FrancophonIA/ELRC3.0 huggingface dataset:
English: Common: - Bleeding inside the skull (intraventricular haemorrhage) and brain injury (periventricular leukomalacia), - Bleeding in the lung, - Perforation of the intestine and injury of intestinal tissue (necrotizing enterocolitis), - Reduced volume of urine passed, blood in the urine, fluid retention
Croatian: Često: - Krvarenje unutar glave (intraventrikularno krvarenje) i oštećenje mozga (periventrikularna leukomalacija), - Krvarenje u pluća, - Perforacija crijeva i ozljeda tkiva crijeva (nekrotizirajući enterokolitis), - Smanjeni volumen mokraće koji se izlučuje, krv u mokraći, zadržavanje tekućine
English: POSSIBLE SIDE EFFECTS
Croatian: MOGUĆE NUSPOJAVE
English: Excipients: trometamol, sodium chloride, sodium hydroxide, hydrochloric acid 25%, water for injections.
Croatian: Pomoćne tvari: trometamol, natrijev klorid, natrijev hidroksid, 25%-tna kloridna kiselina, voda za injekcije.
English: If after this first course of treatment, the ductus arteriosus is not closed or re-opens, your baby's doctor may decide to give a second course of treatment.
Croatian: Ako se nakon prvog ciklusa liječenja arterijski duktus ne zatvori ili se ponovno otvori, liječnik se može odlučiti za primjenu još jednog ciklusa.
English: As ibuprofen may inhibit platelet aggregation, premature neonates should be monitored for signs of bleeding.
Croatian: Kako ibuprofen može inhibirati agregaciju trombocita, treba obratiti pažnju na znakove krvarenja u nedonoščadi.
English: A course of therapy is defined as three intravenous injections of Pedea given at 24 hour intervals.
Croatian: Ciklus terapije definiran je kao tri intravenske injekcije Pedee primijenjene u razmacima od 24 sata.
English: Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.
Croatian: Liječenje hemodinamski značajnog otvorenog arterijskog duktusa u nedonoščadi gestacijske dobi manje od 34 tjedna.
English: - If your baby is already suffering from an infection that is being treated, the doctor will treat your baby with Pedea only after careful consideration of your baby's condition.
Croatian: - Ako Vaše dijete već ima infekciju koja se liječi, liječnici će primijeniti
English: Uncommon: - Acute failure of the kidney's functions - Bleeding in the intestine - Below normal oxygen content in the arterial blood (hypoxemia)
Croatian: Manje često: - Akutno zatajenje funkcije bubrega - Krvarenje u crijevima - Smanjen sadržaj kisika arterijske krvi (hipoksemija)
English: This medicinal product contains less than 1 mmol sodium (15 mg) per 2 ml, i.e. essentially ‘sodiumfree'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (15 mg) u 2 ml, tj. zanemarive količine natrija.
English: - Your baby may develop some bleeding from the intestines and the kidneys.
Croatian: - U Vašeg djeteta se može pojaviti krvarenje u crijevima ili u bubrezima.
English: - The other ingredients are trometamol, sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid 25% (for pH adjustment) and water for injections.
Croatian: - Drugi sastojci su trometamol, natrijev klorid, natrijev hidroksid (za podešavanje pH), 25% -tna kloridna kiselina (za podešavanje pH) i voda za injekcije.
English: To detect this, your baby's stools and urine may be tested to determine if there is any blood present in them.
Croatian: Pregled stolice i mokraće na prisustvo krvi može pomoći u otkrivanju ovih krvarenja.
English: BEFORE PEDEA IS ADMINISTERED TO YOUR BABY
Croatian: PRIJE NEGO VAŠE DIJETE PRIMI PEDEU
English: In order to avoid any substantial variation of pH due to the presence of acidic medicinal products that could remain in the infusion line, the latter must be rinsed before and after administration of Pedea with 1.5 to 2 ml of either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution.
