FrancophonIA/ELRC3.0 huggingface dataset:
English: Capsules are packed in Aluminium/PVC/PVDC blisters containing 30, 50, 100 or 200 capsules.
Croatian: Kapsule su pakirane u blisterima od aluminija/PVC-a/PVDC-a sa 30, 50, 100 ili 200 kapsula.
English: Age There is no clinically relevant effect of age on the exposure of mexiletine in adults.
Croatian: Dob Nema klinički relevantnog učinka dobi na izloženost meksiletinu u odraslih.
English: Electrolytic imbalance such as hypokalaemia, hyperkalaemia or hypomagnesaemia may increase the proarrhythmic effects of mexiletine.
Croatian: Neravnoteža elektrolita poput hipokalemije, hiperkalemije ili hipomagnezemije može povećati proaritmične učinke meksiletina.
English: As a precautionary measure, it is preferable to avoid the use of mexiletine during pregnancy.
Croatian: Kao mjeru predostrožnosti preporuča se izbjegavati primjenu meksiletina tijekom trudnoće.
English: How often these tests will be performed depends on your heart function.
Croatian: Učestalost obavljanja tih pretraga ovisit će o funkciji Vašeg srca.
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.
Croatian: Za srčane poremećaje koji nisu navedeni u dijelu 4.3, korist antimiotoničkih učinaka meksiletina treba usporediti s rizikom od srčanih komplikacija od slučaja do slučaja.
English: Excretion of mexiletine essentially occurs through the kidney (90% of the dose, including 10% as unchanged mexiletine).
Croatian: Ekskrecija meksiletina uglavnom se odvija putem bubrega (90 % doze, uključujući 10 % nepromijenjenog meksiletina).
English: Individualised neuromuscular quality of life - Overall quality of life
Croatian: Individualizirana neuromuskularna kvaliteta života
English: In a clinical study in 12 subjects (5 healthy subjects and 7 patients with cardiac arrhythmias), the clearance of caffeine was decreased by 50% following the administration of mexiletine.
Croatian: U kliničkom ispitivanju na 12 ispitanika (5 zdravih ispitanika i 7 bolesnika sa srčanim aritmijama), klirens kofeina smanjio se za 50 % nakon primjene meksiletina.
English: • Atrial tachyarrhythmia, fibrillation or flutter
Croatian: • Atrijska tahiaritmija, fibrilacija ili lepršanje
English: Taking Namuscla together with any of these medicines increases the risk of a serious heart rhythm disturbance called torsades de pointes.
Croatian: Uzimanje lijeka Namuscla zajedno s bilo kojim od ovih lijekova povećava rizik od teškog poremećaja srčanog ritma pod nazivom torsades de pointes.
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
Croatian: • Potpuna blokada srca (tj. atrioventrikularna blokada trećeg stupnja) ili bilo koja blokada srca koja se može razviti u potpunu blokadu (atrioventrikularni blok prvog stupnja s izrazito produljenim
English: The recommended starting dose of mexiletine is 167 mg daily (1 capsule per day).
Croatian: Preporučena početna doza meksiletina je 167 mg dnevno (1 kapsula dnevno).
English: Fatal outcomes have been reported for acute overdoses at 4.4 g of mexiletine hydrochloride ingestion but survival has also been reported following acute overdose of approximately 4 g of oral mexiletine hydrochloride.
Croatian: Prijavljeni su smrtni ishodi za akutno predoziranje pri gutanju 4,4 g meksiletin hidroklorida, ali je prijavljeno i preživljenje nakon akutnog predoziranja s približno 4 g peroralnog meksiletinhidroklorida.
English: Limited clinical data of the use of mexiletine in pregnant women shows that mexiletine crosses the placenta and reaches the foetus.
Croatian: Ograničeni klinički podaci o primjeni meksiletina u trudnica pokazuju da meksiletin prolazi u placentu i dostiže do ploda.
English: • Symptomatic coronary artery disease
Croatian: • Simptomatska bolest koronarnih arterija
English: Not known: atrioventricular block
Croatian: Nepoznato: atrioventrikularni blok
English: Peak plasma concentrations following oral administration occur within 2 to 3 hours.
