FrancophonIA/ELRC3.0 huggingface dataset:
English: It explains how the Agency assessed the medicine to recommend its authorisation and its conditions of use.
Croatian: Objašnjava kako je Agencija ocijenila lijek da bi preporučila njegovo odobrenje te uvjete za njegovu primjenu.
English: Taking the known side effects into account, the Agency considered Vimpat's benefits to be greater than its risks and recommended that it be given marketing authorisation.
Croatian: Uzimajući u obzir poznate nuspojave, Agencija je zaključila da su prednosti od lijeka Vimpat veće od njegovih rizika i preporučila izdavanje odobrenja za stavljanje u promet.
English: The company also provided data to support dosing of Vimpat in children from 4 years of age and supportive results from studies of the safety of Vimpat in this population.
Croatian: Tvrtka je također dostavila podatke kojim se podržava doziranje lijeka Vimpat u djece od četiri godine i dodatne rezultate tome u prilog iz ispitivanja sigurnosti lijeka Vimpat u toj populaciji.
English: This was found to be 90% in those taking Vimpat and 91% in those taking carbamazepine.
Croatian: Ta stopa je 90 % kod bolesnika koji su uzimali Vimpat i 91 % kod bolesnika koji su uzimali karbamazepin.
English: In younger patients weighing less than 50 kg, the dose is based on body weight, and treatment may be started with the syrup.
Croatian: U mlađih bolesnika koji imaju manje od 50 kg, doza se temelji na tjelesnoj težini, a liječenje može započeti sirupom.
English: This is a summary of the European public assessment report (EPAR) for Vimpat.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Vimpat.
English: If the doctor decides that a faster effect is needed, treatment in some patients with Vimpat may be started with a higher first dose (called a loading dose).
Croatian: Ako liječnik odluči da je potrebno ostvariti brži učinak, u nekih bolesnika terapija lijekom liječenje Vimpat može započeti većom prvom dozom (koja se naziva udarna doza).
English: Lower doses should be used in patients with severely reduced kidney function or reduced liver function.
Croatian: Niže doze treba koristiti u bolesnika s ozbiljno smanjenom funkcijom bubrega ili smanjenom funkcijom jetre.
English: Around 78% of Vimpat-treated and 83% of carbamazepine-treated patients did not have a seizure for 12 months.
Croatian: Približno 78 % bolesnika koji su uzimali Vimpat i 83 % bolesnika koji su uzimali karbamazepin nisu imali napadaj 12 mjeseci.
English: It is not intended to provide practical advice on how to use Vimpat.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Vimpat.
English: Other information about Vimpat
Croatian: Ostale informacije o lijeku Vimpat
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vimpat have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Vimpat nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Vimpat was more effective than placebo (a dummy treatment) at reducing seizures in three main studies involving a total of 1,308 patients aged 16 years and above also taking other epilepsy medicines.
Croatian: Vimpat je bio djelotvorniji od placeba (prividnog liječenja) u smanjenju napadaja u tri glavna ispitivanja koja su uključivala ukupno 1.308 bolesnika u dobi od 16 godina i starijih, koji su istovremeno uzimali i druge lijekove protiv epilepsije.
English: Two additional studies looked at the appropriate duration of the infusion for Vimpat solution and compared its safety with that of placebo infusions in a total of 199 patients.
Croatian: U dva dodatna ispitivanja ispitivano je odgovarajuće trajanje infuzije za otopinu lijeka Vimpat i njegova sigurnost uspoređena s infuzijom placeba u ukupno 199 bolesnika.
English: The 600-mg dose was as effective as the 400-mg dose, but it had more side effects.
Croatian: Doza od 600 mg bila je jednako djelotvorna kao i doza od 400 mg, no izazvala je više nuspojava.
English: Vimpat is an epilepsy medicine used to treat partial-onset seizures (epileptic fits starting in one specific part of the brain) in patients with epilepsy aged 4 years and older.
