FrancophonIA/ELRC3.0 huggingface dataset:
English: - The patch should be replaced by a new one after 24 hours.
Danish: Udskift plasteret med et nyt efter 24 timer.
English: The backing layer is transparent to translucent, labelled with “R10” in a repeated pattern.
Danish: Bagsidelaget er gennemsigtigt til gennemskinneligt, mærket med "R10" i et gentagelsesmønster.
English: As rivastigmine has a plasma half-life of about 3.4 hours and a duration of acetylcholinesterase inhibition of about 9 hours, it is recommended that in cases of asymptomatic overdose all Rivastigmine 3M Health Care Ltd. transdermal patches should be removed immediately and no further transdermal patch should be applied for the next 24 hours.
Danish: Behandling Eftersom rivastigmin har en plasmahalveringstid på ca. 3,4 timer og en acetylkolinesterasehæmning, som varer ca. 9 timer, anbefales det i tilfælde af asymptomatisk overdosering, at alle Rivastigmine 3M depotplastre straks fjernes, og at der ikke påføres nye depotplastre inden for de næste 24 timer.
English: As suggested by compartmental modelling, 9.5 mg/24 h transdermal patches exhibited exposure similar to that provided by an oral dose of 12 mg/day.
Danish: Som antydet ved compartment-modellen viste rivastigmin 9,5 mg/24 timer depotplastre eksponering tilsvarende den, der fås ved en oral dosis på 12 mg dagligt.
English: If the oral dose of 9 mg/day has not been stable and well tolerated, a switch to 4.6 mg/24 h transdermal patches is recommended.
Danish: Hvis den orale dosis på 9 mg/dag ikke er stabil og veltolereret, anbefales et skift til 4,6 mg/24 timer depotplastre.
English: Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller på apoteket, hvis du bruger anden medicin eller har gjort det for nylig.
English: Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.
Danish: Din læge vil fortælle dig, om du kan køre bil eller betjene maskiner i forbindelse med din sygdom.
English: Each patch consists of a combination of a removable, transparent, split release liner, a functional layer containing drug-inadhesive (DIA) matrix, and a protective backing layer.
Danish: Hvert plaster består af en kombination af et aftageligt, gennemsigtigt dæklag, et funktionslag bestående af DIA-matrix og et beskyttelseslag på bagsiden.
English: Absorption of rivastigmine from rivastigmine transdermal patches is slow.
Danish: Rivastigmin fra rivastigmin depotplastre absorberes langsomt.
English: Where to apply your Rivastigmine 3M Health Care Ltd. transdermal patch - Before you apply a patch, make sure that your skin is clean, dry and hairless, free of any powder, oil, moisturiser or lotion that could keep the patch from sticking to your skin properly, free of cuts, rashes and/or irritations.
Danish: Placering af dit Rivastigmine 3M Health Care Ltd. depotplaster - Før du sætter et depotplaster på, skal du sørge for, at huden er ren, tør og glat uden hår, fri for pudder, olie, fugtighedscreme eller lotion, som kan bevirke, at depotplasteret ikke klæber rigtigt til huden, fri for sår/rifter, udslæt og/eller irritation.
English: They may experience more adverse reactions and may be more likely to discontinue due to adverse reactions.
Danish: De kan opleve flere bivirkninger og har større risiko for at måtte afbryde behandlingen på grund af bivirkninger.
English: After oral administration, 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: Efter oral indgift var Cmax for rivastigmin ca. 60% højere, og AUC for rivastigmin var mere end dobbelt så høj hos personer med mildt til moderat nedsat leverfunktion end hos raske personer.
English: Change 265 -4.4 271 -6.2 2.2 (0.8,
Danish: Ændring 265 -4,4 271 -6,2 2,2 (0,8, 3,6) CI - confidence interval.
English: Pruritus, erythema, urticaria, vesicles, allergic dermatitis, disseminated
Danish: Kløe, erytem, urticaria, blærer, allergisk dermatitis, spredte kutane
English: Therefore, the patient/caregiver should avoid contact with the eyes after handling of the patch (see section 4.4).
