FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about using Keytruda, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Keytruda pročitajte u uputi o lijeku odnosno obratite se liječniku ili ljekarniku.
English: The most common side effects of Keytruda given alone (which may affect more than 1 in 5 people) are tiredness, nausea (feeling sick) and diarrhoea.
Croatian: Najčešće nuspojave lijeka Keytruda kada se daje kao monoterapija (mogu se pojaviti u više od 1 na 5 osoba) jesu umor, mučnina (slabost) i proljev.
English: Also, up to 74% of patients treated with Keytruda lived for at least 12 months after the start of their treatment compared with 59% of patients on ipilimumab.
Croatian: Isto tako, do 74 % bolesnika liječenih lijekom Keytruda živjelo je još najmanje 12 mjeseci nakon početka terapije, u usporedbi s 59 % bolesnika koji su primali ipilimumab.
English: For renal cell carcinoma, Keytruda is used in combination with other cancer medicines.
Croatian: U slučaju raka bubrežnih stanica Keytruda se koristi u kombinaciji s drugim lijekovima protiv raka.
English: Keytruda is effective at improving survival or delaying the worsening of disease in patients with advanced cancers or cancers that have spread or come back.
Croatian: Lijek Keytruda učinkovit je u poboljšanju preživljenja ili odgodi pogoršanja bolesti u bolesnika s uznapredovalim rakom ili rakom koji se proširio ili vratio.
English: The side effects with this medicine are manageable and are similar to those of various other cancer treatments.
Croatian: Nuspojave zabilježene prilikom primjene lijeka mogu se kontrolirati i slične su nuspojavama raznih drugih terapija protiv raka.
English: The active substance in Keytruda, pembrolizumab, is a monoclonal antibody, a protein that has been designed to recognise and block a receptor (‘target') called PD-1.
Croatian: Djelatna tvar lijeka Keytruda, pembrolizumab, monoklonsko je protutijelo, tj. vrsta bjelančevine koja prepoznaje i inhibira djelovanje receptora („mete”) naziva PD-1.
English: In a further study of 559 patients with ‘squamous' NSCLC that had spread, patients given Keytruda with carboplatin and paclitaxel or nab-paclitaxel lived on average for 15.9 months compared with 11.3 months for patients given placebo with carboplatin and paclitaxel or nab-paclitaxel.
Croatian: U daljnjem ispitivanju na 559 bolesnika oboljelih od „skvamoznog” raka pluća nemalih stanica koji se proširio, bolesnici koji su primali lijek Keytruda s karboplatinom i paklitakselom ili nab-paklitakselom u prosjeku su živjeli 15,9 mjeseci, u odnosu na 11,3 mjeseca u bolesnika koji su primali placebo s karboplatinom i paklitakselom ili nab-paklitakselom.
English: Keytruda contains the active substance pembrolizumab.
Croatian: Keytruda sadrži djelatnu tvar pembrolizumab.
English: In this study, disease did not get worse for 5.1 months on average in patients taking Keytruda combination, 3.2 months in patients taking Keytruda alone and 5.0 months in patients taking other standard treatments.
Croatian: Tijekom tog ispitivanja bolest se nije pogoršala u prosjeku 5,1 mjesec u bolesnika koji su primali kombinaciju koja sadrži lijek Keytruda, 3,2 mjeseca u onih koji su uzimali samo lijek Keytruda i 5,0 mjeseci u bolesnika koji su primali druge uobičajene terapije.
English: In some cancers, it is only given to patients whose tumours produce high levels of a protein known as PD-L1.
Croatian: Kod nekih vrsta raka daje se samo onim bolesnicima čiji tumor proizvodi visoke razine bjelančevine naziva PD-L1.
English: How does Keytruda work?
Croatian: Kako djeluje Keytruda?
English: In a study of 495 patients, patients treated with Keytruda who had high levels of PD-L1 lived on average for 11.6 months while those taking standard cancer treatments lived for 6.6 months.
