FrancophonIA/ELRC3.0 huggingface dataset:
English: Rivastigmine is rapidly and extensively metabolised (half-life in plasma approximately 1 hour), primarily via cholinesterase-mediated hydrolysis to the decarbamylated metabolite.
Danish: Rivastigmin metaboliseres hurtigt og fuldstændigt (halveringstid i plasma er ca. 1 time), primært via kolinesterasemedieret hydrolyse til den decarbamylerede metabolit.
English: Rivastigmine should be administered twice a day, with morning and evening meals.
Danish: Rivastigmin skal indtages to gange dagligt sammen med henholdsvis morgen- og aftensmåltid.
English: Although a treatment effect was demonstrated in the overall study population, the data suggested that a larger treatment effect relative to placebo was seen in the subgroup of patients with moderate dementia associated with Parkinson's disease.
Danish: Selvom behandlingseffekten blev demonstreret i den samlede studiepopulation, indikerede data, at en større behandlingseffekt i forhold til placebo blev set i subgruppen af patienter med moderat demens, associeret med Parkinsons sygdom.
English: Do not use this medicine after the expiry date which is stated on the packaging after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Taking the two medicines together could cause problems such as slowing of the heartbeat (bradycardia) leading to fainting or loss of consciousness.
Danish: Brug af de to lægemidler sammen kan give problemer som langsommere hjerteslag (bradykardi), hvilket kan føre til besvimelse eller bevistløshed.
English: • Do not open or crush the capsules.
Danish: • Kapslerne må hverken åbnes eller knuses.
English: • Take Nimvastid twice a day, in the morning and evening, with food.
Danish: • Tag Nimvastid to gange om dagen (morgen og aften) sammen med mad.
English: Alzheimer's disease may cause gradual impairment of driving performance or compromise the ability to use machinery.
Danish: Alzheimers sygdom kan medføre gradvis forringelse af køreegenskaber eller nedsætte evnen til at betjene maskiner.
English: However, Nimvastid may be used in this patient population and close monitoring is necessary.
Danish: Nimvastid kan imidlertid anvendes hos denne patientpopulation, men det er nødvendigt at følge patienterne tæt.
English: Female patients in clinical studies were found to be more susceptible than male patients to gastrointestinal adverse reactions and weight loss.
Danish: Kvindelige patienter i kliniske studier viste sig at være mere modtagelige end mandlige patienter med hensyn til gastrointestinale bivirkninger og vægttab.
English: If you accidentally take more Nimvastid than you should, inform your doctor.
Danish: Hvis du ved en fejltagelse er kommet til at tage mere Nimvastid, end du har fået besked på, skal du sige det til din læge.
English: Nimvastid should not be given at the same time as other medicines with similar effects to Nimvastid.
Danish: Du må ikke tage Nimvastid samtidig med andre lægemidler, der har en virkning, der ligner Nimvastids.
English: You may have side effects more often when you start your medicine or when your dose is increased.
Danish: Du kan oftere få bivirkninger, når du starter med medicinen eller går op til en højere dosis.
English: Uncommon (may affect up to 1 in 100 people) • Hyperactivity (high level of activity, restlessness)
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 patienter) • Hyperaktivitet (højt aktivitetsniveau, rastløshed)
English: Subsequent increases to 4.5 mg and then 6 mg twice a day should also be based on good tolerability of the current dose and may be considered after a minimum of two weeks of treatment at that dose level.
Danish: Efterfølgende øgninger til 4,5 mg og dernæst 6 mg to gange dagligt skal også være baseret på god tolerabilitet af den aktuelle dosis og kan overvejes efter mindst to ugers behandling på det pågældende dosisniveau.
English: In a few seconds it begins disintegrating in the mouth and subsequently can be swallowed without water.
Danish: I løbet af få sekunder opløses tabletten i munden og kan derefter synkes uden vand.
English: The results for clinically relevant responders pooled from two flexible dose studies out of the three pivotal 26-week multicentre studies in patients with mild-to-moderately severe Alzheimer's Dementia, are provided in Table 4 below.
Danish: Resultaterne for patienter med klinisk relevant respons, der var poolet fra to fleksible dosisstudier ud af tre pivotale 26-ugers multicenterstudier hos patienter med mild til moderat svær Alzheimers demens, er vist i Tabel 4 nedenfor.
English: Patients without visual hallucinations
Danish: Patienter uden visuelle hallucinationer
English: Patients with mild dementia (MMSE 18-24)
Danish: Patienter med let demens (MMSE 18-24)
English: Extrapyramidal symptoms (including worsening of Parkinson's disease)
Danish: Ekstrapyramidale symptomer (inklusive forværring af Parkinsons sygdom)
English: Since the orodispersible tablet is fragile, it should be taken immediately on opening the blister.
