FrancophonIA/ELRC3.0 huggingface dataset:
English: • Raynaud's syndrome (circulation disorder affecting the fingers and toes)
Croatian: • Raynaudov sindrom (poremećaj cirkulacije koji zahvaća prste ruku i nogu)
English: Raynaud's syndrome
Croatian: Raynaudov sindrom
English: • The active substance is amifampridine.
Croatian: • Djelatna tvar je amifampridin.
English: It can be associated with certain tumour types (paraneoplastic form of LEMS) or in the absence of these tumours (non-paraneoplastic form of LEMS).
Croatian: Može se povezati s određenim tipovima tumora (paraneoplastični oblik LEMS-a) ili se može pojaviti u odsustvu ovih tumora (neparaneoplastični oblik LEMS-a).
English: The tablets should be swallowed with some water and are to be taken with food.
Croatian: Tablete treba progutati s nešto vode te uzeti s hranom.
English: Very common side effects which may affect more than 1 in 10 people are:
Croatian: Vrlo česte nuspojave koje se mogu javiti u više od 1 na 10 osoba su:
English: If you take more FIRDAPSE than you should
Croatian: Ako uzmete više lijeka FIRDAPSE nego što ste trebali
English: If treatment is discontinued, patients may experience some of the symptoms of LEMS.
Croatian: U slučaju prekida liječenja, bolesnici mogu iskusiti neke od simptoma LEMS-a.
English: c CGI-I is a 7-point scale based on changes in symptoms, behaviour, and functional abilities (1=very much improved to 7=very much worse).
Croatian: CGI-I je ljestvica od 1 do 7 temeljena na promjenama u simptomima, ponašanju i funkcionalnim sposobnostima (1 = izrazito poboljšano do 7 = vrlo pogoršano).
English: * Eating a standardised high-fat meal
Croatian: * Standardni punomasni obrok
English: Supportive care should be given as clinically indicated, including close monitoring of vital signs.
Croatian: Potrebno je osigurati suportivnu skrb prema kliničkim indikacijama uključujući pomni nadzor vitalnih znakova.
English: The manifestations of acute overdose include vomiting and abdominal pain.
Croatian: Manifestacije akutnog predoziranja uključuju povraćanje i bol u abdomenu.
English: Warnings and precautions Talk to your doctor or pharmacist before taking FIRDAPSE.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete FIRDAPSE.
English: Amifampridine (n=13)
Croatian: Amifampridin (n = 13)
English: Patients were allowed to use stable doses of peripherally acting cholinesterase inhibitors or corticosteroids.
Croatian: Bolesnicima je bilo dopušteno koristiti stabilne doze periferno aktivnih inhibitora kolinesteraze ili kortikosteroida.
English: If the treatment is stopped, you may experience symptoms such as tiredness, slow reflexes and constipation.
Croatian: Ako prekinete s liječenjem možete osjetiti simptome poput umora, usporenih refleksa i zatvora.
English: One box contains 100 tablets comprising 10 strips with 10 tablets each.
Croatian: Jedna kutija sadrži 100 tableta u 10 stripova, svaki s 10 tableta.
English: No single dose should exceed 20 mg.
Croatian: Nijedna pojedinačna doza ne smije premašiti 20 mg.
English: The tablets have a score-line to allow them to be broken in half.
Croatian: Tablete imaju razdjelnu crtu koja omogućava da se prepolove.
English: A. LABELLING
Croatian: A: OZNAČIVANJE
English: Some medicines may interact with FIRDAPSE when taken together.
Croatian: Neki lijekovi mogu stupati u interakciju s lijekom FIRDAPSE ako se uzimaju zajedno.
English: If you take more FIRDAPSE than you should have, you may suffer from vomiting or a stomach ache.
Croatian: Ako uzmete više lijeka FIRDAPSE nego što ste trebali može doći do povraćanja ili boli u trbuhu.
English: • If you are epileptic
Croatian: • ako imate epilepsiju,
English: • Tingling and numbness around the mouth and extremities (such as feet and hands)
Croatian: • trnci i obamrlost oko usta i udova (poput stopala i šaka),
English: The maximum recommended dose is 60 mg per day (i.e. a total of six tablets to be taken at intervals during the day).
