FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede lægemiddelovervågningsaktiviteter og foranstaltninger, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Application site pruritus led to discontinuation in 1.1% of the patients from each of the treatment groups during the total 48-week double-blind treatment phase.
Danish: Kløe på applikationsstedet førte til seponering hos 1,1% af patienterne fra hver af behandlingsgrupperne under den samlede 48-ugers dobbeltblindet behandlingsfase.
English: Patients who show signs or symptoms of dehydration resulting from prolonged vomiting or diarrhoea can be managed with intravenous fluids and dose reduction or discontinuation if recognised and treated promptly.
Danish: Patienter, som viser tegn eller symptomer på dehydrering som følge af langvarig opkastning eller diarré, kan behandles med intravenøs væske og dosisnedsættelse eller seponering, hvis tilstanden erkendes hurtigt og behandles omgående.
English: Rivastigmine is rapidly and extensively metabolised with an apparent elimination half-life in plasma of approximately 3.4 hours after removal of the transdermal patch.
Danish: Rivastigmin metaboliseres hurtigt og omfattende med en eliminationshalveringstid i plasma på ca. 3,4 timer efter fjernelse af depotplasteret.
English: Where symptoms have occurred, they have included nausea, vomiting and diarrhoea, hypertension or hallucinations.
Danish: I de tilfælde, hvor der er set symptomer, har disse omfattet kvalme, opkastning og diarré, hypertension eller hallucinationer.
English: If it helps you, you may write, for example, the day of the week, on the patch with a thin ball point pen.
Danish: Du kan som hjælp notere ugedagen på plastret med en tynd kuglepen.
English: Return the used patch to its sachet and dispose of it in such a way that children cannot handle it. Do not touch your eyes with your fingers and wash your hands with soap and water after removing the patch.
Danish: Læg det brugte depotplaster i dets brev, og kassér det på en måde, så børn ikke kan få fat i det. Du må ikke røre ved øjnene med fingrene, når du har rørt ved plasteret, før du har vasket hænderne med vand og sæbe.
English: Symptomatic treatment for other adverse reactions should be given as necessary.
Danish: Symptomatisk behandling for andre bivirkninger bør gives, hvis det skønnes nødvendigt.
English: Overdose with rivastigmine transdermal patches resulting from misuse/dosing errors (application of multiple patches at a time) has been reported in the post-marketing setting.
Danish: Overdosering med rivastigmin depotplaster som følge af forkert brug/doseringsfejl (anvendelse af flere plastre på samme tid) er blevet rapporteret post-marketing.
English: The next most common adverse reactions are gastrointestinal in nature including nausea and vomiting.
Danish: De næst mest almindelige bivirkninger er gastrointestinale, herunder kvalme og opkastning.
English: Exposure (AUC∞) to rivastigmine (and metabolite NAP266-90) was highest when the transdermal patch was applied to the upper back, chest, or upper arm and approximately 20-30% lower when applied to the abdomen or thigh.
Danish: Eksponeringen (AUC∞) over for rivastigmin (og metabolitten NAP266-90) var størst, når depotplasteret blev påført øverst på ryggen, på brystet eller på overarmen, og ca. 20-30% lavere, når det blev påført maven eller låret.
English: Positive ADCS-ADL changes indicate improvement.
Danish: Positive ADCS-ADL-ændringer tyder på forbedring.
English: Skin application site reactions may occur with rivastigmine patch and are usually mild or moderate in intensity.
Danish: Hudreaktioner på applikationsstedet kan forekomme med rivastigminplaster og er ofte lette eller moderate i intensitet.
English: You should wash your hands with soap and water after removing the patch.
Danish: Du skal vaske dine hænder med sæbe og vand, når du har fjernet plasteret.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Rivastigmine is an acetyl- and butyrylcholinesterase inhibitor of the carbamate type, thought to facilitate cholinergic neurotransmission by slowing the degradation of acetylcholine released by functionally intact cholinergic neurones.
Danish: Rivastigmin er en acetyl- og butyrylkolinesterasehæmmer af carbamattypen, som menes at lette kolinerg neurotransmission ved at nedsætte nedbrydningen af acetylkolin, som er frigjort af funktionelt intakte kolinerge neuroner.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: Misuse of the medicinal product and dosing errors resulting in overdose Misuse of the medicinal product and dosing errors with rivastigmine transdermal patches have resulted in serious adverse reactions; some cases have required hospitalisation, and rarely led to death (see section 4.9).
