FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment of cultured human hepatocytes with fampridine had little or no effect on induction of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2E1 or CYP3A4/5 enzyme activities.
Danish: Behandlingen af dyrkede humane hepatocytter med fampridin havde ringe eller ingen virkning på induktionen af CYP1A2-, CYP2B6-, CYP2C9-, CYP2C19-, CYP2E1- eller CYP3A4/5enzymaktiviteter.
English: They work by stopping potassium leaving the nerve cells which have been damaged by MS.
Danish: Deres funktion er at forhindre kalium i at forlade de nerveceller, som er blevet beskadiget af MS.
English: If you forget to take a tablet, do not take two tablets at once to make up for a missed dose.
Danish: Hvis du har glemt at tage en tablet, må du ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: The tablet must be swallowed whole.
Danish: Tabletten skal synkes hel.
English: 43% Risk difference: 9.2%
Danish: Risikoforskel: 9,2 %
English: Fampridine was studied in oral repeat dose toxicity studies in several animal species.
Danish: Der er udført toksicitetsstudier af fampridin med gentagen oral dosering hos forskellige dyrearter.
English: Do not use this medicine after the expiry date which is stated on the packaging after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Baseline 0.98 (0.078) Average change -0.09 (0.037) Difference p-value
Danish: Baseline 0,98 (0,078) Gennemsnitlig ændring -0,09 (0,037) Forskel p-værdi
English: Other medicines that affect the kidneys
Danish: Anden medicin, som påvirker nyrerne
English: Fampyra should be administered with caution to patients with cardiovascular symptoms of rhythm and sinoatrial or atrioventricular conduction cardiac disorders (these effects are seen in overdose).
Danish: Fampyra bør administreres med forsigtighed til patienter med kardiovaskulære symptomer som hjerterytmeforstyrrelser og sinoatriale eller atrioventrikulære ledningsforstyrrelser (disse virkninger ses ved overdosering).
English: In animal studies no effects on fertility were seen.
Danish: Der er ikke set nogen uønskede virkninger på fertiliteten i dyrestudier.
English: When Fampyra tablets are taken with food, the reduction in the area under the plasma concentrationtime curve (AUC0-∞) of fampridine is approximately 2-7% (10 mg dose).
Danish: Når Fampyra-tabletterne indtages i forbindelse med et måltid, er reduceringen i arealet under kurven for plasmakoncentration-tid (AUC0-∞) for fampridin cirka 2-7% (10 mg dosis).
English: Alkermes Pharma Ireland Ltd, Monksland, Athlone, Co. Westmeath, Ireland
Danish: Alkermes Pharma Ireland Ltd, Monksland, Athlone, Co. Westmeath, Irland
English: Patients who overdose should be provided supportive care.
Danish: Patienter, som har taget en overdosis, skal gives passende understøttende behandling.
English: − because this medicine may make you feel dizzy or unsteady this may result in an increased risk of falls
Danish: − da dette lægemiddel kan gøre dig svimmel eller usikker på benene, kan det medføre en øget risiko for fald
English: − if you are allergic to fampridine or any of the other ingredients of this medicine (listed in section 6)
Danish: − hvis du er allergisk over for fampridin eller et af de øvrige indholdsstoffer i Fampyra (angivet i punkt 6)
English: If you experience one or more of the following allergic (hypersensitivity) symptoms: swollen face, mouth, lips, throat or tongue, reddening or itching of the skin, chest tightness and breathing problems stop taking Fampyra and see your doctor immediately.
Danish: Hvis du oplever et eller flere af følgende symptomer på allergi (overfølsomhed): hævelse af ansigt, mund, læber, hals eller tunge, hudrødme eller hudkløe, trykken for brystet og problemer med vejrtrækningen, skal du stoppe med at tage Fampyra og kontakte en læge med det samme.
English: Repeated seizure activity should be treated with benzodiazepine, phenytoin, or other appropriate acute anti-seizure therapy.
Danish: Gentagne krampeanfald bør behandles med benzodiazepin, fenytoin eller anden egnet behandling af akutte krampeanfald.
