FrancophonIA/ELRC3.0 huggingface dataset:
English: Several of the resulting metabolites are submitted to further conjugation with glucuronic acid (phase II metabolism); among these are the major metabolites p-hydroxymexiletine, hydroxy-methylmexiletine and N-hydroxymexiletine.
Danish: Flere af de resulterende metabolitter sendes videre til yderligere konjugation med glucoronsyre (fase II-metabolisme); deriblandt er de vigtige metabolitter p-hydroxymexiletin, hydroxy-methylmexiletin og N-hydroxymexiletin.
English: Patients with cardiac disorders
Danish: Patienter med hjertesygdomme
English: Namuscla is used to treat the symptoms of myotonia (when muscles relax slowly and with difficulty after they are used) in adults with non-dystrophic myotonic disorders, which are caused by genetic defects that affect muscle function.
Danish: Namuscla bruges til at behandle symptomer på myotoni (når musklerne er lang tid om og har svært ved at slappe af efter brug) hos voksne med ikke-dystrofiske myotone muskelsygdomme, som er forårsaget af genetiske defekter, der påvirker muskelfunktion.
English: Heart function
Danish: Hjertefunktion
English: Throughout treatment with mexiletine, and in relation with dose changes, cardiac monitoring of patients needs to be adapted as a function of the heart condition of the patient:
Danish: Under behandling med mexiletin og i forbindelse med dosisændringer skal hjertemonitorering af patienter tilpasses patientens hjertefunktion:
English: In case of digestive intolerance, capsules should be taken during a meal.
Danish: I tilfælde af fordøjelsesproblemer skal kapslerne tages med et måltid.
English: Namuscla is available in blister packs containing 30, 50, 100 or 200 capsules.
Danish: Namuscla fås i blisterpakninger med 30, 50, 100 eller 200 kapsler.
English: A period of at least 7 days before dose increase must be respected to ensure that steady-state levels are reached and that mexiletine is well tolerated in all patients, irrespective of CYP450 polymorphism.
Danish: En periode på mindst 7 dage inden øgning af dosen skal respekteres for at sørge for, at steady-state niveauer nås, og at mexiletin er veltolereret hos alle patienter uden hensyntagen til patientens CYP450-polymorfisme.
English: • Co-administration with medicinal products with narrow therapeutic index (see section 4.5).
Danish: • Samtidig administration af lægemidler med et snævert terapeutisk indeks (se pkt.
English: • Highlight the risk of decreased Namuscla clearance in patients with hepatic impairment and provide guidance on how to treat those patients in order to prevent it, ensuring Namuscla cautious titration in patients with mild or moderate hepatic impairment (increasing the dose after at least 2 weeks of treatment).
Danish: • Gøre opmærksom på risikoen for nedsat clearance af Namuscla hos patienter med nedsat leverfunktion og vejlede om behandlingen af disse patienter for at forhindre dette ved at sikre, at Namuscla titreres forsigtigt hos patienter med let eller moderat nedsat leverfunktion (søgning af dosen efter mindst 2 ugers behandling).
English: Mexiletine dose may need to be increased if a patient starts to smoke during mexiletine treatment and decreased if a patient stops smoking.
Danish: Dosen af mexiletin skal muligvis øges, hvis en patient begynder at ryge under behandling med mexiletin, og reduceres, hvis en patient holder op med at ryge.
English: • In patients without cardiac abnormalities, periodic ECG monitoring is recommended (every 2 years or more frequently if considered necessary).
Danish: • Hos patienter uden abnormiteter i hjertet anbefales regelmæssig ekg-monitorering (hver 2. år eller hyppigere, hvis det skønnes nødvendigt).
English: If you notice that the rhythm of your heart changes (the heart beats faster or slower), if you feel fluttering or pain in your chest, if you have difficulty breathing, if you feel dizzy, if you sweat or if you faint, you have to contact an emergency centre immediately.
Danish: Hvis du bemærker, at din hjerterytme ændrer sig (hjertet slår hurtigere eller langsommere), fornemmer hjertebanken eller smerter i brystet, har vejrtrækningsbesvær, føler dig svimmel, sveder eller besvimer, skal du straks kontakte en akutklinik
English: The influence of CYP2D6 phenotype on mexiletine metabolism has been extensively investigated.
