natgillin/translations-raw huggingface dataset:
The safety and efficacy of mexiletine in children and adolescents aged 0 to 18 years have not been established.
Varnost in učinkovitost meksiletina pri otrocih in mladostnikih, starih od 0 do 18 let, nista bili dokazani.
Patients should be carefully monitored if co-treated with other medicinal products with especially emphasis to medicinal products with narrow therapeutic windows.
Bolnike je treba pozorno spremljati, če sočasno jemljejo druga zdravila, s posebnim poudarkom na zdravila z ozkim terapevtskim oknom.
In case of digestive intolerance, capsules should be taken during a meal.
V primeru prebavne intolerance je treba kapsule vzeti med obrokom.
Approximately 10% is excreted unchanged by the kidney.
Približno 10 % ga nespremenjenega izločijo ledvice.
Your doctor will also regularly reassess your treatment to make sure Namuscla is still the best medicine for you.
Vaš zdravnik bo tudi redno ocenjeval vaše zdravljenje, da se prepriča, da je zdravilo Namuscla za vas še vedno najboljše zdravilo.
Individualised neuromuscular quality of life - Overall quality of life
Individualna nevrovaskularna kakovost življenja - splošna kakovost življenja
However, these studies were not performed in accordance with contemporary standards and are, hence, of unclear clinical relevance.
Vendar te študije niso bile izvedene v skladu s sodobnimi standardi, zato imajo omejen klinični pomen.
• Hypersensitivity to any local anaesthetic
• Preobčutljivost na kateri koli lokalni anestetik
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.
Če ste pozabili vzeti odmerek, ne jemljite dvojnega odmerka, temveč vzemite naslednji odmerek po rednem urniku.
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).
Kategorije pogostnosti so oblikovane v skladu z naslednjimi konvencijami: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
The recommended starting dose is 1 capsule per day.
Priporočen začetni odmerek je 1 kapsula dnevno.
Children and adolescents Namuscla should not be used in children and adolescents younger than 18 years old.
Otroci in mladostniki Zdravila Namuscla se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
In case of bradycardia with hypotension, intravenous atropine should be used.
V primeru bradikardije s hipotenzijo je treba uporabiti atropin intravensko.
Food does not affect the rate or extent of absorption of mexiletine.
Hrana ne vpliva na hitrost ali obseg absorpcije meksiletina.
Other side effects that may occur:
Drugi neželeni učinki, ki se lahko pojavijo:
Mexiletine is rapidly distributed in the body; its volume of distribution is large and varies from 5 to 9 L/kg in healthy individuals.
Meksiletin se v telesu hitro porazdeli; njegov volumen porazdelitve je velik in se pri zdravih posameznikih giblje med 5 in 9 l/kg.
• Patients should not take more than 3 capsules of Namuscla per day or a double dose to make up for a forgotten dose;
• Bolniki ne smejo vzeti več kot 3 kapsule zdravila Namuscla na dan, ali dvojnega odmerka če so pozabili vzeti prejšnji odmerek;
OCT2 substrates
Substrati OCT2
How often these tests will be performed depends on your heart function.
Pogostnost pregledov bo odvisna od delovanja vašega srca.
CGI as judged efficient by the investigators CGI as judged efficient by the patients Effect of treatment (Mc Nemar test)
CGI, kot so učinkovitost presodili raziskovalci CGI, kot so učinkovitost presodili bolniki Učinek zdravljenja (McNemarjev test)
• Symptomatic coronary artery disease
• Simptomatska koronarna arterijska bolezen
The doctor will increase the dose gradually depending on how well the medicine is working.
Zdravnik bo odmerek postopoma zviševal glede na učinek zdravila.
Lupin Healthcare (UK) Ltd The Urban Building, second floor, 3-9 Albert Street SL1 2BE Slough, Berkshire, United Kingdom
Lupin Healthcare (UK) Ltd The Urban Building, second floor, 3-9 Albert Street SL1 2BE Slough, Berkshire, Velika Britanija
Mexiletine is eliminated slowly in humans (with a mean elimination half-life of 10 hours, ranging from 5 to 15 hours).
