FrancophonIA/ELRC3.0 huggingface dataset:
English: Be sure not to miss your appointments when you are supposed to receive your injections every two weeks.
Danish: Husk at møde op til alle aftaler, hvor du skal have dine injektioner hver anden uge.
English: If this combination is deemed necessary, particularly in end-stage Parkinson's disease, the lowest effective dose of each treatment should be prescribed.
Danish: Hvis en sådan kombination vurderes nødvendig, særligt ved parkinsonisme på et sent stadie, bør den laveste effektive dosis af hvert lægemiddel gives.
English: Weight should be measured regularly.
Danish: Patienternes vægt bør kontrolleres regelmæssigt.
English: While overdose is less likely to occur with parenteral than with oral medicinal products, information pertaining to oral is presented.
Danish: Selv om overdosis er mindre sandsynlig for parenterale lægemidler end for orale lægemidler, præsenteres information vedrørende oral indgift.
English: Based on the available data, the CHMP is of the opinion that all raised question were adequately addressed and that the harmonised Product Information wording is acceptable.
Danish: Baseret på de tilgængelige data er CHMP af den opfattelse, at alle rejste spørgsmål er blevet tilstrækkeligt behandlet, og at formuleringen af den harmoniserede produktinformation er acceptabel.
English: Furthermore, the PK of Risperdal Consta in the elderly population was adequately described, and it was shown that the pharmacokinetics in the population > 65 years are comparable to the population < 65 years.
Danish: Desuden var PK for Risperdal Consta i den ældre population tilstrækkeligt beskrevet, og det var påvist, at farmakokinetikken i populationen > 65 år er sammenlignelig med populationen < 65 år.
English: Over time efficacy was maintained with RISPERDAL CONSTA (Figure 1).
Danish: Effekten over tid blev vedligeholdt med RISPERDAL CONSTA (figur 1).
English: There are no adequate data from the use of risperidone in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af risperidon hos gravide kvinder.
English: Do not substitute any components in the dose pack.
Danish: Udskift ikke delene i produktpakken.
English: Karla Engliše 3201/6, 15000 Praha 5, Czech Republic
Danish: Karla Engliše 3201/6, 15000 Praha 5, Tjekkiet
English: Agitation, Sleep disorder
Danish: Agitation, søvnforstyrrelser
English: QT prolongation has very rarely been reported postmarketing.
Danish: QT-forlængelse er meget sjældent rapporteret efter markedsføring.
English: Therefore, patients should be advised not to drive or operate machinery until their individual susceptibility is known.
Danish: Patienterne bør derfor frarådes at føre motorkøretøj eller betjene maskiner, før den individuelle følsomhed over for lægemidlet er kendt.
English: RISPERDAL CONSTA is not recommended for use in children below 18 years of age due to a lack of data on safety and efficacy.
Danish: RISPERDAL CONSTA anbefales ikke til børn under 18 år på grund af manglende data for sikkerhed og effekt.
English: Due to the alpha-blocking activity of risperidone, (orthostatic) hypotension can occur, especially during initiation of treatment.
Danish: På grund af risperidons alfablokerende aktivitet kan (ortostatisk) hypotension opstå, specielt ved påbegyndelse af behandlingen.
English: The intramuscular long-acting injection (LAI) formulation provides slow and steady release of risperidone over a period of several weeks.
Danish: Det intramuskulære langtidsvirkende injektionspræparat (LAI) giver en langsom og stabil frigivelse af risperidon over en periode på flere uger.
English: The CHMP was also of the opinion that doses of risperidone > 8 mg/day should not be routinely used and should be restricted to certain group of patients.
Danish: CHMP var også af den opfattelse, at risperidon-doser på > 8 mg/dag ikke bør anvendes rutinemæssigt og bør begrænses til visse patientgrupper.
English: Do not use RISPERDAL CONSTA after the expiry date which is stated on the carton.
