FrancophonIA/ELRC3.0 huggingface dataset:
English: The fourth injection is given four months after the third.
Croatian: Četvrta se injekcija primjenjuje četiri tjedna nakon treće.
English: The vaccine is injected into the shoulder muscle.
Croatian: Cjepivo se ubrizgava u mišić ramena.
English: There should be a gap of one month between the first and second, and between the second and third injections.
Croatian: Potrebno je napraviti pauzu od jednog mjeseca između prve i druge injekcije, te između druge i treće injekcije.
English: The full EPAR for Fendrix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Fendrix nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Croatian: Cjepiva djeluju „učeći“ imunosni sustav (prirodnu obranu tijela) kako da se brani od bolesti.
English: The antibodies will help to protect against the disease caused by the virus.
Croatian: Protutijela pomažu u zaštiti od bolesti koju uzrokuje virus.
English: This system enhances the response of the immune system, which can help when vaccines are used in patients who may have a lower response, such as those with kidney problems.
Croatian: Ovaj sustav pojačava odgovor imunosnog sustava, koji može pomoći ako se cjepiva koriste u bolesnika koji imaju slabiji odgovor, poput onih s insuficijencijom bubrega.
English: The active substance in Fendrix has been available in other vaccines that have been authorised in the European Union (EU) for a number of years.
Croatian: Djelatna tvar lijeka Fendrix dostupna je u drugim cjepivima koja su odobrena u Europskoj uniji (EU) niz godina.
English: Fendrix must not be given to patients with a severe sudden fever.
Croatian: Fendrix se ne smije primjenjivati u bolesnika s ozbiljnom iznenadnom groznicom.
English: The recommended vaccination schedule for Fendrix is four doses.
Croatian: Preporučen raspored cijepljenja za lijek Fendrix je četiri doze.
English: Fendrix is a vaccine, which is available as a suspension for injection.
Croatian: Fendrix je cjepivo koje je dostupno kao suspenzija za injekciju.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fendrix on 2 February 2005.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Fendrix na snazi u Europskoj uniji od 2. veljače 2005.
English: The surface antigens are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Croatian: Površinski antigeni proizvode se metodom poznatom pod nazivom „tehnologija rekombinantne DNK“: proizvodi ih kvasac koji je zaprimio gen (DNK), koji omogućuje proizvodnju proteina.
English: It can be used in patients from the age of 15 years, including patients needing haemodialysis (a blood clearance technique used in patients with kidney disease).
Croatian: Može se koristiti u bolesnika u dobi od 15 godina, uključujući bolesnike kojima je potrebna hemodijaliza (tehnika čišćenja krvi koja se koristi u bolesnika s bolesti bubrega).
English: This is a summary of the European public assessment report (EPAR) for Fendrix.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Fendrix.
English: Other information about Fendrix
Croatian: Ostale informacije o lijeku Fendrix
English: In the future, the immune system will be able to make antibodies more quickly when it is exposed to the hepatitis B virus.
Croatian: U buduće, imunosni sustav može brže proizvoditi antitijela ako se izloži virusu hepatitisa B.
English: For more information about treatment with Fendrix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Fendrix pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Fendrix.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke za uvjete uporabe za lijek Fendrix.
English: When a patient is given the vaccine, the immune system recognises the surface antigens as ‘foreign' and makes antibodies against them.
Croatian: Nakon što bolesnik primi cjepivo, imunosni sustav prepoznaje površinske antigene kao „strane“ i stvara antitijela protiv istih.
English: The company also presented information on the use of Fendrix in liver transplant patients, but it withdrew the application for the use of Fendrix in these patients during the assessment of the vaccine.
Croatian: Tvrtka je također dostavila informacije o uporabi lijeka Fendrix u bolesnika s presađenom jetrom, no povukla je zahtjev za uporabu lijeka Fendrix u ovih bolesnika tijekom ocjene cjepiva.
English: It is recommended that individuals who receive the first dose should complete the course with Fendrix.
Croatian: Preporučuje se da osobe koje prime prvu dozu završe cijelu terapiju lijekom Fendrix.
English: Fendrix was as effective as a double dose of the comparator vaccine.
Croatian: Lijek Fendrix bio je podjednako učinkovit kao dvostruka doza komparatorskog cjepiva.
English: It contains parts of the hepatitis B virus as the active substance.
Croatian: Sadrži dijelove virusa hepatitisa B kao djelatnu tvar.