Croatian: U ispitivanju koje je obuhvatilo 495 bolesnika, bolesnici liječeni lijekom Keytruda koji su imali visoke razine bjelančevine PD-L1 živjeli su u prosjeku 11,6 mjeseci, a bolesnici liječeni standardnim terapijama protiv raka živjeli su 6,6 mjeseci.
English: Keytruda is also effective in preventing melanoma from coming back in patients who have had surgery.
Croatian: Lijek Keytruda učinkovit je i u prevenciji ponovne pojave melanoma u bolesnika koji su imali kirurški zahvat.
English: Patients treated with Keytruda lived on average around 10 months compared with around 7 months with the other cancer medicines.
Croatian: Bolesnici koji su liječeni lijekom Keytruda u prosjeku su živjeli oko 10 mjeseci, u usporedbi s oko sedam mjeseci uz druge lijekove protiv raka.
English: What benefits of Keytruda have been shown in studies?
Croatian: Koje su koristi od lijeka Keytruda utvrđene u ispitivanjima?
English: A second study looked at 834 patients with melanoma who received either Keytruda or another medicine, ipilimumab.
Croatian: Drugo ispitivanje obuhvatilo je 834 osobe oboljele od melanoma koje su primale lijek Keytruda ili drugi lijek, ipilimumab.
English: Skin cancer
Croatian: Rak kože
English: Before starting treatment, patients with NSCLC, previously untreated urothelial cancer or HNSCC should have tests to check their levels of PD-L1.
Croatian: Prije početka terapije bolesnici s rakom pluća nemalih stanica, prethodno neliječenim urotelnim rakom ili rakom skvamoznih stanica glave i vrata moraju provesti pretrage kojima se provjerava njihova razina bjelančevine PD-L1.
English: Results from a study of 540 previously treated patients with melanoma showed that 2 years after start of treatment, the disease had not worsened in 16% of patients treated with Keytruda compared with less than 1% of patients treated with chemotherapy.
Croatian: Rezultati ispitivanja koje je obuhvatilo 540 prethodno liječenih osoba oboljelih od melanoma pokazali su da se dvije godine nakon početka terapije bolest nije pogoršala u 16 % bolesnika liječenih lijekom Keytruda, u usporedbi s 1 % bolesnika liječenih kemoterapijom.
English: • a cancer affecting the head and neck known as head and neck squamous cell carcinoma (HNSCC),
Croatian: • urotelnog raka (raka mokraćnog mjehura i mokraćnog sustava) • raka koji zahvaća glavu i vrat, poznatog pod nazivom rak skvamoznih stanica glave i vrata,
English: In a study of 616 patients with non-squamous NSCLC that had spread, 69% of patients taking Keytruda with pemetrexed and platinum chemotherapy were alive at 11 months, compared with less than half of patients who had only pemetrexed and platinum chemotherapy.
Croatian: U ispitivanju koje je obuhvatilo 616 bolesnika s neskvamoznim rakom pluća nemalih stanica koji se proširio, 69 % bolesnika liječenih lijekom Keytruda i kemoterapijom na bazi pemetrekseda i platine bili su živi nakon 11 mjeseci, u usporedbi s manje od polovice bolesnika liječenih samo pemetreksedom i kemoterapijom na bazi platine.
English: In addition, patients who had Keytruda treatment lived on average for 8.8 months without the disease getting worse compared with 4.9 months for patients who were not given Keytruda.
Croatian: Osim toga, bolesnici koji su liječeni lijekom Keytruda živjeli su u prosjeku 8,8 mjeseci bez pogoršanja bolesti, u usporedbi s 4,9 mjeseci u bolesnika koji nisu primali lijek Keytruda.
English: After one and a half years of treatment, 72% of patients on Keytruda were still disease-free compared with 54% of patients on placebo.
Croatian: Nakon terapije od godinu i pol, u 72 % bolesnika koji su primali lijek Keytruda bolest se nije vratila, u usporedbi s 54 % bolesnika koji su primali placebo (prividno liječenje).
English: Keytruda is also used to help prevent the cancer from coming back after patients had surgery to remove melanoma (adjuvant therapy).
