FrancophonIA/ELRC3.0 huggingface dataset:
English: • The patch should not be cut into pieces.
Danish: • Plasteret må ikke klippes i stykker.
English: Baseline 265 27.5 271 25.8 Week 48 Value
Danish: Baseline 265 27,5 271 25,8
English: Otherwise your doctor will restart your treatment on Prometax 4.6 mg/24 h.
Danish: Ellers vil din læge genstarte din behandling med Prometax 4,6 mg/24 timer.
English: Most cases of accidental overdose of oral rivastigmine have not been associated with any clinical signs or symptoms and almost all of the patients concerned continued rivastigmine treatment 24 hours after the overdose.
Danish: De fleste tilfælde af tilfældig overdosering med oral rivastigmin har ikke været forbundet med kliniske tegn eller symptomer, og næsten alle de pågældende patienter fortsatte behandlingen med rivastigmin 24 timer efter overdoseringen.
English: In peri/postnatal studies in rats, an increased gestation time was observed.
Danish: I peri/postnatale studier på rotter blev der observeret forlænget drægtighedsperiode.
English: • Paediatric population: There is no relevant use of Prometax in the paediatric population in the treatment of Alzheimer's disease.
Danish: • Pædiatrisk population: Der er ingen relevante indikationer for brug af Prometax i den pædiatriske population til behandling af Alzheimers demens.
English: The efficacy of rivastigmine in dementia associated with Parkinson's disease has been demonstrated in a 24-week multicentre, double-blind, placebo-controlled core study and its 24-week open-label extension phase.
Danish: Effekten af rivastigmin ved demens, associeret med Parkinsons sygdom, er demonstreret i et 24-ugers multicenter, dobbelt-blindt, placebo-kontrolleret hovedstudie og dets 24-ugers open-label forlængelsesfase.
English: Cut the sachet along the dotted line with scissors and remove the patch from the sachet.
Danish: Klip i brevet langs den punkterede linje med en saks, og tag plasteret ud af brevet.
English: • A patient on a stable and well tolerated dose of 9 mg/day oral rivastigmine can be switched to
Danish: • En patient, som får en stabil og veltolereret dosis på 9 mg/dag oral rivastigmin, kan skiftes til
English: The following additional adverse reaction has been observed in a study of patients with dementia associated with Parkinson's disease treated with Prometax 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 Prometax depotplaster: agitation (almindelig).
English: By blocking these enzymes, Prometax 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 Prometax medvirke til, at acetylcholin-indholdet øges i hjernen, hvilket hjælper med at reducere symptomerne på Alzheimers sygdom.
English: • Tell your caregiver that you are taking Prometax.
Danish: • Fortæl dine nærmeste, at du er i behandling med Prometax.
English: Patients with severe hepatic impairment have not been studied.
Danish: Patienter med svært nedsat leverfunktion er ikke blevet undersøgt.
English: 30 transdermal patches.
Danish: 30 depotplastre.
English: The patient's weight should be monitored during therapy with Prometax transdermal patches.
Danish: Patientens vægt bør overvåges under behandling med Prometax depotplastre.
English: Atrioventricular block, atrial fibrillation, tachycardia, sick sinus syndrome
Danish: Atrioventrikulært blok, atrieflimren, takykardi, syg sinus-syndrom
English: The patches are available in packs containing 7 or 30 sachets and in multipacks containing 60 or 90 sachets.
Danish: Depotplastrene er tilgængelig i pakninger indeholdende 7 eller 30 breve og i multipakninger indeholdende 60 eller 90 breve.
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,
English: The incidence of application site skin reactions leading to discontinuation was ≤2.3% in patients treated with Prometax transdermal patches.
Danish: Hyppigheden af reaktioner på applikationsstedet førende til behandlingsafbrydelse var ≤2,3% for patienter i behandling med Prometax depotplaster.
English: - Each patch is sealed in its own protective sachet.
Danish: Plasteret ligger i sit eget beskyttende brev.
English: • The previous day's patch must be removed before applying a new one every day (see section 4.9).
