FrancophonIA/ELRC3.0 huggingface dataset:
English: The patients in the study were infected with genotypes 1, 2 or 3 and all received treatment for 12 or 24 weeks.
Croatian: Bolesnici obuhvaćeni ispitivanjem bili su zaraženi genotipovima 1, 2 ili 3 te su svi primali terapiju tijekom 12 tjedana ili 24 tjedna.
English: Daklinza must not be used together with certain medicines that may reduce the effects of Daklinza.
Croatian: Daklinza se ne smije koristiti zajedno s određenim lijekovima koji mogu smanjiti djelovanje lijeka Daklinza.
English: What measures are being taken to ensure the safe and effective use of
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Daklinza?
English: What are the risks associated with Daklinza?
Croatian: Koji su rizici povezani s lijekom Daklinza?
English: By blocking this protein, the medicine stops the hepatitis C virus from multiplying.
Croatian: Blokiranjem tog proteina lijek zaustavlja umnožavanje virusa hepatitisa C.
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 tim lijekovima moglo izložiti osobe koje su imale rak jetre opasnosti od ranog povratka raka.
English: Additional studies involving patients with genotypes 4 indicate that Daklinza is also as effective against genotype 4 as it is against genotype 1.
Croatian: Dodatna ispitivanja koja su obuhvatila bolesnike s genotipom 4 pokazuju da je Daklinza djelotvoran i protiv genotipa 4, kao i protiv genotipa 1.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Daklinza 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 Daklinza nalaze se i u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: How does Daklinza work?
Croatian: Kako djeluje Daklinza?
English: For more information about treatment with Daklinza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Daklinza pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Most patients had not previously been treated for hepatitis C, though some had genotype 1 infection that was resistant to standard medicines (consisting of either telaprevir or boceprevir - the so-called NS3/4A inhibitors - in combination with peginterferon alfa and ribavirin).
Croatian: Većina bolesnika nije prethodno liječena od hepatitisa C iako su pojedini bolesnici zaraženi genotipom 1 bili otporni na standardne lijekove (koji su se sastojali od telaprevira ili boceprevira - takozvanih inhibitora NS3/4A - u kombinaciji s peginterferonom alfa i ribavirinom).
English: Daklinza must be used in combination with other medicines for chronic hepatitis C, such as sofosbuvir, peginterferon alfa and ribavirin.
Croatian: Lijek Daklinza treba koristiti u kombinaciji s drugim lijekovima za liječenje kroničnog hepatitisa C, kao što su sofosbuvir, peginterferon alfa i ribavirin.
English: It is not intended to provide practical advice on how to use Daklinza.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Daklinza.
English: The company that markets Daklinza 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 Daklinza.
Croatian: Tvrtka koja lijek Daklinza stavlja u promet provest će ispitivanje na bolesnicima koji su prethodno bolovali od raka jetre kako bi se procijenio rizik od povratka raka jetre nakon liječenja protuvirusnim lijekom s izravnim djelovanjem kao što je Daklinza.
English: The most common side effects reported with Daklinza in combination with sofosbuvir with or without ribavirin are fatigue (tiredness), nausea (feeling sick) and headache.
Croatian: Najčešće nuspojave lijeka Daklinza u kombinaciji sa sofosbuvirom s ribavirinom ili bez njega jesu iscrpljenost (umor), mučnina (slabost) i glavobolja.
English: Daklinza 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: Daklinza je protuvirusni lijek koji se koristi u kombinaciji s drugim lijekovima za liječenje odraslih osoba s kroničnim (dugotrajnim) hepatitisom C (infektivne bolesti koja zahvaća jetru, a uzrokuje je virus hepatitisa C).
English: The Agency therefore concluded that the benefits of Daklinza outweigh its risks and recommended that
Croatian: Agencija je stoga zaključila da koristi od lijeka Daklinza nadmašuju s njim povezane rizike te je preporučila izdavanje odobrenja za njegovu primjenu u EU-u.
