FrancophonIA/ELRC3.0 huggingface dataset:
English: Regarding the precise correspondence of an oral risperidone dose to a specific dose of Risperdal Consta, a wording in the SPC was adopted, reflecting the available efficacy and safety data and the results of clinical studies, to guide the choice of starting dose of Risperdal Consta:
Danish: Hvad angår den nøjagtige overensstemmelse mellem en oral risperidon-dosis og en specifik dosis Risperdal Consta blev der vedtaget en formulering i produktresuméet, som afspejlede de tilgængelige effektivitets- og sikkerhedsdata og resultaterne af kliniske undersøgelser, der skal være vejledende ved valget af startdosen af Risperdal Consta:
English: RISPERDAL CONSTA should be administered every two weeks by deep intramuscular gluteal injection using the enclosed safety needle.
Danish: RISPERDAL CONSTA bør indgives hver anden uge ved dyb intramuskulær gluteal injektion under anvendelse af den vedlagte sikkerhedskanyle.
English: Finally, the CHMP discussed the use of Risperdal Consta in patients previously treated with oral risperidone at doses ≥6mg/day and noted that the provided efficacy data of these patients, when switched to Risperdal Consta, were not different from the data obtained after previous oral risperidone treatment, despite the high probability of lower plasma level of risperidone being reached.
Danish: Endelig drøftede CHMP anvendelsen af Risperdal Consta til patienter, som tidligere var behandlet med oral risperidon i doser på ≥ 6 mg/dag og bemærkede, at de fremlagte effektivitetsdata for disse patienter, når de skiftede til Risperdal Consta, ikke adskilte sig fra de data, der var opnået efter tidligere behandling med oral risperidon, trods den høje sandsynlighed for lavere plasmaniveauer af risperidon.
English: Therefore, the advantage of breast-feeding should be weighed against the potential risks for the child.
Danish: Fordelene ved amning bør således vurderes i forhold til de potentielle risici for barnet.
English: Concomitant use with furosemide
Danish: Samtidig brug af furosemid
English: Enuresis, Dysuria, Pollakiuria
Danish: Enuresis, dysuri, pollakisuri
English: Additional Adverse Drug Reactions Reported With Oral RISPERDAL but not With RISPERDAL CONSTA by System Organ Class Investigations
Danish: Yderligere bivirkninger rapporteret med oral RISPERDAL, men ikke med RISPERDAL CONSTA efter systemorganklasse
English: Potential for other medicinal products to affect RISPERDAL CONSTA
Danish: Andre lægemidlers potentiale for påvirkning af RISPERDAL CONSTA
English: Hypercalcemia, postulated to contribute to an increased incidence of adrenal medullary tumours in RISPERDAL CONSTA-treated rats, was observed in both dose groups.
Danish: Hyperkalcæmia, som menes at bidrage til øget incidens af binyremarvtumorer hos rotter behandlet med RISPERDAL CONSTA, blev observeret i begge dosisgrupper.
English: To assure that the intended dose of risperidone is delivered, the full contents from the vial must be administered.
Danish: For at sikre, at den ønskede risperidondosis indgives, skal hele indholdet af hætteglasset indgives.
English: Risperidone is metabolised by CYP 2D6 to 9-hydroxy-risperidone, which has a similar pharmacological activity as risperidone.
Danish: Risperidon metaboliseres af CYP 2D6 til 9-hydroxyrisperidon, som har farmakologisk aktivitet svarende til risperidon.
English: • Inability to reach orgasm, ejaculation disorder, menstrual disorder
Danish: • Manglende evne til at opnå orgasme, sædafgangsforstyrrelser, menstruationsforstyrrelser.
English: Slowly withdraw the suspension from the vial in an upright, but slightly angled position as indicated in the picture to ensure that the entire contents are drawn up into the syringe.
Danish: Træk langsomt suspensionen fra hætteglasset i opretstående position, men lidt skrå vinklet som vist på illustrationen for at sikre, at hele indholdet trækkes op i sprøjten.
English: However, the CHMP requested the MAH to further discuss the proposed wording of the indication, and the need to establish tolerability with oral risperidone prior to initiating treatment with Risperdal Consta.