Croatian: Keytruda se koristi i za sprječavanje povratka raka u bolesnika kojima je kirurški odstranjen melanom (pomoćna terapija).
English: Keytruda improves survival of patients with urothelial cancer.
Croatian: Keytruda poboljšava preživljenje bolesnika s urotelnim rakom.
English: In a second study of 370 patients who could not be treated with cisplatin-containing medicines, Keytruda produced a complete or partial remission (clearing) of the cancer in 108 patients (29%); a complete remission occurred in 30 (8%) of them, meaning they no longer had any signs of cancer.
Croatian: U drugom ispitivanju na 370 bolesnika koje se nije moglo liječiti lijekovima koji sadrže cisplatin, primjenom lijeka Keytruda postignuta je potpuna ili djelomična remisija (nestanak) raka u 108 bolesnika (29 %).
English: Another study in 882 patients with HNSCC showed that Keytruda alone or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy is effective at prolonging patients' lives when HNSCC tests positive for a certain level of PD-L1.
Croatian: Drugo ispitivanje na 882 osobe oboljele od raka skvamoznih stanica glave i vrata pokazalo je da lijek Keytruda, kad se uzima kao monoterapija ili u kombinaciji s kemoterapijom koja sadrži platinu i 5fluorouracil (5-FU), učinkovit u smislu produženja života bolesnika u kojih je izmjerena određena razina bjelančevine PD-L1.
English: In a study of 861 patients with renal cell carcinoma, patients given Keytruda in combination with an already authorised medicine for renal cell carcinoma, axitinib, lived for around 15 months without their disease getting worse, compared with 11 months for patients who received treatment with another renal cell carcinoma medicine, sunitinib, which was used as a control treatment.
Croatian: U ispitivanju provedenom na 861 bolesniku s rakom bubrežnih stanica, bolesnici koji su primali lijek Keytruda u kombinaciji s drugim već odobrenim lijekom protiv raka bubrežnih stanica, tj. aksitinibom, živjeli su oko 15 mjeseci bez pogoršanja bolesti, a takvo je razdoblje trajalo 11 mjeseci u bolesnika koji su primali drugi lijek protiv raka bubrežnih stanica, sunitinib, koji je bio kontrolna terapija.
English: • classical Hodgkin lymphoma, a cancer of the white blood cells,
Croatian: • raka pluća nemalih stanica (vrste raka pluća) • klasičnog Hodgkinova limfoma (raka bijelih krvnih stanica)
English: Head and neck cancer
Croatian: Rak glave i vrata
English: Urothelial cancer
Croatian: Urotelni rak
English: For the full list of side effects and restrictions with Keytruda, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Keytruda potražite u uputi o lijeku.
English: Patients taking the Keytruda combination lived on average for 13.6 months compared with 10.4 months for patients taking other standard treatments.
Croatian: Bolesnici koji su primali kombinaciju s lijekom Keytruda živjeli su u prosjeku 13,6 mjeseci, u odnosu na 10,4 mjeseca kad je riječ o onima koji su primali druge uobičajene terapije.
English: The side effects of Keytruda are mostly related to the activity of the immune system, which may cause inflammation of body organs and tissues and can be serious, although most side effects resolve with appropriate treatment or on stopping Keytruda.
Croatian: Nuspojave lijeka Keytruda uglavnom su povezane s aktivnošću imunosnog sustava, što može prouzročiti upalu tjelesnih organa i tkiva.
English: It can be used on its own or in combination with other cancer medicines for NSCLC and HNSCC.
Croatian: Može se koristiti kao monoterapija ili u kombinaciji s drugim lijekovima protiv raka pluća nemalih stanica i raka skvamoznih stanica glave i vrata.
English: For the other cancers, Keytruda is only used on its own.
Croatian: Protiv ostalih vrsta raka Keytruda se koristi isključivo kao monoterapija.
English: In a main study of 210 patients, Keytruda produced a complete or partial remission (clearing) of the cancer in 145 patients (69%); a complete remission occurred in 47 (22%) of them, meaning they no longer had any signs of cancer.
