction of risperidone.
Danish: Carbamazepin reducerer plasmakoncentrationen af risperidons aktive antipsykotiske fraktion.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT [To be completed nationally] OTHER [To be completed nationally]
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER [Udfyldes nationalt] ANDET [Udfyldes nationalt]
English: Ireland:
Danish: Irland:
English: Mixing is complete when the suspension appears uniform, thick, and milky in color, and all the powder is fully dispersed.
Danish: Blandingen er fuldstændig, når suspensionen fremtræder ensartet, tyk og med en mælket farve, og alt pulver er fuldstændigt dispergeret.
English: It has a high affinity for serotoninergic 5-HT2 and dopaminergic D2 receptors.
Danish: Risperidon har høj affinitet over for serotonin 5-HT2- og dopamin D2-receptorer.
English: Open the prefilled syringe by breaking the seal of the closure and remove the white cap together with the rubber tip cap inside
Danish: Åbn sprøjten ved at bryde lukningens forsegling, og fjern den hvide hætte sammen med gummihætten indeni.
English: Higher active antipsychotic fraction plasma concentrations and a reduced clearance of the active antipsychotic fraction by on average 60% were observed in patients with renal insufficiency.
Danish: Der blev observeret højere plasmakoncentration af aktiv antipsykotisk fraktion og gennemsnitlig 60% reduceret clearance af aktiv antipsykotisk fraktion hos patienter med nyreinsufficiens.
English: Germany: RISPERDAL CONSTA / Risperidon-Janssen CONSTA Greece:
Danish: RISPERDAL CONSTA / Risperidon-Janssen CONSTA
English: Oral antipsychotic supplementation should therefore be given during the first 3 weeks of RISPERDAL CONSTA treatment (see section 4.2).
Danish: Supplerende oral antipsykotisk behandling bør derfor gives i de første 3 ugers behandling med RISPERDAL CONSTA (se pkt.
English: Remove air bubbles from the syringe barrel by moving the plunger rod forward with the needle in an upright position.
Danish: Fjern luftbobler fra sprøjten ved at presse stemplet fremad med kanylen i lodret position.
English: France:
Danish: Frankrig:
English: Granulocytopenia
Danish: Granulocytopeni
English: Dyspnoea, Cough, Nasal congestion, Pharyngolaryngeal pain
Danish: Dyspnø, hoste, nasal kongestion, faryngolaryngeale smerter
English: Pharmaceutical Form Route of administration Content (concentration)
Danish: Indhold (Koncentration)
English: “Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin.
Danish: “Undersøgelser af vævskulturer tyder på, at cellevækst i humane brysttumorer kan stimuleres af prolaktin.
English: As with other antipsychotics, caution should be exercised when risperidone is prescribed in patients with known cardiovascular disease, family history of QT prolongation, bradycardia, or electrolyte disturbances (hypokalaemia, hypomagnesaemia), as it may increase the risk of arrhythmogenic effects, and in concomitant use with medicines known to prolong the QT interval.
Danish: Som ved andre antipsykotika bør der udvises forsigtighed, når risperidon ordineres til patienter med kendt kardiovaskulær sygdom, familiær historie af QT-forlængelse, bradykardi eller elektrolytforstyrrelser (hypokaliæmi, hypomagnesiæmi) og ved samtidig brug af lægemidler, som forlænger QT-intervallet.
English: Latvia:
Danish: Letland:
English: • If you have never taken any form of RISPERDAL, you should begin with oral RISPERDAL
Danish: • Hvis du aldrig tidligere har taget nogen form for RISPERDAL®, skal du begynde med oral RISPERDAL, dvs. en behandling, som tages gennem munden, før du påbegynder behandling med RISPERDAL CONSTA.
English: cardiovascular disorder or circulation disorders of the brain
Danish: hjerte-karsygdomme eller problemer med tilstoppede blodkar i hjernen.
English: RISPERDAL CONSTA is indicated for the maintenance treatment of schizophrenia in patients currently stabilised with oral antipsychotics.
Danish: RISPERDAL CONSTA er indiceret til vedligeholdelsesbehandling af skizofreni hos patienter, som er stabiliseret med orale antipsykotika.
English: Although no clear association with the administration of antipsychotics has so far been demonstrated in clinical and epidemiological studies, caution is recommended in patients with relevant medical history.
Danish: Selvom kliniske og epidemiologiske forsøg indtil videre ikke har vist nogen klar sammenhæng med administration af antipsykotika, bør der udvises forsigtighed hos patienter med relevant medicinsk anamnese.
English: Cimetidine and ranitidine increase the bioavailability of risperidone, but only marginally that of the active antipsychotic fraction.
Danish: Cimetidin og ranitidin øger biotilgængeligheden af risperidon, men den aktive antipsykotiske fraktions biotilgængelighed påvirkes kun marginalt.
English: WHAT RISPERDAL CONSTA IS AND WHAT IT IS USED FOR RISPERDAL CONSTA belongs to a group of medicines called ‘anti-psychotics'.
Danish: RISPERDAL CONSTA tilhører den gruppe medicin, der kaldes antipsykotika.
English: • Abnormal heart rhythm, awareness of heart beating, slow beating heart,
Danish: • Unormal hjerterytme, opmærksomhed på hjerteslaget, langsomt hjerteslag.
English: As with other antipsychotics, caution is advised when prescribing risperidone with medicinal products known to prolong the QT interval, e.g., class Ia antiarrhythmics (e.g., quinidine, dysopiramide, procainamide), class III antiarrhythmics (e.g., amiodarone, sotalol), tricyclic antidepressants (i.e., amitriptyline), tetracyclic antidepressant (i.e., maprotiline), some antihistaminics, other antipsychotics, some antimalarials (i.e., chinice and mefloquine), and with medicines causing electrolyte imbalance (hypokalaemia, hypomagnesiaemia), bradycardia, or those which inhibit the hepatic metabolism of risperidone.
Danish: Som ved andre antipsykotika bør der udvises forsigtighed ved ordination af risperidon samtidig med lægemidler, der forlænger QT-intervallet, f.eks. klasse Ia antiarytmika (f.eks. kinidin, dysopiramid, procainamid), klasse III antiarytmika (f.eks. amiodaron, sotalol), tricykliske antidepressiva (f.eks. amitriptylin), tetracykliske antidepressiva (f.eks. maprotilin), visse antihistaminer, andre antipsykotika, visse midler mod malaria (f.eks. kinin og mefloquin) og lægemidler, der forårsager elektrolytforstyrrelser (hypokaliæmi, hypomagnesiæmi), bradykardi eller hæmmer den hepatiske metabolisme af risperdon.
English: RISPERDAL Oral The following side effects have been reported with the use of RISPERDAL Oral.
Danish: Nedenstående bivirkninger er set ved brug af RISPERDAL Oral.
English: Mania, Libido decreased, Nervousness a Hyperprolactinemia can in some cases lead to gynaecomastia, menstrual disturbances, amenorrhoea, galactorrhea.
Danish: Ikke almindelig Mani, nedsat libido, nervøsitet a Hyperprolactinæmi kan i nogle tilfælde føre til gynækomasti, mentruationsforstyrrelser, amenoré og galaktoré.