FrancophonIA/ELRC3.0 huggingface dataset:
English: When changing the patch, you must remove the previous day's patch before you apply the new one to a different location of skin each time (for example on the right side of your body one day, then on the left side the next day, and on your upper body one day, then on your lower body the next day).
Danish: Når du skifter depotplasteret, skal du fjerne plasteret fra i går, inden du sætter det nye plaster et nyt sted på huden hver dag (f.eks. på højre side af kroppen en dag, på venstre side næste dag, på overkroppen en dag, længere nede på kroppen næste dag).
English: The incidence and severity of adverse reactions generally increase with increasing doses, particularly at dose changes.
Danish: Forekomsten og sværhedsgraden af bivirkninger øges generelt ved højere doser, især ved dosisændringer.
English: Efficacy was established by the use of independent, domain-specific assessment tools which were applied at regular intervals during the 24-week treatment period.
Danish: Virkningen blev fastslået ved brug af uafhængige domænespecifikke vurderingsredskaber, som blev anvendt med regelmæssige intervaller i den 24 uger lange behandlingsperiode.
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Danish: Hvis tidsfristen for en periodisk, opdateret sikkerhedsindberetning (PSUR) og for opdatering af en RMP er sammenfaldende, kan de fremsendes samtidig.
English: Worsening of Parkinson's disease, seizure
Danish: Forværring af Parkinsons sygdom, krampeanfald
English: You should only open the pouch when you are ready to apply the patch.
Danish: Brevet bør kun åbnes, når du er klar til at påføre plastret.
English: Marketing Authorisation Holder 3M Health Care Limited, 1 Morley Street,
Danish: Indehaver af markedsføringstilladelsen 3M Health Care Limited, 1 Morley Street,
English: The most commonly observed symptom was erythema which disappeared within 24 hours in the vast majority of patients.
Danish: Det mest almindeligt observerede symptom var erytem, som hos langt de fleste patienter forsvandt inden for 24 timer.
English: Most cases of accidental overdose of oral rivastigmine have not been associated with any clinical signs or symptoms and almost all of the patients concerned continued rivastigmine treatment.
Danish: De fleste tilfælde af tilfældig overdosering med oral rivastigmin har ikke været forbundet med kliniske tegn eller symptomer, og næsten alle de pågældende patienter fortsatte behandlingen med rivastigmin.
English: However, use of rivastigmine patch may lead to allergic contact dermatitis.
Danish: Brug af rivastigminplaster kan imidlertid medføre allergisk kontaktdermatitis.
English: Application site reactions were mostly mild to moderate in severity and were rated as severe in less than 2% of patients.
Danish: Reaktioner på applikationsstedet var for det meste milde til moderate i sværhedsgrad og blev bedømt som alvorlig hos mindre end 2% af patienterne.
English: • Instructions to provide patients and caregivers with the patient reminder card The patient reminder card should contain the following key messages:
Danish: • Instruktioner om at forsyne patienter og sundhedsprofessionelle med huskekort til patienter Huskekort til patienter bør indeholde følgende centrale budskaber:
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle mistænkte bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: At the time of granting the marketing authorisation, the submission of periodic safety update reports is not required for this medicinal product.
Danish: På tidspunktet for udstedelsen af markedsføringstilladelsen er det ikke påkrævet, at der fremsendes periodiske, opdaterede sikkerhedsindberetninger (PSUR) for dette lægemiddel.
English: In patients with Alzheimer's dementia, 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 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: The typical symptoms reported among these cases are similar to those seen with cases of overdose associated with rivastigmine oral formulations.
Danish: Typiske symptomer, der blev rapporteret i disse tilfælde, minder om symptomerne, der er set ved overdosering med de orale formuleringer af rivastigmin.
English: Adverse reactions in Table 1 are listed according to MedDRA system organ class and frequency category.
Danish: Bivirkninger i tabel 1 er opstillet i henhold til MedDRA organklasse og hyppighed.
English: Patients involved in the placebo-controlled study had an MMSE (Mini-Mental State Examination) score of 10-20.
Danish: Patienterne i det placebo-kontrollerede studie havde en MMSE-score (Mini-Mental State Examination) på 10-20.