English: Fendrix has also been studied in one main study involving 165 patients aged 15 years and above who had kidney disease and needed haemodialysis.
Croatian: Lijek Fendrix se također ispitivao u jednom glavnom ispitivanju koje je obuhvatilo 165 bolesnika u dobi od 15 godina i starijih koji su imali bolest bubrega i bila im je potrebna hemodijaliza.
English: Fendrix hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
Croatian: Cjepivo protiv hepatitisa B (rDNA) (s adjuvansom, adsorbirano)
English: Fendrix is a vaccine.
Croatian: Fendrix je cjepivo.
English: A booster dose of Fendrix may be given, according to official recommendations.
Croatian: Može se primijeniti dodatna ili „booster” doza lijeka Fendrix, u skladu sa službenim preporukama.
English: Because the active substance in Fendrix has been available in the EU in other vaccines, some of the information used to support the use of the other vaccines was used to support the use of Fendrix.
Croatian: Budući da je djelatna tvar lijeka Fendrix dostupna u EU-u u drugim lijekovima, određene informacije koje se koriste u prilog primjene drugih cjepiva, korištene su u prilog primjene cjepiva Fendrix.
English: One month after the last dose, 91% of the patients receiving Fendrix had protective levels of antibodies against the hepatitis B virus, compared with 84% of those receiving the comparator.
Croatian: Mjesec dana nakon posljednje doze, 91% bolesnika koji su primali lijek Fendrix imalo je zaštitne koncentracije anttijela protiv virusa hepatitisa B, u usporedbi s 84% onih koji su primali komparator.
English: In Fendrix, it is used with an ‘adjuvant system' which contains ‘MPL', a purified fat from bacteria, and an aluminium compound.
Croatian: U slučaju lijeka Fendrix, koristi se s „adjuvansnim sustavom“ koji sadrži „MPL“, pročišćenu mast bakterija, i spoj aluminija.
English: The effect of Fendrix lasted longer than that of the comparator vaccine: 80% of the patients receiving Fendrix maintained protective levels of antibody for up to three years, compared with 51% of those receiving the comparator.
Croatian: Djelovanje lijeka Fendrix trajalo je dulje od komparatorskog cjepiva: 80% bolesnika koji su primali lijek Fendrix zadržali su zaštitne koncentracije protutijela do tri godine u usporedbi s 51% onih koji su primali komparator.
English: The CHMP decided that Fendrix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Fendrix nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: The most common side effects with Fendrix (seen in more than 1 patient in 10) are headache, pain, redness, swelling at the injection site and fatigue (tiredness).
Croatian: Najčešće nuspojave lijeka Fendrix (mogu se javiti u 1 na 10 bolesnika) su glavobolja, bol, crvenilo, otok u mjestu injekcija i iscrpljenost (umor).
English: The main measure of effectiveness was the proportion of patients who developed protective levels of antibodies against the hepatitis B virus.
Croatian: Glavna mjera djelotvornosti bio je omjer bolesnika koji su razvili zaštitnu koncentraciju antitijela protiv virusa hepatitisa B.
English: Fendrix must not be used in people who are hypersensitive (allergic) to the active substance or any of the other ingredients or have had an allergic reaction after being given a hepatitis B vaccine.
Croatian: Fendrix se ne smije koristiti u osoba koje su preosjetljive (alergične) na djelatnu tvar ili na bilo koju drugu pomoćnu tvar ili koje su imali alergijsku reakciju na cjepivo protiv hepatitisa B.
English: Fendrix contains small amounts of the ‘surface antigen' (proteins from the surface) of the hepatitis B virus.
Croatian: Fendrix sadrži malu količinu „površinskog antigena“ (proteina na površini) virusa hepatitisa B.
English: Why has Fendrix been approved?
Croatian: Zašto je Fendrix odobren?
English: What is the risk associated with Fendrix?
Croatian: Koji su rizici povezani s lijekom Fendrix?
English: Fendrix is used to protect patients with kidney problems against hepatitis B (a disease of the liver due to infection with the hepatitis B virus).
Croatian: Fendrix se koristi za zaštitu bolesnika s bubrežnom insuficijencijom od hepatitisa B (bolesti jetre uslijed infekcije virusom hepatitisa B).
English: Fendrix was compared with a double dose of Engerix B (another hepatitis B vaccine).
Croatian: Lijek Fendrix također je uspoređen s duplom dozom lijeka Engerix B (drugog cjepiva protiv hepatitisa B).
English: What is Fendrix?