English: Fampridine is metabolised in humans by oxidation to 3-hydroxy-4-aminopyridine and further conjugated to the 3-hydroxy-4-aminopyridine sulfate.
Danish: Fampridin metaboliseres hos mennesker ved iltning til 3-hydroxy-4-aminopyridin og konjugeres yderligere til 3-hydroxy-4-aminopyridinsulfat.
English: Fampyra is characterized by linear (dose-proportional) pharmacokinetics with a terminal elimination half-life of approximately 6 hours.
Danish: Fampyra udviser lineær (dosisproportional) farmakokinetik med en endelig halveringstid for udskillelse på cirka 6 timer.
English: Urinary tract infection1 Influenza1
Danish: Urinvejsinfektion1 Influenza1
English: The Fampyra prolonged-release tablet has a delay in the absorption of fampridine manifested by slower rise to a lower peak concentration, without any effect on the extent of absorption.
Danish: Fampyra-depottabletten har en forsinkelse i absorptionen af fampridin, som viser sig i form af en langsommere stigning til en lavere peak-værdi, uden at påvirke absorptionsgraden.
English: There was evidence of direct inhibition of CYP2E1 by fampridine at 30 μM (approximately 12% inhibition) which is approximately 100 times the average plasma fampridine concentration measured for the 10 mg tablet.
Danish: Der var evidens for en direkte hæmning af CYP2E1 forårsaget af fampridin ved 30 μM (cirka 12% hæmning), hvilket er cirka 100 gange så meget som den gennemsnitlige plasmafampridinkoncentration målt for 10 mg tabletten.
English: Determining renal function before treatment and its regular monitoring during treatment is recommended in all patients (particularly in older people in whom renal function might be reduced).
Danish: Det anbefales at evaluere nyrefunktionen inden behandlingen samt overvåge nyrernes funktion regelmæssigt under behandlingen hos alle patienter (især hos ældre mennesker, hvor nyrefunktionen kan være svækket).
English: Interferon: fampridine has been administered concomitantly with interferon-beta and no pharmacokinetic medicinal product interactions were observed.
Danish: Interferon: fampridin er blevet administreret samtidig med interferon-beta, og der er ikke observeret nogen farmakokinetiske lægemiddelinteraktioner.
English: Paediatric Population:
Danish: Pædiatrisk population:
English: Fampridine is eliminated mainly via the kidneys with active renal secretion accounting for about 60% (see section 5.2).
Danish: Fampridin elimineres hovedsageligt via nyrerne med en aktiv nyresekretion på cirka 60% (se pkt.
English: Study 218MS305
Danish: Studie 218MS305
English: As a precautionary measure it is preferable to avoid the use of Fampyra in pregnancy.
Danish: Som en sikkerhedsforanstaltning bør Fampyra undgås under graviditet.
English: Fampyra comes in HDPE (high-density polyethylene) bottles.
Danish: Fampyra leveres i HDPE (polyethylen med høj densitet)-beholdere.
English: Fampyra is a potassium channel blocker.
Danish: Fampyra er en kalium-kanal blokker.
English: Your doctor will be especially careful if fampridine is given at the same time as any medicine which may affect how your kidneys eliminate medicines for example carvedilol, propanolol and metformin.
Danish: Din læge vil være særlig forsigtig, hvis fampridin gives på samme tid som andre lægemidler, der kan påvirke hvordan dine nyrer udskiller medicin, eksempelvis carvedilol, propranolol og metformin.
English: 1171 LP Badhoevedorp The Netherlands
Danish: 1171 LP Badhoevedorp
English: Baclofen: fampridine has been administered concomitantly with baclofen and no pharmacokinetic medicinal product interactions were observed.
Danish: Baclofen: fampridin er blevet administreret samtidig med baclofen, og der er ikke observeret nogen farmakokinetiske lægemiddelinteraktioner.
English: Hypromellose Titanium dioxide (E-171) Polyethylene glycol 400
Danish: Hypromellose Titandioxid (E-171) Polyethylenglykol 400
English: Do not take Fampyra if you are taking any other medicine containing fampridine.
