FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR and risk management plan summary for Exviera 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 Exviera nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Exviera is available as 250 mg tablets, and the recommended dose is two tablets a day, one in the morning and one in the evening for 8, 12 or 24 weeks.
Croatian: Lijek Exviera dostupan je u obliku tableta od 250 mg, a preporučena doza je dvije tablete dnevno, jedna ujutro i jedna navečer tijekom 8, 12 ili 24 tjedna.
English: What is Exviera and what is it used for?
Croatian: Što je Exviera i za što se koristi?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Exviera on 15 January 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Exviera u promet koje vrijedi na prostoru Europske unije od 15. siječnja 2015.
English: Other information about Exviera
Croatian: Ostale informacije o lijeku Exviera
English: What measures are being taken to ensure the safe and effective use of Exviera?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Exviera?
English: This is a summary of the European public assessment report (EPAR) for Exviera.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Exviera.
English: The clearance rate was particularly high in patients infected with genotype 1b.
Croatian: Stopa čišćenja bila je posebice visoka u bolesnika zaraženih genotipom 1b.
English: Almost all the patients in the studies had the virus cleared from their blood after 12 or 24 weeks.
Croatian: U gotovo svih bolesnika u ispitivanjima virus je očišćen iz krvi nakon 12 ili 24 tjedna.
English: This study is being carried out in light of data suggesting that patients treated with these medicines who have had liver cancer could be at risk of their cancer returning early.
Croatian: To ispitivanje provodi se s obzirom na podatke koji upućuju na to da bi liječenje ovim lijekovima bolesnike koji su bolovali od raka jetre moglo izložiti opasnosti od ranog povratka raka.
English: What are the risks associated with Exviera?
Croatian: Koji su rizici povezani s lijekom Exviera?
English: The Agency therefore concluded that the benefits of Exviera outweigh its risks and recommended that it be approved for use in the EU.
Croatian: Stoga je stav Agencije da koristi od lijeka Exviera nadmašuju s njim povezane rizike te je preporučila izdavanje odobrenja za njegovu primjenu u EU-u.
English: It is not intended to provide practical advice on how to use Exviera.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Exviera.
English: This stops the hepatitis C virus from multiplying and infecting new cells.
Croatian: Time se zaustavlja umnožavanje virusa hepatitisa C i inficiranje novih stanica.
English: The active substance in Exviera, dasabuvir, works by blocking the action of an enzyme in the hepatitis C virus called ‘NS5B RNA-dependent polymerase', which the virus needs to multiply.
Croatian: Djelatna tvar u lijeku Exviera, dasabuvir, djeluje blokiranjem aktivnosti enzima u virusu hepatitisa C naziva „NS5B RNK-ovisna polimeraza” koji je virusu potreban za umnožavanje.
English: Between 96% and 100% of patients without liver scarring had their blood cleared of the virus after 12 weeks of treatment (with or without ribavirin).
Croatian: U između 96 % i 100 % bolesnika bez ožiljaka na jetri očišćena je krv od virusa nakon 12 tjedana terapije (sa ribavirinom ili bez njega).
English: Exviera must not be used in women taking ethinylestradiol, an oestrogen found in hormonal contraceptives.
Croatian: Exviera se ne smije primjenjivati u žena koje uzimaju etinilestradiol, estrogen koji je prisutan u hormonskim kontracepcijskim sredstvima.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Exviera have also 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 Exviera nalaze se i u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Exviera is always used in combination with another medicine, Viekirax, which contains the active substances ombitasvir, paritaprevir and ritonavir.
Croatian: Exviera se uvijek koristi u kombinaciji s drugim lijekom Viekirax, koji sadrži djelatne tvari ombitasvir, paritaprevir i ritonavir.
English: Several varieties (genotypes) of hepatitis C virus exist and Exviera is recommended for use in patients with virus of genotypes 1a and 1b.
Croatian: Postoji nekoliko tipova (genotipova) virusa hepatitisa C, a Exviera se preporučuje za primjenu u bolesnika zaraženih virusom genotipova 1a i 1b.
English: The combination of medicines used and the duration of treatment will depend on which genotype of hepatitis C virus the patient is infected with, the nature of the liver problems they have (for example, if they have liver cirrhosis (scarring) or their liver is not working properly) and whether they have received previous treatment.