Croatian: Što je Fendrix?
English: What benefit has Fendrix shown during the studies?
Croatian: Koje su koristi lijeka Fendrix utvrđene u ispitivanjima?
English: What is Fendrix used for?
Croatian: Za što se Fendrix koristi?
English: For the full list of side effects reported with Fendrix, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Fendrix potražite u uputi o lijeku.
English: How does Fendrix work?
Croatian: Kako djeluje Fendrix?
English: How is Fendrix used?
Croatian: Kako se Fendrix koristi?
English: How has Fendrix been studied?
Croatian: Kako je Fendrix ispitivan?
English: (Invented) name Strength Pharmaceutical Form Route of Administration
Croatian: (Zaštićeno) ime Doza Farmaceutski oblik Put primjene Unutarnje pakovanje
English: Adempas (riociguat)
Croatian: Adempas (riocigvat)
English: The dose is then increased every two weeks until the appropriate dose for the individual patient is established.
Croatian: Doza se zatim povećava svaka dva tjedna sve dok se ne utvrdi odgovarajuća doza za pojedinačnog bolesnika.
English: The maximum dose should not exceed 2.5 mg three times a day.
Croatian: Maksimalna doza ne smije premašiti 2,5 mg tri puta dnevno.
English: The usual recommended starting dose is 1 mg three times a day (approximately 6 to 8 hours apart) for two weeks.
Croatian: Obično se preporučuje početna doza od 1 mg tri puta na dan (u razmaku od otprilike 6 do 8 sati) tijekom dva tjedna.
English: Adempas is available as tablets (0.5, 1, 1.5, 2 and 2.5 mg).
Croatian: Lijek Adempas dostupan je u obliku tableta (0,5, 1, 1,5, 2 i 2,5 mg).
English: The ‘class' reflects the seriousness of the disease: ‘class II' involves slight limitation of physical activity while ‘class III' involves marked limitation of physical activity.
Croatian: „Klasa” se odnosi na ozbiljnost bolesti: „klasa II” obuhvaća blago ograničenje fizičke aktivnosti, a „klasa III” obuhvaća značajno ograničenje fizičke aktivnosti.
English: This overview was last updated in 04-2019.
Croatian: Pregled informacija posljednji je put ažuriran: 04. 2019.
English: What is Adempas and what is it used for?
Croatian: Što je Adempas i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Adempas?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Adempas?
English: It also noted that no other medicines have been authorised for CTEPH.
Croatian: Također je uočeno da ne postoje drugi lijekovi odobreni za liječenje KTEPH-a.
English: Further information on Adempas can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/adempas.
Croatian: Više informacija o lijeku Adempas možete naći na internetskim stranicama Agencije: ema.europa.eu/en/medicines/human/EPAR/adempas.
English: An overview of Adempas and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Adempas i zašto je odobren u EU-u
English: Other information about Adempas
Croatian: Ostale informacije o lijeku Adempas
English: For patients unable to swallow whole tablets, the tablets may be crushed and mixed with water or soft food such as apple sauce.
Croatian: Za bolesnike koji ne mogu progutati cijele tablete, one se mogu zdrobiti i pomiješati s vodom ili mekom hranom kao što je kaša od jabuke.
English: Further information on the orphan designation can be found here: ema.europa.eu/en/medicines/human/orphan-designations/eu307518.
Croatian: Više informacija o statusu lijeka za liječenje rijetkih i teških bolesti možete naći ovdje: ema.europa.eu/en/medicines/human/orphan-designations/eu307518.
English: Treatment with the established dose should continue unless patients experience signs and symptoms of low blood pressure, in which case the dose should be reduced.
Croatian: Liječenje utvrđenom dozom mora se nastaviti osim ako bolesnik pokaže znakove i simptome niskog krvnog tlaka, u slučaju čega se doza mora smanjiti.
English: As a result, the amount of oxygen that can get into the blood in the lungs is reduced, making physical activity more difficult.
Croatian: Kao rezultat toga smanjuje se količina kisika koja može ući u pluća, što otežava fizičku aktivnost.
English: Side effects reported with Adempas are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Adempas pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: • The medicine was also compared with placebo in another main study in 445 patients with PAH.
Croatian: • Lijek je također uspoređen s placebom u drugom glavnom ispitivanju na 445 bolesnika s PAH-om.
English: Adempas is used in patients with functional class II to III CTEPH or PAH.
Croatian: Adempas se primjenjuje u bolesnika s funkcionalnim klasama II do III KTEPH-a ili PAH-a.