Danish: Derfor bør patienten/omsorgsgiveren undgå kontakt med øjnene efter at have rørt ved depotplasteret (se pkt.
English: The inter-patient variability in a steady-state study in Alzheimer's dementia was at most 45% (Cmax) and 43% (AUC0-24h) after use of the transdermal patch, and 71% and 73%, respectively, after administration of the oral form.
Danish: Inter-patientvariationerne i et steady statestudie af Alzheimers demens var højst 45% (Cmax) og 43% (AUC0-24h) efter brug af depotplasteret, og henholdsvis 71% og 73% efter administration af den orale formulering.
English: Carefully titrate and monitor these patients for adverse reactions (e.g. excessive nausea or vomiting) and consider reducing the maintenance dose to the 4.6 mg/24 h transdermal patch if such adverse reactions develop.
Danish: Patienter skal titreres forsigtigt og monitoreres for bivirkninger (fx overdreven kvalme eller opkastning) og overvej at reducere vedligeholdelsesdosis til 4,6 mg/24 timer depotplaster, hvis sådanne bivirkninger udvikler sig.
English: Efficacy was established by the use of ADAS-Cog (Alzheimer's Disease Assessment Scale - Cognitive subscale, a performance-based measure of cognition) and the ADCS-IADL (Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living) assessing instrumental activities which include maintaining finances, meal preparation, shopping, ability to orient oneself to surroundings, ability to be left unattended.
Danish: Effekten blev fastslået ved hjælp af ADAS-Cog (Alzheimers Disease Assessment Scale - Cognitive subscale, en præstationsbaseret måling af kognition) og ADCS-IADL (Alzheimers Disease Cooperative StudyInstrumental Activities of Daily Living) der vurderer instrumentale aktiviteter, som omfatter vedligeholdelse af budget, tilberedning af måltider, indkøb, evnen til at orientere sig til omgivelserne, evnen til at klare sig uden opsyn.
English: When doses higher than 13.3 mg/24 h were used in the above-mentioned placebo-controlled study, insomnia and cardiac failure were observed more frequently than with 13.3 mg/24 h or placebo, suggesting a dose effect relationship.
Danish: Når der blev anvendt højere doser end 13,3 mg/24 timer i ovennævnte placebo-kontrollerede studie, blev der observeret søvnløshed og hjertesvigt oftere end med 13,3 mg/24 timer eller placebo.
English: If this applies to you, tell your doctor and do not apply Rivastigmine 3M Health Care Ltd. transdermal patches.
Danish: Hvis dette gælder for dig, skal du fortælle det til din læge og ikke bruge Rivastigmine 3M Health Care Ltd. depotplastre.
English: Gastrointestinal disorders
Danish: Gastrointestinale gener
English: The transdermal patch should not be applied to skin that is red, irritated or cut.
Danish: Depotplasteret må ikke påføres rød eller irriteret hud eller hud med rifter.
English: Atrioventricular block, atrial fibrillation, tachycardia, sick sinus
Danish: Atrioventrikulært blok, atrieflimren, takykardi, syg sinus-syndrom
English: Other side effects seen with Rivastigmine 3M Health Care Ltd. capsules or oral solution and which may occur with the patch:
Danish: Andre bivirkninger, der er set med Rivastigmine 3M Health Care Ltd. kapsler eller oral opløsning, og som kan forekomme ved brug af plasteret:
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 transdermal patch per pouch.
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1 depotplaster pr. brev
English: Rectangular patches, approximately 3.5 cm by 2.6 cm with rounded corners.
Danish: Rektangulære plastre, cirka 3,5 cm x 2,6 cm med afrundede hjørner.
English: The patches are available in packs containing 7, 30, 60 and 90 pouches.
Danish: Depotplastrene fås i æsker med ,7 30, 60 og 90 breve.
