FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for these medicines in the European Union (EU).
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der var behov for harmonisering af ordinationsoplysningerne for disse lægemidler i EU.
English: • Medicines that have a blood pressure-lowering effect.
Danish: • lægemidler, der sænker blodtrykket.
English: The CHMP agreed that Ikorel and Dancor must not be used in:
Danish: CHMP afgjorde, at Ikorel og Dancor ikke må anvendes hos:
English: • Patients with shock, severe hypotension (low blood pressure), or heart problems such as ‘left ventricular dysfunction with low filling pressure' or ‘cardiac decompensation';
Danish: • patienter med shock, svær hypotension (lavt blodtryk) eller hjerteproblemer, såsom "dysfunktion af venstre ventrikel med lavt fyldningstryk" eller "kardial dekompensation"
English: • Patients taking medicines known as ‘phosphodiesterase 5 inhibitors' and/or ‘soluble guanylate cyclase stimulators', since this can lead to a serious drop in blood pressure;
Danish: • patienter, som tager lægemidler af typen "fosfodiesterase 5-hæmmere" og/eller "opløselig guanylatcyklase-stimulatorer", da dette kan medføre alvorligt blodtryksfald
English: These ulcers are difficult to treat and usually resolve only when treatment with Ikorel or Dancor is stopped.
Danish: Disse sår er vanskelige at behandle og svinder sædvanligvis først, når behandlingen med Ikorel eller Dancor stoppes.
English: On 12 December 2013, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Ikorel and Dancor in the EU.
Danish: Den 12. december 2013 indbragte Europa-Kommissionen sagen for CHMP med henblik på harmonisering af markedsføringstilladelserne for Ikorel og Dancor i EU.
English: Depending on the patient's response and tolerance to treatment, the dose can be increased up to a maximum of 40 mg twice a day.
Danish: Alt efter hvor godt behandlingen virker og tåles, kan dosis sættes op til højst 40 mg to gange dagligt.
English: • Patients with known hypersensitivity (allergy) to nicorandil or to any of the other ingredients;
Danish: • patienter med kendt overfølsomhed (allergi) over for nicorandil eller andre af indholdsstofferne
English: Why were Ikorel and Dancor reviewed?
Danish: Hvorfor blev Ikorel og Dancor vurderet igen?
English: • Patients with a build-up of fluids in the lungs (acute pulmonary oedema).
Danish: • patienter med vand i lungerne (akut lungeødem).
English: • Medicines that could increase the levels of potassium in the blood, especially in patients with reduced kidney function;
Danish: • lægemidler, der kan øge indholdet af kalium i blodet, navnlig ved nedsat nyrefunktion
English: Having harmonised the indications, the CHMP also harmonised the recommendations on how to use Ikorel and Dancor.
Danish: Foruden anvendelserne harmoniserede CHMP også anbefalingerne for brug af Ikorel og Dancor.
English: Ikorel and Dancor should no longer be used to prevent heart problems, such as a heart attack, in patients with stable coronary heart disease (heart disease caused by the obstruction of the blood vessels that supply the heart muscle), because the available clinical data do not support this indication.
Danish: Ikorel og Dancor bør ikke længere anvendes til forebyggelse af hjerteproblemer, såsom hjertetilfælde, hos patienten med hjertesygdom forårsaget af tillukning af de blodkar, der forsyner hjertemusklen (stabil koronar hjertesygdom), fordi de foreliggende kliniske oplysninger ikke underbygger denne anvendelse.
English: If ulcers develop, Ikorel or Dancor should be permanently discontinued.
Danish: Hvis der opstår sår, skal behandlingen med Ikorel eller Dancor afbrydes permanent.
English: Additionally, Ikorel and Dancor should be used with caution in patients lacking an enzyme called glucose-6-phosphate dehydrogenase, and in patients with heart failure class III or IV (heart disease that severely limits or makes physical activity not possible without discomfort).
