FrancophonIA/ELRC3.0 huggingface dataset:
English: By attaching to the receptor, nivolumab prevents PD-L1 and PD-L2 from switching off the T cells, thereby increasing the ability of the immune system to kill cancer cells.
Croatian: Vezivanjem na receptor nivolumab sprječava da PD-L1 i PD-L2 prekinu aktivnost T-stanica, čime se povećava sposobnost imunosnog sustava da ubija stanice raka.
English: The European Medicines Agency considered that Opdivo has been convincingly shown to benefit patients with certain advanced cancers (melanoma, NSCLC, renal cell carcinoma or SCCHN) by either increasing patients' survival or the time they could live without their disease getting worse.
Croatian: Europska agencija za lijekove smatrala je da se lijek Opdivo pokazao uvjerljivo korisnim za bolesnike s određenim uznapredovalim vrstama raka (melanomom, NSCLC-om, karcinomom bubrežnih stanica ili SCCHN-om) time što je produžio razdoblje preživljenja bolesnika ili razdoblje bez pogoršanja bolesti.
English: • squamous cell cancer of the head and neck (SCCHN) that has come back or spread to other parts of the body.
Croatian: • skvamoznih stanica raka u glavi i vratu (SCCHN) koji se vratio ili proširio u druge dijelove tijela.
English: After 24 months, 66.5% of patients given the combination were alive compared with 52.9% in the sunitinib group.
Croatian: Nakon 24 mjeseca bilo je živo 66,5 % bolesnika liječenih kombinacijom lijekova, u usporedbi s 52,9 % onih u skupini koja je primala sunitinib.
English: For more information about using Opdivo, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Opdivo pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Why is Opdivo authorised?
Croatian: Zašto je lijek Opdivo odobren?
English: In studies of urothelial cancer where other treatments had failed, patients responded to treatment with Opdivo.
Croatian: U ispitivanjima karcinoma urotela, za koji su ostale terapije bile neuspješne, bolesnici su odgovorili na terapiju lijekom Opdivo.
English: The dose and frequency to be given depends on the condition and whether it is used alone or in combination with ipilimumab.
Croatian: Doza i učestalost davanja lijeka ovise o stanju te o tome primjenjuje li se kao monoterapija ili u kombinaciji s ipilimumabom.
English: Patients given only ipilimumab lived for 2.9 months without their disease getting worse.
Croatian: Bolesnici koji su primili samo ipilimumab živjeli su 2,9 mjeseci bez pogoršanja bolesti.
English: • advanced renal cell carcinoma, a kidney cancer.
Croatian: • uznapredovalog karcinoma bubrežnih stanica, tj. raka bubrega.
English: The active substance in Opdivo, nivolumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a receptor (target) called PD-1 found on certain cells of the immune system called T cells.
Croatian: Djelatna tvar lijeka Opdivo, nivolumab, monoklonsko je protutijelo, tj. vrsta proteina dizajnirana za prepoznavanje i vezivanje na receptor (cilj) naziva PD-1 koji se nalazi na površini određenih stanica imunosnog sustava naziva T-stanice.
English: Patients treated with Opdivo lived on average 31 months before the cancer came back or before a new melanoma occurred or they died, compared with 24 months for patients treated with ipilimumab.
Croatian: Bolesnici liječeni lijekom Opdivo živjeli su u prosjeku 31 mjesec prije ponovne pojave raka ili novog melanoma ili su preminuli, u usporedbi s razdobljem od 24 mjeseca u bolesnika liječenih ipilimumabom.
English: Opdivo was used on its own and not compared with any other medicine.
Croatian: Lijek Opdivo primijenjen je kao monoterapija i nije uspoređivan ni s jednim drugim lijekom.
English: Patients who were given Opdivo plus ipilimumab lived for another 11.5 months without their disease getting worse and patients given only Opdivo lived for another 6.9 months without their disease getting worse.