Danish: Tag ikke Fampyra såfremt du tager anden medicin som indeholder fampridin.
English: Improvement from baseline
Danish: Baseline Forbedring fra baseline
English: • Initial prescription should be limited to two to four weeks of therapy as clinical benefits should generally be identified within two to four weeks after starting Fampyra
Danish: • Behandling med Fampyra bør initieres med en to til fire ugers behandlingsperiode, idet de kliniske fordele normalt vil kunne observeres indenfor to til fire uger efter behandlingsstart.
English: In this study there was a statistically significant treatment difference, with a greater proportion of Fampyra treated patients demonstrating an improvement in walking ability, compared to placebo-controlled patients (relative risk of 1.38 (95% CI: [1.06, 1.70]).
Danish: I dette studie var der en signifikant behandlingsforskel med en større andel af Fampyrabehandlede patienter, der fremviste en forbedring i gangevnen, sammenlignet med patienter i placebogruppen (relativ risiko 1,38 (95 % CI: [1,06; 1,70]).
English: In this secondary endpoint, a greater proportion of Fampyra treated patients achieved ≥ 15% mean improvement from baseline TUG speed over a 24 week period, compared to placebo.
Danish: For dette sekundære endepunkt opnåede en større andel af Fampyra-behandlede patienter en ≥ 15 % gennemsnitlig forbedring i baseline-TUG-hastighed i løbet af en 24-ugers periode sammenlignet med placebogruppen.
English: Older people
Danish: Ældre mennesker
English: Tell your doctor before you take Fampyra if any of these apply to you.
Danish: Tal med din læge inden du tager Fampyra, hvis noget af dette gælder for dig.
English: Improvement from baseline (sec)
Danish: Forbedring fra baseline (sek)
English: If an anaphylactic or other serious allergic reaction occurs, Fampyra should be discontinued and not restarted.
Danish: Hvis der opstår en anafylaktisk eller anden alvorlig overfølsomhedsreaktion, skal Fampyra seponeres, og behandling med Fampyra må ikke påbegyndes igen.
English: Adverse responses to orally administered fampridine were rapid in onset, most often occurring within the first 2 hours post-dose.
Danish: Bivirkningerne over for oralt administreret fampridin observeredes hurtigt, oftest inden for de første to timer efter dosisadministration.
English: Therefore, patients should use walking aids as needed.
Danish: Derfor bør patienter bruge ganghjælpemidler efter behov.
English: The 3-hydroxylation of fampridine to 3-hydroxy-4-aminopyridine by human liver microsomes appeared to be catalyzed by Cytochrome P450 2E1 (CYP2E1).
Danish: 3-hydroxylation af fampridin til 3-hydroxy-4-aminopyridin af humane levermikrosomer så ud til at blive katalyseret af cytochrom P450 2E1 (CYP2E1).
English: Table 2: Study 218MS305
Danish: Tabel 2: Studie 218MS305
English: Three phase III, randomised, double-blind, placebo controlled confirmatory studies, (MS-F203 and MS-F204 and 218MS305) have been performed.
Danish: Der er gennemført tre randomiserede, dobbeltblinde, placebokontrollerede bekræftende fase IIIstudier (MS-F203, MS-F204 og 218MS305).
English: • Fast heart rate (tachycardia)
Danish: • Hurtige hjerteslag (takykardi)
English: Detailed information on this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu
English: The highest incidence of adverse reactions identified from placebocontrolled trials in multiple sclerosis patients with Fampyra given at the recommended dose, are reported as urinary tract infection (in approximately 12% of patients).
Danish: Den største hyppighed af bivirkninger påvist i placebokontrollerede studier hos MS patienter behandlet med Fampyra i den anbefalede dosis er urinvejsinfektion (hos cirka 12% af patienterne).
English: In post-marketing experience, there have been reports of seizure, the frequency is not known (cannot be estimated from the available data).
Danish: Hyppigheden kendes ikke (kan ikke estimeres ud fra eksisterende data).