Croatian: Da bi se izbjegla značajna varijacija pH zbog prisustva kiselog lijeka koji bi mogao zaostati u infuzijskoj liniji, ona se prije i poslije primjene Pedee mora ispirati s 1,5 do 2 ml 0,9%-tne otopine natrijevog klorida za injekciju (9 mg/ml ) ili 5% -tne otopine glukoze (50 mg/ml).
English: As for all parenteral products, ampoules of Pedea should be visually inspected for particulate matter and the integrity of the container prior to use.
Croatian: Kao i kod svih lijekova namijenjenih parenteralnoj primjeni, ampule Pedee se moraju prije upotrebe vizualno pregledati na prisutnost vidljivih čestica te cjelovitost spremnika.
English: Trometamol, sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid 25% (for pH adjustment), water for injections.
Croatian: Trometamol, natrijev klorid, natrijev hidroksid (za podešavanje pH), kloridna kiselina 25% (za podešavanje pH), voda za injekcije.
English: After first opening of an ampoule, any unused portions must be discarded.
Croatian: Nakon prvog otvaranja ampule, sav neiskorišteni lijek mora se baciti.
English: However, overdose has been described in infants and children administered oral ibuprofen: CNS depression, seizures, gastrointestinal disturbances, bradycardia, hypotension, apnoea, abnormal renal function, haematuria have been observed.
Croatian: Uočeni su depresija središnjeg živčanog sustava, napadaji, gastrointestinalni poremećaji, bradikardija, hipotenzija, apneja, poremećaj funkcije bubrega i hematurija.
English: HOW TO STORE PEDEA
Croatian: KAKO ČUVATI PEDEU
English: If after the second course of treatment, the ductus arteriosus is still not closed, a surgery may then be proposed.
Croatian: Ako se arterijski duktus ne zatvori ni nakon drugog ciklusa liječenja, može se preporučiti kirurško zatvaranje.
English: Pedea 5 mg/ml solution for injection
Croatian: Pedea 5 mg/ml otopina za injekciju
English: Before and after administration of Pedea, to avoid contact with any acidic solution, rinse the infusion line over 15 minutes with 1.5 to 2 ml of either sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%), solution for injection.
Croatian: Prije i poslije primjene Pedee, da bi se izbjegao kontakt s kiselim otopinama, infuzijsku liniju treba ispirati tijekom 15 minuta s 1,5 do 2 ml 0,9%-tne otopine natrijevog klorida (9 mg/ml) ili 5%-tne otopine glukoze za injekciju (50 mg/ml).
English: Treatment with Pedea should only be carried out in a neonatal intensive care unit under the supervision of an experienced neonatologist.
Croatian: Liječenje Pedeom treba se provoditi samo u jedinici za intenzivno liječenje novorođenčadi pod nadzorom iskusnog neonatologa.
English: It is 10 mg/kg for the first administration and 5 mg/kg for the second and the third administrations.
Croatian: Prva doza je primjena 10 mg/kg, a druga i treća primjena 5 mg/kg.
English: - nitric oxide: since both medicinal products inhibit platelet function, their combination may in theory increase the risk of bleeding.
Croatian: - kortikosteroidima: ibuprofen može povećati rizik od gastrointestinalnog krvarenja. - dušikovim oksidom: kako oba lijeka inhibiraju funkciju trombocita, njihova istodobna primjena teoretski može povećati rizik od krvarenja.
English: The total volume of solution injected should take into account the total daily fluid volume administered.
Croatian: Ukupni primijenjeni volumen injicirane otopine treba uračunati u ukupni primijenjeni dnevni volumen tekućine.
English: Pedea 5 mg/ml solution for injection Ibuprofen
Croatian: Pedea 5 mg/ml otopina za injekciju ibuprofen
English: Very common: Bronchopulmonary dysplasia* Common: Pulmonary haemorrhage Uncommon: Hypoxemia*
Croatian: Vrlo često: Bronhopulmonarna displazija* Često: Plućno krvarenje
English: If the condition is unchanged after the second course of therapy, surgery of the patent ductus arteriosus may then be necessary.