Danish: Indflydelsen af CYP2D6-fænotype på metabolismen af mexiletin er blevet nøje undersøgt.
English: Very rare: drug reaction with eosinophilia and systemic symptoms Not known: lupus-like syndrome, dermatitis exfoliative, Stevens-Johnson syndrome Psychiatric disorders
Danish: Meget sjælden: lægemiddelreaktion med eosinofili og systemiske symptomer Ikke kendt: lupuslignende syndrom, eksfoliativ dermatitis, Stevens-Johnsons syndrom Psykiske forstyrrelser
English: After at least 1 further week of treatment, based on clinical response, dose can be further increased to 500 mg daily (3 capsules per day).
Danish: Efter mindst 1 uges yderligere behandling og baseret på klinisk respons kan dosen øges yderligere til 500 mg dagligt (3 kapsler per dag).
English: A cardiac evaluation is also recommended shortly after starting Namuscla (e.g. within 48 hours).
Danish: En vurdering af hjertet anbefales også umiddelbart efter opstarten af behandlingen med Namuscla (fx inden for 48 timer).
English: For cardiac disorders not listed in section 4.3, the benefit of the antimyotonic effects of mexiletine needs to be balanced against the risk of cardiac complications on a case by case basis.
Danish: 4.3, skal fordelene ved mexiletins antimyotone virkninger vejes i forhold til risikoen for hjertekomplikationer i det enkelte tilfælde.
English: The concomitant use of mexiletine and antiarrhythmic medicines inducing torsades de pointes is contraindicated (see section 4.3).
Danish: Samtidig anvendelse af mexiletin og antiarytmika, der fremkalder torsade de pointes, er kontraindiceret (se pkt.
English: The symptoms of mexiletine overdose include neurological disorders (paresthesia, confusion, hallucination, seizure) and cardiac disorders (sinusal bradycardia, hypotension, collapse, and in extreme cases, cardiac arrest).
Danish: Symptomerne på en overdosis af mexiletin inkluderer neurologiske forstyrrelser (paræstesi, forvirring, hallucination, krampeanfald) og hjerteforstyrrelser (sinusbradykardi, hypotension, kollaps og i ekstreme tilfælde hjertestop).
English: Examples of such medicines are digoxin (for heart problems), lithium (mood stabiliser), phenytoin (for treating epilepsy), theophylline (against asthma) and warfarin (against blood clots).
Danish: Eksempler på sådanne lægemidler er digoxin (mod hjerteproblemer), lithium (humørstabilisator), phenytoin (mod epilepsi), theophyllin (mod astma) og wafarin (mod blodpropper).
English: Asians
Danish: Asiater
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 pkt.
English: Experience with mexiletine in patients with myotonic disorders aged > 65 years is limited.
Danish: Der er begrænset erfaring med mexiletin hos patienter med myotone sygdomme på > 65 år.
English: It is, therefore, recommended to reduce caffeine intake during treatment with mexiletine.
Danish: Det anbefales derfor at halvere indtag af caffein under behandling med mexiletin.
English: As a precautionary measure, it is preferable to avoid the use of mexiletine during pregnancy.
Danish: For en sikkerheds skyld bør mexiletin undgås under graviditeten.
English: Caucasians
Danish: Kaukasere
English: What Namuscla contains
Danish: Namuscla indeholder:
English: Do not use this medicine after the expiry date which is stated on the carton and blister.
Danish: Tag ikke dette lægemiddel efter den udløbsdato, der står på kartonen og blisteren efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The most serious reported adverse reactions in patients treated with mexiletine are drug reaction with eosinophilia and systemic symptoms and arrhythmia (atrioventricular block, arrhythmia, ventricular fibrillation).
Danish: De mest alvorlige rapporterede bivirkninger hos patienter behandlet med mexiletin er lægemiddelreaktion med eosinofili og systemiske symptomer samt arytmi (atrioventrikulært blok, arytmi, ventrikelflimren).