Danish: Forkert brug af lægemidlet og doseringsfejl, der resulteret i overdosering Forkert brug af lægemidlet og doseringsfejl med rivastigmin depotplaster har resulteret i alvorlige bivirkninger, nogle tilfælde har krævet hospitalsindlæggelse og i sjældne tilfælde ført til dødsfald (se pkt.
English: No effects on fertility or embryofoetal development were observed in rats and rabbits, except at doses related to maternal toxicity.
Danish: Der blev ikke observeret effekt på fertiliteten eller fosterudviklingen hos rotter og kaniner undtaget ved doser, der medførte maternel toksicitet.
English: Oral and topical repeated-dose toxicity studies in mice, rats, rabbits, dogs and minipigs revealed only effects associated with an exaggerated pharmacological action.
Danish: Oral og topikal kronisk toksicitet i undersøgelser af mus, rotter, kaniner, hunde og minigrise viste kun effekt forbundet med en unormalt høj farmakologisk aktivitet.
English: Patients and caregivers should be instructed on important administration instructions: - The previous day's patch must be removed before applying a new one every day (see section 4.9).
Danish: Patienter og omsorgspersoner bør instrueres i vigtige administrationsinstruktioner: - Foregående dags plaster skal fjernes inden det hver dag påføres et nyt plaster (se pkt.
English: Take off your patch and tell your doctor straight away, if you notice any of the side effects above.
Danish: Tag dit plaster af og fortæl straks din læge, hvis du oplever nogen af ovenstående bivirkninger.
English: No untoward effects on cardiac conduction were observed following concomitant administration of digoxin and oral rivastigmine.
Danish: Der sås ingen negative virkninger på kardial overledning efter samtidig indgift af digoxin og oral rivastigmin.
English: - Do not use this medicine after the expiry date, which is stated on the carton and pouch after
Danish: - Brug ikke dette lægemiddel efter den udløbsdato, der står på æsken eller brevet efter udløbsdato (EXP).
English: Age had no impact on the exposure to rivastigmine in Alzheimer's disease patients treated with rivastigmine transdermal patches.
Danish: Alder havde ingen indvirkning på eksponering for rivastigmin hos patienter med Alzheimers demens, som blev behandlet med rivastigmin depotplastre.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Rivastigmin depotplaster kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Rectangular patches, approximately 2.5 cm by 1.8 cm with rounded corners.
Danish: Rektangulære plastre, cirka 2,5 cm x 1,8 cm med afrundede hjørner.
English: Infections and infestations Common
Danish: Infektioner og parasitære sygdomme
English: For patients starting treatment for the first time and for patients restarting Rivastigmine 3M Health Care Ltd. after treatment interruption, please begin with the second picture.
Danish: Til patienter, som starter behandlingen for første gang eller patienter som genstarter Rivastigmine 3M Health Care Ltd. efter behandlingsstop, skal starte med billede 2.
English: In a 24-week double-blind, placebo-controlled clinical trial, skin reactions were measured at each visit using a skin irritation rating scale that rated the degree of erythema, oedema, scaling, fissures, pruritus and pain/stinging/burning at the application site.
Danish: I et 24-ugers dobbeltblindet, placebokontrolleret klinisk forsøg blev hudreaktionerne ved hvert besøg målt i forhold til en hudirritationsskala, som målte graden af erytem, ødem, afskalning, fissurer, kløe og smerte/svie/brænden på applikationsstedet.
English: *A marketing authorisation for Rivastigmine 3M Health Care Ltd. 13.3 mg/24 h transdermal patch is currently not available, this presentation may although be available from other marketing authorisation holders.
Danish: *En marknadsføringstilladelse for Rivastigmine 3M Health Care Ltd. 13,3 mg/24 timer depotplaster er i øjeblikket ikke til rådighed, denne styrke kan være tillgængelig fra andre marknadsføringtilladelse indehavere.
English: Maintenance dose
Danish: Vedligeholdelsesdosis
English: Oral studies in pregnant rats and rabbits gave no indication of teratogenic potential on the part of rivastigmine.
Danish: Undersøgelser på gravide rotter og kaniner med oral indgift af rivastigmin gav ingen indikation af et teratogent potentiale.
English: The European Medicines Agency has waived the obligation to submit the results of studies with rivastigmine in all subsets of the paediatric population in the treatment of Alzheimer's dementia (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med rivastigmin i alle undergrupper af den pædiatriske population med behandling af Alzheimers demens (se pkt.
English: METHOD OF ADMINISTRATION Read the package leaflet before use.
Danish: ADMINISTRATIONSMETODE Læs indlægssedlen inden brug.