English: Rivastigmine 3M Health Care Ltd. transdermal patches may cause fainting or severe confusion.
Danish: Rivastigmine 3M Health Care Ltd. depotplastre kan fremkalde besvimelse eller stærk forvirring.
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 betændelse i huden, hævelse), og hvis det ikke bliver bedre inden for 48 timer efter, at plasteret er fjernet.
English: Each transdermal patch consists of three layers; a backing layer, an adhesive layer containing the medicine and a transparent, split release liner.
Danish: Hvert depotplaster består af tre lag: et bagsidelag, et klæbelag med lægemiddel og et gennemsigtigt dæklag.
English: These include the ADAS-Cog (Alzheimer's Disease Assessment Scale - Cognitive subscale, a performance-based measure of cognition) and the ADCS-CGIC (Alzheimer's Disease Cooperative Study - Clinician's Global Impression of Change, a comprehensive global assessment of the patient by the physician incorporating caregiver input), and the ADCS-ADL (Alzheimer's Disease Cooperative StudyActivities of Daily Living, 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 related to finances).
Danish: Disse omfatter ADAS-Cog (Alzheimer´s Disease Assessment Scale - Cognitive subscale, en præstationsbaseret måling af kognition), ADCS-CGIC (Alzheimer´s Disease Cooperative Study - Clinician´s Global Impression of Change, en omfattende global vurdering af patienten, der dannes af den behandlende læge med input fra den omsorgsgivende person) og ADCS-ADL (Alzheimer´s Disease Cooperative Study - Activities of Daily Living, den omsorgsgivende persons vurdering af dagligdagsaktiviteter herunder personlig hygiejne, fødeindtagelse, påklædning, husføring såsom indkøb, opretholdelse af evnen til at orientere sig i forhold til omgivelserne og involvere sig i økonomiske anliggender).
English: Application site skin reactions (usually mild to moderate application site erythema), are the most frequent adverse reactions observed with the use of rivastigmine transdermal patch.
Danish: Hudreaktioner på applikationsstedet (normalt let til moderat erytem på applikationsstedet), er de hyppigste bivirkninger observeret ved brug af rivastigmin depotplaster.
English: SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from light.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i originalemballagen for at beskytte mod lys.
English: The following adverse reactions have only been observed with rivastigmine capsules and oral solution and not in clinical studies with rivastigmine transdermal patches: somnolence, malaise, tremor, confusion, sweating increased (common); duodenal ulcers, angina pectoris (rare); gastrointestinal haemorrhage (very rare); and some cases of severe vomiting were associated with oesophageal rupture (not known).
Danish: Følgende bivirkninger er kun observeret med rivastigmin-kapsler og oral opløsning og ikke i kliniske studier med rivastigmin depotplaster: Døsighed, utilpashed, tremor, konfusion, øget perspiration (almindelig), sår på tolvfingertarmen, angina pectoris (sjælden), gastrointestinal blødning (meget sjælden) samt nogle tilfælde af svære opkastninger, der blev associeret med øsofagusruptur (ikke kendt).
English: In the 24-week doubleblind study, the most commonly observed symptoms (skin irritation rating scale) with rivastigmine 9.5 mg/24 h transdermal patches were very slight (21.8%), mild (12.5%) or moderate (6.5%) erythema or very slight (11.9%), mild (7.3%) or moderate (5.0%) pruritus.
Danish: I det 24-ugers dobbeltblindede studie var de mest almindeligt observerede symptomer (hudirritationsskalaen) med rivastigmin 9,5 mg/24 timer depotplastre meget let (21,8%), mildt (12,5%) eller moderat (6,5%) erytem eller meget let (11,9%), mild (7,3%) eller moderat (5,0%) kløe.
English: You may become dehydrated (losing too much fluid) if vomiting or diarrhoea are prolonged.
Danish: Du kan blive dehydreret (få væskemangel), hvis du kaster op eller har diarré i længere tid.