English: Adempas can be used on its own or in combination with other medicines for PAH called ‘endothelin receptor antagonists'.
Croatian: Adempas se može primjenjivati kao monoterapija ili u kombinaciji s drugim lijekovima za PAH naziva „antagonisti endotelinskih receptora”.
English: For more information about using Adempas, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Adempas pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: This helps to lower the blood pressure in the lungs and improve symptoms of CTEPH and PAH.
Croatian: To pomaže u snižavanju krvnoga tlaka u plućima i ublažava simptome KTEPH-a i PAH-a.
English: Adempas is a medicine that is used to increase the ability to carry out physical activity in adults with the following forms of pulmonary hypertension (high blood pressure in the blood vessels of the lungs):
Croatian: Adempas je lijek koji se koristi za povećavanje sposobnosti izvođenja fizičke aktivnosti u odraslih osoba sa sljedećim oblicima plućne hipertenzije (visoki krvni tlak u krvnim žilama u plućima):
English: As for all medicines, data on the use of Adempas are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Adempas kontinuirano se prate.
English: What are the risks associated with Adempas?
Croatian: Koji su rizici povezani s lijekom Adempas?
English: Why is Adempas approved?
Croatian: Zašto je lijek Adempas odobren?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Adempas 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 Adempas nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: It must also not be used together with medicines called ‘PDE 5 inhibitors' (a class of medicines used for PAH or erectile dysfunction) or with nitrates or nitric oxide donors (often used to treat high blood pressure, chest pain and heart disease, or as recreational drugs).
Croatian: Također se ne smije primjenjivati zajedno s lijekovima naziva „inhibitori PDE 5” (razred lijekova koji se primjenjuju za liječenje PAH-a ili erektilne disfunkcije), s nitratima ili donorima dušičnog oksida (često se primjenjuju za liječenje visokog krvnog tlaka, boli u prsima i bolesti srca ili kao rekreacijske droge).
English: Regarding safety it considered that side effects of concern, including haemoptysis and pulmonary haemorrhage, have been adequately reflected in the product information and risk management plan.
Croatian: U pogledu sigurnosti, zaključeno je da su zabrinjavajuće nuspojave, uključujući hemoptizu i plućno krvarenje, primjereno prikazane u informacijama o lijeku i planu za upravljanje rizikom.
English: Adempas must not be used in patients with severely reduced liver function, with systolic blood pressure (blood pressure when the heart is contracting) below 95 mmHg before starting treatment, or during pregnancy.
Croatian: Adempas se ne smije primjenjivati u bolesnika s ozbiljno smanjenom funkcijom jetre, sa sistoličnim krvnim tlakom (krvni tlak pri kontrakciji srca) nižim od 95 mmHg prije početka liječenja ili tijekom trudnoće.
English: The European Medicines Agency considered that Adempas led to significant improvements in exercise capacity in patients with CTEPH or PAH.
Croatian: Europska agencija za lijekove zaključila je da je primjena lijeka Adempas dovela do značajnog poboljšanja u kapacitetu podnošenja fizičkog napora u bolesnika s KTEPH-om ili PAH-om.
English: CTEPH and PAH are rare, and Adempas was designated an ‘orphan medicine' (a medicine used in rare diseases) on 20 December 2007.
Croatian: KTEPH i PAH rijetke su bolesti, a Adempas je dobio status „lijeka za liječenje rijetkih i teških bolesti” 20. prosinca 2007.
English: This causes high blood pressure in the vessels taking blood from the heart to the lungs and reduces the blood flow to the lungs.
Croatian: To uzrokuje visok krvni tlak u žilama koje vode krv iz srca u pluća i smanjuje protok krvi do pluća.
English: • Adempas was compared with placebo (a dummy treatment) in one main study in 262 patients with CTEPH who could not be operated, or in whom CTEPH remained or returned after surgery.
Croatian: • Adempas je uspoređen s placebom (slijepo liječenje) u jednom glavnom ispitivanju na 262 bolesnika s KTEPH-om na kojima se nije mogao izvesti kirurški zahvat ili u kojih je KTEPH bio perzistentan ili se vratio nakon kirurškog zahvata.
English: Adempas received a marketing authorisation valid throughout the European Union on 27 March 2014.