Meksiletin se pri ljudeh izloča počasi (s povprečno razpolovno dobo izločanja 10 ur, ki variira od 5 do 15 ur).
The studies in rats on carcinogenic potential were negative, but not performed in accordance with current standards and therefore of unclear clinical relevance.
Študije kancerogenega potenciala pri podganah so bile negativne, vendar niso bile izvedene skladno s trenutno veljavnimi standardi, zato njihov klinični pomen ni znan.
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.
V klinični študiji z 12 udeleženci (5 zdravih oseb in 7 bolnikov s srčnimi aritmijami) se je očistek kofeina po jemanju meksiletina zmanjšal za 50 %.
Effect of treatment (binomial test)
Učinek zdravljenja (bionomski test)
Regular reassessment should be implemented, not to continue long-term treatment in a patient not responding or not experiencing benefit of the treatment.
Treba je izvajati redno ponovno ocenjevanje učinkovitosti, da se prepreči dolgotrajno zdravljenje pri bolnikih, ki se ne odzivajo, ali pri katerih ni koristi od zdravljenja.
A linear relationship between mexiletine dose and plasma concentration has been observed in the dose range of 83 to 500 mg.
Linearno razmerje med odmerkom meksiletina in koncentracijo v plazmi so opazili v razponu odmerkov od 83 do 500 mg.
• Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1
• Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
In these patients, it is recommended that the dose should only be increased after at least 2 weeks of treatment.
Pri njih se zvišanje odmerka priporoča šele po najmanj dveh tednih zdravljenja.
Before starting treatment with Namuscla, you will have tests to check how well your heart is working, including ECG (Electrocardiogram).
Pred začetkom zdravljenja z zdravilom Namuscla bodo preverili, kako dobro deluje vaše srce, vključno z EKG (elektrokardiogramom).
The effects of mexiletine on fertility in humans have not been studied.
Učinkov meksiletina na plodnost pri ljudeh niso preučevali.
Electrolytic imbalance such as hypokalaemia, hyperkalaemia or hypomagnesaemia may increase the proarrhythmic effects of mexiletine.
Elektrolitska neravnovesja, kot so hipokaliemija, hiperkaliemija ali hipomagneziemija, lahko povečajo proaritmične učinke meksiletina.
Very common and common adverse reactions are derived from data from the MYOMEX study; less common adverse effects are derived from post-marketing data.
Zelo pogosti in pogosti neželeni učinki temeljijo na podatkih iz študije MYOMEX, manj pogosti neželeni učinki pa na podatkih po pridobitvi dovoljenja za promet.
30 hard capsules 50 hard capsules 100 hard capsules 200 hard capsules
30 trdih kapsul 50 trdih kapsul 100 trdih kapsul 200 trdih kapsul
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.
O smrtnih izidih so poročali pri zaužitju akutnih prevelikih odmerkov 4,4 g meksiletinijevega klorida, a so preživetje zaznali tudi po akutnem prevelikem odmerjanju približno 4 g peroralnega meksiletinijevega klorida.
Capsules are packed in Aluminium/PVC/PVDC blisters containing 30, 50, 100 or 200 capsules.
Kapsule so pakirane v pretisne omote iz aluminija/PVC/PVDC po 30, 50, 100 ali 200 kapsul.
Excretion of mexiletine essentially occurs through the kidney (90% of the dose, including 10% as unchanged mexiletine).
Izločanje meksiletina v glavnem poteka preko ledvic (90 % odmerka, vključno z 10 % nespremenjenega meksiletina).
The proportions of different ethnic populations across these various classes are tabulated below.
V spodnji preglednici so navedeni deleži različnih etničnih populacij v teh razredih.
Effect of mexiletine on other medicinal products
Vpliv meksiletina na druga zdravila
Mexiletine may interact with drugs transported by OCT2 (such as metformin and dofetilide).
Meksiletin lahko medsebojno deluje z drugimi zdravili, ki jih prenaša OCT2 (kot sta metformin in dofetilid).
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).
Lestvica VAS je zasnovana kot absolutno merilo s 100-milimetrsko ravno vodoravno linijo, pri kateri je na enem skrajnem koncu stanje »brez okorelosti« (0), na drugem pa »najhujša možna okorelost« (100).
