FrancophonIA/ELRC3.0 huggingface dataset:
English: What Nivolumab BMS is and what it is used for What you need to know before you use Nivolumab BMS
Croatian: Što morate znati prije nego počnete primati Nivolumab BMS
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 infuzijski komplet te sterilan i nepirogen in-line filtar male sposobnosti vezanja proteina (veličina pora od 0,2 μm do 1,2 μm).
English: th
Croatian: Za
English: • That Nivolumab BMS treatment may increase the risk of:
Croatian: Koncentrat lijeka Nivolumab BMS može se razrijediti:
English: In addition, symptom improvement and overall health status were assessed using the Lung Cancer Symptom Score (LCSS) average symptom burden index and the EQ-5D Visual Analogue Scale (EQ-VAS), respectively.
Croatian: Osim toga, ocjenjivali su se i poboljšanje simptoma te cjelokupan zdravstveni status na temelju indeksa prosječnog opterećenja simptomima iz Upitnika za ocjenjivanje težine simptoma kod raka pluća (engl.
English: Median time to onset was 5.6 weeks (range: 0.1-91.0).
Croatian: Medijan vremena do nastupa iznosio je 5,6 tjedana (raspon: 0,1-91,0).
English: No clinically important differences in the CL of nivolumab were found between patients with mild or moderate renal impairment and patients with normal renal function.
Croatian: Nisu primijećene klinički značajne razlike u klirensu nivolumaba između bolesnika s blagim ili umjerenim oštećenjem bubrežne funkcije i onih s normalnom bubrežnom funkcijom.
English: No Grade 4 or 5 cases were reported in these studies.
Croatian: U tim ispitivanjima nije bio prijavljen nijedan slučaj 4. ili 5. stupnja.
English: There was no worsening to Grade 3 or 4 in increased ALT, increased alkaline phosphatase, and increased creatinine.
Croatian: Povišene razine ALT-a, povišene razine alkalne fosfataze i povišene razine
English: NAME OF THE MEDICINAL PRODUCT Nivolumab BMS 10 mg/mL concentrate for solution for infusion.
Croatian: NAZIV LIJEKA Nivolumab BMS 10 mg/ml koncentrat za otopinu za infuziju.
English: Withhold Nivolumab BMS until laboratory values return to baseline and management with corticosteroids, if needed, is complete
Croatian: Odgoditi primjenu lijeka Nivolumab BMS dok se laboratorijske vrijednosti ne vrate na početne i dok se ne završi liječenje kortikosteroidima, ako je ono potrebno
English: The total dose of Nivolumab BMS required can be infused directly as a 10 mg/mL solution or can be diluted to as low as 1 mg/mL with sodium chloride 9 mg/mL (0.9%) solution for injection or glucose 50 mg/mL (5%) solution for injection.
Croatian: Ukupna potrebna doza lijeka Nivolumab BMS može se infundirati izravno kao otopina koncentracije 10 mg/ml ili se može razrijediti do vrlo niske koncentracije od čak 1 mg/ml otopinom natrijeva klorida za injekciju od 9 mg/ml (0,9%) ili otopinom glukoze za injekciju od 50 mg/ml (5%).
English: Severe rash has been observed with nivolumab treatment that may be immune-related (see section 4.8).
Croatian: Kod liječenja nivolumabom primijećen je težak osip koji bi mogao biti imunološki uzrokovan (vidjeti dio 4.8).
English: Diarrhoea (watery, loose or soft stools) or any symptoms of inflammation of the intestines (colitis), such as stomach pain and mucus or blood in stool.
Croatian: To mogu biti znakovi upale pluća (pneumonitisa ili intersticijske bolesti pluća). proljev (vodenaste, rijetke ili meke stolice) ili bilo koje simptome upale crijeva (kolitis), poput bolova u trbuhu te sluzi ili krvi u stolici. upalu jetre (hepatitis).
English: Infectious and disease-related aetiologies should be ruled out.
Croatian: Potrebno je isključiti infektivnu etiologiju i onu povezanu s bolešću.
English: What Nivolumab BMS looks like and contents of the pack Nivolumab BMS concentrate for solution for infusion (sterile concentrate) is a clear to opalescent, colourless to pale yellow liquid that may contain few light particles.
Croatian: Nivolumab BMS koncentrat za otopinu za infuziju (sterilni koncentrat) je bistra do opalescentna, bezbojna do blijedožuta tekućina koja može sadržavati malu količinu sitnih čestica.
