FrancophonIA/ELRC3.0 huggingface dataset:
English: The study included patients with and without cirrhosis as well as patients who had not responded to previous therapy.
Croatian: Ispitivanje je obuhvatilo bolesnike s cirozom i bez nje, kao i bolesnike koji nisu reagirali na prethodnu terapiju.
English: How does Olysio work?
Croatian: Kako djeluje Olysio ?
English: What are the risks associated with Olysio?
Croatian: Koji su rizici povezani s lijekom Olysio?
English: It is not intended to provide practical advice on how to use Olysio.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Olysio.
English: The most common side effects during treatment with Olysio (which may affect more than 1 in 10 people) are nausea (feeling sick), rash, pruritus (itching) and dyspnoea (difficulty breathing).
Croatian: Najčešće nuspojave lijeka Olysio (koje se mogu javiti u više od 1 na 10 osoba) jesu mučnina (slabost), osip, pruritus (svrbež) i dispneja (otežano disanje).
English: The European Medicines Agency decided that Olysio's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Europska agencija za lijekove odlučila je da koristi lijeka Olysio nadmašuju s njim povezane rizike te je preporučila njegovo odobrenja za primjenu u Europskoj uniji.
English: The company that markets Olysio 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 Olysio.
Croatian: Tvrtka koja lijek Olysio stavlja na tržište provest će ispitivanje na bolesnicima koji su prethodno imali rak jetre kako bi se procijenio rizik od povratka raka jetre nakon liječenja antivirusnim lijekom s izravnim djelovanjem kao što je Olysio.
English: The Agency also considered that the data available support the use of Olysio in combination with sofosbuvir.
Croatian: Odbor je također zaključio da dostupni podatci idu u prilog primjeni lijeka Olysio u kombinaciji sa sofosbuvirom.
English: The Agency concluded that, in both previously untreated patients and patients who had already been treated, adding Olysio to treatment with peginterferon alfa and ribavirin considerably increased the number of patients showing no sign of infection.
Croatian: Agencija je zaključila da je, u slučaju neliječenih bolesnika i u slučaju bolesnika koji su već liječeni, dodavanje lijeka Olysio terapiji s peginterferonom alfa i ribavirinom značajno povećalo broj bolesnika koji nisu pokazivali znakove infekcije.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Olysio have also been included in the summary of product characteristics and the
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Olysio nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Olysio can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of patients with chronic hepatitis C.
Croatian: Olysio se izdaje samo na liječnički recept, a liječenje treba započeti i nadzirati liječnik iskusan u liječenju osoba oboljelih od kroničnog hepatitisa C.
English: It is used to treat adults with chronic (long-term) hepatitis C, an infectious disease that affects the liver caused by the hepatitis C virus.
Croatian: Primjenjuje se za liječenje odraslih osoba s kroničnim (dugotrajnim) hepatitisom C, zaraznom bolešću koja zahvaća jetru, a uzrokuje je virus hepatitisa C.
English: Several varieties (genotypes) of hepatitis C virus exist and Olysio is recommended for patients with virus of genotypes 1 and 4.
Croatian: Postoji nekoliko tipova (genotipova) virusa hepatitisa C, a Olysio se preporučuje za bolesnike zaražene virusom genotipova 1 i 4.
English: Olysio must be used in combination with other medicines used to treat chronic hepatitis C, such as with peginterferon alfa and ribavirin or with sofosbuvir.
Croatian: Olysio se mora primjenjivati u kombinaciji s drugim lijekovima za liječenje kroničnog hepatitisa C, kao što su peginterferon alfa i ribavirin ili sa sofosbuvirom.
English: Three main studies involving 1,178 patients with hepatitis C virus of genotype 1 investigated the combination with peginterferon alfa and ribavirin.
Croatian: U trima glavnim ispitivanjima koja su obuhvatila 1 178 bolesnika s virusom hepatitisa C genotipa 1 provedeno je istraživanje o kombinaciji s peginterferonom alfa i ribavirinom.
English: Before starting treatment with Olysio, patients with genotypes 1a should have a blood test to check whether the virus they are infected with has a mutation (a change in the genetic material of the virus) called Q80K, as Olysio is known to be less effective in these patients.
Croatian: Prije početka liječenja lijekom Olysio bolesnici zaraženi genotipom 1a trebali bi napraviti krvne pretrage kako bi se provjerilo ima li virus kojim su zaraženi mutaciju (promjena u genetskom materijalu virusa) koja se naziva Q80K, jer je zabilježeno da je lijek Olysio manje djelotvoran u tih bolesnika.
