FrancophonIA/ELRC3.0 huggingface dataset:
English: The studies in rats on carcinogenic potential were negative, but not performed in accordance with current standards and therefore of unclear clinical relevance.
Danish: Rottestudierne vedrørende carcinogene potentialer var negative, men ikke udført i overensstemmelse med nuværende standarder og den kliniske relevans er derfor uklar.
English: The organic cation transporter 2 (OCT2) provides an important pathway for the uptake of cationic compounds in the kidney.
Danish: Den organiske kationtransportør 2 (OCT2) er en vigtig optagelsesvej for kationiske forbindelser i nyrerne.
English: Tell your doctor or pharmacist if you start to smoke or quit smoking while taking Namuscla because smoking impacts the Namuscla blood levels and your dose may need to be adjusted accordingly.
Danish: Fortæl din læge eller apotekspersonalet hvis du begynder eller holder op med at ryge, mens du tager Namuscla, da rygning påvirker niveauet af Namuscla i blodet, og din dosis muligvis skal tilpasses.
English: Age There is no clinically relevant effect of age on the exposure of mexiletine in adults.
Danish: Alder Der er ingen klinisk relevant effekt af alder på eksponering for mexiletin hos voksne.
English: During Namuscla maintenance treatment, a detailed cardiac evaluation should be carried out every 24-48 hour.
Danish: Ved vedligeholdelsesbehandling med Namuscla skal en detaljeret vurdering af hjertefunktionen foretages hver 24-48 timer.
English: Do not take Namuscla with certain medicines which have a so called narrow therapeutic window (these are medicines where small differences in dose or blood concentration may impact the effect of the medicine or side effects).
Danish: Tag ikke Namuscla sammen med visse lægemidler, der har et såkaldt snævert terapeutisk vindue (lægemidler hvor en lille forskel i dosis eller koncentration i blodet kan påvirke effekten af medicinen eller give bivirkninger).
English: Mexiletine may have minor influence on the ability to drive and use machines.
Danish: Mexiletin påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Swallow the capsule with a glass of water, while standing or sitting up.
Danish: Slug kapslen i stående eller siddende stilling med et glas vand.
English: Africans
Danish: Afrikanere
English: It is recommended to reduce your caffeine intake by half while on treatment with mexiletine because the medicine can increase caffeine levels in your blood.
Danish: Det anbefales, at du reducerer dit indtag af koffein med halvdelen under behandling med mexiletin, da lægemidlet kan øge niveauerne af koffein i blodet.
English: Rare: hepatic function abnormal
Danish: Sjælden: anormal leverfunktion
English: Weight In population pharmacokinetic analyses, weight was found to influence mexiletine pharmacokinetics.
Danish: Vægt I populationsfarmakokinetiske analyser blev vægt fundet at påvirke farmakokinetikken af mexiletin.
English: A cardiac evaluation is recommended shortly after treatment start (e.g. within 48 hours).
Danish: En evaluering af hjertet anbefales kort efter start af behandling (f.eks. inden for 48 timer).
English: These tests will also be performed regularly during treatment with Namuscla, and before and after your dose of Namuscla is modified.
Danish: Disse undersøgelser vil desuden blive foretaget regelmæssigt under behandling med Namuscla samt før og efter en tilpasning af din dosis Namuscla.
English: There are no or limited amount of data from the use of mexiletine in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af mexiletin til gravide kvinder.
English: Increased concentrations of caffeine occurring with the co-administration of mexiletine may be of concern in patients with cardiac arrhythmia.
Danish: Øgede koncentrationer af caffein, som forekommer ved samtidig administration af mexiletin, kan være anledning til bekymring hos patienter med hjertearytmier.
English: Taking Namuscla together with any of these medicines increases the risk of a serious heart rhythm disturbance called torsades de pointes.
Danish: Samtidig indtagelse af Namuscla og nogen af disse lægemidler øger risikoen for en alvorlig hjerterytmeforstyrrelse kaldet torsade de pointes.