English: In CA209017 and CA209063, the incidence of pneumonitis, including interstitial lung disease, was 5.2% (13/248).
Croatian: U ispitivanjima CA209017 i CA209063, incidencija pneumonitisa, uključujući intersticijsku bolest pluća, iznosila je 5,2% (13/248).
English: Withhold dose until symptoms resolve and management with corticosteroids is complete
Croatian: Odgoditi primjenu doze dok se simptomi ne povuku i dok se ne završi liječenje kortikosteroidima
English: Nivolumab BMS concentrate is a clear to opalescent, colourless to pale yellow liquid that may contain few light particles.
Croatian: Koncentrat lijeka Nivolumab BMS je bistra do opalescentna, bezbojna do blijedožuta tekućina koja može sadržavati malu količinu sitnih čestica.
English: Persistent elevations in these laboratory values should be managed with corticosteroids at a dose of 0.5 to 1 mg/kg/day methylprednisolone equivalents.
Croatian: Ako povišenja tih laboratorijskih vrijednosti potraju, treba ih zbrinuti kortikosteroidima u dozi ekvivalentnoj 0,5 do 1 mg/kg/dan metilprednizolona.
English: For symptomatic adrenal insufficiency, nivolumab should be withheld, and physiologic corticosteroid replacement should be initiated as needed.
Croatian: U slučaju simptomatske insuficijencije nadbubrežne žlijezde, potrebno je odgoditi primjenu nivolumaba i po potrebi uvesti fiziološku nadomjesnu terapiju kortikosteroidima.
English: Excipient with known effect Each mL of concentrate contains 0.1 mmol (or 2.5 mg) sodium.
Croatian: Jedan ml koncentrata sadrži 0,1 mmol (ili 2,5 mg) natrija.
English: Grade 2 cases were reported in 0.4% (1/248) of patients.
Croatian: Slučajevi 2. stupnja prijavljeni su u 0,4% (1/248) bolesnika.
English: Withhold Nivolumab BMS until symptoms resolve and management with corticosteroids, if needed, is complete
Croatian: Odgoditi primjenu lijeka Nivolumab BMS dok se simptomi ne povuku i dok se ne dovrši liječenje kortikosteroidima, ako je ono potrebno
English: Talk to your doctor before using Nivolumab BMS as it may cause:
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije nego primite lijek Nivolumab BMS:
English: In CA209017 and CA209063, the incidence of thyroid disorders, including hypothyroidism or thyroiditis, was 4.4% (11/248).
Croatian: U ispitivanjima CA209017 i CA209063, incidencija poremećaja štitnjače, uključujući hipotireozu ili tireoiditis, iznosila je 4,4% (11/248).
English: Common increased total bilirubin,b decreased absolute neutrophil count,b hypermagnesaemia,b, hypernatraemiab
Croatian: Često povišene razine ukupnog bilirubina b, smanjen apsolutni broj neutrofila b,
English: Permanently discontinue Nivolumab BMS
Croatian: Trajno prekinuti primjenu lijeka Nivolumab BMS
English: The infusion must be administered through a sterile, non-pyrogenic, low protein binding in-line filter with a pore size of 0.2-1.2 µm.
Croatian: Infuzija se mora primijeniti kroz sterilan i nepirogen in-line filtar male sposobnosti vezanja proteina koji ima pore veličine od 0,2-1,2 µm.
English: Severe nephritis or renal dysfunction has been observed with nivolumab treatment (see section 4.8).
Croatian: Kod liječenja nivolumabom primijećeni su težak nefritis ili disfunkcija bubrega (vidjeti dio 4.8).
English: In CA209017 and CA209063, the incidence of hypersensitivity/infusion reactions was 1.6% (4/248).
Croatian: U ispitivanjima CA209017 i CA209063, incidencija reakcija preosjetljivosti/reakcija na infuziju iznosila je 1,6% (4/248).
English: One patient required permanent discontinuation of nivolumab due to Grade 3 diarrhoea.
Croatian: U jednog se bolesnika liječenje nivolumabom moralo trajno prekinuti zbog proljeva 3. stupnja.
English: For symptomatic hyperthyroidism, nivolumab should be withheld and methimazole should be initiated as needed.
Croatian: U slučaju simptomatske hipertireoze, potrebno je odgoditi primjenu nivolumaba i po potrebi uvesti metimazol.
