FrancophonIA/ELRC3.0 huggingface dataset:
English: Ipilimumab is a human monoclonal antibody that is not metabolized by cytochrome P450 enzymes (CYPs) or other drug metabolizing enzymes.
Croatian: Ipilimumab je ljudsko monoklonsko protutijelo koje se ne metabolizira enzimima citokroma P450 (CYP) niti drugim enzimima koji metaboliziraju lijekove.
English: However, significant exposure of ipilimumab to the infant through breast milk is not expected and no effects on the breast-fed infant are anticipated.
Croatian: Međutim, ne očekuje se značajno izlaganje dojenčeta ipilimumabu preko majčinog mlijeka niti se predviđaju neki učinci na dojenče.
English: Severe or life-threatening adverse reactions
Croatian: Teške ili životno opasne nuspojave
English: Samsung Biologics Co. Ltd 300, Songdo Bio Way (Daero) Yeonsu-gu, Incheon 21987 Korea
Croatian: Ltd 300, Songdo Bio Way (Daero) Yeonsu-gu, Incheon 40621987 Koreja
English: NCI-CTCAE v4 Gradea
Croatian: NCI-CTCAE v4 stupanja
English: Clear to slightly opalescent, colourless to pale yellow liquid that may contain light (few) particulates and has a pH of 7.0 and an osmolarity of 260-300 mOsm/kg.
Croatian: Bistra do blago opalescentna, bezbojna do blijedožuta tekućina koja može sadržavati nekoliko (malu količinu) čestica, ima pH 7,0 i osmolarnost 260-300 mOsm/kg.
English: The recommended infusion period is 30 or 90 minutes, depending on the dose.
Croatian: Preporučeno trajanje infuzije je 30 ili 90 minuta, ovisno o dozi.
English: Symptoms may also include visual field defects, behavioural changes, electrolyte disturbances, and hypotension.
Croatian: Simptomi također mogu uključivati ispade vidnog polja, promjene ponašanja, poremećaje elektrolita i hipotenziju.
English: However, once you are treated with YERVOY, your doctor may give you corticosteroids to reduce the side-effects that you may have with YERVOY.
Croatian: Međutim, kad jednom započnete liječenje lijekom YERVOY, liječnik Vam može dati kortikosteroide kako bi se ublažile nuspojave lijeka YERVOY koje možda imate.
English: CA184332 and CA184338
Croatian: CA184332 i CA184338
English: Check with your doctor or nurse before you are given YERVOY if you have an autoimmune disease (a condition where the body attacks its own cells); if you have, or have ever had, chronic viral infection of the liver, including hepatitis B (HBV) or hepatitis C (HCV); if you have human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS).
Croatian: Obavijestite svog liječnika ili medicinsku sestru prije nego što primite YERVOY ako imate neku autoimunu bolest (stanje u kojem tijelo napada vlastite stanice); ako imate ili ste imali kroničnu virusnu infekciju jetre, uključujući hepatitis B (HBV) i hepatitis C (HCV); ako imate infekciju virusom humane imunodeficijencije (HIV) ili sindrom stečene imunodeficijencije (SIDA). ako ste već doživjeli tešku kožnu nuspojavu na prethodnu terapiju raka.
English: Cytotoxic T-lymphocyte antigen-4 (CTLA-4) is a key regulator of T-cell activity.
Croatian: Antigen 4 citotoksičnih limfocita-T (CTLA-4) ključni je regulator aktivnosti T-stanica.
English: Median OS and estimated 1-year, 2-year, 3-year and 4-year survival rates are presented in Table 9.
Croatian: Medijan OS-a i procijenjene stope preživljenja nakon 1 godine, 2 godine, 3 godine i 4 godine prikazani su u Tablici 9.
English: YERVOY contains sodium
Croatian: YERVOY sadrži natrij
English: Infliximab must not be used if gastrointestinal perforation or sepsis is suspected (see the Summary of Product Characteristics for infliximab).
Croatian: Infliksimab se ne smije primjenjivati ukoliko se sumnja na gastrointestinalnu perforaciju ili na sepsu (vidi sažetak opisa svojstava lijeka za infliksimab).
English: • Information that ipilimumab can cause serious side effects in many parts of the body that can lead to death and require early intervention, as outlined in the guidelines for the management of immune-related adverse reactions in section 4.4 of the SmPC.