Croatian: Kombinacija lijekova koja će se primjenjivati i trajanje terapije ovise o genotipu virusa hepatitisa C kojim je bolesnik zaražen te o prirodi problema koje ima s jetrom (primjerice, ako imaju cirozu jetre (nastajanje ožiljaka) ili ako postoji nepravilna funkcija jetre) te o tome jesu li prethodno liječeni.
English: Exviera can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in managing patients with chronic hepatitis C.
Croatian: Exviera se izdaje samo na liječnički recept, a liječenje treba započeti i nadzirati liječnik iskusan u liječenju osoba oboljelih od kroničnog hepatitisa C.
English: Regarding its safety, although there were some cases of raised liver enzymes in patients treated with Exviera in combination with Viekirax and ribavirin, side effects seen with this combination were generally well tolerated.
Croatian: Što se tiče sigurnosti primjene, iako postoje slučajevi povišenih jetrenih enzima u bolesnika liječenih lijekom Exviera u kombinaciji s lijekom Viekirax i ribavirinom, nuspojave uočene s ovom kombinacijom načelno se dobro podnosilo.
English: Why is Exviera approved?
Croatian: Zašto je lijek Exviera odobren?
English: The company that markets Exviera will carry out a study in patients who previously have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as
Croatian: Tvrtka koja lijek Exviera stavlja na tržište provest će ispitivanje na bolesnicima koje su prethodno bolovali od raka jetre kako bi se procijenio rizik od povratka raka jetre nakon liječenja antivirusnim lijekom s izravnim djelovanjem kao što je Exviera.
English: For more information about treatment with Exviera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Exviera pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: In patients with liver scarring, Exviera treatment in combination with Viekirax and ribavirin resulted in a clearance rate of between 93% and 100% after 24 weeks of treatment.
Croatian: U bolesnika s ožiljcima na jetri, terapija lijekom Exviera u kombinaciji s lijekom Viekirax i ribavirinom rezultirala je stopom čišćenja između 93 % i 100 % nakon 24 tjedana terapije.
English: The most common side effects with Exviera when used with Viekirax and ribavirin (which may affect more than 1 in 10 people) are insomnia (difficulty sleeping), nausea, pruritus (itching), asthenia (weakness) and fatigue (tiredness).
Croatian: Ako se koristi s lijekom Viekirax i ribavirinom, najčešće nuspojave lijeka Exviera (mogu se javiti u više od 1 na 10 osoba) su nesanica (poteškoće sa spavanjem), mučnina, pruritus (svrbež), astenija (slabost) i iscrpljenost (umor).
English: In 6 initial main studies involving around 2,300 patients infected with hepatitis C virus genotypes 1a or 1b, Exviera in combination with Viekirax was effective in clearing the virus from the blood.
Croatian: U šest inicijalnih ispitivanja koja su obuhvaćala oko 2 300 bolesnika zaraženih genotipom 1a ili 1b virusa hepatitisa C, lijek Exviera je u kombinaciji s lijekom Viekirax bio je djelotvoran u čišćenju virusa iz krvi.
English: In a seventh study, patients with liver scarring but stable liver function (compensated cirrhosis) who had genotype 1b infection were treated with Exviera and Viekirax without ribavirin and 100% of patients (60 out of 60 patients) had their blood cleared of the virus.
Croatian: U sedmom ispitivanju bolesnici s ožiljcima na jetri, ali stabilnom funkcijom jetre (kompenzirana ciroza) koji su bili zaraženi genotipom 1b liječeni su lijekovima Exviera i Viekirax bez ribarivina, i u 100% bolesnika (60 od 60 bolesnika) virus se potpuno iščistio iz krvi.
English: Exviera is an antiviral medicine used in combination with other medicines to treat adults with chronic (long-term) hepatitis C, an infectious disease of the liver caused by the hepatitis C virus.
Croatian: Exviera je antivirusni lijek koji se primjenjuje u odraslih osoba za liječenje kroničnog (dugotrajnog) hepatitisa C (infektivne bolesti koja zahvaća jetru, a uzrokuje je virus hepatitisa C).
English: The European Medicines Agency noted that Exviera used in combination with Viekirax is effective in clearing the hepatitis C virus genotypes 1a and 1b from the blood with and without ribavirin.