English: Thus, rivastigmine may have an ameliorative effect on cholinergic-mediated cognitive deficits in dementia associated with Alzheimer's disease.
Danish: Følgelig har rivastigmin muligvis en forbedrende effekt på kolinergmedierede kognitive udfald ved demens, som er forbundet med Alzheimers sygdom.
English: There have been rare post-marketing reports of patients experiencing disseminated skin hypersensitivity reactions when administered rivastigmine irrespective of the route of administration (oral, transdermal).
Danish: Der har været sjældne post-marketing-indberetninger om patienter, der har fået disseminerede overfølsomhedsreaktioner i huden efter administration af rivastigmin uanset administrationsvej (oral, transdermal).
English: • Periodic Safety Update Reports
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR)
English: Any used or unused transdermal patches should be disposed of in accordance with local requirements or returned to the pharmacy.
Danish: Brugte eller ubrugte depotplastre destrueres i henhold til lokale retningslinjer eller indleveres på apoteket.
English: Transdermal patch treatment can be resumed at the same dose if treatment is not interrupted for more than three days.
Danish: Behandling med depotplaster kan genoptages ved samme dosis, hvis behandlingen ikke har været afbrudt i mere end 3 dage.
English: At steady state, trough levels are approximately 50% of peak levels, in contrast to oral administration, with which concentrations fall off to virtually zero between doses.
Danish: Ved steady state er de laveste niveauer ca. 50% af de maksimale niveauer i modsætning til oral administration, hvor koncentrationerne falder næsten til nul mellem doserne.
English: Furthermore, rivastigmine may induce syncope or delirium.
Danish: Ydermere kan rivastigmin medføre synkope eller delirium.
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 anvendelse af antiemetika overvejes.
English: Compared to a patient with a body weight of 65 kg, the rivastigmine steady-state concentrations in a patient with a body weight of 35 kg would be approximately doubled, while for a patient with a body weight of 100 kg the concentrations would be approximately halved.
Danish: Sammenlignet med en patient med en legemsvægt på 65 kg vil rivastigminkoncentrationerne ved steady state hos en patient med en legemsvægt på 35 kg være næsten fordoblet, mens koncentrationerne for en patient med en legemsvægt på 100 kg vil være omtrent halveret.
English: Patients involved in the active comparator controlled study had an initial baseline MMSE score of 10-24.
Danish: Patienter, der deltog i det aktive komparator-kontrollerede studie, havde en indledende baseline MMSE score på 10-24.
English: - if you have ever had an allergic reaction to a similar type of medicine (carbamate derivatives).
Danish: - hvis du nogensinde har haft en allergisk reaktion over for en lignende type medicin
English: - Each patch is sealed in its own protective pouch.
Danish: - Hvert plaster er forseglet i et eget beskyttelsesbrev.
English: Most cases of misuse of the medicinal product and dosing errors have involved not removing the old patch when putting on a new one and the use of multiple patches at the same time.
Danish: De fleste tilfælde af forkert brug af lægemidlet og doseringsfejl har omfattet ikke at fjerne det gamle plaster, når nyt plaster sættes på, og brug af flere plastre på samme tid.
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 bruger denne medicin.
English: It is possible that some patients sensitised to rivastigmine by exposure to rivastigmine patch may not be able to take rivastigmine in any form.
Danish: Det er muligt, at nogle patienter, der er sensibiliseret over for rivastigmin ved eksponering for rivastigminplasteret, ikke vil være i stand til at tage nogen form for rivastigmin.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Usually, the side effects will slowly go away as your body gets used to the medicine.
Danish: I de fleste tilfælde vil bivirkningerne gradvist forsvinde, når kroppen vænner sig til medicinen.
English: In peri/postnatal studies in rats, an increased gestation time was observed.
Danish: I peri-/postnatale undersøgelser på rotter blev der observeret forlænget drægtighedsperiode.
English: Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase.
Danish: Rivastigmin virker ved at blokere de enzymer, der nedbryder acetylcholin: acetylcholinesterase og butyrylcholinesterase.
