FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not stop treatment without consulting your doctor.
Danish: Stop ikke behandlingen uden at have talt med din læge.
English: e p-value based on the Wilcoxon Rank Sum Test for treatment differences.
Danish: e p-værdi baseret på Wilcoxons rank sum test for behandlingsforskelle.
English: Cold extremities1
Danish: Kolde ekstremiteter1
English: c CGI-I is a 7-point scale based on changes in symptoms, behaviour, and functional abilities (1=very much improved to 7=very much worse).
Danish: CGI-I er en 7-punktskala baseret på ændringer i symptomer, adfærd og funktionsevne (1=særdeles meget forbedret til 7=særdeles meget forværret).
English: Treatment should be initiated under supervision of a physician experienced in the treatment of the disease.
Danish: Behandling skal indledes under opsyn af en læge med erfaring i behandling af sygdommen.
English: What FIRDAPSE contains
Danish: FIRDAPSE indeholder
English: Patients had a median age of 55.5 years (range: 31 to 75 years) and 62% were female and 38% were male.
Danish: Patienterne havde en medianalder på 55,5 år (interval: 31 til 75 år) og 62 % var kvinder og 38 % var mænd.
English: The dose of the concomitantly given medicinal product should be adjusted if necessary.
Danish: Dosen af de lægemidler, der gives samtidig, skal om nødvendigt tilpasses.
English: Your doctor will monitor carefully how FIRDAPSE works for you and may need to change the dose of the medicines you take.
Danish: Din læge vil nøje holde øje med, hvordan FIRDAPSE påvirker dig, og vil måske være nødt til at ændre den dosis, du tager.
English: Therefore, in exceptional circumstances higher doses up to a maximum of 80 mg/day may be of benefit when given with the appropriate safety monitoring.
Danish: I særlige tilfælde kan højere doser på op til højst 80 mg/dagen være gavnlige, når de indgives med en passende sikkerhedsmonitorering.
English: Very common side effects which may affect more than 1 in 10 people are:
Danish: Meget almindelige bivirkninger, som kan påvirke mere end 1 ud af 10 personer, er:
English: • If you are allergic to amifampridine, or any of the other ingredients of this medicine (listed in section 6)
Danish: • Hvis du er allergisk over for amifampridin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: b SGI is a 7-point scale which rates the global impression of the effects of study treatment
Danish: b SGI er en 7-punktskala som vurderer helhedsindtrykket for virkningerne af studiebehandlingen
English: If treatment is discontinued, patients may experience some of the symptoms of LEMS.
Danish: Hvis behandling seponeres, kan patienter opleve nogle af symptomerne på LEMS.
English: Tablets are to be taken with food.
Danish: Tabletterne skal indtages sammen med mad.
English: INFORMATION IN BRAILLE FIRDAPSE
Danish: INFORMATION I BRAILLESKRIFT FIRDAPSE
English: The dose you should take is established by your doctor based on the intensity of your symptoms and certain genetic factors.
Danish: Lægen anviser, hvor stor en dosis du skal tage, på baggrund af intensiteten af dine symptomer og visse genetiske faktorer.
English: • If you have uncontrolled asthma
Danish: • Hvis du har ukontrolleret astma
English: • Reduced sense of touch or sensation
Danish: • Reduceret berøringssans eller fornemmelse
English: Do not take FIRDAPSE
Danish: Tag ikke FIRDAPSE
English: Although the metabolite is inactive at potassium channels, potential off target effects due to accumulation are unknown.
Danish: Selvom metabolitten er inaktiv på kaliumkanaler, er potentialet for målvirkninger på grund af akkumulering ukendt.
English: MedDRA System organ class
Danish: Systemorganklasse i henhold til MedDRA
English: If you discover that you are pregnant during the treatment, inform your doctor immediately.
Danish: Hvis du under behandlingen opdager, at du er gravid, skal du straks fortælle det til din læge.
English: Tell your doctor if you have
Danish: Fortæl det til lægen, hvis du har:
English: Date of latest renewal: 1 December 2014
Danish: Dato for første markedsføringstilladelse: 23. december 2009 Dato for seneste fornyelse: 1. december 2014
English: If you forget to take FIRDAPSE, do not take a double dose to make up for the dose you have forgotten but continue to take your treatment as prescribed by your doctor.
Danish: Hvis du glemmer at tage FIRDAPSE, må du ikke tage en dobbeltdosis som erstatning for den glemte dosis, men skal fortsætte behandlingen som anvist af lægen.
English: Carcinogenicity risk
Danish: Risiko for karcinogenicitet
English: The correlation between the use of amifampridine and the development of tumours in humans is unknown at this time.
