FrancophonIA/ELRC3.0 huggingface dataset:
English: Looking at the results of the 3 studies together, 85% of patients treated with Kyntheum obtained a 75% reduction in PASI scores (a measure of disease severity and area of skin affected) after 12 weeks.
Croatian: Ukupna procjena u sva tri ispitivanja dokazuje da je u 85 % bolesnika koji su uzimali lijek Kyntheum došlo do smanjenja PASI ocjena (izračun ozbiljnosti bolesti i područja kože zahvaćene bolešću) za 75 % nakon 12 tjedana.
English: Kyntheum can only be obtained with a prescription and should be used under the supervision of a doctor experienced in diagnosing and treating psoriasis.
Croatian: Kyntheum se izdaje samo na liječnički recept i namijenjen je za primjenu pod nadzorom liječnika iskusnog u dijagnosticiranju i liječenju psorijaze.
English: Kyntheum must not be given to patients who have potentially serious infections such as tuberculosis and to patients with active Crohn's disease (an inflammatory disease affecting the gut).
Croatian: Lijek Kyntheum ne smije se davati bolesnicima koji imaju moguće ozbiljne infekcije kao što su tuberkuloza i bolesnicima koji imaju aktivnu Crohnovu bolest (ili upalnu bolest koja zahvaća crijeva).
English: Kyntheum contains the active substance brodalumab.
Croatian: Kyntheum sadrži djelatnu tvar brodalumab.
English: Kyntheum should be stopped in patients who show new symptoms of depression or anxiety or in case they worsen.
Croatian: Primjena lijeka Kyntheum treba se prekinuti u bolesnika u kojih se jave novi simptomi depresije ili anksioznosti ili se ti simptomi pogoršavaju.
English: Plaque psoriasis improved to a greater extent in patients treated with Kyntheum than with placebo (a dummy treatment) or with ustekinumab (another medicine for psoriasis that targets interleukin molecules).
Croatian: Primijećeno je veće poboljšanje plakpsorijaze u bolesnika koji su primali lijek Kyntheum nego u bolesnika koji su primali placebo (prividno liječenje) ili ustekinumab (drugi lijek za liječenje psorijaze koji cilja molekule interleukina).
English: Interleukins 17 are involved in the process of inflammation that causes plaque psoriasis.
Croatian: Interleukini 17 sudjeluju u postupku upale koja uzrokuje plak-psorijazu.
English: Kyntheum is available as a solution for injection in pre-filled syringes.
Croatian: Kyntheum je dostupan kao suspenzija za injekciju u napunjenim štrcaljkama.
English: By blocking the action of interleukin 17 substances, brodalumab reduces the inflammation and symptoms associated with the disease.
Croatian: Brodalumab blokira djelovanje interleukina 17 i tako smanjuje upalu i simptome povezane s tom bolešću.
English: The European Medicines Agency therefore decided that Kyntheum's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Stoga je stav CHMP-a da koristi lijeka Kyntheum nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za njegovu primjenu u EU-u.
English: For more information about treatment with Kyntheum, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Kyntheum pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: It is used in adults whose disease is moderate to severe and who require systemic treatment (treatment with medicines given by mouth or by injection).
Croatian: Primjenjuje se u odraslih osoba s umjerenom do teškom plak-psorijazom kojima je potrebno sustavno liječenje (liječenje lijekovima koji se uzimaju oralno ili putem injekcije).
English: This compares with 6% of those given placebo and with 70% of patients given ustekinumab.
Croatian: Smanjenje u bolesnika koji su uzimali placebo iznosilo je 6 %, a u bolesnika koji su uzimali ustekinumab 70 %.
English: For practical information about using Kyntheum, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Kyntheum bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: What benefits of Kyntheum have been shown in studies?
Croatian: Koje su koristi lijeka Kyntheum utvrđene u ispitivanjima?
English: Kyntheum is a medicine used to treat plaque psoriasis, a disease causing red, scaly patches on the skin.
Croatian: Kyntheum je lijek za liječenje osoba s plak-psorijazom, bolešću koja na koži uzrokuje crvenkasta žarišta koja se ljušte.
English: For the full list of all side effects and restrictions with Kyntheum, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja zabilježenih pri primjeni lijeka Kyntheum potražite u uputi o lijeku.
English: How is Kyntheum used?
Croatian: Kako se Kyntheum koristi?
English: How does Kyntheum work?
Croatian: Kako djeluje lijek Kyntheum?
English: Kyntheum has been shown to be effective at treating plaque psoriasis in 3 main studies involving over 4,300 patients who required systemic treatment.