Croatian: Europska agencija za lijekove zaključila je kako je lijek Exviera, ako se koristi s lijekom Viekirax, djelotvoran u čišćenju genotipova 1a i 1b virusa hepatitisa C iz krvi sa ribavirinom ili bez njega.
English: What benefits of Exviera have been shown in studies?
Croatian: Koje su koristi lijeka Exviera dokazane u ispitivanjima?
English: For practical information about using Exviera, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Exviera bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Some patients taking Exviera are also treated with another antiviral medicine, ribavirin, in addition to Viekirax.
Croatian: Neke bolesnike koji uzimaju lijek Exviera također se liječi i drugim protuvirusnim lijekom, ribavirinom, uz terapiju lijekom Viekirax.
English: How is Exviera used?
Croatian: Kako djeluje Exviera?
English: For the full list of all side effects, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja potražite u uputi o lijeku.
English: It is generally given once a day, except in life-threatening situations.
Croatian: Obično se daje jedanput na dan, osim u životno opasnim situacijama.
English: This summary was last updated in 01-2016.
Croatian: Ovaj sažetak posljednji je put ažuriran: 01.2016.
English: Patients may sometimes be able to give the medicine themselves after suitable training.
Croatian: Ponekad si bolesnici mogu sami davati lijek nakon što su prikladno podučeni.
English: The full EPAR for Nonafact can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za Nonafact nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Nonafact can be used in adults and children over the age of 6.
Croatian: Nonafact se smije primjenjivati u odraslih osoba i djece starije od 6 godina.
English: Treatment should be started under the supervision of a doctor with experience in treating haemophilia.
Croatian: Liječenje treba započeti pod nadzorom liječnika koji je iskusan u liječenju hemofilije.
English: The full detail on how to calculate the doses is included in the package leaflet.
Croatian: Potpune informacije o načinu izračunavanja doza nalaze se u uputi o lijeku.
English: The dose is also adjusted depending on the severity of the haemorrhage or the type of surgery.
Croatian: Doza se također prilagođava ovisno o ozbiljnosti krvarenja ili vrsti kirurškog zahvata.
English: This is a summary of the European public assessment report (EPAR) for Nonafact.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Nonafact.
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 Nonafact.
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 te preporuke o uvjetima za primjenu lijeka Nonafact.
English: Nonafact human coagulation factor IX
Croatian: Nonafact ljudski faktor koagulacije IX
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Nonafact on 3 July 2001.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Nonafact na snazi u Europskoj uniji od 3. srpnja 2001.
English: Nonafact is intended for either short-term or long-term use.
Croatian: Nonafact je predviđen za kratkotrajnu ili dugotrajnu primjenu.
English: In the body, factor IX is one of the substances (factors) needed for blood coagulation (clotting).
Croatian: U tijelu je faktor IX jedna od tvari (faktora) potrebnih za koagulaciju (zgrušavanje) krvi.
English: Nonafact is given by infusion into a vein at a rate of no more than 2 ml per minute.
Croatian: Nonafact se primjenjuje infuzijom u venu brzinom primjene koja ne prelazi 2 ml po minuti.
English: What measures are being taken to ensure the safe and effective use of Nonafact?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Nonafact?
English: Nonafact is a powder and solvent that are mixed together to form a solution for infusion (drip) into a vein.
Croatian: Nonafact je prašak i otapalo koji se miješaju zajedno kako bi se pripremila otopina za infuziju (drip) u venu.
English: Nonafact has been studied in two clinical studies, including 26 patients who received Nonafact as a prevention treatment (for example before extensive exercise), and 8 patients who received Nonafact during 11 surgical interventions.
Croatian: Nonafact je ispitivan u okviru dvaju kliničkih ispitivanja koja su obuhvaćala 26 bolesnika koji su primali lijek Nonafact u svrhu preventivnog liječenja (primjerice prije napornog vježbanja) te 8 bolesnika koji su primali Nonafact tijekom 11 kirurških zahvata.
English: Patients with haemophilia B lack factor IX, and this causes bleeding problems, such as bleeding in the joints, muscle or internal organs.
Croatian: Bolesnicima s hemofilijom B nedostaje faktor IX što uzrokuje poteškoće s krvarenjem, poput krvarenja u zglobovima, mišićima i unutarnjim organima.
