FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, the company that markets Scenesse will ensure that doctors receive educational material and are trained in how to use the medicine.
Danish: Desuden skal den virksomhed, der markedsfører Scenesse, sørge for, at lægerne får tilsendt oplysningsmateriale og bliver oplært i anvendelsen af lægemidlet.
English: The CHMP noted that Scenesse led to an increase in the amount of time patients could spend in direct sunlight without experiencing pain.
Danish: CHMP bemærkede, at Scenesse medførte en forøgelse af den tid, patienterne kunne opholde sig i direkte sollys uden at få smerter.
English: Protoporphyrin IX is phototoxic and, when exposed to light, causes the painful reactions seen with this condition.
Danish: Protoporfyrin IX bliver giftigt ved lyspåvirkning (fototoksisk), og når det udsættes for lys, forårsager det de smertefulde reaktioner, der optræder ved denne sygdom.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Scenesse, including information on the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Scenesse, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The active substance in Scenesse, afamelanotide, is similar to a hormone in the body known as alphamelanocyte stimulating hormone, which stimulates the production of a brown-black pigment in the skin.
Danish: Det aktive stof i Scenesse, afamelanotid, svarer til kroppens naturlige alfa-melanocytstimulerende hormon, der stimulerer produktionen af sortbrunt pigment i huden.
English: For more information about treatment with Scenesse, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Scenesse, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: For more information on how to use Scenesse, see the summary of product characteristics (also part of the EPAR).
Danish: De nærmere oplysninger om anvendelsen af Scenesse fremgår af produktresuméet (også en del af denne EPAR).
English: This pigment, known as eumelanin, is produced during exposure to sunlight to block the penetration of light into cells.
Danish: Pigmentet kaldes eumelanin og dannes ved udsættelse for sollys for at forhindre, at lyset trænger ind i cellerne.
English: Scenesse has been shown in a study to lead to an increase in the amount of time patients can spend in sunlight.
Danish: Det er i en undersøgelse blevet påvist, at Scenesse medfører en forøgelse af den tid, patienterne er i stand til at opholde sig i sollys.
English: Although the additional time spent in sunlight was small, the Committee considered the possible improvements in quality of life, the unmet medical need in patients with EPP, and the mild side effects seen during short-term treatment with the medicine in deciding to recommend approval for Scenesse in the EU.
Danish: Der var kun var tale om en lille forøgelse af den tid, hvor patienterne opholdt sig i sollys, men i afgørelsen om at anbefale godkendelse af Scenesse i EU tog udvalget hensyn til den mulige forbedring i livskvalitet, det uopfyldte behandlingsbehov for patienter med EPP og de milde bivirkninger ved korttidsbehandling med lægemidlet.
English: Daily records of exposure to sunlight between 10 am and 6 pm showed that patients treated with Scenesse spent on average 116 hours in direct sunlight without experiencing pain during the six-month period compared with 61 hours for patients treated with placebo.
Danish: Det viste sig, at de patienter, der fik Scenesse, opholdt sig gennemsnitligt 116 timer i direkte sollys uden smerter, sammenholdt med 61 timer for dem, der fik placebo.
English: How is Scenesse used?
Danish: Hvordan anvendes Scenesse?
English: For practical information about using Scenesse, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Scenesse, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How does Scenesse work?
Danish: Hvordan virker Scenesse?
English: What benefits of Scenesse have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Scenesse?
English: In patients with EPP, exposure to light can lead to symptoms such as pain and swelling of the skin, which prevent patients from being able to spend time outdoors or in places with bright light.
Danish: Hos patienter med EPP kan udsættelse for lys medføre symptomer såsom smerter og hævet hud.
English: The usual dosing regimen should always be followed.
Danish: Det sædvanlige doseringsregime bør altid følges.
English: Date of first authorisation: 20 July 2011 Date of latest renewal: 18 May 2017
Danish: Dato for første markedsføringstilladelse: 20. juli 2011 Dato for seneste fornyelse: 18. maj 2017
English: ≥20% improvement
Danish: ≥20% forbedring
English: The small reduction in AUC is not expected to cause a reduction in the therapeutic efficacy.
Danish: Den lille reducering i AUC forventes ikke at forårsage en reducering i den terapeutiske effektivitet.