English: left upper chest or right upper chest (avoid breast)
Danish: • ventre over bryst eller højre over bryst (undgå bryst)
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på fremstillerne ansvarlige for batchfrigivelse
English: It is not recommended to apply the transdermal patch to the thigh or to the abdomen due to decreased bioavailability of rivastigmine observed when the transdermal patch is applied to these areas of the body.
Danish: Det frarådes at påføre depotplasteret på låret eller på maven, da der er observeret mindsket biotilgængelighed af rivastigmin, når depotplasteret påføres disse områder af kroppen.
English: Every 24 hours take off the previous patch before putting ONE new patch on to ONLY ONE of the following possible locations.
Danish: Fjern plasteret fra i går hver 24. time, inden ÉT nyt plaster sættes på, KUN PÅ ÉT af følgende steder.
English: If you stop using Rivastigmine 3M Health Care Ltd. Tell your doctor or pharmacist if you stop using the patch.
Danish: Hvis du holder op med at bruge Rivastigmine 3M Health Care Ltd. Fortæl det til lægen eller apoteket, hvis du holder op med at bruge plasteret.
English: Can you wear your Rivastigmine 3M Health Care Ltd. transdermal patch when you are bathing, swimming, or in the sun?
Danish: Kan du have dit Rivastigmine 3M Health Care Ltd. depotplaster på, når du bader, svømmer eller solbader?
English: Rivastigmine capsules 12 mg/day
Danish: Rivastigmin kapsler 12 mg dagligt
English: Do not apply two patches to make up for the one that you missed.
Danish: Du må ikke sætte to plastre på samtidig som erstatning for det glemte plaster.
English: After oral administration, Cmax and AUC of rivastigmine were more than twice as high in Alzheimer patients with moderate renal impairment compared with healthy subjects; however there were no changes in Cmax and AUC of rivastigmine in Alzheimer patients with severe renal impairment.
Danish: Efter oral indgift var Cmax og AUC for rivastigmin mere end dobbelt så høj hos Alzheimers-patienter med moderat nedsat nyrefunktion sammenlignet med raske personer, men der var ingen ændringer i Cmax og AUC for rivastigmin hos Alzheimers-patienter med svært nedsat nyrefunktion.
English: Rivastigmine belongs to a class of substances called cholinesterase inhibitors.
Danish: Rivastigmin tilhører en medicingruppe, der kaldes kolinesterasehæmmere.
English: Heat-sealed pouches made of paper/aluminium/acrylonitrile-methacrylate copolymer laminate.
Danish: Varmeforseglede breve af papir/aluminium/acrylonitril-methacrylatcopolymerlaminat.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS POUCH
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER BREV
English: Elimination was absorption rate limited (flip-flop kinetics), which explains the longer t½ after transdermal patch (3.4 h) versus oral or intravenous administrations (1.4 to 1.7 h).
Danish: Eliminationen var absorptionshastighedsbegrænset (flip-flopkinetik), hvilket forklarer den længere t½ efter depotplaster (3,4 timer) mod oral eller intravenøs indgift (1,4 til 1,7 time).
English: Therefore, in patients with dementia treated with rivastigmine, the ability 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: The efficacy of rivastigmine transdermal patches in patients with Alzheimer's dementia has been demonstrated in a 24-week double-blind, placebo-controlled core study and its open-label extension phase and in a 48-week double-blind comparator study.
Danish: Effekten af rivastigmin depotplastre hos patienter med Alzheimers demens er blevet påvist i et 24ugers dobbeltblindet, placebo-kontrolleret kernestudie og dets open label-forlængelsesfase og i et 48ugers dobbelblindet komparator studie.
English: Similar to any treatment initiated in patients with dementia, therapy with rivastigmine should only be started if a caregiver is available to regularly administer and monitor the treatment.
Danish: Som ved al behandling af patienter med demens bør rivastigminterapi kun påbegyndes, hvis der er en omsorgsgivende person, som løbende vil administrere og holde øje med behandlingen hos patienten.
English: When and for how long to apply your Rivastigmine 3M Health Care Ltd. transdermal patch - To benefit from treatment, you must apply a new patch every day, preferably at the same time of day.
Danish: Hvornår og hvor længe skal dit Rivastigmine 3M Health Care Ltd. depotplaster sidde - Du skal sætte et nyt plaster på hver dag for at få gavn af behandlingen, helst på den samme tid af dagen.
English: When administered to rabbit eyes in primary eye irritation studies, rivastigmine caused reddening and swelling of the conjunctiva, corneal opacities and miosis which persisted for 7 days.