English: Take off your patch and tell your doctor straight away, if you notice any of the following side effects which could become serious:
Danish: Tag plasteret af og fortæl straks din læge, hvis du oplever nogen af følgende bivirkninger, som kan blive alvorlige:
English: You may apply the next patch at the usual time the next day.
Danish: Du kan derefter sætte det næste plaster på til sædvanlig tid næste dag.
English: The exposure to rivastigmine and its metabolites was approximately equivalent to human exposure with highest doses of rivastigmine capsules and transdermal patches.
Danish: Eksponeringen for rivastigmin og dets metabolit svarede omtrent til human eksponering med de højeste doser rivastigminkapsler og -depotplastre.
English: Pharmacotherapeutic group: psychoanaleptics, anticholinesterases, ATC code: N06DA03
Danish: Farmakoterapeutisk klassifikation: Psykoanaleptika, antikolinesteraser, ATC-kode: N06DA03
English: Transdermal use.
Danish: Transdermal anvendelse.
English: In view of its pharmacodynamic effects, rivastigmine should not be given concomitantly with other cholinomimetic substances and might interfere with the activity of anticholinergic medicinal products.
Danish: Som følge af sine farmakodynamiske virkninger bør rivastigmin ikke gives samtidig med andre kolinomimetika, og det kan interferere med antikolinerge lægemidlers aktivitet.
English: The increase in prothrombin time induced by warfarin is not affected by administration of oral rivastigmine.
Danish: Den warfarin-inducerede stigning i protrombin-tid påvirkes ikke af indgift af rivastigmin.
English: Therefore, women on rivastigmine should not breast-feed.
Danish: Kvinder i behandling med rivastigmin bør derfor ikke amme.
English: Caution is recommended when selecting anaesthetic agents.
Danish: Der anbefales at udvise forsigtighed ved valg af anæstesimiddel.
English: If you have not applied a patch for several days, do not apply the next one before you have talked to your doctor.
Danish: Hvis du ikke har brugt et depotplaster i flere dage, skal du ikke bruge det næste, før du har talt med din læge.
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 butyrylkolinesterase-medierede metabolisme af andre stoffer.
English: Do not apply a new patch to the same skin area twice within 14 days.
Danish: Du må ikke sætte et nyt plaster på samme hudområde inden for 14 dage.
English: Rivastigmine interacts with its target enzymes by forming a covalently bound complex that temporarily inactivates the enzymes.
Danish: Rivastigmin reagerer med sine målenzymer ved at danne et kovalentbundet kompleks, som midlertidigt inaktiverer enzymerne.
English: Symptomatic treatment of mild to moderately severe Alzheimer's dementia.
Danish: Symptomatisk behandling af let til moderat svær Alzheimers demens.
English: During the course of the treatment your doctor may adjust the dose to suit your individual needs.
Danish: Under behandlingen kan din læge justere dosis, så den passer bedre til dig.
English: • How to use the reminder card to record patch application and removal.
Danish: • Hvordan huskekortet skal bruges til at registrere påsætning og fjernelse af plaster.
English: How to start treatment
Danish: Start af behandling
English: Based on evidence from in vitro and animal studies, the major cytochrome P450 isoenzymes are minimally involved in rivastigmine metabolism.
Danish: In vitro- og dyreforsøg har vist, at de større cytokrome P450-isoenzymer spiller en minimal rolle i metaboliseringen af rivastigmin.
English: Due to the known vagotonic effect of cholinesterase inhibitors on heart rate, bradycardia and/or syncope may also occur.
Danish: På grund af kolinesterasehæmmeres vagotoniske effekt på hjerterytmen kan der også forekomme bradykardi og/eller synkope.
English: Less NAP226-90 is formed following application of the transdermal patch, presumably because of the lack of presystemic (hepatic first pass) metabolism, in contrast to oral administration.
Danish: Der dannes mindre NAP226-90 efter påføring af depotplasteret, formodentlig på grund af manglende præsystemisk (hepatisk first pass) metabolisering i modsætning til oral indgift.
English: - A protective liner covers the sticky side of the patch.
Danish: - Et beskyttende dæklag dækker plastrets klisterside.
English: In vitro, this metabolite shows minimal inhibition of acetylcholinesterase (<10%).
Danish: In vitro viser metabolitten minimal hæmning af acetylkolinesterase (<10%).