English: • Risk management plan (RMP)
Danish: • Risikostyringsprogram (RMP)
English: Consistent improvement
Danish: Konsistent forbedring
English: Make sure you're not affected before you start driving or use machinery.
Danish: Sørg for ikke at være påvirket, før du begynder at køre eller betjene maskiner.
English: However, Cmax increases by 15-23%.
Danish: Cmax øges dog med 1523%.
English: Do not give Fampyra to children or adolescents under the age of 18 years.
Danish: Giv ikke Fampyra til børn eller unge under 18 år.
English: Reports of hypertension have also been received.
Danish: Der er også modtaget rapporter om hypertension.
English: Over 24 weeks
Danish: I en periode på 24 uger
English: After 2 to 4 weeks the treatment will be reassessed.
Danish: Efter 2 til 4 uger vil behandlingen blive revurderet.
English: There is limited safety information in these patients.
Danish: Der foreligger kun få data om sikkerhed for disse patienter.
English: OCT2 is the transporter responsible for the active secretion of fampridine.
Danish: OCT2 er den transporter, der er ansvarlig for den aktive sekretion af fampridin.
English: Fampridine has a narrow therapeutic index.
Danish: Fampridin har et snævert terapeutisk indeks.
English: Children and in adolescents
Danish: Børn og teenagere
English: − if you are taking a medicine called cimetidine
Danish: − hvis du tager et lægemiddel, som hedder cimetidin
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: Hyppighederne defineres som: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: − you should use a walking aid, such as a cane, as needed
Danish: − du skal bruge hjælpemidler til at gå, såsom en stok, efter behov
English: Fampyra is for oral use.
Danish: Fampyra er til oral brug.
English: The difference in the Berg Balance Scale (BBS; a measure of static balance), was not statistically significant.
Danish: Forskellen i Bergs balanceskala (BBS, et mål for statisk balance) var ikke statistisk signifikant.
English: Difference (95% CI) p - value
Danish: Forskel (95 % CI) p-værdi
English: May affect more than 1 in 10 people: • Urinary tract infection
Danish: Kan forekomme hos flere end 1 ud af 10 brugere: • Urinvejsinfektion
English: Fampyra should be taken without food, on an empty stomach.
Danish: Fampyra bør indtages uden mad, på tom mave.
English: Fampridine has a volume of distribution of approximately 2.6 l/kg.
Danish: Fampridin har en fordelingsvolumen på cirka 2,6 l/kg.
English: 43% Risk difference: 10.4%
Danish: 43 % Risikoforskel: 10,4 %
English: ANNEX II A. MANUFACTURERS(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: You should not breast-feed whilst taking this medicine.
Danish: Du bør ikke amme, mens du tager denne medicin.
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 en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelvoervågning eller risikominimering) er nået.
English: It is unknown whether fampridine is excreted in human or animal milk.
Danish: Det vides ikke, om fampridin udskilles i mælken hos mennesker og dyr.
English: − if you are prone to infections
Danish: − hvis du er tilbøjelig til at få infektioner
English: Fampyra with food and drink
Danish: Brug af Fampyra sammen med mad og drikke
English: Your doctor will consider the benefit of you being treated with Fampyra against the risk to your baby.
Danish: Lægen vil overveje fordelene ved at behandle dig med Fampyra i forhold til risikoen for dit barn.
English: These clinical signs were not unexpected and represent exaggerated pharmacology of fampridine.
Danish: Disse kliniske tegn var ikke uventede og repræsenterer overdrevne farmakologiske effekter af fampridin.
English: 1 See section 4.4 2 These symptoms were observed in the context of hypersensitivity
Danish: 4.4 2 Disse symptomer blev observeret i forbindelse med overfølsomhed
English: You may also notice other effects not listed here.
Danish: Du kan også opleve andre bivirkninger, som ikke er nævnt her.
English: Study 218MS305 was conducted in 636 subjects with multiple sclerosis and walking disability.
Danish: Studie 218MS305 blev udført med 636 patienter med multipel sklerose og nedsat gangevne.
English: Do not take more than two tablets in a day.
Danish: Tag ikke mere end to tabletter om dagen.
English: Clinical studies of Fampyra did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients.
Danish: Kliniske studier af Fampyra inkluderede ikke et tilstrækkeligt antal patienter i aldersgruppen fra 65 år og op til at kunne fastlægge, om de reagerede anderledes end yngre patienter.