Croatian: Ako je stanje nepromijenjeno i nakon drugog ciklusa liječenja, mogao bi biti nužan operativni zahvat radi zatvaranja otvorenog arterijskog duktusa.
English: In preterm newborns ibuprofen significantly reduced plasma concentrations of prostaglandins and their metabolites, particularly PGE2 and 6-keto-PGF-1-alpha. Low levels were sustained up to 72 hours in neonates who received 3 doses of ibuprofen, whereas subsequent re-increases were observed at 72 hours after only 1 dose of ibuprofen.
Croatian: Niske razine su se održale i do 72 sata u novorođenčadi koja je primila 3 doze ibuprofena, dok se naknadno povećanje koncentracije opazilo 72 sata nakon primjene samo 1 doze ibuprofena.
English: - aminoglycosides: since ibuprofen may decrease the clearance of aminoglycosides, their coadministration may increase the risk of nephrotoxicity and ototoxicity (see section 4.4).
Croatian: - ostalim NSAIL: ne preporučuje se istodobna primjena ibuprofena s ostalim NSAIL zbog povećanog rizika od nuspojava. - aminoglikozidima: kako ibuprofen može smanjiti klirens aminoglikozida, njihovom istodobnom primjenom povećava se rizik od nefrotoksičnosti i ototoksičnosti (vidjeti dio 4.4)
English: - Ibuprofen may reduce the ability of your baby's blood to clot.
Croatian: - Ibuprofen može poremetiti zgrušavanje krvi u Vašeg djeteta.
English: Very Common: Blood creatinine increased, Blood sodium decreased
Croatian: Vrlo često: Porast serumskog kreatinina, Smanjenje serumskog natrija
English: Reported adverse reactions are listed below, by system organ class and by frequency.
Croatian: U nastavku se navode zabilježene nuspojave prema organskim sustavima i učestalosti.
English: Any unused portion of the solution should be discarded.
Croatian: Neiskorištenu otopinu treba odbaciti.
English: If necessary, the injection volume may be adjusted with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection.
Croatian: Ako je potrebno, volumen infuzije se može prilagoditi dodavanjem otopine natrijevog klorida 9 mg/ml (0,9%) za injekcije ili otopine glukoze 50 mg/ml (5%) za injekcije.
English: Each ampoule of 2 ml contains 10 mg ibuprofen.
Croatian: Svaka ampula od 2 ml sadrži 10 mg ibuprofena.
English: Read all of this leaflet carefully before this medicine is administered to your baby.
Croatian: Pažljivo pročitajte cijelu uputu prije nego
English: 2 ml solution in a colourless type 1 glass ampoule.
Croatian: 6.5 Vrsta i sadržaj spremnika 2 ml otopine u bezbojnoj staklenoj ampuli (staklo tipa 1).
English: Each ml contains 5 mg ibuprofen.
Croatian: Svaki ml sadrži 5 mg ibuprofena.
English: This medicinal product must not be mixed with other medicinal products except sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution.
Croatian: Lijek se ne smije miješati s drugim lijekovima osim s 0,9% -tnom otopinom natrijevog klorida za injekcije (9 mg/ml) ili 5%-tnom otopinom glukoze (50 mg/ml).
English: OUTER CARTON TEXT
Croatian: TEKST NA VANJSKOJ KUTIJI
English: The total volume of solution injected to preterm infants should take into account the total daily fluid volume administered.
Croatian: Ukupni volumen injicirane otopine u nedonoščadi treba uračunati u ukupni volumen dnevno primijenjene tekućine.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your baby's doctor or your pharmacist.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika Vašeg djeteta ili ljekarnika.