English: What benefits of Olysio have been shown in studies?
Croatian: Koje su koristi lijeka Olysio dokazane u ispitivanjima?
English: The active substance in Olysio, simeprevir, blocks the action of an enzyme called ‘NS3/4A serine protease' in the hepatitis C virus, which is essential for the virus to multiply.
Croatian: Djelatna tvar lijeka Olysio, simeprevir, u virusu hepatitisa C inhibira djelovanje enzima „NS3/4A serin proteaza”, neophodnog za umnožavanje virusa.
English: Several studies show that Olysio in combination with peginterferon alfa and ribavirin or with sofosbuvir is effective in clearing the hepatitis C virus from the blood after 12 or 24 weeks of treatment.
Croatian: U nekoliko je ispitivanja utvrđeno da je lijek Olysio u kombinaciji s peginterferonom alfa i ribavirinom ili sa sofosbuvirom djelotvoran u uklanjanju virusa hepatitisa C iz krvi nakon 12 tjedana ili 24 tjedna liječenja.
English: For more information about treatment with Olysio, read the package leaflet (also part of the EPAR) or contact
Croatian: Više informacija o liječenju lijekom Olysio pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: In two additional studies of simeprevir in combination with sofosbuvir in 413 patients, patients without cirrhosis who were taking Olysio together with sofosbuvir had a clearance rate at 12 weeks of 97%, while patients with cirrhosis had a 12 weeks clearance rate of 83%.
Croatian: U dvama dodatnim ispitivanjima simeprevira u kombinaciji s sofosbuvirom u 413 bolesnika, bolesnici bez ciroze koji su uzimali lijek Olysio sa sofosbuvirom imali su stopu čišćenja od 97 % nakon 12 tjedana, dok su bolesnici s cirozom imali stopu čišćenja od 83 % u 12. tjednu.
English: In two of the studies, which involved previously untreated patients, around 80% (419 out of 521) of patients taking Olysio tested negative for hepatitis C 12 weeks after the end of treatment, compared with 50% (132 out of 264) of patients on placebo.
Croatian: U dvama ispitivanjima koja su obuhvatila bolesnike koji nisu prethodno liječeni, nalaz kod otprilike 80 % (419 od 521) bolesnika koji su uzimali lijek Olysio bio je negativan na hepatitis C 12 tjedana nakon završetka liječenja, u usporedbi s 50 % (132 od 264) bolesnika koji su primali placebo.
English: Olysio taken together with sofosbuvir was investigated in a study involving 167 patients, which showed that the combination (with or without ribavirin) cleared infection with hepatitis C genotype 1 in around 90% of patients 12 weeks after the end of treatment.
Croatian: Primjena lijeka Olysio zajedno sa sofosbuvirom ispitana je u skupini od 167 bolesnika, a rezultati su pokazali da je uz pomoć ove kombinacije (s ribavirinom ili bez njega) 12 tjedana nakon završetka liječenja više od 90 % bolesnika izliječeno od infekcije hepatitisom C genotipa 1.
English: In the third study, involving patients whose infections had come back following treatment with interferon-based therapy, around 80% (206 out of 260) of patients taking Olysio tested negative for hepatitis C 12 weeks after the end of treatment, compared with around 37% (49 out of 133) of
Croatian: U trećem ispitivanju koje je obuhvatilo bolesnike čije su se infekcije vratile nakon terapije koja se temelji na interferonu, nalaz kod otprilike 80 % (206 od 260) bolesnika koji su uzimali lijek Olysio bio je negativan na hepatitis C 12 tjedana nakon završetka liječenja, u usporedbi s 37 % (49 od 133) bolesnika koji su uzimali placebo.
English: For practical information about using Olysio, patients should read the package leaflet or contact their
Croatian: Praktične informacije o primjeni lijeka Olysio bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: The European Commission granted a marketing authorisation valid throughout the European Union for
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Olysio na snazi u Europskoj uniji od 14. svibnja 2014.
English: Additional studies of the combination with peginterferon alfa and ribavirin involving patients with hepatitis C virus of genotype 4 and patients with HIV co-infection showed results consistent with those in patients with genotype 1.
Croatian: Analiza ovih ispitivanja pokazala je da je Olysio bio manje djelotvoran u podskupini bolesnika zaraženih virusom hepatitisa C genotipa 1a koji ima mutaciju Q80K. Dodatna ispitivanja kombinacije s peginterferonom alfa i ribavirinom obuhvatila su bolesnike oboljele od virusa hepatitisa C genotipa 4 i bolesnike koji ujedno imaju infekciju HIV-om, a pokazala su rezultate konzistentne s onima u bolesnika s genotipom 1.
