FrancophonIA/ELRC3.0 huggingface dataset:
English: In these studies, the proportions of patients with no signs of viral activity in their blood 6 months after treatment were 32% with Pegasys and 22% with lamivudine among HBeAg-positive patients (those with the common type of the hepatitis B virus).
Croatian: U tim ispitivanjima udio bolesnika bez znakova virusne aktivnosti u krvi šest mjeseci nakon liječenja iznosio je 32 % s lijekom Pegasys i 22 % s lamivudinom u „HBeAg-pozitivnih” bolesnika (zaraženi čestim tipom virusa hepatitisa B).
English: In a study of 151 children with hepatitis B aged 3 and above, 26% of those treated with Pegasys no longer had viral activity in their blood after 24 weeks, compared with 3% of those not given any treatment.
Croatian: U ispitivanju na 151 djetetu s hepatitisom B u dobi od tri godine i više, u 26 % bolesnika liječenih lijekom Pegasys nije bilo znakova virusne aktivnosti nakon 24 tjedna, u usporedbi s 3 % bolesnika koji nisu bili liječeni.
English: Finally, a study in 55 children showed similar effectiveness with the combination of Pegasys and ribavirin to that seen in adults treated with Pegasys and ribavirin.
Croatian: Naposljetku, ispitivanje koje je obuhvatilo 55 djece pokazalo je sličnu učinkovitost kombinacije lijeka Pegasys i ribavirina u odnosu na zabilježenu učinkovitost u odraslih osoba liječenih kombinacijom lijeka Pegasys i ribavirina.
English: For hepatitis C, Pegasys has been studied on its own and in combination with other medicines.
Croatian: Za liječenje infekcije hepatitisom C, lijek Pegasys ispitivan je kao monoterapija i u kombinaciji s drugim lijekovima.
English: For practical information about using Pegasys, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Pegasys bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: Another study in 1,149 adult patients showed that the combination of Pegasys with ribavirin was also more effective than Pegasys alone (45% responders at follow-up compared with 24%) and as effective as the combination of interferon alfa-2a and ribavirin (39% responders).
Croatian: Drugo ispitivanje na 1 149 odraslih bolesnika pokazalo je da je kombinacija lijeka Pegasys i ribavirina bila također učinkovitija od monoterapije lijekom Pegasys (45 % bolesnika koji su odgovorili na liječenje tijekom praćenja, u usporedbi s 24 %), te je bila jednako učinkovita kao kombinacija interferona alfa-2a i ribavirina (39 % bolesnika koji su odgovorili na liječenje).
English: In Pegasys, the interferon alfa-2a has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Croatian: Kod lijeka Pegasys interferon alfa-2a je „pegiliran” (pričvršćen na kemijski spoj zvan polietilen-glikol).
English: What benefits of Pegasys have been shown in studies?
Croatian: Koje su koristi od lijeka Pegasys utvrđene u ispitivanjima?
English: How does Pegasys work?
Croatian: Kako djeluje Pegasys?
English: How is Pegasys used?
Croatian: Kako se Pegasys koristi?
English: Pegasys can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of hepatitis B or C. For further information see the package leaflet.
Croatian: Lijek Pegasys izdaje se samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u liječenju infekcije hepatitisom B ili hepatitisom C.
English: For the full list of restrictions with Pegasys, see the package leaflet.
Croatian: Potpuni popis ograničenja za lijek Pegasys potražite u uputi o lijeku.
English: The active substance in Pegasys, peginterferon alfa-2a, belongs to the group ‘interferons'.
Croatian: Djelatna tvar lijeka Pegasys, peginterferon alfa-2a, pripada skupini „interferona”.
English: Doses may need to be adjusted for patients who experience side effects.
Croatian: U bolesnika u kojih nastupe nuspojave možda će trebati prilagoditi dozu.
English: Pegasys contains the active substance peginterferon alfa-2a.
Croatian: Lijek Pegasys sadržava djelatnu tvar peginterferon alfa-2a.