Danish: Desuden bør Ikorel og Dancor anvendes med forsigtighed ved mangel på enzymet glukose-6fosfatdehydrogenase, og ved hjertesygdom, der stærkt begrænser fysisk aktivitet eller gør det umuligt uden ubehag (hjertesvigt af klasse III eller IV).
English: • Patients suffering from hypovolaemia (low blood volume);
Danish: • patienter med for lavt blodvolumen (hypovolæmi)
English: Ikorel and Dancor contain the active substance nicorandil, which works by relaxing the muscles in the walls of the blood vessels that supply the heart, thereby improving blood flow to the heart muscle and relieving the symptoms of angina.
Danish: Ikorel og Dancor indeholder det aktive stof nicorandil, der virker ved at afslappe muskulaturen i væggene i de blodkar, der forsyner hjertet.
English: Ikorel and Dancor are medicines used to treat symptoms of angina pectoris (pain in the chest due to problems with the blood flow to the heart) in adult patients for whom treatment with medicines known as beta-blockers and/or calcium antagonists is not sufficiently effective, not indicated or not tolerated.
Danish: Ikorel og Dancor er lægemidler til behandling af symptomerne på angina pectoris (smerter i brystet som følge af problemer med blodtilførslen til hjertet) hos voksne patienter, hos hvem lægemidler af typen betablokkere og/eller calciumantagonister ikke virker tilstrækkeligt, ikke kan bruges eller ikke tåles.
English: The CHMP agreed that Ikorel and Dancor should only be used as a second-line option to treat the symptoms of angina, when patients do not sufficiently respond to, do not tolerate or should not take medicines such as beta-blockers and/or calcium antagonists.
Danish: CHMP fandt, at Ikorel og Dancor kun bør anvendes som andetvalgsbehandling af symptomerne på angina, når lægemidler såsom betablokkere og/eller calciumantagonister ikke virker tilstrækkeligt, ikke tåles eller ikke kan anvendes.
English: Gastrointestinal ulcers and ulcers on the skin and some internal (mucosal) surfaces have been reported in patients taking Ikorel or Dancor.
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen Der er indberettet mavesår og sår på huden og på visse indvendige slimhindeoverflader ved anvendelse af Ikorel eller Dancor.
English: Ikorel and Dancor were identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Danish: Koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMD(h)) fandt det nødvendigt at harmonisere Ikorel og Dancor.
English: • Aspirin or medicines called NSAIDs (non-steroid anti-inflammatory drugs), because these patients are at higher risk of developing complications of ulcers, such as bleeding in the stomach or gut;
Danish: fordi disse lægemidler øger risikoen for komplikationer af sår, såsom blødning fra maven eller tarmen
English: This could be very harmful to your health.
Danish: Det kan være meget skadeligt for dit helbred.
English: The treatment is mainly symptomatic.
Danish: Behandlingen er hovedsageligt symptomatisk.
English: Severe systemic manifestations are responsible for a 10% mortality rate.
Danish: Alvorlige systemiske manifestationer er ansvarlige for en dødelighedsrate på 10 %.
English: Date of first authorisation: 18.12.2018
Danish: Dato for første markedsføringstilladelse: 18.12.2018
English: The seriousness of the symptoms may require hospital supervision.
Danish: Symptomernes sværhedsgrad kan kræve hospitalsovervågning.
English: The dose should not exceed 500 mg/day.
Danish: Dosen må ikke overstige 500 mg/dag.
English: Symptoms typically occur 1-8 weeks after exposure to the medicinal product.
Danish: Symptomer forekommer typisk 1-8 uger efter eksponering for lægemidlet.
English: Period preferred
Danish: Foretrukket periode
English: Incidence of DRESS has been reported between 1:100 and 1:10.000 patients treated.
Danish: Forekomst af DRESS er blevet rapporteret hos mellem 1:100 og 1:10.000 af behandlede patienter.
