FrancophonIA/ELRC3.0 huggingface dataset:
English: years after the start of treatment with bosentan, respectively.
Croatian: godine od početka liječenja bosentanom.
English: Be sure to discuss any questions you may have with your doctor or your gynaecologist - complete the details on the back of this card and take it to your doctor or gynaecologist at your next visit.
Croatian: O svim pitanjima koja imate razgovarajte sa svojim liječnikom ili ginekologom - pažljivo ispunite poleđinu ove kartice i pokažite ju svom liječniku ili ginekologu prilikom sljedeće posjete.
English: The side effects that have been reported in children treated with Tracleer are the same as those in adults.
Croatian: Nuspojave uočene u djece liječene Tracleerom iste su kao u odraslih.
English: In vitro data demonstrated that bosentan had no relevant inhibitory effect on the CYP isoenzymes tested (CYP1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 2E1, 3A4).
Croatian: In vitro podaci pokazali su da bosentan nije imao značajan inhibitorski učinak na ispitane CYP izoenzime (CYP1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 2E1, 3A4).
English: The remaining parts of a divided dispersible tablet can be stored at room temperature and should be used within 7 days.
Croatian: Ostaci razdjeljene tablete za oralnu suspenziju mogu se čuvati na sobnoj temperaturi i trebaju se iskoristiti u roku od 7 dana.
English: What Tracleer looks like and contents of the pack
Croatian: Kako Tracleer izgleda i sadržaj pakiranja
English: Tracleer may harm the development of the foetus.
Croatian: Lijek Tracleer može naškoditi razvoju fetusa.
English: Aspartame (E951), see the package leaflet for further information Aspartame (E951) may be harmful for people with phenylketonuria
Croatian: Aspartam (E951), vidjeti uputu o lijeku za daljnje informacije Aspartam (E951) može naškoditi osobama koje boluju od fenilketonurije
English: Please note that Tracleer is also available as a dispersible 32 mg tablet formulation, which may make correct dosing easier for children and patients with low body weight or difficulties to swallow filmcoated tablets.
Croatian: Molimo obratite pozornost da je Tracleer dostupan i u obliku tableta za oralnu suspenziju od 32 mg koje mogu olakšati točno doziranje za djecu i bolesnike s malom tjelesnom težinom ili za one koji imaju poteškoća s gutanjem filmom obloženih tableta.
English: Tracleer can be taken with or without food.
Croatian: Tracleer se može uzimati s hranom ili bez nje.
English: As a result, a significantly reduced effect of bosentan is expected when it is co-administered with rifampicin.
Croatian: Kao rezultat, očekuje se značajno smanjenje učinka bosentana kod istodobne primjene s rifampicinom.
English: In the FUTURE 1 study, the median exposure to study treatment was 13.1 weeks (range: 8.4 to 21.1).
Croatian: U FUTURE 1 studiji medijan izloženosti ispitivanom liječenju bio je 13,1 tjedana (raspon 8,4 do 21,1).
English: Tracleer contains aspartame and sodium
Croatian: Tracleer sadrži aspartam i natrij
English: Therefore, if you use hormonal contraceptives you must also use a barrier method (e.g., female condom, diaphragm, contraceptive sponge, or your partner must also use a condom).
Croatian: Stoga, ako koristite hormonsku kontracepciju, ujedno morate koristiti i metodu barijere (npr. ženski kondom, dijafragmu, kontracepcijsku spužvu ili Vaš partner mora koristiti kondom).
English: If it is possible that you could become pregnant, use a reliable form of birth control (contraception) while you are taking Tracleer.
Croatian: Ako postoji mogućnost da ostanete trudni, koristite pouzdan oblik kontrole začeća (kontracepciju) za vrijeme uzimanja Tracleera.
English: This medicine contains 3.7 mg of aspartame in each dispersible tablet.
Croatian: Ovaj lijek sadrži 3,7 mg aspartama po jednoj tableti za oralnu suspenziju.
English: 0.1 years; max: 3.3 years) and patients were observed for a mean of 2.0 ± 0.6 years.
Croatian: godina; maks.: 3,3 godine), a bolesnici su praćeni tijekom 2,0 ± 0,6 godina.
