FrancophonIA/ELRC3.0 huggingface dataset:
English: Some medicines may interact with FIRDAPSE when taken together.
Danish: Visse lægemidler kan reagere med FIRDAPSE ved samtidig indtagelse.
English: In patients suffering from this disease, a chemical substance called acetylcholine, which communicates nerve impulses to muscles is not released normally and the muscle doesn't receive some or all of the nerve's signals.
Danish: Hos patienter, som lider af denne sygdom mindskes frigivelsen af et kemisk stof kaldet acetylcholin, som normalt formidler nerveimpulser til musklerne, og musklerne kan ikke modtage nogle af eller alle signalerne fra nerven.
English: Perforated unit dose thermoformed blisters (Thermoformed aluminium-PVC/PVDC laminate sheets) containing 10 tablets.
Danish: Perforerede, termoformede enhedsdosisblistre (termoformede aluminium/PVC/PVDC laminatplader) indeholdende 10 tabletter.
English: Observed mean difference in QMG Total and SGI change from baseline score between treatments were -6.54 (95% CI: -9.78, -3.29; p=0.0004) and 2.95 (95% CI: 1.53, 4.38; p=0.0003) respectively, both statistically significant in favour of amifampridine phosphate.
Danish: Observeret gennemsnitlig forskel i samlet QMG og SGI ændring i forhold til baseline-score mellem behandlingerne var hhv. -6,54 (95 % konfidensinterval: -9,78, -3,29; p=0,0004) og 2,95 (95 % konfidensinterval: 1,53; 4,38; p=0,0003), begge statistisk signifikante i amifampridinphosphats favør.
English: In a 2-year rat dietary carcinogenicity study, amifampridine caused small but statistically significant dose-related increases in the incidence of Schwannomas in both genders and of endometrial carcinomas in females.
Danish: I et 2-årig diætetisk karcinogenicitetsstudie hos rotter medførte amifampridin en lille, men statistisk signifikant dosisrelateret stigning i incidensen af schwannom hos begge køn og af endometriekarcinom hos hunner.
English: Amifampridine had no adverse reaction on male or female fertility in rats at doses up to 75 mg/kg/day, and no effect on post-natal development or fertility was observed in the offspring of the treated animals.
Danish: Amifampridin havde ingen uønskede virkninger på hanlig eller hunlig fertilitet hos rotter ved doser op til 75 mg/kg/dag, og der blev ikke observeret nogen effekt på den post-natale udvikling eller fertiliteten hos afkom af de behandlede dyr.
English: In view of the risk of markedly increased exposure to medicinal product, patients with renal or hepatic impairment must be carefully monitored.
Danish: I lyset af risikoen for markant øget eksponering over for lægemidler bør patienter med nedsat nyre- eller leverfunktion overvåges nøje.
English: In humans, 93.2% to 100% of amifampridine is excreted into the urine within 24 hours after dosing as amifampridine (19%) and its 3-N-acetylated amifampridine metabolite (74.0% to 81.7%).
Danish: Hos mennesker udskilles 93,2-100 % af amifampridin i urinen inden for 24 timer efter dosering som amifampridin (19 %) og den 3-N-acetylerede amifamdiprinmetabolit (74,0-81,7 %).
English: Non-clinical safety data are available regarding the effects of amifampridine on reproductive function.
Danish: Der foreligger ikke-kliniske sikkerhedsdata vedrørende virkningen af amifampridin på reproduktion.
English: In a repeat-dose toxicity studies in rats and dogs, effects on the central and autonomic nervous system, increased liver and kidney weights and cardiac effects (second degree atrioventricular block) were seen.
Danish: I toksicitetsstudier med gentagne doser hos rotter og hunde sås virkninger på det centrale og autonome nervesystem, øget lever- og nyrevægt og kardiale virkninger (2. grads AV-blok).
English: Animal studies evaluating the reproductive and developmental toxicity of amifampridine were conducted in rats and rabbits at doses up to 75 mg/kg/day.
Danish: Dyrestudier til evaluering af reproduktions- og udviklingstoksicitet ved amifampridin blev udført hos rotter og kaniner med doser på op til 75 mg/kg/dag.