Danish: Brug ikke RISPERDAL CONSTA efter den udløbsdato, der står på æsken.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF RISPERDAL CONSTA AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF RISPERDAL CONSTA OG TILKNYTTEDE NAVNE (SE BILAG I)
English: Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias.
Danish: Kardiovaskulær monitorering bør påbegyndes straks og omfatte kontinuert EKG for at opdage mulige arytmier.
English: • Medicines to treat elevated blood pressure.
Danish: • Medicin mod forhøjet blodtryk.
English: The Referral procedure under Article 30 of Directive 2001/83/EC, as amended for Risperdal Consta was initiated in order to resolve divergences amongst the nationally authorised Product Information texts across the EU and EEA Member States, in particular with respect to indications, special warnings and precautions for use and interaction with other medicinal products and other forms of interaction.
Danish: Henvisningsproceduren i henhold til artikel 30 i direktiv 2001/83/EF med senere ændringer for Risperdal Consta blev indledt for at afhjælpe uoverensstemmelser mellem de nationalt godkendte produktinformationstekster Inden for EU-medlemsstaterne og EØS-landene, specielt med hensyn til indikationer, særlige advarsler og forsigtighedsregler vedrørende brugen samt interaktion med andre lægemidler eller andre former for interaktion.
English: • You have a heart problem.
Danish: • Hvis du har hjerteproblemer.
English: “Sedation” should be separated from “somnolence” and not grouped by the term “sedation”.
Danish: “Sedation” skal adskilles fra “somnolens” og ikke grupperes under “sedation”.
English: Irrespective of treatment, dehydration was an overall risk factor for mortality and should therefore be carefully avoided in elderly patients with dementia.
Danish: Uanset behandlingen var dehydrering en overordnet risikofaktor for mortalitet og bør derfor især undgås hos ældre med demens.
English: For section 4.1, the indication “schizophrenic disorders” was assessed in details, as the existing divergences were likely to have implications for the selection of the treatment population and for the dose regiment and concomitant treatments.
Danish: For punkt 4.1 blev indikationen “skizofren forstyrrelse” vurderet i detaljer, idet de eksisterende uoverensstemmelser sandsynligvis ville få indvirkning på valget af behandlingspopulation og for dosisregime og samtidige behandlinger.
English: Very rare side effects (affects less than 1 user in 10,000) may include: • Life-threatening complications of uncontrolled diabetes.
Danish: Meget sjældne bivirkninger (forekommer hos mindre end 1 ud af 10.000 patienter): • Livstruende komplikationer ved ukontrolleret diabetes.
English: As with other antipsychotics, patients should be advised of the potential for weight gain.
Danish: Som ved andre antipsykotika bør patienterne informeres om muligheden for vægtøgning.
English: There is no specific antidote to RISPERDAL.
Danish: Der er ingen specifik antidot til RISPERDAL.
English: Risperidone was not teratogenic in rat and rabbit.
Danish: Risperidon var ikke teratogent i rotter og kaniner.
English: Adverse Drug Reactions by System Organ Class and Frequency Category Investigations
Danish: Bivirkninger efter systemorganklasse og hyppighed Undersøgelser
English: Furthermore, « Anxiety » and « nervousness » should be separated and not grouped by the term “anxiety”.
Danish: Desuden bør “angst” og “nervøsitet” adskilles og ikke grupperes under “angst”.
English: The combination of the release profile and the dosage regimen (intramuscular injection every two weeks) results in sustained therapeutic plasma concentrations.
Danish: Kombinationen af denne afgivelsesprofil og dette dosisregime (intramuskulær injektion hver anden uge) resulterer i opretholdelse af terapeutiske plasmakoncentrationer.
English: This was reflected in the harmonised wording of the SPC, along with the statement “The efficacy of the 12.5 mg dose has not been investigated in clinical trials”.
Danish: Dette blev afspejlet i den harmoniserede formulering i produktresuméet samt i udtalelsen“Effektiviteten af 12,5 mg-dosen er ikke undersøgt ved kliniske undersøgelser”.