English: You are advised to stop breast-feeding if Tracleer is prescribed for you, because it is not known whether this medicine passes into breast milk.
Croatian: Prekinite s dojenjem ako Vam je propisan Tracleer jer nije poznato prelazi li ovaj lijek u majčino mlijeko.
English: 43 (67.2%) were ≥ 2 years to 11 years old, 15 (23.4%) were between 1 and 2 years old, and 6 (9.4%) were between 3 months and 1 year old.
Croatian: 43 (67,2%) ih je bilo ≥ 2 do 11 godina starosti, 15 (23,4%) ih je bilo između 1 i 2 godine starosti te njih 6 (9,4%) bilo je staro između 3 mjeseca i 1 godine.
English: • Hormonal contraceptives cannot be the sole method of contraception during treatment with Tracleer
Croatian: • Hormonski kontraceptivi ne mogu biti jedina kontracepcija tijekom liječenja Tracleerom
English: Each dispersible tablet contains 3.7 mg of aspartame (E951).
Croatian: Jedna tableta za oralnu suspenziju sadrži 3,7 mg aspartama (E951).
English: In PAH and heart failure, in the absence of endothelin receptor antagonism, elevated ET-1 concentrations are strongly correlated with the severity and prognosis of these diseases.
Croatian: Kod PAH-a i zatajenja srca, u odsutnosti antagonista endotelinskih receptora, povišene koncentracije ET-1 strogo koreliraju s težinom i prognozom tih bolesti.
English: Tracleer therefore causes blood vessels to expand and belongs to the class of medicines called “endothelin receptor antagonists”.
Croatian: Zbog toga Tracleer širi krvne žile i ubraja se u skupinu lijekova pod nazivom „antagonisti endotelinskih receptora“.
English: Tracleer is contraindicated in pregnancy (see section 4.3).
Croatian: Tracleer je kontraindiciran u trudnoći (vidjeti dio 4.3).
English: Tracleer tablets contain bosentan, which blocks a naturally occurring hormone called endothelin-1 (ET-1), which causes blood vessels to narrow.
Croatian: Tablete Tracleer sadrže bosentan, blokator prirodnog hormona endotelina-1 (ET-1) koji sužava krvne žile.
English: Do not use this medicine after the expiry date which is stated on the carton and on the blister after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji ili blisteru iza oznake „EXP“.
English: Adverse reactions observed in 20 placebo-controlled studies and post-marketing experience with bosentan are ranked according to frequency using the following convention: 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: Nuspojave uočene u 20 placebom kontroliranih studija s bosentanom i razdoblju nakon stavljanja lijeka u promet poredane su prema učestalosti koristeći sljedeću konvenciju: 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 (<
English: Remember to have your liver blood test every month.
Croatian: Sjetite se svaki mjesec napraviti testove jetrene funkcije.
English: After 16 weeks, the mean oxygen saturation was increased in the bosentan group by 1.0% (95% CI -0.7%-2.8%) as compared to the placebo group (n = 17), showing that bosentan did not worsen hypoxaemia.
Croatian: Nakon 16 tjedana srednje zasićenje kisikom bilo je povećano za 1,0% u skupini koja je dobivala bosentan (95% CI -0,7%-2,8%) u odnosu na skupinu koja je dobivala placebo (n = 17), što pokazuje da bosentan nije pogoršao hipoksemiju.
English: • hormonal contraceptives, which are not effective as the sole method of contraception when you take Tracleer.
Croatian: • hormonske kontraceptive koji nisu učinkoviti kao jedina metoda kontracepcije kod uzimanja Tracleera.
English: Tracleer”
Croatian: Tracleerom.
English: In the event of late clinical deterioration despite treatment with Tracleer (i.e., after several months of treatment), the treatment should be re-assessed.
Croatian: U slučaju naknadnog pogoršanja kliničke slike unatoč uzimanju Tracleera (tj. nakon nekoliko mjeseci liječenja), treba ponovo razmotriti način liječenja.
English: In a juvenile rat toxicity study, where rats were treated from Day 4 post partum up to adulthood, decreased absolute weights of testes and epididymides, and reduced number of sperm in epididymides were observed after weaning.