Croatian: Maksimalna preporučena doza je 60 mg na dan (tj. ukupno šest tableta u razmacima tijekom dana).
English: Carcinogenicity risk
Croatian: Rizik od kancerogenosti
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/601/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/601/001
English: This disease is a disorder affecting the transmission of nerve impulses to muscles, resulting in muscle weakness.
Croatian: Ova bolest je poremećaj koji zahvaća prijenos živčanih impulsa do mišića, što uzrokuje slabost mišića.
English: • If you were born with heart problems (congenital QT syndromes)
Croatian: • ako imate urođene srčane poteškoće (kongenitalni QT sindromi).
English: For the full list of excipients, see section 6.1.
Croatian: Za cjelovit popis pomoćnih tvari vidjeti dio 6.1.
English: • Increase in certain liver enzymes (transaminases) seen on blood tests
Croatian: • porast razine određenih jetrenih enzima (transaminaza) što je vidljivo iz krvnih pretraga
English: Tell any physician you consult that you are using FIRDAPSE.
Croatian: Recite svakom liječniku koji Vas liječi da uzimate FIRDAPSE.
English: Medicinal products eliminated through metabolism or active secretion There are no data on the effects of amifampridine on the metabolism or active secretion of other medicinal products.
Croatian: Lijekovi koji se eliminiraju metabolizmom ili aktivnom sekrecijom Nisu dostupni podaci o učincima amifampridina na metabolizam ili aktivnu sekreciju drugih lijekova.
English: Orally administered amifampridine is rapidly absorbed in humans, reaching peak plasma concentrations by 0.6 to 1.3 hours (mean values).
Croatian: Peroralno primijenjeni amifampridin brzo se apsorbira u ljudi, a vršne koncentracije u plazmi postižu se za 0,6 do 1,3 sata (srednje vrijednosti).
English: Two further studies in a total of 57 patients with LEMS have reported data from higher doses of amifampridine.
Croatian: U dva daljnja ispitivanja na ukupno 57 bolesnika s LEMS-om zabilježeni su podaci na višim dozama amifampridina.
English: Prolonging the action potential enhances the transport of calcium into the nerve ending.
Croatian: Produljivanje akcijskog potencijala povećava transport kalcija u završetak živca.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 December 2009
Croatian: Datum prvog odobrenja: 23. prosinca 2009.
English: Patients must be told to inform any physician they consult that they are taking this medicinal product, since close monitoring of a concomitant disease, particularly asthma, may be necessary.
Croatian: Bolesnike se mora uputiti da obavijeste svakog liječnika koji ih liječi da uzimaju ovaj lijek s obzirom da može biti potrebno pomno praćenje istodobne bolesti, a posebice astme.
English: d CFB for QMG total score was modelled as the response, with fixed effects terms for treatment and QMG at Baseline.
Croatian: d Rezultat CFB-a za ukupni QMG modeliran je kao odgovor, s uvjetima fiksnih učinaka za liječenje i početnoj vrijednosti QMG-a.
English: In the event of a seizure, treatment should be discontinued.
Croatian: U slučaju napadaja liječenje treba prekinuti.
English: Although the metabolite is inactive at potassium channels, potential off target effects due to accumulation are unknown.
Croatian: Iako metabolit nije aktivan na kalijevim kanalima, mogući učinci zbog akumulacije, izuzev ciljnog učinka, nisu poznati.
English: No single dose should exceed 20 mg (two tablets).
Croatian: Nijedna pojedinačna doza ne smije premašiti 20 mg (dvije tablete).
English: In patients suffering from this disease, a chemical substance called acetylcholine, which communicates nerve impulses to muscles is not released normally and the muscle doesn't receive some or all of the nerve's signals.
Croatian: U bolesnika koji boluju od ove bolesti, kemijska tvar zvana acetilkolin koja prenosi živčane impulse do mišića ne otpušta se na normalan način i mišić ne prima neke ili sve živčane signale.