Danish: CHMP bad dog indehaveren af markedsføringstilladelsen om yderligere at drøfte den foreslåede formulering af indikationen og behovet for at opnå tolerabilitet med oral risperidon, inden behandling med Risperdal Consta indledes.
English: RISPERDAL CONSTA has not been studied in elderly patients with dementia, hence it is not indicated for use in this group of patients.
Danish: RISPERDAL CONSTA er ikke undersøgt til ældre med demens og er således ikke indiceret til denne patientgruppe.
English: Parkinson's disease and dementia with Lewy bodies
Danish: Parkinsons sygdom og Lewy-body-demens
English: A single-dose pharmacokinetic study with oral risperidone showed on average a 43% higher active antipsychotic fraction plasma concentrations, a 38% longer half-life and a reduced clearance of the active antipsychotic fraction by 30% in the elderly.
Danish: Hos ældre viste et enkeltdosis-farmakokinetikforsøg med oral risperidon viste gennemsnitligt 43% højere plasmakoncentrationer af den aktive antipsykotiske fraktion, 38% længere halveringstid og en reduktion af clearance af den aktive antipsykotiske fraktion med 30 %.
English: Germany Janssen-Cilag GmbH Raiffeisenstr.
Danish: Tyskland Janssen-Cilag GmbH Raiffeisenstr.
English: If Risperdal Consta is used in accordance with the SPC recommendations for dosing, no particular safety or efficacy risks for the patient would be foreseen, even if acutely ill.
Danish: Hvis Risperdal Consta anvendes i overensstemmelse med doseringsanbefalingerne i produktresuméet, kan der ikke forventes nogen særlige sikkerheds- eller effektivitetsrisici for patienten, selv ved akut sygdom.
English: • Intentionally disengage the Needle-Pro device
Danish: • At frigøre Needle-Pro-udstyret med vilje
English: Shake the vial vigorously for at least 10 seconds until obtaining a homogeneous suspension.
Danish: Omryst hætteglasset omhyggeligt i mindst 10 sekunder, indtil suspensionen er ensartet.
English: Studies conducted to explore the substrain differences in the tumour organ profile suggest that the Wistar (Hannover) substrain employed in the carcinogenicity study differs substantially from the Wistar (Wiga) substrain employed in the oral carcinogenicity study with respect to spontaneous age-related non-neoplastic renal changes, serum prolactin increases, and renal changes in response to risperidone.
Danish: Forsøg, som er udført for at undersøge underraceforskellene i tumororganprofilen, tyder på, at den Wistar-underrace (Hannover), som blev anvendt i carcinogenicitetsforsøget, adskiller sig væsentligt fra den Wistar-underrace (Wiga), som blev anvendt i det orale carcinogenicitetsforsøg, med hensyn til spontane aldersrelaterede ikke-neoplastiske renale ændringer, serumprolactinstigninger og ændringer i renal respons på risperidon.
English: How to store RISPERDAL CONSTA Further information
Danish: Sådan opbevarer du RISPERDAL CONSTA Yderligere oplysninger
English: The following side effects may happen: Very common side effects (affects more than 1 user in 10):
Danish: Følgende bivirkninger kan forekomme: Meget almindelige bivirkninger (forekommer hos mere end 1 ud af 10 patienter):
English: Your doctor will choose RISPERDAL CONSTA 25 mg or 37.5 mg.
Danish: Din læge vil vælge RISPERDAL CONSTA 25 mg eller 37,5 mg.
English: • Fainting, drop in blood pressure after standing, feeling dizzy after changing body position
Danish: • Besvimelse, blodtryksfald, når du rejser dig, svimmelhed efter ændring af kroppens stilling.
English: The MAH provided further justifications, being of the position that restricting the use of Risperdal Consta to patients with an initial treatment response to oral risperidone would be unjustified and would introduce an unnecessary and potentially prolonged additional step for the prescribing physicians, delaying access of Risperdal Consta to those patients who may not be adherent to their oral medication and who may be among the most suitable candidates for a long-acting injectable medication.