English: Date of first authorisation: 04 January 2017
Croatian: Datum prvog odobrenja: 04. siječnja 2017.
English: DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION
Croatian: DATUM PRVOG ODOBRENJA / DATUM OBNOVE ODOBRENJA
English: This is of importance particularly when changing the laboratory and/or reagents used in the assay.
Croatian: Ovo je posebno važno kod promjene laboratorija i/ili reagensa koji se upotrebljavaju u testu.
English: - Reconstitution and withdrawal must be carried out under aseptic conditions.
Croatian: - Rekonstitucija i izvlačenje moraju se izvesti u aseptičkim uvjetima.
English: Paediatric population <12 years of age
Croatian: Pedijatrijska populacija < 12 godina
English: Your doctor should inform you of the early signs of allergic reactions.
Croatian: Vaš liječnik treba Vas obavijestiti o ranim znakovima alergijskih reakcija.
English: After reconstitution the chemical and physical in-use stability has been demonstrated for 48 hours at room temperature (below 25 °C).
Croatian: Nakon rekonstitucije dokazana je kemijska i fizička stabilnost tijekom 48 sati na sobnoj temperaturi (ispod 25 °C).
English: VWF stabilizes factor VIII and protects it from degradation.
Croatian: VWF stabilizira faktor VIII i štiti ga od degradacije.
English: The vials must not be heated above body temperature (37 °C).
Croatian: Bočice se ne smiju zagrijati iznad tjelesne temperature (37 °C).
English: • your clinical condition and response
Croatian: • Vašem kliničkom stanju i odgovoru
English: The amount of AFSTYLA you need to take and the duration of treatment depend on:
Croatian: Količina lijeka AFSTYLA koju trebate uzeti i trajanje liječenja ovise o:
English: Osmolality: 500 - 600 mOsm/kg
Croatian: Osmolalnost: 500 - 600 mOsm/kg
English: However depending on your body weight and your dose of AFSTYLA, you could receive more than one vial.
Croatian: Međutim, ovisno o Vašoj tjelesnoj težini i dozi lijeka AFSTYLA, možete primiti više od jedne bočice.
English: This can be done either by leaving the vials at room temperature for about an hour, or by holding them in your hands for a few minutes.
Croatian: To možete postići tako da bočice ostavite na sobnoj temperaturi otprilike jedan sat ili držeći ih u rukama nekoliko minuta.
English: • Before the AFSTYLA powder is reconstituted it may be kept at room temperature (below
Croatian: • Prije nego što se prašak AFSTYLA rekonstituira, može se čuvati na sobnoj temperaturi (ispod
English: Elderly Clinical studies of AFSTYLA did not include subjects over 65 years of age.
Croatian: Starije osobe Klinička ispitivanja lijeka AFSTYLA nisu uključivala ispitanike starije od 65 godina.
English: ATC code: B02BD02
Croatian: ATK oznaka: B02BD02
English: No patient developed an inhibitor or experienced an anaphylactic reaction.
Croatian: Nijedan bolesnik nije razvio inhibitor niti doživio anafilaktičku reakciju.
English: Repeat injection every 12 to 24 hours.
Croatian: Ponavljati injekciju svakih 12 do 24 sata.
English: Proceed with the next dose immediately and continue as advised by your doctor or pharmacist.
Croatian: Odmah uzmite sljedeću dozu i nastavite kako Vas je savjetovao liječnik ili ljekarnik.
English: What AFSTYLA is and what it is used for
Croatian: Što je AFSTYLA i za što se koristi
English: Like all medicines, AFSTYLA can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, AFSTYLA može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: • The reconstituted product should preferably be used immediately.
Croatian: • Rekonstituirani lijek trebao bi se upotrijebiti odmah.
English: • your body weight
Croatian: • Vašoj tjelesnoj težini
English: Other medicines and AFSTYLA
Croatian: Drugi lijekovi i AFSTYLA
English: The specific activity of AFSTYLA is 7400 - 16000 IU/mg protein.
Croatian: Specifična je aktivnost lijeka AFSTYLA 7400 - 16 000 IU/mg proteina.
English: What AFSTYLA looks like and contents of the pack
Croatian: Kako AFSTYLA izgleda i sadržaj pakiranja
English: Factor VIII is involved in blood clotting.
Croatian: Faktor VIII uključen je u zgrušavanje krvi.
English: From a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog stajališta lijek se mora upotrijebiti odmah.
English: Without opening the vials, warm the AFSTYLA powder and the liquid to room or body temperature.
