FrancophonIA/ELRC3.0 huggingface dataset:
English: While bioavailability of rivastigmine is greater in elderly than in young healthy volunteers, studies in Alzheimer patients aged between 50 and 92 years showed no change in bioavailability with age.
Danish: Selv om biotilgængeligheden for rivastigmin er højere hos ældre end hos yngre raske frivillige forsøgspersoner, viste studier af Alzheimerpatienter i alderen mellem 50 og 92 år ingen ændring i biotilgængelighed med alderen.
English: Dose titration should then be carried out as described above.
Danish: Dosistitreringen skal udføres som tidligere beskrevet.
English: Peak plasma concentrations are reached in approximately 1 hour.
Danish: Maksimale plasmakoncentrationer nås på ca. 1 time.
English: It is important to note that the scales used in this indication vary and direct comparisons of results for different therapeutic agents are not valid.
Danish: Det er vigtigt at bemærke, at de benyttede skalaer til sådanne målinger varierer, og at direkte sammenligninger af resultater for forskellige terapeutiske stoffer ikke er valide.
English: It readily crosses the blood brain barrier and has an apparent volume of distribution in the range of 1.8-2.7 l/kg.
Danish: Det krydser let blodhjernebarrieren og har et tilsyneladende fordelingsvolumen på 1,8-2,7 l/kg.
English: If you have not taken Nimvastid for more than three days, do not take the next dose until you have talked to your doctor.
Danish: Hvis du ikke har taget Nimvastid i mere end tre dage, må du ikke tage den næste dosis, før du har talt med din læge.
English: Talk to your doctor before taking Nimvastid: - if you have, or have ever had, irregular or slow heartbeat.
Danish: Kontakt lægen, før du bruger Nimvastid: hvis du har eller har haft uregelmæssig eller langsom hjerterytme (puls).
English: Discontinuation should also be considered when evidence of a therapeutic effect is no longer present.
Danish: Behandlingsophør bør også overvejes, når der ikke længere eksisterer nogen tegn på terapeutisk effekt.
English: Clinical monitoring is recommended for these adverse reactions.
Danish: Klinisk monitorering er anbefalet for disse bivirkninger.
English: To be swallowed whole without crushing or opening.
Danish: Synkes hele, må ikke knuses eller åbnes.
English: Most cases of accidental overdose have not been associated with any clinical signs or symptoms and almost all of the patients concerned continued rivastigmine treatment 24 hours after the overdose.
Danish: De fleste tilfælde af tilfældig overdosering har ikke været forbundet med kliniske tegn eller symptomer, og næsten alle de pågældende patienter fortsatte behandlingen med rivastigmin 24 timer efter overdoseringen.
English: Patients with dementia and Parkinson's disease These patients have some side effects more often.
Danish: Patienter med demens og Parkinsons sygdom Disse patienter får visse bivirkninger oftere.
English: Clinical studies in Alzheimer's dementia
Danish: Kliniske undersøgelser af Alzheimers demens
English: Do not handle the tablets with wet hands as the tablets may break up.
Danish: Håndtér ikke tabletterne med våde hænder, da tabletterne kan opløses.
English: • Unusually slow movements or movements you cannot control
Danish: • Unormalt langsomme eller ukontrollerede bevægelser
English: • Urinary incontinence (inability to retain adequate urine)
Danish: • Urininkontinens (manglende evne til at holde på urinen)
English: A population pharmacokinetic analysis showed that nicotine use increases the oral clearance of rivastigmine by 23% in patients with Alzheimer's disease (n=75 smokers and 549 non-smokers) following rivastigmine oral capsule doses of up to 12 mg/day.
Danish: En farmakokinetisk populationsanalyse viste, at nicotin øger den orale clearence af rivastigmin med 23% hos patienter med Alzheimers sygdom (n=75 rygere og 549 ikke-rygere), der får rivastigminkapsler i en dosis på op til 12 mg/dag.