English: For the full list of all side effects reported with Pegasys, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih prilikom primjene lijeka Pegasys potražite u uputi o lijeku.
English: Pegasys is usually used alone for hepatitis B infection but is taken in combination with other medicines for hepatitis C. For more information about when to use this medicine in adults and children, see the summary of product characteristics (SmPC).
Croatian: Lijek Pegasys uglavnom se primjenjuje kao monoterapija za liječenje infekcije virusom hepatitisa B, ali se za liječenje infekcije virusom hepatitisa C uzima u kombinaciji s drugim lijekovima.
English: What is in this leaflet?
Croatian: Što se nalazi u ovoj uputi?
English: You may also have difficulty sleeping.
Croatian: Možete imati i problema sa spavanjem.
English: Your doctor will need to check this regularly while you are taking
Croatian: Liječnik će Vam to morati redovito provjeravati dok uzimate
English: - You have heart problems.
Croatian: - ako imate srčanih problema.
English: Date of first authorisation: 31/03/2016
Croatian: Datum prvog odobrenja: 31/03/2016
English: Component of a multipack, cannot be sold separately.
Croatian: Dio višestrukog pakiranja, ne može se prodavati pojedinačno.
English: In case of overdose, hospitalisation and monitoring of the vital functions are recommended.
Croatian: U slučaju predoziranja, preporučuje se hospitalizacija i praćenje vitalnih funkcija.
English: Do not take a dose of Wakix in the afternoon since you may have difficulty sleeping.
Croatian: Ne uzimajte dozu Wakixa poslijepodne jer biste mogli imati problema sa spavanjem.
English: You should be cautious with activities that require attention such as driving a car and handling machinery.
Croatian: Trebali biste biti oprezni s aktivnostima koje zahtijevaju pažnju poput upravljanja autom ili upravljanja strojevima.
English: If you forget to take your medicine take the next dose at the usual time, do not take a double dose to make up for the forgotten one.
Croatian: Ako ste zaboravili uzeti lijek, uzmite sljedeću dozu u uobičajeno vrijeme, nemojte uzimati dvostruku dozu kako biste nadoknadili zaboravljenu.
English: Take Wakix once a day by mouth, in the morning with your breakfast.
Croatian: Wakix uzimajte kroz usta jednom dnevno, ujutro uz doručak.
English: However, treatment discontinuation should be monitored.
Croatian: Međutim, prekid liječenja treba nadzirati.
English: Take this leaflet and any remaining tablets with you.
Croatian: Sa sobom ponesite ovu uputu i preostale tablete.
English: Limited data are available in elderly.
Croatian: Za starije osobe dostupni su ograničeni podaci.
English: This leaflet was last revised in
Croatian: Ova uputa je zadnji put revidirana
English: 75002 Paris
Croatian: 75002 Pariz
English: - Substrates of OCT1
Croatian: - Supstrati OCT1
English: Inter individual variability is rather high, some volunteers showing outlier high profile (without tolerance issues).
Croatian: Interindividualna varijabilnost prilično je visoka, neki dobrovoljci pokazuju naglašeno visoki profil (bez problema s tolerancijom).
English: 40 Boulevard de Champaret 38300 Bourgoin-Jallieu France
Croatian: 40 Boulevard de Champaret 38300 Bourgoin-Jallieu Francuska
English: In case of significant weight change, treatment should be re-evaluated by the physician.
Croatian: U slučaju značajne promjene težine, liječnik treba ponovno procijeniti liječenje.
English: The safety and efficacy of pitolisant in children aged from 0 to 18 years old have not yet been established.
Croatian: Sigurnost i djelotvornost pitolizanta u djece dobi od 0 do 18 godina nisu još ustanovljene.
English: Your doctor may need to adjust your doses.
Croatian: Možda će Vam liječnik morati prilagoditi dozu.
English: It might take a few days before you feel the benefit of the medicine and the maximum benefit is usually felt after a few weeks.
Croatian: Može proći nekoliko dana prije nego što osjetite povoljno djelovanje lijeka, a najveće djelovanje obično se osjeti nakon nekoliko tjedana.