English: Elevated liver enzyme levels (transaminases)
Croatian: Povišene razine jetrenih enzima (transaminaze)
English: If you forget to take FIRDAPSE
Croatian: Ako ste zaboravili uzeti FIRDAPSE
English: In a repeat-dose toxicity studies in rats and dogs, effects on the central and autonomic nervous system, increased liver and kidney weights and cardiac effects (second degree atrioventricular block) were seen.
Croatian: U ispitivanjima toksičnosti ponovljene doze na štakorima i psima uočeni su učinci na središnji i autonomni živčani sustav, povećanje mase jetre i bubrega kao i učinci na srce (atrioventrikularni blok drugog stupnja).
English: You must use effective contraception throughout the treatment.
Croatian: Tijekom liječenja morate koristiti učinkovitu kontracepciju.
English: Following oral administration of radiolabelled [14C] amifampridine, radioactive material is rapidly absorbed from the gastrointestinal tract and widely distributed throughout the body.
Croatian: Nakon peroralne primjene radioaktivno označenog amifampridina [14C], radioaktivni materijal se brzo apsorbira iz gastrointestinalnog trakta i široko raspodjeljuje u tijelu.
English: The benefit of continuing treatment with amifampridine should be reviewed for any patient who develops a Schwannoma.
Croatian: Korist od nastavka liječenja s amifampridinom treba se razmotriti za svakog bolesnika koji razvije švanom.
English: NAME OF THE MARKETING AUTHORISATION HOLDER BioMarin International Limited
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET BioMarin International Limited
English: Patient should discontinue the treatment in the event of overdose.
Croatian: Bolesnici trebaju prekinuti liječenje u slučaju predoziranja.
English: In humans, the rate and extent of absorption of amifampridine is influenced by food (see Table 2).
Croatian: U ljudi su brzina i opseg apsorpcije amifampridina pod utjecajem hrane (vidjeti tablicu 2).
English: Hyperhidrosis1, cold sweat1
Croatian: Hiperhidroza1, hladan znoj1
English: • Heart rhythm disorders, fast or irregular heartbeats (palpitations)
Croatian: • poremećaji srčanog ritma, brzi ili nepravilni otkucaji (palpitacije)
English: The intensity and incidence of most side effects depends on the dose you are taking.
Croatian: Težina i učestalost većine nuspojava ovise o dozi koju uzimate.
English: The plasma elimination half-life is approximately 2.5 hours for the amifampridine and 4 hours for the 3-N-acetylated amifampridine metabolite.
Croatian: Poluvijek eliminacije iz plazme iznosi približno 2,5 sata za amifampridin i 4 sata za metabolit 3-N-acetilirani amifampridin.
English: Common side effects which may affect up to 1 in 10 people are:
Croatian: Česte nuspojave koje se mogu javiti u do 1 na 10 osoba su:
English: • Concomitant use with medicinal products with a known potential to cause QTc prolongation
Croatian: • Istodobna primjena s lijekovima za koje se zna da mogu prouzročiti produljenje QTc intervala.
English: SPECIAL STORAGE CONDITIONS Do not store above 30ºC.
Croatian: POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 30ºC.
English: If treatment with a potent inhibitor is discontinued, patients should be monitored for efficacy as an increase of amifampridine dose may be necessary.
Croatian: U slučaju prekida liječenja potentnim inhibitorom, bolesnike treba nadzirati kako bi se pratila djelotvornost lijeka jer će možda biti potrebno povećanje doze amifampridina.
English: Thus, special care should be taken in patients undergoing concomitant treatment with medicinal products eliminated through metabolism or active secretion.
Croatian: Stoga treba biti posebno oprezan s bolesnicima koji se podvrgavaju istodobnom liječenju s lijekovima koji se eliminiraju metaboliziranjem ili aktivnom sekrecijom.
English: Sanders et al 1998 presented data on efficacy and safety of amifampridine treatment at doses up to 100 mg/day in 45 patients with LEMS who were treated for an average of 31 months.
Croatian: Sanders et al 1998 prikazali su podatke o djelotvornosti i sigurnosti amifampridina pri dozama do 100 mg/dan na 45 bolesnika s LEMS-om koji su liječeni u prosjeku 31 mjesec.