Croatian: U tri glavna ispitivanja u kojima je sudjelovalo više od 4300 bolesnika kojima treba sustavno liječenje utvrđeno je da lijek Kyntheum djelotvorno liječi plak-psorijazu.
English: The full EPAR for Kisplyx can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Kisplyx nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Kisplyx is available as capsules (4 mg and 10 mg).
Croatian: Kisplyx je dostupan u obliku kapsula (4 i 10 mg).
English: The recommended dose is 18 mg (made up of one 10 mg capsule and two 4 mg capsules) once a day at the same time each day in combination with 5 mg of everolimus once a day.
Croatian: Preporučena doza je 18 mg (jedna kapsula od 10 mg i dvije kapsule od 4 mg) jedanput na dan u isto vrijeme svakoga dana u kombinaciji s 5 mg everolimusa jedanput na dan.
English: The main measure of effectiveness was how long the patients lived without their disease getting worse (progression-free survival).
Croatian: Glavna mjera djelotvornosti bilo je vrijeme koje su bolesnici preživjeli bez pogoršanja bolesti (preživljenje bez progresije bolesti).
English: What measures are being taken to ensure the safe and effective use of Kisplyx?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Kisplyx?
English: Patients who took the combination of Kisplyx and everolimus lived for an average of 14.6 months without their disease getting worse, compared with 7.4 months for the patients who took Kisplyx alone and 5.5 months for the patients who took everolimus alone.
Croatian: Bolesnici koji su uzimali kombinaciju lijeka Kisplyx i everolimusa živjeli su prosječno 14,6 mjeseci bez pogoršanja bolesti, u usporedbi sa 7,4 mjeseca u bolesnika koji su uzimali samo Kisplyx i 5,5 mjeseci u bolesnika koji su uzimali samo everolimus.
English: Why is Kisplyx approved?
Croatian: Zašto je Kisplyx odobren?
English: By blocking these enzymes, lenvatinib can block the formation of new blood vessels, cutting off the blood supply that keeps cancer cells growing, and reduce the growth of the cancer.
Croatian: Blokirajući te enzime, lenvatinib može blokirati formiranje novih krvnih žila, prekinuti opskrbu krvlju koja omogućuje rast stanicama raka te smanjiti rast raka.
English: What is Kisplyx and what is it used for?
Croatian: Što je Kisplyx i za što se koristi?
English: It is not intended to provide practical advice on how to use Kisplyx.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Kisplyx.
English: Other information about Kisplyx
Croatian: Ostale informacije o lijeku Kisplyx
English: This is a summary of the European public assessment report (EPAR) for Kisplyx.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Kisplyx.
English: Kisplyx can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in using cancer medicines.
Croatian: Kisplyx se izdaje samo na recept, a liječenje mora započeti i nadzirati liječnik koji je iskusan u primjeni lijekova za liječenje raka.
English: Treatment is given for as long as the patient benefits from it or until side effects become unacceptable.
Croatian: Terapiju se primjenjuje sve dok bolesnik ima koristi od terapije ili dok bolesnik ne razvije neprihvatljive nuspojave.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Kisplyx's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji stoga je odlučilo da koristi od lijeka Kisplyx nadmašuju s njime povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: What are the risks associated with Kisplyx?
Croatian: Koji su rizici povezani s lijekom Kisplyx?
English: The dose of Kisplyx should be decreased in patients with severely reduced kidney or liver function.
Croatian: Dozu lijeka Kisplyx potrebno je smanjiti u bolesnika s ozbiljno smanjenom funkcijom bubrega ili jetre.
English: These enzymes can be found in certain receptors (such as VEGF, FGFR, PDGF, KIT and RET receptors) in cancer cells, where they activate several processes including cell division and the growth of new blood vessels.
Croatian: Ti se enzimi nalaze u određenim receptorima (poput receptora VEGF, FGFR, PDGF, KIT i RET) u stanicama raka, gdje aktiviraju nekoliko procesa, uključujući diobu stanica i rast novih krvnih žila.
English: The most important serious side effects are kidney failure and reduced kidney function; problems with the heart and circulation such as heart failure and blood clots in the arteries leading to stroke or heart attack; bleeding in the brain or bleeding of a tumour within the skull; a syndrome known as ‘posterior reversible encephalopathy syndrome' characterised by headache, confusion, fits and loss of vision; and liver failure.
