FrancophonIA/ELRC3.0 huggingface dataset:
English: Excipients: sodium citrate dihydrate, sodium chloride, mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid, water for injections.
Slovenian: Pomožne snovi: natrijev citrat dihidrat, natrijev klorid, manitol (E421), pentetska kislina,
English: If you become pregnant while using Nivolumab BMS tell your doctor.
Slovenian: Če med zdravljenjem z zdravilom Nivolumab BMS zanosite, o tem obvestite zdravnika.
English: Nivolumab is a human monoclonal antibody, as such pharmacokinetic interaction studies have not been conducted.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Nivolumab je humano monoklonsko protitelo, zato študij farmakokinetičnih interakcij niso izvedli.
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.
Slovenian: Zdravilo je treba infundirati preko sterilnega, nepirogenega linijskega filtra, ki minimalno veže proteine, z velikostjo por od 0,2 do 1,2 μm.
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.
Slovenian: Pri bolnikih z blago ali zmerno okvaro ledvic niso ugotovili pomembnejših razlik v očistku nivolumaba v primerjavi z bolniki z normalnim delovanjem ledvic.
English: Nivolumab BMS infusion must not be administered as an intravenous push or bolus injection.
Slovenian: Nivolumab BMS raztopine za infundiranje ne smete aplicirati v obliki hitre intravenske ali bolusne injekcije.
English: The MAH shall ensure that in each Member State where Nivolumab BMS is marketed, all healthcare professionals and patients/carers who are expected to prescribe and use Nivolumab BMS have access to/are provided with the following educational package:
Slovenian: Nivolumab BMS, in bolniki/osebe, ki zanje skrbijo, ki bodo zdravilo uporabljali, imeli dostop/bodo
English: Median time to onset was 5.6 weeks (range: 0.1-91.0).
Slovenian: Mediani čas do pojava je znašal 5,6 tednov (razpon: 0,1-91,0).
English: More than one vial of Nivolumab BMS concentrate may be needed to give the total dose for the patient.
Slovenian: Za aplikacijo celotnega odmerka boste morda potrebovali več kot eno vialo s koncentratom zdravila Nivolumab BMS.
English: PVC infusion sets In-line filters with polyethersulfone membranes with pore sizes of 0.2 µm to 1.2 µm.
Slovenian: z linijskimi filtri z membranami iz polietersulfona z velikostjo por od 0,2 µm do 1,2 µm.
English: Inspect the Nivolumab BMS concentrate for particulate matter or discoloration.
Slovenian: Koncentrat zdravila Nivolumab BMS preglejte glede prisotnosti trdnih delcev ali spremembe barve.
English: One patient required permanent discontinuation of nivolumab due to Grade 3 diarrhoea.
Slovenian: Pri enem bolniku je bilo zaradi driske stopnje 3 zdravljenje z nivolumabom treba trajno ukiniti.
English: 6.6 Special precautions for disposal and other handling Preparation should be performed by trained personnel in accordance with good practices rules, especially with respect to asepsis.
Slovenian: Priprava in aplikacija zdravila Nivolumab BMS Zdravilo mora pripraviti ustrezno usposobljena oseba v skladu s pravili dobre prakse, še posebej glede
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.
Slovenian: (67 %), mediani čas do izboljšanja pa je znašal 4,1 tedna (razpon: 2,9-22,3+); + označuje krnjene
English: No clinically important differences in the CL of nivolumab were found between patients with mild hepatic impairment and normal hepatic function.
Slovenian: Pri bolnikih z blago okvaro jeter niso ugotovili pomembnejših razlik v očistku nivolumaba v primerjavi z bolniki z normalnim delovanjem jeter.
English: PHARMACEUTICAL PARTICULARS
Slovenian: Zdravljenje z zdravilom
English: Nivolumab BMS infusion is compatible with PVC and polyolefin containers, glass bottles, PVC infusion sets and in-line filters with polyethersulfone membranes with pore sizes of 0.2 µm to 1.2 µm.
Slovenian: steklenicami, infuzijskimi sistemi iz PVC-ja in linijskimi filtri z membranami iz polietersulfona z velikostjo por od 0,2 µm do 1,2 µm.
English: Nivolumab showed numerically less effect on OS (HR 1.85; 95% CI: 0.76, 4.51), PFS (HR=1.76; 95%-CI: 0.77, 4.05 ) and ORR (9.1% vs 16.7%).