Danish: Korrelationen mellem brug af amifampridin og udvikling af tumorer hos mennesker er i øjeblikket ukendt.
English: • The active substance is amifampridine.
Danish: • Aktivt stof: amifampridin.
English: If you have LEMS but do not have cancer, your doctor will make a thorough assessment of the potential risk of cancer with FIRDAPSE before commencing treatment.
Danish: Hvis du har Lambert-Eatons syndrom, men ikke har kræft, vil din læge foretage en grundig vurdering af din potentielle risiko for at udvikle kræft ved brug af FIRDAPSE, inden behandlingen indledes.
English: Tell any physician you consult that you are using FIRDAPSE.
Danish: Fortæl det til alle læger, du konsulterer, at du tager FIRDAPSE.
English: Common side effects which may affect up to 1 in 10 people are:
Danish: Almindelige bivirkninger, som kan påvirke op til 1 ud af 10 personer er:
English: • Tingling and numbness around the mouth and extremities (such as feet and hands)
Danish: • Snurren og følelsesløshed omkring munden og lemmerne (f.eks. fødder og hænder)
English: The tablets should be swallowed with some water and are to be taken with food.
Danish: Tabletterne synkes med lidt vand og skal indtages sammen med mad.
English: Patients with liver/kidney problems:
Danish: Patienter med lever-/nyreproblemer:
English: Patients must be told to inform any physician they consult that they are taking this medicinal product, since close monitoring of a concomitant disease, particularly asthma, may be necessary.
Danish: Patienterne skal informeres om, at de skal oplyse til alle læger, de kontakter, at de tager dette lægemiddel, da en nøje overvågning af en ledsagende sygdom, navnlig astma, kan være nødvendig.
English: • Increase in certain liver enzymes (transaminases) seen on blood tests
Danish: • Øget niveau af visse leverenzymer (transaminaser), der ses i blodprøver
English: Clinical and electrocardiogram (ECG) monitoring are indicated at the initiation of the treatment and yearly thereafter.
Danish: Klinisk overvågning og overvågning via elektrokardiogram (EKG) er indiceret ved behandlingens start og derefter en gang om året.
English: FIRDAPSE should be given in divided doses, three or four times a day.
Danish: FIRDAPSE bør gives i doser fordelt på tre til fire gange pr. dag.
English: Raynaud's syndrome
Danish: Raynauds syndrom
English: Pharmacotherapeutic group: other nervous system drugs, ATC code: N07XX05.
Danish: Farmakoterapeutisk klassifikation: andre lægemidler med virkning på nervesystemet ATC-kode: N07XX05.
English: One box contains 100 tablets comprising 10 strips with 10 tablets each.
Danish: En æske indeholdende 100 tabletter bestående af 10 plader med hver 10 tabletter.
English: The patients were maintained on a stable dose and frequency of amifampridine phosphate for at least 7 days prior to randomization.
Danish: Patienterne opretholdt en stabil dosis og hyppighed af amifampridinphosphat i mindst 7 dage før randomisering.
English: The benefit of continuing treatment with amifampridine should be reviewed for any patient who develops a Schwannoma.
Danish: Fordelen ved fortsat behandling med amifampridin skal evalueres for alle patienter, som udvikler et schwannom.
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: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår på 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: NAME OF THE MARKETING AUTHORISATION HOLDER BioMarin International Limited
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN BioMarin International Limited
English: No single dose should exceed 20 mg.
Danish: En enkelt dosis bør ikke overstige 20 mg.
English: Total daily doses above 20 mg should be divided into two to four separate doses.
Danish: Daglige doser på over 20 mg bør opdeles i to til fire separate doser.
English: • Increase sweating, cold sweat
Danish: • Øget svedafsondring, koldsved
English: You and your doctor should discuss the risks and benefits of continuing to take FIRDAPSE while breastfeeding.
Danish: Du og din læge bør tale sammen om fordele og ulemper ved fortsat at tage FIRDAPSE, mens du ammer.
English: Amifampridine was not genotoxic in a standard battery of in vitro and in vivo tests.
Danish: Amifampridin var ikke genotoksisk i et standardbatteri af in vitro og in vivo tests.
English: Diarrhoea, epigastralgia
Danish: Diarré, epigastralgi
English: FIRDAPSE should not be used during pregnancy.
Danish: FIRDAPSE bør ikke anvendes under graviditeten.
English: Medicinal products eliminated through metabolism or active secretion There are no data on the effects of amifampridine on the metabolism or active secretion of other medicinal products.
