FrancophonIA/ELRC3.0 huggingface dataset:
English: Misuse of the medicinal product and dosing errors resulting in overdose
Danish: Forkert brug af lægemidlet og doseringsfejl, der resulteret i overdosering
English: • Bathing, swimming or showering should not affect the patch.
Danish: • Badning, svømning eller brusebad påvirker ikke plasteret.
English: Based on CMH test (van Elteren test) blocking for country.
Danish: Baseret på CMH-testblokning (van Elteren-test) for land.
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: Hvis det er en hjælp for dig, kan du f.eks. skrive ugedagen på plasteret med en tynd kuglepen.
English: • Seeing things that are not really there (hallucinations)
Danish: • Ser ting, der ikke er der i virkeligheden (hallunicationer)
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: • Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: N is the number of patients with an assessment at baseline (last assessment in the initial openlabel phase) and with at least 1 post-baseline assessment (for the LOCF).
Danish: N er antal af patienter med vurdering ved baseline (sidste vurdering i den første open-label fase) og med mindst 1 post baseline vurdering (for LOCF).
English: Can you wear your Prometax transdermal patch when you are bathing, swimming, or in the sun?
Danish: Kan du have dit Prometax depotplaster på, når du bader, svømmer eller solbader?
English: The patient reminder card should contain the following key messages:
Danish: Huskekort til patienter bør indeholde følgende centrale budskaber:
English: INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
Danish: INTERMEDIÆR KARTON AF MULTIPAKNING (UDEN BLUE BOX)
English: • Pull the plunger upwards until it reaches the right mark for the dose that your doctor has prescribed.
Danish: • Træk stemplet opad, indtil det når målestregen for den dosis, din læge har foreskrevet.
English: In case of severe vomiting associated with rivastigmine treatment, appropriate dose adjustments as recommended in section 4.2 must be made.
Danish: I tilfælde af alvorlig opkastning, der er associeret med rivastigminbehandling, skal der foretages passende dosisjustering som anbefalet i afsnit 4.2.
English: Rivastigmine transdermal patches were not phototoxic and considered to be a non-sensitiser.
Danish: Rivastigmin-depotplastre var ikke fototoksiske og anses for at være ikke-sensibiliserende.
English: - HDPE bottles with plastic closure with induction innerseal.
Danish: - HDPE-flaske med plastiklukke med indre tætningsanordning.
English: You should only open the sachet when you are ready to apply the patch.
Danish: Du må kun åbne brevet, når du er klar til at sætte plasteret på.
English: The incidence of application site skin reactions leading to discontinuation was higher in the Asian population with 4.9% and 8.4% in the Chinese and Japanese population respectively.
Danish: Hyppigheden af reaktioner på applikationsstedet førende til behandlingsafbrydelse var højere i den asiatiske population med henholdsvis 4,9% og 8,4% for den kinesiske og japanske population.
English: Treatment effect has not been studied in placebo-controlled trials beyond 6 months.
Danish: Behandlingens effekt er ikke blevet undersøgt i placebo-kontrollerede studier ud over 6 måneder.
English: times the foreseen clinical exposure.
Danish: gange den forudsete kliniske eksponering.
English: In some other dermal toxicity studies, a mild irritant effect on the skin of laboratory animals, including controls, was observed.
Danish: I nogle andre dermale toksicitetsstudier blev der observeret en mild irriterende effekt på laboratoriedyr, herunder kontroldyr.
English: If you find you have forgotten to take your dose of Prometax, wait and take the next dose at the usual time.
Danish: Hvis du finder ud af, at du har glemt at tage en dosis Prometax, skal du blot vente og tage næste dosis på det sædvanlige tidspunkt.
English: Component of a multipack.
Danish: Delpakning af multipakning.
English: OUTER CARTON OF MULTIPACK (WITH BLUE BOX)
Danish: YDERKARTON AF MULTIPAKNING (MED BLUE BOX)
English: Absolute bioavailability after a 3 mg dose is about 36%13%.