English: Adjusted treatment difference p-value versus placebo
Danish: Justeret behandlingsforskel p-værdi versus placebo
English: Based on ANCOVA with treatment and country as factors and baseline ADAS-Cog as a covariate.
Danish: Baseret på ANCOVA med behandling og land som faktorer og baseline ADAS-Cog som kovariat.
English: These events led to the discontinuation of rivastigmine in some cases (e.g. discontinuations due to tremor 1.7% on rivastigmine vs 0% on placebo).
Danish: Disse hændelser førte til seponering af rivastigmin i nogle tilfælde (f.eks. seponering grundet tremor 1,7% på rivastigmin versus 0% på placebo).
English: • Tell your caregiver that you are taking Nimvastid.
Danish: • Fortæl dit plejepersonale, at du er i behandling med Nimvastid.
English: The efficacy of rivastigmine has been established through the use of three independent, domain specific, assessment tools which were assessed at periodic intervals during 6 month treatment periods.
Danish: Effekten af rivastigmin er blevet påvist ved brug af tre uafhængige og domænespecifikke vurderingsredskaber, som blev vurderet med periodiske intervaller gennem 6 måneders behandlingsperioder.
English: Taking this medicine
Danish: Brug af denne medicin
English: If you feel dizzy or sleepy, do not drive, use machines or perform any tasks that require your attention.
Danish: Hvis du føler dig svimmel eller træt, skal du lade være med at køre bil, betjene maskiner eller gøre andet, som kræver opmærksomhed.
English: The increase in prothrombin time induced by warfarin is not affected by administration of rivastigmine.
Danish: Den warfarin-inducerede stigning i protrombin-tid påvirkes ikke af indgift af rivastigmin.
English: • Take Nimvastid twice a day, once with your breakfast and once with your evening meal.
Danish: • Du skal tage Nimvastid to gange dagligt, én gang sammen med din morgenmad og én gang sammen med din aftensmad.
English: Effects of rivastigmine on human fertility are not known.
Danish: Rivastigmins virkning på human fertilitet er ukendt.
English: There have been rare post-marketing reports of patients experiencing allergic dermatitis (disseminated) when administered rivastigmine irrespective of the route of administration (oral, transdermal).
Danish: Der har været sjældne post-marketing-indberetninger om patienter, der har fået allergisk dermatitis (dissemineret) efter administration af rivastigmin uanset administrationsvej (oral, transdermal).
English: • Severe confusion
Danish: • Svær forvirring
English: In peri/postnatal studies in rats, an increased gestation time was observed.
Danish: I peri-/postnatale studier på rotter blev der observeret en forlænget drægtighedsperiode.
English: Therapy with rivastigmine should only be started if a caregiver is available who will regularly monitor intake of the medicinal product by the patient.
Danish: Rivastigminterapi bør kun påbegyndes, hvis der er en plejegivende person, som løbende vil holde øje med indtagelsen af lægemidlet hos patienten.
English: At least 4 points improvement on ADASCog with no worsening on CIBIC-Plus and PDS *p<0.05, **p<0.01, ***p<0.001
Danish: Mindst 4-pointsforbedring af ADAS-Cog og med ingen forværring af CIBIC-Plus og PDS *p<0,05, **p<0,01, ***p<0,001
English: Adverse reactions in Table 1 and Table 2 are listed according to MedDRA system organ class and frequency category.
Danish: Bivirkninger i tabel 1 og tabel 2 er opstillet i henhold til MedDRA organklasse og hyppighed.
English: Your mouth should be empty before taking the tablet.
Danish: Din mund bør være tom, inden du tager tabletten.
English: Mean data shown for convenience, categorical analysis performed using van Elteren test ITT: Intent-To-Treat; RDO: Retrieved Drop Outs; LOCF: Last Observation Carried Forward
Danish: Middeldata vist for anvendelighed, kategorisk analyse, der blev udført ved brug af van Elteren-test ITT: Intent-To-Treat; RDO: Retrieved Drop Outs; lOCF: last Observation Carried Forward.