Croatian: U glavnom ispitivanju koje je obuhvatilo 210 bolesnika, primjenom lijeka Keytruda postignuta je potpuna ili djelomična remisija (nestanak) raka u 145 bolesnika (69 %).
English: Keytruda is also effective in delaying worsening of the disease and improving survival in patients with NSCLC that tested positive for the PD-L1 protein.
Croatian: Lijek Keytruda pokazao se učinkovitim i u odgodi pogoršanja bolesti te u poboljšanju preživljenja osoba oboljelih od raka pluća nemalih stanica pozitivnog na bjelančevinu PD-L1.
English: In a study looking at around 1,000 previously treated patients, patients lived longer with Keytruda given alone (around 11 months) than with another cancer medicine called docetaxel (around 8 months) and the period during which the disease did not get worse was around 4 months with both treatments.
Croatian: Tijekom ispitivanja koje je obuhvatilo oko 1 000 prethodno liječenih bolesnika, duže su živjeli bolesnici koji su lijek Keytruda primali kao monoterapiju (oko 11 mjeseci) nego oni liječeni docetakselom, drugim lijekom protiv raka (oko 8 mjeseci).
English: In addition, patients taking Keytruda alone lived on average 12.3 months compared with 10.3 months for patients taking other standard treatments.
Croatian: Osim toga, bolesnici koji su primali monoterapiiju lijekom Keytruda živjeli su u prosjeku 12,3 mjeseca, u odnosu na 10,3 mjeseca kad je riječ o onima koji su primali druge uobičajene terapije.
English: Patients treated with Keytruda lived for up to 5.6 months without their disease getting worse compared with 2.8 months with ipilimumab.
Croatian: Rezultati tog ispitivanja pokazali su da su bolesnici liječeni lijekom Keytruda živjeli do 5,6 mjeseci bez pogoršanja bolesti, u usporedbi s 2,8 mjeseci uz terapiju ipilimumabom.
English: Patients in the Keytruda group lived on average for around 6 months without their disease getting worse compared with 4.8 months for patients in the placebo group.
Croatian: Skupina bolesnika koja je primala lijek Keytruda živjela je otprilike šest mjeseci bez pogoršanja bolesti, u usporedbi s 4,8 mjeseci u bolesnika koji su primali placebo.
English: Keytruda is also effective in improving survival of patients with head and neck squamous cell carcinoma (HNSCC) that had spread or come back.
Croatian: Lijek Keytruda učinkovit je i s obzirom na poboljšanje preživljenja bolesnika s rakom skvamoznih stanica glave i vrata koji se proširio ili se ponovno pojavio.
English: • renal cell carcinoma (a type of kidney cancer).
Croatian: • raka bubrežnih stanica (vrste raka bubrega).
English: Keytruda is a cancer medicine used to treat:
Croatian: Keytruda je lijek protiv raka koji se koristi za liječenje: • melanoma (raka kože)
English: Keytruda is also effective in improving survival of patients with renal cell cancer.
Croatian: Lijek Keytruda učinkovit je i s obzirom na poboljšanje preživljenja bolesnika s rakom bubrežnih stanica.
English: Kidney cancer
Croatian: Rak bubrega
English: Keytruda was more effective in patients who tested strongly for PD-L1, with these patients living for 15 months on average, 5 months of which without their disease worsening.
Croatian: Ti su bolesnici u prosjeku živjeli 15 mjeseci, od čega pet mjeseci bez pogoršanja bolesti.
English: In a second lung cancer study of 305 patients whose tumours tested strongly for PD-L1 who had not been treated before, patients on Keytruda lived for around 10 months without their disease getting worse compared with 6 months in patients receiving platinum-based chemotherapy.
Croatian: Drugo ispitivanje raka pluća provedeno je na 305 bolesnika u čijim je tumorima izmjerena visoka razina bjelančevine PD-L1 i koji nisu bili prethodno liječeni.
