FrancophonIA/ELRC3.0 huggingface dataset:
English: Insuman Comb 15 must not be used if this cannot be achieved, i.e. if the suspension remains clear, for example, or if clumps, particles or flocculation appear in the insulin or stick to the wall or bottom of the cartridge.
Croatian: Insuman Comb 15 ne smije se upotrijebiti ako se to ne može postići, tj. ako suspenzija, primjerice, ostane bistra ili ako se u inzulinu nalaze grudice, čestice ili pahuljice koje se mogu slijepiti za stijenke ili dno bočice.
English: Insuman Comb 15 100 IU/ml in a cartridge
Croatian: Insuman Comb 15 100 IU/ml u bočici
English: Side effects reported uncommonly • Injection site urticaria (itchy rash)
Croatian: Manje često prijavljene nuspojave • koprivnjača na mjestu injiciranja (osip koji svrbi)
English: 05 June 2015
Croatian: 5. lipnja 2015.
English: EMA/385522/2015 EMEA/H/A-30/1380
Croatian: EMA/385522/2015 EMEA/H/C/-30/1380
English: The European Commission issued an EU-wide legally binding decision to implement these changes on 05 June 2015.
Croatian: Europska Komisija izdala je pravno obvezujuću odluku na razini EU-a o provedbi ovih izmjena 5. lipnja
English: The usual starting dose is 10 mg taken twice a day, preferably in the morning and in the evening.
Croatian: Uobičajena početna doza od 10 mg uzima se dva puta na dan, po mogućnosti ujutro i navečer.
English: Ikorel and Dancor are marketed in the following EU Member States: Austria, Denmark, France, Ireland, the Netherlands, Portugal, and the United Kingdom.
Croatian: Lijekovi Ikorel i Dancor stavljeni su u promet u sljedećim državama članicama EU-a: Austriji, Danskoj, Francuskoj, Irskoj, Nizozemskoj, Portugalu i Ujedinjenoj Kraljevini.
English: The companies that market these medicines are Sanofi-Aventis and Merck KGaA.
Croatian: Tvrtke koje stavljaju lijekove u promet su Sanofi-Aventis i Merck KGaA.
English: 4.1 Therapeutic indication
Croatian: 4.1. Terapijske indikacije
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.
Croatian: Ovisno o odgovoru bolesnika i podnošenju liječenja, doza se može povećati na maksimalno 40 mg dva puta na dan.
English: The CHMP also harmonised other sections of the SmPC including sections 4.5 (interactions with other medicinal products), 4.8 (undesirable effects) and 5.1 (pharmacodynamic properties).
Croatian: CHMP je također uskladio druge dijelove SPC-a uključujući dio 4.5. (interakcije s drugim lijekovima), 4.8. (neželjeni učinci) i 5.1.(farmakodinamička svojstva).
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).
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je da postoji potreba za usklađivanjem informacija za propisivanje za ove lijekove u Europskoj uniji (EU).
English: Ikorel and Dancor have been authorised in the EU via national procedures.
Croatian: Ikorel i Dancor odobreni su u EU nacionalnim postupcima.
English: What are Ikorel and Dancor?
Croatian: Što su Ikorel i Dancor?
English: The CHMP agreed that Ikorel and Dancor must not be used in:
Croatian: CHMP je suglasan da se Ikorel i Dancor ne smiju koristiti u:
English: Ikorel and Dancor should be used with caution in patients taking the following medicines:
Croatian: Ikorel i Dancor trebaju se koristiti oprezno u bolesnika koji uzimaju sljedeće lijekove:
English: • Patients with shock, severe hypotension (low blood pressure), or heart problems such as ‘left ventricular dysfunction with low filling pressure' or ‘cardiac decompensation';
Croatian: • bolesnika u šoku, s ozbiljnom hipotenzijom (niskom krvnim tlakom) ili srčanim problemima poput "lijeve ventrikularne disfunkcije s niskim tlakom punjenja" ili "srčane dekompenzacije";
English: • Medicines that could increase the levels of potassium in the blood, especially in patients with reduced kidney function;
Croatian: • lijekovi koji mogu povećati razine natrija u krvi, posebice u bolesnika sa smanjenom funkcijom bubrega;
English: • Patients suffering from hypovolaemia (low blood volume);
Croatian: • bolesnika koji pate od hipovolemije (malog volumena krvi);
English: In patients particularly predisposed to headaches, the starting dose can be lowered to 5 mg twice a day.