English: What you need to know before you take Fampyra Do not take Fampyra
Danish: Det skal du vide, før du begynder at tage Fampyra Tag ikke Fampyra
English: Hypromellose Microcrystalline cellulose Silica, colloidal anhydrous Magnesium stearate
Danish: Hypromellose Mikrokrystallinsk cellulose Silica, kolloid vandfri Magnesiumstearat
English: Fampyra may have an effect on people's ability to drive or use machines, it can cause dizziness.
Danish: Fampyra kan påvirke evnen til at køre eller betjene maskiner, det kan forårsage svimmelhed.
English: Store the tablets in the original packaging in order to protect from light and moisture.
Danish: Tabletterne opbevares i den originale pakning for at beskytte dem mod lys og fugt.
English: Proportion of patients with mean improvement of ≥ 15%
Danish: Andel af patienter med gennemsnitlig forbedring på ≥ 15 % i TUG-hastighed
English: Orally administered fampridine is rapidly and completely absorbed from the gastrointestinal tract.
Danish: Oralt administreret fampridin absorberes hurtigt og fuldstændigt fra mave-tarmkanalen.
English: Foil blisters (aluminium / aluminium), each blister tray contains 14 tablets.
Danish: Folie (aluminium/aluminium), hvert blisterpakning indeholder 14 tabletter.
English: − if you have a seizure or have ever had a seizure (also referred to as a fit or convulsion)
Danish: − hvis du har kramper eller nogensinde har haft et krampeanfald (kaldes også anfald eller kramper)
English: Exacerbation of trigeminal neuralgia
Danish: Forværring af trigeminusneuralgi
English: A double dose should not be taken if a dose is missed.
Danish: Der må ikke tages en dobbeltdosis som erstatning for en glemt dosis.
English: Take the Fampyra box with you if you go to see the doctor.
Danish: Tag Fampyra-æsken med til lægen.
English: The proportion of responders was independent of concomitant immunomodulatory therapy (including interferons, glatiramer acetate, fingolimod and natalizumab).
Danish: Andelen af patienter, der responderede, var uafhængig af samtidig immunmodulerende behandling (herunder interferoner, glatirameracetat, fingolimod og natalizumab).
English: Concurrent treatment with other medicinal products containing fampridine (4-aminopyridine).
Danish: Samtidig behandling med andre lægemidler indeholdende fampridin (4-aminopyridin).
English: − if you are taking any other medicine containing fampridine.
Danish: − hvis du tager andre lægemidler indeholdende fampridin.
English: A significantly greater proportion of Fampyra treated patients were responders as compared to placebo (MS-F203: 34.8% vs. 8.3%, p<0.001; MS-F204: 42.9% vs. 9.3%, p<0.001).
Danish: En betydelig større del af patienterne i behandling med Fampyra var respondere i sammenligning med placebo (MS-F203: 34,8% mod 8,3%, p<0,001; MS-F204: 42,9% mod 9,3%, p<0,001).
English: Since there is a clear relationship between Cmax and dose related adverse reactions, it is recommended to take Fampyra without food (see section 4.2).
Danish: Der er et tydeligt forhold mellem Cmax og dosisrelaterede bivirkninger, og derfor anbefales det ikke at tage Fampyra i forbindelse med et måltid (se pkt.
English: Viral infection1
Danish: Virusinfektion1
English: In multiple sclerosis, inflammation destroys the protective sheath around the nerves leading to muscle weakness, muscle stiffness and difficulty walking.
Danish: I multipel sklerose ødelægger en betændelsestilstand den beskyttende hinde omkring nerverne hvilket medfører muskelsvaghed, muskelstivhed og gangproblemer.
English: Fampyra is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7).
Danish: Fampyra er indiceret til forbedring af gangevnen hos voksne patienter med multipel sklerose (MS) med gangbesvær (EDSS 4-7).
English: − if you have any factors or are taking any medicine which affects your risk of fits (seizure).
Danish: − hvis du har nogen risiko eller får medicin, der påvirker din risiko for at få krampeanfald.