English: How often these tests will be performed depends on your heart function.
Danish: Hvor ofte disse undersøgelser vil blive foretaget, afhænger af din hjertefunktion.
English: Therefore, mexiletine can be taken with or without food.
Danish: Mexiletin kan derfor tages med eller uden mad.
English: The most serious side effects are:
Danish: De mest alvorlige bivirkninger er:
English: The doctor will increase the dose gradually depending on how well the medicine is working.
Danish: Lægen vil gradvist øge dosen afhængig af, hvor godt lægemidlet virker.
English: Peak plasma concentrations following oral administration occur within 2 to 3 hours.
Danish: Peak plasmakoncentrationer efter oral administration forekommer inden for 2 til 3 timer.
English: Substrates of other enzymes and transporters
Danish: Substrater for andre enzymer og transportører
English: Patients who experienced myotonic symptoms that involved at least 2 segments and that had an impact on at least 3 daily activities were included into the study.
Danish: Patienter med myotoniske symptomer, der involverede mindst 2 segmenter, og som påvirkede mindst 3 daglige aktiviteter, blev inkluderet i studiet.
English: Other side effects that may occur:
Danish: Andre bivirkninger, der kan opstå:
English: Age of the overall study population ranged from 20 to 66 years old and about 2/3 of the patients were male.
Danish: Den samlede forsøgspopulationens alder var mellem 20 og 66 år, og cirka 2/3 af patienterne var mænd.
English: Results for the primary and key secondary endpoints are summarised in the table below.
Danish: Resultaterne for de primære og sekundære endepunkter er sammenfattet i nedenstående tabel.
English: Preference between the 2 treatment periods Number of subjects
Danish: Præference mellem de 2 behandlingsperioder Antal forsøgspersoner
English: No notable accumulation of mexiletine was observed after repeated administration.
Danish: Ingen mærkbar ophobning af mexiletin blev set efter gentagen administration.
English: Mexiletine is weakly bound to plasma proteins (55%).
Danish: Mexiletin har svag binding til plasmaproteiner (55 %).
English: Approximately 10% is excreted unchanged by the kidney.
Danish: Cirka 10 % udskilles uændret af nyrerne.
English: Your doctor will also regularly reassess your treatment to make sure Namuscla is still the best medicine for you.
Danish: Din læge vil også regelmæssigt revurdere din behandling for at sikre, at Namuscla stadig er det bedste lægemiddel til dig.
English: More than 50% Up to 2%
Danish: Mere end 50 % Op til 2 %
English: 30 hard capsules 50 hard capsules 100 hard capsules 200 hard capsules
Danish: 30 hårde kapsler 50 hårde kapsler 100 hårde kapsler 200 hårde kapsler
English: Do not take more than 3 capsules a day.
Danish: Tag ikke mere end 3 kapsler dagligt.
English: • Heart failure with mid-range (40-49%) and reduced (<40%) ejection fraction
Danish: • Hjerteinsufficiens med uddrivningsfraktion på mellemniveau (40-49 %) og reduceret (< 40 %)
English: The proportions of different ethnic populations across these various classes are tabulated below.
Danish: Proportionerne i de forskellige etniske populationer på tværs af de forskellige klasser ses i tabellen nedenfor.
English: Children and adolescents Namuscla should not be used in children and adolescents younger than 18 years old.
Danish: Børn og unge Namuscla må ikke anvendes til børn og unge under 18 år.
English: Individualised neuromuscular quality of life - Overall quality of life
Danish: Individualiseret neuromuskulær livskvalitet - Overordnet livskvalitet
English: See section “Warnings and precautions”.
Danish: Se afsnittet ”Advarsler og forsigtighedsregler”.
English: However, these studies were not performed in accordance with contemporary standards and are, hence, of unclear clinical relevance.
Danish: Disse studier blev dog ikke udført i overensstemmelse med nuværende standarder og den kliniske relevans er derfor uklar.