Danish: Absolut biotilgængelighed efter en 3 mg dosis er ca. 36%13%.
English: • Take Prometax twice a day, in the morning and evening, with food.
Danish: • Tag Prometax to gange om dagen (morgen og aften) sammen med mad.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl
English: Your doctor will tell you what dose of Prometax to take.
Danish: Din læge vil fortælle dig, hvilken dosis Prometax du skal tage.
English: Based on ANCOVA with treatment and country as factors and baseline ADAS-Cog as a covariate.
Danish: Baseret på ANCOVA med behandling og land som faktorer og baseline ADAS-Cog som covariat.
English: Patients and caregivers should be instructed on important administration instructions:
Danish: Patienter og omsorgspersoner bør instrueres i vigtige administrationsinstruktioner:
English: • Instructions to provide patients and caregivers with the patient reminder card
Danish: • Instruktioner om at forsyne patienter og sundhedsprofessionelle med huskekort til patienter
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Prometax patch is marketed, all physicians who are expected to prescribe Prometax 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 Prometax depotplaster er markedsført, sikre at alle læger, der forventes at udskrive Prometax depotplaster, er forsynet med en informationspakke indeholdende følgende ting:
English: Mean data shown for convenience, categorical analysis performed using van Elteren test ITT: Intent-To-Treat; RDO: Retrieved Drop Outs; LOCF: Last Observation Carried Forward
Danish: Middeldata vist for belejlighed, kategorisk analyse, der blev udført ved brug af van Elteren-test ITT: Intent-To-Treat; RDO: Retrieved Drop Outs; LOCF: Last Observation Carried Forward.
English: Oral and topical dosing in animal studies was limited due to the sensitivity of the animal models used.
Danish: Oral og topisk dosering i dyreforsøg var begrænset på grund af følsomheden af de anvendte dyremodeller.
English: • Periodic Safety Update Reports
Danish: • Periodiske, opdaterede sikkerhedsindberetinger (PSUR'er)
English: Prometax 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: Prometax anvendes til behandling af voksne patienter med mild til moderat svær Alzheimers demens, en fremadskridende hjernesygdom, der gradvis påvirker hukommelse, åndsevner og adfærd.
English: For patients starting treatment for the first time and for patients restarting Prometax after treatment interruption, please begin with the second picture.
Danish: Til patienter, som starter behandlingen for første gang eller patienter som genstarter Prometax efter behandlingsstop, skal starte med billede 2.
English: CARTON FOR UNIT PACK
Danish: KARTON TIL ENHEDSPAKNINGER
English: • to patients predisposed to urinary obstruction and seizures because cholinomimetics may induce or exacerbate these diseases;
Danish: • til patienter, som er prædisponeret for urinvejsobstruktion og krampeanfald, da kolinomimetika kan forårsage eller forværre disse sygdomme
English: However, Prometax may be used in this patient population and close monitoring is necessary.
Danish: Prometax kan imidlertid anvendes hos denne patientpopulation, men det er nødvendigt at følge patienterne tæt.
English: PC: [folding box only] SN: [folding box only] NN: [folding box only]
Danish: PC: [kun på karton] SN: [kun på karton] NN: [kun på karton]
English: Your doctor will tell you which Prometax transdermal patch is most suitable for you.
Danish: Din læge vil fortælle dig, hvilket Prometax depotplaster, der er bedst egnet til dig.
English: Based on population analysis, creatinine clearance did not show any clear effect on steady state concentrations of rivastigmine or its metabolite.
Danish: I en populationsanalyse viste kreatininclearance ikke nogen klar effekt på steady state koncentrationerne af rivastigmin eller dets metabolit.
English: A mild eye/mucosal irritation potential of rivastigmine was identified in a rabbit study.