Croatian: Vimpat je lijek za epilepsiju koji se koristi za liječenje parcijalnih napadaja (epileptični napadaji koji započinju u određenom dijelu mozga) u bolesnika s epilepsijom u dobi od 4 ili više godina.
English: How is Vimpat used?
Croatian: Kako se Vimpat koristi?
English: The main measure of effectiveness was the proportion of patients who did not have a seizure for at least 6 months after reaching a stable dose.
Croatian: Glavno mjerilo djelotvornosti bila je stopa bolesnika koji najmanje šest mjeseci nisu imali napadaj nakon dostizanja stabilne doze.
English: Vimpat can only be obtained with a prescription and is available as tablets (50 mg; 100 mg; 150 mg; 200 mg), as a syrup (10 mg/ml) and as a solution for infusion (drip) into a vein.
Croatian: Vimpat se može dobiti samo na liječnički recept i dostupan je u obliku tableta (od 50 mg, 100 mg, 150 mg i 200 mg), kao sirup (10 mg/ml) i kao otopina za infuziju (drip) u venu.
English: The European Medicines Agency decided that Vimpat, used alone or added to other epilepsy medicines, had been shown to be effective in the treatment of partial onset seizures.
Croatian: Europska agencija za lijekove odlučila je da se lijek Vimpat, bilo kao monoterapija ili dodatak drugim lijekovima protiv epilepsije, pokazao djelotvornim u liječenju djelomičnih napadaja.
English: It can be used to treat partial-onset seizures with or without secondary generalisation (where the seizure subsequently spreads to other parts of the brain).
Croatian: Može se koristiti za liječenje parcijalnih napadaja sa sekundarnom generalizacijom (širenje napadaja na druge dijelove mozga) ili bez nje.
English: The main measure of effectiveness was the number of patients whose number of seizures was at least halved after 12 weeks of treatment with a stable dose.
Croatian: Glavno mjerilo djelotvornosti bio je broj bolesnika čiji su se napadaji barem dvostruko smanjili nakon 12 tjedana liječenja stabilnom dozom.
English: For more information about treatment with Vimpat read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Vimpat pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: How does Vimpat work?
Croatian: Kako djeluje Vimpat?
English: The usual starting dose in adults and older children (weighing at least 50 kg) is 50 mg twice a day which may be increased weekly to a maximum dose of 300 mg twice a day if used alone, or 200 mg twice a day if given with other epilepsy medicines.
Croatian: Uobičajena početna doza u odraslih i starije djece (koji imaju barem 50 kg) jest 50 mg dvaput na dan, koja se na tjednoj osnovi može povećati na najveću dopuštenu dozu od 300 mg dvaput na dan ako se lijek koristi kao monoterapija ili od 200 mg dvaput na dan ako se lijek daje s drugim lijekovima za epilepsiju.
English: The most common side effects with Vimpat (seen in more than 1 patient in 10) are dizziness, headache, diplopia (double vision) and nausea (feeling sick).
Croatian: Najčešće nuspojave lijeka Vimpat (uočene u više od 1 na 10 osoba) su vrtoglavica, diplopija (dvostruki vid) i mučnina (slabost).
English: An additional study in 118 patients was carried out to test that starting treatment with doses of 200 mg Vimpat by infusion, followed by regular doses taken by mouth, can be applied safely and that adequate levels in the body are achieved.
Croatian: Provedeno je dodatno ispitivanje na 118 bolesnika kojim se ispitivalo može li se sigurno primijeniti početna terapija dozama od 200 mg infuzije lijeka Vimpat, i nastavak terapije uobičajenim dozama uzimanim na usta uz postizanje odgovarajuće razine u organizmu.
English: For practical information about using Vimpat, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Vimpat bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: Vimpat is given on its own or combined with other medicines for epilepsy.
Croatian: Vimpat daje se kao monoterapija ili u kombinaciji s drugim lijekovima za epilepsiju.