Danish: • Foregående dags plaster skal fjernes inden det hver dag påføres et nyt plaster (se pkt.
English: Prometax may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose.
Danish: Prometax kan give svimmelhed og døsighed, specielt i starten af behandlingen, eller når dosis øges.
English: Do not use Prometax - if you are allergic to rivastigmine (the active substance in Prometax) or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Prometax - hvis du er allergisk over for rivastigmin (det aktive stof i Prometax) eller et af de øvrige indholdsstoffer i Prometax (angivet i punkt 6).
English: Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational material with the National Competent Authority.
Danish: • Yderligere risikominimeringsforanstaltninger Inden lancering i hvert medlemsland skal indehaveren af markedsføringstilladelsen blive enig med de nationale myndigheder om uddannelsesmateriale.
English: This may indicate a potential for Prometax transdermal patches to induce mild erythema in patients.
Danish: Det kan tyde på, at Prometax depotplastre kan fremkalde mildt erytem hos patienterne.
English: Fall *In a 24-week controlled study in Japanese patients, application site erythema, application site oedema and application site pruritus were reported as “very common”.
Danish: Fald *I et 24-ugers kontrolleret studie med japanske patienter blev rødme ved applikationsstedet, ødem ved applikationsstedet og kløe ved applikationsstedet rapporteret som ”meget almindelig”.
English: Aggression, restlessness
Danish: Aggression, rastløshed
English: Polyester film, fluoropolymer-coated
Danish: Polyesterfilm, fluoropolymerbelagt
English: N = 256 N = 282
Danish: N = 251 N = 256 N = 282
English: • Do not use any patch that is damaged or shows signs of tampering.
Danish: • Brug ikke Prometax, hvis emballagen er beskadiget eller viser tegn på, at nogen har forsøgt at åbne den.
English: At least 4 points improvement on ADASCog with no worsening on CIBIC-Plus and PDS *p<0.05, **p<0.01, ***p<0.001
Danish: CIBIC-Plus: forbedring PDS: mindst 10% forbedring Mindst 4-pointsforbedring af ADAS-Cog med ingen forværring af CIBIC-Plus og PDS *p<0,05, **p<0,01, ***p<0,001
English: Do not take Prometax - if you are allergic to rivastigmine (the active substance in Prometax) or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Prometax - hvis du er allergisk over for rivastigmin (det aktive stof i Prometax) eller et af de øvrige indholdsstoffer i Prometax (angivet i punkt 6).
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske aller apoteket.
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 topisk kronisk toksicitetsstudier af mus, rotter, kaniner, hunde og minigrise viste kun effekt forbundet med en unormalt høj farmakologisk aktivitet.
English: • Hepatic impairment: Patients with clinically significant hepatic impairment may experience more adverse reactions.
Danish: • Nedsat leverfunktion: Patienter med klinisk signifikant nedsat leverfunktion kan opleve flere bivirkninger.
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 Prometax 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 Prometax depotplastre straks fjernes, og at der ikke påføres nye depotplastre inden for de næste 24 timer.
English: If you have not applied a patch for more than three days, do not apply the next one before you have talked to your doctor.
Danish: Hvis du ikke har brugt et depotplaster i mere end tre dage, skal du ikke bruge det næste, før du har talt med din læge.
English: In two 24-week double-blind, placebo-controlled clinical trials, skin reactions were measured at each visit using a skin irritation rating scale.
Danish: I to 24-ugers dobbeltblindede, placebokontrollerede kliniske studier blev hudreaktionerne målt i forhold til en hudirritationsskala ved hvert besøg.
English: When observed in patients treated with Prometax transdermal patches, skin irritation was mostly slight or mild in severity.
Danish: For patienter behandlet med Prometax depotplaster blev det observeret, at hudirritation oftest var ringe til let i sværhedsgrad.
English: If this applies to you, tell your doctor and do not apply Prometax transdermal patches.
Danish: Hvis dette gælder for dig, skal du fortælle det til din læge og ikke bruge Prometax depotplastre.