English: Two patients, including the one patient with a Grade 3 case (tubulointerstitial nephritis), received high-dose corticosteroids (at least 40 mg prednisone equivalents) at a median initial dose of 0.8 mg/kg (range: 0.5-1.2) for a median duration of 5.3 weeks (range: 0.9-9.7).
Croatian: Dva bolesnika, uključujući jednog bolesnika sa slučajem 3. stupnja (tubulointersticijski nefritis), primala su visoke doze kortikosteroida (najmanje 40 mg ekvivalenata prednizona), uz medijan početne doze od 0,8 mg/kg (raspon: 0,5-1,2), tijekom medijana od 5,3 tjedna (raspon: 0,9-9,7).
English: Severe rash should be managed with high-dose corticosteroid at a dose of 1 to 2 mg/kg/day prednisone equivalents.
Croatian: Težak osip treba zbrinuti visokim dozama kortikosteroida ekvivalentnim 1 do 2 mg/kg/dan prednizona.
English: Resolution occurred in 2 patients (67%) with a median time to resolution of 4.1 weeks (range: 2.9-22.3+); + denotes a censored observation.
Croatian: Nuspojave su se povukle u 2 bolesnika (67%), a medijan vremena do njihova povlačenja iznosio je 4,1 tjedan (raspon: 2,9-22,3+); + označava
English: Withhold Nivolumab BMS until creatinine returns to baseline and management with corticosteroids is complete
Croatian: Odgoditi primjenu lijeka Nivolumab BMS dok se razina kreatinina ne vrati na početnu vrijednost i dok se ne završi liječenje kortikosteroidima
English: Non-corticosteroid immunosuppressive therapy should be added if there is worsening or no improvement despite corticosteroid use.
Croatian: Ako unatoč primjeni kortikosteroida nastupi pogoršanje ili izostane poboljšanje, potrebno je uvesti i imunosupresivnu terapiju koja ne uključuje kortikosteroide.
English: Depending on your dose, the appropriate amount of Nivolumab BMS will be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection or glucose 50 mg/mL (5%) solution for injection before use.
Croatian: Ovisno o Vašoj dozi, odgovarajuća količina lijeka Nivolumab BMS će se prije primjene razrijediti otopinom natrijeva klorida za injekciju od 9 mg/ml (0,9%) ili otopinom glukoze za injekciju od 50 mg/ml (5%).
English: Eleven patients received high-dose corticosteroids (at least 40 mg prednisone equivalents) at a median initial dose of 1.1 mg/kg (range: 0.5-4.0) for a median total duration of 4.3 weeks (range: 0.6-13.1).
Croatian: Jedanaest je bolesnika primalo visoke doze kortikosteroida (najmanje 40 mg ekvivalenata prednizona), uz medijan početne doze od 1,1 mg/kg (raspon: 0,5-4,0), tijekom medijana od ukupno 4,3 tjedna (raspon: 0,6-13,1).
English: For Grade 2 (symptomatic) pneumonitis, nivolumab should be withheld and corticosteroids initiated at a dose of 1 mg/kg/day methylprednisolone equivalents.
Croatian: U slučaju (simptomatskog) pneumonitisa 2. stupnja, potrebno je odgoditi primjenu nivolumaba i uvesti liječenje kortikosteroidima u dozi ekvivalentnoj 1 mg/kg/dan metilprednizolona.
English: If worsening or no improvement occurs despite initiation of corticosteroids, corticosteroid dose should be increased to 1 to 2 mg/kg/day methylprednisolone equivalents, and nivolumab must be permanently discontinued.
Croatian: Ako unatoč uvođenju kortikosteroida nastupi pogoršanje ili izostane poboljšanje, dozu kortikosteroida treba povećati na 1 do 2 mg/kg/dan ekvivalenata metilprednizolona, a liječenje nivolumabom mora se trajno prekinuti.
English: Gently mix the infusion by manual
Croatian: Nježno promiješajte infuziju
English: Immune-related nephritis or renal dysfunction present with asymptomatic increases in serum creatinine.
Croatian: U većine bolesnika prisutno je asimptomatsko povećanje razine kreatinina u serumu.
English: Special populations
Croatian: Posebne populacije Pedijatrijska populacija
English: Nivolumab BMS infusion
Croatian: Nivolumab BMS
English: Data from patients with severe renal impairment are too limited to draw conclusions on this population.