English: If you experience this while taking RISPERDAL CONSTA, contact your doctor straight away
Danish: Hvis du oplever dette, mens du tager RISPERDAL CONSTA, skal du straks kontakte lægen.
English: Pharmacotherapeutic group: Other antipsychotics, ATC code: N05AX08
Danish: Farmakoterapeutisk klassifikation: Andre antipsykotika: ATC-kode: N05AX08.
English: Establish and maintain a clear airway and ensure adequate oxygenation and ventilation.
Danish: Etabler og vedligehold frie luftveje, og sørg for tilstrækkelig iltning og ventilation.
English: DO NOT ADMINISTER INTRAVENOUSLY.
Danish: MÅ IKKE INDGIVES INTRAVENØST.
English: Examples include an irregular heart rhythm or if you are prone to low blood pressure or if you are using medicines for your blood pressure.
Danish: Det gælder f.eks. uregelmæssig hjerterytme, eller hvis du har tendens til lavt blodtryk eller tager blodtryksmedicin.
English: Mean in total PANSS score over time (LOCF) in patients with schizophrenia.
Danish: Gennemsnit af samlet PANSS-score over tid (LOCF) hos patienter med skizofreni.
English: Janssen Cilag 1 rue Desmoulins TSA 91003
Danish: Frankrig Janssen Cilag 1 rue Desmoulins TSA 91003
English: Elderly patients with dementia
Danish: Ældre med demens
English: The mean age (range) of patients who died was 86 years (range 67-100).
Danish: Gennemsnitsalderen for de patienter, som døde, var 86 år (spændvidde 67-100).
English: The efficacy of the 12.5 mg dose has not been investigated in clinical trials.
Danish: Effekten af doseringen på 12,5 mg er ikke blevet undersøgt i kliniske forsøg.
English: In a 24-month intramuscular carcinogenicity study in rats, no increased incidence of injection site tumours was seen in either the vehicle or active groups.
Danish: I et 24-måneders intramuskulært carcinogenicitetsforsøg med rotter blev der ikke observeret stigning i incidensen af tumorer på injektionsstedet i hverken vehikelgruppen eller de aktive grupper.
English: Risperidone is a selective monoaminergic antagonist with unique properties.
Danish: Risperidon er en selektiv monoamin antagonist med unikke egenskaber.
English: • You have Parkinson's disease or dementia
Danish: • Hvis du har Parkinsons sygdom eller demens.
English: The onset of extrapyramidal symptoms is a risk factor for tardive dyskinesia.
Danish: Forekomst af ekstrapyramidale symptomer er en risikofaktor for tardive dyskinesier.
English: In overdose, QT-prolongation and convulsions have been reported.
Danish: Ved overdosering er der rapporteret QT-forlængelse og krampeanfald.
English: The effect dose for osteodystrophy in rats was on a mg/m2 basis 8 times the maximum recommended human dose and is associated with a plasma exposure 2 times the maximum anticipated exposure in humans at the maximum recommended dose.
Danish: Effektdosis for osteodystrofi i rotter på basis af mg/m2 var otte gange den maksimalt anbefalede dosis til mennesker og er associeret med en plasmaeksponering, der er det dobbelte af den maksimalt forventede eksponering hos mennesker ved den maksimalt anbefalede dosis.
English: Netherlands Janssen-Cilag Dr. Paul Janssenweg 150 PO Box 90240
Danish: Holland Janssen-Cilag Dr. Paul Janssenweg 150 PO Box 90240
English: Finally, « Extrapyramidal symptoms » should be the grouped term in the subparagraph Nervous System Disorders and the single symptoms should be mentioned with an asterix.
Danish: Endelig skal “ekstrapyramidale symptomer” være den grupperende term i underafsnittet Lidelser i nervesystemet, og de enkelte symptomer skal nævnes med en asterisk.
English: No renal tumours occurred in the low dose, the NaCl 0.9%, or the microspheres vehicle control group.