Croatian: Najvažnije ozbiljne nuspojave su zatajenje i smanjena funkcija bubrega; problemi sa srcem i krvotokom poput zatajenja srca i krvnih ugrušaka u arterijama koji rezultiraju moždanim ili srčanim udarom; krvarenje u mozgu ili krvarenje tumora unutar lubanje; sindrom poznat pod nazivom „sindrom posteriorne reverzibilne encefalopatije” koji karakteriziraju glavobolja, konfuzija, napadaji i gubitak vida; te zatajenje jetre.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kisplyx 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 Kisplyx nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The most common side effects with Kisplyx, when used in combination with everolimus or alone and which may affect more than 3 in 10 people, are diarrhoea, high blood pressure, tiredness, loss of appetite and weight, vomiting, nausea (feeling sick), proteinuria (protein in the urine), stomatitis (inflammation of the lining of the mouth), headache, dysphonia (speech disturbances), palmar-plantar erythrodysaesthesia syndrome (hand-foot syndrome, which involves rash and numbness on the palms and soles), peripheral oedema (swelling, especially of the ankles and feet) and hypercholesterolemia (high levels of cholesterol [type of fat] in the blood).
Croatian: Najčešće nuspojave lijeka Kisplyx, kada se primjenjuje u kombinaciji s everolimusom ili kada se primjenjuje sam, a koje se mogu javiti u više od 3 na 10 osoba, jesu proljev, visoki krvni tlak, umor, gubitak apetita i težine, povraćanje, mučnina, proteinurija (proteini u mokraći), stomatitis (upala usne šupljine), glavobolja, disfonija (poremećaji govora), sindrom palmarno-plantarne eritrodizestezije (sindrom šaka-stopalo kod kojeg se javlja osip i utrnulost dlanova i stopala), periferni edem (oticanje, osobito zglobova i stopala) i hiperkolesterolemija (visoke razine kolesterola (vrsta masnoće) u krvi).
English: The safety of Kisplyx used in combination with everolimus is similar to that of these medicines when used individually, and side effects are considered manageable.
Croatian: Sigurnost lijeka Kisplyx u kombinaciji s everolimusom slična je onoj kada se ti lijekovi primjenjuju pojedinačno, a nuspojave je moguće kontrolirati.
English: Kisplyx contains the active substance lenvatinib.
Croatian: Kisplyx sadrži djelatnu tvar lenvatinib.
English: Kisplyx is used together with another cancer medicine called everolimus.
Croatian: Kisplyx se primjenjuje zajedno s drugim lijekom za liječenje raka pod nazivom everolimus.
English: Kisplyx is a cancer medicine used to treat adults with advanced renal cell carcinoma (a type of kidney cancer) who have been previously treated with a type of cancer medicine called a ‘vascular endothelial growth factor (VEGF) inhibitor'.
Croatian: Kisplyx je lijek za liječenje raka koji se primjenjuje za liječenje uznapredovaloga karcinoma bubrežnih stanica (vrsta raka bubrega) u odraslih osoba koje su prethodno liječene vrstom lijeka za liječenje raka koji se naziva „inhibitor vaskularnog endotelnog čimbenika rasta (VEGF)”.
English: For more information about treatment with Kisplyx, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Kisplyx pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Kisplyx has been investigated in one main study involving 153 adults with advanced renal cell carcinoma that had got worse despite treatment with a VEGF inhibitor.
Croatian: Lijek Kisplyx ispitivan je u okviru jednog glavnog ispitivanja provedenog na 153 odraslih osoba s uznapredovalim karcinomom bubrežnih stanica koji se pogoršao unatoč liječenju inhibitorom VEGF-a.
English: Kisplyx, used in combination with everolimus, was shown to significantly improve the time these patients lived without their disease getting worse.
Croatian: Pokazalo se da lijek Kisplyx, u kombinaciji s everolimusom, znatno produljuje vrijeme tijekom kojeg su bolesnici živjeli bez pogoršanja bolesti.
English: The active substance in Kisplyx, lenvatinib, is a ‘tyrosine-kinase inhibitor'.
Croatian: Djelatna tvar lijeka Kisplyx, lenvatinib, inhibitor je tirozin kinaze.
English: Kisplyx must not be taken by breastfeeding women.
Croatian: Lijek Kisplyx ne smiju uzimati dojilje.
English: For practical information about using Kisplyx, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Kisplyx bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Previously treated patients with advanced renal cell carcinoma have poor outcomes and a high unmet medical need.
Croatian: Prethodno liječeni bolesnici s uznapredovalim karcinomom bubrežnih stanica pokazuju loše rezultate liječenja i potrebe za liječenjem njihova stanja uvelike su nezadovoljene.
English: What benefits of Kisplyx have been shown in studies?
Croatian: Koje su koristi lijeka Kisplyx utvrđene u ispitivanjima?