English: Prior to launch of Namuscla in each Member State (MS) the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority (NCA).
Danish: Forud for markedsføring af Namuscla i hvert medlemsland skal indehaveren af markedsføringstilladelsen være enig med den relevante nationale myndighed om indholdet og udformningen af uddannelsesmaterialet, inklusive kommunikationsmedier, distributionsmetoder og alle andre aspekter af uddannelsesmaterialet.
English: Mexiletine is, therefore, mostly active on muscle fibres subject to repeated discharges (such as skeletal muscles).
Danish: Mexiletin er derfor mest aktiv på muskelfibre, der udsættes for gentagne udløsninger (såsom skeletmuskler).
English: Ultra-rapid metabolisers(UM)
Danish: Ultra-hurtige metabolisatorer (UM)
English: Maintenance treatment is between 167 mg - 500 mg daily (1 to 3 capsules per day), according to the intensity of symptoms and the clinical response, taken regularly throughout the day.
Danish: Vedligeholdelsesbehandling er mellem 167 mg og 500 mg dagligt (1 til 3 kapsler per dag) i henhold til intensiteten af symptomer og klinisk respons, som måles regelmæssigt i løbet af dagen.
English: See section “Do not take Namuscla”.
Danish: Se punktet "Tag ikke Namuscla".
English: The recommended starting dose of mexiletine is 167 mg daily (1 capsule per day).
Danish: Den anbefalede startdosis af mexiletin er 167 mg dagligt (1 kapsel per dag).
English: Fatigue, confusion, blurred vision may occur following administration of mexiletine (see section 4.8).
Danish: Træthed, forvirring og sløret syn kan forekomme efter administration af mexiletin (se pkt.
English: If mexiletine and other OCT2 substrates are to be used concurrently, the OCT2 substrate blood levels should be monitored, particularly when the mexiletine dose is changed.
Danish: Hvis mexiletin og andre OCT2-substrater skal bruges samtidig, skal niveauerne af OCT2-substrat i blodet monitoreres, særligt når dosen af mexiletin ændres.
English: If you forget to take Namuscla If you have forgotten a dose, do not take a double dose and take the next dose at your regular schedule.
Danish: Hvis du har glemt en dosis, må du ikke tage en dobbeltdosis som erstatning, men skal tage den næste dosis på det sædvanlige planlagte tidspunkt.
English: Mexiletine may induce an arrhythmia or accentuate a pre-existing arrhythmia, either diagnosed or undiagnosed.
Danish: Mexiletin kan fremkalde arytmi eller forstærke en allerede eksisterende arytmi, enten diagnosticeret eller udiagnosticeret.
English: Contact your doctor or go to your nearest emergency center immediately if you experience any of the following side effects: - severe allergy to mexiletine (with symptoms such as severe rash with fever); this is a very rare side effect, may affect up to 1 in 10,000 people.
Danish: Kontakt straks din læge eller tag til den nærmeste skadestue, hvis du oplever disse bivirkninger: - alvorlig allergi over for mexiletin (med symptomer såsom alvorligt udslæt med feber); denne bivirkning ses meget sjældent og kan påvirke op til 1 ud af 10.000 personer.
English: Common: flushing, hypotension
Danish: Almindelig: blussen, hypotension
English: Lupin Healthcare (UK) Ltd The Urban Building, second floor, 3-9 Albert Street SL1 2BE Slough, Berkshire, United Kingdom
Danish: Lupin Healthcare (UK) Ltd The Urban Building, second floor, 3-9 Albert Street SL1 2BE Slough, Berkshire, Storbritannien
English: A period of at least 7 days before dose increase must be respected to ensure that steady-state levels are reached, irrespective of the patient's CYP450 polymorphism.
Danish: En periode på mindst 7 dage inden øgning af dosen skal respekteres for at sørge for, at steady-state niveauer nås uanset patientens CYP450-polymorfisme.