English: These effects were mostly mild to moderate.
Croatian: Ti su učinci uglavnom bili blagi do umjereni.
English: It caused a delay in post-natal development (safety margin of 1).
Croatian: Uzrokovao je odgodu postnatalnog razvoja (sigurnosna granica 1).
English: The total daily dose should be administered as a single dose in the morning during breakfast.
Croatian: Ukupnu dnevnu dozu treba uzeti kao jednu dozu ujutro tijekom doručka.
English: - You have severe epilepsy.
Croatian: - ako imate tešku epilepsiju.
English: Any change in dosage must be prescribed and monitored by your doctor.
Croatian: Svaku promjenu doze mora propisati i nadzirati liječnik.
English: There is not enough information available to know whether any particular risk is associated with the use of Wakix during pregnancy.
Croatian: Nema dovoljno dostupnih informacija kako bi se znalo je li ikakav poseban rizik povezan s primjenom Wakixa tijekom trudnoće.
English: Maintenance of efficacy
Croatian: Održavanje djelotvornosti
English: At any time, your doctor can increase or decrease your dose depending on how well the medicine works for you and how well you tolerate it.
Croatian: Liječnik Vam u svakom trenutku može povećati ili smanjiti dozu, ovisno o tome kako dobro lijek djeluje te kako dobro ga podnosite.
English: What Wakix is and what it is used for
Croatian: Što je Wakix i za što se koristi
English: If they persist a corrective treatment with proton pump inhibitor could be initiated.
Croatian: Ako se nastave, moglo bi se započeti korektivno liječenje inhibitorima protonske pumpe.
English: As long-term efficacy data are limited (see section 5.1), the continued efficacy of treatment should be regularly evaluated by the physician.
Croatian: Budući da su podaci o dugotrajnoj djelotvornosti ograničeni (vidjeti dio 5.1), liječnik treba redovito provjeravati kontinuiranu djelotvornost liječenja.
English: Treatment should be initiated by a physician experienced in the treatment of sleep disorders.
Croatian: Liječenje treba započeti liječnik s iskustvom u liječenju poremećaja spavanja.
English: Studies in animals have shown reproductive toxicity, including teratogenicity.
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost, uključujući teratogenost.
English: *p<0.0001 vs placebo
Croatian: *p<0,0001 u odnosu na placebo
English: The most serious ADRs are abnormal weight decrease (0.09%) and abortion spontaneous (0.09%).
Croatian: Najozbiljnije nuspojave su abnormalno smanjenje težine (0,09 %) i spontani pobačaji (0,09 %).
English: Other medicines and Wakix
Croatian: Drugi lijekovi i Wakix
English: You should continue to take Wakix for as long as instructed by your doctor.
Croatian: Trebali biste nastaviti uzimati Wakix onoliko dugo koliko je odredio Vaš liječnik.
English: If you are unsure whether your condition has a negative effect on your ability to drive, talk to your doctor.
Croatian: Ako niste sigurni utječe li Vaše stanje negativno na sposobnost upravljanja vozilima, obratite se liječniku.
English: Pain Night sweats Sense of oppression
Croatian: Bol Noćno znojenje Osjećaj opresije
English: Pitolisant should not be used during pregnancy unless the potential benefit outweighs the potential risk for foetus.
Croatian: Pitolizant se ne smije primjenjivati tijekom trudnoće, osim ako je moguća korist veća od mogućeg rizika za fetus.
English: Wakix passes into breast milk in animal.
Croatian: Wakix prelazi u mlijeko kod životinja.
English: Final report: 3Q 2023
Croatian: Završno izvješće: 3. kvartal 2023. godine
English: No clinical data on the magnitude of this interaction are available.
Croatian: Klinički podaci o jačini te interakcije nisu dostupni.
English: Headache and insomnia During clinical studies, episodes of headache and insomnia have been reported (7.7 % to 8.4%).
Croatian: Glavobolja i nesanica Tijekom kliničkih ispitivanja, zabilježene su epizode glavobolje i nesanice (7,7 % do 8,4 %).