English: Klöcknerstraat 1 3930 Hamont-Achel Belgium
Danish: Klöcknerstraat 1 3930 Hamont-Achel Belgien
English: Rivastigmine 3M Health Care Ltd. can be used with food, drink and alcohol.
Danish: Rivastigmine 3M Health Care Ltd. kan anvendes sammen med mad, drikke og alkohol.
English: If your community burns domestic rubbish, you can dispose of the patch with your domestic rubbish.
Danish: Hvis din kommune brænder dagrenovation, kan du smide depotplasteret i skraldespanden.
English: The patch should be worn continuously until it is time to replace it with a new one.
Danish: Plasteret skal sidde på hele tiden, indtil det skal udskiftes med et nyt.
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 eller betjene maskiner.
English: No pharmacokinetic interaction was observed between oral rivastigmine and digoxin, warfarin, diazepam or fluoxetine in studies in healthy volunteers.
Danish: Der sås ingen farmakokinetisk interaktion mellem oral rivastigmin og digoxin, warfarin, diazepam eller fluoxetin i undersøgelser med raske frivillige forsøgspersoner.
English: At least 4 points improvement on ADAS-Cog with no worsening on ADCSCGIC and ADCS-ADL
Danish: Mindst 4 pointsforbedring på ADAS-Cog og ingen forværring på ADCS-CGIC og ADCS-ADL
English: Available in packs containing 7, 30, 60 and 90 pouches.
Danish: Fås i pakker med 7, 30, 60 og 90 breve.
English: Rivastigmine may exacerbate or induce extrapyramidal symptoms.
Danish: Rivastigmin kan forværre eller inducere ekstrapyramidale symptomer.
English: Rivastigmine 3M Health Care Ltd. 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: Rivastigmine 3M Health Care Ltd. anvendes til behandling af voksne patienter med mild til moderat svær Alzheimers demens, en fremadskridende hjernesygdom, der gradvis påvirker hukommelse, åndsevner og adfærd.
English: In patients with Alzheimer's disease, inhibition of AChE in CSF by oral 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 dosisafhængig op til 6 mg, der blev indgivet to gange dagligt, som var den højeste dosis, der blev testet.
English: Hands should be washed with soap and water after removing the patch.
Danish: Hænderne skal vaskes med sæbe og vand efter fjernelse af plasteret.
English: An initial dose of 0.03 mg/kg intravenous atropine sulphate is recommended, with subsequent doses based on clinical response.
Danish: En initialdosis på 0,03 mg/kg intravenøs atropinsulfat anbefales med efterfølgende doser afhængigt af klinisk respons.
English: Patients with Alzheimer's disease may lose weight whilst taking cholinesterase inhibitors, including rivastigmine.
Danish: Patienter med Alzheimers demens kan tabe sig, når de tager kolinesterasehæmmere, inklusive rivastigmin.
English: To prevent interference with the adhesive properties of the transdermal patch, no cream, lotion or powder should be applied to the skin area where the medicinal product is to be applied.
Danish: For at forhindre interferens med depotplasterets klæbeegenskaber må huden ikke påføres creme, lotion eller pudder på det område, hvor lægemidlet skal påføres.
English: The 48-week results for the two assessment tools are summarised in Table 4.
Danish: 48-ugers resultaterne af de to vurderingsværktøjer er opsummeret i tabel 4.
English: Alzheimer's disease may cause gradual impairment of driving performance or compromise the ability to use machines.
Danish: Alzheimers sygdom kan medføre en gradvis forringelse af køreegenskaberne eller nedsætte evnen til at betjene maskiner.
English: By blocking these enzymes, Rivastigmine 3M Health Care Ltd. allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's disease.
Danish: Ved at blokere disse enzymer kan Rivastigmine 3M Health Care Ltd. medvirke til, at acetylcholin-indholdet øges i hjernen, hvilket hjælper med at reducere symptomerne på Alzheimers sygdom.
English: With multiple dosing (such as at steady state), after the previous transdermal patch is replaced with a new one, plasma concentrations initially decrease slowly for about 40 minutes on average, until absorption from the newly applied transdermal patch becomes faster than elimination, and plasma levels begin to rise again to reach a new peak at approximately 8 hours.