Croatian: • Upozorenje da ipilimumab može izazvati ozbiljne nuspojave u brojnim dijelovima tijela koje mogu imati smrtni ishod i zahtijevaju brzu intervenciju, kako je opisano u smjernicama za liječenje imunološki uzrokovanih nuspojava u dijelu 4.4 Sažetka opisa svojstava lijeka.
English: Ipilimumab is a CTLA-4 immune checkpoint inhibitor that blocks T-cell inhibitory signals induced by the CTLA-4 pathway, increasing the number of reactive T-effector cells which mobilize to mount a direct T-cell immune attack against tumour cells.
Croatian: Ipilimumab je inhibitor imunološke kontrolne točke CTLA-4 koji blokira inhibicijske signale T-stanice inducirane CTLA-4 putem, povećavajući broj reaktivnih efektorskih T-stanica koje se mobiliziraju kako bi se pokrenuo direktan imunološki napad T-stanica protiv tumorskih stanica.
English: Unexplained motor neuropathy, muscle weakness, or sensory neuropathy lasting > 4 days must be evaluated, and non-inflammatory causes such as disease progression, infections, metabolic syndromes and concomitant medication should be excluded.
Croatian: Neobjašnjena motorička neuropatija, mišićna slabost ili senzorna neuropatija koje traju > 4 dana moraju se ispitati i moraju se isključiti neupalni uzroci poput napredovanja bolesti, infekcije, metaboličkog sindroma i istodobno primijenjenih lijekova.
English: Additionally, based on these relationships, there were no clinically significant differences between a nivolumab dose of 480 mg every 4 weeks or 3 mg/kg every 2 weeks in advanced melanoma and RCC.
Croatian: Nadalje, na temelju tih odnosa nisu utvrđene klinički značajne razlike između doze nivolumaba od 480 mg svaka 4 tjedna i doze od 3 mg/kg svaka 2 tjedna kod uznapredovalog melanoma i RCC-a.
English: Tapering should occur over a period of at least 1 month.
Croatian: Smanjenje doze mora trajati najmanje 1 mjesec.
English: 1-year OS (%) (95% CI) BORR (%) (95% CI) SD (n/N)a
Croatian: 1-godišnji OS (%) (95% CI) BORR (%) (95% CI) SD (n/N)a
English: Data outside the 9 completed clinical trials in melanoma were included in frequency determinations.
Croatian: Podaci izvan 9 završenih kliničkih ispitivanja primjene kod melanoma bili su uključeni u procjenu učestalosti.
English: If there are any signs of adrenal crisis such as severe dehydration, hypotension, or shock, immediate administration of intravenous corticosteroids with mineralocorticoid activity is recommended, and the patient must be evaluated for presence of sepsis or infections.
Croatian: Ukoliko postoje ikakvi znakovi adrenalne krize, kao što su teška dehidracija, hipotenzija ili šok, preporučuje se hitna primjena intravenskih kortikosteroida s mineralokortikoidnim djelovanjem, a kod bolesnika se mora provjeriti je li prisutna sepsa ili infekcija.
English: Thirty-two percent of patients had BRAF mutation-positive melanoma; 26.5% of patients had PD-L1 ≥ 5% tumour cell membrane expression.
Croatian: Trideset i dva posto bolesnika imalo je melanom pozitivan na mutaciju BRAF; 26,5% bolesnika imalo je ekspresiju PD L1 na tumorskoj staničnoj membrani ≥ 5%.
English: Data from first-line RCC patients 75 years of age or older are too limited to draw conclusions on this population (see section 5.1).
Croatian: Podaci o prvolinijski liječenim bolesnicima s RCC-om u dobi od 75 ili više godina preoskudni su da bi se mogli donijeti zaključci o primjeni u toj populaciji (vidjeti dio 5.1).
English: Clinical experience with ipilimumab-associated endocrinopathy is limited.
Croatian: Kliničko iskustvo s endokrinopatijama povezanima s ipilimumabom je ograničeno.
English: Exposures in adolescents are comparable with those in adults receiving the same mg/kg dose.
Croatian: Izloženost u adolescenata bila je usporediva s onom u odraslih koji su primali istti broj mg/kg.