English: Daklinza 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: Daklinza se izdaje samo na liječnički recept, a liječenje treba započeti i nadzirati liječnik iskusan u liječenju osoba oboljelih od kroničnog hepatitisa C.
English: What benefits of Daklinza have been shown in studies?
Croatian: Koje su koristi lijeka Daklinza dokazane u ispitivanjima?
English: The active substance in Daklinza, daclatasvir, blocks the action of a protein in the hepatitis C virus called ‘NS5A', which is essential for the virus to multiply.
Croatian: Djelatna tvar lijeka Daklinza, daklatasvir, inhibira djelovanje proteina ‘NS5A' u virusu hepatitisa C, koji je neophodan za širenje virusa.
English: Regarding its safety, Daklinza was well tolerated and the side effects were similar to those experienced
Croatian: U pogledu sigurnosti, bolesnici su dobro podnosili lijek Daklinza, a nuspojave su bile slične onima koje su imali bolesnici koji su uzimali placebo.
English: The European Medicines Agency noted that Daklinza used in combination with other medicines was shown to be effective against hepatitis C virus, including in patients with genotype 1 resistant to previous treatment.
Croatian: Europska agencija za lijekove zaključila je da je potvrđena djelotvornost lijeka Daklinza u liječenju virusa hepatitisa C, uključujući i u liječenju bolesnika s genotipom 1 otpornim na prethodno liječenje.
English: For more information on the medicines that should not be taken with Daklinza, see the package leaflet.
Croatian: Potpuni popis lijekova koji se ne smiju primjenjivati s lijekom Daklinza potražite u uputi o lijeku.
English: For practical information about using Daklinza, patients should read the package leaflet or contact their
Croatian: Praktične informacije o primjeni lijeka Daklinza bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: For the full list of all side effects reported with Daklinza, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih za lijek Daklinza potražite u uputi o lijeku.
English: The combination of medicines to use and the duration of treatment will depend on the genotype of hepatitis C virus the patient is infected with and the nature of the liver problem, for example liver cirrhosis (scarring) or the liver not working well enough.
Croatian: Postoji nekoliko tipova (genotipova) virusa hepatitisa C, a lijek Daklinza preporučuje se za bolesnike zaražene virusom genotipova 1, 3 ili 4. Kombinacija lijekova koja će se koristiti i trajanje terapije ovise o genotipu virusa hepatitisa C kojim je bolesnik zaražen te prirodi problema koje ima s jetrom, kao što su ciroza jetre (nastajanje ožiljaka) ili nepravilna funkcija jetre.
English: Daklinza used in combination with sofosbuvir (with or without ribavirin) was effective at clearing the hepatitis C virus from the blood in a main study involving 211 adults.
Croatian: U glavnom ispitivanju koje je obuhvatilo 211 odraslih osoba utvrđena je djelotvornost u uklanjanju virusa hepatitisa C iz krvi kada se Daklinza koristi u kombinaciji sa sofosbuvirom (s ribavirinom ili bez njega).
English: Other side effects seen were uncommon, mild and short-lived.
Croatian: Druge uočene nuspojave su rijetke, blage i kratkoga roka.
English: The full EPAR and risk management plan summary for Lymphoseek 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 Lymphoseek nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It contains the active substance tilmanocept.
Croatian: Sadrži djelatnu tvar tilmanocept.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Lymphoseek on 19 November 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Lymphoseek na snazi u Europskoj uniji od 19. studenog 2014.
English: This is a summary of the European public assessment report (EPAR) for Lymphoseek.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Lymphoseek.
English: What is Lymphoseek and what is it used for?
Croatian: Što je Lymphoseek i za što se koristi?
English: Why is Lymphoseek approved?
Croatian: Zašto je Lymphoseek odobren?
English: Before being injected into the patient, Lymphoseek is ‘radiolabelled', which means that it is tagged with a small amount of radiation.
Croatian: Prije ubrizgavanja u bolesnika, Lymphoseek se „radioobilježava“, što znači da se označava manjom količinom zračenja.
English: What measures are being taken to ensure the safe and effective use of Lymphoseek?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Lymphoseek?