English: Mexiletine Placebo
Danish: Mexiletin Placebo
English: Contact your doctor if you take more than the recommended dose of Namuscla.
Danish: Kontakt lægen, hvis du tager mere end den anbefalede dosis af Namuscla.
English: The recommended starting dose is 1 capsule per day.
Danish: Den anbefalede startdosis er 1 kapsel per dag.
English: In these patients, it is recommended that the dose should only be increased after at least 2 weeks of treatment.
Danish: Det anbefales først at øge dosen hos disse patienter efter mindst 2 ugers behandling.
English: See also sections 4.3 and 4.5 regarding association with other products with arrhythmogenic effects.
Danish: 4.3 og 4.5 vedrørende forbindelse med andre produkter med arytmogene virkninger.
English: Primary Analysis
Danish: Primær analyse
English: Patients should be carefully monitored if co-treated with other medicinal products with especially emphasis to medicinal products with narrow therapeutic windows.
Danish: Patienter skal monitoreres nøje, hvis de samtidig bliver behandlet med andre medicinske produkter med særligt fokus på lægemidler med et snævert terapeutisk vindue.
English: Regular reassessment should be implemented, not to continue long-term treatment in a patient not responding or not experiencing benefit of the treatment.
Danish: Regelmæssige revurderinger bør finde sted for ikke at fortsætte en længerevarende behandling hos en patient, der ikke reagerer på eller har fordel af behandlingen.
English: Several medicinal products including anticonvulsants, antibiotics and also mexiletine have been identified as possible causes.
Danish: Flere lægemidler, inklusive krampestillende lægemidler, antibiotika og også mexiletin, er blevet identificeret som mulige årsager.
English: Frequency categories are derived according to the following conventions: 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: Hyppighedskategorier er bestemt i henhold til følgende konventioner: 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: The primary efficacy measure for both MC and PC was the score of stiffness severity as self-reported by the patients on a Visual Analogue Scale (VAS).
Danish: Det primære effektmål for både MC og PC var scoren for stivhedens sværhedsgrad som selvrapporteret af patienter på en visuel analog skala (VAS).
English: Depending on your heart function you may also need testing before and after any dose adjustment.
Danish: Afhængigt af din hjertefunktion skal du muligvis også testes før og efter en tilpasning af dosis.
English: Namuscla is a medicine that contains the active substance mexiletine.
Danish: Namuscla er et lægemiddel, som indeholder det aktive stof mexiletin.
English: CGI as judged efficient by the investigators CGI as judged efficient by the patients Effect of treatment (Mc Nemar test)
Danish: CGI som bedømt effektiv af investigatorer CGI som bedømt effektiv af patienter Effekt af behandling (McNemar-test)
English: Mexiletine is rapidly distributed in the body; its volume of distribution is large and varies from 5 to 9 L/kg in healthy individuals.
Danish: Mexiletin fordeles hurtigt i kroppen; dets fordelingsvolumen er stort og varierer fra 5 til 9 l/kg hos raske personer.
English: The VAS is constructed as an absolute measure, with a 100 mm straight horizontal line having the endpoints “no stiffness at all” (0) and “worst possible stiffness” (100).
Danish: VAS'en er konstrueret som et absolut mål med en 100 mm lige vandret linje med endepunkterne "slet ingen stivhed" (0) og "værst mulige stivhed" (100).
English: Up to 10%
Danish: Op til 10 %
English: Very common and common adverse reactions are derived from data from the MYOMEX study; less common adverse effects are derived from post-marketing data.
Danish: Meget almindelige og almindelige bivirkninger er udledt fra data fra MYOMEX-studiet; mindre almindelige bivirkninger er udledt fra data efter markedsføring.
English: The negative genotoxicity potential does not indicate an increased carcinogenic risk of treatment with mexiletine.
Danish: Det negative genotoxicitetspotentiale indikerer ikke en øget carcinogen risiko ved behandling med mexiletin.