Danish: Indehaveren af markedsføringstilladelsen fremkom med yderligere begrundelser og var af den opfattelse, at begrænsningen af anvendelsen af Risperdal Consta til patienter med en initiel behandlingsrespons på oral risperidon ville være uberettiget og ville påføre de ordinerende læger et unødigt og potentielt længerevarende ekstra trin og forsinke adgang til Risperdal Consta for de patienter, der ikke overholder deres orale medicinering og som kan være blandt de mest egnede kandidater til et langtidsvirkende injicérbart lægemiddel.
English: There are no data suggesting kidney-related changes in dogs treated chronically with RISPERDAL CONSTA.
Danish: Der findes ingen data, som indikerer nyrerelaterede ændringer hos hunde, som har modtaget kronisk behandling med RISPERDAL CONSTA.
English: Risperidone plasma concentrations were normal in patients with liver insufficiency, but the mean free fraction of risperidone in plasma was increased by about 35%.
Danish: Plasmakoncentrationen af risperidon var normal hos patienter med leverinsufficiens, men den gennemsnitlige frie fraktion af risperidon i plasma var forhøjet med ca. 35 %.
English: In the 12-week double-blind, placebo-controlled trial, 9% of patients treated with RISPERDAL CONSTA, compared with 6% of patients treated with placebo, experienced a weight gain of ≥ 7% of body weight at endpoint.
Danish: I et 12-ugers dobbeltblindet, placebokontrolleret forsøg havde 9 % af de patienter, som blev behandlet med RISPERDAL CONSTA, en vægtøgning på ≥ 7 % af legemsvægten ved slutvurderingen sammenlignet med 6 % af de patienter, som blev behandlet med placebo.
English: The CHMP adopted the following text in section 4.2:
Danish: CHMP vedtog følgende tekst i punkt
English: Clinically significant hypotension has been observed postmarketing with concomitant use of risperidone and antihypertensive treatment.
Danish: Klinisk signifikant hypotension er observeret efter markedsføring ved samtidig brug af risperidon og antihypertensiva.
English: • Water tablets (diuretics) used for heart problems or swelling of parts of your body due to a build up of too much fluid (such as furosemide or chlorothiazide).
Danish: • Vanddrivende midler (diuretika), som anvendes mod hjerteproblemer eller hævelser i kroppen på grund af væskeansamlinger (f.eks. furosemid eller chlorthiazid).
English: 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.
Danish: Velafbalanceret central serotonin- og dopaminantagonisme kan nedsætte risikoen for ekstrapyramidale symptomer og øge den terapeutiske effekt over for skizofreniens negative og affektive symptomer.
English: Janssen-Cilag Pharmaceuticals Risperdal Consta 50 mg
Danish: Grækenland Janssen-Cilag Pharmaceuticals Risperdal Consta 50 mg
English: • Body shakes rapidly and uncontrollably (convulsion)
Danish: • Hurtige og ukontrollerbare rystelser af kroppen (kramper).
English: Janssen-Cilag Pharma GmbH Pfarrgasse 75, 1232 Wien, Austria
Danish: Janssen-Cilag Pharma GmbH Pfarrgasse 75, 1232 Wien, Østrig
English: • Shaking, muscle stiffness and problems feeding, all of which are reversible, have been seen in newborn babies when RISPERDAL was used during the last trimester of pregnancy.
Danish: • Rystelser, muskelstivhed og sutteproblemer er set hos nyfødte, når RISPERDAL CONSTA blev anvendt i de sidste tre måneder af graviditeten.
English: Janssen-Cilag Pharmaceuticals Aebe Eirinis Avenue 56, Pefki, 15121, Greece
Danish: Grækenland Janssen-Cilag Pharmaceuticals Aebe Eirinis Avenue 56, Pefki, 15121, Grækenland
English: The CHMP assessed the need for a warning, advising against the use of Risperdal Consta in acute exacerbations of schizophrenia, but considered it to potentially raise a safety concern that is not valid or clinically justified and that there are no particular risks associated with using Risperdal Consta in acute exacerbations of schizophrenia that warrant a warning.