English: Ipilimumab is associated with inflammatory adverse reactions resulting from increased or excessive immune activity (immune-related adverse reactions), likely to be related to its mechanism of action.
Croatian: Ipilimumab je povezan s upalnim nuspojavama koje su posljedica pojačane ili pretjerane imunološke aktivnosti (imunološki uzrokovane nuspojave), koja je najvjerojatnije povezana s njegovim mehanizmom djelovanja.
English: - inflammation of the skin that can lead to severe skin reaction (known as toxic epidermal necrolysis, Stevens-Johnson syndrome and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).
Croatian: - upala kože koja može dovesti do teških kožnih reakcija (poznate kao toksična epidermalna nekroliza, Stevens-Johnsonov sindrom i reakcija na lijek sa eozinofilijom i sistemskim simptomima (DRESS)).
English: • Obligation to conduct post-authorisation measure
Croatian: • Obveza provođenja mjera nakon davanja odobrenja
English: Hepatic transaminase and bilirubin must be evaluated before each dose of ipilimumab, as early laboratory changes may be indicative of emerging immune-related hepatitis (see section 4.2).
Croatian: Jetrene transaminaze i bilirubin moraju se odrediti prije svake doze ipilimumaba, jer rane laboratorijske promjene mogu ukazivati na imunološki uzrokovan hepatitis (vidjeti dio 4.2).
English: • The importance of not attempting to self-treat any symptoms without consulting their Healthcare professional first.
Croatian: • Naglasiti da je važno da bolesnik ne pokušava sam liječiti niti jedan simptom prije nego se posavjetuje sa zdravstvenim radnikom.
English: Non-corticosteroid immunosuppressive therapy should be added if there is worsening or no improvement despite corticosteroid use.
Croatian: Imunosupresivnu terapija koja ne uključuje kortikosteroide treba uvesti ako nastupi pogoršanje ili ako ne nastupi poboljšanje unatoč primjeni kortikosteroida.
English: For patients with moderate (Grade 2) neuropathy (motor with or without sensory) likely related to ipilimumab, the scheduled dose should be withheld.
Croatian: Kod bolesnika s umjerenom (2. stupanj) neuropatijom (motoričkom sa senzoričkom ili bez nje) vjerojatno povezanom s ipilimumabom primjena planirane doze mora se odgoditi.
English: The ipilimumab-containing regimens demonstrated a statistically significant advantage over the gp100 control group in OS.
Croatian: Režimi s ipilimumabom pokazali su statistički značajno poboljšan OS u odnosu na kontrolnu skupinu koja je primala gp100.
English: Table 3B
Croatian: Tablica 3B
English: Please refer to the package leaflet of nivolumab in order to understand the use of this medicine.
Croatian: Pročitajte uputu o lijeku za nivolumab da biste shvatili za što se taj lijek koristi.
English: Median and estimated rates of OS at 1 year and 2 years are presented in Table 8.
Croatian: Medijan i procijenjene stope OS-a nakon 1 godine i 2 godine prikazani su u Tablici 8.
English: You should not be given YERVOY if you are allergic to ipilimumab or any of the other ingredients of this medicine (listed in Section 6 "Contents of the pack and other information").
Croatian: Ne smijete primiti YERVOY ako ste alergični na ipilimumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Rare cases of toxic epidermal necrolysis (TEN) (including Steven Johnson Syndrome) have been observed, some with fatal outcome.
Croatian: Zabilježeni su rijetki slučajevi toksične epidermalne nekrolize (TEN) (uključujući Stevens-Johnson-ov sindrom) od kojih neki i sa smrtnim ishodom.
English: The majority (71-73%) of patients had M1c stage disease and 37-40% of patients had an elevated lactate dehydrogenase (LDH) at baseline.
Croatian: Većina (71-73%) bolesnika imala je stadij bolesti M1c, a 37-40% bolesnika imalo je povišenu razinu laktat dehidrogenaze (LDH) na početku ispitivanja.
English: Preparing the infusion: Take care to ensure aseptic handling when you prepare the infusion.
Croatian: Priprema infuzije: Tijekom pripremanja infuzije pazite na aseptičko rukovanje lijekom.