English: Tmax (hr) t 1/2 (hr)
Danish: Tmax (t) t 1/2 (t)
English: • Heart rhythm disorders, fast or irregular heartbeats (palpitations)
Danish: • Hjerterytmeforstyrrelser, hurtige eller uregelmæssige hjerteslag (palpitationer)
English: Statistically significant differences in amifampridine PK parameters Cmax, AUC0-∞, t1/2 and apparent clearance was observed between fast and slow acetylators at all dose levels.
Danish: Der blev observeret statistisk signifikante forskelle i PK-parametrene Cmax, AUC0-∞, t1/2 og tilsyneladende clearance for amifampridin mellem hurtige og langsomme acetylatorer på alle dosisniveauer.
English: In addition, CGI-I scores at day 4 as determined by physicians showed significant improvement in patients remaining on amifampridine phosphate compared to placebo (p=0.0020).
Danish: Derudover viste den lægeligt vurderede CGI-I-score på dag 4 en signifikant forbedring hos patienter, der forblev på amifampridinphosphat sammenlignet med placebo (p=0,0020).
English: If you stop taking FIRDAPSE
Danish: Hvis du holder op med at tage FIRDAPSE
English: Regardless, patients should be closely monitored for adverse reactions when initiating treatment with a potent enzyme or renal transporter inhibitor.
Danish: Uanset dette bør patienterne monitoreres nøje for bivirkninger, når behandlingen med en potent enzyminhibitor eller renal transporter-hæmmer indledes.
English: Sanders et al 1998 presented data on efficacy and safety of amifampridine treatment at doses up to 100 mg/day in 45 patients with LEMS who were treated for an average of 31 months.
Danish: Sanders et al 1988 fremlagde data om effektiviteten og sikkerheden af amifampridinbehandling ved doser på op til 100 mg/dag hos 45 patienter med Lambert-Eatons syndrom, som blev behandlet i gennemsnitligt 31 måneder.
English: It is unknown whether amifampridine is excreted in human breast milk.
Danish: Det er ukendt, om amifampridin udskilles i human mælk.
English: To establish a Lambert Eaton Patient Registry as defined in the RMP and also incorporating measures of efficacy.
Danish: Der skal oprettes et Lambert-Eatons-patientregister som fastsat i risikostyringsplanen, som også omfatter mål for virkning.
English: Mean 3-N-acetyl Amifampridine PK Parameters
Danish: Middel 3-N-acetyl amifampridin PK-parametre
English: No subjects developed new clinically relevant ECG morphological changes following administration of amifampridine phosphate.
Danish: Ingen forsøgspersoner udviklede nye klinisk relevante morfologiske EKG-forandringer efter indgivelse af amifampradinphosphat.
English: It improves muscle strength and resting compound muscle action potential (CMAP) amplitudes with an overall weighted mean difference of 1.69 mV (95% CI 0.60 to 2.77).
Danish: Det øger muskelstyrken og amplituden af det sammensatte motoriske muskelaktionspotentiale (CMAP) med en samlet vægtet gennemsnitsforskel på 1,69 mV (95 % CI 0,60 til 2,77).
English: The resulting increase in intra-cellular calcium concentrations facilitates exocytosis of acetylcholine-containing vesicles, which in turn enhances neuromuscular transmission.
Danish: Den deraf følgende stigning i calciumkoncentrationerne inde i cellerne fremmer exocytose af acetylcholinholdige vesikler, hvilket igen øger den neuromuskulære transmission.
English: The risk of seizures is dose-dependent and is increased in patients with risk factors which lower the epileptic threshold; including use in combination with other medicinal products known to lower the epileptic threshold (see section 4.5).
Danish: Risikoen for anfald er dosisafhængig og vokser hos patienter med risikofaktorer, der sænker krampetærsklen, herunder brug i kombination med andre lægemidler, der er kendt for at sænke krampetærsklen (se pkt.
English: Women of childbearing potential must use effective contraception during FIRDAPSE treatment.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen med FIRDAPSE.
English: In this study, slow acetylators experienced more adverse reactions than the fast acetylators.