English: Smoking and Namuscla
Danish: Rygning og Namuscla
English: Effect of mexiletine on other medicinal products
Danish: Mexiletins virkning på andre lægemidler
English: An appropriate adjustment in the dose of the OCT2 substrate should be considered.
Danish: Passende justering af dosen af OCT2substrat bør overvejes.
English: You or your companion should contact the doctor immediately if you have tingling in the arms and legs, if you feel unable to think clearly or concentrate, if you have hallucinations, convulsions, if you feel that your heart beats slower, if you feel dizzy and faint, if you collapse or if your heart stops beating.
Danish: Du eller din ledsager skal straks kontakte lægen, hvis du mærker prikken i armene eller benene, hvis du ikke kan tænke klart eller koncentrere dig, hvis du har hallucinationer eller kramper, hvis du føler, at din puls bliver langsommere, hvis du føler dig svimmel og svag, hvis du kollapser, eller hvis dit hjerte stopper.
English: Intermediate metabolisers (IM)
Danish: Intermediære metabolisatorer (IM)
English: Electrolytic imbalance such as hypokalaemia, hyperkalaemia or hypomagnesaemia may increase the proarrhythmic effects of mexiletine.
Danish: Elektrolytforstyrrelser, som f.eks. hypokaliæmi, hyperkaliæmi eller hypomagnesæmi, kan øge mexiletins proarytmiske virkninger.
English: The patients were randomized according to a cross-over design to a sequence including the 2 following treatments: a) mexiletine, started at 167 mg/day and titrated by increments of 167 mg every 3 days to reach a maximum dose of 500 mg/day in 1 week or b) placebo.
Danish: Patientenerne blev randomiseret ifølge et overkrydsningsdesign til en sekvens med de 2 følgende behandlinger: a) mexiletin med start fra 167 mg/dag og titreret i trin på 167 mg hver 3. dag til en maksimal dosis på 500 mg/dag i 1 uge eller b) placebo.
English: • Symptomatic coronary artery disease
Danish: • Symptomatisk koronararteriesygdom
English: Poor metabolisers (PM)
Danish: Dårlige metabolisatorer (PM)
English: • Contraindications with Namuscla which may increase the susceptibility to arrhythmias;
Danish: • kontraindikationer ved Namuscla, som kan øge tilbøjeligheden for arytmier;
English: Namuscla should not be used in patients with severe hepatic impairment;
Danish: Namuscla bør ikke bruges til patienter med alvorligt nedsat leverfunktion;
English: • Hypersensitivity to any local anaesthetic
Danish: • Overfølsomhed over for ethvert lokalt bedøvelsesmiddel
English: Mexiletine dose may need to be increased if a patient starts to smoke and decreased if a patient stops to smoke.
Danish: Dosen af mexiletin skal muligvis øges, hvis en patient begynder at ryge, og reduceres, hvis en patient holder op med at ryge.
English: Stiffness score (VAS) (mm) Number of subjects
Danish: Score for stivhed (VAS) (mm) Antal forsøgspersoner
English: • Guidance to identify (and exclude) patients at a greater risk of developing arrhythmias due to Namuscla treatment;
Danish: • en vejledning til at identificere (og udelukke) patienter med en øget risiko for at udvikle arytmi ved brug af Namuscla;
English: Effect of other medicinal products on mexiletine
Danish: Virkning af andre lægemidler på mexiletin
English: The efficacy and safety of mexiletine in non-dystrophic myotonia was evaluated in MYOMEX, a multi-centre, double-blind, placebo-controlled, cross-over (2 treatment periods of 18 days) study with a 4-day wash-out period in 13 patients with myotonia congenita (MC) and 12 patients with paramyotonia congenita (PC).
Danish: Effekten og sikkerheden af mexiletin ved ikke-dystrofisk myotoni blev evalueret i MYOMEX, et multicenter, dobbeltblindet, placebokontrolleret, overkrydsningsstudie (2 behandlingsperioder på 18 dage) med en udvaskningsperiode på 4 dage hos 13 patienter med myotonia congenita (MC) og 12 patienter med paramyotonia congenita (PC).