Danish: CHMP vurderede behovet for en advarsel mod brug af Risperdal Consta ved akutte eksacerbationer af skizofreni, men mente, at det potentielt kunne give anledning til et sikkerhedsspørgsmål, som ikke er begrundet eller klinisk berettiget, og at der ikke er nogen specielle risici forbundet med brug af Risperdal Consta ved akutte eksacerbationer af skizofreni, som kræver en advarsel.
English: • If you are allergic (hypersensitive) to risperidone or any of the other ingredients of
Danish: • Hvis du er overfølsom (allergisk) over for risperidon eller et af de øvrige indholdsstoffer i RISPERDAL
English: • Medicines that work on your brain to help you calm down (benzodiazepines), or some medicines for pain (opiates), medicines for allergy (some antihistamines), as Risperidone may increase the sedative effect of all of these.
Danish: • Beroligende medicin, som virker i hjernen, f.eks. for at hjælple dig med at slappe af (benzodiazepiner), eller visse smertestillende midler (opioider), midler mod allergi (nogle antihistaminer), da risperidon kan øge den sløvende effekt af disse midler.
English: Potential for RISPERDAL CONSTA to affect other medicinal products
Danish: RISPERDAL CONSTAS potentiale for påvirkning af andre lægemidler
English: • Decrease in white blood cells that help against infection, decrease in platelets (blood cells that help you stop bleeding).
Danish: • Fald i antallet af hvide blodlegemer, som medvirker ved bekæmpelse af infektioner, fald i antallet af blodplader (blodlegemer, som får blodet til at størkne).
English: - the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Danish: - Produktresuméerne, etiketteringen og indlægssedlen, der var fremlagt af indehaverne af markedsføringstilladelsen, er blevet vurderet på basis af den fremlagte dokumentation og de faglige drøftelser i udvalget anbefalede CHMP at ændre markedsføringstilladelserne.
English: • Lack of emotion, confusion, poor attention, loss of consciousness, balance disorder
Danish: • Mangel på følelser, forvirring, nedsat opmærksomhed, bevidstløshed, balanceforstyrrelser.
English: The relevance of the osteodystrophy, the prolactin-mediated tumours and of the presumed rat substrain-specific renal tumours in terms of human risk is unknown.
Danish: Det er uvist, hvilken relevans osteodystrofien, de prolactinmedierede tumorer og de formodede rotteunderracespecifikke nyretumorer har for risikoen hos mennesker.
English: The pooled data from six placebo-controlled studies in mainly elderly patients (>65 years of age) with dementia showed that CVAEs (serious and nonserious, combined) occurred in 3.3% (33/1009) of patients treated with risperidone and 1.2% (8/712) of patients treated with placebo.
Danish: Poolede data fra seks placebokontrollerede forsøg primært med ældre (> 65 år) med demens viste, at uønskede cerebrovaskulære hændelser (alvorlige og ikke-alvorlige, kombineret) optrådte hos 3,3 % (33/1.009) af de patienter, der blev behandlet med risperidon, og hos 1,2 % (8/712) af de patienter, der blev behandlet med placebo.
English: • No granulocytes (a type of white blood cell to help you against infection)
Danish: • Fravær af en type hvide blodceller (granulocytter), som hjælper dig med at bekæmpe infektioner.
English: Aebe Eirinis Avenue 56, Pefki, 15121, Greece suspension for injection
Danish: Aebe Eirinis Avenue 56, Pefki, 15121, Grækenland pulver og solvens til suspension
English: Based on the submitted data, the CHMP was of the opinion that the presented clinical data show that patients stabilised with any antipsychotic medication (oral or depot formulations) can safely be switched to Risperdal Consta and achieve a clinical benefit similar to that seen in patients being switched from oral risperidone and without a higher incidence of clinical deterioration.
Danish: Baseret på de fremlagte data var CHMP af den opfattelse, at de fremlagte kliniske data viser, at patienter, som er stabiliseret med et psykofarmakum (oralt eller som depotpræparat), kan skifte sikkert over til Risperdal Consta og opnå en klinisk fordel svarende til den, der ses hos patienter, der skifter over fra oral risperidon, og uden højere forekomst af klinisk forværring.
