natgillin/translations-raw huggingface dataset:
Bagsidelaget er gennemsigtigt til gennemskinneligt, mærket med "R10" i et gentagelsesmønster.
The backing layer is transparent to translucent, labelled with “R10” in a repeated pattern.
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.
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.
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.
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.
Hvis den orale dosis på 9 mg/dag ikke er stabil og veltolereret, anbefales et skift til 4,6 mg/24 timer depotplastre.
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.
Fortæl altid lægen eller på apoteket, hvis du bruger anden medicin eller har gjort det for nylig.
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Din læge vil fortælle dig, om du kan køre bil eller betjene maskiner i forbindelse med din sygdom.
Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.
Hvert plaster består af en kombination af et aftageligt, gennemsigtigt dæklag, et funktionslag bestående af DIA-matrix og et beskyttelseslag på bagsiden.
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.
Rivastigmin fra rivastigmin depotplastre absorberes langsomt.
Absorption of rivastigmine from rivastigmine transdermal patches is slow.
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.
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.
De kan opleve flere bivirkninger og har større risiko for at måtte afbryde behandlingen på grund af bivirkninger.
They may experience more adverse reactions and may be more likely to discontinue due to adverse reactions.
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.
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.
Ændring 265 -4,4 271 -6,2 2,2 (0,8, 3,6) CI - confidence interval.
Change 265 -4.4 271 -6.2 2.2 (0.8,
Kløe, erytem, urticaria, blærer, allergisk dermatitis, spredte kutane
Pruritus, erythema, urticaria, vesicles, allergic dermatitis, disseminated
Derfor bør patienten/omsorgsgiveren undgå kontakt med øjnene efter at have rørt ved depotplasteret (se pkt.
Therefore, the patient/caregiver should avoid contact with the eyes after handling of the patch (see section 4.4).
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.
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.
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.
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.
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.
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.
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.
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.
Hvis dette gælder for dig, skal du fortælle det til din læge og ikke bruge Rivastigmine 3M Health Care Ltd. depotplastre.
If this applies to you, tell your doctor and do not apply Rivastigmine 3M Health Care Ltd. transdermal patches.
Gastrointestinale gener
Gastrointestinal disorders
Depotplasteret må ikke påføres rød eller irriteret hud eller hud med rifter.
The transdermal patch should not be applied to skin that is red, irritated or cut.
Atrioventrikulært blok, atrieflimren, takykardi, syg sinus-syndrom
Atrioventricular block, atrial fibrillation, tachycardia, sick sinus
Andre bivirkninger, der er set med Rivastigmine 3M Health Care Ltd. kapsler eller oral opløsning, og som kan forekomme ved brug af plasteret:
Other side effects seen with Rivastigmine 3M Health Care Ltd. capsules or oral solution and which may occur with the patch:
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1 depotplaster pr. brev
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 transdermal patch per pouch.
Rektangulære plastre, cirka 3,5 cm x 2,6 cm med afrundede hjørner.
Rectangular patches, approximately 3.5 cm by 2.6 cm with rounded corners.
Depotplastrene fås i æsker med ,7 30, 60 og 90 breve.
The patches are available in packs containing 7, 30, 60 and 90 pouches.
Rivastigmine 3M Health Care Ltd. depotplastre kan fremkalde besvimelse eller stærk forvirring.
Rivastigmine 3M Health Care Ltd. transdermal patches may cause fainting or severe confusion.
- 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.
- 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.
Hvert depotplaster består af tre lag: et bagsidelag, et klæbelag med lægemiddel og et gennemsigtigt dæklag.
Each transdermal patch consists of three layers; a backing layer, an adhesive layer containing the medicine and a transparent, split release liner.
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).
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).
Hudreaktioner på applikationsstedet (normalt let til moderat erytem på applikationsstedet), er de hyppigste bivirkninger observeret ved brug af rivastigmin depotplaster.
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.
SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i originalemballagen for at beskytte mod lys.
SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from light.
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).
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).
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.
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.
Du kan blive dehydreret (få væskemangel), hvis du kaster op eller har diarré i længere tid.
You may become dehydrated (losing too much fluid) if vomiting or diarrhoea are prolonged.
p-værdi versus placebo *p<0,05 versus placebo
p-value versus placebo *p<0.05 versus placebo
• ventre øvre ryg eller højre øvre ryg
left upper back or right upper back left lower back or right lower back
Brug ikke Rivastigmine 3M Health Care Ltd. - hvis du er allergisk over for rivastigmin eller et af de øvrige indholdsstoffer i dette lægemiddel
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).
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.
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).
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.
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.
Din læge vil fortælle dig, hvilket Rivastigmine 3M Health Care Ltd. depotplaster, der er bedst egnet til dig.
Your doctor will tell you which Rivastigmine 3M Health Care Ltd. transdermal patch is most suitable for you.
Hvorvidt rivastigmin udskilles i human mælk, vides ikke.
It is not known if rivastigmine is excreted into human milk.
Fjern forsigtigt det eksisterende plaster inden et nyt sættes på.
Carefully remove the existing patch before putting on a new one.
7 depotplastre 30 depotplastre 60 depotplastre 90 depotplastre
7 transdermal patches 30 transdermal patches 60 transdermal patches 90 transdermal patches
- hvis du har nedsat leverfunktion.
- if you have impaired liver function.