Croatian: U studiji toksičnosti na mladim štakorima, u kojoj su štakori liječeni od 4. postpartalnog dana sve do odrasle dobi, nakon odvikavanja je zabilježena smanjena apsolutna težina testisa i epididimisa i smanjen broj spermija u epididimisima.
English: • Tracleer treatment must not be initiated in women of childbearing potential unless they practise reliable contraception and the result of the pre-treatment pregnancy test is negative
Croatian: • Liječenje Tracleerom ne smije se započeti u žena reproduktivne dobi ako ne provode pouzdane metode kontracepcije i ako test na trudnoću prije liječenja nije negativan
English: The steady-state AUC of bosentan was 9% higher and the AUC of the active metabolite, Ro 48-5033, was 33% higher in patients with mild hepatic impairment than in healthy volunteers.
Croatian: AUC bosentana u stanju dinamičke ravnoteže bila je 9% veća, a AUC njegovog aktivnog metabolita, Ro 48-5033, bila je 33% veća u bolesnika s blagim smanjenjem jetrene funkcije nego u zdravih dobrovoljaca.
English: CL = confidence limit; PVR = pulmonary vascular resistance; SD = standard deviation.
Croatian: CL = granica pouzdanosti; PVR = plućni krvnožilni otpor; SD = standardna devijacija
English: Re-introduction of treatment with Tracleer should only be considered if the potential benefits of treatment with Tracleer outweigh the potential risks and when liver aminotransferase levels are within pre-treatment values.
Croatian: Ponovno liječenje Tracleerom treba razmotriti samo ako moguće koristi od liječenja Tracleerom nadmašuju moguće rizike te kada su vrijednosti jetrenih aminotransferaza unutar vrijednosti prije liječenja.
English: The same recommendations apply to re-introduction of Tracleer after treatment interruption (see section 4.4).
Croatian: Iste preporuke vrijede i pri ponovnom uvođenju liječenja Tracleerom nakon prekida terapije (vidjeti dio 4.4).
English: Hold the tablet between the thumb and index finger on either side of one of the lines, with the line facing upwards, and break the tablet along the line (see figure below).
Croatian: Držite tabletu između palca i kažiprsta s bilo koje strane jedne od crta, koja treba biti usmjerena prema gore, i zatim prelomite tabletu duž crte (vidi sliku ispod).
English: If these results are abnormal, your doctor may decide to reduce your dose or stop treatment with Tracleer and to perform further tests to investigate the cause.
Croatian: Ako ti rezultati nisu uredni, liječnik će odlučiti da li smanjiti dozu ili prekinuti liječenje Tracleerom te će možda provesti dodatne nalaze kako bi ispitao moguće razloge.
English: Suddenly stopping your treatment with Tracleer may lead to your symptoms getting worse.
Croatian: Nagli prestanak liječenja s Tracleerom može dovesti do pogoršanja Vaših simptoma.
English: • primary (with no identified cause or familial);
Croatian: Tracleer može biti: • primarna (bez poznatog uzroka ili obiteljska);
English: Oedema, fluid retention5
Croatian: Edem, retencija tekućine5
English: This difference in infection frequency may in part be due to the longer median treatment exposure in the paediatric set (median 71.8 weeks) compared with the adult set (median 17.4 weeks).
Croatian: Ova razlika u učestalosti infekcija djelomično može biti posljedica duljeg medijana izloženosti pedijatrijske populacije (medijan 71,8 tjedana) u usporedbi s odraslom populacijom (medijan 17,4 tjedna).
English: No dose adjustment of Tracleer is considered necessary.
Croatian: Prilagođavanje doze Tracleera nije potrebno.
English: Because of possible hormonal contraception failure during Tracleer treatment, and also bearing in mind the risk that pulmonary hypertension severely deteriorates with pregnancy, monthly pregnancy tests during treatment with Tracleer are recommended to allow early detection of pregnancy.
Croatian: Zbog mogućeg zatajenja hormonske kontracepcije tijekom liječenja Tracleerom te uzimajući u obzir da u trudnoći dolazi do teškog pogoršanja plućne hipertenzije, preporučuju se mjesečni testovi na trudnoću tijekom liječenja Tracleerom kako bi se trudnoća rano otkrila.