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: You and your doctor should discuss the risks and benefits of continuing to take FIRDAPSE while breastfeeding.
Croatian: Vaš liječnik i Vi trebate razmotriti rizike i koristi nastavka liječenja lijekom FIRDAPSE za vrijeme dojenja.
English: MedDRA System organ class
Croatian: MedDRA - klasifikacija organskih sustava
English: FIRDAPSE should not be used during pregnancy.
Croatian: FIRDAPSE se ne smije primjenjivati tijekom trudnoće.
English: • In patients with congenital QT syndromes (see section 4.4)
Croatian: • U bolesnika s kongenitalnim QT sindromima (vidjeti dio 4.4).
English: The risk of seizures is dose-dependent and is increased in patients with risk factors which lower the epileptic threshold; including use in combination with other medicinal products known to lower the epileptic threshold (see section 4.5).
Croatian: Rizik od napadaja ovisi o dozi te je povećan u bolesnika s čimbenicima rizika koji snižavaju epileptički prag; uključujući uporabu u kombinaciji s drugim lijekovima koji su poznati da snižavaju epileptički prag (vidjeti dio 4.5).
English: In humans, 93.2% to 100% of amifampridine is excreted into the urine within 24 hours after dosing as amifampridine (19%) and its 3-N-acetylated amifampridine metabolite (74.0% to 81.7%).
Croatian: Kod ljudi se 93,2% do 100% amifampridina izlučuje u mokraću unutar 24 sata nakon doziranja, kao amifampridin (19%) i njegov metabolit 3-N-acetilirani amifampridin (74,0% do 81,7%).
English: If you stop taking FIRDAPSE
Croatian: Ako prestanete uzimati FIRDAPSE
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: U svakoj skupini učestalosti nuspojave su prikazane slijedom prema sve manjoj ozbiljnosti.
English: Apparent plasma terminal elimination half-life differences were 3-4 fold between subjects in the food effect study.
Croatian: Razlike prividnog terminalnog poluvijeka eliminacije iz plazme bile su 3-struke do 4-struke između ispitanika u ispitivanjima utjecaja hrane.
English: Non-clinical safety data are available regarding the effects of amifampridine on reproductive function.
Croatian: Dostupni su neklinički podaci o sigurnosti utjecaja amifampridina na reproduktivnu funkciju.
English: It is recommended that dose titration from 60 mg/day to 80 mg/day is performed in 5 mg increments every 7 days.
Croatian: Preporučuje se titracija doze od 60 mg/dan do 80 mg/dan u povećanjima od 5 mg svakih 7 dana.
English: Women of childbearing potential must use effective contraception during FIRDAPSE treatment.
Croatian: Žene u reproduktivnoj dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja lijekom FIRDAPSE.
English: No subjects developed new clinically relevant ECG morphological changes following administration of amifampridine phosphate.
Croatian: Niti jedan ispitanik nije razvio nove klinički značajne morfološke promjene EKG-a nakon primjene amifampridin fosfata.
English: Amifampridine was not genotoxic in a standard battery of in vitro and in vivo tests.
Croatian: Amifampridin se nije pokazao genotoksičan u standardnoj bateriji in vitro i in vivo testova.
English: What FIRDAPSE looks like and contents of the pack White, round tablet, flat-faced on one side and scored on the other side.
Croatian: Kako FIRDAPSE izgleda i sadržaj pakiranja Bijela, okrugla tableta, plosnata na jednoj strani i s razdjelnom crtom na drugoj strani.
English: • Concomitant use with sultopride (see sections 4.5 and 5.1)
Croatian: • Istodobna primjena sa sultopridom (vidjeti dijelove 4.5 i 5.1).
English: However, in a similar study in pregnant rabbits, there was no effect on embryo-foetal viability when evaluated just prior to birth at doses up to 57 mg/kg/day.
Croatian: Međutim, u sličnom ispitivanju na skotnim kunićima nije bilo učinka na embriofetalnu održivost procijenjenu neposredno prije okota pri dozama do 57 mg/kg/dan.