English: RISPERDAL CONSTA should be administered with caution in this group of patients (see section 4.2).
Danish: RISPERDAL CONSTA bør indgives med forsigtighed til denne patientgruppe (se pkt.
English: In an intramuscular carcinogenicity study with RISPERDAL CONSTA in Wistar (Hannover) rats (doses of 5 and 40 mg/kg/2 weeks), increased incidences of endocrine pancreas, pituitary gland, and adrenal medullary tumours were observed at 40 mg/kg, while mammary gland tumours were present at 5 and 40 mg/kg.
Danish: I et intramuskulært carcinogenicitetsforsøg med RISPERDAL CONSTA hos Wistar-rotter (Hannover) (doser på 5 og 40 mg/kg/2 uger) blev der observeret øget incidens af tumorer i endokrin pankreas, hypofyse og binyremarv ved 40 mg/kg, mens brystkirteltumorer blev observeret ved både 5 and 40 mg/kg.
English: Similar to the (sub)chronic toxicity studies with oral risperidone in rats and dogs, the major effects of treatment with RISPERDAL CONSTA (up to 12 months of intramuscular administration) were prolactin-mediated mammary gland stimulation, male and female genital tract changes, and central nervous system (CNS) effects, related to the pharmacodynamic activity of risperidone.
Danish: Svarende til (sub)kroniske toksicitetsforsøg med oral risperidon til rotter og hunde var hovedeffekten af behandling med RISPERDAL CONSTA (op til 12 måneders intramuskulær indgift) prolactinmedieret brystkirtelstimulation, ændringer i kønsorganer hos begge køn og påvirkninger af centralnervesystemet (CNS), forbundet med risperidons farmakodynamiske aktivitet.
English: The CHMP further assessed the need for special mention of hyperprolactinaemia and stimulation of cell growth in breast tumours linked to prolactin.
Danish: CHMP vurderede desuden behovet for specifik omtale af hyperprolaktinæmi og stimulation af cellevækst ved brysttumorer i forbindelse med prolaktin.
English: • Eosinophil (special white blood cells ) count increased, blood creatine phosphokinase increased
Danish: • Forhøjet eosinofiltal ((specielle) hvide blodlegemer), forhøjet indhold i blodet af kreatinfosfokinase.
English: The CHMP agreed that the presence of cerebrovascular risk factors is poorly predictive for a risperidone-mediated increased cerebrovascular risk and was therefore of the opinion that a contraindication for Risperdal Consta in patients with high risk factors for cerebrovascular events was not justified.
Danish: CHMP var enig i, at tilstedeværelse af cerebrovaskulære risikofaktorer ikke er videre prædiktivt for en risperidon-medieret forøgelse af den cerebrovaskulære risiko og var derfor af den opfattelse, at en kontraindikation for Risperdal Consta hos patienter med høje risikofaktorer for cerebrovaskulære hændelser ikke var berettiget.
English: One week after oral risperidone administration, 70% of the dose is excreted in the urine and 14% in the faeces.
Danish: 1 uge efter peroral indgift af risperidon udskilles 70 % af dosis med urin og 14 % med fæces.
English: Care must be taken to avoid inadvertent injection of RISPERDAL CONSTA into a blood vessel.
Danish: Der bør udvises forsigtighed, således at RISPERDAL CONSTA ikke utilsigtet injiceres i en blodåre.
English: In the oral RISPERDAL placebo-controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide plus risperidone (7.3%; mean age 89 years, range 75-97) when compared to patients treated with risperidone alone (3.1%; mean age 84 years, range 70-96) or furosemide alone (4.1%; mean age 80 years, range 67-90).
Danish: I de placebokontrollerede forsøg med oral RISPERDAL til ældre med demens blev der observeret en højere mortalitetsincidens hos patienter, som blev behandlet med furosemid plus risperidon (7,3 %, gennemsnitsalder 89 år, spændvidde 75-97) end hos patienter, som blev behandlet med risperidon alene (3,1 %, gennemsnitsalder 84 år, spændvidde 70-96) eller furosemid alene (4,1 %, gennemsnitsalder 80 år, spændvidde 67-90).