English: Athlone, Co. Westmeath Ireland
Danish: Athlone, Co. Westmeath Irland
English: This is consistent with fampridine's pharmacological activity.
Danish: Dette stemmer overens med fampridins farmakologiske aktivitet.
English: There are limited amount of data from the use of fampridine in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af fampridin til gravide kvinder.
English: Duration of double-blind treatment was 24 weeks with a 2 week post-treatment follow-up.
Danish: Varigheden af den dobbeltblinde behandling var 24 uger med opfølgning 2 uger efter behandlingsafslutning.
English: Do not take the tablets more often than every 12 hours.
Danish: Tag ikke tabletterne oftere end hver 12. time.
English: Fampridine is not a substrate for P-glycoprotein.
Danish: Fampridin er ikke substrat for P-glykoprotein.
English: This medicine is thought to work by letting signals pass down the nerve more normally, which allows you to walk better.
Danish: Det antages, at lægemidlet virker ved at lade signaler passere mere normalt ned gennem nerven, hvilket giver dig mulighed for at gå bedre.
English: MSIS-29 physical score
Danish: MSIS-29-fysisk score
English: The improvement appeared rapidly (within weeks) after starting Fampyra.
Danish: Forbedringen viste sig hurtigt (inden for uger) efter behandlingsstart med Fampyra.
English: Adverse reactions are presented below by system organ class and absolute frequency.
Danish: Bivirkningerne er anført nedenfor efter organklasser og absolut frekvens.
English: However, no increased risk for malformations or adverse effects on fertility was noted.
Danish: Der sås dog ikke øget risiko for misdannelser eller uønskede virkninger på fertiliteten.
English: The clinical relevance of these findings remains to be elucidated, but a causal relationship with fampridine treatment cannot be excluded.
Danish: Den kliniske relevans af disse fund er endnu ikke klarlagt, men en årsagssammenhæng med fampridinbehandlingen kan ikke udelukkes.
English: Creatinine clearance can be estimated using the Cockroft-Gault formula.
Danish: Kreatininclearance kan vurderes vha. Cockroft-Gault-formlen.
English: The maximum plasma concentration (Cmax) and, to a smaller extent, area under the plasma concentration-time curve (AUC) increase proportionately with dose.
Danish: Den maksimale plasmakoncentration (Cmax) og, i mindre udstrækning, arealet under kurven for plasmakoncentration-tid (AUC) stiger proportionalt med dosis.
English: May affect up to 1 in 100 people
Danish: Kan forekomme hos op til 1 ud af 100 brugere
English: The safety and efficacy of Fampyra in children aged 0 to 18 years have not been established.
Danish: Fampyras sikkerhed og virkning hos børn i alderen 0-18 år er ikke undersøgt.
English: Presumably, by enhancing action potential formation, more impulses might be conducted in the central nervous system.
Danish: Ved at forstærke dannelse af aktionspotentialet formodes det, at flere impulser ledes i centralnervesystemet.
English: Fampridine is a lipid-soluble medicinal product which readily crosses the blood-brain barrier.
Danish: Fampridin er et fedtopløseligt lægemiddel, som let passerer blod-hjernebarrieren.
English: If no improvement is observed, Fampyra should be discontinued
Danish: Såfremt der ikke observeres nogen forbedring, bør Fampyra seponeres.
English: Frequency category
Danish: Frekvenskategori
English: Before starting treatment and during treatment your doctor may check that your kidneys are working properly.
Danish: Inden du starter behandlingen og under behandlingen, vil din læge muligvis undersøge, om dine nyrer fungerer, som de skal.
English: You can get a larger print version of this leaflet by calling the local representatives (see list below).
Danish: Du kan få en version af denne indlægsseddel med større skrifttype ved at kontakte den lokale repræsentant (se listen herunder).
English: May affect up to 1 in 10 people:
Danish: Kan forekomme hos op til 1 ud af 10 brugere:
English: Pharmacotherapeutic group: Other nervous system drugs, ATC code: N07XX07.
Danish: Farmakoterapeutisk klassifikation: Andre midler mod lidelser i nervesystemet, ATC-kode: N07XX07.
English: Your doctor will give you an initial prescription for 2 to 4 weeks.
Danish: Din læge vil starte med at udskrive medicin til 2 til 4 uger.