Danish: Da smeltetabletten er skrøbelig, bør den tages, umiddelbart efter den er taget ud af blisteret.
English: Cmax and AUC of rivastigmine were more than twice as high in subjects with moderate renal impairment compared with healthy subjects; however there were no changes in Cmax and AUC of rivastigmine in subjects with severe renal impairment.
Danish: Cmax og AUC for rivastigmin var mere end dobbelt så høj hos personer med moderat nedsat nyrefunktion sammenlignet med raske personer; der var dog ingen ændringer af Cmax og AUC for rivastigmin hos personer med svært nedsat nyrefunktion.
English: Therefore, the ability of patients with dementia on rivastigmine to continue driving or operating complex machines should be routinely evaluated by the treating physician.
Danish: Derfor bør rivastigminbehandlede demenspatienters evne til fortsat at køre bil eller betjene indviklede maskiner løbende vurderes af den behandlende læge.
English: - if you have, or have ever had, asthma or severe respiratory disease.
Danish: hvis du har eller har haft astma eller en svær luftvejssygdom.
English: No untoward effects on cardiac conduction were observed following concomitant administration of digoxin and rivastigmine.
Danish: Der sås ingen negative virkninger på kardial overledning efter samtidig indgift af digoxin og rivastigmin.
English: Nimvastid should not be given at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting).
Danish: Nimvastid bør ikke gives sammen med metoclopramid (et lægemiddel som bruges til at lindre eller forebygge kvalme og opkastning).
English: • Liver disorders (yellow skin, yellowing of the whites of the eyes, abnormal darkening of the urine or unexplained nausea, vomiting, tiredness and loss of appetite)
Danish: • Leversygdomme (gulfarvet hud, gulfarvning af det hvide i øjnene, unormalt mørk urin eller uforklarlig kvalme, opkastning, træthed og appetitløshed)
English: Hyperhydrosis Allergic dermatitis (disseminated)
Danish: Hyperhidrose Allergisk dermatitis (dissemineret)
English: They may respond to a dose reduction.
Danish: Nævnte bivirkninger responderer muligvis på dosisreduktion.
English: ADAS-Cog: improvement of at least 4 points CIBIC-Plus: improvement PDS: improvement of at least 10%
Danish: ADAS-Cog og: mindst 4points forbedring CIBIC-Plus: forbedring PDS: mindst 10% forbedring
English: However, due to increased exposure in these populations dosing recommendations to titrate according to individual tolerability should be closely followed as patients with clinically significant renal or hepatic impairment might experience more dose-dependent adverse reactions.
Danish: På grund af øget biotilgængelighed hos disse patienter bør anbefalingerne vedrørende titrering i henhold til individuel tolerance dog følges nøje, da patienter med klinisk signifikant nedsat nyre- eller leverfunktion kan opleve flere dosisafhængige bivirkninger.
English: • Accidentally falling
Danish: • Tilfældige fald
English: Decreased appetite Dehydration
Danish: Nedsat appetit Dehydrering
English: Rivastigmine orodispersible tablets may be used as an alternative to rivastigmine capsules.
Danish: Rivastigmin smeltetabletter kan anvendes som et alternativ til rivastigmin kapsler.
English: Less than 1% of the administered dose is excreted in the faeces.
Danish: Under 1% af den indgivne dosis udskilles med fæces.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Danish: SÆRLIG ADVARSEL OM, AT lÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
English: Patients involved in this study had an MMSE (Mini-Mental State Examination) score of 10-24.
Danish: Patienter, der var involveret i dette studie, havde en MMSE-score (Mini-Mental State Examination) på 10-24.
English: Additive effects leading to bradycardia (which may result in syncope) have been reported with the combined use of various beta-blockers (including atenolol) and rivastigmine.
Danish: Der er blevet rapporteret additive virkninger, som medfører bradykardi (der kan resultere i synkope), ved brug af forskellige betablokkere (inklusive atenolol) sammen med rivastigmin.
English: If you have to undergo surgery whilst taking Nimvastid, tell your doctor before you are given any anaesthetics, because Nimvastid may exaggerate the effects of some muscle relaxants during anaesthesia.
Danish: Hvis du skal opereres, mens du er i behandling med Nimvastid, skal du fortælle det til din læge, inden du får nogen form for bedøvende medicin, da Nimvastid kan forstærke virkningen af visse muskelafslappende midler under bedøvelse.
English: By blocking these enzymes, Nimvastid allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's disease and dementia associated with Parkinson's disease.