English: Thus its use in adults should be reserved for patients who cannot take the film-coated tablet.
Croatian: Stoga primjena tableta za oralnu suspenziju u odraslih treba biti ograničena na bolesnike koji ne mogu uzeti filmom obloženu tabletu.
English: Tracleer has no or negligible influence on the ability to drive and use machines.
Croatian: Tracleer ima zanemariv ili nikakav utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: If necessary the dispersible tablet can be divided by breaking it along the lines cut into the surface (see section 6.6).
Croatian: Ako je potrebno, tableta za oralnu suspenziju može se razdijeliti lomljenjem duž ureznih linija na površini (vidjeti dio 6.6).
English: Tracleer is used to treat patients with class III PAH to improve exercise capacity (the ability to carry out physical activity) and symptoms.
Croatian: Tracleer se koristi u liječenju bolesnika s III. stupnjem plućne arterijske hipertenzije (PAH) kako bi se poboljšalo podnošenje fizičkog opterećenja (mogućnost izvođenja fizičke aktivnosti) i simptomi.
English: At enrolment, six patients were between 3 months and 1 year old, 15 children were between 1 and less than 2 years old, and 79 were between 2 and 12 years old.
Croatian: Pri uključenju, 6 bolesnika bilo je u dobi između od 3 mjeseca do 1 godine, 15 djece bilo je u dobi od 1 do manje od 2 godine i 79 ih je bilo u dobi od 2 do 12 godina.
English: 1 Data derived from post-marketing experience, frequencies based on statistical modelling of placebo-controlled clinical trial data.
Croatian: 1 Podaci dobiveni iz razdoblja nakon stavljanja lijeka u promet, učestalosti se temelje na statističkom modeliranju podataka iz placebom kontroliranog kliničkog istraživanja.
English: The mean duration of exposure to bosentan was 1.9 years ± 0.7 years (min:
Croatian: Srednje trajanje izloženosti bosentanu bilo je 1,9 godina ± 0,7 godina (min.: 0,1
English: For the same reason, concomitant administration of both a potent CYP3A4 inhibitor (such as ketoconazole, itraconazole or ritonavir) and a CYP2C9 inhibitor (such as voriconazole) with Tracleer is not recommended.
Croatian: Iz istog razloga ne preporučuje se istodobna primjena jakog inhibitora CYP3A4 (poput ketokonazola, itrakonazola ili ritonavira) i inhibitora CYP2C9 (poput vorikonazola) s Tracleerom.
English: However, Tracleer may induce hypotension, with symptoms of dizziness, blurred vision or syncope that could affect the ability to drive or use machines.
Croatian: Ipak, Tracleer može uzrokovati hipotenziju sa simptomima omaglice, zamagljenog vida ili sinkope koji mogu utjecati na sposobnost upravljanja vozilima ili rada sa strojevima.
English: The most serious side effects with Tracleer are
Croatian: Najozbiljnije nuspojave Tracleera su:
English: No specific studies have been conducted to assess the direct effect of Tracleer on the ability to drive and use machines.
Croatian: Nisu provedene specifične studije za procjenu direktnog utjecaja Tracleera na sposobnost upravljanja vozilima i rada sa strojevima.
English: As Tracleer may render hormonal contraceptives ineffective, and taking into account the risk that pulmonary hypertension deteriorates with pregnancy as well as the teratogenic effects observed in animals:
Croatian: Budući da Tracleer može smanjiti učinkovitost hormonskih kontracepctiva te uzimajući u obzir rizik od pogoršanja plućne hipertenzije u trudnoći i teratogene učinke uočene u životinja:
English: Please read this card carefully before starting your treatment with Tracleer.
Croatian: Molimo Vas da pažljivo pročitate sljedeći tekst prije nego što počnete uzimati Tracleer.
English: In the event of associated clinical symptoms of liver injury, i.e., nausea, vomiting, fever, abdominal pain, jaundice, unusual lethargy or fatigue, flu-like syndrome (arthralgia, myalgia, fever), treatment must be stopped and re-introduction of Tracleer is not to be considered.