Danish: I dette studie oplevede langsomme acetylatorer flere bivirkninger end de hurtige acetylatorer.
English: In humans, the rate and extent of absorption of amifampridine is influenced by food (see Table 2).
Danish: Hos mennesker påvirker føde amifampridins absorptionshastighed og absorptionsfraktion (se Tabel 2).
English: FIRDAPSE works by increasing the release of acetylcholine and helps the muscle to receive the nerve signals.
Danish: FIRDAPSE virker ved at øge frigivelsen af acetylcholin og hjælper musklen til at modtage nervesignalerne.
English: Healthcare professionals are asked to report any suspected adverse reactions.
Danish: Læger og sundhedspersonale anmodes om at indberette alleformodede bivirkninger.
English: The decision to administer proconvulsant or epileptic-threshold lowering substances concomitantly should be carefully considered in the light of the severity of the associated risks.
Danish: Beslutningen om at give prokonvulsive lægemidler eller lægemidler, der sænker krampetærsklen, samtidig, bør overvejes nøje i lyset af sværhedsgraden af de dermed forbundne risici.
English: Patients with recent use of immunomodulatory therapies (e.g., azathioprine, mycophenolate, cyclosporine), rituximab, intravenous immunoglobulin G, and plasmapheresis were excluded from the study.
Danish: Patienter med nylig brug af immunmodulerende behandlinger (f.eks. azathioprin, mycophenolat, cyclosporin), rituximab, intravenøs immunoglobulin G og plasmaferese blev udelukket fra studiet.
English: It can be associated with certain tumour types (paraneoplastic form of LEMS) or in the absence of these tumours (non-paraneoplastic form of LEMS).
Danish: Den kan være sammenkoblet med visse tumortyper (paraneoplastisk form af Lambert-Eatons syndrom) eller fravær af sådanne tumorer (ikke-paraneoplastisk form for Lambert-Eatons syndrom).
English: In vitro and in vivo studies in humans indicate that amifampridine is metabolised to a single major 3-N-acetylated amifampridine metabolite.
Danish: In vitro- og in vivo-studier på mennesker tyder på, at amifamdiprin metaboliseres til en enkelt primær 3-N-acetyleret amifamdiprinmetabolit.
English: Substances which are potent inhibitors of enzymes that metabolise medicinal products (see section 5.2)
Danish: Stoffer, der er potente inhibitorer af enzymer, der metaboliserer lægemidler (se pkt.
English: The recommended starting dose is 15 mg amifampridine a day, which can be increased in 5 mg increments every 4 to 5 days, to a maximum of 60 mg per day.
Danish: Den anbefalede startdosis er på 15 mg amifampridin om dagen, som kan øges med 5 mg hver 4. eller 5. dag til maksimalt 60 mg pr. dag.
English: Mean (SD) p-valuee a
Danish: Gennemsnit (SD) p-værdie a
English: Amifampridine blocks voltage-dependent potassium channels, thereby prolonging pre-synaptic cell membrane depolarisation.
Danish: Amifampridin blokerer spændingsafhængige kaliumkanaler, hvorved den præsynaptiske depolarisering af cellemembranen forlænges.
English: Assessment of breast-feeding neo-natal animals showed no indication of adverse reactions when exposed to amifampridine through breast-milk.
Danish: Vurdering af amning af neo-natale dyr viste ingen indikation på bivirkninger under eksponering for amifampridin gennem brystmælk.
English: SGI Scoresb
Danish: SGI-scorerb
English: FIRDAPSE 10 mg tablets amifampridine
Danish: FIRDAPSE 10 mg tabletter Amifampridin
English: Bioavailability is approximately 93-100% based on recoveries of unmetabolised amifampridine and a major 3-N-acetylated amifampridine metabolite in urine.
Danish: Biotilgængeligheden er ca. 93-100 % baseret på genfinding af ikke-metaboliseret amifampridin og den primære 3-N-acetylerede amifampridinnmetabolit i urinen.
English: You must use effective contraception throughout the treatment.
Danish: Du skal bruge sikker prævention under hele behandlingen.