English: What benefits of Vimpat have been shown in studies?
Croatian: Koje su koristi lijeka Vimpat utvrđene u ispitivanjima?
English: A fourth study involving 888 recently diagnosed patients showed that Vimpat, used on its own by mouth at a dose of 200 mg to 600 mg a day, was at least as effective as carbamazepine, another medicine for epilepsy.
Croatian: U četvrtom ispitivanju koje je uključivalo 888 bolesnika koji su nedavno dijagnosticirani, pokazalo se da je Vimpat bio barem jednako djelotvoran kao karbamazepin, drugi lijek protiv epilepsije, ako je uziman kroz usta u dozi od 200 mg do 600 mg dnevno.
English: Patients were given Vimpat by mouth at a dose of 200 mg, 400 mg or 600 mg a day, or placebo in addition to their existing treatment of up to three other epilepsy medicines.
Croatian: Bolesnici su lijek Vimpat primali kroz usta u dozama od 200 mg, 400 mg ili 600 mg na dan, ili placebo uz postojeću terapiju od najviše tri lijeka protiv epilepsije.
English: For the full list of all side effects and restrictions with Vimpat, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja pri primjeni lijeka Vimpat potražite u uputi o lijeku.
English: Vimpat lacosamide
Croatian: Vimpat lakozamid
English: Side effects affecting the nervous system such as dizziness may be higher after a loading dose and dizziness was the most common reason for stopping treatment.
Croatian: Nuspojave koje utječu na živčani sustav kao što je vrtoglavica mogu biti intenzivnije nakon početne udarne doze.
English: Taking the results of the three main studies together, 34% of the patients taking Vimpat 200 mg a day and 40% of the patients taking Vimpat 400 mg a day with their existing treatment had a reduction in their seizures by at least half.
Croatian: Kada se rezultati triju glavnih ispitivanja zbroje, frekvencija napadaja smanjena je za najmanje 50% kod 34 % bolesnika koji su uzimali 200 mg lijeka Vimpat jednom dnevno i 40 % bolesnika koji su uzimali 400 mg lijeka Vimpat jednom dnevno uz svoju postojeću terapiju, u usporedbi s 23% bolesnika koji su primali placebo.
English: For more details see the package leaflet.
Croatian: Za dodatne informacije vidjeti uputu o lijeku.
English: It contains the active substance lacosamide.
Croatian: Sadrži djelatnu tvar lakozamid.
English: The active substance in Vimpat, lacosamide, is an epilepsy medicine.
Croatian: Djelatna tvar lijeka Vimpat, lakozamid, lijek je protiv epilepsije.
English: They are available in packs of:
Croatian: Dostupne su u pakiranjima od:
English: Your doctor will regularly monitor you.
Croatian: Vaš će Vas liječnik redovito pratiti.
English: Your doctor will check this.
Croatian: Vaš će liječnik ovo provjeriti.
English: No such effects were observed in adult rats.
Croatian: Takvi učinci nisu opaženi u odraslih štakora.
English: 65 years or older
Croatian: U dobi od 65 godina ili stariji
English: Do not take Adempas during pregnancy.
Croatian: Nemojte uzimati Adempas tijekom trudnoće.
English: Riociguat has a dual mode of action.
Croatian: Riocigvat ima dvojni način djelovanja.
English: Special considerations for patients who smoke
Croatian: Posebne napomene za bolesnike koji puše
English: Your doctor will check if Adempas is suitable for you.
Croatian: Vaš liječnik će provjeriti da li je Adempas prikladan za Vas.
English: Date of latest renewal: 18 January 2019
Croatian: Datum posljednje obnove odobrenja: 18. siječanj 2019.
English: If you smoke, it is recommended that you stop, as smoking may reduce the effectiveness of these tablets.
Croatian: Ako pušite, preporučuje se da prestanete, jer pušenje može smanjiti učinkovitost ovih tableta.