English: Other information about Lymphoseek
Croatian: Ostale informacije o lijeku Lymphoseek
English: Because it attaches to these proteins, the radiolabelled medicine builds up in the lymph nodes surrounding the cancer, making them visible with the special camera.
Croatian: Budući da se vezuje na proteine, radiooznačeni lijek nakuplja se u limfnim čvorovima koji okružuju rak, čime ih čini vidljivima za posebnu kameru.
English: In these two studies, doctors were able to detect a higher number of sentinel lymph nodes with Lymphoseek than with the blue dye: almost all of the lymph nodes identified using the blue dye (98% in one study and 100% in the other) were identified using Lymphoseek, while only around 70% and 60%, respectively, of the lymph nodes detected using Lymphoseek were detected with the blue dye.
Croatian: U ova dva ispitivanja, liječnici su bili u stanju otkriti veći broj limfnih čvorova čuvara pomoću lijeka Lymphoseek u odnosu na plavu boju: gotovo svi limfni čvorovi identificirani su primjenom plave boje (98% u jednom ispitivanju i 100% u drugom) identificirano je i primjenom lijeka Lymphoseek, dok je samo 70%, odnosno 60% limfnih čvorova detektirano primjenom lijeka Lymphoseek detektirano i primjenom plave boje.
English: This helps to decide if further surgery to remove more lymph nodes is needed.
Croatian: Ovo pomaže pri donošenju odluke je li potrebno uklanjanje dodatnih limfnih čvorova daljnjim kirurškim zahvatom.
English: The most common side effects with Lymphoseek seen in clinical studies are pain and irritation at the injection site (seen in less than 1 patient in 100).
Croatian: Najčešće nuspojave lijeka Lymphoseek uočene u kliničkim ispitivanjima su bol i nadraženost u mjestu injekcije (mogu se javiti u više od 1 na 100 osoba).
English: It is not intended to provide practical advice on how to use Lymphoseek.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Lymphoseek.
English: What are the risks associated with Lymphoseek?
Croatian: Koji su rizici povezani s lijekom Lymphoseek?
English: A special camera that detects radiation is then used to see where the lymph nodes are and therefore where the cancer is likely to spread.
Croatian: Posebna kamera koja otkriva zračenje koristi se zatim kako bi se pronašlo mjesto limfnih čvorova, i stoga mjesto izgledno za širenje raka.
English: For more information about treatment with Lymphoseek, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Lymphoseek pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: In a third study in patients with cancer of the head and neck including mouth cancer, Lymphoseek was used to detect sentinel lymph nodes before patients had their lymph nodes removed surgically.
Croatian: U trećem ispitivanju u bolesnika s rakom glave i vrata, uključujući i rak usta, lijek Lymphoseek korišten je za detekciju limfnih čvorova prije nego što su limfni čvorovi uklonjeni bolesnicima kirurškim putem.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Lymphoseek, 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 Lymphoseek nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Given the importance of locating lymph nodes in the treatment of cancers and the manageable side effects seen with Lymphoseek, the Committee concluded that its benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Uzimajući u obzir važnost lociranja limfnih čvorova u liječenju rakova i upravljive nuspojave uočene s lijekom Lymphoseek, Odbor je odlučio da koristi od lijeka Lymphoseek nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za korištenje u Europskoj uniji.
English: A risk management plan has been developed to ensure that Lymphoseek is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Lymphoseek.
English: The active substance in Lymphoseek, tilmanocept, attaches to proteins called mannose binding proteins which are found in high amounts in certain immune cells in the lymph nodes.
Croatian: Djelatna tvar lijeka Lymphoseek, tilmanocept, vezuje se na proteine naziva receptorske proteine koji vežu manozu koji su prisutni u velikim količinama u određenim imunosnim stanicama u limfnim čvorovima.
English: Lymphoseek is a solution that is injected either around or inside the cancerous tissue and and is expected to attach to and build up in the nearby lymph nodes.
Croatian: Lymphoseek je otopina koja se ubrizgava okolo ili unutar kancerogenog tkiva i očekuje se da će se vezati i nakupiti u obližnjim limfnim čvorovima.