English: Conversely, a lower incidence of neonatal grade III-IV intraventricular haemorrhage and of surgical ligation was associated with prophylactic use of Pedea.
Croatian: Pedee bila je povezana s manjom incidencijom neonatalnog intraventrikularnog krvarenja III -IV stupnja te kirurškog podvezivanja duktusa.
English: Pedea will only be given to your baby in a special neonatal intensive care unit by qualified health care professionals.
Croatian: Pedea će biti primjenjena Vašem djetetu samo u jedinici za intenzivno liječenje novorođenčadi pod nadzorom osposobljenog medicinskog osoblja.
English: Common: Oliguria, Fluid retention, Haematuria Uncommon: Acute renal failure
Croatian: Poremećaji bubrega i mokraćnog sustava Često: Oligurija, Retencija tekućine, Hematurija Manje često: Akutno zatajenje bubrega
English: What Pedea is and what it is used for Before Pedea is administered to your baby How Pedea is used
Croatian: Što je Pedea i za što se koristi Prije nego
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA STAKLENE AMPULE
English: Pedea will only be given to your baby in a special neonatal intensive care unit by qualified healthcare professional.
Croatian: Pedeu će Vašem djetetu primjeniti iskusni zdravstveni radnici u specijalnoj jedinici intenzivne njege novorođenčadi.
English: Common: Necrotizing enterocolitis, Intestinal perforation
Croatian: Često: Nekrotizirajući enterokolitis, Perforacija crijeva Manje često: Gastrointestinalno krvarenje
English: Ibuprofen may increase the anti-clotting effect of this product.
Croatian: Ibuprofen može pojačati njihovo djelovanje.
English: Gastrointestinal disorders
Croatian: Poremećaji probavnog sustava
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: United Kingdom Recordati Rare Diseases UK Ltd. Tel: +44 (0)1491 414333
Croatian: Tel: +44 (0)1491 414333
English: Use only sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution to adjust injection volume.
Croatian: Da bi se prilagodio volumen injekcije treba koristiti samo 0,9% -tnu otopinu natrijevog klorida za injekcije (9 mg/ml ) ili 5%-tnu otopinu glukoze (50 mg/ml).
English: Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux France
Croatian: Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux Francuska
English: Intravenous use as short infusion Read the package leaflet before use
Croatian: Intravenska primjena u obliku kratkotrajne infuzije.
English: Recordati Rare Diseases Immeuble “Le Wilson” 70 avenue du Général de Gaulle F- 92800 Puteaux France
Croatian: Recordati Rare Diseases Immeuble “Le Wilson” 70 avenue du Général de Gaulle F- 92800 Puteaux, Francuska
English: Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux France or
Croatian: Recordati Rare Diseases Immeuble “Le Wilson” 70, Avenue du Général de Gaulle F-92800 Puteaux Francuska ili
English: Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F- 92800 Puteaux, France or
Croatian: Recordati Rare Diseases Immeuble “Le Wilson” 70 avenue du Général de Gaulle F- 92800 Puteaux, Francuska ili
English: Medicinal product subject to medical prescription
Croatian: SAŽETAK OPISA SVOJSTAVA LIJEKA
English: Melanoma
Croatian: Melanom
English: • melanoma, a type of skin cancer.
Croatian: • melanoma, vrste raka kože.
English: This overview was last updated in 12-2018.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u 12. 2018.
English: Further information on Opdivo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/opdivo.
Croatian: Više informacija o lijeku Opdivo nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/opdivo.
English: What measures are being taken to ensure the safe and effective use of Opdivo?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Opdivo?
English: Classical Hodgkin lymphoma
Croatian: Klasični Hodgkinov limfom
English: Studies of classical Hodgkin lymphoma involved only a small number of patients.
Croatian: Ispitivanja klasičnog Hodgkinova limfoma uključivala su mali broj bolesnika.
English: What is Opdivo and what is it used for?
Croatian: Što je Opdivo i za što se primjenjuje?