English: [folding box only]
Danish: [kun på karton]
English: Adhesive matrix
Danish: Klæbende matrix
English: Oral studies in pregnant rats and rabbits gave no indication of teratogenic potential on the part of rivastigmine.
Danish: Studier på gravide rotter og kaniner med oral indgift af rivastigmin gav ingen indikation af et teratogent potentiale.
English: • Treatment usually starts with Prometax 4.6 mg/24 h.
Danish: • Behandlingen starter normalt med Prometax 4,6 mg/24 timer.
English: Care must be taken when using rivastigmine in patients with sick sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section 4.8).
Danish: Der skal udvises forsigtighed ved brug af rivastigmin til patienter med sygt sinussyndrom eller overledningsdefekter (sino-atrialt blok, atrio-ventrikulært blok) (jævnfør afsnit 4.8).
English: • Chest pain - this may be caused by heart spasm
Danish: Brystsmerter - kan skyldes hjertekramper
English: Administration of rivastigmine with food delays absorption (tmax) by 90 min and lowers Cmax and increases AUC by approximately 30%.
Danish: Indgift af rivastigmin sammen med føde forsinker optagelsen (tmax) med 90 min, sænker Cmax og øger AUC med ca. 30%.
English: Each transdermal patch is a thin, matrix-type transdermal patch consisting of three layers.
Danish: Hvert depotplaster er et tyndt depotplaster af matrixtypen og består af tre lag.
English: ADAS-cog scores: A negative difference in DLSM indicates greater improvement in Prometax 15 cm as compared to Prometax 10 cm
Danish: ADAS-cog score: En negativ forskel i DLSM indikerer større forbedring med Prometax 15 cm2
English: No pharmacokinetic interaction was observed between oral rivastigmine and digoxin, warfarin, diazepam or fluoxetine in studies in healthy volunteers.
Danish: Der sås ingen farmakokinetisk interaktion mellem oral rivastigmin og digoxin, warfarin, diazepam eller fluoxetin i studier med raske frivillige forsøgspersoner.
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: How to apply your Prometax transdermal patch Prometax patches are thin, opaque, plastic patches that stick to the skin.
Danish: Prometax depotplastre er tynde, uigennemsigtigte plast-plastre, som klæber til huden.
English: Magnesium stearate Hypromellose Microcrystalline cellulose Silica, colloidal anhydrous Yellow iron oxide (E172) Red iron oxide (E172) Titanium dioxide (E171) Shellac
Danish: Magnesiumstearat Hypromellose Mikrokrystallinsk cellulose Silica, kolloid vandfri Gul jernoxid (E 172) Rød jernoxid (E 172) Titandioxid (E 171) Shellac
English: Apply one patch per day.
Danish: Påsæt et plaster om dagen.
English: One of the inactive ingredients in Prometax oral solution is sodium benzoate.
Danish: En af de inaktive indholdstoffer i Prometax oral opløsning er natriumbenzoat.
English: • Push the nozzle of the syringe into the hole in the white stopper.
Danish: • Sæt doseringssprøjtens spids ned i hullet i flaskens hvide gummilukke.
English: • After removing a patch, fold it in half with the sticky sides on the inside and press them together.
Danish: • Når depotplasteret er taget af, folder du det sammen på midten med den klæbende side indad.
English: • Do not use this medicine after the expiry date which is stated on the carton after EXP.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Prometax capsules 12 mg/day N = 256
Danish: Prometax kapsler 12 mg dagligt N = 256
English: • The patch should be replaced by a new one after 24 hours.
Danish: • Plasteret udskiftes efter 24 timer.
English: Allergic dermatitis (disseminated) General disorders and administration site conditions Very common
Danish: Allergisk dermatitis (dissemineret) Almene symptomer og reaktioner på administrationsstedet Meget almindelig
English: Hypersensitivity to the active substance rivastigmine, to other carbamate derivatives or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof rivastigmin, over for andre carbamatderivater eller over for et eller flere af hjælpestofferne anført i pkt.