English: • In patients with congenital QT syndromes (see section 4.4)
Danish: • Hos patienter med medfødt QT-syndrom (se pkt.
English: Convulsions, chorea, myoclonia drowsiness, weakness, fatigue, headache
Danish: Kramper, chorea, myokloni, døsighed, svaghed, træthed, hovedpine
English: • Weakness, tiredness, headache
Danish: • Svaghed, træthed, hovedpine
English: In a 2-year dietary carcinogenicity study, benign and malignant Schwannomas have been observed in rats treated with amifampridine (see section 5.3).
Danish: I et 2-årig diætetisk karcinogenicitetsstudie blev der observeret benigne og maligne schwannomer hos rotter, der blev behandlet med amifampridin (se pkt.
English: • Chorea (movement disorder), myoclonia (muscle spasm or twitching)
Danish: • Chorea (bevægelsesforstyrrelse), myokloni (muskelspasme eller muskeltrækninger)
English: The starting dose is 5 mg amifampridine (half a tablet) three times daily (i.e. 15 mg per day).
Danish: Startdosis er 5 mg amifampridin (en halv tablet) tre gange dagligt (dvs. 15 mg/dag).
English: Bronchial hypersecretion, asthma attack in asthmatic patients or patients with a history of asthma, cough
Danish: Bronkial hypersekretion, astmaanfald hos astmapatienter eller patienter, der tidligere har haft astma, hoste
English: Hyperhidrosis1, cold sweat1
Danish: Hyperhidrose1, koldsved1
English: Table 1 below lists the adverse reactions reported with amifampridine.
Danish: Tabel 1 nedenfor viser de indberettede bivirkninger med amifampridin:
English: NAME OF THE MEDICINAL PRODUCT FIRDAPSE 10 mg tablets
Danish: LÆGEMIDLETS NAVN FIRDAPSE 10 mg tabletter
English: In contrast, the 3-N-acetyl metabolite exposure levels were affected to a greater extent by renal impairment than those for amifampridine.
Danish: I modsætning hertil blev 3-N-acetyl-metaboliteksponeringsniveauerne i højere grad påvirket af nedsat nyrefunktion end dem for amifampridin.
English: The plasma elimination half-life is approximately 2.5 hours for the amifampridine and 4 hours for the 3-N-acetylated amifampridine metabolite.
Danish: Plasma-halveringstiden er cirka 5 timer for ∞ amifampridin og 4 timer for den 3-N-acetylerede amifamdiprinmetabolit.
English: Due to adverse reactions such as drowsiness, dizziness, seizures and blurred vision, amifampridine may have minor or moderate influence on the ability to drive or use machines (see section 4.8).
Danish: På grund af bivirkninger som f.eks. døsighed, svimmelhed, anfald og sløret syn kan amifampridin have en mindre eller moderat virkning på evnen til at føre motorkøretøj og betjene maskiner (se pkt.
English: The intensity and incidence of most adverse reactions is dose-dependent.
Danish: Intensiteten og incidensen af de fleste bivirkninger er dosisafhængig.
English: The intensity and incidence of most side effects depends on the dose you are taking.
Danish: Intensiteten og forekomsten af de fleste bivirkninger er afhængig af dosis.
English: McEvoy et al 1989 reported data from a short-term study in 12 patients with LEMS, which demonstrated that administration of amifampridine at doses up to 100 mg/day for a period of 3 days was effective in treating the autonomic and motor symptoms of LEMS.
Danish: McEvoy et al 1989 rapporterede data fra et kort studie hos 12 patienter med Lambert-Eatons syndrom, der viste, at indgivelse af amifampridin ved doser på op til 100 mg/dag i en periode på 3 dage var effektiv til behandling af de autonome og motoriske symptomer på Lambert-Eatons syndrom.
English: Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
Danish: Symptombehandling af Lambert-Eatons syndrom hos voksne.
English: The pharmacokinetics of amifampridine has been assessed in a single dose Phase I study in patients with renal impairment (see section 5.2).
Danish: Amifampridins farmakokinetik er blevet vurderet i et fase I-studie med en enkelt dosis hos patienter med nedsat nyrefunktion (se pkt.