English: Harmony Ibis, study with a similar design, was limited to 18 mg once a day.
Croatian: Harmony Ibis, slično osmišljeno istraživanje, bilo je ograničeno na 18 mg jednom dnevno.
English: In patients with mild hepatic impairment (Child-Pugh A), there was no significant changes in pharmacokinetics compared with normal healthy volunteers.
Croatian: Kod bolesnika s blagim oštećenjem jetre (Child-Pugh A), nije bilo značajnih promjena u farmakokinetici u odnosu na normalne zdrave dobrovoljce.
English: Extrasystoles Bradycardia
Croatian: Ekstrasistole Bradikardija
English: You can find the information also when flashing the QR code below.
Croatian: Informacije možete pronaći i skeniranjem QR koda u nastavku.
English: Pitolisant has a plasma half-life of 10-12 hours.
Croatian: Pitolizantov poluvijek u plazmi je 10 - 12 sati.
English: To date, there are limited amount of data from an open label study on long term efficacy of Wakix in this indication.
Croatian: Do danas su prikupljene ograničene količine podataka iz otvorenog ispitivanja o dugotrajnoj djelotvornosti Wakixa za ovu indikaciju.
English: If you take too many tablets of Wakix, contact your nearest hospital casualty department or tell your doctor or pharmacist immediately.
Croatian: Ako uzmete previše tableta Wakixa, javite se u najbliži hitni bolnički prijem ili odmah obavijestite svog liječnika ili ljekarnika.
English: Narcolepsy is a condition that causes excessive daytime sleepiness and a tendency to suddenly fall asleep in inappropriate situations (sleep attacks).
Croatian: Narkolepsija je stanje koje uzrokuje pretjeranu pospanost tijekom dana i sklonost prema iznenadnom padanju u san u neprikladnim situacijama (napadaji sna).
English: Pitolisant was neither genotoxic nor carcinogenic.
Croatian: Pitolizant nije ni genotoksičan niti kancerogen.
English: Cataplexy is the onset of sudden muscle weakness or paralysis without losing consciousness, in response to a sudden emotional reaction such as anger, fear, joy, laughter or surprise.
Croatian: Katapleksija je nastup iznenadne mišićne slabosti ili paralize bez gubitka svijesti, kao odgovor na iznenadnu emocionalnu reakciju kao što je ljutnja, strah, radost, smijeh ili iznenađenje.
English: What Wakix looks like and contents of the pack
Croatian: Kako Wakix izgleda i sadržaj pakiranja
English: If you take more Wakix than you should
Croatian: Ako uzmete više Wakixa nego što ste trebali
English: If symptoms persist a reduced daily dose or discontinuation should be considered.
Croatian: Ako simptomi ustraju, treba razmotriti smanjenje dnevne doze ili prekid uzimanja lijeka.
English: This effect on EDS was confirmed by the results on Maintenance of Wakefulness Test (MWT).
Croatian: Taj učinak na EDS potvrdili su rezultati testa održavanja budnosti (MWT).
English: Pitolisant exhibits high serum protein binding (>90%) and demonstrates approximately equal distribution between red blood cells and plasma.
Croatian: Pitolizant ima svojstvo visokog vezivanja serumskih proteina (>90 %) i otprilike se jednako distribuira između crvenih krvnih stanica i plazme.
English: There is no clearly identified antidote.
Croatian: Ne postoji jasno utvrđeni protulijek.
English: Pharmacotherapeutic group: Other nervous system drugs, ATC code: N07XX11.
Croatian: Farmakoterapijska skupina: ostali lijekovi koji djeluju na živčani sustav, ATK oznaka: N07XX11.
English: Severe hepatic impairment (Child-Pugh C).
Croatian: Teško oštećenje jetre (Child-Pugh C).
English: When pitolisant dose is doubled from 27 to 54 mg, AUC0-∞ is increased by about 2.3.
Croatian: Kad se doza pitolizanta udvostruči s 27 na 54 mg, AUC0-∞ se povećava za otprilike 2,3.