English: Do not take Nimvastid - if you are allergic to rivastigmine (the active substance in Nimvastid) or to any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Nimvastid - hvis du er allergisk over for rivastigmin eller et af de øvrige indholdsstoffer i Nimvastid (angivet i punkt 6).
English: Rivastigmine may cause bradycardia which constitutes a risk factor in the occurrence of torsade de pointes, predominantly in patients with risk factors.
Danish: Rivastigmin kan medføre bradykardi, som udgør en risikofaktor i forekomsten af torsade de pointes, primært hos patienter med risikofaktorer.
English: There is no accumulation of rivastigmine or the decarbamylated metabolite in patients with Alzheimer's disease.
Danish: Der er ikke nogen akkumulering af rivastigmin eller decarbamyleret metabolit hos patienter med Alzheimers sygdom.
English: Therefore, the clinical benefit of rivastigmine should be reassessed on a regular basis, especially for patients treated at doses less than 3 mg twice a day.
Danish: Derfor bør den kliniske effekt af rivastigmin revurderes løbende, specielt hos patienter, der behandles med doser mindre end 3 mg to gange dagligt.
English: Unchanged rivastigmine is not found in the urine; renal excretion of the metabolites is the major route of elimination.
Danish: Der findes ikke uændret rivastigmin i urinen; renal udskillelse af metabolitterne er den væsentligste udskillelsesvej.
English: If you forget to take Nimvastid
Danish: Hvis du har glemt at tage Nimvastid
English: It has the same dosage and frequency of administration as rivastigmine capsules.
Danish: Der gælder samme dosering og administrationsfrekvens som for rivastigmin kapsler.
English: The tablets are round and white.
Danish: Tabletterne er runde og hvide.
English: The effective dose is 3 to 6 mg twice a day; to achieve maximum therapeutic benefit patients should be maintained on their highest well tolerated dose.
Danish: Den effektive dosis er 3 til 6 mg to gange dagligt; for at opnå maksimal terapeutisk fordel skal patienterne holdes på den højeste dosis, som de tåler godt.
English: Nimvastid is used for the treatment of adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Danish: Nimvastid anvendes til behandling af voksne patienter med mild til moderat svær Alzheimers demens, en fremadskridende hjernesygdom, der gradvis påvirker hukommelse, åndsevner og adfærd.
English: The incidence and severity of adverse reactions generally increase with higher doses.
Danish: Forekomsten og sværhedsgraden af bivirkninger øges generelt ved højere doser.
English: • High blood pressure
Danish: • Forhøjet blodtryk
English: Motor dysfunction
Danish: Motorisk dysfunktion
English: The mouth should be empty before placing the tablet on the tongue.
Danish: Munden bør være tom, inden du lægger tabletten på tungen.
English: Taking the two medicines together could cause problems such as stiff limbs and trembling hands.
Danish: Samtidig brug af de to lægemidler kan give problemer såsom stive lemmer og rysten på hænderne.
English: Nimvastid orodispersible tablets are fragile.
Danish: Nimvastid smeltetabletter er skrøbelige.
English: As rivastigmine has a plasma half-life of about 1 hour and a duration of acetylcholinesterase inhibition of about 9 hours, it is recommended that in cases of asymptomatic overdose no further dose of rivastigmine should be administered for the next 24 hours.
Danish: Eftersom rivastigmin har en plasmahalveringstid på ca. 1 time og en acetylkolinesterasehæmning, som varer ca. 9 timer, anbefales det i tilfælde af asymptomatisk overdosering ikke at indgive yderligere dosis af rivastigmin i de efterfølgende 24 timer.
English: - if you suffer from trembling.
Danish: hvis du ryster meget.
English: Cardiovascular betablockers are expected to be associated with the greatest risk, but reports have also been received in patients using other beta-blockers.
Danish: Kardiovaskulære betablokkere forventes at være forbundet med den største risiko, men der er også modtaget rapporter fra patienter, som har brugt andre betablokkere.