Croatian: Vršne koncentracije u plazmi nakon oralne primjene postižu se unutar 2 do 3 sata.
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.
Croatian: Preporuča se prepoloviti unos kofeina tijekom liječenja meksiletinom, jer taj lijek može povisiti razine kofeina u Vašoj krvi.
English: Regular reassessment should be implemented, not to continue long-term treatment in a patient not responding or not experiencing benefit of the treatment.
Croatian: Potrebno je ponoviti redovnu procjenu, ne smije se provesti dugotrajno liječenje kod bolesnika bez odgovora na liječenje ili koji nemaju koristi od liječenja.
English: It improves myotonic symptoms by decreasing muscle stiffness through reduction of the delay of muscle relaxation.
Croatian: Ublažuje simptome miotonije smanjujući ukočenost mišića skraćivanjem odgode opuštanja mišića.
English: Therefore, based on the clinical response, the mexiletine dosage should be adapted during and after treatment with the enzyme inducer.
Croatian: Zato, na osnovi kliničkog odgovora, dozu meksiletina treba prilagođavati tijekom i nakon liječenja induktorom enzima.
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.
Croatian: Terapija održavanja je između 167 - 500 mg dnevno (1 do 3 kapsule dnevno), prema intenzitetu simptoma i kliničkom odgovoru, koje se redovito uzimaju kroz cijeli dan.
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).
Croatian: Nemojte uzimati lijek Namuscla s određenim lijekovima koji imaju takozvanu usku terapijsku širinu (to su lijekovi kod kojih male razlike u dozi ili koncentraciji u krvi mogu utjecati na učinak lijeka ili nuspojave).
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).
Croatian: Prije puštanja lijeka Namuscla u promet u svakoj državi članici, nositelj odobrenja za stavljanje lijeka u promet mora dogovoriti sadržaj i oblik programa edukacije, uključujući komunikacijske kanale, načine distribucije i sve druge aspekte programa s nadležnim državnim tijelom.
English: Results for the primary and key secondary endpoints are summarised in the table below.
Croatian: Rezultati za primarne i ključne sekundarne mjere ishoda sažeti su tablici u nastavku.
English: Mexiletine crosses the placental barrier and diffuses into breast milk.
Croatian: Meksiletin prelazi placentalnu barijeru i širi se u majčino mlijeko.
English: Namuscla with drink
Croatian: Namuscla uz piće
English: Depending on your heart function you may also need testing before and after any dose adjustment.
Croatian: Ovisno o funkciji vašeg srca, pretrage će možda biti potrebne i prije i nakon prilagodbe doze.
English: The studies in rats on carcinogenic potential were negative, but not performed in accordance with current standards and therefore of unclear clinical relevance.
Croatian: Ispitivanja kancerogenog potencijala na štakorima dala su negativan rezultat, ali nisu provedena u skladu s tekućim standardima i stoga je njihov klinički značaj nejasan.
English: There is insufficient information on the effects of mexiletine in newborns/infants.
Croatian: Nema dostatnih podataka o učincima meksiletina na novorođenčad/dojenčad.
English: Effect of mexiletine on other medicinal products
Croatian: Učinak meksiletina na druge lijekove
English: Patients with known hypersensitivity to mexiletine or any other ingredients of this product or to any local anaesthetic are at high risk of developing DRESS and should not receive mexiletine.
Croatian: Bolesnici s poznatom preosjetljivošću na meksiletin i bilo koji drugi sastojak ovog lijeka ili na bilo koji lokalni anestetik, izloženi su visokoj stopi rizika od razvoja DRESS-a i ne smiju primati meksiletin.
English: Very common and common adverse reactions are derived from data from the MYOMEX study; less common adverse effects are derived from post-marketing data.
Croatian: Vrlo česte i česte nuspojave izvedene su iz podataka iz ispitivanja MYOMEX; manje česte nuspojave izvedene su iz podataka nakon stavljanja lijeka u promet.
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.
Croatian: Ako primijetite promjenu Vašeg srčanog ritma (srce Vam kuca brže ili polakše), ako osjetite treperenje ili bol u prsnom košu, ako teško dišete, ako osjećate omaglicu, znojite se ili gubite svijest, odmah se morate javiti u hitnu medicinsku službu.