English: By blocking these enzymes, Prometax allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's disease and dementia associated with Parkinson's disease.
Danish: Ved at blokere disse enzymer kan Prometax medvirke til, at acetylcholin-indholdet øges i hjernen, hvilket hjælper med at reducere symptomerne på Alzheimers sygdom og demens forbundet med Parkinsons sygdom.
English: Rivastigmine was not mutagenic in a standard battery of in vitro and in vivo tests, except in a chromosomal aberration test in human peripheral lymphocytes at a dose 10
Danish: Rivastigmin var ikke mutagen i et standardbatteri af in vitro- og in vivo-test, på nær i en kromosomal Aberration Test i humane perifere lymfocytter ved en dosis på 10
English: • Inflammation of the pancreas - signs include serious upper stomach pain, often with feeling sick
Danish: • Betændelse i bugspytkirtelen - symptomerne omfatter alvorlige smerter øverst i maven, ofte med kvalme eller opkastning
English: Bradykinesia
Danish: Bradykinesi
English: Some cases of severe vomiting were associated with oesophageal rupture (see section 4.8).
Danish: Nogle tilfælde af alvorlig opkastning blev associeret med esophagusruptur (jævnfør afsnit 4.8).
English: Some people who have accidentally taken too much Prometax 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 Prometax, har haft kvalme, kastet op, haft diarré, højt blodtryk og hallucinationer.
English: Cardiac arrhythmia (e.g. bradycardia, atrio-ventricular block, atrial fibrillation and tachycardia)
Danish: Kardielle arytmier (f.eks. bradykardi, atrio-ventrikulært blok, atrieflimren og takykardi)
English: Crivastigmine, renal elimination was rapid and essentially complete (>90%) within 24 hours.
Danish: C-rivastigmin var renal udskillelse hurtig og nærmest fuldstændig (>90%) inden for 24 timer.
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 Prometax 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: • Hyperactivity (high level of activity, restlessness)
Danish: Hyperaktivitet (højt aktivitetsniveau, rastløshed) Aggressiv adfærd
English: The fluctuation index (FI), a measure of the relative difference between peak and trough concentrations ((Cmax-Cmin)/Cavg), was 0.58 for Prometax 4.6 mg/24 h transdermal patches, 0.77 for Prometax 9.5 mg/24 h transdermal patches and 0.72 for Prometax 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 Prometax 4,6 mg/24 timer depotplastre, 0,77 for Prometax 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: Multipack: 60 (2 packs of 30) transdermal patches Multipack: 90 (3 packs of 30) transdermal patches
Danish: Multipakning: 90 (3 pakninger med 30) depotplastre.
English: The efficacy of Prometax 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 Prometax 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: Baseline 264 34.4 268 34.9 DB-week 48 Value
Danish: Baseline 264 34,4 268 34,9
English: The active substance of Prometax is rivastigmine.
Danish: Det aktive stof i Prometax er rivastigmin.
English: If you forget to use Prometax
Danish: Hvis du har glemt at bruge Prometax
English: Absorption of rivastigmine from Prometax transdermal patches is slow.
Danish: Rivastigmin fra Prometax depotplastre absorberes langsomt.
English: • The patch should be pressed down firmly for at least 30 seconds using the palm of the hand until the edges stick well.
Danish: • Plasteret trykkes godt ned i mindst 30 sekunder med håndfladen , indtil kanterne sidder godt fast.
English: Clinical studies in dementia associated with Parkinson's disease
Danish: Kliniske studier af demens, associeret med Parkinsons sygdom
English: Like all medicines, Prometax transdermal patches can cause side effects, although not everybody gets them.
Danish: Prometax depotplaster kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Also contains: polyethylene terephthalate film lacquered, alpha-tocopherol, poly(butylmethacrylate, methylmethacrylate), acrylic copolymer, silicone oil, dimethicone, polyester film fluoropolymercoated.