English: Absolute bioavailability of Fampyra prolonged-release tablets has not been assessed, but relative bioavailability (as compared to an aqueous oral solution) is 95%.
Danish: Fampyra-depottabletternes absolutte biotilgængelighed er ikke blevet vurderet, men den relative biotilgængelighed (sammenlignet med en vandig oral opløsning) er 95%.
English: Side effects are listed below by frequency:
Danish: Bivirkninger anføres i det følgende efter hyppighed:
English: − The other ingredients are:
Danish: − Øvrige indholdsstoffer:
English: Fampyra should be administered with caution in the presence of any factors which may lower seizure threshold.
Danish: Fampyra bør administreres med forsigtighed ved tilstedeværelse af faktorer, som kan sænke tærsklen for krampeanfald.
English: Patients with renal impairment have higher plasma concentrations which are associated with increased adverse reactions, in particular neurological effects.
Danish: Patienter med nyreinsufficiens har højere plasmakoncentrationer, som associeres med øgede bivirkninger, især neurologiske bivirkninger.
English: − if you have kidney problems
Danish: − hvis du har nyreproblemer
English: Fampyra treated patients also demonstrated a statistically significant improvement in the Timed Up and Go (TUG) test, a measure of static and dynamic balance and physical mobility.
Danish: Fampyra-behandlede patienter viste også en statistisk signifikant forbedring i TUG (Timed Up and Go)-testen, som er et mål for statisk og dynamisk balance og fysisk mobilitet.
English: Patients with mild renal impairment can be expected to have approximately 1.7 to 1.9 times the fampridine concentrations achieved by patients with normal renal function.
Danish: Patienter med mild nyreinsufficiens kan forventes at have cirka 1,7 til 1,9 gange så stor en fampridinkoncentration, som den, der ses hos patienter med normal nyrefunktion.
English: If you forget to take Fampyra
Danish: Hvis du har glemt at tage Fampyra
English: If decline in walking ability is observed, physicians should consider an interruption to treatment in order to reassess the benefits of Fampyra (see above).
Danish: Hvis der observeres en forværring i gangevnen, bør lægerne overveje at afbryde behandlingen med henblik på at revurdere fordelene ved Fampyra (se ovenfor).
English: Improvements generally appeared within 2 to 4 weeks of initiation of treatment, and disappeared within 2 weeks of treatment cessation.
Danish: Forbedringerne viste sig generelt i løbet af 2 til 4 uger efter behandlingsstart og forsvandt i løbet af 2 uger efter behandlingsophør.
English: In clinical studies low white blood cell counts were seen in 2.1% of Fampyra patients versus 1.9% of patients on placebo.
Danish: I kliniske studier blev der observeret et lavt antal hvide blodlegemer hos 2,1 % af Fampyrapatienterne, versus 1,9 % af patienterne, der fik placebo.
English: The tablets should be taken without food (see section 5.2).
Danish: Tabletterne skal ikke indtages i forbindelse med et måltid (se pkt 5.2).
English: Faecal excretion accounts for less than 1% of the administered dose.
Danish: Udskillelse gennem fæces udgør under 1% af den administrerede dosis.
English: Fampridine is largely unbound to plasma proteins (bound fraction varied between 3-7% in human plasma).
Danish: Fampridin bindes stort set ikke til plasmaproteiner (bindingsfraktionen varierede mellem 3-7% i humant plasma).
English: In reproduction toxicity studies in rats and rabbits, decreased weight and viability of foetuses and offspring were observed at maternally toxic doses.
Danish: I reproduktionstoksicitetsstudier på rotter og kaniner blev der observeret nedsat vægt og levedygtighed hos fostre og afkom ved toksiske doser hos moderen.
English: The increased incidence of dizziness and balance disorder seen with Fampyra may result in an increased risk of falls.
Danish: Den øgede forekomst af svimmelhed eller balanceforstyrrelser set med Fampyra kan resultere i en øget risiko for fald.
English: • Feeling weak and tired
Danish: • Følelse af svaghed og træthed
English: In addition, single cases of fatal urinary tract obstructions were observed in rats.
Danish: Der blev herudover observeret enkelte tilfælde af fatal urinvejsobstruktion hos rotter.
English: Starting and Evaluating Fampyra Treatment
Danish: Påbegyndelse og evaluering af behandlingen med Fampyra
English: In a battery of in vitro and in vivo studies fampridine did not show any potential to be mutagenic, clastogenic or carcinogenic.