English: Other information about Opdivo
Croatian: Ostale informacije o lijeku Opdivo
English: An overview of Opdivo and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Opdivo i zašto je odobren u EU-u
English: After treatment, cancer cells were partially or completely cleared in around 66% of patients (63 out of 95).
Croatian: Nakon liječenja stanice raka djelomično su se ili potpuno povukle u oko 66 % bolesnika (63 od 95).
English: The Agency therefore decided that Opdivo's benefits are greater than its risks and recommended that it can be authorised for use in the EU.
Croatian: Stoga je Agencija zaključila da koristi od lijeka Opdivo nadmašuju s njim povezane rizike te je preporučila izdavanje odobrenja za njegovu primjenu u EU-u.
English: Treatment with Opdivo must be started and supervised by a doctor experienced treating cancer.
Croatian: Liječenje lijekom Opdivo mora započeti i nadzirati liječnik s iskustvom u liječenju raka.
English: Opdivo is also commonly associated with side effects related to the activity of the immune system on body organs.
Croatian: Lijek Opdivo također se često povezuje s nuspojavama koje se odnose na djelovanje imunosnog sustava na tjelesne organe.
English: Side effects reported with Opdivo are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Opdivo pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: As for all medicines, data on the use of Opdivo are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Opdivo kontinuirano se prate.
English: What are the risks associated with Opdivo?
Croatian: Koji su rizici povezani s lijekom Opdivo?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Opdivo 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 Opdivo također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: Opdivo is given as an infusion (drip) into a vein.
Croatian: Opdivo se daje kao infuzija (ukapavanje) u venu.
English: In addition, 41.6% of patients (177 out of 423) responded to the treatment with the combination compared with 26.5% (112 out of 416) of those receiving sunitinib.
Croatian: Osim toga, 41,6 % bolesnika (177 od 423) odgovorilo je na liječenje kombinacijom lijekova, u usporedbi s 26,5 % bolesnika (112 od 416) koji su primali sunitinib.
English: As it is not clear how much ipilimumab contributes to the benefits when given in combination with Opdivo in patients with advanced renal cell carcinoma, the company must conduct a study to determine the precise contribution of ipilimumab and if the risks associated with ipilimumab can be further minimised.
Croatian: Budući da nije jasno u kojoj mjeri ipilimumab doprinosi koristima lijeka ako se primjenjuje u kombinaciji s lijekom Opdivo u bolesnika s uznapredovalim karcinomom bubrežnih stanica, tvrtka mora provesti ispitivanje kako bi se utvrdio točan doprinos ipilimumaba kao i to mogu li se rizici povezani s ipilimumabom dodatno smanjiti.
English: Opdivo received a marketing authorisation valid throughout the EU on 19 June 2015.
Croatian: Lijek Opdivo dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 19. lipnja
English: The doctor may need to delay doses if certain side effects occur, or stop treatment altogether if side effects are severe.
Croatian: Liječnik će možda morati odgoditi primjenu doze ako nastupe određene nuspojave ili u potpunosti prekinuti terapiju kod težih nuspojava.
English: The company that markets Opdivo will provide educational packs for doctors who are expected to prescribe Opdivo containing information on how the medicine should be used, how to manage side effects, particularly those related to the activity of the immune system, and possible risks for classical Hodgkin lymphoma patients if they go on to have an allogeneic stem cell transplant (a transplant of stem cells from a donor).
Croatian: Tvrtka koja stavlja na tržište lijek Opdivo dostavit će liječnicima koji bi trebali propisivati Opdivo edukativne pakete s informacijama o načinu primjene lijeka, kontroli nuspojava, posebno onih koje se odnose na aktivnost imunosnog sustava, te o mogućim rizicima za bolesnike s klasičnim Hodgkinovim limfomom ako budu podvrgnuti alogenoj transplantaciji matičnih stanica (presađivanje matičnih stanica darivatelja).