English: Medicinal products known to lower the epileptic threshold The concomitant use of amifampridine and substances known to lower the epileptic threshold may lead to an increased risk of seizures.
Danish: Lægemidler, der er kendt for at sænke krampetærsklen Samtidig brug af amifampridin og stoffer, der er kendt for at sænke krampetærsklen, kan medføre en øget risiko for anfald.
English: No effect was observed of amifampridine phosphate on cardiac repolarization as assessed using the QTc interval.
Danish: Der blev ikke observeret nogen effekt af amifampradinphosphat på kardial repolarisering vurderet ud fra QTc-intervallet.
English: A diagnosis of Schwannoma should be considered for patients who present with symptoms such as a mass that is painful on palpation or symptoms similar to a compressive neuropathy.
Danish: En schwannomdiagnose bør overvejes hos patienter med symptomer som f.eks. en udfyldning, der er smertefuld ved palpation, eller symptomer, som svarer til kompressionsneuropati.
English: If you take more FIRDAPSE than you should have, you may suffer from vomiting or a stomach ache.
Danish: Hvis du har taget for meget FIRDAPSE, kan du kaste op eller få ondt i maven.
English: • Cough, excessive or viscous mucus in the breathing passage, asthma attack in asthmatic patients or patients with a history of asthma
Danish: • Hoste, øget eller viskøs slim i luftvejene, astmaanfald hos astmapatienter eller patienter, der tidligere har haft astma
English: No impairment of fertility has been observed in non-clinical studies with amifampridine (see section 5.3).
Danish: Der er ikke observeret nedsat fertilitet i ikke-kliniske studier med amifampridin (se pkt.
English: • Medicines for malaria (e.g. halofantrine and mefloquine)
Danish: • Malariamedicin (f.eks. halofantrin og mefloquin)
English: Exposure by Cmax was only marginally affected by renal impairment regardless of acetylation status.
Danish: Eksponering for Cmax blev kun marginalt påvirket af nedsat nyrefunktion uanset acetyleringsstatus.
English: A prospective, placebo-controlled, randomised study in 26 patients with Lambert-Eaton myasthenic syndrome (LEMS) reported clinical efficacy for amifampridine at the standard recommended maximum dose of 60 mg/day (Sanders et al 2000).
Danish: Et prospektivt, placebokontrolleret, randomiseret studie af 26 patienter med Lambert-Eatons syndrom viste en klinisk effekt for amifampridin ved den anbefalede maksimale standarddosis på 60 mg/dag (Sanders et al 2000).
English: In the event of a seizure, treatment should be discontinued.
Danish: I tilfælde af overdosering skal behandlingen seponeres.
English: Concentrations in tissues are generally similar to or greater than concentrations in plasma, with the greatest concentration in organs of excretion (liver, kidney and the gastrointestinal tract) and some tissues of glandular function (lacrimal, salivary, mucous, pituitary and thyroid glands).
Danish: Vævskoncentrationerne svarer generelt til eller er større end koncentrationerne i plasma med den højeste koncentration i ekskretionsorganer (lever, nyrer og mave-tarmkanal) og visse væv med kirtelfunktion (tåre, spyt, slim samt hypofyse og thyroidea).
English: Concomitant diseases
Danish: Ledsagende sygdomme
English: • The other ingredients are microcrystalline cellulose, anhydrous colloidal silica and calcium stearate.
Danish: • Øvrige indholdsstoffer: mikrokrystallinsk cellulose, kolloid vandfri silica og calciumstearat.
English: If the treatment is stopped, you may experience symptoms such as tiredness, slow reflexes and constipation.
Danish: Du kan opleve symptomer som f.eks. træthed, langsomme reflekser og forstoppelse, hvis behandlingen stoppes.
English: The most commonly reported adverse reactions are paraesthesias (such as peripheral and peribucal paraesthesias) and gastro-intestinal disorders (such as epigastralgia, diarrhoea, nausea and abdominal pain).
