FrancophonIA/ELRC3.0 huggingface dataset:
English: The 1 mg daily dose is also used in adults with decompensated liver disease and stopping treatment is not recommended in these patients.
Danish: Dosen på 1 mg dagligt anvendes desuden hos voksne med dekompenseret leversygdom, og det frarådes at ophøre med behandlingen hos sådanne patienter.
English: It is used in adults with signs of ongoing liver injury (such as inflammation and fibrosis) when the liver is still working properly (compensated liver disease) and also when the liver is no longer working properly (decompensated liver disease).
Danish: Det anvendes hos voksne med tegn på aktiv leversygdom (f.eks. inflammation og fibrose), når leveren stadig fungerer korrekt (kompenseret leversygdom), men også når leveren ikke længere virker korrekt (dekompenseret leversygdom).
English: Other information about Entecavir Accord
Danish: Andre oplysninger om Entecavir Accord
English: What are the benefits and risks of Entecavir Accord?
Danish: Hvilke fordele og risici er der forbundet med Entecavir Accord?
English: What measures are being taken to ensure the safe and effective use of Entecavir Accord?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Entecavir Accord?
English: For adults with compensated liver disease, the dose depends on whether or not the patient has been previously treated with a medicine in the same group as Entecavir Accord (a nucleoside analogue, such as lamivudine).
Danish: Hos voksne patienter med kompenseret leversygdom afhænger dosis af, om de tidligere er blevet behandlet med et lægemiddel i samme gruppe som Entecavir Accord (en nukleosidanalog, f.eks. lamivudin).
English: It is not intended to provide practical advice on how to use Entecavir Accord.
Danish: Det er ikke en praktisk vejledning i, hvordan Entecavir Accord bør anvendes.
English: Because Entecavir Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Entecavir Accord er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Patients who have not been treated before with a nucleoside analogue receive a 0.5 mg dose, while those who have received lamivudine before but whose infection is no longer responding to it are given a 1 mg dose.
Danish: Patienter, der ikke tidligere er blevet behandlet med en nukleosidanalog, skal have en dosis på 0,5 mg, mens patienter, der tidligere har fået lamivudin, men hvis infektion ikke længere reagerer på dette middel, skal have en dosis på 1 mg.
English: Entecavir Accord contains the active substance entecavir and is a ‘generic medicine'.
Danish: Entecavir Accord indeholder det aktive stof entecavir og er et "generisk lægemiddel".
English: For more information about treatment with Entecavir Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Entecavir Accord, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This means that Entecavir Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Baraclude.
Danish: Det betyder, at Entecavir Accord er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Baraclude.
English: Children weighing 32.6 kg and above can be given the 0.5 mg tablets, while an oral solution of entecavir may be available for children weighing less than 32.6 kg. For further information, see the package leaflet.
Danish: Børn, der vejer 32,6 kg eller derover, kan få 0,5 mg-tabletter, mens en oral opløsning af entecavir eventuelt kan gives til børn, der vejer under 32,6 kg.
English: Entecavir Accord is a medicine used to treat chronic (long-term) hepatitis B (an infectious disease of the liver, caused by the hepatitis B virus).
Danish: Entecavir Accord anvendes til behandling af langvarig (kronisk) hepatitis B, der er en smitsom leversygdom forårsaget af hepatitis B-virus.
English: Therefore, the Agency's view was that, as for Baraclude, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Baraclude.
English: For practical information about using Entecavir Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Entecavir Accord, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Entecavir interferes with the action of a viral enzyme, DNA polymerase, which is involved in the formation of viral DNA.
Danish: Entecavir påvirker virkningsmekanismen hos et viralt enzym, dna-polymerase, der indgår i dannelsen af viralt dna.
English: The active substance in Entecavir Accord, entecavir, is an antiviral belonging to the class of the nucleoside analogues.
Danish: Det aktive stof i Entecavir Accord, entecavir, er et antiviralt middel, der tilhører gruppen af nukleosidanaloger.
English: How has Entecavir Accord been studied?
Danish: Hvordan blev Entecavir Accord undersøgt?
English: Why is Entecavir Accord approved?
Danish: Hvorfor blev Entecavir Accord godkendt?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Entecavir Accord have been included in the summary of product characteristics and the package leaflet.