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).
Glavni sekundarni opazovani dogodek so bile spremembe z zdravjem povezane kakovosti življenja, merjene individualno po lestvici nevrovaskularne kakovosti življenja (INQoL - individualised neuromuscular quality of life), ter čas potreben za dviganje s stola, hojo okrog stola in ponovno usedanje (test s stolom).
Depending on your heart function you may also need testing before and after any dose adjustment.
Glede na to, kako deluje vaše srce bo morda treba opraviti teste pred vsako prilagoditvijo odmerka in po njej.
The recommended starting dose of mexiletine is 167 mg daily (1 capsule per day).
Priporočen začetni odmerek meksiletina je 167 mg dnevno (1 kapsula na dan).
Limited clinical data of the use of mexiletine in pregnant women shows that mexiletine crosses the placenta and reaches the foetus.
Omejeni klinični podatki o uporabi meksiletina pri nosečnicah kažejo, da meksiletin prehaja skozi posteljico in doseže plod.
Mexiletine may induce an arrhythmia or accentuate a pre-existing arrhythmia, either diagnosed or undiagnosed.
Meksiletin lahko inducira aritmijo ali poudari obstoječo aritmijo, bodisi diagnosticirano ali brez diagnoze.
A cardiac evaluation is recommended shortly after treatment start (e.g. within 48 hours).
Pregled srca se priporoča kmalu po začetku zdravljenja (npr. v 48 urah).
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.
Povejte zdravniku ali farmacevtu, če med jemanjem zdravila začnete ali prenehate kaditi, ker kajenje vpliva na ravni zdravila Namuscla v krvi in bo morda treba skladno s tem prilagoditi vaš odmerek.
Not known: atrioventricular block
Neznana: atrioventrikularni blok
See section “Do not take Namuscla”.
Glejte poglavje »Ne jemljite zdravila Namuscla«.
You may take Namuscla during a meal to avoid belly pain (see section “Possible side effects”).
Zdravilo Namuscla lahko vzamete med obrokom, da se izognete bolečinam v trebuhu (glejte poglavje »Možni neželeni učinki«).
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).
Ne jemljite zdravila Namuscla skupaj z nekaterimi zdravili s tako imenovanim ozkim terapevtskim oknom (to so zdravila, pri katerih majhne razlike v odmerku ali koncentraciji v krvi lahko vplivajo na učinek zdravila ali neželene učinke).
Mexiletine is, therefore, mostly active on muscle fibres subject to repeated discharges (such as skeletal muscles).
Meksiletin torej deluje predvsem na mišična vlakna, ki so predmet večkratnih sproščanj (kot so skeletne mišice).
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:
Izobraževalni vodnik za zdravstvene delavce, ki ga je treba vedno prebrati skupaj s povzetkom glavnih značilnosti zdravila (SmPC) pred predpisovanjem zdravila Namuscla, mora vsebovati naslednje ključne elemente:
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.
Pri nekaterih bolnikih so lahko ravni zdravila Namuscla v krvi povišane zaradi počasnejše razgradnje v jetrih, zato je treba odmerek skladno s tem prilagoditi.
The maintenance dose is 1 to 3 capsules daily taken at regular intervals throughout the day.
Vzdrževalni odmerek je 1 do 3 kapsule dnevno, ki jih jemljete v rednih presledkih tekom dneva.
Mexiletine is a substrate for the metabolic pathways involving hepatic enzymes; inhibition or induction of these enzymes is expected to alter mexiletine plasma concentrations.
Meksiletin je substrat za metabolične poti, ki vključujejo jetrne encime; pričakuje se inhibicija ali indukcija teh encimov, ki naj bi spremenila koncentracije meksiletina v plazmi.
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).
Evropska agencija za zdravila je odložila zahtevo za predložitev rezultatov študij z zdravilom Namuscla za vse podskupine pediatrične populacije pri simptomatskem zdravljenju miotoničnih motenj (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Africans
Afričani
As a precautionary measure, it is preferable to avoid the use of mexiletine during pregnancy.