English: --1 1 dose (0.5 ml) contains:
Croatian: 1 Jedna doza (0,5 ml) sadrži:
English: Recombinant lipidated fHbp (factor H binding protein) Produced in Escherichia coli cells by recombinant DNA technology Adsorbed on aluminium phosphate (0.25 milligram aluminium per dose)
Croatian: rekombinantni lipidirani fHbp (faktor H vezujući protein) proizvedeno tehnologijom rekombinantne DNK u soju E. coli adsorbirano na aluminijev fosfat (0,25 miligrama aluminija po dozi)
English: Neisseria meningitidis serogroup B fHbp subfamily B
Croatian: fHbp iz Neisseria meningitidis grupe B, podobitelji B
English: 1 pre-filled syringe with needle
Croatian: 1 napunjena štrcaljka s iglom
English: This overview was last updated in December 2018.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u prosincu 2018.
English: The vaccine is given to chicks from one day old.
Croatian: Cjepivo se daje pilićima starijima od jednog dana.
English: This will help protect against coccidiosis.
Croatian: To pomaže pri njihovoj zaštiti od kokcidioze.
English: Hands and equipment should be washed and disinfected after use.
Croatian: Nakon primjene potrebno je oprati i dezinficirati ruke i opremu.
English: Evant received a marketing authorisation valid throughout the EU on 5 February 2019.
Croatian: VMP Evant dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 5. veljače 2019.
English: Further information on Evant can be found on the Agency's website: ema.europa.eu/Find medicine/veterinary/EPAR/evant.
Croatian: Više informacija o VMP-u Evant nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/veterinary/EPAR/evant.
English: In the future if the animals are exposed to the same Eimeria species the immune system will be able to respond more quickly.
Croatian: Ako životinje ubuduće budu izložene istoj vrsti parazita Eimeria, imunosni sustav moći će brže reagirati.
English: Evant is a vaccine.
Croatian: Evant je cjepivo.
English: What is Evant and what is it used for?
Croatian: Što je Evant i za što se primjenjuje?
English: The withdrawal period for meat and eggs from chickens treated with Evant is ‘zero' days, which means that there is no mandatory waiting time.
Croatian: Razdoblje karencije za meso i jaja pilića liječenih VMP-om Evant iznosi „nula” dana, odnosno, nema obveznog razdoblja čekanja.
English: The vaccine suspension should be diluted with the solvent and water according to dosing instructions and sprayed on the birds so that each bird receives one dose.
Croatian: Suspenziju cjepiva treba razrijediti s otapalom i vodom prema uputama o doziranju te poprskati na perad kako bi svaka ptica primila jednu dozu.
English: Protection starts at 2 weeks after vaccination and lasts until 9 weeks after vaccination.
Croatian: Zaštita nastupa dva tjedna nakon cijepljenja i traje 9 tjedana nakon cijepljenja.
English: Other information about Evant
Croatian: Ostale informacije o VMP-u Evant
English: Evant (avian coccidiosis vaccine, live) EMA/893808/2018
Croatian: Evant (cjepivo protiv kokcidioze peradi, živo) EMA/893808/2018
English: Evant (avian coccidiosis vaccine, live)
Croatian: Evant (cjepivo protiv kokcidioze peradi, živo)
English: The vaccine contains the oocysts of Eimeria species that have been weakened so that they cannot cause disease.
Croatian: Cjepivo sadrži oociste vrste Eimeria koje su oslabljene tako da ne mogu uzrokovati bolest.
English: When Evant is given to chickens, the animals' immune system recognises the Eimeria oocysts as foreign and makes defences against them.
Croatian: Kada se Evant daje pilićima, imunosni sustav životinje prepoznaje oociste vrste Eimeria kao strano tijelo i stvara obrambeni mehanizam protiv njih.
English: The European Medicines Agency decided that Evant's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Evant nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Why is Evant authorised in the EU?
Croatian: Zašto je Evant odobren u EU-u?
English: An overview of Evant and why it is authorised in the EU
Croatian: Pregled informacija o VMP-u Evant i zašto je odobren u EU-u
English: What are the risks associated with Evant?