English: DRESS refers to a syndrome which includes in its complete form severe cutaneous eruptions, fever, lymphadenopathy, hepatitis, haematological abnormalities with eosinophilia and atypical lymphocytes, and can involve other organs.
Danish: DRESS henviser til et syndrom, som i sin fulde form omfatter alvorligt hududslæt, feber, lymfadenopati, hepatitis, hæmatologiske abnormiteter med eosinofili og atypiske lymfocytter, og som kan involvere andre organer.
English: The patient alert card (wallet size), to be handed by prescribing specialist and to be read in conjunction with the patient leaflet, should contain the following key messages:
Danish: Patientkortet (tegnebogsstørrelse), som skal udleveres af den ordinerende læge og som skal læses sammen med indlægssedlen, skal indeholde følgende hovedbudskaber:
English: The most commonly reported adverse reactions in patients treated with mexiletine are abdominal pain (12%), vertigo (8%) and insomnia (12%).
Danish: De hyppigst rapporterede bivirkninger hos patienter behandlet med mexiletin er mavesmerter (12 %), vertigo (8 %) og søvnløshed (12 %).
English: Holter-monitoring and echocardiography are recommended at least annually, or more frequently, if considered necessary, as part of routine cardiac assessment.
Danish: Holter-monitorering og ekkokardiografi anbefales mindst en gang om året eller oftere, hvis det skønnes nødvendigt, som en del af den rutinemæssige vurdering af hjertefunktionen.
English: What you need to know before you take Namuscla 3.
Danish: Det skal du vide, før du begynder at tage Namuscla 3.
English: The main observed effects in rats and/or dogs were vomiting, diarrhoea, tremor, ataxia, convulsions and tachycardia.
Danish: De vigtigste observerede effekter hos rotter og/eller hunde var opkastning, diarré, tremor, ataksi, kramper og takykardi.
English: Mexiletine is a substrate for the metabolic pathways involving hepatic enzymes; inhibition or induction of these enzymes is expected to alter mexiletine plasma concentrations.
Danish: Mexiletin er et substrat for de metaboliseringsveje, der involverer leverenzymer; hæmning eller induktion af disse enzymer forventes at ændre plasmakoncentrationerne af mexiletin.
English: Pharmacotherapeutic group: Cardiac therapy, antiarrhythmics, class Ib, ATC code: C01BB02.
Danish: Farmakoterapeutisk klassifikation: Hjerteterapi, antiarytmika, klasse Ib, ATC-kode: C01BB02.
English: Before starting treatment with Namuscla and regularly during treatment, you will have tests to check how well your heart is working,.
Danish: Inden opstart af behandling med Namuscla og løbende under behandlingen, skal du undersøges for at se, hvor godt dit hjerte fungerer.
English: You should talk to your doctor about this, together you will make a decision whether to abstain breast-feeding or to discontinue/abstain from mexiletine therapy.
Danish: Du skal tale med din læge om dette, så I sammen kan beslutte, omdu skal undlade at amme eller stoppe/afholde dig fra behandling med mexiletin.
English: The metabolic degradation proceeds via various pathways, including aromatic and aliphatic hydroxylation, dealkylation, deamination and N-oxidation.
Danish: Den metaboliske nedbrydning fortsætter gennem flere forskellige metaboliseringsveje, inklusive aromatisk og alifatisk hydroxylering, dealkylering, deaminering og N-oxidering.
English: Mexiletine pharmacokinetics are characterised by significantly lower total and renal clearance resulting in prolonged elimination half-life, higher exposure, and lower volume of distribution in poor metabolisers compared to extensive metabolisers.
Danish: Farmakokinetikken af mexiletin er karakteriseret ved væsentligt lavere total og renal clearance, hvilket resulterer i en forlænget eliminationshalveringstid, højere eksponering og lavere fordelingsvolumen, i dårlige metabolisatorer sammenlignet med ekstensive metabolisatorer.
