FrancophonIA/ELRC3.0 huggingface dataset:
English: What are the risks associated with Xtandi?
Croatian: Koji su rizici povezani s lijekom Xtandi?
English: Xtandi received a marketing authorisation valid throughout the EU on 21 June 2013.
Croatian: Lijek Xtandi dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 21. lipnja
English: As for all medicines, data on the use of Xtandi are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Xtandi kontinuirano se prate.
English: For more information about using Xtandi, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Xtandi pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Xtandi is a cancer medicine used to treat men with prostate cancer.
Croatian: Xtandi je lijek protiv raka za liječenje muškaraca s rakom prostate.
English: The Agency therefore concluded that Xtandi's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Stoga je Agencija zaključila da koristi od lijeka Xtandi nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Other information about Xtandi
Croatian: Ostale informacije o lijeku Xtandi
English: The company that markets Xtandi will provide the results of an ongoing study on the long-term effects of Xtandi in men with non-metastatic prostate cancer.
Croatian: Tvrtka koja stavlja lijek Xtandi u promet dostavit će rezultate ispitivanja koje je u tijeku o dugoročnim učincima lijeka Xtandi u muškaraca s nemetastatskim rakom prostate.
English: Metastatic prostate cancer
Croatian: Metastatski rak prostate
English: Non-metastatic prostate cancer
Croatian: Nemetastatski rak prostate
English: How is Xtandi used?
Croatian: Kako se Xtandi koristi?
English: Treatment with Xtandi should be started and monitored by a doctor who has experience in treating prostate cancer.
Croatian: Terapiju lijekom Xtandi mora započeti i nadzirati liječnik s iskustvom u primjeni lijekova protiv raka prostate.
English: Xtandi has also been compared with placebo in a second main study involving 1,717 patients with metastatic, castration-resistant prostate cancer in whom hormone therapy had failed, but who had no symptoms or mild symptoms and had not previously been treated with chemotherapy.
Croatian: Xtandi je uspoređen s placebom i u drugom glavnom ispitivanju u koje je bilo uključeno 1717 bolesnika s metastatskim rakom otpornim na kastraciju, u kojih hormonska terapija nije bila uspješna, ali koji nisu imali simptome ili su simptomi bili blagi te koji prethodno nisu primili kemoterapiju.
English: What benefits of Xtandi have been shown in studies?
Croatian: Koje su koristi od lijeka Xtandi utvrđene u ispitivanjima?
English: In addition, patients treated with Xtandi lived for longer without their disease showing signs of worsening in a radiographic scan: 20 months compared with 5 months for patients treated with placebo.
Croatian: Osim toga, bolesnici liječeni lijekom Xtandi živjeli su dulje bez znakova pogoršanja bolesti na radiografskim snimkama: 20 mjeseci u usporedbi s 5 mjeseci koliko su živjeli bolesnici koji su primili placebo.
English: Xtandi has been compared with placebo (a dummy treatment) in a main study involving 1,199 patients with metastatic, castration-resistant prostate cancer who were previously treated with docetaxel.
Croatian: Xtandi je uspoređen s placebom (prividno liječenje) u glavnom ispitivanju u koje je bilo uključeno 1199 bolesnika s metastatskim rakom prostate rezistentnim na kastraciju koji su prethodno bili liječeni docetakselom.
English: The doctor may have to reduce the dose or interrupt treatment if a patient gets certain side effects.
Croatian: Ako se u bolesnika razviju određene nuspojave, liječnik će možda morati smanjiti dozu ili prekinuti liječenje.
English: How does Xtandi work?
Croatian: Kako djeluje Xtandi?
English: The average survival of patients treated with Xtandi was around 32 months compared with 30 months for patients treated with placebo.
Croatian: Prosječno preživljenje bolesnika liječenih lijekom Xtandi bilo je oko 32 mjeseca u usporedbi s 30 mjeseci u bolesnika koji su primili placebo.
English: Xtandi has been compared with placebo in a study involving 1,401 patients with castration-resistant prostate cancer at high risk of becoming metastatic.
Croatian: Xtandi je bio uspoređen s placebom u ispitivanju koje je uključivalo 1401 bolesnika s rakom prostate rezistentnim na kastraciju uz visok rizik od njegova širenja.
English: For the full list of side effects with Xtandi, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Xtandi potražite u uputi o lijeku.
English: Patients treated with Xtandi lived for an average of 37 months without their disease becoming metastatic compared with 15 months on placebo.