English: The blue dye is used during surgery to stain the lymph nodes so they can be seen and then checked for cancerous tissue.
Croatian: Plava se boja koristi tijekom kirurškog zahvata za bojanje limfnih čvorova tako da se isti mogu vidjeti, te zatim provjeriti ako postoji kancerogeno tkivo.
English: If the sentinel nodes are found to have no cancer then more extensive lymph nodal surgery can be avoided.
Croatian: Ako se utvrdi da limfni čvorovi čuvari ne sadrže rak, može se izbjeći opsežniji kirurški zahvat limfnih čvorova.
English: Lymphoseek is used in patients with breast cancer, melanoma (a skin cancer) and a type of cancer of the mouth known as squamous cell carcinoma.
Croatian: Lymphoseek se koristi u bolesnika s rakom dojke, melanomom (rakom kože) i tipom raka usta poznatim pod nazivom karcinom pločastih stanica usne šupljine.
English: The benefits of Lymphoseek were shown in two main studies in which 311 patients with breast or skin cancer had their lymph nodes first mapped with Lymphoseek and then with another method involving the use of a dye known as ‘vital blue dye'.
Croatian: koristi lijeka Lymphoseek dokazane su u dva glavna ispitivanja, u kojih je 311 bolesnika s rakom dojke ili rakom kože podvrgnut označavanju limfnih čvorova lijekom Lymphoseek te zatim drugom metodom koja je obuhvatila primjenu boje poznate pod nazivom „vitalna plava boja“.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that studies showed that the use of Lymphoseek led to a higher detection rate for sentinel lymph nodes than the use of vital blue dye.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji napomenuo je kako je u ispitivanjima utvrđeno da primjena lijeka Lymphoseek rezultira višim stopama detekcije limfnih čvorova čuvara u odnosu na vitalnu plavu boju.
English: The sentinel lymph nodes are the regional lymph nodes where the cancer is likely to spread to first.
Croatian: Limfni čvorovi čuvari su regionalni limfni čvorovi u koje je izgledno da će se rak prvo proširiti.
English: Almost all the patients (38 out of 39) with cancerous lymph nodes were identified by Lymphoseek.
Croatian: Lijekom Lymphoseek identificirani su gotovo svi bolesnici (38 od 39) s kancerogenim limfnim čvorovima.
English: Lymphoseek is a diagnostic medicine used in patients with cancer to identify sentinel lymph nodes.
Croatian: Lymphoseek je dijagnostički lijek koji se koristi u bolesnika s rakom za potrebe identifikacije limfnih čvorova čuvara.
English: For practical information about using Lymphoseek, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Lymphoseek pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: How is Lymphoseek used?
Croatian: Kako se Lymphoseek koristi?
English: How does Lymphoseek work?
Croatian: Kako djeluje Lymphoseek?
English: What benefits of Lymphoseek have been shown in studies?
Croatian: Koje su koristi lijeka Lymphoseek utvrđene u ispitivanjima?
English: The lymph nodes can then be checked for cancer cells.
Croatian: Limfni čvorovi se zatim provjeravaju za postojanje stanica raka.
English: Lymphoseek should only be used by healthcare professionals with expertise in mapping lymph nodes.
Croatian: Lymphoseek smiju primjenjivati samo educirani zdravstveni djelatnici koji poznaju tehniku provođenja i tumačenja postupaka označavanja limfnih čvorova čuvara
English: For the full list of all side effects and restrictions with Lymphoseek, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Lymphoseek potražite u uputi o lijeku.
English: When sentinel lymph nodes are found they are removed surgically and checked for cancer cells.
Croatian: Nakon što se limfni čvorovi čuvari pronađu, isti se uklanjaju kirurškim putem te se testiraju na postojanje stanica raka.
English: The full EPAR for Afstyla can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Afstyla nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The injection is given into a vein over several minutes.
Croatian: Injekcija se ubrizgava u venu tijekom nekoliko minuta.