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.
Croatian: Recite liječniku ili ljekarniku ako počnete ili prestanete pušiti tijekom uzimanja lijeka Namuscla jer pušenje utječe na razine lijeka Namuscla u krvi i možda će biti potrebno prilagoditi Vam dozu.
English: If you or your doctor detects any heart rhythm disturbances or any of the conditions stated in section “Do not take Namuscla”, your doctor will stop your treatment with Namuscla.
Croatian: Ako Vi ili Vaš liječnik otkrijete bilo kakve smetnje srčanog ritma ili bilo koje od stanja navedenih u dijelu „Nemojte uzimati lijek Namuscla”, Vaš liječnik će prekinuti Vaše liječenje lijekom Namuscla.
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.
Croatian: Vi ili osoba u Vašoj pratnji odmah se trebate obratiti liječniku ako osjećate trnce u rukama i nogama, ako ne možete bistro razmišljati i koncentrirati se, ako imate halucinacije, konvulzije ili osjećate da Vam srce kuca sporije, ako osjećate omaglicu i izgubite svijest, ako se srušite ili Vam srce prestane kucati.
English: Some patients may have higher blood levels of Namuscla because of slower break down in the liver and the dose may need to be adjusted accordingly.
Croatian: Neki bolesnici mogu imate veće razine lijeka Namuscla u krvi radi sporije razgradnje u jetri pri čemu će možda biti potrebna prilagodba doze.
English: You may take Namuscla during a meal to avoid belly pain (see section “Possible side effects”).
Croatian: Možete uzeti lijek Namuscla tijekom obroka kako biste izbjegli bol u trbuhu (pogledajte dio „Moguće nuspojave”).
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).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Namuscla u svim podskupinama pedijatrijske populacije u simptomatskom liječenju miotoničkih poremećaja (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Chair test (s)
Croatian: Test(ovi) stolice
English: Not known: diplopia, dysgeusia
Croatian: Nepoznato: diplopija, dizgeuzija
English: During Namuscla maintenance treatment, a detailed cardiac evaluation should be carried out every 24-48 hour.
Croatian: Tijekom održavanja liječenja lijekom Namuscla, mora se provesti detaljna kardijalna procjena svakih 24-48 sati.
English: See section “Do not take Namuscla”.
Croatian: Pogledajte dio „Nemojte uzimati lijek Namuscla”.
English: Effect of other medicinal products on mexiletine
Croatian: Učinak drugih lijekova na meksiletin
English: Increased concentrations of caffeine occurring with the co-administration of mexiletine may be of concern in patients with cardiac arrhythmia.
Croatian: Povećane koncentracije kofeina koje se pojavljuju kod istodobne primjene meksiletina mogu biti zabrinjavajuće u slučaju bolesnika sa srčanom aritmijom.
English: Patients should be carefully monitored if co-treated with other medicinal products with especially emphasis to medicinal products with narrow therapeutic windows.
Croatian: Bolesnike je potrebno pažljivo nadzirati ako se istodobno liječe drugim lijekovima, naročito ako se radi o lijekovima s uskim terapijskim indeksom.
English: The primary efficacy measure for both MC and PC was the score of stiffness severity as self-reported by the patients on a Visual Analogue Scale (VAS).
Croatian: Primarna mjera djelotvornosti za MC i PC bio je rezultat intenziteta ukočenosti prema samostalnom izvješću bolesnika na vizualnoj analognoj ljestvici (engl.
English: • Guidance to identify (and exclude) patients at a greater risk of developing arrhythmias due to Namuscla treatment;
Croatian: • Vodič za identifikaciju (i isključenje) bolesnika koji imaju veći rizik za razvijanje aritmija uslijed liječenja lijekom Namuscla;
English: The metabolic degradation proceeds via various pathways, including aromatic and aliphatic hydroxylation, dealkylation, deamination and N-oxidation.
Croatian: Metabolički raspad odvija se različitim putovima, uključujući aromatsku i alifatsku hidroksilaciju, dealkilaciju, deaminaciju i N-oksidaciju.