English: Storage conditions and shelf life:
Croatian: Uvjeti čuvanja i rok valjanosti:
English: In addition, the following uncommon (may affect up to 1 in 100 people) side effects have been reported in patients who received doses other than 3mg/kg of YERVOY in clinical trials:
Croatian: Osim toga, sljedeće manje česte nuspojave (mogu se javiti u do 1 na 100 osoba) prijavljene su u bolesnika koji su primali drugačije doze od 3 mg/kg lijeka YERVOY u kliničkim ispitivanjima:
English: Rare (may affect up to 1 in 1000 people) severe and possibly fatal peeling of the skin (toxic epidermal necrolysis) loosening of membrane at the back of the eye (serous retinal detachment)
Croatian: Rijetko (mogu se javiti u do 1 na 1000 osoba) teško i moguće smrtonosno ljuštenje kože (toksična epidermalna nekroliza) gubitak membrane u stražnjem dijelu oka (serozno odljepljenje mrežnice)
English: YERVOY contains the active substance ipilimumab, a protein which helps your immune system to attack and destroy cancer cells by your immune cells.
Croatian: YERVOY sadrži djelatnu tvar ipilimumab, bjelančevinu koja pomaže stanicama Vašeg imunološkog sustava da napadnu i unište stanice raka.
English: Tris hydrochloride (2-amino-2-hydroxymethyl-1,3-propanediol hydrochloride) Sodium chloride
Croatian: Trometamin klorid (2-amino-2-hidroksimetil-1,3-propanediol klorid) Natrijev klorid
English: Patients with ocular melanoma were not included in the CA184-169 clinical trial.
Croatian: Bolesnici s melanomom oka nisu bili uključeni u kliničko ispitivanje CA184-169.
English: Use a separate infusion line for the infusion.
Croatian: Za infuziju koristite posebnu infuzijsku liniju.
English: 2.9 (0.7,NEa)
Croatian: 2,9 (0,7,NPa)
English: One female infant had unilateral renal agenesis of the left kidney and ureter, and one male infant had an imperforate urethra with associated urinary obstruction and subcutaneous scrotal edema.
Croatian: Jedna je ženka imala jednostranu agenezu lijevog bubrega i mokraćovoda, a jedan mužjak neperforiranu mokraćnu cijev te s time povezanu opstrukciju mokraće i supkutani edem skrotuma.
English: Rare proctitisd
Croatian: Rijetko proktitisd
English: For storage conditions after first opening or dilution of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja nakon prvog otvaranja ili razrjeđivanja lijeka vidjeti u dijelu 6.3.
English: Progressive signs of motor neuropathy must be considered immune-related and managed accordingly.
Croatian: Znakovi napredovanja motoričke neuropatije moraju se smatrati imunološki uzrokovanima i liječiti sukladno tome.
English: Withdraw the required volume of YERVOY concentrate using an appropriate sterile syringe.
Croatian: Izvucite potrebni volumen koncentrata lijeka YERVOY pomoću odgovarajuće sterilne štrcaljke.
English: Patients may present with muscle weakness.
Croatian: Bolesnici mogu imati znakove mišićne slabosti.
English: Other organ systemsb: (e.g. nephritis, pneumonitis, pancreatitis, non-infectious myocarditis)
Croatian: Drugi organski sustavib: (npr. nefritis, pneumonitis, pankreatitis, neinfektivni miokarditis)
English: The Kaplan-Meier OS curve revealed a plateau beginning around year 3 (OS rate = 21% [95% CI: 17-24]) that extended up to 10 years in some patients (see Figure 1).
Croatian: Kaplan-Meierova krivulja za OS postigla je plato počevši od oko 3. godine (OS stopa = 21% [95% CI: 17-24]), koji je u nekih bolesnika produžen i do 10 godina (vidjeti sliku 1).
English: Rare cases of SJS and TEN, some of them with fatal outcome, have been observed.
Croatian: Primijećeni su rijetki slučajevi SJS-a i TEN-a, od kojih neki sa smrtnim ishodom.
English: - inflammation of hormone producing glands (especially the pituitary, adrenal and thyroid glands) that may affect how these glands work.
Croatian: - upala žlijezda koje proizvode hormone (osobito hipofize, nadbubrežne i štitne žlijezde) koji mogu utjecati na rad tih žlijezda.
English: - problems with your heart such as a change in the rhythm or rate of the heartbeat or an abnormal heart rythm.