English: If any of these apply to you, talk to your doctor or pharmacist before taking Wakix.
Croatian: Ako se bilo što od navedenog odnosi na Vas, obratite se liječniku ili ljekarniku prije nego što uzmete Wakix.
English: Narcolepsy (with or without cataplexy) is a chronic condition.
Croatian: Narkolepsija (s katapleksijom ili bez nje) kronično je stanje.
English: Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
Croatian: Ovojnica poli(vinilni alkohol) titanijev dioksid (E171) makrogol 3350 talk
English: QR code to be included URL {EMA website corresponding product information not yet known}.
Croatian: QR kod koji treba biti umetnut URL {internetska stranica EMA-e s odgovarajućim informacijama o lijeku još nije poznata}.
English: Treatment is normally started with a dose of 9 mg once per day, and gradually increased over three weeks to the most appropriate dose.
Croatian: Liječenje se obično započinje dozom od 9 mg jednom dnevno te se postupno povećava tijekom tri tjedna do najprikladnije doze.
English: If you are a woman, you have to take a contraceptive during your treatment with Wakix and at least up to 21 days after treatment discontinuation.
Croatian: Ako ste žena, morate koristiti kontracepciju tijekom liječenja Wakixom, i barem 21 dan nakon prekida liječenja.
English: Decreased appetite Increased appetite Fluid retention
Croatian: Smanjeni apetit Povećani apetit Zadržavanje tekućine
English: A clinical monitoring should be made when both active substances are combined and, eventually a dosage adjustment during the combination and one week after the inducer treatment.
Croatian: Treba provesti klinički nadzor pri kombinaciji obiju djelatnih tvari, i na kraju prilagodbu doze tijekom kombiniranja lijekova i jedan tjedan nakon liječenja induktorom.
English: Above 80 years old, kinetics show a slight variation without clinical relevance.
Croatian: Kod bolesnika u dobi iznad 80 godina, kinetika pokazuje neznatne varijacije bez kliničke značajnosti.
English: In 68 to 80 years old patients the pharmacokinetics of pitolisant is not different compared to younger patients (18 to 45 years of age).
Croatian: Farmakokinetika pitolizanta u bolesnika u dobi od 68 do 80 godina ne razlikuje se od one u mlađih bolesnika (dobi od 18 do 45 godina).
English: Upon repeated administrations, the steady state is achieved after 5-6 days of administration leading to an increased serum level around 100%.
Croatian: Nakon ponovljene primjene, stanje dinamičke ravnoteže postiže se 5 - 6 dana nakon primjene što dovodi do povećane razine serume za otprilike 100 %.
English: Non-interventional post-authorisation safety study (PASS): A multi-center, observational post-authorization safety study to document the drug utilisation of Wakix and to collect information on the safety of Wakix when used in routine medical practice
Croatian: Post-Authorisation Safety Study, PASS): multicentrično, opservacijsko ispitivanje sigurnosti primjene lijeka nakon dobivanja odobrenja za stavljanje lijeka u promet u svrhu dokumentiranja potrošnje lijeka Wakix i prikupljanja informacija o sigurnosti primjene Wakixa kad se koristi u rutinskoj medicinskoj praksi.
English: Patients taking Wakix must stop breastfeeding.
Croatian: Bolesnice koje uzimaju Wakix moraju prestati dojiti.
English: You may experience headaches, stomach pain, feeling sick or irritable.
Croatian: Možete osjetiti glavobolje, bol u trbuhu, mučninu ili razdražljivost.
English: • Risk Management Plan (RMP) The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: • Plan upravljanja rizikom (RMP) Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim nadopunama Plana.
English: The elimination is mainly achieved via urine (approximately 63%) through an inactive non conjugated metabolite (BP2.951) and a glycine conjugated metabolite.
Croatian: Izlučivanje se uglavnom postiže putem urina (otprilike 63 %) putem neaktivnog nekonjugiranog metabolita (BP2.951) i konjugiranog metabolita glicina.
English: A dosage adjustment during the combination could eventually be considered.