Croatian: U bolesnika koji imaju predispoziciju za glavobolju, početna se doza može sniziti na 5 mg dva puta na dan.
English: • Patients with a build-up of fluids in the lungs (acute pulmonary oedema).
Croatian: • bolesnika s nakupljenim tekućinama u plućima (akutnim pulmonarnim endemom).
English: On 26 March 2015, the European Medicines Agency completed a review of Ikorel and Dancor.
Croatian: Dana 26. ožujka 2015., Europska agencija za lijekove završila je pregled lijekova Ikorel i Dancor.
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;
Croatian: • bolesnika koji uzimaju lijekove poznate pod nazivom "inhibitori fosfodiesteraze 5" i/ili "stimulatori topive guanilat siklaze", budući da to može rezultirati ozbiljnim padom krvnog tlaka;
English: The labelling and package leaflet were also revised in line with the changes to the SmPC.
Croatian: Etiketa i uputa o lijeku su također pregledani u skladu s izmjenama SPC-a.
English: Why were Ikorel and Dancor reviewed?
Croatian: Zašto su lijekovi Ikorel i Dancor pregledani?
English: Gastrointestinal ulcers and ulcers on the skin and some internal (mucosal) surfaces have been reported in patients taking Ikorel or Dancor.
Croatian: Gastrointestinalni čirevi i čirevi na koži i određenim internim površinama (na sluznici) prijavljeni su u bolesnika koji su uzimali Ikorel i Dancor.
English: Having harmonised the indications, the CHMP also harmonised the recommendations on how to use Ikorel and Dancor.
Croatian: Nakon usklađivanja indikacija, CHMP je također uskladio preporuke o načinu primjene lijekova Ikorel i Dancor.
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).
Croatian: Nadalje, Ikorel i Dancor treba koristiti oprezno u bolesnika kojima nedostaje enzim naziva glukoza-6fosfat dehidrogenaza, i u bolesnika sa zatajenjem srca klase III ili IV (srčana bolest koja ozbiljno ograničava ili čini fizičku aktivnost nemogućom bez osjećaja nelagode).
English: • Medicines that have a blood pressure-lowering effect.
Croatian: • lijekova koji djeluju tako da snižavaju krvni tlak.
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.
Croatian: Dana 12. prosinca 2013., Europska je komisija uputila predmet CHMP-u sa ciljem usklađivanja odobrenja za stavljanje u promet lijekova Ikorel i Dancor u EU.
English: 4.4 Special warnings and precautions for use
Croatian: Posebna upozorenja i mjere opreza kod primjene
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;
Croatian: • aspirin ili lijekove naziva NSAID-i (nesteroidni protuupalni lijekovi) budući da su ti bolesnici izloženi većem riziku od razvoja komplikacija od čireva, poput krvarenja u želudac ili crijeva;
English: If ulcers develop, Ikorel or Dancor should be permanently discontinued.
Croatian: Ako se čirevi razviju, terapiju lijekovima Ikorel ili Dancor treba odmah prekinuti.
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.
Croatian: CHMP je suglasan da lijekove Ikorel i Dancor treba upotrebljavati samo kao opciju druge linije liječenja za liječenje simptoma angine, u slučaju kada bolesnici u dovoljnoj mjeri ne odgovaraju na, ne podnose ili ne smiju uzeti lijekove poput beta blokatora i/ili antagonista kalcija.
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.
Croatian: Ikorel i Dancor ne smiju se više koristiti za sprječavanje srčanih problema poput srčanog zastoja u bolesnika s stabilnom koronarnom srčanom bolesti (srčana bolest uzrokovana opstrukcijom krvnih žila koje opskrbljuju srčani mišić), budući da dostupni klinički podaci ne podržavaju indikaciju.
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.
Croatian: Ikorel i Dancor sadrže djelatnu tvar nikorandil, koji djeluje opuštajući mišiće u stjenkama krvnih žila koje opskrbljuju srce, te tako poboljšavaju protok u srčani mišić i ublažavaju simptome angine.
English: These ulcers are difficult to treat and usually resolve only when treatment with Ikorel or Dancor is stopped.
Croatian: Ti se čirevi teško liječe i najčešće nestaju tek nakon što se prekine terapija lijekovima Ikorel ili Dancor.