Danish: Potentiel mild øjen/mucosal irritation af rivastigmin blev identificeret i et studie på kaniner.
English: Hallucinations, restlessness, nightmares
Danish: Hallucinationer, rastløshed, mareridt
English: Following administration of oral
Danish: Efter indgift af oral
English: • To benefit from treatment, you must apply a new patch every day, preferably at the same time of day.
Danish: • Du skal sætte et nyt plaster på hver dag for at få gavn af behandlingen, helst på den samme tid af dagen.
English: Parkinson's disease (worsening)
Danish: Parkinsons sygdom (forværring)
English: Abdominal pain and dyspepsia
Danish: Abdominale smerter og dyspepsi
English: • Unusually slow movements or movements you cannot control
Danish: Unormalt langsomme eller ukontrollerede bevægelser
English: Talk to your doctor before using Prometax: - if you have, or have ever had, an irregular or slow heartbeat.
Danish: Kontakt lægen, før du bruger Prometax: - hvis du har eller har haft uregelmæssig eller langsom hjerterytme (puls).
English: Peel off one side of the protective liner and do not touch the sticky part of the patch with the fingers.
Danish: Træk den ene side af den beskyttende film af, og undgå at røre ved den klæbende side af plasteret med fingrene.
English: Atrioventricular block
Danish: Atrioventrikulært blok
English: The capsules and oral solution can also be used for the treatment of dementia in adult patients with Parkinson's disease.
Danish: Kapsler og oral opløsning kan også anvendes til behandling af demens hos voksne patienter med Parkinsons sygdom.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: • Store in an upright position.
Danish: • Opbevares i opretstående stilling.
English: If this applies to you, tell your doctor and do not take Prometax.
Danish: Hvis dette gælder for dig, skal du fortælle det til din læge og ikke tage Prometax.
English: If you stop using Prometax Tell your doctor or pharmacist if you stop using the patch.
Danish: Hvis du holder op med at bruge Prometax Fortæl det til lægen eller apoteket, hvis du holder op med at bruge plasteret.
English: • Only wear one Prometax 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: It was rated as severe in ≤2.2% of patients in these studies and in ≤3.7% of patients treated with Prometax 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 Prometax depotplaster.
English: A relationship between active substance exposure at steady state (rivastigmine and metabolite NAP226-90) and bodyweight was observed in Alzheimer's dementia patients.
Danish: Der blev observeret en sammenhæng mellem eksponering for aktive stoffer ved steady state (rivastigmin og metabolit NAP226-90) og legemsvægt hos patienter med Alzheimers demens.
English: Put the sticky side of the patch on the upper or lower back, upper arm or chest and then peel off the second side of the protective liner.
Danish: Placer den klæbende side af plasteret øverst eller nederst på ryggen, på overarmen eller på brystet, og træk den anden side af den beskyttende film af.
English: • Then, put the syringe back in its protective case.
Danish: • Læg derefter doseringsprøjten tilbage i det beskyttende hylster.
English: • Apply ONE patch per day to ONLY ONE of the possible locations shown in the following diagrams: left upper arm or right upper arm left upper chest or right upper chest (avoid breast) left upper back or right upper back left lower back or right lower back
Danish: • Sæt ÉT depotplaster på hver dag og KUN PÅ ÉT af de mulige steder, som vist på nedenstående tegninger: Venstre overarm eller højre overarm Øverst på venstre brystkasse eller øverst på højre brystkasse (undgå brysterne) Venstre øvre del af ryggen eller højre øvre del af ryggen Venstre nedre del af ryggen eller højre nedre del af ryggen
English: Alpha-tocopherol Silicone oil Dimethicone
Danish: Alfa-tokoferol Silikoneolie Dimethicon
English: Poly(butylmethacrylate, methylmethacrylate) Acrylic copolymer
Danish: Poly(butylmethacrylat, methylmethacrylat) Akryl-co-polymer
English: • Before you apply a patch, make sure that your skin is clean, dry and hairless, free of any powder, oil, moisturiser or lotion that could keep the patch from sticking to your skin properly, free of cuts, rashes and/or irritations.