Croatian: Podaci o bolesnicima s teškim oštećenjem bubrežne funkcije su preoskudni da bi se mogli donijeti zaključci o primjeni u toj
English: Treatment should be continued as long as clinical benefit is observed or until treatment is no longer tolerated by the patient.
Croatian: Liječenje treba nastaviti sve dok ima kliničke koristi ili do trenutka kada
English: Body weight normalised dosing produced approximately uniform steady-state trough concentration over a wide range of body weights (34-162 kg).
Croatian: Doziranje normalizirano za tjelesnu težinu dovelo je do približno jednake najniže koncentracije u stanju dinamičke ravnoteže u širokom
English: Diabetes (symptoms include excessive thirst, the passing of a greatly increased amount of urine, increase in appetite with a loss of weight, feeling tired, drowsy, weak, depressed, irritable and generally unwell) or diabetic ketoacidosis (acid in the blood produced from diabetes).
Croatian: Znakovi i simptomi koji pokazuju da te žlijezde ne rade pravilno mogu uključivati izrazit umor, promjenu tjelesne težine ili glavobolju te smetnje vida. šećernu bolest (simptomi uključuju prekomjernu žeđ, mokrenje uvelike povećane količine mokraće, pojačan tek praćen gubitkom tjelesne težine, umor, omamljenost, slabost, depresiju, razdražljivost i opće loše osjećanje) ili dijabetičku ketoacidozu (kiselinu u krvi koja nastaje kao posljedica šećerne bolesti). upalu kože, koja može uzrokovati osip i svrbež.
English: More than one vial of Nivolumab BMS concentrate may be needed to give the total dose for the patient.
Croatian: Može biti potrebno više od jedne bočice koncentrata lijeka
English: Uncommon (may affect up to 1 in 100 people) Bronchitis, infections of the upper respiratory tract A disease causing the inflammation or enlargement of a lymph node (Kikuchi lymphadenitis) Allergic reaction, reactions related to the administration of the medicine Adrenal glands not working properly, inflammation of the thyroid gland A condition in which the muscles become weak and tire easily (myasthenic syndrome), damage to the nerves in different parts of the body that can cause decreased feeling or affect movement
Croatian: Česte (mogu se javiti u do 1 na 10 osoba) smanjena aktivnost štitnjače, što može izazvati umor ili povećanje tjelesne težine upala živaca koja uzrokuje utrnulost, slabost, trnce ili žareću bol u rukama i nogama, glavobolja, omaglica upala pluća (pneumonitis), koju karakteriziraju kašalj i otežano disanje, nedostatak zraka (dispneja), kašalj proljev (vodenasta, rijetka ili meka stolica), vrijedovi i afte u ustima (stomatitis), povraćanje, bol u trbuhu, zatvor, suha usta kožni osip, svrbež bol u mišićima, kostima i zglobovima vrućica, edem (oticanje)
English: More than one vial of Nivolumab BMS may be necessary to obtain the required dose.
Croatian: Da bi se dobila potrebna doza, možda će biti potrebno više od jedne bočice lijeka
English: In CA209017 and CA209063, the incidence of rash was 12.1% (30/248).
Croatian: U ispitivanjima CA209017 i CA209063, incidencija osipa iznosila je 12,1% (30/248).
English: In CA209017 and CA209063, the incidence of nephritis or renal dysfunction was 3.2% (8/248).
Croatian: U ispitivanjima CA209017 i CA209063, incidencija nefritisa ili bubrežne disfunkcije iznosila je 3,2% (8/248).
English: Nausea
Croatian: Težina
English: Three patients, including 2 patients with a Grade 3 case, received high-dose corticosteroids (at least 40 mg prednisone equivalents) at a median initial dose of 0.6 mg/kg (range: 0.4-1.3) for a median duration of 2.0 weeks (range: 1.4-14.1).
Croatian: Tri su bolesnika, uključujući 2 bolesnika sa slučajem 3. stupnja, primala visoke doze kortikosteroida (najmanje 40 mg ekvivalenata prednizona), uz medijan početne doze od 0,6 mg/kg (raspon: 0,4-1,3), tijekom medijana od 2,0 tjedna (raspon: 1,4-14,1).
English: For Grade 2 or 3 serum creatinine elevation, nivolumab should be withheld, and corticosteroids should be initiated at a dose of 0.5 to 1 mg/kg/day methylprednisolone equivalents.