English: The safety and efficacy of mexiletine in children and adolescents aged 0 to 18 years have not been established.
Danish: Mexiletins sikkerhed og virkning hos børn og unge i alderen 0 til 18 år er ikke klarlagt.
English: Common: vertigo
Danish: Almindelig: vertigo
English: Some patients may have higher blood levels of Namuscla because of slower break down in the liver and the dose may need to be adjusted accordingly.
Danish: Nogle patienter kan få højere niveauer af Namuscla i blodet pga. en langsommere nedbrydning i leveren, og dosis skal muligvis tilpasses dette.
English: Effect of treatment (binomial test)
Danish: Effekt af behandling (binomial test)
English: Limited clinical data of the use of mexiletine in pregnant women shows that mexiletine crosses the placenta and reaches the foetus.
Danish: Begrænsede kliniske data om anvendelse af mexiletin til gravide kvinder viser, at mexiletin krydser placenta og når fosteret.
English: Method of administration Namuscla is for oral use.
Danish: Indtagelsesmetode Namuscla er til oral anvendelse.
English: • Myocardial infarction (acute or past), or abnormal Q-waves
Danish: • Myokardieinfarkt (akut eller tidligere) eller abnorme Q-bølger
English: Epileptic patients need to be monitored because mexiletine can increase the frequency of seizure episodes.
Danish: Epileptiske patienter skal monitoreres, da mexiletin kan øge hyppigheden af krampeanfald.
English: Mexiletine is rapidly and almost completely absorbed following oral administration with a bioavailability of about 90% in healthy subjects.
Danish: Mexiletin absorberes hurtigt og næsten fuldstændigt efter oral administration med en biotilgængelig på cirka 90 % hos raske forsøgspersoner.
English: Caffeine
Danish: Caffein
English: The main secondary endpoints were changes in health-related quality of life as measured by individualised neuromuscular quality of life (INQoL) scale and the time needed to stand up from a chair, walk around the chair and sit down again (chair test).
Danish: De vigtigste sekundære endepunkter var ændringer i helbredsrelateret livskvalitet som målt på skalaen for individualiseret neuromuskulær livskvalitet (INQoL), og tid påkrævet til at rejse sig fra en stol, gå rundt om stolen og sætte sig ned igen (stoletest).
English: Mexiletine may interact with drugs transported by OCT2 (such as metformin and dofetilide).
Danish: Mexiletin kan interagere med lægemidler, som transporteres af OCT2 (såsom metformin og dofetilid).
English: Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, toxicity to reproduction and development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser samt reproduktions- og udviklingstoksicitet.
English: A linear relationship between mexiletine dose and plasma concentration has been observed in the dose range of 83 to 500 mg.
Danish: Et lineært forhold mellem dosis og plasmakoncentration af mexiletin er blevet observeret i dosisområdet 83 til 500 mg.
English: Iron (III) oxide (E 172) Titanium dioxide (E 171) Gelatin
Danish: Jern (III)-oxid (E 172) Titandioxid (E 171) Gelatine
English: In case of seizure, benzodiazepines should be used.
Danish: I tilfælde af krampeanfald skal der bruges benzodiazepiner.
English: Mexiletine is eliminated slowly in humans (with a mean elimination half-life of 10 hours, ranging from 5 to 15 hours).
Danish: Mexiletin elimineres langsomt hos mennesker (med en gennemsnitlig halveringstid på 10 timer, interval: 5 til 15 timer).
English: Fatal outcomes have been reported for acute overdoses at 4.4 g of mexiletine hydrochloride ingestion but survival has also been reported following acute overdose of approximately 4 g of oral mexiletine hydrochloride.
Danish: Dødelig udgang er blevet rapporteret for akutte overdoser ved indtagelse af 4,4 g mexiletinhydrochlorid, men overlevelse er ligeledes blevet rapporteret efter en akut overdosis på cirka 4 g oral mexiletinhydrochlorid.