English: According to its metabolism, metabolic interactions with other medicinal products appear unlikely, although rivastigmine may inhibit the butyrylcholinesterase mediated metabolism of other substances.
Danish: Ifølge dets metabolisme forekommer metaboliske interaktioner med andre lægemidler højst sandsynligt ikke, selvom rivastigmin kan hæmme den butylkolinesterase-medierede metabolisme hos andre stoffer.
English: During therapy patient's weight should be monitored.
Danish: Patienters vægt bør monitoreres gennem behandlingen.
English: Total plasma clearance of rivastigmine was approximately 130 l/h after a 0.2 mg intravenous dose and decreased to 70 l/h after a 2.7 mg intravenous dose.
Danish: Rivastigmins totale plasmaclearance var ca. 130 l/t efter en 0,2 mg intravenøs dosis og faldt til 70 l/t efter en 2,7 mg intravenøs dosis.
English: Treatment effect has not been studied in placebo-controlled trials beyond 6 months.
Danish: Behandlingens effekt er ikke blevet undersøgt i placebo-kontrollerede undersøgelser ud over 6 måneder.
English: An initial dose of 0.03 mg/kg intravenous atropine sulphate is recommended, with subsequent doses based on clinical response.
Danish: En initial dosis på 0,03 mg/kg intravenøs atropinsulfat anbefales med efterfølgende doser afhængigt af klinisk respons.
English: Administration of rivastigmine with food delays absorption (tmax) by 90 min and lowers Cmax and increases AUC by approximately 30%.
Danish: Administration af rivastigmin sammen med føde forsinker optagelsen (tmax) med 90 min, sænker Cmax og øger AUC med ca. 30%.
English: Biotranformation
Danish: Biotransformation
English: If adverse reactions persist, the daily dose should be temporarily reduced to the previous well-tolerated dose or the treatment may be discontinued.
Danish: Hvis bivirkningerne varer ved, bør den daglige dosis midlertidigt nedsættes til det niveau, som tidligere tåltes godt, eller behandlingen kan seponeres.
English: Rivastigmine n (%)
Danish: Rivastigmin n (%)
English: As a consequence, rivastigmine has minor or moderate influence on the ability to drive and use machines.
Danish: Som følge heraf påvirker rivastigmin i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: In case of severe vomiting associated with rivastigmine treatment, appropriate dose adjustments as recommended in section 4.2 must be made.
Danish: I tilfælde af alvorlig opkastning, der er associeret med rivastigminbehandling, skal der foretages passende dosisjustering som anbefalet i pkt.
English: In patients with Alzheimer's dementia or dementia due to Parkinson's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other).
Danish: Hos patienter med Alzheimers demens eller demens som følge af Parkinsons sygdom, dør visse nerveceller i hjernen, hvilket resulterer i lave niveauer af neurotransmitteren acetylcholin (et stof, som bruges af nervecellerne til at kommunikere med hinanden).
English: Slow heartbeat and fainting may also occur.
Danish: langsom hjerterytme og besvimelsesanfald kan ligeledes forekomme.
English: The active substance of Nimvastid is rivastigmine.
Danish: Det aktive stof i Nimvastid er rivastigmin.
English: In vitro, this metabolite shows minimal inhibition of acetylcholinesterase (<10%).
Danish: Denne metabolit viser in vitro minimal hæmning af acetylkolinesterase (<10%).
English: Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia or dementia associated with Parkinson's disease.
Danish: Behandlingen bør indledes og overvåges af en læge, der har erfaring med diagnosticering og behandling af Alzheimers demens eller demens, associeret med Parkinsons sygdom.
English: Following administration of 14C-rivastigmine, renal elimination was rapid and essentially complete (>90%) within 24 hours.
Danish: C-rivastigmin var renal udskillelse hurtig og nærmest fuldstændig (>90%) inden for 24 timer.