Croatian: Bolesnici koji su primili lijek Opdivo s ipilimumabom živjeli su još 11,5 mjeseci bez pogoršanja bolesti, dok su bolesnici koji su primili samo lijek Opdivo živjeli još 6,9 mjeseci bez pogoršanja bolesti.
English: What benefits of Opdivo have been shown in studies?
Croatian: Koje su koristi od lijeka Opdivo utvrđene u ispitivanjima?
English: The most common side effects with Opdivo (which may affect more than 1 in 10 people) include tiredness, diarrhoea, nausea (feeling sick), rash and itching, pain in joints, muscles and bones, and hypothyroidism (an underactive thyroid gland), most of which are mild to moderate in severity.
Croatian: Najčešće nuspojave lijeka Opdivo (mogu se pojaviti u više od 1 na 10 bolesnika) su umor, proljev, mučnina, osip i svrbež, bol u zglobovima, mišićima i kostima te hipotireoza (nedovoljno aktivna štitnjača), od kojih je većina blaga do umjerena.
English: • a lung cancer called non-small cell lung cancer (NSCLC) that has spread locally or to other parts of the body.
Croatian: • raka pluća naziva rak pluća nemalih stanica (NSCLC) koji se proširio lokalno ili na druge dijelove tijela.
English: Opdivo contains the active substance nivolumab.
Croatian: Opdivo sadržava djelatnu tvar nivolumab.
English: A third study in 906 adults with melanoma who had undergone surgery and who were at high risk of the cancer coming back compared Opdivo with ipilimumab.
Croatian: U trećem ispitivanju na 906 odraslih osoba s melanomom koji su bili podvrgnuti kirurškom zahvatu i izloženi visokom riziku od ponovne pojave raka lijek Opdivo uspoređen je s ipilimumabom.
English: The study included patients whose cancer cells produced high levels of PD-L1 as well as patients whose cancer cells produced low levels of PD-L1.
Croatian: Ispitivanje je obuhvatilo bolesnike čije su stanice raka proizvodile visoke razine proteina PD-L1 te bolesnike čije su stanice raka proizvodile niske razine proteina PD-L1.
English: The average survival with Opdivo was 12.2 months, compared with 9.4 months with docetaxel.
Croatian: Prosječno preživljenje uz primjenu lijeka Opdivo bilo je 12,2 mjeseca u usporedbi s 9,4 mjeseca s docetakselom.
English: The results showed that in patients at moderate or high risk of their cancer getting worse, patients given the combination lived overall longer than those given sunitinib.
Croatian: Rezultati su pokazali da su među bolesnicima u kojih postoji umjeren ili visok rizik od pogoršanja bolesti ukupno duže živjeli oni koji su primali kombinaciju lijekova nego oni koji su primali sunitinib.
English: The first study, involving 418 previously untreated advanced melanoma patients, found that patients treated with Opdivo survived longer than patients who received the cancer medicine dacarbazine: 73% of patients treated with Opdivo were alive at 12 months compared with 42% of patients given dacarbazine.
Croatian: Prvo je ispitivanje obuhvatilo 418 bolesnika s uznapredovalim melanomom koji prethodno nisu bili liječeni, te je pokazalo da su bolesnici liječeni lijekom Opdivo živjeli duže od bolesnika liječenih lijekom protiv raka dakarbazinom: 73 % bolesnika liječenih lijekom Opdivo bilo je živo nakon 12 mjeseci u usporedbi s 42 % bolesnika koji su primili dakarbazin.
English: Opdivo was studied in one main study and a supportive study involving a total of 95 adults with classical Hodgkin lymphoma whose disease had not responded or had returned after autologous stem cell transplantation and treatment with brentuximab vedotin.
Croatian: Lijek Opdivo ispitan je u jednom glavnom ispitivanju i dodatnom ispitivanju koje je uključivalo ukupno 95 odraslih osoba s klasičnim Hodgkinovim limfomom, koje nisu odgovorile na terapiju ili kojima se bolest vratila nakon autologne transplantacije matičnih stanica i terapije brentuksimab vedotinom.