English: p-value versus placebo *p<0.05 versus placebo
Danish: p-værdi versus placebo *p<0,05 versus placebo
English: left upper back or right upper back left lower back or right lower back
Danish: • ventre øvre ryg eller højre øvre ryg
English: Do not use Rivastigmine 3M Health Care Ltd. - if you are allergic to rivastigmine or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Rivastigmine 3M Health Care Ltd. - hvis du er allergisk over for rivastigmin eller et af de øvrige indholdsstoffer i dette lægemiddel
English: The effect of bodyweight on active substance exposure suggests special attention to patients with very low body weight during up-titration (see section 4.4).
Danish: Legemsvægtens indvirkning på eksponeringen for aktive stoffer tyder på, at man under titreringen skal være særligt opmærksom på patienter med meget lav legemsvægt (se pkt.
English: Most skin reactions were limited to the application site and resulted in discontinuation in only 2.4% of the patients in the rivastigmine 9.5 mg/24 h transdermal patch group.
Danish: De fleste hudreaktioner var begrænset til applikationsstedet og resulterede kun i afbrydelse hos 2,4% af patienterne i rivastigmin 9,5 mg/24 timer depotplastre-behandlingsgruppen.
English: Your doctor will tell you which Rivastigmine 3M Health Care Ltd. transdermal patch is most suitable for you.
Danish: Din læge vil fortælle dig, hvilket Rivastigmine 3M Health Care Ltd. depotplaster, der er bedst egnet til dig.
English: It is not known if rivastigmine is excreted into human milk.
Danish: Hvorvidt rivastigmin udskilles i human mælk, vides ikke.
English: Carefully remove the existing patch before putting on a new one.
Danish: Fjern forsigtigt det eksisterende plaster inden et nyt sættes på.
English: 7 transdermal patches 30 transdermal patches 60 transdermal patches 90 transdermal patches
Danish: 7 depotplastre 30 depotplastre 60 depotplastre 90 depotplastre
English: - if you have impaired liver function.
Danish: - hvis du har nedsat leverfunktion.
English: Mean score  SD p-value versus placebo ADCS-ADL
Danish: Gennemsnitsscore  SD p-værdi versus placebo ADCS-ADL
English: One transdermal patch is sealed in one pouch.
Danish: Hvert depotplaster er forseglet i et brev.
English: The study was designed to compare the efficacy of the 13.3 mg/24 h transdermal patch against the 9.5 mg/24 h transdermal patch during a 48-week double-blind treatment phase in Alzheimer's disease patients who demonstrated functional and cognitive decline after an initial 24-48 week openlabel treatment phase while on a maintenance dose of 9.5 mg/24 h transdermal patch.
Danish: Studiet var designet til at sammenligne effekten af 13,3 mg/24 timer depotplaster med 9,5 mg/24 timer depotplaster i løbet af en 48-ugers dobbeltblindet behandlingsfase hos patienter med Alzheimers sygdom, som viste funktionel og kognitiv tilbagegang efter en indledende 24-48 ugers åben behandlingsfase med anvendelse af en vedligeholdelsesdosis på 9,5 mg/24 timer depotplaster.
English: Special populations - Paediatric population: There is no relevant use of Rivastigmine 3M Health Care Ltd. in the paediatric population in the treatment of Alzheimer's disease.
Danish: • Pædiatrisk population: Der er ingen relevante indikationer for brug af Rivastigmine 3M Health Care Ltd. i den pædiatriske population til behandling af Alzheimers demens.
English: The single-dose inter-subject variability in rivastigmine pharmacokinetic parameters (normalised to dose/kg bodyweight) was 43% (Cmax) and 49% (AUC0-24h) after transdermal administration versus 74% and 103%, respectively, after the oral form.
Danish: Enkelt-dosis inter-patientvariationerne i rivastigmins farmakokinetiske parametre (normaliseret til dosis/kg legemsvægt) var 43% (Cmax) og 49% (AUC0-24h) efter transdermal administration mod henholdsvis 74% og 103% efter den orale formulering.