English: You are also advised to take monthly pregnancy tests.
Croatian: Također Vam se savjetuje da svaki mjesec radite testove na trudnoću.
English: If there is a chance you could become pregnant, use reliable forms of contraception while you are taking these tablets.
Croatian: Ako postoji šansa da biste mogli zatrudnjeti, koristite pouzdane oblike kontracepcije dok uzimate ove tablete.
English: Doses above 1 mg riociguat were not investigated in this study.
Croatian: Doze iznad 1 mg riocigvata nisu bile ispitane u ovom ispitivanju.
English: These medicinal products should be used with caution.
Croatian: Ovi lijekovi moraju se primjenjivati s oprezom.
English: Elimination half-life is about 7 hours in healthy subjects and about 12 hours in patients.
Croatian: Poluvrijeme eliminacije je približno 7 sati u zdravih ispitanika, a oko 12 sati u bolesnika.
English: In case of pronounced hypotension, active cardiovascular support may be required.
Croatian: U slučaju naglašene hipotenzije, može biti potrebna aktivna kardiovaskularna potpora.
English: A dose decrease may be required in patients who stop smoking.
Croatian: Sniženje doze može biti potrebno kod bolesnika koji prestanu pušiti.
English: Your doctor may decide to monitor your blood pressure.
Croatian: Liječnik Vam može odlučiti kontrolirati krvni tlak.
English: Improved Stable Deteriorated p-value
Croatian: Poboljšano Stabilno Pogoršano p-vrijednost
English: Current smokers should be advised to stop smoking due to a risk of a lower response.
Croatian: Aktivnim pušačima treba savjetovati da prestanu pušiti zbog rizika od slabijeg odgovora.
English: • inoperable CTEPH,
Croatian: • inoperabilnim KTEPH-om,
English: Adempas is used in either of two types of pulmonary hypertension:
Croatian: Adempas se koristi u bilo kojem od dva tipa plućne hipertenzije:
English: The safety and efficacy of riociguat in children and adolescents below 18 years have not been established.
Croatian: Sigurnost i djelotvornost riocigvata u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: What you need to know before you take Adempas 3.
Croatian: Što morate znati prije nego počnete uzimati Adempas 3.
English: Riociguat also directly stimulates sGC independently of NO.
Croatian: Riocigvat također izravno stimulira sGC neovisno o NO.
English: Six patients (10%) experienced at least one clinical worsening event, including 2 deaths unrelated to study drug.
Croatian: Šest bolesnika (10%) imalo je najmanje jedan događaj kliničkog pogoršanja, uključujući 2 smrtna slučaja nevezana uz ispitivani lijek.
English: If you have taken more tablets than you should and experience any side effects (see section 4), please contact your doctor.
Croatian: Ako ste uzeli više tableta nego što ste trebali i osjećate neke nuspojave (pogledajte dio 4), molimo obratite se Vašem liječniku.
English: If this happens, contact your doctor immediately as you may need urgent medical treatment.
Croatian: Ako se to dogodi, odmah se obratite liječniku jer Vam možda treba hitno liječenje.
English: Overall, the safety profile observed in the study was comparable with that observed in the pivotal trials, with no serious adverse events reported during the transition period.
Croatian: Sveukupno, sigurnosni profil opažen u ispitivanju bio je usporediv s onim iz pivotalnih ispitivanja, bez ozbiljnih štetnih događaja zabilježenih tijekom prijelaznog razdoblja.
English: If your treatment has to be stopped for 3 days or more, please tell your doctor before restarting your treatment.
Croatian: Ako morate prekinuti liječenje na 3 dana ili dulje, molimo obavijestite svog liječnika prije nego što ponovno počnete s liječenjem.
English: The established individual dose should be maintained unless signs and symptoms of hypotension occur.
Croatian: Uspostavljenu individualnu dozu potrebno je održavati osim ako se jave znakovi i simptomi hipotenzije.