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.
Croatian: Ikorel i Dancor su lijekovi koji se koriste za liječenje simptoma angine pektoris (boli u prsima zbog problema s dotokom krvi u srce) u odraslih bolesnika za koje terapija lijekovima poznatima pod nazivom beta blokatori i/ili antagonisti kalcija nije bila dovoljna, nije indicirana ili nije tolerirana.
English: • Patients with known hypersensitivity (allergy) to nicorandil or to any of the other ingredients;
Croatian: • bolesnika za koje je poznato da su preosjetljivi (alergični) na nikorandil ili na bilo koju drugu pomoćnu tvar;
English: Ikorel and Dancor were identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Croatian: Koordinacijska grupa za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh) identificirala je potrebu za usklađivanjem lijekova Ikorel i Dancor.
English: This could be very harmful to your health.
Croatian: To bi moglo biti vrlo štetno po Vaše zdravlje.
English: Date of first authorisation: 18.12.2018
Croatian: Datum prvog odobrenja: 18.12.2018
English: The treatment is mainly symptomatic.
Croatian: Liječenje je uglavnom simptomatsko.
English: Severe systemic manifestations are responsible for a 10% mortality rate.
Croatian: Teške sistemske manifestacije odgovorne su za stopu smrtnosti od 10 %.
English: Therefore, mexiletine can be taken with or without food.
Croatian: Stoga se meksiletin može uzimati sa ili bez hrane.
English: Do not take more than 3 capsules a day.
Croatian: Nemojte uzeti više od 3 kapsule dnevno.
English: Age of the overall study population ranged from 20 to 66 years old and about 2/3 of the patients were male.
Croatian: Dob ukupne populacije ispitivanja bila je u rasponu od 20 do 66 godina i oko 2/3 bolesnika bili su muškarci.
English: The dose should not exceed 500 mg/day.
Croatian: Doza ne smije prijeći 500 mg/dan.
English: The seriousness of the symptoms may require hospital supervision.
Croatian: Ovisno o ozbiljnosti simptoma, može biti potreban bolnički nadzor.
English: The most serious side effects are:
Croatian: Najozbiljnije nuspojave su:
English: The doctor will increase the dose gradually depending on how well the medicine is working.
Croatian: Liječnik će postupno povećavati dozu ovisno o tome koliko dobro lijek djeluje.
English: Substrates of other enzymes and transporters
Croatian: Supstrati ostalih enzima i transportera
English: Period preferred
Croatian: Preferirano razdoblje
English: Symptoms typically occur 1-8 weeks after exposure to the medicinal product.
Croatian: Simptomi se obično pojavljuju 1-8 tjedana nakon izlaganja lijeku.
English: Swallow the capsule with a glass of water, while standing or sitting up.
Croatian: Progutajte kapsulu s čašom vode dok stojite ili uspravno sjedite.
English: The capsules should be swallowed with water, avoiding the supine position.
Croatian: Kapsule treba progutati s vodom, izbjegavajući polegnuti položaj.
English: In these patients, it is recommended that the dose should only be increased after at least 2 weeks of treatment.
Croatian: Kod tih bolesnika se preporuča da se doza povećava tek nakon najmanje 2 tjedna liječenja.
English: Primary Analysis
Croatian: Primarna analiza
English: Mexiletine is weakly bound to plasma proteins (55%).
Croatian: Meksiletin se slabo veže za proteine plazme (55 %).
English: The safety and efficacy of mexiletine in children and adolescents aged 0 to 18 years have not been established.
Croatian: Sigurnost i djelotvornost meksiletina u djece i adolescenata u dobi od 0 do 18 godina nisu ustanovljene.
English: Mexiletine Placebo
Croatian: Meksiletin Placebo
English: See section “Warnings and precautions”.
Croatian: Pogledajte dio „Upozorenja i mjere opreza“.
English: 30 hard capsules 50 hard capsules 100 hard capsules 200 hard capsules
Croatian: 30 tvrdih kapsula 50 tvrdih kapsula 100 tvrdih kapsula 200 tvrdih kapsula
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.
Croatian: Bolesnici koji su iskusili miotonske simptome koji su uključili barem dva segmenta i koji su imali utjecaj na barem 3 dnevne aktivnosti uključeni su u ispitivanje.