Croatian: Bez otvaranja bočica zagrijte prašak AFSTYLA i tekućinu na sobnu ili tjelesnu temperaturu.
English: Monitoring laboratory tests
Croatian: Laboratorijske pretrage za nadziranje
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Croatian: Doza koja se temelji na tjelesnoj težini možda će se trebati prilagoditi u pothranjenih ili pretilih bolesnika.
English: Lack of this factor means that blood does not clot as quickly as it should so there is an increased tendency to bleed.
Croatian: Nedostatak ovog faktora znači da se krv ne zgrušava onoliko brzo koliko bi trebala i stoga postoje veći izgledi za krvarenje.
English: No paediatric subjects <18 years of age were included in the surgery population.
Croatian: Nijedan pedijatrijski ispitanik <18 godina nije bio uključen u populaciju s kirurškim zahvatima.
English: For patients with previous hypersensitivity reactions appropriate pre-medication may be considered.
Croatian: Za bolesnike s ranijim reakcijama preosjetljivosti može se uzeti u obzir odgovarajuća premedikacija.
English: Do not stop using AFSTYLA without consulting your doctor.
Croatian: Nemojte prestati primjenjivati lijek AFSTYLA bez savjetovanja sa svojim liječnikom.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products or solvents except those mentioned in sections 2 and 6.5.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima ili otapalima osim onih navedenih u dijelovima 2 i 6.5.
English: If you stop using AFSTYLA you may no longer be protected against bleeding or a current bleed may not stop.
Croatian: Ako prestanete primjenjivati lijek AFSTYLA, možda više nećete biti zaštićeni od krvarenja ili trenutno krvarenje možda neće prestati.
English: Talk to your doctor, pharmacist or nurse before using AFSTYLA.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite lijek AFSTYLA.
English: Of note, annualized bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies.
Croatian: Važno je napomenuti da anualizirana stopa krvarenja (ABR) nije usporediva kod različito koncentriranih faktora i kod različitih kliničkih ispitivanja.
English: May be stored at room temperature up to 25 °C for a single 3 months period.
Croatian: Može se čuvati na sobnoj temperaturi do 25 °C u jednokratnom razdoblju od 3 mjeseca.
English: The chromogenic assay result most accurately reflects the clinical hemostatic potential of AFSTYLA and is preferred.
Croatian: Rezultat kromogenog testa najtočnije odražava klinički hemostatski potencijal lijeka AFSTYLA i preferira se.
English: What AFSTYLA is and what it is used for What you need to know before you use AFSTYLA How to use AFSTYLA
Croatian: Što je AFSTYLA i za što se koristi Što morate znati prije nego počnete primjenjivati lijek AFSTYLA
English: The product contain traces of hamster proteins (see also “Do not use AFSTYLA”).
Croatian: Lijek sadrži proteine hrčka u tragovima (vidjeti „Nemojte primjenjivati lijek AFSTYLA”).
English: • Store in a refrigerator (2 °C to 8 °C).
Croatian: • Čuvati u hladnjaku (2 °C do 8 °C).
English: Adult and adolescent population 12 - 65 years of age Study 1001 determined the efficacy and safety in the prevention of bleeding events in prophylaxis, hemostatic efficacy in the control of bleeding events and during perioperative management.
Croatian: Populacija odraslih i adolescenata u dobi od 12 - 65 godina Ispitivanje 1001 odredilo je djelotvornost i sigurnost u prevenciji događaja krvarenja u profilaksi, hemostatsku djelotvornost u kontroli događaja krvarenja i tijekom perioperacijskog liječenja.
English: If you have any side effects that might be related to the administration of AFSTYLA, the injection should be stopped (see also section
Croatian: Ako opazite neku nuspojavu koja bi mogla biti povezana s primjenom lijeka AFSTYLA, potrebno je prekinuti injekciju (vidjeti također dio
English: • if you have had an allergic reaction to AFSTYLA, or any of its ingredients (listed in section 6).
Croatian: • ako ste imali alergijsku reakciju na lijek AFSTYLA ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: • tingling or numbness (paraesthesia)
Croatian: • trnci ili utrnulost (parestezija)
English: Repeat injection every 8 to 24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl).
Croatian: Ponavljati injekciju svakih 8 do 24 sata do odgovarajućeg zacjeljenja rane, a zatim nastaviti liječenje tijekom još najmanje 7 dana kako bi se aktivnost faktora VIII održala između 30 % i 60 % (IU/dl).
English: Allow the vials to dry before opening the Mix2Vial package (which contains the filter transfer device), then follow the instructions given below.