English: How does Kisplyx work?
Croatian: Kako djeluje Kisplyx?
English: For further information, see the package leaflets for Kisplyx and the medicine containing everolimus.
Croatian: Za dodatne informacije vidjeti upute o lijeku za Kisplyx i lijek koji sadržava everolimus.
English: The study compared the combination of Kisplyx and everolimus with Kisplyx or everolimus alone.
Croatian: U ispitivanju je uspoređena kombinacija lijeka Kisplyx i everolimusa s monoterapijom lijekom Kisplyx ili everolimusom.
English: How is Kisplyx used?
Croatian: Kako se Kisplyx koristi?
English: For the list of all side effects reported with everolimus, see the package leaflet of the medicine containing everolimus.
Croatian: Popis svih nuspojava zabilježenih pri primjeni everolimusa potražite u uputi o lijeku za lijek koji sadržava everolimus.
English: The dose of Kisplyx may need to be reduced or treatment stopped temporarily if certain side effects occur.
Croatian: U slučaju pojave određenih nuspojava potrebno je smanjiti dozu lijeka Kisplyx ili privremeno prekinuti liječenje.
English: For the full list of all side effects reported with Kisplyx, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Kisplyx potražite u uputi o lijeku.
English: Your name: __________________________________________________ Prescribing doctor: ________________________________________ If you have questions about Tracleer ask your doctor.
Croatian: ime Vašeg liječnika: ________________________________________ Ako imate pitanja o Tracleeru, pitajte svog liječnika.
English: Animal models
Croatian: Životinjski modeli
English: Comparison between formulations
Croatian: Usporedba formulacija
English: PVR (dyn.sec/cm5)
Croatian: PVR (dyn.s/cm5)
English: Do not stop taking Tracleer unless your doctor tells you to.
Croatian: Nemojte prestati koristiti Tracleer, osim ako Vam je liječnik tako rekao.
English: Use enough water to cover the whole tablet.
Croatian: Upotrijebite dovoljno vode kako bi se prekrila cijela tableta.
English: Recommendations in the event of ALT/AST elevations
Croatian: Preporuke u slučaju povećanja vrijednosti ALT/AST
English: Tracleer with food and drink
Croatian: Tracleer s hranom i pićem
English: Tracleer is used to treat:
Croatian: Tracleer se koristi za liječenje:
English: Important Safety Alerts for Patients taking Tracleer (bosentan)
Croatian: Važna sigurnosna upozorenja za bolesnike koji uzimaju Tracleer (bosentan)
English: What Tracleer is and what it is used for
Croatian: Što je Tracleer i za što se koristi
English: If you forget to take Tracleer, take a dose as soon as you remember, then continue to take your tablets at the usual times.
Croatian: Ako ste zaboravili uzeti Tracleer, uzmite dozu čim se sjetite i zatim nastavite s uzimanjem tableta u uobičajeno vrijeme.
English: Tracleer should only be initiated if the systemic systolic blood pressure is higher than 85 mmHg.
Croatian: Tracleer se smije započeti davati samo ako je sistemski sistolički krvni tlak viši od 85 mmHg.
English: 125 mg twice daily.
Croatian: 125 mg dvaput dnevno.
English: Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age.
Croatian: Nisu dostupni ni neklinički ni klinički podaci za ocjenu primjene aspartama u dojenčadi mlađe od 12 tjedana.
English: Date of first authorisation: 15 May 2002 Date of latest renewal: 20 April 2012
Croatian: Datum posljednje obnove odobrenja: 20. travnja 2012.
English: If you have the impression that the effect of Tracleer is too strong or too weak, talk to your doctor in order to find out whether your dose needs to be changed.
Croatian: Ako imate osjećaj da je učinak Tracleera prejak ili preslab, razgovarajte sa svojim liječnikom kako biste utvrdili postoji li potreba za promjenom doze.
English: Separate the individual blister cavity at the perforations.
Croatian: Odvojite pojedinačna udubljenja blistera na perforacijama.
English: This may be harmful for people with phenylketonuria.
Croatian: To može biti štetno za osobe s fenilketonurijom.
English: Tmax and t1/2 of bosentan were not significantly affected by the formulation.
Croatian: Tmax i t1/2 bonsetana nisu znatno izmijenjena formulacijom.
English: When the tablet has fully dissolved, give the liquid to the patient.
Croatian: Kada se tableta potpuno otopi, tekućinu dajte bolesniku.
English: If you take more Tracleer than you should
Croatian: Ako uzmete više Tracleera nego što ste trebali
English: If the decision to withdraw Tracleer is taken, it should be done gradually while an alternative therapy is introduced.