Croatian: Na kraju se može razmotriti prilagodba doze tijekom kombiniranja lijekova.
English: Pitolisant is well and rapidly absorbed with peak plasma concentration reached approximately three hours after administration.
Croatian: Pitolizant se brzo i dobro apsorbira, pri čemu se vršna koncentracija u plazmi dostiže približno tri sata nakon primjene.
English: However no increase in dopamine release in the striatal complex including nucleus accumbens was evidenced for pitolisant.
Croatian: Međutim, povećano otpuštanje dopamina u strijatalnom kompleksu, uključujući nucleus accumbens, nije primijećeno pri uzimanju pitolizanta.
English: In clinical trials, no specific cardiac safety signal was identified at therapeutic doses of pitolisant.
Croatian: U kliničkim ispitivanjima nije utvrđen određeni srčani sigurnosni signal pri terapijskim dozama pitolizanta.
English: Do not change doses of Wakix on your own.
Croatian: Nemojte sami mijenjati dozu Wakixa.
English: In the up-titration scheme, dose increment should take into account this higher exposure.
Croatian: U planu povećanja doze, treba uzeti u obzir tu veću izloženost prilikom povećanja doze.
English: Toxic skin eruption Photosensitivity
Croatian: Toksične kožne erupcije Fotoosjetljivost
English: The primary efficacy endpoint was the change in the average number of cataplexy attacks per week between the 2 weeks of baseline and the 4 weeks of stable treatment period at the end of study.
Croatian: Primarni ishod djelotvornosti bila je promjena prosječnog broja napadaja katapleksije tjedno između 2 tjedna na početku ispitivanja i 4 tjedna stabilnog liječenja na kraju ispitivanja.
English: In clinical trials, one epilepsy aggravation was reported in one epileptic patient.
Croatian: U kliničkim ispitivanjima zabilježeno je jedno pogoršanje epilepsije u jednog bolesnika s epilepsijom.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Wakix in one or more subsets of the paediatric population in narcolepsy with or without cataplexy (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka Wakix u jednoj ili više podskupina pedijatrijske populacije za narkolepsiju s katapleksijom ili bez nje (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: The MWT value in the pitolisant group was 80% higher than in the placebo group.
Croatian: Vrijednost MWT-a u skupini koja je primala pitolizant bila je 80 % viša nego u skupini koja je primala placebo.
English: Wakix can affect the way other medicines work and other medicines can affect the way Wakix works.
Croatian: Wakix može utjecati na djelovanje drugih lijekova, a drugi lijekovi mogu utjecati na djelovanje Wakixa.
English: Pitolisant blocked hERG channel with an IC50 exceeding therapeutic concentrations and induced a slight QTc prolongation in dogs.
Croatian: Pitolizant je blokirao hERG kanal s IC50 koji premašuje terapijske koncentracije i inducirao je lagano produljenje intervala QTc kod pasa.
English: Pitolisant also modulates various neurotransmitter systems, increasing acetylcholine, noradrenaline and dopamine release in the brain.
Croatian: Pitolizant također utječe na razne neurotransmiterske sustave, povećano otpuštanje acetilkolina, noradrenalina i dopamina u mozgu.
English: Maintenance of Wakefulness Test (MWT)) and attention (e.g.
Croatian: Maintenance of Wakefulness Test, MWT)) i pažnje (npr. test održavanja pažnje za odgovor (engl.
English: Study in animals has shown effects on semen parameters, without a significant impact on reproductive performance in males and reduction on the percentage of live foetuses in treated females (see section
Croatian: Ispitivanja na životinjama pokazala su učinak na parametre sjemena, bez značajnog utjecaja na reproduktivnu sposobnost u mužjaka i smanjenje postotka živih fetusa u liječenih ženki (vidjeti dio
English: Wakix should not be used during pregnancy unless your doctor says so.
Croatian: Wakix se ne smije primjenjivati tijekom trudnoće, osim prema uputi liječnika.
English: - Enzyme inducers
Croatian: - Induktori enzima