Danish: • Før du sætter et depotplaster på, skal du sørge for, at huden er ren, tør og glat uden hår, fri for pudder, olie, fugtighedscreme eller lotion, som kan bevirke, at depotplasteret ikke klæber rigtigt til huden, fri for sår/rifter, udslæt og/eller irritation.
English: times the maximum clinical exposure.
Danish: gange den maksimale kliniske relevante.
English: Cardiovascular betablockers are expected to be associated with the greatest risk, but reports have also been received in patients using other beta- blockers.
Danish: Kardiovaskulære betablokkere forventes at være forbundet med den største risiko, men der er også modtaget rapporter fra patienter, som har brugt andre betablokkere.
English: When and for how long to apply your Prometax transdermal patch
Danish: Hvornår og hvor længe skal dit Prometax depotplaster sidde
English: ADCS-IADL scores: A positive difference in DLSM indicates greater improvement in Prometax 15 cm as compared to Prometax 10 cm
Danish: ADCS-IADL score: En positiv forskel i DLSM indikerer større forbedring med Prometax 15 cm sammenlignet med Prometax 10 cm
English: Prometax transdermal patches may cause fainting or severe confusion.
Danish: Prometax depotplastre kan fremkalde besvimelse eller stærk forvirring.
English: Prometax contains sodium benzoate
Danish: Prometax indeholder natriumbenzoat
English: Application site skin reactions (usually mild to moderate application site erythema), are the most frequent adverse reactions observed with the use of Prometax transdermal patch.
Danish: Hudreaktioner på applikationsstedet (normalt let til moderat erytem på applikationsstedet), er de hyppigste bivirkninger observeret ved brug af Prometax depotplaster.
English: Table 3 lists the number and percentage of patients from the specific 24-week clinical study conducted with Prometax 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 Prometax hos patienter med demens, associeret med Parkinsons sygdom med præ-definerede bivirkninger, der muligvis kan reflektere en forværring af Parkinsons symptomer.
English: • Hepatic impairment: Due to increased exposure in mild to moderate hepatic impairment as observed with the oral formulation, dosing recommendations to titrate according to individual tolerability should be closely followed.
Danish: • Nedsat leverfunktion: Da der er observeret øget biotilgængelighed ved let til moderat nedsat leverfunktion for den orale formulering, skal anbefalingerne vedrørende titrering i henhold til individuel tolerance følges nøje.
English: Always use Prometax transdermal patches exactly as your doctor has told you.
Danish: Brug altid Prometax depotplastre nøjagtigt efter lægens anvisning.
English: Medicinal product matrix
Danish: Lægemiddelmatrix
English: If you accidentally take more Prometax than you should, inform your doctor.
Danish: Hvis du ved en fejltagelse er kommet til at tage mere Prometax, end du har fået besked på, skal du sige det til din læge.
English: Rivastigmine in vivo release rates per 24 h
Danish: Rivastigminfrigivelse pr. 24 timer in vivo
English: Prometax 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: Prometax 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: Alpha-tocopherol
Danish: Alfa-tokoferol
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 specific interaction studies have been performed with Prometax transdermal patches.
Danish: Der er ikke udført specifikke interaktionsstudier med Prometax depotplastre.
English: Patients and their caregivers must be instructed on important administration instructions for Prometax transdermal patch (see section 4.2).
Danish: Patienterne og deres omsorgspersoner skal instrueres i vigtige administrationsinstruktioner for Prometax depotplaster (se pkt.
English: Following a single 3 mg or 6 mg oral dose, the mean oral clearance of rivastigmine was approximately 46-63% lower in patients with mild to moderate hepatic impairment (n=10, Child-Pugh score 5-12, biopsy proven) than in healthy subjects (n=10).