Iz previdnostnih razlogov se je med nosečnostjo uporabi meksiletina bolje izogibati.
It improves myotonic symptoms by decreasing muscle stiffness through reduction of the delay of muscle relaxation.
Izboljšuje miotonične simptome z zmanjševanjem okorelosti mišic na podlagi krajšega zamika pri sprostitvi mišice.
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.
Pri bolnikih z znano preobčutljivostjo na meksiletin ali katero koli sestavino tega zdravila oziroma na kateri koli lokalni anestetik obstaja visoko tveganje za pojav DRESS, zato ne smejo prejemati meksiletina.
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).
Pred sprostitvijo zdravila Namuscla na trg v vsaki državi članici mora imetnik dovoljenja za promet z zdravilom dogovoriti s pristojnim nacionalnim organom glede vsebine in oblike izobraževalnega programa, vključno z mediji za komunikacijo, načini distribucije in vsemi drugimi vidiki programa.
Swallow the capsule with a glass of water, while standing or sitting up.
Kapsulo pogoltnite v stoječem ali sedečem položaju s kozarcem vode.
Mexiletine is rapidly and almost completely absorbed following oral administration with a bioavailability of about 90% in healthy subjects.
Meksiletin se hitro in skoraj popolnoma absorbira pri peroralni uporabi z biološko uporabnostjo okoli 90 % pri zdravih osebah.
Mexiletine is mainly (90%) metabolized in the liver, the primary pathway being CYP2D6 metabolism, although it is also a substrate for CYP1A2.
Meksiletin se večinoma (90 %) presnavlja v jetrih, pri čemer je primarna pot presnove CYP2D6, čeprav je tudi substrat za CYP1A2.
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.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z meksiletinom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
Check of heart function
Preverjanje delovanja srca
Based on the pharmacokinetic properties of mexiletine, no dosage adjustment is required in patients aged 65 years and over.
Na podlagi farmakokinetičnih lastnosti meksiletina prilagoditev odmerka pri bolnikih nad 65 let ni potrebna.
• Guidance to identify (and exclude) patients at a greater risk of developing arrhythmias due to Namuscla treatment;
• Smernice za identifikacijo (in izključevanje) bolnikov z večjim tveganjem za pojav aritmij zaradi zdravljenja z zdravilom Namuscla;
The capsules should be swallowed with water, avoiding the supine position.
Kapsule je treba pogoltniti z vodo, česar po možnosti ne storimo v ležečem položaju.
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).
Meksiletin blokira natrijeve kanale z močnejšo jakostjo v primerih prekomernega pojava akcijskega potenciala (uporaba odvisna od bloka) in/ali podaljšano depolarizacijo (blok odvisen od napetosti), ki se pojavljajo v obolelem tkivu, namesto fiziološke razdražljivosti (mirovanje ali tonični blok).
Stiffness score (VAS) (mm) Number of subjects
Rezultat okorelosti (VAS) (mm) Število udeležencev
Pharmacotherapeutic group: Cardiac therapy, antiarrhythmics, class Ib, ATC code: C01BB02.
Farmakoterapevtska skupina: zdravila za bolezni srca, antiaritmiki skupine IB, oznaka ATC: C01BB02.
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.
Priporoča se, da med zdravljenjem z meksiletinom za polovico zmanjšate vnos kofeina, saj lahko zdravilo zviša koncentracijo kofeina v krvi.
During Namuscla maintenance treatment, a detailed cardiac evaluation should be carried out every 24-48 hour.
Med vzdrževalnim zdravljenjem z zdravilom Namuscla je treba vsakih 24-48 ur opraviti podroben pregled srca.
Very common: insomnia
Zelo pogosti: insomnija
What you need to know before you take Namuscla 3.
Kaj morate vedeti, preden boste vzeli zdravilo Namuscla 3.
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).
Varnost in učinkovitost meksiletina pri nedistrofični miotoniji so ocenjevali v študiji MYOMEX, multicentrični, dvojno slepi, s placebom nadzorovani, navzkrižni (2 obdobji zdravljenja po 18 dni) študiji s 4-dnevnim obdobjem izpiranja pri 13 bolnikih s prirojeno miotonijo (MC - myotonia congenita) in pri 12 bolnikih s prirojeno paramiotonijo (PC - paramyotonia congenita).