English: See also sections 4.3 and 4.5 regarding association with other products with arrhythmogenic effects.
Croatian: Također vidjeti dijelove 4.3 i 4.5 koji se odnose na povezanost s drugim lijekovima s aritmogenim učincima.
English: The recommended starting dose is 1 capsule per day.
Croatian: Preporučena početna doza je 1 kapsula dnevno.
English: Other side effects that may occur:
Croatian: Ostale nuspojave koje se mogu pojaviti su:
English: • Hypersensitivity to any local anaesthetic
Croatian: • Preosjetljivost na bilo koji lokalni anestetik
English: Your doctor will also regularly reassess your treatment to make sure Namuscla is still the best medicine for you.
Croatian: Vaš liječnik će također redovno procjenjivati Vaše liječenje kako bi se uvjerio da je Namuscla još uvijek najbolji lijek za Vas.
English: In case of bradycardia with hypotension, intravenous atropine should be used.
Croatian: U slučaju bradikardije s hipotenzijom, treba primijeniti intravenski atropin.
English: • Heart failure with mid-range (40-49%) and reduced (<40%) ejection fraction
Croatian: • Zatajenje srca s ejekcijskom frakcijom srednjeg raspona (40-49 %) i smanjenom ejekcijskom frakcijom (< 40 %)
English: Incidence of DRESS has been reported between 1:100 and 1:10.000 patients treated.
Croatian: Incidencija DRESS-a prijavljena je za 1:100 do 1:10 000 liječenih bolesnika.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego što počnete uzimati ovaj lijek.
English: Preference between the 2 treatment periods Number of subjects
Croatian: Preferencija između 2 razdoblja liječenja Broj ispitanika
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.
Croatian: Meksiletin se brzo distribuira po tijelu; njegov volumen distribucije je velik i kod zdravih osoba varira od 5 do 9 l/kg.
English: However, these studies were not performed in accordance with contemporary standards and are, hence, of unclear clinical relevance.
Croatian: Međutim, ta ispitivanja nisu provedena sukladno suvremenim standardima i stoga je njihov klinički značaj nejasan.
English: The negative genotoxicity potential does not indicate an increased carcinogenic risk of treatment with mexiletine.
Croatian: Negativni genotoksični potencijal ne ukazuje na povećani karcinogeni rizik od liječenja meksiletinom.
English: OCT2 substrates
Croatian: Supstrati OCT2
English: Approximately 10% is excreted unchanged by the kidney.
Croatian: Oko 10 % se nepromijenjeno eliminira putem bubrega.
English: Epileptic patients need to be monitored because mexiletine can increase the frequency of seizure episodes.
Croatian: Epileptične bolesnike treba nadzirati jer meksiletin može povećati učestalost epizoda napadaja.
English: Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza ni toksičnosti na reproduktivni potencijal i razvoj.
English: Children and adolescents Namuscla should not be used in children and adolescents younger than 18 years old.
Croatian: Djeca i adolescenti Lijek Namuscla ne smiju koristiti djeca ni adolescenti mlađi od 18 godina.
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.
Croatian: Morate razgovarati s liječnikom o tome, zajedno ćete odlučiti o tome hoćete li se suzdržati od dojenja ili prekinuti/suzdržati se od terapije meksiletinom.
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).
Croatian: Kategorije učestalosti izvedene su prema sljedećim konvencijama: vrlo često (≥1/10); često (≥1/100 i<1/10); manje često (≥1/1000 i<1/100); rijetko (≥1/10 000 i<1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Mexiletine may interact with drugs transported by OCT2 (such as metformin and dofetilide).
Croatian: Meksiletin može imati interakcije s lijekovima koji se prenose pomoću OCT2 (poput metformina i dofetilida).
English: In case of digestive intolerance, capsules should be taken during a meal.
Croatian: U slučaju probavne netolerancije, kapsule treba uzimati uz jelo.
English: • Myocardial infarction (acute or past), or abnormal Q-waves
Croatian: • Infarkt miokarda (akutni ili prošli) ili abnormalni Q-valovi
English: Read the Alert Card in conjunction with this leaflet and keep the card it with you at all times.
Croatian: Pročitajte Karticu upozorenja zajedno s ovom uputom o lijeku i nosite karticu cijelo vrijeme sa sobom.
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.