Croatian: Lijek Adempas dobio je odobrenje za stavljanje lijeka u promet koje je na snazi u EU-u od 27. ožujka
English: Adempas has been shown to be effective at improving the distance patients with CTEPH or PAH could walk in 6 minutes (a way of measuring exercise capacity):
Croatian: Lijek Adempas pokazao se učinkovitim u povećanju udaljenosti koju su bolesnici s KTEPH-om ili PAHom mogli prehodati u šest minuta (način mjerenja kapaciteta podnošenja fizičkog napora):
English: Adempas can only be obtained with a prescription and treatment should only be started and monitored by a doctor who has experience in the treatment of CTEPH or PAH.
Croatian: Adempas se izdaje samo na recept, a terapiju mora započeti i pratiti samo liječnik s iskustvom u liječenju KTEPH-a ili PAH-a.
English: The most common side effects with Adempas (which may affect more than 1 in 10 people) are headache, dizziness, dyspepsia (heartburn), peripheral oedema (swelling, especially of the ankles and feet), nausea (feeling sick), diarrhoea and vomiting.
Croatian: Najčešće nuspojave lijeka Adempas (koje se mogu javiti u više od 1 na 10 osoba) su glavobolja, vrtoglavica, dispepsija (žgaravica), periferni edem (oticanje, posebno gležnjeva i stopala), mučnina, proljev i povraćanje.
English: The Agency therefore decided that Adempas's benefits are greater than its risks and that it can be authorised for use in the EU.
Croatian: Stoga je Agencija zaključila da koristi lijeka Adempas nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Adempas contains the active substance riociguat.
Croatian: Adempas sadrži djelatnu tvar riocigvat.
English: What benefits of Adempas have been shown in studies?
Croatian: Koje su koristi od lijeka Adempas utvrđene u ispitivanjima?
English: After 12 weeks, patients treated with Adempas could walk 36 metres further in 6 minutes than patients taking placebo.
Croatian: Nakon 12 tjedana bolesnici liječeni lijekom Adempas mogli su prehodati 36 metara više u šest minuta u odnosu na bolesnike koji su uzimali placebo.
English: Adempas is used to treat patients with CTEPH who cannot be operated on, or in whom CTEPH remains or returns after surgery.
Croatian: Adempas se primjenjuje za liječenje bolesnika s KTEPH-om na kojima se ne može izvesti kirurški zahvat ili u kojih je KTEPH perzistentan ili se vraća nakon kirurškog zahvata.
English: CTEPH and PAH are debilitating diseases where there is severe narrowing of the blood vessels of the lungs.
Croatian: KTEPH i PAH onesposobljavajuće su bolesti kod kojih dolazi do ozbiljnog suženja krvnih žila u plućima.
English: After 16 weeks, patients treated with Adempas could walk on average 46 metres further in 6 minutes than patients taking placebo.
Croatian: Nakon 16 tjedana bolesnici liječeni lijekom Adempas mogli su prosječno prehodati 46 metara više u šest minuta u odnosu na bolesnike koji su uzimali placebo.
English: • Chronic thromboembolic pulmonary hypertension (CTEPH, where the blood vessels of the lungs are blocked or narrowed with blood clots).
Croatian: • kronična tromboembolijska plućna hipertenzija (KTEPH, kada su krvne žile pluća začepljene ili sužene krvnim ugrušcima).
English: Before treatment, the patients could walk an average of 347 metres in 6 minutes.
Croatian: Prije liječenja bolesnici su u prosjeku mogli prehodati 347 metara u šest minuta.
English: The active substance in Adempas, riociguat, stimulates an enzyme called ‘soluble guanylate cyclase' in the blood vessels of the lungs, which causes the blood vessels to relax and widen.
Croatian: Djelatna tvar u lijeku Adempas, riocigvat, stimulira enzim naziva „topljiva gvanilat ciklaza” u krvnim žilama pluća, što dovodi do opuštanja i širenja krvnih žila.
English: • Pulmonary arterial hypertension (PAH, where the walls of the blood vessels of the lungs are thickened and the vessels become narrowed).
Croatian: • plućna arterijska hipertenzija (PAH, kada su stijenke krvnih žila pluća zadebljane, a krvne žile postanu sužene).
English: Serious side effects include haemoptysis (coughing up blood) and pulmonary haemorrhage (bleeding in the lungs).
Croatian: Ozbiljne nuspojave uključuju hemoptizu (iskašljavanje krvi) i krvarenje u plućima.
English: Before treatment the patients could walk an average of 363 metres in 6 minutes.
Croatian: Prije liječenja bolesnici su u prosjeku mogli prehodati 363 metra u šest minuta.