Croatian: - srčane tegobe, poput promjena ritma ili brzine otkucaja srca ili odstupanja od normalnog srčanog ritma
English: Do not use if unusual amount of particles and signs of discoloration are present.
Croatian: Nemojte ga koristiti ukoliko je prisutna veća količina čestica ili postoje znakovi promjene boje.
English: A mean increase in the percent of central memory (CCR7+ CD45RA-) CD4+ and CD8+ T cells and a smaller, but significant, mean increase in the percent of effector memory (CCR7- CD45RA-) CD8+ T cells also was observed after treatment with ipilimumab.
Croatian: Povećanje srednje vrijednosti postotka glavnih memorijskih (CCR7+ CD45RA-) CD4+ i CD8+ T stanica i manje, ali značajno, prosječno povećanje srednje vrijednosti postotka efektorskih memorijskih (CCR7- CD45RA-) CD8+ T stanica također je bilo primijećeno nakon liječenja ipilimumabom.
English: - Problems with your lungs such as breathing difficulties or cough.
Croatian: - plućne tegobe, poput otežana disanja ili kašlja.
English: NA = not assessed For adults, deaths reported in this table are within 70 days of the last dose, regardless of relationship.
Croatian: Kod odraslih smrt navedena u ovoj tablici desila se unutar 70 dana od posljednje doze i navedena je bez obzira na povezanost.
English: Severe symptoms (abdominal pain, severe diarrhoea or significant change in the number of stools, blood in stool, gastrointestinal haemorrhage, gastrointestinal perforation)
Croatian: Teški simptomi (bol u abdomenu, jaki proljev ili značajna promjena broja stolica, krv u stolici, gastrointestinalno krvarenje, gastrointestinalna perforacija)
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalaziu Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama.
English: Preparation should be performed by trained personnel in accordance with good practices rules, especially with respect to asepsis.
Croatian: Lijek treba pripremiti obučeno osoblje u skladu s pravilima dobre prakse, s osobitom pažnjom na asepsu.
English: Beginning in the third trimester, both ipilimumab groups experienced higher incidences of abortion, stillbirth, premature delivery (with corresponding lower birth weight), and infant mortality relative to control animals; these findings were dose-dependent.
Croatian: Počevši od trećeg tromjesečja, u obje skupine koje su primale ipilimumab zabilježena je veća učestalost pobačaja, mrtvookoćenih mladunaca, prijevremenih okota (uz odgovarajuće smanjenje okotne težine) i mortaliteta mladunčadi u odnosu na životinje u kontrolnoj skupini; ovi su nalazi bili ovisni o dozi.
English: Based on a population PK analysis using available pooled data from 565 patients from 4 phase 2 adult studies (N=521) and 2 paediatric studies (N=44), CL of ipilimumab increased with increasing baseline body weight.
Croatian: Prema populacijskoj farmakokinetičkoj analizi dostupnih objedinjenih podataka prikupljenih u 565 bolesnika iz 4 ispitivanja faze 2 provedenih u odraslih bolesnika (N=521) i 2 ispitivanja provedena u pedijatrijskih bolesnika (N=44), klirens ipilimumaba povećavao se s povećanjem početne tjelesne težine.
English: Your doctor will continue giving you YERVOY for a total of 4 doses, depending on your tolerance to the treatment.
Croatian: Liječnik Vam može nastaviti davati YERVOY do ukupno 4 doze, ovisno o tome koliko dobro podnosite liječenje.
English: Assessments of tumour response should be conducted only after completion of induction therapy.
Croatian: Procjenu tumorskog odgovora treba napraviti tek nakon završetka uvodne terapije.
English: Vogt-Koyanagi-Harada syndromeh
Croatian: Vogt Koyanagi Harada sindromh
English: The median age was 61 years (range: 18 to 90 years), 65% of patients were men, and 97% were white.
Croatian: Medijan dobi iznosio je 61 godinu (raspon: 18 do 90 godina), 65% bolesnika bili su muškarci, a 97% njih bijelci.
English: Median OS in the subgroup with brain metastases at baseline was 5.67 months at the recommended dose of 3 mg/kg.
Croatian: Medijan OS u podskupini s metastazama u mozgu na početku ispitivanja bio je 5,67 mjeseci u preporučenoj dozi od 3 mg/kg.