Croatian: Ukoliko se donijela odluka o ukidanju Tracleera, to treba provesti postupno uz uvođenje alternativne terapije.
English: This card contains important information about Tracleer.
Croatian: Ova kartica sadrži važne informacije o lijeku Tracleer.
English: 56 dispersible tablets (14 x 4)
Croatian: 56 tableta za oralnu suspenziju (14 x 4)
English: Your doctor and/or gynaecologist will establish the contraception which is appropriate for you.
Croatian: Vaš liječnik i/ili ginekolog odredit će kontracepciju prikladnu za
English: Tracleer may harm unborn babies conceived before starting or during treatment.
Croatian: Tracleer može naškoditi nerođenoj djeci začetoj prije početka ili tijekom liječenja.
English: Contents of the pack and other information What Tracleer contains
Croatian: Sadržaj pakiranja i druge informacije Što Tracleer sadrži
English: You should have a pregnancy test before initiation of Tracleer and every month during the treatment even if you think that you are not pregnant.
Croatian: Morate napraviti test na trudnoću prije uvođenja Tracleera i svaki mjesec tijekom liječenja, iako mislite da niste trudni.
English: If you notice any of these signs tell your doctor immediately.
Croatian: Ako primijetite bilo koji od ovih znakova odmah recite svom liječniku.
English: Tell your doctor immediately if you become pregnant while you are taking Tracleer, or plan to become pregnant in the near future.
Croatian: Odmah recite svom liječniku ako zatrudnite tijekom uzimanja Tracleera ili planirate zatrudnjeti u skoroj budućnosti.
English: • other medicines for the treatment of HIV infection, which may require special monitoring if used together with Tracleer.
Croatian: • druge lijekove za liječenje HIV infekcije koji mogu zahtijevati poseban nadzor ako se koriste zajedno s Tracleerom
English: If you are a man taking Tracleer, it is possible that this medicine may lower your sperm count.
Croatian: Ako ste muškarac i uzimate Tracleer, moguće je da Vam taj lijek smanji broj spermija.
English: Therefore, if you feel dizzy or that your vision is blurred while taking Tracleer, do not drive or operate any tools or machines.
Croatian: Zato, ako osjećate omaglicu ili primijetite zamagljen vid tijekom uzimanja Tracleera nemojte voziti niti koristiti alate ili strojeve.
English: Leave for about one minute, until the tablet has fully dissolved, and then swallow all of the liquid.
Croatian: Ostavite otprilike jednu minutu dok se tableta potpuno ne otopi te progutajte svu tekućinu.
English: Please read the information under “Contraceptives” and “Other medicines and
Croatian: Molimo vas pročitajte informacije pod „Kontracepcijska sredstva“ i „Drugi lijekovi i Tracleer“
English: Due to the potential for interactions related to the inducing effect of bosentan on CYP450 (see section 4.5), which could affect the efficacy of antiretroviral therapy, these patients should also be monitored carefully regarding their HIV infection.
Croatian: Zbog mogućnosti interakcija, koje su vezane za inducirajući učinak bosentana na CYP450 (vidjeti dio 4.5), a koje mogu utjecati na učinkovitost antiretrovirusne terapije, te bolesnike treba također pažljivo nadzirati s obzirom na kontrolu HIV-infekcije.
English: Tracleer widens the pulmonary arteries, making it easier for the heart to pump blood through them.
Croatian: Tracleer širi plućne arterije olakšavajući srcu pumpanje krvi kroz njih.
English: Efficacy has been shown in:
Croatian: Djelotvornost se dokazala kod:
English: Your doctor or gynaecologist will advise you about reliable contraceptive methods while taking Tracleer.
Croatian: Vaš liječnik ili ginekolog savjetovat će Vas o sigurnim kontracepcijskim metodama tijekom uzimanja Tracleera.
English: Other medicines and Tracleer
Croatian: Drugi lijekovi i Tracleer
English: In this study, the exposure to bosentan decreased with time in a manner consistent with the known auto-induction properties of bosentan.
Croatian: U ovoj studiji izloženost bosentanu smanjila se s vremenom u skladu s poznatim autoindukcijskim svojstvima bosentana.
English: Patients and prescribers must be aware that due to potential pharmacokinetic interactions, Tracleer may render hormonal contraceptives ineffective (see section 4.5).
Croatian: Bolesnici i liječnici moraju znati da zbog mogućih farmakokinetičkih interakcija Tracleer može smanjiti učinkovitost hormonskih kontraceptiva (vidjeti dio 4.5).