Croatian: Bolesnici liječeni lijekom Xtandi živjeli su u prosjeku 37 mjeseci tijekom kojih rak nije metastazirao, u usporedbi s 15 mjeseci koliko su živjeli bolesnici koji su primili placebo.
English: In this study, Xtandi was more effective than placebo at prolonging patients' lives: on average, patients treated with Xtandi lived for 18 months, compared with 14 months for patients given placebo.
Croatian: U prosjeku su bolesnici na terapiji lijekom Xtandi živjeli 18 mjeseci, u usporedbi s 14 mjeseci koliko su živjeli bolesnici koji su primili placebo.
English: The review of Zydelig was initiated at the request of the European Commission on 17 March 2016, under Article 20 of Regulation (EC) No 726/2004.
Croatian: Ocjenjivanje lijeka Zydelig započeto je 17. ožujka 2016. na zahtjev Europske komisije, u skladu s člankom 20. Uredbe (EZ) br. 726/2004.
English: CHMP confirms recommendations for use of Zydelig
Croatian: CHMP potvrđuje preporuku za korištenje lijeka Zydelig
English: In its review the PRAC evaluated data from these studies, together with other available evidence as well as advice from experts in this field.
Croatian: PRAC je u svojoj ocjeni procijenio podatke iz tih ispitivanja, zajedno s drugim dostupnim dokazima te savjetima stručnjaka iz tog područja.
English: If you are taking Zydelig and have any questions or concerns speak to your doctor, nurse or pharmacist.
Croatian: Ako uzimate lijek Zydelig i imate bilo kakvih pitanja ili nedoumica, obratite se svom liječniku, medicinskoj sestri ili ljekarniku.
English: A letter will be sent to healthcare professionals, advising them of these changes.
Croatian: Zdravstveni radnici pisanim će putem biti obaviješteni o tim promjenama.
English: 1 17p deletion or TP53 mutation, see http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/03/news_detail_002490.jsp
Croatian: 1 Za deleciju 17p ili mutaciju TP53 vidi http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/03/news_detail_002490.jsp
English: • Your doctor will regularly check you for signs of infections.
Croatian: • Vaš liječnik će vas redovito pregledavati radi utvrđivanja eventualnih znakova infekcije.
English: The relevance of these results to the authorised use of Zydelig is therefore limited, but suggests a need to strengthen measures to minimise the risk of infection.
Croatian: Relevantnost tih rezultata u odnosu na odobrenu uporabu lijeka Zydelig stoga je ograničena, ali upućuje na potrebu da se ojačaju mjere kojima bi se smanjio rizik od infekcije.
English: If you develop fever, cough or difficulty breathing you should contact your doctor straight away.
Croatian: Ako uočite da imate vrućicu, kašalj ili teškoće pri disanju, smjesta se obratite svom liječniku.
English: Patients should be monitored for respiratory signs and symptoms.
Croatian: Bolesnici trebaju biti pod nadzorom radi praćenja respiratornih znakova i simptoma.
English: The percentage of deaths in the treatment arms was 8% in the CLL study and 8% and 5% in the lymphoma studies, compared with 3%, 6% and 1% respectively in the placebo arms.
Croatian: Postotak smrtnih slučajeva u terapijskim skupinama bio je 8 % u ispitivanju CLL-a i 8 % te 5 % u ispitivanjima limfoma, u usporedbi s 3 %, 6 % i 1 % u skupinama koje su primale placebo.
English: Zydelig is a cancer medicine containing the active substance idelalisib.
Croatian: Zydelig je lijek za liječenje raka koji sadrži djelatnu tvar idelalisib.
English: • You should not stop Zydelig without speaking to your doctor.
Croatian: • Liječenje lijekom Zydelig ne smijete prekidati prije nego što razgovarate sa svojim liječnikom.
English: Patients should be monitored for infection and given antibiotics during and after treatment
Croatian: Bolesnici trebaju biti pod nadzorom radi utvrđivanja moguće infekcije i dobiti antibiotike tijekom i nakon liječenja
English: Low white cell counts can indicate an increased risk of infection and treatment may need to be interrupted.
Croatian: Niska razina bijelih krvnih stanica može upućivati na povećani rizik od infekcije te je možda potrebno prekinuti liječenje.
English: Because some infections have occurred after patients had finished their cancer treatment, you will have to keep taking these antibiotics for 2 to 6 months after stopping Zydelig.
Croatian: Budući da je do nekih infekcija došlo nakon što su bolesnici dovršili terapiju za liječenje raka, morat ćete nastaviti s uzimanjem tih antibiotika dva do šest mjeseci nakon što prestanete uzimati lijek Zydelig.