English: Opdivo is a cancer medicine used to treat the following:
Croatian: Opdivo je lijek protiv raka koji se primjenjuje za liječenje sljedećih bolesti:
English: Supportive information was also provided from another study indicating that Opdivo could produce a response in patients with squamous NSCLC whose disease had progressed despite several previous treatments.
Croatian: Podupiruće informacije dobivene iz dodatnog ispitivanja upućuju na to da bi lijek Opdivo mogao proizvesti odgovor u bolesnika sa skvamoznim NSCLC-om čija je bolest uznapredovala usprkos nekoliko prethodnih terapija.
English: Opdivo is used on its own after treatment with brentuximab vedotin (another cancer medicine);
Croatian: Opdivo se primjenjuje kao monoterapija nakon liječenja brentuksimab vedotinom (drugim lijekom protiv raka);
English: The time patients lived before their disease got worse was 11.6 months with the combination compared with 8.4 with sunitinib.
Croatian: Vrijeme tijekom kojeg su bolesnici živjeli bez pogoršanja bolesti bilo je 11,6 mjeseci u onih koji su primali kombinaciju lijekova, u usporedbi s 8,4 mjeseca u onih koji su primali sunitinib.
English: Opdivo used on its own was studied in two main studies in adults with advanced melanoma who had not undergone surgery.
Croatian: Lijek Opdivo primijenjen kao monoterapija ispitivan je u dvama glavnim ispitivanjima u odraslih osoba s uznapredovalim melanomom koji prethodno nisu bili podvrgnuti kirurškom zahvatu.
English: For squamous NSCLC, a study involving 272 adults showed that patients given Opdivo survived for 9.2 months, compared with 6.0 months in patients given docetaxel.
Croatian: Za skvamozni NSCLC ispitivanje na 272 odrasle osobe pokazalo je da su bolesnici kojima je davan lijek Opdivo živjeli 9,2 mjeseca, dok su bolesnici koji su primili docetaksel živjeli 6,0 mjeseci.
English: The second study looked at 405 advanced melanoma patients whose disease had got worse despite previous treatment with a cancer medicine.
Croatian: U drugom ispitivanju sudjelovalo je 405 bolesnika s uznapredovalim melanomom čija se bolest pogoršala usprkos prethodnoj terapiji lijekom protiv raka.
English: Opdivo is used on its own or with another cancer medicine, ipilimumab, to treat adults whose cancer has spread to other parts of the body or cannot be surgically removed.
Croatian: Opdivo se primjenjuje kao monoterapija ili u kombinaciji s drugim lijekom protiv raka, ipilimumabom, za liječenje odraslih čiji se rak proširio na druge dijelove tijela ili se ne može kirurški odstraniti.
English: Opdivo was compared with everolimus (another cancer medicine) in one main study involving 821 patients with advanced renal cell carcinoma whose disease advanced despite previous treatment.
Croatian: Lijek Opdivo uspoređen je s everolimusom (drugim lijekom protiv raka) u glavnom ispitivanju koje je uključivalo 821 bolesnika s uznapredovalim karcinomom bubrežnih stanica čija se bolest pogoršala usprkos prethodnoj terapiji.
English: For non-squamous NSCLC, one main study involved 582 adults whose disease had progressed despite previous treatments.
Croatian: Za neskvamozni NSCLC glavno je ispitivanje obuhvatilo 582 odrasle osobe čija je bolest uznapredovala unatoč prethodnim terapijama.
English: Opdivo is used on its own in patients who have been previously treated with other cancer medicines; it is used in combination with ipilimumab (another cancer medicine) in patients with previously untreated disease that is considered to be at moderate or high risk of worsening;
Croatian: Opdivo se primjenjuje kao monoterapija u bolesnika koji su prethodno liječeni drugim lijekovima protiv raka; u kombinaciji s ipilimumabom (drugim lijekom protiv raka) primjenjuje se u bolesnika u kojih bolest nije prethodno liječena i u kojih postoji umjeren ili visok rizik od pogoršanja bolesti;
English: • urothelial cancer, a cancer of the bladder and urinary tract, that has spread locally and cannot be surgically removed or has spread to other parts of the body.