Danish: Indeholder også: lakeret polyethylenterephthalatfilm, alfa-tocopherol, poly(butylmethacrylat, methylmethacrylat), akryl-co-polymer, silikoneolie, dimeticon, fluoropolymerbelagt polyesterfilm.
English: • to patients with sick sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section 4.8);
Danish: • til patienter med sygt sinus-syndrom eller overledningsforstyrrelser (sinoatrialt blok, atrioventrikulært blok) (se pkt.
English: Mean baseline  SD Mean change at week 24  SD -0.1  9.1 p-value versus placebo * p≤0.05 versus placebo ITT: Intent-To-Treat; LOCF: Last Observation Carried Forward Based on ANCOVA with treatment and country as factors and baseline value as a covariate.
Danish: (n=281) Gennemsnitsbaseline  SD 50,1  16,3 49,3  15,8 49,2  16,0 Gennemsnitsændring ved uge 24  SD p-værdi versus placebo * p≤0,05 versus placebo ITT: Intent-To-Treat; LOCF: Last Observation Carried Forward Baseret på ANCOVA med behandling og land som faktorer og baselineværdi som co-variant.
English: Contact with the eyes should be avoided after handling Prometax transdermal patches (see section 5.3).
Danish: Undgå kontakt med øjnene efter håndtering af Prometax depotplastre (se pkt.
English: Prometax 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: Prometax 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: • to patients with active gastric or duodenal ulcers or patients predisposed to these conditions because rivastigmine may cause increased gastric secretions (see section 4.8);
Danish: • til patienter med aktivt mavesår eller sår på tolvfingertarmen eller patienter, som er prædisponeret for sådanne sygdomme, da rivastigmin kan medføre øget mavesyresekretion (se pkt.
English: Alzheimer's disease may cause gradual impairment of driving performance or compromise the ability to use machines.
Danish: Alzheimers sygdom kan medføre gradvis forringelse af køreegenskaber eller nedsætte evnen til at betjene maskiner.
English: Care must be taken when prescribing Prometax transdermal patches:
Danish: Der skal udvises forsigtighed ved ordination af Prometax depotplastre:
English: The following adverse reactions have only been observed with Prometax capsules and oral solution and not in clinical studies with Prometax transdermal patches: malaise, 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 Prometax-kapsler og oral opløsning og ikke i kliniske studier med Prometax depotplaster: Utilpashed, 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: Pruritus, erythema, urticaria, vesicles, allergic dermatitis (disseminated) Renal and urinary disorders Common
Danish: Kløe, erytem, urticaria, blærer, allergisk dermatitis (dissemineret)
English: You should not breast-feed during treatment with Prometax.
Danish: Du må ikke amme, mens du er i behandling med Prometax.
English: Other side effects seen with Prometax capsules or oral solution and which may occur with the patch:
Danish: Andre bivirkninger, der er set med Prometax kapsler eller oral opløsning, og som kan forekomme ved brug af plasteret:
English: Table 1 displays the adverse reactions reported in 1,670 patients with Alzheimer's dementia treated in randomised, double-blind, placebo and active-controlled clinical studies with Prometax transdermal patches for a duration of 24-48 weeks and from post-marketing data.
Danish: Tabel 1 viser de bivirkninger, som blev rapporteret hos 1.670 patienter med Alzheimers demens behandlet med Prometax depotplastre med en varighed på 24-48 uger og fra post-marketing data i randomiserede, dobbeltblindede, placebo- og aktivkontrollerede kliniske studier.
English: The following additional adverse reactions have been observed with Prometax transdermal patches: delirium, pyrexia, decreased appetite, urinary incontinence (common), psychomotor hyperactivity (uncommon), erythema, urticaria, vesicles, allergic dermatitis (not known).
Danish: Følgende bivirkninger er blevet observeret med Prometax depotplaster: delirium, feber, nedsat appetit, urininkontinens (almindelig), psykomotorisk hyperaktivitet (ikke almindelig), erytem, urticaria, blærer, allergisk dermatitis (ikke kendt).
English: If you forget to take Prometax
Danish: Hvis du har glemt at tage Prometax