Croatian: U slučaju povišenja razine kreatinina 2. ili 3. stupnja, potrebno je odgoditi primjenu nivolumaba i uvesti liječenje kortikosteroidima u dozi ekvivalentnoj 0,5 do 1 mg/kg/dan metilprednizolona.
English: Resolution occurred in 6 patients (50%) with a median time to resolution of 20.6 weeks (0.4-47.6+); +
Croatian: Nuspojave su se povukle u 6 bolesnika (50%), a medijan vremena do njihova povlačenja iznosio je 20,6 tjedana (raspon: 0,4-47,6+);+ označava cenzurirano opažanje.
English: After administration of the nivolumab dose, flush the line with sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose solution for injection.
Croatian: Nakon primjene doze nivolumaba, isperite liniju otopinom natrijeva klorida za injekciju od 9 mg/ml (0,9%) ili otopinom glukoze za injekciju od 50 mg/ml (5%).
English: For symptomatic hypophysitis, nivolumab should be withheld, and hormone replacement should be initiated as needed.
Croatian: U slučaju simptomatskog hipofizitisa, potrebno je odgoditi primjenu nivolumaba i po potrebi uvesti hormonsku nadomjesnu terapiju.
English: In CA209017 and CA209063, the incidence of liver function test abnormalities was 1.2% (3/248).
Croatian: U ispitivanjima CA209017 i CA209063, incidencija odstupanja u nalazima testova jetrene funkcije iznosila je 1,2% (3/248).
English: PVC infusion sets In-line filters with polyethersulfone membranes with pore sizes of 0.2 µm to 1.2 µm.
Croatian: Infuzija lijeka Nivolumab BMS kompatibilna je sa: spremnicima od PVC-a poliolefinskim spremnicima staklenim bocama infuzijskim kompletima od PVC-a in-line filtrima koji imaju polietersulfonske membrane s veličinom pora od 0,2 µm do 1,2 µm
English: Three patients, including the one patient with Grade 3 adrenal insufficiency, received high-dose corticosteroids (at least 40 mg prednisone equivalents) at a median initial dose of 1.1 mg/kg (range: 0.5-1.3) for 2.7 weeks (range: 0.6-4.6).
Croatian: Tri bolesnika, uključujući jednog bolesnika s insuficijencijom nadbubrežne žlijezde 3. stupnja, primala su visoke doze kortikosteroida (najmanje 40 mg ekvivalenata prednizona), uz medijan početne doze od 1,1 mg/kg (raspon: 0,5-1,3), tijekom 2,7 tjedana (raspon: 0,6-4,6).
English: To further investigate the associative analyses between PDL-1 and PDL-2 expression conducted in Study CA209-066.
Croatian: Dodatno istražiti odnos između ekspresije PDL1 i PD-L2 u fazi 1
English: Persistent diarrhoea or colitis should be managed with corticosteroids at a dose of 0.5 to 1 mg/kg/day methylprednisolone equivalents.
Croatian: Ako proljev ili kolitis potraju, treba ih zbrinuti kortikosteroidima u dozi ekvivalentnoj 0,5 do 1 mg/kg/dan metilprednizolona.
English: Problems with your lungs such as breathing difficulties or cough.
Croatian: Obratite se svom liječniku prije nego primite Nivolumab BMS jer on može uzrokovati: plućne tegobe, poput otežana disanja ili kašlja.
English: Summary of the safety profile
Croatian: Tablični prikaz nuspojava
English: For Grade 3 or 4 transaminase or total bilirubin elevation, nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Croatian: U slučaju povišenja razine transaminaza ili ukupnog bilirubina 3. ili 4. stupnja, liječenje nivolumabom mora se trajno prekinuti i treba uvesti liječenje kortikosteroidima u dozi ekvivalentnoj 1 do 2 mg/kg/dan metilprednizolona.
English: Inspect the Nivolumab BMS concentrate for particulate matter or discoloration.
Croatian: Provjerite sadrži li koncentrat lijeka Nivolumab BMS čestice i je li promijenio boju.
English: If worsening or no improvement occurs despite initiation of corticosteroids, nivolumab must be permanently discontinued.
Croatian: Ako unatoč uvođenju kortikosteroida nastupi pogoršanje ili izostane poboljšanje,
English: Grade 2 and Grade 3 cases were reported in 2.8% (7/248) and 1.6% (4/248) of patients, respectively.
Croatian: Slučajevi 2. stupnja prijavljeni su u 2,8% (7/248) bolesnika, a slučajevi 3. stupnja u 1,6% (4/248) bolesnika.