Danish: Lægemidler, der elimineres via metabolisme eller aktiv sekretion Der foreligger ingen data om amifampridins virkning på andre lægemidlers metabolisme eller aktive sekretion.
English: The tablets can be divided into equal halves.
Danish: Tabletterne kan deles i to lige store halvdele.
English: The manifestations of acute overdose include vomiting and abdominal pain.
Danish: Symptomerne på akut overdosering omfatter opkastning og abdominalsmerter.
English: • If you are epileptic
Danish: • Hvis du har epilepsi,
English: Warnings and precautions Talk to your doctor or pharmacist before taking FIRDAPSE.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apoteketspersonalet, før du tager FIRDAPSE.
English: In this four-day study, patients were randomized (1:1) to amifampridine phosphate (at patient's optimal dose) or placebo on Day 0.
Danish: I dette fire-dages studie, blev patienterne randomiseret (1:1) til amifampridinphosphat (på patientens optimale dosis) eller placebo på dag 0.
English: Exposure to amifampridine is associated with an increased risk for epileptic seizures.
Danish: Indtagelse af amifampridin er forbundet med øget risiko for epileptiske anfald.
English: d CFB for QMG total score was modelled as the response, with fixed effects terms for treatment and QMG at Baseline.
Danish: d CFB for QMG samlet score blev modelleret som respons med faste termer for effekter af behandling og QMG ved baseline.
English: Orally administered amifampridine is rapidly absorbed in humans, reaching peak plasma concentrations by 0.6 to 1.3 hours (mean values).
Danish: Oralt administreret amifampridin absorberes hurtigt hos mennesker og når maksimale plasmakoncentrationer i løbet af 0,6 til 1,3 timer (gennemsnitsværdier).
English: Patients were allowed to use stable doses of peripherally acting cholinesterase inhibitors or corticosteroids.
Danish: Patienterne fik lov at bruge stabile doser af perifert virkende cholinesteraseinhibitorer eller kortikosteroider.
English: The mean caffeine acetylator ratio for these 12 subjects receiving four escalating doses were 0.408 and 0.172 for fast and slow acetylators types respectively.
Danish: Den gennemsnitlige caffeinacetylator-ratio for disse 12 forsøgspersoner, der fik fire eskalerende doser, var 0,408 og 0,172 for henholdsvis hurtige og langsomme acetylator- typer.
English: Thus, special care should be taken in patients undergoing concomitant treatment with medicinal products eliminated through metabolism or active secretion.
Danish: Der bør således udvises særlig opmærksomhed hos patienter, der samtidig behandles med lægemidler, der elimineres via metabolisme eller aktiv sekretion.
English: • Raynaud's syndrome (circulation disorder affecting the fingers and toes)
Danish: • Raynauds syndrom (kredsløbslidelse, der rammer fingre og tæer)
English: Table 1: Adverse Reactions Reported with FIRDAPSE
Danish: Tabel 1: Bivirkninger indberettet med FIRDAPSE
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from FIRDAPSE therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med FIRDAPSE skal seponeres/undgås, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: • If you were born with heart problems (congenital QT syndromes)
Danish: • Hvis du har medfødte hjerteproblemer (medfødt QT-syndrom).
English: The pharmacodynamic profile of amifampridine has been studied for a range of doses.
Danish: Amifampridins farmakodynamiske profil er blevet undersøgt for en række doser.
English: The NAT genes are highly polymorphic and result in phenotypes with variable acetylation activity rates ranging from slow to fast.
Danish: NAT-generne er stærkt polymorfe og resulterer i fænotyper med variable acetyleringsaktivitetsrater fra langsom til hurtig.
English: PHARMACEUTICAL FORM AND CONTENTS 100 tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 100 tabletter
English: There was a decrease in Cmax and AUC, and an increase in the time to reach maximum plasma concentrations when amifampridine phosphate was administered with food as compared to without food.
Danish: Der var et fald i Cmax og AUC og en stigning i tid, før de maksimale plasmakoncentrationer blev nået, når amifampridinphosphat blev administreret sammen med føde sammenlignet med uden føde.
English: Apparent plasma terminal elimination half-life differences were 3-4 fold between subjects in the food effect study.
Danish: Forskellen i den tilsyneladende terminale plasma-halveringstid var 3-4 fold mellem forsøgspersoner i studiet af effekten af føde.
English: Following oral administration of radiolabelled [14C] amifampridine, radioactive material is rapidly absorbed from the gastrointestinal tract and widely distributed throughout the body.
Danish: Efter oral administration af radioaktivt mærket [14C] amifamdiprin absorberes det radioaktivt mærkede hurtigt fra mave-tarmkanalen og distribueres udstrakt i hele kroppen.