English: An appropriate adjustment in the dose of the CYP1A2 substrate should be considered.
Danish: En passende justering af dosen af CYP1A2-substrat bør overvejes.
English: Not known: atrioventricular block
Danish: Ikke kendt: atrioventrikulært blok
English: If you become pregnant while taking Namuscla, see your doctor immediately as it is preferable not to take Namuscla while you are pregnant.
Danish: Hvis du bliver gravid, mens du tager Namuscla, skal du straks kontakte lægen, da det ikke er tilrådeligt at tage Namuscla, mens du er gravid..
English: Mexiletine blocks sodium channels with a stronger potency in situations of excessive burst of action potentials (use-dependent block) and/or prolonged depolarization (voltage-dependent block), as occurring in diseased tissues, rather than on physiological excitability (resting or tonic block).
Danish: Mexiletin blokerer natriumkanaler med højere styrke i situationer med overdreven udløsning af aktionspotentialer (brugsafhængig blokering) og/eller forlænget depolarisering (spændingsafhængig blokering), som det forekommer i sygt væv, snarere end ved fysiologisk excitabilitet (hvile eller tonisk blokering).
English: There is an Alert Card distributed with Namuscla, to remind you and medical staff of the risk of cardiac arrythmias.
Danish: Du får udleveret et patientkort sammen med Namuscla for at minde dig og lægeligt personale om risikoen for hjertearytmi.
English: Namuscla may in rare cases cause tiredness, confusion, blurred vision: If you have these effects do not drive, cycle and use machines.
Danish: Namuscla kan i sjældne tilfælde forårsage træthed, forvirring, sløret syn: Undlad at køre, cykle og betjene maskiner, hvis du oplever disse effekter.
English: You may take Namuscla during a meal to avoid belly pain (see section “Possible side effects”).
Danish: Du kan tage Namuscla med et måltid for at undgå mavesmerter (se punktet "Bivirkninger").
English: Therefore, electrolytic evaluation should be done prior to initiating therapy with mexiletine in every patient.
Danish: Der skal derfor fortages en elektrolytevaluering inden start af behandling med mexiletin hos hver patient.
English: Tell your doctor or pharmacist if you are taking any of the following since these medicines may affect or be affected by Namuscla:
Danish: Fortæl lægen eller apotekspersonalet, hvis du tager en eller flere af følgende, eftersom disse lægemidler kan påvirke eller blive påvirket af Namuscla:
English: Mexiletine is excreted in human milk.
Danish: Mexiletin udskilles i human mælk.
English: Mexiletine is mainly (90%) metabolized in the liver, the primary pathway being CYP2D6 metabolism, although it is also a substrate for CYP1A2.
Danish: Mexiletin metaboliseres hovedsageligt (90 %) i leveren, hvor den primære metaboliseringsvej er CYP2D6-metabolisme, omend det også er et substrat for CYP1A2.
English: Mexiletine excretion may increase when the urinary pH is acidic, compared to normal or alkaline pH.
Danish: Udskillelse af mexiletin kan stige, når urinens pH-værdi er sur sammenlignet med en normal eller alkalisk pH-værdi.
English: In a clinical study, co-administration of mexiletine with phenytoin resulted in a significant decrease in exposure to mexiletine (p < 0.003) due to enhanced clearance as reflected in significantly decreased elimination half-life (17.2 to 8.4 hours, p < 0.02).
Danish: I et klinisk studie resulterede samtidig administration af mexiletin med phenytoin i en signifikant reduktion i eksponering for mexiletin (p < 0,003) på grund af øget clearance som set ved en signifikant reduceret halveringstid (17,2 til 8,4 timer, p < 0,02).
English: In a single-dose interaction study, the clearance of mexiletine was decreased by 38% following the coadministration of fluvoxamine, an inhibitor of CYP1A2.