English: Central nervous system side effects at high doses of 4-aminopyridine include confusion, seizures, status epilepticus, involuntary and choreoathetoid movements.
Danish: Bivirkninger relateret til centralnervesystemet ved høje doser af 4-aminopyridin inkluderer forvirring, krampeanfald, status epilepticus, ufrivillige og koreoatetoide bevægelser.
English: Table 1: Studies MS-F203 and MS-F204 STUDY *
Danish: Tabel 1: Studierne MS-F203 og MS-F204 STUDIE*
English: Fampridine is eliminated primarily by the kidneys as unchanged medicinal product and therefore renal function should be checked in patients where renal function might be compromised.
Danish: Fampridin udskilles overvejende uændret gennem nyrerne, og derfor bør nyrefunktionen undersøges hos patienter, hvor funktionen kan være svækket.
English: Re-Evaluating Fampyra Treatment
Danish: Reevaluering af behandlingen med Fampyra
English: • Numbness or tingling of skin
Danish: • Følelsesløshed eller prikken i huden
English: Patients who responded to Fampyra increased their walking speed on average by 26.3% vs 5.3% on placebo (p<0.001) (MS-F203) and 25.3% vs 7.8% (p< 0.001) (MS-F204).
Danish: Patienter, som viste respons på Fampyra, øgede i gennemsnit ganghastigheden med 26,3% mod 5,3% af patienterne på placebo (p< 0,001) (MS-F203) og 25,3% mod 7,8% (p< 0,001) (MS-F204).
English: Very Common side effects
Danish: Meget almindelige bivirkninger
English: − Tablet core: hypromellose, microcrystalline cellulose, silica colloidal anhydrous, magnesium stearate; film coat: hypromellose, titanium dioxide (E-171), polyethylene glycol 400
Danish: − Tabletkerne: hypromellose, mikrokrystallinsk cellulose, kolloid vandfri silica, magnesiumstearat; filmovertræk: hypromellose, titandioxid (E-171), polyethylenglykol 400
English: Concomitant use of Fampyra with medicinal products that are inhibitors of Organic Cation Transporter 2 (OCT2) for example, cimetidine.
Danish: Samtidig brug af Fampyra med lægemidler, som hæmmer organisk kationstransporter 2 (OCT2), f.eks. cimetidin.
English: Statistically and clinically meaningful improvements in walking were seen, as measured by the 12item Multiple Sclerosis Walking Scale.
Danish: Der blev observeret statistisk og klinisk betydningsfulde forbedringer i ganghastigheden målt vha. 12punkts MS-gangskalaen (12-item Multipel Sclerosis Walking Scale).
English: Fampyra is a medicine used to improve walking in adults (18 years and over) with Multiple Sclerosis (MS) related walking disability.
Danish: Fampyra er et lægemiddel der anvendes til at forbedre gangfunktionen hos voksne (18 år og ældre) med gangproblemer grundet multipel sklerose (MS).
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, eller apotekspersonalet.
English: In addition, patients treated with Fampyra demonstrated a statistically significant mean improvement from baseline compared to placebo in the Multiple Sclerosis Impact Scale (MSIS-29) physical score (LSM difference -3.31, p<0.001).
Danish: Endvidere viste patienter behandlet med Fampyra en statistisk signifikant gennemsnitlig forbedring fra baseline i fysisk score på MSIS-29-skalaen (Multiple Sclerosis Impact Scale) (LSM-forskel -3,31, p < 0,001) sammenlignet med placebo-gruppen.
English: The re-evaluation should include withdrawal of Fampyra and performing an assessment of walking ability.
Danish: Revurderingen bør omfatte et behandlingsstop med Fampyra og gennemførelse af en vurdering af gangevnen.
English: Renal clearance (CLR 370 ml/min) is substantially greater than glomerular filtration rate due to combined glomerular filtration and active excretion by the renal OCT2 transporter.
Danish: er væsentlig større end den glomerulære filtrationrate på grund af kombineret glomerulær filtration og aktiv udskillelse ved hjælp af den renale OCT2-transporter.