English: The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Croatian: Ocjenjivanje je prvotno proveo Odbor za procjenu rizika u području farmakovigilancije (PRAC), odbor odgovoran za procjenu sigurnosnih pitanja u području lijekova za humanu uporabu, koji je donio niz preporuka.
English: • You will have regular blood tests to check if you have a low white blood cell count, as a low count can put you at more risk of developing an infection.
Croatian: • Obavljat ćete redovite krvne pretrage kako bi se utvrdilo imate li nisku razinu bijelih krvnih stanica jer ona povećava rizik od nastanka infekcije.
English: The CHMP has confirmed the recommendations from the PRAC review, and its opinion will now be sent to the European Commission for a final legally binding decision.
Croatian: CHMP je potvrdio preporuke iz ocjene PRAC-a te je njegovo mišljenje poslano Europskoj komisiji koja je izdala konačnu, zakonski obvezujuću odluku.
English: • If you are taking Zydelig, you will receive antibiotics to prevent a type of lung infection (Pneumocystis jirovecii pneumonia).
Croatian: • Ako uzimate lijek Zydelig, primat ćete antibiotike radi prevencije određene vrste upale pluća (upala pluća uzrokovana gljivicom Pneumocystis jiroveci).
English: The additional deaths were mainly caused by infections, including Pneumocystis jirovecii pneumonia and cytomegalovirus infections.
Croatian: Uzrok dodatnih smrtnih slučajeva bile su uglavnom infekcije, uključujući upalu pluća uzrokovanu gljivicom Pneumocystis jirovecii i citomegalovirusne infekcije.
English: Although the studies did not use the medicine in the same way as currently authorised, the review concluded that the risk of serious infection had some relevance to the authorised use.
Croatian: Iako lijek u ispitivanjima nije primjenjivan na način koji je trenutačno odobren, u ocjeni je zaključeno da je rizik od ozbiljnih infekcija u određenoj mjeri relevantan za odobrenu primjenu.
English: However, following a review it has updated recommendations to minimise the risk of serious infections in patients treated with the medicine.
Croatian: Međutim, nakon ocjenjivanja preporuke su ažurirane kako bi se smanjio rizik od ozbiljnih infekcija u bolesnika liječenih ovim lijekom.
English: The review, which was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), was started because of deaths seen in 3 studies in which Zydelig was given to patient groups for whom it is not licensed, or in unlicensed combinations with other medicines.
Croatian: Ocjenjivanje koje je proveo Odbor za procjenu rizika u području farmakovigilancije (PRAC) pri EMA-i pokrenuto je zbog zabilježenih smrtnih slučajeva u trima ispitivanjima u kojima je lijek Zydelig primjenjivan u skupinama bolesnika za koje nije odobren, ili u neodobrenim kombinacijama s drugim lijekovima.
English: • These studies included patients with disease characteristics that were different from those covered by the currently approved indications for Zydelig and investigated use with treatment combinations that are not currently licensed and which may have influenced the infection rate.
Croatian: • Ta su ispitivanja uključivala bolesnike s obilježjima bolesti koje su se razlikovale od onih obuhvaćenih trenutačno odobrenim indikacijama za lijek Zydelig i istraživala su primjenu kombinacija liječenja koje nisu trenutačno odobrene i koje su mogle utjecati na stopu infekcija.
English: Patients receiving Zydelig should also be monitored for signs of infection and have regular blood tests to measure the level of white blood cells.
Croatian: Bolesnici koji primaju lijek Zydelig također trebaju biti pod nadzorom radi utvrđivanja znakova moguće infekcije i obavljati redovite krvne pretrage radi provjere razine bijelih krvnih stanica.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 July 2016 EMA/488322/2016
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Croatian: Preporuke PRAC-a poslane su Odboru za lijekove za humanu uporabu (CHMP), odgovornom za pitanja koja se odnose na lijekove za humanu uporabu, koji je 21. srpnja 2016. usvojio mišljenje Agencije.
English: Zydelig should also not be started in patients with any generalised infection.
Croatian: Liječenje lijekom Zydelig također se ne smije započeti u bolesnika s bilo kakvom generaliziranom infekcijom.
English: Regular clinical and laboratory monitoring for cytomegalovirus infection is also recommended and specific guidance is included in the updated summary of product characteristics (SmPC).
Croatian: Preporučuje se također redovito kliničko i laboratorijsko praćenje radi utvrđivanja mogućih citomegalovirusnih infekcija, a specifične smjernice nalaze se u ažuriranom sažetku opisa svojstava lijeka.