English: Before starting mexiletine treatment, detailed and careful cardiac evaluation (ECG, 24-48-hour Holtermonitoring and echocardiography) should be carried out in all patients in order to determine the cardiac tolerability of mexiletine.
Danish: Inden start af behandling med mexiletin skal der foretages en omhyggelig og nøje evaluering af hjertet (ekg, 24-48-timers Holter-monitorering og ekkokardiografi) hos alle patienter for at fastslå hjertets tolerabilitet af mexiletin.
English: Overdose management
Danish: Behandling af overdosis
English: Therefore, based on the clinical response, the mexiletine dosage should be adapted during and after treatment with the enzyme inducer.
Danish: Dosering af mexiletin skal derfor tilpasses baseret på det kliniske respons under og efter behandling med det enzyminducerende stof.
English: Common: somnolence
Danish: Almindelig: somnolens
English: Mexiletine should be stopped immediately in case any cardiac conduction abnormalities or any of the contraindications listed in the section 4.3 are detected.
Danish: Mexiletin skal straks seponeres, hvis der detekteres nogen hjerteledningsabnormiteter eller nogen af kontraindikationerne angivet i pkt.
English: • Namuscla should be stopped immediately if the patient develops cardiac abnormalities, is not responding or experiencing benefit within Namuscla long-term treatment;
Danish: • Behandlingen med Namuscla skal stoppes med det samme, hvis patienten udvikler hjerteabnormaliteter, ikke reagerer på eller ikke har fordel af en længerevarende behandling med Namuscla;
English: • Before starting treatment, HCPs should perform a detailed and careful cardiac evaluation in all patients, in order to determine the cardiac tolerability of Namuscla.
Danish: • inden påbegyndelsen af en behandling, bør sundhedsfagligt personale foretage en detaljeret og omhyggelig vurdering af hjertet hos alle patienter for at bestemme hjertets tolerance over for Namuscla.
English: Common: nausea
Danish: Almindelig: kvalme
English: • Patients should carry the card at all times, and show it at all medical visits to HCPs other than the prescriber (e.g. emergency HCPs);
Danish: • patienten skal bære kortet på sig hele tiden og vise det ved ethvert besøg hos sundhedsfagligt personale ud over den ordinerende læge (fx til sundhedsfagligt personale på skadestuen);
English: Common side effects (may affect up to 1 in 10 people): - Somnolence (sleepiness) - Headache - Tingling in the arms and legs - Blurred vision - Vertigo (sensation of feeling off balance) - Rapid heart rate - Flushing - Low blood pressure (which can cause dizziness and feeling faint) - Nausea (feeling sick) - Acne - Pain in the arms and legs - Tiredness - Weakness - Chest discomfort - Malaise (a feeling of general discomfort and illness)
Danish: Almindelige bivirkninger (kan påvirke op til 1 ud af 10 personer): - Somnolens (søvnighed) - Hovedpine - Prikken i arme og ben - Sløret syn - Svimmelhed - Hurtig hjertefrekvens - Blussen - Lavt blodtryk (som kan forårsage svimmelhed og svaghed) - Kvalme - Akne - Smerter i arme eller ben - Træthed - Svaghed - Ubehag i brystet - Utilpashed (en almen følelse af ubehag og sygdom)
English: Very rare side effects (may affect up to 1 in 10,000 people): - Liver injury including inflammation (hepatitis) - Severe reaction to the medicine (with rash and fever)
Danish: Meget sjældne bivirkninger (kan påvirke op til 1 ud af 10.000 personer): - Leverskade inklusive betændelse (hepatitis) - Alvorlig reaktion på lægemidlet (med udslæt og feber)
English: Patients should be informed about the presenting symptoms of arrhythmias (fainting, palpitation, chest pain, shortness of breath, light-headedness, lipothymia, and syncope) and should be advised to immediately contact an emergency centre if there are any symptoms of arrhythmias.
Danish: Patienter skal informeres om de umiddelbare symptomer på arytmi (besvimelse, hjertebanken, brystsmerter, åndenød, svimmelhed, lipothymi og synkope) og tilrådes straks at kontakte en akutklinik, hvis de har nogen symptomer på arytmi.