Danish: Der er indført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Entecavir Accord.
English: How does Entecavir Accord work?
Danish: Hvordan virker Entecavir Accord?
English: How is Entecavir Accord used?
Danish: Hvordan anvendes Entecavir Accord?
English: Date of first authorisation: 12 May 1998 Date of latest renewal: 20 May 2008
Danish: Dato for første markedsføringstilladelse: 12. maj 1998 Dato for seneste fornyelse: 20. maj 2008
English: Exelon can be used with food, drink and alcohol.
Danish: Exelon kan anvendes sammen med mad, drikke og alkohol.
English: Can you wear your Exelon transdermal patch when you are bathing, swimming, or in the sun?
Danish: Kan du have dit Exelon depotplaster på, når du bader, svømmer eller solbader?
English: • Hyperactivity (high level of activity, restlessness)
Danish: • Hyperaktivitet (højt aktivitetsniveau, rastløshed)
English: Your doctor will tell you what dose of Exelon to take.
Danish: Din læge vil fortælle dig, hvilken dosis Exelon du skal tage.
English: If you find you have forgotten to take your dose of Exelon, wait and take the next dose at the usual time.
Danish: Hvis du finder ud af, at du har glemt at tage en dosis Exelon, skal du blot vente og tage næste dosis på det sædvanlige tidspunkt.
English: • Seeing things that are not really there (hallucinations)
Danish: • Ser ting, der ikke er der i virkeligheden (hallucinationer)
English: • Take Exelon twice a day, in the morning and evening, with food.
Danish: • Tag Exelon to gange om dagen (morgen og aften) sammen med mad.
English: Exelon 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: Exelon anvendes til behandling af voksne patienter med mild til moderat svær Alzheimers demens, en fremadskridende hjernesygdom, der gradvis påvirker hukommelse, åndsevner og adfærd.
English: Your doctor will tell you which Exelon transdermal patch is most suitable for you.
Danish: Din læge vil fortælle dig, hvilket Exelon depotplaster, der er bedst egnet til dig.
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Exelon patch is marketed, all physicians who are expected to prescribe Exelon patch are provided with an information pack containing the following elements:
Danish: Indehaveren af markedsføringstilladelsen skal, efter diskussioner og enighed med de nationale myndigheder i hvert medlemsland, hvor Exelon depotplaster er markedsført, sikre at alle læger, der forventes at udskrive Exelon depotplaster, er forsynet med en informationspakke indeholdende følgende ting:
English: Exelon patches are thin, opaque, plastic patches that stick to the skin.
Danish: Exelon depotplastre er tynde, uigennemsigtigte plast-plastre, som klæber til huden.
English: Exelon contains sodium benzoate
Danish: Exelon indeholder natriumbenzoat
English: For patients starting treatment for the first time and for patients restarting Exelon after treatment interruption, please begin with the second picture.
Danish: Til patienter, som starter behandlingen for første gang eller patienter som genstarter Exelon efter behandlingsstop, skal starte med billede 2.
English: It was rated as severe in ≤2.2% of patients in these studies and in ≤3.7% of patients treated with Exelon transdermal patches in a Japanese study.
Danish: Hudirritation blev vurderet som alvorlig hos ≤2,2% af patienterne i disse studier og hos ≤3,7% af patienterne i et japansk studie, hvor patienterne blev behandlet med Exelon depotplaster.
English: However, Exelon may be used in this patient population and close monitoring is necessary.
Danish: Exelon kan imidlertid anvendes hos denne patientpopulation, men det er nødvendigt at følge patienterne tæt.
English: If you stop using Exelon Tell your doctor or pharmacist if you stop using the patch.
Danish: Hvis du holder op med at bruge Exelon Fortæl det til lægen eller apoteket, hvis du holder op med at bruge plasteret.
English: • Only wear one Exelon patch at a time and replace the patch with a new one after 24 hours.
Danish: • Brug kun ét plaster ad gangen og udskift plasteret med et nyt efter 24 timer.
English: Always use Exelon transdermal patches exactly as your doctor has told you.
Danish: Brug altid Exelon depotplastre nøjagtigt efter lægens anvisning.