Danish: Ved at blokere disse enzymer kan Nimvastid medvirke til, at acetylcholin-indholdet øges i hjernen, hvilket hjælper med at reducere symptomerne på Alzheimers sygdom og demens forbundet med Parkinsons sygdom.
English: Cholinomimetics may induce or exacerbate urinary obstruction and seizures.
Danish: Kolinomimetika kan forårsage eller forværre urinvejsobstruktion og krampeanfald.
English: The secondary definition of response required a 4-point or greater improvement on the ADAS-Cog, no worsening on the CIBIC-Plus, and no worsening on the PDS.
Danish: Den sekundære definition af respons krævede en mindst 4-pointsforbedring af ADAS-Cog og, ingen forværring af CIBIC-Plus og ingen forværring af PDS.
English: ADAS-Cog Rivastigmine
Danish: ADAS-Cog rivastigmin
English: Mean baseline ± SD Mean change at 24 weeks ± SD
Danish: Gennemsnitlig baseline ± SD Gennemsnitsændring ved 24 uger ± SD
English: The recommended maximum daily dose is 6 mg twice a day.
Danish: Den anbefalede maksimale daglige dosis er 6 mg to gange dagligt.
English: Pruritus, allergic dermatitis (disseminated)
Danish: Kløe, allergisk dermatitis (dissemineret)
English: Patients with severe hepatic impairment have not been studied.
Danish: Patienter med stærkt nedsat leverfunktion er ikke blevet undersøgt.
English: (on carton label only)
Danish: (kun på æsken)
English: Your doctor will regularly check if the medicine is working for you.
Danish: Din læge vil løbende vurdere, om medicinen har den ønskede effekt.
English: Nimvastid orodispersible tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
Danish: Nimvastid smeltetablet skal lægges i munden, hvor den hurtigt opløses af spyt, så den nemt kan synkes.
English: A mild eye/mucosal irritation potential of rivastigmine was identified in a rabbit study.
Danish: Rivastigmin viste potentiale for let øjen/mucosal irritation i et studie med kaniner.
English: Response Measure
Danish: Måling af respons
English: • Slow and fast heartbeat
Danish: • Langsom og hurtig hjerterytme (puls)
English: When normalised to body surface area, the exposure to rivastigmine and its metabolites was approximately equivalent to the maximum recommended human dose of 12 mg/day; however, when compared to the maximum human dose, a multiple of approximately 6-fold was achieved in animals.
Danish: Når mængde og koncentration af rivastigmin og dets metabolitter blev sat i relation til arealet af legemsoverfladen var det omtrent ækvivalent til den maksimalt anbefalede humane daglige dosis på 12 mg; ved sammenligning med maksimal human dosis blev der dog opnået en seksdobling af dosis hos dyr.
English: Infections and infestations Very rare
Danish: Infektioner og parasitære sygdomme Meget sjælden
English: • The highest dose that should be taken is 6.0 mg twice a day.
Danish: • Den højeste dosis, som bør tages, er 6 mg to gange daglig.
English: No adverse effects of rivastigmine were observed on fertility or reproductive performance in rats (see section 5.3).
Danish: Der blev ikke observeret negative virkninger af rivastigmin på fertilitet eller reproduktionsevne hos rotter (se pkt.
English: Like other cholinomimetics, rivastigmine may exacerbate or induce extrapyramidal symptoms.
Danish: Som andre kolinomimetika kan rivastigmin forværre eller fremkalde ekstrapyramidale symptomer.
English: Rivastigmine might interfere with the activity of anticholinergic medicinal products (e.g oxybutynin, tolterodine).
Danish: Rivastigmin kan interferere med antikolinerge lægemidlers aktivitet (f.eks. oxybutynin, tolterodin).
English: Clinically relevant improvement in these studies was defined a priori as at least 4-point improvement on the ADAS-Cog, improvement on the CIBIC-Plus, or at least a 10% improvement on the PDS.
Danish: Klinisk relevant forbedring var i disse studier på forhånd defineret som en mindst 4-pointsforbedring af ADAS-Cog, forbedring af CIBIC-Plus eller en forbedring på mindst 10% af PDS.
English: Table 3 lists the number and percentage of patients from the specific 24-week clinical study conducted with rivastigmine in patients with dementia associated with Parkinson's disease with pre-defined adverse events that may reflect worsening of parkinsonian symptoms.
Danish: Tabel 3 angiver antallet og procentdelen af patienterne fra det specifikke 24-ugers studie, der blev udført med rivastigmin hos patienter med demens, associeret med Parkinsons sygdom med prædefinerede bivirkninger, der muligvis kan reflektere en forværring af Parkinsons symptomer.