English: Capsules are packed in Aluminium/PVC/PVDC blisters containing 30, 50, 100 or 200 capsules.
Danish: Kapsler er pakket i aluminium/PVC/PVDC-blistre med 30, 50, 100 eller 200 kapsler.
English: • Patients should not take more than 3 capsules of Namuscla per day or a double dose to make up for a forgotten dose;
Danish: patienter bør ikke tage mere end 3 Namuscla kapsler om dagen eller en dobbelt dosis for at kompensere for en glemt dosis.
English: Before starting treatment with Namuscla, you will have tests to check how well your heart is working, including ECG (Electrocardiogram).
Danish: Inden du starter behandling med Namuscla, vil du få foretaget undersøgelser for at kontrollere, hvor godt dit hjerte virker, herunder ekg (elektrokardiogram).
English: In case of bradycardia with hypotension, intravenous atropine should be used.
Danish: I tilfælde af bradykardi med hypotension skal der bruges intravenøst administreret atropin.
English: Up to 5%
Danish: Op til 5 %
English: It improves myotonic symptoms by decreasing muscle stiffness through reduction of the delay of muscle relaxation.
Danish: Lægemidlet forbedrer myotone symptomer ved at mindske muskelstivheden gennem en reduktion i forsinkelsen af muskelafslapning.
English: Excretion of mexiletine essentially occurs through the kidney (90% of the dose, including 10% as unchanged mexiletine).
Danish: Udskillelse af mexiletin sker hovedsageligt gennem nyrerne (90 % af dosen, inklusive 10 % som uændret mexiletin).
English: Patients with known hypersensitivity to mexiletine or any other ingredients of this product or to any local anaesthetic are at high risk of developing DRESS and should not receive mexiletine.
Danish: Patienter med kendt overfølsomhed over for mexiletin eller andre af produktets indholdsstoffer eller over for noget lokalt bedøvelsesmiddel har høj risiko for at udvikle DRESS og må ikke få mexiletin.
English: Read the Alert Card in conjunction with this leaflet and keep the card it with you at all times.
Danish: Læs patientkortet sammen med denne indlægsseddel og opbevar kortet på dig hele tiden.
English: • Additional risk minimisation measures
Danish: • Ydeligere risikominimeringsforanstaltninger
English: The maintenance dose is 1 to 3 capsules daily taken at regular intervals throughout the day.
Danish: Vedligeholdelsesdosen er 1 til 3 kapsler dagligt taget med regelmæssige mellemrum hele dagen.
English: If you or your doctor detects any heart rhythm disturbances or any of the conditions stated in section “Do not take Namuscla”, your doctor will stop your treatment with Namuscla.
Danish: Hvis du eller din læge bemærker nogen hjerterytmeforstyrrelser eller nogen af tilstandene angivet i afsnittet "Tag ikke Namuscla", vil din læge stoppe din behandling med Namuscla.
English: Food does not affect the rate or extent of absorption of mexiletine.
Danish: Mad påvirker ikke hastigheden eller omfanget af absorption af mexiletin.
English: In a clinical study in 12 subjects (5 healthy subjects and 7 patients with cardiac arrhythmias), the clearance of caffeine was decreased by 50% following the administration of mexiletine.
Danish: I et klinisk studie med 12 forsøgspersoner (5 raske forsøgspersoner og 7 patienter med hjertearytmier) var clearance af caffein reduceret med 50 % efter administration af mexiletin.
English: The effects of mexiletine on fertility in humans have not been studied.
Danish: Virkningen af mexiletin på fertiliteten hos mennesker er ikke undersøgt.
English: Based on the pharmacokinetic properties of mexiletine, no dosage adjustment is required in patients aged 65 years and over.
Danish: Baseret på mexiletins farmakokinetiske egenskaber er det ikke nødvendigt at justere dosen hos patienter på 65 år eller derover.