English: • Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1
Croatian: • Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1
English: A cardiac evaluation is recommended shortly after treatment start (e.g. within 48 hours).
Croatian: Kardijalna procjena se preporuča kratko nakon početka liječenja (npr. unutar 48 sati).
English: Mexiletine may induce an arrhythmia or accentuate a pre-existing arrhythmia, either diagnosed or undiagnosed.
Croatian: Meksiletin može izazvati aritmiju ili naglasiti prethodno prisutnu aritmiju, dijagnosticiranu ili nedijagnosticiranu.
English: Mexiletine is mainly (90%) metabolized in the liver, the primary pathway being CYP2D6 metabolism, although it is also a substrate for CYP1A2.
Croatian: Meksiletin se uglavnom (90 %) metabolizira u jetri, glavni put je metabolizam CYP2D6, iako je također i supstrat za CYP1A2.
English: The main observed effects in rats and/or dogs were vomiting, diarrhoea, tremor, ataxia, convulsions and tachycardia.
Croatian: Glavne zabilježene nuspojave u štakora i/ili pasa bile su povraćanje, proljev, tremor, ataksija, konvulzije i tahikardija.
English: There is an Alert Card distributed with Namuscla, to remind you and medical staff of the risk of cardiac arrythmias.
Croatian: Uz lijek Namuscla podijeljena je Kartica upozorenja kako bi podsjetila Vas i medicinsko osoblje na rizik od srčanih aritmija.
English: Mexiletine excretion may increase when the urinary pH is acidic, compared to normal or alkaline pH.
Croatian: Ekskrecija meksiletina može se povećati kod kiselog pH mokraće, u usporedbi s normalnim ili alkalnim pH.
English: The effects of mexiletine on fertility in humans have not been studied.
Croatian: Učinci meksiletina na plodnost u ljudi nisu ispitivani.
English: What you need to know before you take Namuscla 3.
Croatian: Što morate znati prije nego počnete uzimati lijek Namuscla 3.
English: Caffeine
Croatian: Kofein
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.
Croatian: Meksiletin je supstrat metaboličkih puteva koji uključuju jetrene enzime; očekuje se da inhibicija ili indukcija tih enzima mijenja koncentracije meksiletina u plazmi.
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).
Croatian: Nakon najmanje 1 tjedna liječenja, na osnovi kliničkog odgovora, dnevna doza može se povećati na 333 mg dnevno (2 kapsule dnevno).
English: Secondary Analysis
Croatian: Sekundarna analiza
English: Stiffness score (VAS) (mm) Number of subjects
Croatian: Rezultat ukočenosti (VAS) (mm) Broj ispitanika
English: Mexiletine is rapidly and almost completely absorbed following oral administration with a bioavailability of about 90% in healthy subjects.
Croatian: Meksiletin se brzo i gotovo u potpunosti apsorbira nakon oralne primjene, uz bioraspoloživost od oko 90 % u zdravih ispitanika.
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.
Croatian: Stoga kliničko i EKG praćenje, kao i prilagodba doze meksiletina, mogu biti indicirani tijekom i nakon liječenja inhibitorom CYP1A2 ili CYP2D6.
English: Effect of treatment (binomial test)
Croatian: Učinak liječenja (binominalni test)
English: The most commonly reported adverse reactions in patients treated with mexiletine are abdominal pain (12%), vertigo (8%) and insomnia (12%).
Croatian: Najčešće prijavljivane nuspojave u bolesnika liječenih meksiletinom su bol u području abdomena (12 %), vrtoglavica (8 %) i nesanica (12 %).
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.
Croatian: Namuscla se koristi za liječenje simptoma miotonije (kada se mišići nakon napora polako i teško opuštaju) u odraslih s nedistrofičnim poremećajima miotonije, uzrokovanim genetskim oštećenjima koja djeluju na mišićnu funkciju.
English: Experience with mexiletine in patients with myotonic disorders aged > 65 years is limited.
Croatian: Iskustvo s meksiletinom u bolesnika s poremećajima miotonije u dobi od > 65 godina je ograničeno.