Croatian: • karcinoma urotela, tj. raka mjehura i mokraćnih putova, koji se proširio lokalno i ne može se kirurški odstraniti ili se proširio u druge dijelove tijela.
English: Opdivo is used on its own in patients who have previously been treated with other cancer medicines (chemotherapy);
Croatian: Opdivo se primjenjuje kao monoterapija u bolesnika koji su prethodno liječeni drugim lijekovima protiv raka (kemoterapijom);
English: One main study involving 1,096 adults with previously untreated advanced renal cell carcinoma compared treatment with Opdivo and ipilimumab versus treatment with another cancer medicine for renal cell carcinoma, sunitinib.
Croatian: Tijekom glavnog ispitivanja koje je obuhvatilo 1 096 odraslih osoba s uznapredovalim karcinomom bubrežnih stanica koje nisu prethodno liječene uspoređeno je liječenje lijekom Opdivo u kombinaciji s ipilimumabom u odnosu na liječenje drugim lijekom protiv karcinoma bubrežnih stanica, tj. sunitinibom.
English: It is used on its own when treatment with platinum-based cancer medicines has not worked.
Croatian: Primjenjuje se kao monoterapija kad terapija lijekovima protiv raka na bazi platine nije djelovala.
English: A fourth study in 945 previously untreated advanced melanoma adult patients investigated Opdivo in combination with ipilimumab, Opdivo used alone or ipilimumab used alone.
Croatian: U četvrtom ispitivanju na 945 odraslih bolesnika s uznapredovalim melanomom koji prethodno nisu liječeni analizirani su Opdivo u kombinaciji s ipilimumabom, Opdivo kao monoterapija ili ipilimumab kao monoterapija.
English: However, high response rates were seen in these patients, in whom other treatments had failed and who had few other treatment options.
Croatian: Međutim, u tih je bolesnika zabilježena visoka stopa odgovora na terapiju, dok na prethodne terapije nisu odgovorili i na raspolaganju su imali ograničene mogućnosti liječenja.
English: Improvements in the time patients lived without their disease getting worse when treated with Opdivo plus ipilimumab relative to Opdivo used on its own were only seen for patients whose cancer cells produced low levels of PD-L1.
Croatian: Produženje razdoblja u kojem su bolesnici živjeli bez pogoršanja bolesti uz terapiju lijekom Opdivo u kombinaciji s ipilimumabom u odnosu na lijek Opdivo kao monoterapiju zabilježeno je samo u bolesnika čije su stanice raka proizvodile niske razine proteina PD-L1.
English: It is also used on its own in patients who have had surgery for the removal of melanoma that has spread to the lymph nodes or elsewhere in the body.
Croatian: Kao monoterapija primjenjuje se i u bolesnika kojima je kirurški odstranjen melanom koji se proširio na limfne čvorove ili u druge dijelove tijela;
English: For the full list of side effects and restrictions with Opdivo, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja zabilježenih pri primjeni lijeka Opdivo potražite u uputi o lijeku.
English: How does Opdivo work?
Croatian: Kako djeluje Opdivo?
English: Patients given Opdivo survived on average for 7.5 months, compared with 5.1 months in patients given other treatments.
Croatian: Bolesnici koji su primili Opdivo živjeli su u prosjeku 7,5 mjeseci, u usporedbi s onima koji su primili drugu terapiju, čije je preživljenje bilo 5,1 mjesec.
English: Opdivo was used on its own and was compared with another cancer medicine (cetuximab, methotrexate or docetaxel) chosen by the treating doctor.
Croatian: Lijek Opdivo primijenjen je kao monoterapija te je uspoređen s drugim lijekom protiv raka (cetuksimabom, metotreksatom ili docetakselom) prema odabiru liječnika koji je propisivao terapiju.