Croatian: Pustite da se bočice osuše prije nego što otvorite Mix2Vial pakiranje (koje sadrži napravu za prijenos s filtrom), a potom se pridržavajte uputa u nastavku.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity studies, local tolerability and thrombogenicity assessments.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, ispitivanja toksičnosti jedne i ponovljenih doza, lokalne podnošljivosti i procjena trombogenosti.
English: In children below the age of 12 higher doses or more frequent injections may be needed.
Croatian: U djece dobi manje od 12 godina mogu biti potrebne više doze ili češće injekcije.
English: In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Croatian: U svrhu poboljšanja sljedivost bioloških lijekova, ime i broj serije lijeka moraju biti jasno zabilježeni.
English: General instructions - The solution should be almost colourless, clear or slightly opalescent.
Croatian: Opće upute - Otopina treba biti gotovo bezbojna, bistra ili blago opalescentna.
English: • During pregnancy and breast-feeding, AFSTYLA should be given only if it is clearly needed.
Croatian: • Tijekom trudnoće i dojenja lijek AFSTYLA treba davati samo ako je to prijeko potrebno.
English: • Allergic (hypersensitivity) reactions are possible.
Croatian: • Moguće su alergijske reakcije (preosjetljivost).
English: What AFSTYLA contains
Croatian: Što AFSTYLA sadrži
English: The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre posing less of a risk of insufficient clinical response than high titre inhibitors.
Croatian: Klinički značaj razvoja inhibitora ovisit će o titru inhibitora, pri čemu inhibitori s niskim titrom predstavljaju manji rizik za pojavu nedovoljnog kliničkog odgovora nego inhibitori s visokim titrom.
English: Please stop using the medicine immediately and contact your doctor if:
Croatian: Molimo odmah prestanite uzimati lijek te se obratite svom liječniku ako:
English: • If you have been told you have heart disease or are at risk for heart disease, tell your doctor or pharmacist.
Croatian: • Ako Vam je rečeno da imate bolest srca ili postoji rizik od bolesti srca, obratite se svojem liječniku ili ljekarniku.
English: More frequent or higher doses may be required in children <12 years of age to account for the higher clearance in this age group.
Croatian: Češće ili više doze mogu biti potrebne u djece < 12 godina kako bi se uzeo u obzir viši klirens u ovoj dobnoj skupini.
English: This should be taken into consideration if you are on a controlled sodium diet.
Croatian: Ovo se mora uzeti u obzir ako ste na prehrani s kontroliranim unosom natrija.
English: If this happens you or your child´s medicines may stop working properly and you or your child may experience persistent bleeding.
Croatian: Ako se to dogodi, Vama ili Vašem djetetu lijek može prestati djelovati kako treba i može se Vama ili Vašem djetetu javiti krvarenje koje ne prestaje.
English: For adolescents of 12 years of age and above, the dose recommendations are the same as for adults (please refer to section 5.2).
Croatian: Za adolescente u dobi od 12 godina ili starije preporuke za doziranje iste su kao i za odrasle osobe (vidjeti dio 5.2).
English: No interactions of human coagulation factor VIII products with other medicinal products have been reported.
Croatian: Nisu zabilježene interakcije lijekova s ljudskim koagulacijskim faktorom VIII s drugim lijekovima.
English: Pharmacotherapeutic group: Antihemorrhagics: Blood coagulation factor VIII.
Croatian: Farmakoterapijska skupina: Antihemoragici: krvni koagulacijski faktor VIII.
English: At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Croatian: Barem 1 dan, dok se ne zaustavi krvarenje na koje upućuje bol ili do zacjeljenja.
English: AFSTYLA can be used in children and adolescents of all ages.
Croatian: AFSTYLA se može primjenjivati u djece i adolescenata svih dobi.
English: Care should be taken that no blood enters the syringe filled with product, as there is a risk that the blood could coagulate in the syringe and fibrin clots could therefore be administered to the patient.
Croatian: Treba paziti da krv ne uđe u štrcaljku napunjenu lijekom jer postoji rizik od zgrušavanja krvi u štrcaljki, te bi se ugrušci fibrina stoga mogli primijeniti bolesniku.
English: The risk of developing inhibitors is correlated to the severity of the disease as well as the exposure to factor VIII, this risk being highest within the first 50 exposure days but continues throughout life although the risk is uncommon.
Croatian: Rizik od razvijanja inhibitora u korelaciji je s težinom bolesti, kao i s izloženošću faktoru VIII, a najveći je unutar prvih 50 dana izloženosti i nastavlja se tijekom čitavog života iako je rizik manje čest.