English: In clinical trials, rapid tapering (over periods < 1 month) resulted in recurrence of diarrhoea or colitis in some patients.
Croatian: U kliničkim je ispitivanjima brzo smanjenje doza (u razdoblju < 1 mjeseca) u nekih bolesnika dovelo do ponovne pojave proljeva ili kolitisa.
English: Efficacy results for the intermediate/poor risk patients are shown in Table 12.
Croatian: Rezultati za djelotvornost u bolesnika s umjerenim/visokim rizikom prikazani su u Tablici 12.
English: Use an infusion set and an in-line, sterile, non-pyrogenic, low protein binding filter (pore size of 0.2 μm to 1.2 μm).
Croatian: Upotrijebite komplet za infuziju i ugrađeni sterilni, nepirogeni filter koji slabo veže proteine (veličina pora od 0,2 μm do 1,2 μm).
English: • Brief introduction to ipilimumab (and the purpose of this risk minimisation tool).
Croatian: • Kratke uvodne informacije o ipilimumabu (namjena brošure za minimizaciju rizika).
English: Disease specific precautions
Croatian: Mjere opreza specifične za pojedine bolesti
English: ORRs were higher for the combination of nivolumab and ipilimumab relative to nivolumab monotherapy across tumour PD-L1 expression levels (Table 11) after 28 months of follow-up, with a best overall response of complete response correlating to an improved survival rate.
Croatian: ORR je nakon 28 mjeseci praćenja bio veći uz kombinaciju nivolumaba i ipilimumaba nego uz monoterapiju nivolumabom kod svih razina tumorske ekspresije PD-L1 (Tablica 11), a najbolji ukupni odgovor bio je potpuni odgovor u korelaciji s poboljšanom stopom preživljenja.
English: The Kaplan-Meier curves for OS (with a minimum follow-up of 24 months) in intermediate/poor risk patients are shown in Figure 7.
Croatian: Kaplan-Meierove krivulje za OS (uz minimalno praćenje od 24 mjeseca) u bolesnika s umjerenim/visokim rizikom prikazane su na Slici 7.
English: Cmax, Cmin and AUC of ipilimumab were found to be dose proportional within the dose range examined.
Croatian: Pronašlo se da su Cmax, Cmin i AUC ipilimumaba proporcionalne dozi u ispitivanom rasponu doza.
English: Treatment beyond initial investigator-assessed RECIST, version 1.1-defined progression was permitted if the patient had a clinical benefit and was tolerating study drug as determined by the investigator.
Croatian: Liječenje nakon početne progresije koju je utvrdio ispitivač prema verziji 1.1 RECIST kriterija bilo je dopušteno ako je bolesnik ostvarivao kliničku korist i ako je dobro podnosio ispitivani lijek, prema ocjeni ispitivača.
English: Ipilimumab is a T-cell potentiator that enables the immune response (see section 5.1) and may interfere with immunosuppressive therapy, resulting in an exacerbation of the underlying disease or increased risk of graft rejection.
Croatian: Ipilimumab je pojačivač aktivnosti T-stanica koji omogućuje imunološki odgovor (vidjeti dio 5.1) i može ometati imunosupresivnu terapiju te tako dovesti do pogoršanja osnovne bolesti ili povećanja rizika odbacivanja presatka.
English: The Marketing Authorisation Holder shall agree the format and content of the above material with the National Competent Authority prior to launch in the Member State.
Croatian: Nositelj odobrenja će prije stavljanja lijeka na tržište u pojedinoj državi članici usuglasiti oblik i sadržaj navedenih materijala s nacionalnim nadležnim tijelom.
English: No other endocrine abnormalities were reported.
Croatian: Nisu prijavljeni drugi endokrini poremećaji.
English: Use of ipilimumab in combination with nivolumab in melanoma patients with rapidly progressing disease.
Croatian: Primjena ipilimumaba u kombinaciji s nivolumabom u bolesnika s melanomom u kojih bolest brzo progredira.
English: The safety of re-initiating ipilimumab in combination with nivolumab therapy in patients previously experiencing immune-related myocarditis is not known.
Croatian: Sigurnost ponovnog uvođenja ipilimumba u kombinaciji s nivolumabom u bolesnika koji su prethodno imali imunološki uzrokovan miokarditis nije poznata.