English: Other information about Nonafact
Croatian: Ostale informacije o lijeku Nonafact
English: A risk management plan has been developed to ensure that Nonafact is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Nonafact.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Nonafact, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka, kao i u uputi o lijeku za lijek Nonafact, nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The doctor will calculate a suitable dose, depending on whether Nonafact is used to treat haemorrhage (bleeding) or to prevent bleeding during surgery.
Croatian: Liječnik će izračunati primjerenu dozu, ovisno o tome primjenjuje li se Nonafact za liječenje krvarenja ili sprječavanje krvarenja tijekom kirurškog zahvata.
English: Nonafact must not be used in people who are hypersensitive (allergic) to human coagulation factor IX or to any of the other ingredients, or to mouse proteins.
Croatian: Lijek Nonafacat ne smiju koristiti osobe preosjetljive (alergične) na ljudski faktor koagulacije IX ili na bilo koji drugi sastojak ovog lijeka ili na proteine miša.
English: Nonafact was rated as “good” or “excellent” in its ability to prevent bleeding in patients with haemophilia B.
Croatian: Lijek Nonafact ocijenjen je kao „dobar″ ili „izvrstan″ u svojoj sposobnosti sprječavanja krvarenja u bolesnika s hemofilijom B.
English: Nonafact is used for the treatment and prevention of bleeding in patients with haemophilia B (an inherited bleeding disorder caused by lack of factor IX).
Croatian: Nonafact se koristi za liječenje i sprječavanje krvarenja u bolesnika s hemofilijom B (nasljednim poremećajem krvarenja uzrokovanim manjkom faktora IX).
English: For more information about treatment with Nonafact, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Nonafact pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Nonafact is used to replace the missing factor IX; it corrects the factor IX deficiency and gives temporary control of the bleeding disorder.
Croatian: Nonafact se koristi kao zamjena za faktor IX koji nedostaje; ispravlja nedostatak faktora IX te omogućuje privremenu kontrolu poremećaja krvarenja.
English: Nonafact contains human coagulation factor IX, a protein extracted and purified from human plasma (the liquid part of the blood).
Croatian: Nonafact sadrži ljudski faktor koagulacije IX, protein izdvojen i pročišćen iz ljudske plazme (tekućeg dijela krvi).
English: What is the risk associated with Nonafact?
Croatian: Koji su rizici povezani s lijekom Nonafact?
English: Why has Nonafact been approved?
Croatian: Zašto je Nonafact odobren?
English: Most patients had severe haemophilia B. The studies assessed the number of major or life-threatening bleeding episodes that occurred during treatment, or during and after surgery.
Croatian: U ispitivanjima je utvrđen broj većih ili po život opasnih pojava krvarenja koje su se javile tijekom liječenja ili tijekom i nakon kirurškog zahvata.
English: Nonafact contains the active substance human coagulation factor IX, which helps blood to clot.
Croatian: Nonafact sadrži djelatnu tvar ljudski faktor koagulacije IX koji pomaže zgrušavanju krvi.
English: What is Nonafact?
Croatian: Što je Nonafact?
English: What benefit has Nonafact shown during the studies?
Croatian: Koje su koristi lijeka Nonafact utvrđene u ispitivanjima?
English: Haemophilia B patients may develop antibodies (inhibitors) to factor IX.
Croatian: Bolesnici s hemofilijom B mogu razviti protutijela (inhibitore) na faktor IX. Ako se to dogodi, lijek Nonafact možda neće biti djelotvoran.
English: Hypersensitivity (allergic reactions) has been sometimes seen in patients treated with factor IX-containing products.
Croatian: Ponekad je uočena reakcija preosjetljivosti (alergijske reakcije) u bolesnika liječenih lijekovima koji sadrže faktor IX. Potpuni popis nuspojava zabilježenih pri primjeni lijeka Nonafact potražite u uputi o lijeku.
English: The CHMP decided that Nonafact's benefits are greater than its risks for the treatment and prevention of bleeding in patients with haemophilia B. They recommended that Nonafact be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Nonafact nadmašuju s njim povezane rizike u liječenju i sprječavanju krvarenja u bolesnika s hemofilijom B.
English: How does Nonafact work?