English: Tell your doctor if you are on a low-sodium (low-salt) diet before you are given Nivolumab BMS.
Croatian: Prije nego primite lijek Nivolumab BMS, obavijestite svog liječnika ako ste na dijeti s niskim unosom natrija (soli).
English: In CA209017 and CA209063, the incidence of diarrhoea or colitis was 9.3% (23/248).
Croatian: U ispitivanjima CA209017 i CA209063, incidencija proljeva ili kolitisa iznosila je 9,3% (23/248).
English: For Grade 3 or 4 pneumonitis, nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 2 to 4 mg/kg/day methylprednisolone equivalents.
Croatian: U slučaju pneumonitisa 3. ili 4. stupnja, liječenje nivolumabom mora se trajno prekinuti i treba uvesti liječenje kortikosteroidima u dozi ekvivalentnoj 2 do 4 mg/kg/dan metilprednizolona.
English: For symptomatic diabetes, nivolumab should be withheld, and insulin replacement should be initiated as needed.
Croatian: U slučaju simptomatskog dijabetesa, potrebno je odgoditi primjenu nivolumaba i po potrebi uvesti inzulinsku nadomjesnu terapiju.
English: For Grade 4 serum creatinine elevation, nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Croatian: U slučaju povišenja razine kreatinina 4. stupnja, liječenje nivolumabom mora se trajno prekinuti i treba uvesti liječenje kortikosteroidima u dozi ekvivalentnoj 1 do 2 mg/kg/dan metilprednizolona.
English: Grade 2 and Grade 3 cases were reported in 1.6% (4/248) and 0.8% (2/248) of patients, respectively.
Croatian: Slučajevi 2. stupnja prijavljeni su u 1,6% (4/248) bolesnika, a slučajevi 3. stupnja u 0,8% (2/248) bolesnika.
English: Inflammation of the intestines (colitis), ulcer of the small intestines Inflammation of muscles causing pain or stiffness
Croatian: bolest kod koje mišići oslabe i brzo se umaraju (mijastenički sindrom), oštećenje živaca u različitim dijelovima tijela koje može oslabiti osjet ili utjecati na kretnje
English: Grade 2 and Grade 3 cases were reported in 1.2% (3/248) and 0.4% (1/248) of patients, respectively.
Croatian: Slučajevi 2. stupnja prijavljeni su u 1,2% (3/248) bolesnika, a slučajevi 3. stupnja u 0,4% (1/248) bolesnika.
English: For symptomatic hypothyroidism, nivolumab should be withheld, and thyroid hormone replacement should be initiated as needed.
Croatian: U slučaju simptomatske hipotireoze, potrebno je odgoditi primjenu nivolumaba i po potrebi uvesti nadomjesnu terapiju hormonima štitnjače.
English: Severe diarrhoea or colitis has been observed with nivolumab treatment (see section 4.8).
Croatian: Kod liječenja nivolumabom primijećeni su težak proljev ili kolitis (vidjeti dio 4.8).
English: Grade 2 and Grade 3 cases were reported in 2% (5/248) and 1.6% (4/248) of patients, respectively.
Croatian: Slučajevi 2. stupnja prijavljeni su u 2% (5/248) bolesnika, a slučajevi 3. stupnja su u 1,6% (4/248) bolesnika.
English: If worsening or no improvement occurs despite initiation of corticosteroids, corticosteroid dose should be increased to 2 to 4 mg/kg/day methylprednisolone equivalents and nivolumab must be permanently discontinued.
Croatian: Ako unatoč uvođenju kortikosteroida nastupi pogoršanje ili izostane poboljšanje, dozu kortikosteroida treba povećati na 2 do 4 mg/kg/dan ekvivalenata metilprednizolona, a liječenje
English: The following information is intended for healthcare professionals only:
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim djelatnicima: Priprema i primjena lijeka Nivolumab BMS
English: BRISTOL-MYERS SQUIBB S.R.L.
Croatian: Bristol-Myers Squibb B.V.
English: Fertility studies have not been performed with nivolumab.
Croatian: Nisu provedena ispitivanja učinka nivolumaba na plodnost.
English: For Grade 2 diarrhoea or colitis, nivolumab should be withheld.
Croatian: U slučaju proljeva ili kolitisa 2. stupnja, potrebno je odgoditi primjenu nivolumaba.
English: Immune-related adverse reaction
Croatian: Imunološki uzrokovana nuspojava