English: • Chest pain - this may be caused by heart spasm
Danish: • Brystsmerter - kan skyldes hjertekramper
English: Exelon transdermal patches may cause fainting or severe confusion.
Danish: Exelon depotplastre kan fremkalde besvimelse eller stærk forvirring.
English: Table 3 lists the number and percentage of patients from the specific 24-week clinical study conducted with Exelon in patients with dementia associated with Parkinson's disease with pre-defined adverse events that may reflect worsening of parkinsonian symptoms.
Danish: Tabel 3 angiver antallet og procentdelen af patienterne fra det specifikke 24-ugers studie, der blev udført med Exelon hos patienter med demens, associeret med Parkinsons sygdom med præ-definerede bivirkninger, der muligvis kan reflektere en forværring af Parkinsons symptomer.
English: Gently pull at one edge of the patch to remove it slowly from the skin.
Danish: Træk forsigtigt i kanten af plasteret for at fjerne det langsomt helt fra huden.
English: If this applies to you, tell your doctor and do not take Exelon.
Danish: Hvis dette gælder for dig, skal du fortælle det til din læge og ikke tage Exelon.
English: If you accidentally take more Exelon than you should, inform your doctor.
Danish: Hvis du ved en fejltagelse er kommet til at tage mere Exelon, end du har fået besked på, skal du sige det til din læge.
English: Taking the two medicines together could cause problems such as such as stiff limbs and trembling hands.
Danish: Samtidig brug af de to lægemidler kan give problemer såsom stive lemmer og rysten på hænderne.
English: When and for how long to apply your Exelon transdermal patch
Danish: Hvornår og hvor længe skal dit Exelon depotplaster sidde
English: Patients and their caregivers must be instructed on important administration instructions for Exelon transdermal patch (see section 4.2).
Danish: Patienterne og deres omsorgspersoner skal instrueres i vigtige administrationsinstruktioner for Exelon depotplaster (se pkt.
English: Application site skin reactions (usually mild to moderate application site erythema), are the most frequent adverse reactions observed with the use of Exelon transdermal patch.
Danish: Hudreaktioner på applikationsstedet (normalt let til moderat erytem på applikationsstedet), er de hyppigste bivirkninger observeret ved brug af Exelon depotplaster.
English: Age had no impact on the exposure to rivastigmine in Alzheimer's disease patients treated with Exelon transdermal patches.
Danish: Alder havde ingen indvirkning på eksponering for rivastigmin hos patienter med Alzheimers demens, som blev behandlet med Exelon depotplastre.
English: No specific interaction studies have been performed with Exelon transdermal patches.
Danish: Der er ikke udført specifikke interaktionsstudier med Exelon depotplastre.
English: ADCS-IADL scores: A positive difference in DLSM indicates greater improvement in Exelon 15 cm as compared to Exelon 10 cm
Danish: ADCS-IADL score: En positiv forskel i DLSM indikerer større forbedring med Exelon 15 cm sammenlignet med Exelon 10 cm
English: Exelon 9 mg/5 cm 2, 18 mg/10 cm and 27 mg/15 cm transdermal patches are individually packaged in child-resistant, heat-sealed sachets made of a paper/polyethyleneterephthalate/aluminum/polyacrylnitrile (PAN) multi-laminated material (paper/PET/alu/PAN) or in heat-sealed, child-resistant sachets made of multi-layer composite laminate consisting of paper/polyethylene terephthalate/polyethylene/aluminum/polyamide (paper/PET/PE/alu/PA).
Danish: Exelon 9 mg/5 cm 2, 18 mg/10 cm og 27 mg/15 cm depotplastre er pakket enkeltvis i børnesikrede og varmeforseglede breve og er fremstillet af papir/polyethylenterephthalat/aluminium/polyacrylnitril (PAN) multilamineret materiale (papir/PET/alu/PAN) eller i varmeforseglede og børnesikrede breve fremstillet af multilagskompositlaminat, som indeholder papir/polyehylenterephthalat/polyethylen/aluminium/polyamid (papir/PET/PE/alu/PA).
English: • Tell your caregiver that you are taking Exelon.
Danish: • Fortæl dine nærmeste, at du er i behandling med Exelon.