Taking Namuscla together with any of these medicines increases the risk of a serious heart rhythm disturbance called torsades de pointes.
Jemanje zdravila Namuscla sočasno z navedenimi zdravili poveča tveganje za resne motnje srčnega ritma, imenovane torsades de pointes.
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:
Opozorilna kartica za bolnika (velikosti denarnice), ki jo mora zdravnik, ki predpisuje zdravilo, dati bolniku, in ki jo je treba prebrati skupaj z navodilom za uporabo, mora vsebovati naslednja ključna sporočila:
• Myocardial infarction (acute or past), or abnormal Q-waves
• Miokardni infarkt (akutni ali pretekli), ali nenormalni valovi Q
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.
Pri srčnih boleznih, ki niso na seznamu v poglavju 4.3, je treba pri vsakem posameznem primeru pretehtati koristi antimiotoničnih učinkov meksiletina v odnosu do tveganja za srčne zaplete.
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.
Vi ali vaš spremljevalec se takoj obrnite na zdravnika, če čutite mravljinčenje v rokah in nogah, če ne morete jasno razmišljati ali se osredotočiti, če imate halucinacije, krče, če čutite, da vaše srce bije počasneje, če ste omotični in čutite omedlevico, če doživite kolaps ali če vaše srce preneha biti.
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.
Zato je lahko klinično in EKG spremljanje kot tudi prilagoditev odmerka meksiletina indicirano skozi celotno zdravljenje z zaviralcem CYP1A2 ali CYP2D6 in po njem.
The organic cation transporter 2 (OCT2) provides an important pathway for the uptake of cationic compounds in the kidney.
Organski kationski prenašalec 2 (OCT2 - organic cation transporter 2) zagotavlja pomembno pot za absorpcijo kationskih spojin v ledvicah.
Iron (III) oxide (E 172) Titanium dioxide (E 171) Gelatin
Ovojnica kapsule železov (III) oksid (E 172) titanov dioksid (E 171) želatina
The metabolic degradation proceeds via various pathways, including aromatic and aliphatic hydroxylation, dealkylation, deamination and N-oxidation.
Presnovna razgradnja poteka preko različnih poti, vključno z aromatsko in alifatsko hidroksilacijo, dealkilacijo, deaminacijo in N-oksidacijo.
Increased concentrations of caffeine occurring with the co-administration of mexiletine may be of concern in patients with cardiac arrhythmia.
Povišane koncentracije kofeina ob sočasnem jemanju meksiletina so lahko skrb vzbujajoče pri bolnikih s srčno aritmijo.
Mexiletine excretion may increase when the urinary pH is acidic, compared to normal or alkaline pH.
Izločanje meksiletina se lahko poveča pri kislem pH urina v primerjavi z normalnim ali alkalnim pH.
Electrolyte imbalance needs to be corrected before administering mexiletine and to be monitored throughout treatment (with a periodicity to be adapted patient by patient).
Elektrolitsko neravnovesje je treba odpraviti pred dajanjem meksiletina in ga spremljati skozi celotno zdravljenje (pogostnost spremljanja je treba prilagoditi posameznemu bolniku).
Effect of other medicinal products on mexiletine
Vpliv drugih zdravil na meksiletin
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.
DRESS se nanaša na sindrom, ki v svoji polni obliki vključuje hude kožne erupcije, vročino, limfadenopatijo, hepatitis, hematološke motnje z eozinofilijo in atipičnimi limfociti ter lahko prizadene druge organe.
The main observed effects in rats and/or dogs were vomiting, diarrhoea, tremor, ataxia, convulsions and tachycardia.
Glavni opaženi učinki pri podganah in/ali psih so bili bruhanje, driska, tremor, ataksija, krči in tahikardija.
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.
Če vi sami ali vaš zdravnik odkrije morebitne motnje srčnega ritma ali katero koli od stanj, navedenih v poglavju »Ne jemljite zdravila Namuscla«, bo zdravnik prekinil vaše zdravljenje z zdravilom Namuscla.