English: Tip the tablet out onto your hand.
Danish: Vip tabletten ud i hånden.
English: Date of first authorisation: 11/5/2009 Date of latest renewal: DD month YYYY
Danish: Dato for første markedsføringstilladelse: 11/5/2009 Dato for seneste fornyelse: 16. januar 2014
English: Movement disorder Bradykinesia
Danish: Bevægelsesforstyrrelser Bradykinesi
English: The capsules and oral solution can also be used for the treatment of dementia in adult patients with Parkinson's disease.
Danish: Kapsler og smeltetabletter kan også anvendes til behandling af demens hos voksne patienter med Parkinsons sygdom.
English: Balance disorder Musculoskeletal stiffness Rigors
Danish: Balanceforstyrrelser Muskuloskeletal stivhed Rigor
English: CARTON FOR BLISTERS AND CONTAINER, AND LABEL FOR CONTAINER
Danish: ÆSKE TIL BLISTER OG ÆSKE TIL BEHOLDER - ETIKET TIL BEHOLDER
English: The Cmax of rivastigmine was approximately 60% higher and the AUC of rivastigmine was more than twice as high in subjects with mild to moderate hepatic impairment than in healthy subjects.
Danish: Cmax for rivastigmin var cirka 60% højere, og AUC for rivastigmin var mere end dobbelt så høj hos personer med let til moderat nedsat leverfunktion end hos raske personer.
English: Capsule content Microcrystalline cellulose Hypromellose Silica, colloidal anhydrous Magnesium stearate
Danish: Kapselindhold Mikrokrystallinsk cellulose Hypromellose Silica, kolloid vandfri Magnesiumstearat
English: Additionally there have been post-marketing cases of dizziness, tremor, headache, somnolence, confusional state, hypertension, hallucinations and malaise.
Danish: Derudover har der efter markedsføringen været tilfælde af svimmelhed, tremor, hovedpine, døsighed, konfusion, hypertension, hallucinationer og utilpashed.
English: • Trembling or feeling confused
Danish: • Rysten eller følelse af forvirring
English: What you need to know before you take Nimvastid
Danish: Det skal du vide, før du begynder at tage Nimvastid
English: If treatment is interrupted for more than three days, it should be re-initiated at 1.5 mg twice daily to reduce the possibility of adverse reactions (e.g. vomiting).
Danish: Hvis behandlingen afbrydes i mere end tre dage, skal behandlingen genoptages med 1,5 mg 2 gange daglig for at mindske risikoen for bivirkninger (f.eks. opkastning).
English: These include the ADAS-Cog (Alzheimer's Disease Assessment Scale - Cognitive subscale, a performance based measure of cognition), the CIBIC-Plus (Clinician's Interview Based Impression of Change-Plus, a comprehensive global assessment of the patient by the physician incorporating caregiver input), and the PDS (Progressive Deterioration Scale, a caregiver-rated assessment of the activities of daily living including personal hygiene, feeding, dressing, household chores such as shopping, retention of ability to orient oneself to surroundings as well as involvement in activities relating to finances, etc.).
Danish: Disse omfatter ADAS-Cog (Alzheimer´s Disease Assessment Scale - Cognitive subscale, en præstationsbaseret måling af kognition), CIBIC-Plus (Clinician´s Interview Based Impression of Change-Plus, en omfattende global vurdering af patienten, der dannes af den behandlende læge med input fra den omsorgsgivende person) og PDS (Progressive Deterioration Scale, den omsorgsgivende persons vurdering af dagligdagsaktiviteter, som indbefatter personlig hygiejne, fødeindtagelse, påklædning, husføring som indkøb, opretholdelse af evner så som at orientere sig i forhold til omgivelserne og involvere sig i økonomiske anliggender, og så videre).
English: You should not breast-feed during treatment with Nimvastid.
Danish: Du må ikke amme, mens du er i behandling med Nimvastid.
English: If treatment is interrupted for more than three days, it should be re-initiated at 1.5 mg twice daily.
Danish: Hvis behandlingen afbrydes i mere end tre dage, skal behandlingen genoptages med 1,5 mg 2 gange daglig.
English: Care must be taken when using rivastigmine in patients with sick sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section 4.8).
Danish: Der skal udvises forsigtighed ved brug af rivastigmin til patienter med syg sinus syndrom eller overledningsforstyrrelser (sino-atrialt blok, atrio-ventrikulært blok) (se pkt.