English: Table 1 displays the adverse reactions reported in 854 patients with Alzheimer's dementia treated in randomised, double-blind, placebo and active-controlled clinical studies with rivastigmine transdermal patches for a duration of 24-48 weeks and from post-marketing data.
Danish: Tabel 1 viser de bivirkninger, som blev rapporteret hos 854 patienter med Alzheimers demens behandlet med rivastigmin depotplastre med en varighed på 24-48 uger og fra post-marketing data i randomiserede, dobbeltblindede, placebo- og aktivkontrollerede kliniske studier.
English: Only one patch should be worn at a time (see section 4.9).
Danish: Der må kun påføres ét plaster ad gangen (se pkt.
English: The most commonly observed severe symptoms with rivastigmine 9.5 mg/24 h transdermal patches were pruritus (1.7%) and erythema (1.1%).
Danish: De mest almindeligt observerede svære symptomer med rivastigmin 9,5 mg/24 timer depotplastre var kløe (1,7%) og erytem (1,1%).
English: If well tolerated and only after a minimum of six months of treatment at 9.5 mg/24 h, the treating physician may consider increasing the dose to 13.3 mg/24 h in patients who have demonstrated a meaningful cognitive deterioration (e.g. decrease in the MMSE) and/or functional decline (based on physician judgement) while on the recommended daily effective dose of 9.5 mg/24 h (see section 5.1).
Danish: Hvis dette tåles godt, og kun efter minimum 6 måneders behandling med 9,5 mg/24 timer, kan den behandlende læge overveje at øge dosis til 13,3 mg/24 timer, hos patienter som har vist betydningsfuld kognitiv tilbagegang (fx nedgang i MMSE) og/eller funktionel nedgang (baseret på lægens bedømmelse) ved anvendelse af den anbefalede daglige vedligeholdelsesdosis på 9,5 mg/24 timer (se pkt 5.1).
English: One pouch contains one transdermal patch.
Danish: Et brev indeholder et depotplaster.
English: If you have not applied a patch for three days, do not apply the next one before you have talked to your doctor.
Danish: Hvis du ikke har brugt et depotplaster i 3 dage, skal du tale med din læge, før du bruger det næste.
English: - The patch should not be cut into pieces.
Danish: - Plasteret må ikke klippes i stykker.
English: Each transdermal patch of 8.3 cm2 contains 14.33 mg of rivastigmine.
Danish: Hvert depotplaster på 8,3 cm2 indeholder 14,33 mg rivastigmin.
English: As a cholinesterase inhibitor, rivastigmine may exaggerate the effects of succinylcholine-type muscle relaxants during anaesthesia.
Danish: Rivastigmin er en kolinesterasehæmmer og kan forstærke virkningen af muskelrelaksantia af succinylkolintypen under anæstesi.
English: Rare (may affect up to 1 in 1,000 people) - Falling
Danish: Sjælden (kan forekomme hos op til 1 ud af 1.000 patienter) Fald
English: Each transdermal patch of 4.15 cm2 contains 7.17 mg of rivastigmine.
Danish: Hvert depotplaster på 4,15 cm2 indeholder 7,17 mg rivastigmin.
English: • Patient reminder card
Danish: • Huskekort til patienter
English: If you use more Rivastigmine 3M Health Care Ltd. than you should If you accidentally apply more than one patch, remove all the patches from your skin, then inform your doctor that you have accidentally applied more than one patch.
Danish: Hvis du har brugt for mange Rivastigmine 3M Health Care Ltd. depotplastre Hvis du kommer til at sætte mere end ét plaster på, skal du tage alle plastre af huden og informere din læge om, at du er kommet til at sætte flere plastre på.
English: Skin application site reactions
Danish: Hudreaktioner på applikationsstedet
English: Posology
Danish: Posologi
English: What Rivastigmine 3M Health Care Ltd. contains - The active substance is rivastigmine.
Danish: Rivastigmine 3M Health Care Ltd. indeholder: - Aktivt stof: rivastigmin.