Danish: Der blev ikke observeret nyretumorer i gruppen med lav dosis, gruppen med NaCl 0,9 % eller mikrosfærevehikelkontrolgruppen.
English: In a 12-week comparative trial in stable patients with schizophrenia, RISPERDAL CONSTA was shown to be as effective as the oral tablet formulation.
Danish: I et 12-ugers sammenligningsforsøg med stabile skizofrenipatienter viste RISPERDAL CONSTA sig at være lige så effektivt som den orale tabletformulering.
English: • Sudden loss of vision or blindness.
Danish: • Pludseligt opstået synstab eller blindhed.
English: Doses higher than 50 mg every 2 weeks are not recommended.
Danish: Doser over 50 mg hver anden uge kan ikke anbefales.
English: Anorexia, Polydipsia
Danish: Anoreksi, polydipsi
English: Therefore, the advantage of breast-feeding should be weighed against the potential risks for the child.”
Danish: Derfor skal fordelen ved amning vægtes mod den potentielle risiko for barnet.”
English: Hyperglycemia or exacerbation of pre-existing diabetes has been reported in very rare cases during treatment with RISPERDAL CONSTA.
Danish: Hyperglycæmi eller forværring af eksisterende diabetes er rapporteret i meget sjældne tilfælde under behandling med RISPERDAL CONSTA.
English: In case of acute overdose, the possibility of multiple drug involvement should be considered.
Danish: I tilfælde af akut overdosis bør muligheden for, at patienten har indtaget flere stoffer, tages i betragtning.
English: All differences were accordingly justified and the proposed wording in the SPC is acceptable.
Danish: Alle forskelle blev justeret derefter, og den foreslåede formulering i produktresuméet er acceptabel.
English: Do not remove the sheath from the needle at this time.
Danish: Fjern ikke hylsteret fra kanylen på nuværende tidspunkt.
English: • You are a man and have ever had a prolonged or painful erection.
Danish: • Hvis du har oplevet at have en langvarig eller smertefuld rejsning.
English: If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics should be considered.
Danish: Hvis der opstår tegn og symptomer på tardiv dyskinesi, skal det overvejes at seponere alle antipsykotika.
English: Another metabolic pathway of risperidone is N-dealkylation.
Danish: En anden metaboliseringsvej for risperidon er N-dealkylering.
English: For section 4.4, the CHMP implemented the wording on tardive dyskinesia, agreed upon by the Pharmacovigilance Working Party.
Danish: For punkt 4.4 indførte CHMP formuleringen om tardiv dyskinesi, som er godkendt af arbejdsgruppen vedrørende lægemiddelovervågning.
English: Risperidone was not teratogenic in animal studies but other types of reproductive toxicity were seen (see section 5.3).
Danish: Risperidon var ikke teratogent i dyreforsøg, men der blev observeret andre former for reproduktionstoksicitet (se pkt.
English: Concomitant use of risperidone with other diuretics (mainly thiazide diuretics used in low dose) was not associated with similar findings.
Danish: Samtidig brug af risperidon med andre diuretika (hovedsagelig thiazid-diuretika i lave doser) gav ikke anledning til lignende observationer.
English: The main release of risperidone starts from Week 3 onwards, is maintained from 4 to 6 weeks, and subsides by Week 7.
Danish: Hovedafgivelsen af risperidon sker efter 3 uger og fremefter, den vedligeholdes i uge 4-6 og aftager igen i uge 7.
English: • Phenothiazines (e.g. used to treat psychosis or to calm down)
Danish: • Phenothiaziner (bruges f.eks. til behandling af psykoser eller til at slappe af)
English: For section 4.6, the CHMP discussed the wording, moving the mention of galactorrhea to section 4.8 and adopting the following harmonised wording:
Danish: For punkt 4.6 drøftede CHMP formuleringen, flyttede omtalen af galaktorré til punkt 4.8 og vedtog følgende harmoniserede formulering:
English: There is no evidence to suggest that hypercalcemia might cause phaeochromocytomas in humans.