English: During maintenance treatment, detailed cardiac evaluation, including ECG, 24-48 hour Holtermonitoring and echocardiography, is recommended at least annually, or more frequently if considered necessary as part of routine cardiac assessment.
Danish: Under vedligeholdelsesbehandling anbefales detaljeret evaluering af hjertet, inklusive ekg, 24-48-timers Holter-monitorering og ekkokardiografi mindst én gang årligt eller hyppigere, hvis det skønnes nødvendigt som del af den rutinemæssige vurdering af hjertet.
English: If you take more Namuscla than you should
Danish: Hvis du har taget for meget Namuscla
English: Not known (frequency cannot be estimated from the available data): - Decrease in white blood cells or in platelets - Lupus syndrome (disease of the immune system) - Redness and peeling of the skin - Stevens-Johnson syndrome: a severe allergic reaction with skin rashes, often in the form of blisters and sores in the mouth and eyes, and other mucous membranes - Blisters of the skin, malaise and fever in the context of a condition called DRESS - Hallucinations (seeing or hearing something that is not present).
Danish: Ikke kendt (hyppigheden kan ikke bestemmes ud fra de tilgængelige data) - Reduceret antal hvide blodlegemer eller blodplader - Lupussyndrom (sygdom i immunsystemet) - Rødme og afskalning af huden - Stevens-Johnsons syndrom: en alvorlig allergisk reaktion med hududslæt, ofte i form af blærer og sår i mund, øjne og andre slimhinder - Blærer på huden, utilpashed og feber i forbindelse med en tilstand kaldet DRESS.
English: Namuscla capsules are Swedish orange hard shell gelatin capsules (20 mm) filled with white powder.
Danish: Namuscla kapsler er rødbrune gelatinekapsler med hård skal (20 mm) fyldt med hvidt pulver.
English: • Ventricular tachyarrhythmia
Danish: • Ventrikulær takyarytmi
English: Higher systemic exposure is expected in patients who are CYP2D6 poor metabolisers or who take medicinal products that inhibit CYP2D6 (see section 4.5).
Danish: Højere systemisk indvirkning kan forventes hos patienter, som er dårlige metabolisatorer af CYP2D6, eller som tager lægemidler, der hæmmer CYP2D6 (se pkt.
English: Individuals who are CYP2D6 poor metabolisers (PM) exhibit higher mexiletine concentrations than CYP2D6 intermediate (IM), extensive (i.e. normal) or ultra-rapid (UM) metabolisers.
Danish: Personer, som er dårlige metabolisatorer af CYP2D6 (PM), har højere koncentrationer af mexiletin end intermediære (IM), ekstensive (dvs. normale) eller ultra-hurtige (UM) CYP2D6-metabolisatorer.
English: • In patients with cardiac abnormalities, and in patients prone to such abnormalities, detailed cardiac evaluation, including ECG, should be carried out before and after any dose increase.
Danish: • Hos patienter med abnormiteter i hjertet og hos patienter disponeret for sådanne abnormiteter skal der foretages en detaljeret evaluering af hjertet, inklusive ekg, inden og efter dosen øges.
English: If you have any doubt, ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet.
English: Rare side effects (may affect up to 1 in 1,000 people): - Abnormal functioning of the liver (observed after blood analysis).
Danish: Sjældne bivirkninger (kan påvirke op til 1 ud af 1.000 personer): - Unormal leverfunktion (set efter analyse af blodet)
English: Mexiletine crosses the placental barrier and diffuses into breast milk.
Danish: Mexiletin krydser placentabarrieren og udskilles i human mælk.
English: • Information about symptoms of cardiac arrhythmias, which can be life-threatening, and when patients should seek HCP attention;
Danish: • information om symptomer på hjertearytmi, som kan være livstruende, og information om hvornår patienter skal opsøge sundhedsfagligt personale;
English: Mexiletine should be used with caution in patients with mild or moderate hepatic impairment.
Danish: Der skal udvises forsigtighed ved brug af mexiletin hos patienter med mild eller moderat nedsat leverfunktion.