English: In addition, following an interim precautionary recommendation not to start Zydelig treatment in previously untreated patients with CLL that has certain genetic mutations1, the CHMP now concludes that treatment with Zydelig can again be started in these patients provided they alternative treatments are not suitable and provided that the measures to prevent infection are followed.
Croatian: Osim toga, sukladno privremenoj sigurnosnoj preporuci da se liječenje lijekom Zydelig ne započinje u bolesnika s CLL-om koji nisu prethodno liječeni, a čije stanice raka imaju određene genske mutacije1, CHMP je zaključio da se liječenje lijekom Zydelig u tih bolesnika može ponovo započeti ako alternativni načini liječenja nisu prikladni i ako se slijede mjere za sprečavanje infekcije.
English: In the EU, Zydelig is authorised for the treatment of two cancers of white blood cells, chronic lymphocytic leukaemia and follicular lymphoma (one of a group of cancers called non-Hodgkin's lymphomas).
Croatian: Lijek Zydelig odobren je u EU-u za liječenje dviju vrsta raka bijelih krvnih stanica, kronične limfocitne leukemije (CLL) i folikularnog limfoma (skupina raka koji se naziva ne-Hodgkinovim limfomom).
English: All patients treated with Zydelig should be given preventive medication against the lung infection Pneumocystis jirovecii pneumonia during treatment and this should be continued for up to 6 months after treatment with Zydelig has stopped.
Croatian: Svi bolesnici liječeni lijekom Zydelig trebaju preventivno primati lijekove protiv upale pluća uzrokovane gljivicom Pneumocystis jiroveci tijekom liječenja, što treba nastaviti do šest mjeseci nakon prestanka liječenja lijekom Zydelig.
English: Some changes have now been made in how the medicine is used to ensure it is given as safely as possible.
Croatian: Kako bi se osiguralo da se lijek upotrebljava na što sigurniji način, uvedene su neke promjene u načinu upotrebe lijeka.
English: If the patient develops severe neutropenia, treatment with Zydelig may have to be interrupted, in line with the updated SmPC.
Croatian: Ako se u bolesnika pojavi neutropenija teškog stupnja, liječenje lijekom Zydelig možda će biti potrebno prekinuti, u skladu s ažuriranim sažetkom opisa svojstava lijeka.
English: • In chronic lymphocytic leukaemia, Zydelig is used in combination with another medicine (rituximab) in patients who have received at least one previous treatment and in previously untreated patients who have genetic mutations in their cancer cells called 17p deletion or TP53 mutation and who are not eligible for other therapies.
Croatian: • U slučaju kronične limfocitne leukemije, lijek Zydelig primjenjuje se u kombinaciji s drugim lijekom (rituksimab) u bolesnika koji su prethodno primili barem jednu terapiju i u bolesnika koji prethodno nisu bili liječeni, a koji u svojim stanicama raka imaju genske mutacije naziva delecija 17p ili mutacija TP53 i koji ne ispunjavaju uvjete za drugi oblik liječenja.
English: • All patients should receive prophylaxis for P. jirovecii pneumonia during Zydelig treatment and for 2 to 6 months after stopping treatment.
Croatian: • Svi bolesnici moraju primiti preventivnu terapiju za upalu pluća uzrokovanu gljivicom P. jirovecii tijekom liječenja lijekom Zydelig te u trajanju od dva do šest mjeseci nakon prestanka liječenja.
English: • In follicular lymphoma, Zydelig is used on its own in patients whose disease has not responded to two previous treatments.
Croatian: • U slučaju folikularnog limfoma, lijek Zydelig primjenjuje se kao monoterapija u bolesnika kod kojih bolest nije reagirala na prethodna dva liječenja.
English: • Zydelig may also be used in combination with rituximab, as first line treatment in CLL in the presence of 17p deletion or TP53 mutation provided patients cannot take any alternative treatment and provided again that the below measures are followed to reduce the risk of infection.
Croatian: • Lijek Zydelig također se može upotrebljavati s rituksimabom kao prva linija terapije u liječenju CLL-a u slučaju prisutnosti delecije 17p ili mutacije TP53 ako bolesnici nisu prikladni ni za jedan alternativni način liječenja i ako se slijede mjere za smanjenje rizika od infekcije navedene ispod.
English: • Provided that strengthened measures are followed to minimise the risk of infection (see below), Zydelig can continue to be used in combination with rituximab in CLL patients who have received at least one prior therapy, and as monotherapy in patients with follicular lymphoma that is refractory to two lines of treatment.