Croatian: U slučaju drugih kliničkih simptoma oštećenja jetre, tj. mučnine, povraćanja, vrućice, bolova u abdomenu, žutice, neuobičajene slabosti ili umora, simptoma sličnih gripi (artralgija, mialgija, vrućica), liječenje treba prekinuti bez razmatranja ponovnog liječenja Tracleerom.
English: To make a liquid medicine, add the tablet to a little water on a spoon.
Croatian: Da biste napravili tekući lijek, dodajte malo vode tableti na žlici.
English: During treatment with Tracleer, your doctor will arrange for regular blood tests to check for changes in your liver function.
Croatian: Tijekom liječenja Tracleerom liječnik će zakazati redovite krvne pretrage kako bi provjerio promjene u funkciji jetre.
English: Aminotransferase elevations associated with hepatitis (including possible exacerbation of underlying hepatitis) and/or jaundice1 (see section 4.4)
Croatian: Povišene razine aminotransferaze povezane s hepatitisom (uključujući moguće pogoršanje podležećeg hepatitisa) i/ili žuticom1 (vidjeti dio 4.4)
English: Some improvements have also been shown in patients with pulmonary arterial hypertension WHO functional class II (see section 5.1).
Croatian: Neka poboljšanja zapažena su kod bolesnika s plućnom arterijskom hipertenzijom WHO funkcionalnog stupnja II (vidjeti dio 5.1).
English: The majority of patients were diagnosed as primary pulmonary hypertension (72%) and were in WHO functional class III (84%).
Croatian: Većina bolesnika imala je dijagnozu plućne arterijske hipertenzije (72%) te su bili u skupini III prema WHO funkcionalnom stupnju (84%).
English: Following treatment with the dispersible tablet, exposure to bosentan was lower than with the film-coated tablet (ratio of geometric means for AUC0-∞ 0.87 [90% CI: 0.78, 0.97]).
Croatian: Nakon liječenja tabletom za oralnu suspenziju, izloženost bosentanu bila je manja nego kod filmom obloženih tableta (geometrijsko odnos za AUC0-∞ 0,87 [90% CI: 0,78, 0,97]).
English: In the post-marketing period there was one reported overdose of 10,000 mg of Tracleer taken by an adolescent male patient.
Croatian: Tijekom postmarketinškog razdoblja zabilježen je jedan slučaj predoziranja s 10 000 mg Tracleera u muškog adolescenta.
English: Treatment must be stopped and re-introduction of Tracleer is not to be considered.
Croatian: Liječenje treba prekinuti bez razmatranja ponovnog liječenja Tracleerom.
English: Tracleer 32 mg dispersible tablets contain a source of phenylalanine (Aspartame - E951).
Croatian: Tablete za oralnu suspenziju Tracleer od 32 mg sadrže izvor fenilalanina (aspartam - E951).
English: The aetiology of PAH, according to Dana Point classification, included idiopathic PAH (46%), heritable PAH (3%), associated PAH after corrective cardiac surgery (38%), and PAH related to congenital heart disease associated with systemic-topulmonary shunts, including Eisenmenger syndrome (13%).
Croatian: Etiologija PAH-a, prema Dana Point klasifikaciji, uključivala je idiopatski PAH (46%), nasljedni PAH (3%), udruženi PAH nakon korektivne operacije srca (38%) te PAH udružen s prirođenom srčanom manom sa sistemsko-plućnim šantom, uključujući i Eisenmengerov sindrom
English: If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy test before you start taking Tracleer, and regularly while you are taking Tracleer.
Croatian: Ako ste žena koja može zatrudnjeti, Vaš liječnik će tražiti da napravite test na trudnoću prije nego što počnete uzimati
English: There was no relevant difference in adverse event frequencies between patients above and below the age of 2 years; however, this is based on only 21 children less than 2 years including 6 patients between 3 months to 1 year of age.
Croatian: Nije bilo značajne razlike u učestalosti štetnih događaja između bolesnika mlađih i starijih od 2 godine, no to se temelji na samo 21 djetetu mlađem od 2 godine, uključujući 6 bolesnika između 3 mjeseca i 1 godine starosti.