Danish: Ved administration på kaninøjne i primære øjenirritationsstudier forårsagede rivastigmin rødme og hævelse af konjunktiva, uklarhed i cornea og myosis, som varede i 7 dage.
English: - Put the sticky side of the patch on the upper or lower back, upper arm or chest and then peel off the second half of the protective liner.
Danish: - Placer plastrets klisterside på øvre eller nedre del af ryggen, overarmen eller over brystet, og træk herefter den anden halvdel af dæklaget af.
English: In a 48-week active-controlled clinical trial, cases of skin irritation were captured as patient or caregiver reported adverse reactions.
Danish: I et 48-ugers aktivkontrolleret klinisk forsøg blev tilfælde af hudreaktioner indsamlet samtidig med, at patienter eller pårørende rapporterede bivirkninger.
English: If treatment is interrupted for more than three days, it should be re-initiated with 4.6 mg/24 h.
Danish: Hvis behandlingen afbrydes i mere end 3 dage, skal den genoptages med 4,6 mg/24 timer.
English: ADCS-CGIC scores <4 indicate improvement.
Danish: ADCS-CGIC-scorer <4 tyder på forbedring.
English: rivastigmine, renal elimination was rapid and essentially complete (>90%) within 24 hours.
Danish: Efter indgift af oral 14C-rivastigmin var den renale udskillelse hurtig og nærmest fuldstændig (>90%) inden for 24 timer.
English: Total plasma clearance of rivastigmine was approximately 130 litres/h after a 0.2 mg intravenous dose and decreased to 70 litres/h after a 2.7 mg intravenous dose, which is consistent with the non-linear, over-proportional pharmacokinetics of rivastigmine due to saturation of its elimination.
Danish: Rivastigmins totale plasmaclearance var ca. 130 liter/time efter en intravenøs dosis på 0,2 mg og faldt til 70 liter/time efter en intravenøs dosis på 2,7 mg, hvilket er konsistent med rivastigmins ikke-lineære, overproportionale farmakokinetik på grund af mætning af eliminationen.
English: Manufacturer Enestia
Danish: Fremstiller Enestia
English: Inhibition of butyrylcholinesterase activity in CSF of 14 Alzheimer patients treated by oral rivastigmine was similar to the inhibition of AChE activity.
Danish: Rivastigmins hæmning af butyrylkolinesterase-aktivitet i CSF hos 14 patienter med Alzheimers var sammenlignelig med hæmningen af AChE aktivitet.
English: The 24-week results for the three assessment tools are summarised in Table 2.
Danish: Resultaterne af de tre vurderingsredskaber for de 24 uger er opsummeret i tabel 2.
English: Negative ADAS-Cog changes indicate improvement.
Danish: Negative ADAS-Cog-ændringer tyder på forbedring.
English: Used transdermal patches should be folded in half, with the adhesive side inwards, placed in the original pouch and discarded safely and out of the sight and reach of children.
Danish: Brugte depotplastre foldes sammen på midten med den klæbende side indad, placeres i det originale brev og kasseres på en sikker måde utilgængeligt for børn.
English: Allergic contact dermatitis should be suspected if application site reactions spread beyond the patch size, if there is evidence of a more intense local reaction (e.g. increasing erythema, oedema, papules, vesicles) and if symptoms do not significantly improve within 48 hours after patch removal.
Danish: Allergisk kontaktdermatitis skal mistænkes, hvis reaktioner på applikationsstedet spreder sig uden for selve plasteret, hvis der er tegn på en kraftigere lokal reaktion (f.eks. tiltagende erytem, ødem, papler, vesikler), og hvis symptomerne ikke forbedres betydeligt inden for 48 timer efter fjernelse af plasteret.
English: OTHER Apply one patch per day.
Danish: ANDET Påsæt et plaster om dagen.
English: - to patients with a history of asthma or obstructive pulmonary disease.
Danish: • til patienter, som tidligere har haft astma eller kronisk obstruktiv lungesygdom.
English: Talk to your doctor before using Rivastigmine 3M Health Care Ltd.: - if you have, or have ever had, an irregular heartbeat.
Danish: Kontakt lægen, før du bruger Rivastigmine 3M Health Care Ltd. : - hvis du har eller har haft uregelmæssig hjerterytme (puls).
English: - Patients with body weight below 50 kg: Particular caution should be exercised in titrating patients with body weight below 50 kg above the recommended effective dose of 9.5 mg/24 h (see section 4.4).