English: If an oral total daily dose of at least 2 mg is well tolerated, an injection of 25 mg RISPERDAL CONSTA can be administered every 2 weeks.
Danish: Hvis en samlet daglig oral dosis på mindst 2 mg tolereres godt, kan en injektion på 25 mg RISPERDAL CONSTA indgives hver anden uge.
English: Elderly people with dementia RISPERDAL CONSTA is not for use in elderly people with dementia.
Danish: Ældre med demens RISPERDAL CONSTA må ikke anvendes til ældre patienter med demens.
English: When concomitant fluoxetine or paroxetine is initiated or discontinued, the physician should re-evaluate the dosing of RISPERDAL CONSTA.
Danish: Ved initiering eller seponering af fluoxetin eller paroxetin bør doseringen af RISPERDAL CONSTA reevalueres.
English: 6.6 Special precautions for disposal and other handling Instructions for Three Needle System
Danish: 6.6 Regler for destruktion og anden håndtering Vejledning i anvendelse af trenålesystem
English: Risperidone should be used with caution in patients with known cardiovascular disease (e.g. heart failure, myocardial infarction, conduction abnormalities, dehydration, hypovolemia, or cerebrovascular disease).
Danish: Risperidon skal anvendes med forsigtighed til patienter med kendt kardiovaskulær sygdom (f.eks. hjerteinsufficiens, myokardieinfarkt, ledningsforstyrrelser, dehydrering, hypovolæmi eller cerebrovaskulær sygdom).
English: Water intoxication Infections and infestations Very common Upper respiratory tract infection Common
Danish: Infektioner og parasitære sygdomme Meget almindelig Infektion i de øvre luftveje Almindelig
English: • Medicines that may change the electrical activity of your heart, such as medicines for malaria, heart rhythm problems (such as quinidine), allergies (anti-histamines), some antidepressants or other medicines for mental problems
Danish: • Medicin, som kan ændre hjertets elektriske aktivitet, f.eks. malariamidler, medicin mod forstyrrelser af hjerterytmen (f.eks. kinidin), allergimidler (antihistaminer), visse depressionsmidler (antidepressiva) eller andre lægemidler mod psykiske problemer.
English: Remove the dose pack of RISPERDAL CONSTA from the refrigerator and allow it to come to room temperature prior to reconstitution.
Danish: Tag produktpakken med RISPERDAL CONSTA ud af køleskabet, og lad den få stuetemperatur inden rekonstitution.
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 a relevant medical history.
Danish: Selv om der endnu ikke er dokumenteret nogen klar forbindelse med administration af psykofarmaka via kliniske og epidemiologiske undersøgelser, anbefales det at udvise forsigtighed i forbindelse med patienter med en relevant anamnese.
English: Dizziness, Sedation, Somnolence, Tremor, Dystoniab, Tardive dyskinesia, Dyskinesiab
Danish: Svimmelhed, sedation, somnolens, tremor, dystonib, tardiv dyskinesi, dyskinesi b
English: A treatment-related increase in renal tumour incidence did not occur in the oral carcinogenicity studies with Wistar (Wiga) rats or in Swiss mice administered oral risperidone.
Danish: En behandlingsrelateret stigning i incidensen af nyretumorer blev ikke observeret i de orale carcinogenicitetsforsøg med Wistar-rotter (Wiga) eller hos Swiss-mus, som modtog oral risperidon.
English: If hepatically or renally impaired patients require treatment with RISPERDAL CONSTA, a starting dose of 0.5 mg twice daily oral risperidone is recommended during the first week.
Danish: Hvis patienter med lever- eller nyreinsufficiens får behov for behandling med RISPERDAL CONSTA, anbefales en startdosis på 0,5 mg oral risperidon to gange dagligt i den første uge.
English: • Yellowing of the skin and the eyes (jaundice)
Danish: • Gulfarvning af hud og det hvide i øjnene (gulsot).