Croatian: • Ako se slijede pojačane mjere za smanjenje rizika od infekcije (vidi ispod), lijek Zydelig može se i dalje upotrebljavati u kombinaciji s rituksimabom u bolesnika s CLL-om koji su prethodno primili barem jednu terapiju i kao monoterapija u bolesnika s folikularnim limfomom koji se pokazao otpornim na dvije prethodne linije terapije.
English: The CHMP (EMA's Committee for Medicinal Products for Human Use) has confirmed that the benefits of Zydelig (idelalisib) in the treatment of the blood cancers chronic lymphocytic leukaemia (CLL) and follicular lymphoma outweigh the risk of side effects.
Croatian: CHMP (Odbor za lijekove za humanu uporabu pri Agenciji) potvrdio je 21. srpnja 2016. da koristi od lijeka Zydelig (idelalisib) u liječenju dviju vrsta raka krvi, kronične limfocitne leukemije (CLL) i folikularnog limfoma nadmašuju rizike od nuspojava.
English: The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States in due course.
Croatian: Mišljenje CHMP-a proslijeđeno je Europskoj komisiji koja je izdala konačnu zakonski obvezujuću odluku primjenjivu u svim državama članicama EU-a od 15/09/2016.
English: • There have been reports of serious infections in clinical studies with the cancer medicine Zydelig.
Croatian: • U kliničkim ispitivanjima lijeka za liječenje raka Zydelig zabilježene su teške infekcije.
English: GS-US-313-0125 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with bendamustine and rituximab for previously treated iNHL;
Croatian: GS-US-313-0125 randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje faze 3 za procjenu djelotvornosti i sigurnosti idelalisiba u kombinaciji s bendamustinom i rituksimabom za prethodno liječeni iNHL;
English: GS-US-313-0124 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with rituximab for previously treated iNHL;
Croatian: GS-US-313-0124 randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje faze 3 za procjenu djelotvornosti i sigurnosti idelalisiba u kombinaciji s rituksimabom za prethodno liječeni iNHL;
English: • Increased rates of serious adverse effects including deaths were seen in the treatment arm of 3 clinical trials2 evaluating the addition of Zydelig to standard therapy in first-line treatment of CLL and relapsed indolent non-Hodgkin lymphoma.
Croatian: • U trima kliničkim ispitivanjima2 procjene učinka dodavanja lijeka Zydelig standardnoj prvoj liniji terapije u liječenju CLL-a i ponovne pojave indolentnog ne-Hodgkinova limfoma uočene su veće stope nuspojava, uključujući i smrtne slučajeve.
English: 2 GS-US-312-0123 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with bendamustine and rituximab for previously untreated CLL;
Croatian: GS-US-312-0123 randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje faze 3 za procjenu djelotvornosti i sigurnosti idelalisiba u kombinaciji s bendamustinom i rituksimabom za CLL koji prethodno nije liječen;
English: Your doctor may stop your treatment with Zydelig if your white blood cell count is too low.
Croatian: Ako vaša razina bijelih krvnih stanica bude preniska, liječnik može prekinuti terapiju lijekom Zydelig.
English: player
Croatian: DODATAK
English: Explanation of the Turbospin and how it works.
Croatian: Objašnjenje uređaja Turbospin i njegovog rada.
English: These are only of nuisance value for most patients
Croatian: − predstavljaju za većinu bolesnika samo neugodu
English: • Discussion about common side effects and in particular cough and taste abnormality: Explanation that:
Croatian: • Rasprava o čestim nuspojavama i naročito o kašlju i promijenjenom okusu: Objašnjenje da:
English: That cough decreases with repeated use of the product and should stabilize after the first month or so.
Croatian: − se kašalj smanjuje s ponavljanom primjenom lijeka i da se stabilizira približno nakon mjesec dana.
English: Emphasise that patients should persist with the treatment.
Croatian: − naglasak da bolesnik mora nastaviti s liječenjem
English: • Detailed instructions about how to use the medication: starting from unpacking of the product and finishing with disposal of the used capsule and device.
Croatian: • Detaljne upute o primjeni lijeka: kako se otvara pakovanje lijeka i kako se na kraju odlažu iskorištene kapsule i uređaj.
English: ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU
English: The Member States shall ensure that all physicians who are expected to prescribe or use Colobreathe are provided with a healthcare professional and patient educational pack containing the following:
Croatian: Zemlje članice će osigurati edukacijski materijal za zdravstvene djelatnike i bolesnike svim liječnicima koji bi mogli propisati ili primijeniti lijek Colobreathe.