English: However, due to increased exposure in these populations as observed with the oral forms, dosing recommendations to titrate according to individual tolerability should be closely followed as patients with clinically significant hepatic impairment might experience more adverse reactions.
Danish: På grund af øget biotilgængelighed hos disse patienter observeret med de orale formuleringer, bør anbefalingerne vedrørende titrering i henhold til individuel tolerance dog følges nøje, da patienter med klinisk signifikant nedsat leverfunktion kan opleve flere bivirkninger.
English: Previous history of application site reactions suggestive of allergic contact dermatitis with rivastigmine patch (see section 4.4).
Danish: Anamnese med reaktioner på applikationsstedet, der tyder på allergisk kontaktdermatitis af rivastigminplaster (se pkt.
English: Not known (frequency cannot be estimated from the available data) - Allergic reaction where the patch was used, such as blisters or inflamed skin - The signs of Parkinson's disease get worse - such as tremor, stiffness and shuffling - Inflammation of the pancreas - signs include serious upper stomach pain, often with feeling sick
Danish: Ikke kendt (hyppighed kan ikke beregnes ud fra tilgængelige data) Reaktioner på applikationsstedet, såsom blister eller betændelse i huden Symptomer på Parkinsons sygdom bliver værre- såsom rysten, stivhed og slæben Betændelse i bugspytkirtelen - symptomerne omfatter alvorlige smerter øverst i maven, ofte med kvalme eller opkastning Hurtig eller uregelmæssig hjerterytme (puls)
English: Transdermal patches should be applied once a day to clean, dry, hairless, intact healthy skin on the upper or lower back, upper arm or chest, in a place which will not be rubbed by tight clothing.
Danish: Depotplasteret påføres én gang dagligt på ren, tør, hårløs intakt sund hud på ryg, overarm eller bryst på et sted, hvor stramt tøj ikke kan gnide mod plasteret.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each transdermal patch releases 9.5 mg of rivastigmine per 24 hours.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert depotplaster frigiver 9,5 mg rivastigmin pr. 24 timer.
English: Common (may affect up to 1 in 10 people) - Loss of appetite - Feeling dizzy - Feeling agitated or sleepy - Urinary incontinence (inability to retain adequate urine)
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 patienter) - Appetitløshed - Svimmelhed - Træthed- eller svaghedsfornemmelse - Urininkontinens (manglende evne til at holde på urinen)
English: Otherwise your doctor will restart your treatment on Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h.
Danish: Ellers vil din læge genstarte din behandling med Rivastigmine 3M Health Care Ltd. 4,6 mg/24 timer.
English: Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain
Danish: Kvalme, opkastning, diarré, dyspepsi, mavesmerter
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each transdermal patch releases 4.6 mg of rivastigmine per 24 hours.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert depotplaster frigiver 4,6 mg rivastigmin pr. 24 timer.
English: No specific interaction studies have been performed with Rivastigmine 3M Health Care Ltd. transdermal patches.
Danish: Der er ikke udført specifikke interaktionsstudier med Rivastigmine 3M Health Care Ltd. depotplastre.
English: Transdermal use
Danish: Transdermal anvendelse
English: The dose of rivastigmine released from the transdermal patch over 24 hours (mg/24 h) cannot be directly equated to the amount (mg) of rivastigmine contained in a capsule with respect to plasma concentration produced over 24 hours.
Danish: I forhold til plasmakoncentrationen over 24 timer, kan der ikke direkte sættes lighedstegn mellem dosen af rivastigmin frigivet fra depotplastret over 24 timer (mg/24 timer) og mængden (mg) rivastigmin en kapsel indeholder.
English: Very rare (may affect up to 1 in 10,000 people) - Stiff arms or legs - Trembling hands
Danish: Meget sjælden (kan forekomme hos op til 1 ud af 10.000 patienter) Stivhed i arme eller ben
English: Reporting of suspected adverse reactions
Danish: Indberetning af mistænkte bivirkninger