Danish: Med multidosering (f.eks. ved steady state) efter udskiftning af det foregående depotplaster falder plasmakoncentrationerne først langsomt i ca. 40 minutter i gennemsnit, indtil absorptionen fra det nypåførte depotplaster bliver hurtigere end eliminationen, og plasmaniveauerne begynder at stige igen for atter at nå den maksimale koncentration efter ca. 8 timer.
English: Less than 1% of the administered dose is excreted in the faeces.
Danish: Under 1% af den givne dosis udskilles i fæces.
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 oral dosis på 3 mg aktiviteten af acetylkolinesterase (AChE) i CSF med ca. 40% inden for den første 1,5 time efter indgift.
English: Klöcknerstraat 1, 3930 Hamont-Achel Belgium
Danish: Klöcknerstraat 1, 3930 Hamont-Achel Belgien
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 exceeding 104 times the foreseen clinical exposure.
Danish: Rivastigmin var ikke mutagen i et standardbatteri af in vitro- og in vivo-test, på nær i en kromosomal Aberration Test i humane perifere lymfocytter ved en dosis på 104 gange den forudsete kliniske eksponering.
English: Slow heartbeat and fainting may also occur.
Danish: Langsom hjerterytme og besvimelsesanfald kan også forekomme.
English: The results for clinically relevant responders from the 24-week placebo-controlled study are provided in Table 3.
Danish: Resultaterne for patienter med klinisk relevant respons fra de 24 ugers placebo-kontrolleret studie er angivet i tabel 3.
English: Patients who develop application site reactions suggestive of allergic contact dermatitis to rivastigmine patch and who still require rivastigmine treatment should only be switched to oral rivastigmine after negative allergy testing and under close medical supervision.
Danish: Patienter, der får reaktioner på applikationsstedet, der tyder på allergisk kontaktdermatitis af rivastigminplasteret, og som fortsat har behov for rivastigminbehandling, bør kun skiftes over til oral rivastigmin efter en negativ allergitest og under tæt supervision.
English: Clinically relevant improvement was defined a priori as at least 4-point improvement on the ADAS-Cog, no worsening on the ADCS-CGIC, and no worsening on the ADCS-ADL.
Danish: Klinisk relevant forbedring var på forhånd defineret som mindst en 4pointsforbedring på ADAS-Cog, ingen forværring på ADCS-CGIC og ingen forværring på ADCSADL.
English: After the peak, plasma concentrations slowly decrease over the remainder of the 24-hour period of application.
Danish: Efter at have nået den maksimale koncentration mindskes plasmakoncentrationen langsomt over den resterende del af 24-timers-behandlingsperioden.
English: - if you have, or have ever had, asthma or a severe respiratory disease.
Danish: - hvis du har eller har haft astma eller en svær luftvejssygdom.
English: In case of contact with eyes or if the eyes become red after handling the patch, rinse immediately with plenty of water and seek medical advice if symptoms do not resolve.
Danish: I tilfælde af kontakt med øjnene, eller hvis øjnene bliver røde efter håndtering af plasteret, skyl straks grundigt med vand og søg læge, hvis symptomerne ikke forsvinder.
English: No evidence of carcinogenicity was found in oral and topical studies in mice and in an oral study in rats at the maximum tolerated dose.
Danish: Der var ingen tegn på karcinogenitet i orale og topiske studier på mus og i en oral undersøgelse på rotter ved maksimalt tolereret dosis.
English: Peel off one half of the protective liner and do not touch the sticky part of the patch with the fingers.
Danish: Træk halvdelen af dæklaget af, og rør ikke klisterdelen på plastret med fingrene.
English: Consider using the 4.6 mg/24 h transdermal patch both as initial and maximum dose in these patients.
Danish: Overvej at anvende 4,6 mg/24 timer depotplaster både som start og maksimum dosis hos disse patienter.
English: Having multiple patches on your body could expose you to an excessive amount of this medicine which could be potentially dangerous.
Danish: Hvis du har flere depotplastre på din krop samtidigt, kan du udsætte dig for en for stor mængde medicin, hvilket kan være farligt.