English: Patients older than 65 years are at increased risk of hypotension.
Croatian: Bolesnici stariji od 65 godina imaju povećan rizik od hipotenzije.
English: What Adempas is and what it is used for 2.
Croatian: Što je Adempas i za što se koristi 2.
English: If your blood pressure drops (which can make you feel dizzy) then you may need immediate medical attention.
Croatian: Ako Vam se snizi krvni tlak (zbog čega možete osjećati omaglicu), onda Vam možda treba hitna medicinska pomoć.
English: Non-clinical data revealed no specific hazard for humans based on conventional studies of safety pharmacology, single dose toxicity, phototoxicity, genotoxicity and carcinogenicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti jednokratne doze, fototoksičnosti, genotoksičnosti i kancerogenog potencijala.
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) and not known (cannot be estimated from the available data).
Croatian: Učestalost se definira na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (1/10 000 i <1/1000), vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Terminal half-life increased from 7.3 to 9.2 hours and total body clearance decreased from 6.1 to 2.4 L/h.
Croatian: Terminalno poluvrijeme povećano je s 7,3 na 9,2 h, a ukupni klirens se smanjio s 6,1 na 2,4 l/h.
English: Monthly pregnancy tests are recommended.
Croatian: Preporučuju se testovi na trudnoću svaki mjesec.
English: Results were consistent in the main sub-groups evaluated (ITT analysis, see table 2).
Croatian: Rezultati u glavnim podskupinama koje su bile procijenjene bili su sukladni tome (ITT analiza, vidjeti tablicu 2).
English: Tablets can generally be taken with or without food.
Croatian: Tablete se općenito mogu uzimati s hranom ili bez nje.
English: What Adempas looks like and contents of the pack
Croatian: Kako Adempas izgleda i sadržaj pakiranja
English: Adempas is available in different strengths and by checking your blood pressure regularly at the beginning of your treatment, your doctor will ensure that you are taking the appropriate dose.
Croatian: Adempas je dostupan u različitim jačinama i redovitim provjeravanjem Vašeg krvnog tlaka u početku liječenja, Vaš će liječnik osigurati da uzimate odgovarajuću dozu.
English: Until more is known about the implications of these findings the use of riociguat in children and in growing adolescents should be avoided.
Croatian: Dok se ne sazna više o značenju ovih nalaza potrebno je izbjegavati primjenu riocigvata u djece i adolescenata koji rastu.
English: Stable
Croatian: Stabilno
English: If not tolerated, dose reduction should be considered at any time.
Croatian: Ako se lijek ne podnosi, potrebno je razmotriti sniženje doze, u bilo kojem trenutku.
English: Adempas can be taken alone or together with certain other medicines used to treat PAH.
Croatian: Adempas se može uzimati sam ili zajedno s određenim drugim lijekovima koji se primjenjuju za liječenje PAH-a.
English: Alternative treatments should be considered.
Croatian: Potrebno je razmotriti druge terapijske opcije.
English: Patients should be aware of how they react to this medicinal product, before driving or using machines.
Croatian: Bolesnici moraju biti svjesni kako reagiraju na ovaj lijek prije upravljanja vozilima ili rada sa strojevima.
English: During the first weeks of treatment your doctor will need to measure your blood pressure at regular intervals.
Croatian: Tijekom prvih tjedana liječenja, liječnik će Vam morati mjeriti krvni tlak u redovnim vremenskim razmacima.
English: A careful monitoring of patients taking anticoagulants according to common medical practice is recommended.
Croatian: Preporučuje se pažljiv nadzor bolesnika koji uzimaju antikoagulanse, sukladno uobičajenoj medicinskoj praksi.
English: If you have difficulty swallowing the whole tablet, talk to your doctor about other ways to take Adempas.
Croatian: Ako imate poteškoća s gutanjem cijele tablete, razgovarajte sa svojim liječnikom o drugim načinima uzimanja lijeka Adempas.