Croatian: Koji su rizici povezani s VMP-om Evant?
English: Laboratory studies have shown that 1-day-old chicks vaccinated with Evant were protected against coccidiosis when exposed to each of the five Eimeria species at 2 weeks after vaccination and protection lasted 9 weeks after vaccination.
Croatian: Laboratorijska ispitivanja pokazala su da su pilići stari jedan dan cijepljeni VMP-om Evant bili zaštićeni od kokcidioze pri izloženosti svakoj od pet vrsta parazita Eimeria dva tjedna nakon cijepljenja, te je zaštita trajala devet tjedana nakon cijepljenja.
English: Evant is available as a suspension and solvent and can only be obtained with a prescription.
Croatian: Evant je dostupan kao suspenzija i otapalo te se izdaje samo na veterinarski recept.
English: The birds ingest the vaccine when preening their feathers.
Croatian: Perad konzumira cjepivo kljucanjem svog perja.
English: There are no known side effects with Evant.
Croatian: Nema poznatih nuspojava prilikom primjene VMP-a Evant.
English: Infected birds shed disease spores (oocysts) in their faeces that can spread the infection.
Croatian: U stolici zaražene peradi nalaze se spore bolesti (oociste) koje mogu širiti bolest.
English: The vaccine contains live attenuated (weakened) oocysts of Eimeria acervulina, Eimeria maxima, Eimeria mitis, Eimeria praecox and Eimeria tenella.
Croatian: Cjepivo sadrži žive atenuirane (oslabljene) oociste parazita Eimeria acervulina, Eimeria maxima, Eimeria mitis, Eimeria praecox i Eimeria tenella.
English: What benefits of Evant have been shown in studies?
Croatian: Koje su koristi od VMP-a Evant utvrđene u ispitivanjima?
English: Safety information has been included in the summary of product characteristics and the package leaflet for Evant, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Croatian: U sažetku opisa svojstava kao i u uputi o VMP-u Evant nalaze se informacije o sigurnosti primjene, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja ili uzgajivači trebaju pridržavati.
English: Evant is a veterinary vaccine used to protect chickens against coccidiosis caused by the coccidia parasites Eimeria acervulina, Eimeria maxima, Eimeria mitis, Eimeria praecox and Eimeria tenella.
Croatian: Evant je veterinarsko cjepivo za zaštitu pilića od kokcidioze koju uzrokuju paraziti kokcidije Eimeria acervulina, Eimeria maxima, Eimeria mitis, Eimeria praecox i Eimeria tenella.
English: For more information, see the package leaflet.
Croatian: Za dodatne informacije vidjeti uputu o VMP-u.
English: How is Evant used?
Croatian: Kako djeluje Evant?
English: For more information about using Evant, see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Više informacija o primjeni VMP-a Evant pročitajte u uputi o VMP-u, odnosno obratite se veterinaru ili ljekarniku.
English: The studies showed Evant reduced damage to the gut and oocysts in the faeces for each Eimeria species and that it reduced diarrhoea caused by Emeria acervulina, Eimeria maxima and Eimeria tenella.
Croatian: Ispitivanja su obuhvaćala skupine pilića koje su primile prividno cjepivo te su pokazala da VMP Evant smanjuje oštećenja crijeva i oociste u stolici kod svake vrste parazita Eimeria te da smanjuje proljev uzrokovan vrstama Emeria acervulina, Eimeria maxima i Eimeria tenella.
English: The full EPAR for Truberzi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Truberzi nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended dose is 100 mg with food each morning and evening.
Croatian: Preporučena doza od 100 mg uzima se uz hranu svako jutro i svaku večer.
English: This is a summary of the European public assessment report (EPAR) for Truberzi.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za lijek Truberzi.
English: What is Truberzi and what is it used for?
Croatian: Što je Truberzi i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Truberzi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Truberzi?
English: It is available as tablets containing 75 mg and 100 mg eluxadoline.
Croatian: Dostupan je u obliku tableta koje sadrže 75 ili 100 mg eluksadolina.