English: Opdivo was investigated in one main study involving 361 adults with SCCHN whose cancer progressed despite previous treatment with platinum medicines.
Croatian: Lijek Opdivo ispitan je u jednom glavnom ispitivanju na 361 odrasloj osobi s SCCHN-om čiji je rak uznapredovao usprkos prethodnoj terapiji lijekovima s platinom.
English: Opdivo is used on its own in patients whose cancer is progressing despite treatment with platinum-based cancer medicines;
Croatian: Opdivo se primjenjuje kao monoterapija u bolesnika čiji se rak nastavio širiti usprkos terapiji lijekovima protiv raka na bazi platine;
English: Opdivo was investigated in one main study involving 270 adults with urothelial cancer whose cancer got worse or returned despite previous treatment with platinum medicines.
Croatian: Lijek Opdivo ispitan je u jednom glavnom ispitivanju na 270 odraslih osoba s karcinomom urotela čija se bolest pogoršala ili vratila usprkos prethodnoj terapiji lijekovima na bazi platine.
English: Urothelial cancer
Croatian: Karcinom urotela
English: How is Opdivo used?
Croatian: Kako se Opdivo primjenjuje?
English: Patients given Opdivo survived for 25.0 months, compared with 19.6 months for patients given everolimus.
Croatian: Bolesnici koji su primili lijek Opdivo živjeli su 25 mjeseci u usporedbi s onima koji su primili everolimus, čije je preživljenje bilo 19,6 mjeseci.
English: Side effects from Opdivo were considered manageable with appropriate measures and were outweighed by the benefits.
Croatian: Smatralo se da se nuspojave lijeka Opdivo mogu kontrolirati odgovarajućim mjerama te da su koristi od lijeka veće.
English: Date of first authorisation: 10/02/2015.
Croatian: Datum prvog odobrenja: 10/02/2015.
English: Council Directive 2001/89/EC and Commission Decision 2002/106 prohibit prophylactic vaccination within the European Union.
Croatian: Direktiva Vijeća 2001/89/EZ i Odluka Komisije 2002/106 zabranjuju profilaktička cijepljenja unutar Europske unije.
English: See section 4.4
Croatian: Vidjeti odjeljak 4.4.
English: According to Community Legislation on classical swine fever (Council Directive 2001/89/EC, as amended), in the European Union:
Croatian: Sukladno zakonodavstvu Zajednice o klasičnoj svinjskoj kugi (Direktiva Vijeća 2001/89/EZ, kako je izmijenjena i dopunjena), u Europskoj uniji:
English: 6.2 Major Incompatibilities
Croatian: 6.2 Glavne inkompatibilnosti
English: ADVICE ON CORRECT ADMINISTRATION
Croatian: SAVJET ZA ISPRAVNU PRIMJENU
English: EU/2/14/179/001 (10 doses) EU/2/14/179/002 (50 doses)
Croatian: EU/2/14/179/001 (10 doza) EU/2/14/179/002 (50 doza)
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Croatian: Djelatna tvar biološkog podrijetla namijenjena za proizvodnju aktivnog imuniteta nije u okviru Uredbe (EZ) br 470/2009.
English: * min 100 PD50 ** Tissue culture infectious dose
Croatian: * min 100 PD50 ** Infektivna doza za tkivnu kulturu
English: Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 2 godine.
English: Sorbitol 70% (solution)
Croatian: Sorbitol 70% (otopina)
English: After reconstitution, the suspension should be slightly pink clear liquid.
Croatian: Nakon rekonstitucije, suspenzija mora biti svijetlo ružičasta bistra tekućina.
English: 10 doses 50 doses
Croatian: 10 doza 50 doza
English: The virus is grown in porcine cells.
Croatian: Virus se uzgaja na stanicama svinje.