Danish: Efter en enkelt 3 mg eller 6 mg oral dosis var den gennemsnitlige orale clearance af rivastigmin ca. 43-63% lavere hos patienter med let til moderat nedsat leverfunktion (n=10, Child-Pugh score 5-12, påvist ved biopsi) end hos raske frivillige (n=10).
English: Age had no impact on the exposure to rivastigmine in Alzheimer's disease patients treated with Prometax transdermal patches.
Danish: Alder havde ingen indvirkning på eksponering for rivastigmin hos patienter med Alzheimers demens, som blev behandlet med Prometax depotplastre.
English: In double-blind controlled clinical trials, application site reactions were mostly mild to moderate in severity.
Danish: I dobbeltblindede, kontrollerede kliniske studier var reaktioner på applikationsstedet oftest lette til moderate i sværhedgrad.
English: Each box contains 28, 56 or
Danish: Hver æske indeholder 28, 56 eller 112 kapsler.
English: No evidence of carcinogenicity was found in oral and topical studies in mice and in an oral study in rats at the maximum tolerated dose.
Danish: Der var ingen tegn på karcinogenitet i orale og topiske studier på mus og i et oralt studie på rotter ved maksimalt tolereret dosis.
English: Overdose with Prometax 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 Prometax 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: Polyethylene terephthalate film, lacquered
Danish: Polyethylenterephthalatfilm, lakeret
English: Worsening of Parkinson's disease, seizure, tremor, somnolence
Danish: Forværring af Parkinsons sygdom, krampeanfald, tremor, døsighed
English: A population pharmacokinetic analysis showed that nicotine use increases the oral clearance of rivastigmine by 23% in patients with Alzheimer's disease (n=75 smokers and 549 non-smokers) following rivastigmine oral capsule doses for up to 12 mg/day.
Danish: En farmakokinetisk populationsanalyse viste, at nicotin øger den orale clearence af rivastigmin med 23% hos patienter med Alzheimers sygdom (n=75 rygere og 549 ikke-rygere), der får rivastigminkapsler i en dosis på op til 12 mg/dag.
English: Prometax should not be given at the same time as other medicines with similar effects to Prometax.
Danish: Du må ikke tage Prometax samtidig med andre lægemidler, der har en virkning, der ligner Prometaxs.
English: As suggested by compartmental modelling, 9.5 mg/24 h transdermal patches exhibited exposure similar to that provided by an oral dose of 12 mg/day.
Danish: Som antydet ved compartment-modellen viste 9,5 mg/24 timer depotplastre eksponering tilsvarende den, der fås ved en oral dosis på 12 mg dagligt.
English: Quinoline yellow WS dye (E104) Purified water
Danish: Vandopløselig quinolingult farve (E 104) Renset vand
English: If you have not taken Prometax for more than three days, do not take the next dose until you have talked to your doctor.
Danish: Hvis du ikke har taget Prometax 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 Prometax 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 Prometax depotplaster har resulteret i alvorlige bivirkninger, nogle tilfælde har krævet hospitalsindlæggelse og i sjældne tilfælde ført til dødsfald (se pkt.
English: However, these events did not occur at a higher frequency with Prometax 13.3 mg/24 h transdermal patches than with placebo.
Danish: Disse bivirkninger forekom dog ikke med en højere frekvens for Prometax 13,3 mg/24 timer end for placebo.
English: In other cases, Prometax has been discontinued (see section 4.8).
Danish: I andre tilfælde er Prometax blevet seponeret (se pkt.
English: Used transdermal patches should be folded in half, with the adhesive side inwards, placed in the original sachet and discarded safely and out of the reach and sight 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: C-rivastigmine, renal elimination was rapid and essentially complete (>90%) within 24 hours.
Danish: C-rivastigmin var den renale udskillelse hurtig og nærmest fuldstændig (>90%) inden for 24 timer.