Danish: I en gruppe in vitro og in vivo studier viste fampridin ikke noget mutagent, klastogent eller karcinogent potentiale.
English: • An assessment of walking ability, e.g. the Timed 25 Foot Walk (T25FW) or Twelve Item Multiple Sclerosis Walking Scale (MSWS-12), is recommended to evaluate improvement within two to four weeks.
Danish: • Vurdering af gangevnen, eksempelvis 25 fods testen (Timed 25 Foot Walk; T25FW) eller 12punkts multipel sklerose-gangskalaen (12-item Sclerosis Walking Scale; MSWS-12), anbefales for at vurdere forbedringer i løbet af to til fire uger.
English: • Worsening of nerve pain in the face (trigeminal neuralgia)
Danish: • Forværring af nervesmerter i ansigtet (trigeminusneuralgi)
English: It must not be divided, crushed, dissolved, sucked or chewed.
Danish: Den må ikke deles, knuses, opløses, suttes eller tygges.
English: One tablet in the morning and one tablet in the evening (12 hours apart).
Danish: Én tablet om morgenen og én tablet om aftenen (med 12 timers mellemrum).
English: Other side effects at high doses include cases of cardiac arrhythmias (for example, supraventricular tachycardia and bradycardia) and ventricular tachycardia as a consequence of potential QT prolongation.
Danish: Andre bivirkninger forårsaget af høje doser inkluderer tilfælde af hjertearytmi (f.eks. supraventrikulær takykardi og bradykardi) og ventrikulær takykardi som en konsekvens af potentiel QT-forlængelse.
English: By blocking potassium channels, Fampyra reduces the leakage of ionic current through these channels, thereby prolonging repolarization and thus enhancing action potential formation in demyelinated axons and neurological function.
Danish: Ved blokering af kalium-kanaler reducerer Fampyra ionstrømmen gennem disse kanaler og forlænger derved repolarisering og forstærker således dannelsen af aktionspotentialer i demyeliniserede axoner og den neurologiske funktion.
English: The safety of Fampyra has been evaluated in randomised controlled clinical studies, in open label long term studies and in the post marketing setting.
Danish: Sikkerheden ved Fampyra er blevet vurderet i randomiserede, kontrollerede kliniske studier, i ublindede længerevarende studier og efter markedsføring.
English: Fampyra contains the active substance fampridine which belongs to a group of medicines called potassium channel blockers.
Danish: Fampyra indeholder det aktive stof fampridin, som tilhører en gruppe lægemidler, der kaldes kaliumkanal-blokkere.
English: This may increase your risk of side effects.
Danish: Det kan øge risikoen for alvorlige bivirkninger
English: Missed Dose
Danish: Glemt dosis
English: The recommended dose is one 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening).
Danish: Den anbefalede dosis er én 10 mg tablet, to gange dagligt, som tages med 12 timers mellemrum (én tablet om morgenen og én tablet om aftenen).
English: No pharmacological activity was found for the fampridine metabolites against selected potassium channels in vitro.
Danish: Der blev ikke observeret farmakologisk aktivitet for fampridinmetabolitterne mod udvalgte kalium-kanaler in vitro.
English: Particular attention should be given to patients with a previous history of allergic reactions.
Danish: Særlig opmærksomhed bør udvises ved behandling af patienter med allergiske reaktioner i anamnesen.
English: Fampyra should not be administered more frequently or at higher doses than recommended (see section 4.4).
Danish: Fampyra bør ikke tages hyppigere eller i højere doser end anbefalet (se pkt.
English: Nasopharyngitis1
Danish: Nasofaryngitis1
English: If you have a seizure, stop taking Fampyra and tell your doctor immediately.
Danish: Hvis du får et krampeanfald, skal du omgående stoppe med at tage Fampyra og informere din læge herom.
English: Renal function should be checked in older people before starting treatment with Fampyra.
Danish: Nyrefunktionen skal undersøges hos ældre patienter, inden behandlingen med Fampyra påbegyndes.
English: There is no evidence of clinically relevant accumulation of fampridine taken at the recommended dose in patients with full renal function.
Danish: Der er intet der tyder på klinisk relevant ophobning af fampridin taget i den anbefalede dosis hos patienter med fuld nyrefunktion.