English: Up to 10%
Croatian: Do 10 %
English: • Ventricular tachyarrhythmia
Croatian: • Ventrikularna tahiaritmija
English: A cardiac evaluation is also recommended shortly after starting Namuscla (e.g. within 48 hours).
Croatian: Kardijalna procjena također se preporučuje ubrzo nakon početka davanja lijeka Namuscla (npr. u roku od 48 sati).
English: There are no or limited amount of data from the use of mexiletine in pregnant women.
Croatian: Ne postoje ili su ograničeni podaci o primjeni meksiletina u trudnica.
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).
Croatian: Meksiletin blokira kanale natrija većom jačinom u situacijama prekomjernog nastupa akcijskih potencijala (blokada ovisna o uporabi) i/ili produljene depolarizacije (blokada ovisna o naponu), što se javlja u oboljelim tkivima, nego pri fiziološkoj ekscitabilnosti (blokada u mirovanju ili blokada tonusa).
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).
Croatian: Nakon najmanje još 1 tjedna liječenja, na osnovi kliničkog odgovora, doza se može dodatno povećati na 500 mg dnevno (3 kapsule dnevno).
English: The maintenance dose is 1 to 3 capsules daily taken at regular intervals throughout the day.
Croatian: Doza održavanja je 1 do 3 kapsule na dan, koje se tijekom cijelog dana uzimaju u redovitim vremenskim razmacima.
English: Mexiletine dose may need to be increased if a patient starts to smoke and decreased if a patient stops to smoke.
Croatian: Dozu meksiletina možda će trebati povećati ako bolesnik počne pušiti, a smanjiti ako bolesnik prekine s pušenjem.
English: Pharmacotherapeutic group: Cardiac therapy, antiarrhythmics, class Ib, ATC code: C01BB02.
Croatian: Farmakoterapijska skupina: Pripravci koji djeluju na srce, antiaritmici, skupina Ib, ATK oznaka: C01BB02.
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:
Croatian: Kartica upozorenja za bolesnika (veličine lisnice) koju mora uručiti liječnik koji propisuje lijek i koja se mora pročitati zajedno s uputom o lijeku, mora sadržavati sljedeće ključne poruke:
English: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Croatian: Reakcija na lijek s eozinofilijom i sistemskim simptomima (DRESS)
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).
Croatian: Djelotvornost i sigurnost meksiletina kod nedistrofične miotonije procijenjene su u MYOMEX multicentričnom, dvostruko slijepom, placebom kontroliranom, ukriženom (2 razdoblja liječenja po 18 dana) ispitivanju s 4-dnevnim razdobljem ispiranja u 13 bolesnika s kongenitalnom miotonijom (myotonia congenita, MC) i 12 bolesnika s kongenitalnom paramiotonijom (paramyotonia congenita, PC).
English: In case of modification of the mexiletine dose, or if medicinal products susceptible to affect cardiac conduction are co-administered with mexiletine, patients should be closely monitored by ECG (especially patients with conduction anomalies) (see sections 4.3 and 4.4).
Croatian: U slučaju modifikacije doze meksiletina, ili ako se lijekovi koji imaju sklonost utjecati na provodljivost srca daju istovremeno s meksiletinom, bolesnike treba pažljivo nadzirati EKG-om (pogotovo bolesnike s anomalijama provodljivosti) (vidjeti dijelove 4.3 i 4.4).
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.
Croatian: DRESS se odnosi na sindrom koji u svojem cjelovitom obliku sadrži teške kožne erupcije, vrućicu, limfadenopatiju, hepatitis, hematološke anomalije s eozinofilijom i atipičnim limfocitima i može zahvatiti druge organe.
English: Namuscla is available in blister packs containing 30, 50, 100 or 200 capsules.
Croatian: Lijek Namuscla dostupan je u blister pakiranjima s 30, 50, 100 ili 200 kapsula.
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.
Croatian: Nakon peroralne primjene jedne (167 mg) i višestrukih (83 mg dvaput dnevno tijekom 8 dana) doza meksiletina, ukupni klirens meksiletina značajno se povećao kod pušača (1,3 do 1,7 puta), zbog indukcije CYP1A2, što je uzrokovalo odgovarajuće skraćenje poluvijeka eliminacije i smanjenje izloženosti lijeku.