Danish: Der er ingen evidens for, at hyperkalcæmi kan forårsage fæokromocytom hos mennesker.
English: If you are currently treated with other oral antipsychotics than risperidone, your starting dose of RISPERDAL CONSTA will depend on your current treatment.
Danish: Hvis du er i behandling med andre orale antipsykotika end risperidon, vil din startdosis af RISPERDAL CONSTA afhænge af din nuværende behandling.
English: RISPERDAL CONSTA may antagonise the effect of levodopa and other dopamine agonists.
Danish: RISPERDAL CONSTA kan antagonisere effekten af levodopa og andre dopaminagonister.
English: The odds ratio (95% exact confidence interval) was 1.21 (0.7, 2.1).
Danish: Oddsratio (95 % nøjagtigt konfidensinterval) var 1,21 (0,7, 2,1).
English: Due to the known efficacy and safety profile of risperidone, this additional dose is approvable without its own efficacy data and can be based solely on the PK data.
Danish: Da effektivitets- og sikkerhedsprofilen for risperidon allerede er kendt, kan denne ekstra dosis godkendes uden særskilte effektivitetsdata og kan baseres alene på PK-data.
English: 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.
Danish: In vitro-forsøg med humane levermikrosomer har vist, at risperidon i klinisk relevante koncentrationer ikke væsentligt inhiberer metaboliseringen af lægemidler, der metaboliseres af cytokrom P450-isozymer, bl.a. CYP 1A2, CYP 2A6, CYP 2C8/9/10, CYP 2D6, CYP 2E1, CYP 3A4 og CYP 3A5.
English: RISPERDAL CONSTA has minor or moderate influence on the ability to drive and use machines due to potential nervous system and visual effects (see section 4.8).
Danish: RISPERDAL CONSTA påvirker i mindre eller moderat grad evnen til at føre motorkøretøj eller betjene maskiner på grund af den potentielle påvirkning af nervesystemet og synet (se pkt.
English: Immediately discard appropriately.
Danish: Kassér straks på passende måde.
English: • Prolonged and painful erection
Danish: • Langvarig og smertefuld rejsning.
English: Additional signs may include myoglobinuria (rhabdomyolysis) and acute renal failure.
Danish: Andre tegn kan være myoglobinuri (rhabdomyolose) og akut nyresvigt.
English: Like all medicines, RISPERDAL CONSTA can cause side effects, although not everybody gets them.
Danish: RISPERDAL CONSTA kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Appropriate clinical monitoring is advisable in diabetic patients and in patients with risk factors for the development of diabetes mellitus.
Danish: Relevant klinisk monitorering tilrådes af patienter med diabetes og patienter med risikofaktorer for udvikling af diabetes mellitus.
English: The CHMP considered that the requested efficacy analysis had been provided and that the efficacy of Risperdal Consta was shown in all doses separately.
Danish: CHMP mente, at den ønskede effektivitetsanalyse var blevet forelagt, og at effektiviteten af Risperdal Consta var påvist i alle doser hver for sig.
English: Medicines with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterised by rhythmical involuntary movements, predominantly of the tongue and/or face.
Danish: Lægemidler med dopaminreceptorantagonistiske egenskaber er blevet sat i forbindelse med induktion af tardiv dyskinesi karakteriseret ved ufrivillige rytmiske bevægelser, overvejende i tungen og/eller ansigtet.
English: • Medicines for Parkinson's disease (such as levodopa)
Danish: • Medicin mod Parkinsons sygdom, f.eks. levodopa.
English: • Antidepressants such as paroxetine, fluoxetines, tricyclic antidepressants
Danish: • Medicin mod depression, såsom paroxetin, fluoxetin, tricykliske antidepressiva
English: The length of the oral supplementation period was also discussed and the CHMP concluded that 3 weeks is the most appropriate length, leading neither to an overdose at the end of the oral supplementation period in those patients who have a relatively early release, nor to clinically relevant ‘underdosing' in patients for whom the main release starts from 4 weeks onwards only, given the relatively long half-life of the active moiety following oral risperidone.