English: After 16 weeks, the mean placebo-corrected increase in 6-minute walk distance was 53 metres (p = 0.0079), reflecting improvement in exercise capacity.
Croatian: Nakon 16 tjedana srednje povećanje 6-minutne udaljenosti prijeđene hodanjem bilo je 53 metra (ispravljeno s obzirom na placebo; p = 0,0079), što odražava poboljšanje fizičkih sposobnosti.
English: • At the request of the European Medicines Agency.
Croatian: Ažurirani RMP treba dostaviti: • na zahtjev Europske agencije za lijekove;
English: These will be done every month for the duration of treatment with Tracleer.
Croatian: Ove pretrage provodit će se svakog mjeseca tijekom liječenja Tracleerom.
English: Inside your pack of Tracleer tablets you will find a Patient Alert Card which you should read carefully.
Croatian: U Vašem pakiranju tableta Tracleer naći ćete Karticu s upozorenjima za bolesnika koju trebate pažljivo pročitati.
English: The placebo-corrected increases in walk distance compared with baseline were 76 metres (p = 0.02; t-test) and 44 metres (p = 0.0002; Mann-Whitney U test) at the primary endpoint of each study, respectively.
Croatian: Povećanja u prijeđenoj udaljenosti u odnosu na početnu vrijednost ispravljena s obzirom na placebo iznosila su 76 metara (p = 0,02, t test), odnosno 44 metra (p = 0,0002, Mann-Whitney U-test) u primarnom ishodu svake studije.
English: Add a little more water to the spoon and swallow all of the liquid to make sure all of the medicine has been taken.
Croatian: Dodajte još malo vode na žlicu i progutajte svu tekućinu kako biste bili sigurni da ste uzeli sav lijek.
English: In the event of clinical deterioration (e.g., decrease in 6-minute walk test distance by at least 10% compared with pre-treatment measurement) despite Tracleer treatment for at least 8 weeks (target dose for at least 4 weeks), alternative therapies should be considered.
Croatian: U slučaju kliničkog pogoršanja (npr. smanjenje prijeđene udaljenosti u 6-minutnom testu hoda za najmanje 10% u odnosu na mjerenje prije liječenja) unatoč liječenju s lijekom Tracleer u trajanju od najmanje 8 tjedana (ciljna doza uzimana najmanje 4 tjedna), potrebno je razmotriti alternativne terapije.
English: Each Tracleer dispersible tablet can be dissolved in water to make a liquid medicine.
Croatian: Svaka tableta za oralnu suspenziju može se otopiti u vodi kako bi se napravio tekući lijek.
English: If you forget to take Tracleer
Croatian: Ako ste zaboravili uzeti Tracleer
English: Tracleer 125 mg film-coated tablets EU/1/02/220/004
Croatian: Tracleer 125 mg filmom obložene tablete EU/1/02/220/004
English: Long-term data were generated from all 173 patients who were treated with bosentan in the controlled phase and/or were switched from placebo to bosentan in the open-label extension phase of the EARLY study.
Croatian: Dugoročni podaci su dobiveni od svih 173 pacijenata koji su liječeni s bosentanom u kontrolnoj fazi i/ili koji su s placeba prešli na bosentan u produženoj otvorenoj fazi liječenja u ispitivanju EARLY.
English: For all these tests please refer also to the Patient Alert Card (inside your pack of Tracleer tablets).
Croatian: Molimo da za sve ove pretrage pogledate i Karticu s upozorenjima za bolesnika (unutar Vašeg pakiranjaa Tracleer tableta).
English: An interaction study between bosentan and lopinavir+ritonavir in healthy subjects showed increased plasma concentrations of bosentan, with the maximum level during the first 4 days of treatment (see section 4.5).
Croatian: Studija interakcije između bosentana i lopinavira te ritonavira na zdravim dobrovoljcima je pokazala povišene koncentracije bosentana u plazmi s maksimalnom razinom tijekom prva 4 dana terapije (vidjeti dio
English: There are no reliable data on the use of Tracleer in pregnant women.
Croatian: Nema pouzdanih podataka o primjeni Tracleera kod trudnica.