English: Camprodon s/n “La Riba”, 17813 Vall de Bianya
Croatian: Camprodon s/n “La Riba”, 17813 Vall de Bianya Girona
English: Onset of immunity: 14 days after vaccination Duration of immunity: at least 6 months after vaccination
Croatian: Početak imunosti: 14 dana nakon cijepljenja Trajanje imunosti: najmanje 6 mjeseci nakon cijepljenja.
English: Dulbecco's Modified Eagle culture medium (DMEM)
Croatian: Dulbeccov modificirani Eagleov medij (DMEM)
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label and carton after EXP {month/year}.
Croatian: Ne koristite ovaj veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi i kutiji poslije EXP {mjesec/godina}
English: a) the use of classical swine fever vaccines is prohibited.
Croatian: a) uporaba cjepiva protiv klasične svinjske kuge je zabranjena.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Croatian: Pomoćne tvari (uključujući adjuvanse) navedene u odjeljku 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1. dodatka Uredbe Komisije (EU) br. 37/2010 naznačeno da se za njih ne zahtjeva određivanje NDK (MRL) ili nisu obuhvaćene odredbama Uredbe (EZ) br. 470/2009 kada se koriste u ovom veterinarsko-medicinskom proizvodu.
English: DIVA tests:
Croatian: DIVA ispitivanja:
English: b) the manipulation, manufacture, storage, supply, distribution and sale of classical swine fever vaccines must be carried out under supervision and in accordance with the eventual instructions established by the competent authority of the Member State.
Croatian: b) rukovanje, proizvodnja, skladištenje, opskrba, distribucija i prodaja cjepiva klasične svinjske kuge mora se provoditi pod nadzorom i u skladu s eventualnim uputama koje je izdalo nadležno tijelo države članice.
English: If you notice any side effects, whether or not listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon..
Croatian: Ako zamijetite bilo koju nuspojavu, čak i one koje nisu navedene u ovoj uputi o VMP ili mislite da veterinarsko-medicinski proizvod ne djeluje, molimo obavijestite svog veterinara.
English: Shedding of vaccine virus has however not been detected but cannot be excluded.
Croatian: Izlučivanje cjepnog virusa, međutim, nije otkriveno, ali se ne može isključiti.
English: However, the use of vaccines may be authorised in the framework of an emergency vaccination plan, implemented by the competent authority of a Member State following confirmation of disease, in accordance with Community Legislation on control and eradication of classical swine fever.
Croatian: Međutim, primjena cjepiva može se odobriti u okviru plana hitnog cijepljenja, koje provodi nadležno tijelo države članice po utvrđivanju bolesti, u skladu sa zakonodavstvom Zajednice o kontroli i iskorjenjivanju klasične svinjske kuge.
English: Limited studies in young pigs support protection against CSF1045 (genotype 2, Germany 2009) and CSF1047 (genotype 2, Israel 2009) field strains.
Croatian: Ograničena ispitivanja u mlade prasadi pružaju zaštitu protiv KSG1045 (genotip 2, Njemačka 2009) i KSG1047 (genotip 2, Izrael 2009) terenskih sojeva virusa.
English: Solvent for Suvaxyn CSF Marker
Croatian: Otapalo za Suvaxyn CSF Marker
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Croatian: 13. RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju nehotičnog samoinjiciranja odmah potražiti pomoć liječnika i pokažite mu uputu o VMP ili etiketu.
English: c) special provisions regulate the movement of pigs from areas where classical swine fever vaccine is being or has been used and the processing or marking of pig meat from vaccinated pigs.
Croatian: c) posebne odredbe reguliraju kretanje svinja iz područja gdje se primjenjuje ili se primijenilo cjepivo protiv klasične svinjske kuge te obradu i označavanje svinjskog mesa cijepljenih svinja.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: Keep out of the sight and reach of children.
Croatian: I DOSEGA DJECE” Čuvati izvan pogleda i dosega djece.
English: Diagnostic tools targeted to detection of antibody responses could enable DIVA strategies.
Croatian: Dijagnostički alati namjenjeni za otkrivanje reakcije antitijela mogu omogućiti DIVA strategije.