English: In patients with Alzheimer's disease, inhibition of AChE in CSF by rivastigmine was dose-dependent up to 6 mg given twice daily, the highest dose tested.
Danish: Hos patienter med Alzheimers sygdom var rivastigmins hæmning af AChE i CSF afhængig af dosis op til 6 mg, der blev indgivet to gange daglig, som var den højeste dosis, som blev testet.
English: Efficacy has been established by the use of two independent scales which were assessed at regular intervals during a 6-month treatment period as shown in Table 5 below: the ADAS-Cog, a measure of cognition, and the global measure ADCS-CGIC (Alzheimer's Disease Cooperative StudyClinician's Global Impression of Change).
Danish: Effekten blevet fastslået ved hjælp af to uafhængige skalaer, som blev vurderet ved regelmæssige intervaller i løbet af en 6-måneders behandlingsperiode, som vist i tabel 5 nedenfor: ADAS-Cog, en måling af kognition og den globale måling ADCS-CGIC (Alheimer's Disease Cooperative Study-Clinician's Global Impression of Change).
English: • Too much saliva and dehydration
Danish: • For meget spyt, dehydrering
English: No evidence of carcinogenicity was found in studies in mice and rats at the maximum tolerated dose, although the exposure to rivastigmine and its metabolites was lower than the human exposure.
Danish: Der var ingen tegn på karcinogenicitet i studier med mus og rotter ved den maksimalt tolererede dosis, selvom optagelsen af rivastigmin og dets metabolitter var lavere end den humane optagelse.
English: Put the tablet on the tongue as soon as it is removed from the packaging.
Danish: Læg tabletten på tungen, så snart du har taget den ud af pakningen.
English: In healthy young men, an oral 3 mg dose decreases acetylcholinesterase (AChE) activity in CSF by approximately 40% within the first 1.5 hours after administration.
Danish: Hos raske, unge mænd sænker en peroral dosis på 3 mg aktiviteten af acetylkolinesterase (AChE) i CSF med ca. 40% inden for den første 1,5 time efter indgift.
English: No pharmacokinetic interaction was observed between rivastigmine and digoxin, warfarin, diazepam or fluoxetine in studies in healthy volunteers.
Danish: Der sås ingen farmakokinetisk interaktion mellem rivastigmin og digoxin, warfarin, diazepam eller fluoxetin i studier med raske frivillige forsøgspersoner.
English: In view of its pharmacodynamic effects and possible additive effects, rivastigmine should not be given concomitantly with other cholinomimetic substances.
Danish: Som følge af de farmakodynamiske virkninger og mulige additive virkninger bør rivastigmin ikke gives samtidig med andre parasympatomimetika.
English: Inhibition of butyrylcholinesterase activity in CSF of 14 Alzheimer patients treated by rivastigmine was similar to that of AChE.
Danish: Rivastigmins hæmning af butyrylcholinesterase-aktivitet i CSF hos 14 patienter med Alzheimer var sammenlignelig med hæmningen af AChE.
English: If after 3 months of maintenance dose treatment the patient's rate of decline in dementia symptoms is not altered favourably, the treatment should be discontinued.
Danish: Hvis der ikke er en positiv ændring i patientens tilbagefaldsrate af demenssymptomer efter 3 måneders vedligeholdelsesbehandling, bør behandlingen afbrydes.
English: As a consequence of rivastigmine's interaction with its target enzyme, the increase in bioavailability is about 1.5-fold greater than that expected from the increase in dose.
Danish: Som følge af rivastigmins reaktion med sit målenzym er stigningen i biotilgængelighed ca. 1,5 gange højere end forventet fra øgningen af dosis.
English: Repeated-dose toxicity studies in rats, mice and dogs revealed only effects associated with an exaggerated pharmacological action.
Danish: Kroniske toksicitetsstudier af rotter, mus og hunde viste kun effekter, der var forbundet med en unormal høj farmakologisk aktivitet.
English: Removal of the intact orodispersible tablet from the mouth is difficult.