Danish: Længden af den orale suppleringsperiode blev også drøftet, og CHMP konkluderede, at 3 uger er den mest passende længde, som hverken fører til overdosering i slutningen af den orale suppleringsperiode hos de patienter, der har en relativt tidlig frigørelse, eller til klinisk relevant ‘underdosering' hos patienter, for hvem den vigtigste frigørelse først starter fra 4 uger og videre frem, i kraft af den relativt lange halveringstid for den aktive del, der følger efter oral risperidon.
English: For section 4.3, the CHMP discussed the relevance of a Contraindication warning for patients with high risk factors for cerebrovasular adverse events.
Danish: For punkt 4.3 drøftede CHMP relevansen af en kontraindikationsadvarsel for patienter med høje risikofaktorer for cerebrovaskulære bivirkning.
English: Norway Janssen-Cilag AS Hoffsveien 1D 0275 Oslo Norway
Danish: Janssen-Cilag AS Hoffsveien 1D 0275 Oslo Norge
English: In addition, long-acting risperidone offers an advantage in increased compliance to the treatment, which could result in more stable plasma levels of risperidone.
Danish: Desuden har langtidsvirkende risperidon den fordel, at behandling bedre kan overholdes, hvilket kan give et mere stabilt plasmaindhold af risperidon.
English: The increase in mortality in patients treated with furosemide plus risperidone was observed in two of the four clinical trials.
Danish: Mortalitetsstigningen hos patienter, som blev behandlet med furosemid plus risperidon, blev observeret i to af de fire kliniske forsøg.
English: • You have an abnormally high level of the hormone prolactin in your blood or if you have a tumour, which is possibly dependent on prolactin.
Danish: • Hvis tests har vist, at du har et unormalt højt indhold af hormonet prolactin i blodet, eller hvis du har en svulst, som muligvis er afhængig af prolactin.
English: Maintenance dose:
Danish: Vedligeholdelsesdosis:
English: Place vial on a hard surface.
Danish: Stil hætteglasset på en hård overflade.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJ, ANSØGERE, INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE
English: Local irritation at the injection site in dogs and rats was observed after administration of high doses of RISPERDAL CONSTA.
Danish: Lokal irritation på injektionsstedet blev observeret hos hunde og rotter efter indgift af høje doser af RISPERDAL CONSTA.
English: Medical treatment should be sought straight away if you or your carer notice a sudden change in your mental state or sudden weakness or numbness of your face, arms or legs, especially on one side, or slurred speech, even for a short period of time.
Danish: Søg straks læge, hvis du eller din pårørende bemærker en pludselig ændring i din psykiske tilstand eller pludselig svaghed eller følelsesløshed i dit ansigt, arme eller ben, især i den ene side, eller sløret tale, også selv om det blot er i en kort periode.
English: In vitro and in vivo, animal models show that at high doses risperidone may cause QT interval prolongation, which has been associated with a theoretically increased risk of torsade de pointes in patients.
Danish: Både in vivo og in vitro viser dyremodeller, at høje doser af risperidon kan forårsage forlængelse af QTintervallet, hvilket er blevet forbundet med en teoretisk øget risiko for torsade de points hos patienterne.
English: Johnson & Johnson d.o.o., Šmartinska 53, Ljubljana, Slovenia
Danish: Slovenien Johnson & Johnson d.o.o., Šmartinska 53, Ljubljana, Slovenien
English: All sections of the SPC were thoroughly assessed and all revisions were implemented accordingly in the Labelling and in the Package Leaflet, achieving a harmonised Product Information text.
Danish: Alle punkter i produktresuméet blev omhyggeligt vurderet, og alle revisioner blev korrekt indført i etiketteringen og indlægssedlen, så der opnåedes en harmoniseret produktinformationstekst.