English: Prolonging the action potential enhances the transport of calcium into the nerve ending.
Danish: Forlængelse af den potentielle virkning øger transporten af calcium til nerveenderne.
English: Cardiac effects
Danish: Kardiale virkninger
English: A 2-fold increase in the time to reach Cmax (Tmax) was observed in the presence of food.
Danish: Der blev set en stigning (fordobling) i tid, før Cmax og (Tmax) blev nået ved tilstedeværelsen af føde.
English: • Uncontrolled asthma
Danish: • Ukontrolleret astma
English: No single dose should exceed 20 mg (two tablets).
Danish: En enkelt dosis bør ikke overstige 20 mg (to tabletter).
English: Amifampridine (n=13)
Danish: Amifampridin (n=13)
English: Amifampridine should be used with caution in patients with an increased risk of Schwannomas, such as patients with past medical history of such tumours, neurofibromatosis Type 2 or schwannomatosis.
Danish: Amifampridin skal anvendes med forsigtighed hos patienter med en øget risiko for schwannom, som f.eks. patienter med tidligere anamnese med sådanne tumorer, neurofibromatose type 2 eller schwannomatose.
English: The safety profile in this study is consistent with adverse reactions observed with patients on amifampridine.
Danish: Sikkerhedsprofilen i dette studie er i overensstemmelse med de bivirkninger, der er observeret hos patienter, som får amifampridin.
English: The primary endpoints were change from baseline (CFB) in Patient Global Impression (SGI) and Quantitative Myasthenia Gravis (QMG) score at Day 4.
Danish: De primære endepunkter var ændring fra baseline (CFB) i patientens helhedsindtryk (SGI) og i den kvantitative myastenia gravis (QMG) score på dag 4.
English: If treatment with a potent inhibitor is discontinued, patients should be monitored for efficacy as an increase of amifampridine dose may be necessary.
Danish: Hvis behandlingen med en potent enzyminhibitor seponeres, bør patienterne overvåges, da en forøgelse af amifampridin-dosis kan være nødvendig.
English: In case of signs and symptoms indicative of cardiac arrhythmias, ECG should be performed immediately.
Danish: Opstår der tegn og symptomer på hjertearytmi, skal der straks tages et EKG.
English: Available reproductive data in animals have shown presence of amifampridine in milk of breast-feeding mothers.
Danish: Tilgængelige reproduktive data fra dyr har vist tilstedeværelse af amifampridin i mælk fra ammende mødre.
English: • Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1
Danish: • Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i punkt 6.1.
English: It is recommended that dose titration from 60 mg/day to 80 mg/day is performed in 5 mg increments every 7 days.
Danish: Det anbefales, at dosistitreringen fra 60 mg/dag til 80 mg/dag sker med 5 mg hver 7. dag.
English: This disease is a disorder affecting the transmission of nerve impulses to muscles, resulting in muscle weakness.
Danish: Denne sygdom medfører forstyrrelse i overføringen af nerveimpulser til musklerne, hvilket resulterer i muskelsvaghed.
English: If you forget to take FIRDAPSE
Danish: Hvis du har glemt at tage FIRDAPSE
English: No studies have been conducted in patients with hepatic impairment.
Danish: Der er ikke udført studier hos patienter med nedsat leverfunktion.
English: Two further studies in a total of 57 patients with LEMS have reported data from higher doses of amifampridine.
Danish: To yderligere studier omfattende i alt 57 patienter med Lambert-Eatons syndrom resulterede i data om højere doser af amifampridin.
English: The tablets have a score-line to allow them to be broken in half.
Danish: Tabletterne har en særlig delekærv, så de nemt kan brækkes over i to halvdele.
English: Following the 4 day double-blind discontinuation period, patients treated with amifampridine phosphate maintained muscle strength compared to patients treated with placebo who showed worsening of muscle strength.
Danish: Efter den 4 dages dobbeltblindede seponeringsperiode, bibeholdte patienter behandlet med amifampridinphosphat deres muskelstyrke sammenlignet med patienter behandlet med placebo, som udviste forværring af muskelstyrken.
English: Combinations requiring precautions for use
Danish: Kombinationer, der kræver sikkerhedsforanstaltninger
English: In the healthy volunteer study, fast acetylators were defined by having a caffeine metabolite ratio >0.3 and slow acetylators with a caffeine metabolite ratio <0.2 .
Danish: I studiet med raske frivillige blev hurtige acetylatorer defineret som havende en caffeinmetabolit-ratio på >0,3 og langsomme acetylatorer som havende en caffeinmetabolit-ratio på <0,2.
English: Similarly Cmax and AUC0-∞ were greater in the fasted state than in the fed state.