English: Other information about Afstyla
Croatian: Ostale informacije o lijeku Afstyla
English: Further safety data should be provided by ongoing studies.
Croatian: Daljnjim ispitivanjima trebali bi se omogućiti dodatni podatci o sigurnosti.
English: What is Afstyla and what is it used for?
Croatian: Što je Afstyla i za što se koristi?
English: This is a summary of the European public assessment report (EPAR) for Afstyla.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za lijek Afstyla.
English: Afstyla lonoctocog alfa
Croatian: Afstyla lonoktokog alfa
English: The second study involved 83 patients below 12 years of age.
Croatian: U drugo je ispitivanje bilo uključeno 83 bolesnika mlađih od 12 godina.
English: What measures are being taken to ensure the safe and effective use of Afstyla?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Afstyla?
English: They may include: angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash over the whole body, headache, hives, hypotension (low blood pressure), lethargy, nausea (feeling sick), restlessness, tachycardia (rapid heartbeat), tightness of the chest, tingling, vomiting and wheezing.
Croatian: Reakcije mogu uključivati: angioedem (oticanje tkiva ispod kože), žarenje i peckanje na mjestu ubrizgavanja, zimicu, navalu crvenila, osip praćen svrbežom po cijelom tijelu, glavobolju, koprivnjaču, hipotenziju (niski krvni tlak), letargiju, mučninu (osjećaj slabosti), nemir, tahikardiju (ubrzane otkucaje srca), stezanje u prsima, trnce, povraćanje i piskanje pri disanju.
English: The first study involved 173 patients aged 12 years and above.
Croatian: U prvo je ispitivanje bilo uključeno 173 bolesnika u dobi od 12 i više godina.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Afstyla'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 odlučilo je da koristi lijeka Afstyla nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za korištenje u Europskoj uniji.
English: Hypersensitivity (allergic) reactions are common with Afstyla, affecting up to 1 in 10 people.
Croatian: Reakcije preosjetljivosti (alergijske reakcije) uobičajene su kod primjene lijeka Afstyla i javljaju se u do 1 na 10 osoba.
English: The active substance in Afstyla, lonoctocog alfa, is a shorter version of human factor VIII that works in the body in the same way as human factor VIII.
Croatian: Djelatna tvar lijeka Afstyla, lonoktokog alfa, kraća je verzija ljudskog faktora VIII, koja djeluje u tijelu na isti način kao ljudski faktor VIII.
English: Why is Afstyla approved?
Croatian: Zašto je lijek Afstyla odobren?
English: What are the risks associated with Afstyla?
Croatian: Koji su rizici povezani s lijekom Afstyla?
English: A total of 848 bleeding episodes were recorded during the study, 94% of which resolved with one or two injections of Afstyla.
Croatian: Tijekom ispitivanja zabilježeno je ukupno 848 epizoda krvarenja, od kojih je 94 % zaustavljeno s jednom ili dvije injekcije lijeka Afstyla.
English: It is not intended to provide practical advice on how to use Afstyla.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Afstyla.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Afstyla 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 Afstyla nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Among those patients who received Afstyla to prevent bleeding, an average of 1.14 bleeding episodes per year was recorded for each patient which was lower than the 19.64 episodes per year in patients not receiving Afstyla for prevention.
Croatian: Među bolesnicima koji su primali lijek Afstyla radi sprečavanja krvarenja, zabilježeno je prosječno 1,14 epizoda krvarenja godišnje, što je manje od 19,64 epizoda godišnje u bolesnika koji nisu primali lijek Afstyla radi prevencije.
English: It replaces the missing factor VIII, thereby helping the blood to clot and giving temporary control of bleeding.
Croatian: Zamjenjuje faktor VIII koji nedostaje i time potpomaže zgrušavanje krvi i omogućuje privremenu kontrolu krvarenja.
English: Afstyla can only be obtained with a prescription and treatment should be under the supervision of a doctor who has experience in the treatment of haemophilia.
Croatian: Afstyla se izdaje samo na liječnički recept, a liječenje se mora provoditi pod nadzorom liječnika s iskustvom u liječenju hemofilije.