English: The patients were maintained on a stable dose and frequency of amifampridine phosphate for at least 7 days prior to randomization.
Croatian: Kod bolesnika je održavana stabilna doza i učestalost primjene amifampridinfosfata kroz najmanje 7 dana prije randomizacije.
English: MedDRA Preferred term
Croatian: MedDRA Preporučeni pojam
English: In a study of healthy volunteers, systemic exposure of amifampridine was notably influenced by the overall metabolic acetylation activity of NAT enzymes and NAT2 genotype.
Croatian: U ispitivanju na zdravim dobrovoljcima, na sistemsku izloženost amifampridinu znatno je utjecala ukupna metabolička aktivnost acetilacije enzimima NAT i genotip NAT2.
English: Patients with liver/kidney problems:
Croatian: Bolesnici s oštećenjem jetre/bubrega:
English: • Uncontrolled asthma
Croatian: • Nekontrolirana astma.
English: Hypoaesthasia oral1, paraesthesia oral1, peripheral and peribucal paraesthesias, nausea1
Croatian: Oralna hipoestezija1, oralna parestezija1, periferne i peribukalne parestezije, mučnina1
English: In safety pharmacology studies in rats, no respiratory system related effects were seen up to 10 mg/kg or on the central nervous system up to 40 mg/kg.
Croatian: U ispitivanjima sigurnosne farmakologije na štakorima nisu uočeni učinci na dišni sustav u dozama do 10 mg/kg niti na središnji živčani sustav u dozama do 40 mg/kg.
English: There was a decrease in Cmax and AUC, and an increase in the time to reach maximum plasma concentrations when amifampridine phosphate was administered with food as compared to without food.
Croatian: Došlo je do pada Cmax i AUC te produljenja vremena do postizanja maksimalne koncentracije u plazmi kad se amifampridin fosfat primjenjivao s hranom, a u usporedbi bez hrane.
English: This medicine may cause drowsiness, dizziness, fits (convulsions) and blurred vision, which may affect your ability to drive or use machines.
Croatian: Ovaj lijek može izazvati omamljenost, omaglicu, napadaje (konvulzije) i zamagljen vid, što može utjecati na sposobnost upravljanja vozilom i rada sa strojevima.
English: FIRDAPSE 10 mg tablets amifampridine
Croatian: FIRDAPSE 10 mg tablete amifampridin
English: Regardless, patients should be closely monitored for adverse reactions when initiating treatment with a potent enzyme or renal transporter inhibitor.
Croatian: Bez obzira na to, bolesnike treba pomno nadzirati na nuspojave prilikom početka liječenja potentnim inhibitorom enzima ili bubrežnog transportera.
English: Perforated unit dose thermoformed blisters (Thermoformed aluminium-PVC/PVDC laminate sheets) containing 10 tablets.
Croatian: Perforirani termoformirani blisteri s jediničnim dozama (termoformirani aluminij-PVC/PVDC laminirani listovi) s 10 tableta.
English: There was significantly higher exposure to amifampridine in slow acetylators compared to fast acetylators.
Croatian: Postojala je znatno viša izloženost amifampridinu u sporih acetilatora u usporedbi s brzim acetilatorima.
English: The NAT genes are highly polymorphic and result in phenotypes with variable acetylation activity rates ranging from slow to fast.
Croatian: Geni NAT visoko su polimorfni te izražavaju fenotipe s promjenjivom aktivnosti acetilacije u rasponima od sporih do brzih.
English: White, round tablet, flat-faced on one side and scored on the other side.
Croatian: Bijela, okrugla tableta, plosnata na jednoj strani i s razdjelnom crtom na drugoj strani.
English: • Fits (convulsions)
Croatian: • napadaji (konvulzije)
English: Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
Croatian: Simptomatsko liječenje Lambert-Eatonovog mijasteničnog sindroma (LEMS) u odraslih.
English: In a 2-year rat dietary carcinogenicity study, amifampridine caused small but statistically significant dose-related increases in the incidence of Schwannomas in both genders and of endometrial carcinomas in females.