Danish: Det er svært at fjerne den intakte smeltetablet fra munden.
English: Clinical studies in dementia associated with Parkinson's disease The efficacy of rivastigmine in dementia associated with Parkinson's disease has been demonstrated in a 24-week multicentre, double-blind, placebo-controlled core study and its 24-week open-label extension phase.
Danish: Kliniske studier af demens, associeret med Parkinsons sygdom Effekten af rivastigmin ved demens, associeret med Parkinsons sygdom, er demonstreret i et 24-ugers multicenter, dobbelt-blindt, placebo-kontrolleret hovedstudie og dets 24-ugers open-label forlængelsesfase.
English: The most commonly reported adverse reactions (ADRs) are gastrointestinal, including nausea (38%) and vomiting (23%), especially during titration.
Danish: De mest almindeligt rapporterede bivirkninger er gastrointestinale, inklusive kvalme (38%) og opkastning (23%), særligt under dosistitrering.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil ønsker yderligere oplysninger om Nimvastid, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Patients with moderate dementia (MMSE 10-17)
Danish: Patienter med moderat demens (MMSE 10-17)
English: In more severe cases nicotinic effects might develop such as muscular weakness, fasciculations, seizures and respiratory arrest with possible fatal outcome.
Danish: I alvorligere tilfælde kan der udvikles nikotinerge virkninger såsom muskelsvaghed, fascikulationer, krampeanfald og respirationsstop med mulig dødelig udgang.
English: If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.
Danish: Hvis en eller flere af disse symptomer gælder for dig, kan det være nødvendigt, at din læge følger dig tæt, så længe du tager denne medicin.
English: The use of rivastigmine in patients with severe dementia of Alzheimer's disease or associated with Parkinson's disease, other types of dementia or other types of memory impairment (e.g. age-related cognitive decline) has not been investigated and therefore use in these patient populations is not recommended.
Danish: Brugen af rivastigmin til patienter med svær demens af Alzheimers sygdom eller associeret med Parkinsons sygdom, andre typer demens eller andre typer hukommelsessvækkelse (f.eks. aldersrelateret kognitiv tilbagegang) er ikke blevet undersøgt, og anvendelse hos disse patientpopulationer kan derfor ikke anbefales.
English: Similarly a larger treatment effect was observed in those patients with visual hallucinations (see Table 6).
Danish: Tilsvarende blev der observeret en større behandlingseffekt hos patienter med visuelle hallucinationer (se tabel 6).
English: • Allergic reaction where the patch was used, such as blisters or skin inflammation If you get any of these side effects, contact your doctor as you may need medical assistance.
Danish: • Allergisk reaktion der, hvor plastret har siddet, som fx blærer eller betændelse i huden Kontakt din læge, hvis sådanne symptomer opstår, da du muligvis har brug for lægehjælp.
English: Caution is recommended when selecting anaesthetic agents.
Danish: Det anbefales at udvise forsigtighed ved valg af anæstesimiddel.
English: Patients with body weight below 50 kg may experience more adverse reactions and may be more likely to discontinue due to adverse reactions.
Danish: Patienter med legemsvægt under 50 kg kan opleve flere bivirkninger og har større risiko for at måtte afbryde behandlingen på grund af bivirkninger.
English: In overdose accompanied by severe nausea and vomiting, the use of antiemetics should be considered.
Danish: I tilfælde af overdosering, som efterfølges af svær kvalme og opkastning, bør antiemetika overvejes.
English: Cholinesterase inhibitors, including rivastigmine, have been associated with weight loss in these patients.
Danish: Kolinesterasehæmmere, inklusive rivastigmin, har været sat i forbindelse med vægttab hos disse patienter.
English: If this dose is well tolerated after a minimum of two weeks of treatment, the dose may be increased to 3 mg twice a day.
Danish: Hvis denne dosis tåles godt efter mindst to ugers behandling, kan dosis øges til 3 mg to gange dagligt.