Danish: Tilsvarende var Cmax og AUC0-∞ højere i fastende tilstand end efter fødeindtagelse.
English: It is not known whether FIRDAPSE is excreted in human breast milk.
Danish: Det vides ikke, om FIRDAPSE udskilles i human brystmælk.
English: A secondary efficacy endpoint was the change from baseline at Day 4 in CGI-I score, which was determined by treating physicians.
Danish: Et sekundært endepunkt for virkning var ændring fra baseline til dag 4 i CGI-I score, som blev vurderet af behandlende læger.
English: White, round tablet, flat-faced on one side and scored on the other side.
Danish: Hvid, rund tablet med én flad side og delekærv på den anden side.
English: In safety pharmacology studies in rats, no respiratory system related effects were seen up to 10 mg/kg or on the central nervous system up to 40 mg/kg.
Danish: I studier af sikkerhedsfarmakologi hos rotter sås ingen virkninger på åndedrætssystemet ved doser på op til 10 mg/kg eller på centralnervesystemet ved doser på op til 40 mg/kg.
English: The effect of age on the pharmacokinetics of amifampridine has not been studied.
Danish: Alderens betydning for amifampridins farmakokinetik er ikke blevet undersøgt.
English: This medicine may cause drowsiness, dizziness, fits (convulsions) and blurred vision, which may affect your ability to drive or use machines.
Danish: Denne medicin kan forårsage døsighed, svimmelhed, anfald (kramper) og sløret syn, som kan påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: In a study of healthy volunteers, systemic exposure of amifampridine was notably influenced by the overall metabolic acetylation activity of NAT enzymes and NAT2 genotype.
Danish: I et studie med raske frivillige var den systemiske eksponering for amifampridin betragteligt påvirket af den samlede metaboliske acetyleringsaktivitet af NAT-enzymer og NAT2-genotype.
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Total QMG score range 0 - 39, 13 items, 0-3 points on each test.
Danish: Samlet interval for QMD-score 0 - 39, 13 emner, 0-3 point for hver test. Jo flere point = jo værre symptomer.
English: In a perinatal/postnatal reproduction study in pregnant rats treated with amifampridine, a dose-related increase in the percentage of mothers with stillborn offspring (16.7%-20%) was observed at 22.5 mg/kg/day and 75 mg/kg/day (1.1 and 2.7 times the 80 mg per day dose in humans based on Cmax).
Danish: I et perinatalt/postnatalt reproduktionsstudie hos drægtige rotter, der fik amifampridin, blev der observeret en dosisrelateret stigning i procentdelen af mødre med dødfødt afkom (16,7 %-20 %) ved 22,5 mg/kg/dag og 75 mg/kg/dag (1,1 og 2,7 gange den daglige 80 mg-dosis hos mennesker på basis af Cmax).
English: This evaluation was conducted in a Phase 1, double-blind, randomized, crossover study to define the ECG effects of amifampridine phosphate at these doses compared to placebo and moxifloxacin (a positive control) in healthy men and women who are slow acetylators (n=52).
Danish: Denne evaluering blev udført i et fase 1, dobbeltblindet, randomiseret, overkrydsningsstudie for at definere virkningerne af amifampridinphosphat på EKG ved disse doser sammenlignet med placebo og moxifloxacin (positiv kontrol) hos raske mænd og kvinder, som acetylerer langsomt (n=52).
English: Do not drive or operate machines if you experience these side effects.
Danish: Kør ikke bil eller motorcykel, og lad være med at cykle eller arbejde med værktøj eller maskiner, hvis du oplever disse bivirkninger.
English: The maximum recommended dose is 60 mg per day (i.e. a total of six tablets to be taken at intervals during the day).
Danish: Den maksimale, anbefalede dosis er 60 mg/dag (dvs. i alt seks tabletter, som tages jævnt fordelt over dagen).
English: Distribution of amifampridine was studied in the rat.
Danish: Distribution af amifamdiprin er undersøgt hos rotter.
English: What you need to know before you take FIRDAPSE
Danish: Det skal du vide, før du begynder at tage FIRDAPSE
English: However, in a similar study in pregnant rabbits, there was no effect on embryo-foetal viability when evaluated just prior to birth at doses up to 57 mg/kg/day.
Danish: I et lignende studie hos drægtige kaniner var der imidlertid ingen virkning på den embryo-føtale levedygtighed ved doser op til 57 mg/kg/dag ved evaluering lige før fødslen.
English: EXCELLA GmbH & Co KG Nürnberger Strasse 12 90537 Feucht
Danish: KG Nürnberger Strasse 12 90537 Feucht