Croatian: Ako ste zaboravili uzeti dozu, nemojte uzeti dvostruku dozu, nego sljedeću dozu uzmite prema rasporedu.
English: Several medicinal products including anticonvulsants, antibiotics and also mexiletine have been identified as possible causes.
Croatian: Nekoliko lijekova uključujući antikonvulzivne lijekove, antibiotike i meksiletin prepoznati su kao mogući uzročnici.
English: Based on the pharmacokinetic properties of mexiletine, no dosage adjustment is required in patients aged 65 years and over.
Croatian: Na osnovi farmakokinetičkih svojstava meksiletina, nije potrebna prilagodba doze u bolesnika u dobi od 65 godina i više.
English: Iron (III) oxide (E 172) Titanium dioxide (E 171) Gelatin
Croatian: Željezov(III) oksid (E 172) Titanijev dioksid (E 171) Želatina
English: Mexiletine may have minor influence on the ability to drive and use machines.
Croatian: Meksiletin može imati manji utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: Lupin Healthcare (UK) Ltd The Urban Building, second floor, 3-9 Albert Street SL1 2BE Slough, Berkshire, United Kingdom
Croatian: Lupin Healthcare (UK) Ltd The Urban Building, second floor, 3-9 Albert Street SL1 2BE Slough, Berkshire, Ujedinjeno Kraljevstvo
English: Mexiletine is eliminated slowly in humans (with a mean elimination half-life of 10 hours, ranging from 5 to 15 hours).
Croatian: Meksiletin se sporo eliminira u ljudi (sa srednjom vrijednosti poluvijeka eliminacije od 10 sati, u rasponu od 5 do 15 sati).
English: In case of seizure, benzodiazepines should be used.
Croatian: U slučaju napadaja treba primijeniti benzodiazepine.
English: Africans
Croatian: Afrikanci
English: • Patients should not take more than 3 capsules of Namuscla per day or a double dose to make up for a forgotten dose;
Croatian: • Bolesnici ne smiju uzeti više od 3 kapsule lijeka Namuscla dnevno niti uzeti dvostruku dozu kako bi nadoknadili dozu koju su zaboravili uzeti;
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).
Croatian: Glavne sekundarne mjere ishoda bile su promjene kvalitete života povezane sa zdravljem mjerene prema ljestvici individualizirane neuromuskularne kvalitete života (engl. individualised neuromuscular quality of life, INQoL) i vremenu potrebnom za ustajanje sa stolice, obilazak oko stolice i ponovno sjedanje (test stolice).
English: The proportions of different ethnic populations across these various classes are tabulated below.
Croatian: Odnosi različitih etničkih skupina u raznim klasama navode se u tablici u nastavku.
English: No notable accumulation of mexiletine was observed after repeated administration.
Croatian: Nije zabilježeno značajno nakupljanje meksiletina nakon ponovljene primjene.
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.
Croatian: Potrebno je odlučiti hoće li se prekinuti dojenje ili prekinuti/ustegnuti terapija meksiletinom, uzimajući pritom u obzir korist dojenja za dijete i korist terapije za ženu.
English: What Namuscla is and what it is used for 2.
Croatian: Što je Namuscla i za što se koristi 2.
English: • Sinus node dysfunction (including sinus rate < 50 bpm)
Croatian: • Disfunkcija sinusnog čvora (uključujući stopu sinua < 50 bpm)
English: The organic cation transporter 2 (OCT2) provides an important pathway for the uptake of cationic compounds in the kidney.
Croatian: Transporter organskih kationa 2 (OCT2) omogućuje važan put za unos kationskih spojeva u bubregu.
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).
Croatian: VAS je izrađen kao apsolutna mjera, s ravnom vodoravnom crtom dužine 100 mm i krajnjim točkama označenima kao „bez ukočenosti” (0) i „najjača moguća ukočenost” (100).
English: CGI as judged efficient by the investigators CGI as judged efficient by the patients Effect of treatment (Mc Nemar test)
Croatian: CGI procijenjen od strane ispitivača kao učinkovit CGI procijenjen od strane bolesnika kao učinkovit Učinak liječenja (McNemarov test)
English: A linear relationship between mexiletine dose and plasma concentration has been observed in the dose range of 83 to 500 mg.
Croatian: Zabilježen je linearni odnos između doze meksiletina i koncentracije u plazmi, u rasponu doze od 83 do 500 mg.