English: Patients with visual hallucinations
Danish: Patienter med visuelle Hallucinationer
English: Bradycardia Atrial Fibrillation Atrioventricular block Sick sinus syndrome
Danish: Bradykardi Atrieflimren Atrioventrikulært blok Syg sinus-syndrom
English: - if you have a skin reaction spreading beyond the patch size, if there is a more intense local reaction (such as blisters, increasing skin inflammation, swelling) and if it does not improve within 48 hours after removal of the transdermal patch.
Danish: - hvis du får en hudreaktion, som spreder sig uden for selve plasteret, hvis der er en kraftigere lokal reaktion (som fx blærer, tiltagende hudirritation, hævelse), og hvis det ikke bliver bedre inden for 48 timer efter, at plasteret er fjernet.
English: Orodispersible tablets are round and white tablets.
Danish: Smeltetabletterne er runde og hvide tabletter.
English: Marketing Authorisation Holder and Manufacturer KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Danish: Indehaver af markedsføringstilladelsen og fremstiller KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenien
English: Based on in vitro studies, no pharmacokinetic interaction is expected with medicinal products metabolised by the following cytochromes isoemzymes: CYP1A2, CYP2D6, CYP3A4/5, CYP2E1, CYP2C9, CYP2C8, CYP2C19, or CYP2B6.
Danish: Resultater fra in vitro studier giver ikke anledning til forventning om farmakokinetiske interaktioner med lægemidler, som metaboliseres af følgende CYP-isoenzymer: CYP1A2, CYP2D6, CYP3A4/5, CYP2E1, CYP2C9, CYP2C8, CYP2C19 eller CYP2B6.
English: HDPE container: 200 or 250 hard capsules in a box.
Danish: HDPE-beholder: 200 eller 250 hårde kapsler i en æske.
English: Other side effects seen with rivastigmine transdermal patches and which may occur with the hard capsules:
Danish: Andre bivirkninger, der er set med rivastigmin depotplaster, og som kan forekomme ved brug af hårde kapsler:
English: ADCS-CGIC Rivastigmine
Danish: ADCS-CGIC rivastigmin
English: Some people who have accidentally taken too much Nimvastid have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations.
Danish: Nogle personer, som er kommet til at tage for meget Nimvastid, har oplevet kvalme, opkastning, diarré, forhøjet blodtryk og hallucinationer.
English: However, a greater treatment effect was seen in Parkinson's disease patients with moderate dementia.
Danish: Dog blev der set en bedre effekt hos Parkinsons patienter med moderat demens.
English: Nimvastid might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson's disease or to prevent travel sickness).
Danish: Nimvastid kan påvirke antikolinerg medicin (medicin, der bruges mod mavekramper og Parkinsons sygdom eller til at forebygge transportsyge).
English: Rivastigmine orodispersible tablet is bioequivalent to rivastigmine capsules, with a similar rate and extent of absorption.
Danish: Rivastigmin smeltetablet er bioækvivalent til rivastigmin kapsler, med en lignende absorptionshastighed og -udbredelse.
English: The patients studied had an MMSE (Mini-Mental State Examination) score of 10-24.
Danish: Patienterne i studiet havde en MMSE (Mini-Mental State Examination) score på 10-24.
English: Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Danish: Symptomatisk behandling af let til moderat svær demens hos patienter med idiopatisk Parkinsons sygdom.
English: Rivastigmine was not mutagenic in a standard battery of in vitro and in vivo tests, except in a chromosomal aberration test in human peripheral lymphocytes at a dose 10
Danish: Rivastigmin var ikke mutagent i et standardbatteri af in vitro- og in vivo-tests, på nær i en kromosonal Abberation Test i humane perifere lymfocytter ved en dosis på 104 gange den maksimale kliniske relevante.
English: Dementia associated with Parkinson's Disease
Danish: Demens associeret med Parkinsons sygdom
English: Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.
Danish: Kolinesterasehæmmere bør ordineres med forsigtighed til patienter, som tidligere har haft astma eller kronisk obstruktiv lungesygdom.
English: Thus, rivastigmine may have an ameliorative effect on cholinergic-mediated cognitive deficits in dementia associated with Alzheimer's disease and Parkinson's disease.
Danish: Følgelig har rivastigmin muligvis en forbedrende effekt på kolinergmedierede kognitive udfald af demens, som er forbundet med Alzheimers sygdom og Parkinsons sygdom.
English: Furthermore, rivastigmine can induce dizziness and somnolence, mainly when initiating treatment or increasing the dose.
Danish: Ydermere kan rivastigmin medføre svimmelhed og døsighed, specielt ved indledning af behandling eller øgning af dosis.
English: Magnesium stearate.
Danish: Magnesiumstearat
English: No dose adjustment is necessary for patients with mild to moderate renal or hepatic impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let til moderat nedsat nyre- eller leverfunktion.