Gennemsnitsscore  SD p-værdi versus placebo ADCS-ADL
Mean score  SD p-value versus placebo ADCS-ADL
Hvert depotplaster er forseglet i et brev.
One transdermal patch is sealed in one pouch.
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.
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.
• Pædiatrisk population: Der er ingen relevante indikationer for brug af Rivastigmine 3M Health Care Ltd. i den pædiatriske population til behandling af Alzheimers demens.
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.
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.
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.
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.
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.
Der må kun påføres ét plaster ad gangen (se pkt.
Only one patch should be worn at a time (see section 4.9).
De mest almindeligt observerede svære symptomer med rivastigmin 9,5 mg/24 timer depotplastre var kløe (1,7%) og erytem (1,1%).
The most commonly observed severe symptoms with rivastigmine 9.5 mg/24 h transdermal patches were pruritus (1.7%) and erythema (1.1%).
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).
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).
Et brev indeholder et depotplaster.
One pouch contains one transdermal patch.
Hvis du ikke har brugt et depotplaster i 3 dage, skal du tale med din læge, før du bruger det næste.
If you have not applied a patch for three days, do not apply the next one before you have talked to your doctor.
- Plasteret må ikke klippes i stykker.
- The patch should not be cut into pieces.
Hvert depotplaster på 8,3 cm2 indeholder 14,33 mg rivastigmin.
Each transdermal patch of 8.3 cm2 contains 14.33 mg of rivastigmine.
Rivastigmin er en kolinesterasehæmmer og kan forstærke virkningen af muskelrelaksantia af succinylkolintypen under anæstesi.
As a cholinesterase inhibitor, rivastigmine may exaggerate the effects of succinylcholine-type muscle relaxants during anaesthesia.
Sjælden (kan forekomme hos op til 1 ud af 1.000 patienter) Fald
Rare (may affect up to 1 in 1,000 people) - Falling
Hvert depotplaster på 4,15 cm2 indeholder 7,17 mg rivastigmin.
Each transdermal patch of 4.15 cm2 contains 7.17 mg of rivastigmine.
• Huskekort til patienter
• Patient reminder card
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.
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.
Hudreaktioner på applikationsstedet
Skin application site reactions
Posologi
Posology
Rivastigmine 3M Health Care Ltd. indeholder: - Aktivt stof: rivastigmin.
What Rivastigmine 3M Health Care Ltd. contains - The active substance is rivastigmine.
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.
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.
Anamnese med reaktioner på applikationsstedet, der tyder på allergisk kontaktdermatitis af rivastigminplaster (se pkt.
Previous history of application site reactions suggestive of allergic contact dermatitis with rivastigmine patch (see section 4.4).
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)
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
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.
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.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert depotplaster frigiver 9,5 mg rivastigmin pr. 24 timer.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each transdermal patch releases 9.5 mg of rivastigmine per 24 hours.
Almindelig (kan forekomme hos op til 1 ud af 10 patienter) - Appetitløshed - Svimmelhed - Træthed- eller svaghedsfornemmelse - Urininkontinens (manglende evne til at holde på urinen)
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)
Ellers vil din læge genstarte din behandling med Rivastigmine 3M Health Care Ltd. 4,6 mg/24 timer.
Otherwise your doctor will restart your treatment on Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h.
Kvalme, opkastning, diarré, dyspepsi, mavesmerter
Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert depotplaster frigiver 4,6 mg rivastigmin pr. 24 timer.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each transdermal patch releases 4.6 mg of rivastigmine per 24 hours.
Der er ikke udført specifikke interaktionsstudier med Rivastigmine 3M Health Care Ltd. depotplastre.
No specific interaction studies have been performed with Rivastigmine 3M Health Care Ltd. transdermal patches.
Transdermal anvendelse
Transdermal use
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.
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.
Meget sjælden (kan forekomme hos op til 1 ud af 10.000 patienter) Stivhed i arme eller ben
Very rare (may affect up to 1 in 10,000 people) - Stiff arms or legs - Trembling hands
Indberetning af mistænkte bivirkninger
Reporting of suspected adverse reactions
I tilfælde af, at limrester er tilovers på din hud, opblød forsigtigt området med varmt vand og mild sæbe eller brug babyolie til at fjerne det.
In case the adhesive residue is left over on your skin, gently soak the area with warm water and mild soap or use baby oil to remove it. Alcohol or other dissolving liquids (nail polish remover or other solvents) should not be used.
Graviditet, amning og frugtbarhed
Pregnancy, breast feeding and fertility
Rivastigmin udskilles i mælken hos dyr.
In animals, rivastigmine is excreted into milk.
• Nedsat nyrefunktion: Dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion.
- Renal impairment: No dose adjustment is necessary for patients with renal impairment.
Opbevares i originalemballagen for at beskytte mod lys.
Store in the original package in order to protect from light.
Denne indlægsseddel blev senest ændret <{MM/ÅÅÅÅ}>
This leaflet was last revised in {month YYYY}
Initialdosis Behandlingen indledes med 4,6 mg/24 timer.
Initial dose Treatment is started with 4.6 mg/24 h.
Hvis der observeres gastrointestinale bivirkninger, bør behandlingen afbrydes midlertidigt, indtil bivirkningerne er ophørt.
Treatment should be temporarily interrupted if gastrointestinal adverse reactions are observed until these adverse reactions resolve.