English: Overdose with Exelon transdermal patch resulting from misuse/dosing errors (application of multiple patches at a time) has been reported in the post-marketing setting and rarely in clinical trials.
Danish: Overdosering med Exelon depotplaster som følge af forkert brug/doseringsfejl (anvendelse af flere plastre på samme tid) er blevet rapporteret efter markedsføringen og sjældent i kliniske forsøg.
English: However, these events did not occur at a higher frequency with Exelon 13.3 mg/24 h transdermal patches than with placebo.
Danish: Disse bivirkninger forekom dog ikke med en højere frekvens for Exelon 13,3 mg/24 timer end for placebo.
English: If you have not taken Exelon for more than three days, do not take the next dose until you have talked to your doctor.
Danish: Hvis du ikke har taget Exelon i mere end tre dage, må du ikke tage den næste dosis, før du har talt med din læge.
English: Misuse of the medicinal product and dosing errors with Exelon transdermal patch 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 med Exelon depotplaster har resulteret i alvorlige bivirkninger, nogle tilfælde har krævet hospitalsindlæggelse og i sjældne tilfælde ført til dødsfald (se pkt.
English: • Paediatric population: There is no relevant use of Exelon in the paediatric population in the treatment of Alzheimer's disease.
Danish: • Pædiatrisk population: Der er ingen relevante indikationer for brug af Exelon i den pædiatriske population til behandling af Alzheimers demens.
English: ADAS-cog scores: A negative difference in DLSM indicates greater improvement in Exelon 15 cm as compared to Exelon 10 cm
Danish: ADAS-cog score: En negativ forskel i DLSM indikerer større forbedring med Exelon 15 cm sammenlignet med Exelon 10 cm
English: The patient's weight should be monitored during therapy with Exelon transdermal patches.
Danish: Patientens vægt bør overvåges under behandling med Exelon depotplastre.
English: The following additional adverse reaction has been observed in a study of patients with dementia associated with Parkinson's disease treated with Exelon transdermal patches: agitation (common).
Danish: Yderligere er følgende bivirkning blevet observeret i et studie med patienter med demens associeret med Parkinsons sygdom, som har fået behandling med Exelon depotplaster: agitation (almindelig).
English: Exelon should not be given at the same time as other medicines with similar effects to Exelon.
Danish: Du må ikke tage Exelon samtidig med andre lægemidler, der har en virkning, der ligner Exelons.
English: Talk to your doctor before using Exelon: - if you have, or have ever had, an irregular or slow heartbeat.
Danish: Kontakt lægen, før du bruger Exelon: - hvis du har eller har haft uregelmæssig eller langsom hjerterytme (puls).
English: This may indicate a potential for Exelon transdermal patches to induce mild erythema in patients.
Danish: Det kan tyde på, at Exelon depotplastre kan fremkalde mildt erytem hos patienterne.
English: Exelon may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose.
Danish: Exelon kan give svimmelhed og døsighed, specielt i starten af behandlingen, eller når dosis øges.
English: • Do not use any patch that is damaged or shows signs of tampering.
Danish: • Brug ikke Exelon, hvis emballagen er beskadiget eller viser tegn på, at nogen har forsøgt at åbne den.
English: In other cases, Exelon has been discontinued (see section 4.8).
Danish: I andre tilfælde er Exelon blevet seponeret (se pkt.
English: Otherwise your doctor will restart your treatment on Exelon 4.6 mg/24 h.
Danish: Ellers vil din læge genstarte din behandling med Exelon 4,6 mg/24 timer.
English: The incidence of application site skin reactions leading to discontinuation was ≤2.3% in patients treated with Exelon transdermal patches.
Danish: Hyppigheden af reaktioner på applikationsstedet førende til behandlingsafbrydelse var ≤2,3% for patienter i behandling med Exelon depotplaster.
English: Do not use Exelon - if you are allergic to rivastigmine (the active substance in Exelon) or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Exelon - hvis du er allergisk over for rivastigmin (det aktive stof i Exelon) eller et af de øvrige indholdsstoffer i Exelon (angivet i punkt 6).
English: • Too much saliva
Danish: • For meget spyt
English: By blocking these enzymes, Exelon 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 Exelon medvirke til, at acetylcholin-indholdet øges i hjernen, hvilket hjælper med at reducere symptomerne på Alzheimers sygdom.