English: 1 Clinical Study Report refers to 200 mg dose which is the amount of mexiletine hydrochloride (corresponding to 166.62mg mexiletine base)
Danish: 1 Klinisk studierapport henviser til 200 mg dosis, som er mængden af mexiletinhydrochlorid (svarende til 166,62 mg mexiletin base)
English: • medicines for heart problems (lidocaine, tocainide, propranolol, esmolol, metoprolol, atenolol, carvedilol, bisoprolol, nebivolol, verapamil, diltiazem),
Danish: • medicin for hjerteproblemer (lidocain, tocainid, propranolol, esmolol, metoprolol, atenolol, carvedilol, bisoprolol, nebivolol, verapamil, diltiazem)
English: Median absolute change from baseline Effect of treatment (linear mixed model)
Danish: Gennemsnitlig absolut ændring i forhold til baseline Effekt af behandling (lineær model til blandet effekt)
English: Very common: insomnia
Danish: Meget almindelig: søvnløshed
English: Do not take Namuscla - if you are allergic to mexiletine or to any of the other ingredients of this medicine (listed in section 6) - if you are allergic to any local anaesthetic - if you have had heart attack - if your heart does not work well enough - if you have certain disorders of the heart rhythm - if your heart beats too fast - if the blood vessels of your heart are damaged - if you also take certain medicines to treat disorders of the heart rhythm (see Other medicines and Namuscla) - if you also take certain medicines which have a narrow therapeutic window (see Other medicines and Namuscla).
Danish: (angivet i punkt 6) - hvis du er allergisk over for noget lokalt bedøvelsesmiddel - hvis du har haft et hjerteanfald - hvis dit hjerte ikke virker godt nok - hvis du har visse hjerterytmeforstyrrelser - hvis din puls er for hurtig - hvis blodkarrene i dit hjerte er beskadigede - hvis du også tage visse lægemidler til behandling af hjerterytmeforstyrrelser (se "Brug af anden medicin sammen med Namuscla") - hvis du også tager visse lægemidler med et snævert terapeutisk vindue (se "Brug af anden medicin sammen med Namuscla")
English: Read the package leaflet before use Oral use
Danish: Læs indlægssedlen inden brug.
English: The capsules should be swallowed with water, avoiding the supine position.
Danish: Kapslerne skal sluges med vand.
English: Poor and extensive CYP2D6 metabolisers
Danish: Dårlige og ekstensive metabolisatorer af CYP2D6
English: Check of heart function
Danish: Undersøgelse af hjertefunktion
English: Median VAS absolute change from baseline Percentage of Patients with an Absolute VAS Change from Baseline ≥ 50 mm at Day 18 Effect of treatment (Mixed Effect Linear Model)
Danish: Absolut ændring i gennemsnitlig VAS i forhold til baseline Procentdel af patienter med en absolut ændring i VAS i forhold til baseline ≥ 50 mm på dag 18
English: In a clinical study, 51% of the mexiletine dose was excreted via the kidney at a urinary pH of 5, compared to 10% at normal pH. Changes in urinary pH are not expected to affect efficacy or safety.
Danish: I et klinisk studie blev 51 % af dosen af mexiletin udskilt via nyrerne ved en urin pH-værdi på 5 sammenlignet med 10 % ved en normal pH-værdi.
English: Smoking affects mexiletine pharmacokinetics (see section 4.5).
Danish: Rygning påvirker farmakokinetikken af mexiletin (se pkt.
English: Mexiletine is a potent inhibitor of CYP1A2; therefore, co-administration of mexiletine with medicinal products metabolised by CYP1A2 (such as theophylline, caffeine, lidocaine or tizanidine) may be associated with elevations in plasma concentrations of the concomitant medicine that could increase or prolong the therapeutic efficacy and/or the adverse reactions, especially if mexiletine is coadministered with CYP1A2 substrates with narrow therapeutic window, e.g. theophylline and tizanidine.
Danish: Mexiletin er en potent hæmmer af CYP1A2; samtidig administration af mexiletin med lægemidler, som metaboliseres af CYP1A2 (såsom theophyllin, caffein, lidocain eller tizanidin), kan derfor være forbundet med forhøjede plasmakoncentrationer af den samtidige medicin, hvilket kan øge eller forlænge lægemidlets terapeutiske virkning og/eller bivirkninger, særligt hvis mexiletin gives sammen med CYP1A2-substrater med et snævert terapeutisk vindue, såsom theophyllin og tizanidin.