English: Individual dose titration at treatment initiation allows adjustment of the dose to the patient´s needs.
Croatian: Individualna titracija doze na početku liječenja omogućuje prilagodbu doze potrebama bolesnika.
English: If you take more Adempas than you should
Croatian: Ako uzmete više lijeka Adempas nego što ste trebali
English: Deteriorated p-value
Croatian: Pogoršano p-vrijednost
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Adempas in one or more subsets of the paediatric population in the treatment of pulmonary hypertension.
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Adempas u jednoj ili više podskupina pedijatrijske populacije u liječenju plućne hipertenzije.
English: If you are 65 years or older your doctor will take extra care in adjusting your dose of Adempas, because you may be at greater risk of low blood pressure.
Croatian: Ako ste u dobi od 65 godina ili stariji, Vaš će liječnik obratiti dodatnu pažnju na prilagodbu Vaše doze lijeka Adempas, jer biste mogli biti pod povećanim rizikom od sniženog krvnog tlaka.
English: Overall list of possible side effects:
Croatian: Pregledni popis mogućih nuspojava:
English: The use of Adempas in children and adolescents (under 18 years of age) should be avoided because efficacy and safety have not been established for this age group.
Croatian: Primjena lijeka Adempas u djece i adolescenata (mlađih od 18 godina) se mora izbjegavati jer djelotvornost i sigurnost primjene nisu utvrđene za ovu dobnu skupinu.
English: - Pregnancy (see sections 4.4; 4.5 and 4.6).
Croatian: - Trudnoća (vidjeti dijelove 4.4, 4.5 i 4.6).
English: The absolute bioavailability of riociguat is high (94%).
Croatian: Riocigvat ima visoku apsolutnu bioraspoloživost (94%).
English: Based on this study and as riociguat is not an inducer of any of the relevant metabolic enzymes, also no pharmacokinetic interaction is expected with other hormonal contraceptives.
Croatian: S obzirom na ovo ispitivanje i na to da riocigvat nije induktor ikojeg značajnog metaboličkog enzima, također se ne očekuju farmakokinetičke interakcije s drugim hormonskim kontraceptivima.
English: You should not breast-feed while taking this medicine.
Croatian: Ne smijete dojiti dok uzimate ovaj lijek.
English: Warfarin/phenprocoumon
Croatian: Varfarin/fenprokumon
English: PDE5 inhibitors
Croatian: Inhibitori PDE-5
English: In case of overdose, standard supportive measures should be adopted as required.
Croatian: U slučaju predoziranja potrebno je primijeniti standardne potporne mjere prema potrebi.
English: What Adempas is and what it is used for
Croatian: Što je Adempas i za što se koristi
English: Please tell your doctor if you smoke or if you stop smoking during treatment.
Croatian: Molimo obavijestite svog liječnika ako pušite ili ako prestanete pušiti tijekom liječenja.
English: If any of these applies to you, talk to your doctor first and do not take Adempas.
Croatian: Ako se nešto od ovoga odnosi na Vas, prvo se obratite liječniku i nemojte uzimati Adempas.
English: Developmental toxicity studies in rats and rabbits have shown reproductive toxicity of riociguat.
Croatian: Ispitivanja razvojne toksičnosti na štakorima i kunićima pokazala su reproduktivnu toksičnost riocigvata.
English: Adverse reactions were similar to those seen at lower doses (see section 4.8).
Croatian: Nuspojave su bile slične onima koje se opažaju pri nižim dozama (vidjeti dio 4.8).
English: What you need to know before you take Adempas
Croatian: Što morate znati prije nego počnete uzimati Adempas
English: Monitor for signs and symptoms of hypotension on initiation and on treatment.
Croatian: Pratite znakove i simptome hipotenzije na početku i tijekom liječenja.
English: If you forget to take Adempas
Croatian: Ako ste zaboravili uzeti Adempas