Croatian: U dvogodišnjem ispitivanju kancerogenosti provedenom s djelatnom tvari u hrani, amifampridin je izazvao mali, ali statistički značajan porast povezan s dozom u incidenciji švanoma u oba spola te endometrijskih karcinoma u žena.
English: The safety profile in this study is consistent with adverse reactions observed with patients on amifampridine.
Croatian: Sigurnosni profil u tom ispitivanju u skladu je sa nuspojavama uočenim kod bolesnika koji su uzimali amifampridin.
English: The recommended starting dose is 15 mg amifampridine a day, which can be increased in 5 mg increments every 4 to 5 days, to a maximum of 60 mg per day.
Croatian: Preporučena početna doza je 15 mg amifampridina dnevno, koja se može povećavati za po 5 mg svakih 4 do 5 dana, do najviše 60 mg dnevno.
English: Then your doctor may continue to increase your total daily dose adding 5 mg (half a tablet) per day, every 4 or 5 days.
Croatian: Potom liječnik može nastaviti povećavati Vašu ukupnu dnevnu dozu dodavanjem 5 mg (polovica tablete) na dan, svakih 4 ili 5 dana.
English: Amifampridine has shown no effect on embryo-foetal viability and development in rabbits; however, in rats, an increase in the number of mothers delivering still-born offspring was observed (see section 5.3).
Croatian: Amifampridin nije pokazao utjecaj na embriofetalnu održivost i razvoj u kunića, ali je u štakora uočen povećan broj majki koje su rađale mrtvorođene potomke (vidjeti dio 5.3).
English: Stop the treatment and immediately consult your doctor in the event of:
Croatian: Odmah prekinite liječenje i obratite se liječniku ako se jave:
English: The pharmacodynamic profile of amifampridine has been studied for a range of doses.
Croatian: Farmakodinamički profil amifampridina proučavan je u rasponu doza.
English: In this four-day study, patients were randomized (1:1) to amifampridine phosphate (at patient's optimal dose) or placebo on Day 0.
Croatian: U ovom četverodnevnom ispitivanju bolesnici su na dan 0 randomizirani (1:1) na amifampridinfosfat (pri optimalnoj dozi za svakog bolesnika) ili placebo.
English: It improves muscle strength and resting compound muscle action potential (CMAP) amplitudes with an overall weighted mean difference of 1.69 mV (95% CI 0.60 to 2.77).
Croatian: Poboljšava snagu mišića i amplitude sumacijskog mišićnog akcijskog potencijala (CMAP) u mirovanju s ukupnom ponderiranom srednjom vrijednosti razlike od 1,69 mV (95% CI 0,60 do 2,77).
English: The mean caffeine acetylator ratio for these 12 subjects receiving four escalating doses were 0.408 and 0.172 for fast and slow acetylators types respectively.
Croatian: Srednja vrijednost omjera acetilatora kofeina za ovih 12 ispitanika koji su primili četiri rastuće doze bila je 0,408 za brze, odnosno 0,172 spore acetilatore.
English: Bronchial hypersecretion, asthma attack in asthmatic patients or patients with a history of asthma, cough
Croatian: Hipersekrecija bronhija, astmatični napadaji u astmatičnih bolesnika ili u bolesnika s anamnezom astme, kašalj
English: This evaluation was conducted in a Phase 1, double-blind, randomized, crossover study to define the ECG effects of amifampridine phosphate at these doses compared to placebo and moxifloxacin (a positive control) in healthy men and women who are slow acetylators (n=52).
Croatian: Ova je procjena provedena u dvostruko slijepom, randomiziranom, ukriženom ispitivanju faze 1 za definiranje EKG učinka amifampridin fosfata u tim dozama u usporedbi s placebom i moksifloksacinom (pozitivna kontrola) u zdravih muškaraca i žena koji su spori acetilatori (n=52).
English: Cardiac effects
Croatian: Kardiološki učinci
English: The decision to administer proconvulsant or epileptic-threshold lowering substances concomitantly should be carefully considered in the light of the severity of the associated risks.
Croatian: Odluku o istovremenoj primjeni prokonvulziva ili tvari koje snižavaju epileptički prag treba pažljivo razmotriti u svjetlu težine pridruženih rizika.