English: Do not take Exelon - if you are allergic to rivastigmine (the active substance in Exelon) or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Exelon - hvis du er allergisk over for rivastigmin (det aktive stof i Exelon) eller et af de øvrige indholdsstoffer i Exelon (angivet i punkt 6).
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 Exelon transdermal patches should be removed immediately and no further transdermal patch should be applied for the next 24 hours.
Danish: 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 Exelon depotplastre straks fjernes, og at der ikke påføres nye depotplastre inden for de næste 24 timer.
English: If this applies to you, tell your doctor and do not apply Exelon transdermal patches.
Danish: Hvis dette gælder for dig, skal du fortælle det til din læge og ikke bruge Exelon depotplastre.
English: When observed in patients treated with Exelon transdermal patches, skin irritation was mostly slight or mild in severity.
Danish: For patienter behandlet med Exelon depotplaster blev det observeret, at hudirritation oftest var ringe til let i sværhedsgrad.
English: • Stiff arms or legs
Danish: • Stivhed i arme eller ben
English: One of the inactive ingredients in Exelon oral solution is sodium benzoate.
Danish: En af de inaktive indholdstoffer i Exelon oral opløsning er natriumbenzoat.
English: Care must be taken when prescribing Exelon transdermal patches:
Danish: Der skal udvises forsigtighed ved ordination af Exelon depotplastre:
English: • Treatment usually starts with Exelon 4.6 mg/24 h.
Danish: • Behandlingen starter normalt med Exelon 4,6 mg/24 timer.
English: Exelon capsules 12 mg/day N = 256
Danish: Exelon kapsler 12 mg dagligt N = 256
English: Absorption of rivastigmine from Exelon transdermal patches is slow.
Danish: Rivastigmin fra Exelon depotplastre absorberes langsomt.
English: Contact with the eyes should be avoided after handling Exelon transdermal patches (see section 5.3).
Danish: Undgå kontakt med øjnene efter håndtering af Exelon depotplastre (se pkt.
English: The efficacy of Exelon 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 Exelon depotplastre hos patienter med Alzheimers demens er blevet påvist i et 24-ugers dobbeltblindet, placebo-kontrolleret kernestudie og dets open label-forlængelsesfase og i et 48-ugers dobbelblindet komparator studie.
English: Some people who have accidentally taken too much Exelon 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 Exelon, har haft kvalme, kastet op, haft diarré, højt blodtryk og hallucinationer.
English: • Allergic reaction where the patch was used, such as blisters or inflamed skin
Danish: • Reaktioner på applikationsstedet, såsom blister eller betændelse i huden
English: 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 Exelon 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: Exelon capsules 12 mg/day
Danish: Exelon kapsler 12 mg dagligt
English: One of the excipients in Exelon oral solution is sodium benzoate.
Danish: Et af hjælpestofferne i Exelon oral opløsning er natriumbenzoat.
English: The fluctuation index (FI), a measure of the relative difference between peak and trough concentrations ((Cmax-Cmin)/Cavg), was 0.58 for Exelon 4.6 mg/24 h transdermal patches, 0.77 for Exelon 9.5 mg/24 h transdermal patches and 0.72 for Exelon 13.3 mg/24 h transdermal patches, thus demonstrating a much smaller fluctuation between trough and peak concentrations than for the oral formulation (FI = 3.96 (6 mg/day) and 4.15 (12 mg/day)).
Danish: Fluktuationsindekset (FI), som er et mål for den relative forskel mellem højeste og laveste koncentration ((Cmax-Cmin)/Cavg), var 0,58 for Exelon 4,6 mg/24 timer depotplastre, 0,77 for Exelon 9,5 mg/24 timer depotplastre og 0,72 for 13,3 mg/24 timer depotplaster, og viste dermed et mindre udsving mellem laveste og højeste koncentration end den orale formulering (FI = 3,96 (6 mg dagligt) og 4,15 (12 mg dagligt)).
English: Like all medicines, Exelon transdermal patches can cause side effects, although not everybody gets them.
Danish: Exelon depotplaster kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: 42 transdermal patches.
Danish: 42 depotplastre.