Danish: I et enkelt-dosis interaktionsstudie var clearance af mexiletin reduceret med 38 % efter samtidig administration af fluvoxamin, en CYP1A2-hæmmer.
English: The CYP1A2 substrate blood levels should be monitored, particularly when the mexiletine dose is changed.
Danish: Niveauerne af CYP1A2-substrat i blodet skal monitoreres, særligt ved ændring af dosen af mexiletin.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from mexiletine 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 mexiletin seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: After the oral administration of single (167 mg) and multiple (83 mg twice a day during 8 days) doses of mexiletine, total clearance of mexiletine is significantly increased in smokers (1.3 to 1.7-fold) due to induction of CYP1A2, resulting in a correspondingly decreased elimination half-life and drug exposure.
Danish: Efter oral administration af enkelte (167 mg) og flere (83 mg to gange dagligt i 8 dage) doser af mexiletin er total clearance af mexiletin signifikant øget hos rygere (1,3 til 1,7 gange) på grund af induktion af CYP1A2, hvilket resulterer i en tilsvarende reduceret eliminationshalveringstid og lægemiddeleksponering.
English: Electrolyte imbalance needs to be corrected before administering mexiletine and to be monitored throughout treatment (with a periodicity to be adapted patient by patient).
Danish: Elektrolytforstyrrelser skal korrigeres inden administration af mexiletin og skal monitoreres under behandling (med en hyppighed tilpasset den enkelte patient).
English: Therefore, clinical and ECG monitoring, as well as adaptation of mexiletine dosage may be indicated throughout and after treatment with a CYP1A2 or CYP2D6 inhibitor.
Danish: Klinisk og ekg-monitorering såvel som tilpasning af dosen af mexiletin kan derfor være indiceret under og efter behandling med en CYP1A2- eller CYP2D6-hæmmer.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Namuscla in all subsets of the paediatric population in the symptomatic treatment of myotonic disorders (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Namuscla i alle undergrupper af den pædiatriske population ved symptomatisk behandling af myotone sygdomme (se pkt.
English: Namuscla is indicated for the symptomatic treatment of myotonia in adult patients with nondystrophic myotonic disorders.
Danish: Namuscla er indiceret til symptomatisk behandling af myotoni hos voksne patienter med ikkedystrofiske myotone sygdomme.
English: Other antiarrhythmics (class Ib, II, IV antiarrhythmics):
Danish: Andre antiarytmika (klasse Ib, II, IV antiarytmika):
English: After at least 1 week of treatment, based on the clinical response, the daily dose can be increased to 333 mg daily (2 capsules per day).
Danish: Efter mindst 1 uges behandling og baseret på klinisk respons kan den daglige dosis øges til 333 mg dagligt (2 kapsler per dag).
English: In order to prevent and / or minimise the important identified risks of Cardiac Arrhythmia in patients with Dystrophic Myotonia (off-label use) and Decreased Namuscla clearance, thus the risk of adverse reactions in patients with hepatic impairment, the MAH shall ensure that in each MS where Namuscla is marketed, all healthcare professionals (HCPs) and patients are provided, respectively, with:
Danish: For at forhindre og/eller minimere de vigtige identificerede risici for hjertearytmi hos patienter med dystrofisk myotoni (off label-brug) og nedsat clearance af Namuscla og dermed risiko for bivirkninger hos patienter med nedsat leverfunktion, skal indehaveren af markedsføringstilladelsen sikre, at alt sundhedsfagligt personale i hvert medlemsland, hvor Namuscla markedsføres, er udstyret med henholdsvis:
English: The Educational guide for HCPs, which should always be read in conjunction with the Summary of Product Characteristics (SmPC) before prescribing Namuscla, should contain the following key elements:
Danish: Vejledningen til sundhedsfagligt personale, som altid skal læses sammen med produktresuméet inden udskrivningen af Namuscla, skal indeholde følgende nøgleelementer: