FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, the company that markets Scenesse will ensure that doctors receive educational material and are trained in how to use the medicine.
Croatian: Nadalje, tvrtka koja stavlja lijek Scenesse u promet osigurat će da liječnici prime edukativne materijale te da završe obuku za uporabu lijeka.
English: Since Scenesse has been approved under exceptional circumstances, the company that markets Scenesse will provide longer-tem data on the benefits and safety of the medicine from an EU registry of patients taking the medicine.
Croatian: Budući da je lijek Scenesse odobren u iznimnim okolnostima, tvrtka koja lijek Scenesse stavlja u promet mora dostaviti dugoročne podatke o koristima i sigurnoj primjeni lijeka iz registra EU-a za bolesnike koji uzimaju lijek.
English: The CHMP noted that Scenesse led to an increase in the amount of time patients could spend in direct sunlight without experiencing pain.
Croatian: CHMP je zaključio da Scenesse rezultira povećanjem u količini vremena koju bolesnici mogu provesti na izravnoj sunčevoj svjetlosti bez da iskuse bol.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Scenesse, including information on the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Scenesse nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Scenesse is only prescribed by specialist doctors in recognised centres for treating EPP and should only be used by doctors who have been properly trained.
Croatian: Scenesse smije propisivati samo liječnik specijalist u priznatim centrima zaliječenje EPP-a, a lijek treba primjenjivati liječnik koji je prošao odgovarajuću obuku.
English: How does Scenesse work?
Croatian: Kako djeluje Scenesse?
English: For more information about treatment with Scenesse, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Scenesse pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: What benefits of Scenesse have been shown in studies?
Croatian: Koje su koristi lijeka Scenesse utvrđene u ispitivanjima?
English: How is Scenesse used?
Croatian: Kako se Scenesse koristi?
English: Scenesse has been shown in a study to lead to an increase in the amount of time patients can spend in sunlight.
Croatian: Ispitivanjima je utvrđeno da Scenesse rezultira povećanjem količine vremena koju bolesnici mogu provesti izloženi sunčevoj svjetlosti.
English: For practical information about using Scenesse, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Scenesse pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: Although the additional time spent in sunlight was small, the Committee considered the possible improvements in quality of life, the unmet medical need in patients with EPP, and the mild side effects seen during short-term treatment with the medicine in deciding to recommend approval for Scenesse in the EU.
Croatian: Odbor je razmotrio moguća poboljšanja u kvaliteti života, neudovoljenu medicinsku potrebu u bolesnika s EPP-om, i blage nuspojave uočene tijekom kratkoročnog liječenja lijekom.
English: For more information on how to use Scenesse, see the summary of product characteristics (also part of the EPAR).
Croatian: Za dodatne informacije o primjeni lijeka Scenesse, pogledajte sažetak opisa svojstava lijeka (također dio EPAR-a).
English: For the full list of all side effects and restrictions with Scenesse, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Scenesse potražite u uputi o lijeku.
English: Over 24 weeks
Croatian: Tijekom 24 tjedna
English: However, Cmax increases by 15-23%.
Croatian: Međutim, Cmax se povećava za 15-23%.
English: The usual dosing regimen should always be followed.
Croatian: Treba se uvijek pridržavati uobičajenog režima doziranja.
English: You may also notice other effects not listed here.
Croatian: Isto tako možete opaziti druge učinke koji nisu ovdje navedeni.
English: There is limited safety information in these patients.
Croatian: Za ove bolesnike postoje ograničene informacije o sigurnosti.
English: Do not give Fampyra to children or adolescents under the age of 18 years.
Croatian: Nemojte dati Fampyru djeci i adolescentima mlađima od 18 godina.
English: The safety and efficacy of Fampyra in children aged 0 to 18 years have not been established.
Croatian: Sigurnost i djelotvornost Fampyre u djece u dobi od 0 do 18 godina nisu ustanovljene.
English: Children and in adolescents
Croatian: Djeca i adolescenti
English: − The other ingredients are:
Croatian: Drugi sastojci su:
English: The small reduction in AUC is not expected to cause a reduction in the therapeutic efficacy.
Croatian: Ne očekuje se da bi malo smanjenje u AUC uzrokovalo smanjenje terapijske djelotvornosti.
English: Fampyra should be taken without food, on an empty stomach.
Croatian: Fampyru treba uzeti bez hrane na prazan želudac.
English: Frequencies are defined as: 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: Učestalosti su definirane kao: vrlo često (≥1/10); često (≥1/100 do <1/10); manje često (≥1/1000 do <1/100); rijetko (≥1/10 000 do <1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The improvement appeared rapidly (within weeks) after starting Fampyra.
Croatian: Poboljšanje se pojavilo brzo (unutar nekoliko tjedana) nakon početka uzimanja Fampyre.
English: Fampyra with food and drink
Croatian: Fampyra s hranom i pićem
English: Do not take more than two tablets in a day.
Croatian: Nemojte uzeti više od dvije tablete u danu.
English: Interaction studies have only been performed in adults.
Croatian: Ispitivanja interakcija provedena su samo u odraslih ispitanika.
English: Reports of hypertension have also been received.
Croatian: Također su zabilježeni izvještaji o hipertenziji.
English: ≥20% improvement
Croatian: ≥20% poboljšanje Razlika
English: Contents of the pack and other information
Croatian: Sadržaj pakiranja i dodatne informacije
English: Creatinine clearance can be estimated using the Cockroft-Gault formula.
Croatian: Klirens kreatitnina se može procijeniti pomoću Cockroft-Gaultove formule.
English: Fampridine has a narrow therapeutic index.
Croatian: Fampridin ima uzak terapijski indeks.
English: May affect up to 1 in 10 people:
Croatian: Može zahvatiti do 1 od 10 osoba:
English: 43% Risk difference: 10.4%
Croatian: 43% Razlika rizika: 10,4%
English: Leave the desiccant in the bottle, do not swallow it.
Croatian: Ostavite sredstvo za sušenje u boci, nemojte ga progutati.
English: After 2 to 4 weeks the treatment will be reassessed.
Croatian: Nakon 2 do 4 tjedna, liječenje će biti ponovno procijenjeno.
English: What Fampyra is and what it is used for
Croatian: Što je Fampyra i za što se koristi
English: After first opening a bottle, use within 7 days.
Croatian: Nakon prvog otvaranja boce, upotrijebiti u roku od 7 dana.
English: The difference in the Berg Balance Scale (BBS; a measure of static balance), was not statistically significant.
Croatian: Razlika na Bergovoj ljestvici za mjerenje ravnoteže (Berg Balance Scale, BBS; mjerenje statičke ravnoteže) nije bila statistički značajna.
English: Date of first authorisation: 20 July 2011 Date of latest renewal: 18 May 2017
Croatian: Datum posljednje obnove odobrenja: 18. svibnja 2017.
English: Take the Fampyra box with you if you go to see the doctor.
Croatian: Ponesite kutiju Fampyre sa sobom ako idete liječniku.
English: OCT2 is the transporter responsible for the active secretion of fampridine.
Croatian: OCT2 je transporter odgovoran za aktivno izlučivanje fampridina.
English: Make sure you're not affected before you start driving or use machinery.
Croatian: Pobrinite se da niste pod utjecajem lijeka prije početka upravljanja vozilom ili korištenja strojeva.
English: Fampridine has a volume of distribution of approximately 2.6 l/kg.
Croatian: Volumen distribucije fampridina je otprilike 2,6 l/kg.
English: − you should use a walking aid, such as a cane, as needed
Croatian: − koristite pomagala za hodanje, npr. štap za hodanje, po potrebi
English: The tablets should be taken without food (see section 5.2).
Croatian: Tablete treba uzimati bez hrane (vidjeti dio 5.2).
English: The tablet must be swallowed whole.
Croatian: Tabletu treba progutati cijelu.
English: These clinical signs were not unexpected and represent exaggerated pharmacology of fampridine.
Croatian: Ti klinički znakovi nisu bili neočekivani i predstavljaju pojačano izraženu farmakologiju fampridina.
English: If you forget to take a tablet, do not take two tablets at once to make up for a missed dose.
Croatian: Ukoliko zaboravite uzeti tabletu, nemojte uzeti dvije tablete odjednom kako biste nadoknadili propuštenu dozu.
English: Study 218MS305 was conducted in 636 subjects with multiple sclerosis and walking disability.
Croatian: Ispitivanje 218MS305 provedeno je u 636 ispitanika s multiplom sklerozom i nesposobnošću hodanja.
English: A double dose should not be taken if a dose is missed.
Croatian: Ne smije se uzeti dvostruka doza ukoliko je jedna doza propuštena.
English: Your doctor will consider the benefit of you being treated with Fampyra against the risk to your baby.
Croatian: Liječnik će razmotriti koristi liječenja Fampyrom za Vas naspram rizika za Vašu bebu.
English: • Flu (influenza)
Croatian: • Gripa (influenca)
English: If an anaphylactic or other serious allergic reaction occurs, Fampyra should be discontinued and not restarted.
Croatian: Ako dođe do anafilaktičke ili druge ozbiljne alergijske reakcije, liječenje Fampyrom treba prekinuti i ne ponovno započinjati.
English: Difference (95% CI) p - value
Croatian: Razlika (95% CI) p-vrijednost
English: 1171 LP Badhoevedorp The Netherlands
Croatian: 1171 LP Badhoevedorp
English: You should not breast-feed whilst taking this medicine.
Croatian: Ne smijete dojiti dok uzimate ovaj lijek.
English: Do not take the tablets more often than every 12 hours.
Croatian: Nemojte uzeti tablete češće nego svakih 12
English: Other medicines and Fampyra
Croatian: Drugi lijekovi i Fampyra
English: Biotransformation:
Croatian: Biotransformacija
English: − if you feel aware of your heartbeat (palpitations)
Croatian: − ako svjesno osjećate svoje otkucaje srca (palpitacije)
English: If your Fampyra is supplied in bottles, only one bottle should be opened at a time.
Croatian: Ako je Vaša Fampyra dostupna u bocama, treba otvoriti samo jednu bocu u isto vrijeme.
English: Animal studies have shown reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama su pokazala reproduktivnu toksičnost (vidjeti dio 5.3).
English: Your doctor will give you an initial prescription for 2 to 4 weeks.
Croatian: Liječnik će Vam na početku propisati lijek za 2 do 4 tjedna.
English: Pharmacotherapeutic group: Other nervous system drugs, ATC code: N07XX07.
Croatian: Farmakoterapijska skupina: Drugi lijekovi za živčani sustav, ATK oznaka: N07XX07.
English: • Initial prescription should be limited to two to four weeks of therapy as clinical benefits should generally be identified within two to four weeks after starting Fampyra
Croatian: • Početno propisivanje treba biti ograničeno na dva do četiri tjedna terapije, jer se klinička korist općenito treba uočiti unutar dva do četiri tjedna nakon početka liječenja Fampyrom
English: MSIS-29 physical score
Croatian: MSIS-29 fizički rezultat Početak
English: *Intent to treat population = 633; LSM = Least square mean
Croatian: *Populacija predviđena za liječenje = 633; LSM (engl. least square mean) = metoda najmanjih kvadrata
English: Duration of double-blind treatment was 24 weeks with a 2 week post-treatment follow-up.
Croatian: Trajanje dvostruko slijepog ispitivanja iznosilo je 24 tjedna s praćenjem poslije liječenja od 2 tjedna.
English: Clinical studies of Fampyra did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients.
Croatian: Klinička ispitivanja Fampyre nisu uključila dovoljno ispitanika u dobi od 65 i više godina, da bi se moglo utvrditi jesu li njihove reakcije na lijek drugačije nego u mlađih bolesnika.
English: − if you are allergic to fampridine or any of the other ingredients of this medicine (listed in section 6)
Croatian: − ako ste alergični na fampridin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: It is unknown whether fampridine is excreted in human or animal milk.
Croatian: Nije poznato izlučuje li se fampridin u majčino mlijeko u ljudi ili životinja.
English: What Fampyra is and what it is used for What you need to know before you take Fampyra How to take Fampyra
Croatian: Što je Fampyra i za što se koristi Što morate znati prije nego počnete uzimati Fampyru
English: If you forget to take Fampyra
Croatian: Ako ste zaboravili uzeti Fampyru
English: Orally administered fampridine is rapidly and completely absorbed from the gastrointestinal tract.
Croatian: Peroralno primijenjen fampridin se brzo i potpuno apsorbira iz gastrointestinalnog trakta.
English: If you have a seizure, stop taking Fampyra and tell your doctor immediately.
Croatian: Ukoliko imate epileptički napadaj, prestanite uzimati Fampyru i odmah o tome obavijestite svog liječnika.
English: If decline in walking ability is observed, physicians should consider an interruption to treatment in order to reassess the benefits of Fampyra (see above).
Croatian: Ukoliko se opazi da je došlo do smanjenja mogućnosti hodanja, liječnik treba razmotriti prekid liječenja kako bi ponovno procijenio koristi Fampyre (vidjeti gore).
English: The re-evaluation should include withdrawal of Fampyra and performing an assessment of walking ability.
Croatian: Ponovna procjena treba uključiti prekid davanja Fampyre i procjenu mogućnosti hodanja.
English: • Upset stomach
Croatian: • Nadražen želudac
English: One tablet in the morning and one tablet in the evening (12 hours apart).
Croatian: Jedna tableta ujutro i jedna tableta navečer (12 sati razmaka).
English: However, no increased risk for malformations or adverse effects on fertility was noted.
Croatian: Međutim, nije opažen povećan rizik za pojavu malformacija ili za smanjenje plodnosti.
English: Since there is a clear relationship between Cmax and dose related adverse reactions, it is recommended to take Fampyra without food (see section 4.2).
Croatian: Budući da postoji jasna veza između Cmax i nuspojava povezanih uz dozu, preporučuje se uzeti Fampyru bez hrane (vidjeti dio 4.2).
English: Infections were seen in the clinical studies (see section 4.8) and increased infection rate and impairment of the immune response cannot be excluded.
Croatian: U kliničkim su ispitivanjima opažene infekcije (vidjeti dio 4.8) i ne mogu se isključiti povećana stopa infekcija i narušenost imunološkog sustava.
English: In post-marketing experience, serious hypersensitivity reactions (including anaphylactic reaction) have been reported, the majority of these cases occurred within the first week of treatment.
Croatian: U postmarketinškom razdoblju bilo je prijava ozbiljnih reakcija preosjetljivosti (uključujući i anafilaktičke reakcije) a većina tih slučajeva se pojavila unutar prvog tjedna liječenja.
English: • Difficulty sleeping
Croatian: • Poremećaj spavanja
English: Older people:
Croatian: Starije osobe:
English: In post-marketing experience, there have been reports of seizure, the frequency is not known (cannot be estimated from the available data).
Croatian: U postmarketinškom iskustvu bilo je prijava napadaja nepoznate učestalosti (ne može se procijeniti iz dostupnih podataka).
English: The clinical relevance of these findings remains to be elucidated, but a causal relationship with fampridine treatment cannot be excluded.
Croatian: Klinička relevantnost ovih nalaza još će se morati razjasniti, međutim uzročna veza s terapijom fampridina se ne može isključiti.
English: The recommended dose is one 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening).
Croatian: Preporučena doza je jedna tableta od 10 mg, dva puta na dan, uzeta svakih 12 sati (jedna tableta ujutro i jedna navečer).
English: Fampridine is largely unbound to plasma proteins (bound fraction varied between 3-7% in human plasma).
Croatian: Fampridin uglavnom nije vezan na proteine u plazmi (vezana frakcija u ljudskoj plazmi varira između 3-7%).
English: If you experience one or more of the following allergic (hypersensitivity) symptoms: swollen face, mouth, lips, throat or tongue, reddening or itching of the skin, chest tightness and breathing problems stop taking Fampyra and see your doctor immediately.
Croatian: Ako imate jedan ili više od sljedećih simptoma alergijske reakcije (preosjetljivosti): natečeno lice, usta, usne, grlo ili jezik, crvenilo ili svrbež kože, stezanje u prsnom košu i probleme s disanjem prestanite uzimati Fampyru i javite se odmah svom liječniku.
English: Sat.
Croatian: sati.
English: Fampridine was studied in oral repeat dose toxicity studies in several animal species.
Croatian: Fampridin je ispitan u ispitivanju toksičnosti s ponavljanim oralnim dozama u nekoliko životinjskih vrsta.
English: Renal clearance (CLR 370 ml/min) is substantially greater than glomerular filtration rate due to combined glomerular filtration and active excretion by the renal OCT2 transporter.
Croatian: Bubrežni klirens (CLR 370 ml/min) je znatno veći nego brzina glomerularne filtracije zbog kombinirane glomerularne filtracije i aktivnog izlučivanja preko renalnih OCT2 transportera.
English: Fampyra is characterized by linear (dose-proportional) pharmacokinetics with a terminal elimination half-life of approximately 6 hours.
Croatian: Fampyra pokazuje linearnu (razmjernu dozi) farmakokinetiku s vremenom poluživota terminalne eliminacije od otprilike 6 sati.
English: Fampridine is not a substrate for P-glycoprotein.
Croatian: Fampridin nije supstrat za P-glikoprotein.
English: A responder was defined as a patient who consistently had a faster walking speed for at least three visits out of a possible four during the double blind period as compared to the maximum value among five off-treatment visits.
Croatian: Bolesnik s odgovorom definiran je kao bolesnik koji dosljedno hoda većom brzinom tijekom najmanje tri od mogućih četiri posjeta u dvostruko slijepom razdoblju u odnosu na maksimalnu brzinu u pet posjeta koji nisu bili u okviru terapije.
English: Other side effects at high doses include cases of cardiac arrhythmias (for example, supraventricular tachycardia and bradycardia) and ventricular tachycardia as a consequence of potential QT prolongation.
Croatian: Druge nuspojave pri visokim dozama uključuju slučajeve srčane aritmije (na primjer, supraventrikularna tahikardija i bradikardija) i ventrikularnu tahikardiju kao posljedicu potencijalnog produljenja QT vala.
English: Improvements generally appeared within 2 to 4 weeks of initiation of treatment, and disappeared within 2 weeks of treatment cessation.
Croatian: Poboljšanja su se uglavnom javljala unutar 2 do 4 tjedna od početka liječenja, a nestajala unutar 2 tjedna nakon prestanka liječenja.
English: Patients with prior history or current presentation of seizure.
Croatian: Bolesnici s prethodnom anamnezom ili trenutnim postojanjem napadaja.
English: Hypotension2
Croatian: Hipotenzija2
English: The increased incidence of dizziness and balance disorder seen with Fampyra may result in an increased risk of falls.
Croatian: Povećana incidencija omaglice i poremećaja ravnoteže opažena sa Fampyrom može dovesti do povećanog rizika od pada.
English: − if you are taking a medicine called cimetidine
Croatian: − ako uzimate lijek cimetidin
English: It must not be divided, crushed, dissolved, sucked or chewed.
Croatian: Ne smije se razdijeliti, zdrobiti, otopiti, cuclati ili žvakati.
English: The maximum plasma concentration (Cmax) and, to a smaller extent, area under the plasma concentration-time curve (AUC) increase proportionately with dose.
Croatian: Maksimalna koncentracija u plazmi (Cmax) i, u manjem obimu, površina ispod krivulje koncentracije u plazmi i vremena (AUC) se povećavaju razmjerno dozi.
English: Do not take Fampyra if you are taking any other medicine containing fampridine.
Croatian: Nemojte uzeti Fampyru ako uzimate neki drugi lijek koji sadrži fampridin.
English: − if you are prone to infections
Croatian: − ako ste skloni infekcijama
English: Determining renal function before treatment and its regular monitoring during treatment is recommended in all patients (particularly in older people in whom renal function might be reduced).
Croatian: Preporučuje se određivanje bubrežne funkcije prije liječenja te njezino redovito nadziranje tijekom liječenja za sve bolesnike (naročito za starije osobe u kojih bi funkcija bubrega mogla biti smanjena).
English: For further information on hypersensitivity reactions, please refer to sections 4.3 and 4.4.
Croatian: Za više informacija o reakcijama preosjetljivosti, pogledajte dijelove 4.3 i 4.4.
English: Tell your doctor before you take Fampyra if any of these apply to you.
Croatian: Obavijestite svog liječnika prije nego uzmete Fampyru ako se bilo što od ovog odnosi na Vas.
English: Detailed information on this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu/.
English: This medicine is thought to work by letting signals pass down the nerve more normally, which allows you to walk better.
Croatian: Za ovaj lijek se smatra da djeluje tako što omogućuje normalnije provođenje živčanih impulsa duž živaca, što Vam omogućava da bolje hodate.
English: Other medicines that affect the kidneys
Croatian: Drugi lijekovi koji utječu na bubrege
English: 43% Risk difference: 9.2%
Croatian: Razlika rizika: 9,2%
English: The safety of Fampyra has been evaluated in randomised controlled clinical studies, in open label long term studies and in the post marketing setting.
Croatian: Sigurnost Fampyre je procijenjena u randomiziranim kontroliranim kliničkim ispitivanjima, u otvorenim dugoročnim ispitivanjima kao i nakon stavljanja lijeka u promet.
English: Renal function should be checked in older people before starting treatment with Fampyra.
Croatian: U starijih osoba treba provjeriti funkciju bubrega prije početka liječenja Fampyrom.
English: By blocking potassium channels, Fampyra reduces the leakage of ionic current through these channels, thereby prolonging repolarization and thus enhancing action potential formation in demyelinated axons and neurological function.
Croatian: Blokiranjem tih kanala, Fampyra smanjuje protok ionske struje kroz te kanale, čime se produljuje repolarizacija i tako olakšava nastanak akcijskog potencijala u demijeliniziranim aksonima, a time i neurološka funkcija.
English: This is consistent with fampridine's pharmacological activity.
Croatian: To je u skladu s poznatom farmakološkom aktivnošću fampridina.
English: When Fampyra tablets are taken with food, the reduction in the area under the plasma concentrationtime curve (AUC0-∞) of fampridine is approximately 2-7% (10 mg dose).
Croatian: Kada se Fampyra tablete uzimaju s hranom, smanjenje površine ispod krivulje koncentracije u plazmi i vremena (AUC0-∞) fampridina je otprilike 2-7% (10 mg doza).
English: You can get a larger print version of this leaflet by calling the local representatives (see list below).
Croatian: Sadržaj pakiranja i druge informacije Možete dobiti veću tiskanu verziju ove upute o lijeku tako da nazovete lokalnog predstavnika (vidjeti popis dolje).
English: Do not divide, crush, dissolve, suck or chew the tablet.
Croatian: Nemojte razdijeliti, zdrobiti, otopiti, cuclati ili žvakati tabletu.