Croatian: Kako djeluje Nonafact?
English: How has Nonafact been studied?
Croatian: Kako je Nonafact ispitivan?
English: How is Nonafact used?
Croatian: Kako se Nonafact koristi?
English: What is Nonafact used for?
Croatian: Za što se Nonafact koristi?
English: In particular, do not take Sovaldi if you are taking any of the following medicines:
Croatian: Osobito nemojte uzimati Sovaldi ako uzimate neke od sljedećih lijekova:
English: • Decide what other medicines you should take with Sovaldi and for how long;
Croatian: • odlučiti koje još lijekove trebate uzimati sa Sovaldijem i koliko dugo;
English: Eight subjects (20%) received epoetin and/or a blood product.
Croatian: Osam ispitanika (20%) primilo je epoetin i/ili krvni pripravak.
English: Most subjects had no prior HCV treatment (81.3%).
Croatian: Većina ispitanika prethodno nije primala liječenje za HCV (81,3%).
English: In 5 subjects (12.5%), study drugs were discontinued, modified or interrupted due to adverse events.
Croatian: U 5 ispitanika (12,5%) primjena ispitivanih lijekova bila je prekinuta, prilagođena ili privremeno obustavljena zbog štetnih događaja.
English: Furthermore, the appropriate dose has not been established.
Croatian: odgovarajuća doza nije ustanovljena.
English: The recommended dose is one tablet once a day with food.
Croatian: Preporučena doza Preporučena doza je jedna tableta jedanput na dan s hranom.
English: • Currently take, or have taken in the last few months, the medicine amiodarone to treat irregular heartbeats (your doctor may consider alternative treatments if you have taken this medicine);
Croatian: • trenutno uzimate ili ste u posljednjih nekoliko mjeseci uzimali lijek amiodaron za liječenje nepravilnih otkucaja srca (Vaš liječnik može razmotriti zamjensko liječenje ako ste uzimali ovaj lijek)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 January 2014
Croatian: Datum prvog odobrenja: 16 siječanj 2014
English: Preliminary SVR12 data are available for 210 subjects.
Croatian: Preliminarni podaci o SVR12 dostupni su za 210 ispitanika.
English: • If you are allergic to sofosbuvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Croatian: • Ako ste alergični na sofosbuvir ili neki drugi sastojak ovog lijeka (naveden u dijelu 6 ove upute).
English: The response rates observed for subjects over 65 years of age were similar to that of younger subjects across treatment groups.
Croatian: Stope odgovora opažene za ispitanike u dobi iznad 65 godina bile su slične onima u mlađih ispitanika u svim terapijskim skupinama.
English: • If you or your partner become pregnant during Sovaldi treatment or in the months that follow, you must contact your doctor immediately.
Croatian: • Ako Vi ili Vaša partnerica zatrudnite tijekom liječenja lijekom Sovaldi ili u mjesecima nakon liječenja, morate se odmah obratiti liječniku.
English: ANALEPTICS Modafinil
Croatian: ANALEPTICI Modafinil
English: • Have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely;
Croatian: • imate ili ste prethodno imali infekciju virusom hepatitisa B, jer će Vas liječnik možda htjeti pobliže pratiti
English: Sovaldi is not recommended for use in children and adolescents under 18 years of age because the safety and efficacy have not been established in this population.
Croatian: Sovaldi se ne preporučuje za primjenu u djece i adolescenata u dobi do 18 godina zato što njegova sigurnost i djelotvornost nisu ustanovljene u ovoj populaciji.
English: Previously treated adults - FUSION (study 108)
Croatian: Prethodno liječeni odrasli - FUSION (ispitivanje 108)
English: ↔ GS-331007 (TPV or BOC)
Croatian: ↔ GS-331007 (TPV ili BOC)
English: • changes in your liver (as shown by increased amounts of a substance called bilirubin in the blood)
Croatian: • promjene u jetri (koje pokazuju povišene količine tvari koja se zove bilirubin u krvi)
English: • hair loss and thinning hair
Croatian: • ispadanje kose i prorijeđena kosa
English: • Have liver problems other than hepatitis C, e.g. if you are awaiting a liver transplantation;
Croatian: • imate i druge tegobe s jetrom osim hepatitisa C, npr. ako čekate na transplantaciju jetre