English: The primary endpoint was improvement in walking ability, measured as the proportion of patients achieving a mean improvement of ≥ 8 points from baseline MSWS-12 score over 24 weeks.
Danish: Det primære endepunkt var forbedring i gangevnen målt som andelen af patienter, der opnåede en gennemsnitlig forbedring på ≥ 8 point i baseline-MSWS-12-scoren over
English: HDPE (high-density polyethylene) bottle with polypropylene caps, each bottle contains 14 tablets and a silica gel desiccant.
Danish: HDPE (polyethylen med høj densitet)-beholder med polypropylenlåg, hvert beholder indeholder 14 tabletter og en kapsel med silicagel.
English: Concurrent treatment with other medicinal products containing fampridine (4-aminopyridine) is contraindicated (see section 4.3).
Danish: Samtidig behandling med andre lægemidler der indeholder fampridin (4-aminopyridine) er kontraindiceret (se pkt 4.3).
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: The major route of elimination for fampridine is renal excretion, with approximately 90% of the dose recovered in urine as parent medicinal product within 24 hours.
Danish: Fampridin udskilles overvejende gennem nyrerne, og cirka 90% af dosis udskilles i urinen som oprindeligt stof inden for 24 timer.
English: − if you feel aware of your heartbeat (palpitations)
Danish: − hvis du kan mærke dine hjerteslag (har hjertebanken)
English: If you take more Fampyra than you should Contact your doctor immediately if you take too many tablets.
Danish: Kontakt straks lægen, hvis du har taget for mange tabletter.
English: Talk to your doctor or pharmacist before taking Fampyra:
Danish: Kontakt lægen eller apoteket, før du tager Fampyra
English: Patients with mild, moderate or severe renal impairment (creatinine clearances <80 ml/min).
Danish: Patienter med mild, moderat eller alvorlig nyreinsufficiens (kreatininclearance <80 ml/min.).
English: Older people:
Danish: Ældre population:
English: How to take Fampyra
Danish: Sådan skal du tage Fampyra
English: Balance disorder Paraesthesia
Danish: Balanceforstyrrelse Paræstesi
English: Fampyra has a moderate influence on the ability to drive and use machines because Fampyra can cause dizziness.
Danish: Fampyra påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner, idet Fampyra kan forårsage svimmelhed.
English: In post-marketing experience, there have been reports of hypersensitivity reactions (including anaphylaxis) which have occurred with one or more of the following: dyspnoea, chest discomfort, hypotension, angioedema, rash and urticaria.
Danish: Efter markedsføringen er der indberettet overfølsomhedsreaktioner (herunder anafylaksi) i forbindelse med et eller flere af følgende symptomer: dyspnø, brystgener, hypotension, angioødem, udslæt og urticaria.
English: After first opening use within 7 days.
Danish: Anvendes inden 7 dage efter første åbning.
English: An off-white, film coated, oval biconvex 13 x 8 mm tablet with flat edge debossed with A10 on one side.
Danish: En cremefarvet, filmovertrukket, oval bikonveks 13 x 8 mm tablet med flad kant mærket med A10 på den ene side.
English: Hypersensitivity Reactions
Danish: Overfølsomhedsreaktioner
English: • Fampyra should be discontinued if benefit is not reported by patients.
Danish: • Fampyra bør seponeres, såfremt patienten ikke oplever nogen fordele.
English: Clinical signs evident after large single doses or repeated lower doses were similar in all species studied and included tremors, convulsions, ataxia, dyspnoea, dilated pupils, prostration, abnormal vocalization, increased respiration, and excess salivation.
Danish: De kliniske tegn, som var tydelige efter store enkeltdoser eller gentagne mindre doser, lignede hinanden hos alle undersøgte arter og inkluderede rysten, kramper, ataksi, dyspnø, udvidede pupiller, svækkelse, unormal stemmeføring, øget åndedrætsfrekvens, og øget spytsekretion.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Fampyra Fortæl altid lægen eller på apoteket, hvis du bruger anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.