Danish: De hyppigst indberettede bivirkninger er paræstesi (f.eks. perifer og peribukkal paræstesi) og gastrointestinale lidelser (f.eks. epigastralgi, diarré, kvalme og abdominalsmerter).
English: Exposure by Cmax was marginally affected by renal impairment regardless of acetylation status.
Danish: Eksponering for Cmax var marginalt påvirket af nedsat nyrefunktion uanset acetyleringsstatus.
English: The overall clearance of amifampridine is predominantly due to metabolism by N-acetylation and acetylator phenotype has a greater effect on an individual's metabolism and elimination of amifampridine than does elimination by renal function (See Table 4).
Danish: Den generelle amifampridin-clearance er overvejende grundet metabolismen af N-acetylering, og acetylator-fænotype har en større virkning på et menneskes stofskifte og elimination af amifampridin end eliminationen af nyrefunktion (se Tabel 4).
English: Based on the pharmacodynamic properties of amifampridine, the concomitant use with sultopride or other medicinal products known to cause QT prolongation (e.g., disopyramide, cisapride, domperidone, rifampicin and ketoconazole) is contraindicated as this combination may lead to an enhanced risk of ventricular tachycardia, notably torsade de pointes (see sections 4.3 and 5.1).
Danish: På grundlag af amifampridins farmakodynamiske egenskaber er samtidig brug af sultoprid eller andre lægemidler, som vides at forårsage QT-forlængelse (f.eks. disopyramid, cisaprid, domperidon, rifampicin og ketoconazol) kontraindiceret, da kombinationen kan medføre øget risiko for ventrikulær takykardi, navnlig torsades de pointes (se pkt.
English: • Medicines to treat allergies - antihistamines (e.g. terfenadine, astemizole, cimetidine)
Danish: • Lægemidler til behandling af allergi - antihistaminer (f.eks. terfenadin, astemizol, cimetidin)
English: Hypoaesthasia oral1, paraesthesia oral1, peripheral and peribucal paraesthesias, nausea1
Danish: Oral hypæstesi1, oral paraæstesi1, perifer og peribucal paræstesi, kvalme1
English: The concomitant use of amifampridine and medicinal products with atropinic effects may reduce the effect of both active substances and should be taken into consideration.
Danish: Samtidig brug af amifampridin og lægemidler med atropinlignende virkning kan nedsætte effekten af begge de aktive stoffer og bør tages i betragtning.
English: • Tramadol (a painkiller)
Danish: • Tramadol (et smertestillende middel)
English: Overall, food slowed and decreased the absorption of amifampridine with a lowering of exposure by Cmax on average by ~44% and lowered exposure by AUC ~20%.
Danish: Generelt blev absorptionen af amifampridin forsinket og nedsat af føde med en gennemsnitlig forsinkelse af eksponering for Cmax på ~44 % og en nedsat eksponering for AUC på ~20 % baseret på geometriske middelratioer (efter føde-til-fastenede).
English: For these patients the dose of FIRDAPSE should be increased more slowly than in those without liver or kidney problems with doses increased in 5 mg increments every 7 days.
Danish: Hos disse patienter bør dosis af FIRDAPSE øges langsommere end hos patienter uden nyre- eller leverproblemer, og doserne bør øges med 5 mg hver 7. dag.
English: The results from the in vitro CYP450 inhibition study indicate amifampridine is unlikely to play a role in metabolic-based clinical drug-drug interactions related to inhibition of CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4 metabolism of co-administered medicinal products.
Danish: Resultaterne fra studiet af CYP-hæmming in vitro tyder på, at amifampridin sandsynligvis ikke vil spille nogen rolle for interaktioner mellem lægemidler relateret til hæmning af CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 og CYP3A4-metabolisme af samtidigt administrerede lægemidler.
English: The dose of amifampridine should be titrated more slowly in patients with renal and hepatic impairment than those with normal renal and hepatic function.
Danish: Amifampridin-dosis bør titreres langsommere hos patienter med nedsat nyre- eller leverfunktion end hos patienter med normal nyre- og leverfunktion.
English: Store in the original blister in order to protect from light and moisture.
Danish: Opbevares i den originale blister for at beskytte mod lys og fugt.