Danish: • Patienter med en legemsvægt på under 50 kg: Særlig forsigtighed bør udvises ved titrering hos patienter med en legemsvægt på under 50 kg ud over den anbefalede virksomme dosis på 9,5 mg/24 timer (se pkt.
English: No clinical data on exposed pregnancies are available.
Danish: Der foreligger ingen kliniske data om eksponering for rivastigmin under graviditet.
English: No target organ toxicity was observed.
Danish: Der blev ikke observeret nogen målorgan toksicitet.
English: Some people who have accidentally taken too much Rivastigmine 3M Health Care Ltd. have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations.
Danish: Nogle mennesker, som ved et uheld er kommet til at bruge for meget Rivastigmine 3M Health Care Ltd. , har haft kvalme, kastet op, haft diarré, højt blodtryk og hallucinationer.
English: Warnings and precautions
Danish: Advarsel og forsigtighedsregler
English: 9.5 mg/24 h is the recommended daily effective dose which should be continued for as long as the patient continues to demonstrate therapeutic benefit.
Danish: 9,5 mg/24 timer er den anbefalede daglige virksomme dosis, som bør anvendes, så længe der er terapeutisk effekt for patienten.
English: Rivastigmine capsules 12 mg/day N = 256
Danish: Rivastigmin kapsler 12 mg dagligt N = 256
English: In animals, rivastigmine crosses the placenta and is excreted into milk.
Danish: Rivastigmin passerer placenta og udskilles i mælken hos dyr.
English: Gastrointestinal disorders such as nausea, vomiting and diarrhoea are dose-related, and may occur when initiating treatment and/or increasing the dose (see section 4.8).
Danish: Gastrointestinale gener som kvalme, opkastning og diarré er dosisrelaterede og kan specielt forekomme, når behandlingen påbegyndes, og/eller når dosis øges (se pkt.
English: Otherwise, return used patches to a pharmacy, preferably in the original packaging.
Danish: Hvis den ikke gør det, kan du aflevere depotplastrene på apoteket, gerne i den originale emballage.
English: The backing layer is transparent to translucent, labelled with “R5” in a repeated pattern.
Danish: Bagsidelaget er gennemsigtigt til gennemskinneligt, mærket med "R5" i et gentagelsesmønster.
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Rivastigmine 3M Health Care Ltd. is marketed, at launch and after launch of the transdermal patch all physicians who are expected to prescribe Rivastigmine 3M Health Care Ltd. are provided with an information pack containing the following elements:
Danish: Indehaveren af markedsføringstilladelsen skal ved lancering og efter lancering af depotplaster, og efter diskussioner og enighed med de nationale myndigheder i hvert medlemsland, hvor Rivastigmine 3M Health Care Ltd. er markedsført, sikre at alle læger, der forventes at udskrive Rivastigmine 3M Health Care Ltd. er forsynet med en informationspakke indeholdende følgende ting:
English: However, these events did not occur at a higher frequency with rivastigmine 13.3 mg/24 h transdermal patches than with placebo.
Danish: Disse bivirkninger forekom dog ikke med en højere frekvens for rivastigmin 13,3 mg/24 timer end for placebo.
English: - Apply ONE patch per day to ONLY ONE of the possible locations shown in the following diagrams:
Danish: Sæt ÉT depotplaster på hver dag og KUN PÅ ÉT af de mulige steder, som vist på
English: Other warnings and precautions
Danish: Andre advarsler og forsigtighedsregler
English: Ask your pharmacist how to throw away medicines you no longer use.
Danish: Spørg på apoteket, hvordan De skal bortskaffe medicinrester.
English: Rivastigmine 3M Health Care Ltd. might interfere with anticholinergic medicines some of which are medicines used to relieve stomach cramps or spasms (e.g. dicyclomine), to treat Parkinson's disease (e.g. amantadine) or to prevent motion sickness (e.g. diphenhydramine, scopolamine or meclizine).
Danish: Rivastigmine 3M Health Care Ltd. kan påvirke antikolinerg medicin hvoraf noget er medicin, der bruges mod mavekramper eller spasmer (fx dicyclomin), til at behandle Parkinsons sygdom (fx amantadin) eller til at forebygge transportsyge (fx difenhydramin, scopolamin eller meclizin).
English: This may indicate a potential for rivastigmine transdermal patches to induce mild erythema in patients.
Danish: Det kan tyde på, at rivastigmin depotplastre kan fremkalde mildt erytem hos patienterne.
English: - The patch should not be exposed to any external heat sources (e.g. excessive sunlight, saunas,
Danish: - Du må ikke udsætte depotplasteret for eksterne varmekilder (f.eks. kraftigt sollys, sauna,