English: • Information about the risk of cardiac arrhythmias in patients using Namuscla;
Danish: • information om risikoen for hjertearytmi hos patienter, der bruger Namuscla;
English: • Prompts to enter the contact details of the patient, the treating physician, and Namuscla treatment starting date;
Danish: • Foranledige udfyldelse af patientens og den behandlende læges kontaktinformation samt startdatoen for behandlingen med Namuscla;
English: CYP2D6 polymorphism affects mexiletine pharmacokinetics.
Danish: CYP2D6-polymorfisme påvirker farmakokinetikken af mexiletin.
English: Common: tachycardia
Danish: Almindelig: takykardi
English: There is insufficient information on the effects of mexiletine in newborns/infants.
Danish: Der foreligger utilstrækkelige data for virkningen af mexiletin på det ammede barn.
English: Very rare: drug-induced liver injury, liver disorder, hepatitis Skin and subcutaneous tissue disorders Common: acne
Danish: Meget sjælden: lægemiddelforårsaget leverskade, leversygdom, hepatitis Hud og subkutane væv
English: Clinical Myotonia Scale - Severity Global Score Number of subjects
Danish: Klinisk myotoni-skala - Overordnet score for sværhedsgrad Antal forsøgspersoner
English: Chair test (s)
Danish: Stoletest (s)
English: Animal studies with mexiletine do not indicate harmful effects with respect to fertility (see section 5.3).
Danish: Dyreforsøg med mexiletin indikerer hverken direkte eller indirekte skadelige virkninger, hvad angår fertilitet (se pkt.
English: • Reporting of adverse reactions in patients using Namuscla.
Danish: • rapportering af bivirkninger hos patienter, der bruger Namuscla.
English: Do not take Namuscla with certain medicines for treating heart rhythm disorders (quinidine, procainamide, disopyramide, ajmaline, encainide, flecainide, propafenone, moricizine, amiodarone, sotalol, ibutilide, dofetilide, dronedarone, vernakalant).
Danish: Tag ikke Namuscla sammen med visse andre lægemidler til behandling af hjerterytmeforstyrrelser (quinidin, procainamid, disopyramid, ajmalin, encainid, flecainid, propafenon, moricizin, amiodaron, sotalol, ibutilid, dofetilid, dronedaron, vernakalant).
English: • Co-administration with medicinal products inducing torsades de pointes (see section 4.5)
Danish: • Samtidig administration af lægemidler, som fremkalder torsade de pointes (se pkt.
English: Uncommon side effects (may affect up to 1 in 100 people): - Convulsions (fits) - Speech disorders - Slow heart rate
Danish: Ikke almindelige bivirkninger (kan påvirke op til 1 ud af 100 personer): - Kramper (anfald) - Taleforstyrrelser - Langsom puls
English: • Complete heart block (i.e. third-degree atrioventricular block) or any heart block susceptible to evolve to complete heart block (first-degree atrioventricular block with markedly prolonged PR
Danish: • Totalt hjerteblok (dvs. tredjegrads atrioventrikulært blok) eller ethvert hjerteblok med disposition for at udvikle sig til totalt hjerteblok (dvs. førstegrads atrioventrikulært blok med markant forlænget PR-interval (≥ 240 ms) og/eller bredt QRS-kompleks (≥ 120 ms), andengrads atrioventrikulært blok, grenblok, bifascikulært blok og trifascikulært blok)
English: Not known: leukopenia, thrombocytopenia Immune system disorders
Danish: Ikke kendt: leukopeni, trombocytopeni
English: Very common side effects (may affect more than 1 in 10 people): - Abdominal (belly) pain - Insomnia (difficulty sleeping)
Danish: Meget almindelige bivirkninger (kan påvirke flere end 1 ud af 10 personer): - Mavesmerter - Søvnløshed (søvnbesvær)
English: • Sinus node dysfunction (including sinus rate < 50 bpm)
Danish: • Sinusknudedysfunktion (inklusiv sinusfrekvens < 50 slag pr. minut)