English: Cancer cells can produce proteins (PD-L1 and PD-L2) that attach to this receptor and switch off the activity of the T cells, preventing them from attacking the cancer.
Croatian: Stanice raka mogu proizvesti proteine (PD-L1 i PD-L2) koji se vežu na taj receptor i prekidaju aktivnost T-stanica, tako ih sprječavajući da napadaju rak.
English: Most will go away with appropriate treatment or on stopping Opdivo.
Croatian: Većina nuspojava povlači se nakon odgovarajuće terapije ili prekida terapije lijekom Opdivo.
English: In this study, where patients were followed up for at least 6 months, around 32% (38 out of 120) of patients given Opdivo responded to treatment and had a reduction in their tumours compared with about 11% (5 out of 47) of patients given investigator's choice of treatment (dacarbazine or a combination of carboplatin and paclitaxel).
Croatian: U tom ispitivanju, u kojem su bolesnici praćeni barem šest mjeseci, oko 32 % (38 od 120) bolesnika koji su primili lijek Opdivo odgovorilo je na liječenje i tumor im se smanjio, u usporedbi s oko 11 % (5 od 47) bolesnika koji su primili lijek po izboru ispitivača (dakarbazin ili kombinaciju karboplatina i paklitaksela).
English: More patients were alive after 2 years with Opdivo and ipilimumab treatment (64%) than with Opdivo alone (59%) or ipilimumab alone (45%).
Croatian: Više bolesnika bilo je živo nakon 2 godine uz primjenu lijeka Opdivo i ipilimumaba (64 %) nego uz primjenu lijeka Opdivo kao monoterapije (59 %) ili ipilimumaba kao monoterapije (45 %).
English: • classical Hodgkin lymphoma, a cancer of the lymphocytes (a type of white blood cell), that has not improved or has returned after an autologous stem cell transplant (a procedure where the bone marrow is replaced with the patient's own stem cells to form new bone marrow that produces healthy blood cells).
Croatian: • klasičnog Hodgkinova limfoma, raka limfocita (vrste bijelih krvnih stanica) koji se nije djelomično povukao ili se vratio nakon autologne transplantacije matičnih stanica (postupka u kojem se koštana srž zamjenjuje vlastitim matičnim stanicama bolesnika radi stvaranja nove koštane srži koja proizvodi zdrave krvne stanice).
English: In the study, 20% of patients (54 out of 270) responded to treatment and had a tumour size reduction.
Croatian: U ispitivanju je 20 % bolesnika (54 od 270) odgovorilo na terapiju te im se tumor smanjio.
English: Other common side effects with Opdivo in combination with ipilimumab, which are also mostly mild or moderate, include pyrexia (fever), thyroid issues, decreased appetite, vomiting, colitis (inflammation of the gut), abdominal (belly) pain, headache and breathing difficulty.
Croatian: Ostale česte nuspojave lijeka Opdivo u kombinaciji s ipilimumabom, koje su također uglavnom blage ili umjerene, uključuju pireksiju (vrućicu), probleme sa štitnjačom, smanjeni apetit, povraćanje, kolitis (upalu crijeva), bol u abdomenu (trbuhu), glavobolju i teškoće pri disanju.
English: The company will also provide further data on the long-term benefits of Opdivo and carry out studies to try to identify which patients are most likely to benefit from treatment with the medicine.
Croatian: Tvrtka će također dostaviti dodatne podatke o dugoročnim koristima lijeka Opdivo te provesti ispitivanja za utvrđivanje onih bolesnika koji bi najvjerojatnije mogli imati koristi od lijeka.
English: The company will also provide an alert card for patients with information on the risks of the medicine, as well as instructions on when to contact their doctor if they experience symptoms.
Croatian: Tvrtka će također dostaviti karticu s upozorenjima o rizicima od lijeka, kao i upute o tome kada se obratiti liječniku u slučaju nastupa nuspojava.