Slovenian: Nivolumab je bil numerično manj učinkovit pri celokupnem preživetju (razmerje ogroženosti 1,85; 95 % interval zaupanja: 0,76; 4,51), preživetju brez napredovanja bolezni (razmerje ogroženosti=1,76; 95 % interval zaupanja: 0,77; 4,05) in deležu objektivnega odziva (9,1 % v primerjavi s 16,7 %).
English: Feeling tired or weak
Slovenian: zmanjšanje apetita siljenje na bruhanje občutek utrujenosti ali šibkosti
English: Efficacy results (CA209017)
Slovenian: Preglednica 3: Rezultati učinkovitosti (študija CA209017) nivolumab
English: Grade 2 cases were reported in 0.4% (1/248) of patients.
Slovenian: O primerih stopnje 2 so poročali pri 0,4 % (1/248) bolnikov.
English: The effects of nivolumab on prenatal and postnatal development were evaluated in monkeys that received nivolumab twice weekly from the onset of organogenesis in the first trimester through delivery, at exposure levels either 8 or 35 times higher than those observed at the clinical dose of 3 mg/kg of nivolumab (based on AUC).
Slovenian: Vpliv nivolumaba na prenatalni in postnatalni razvoj so raziskovali pri opicah, ki so prejemale nivolumab dvakrat na teden od začetka organogeneze v prvem trimesečju do kotitve.
English: One vial of 10 mL contains 100 mg of nivolumab.
Slovenian: Ena viala z 10 ml vsebuje 100 mg nivolumaba.
English: Each mL of concentrate for solution for infusion contains 10 mg of nivolumab.
Slovenian: En mililiter koncentrata za raztopino za infundiranje vsebuje 10 mg nivolumaba.
English: If you miss an appointment, ask your doctor when to schedule your next dose.
Slovenian: Če ob dogovorjenem terminu niste uspeli priti, se o prejemu naslednjega odmerka zdravila posvetujte z
English: One vial of 4 mL contains 40 mg of nivolumab.
Slovenian: Ena viala s 4 ml vsebuje 40 mg nivolumaba.
English: In CA209017 and CA209063, the incidence of pneumonitis, including interstitial lung disease, was 5.2% (13/248).
Slovenian: V študijah CA209017 in CA209063 je pojavnost pnevmonitisa, vključno z boleznijo pljučnega intersticija, znašala 5,2 % (13/248).
English: • Contact details of the Nivolumab BMS prescriber
Slovenian: • Kontaktne podatke zdravnika, ki je predpisal zdravljenje z zdravilom Nivolumab BMS.
English: Withhold Nivolumab BMS until creatinine returns to baseline and management with corticosteroids is complete
Slovenian: Aplikacijo zdravila Nivolumab BMS zadržite dokler se vrednost kreatinina ne povrne do izhodiščne vrednosti in zdravljenje s kortikosteroidi ni končano.
English: No Grade 4 or 5 cases were reported in these studies.
Slovenian: O primerih stopnje 4 ali 5 v teh študijah niso poročali.
English: For symptomatic adrenal insufficiency, nivolumab should be withheld, and physiologic corticosteroid replacement should be initiated as needed.
Slovenian: V primeru simptomatske insuficience nadledvičnih žlez je treba zdravljenje z nivolumabom zadržati in po potrebi uvesti zdravljenje s fiziološkim nadomeščanjem kortikosteroidov.
English: Docetaxel
Slovenian: docetaksel
English: Common diarrhoea, stomatitis, vomiting, abdominal pain, constipation, dry mouth
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora driska, stomatitis, bruhanje, bolečina v trebuhu, zaprtost, suha usta
English: Excipient with known effect Each mL of concentrate contains 0.1 mmol (or 2.5 mg) sodium.
Slovenian: En ml koncentrata vsebuje 0,1 mmol (ali 2,5 mg) natrija.
English: Your doctor may give you other medicines in order to prevent complications and reduce your symptoms,
Slovenian: predpiše uporabo drugih zdravil, da prepreči zaplete in ublaži simptome, zadrži naslednji odmerek zdravila Nivolumab BMS,
English: Nivolumab BMS infusion should not be infused at the same time in the same intravenous line with other agents.
Slovenian: Nivolumab BMS raztopine za infundiranje ne smete infundirati sočasno z drugimi zdravili preko iste intravenske linije.
English: Bristol-Myers Squibb spol.
Slovenian: Slovenija Bristol-Myers Squibb spol.
English: Bristol-Myers Squibb Farmacêutica Portuguesa, S.A.
Slovenian: Portugal Bristol-Myers Squibb Farmacêutica Portuguesa,
English: The infusion should be prepared in a laminar flow hood or safety cabinet using standard precautions for the safe handling of intravenous agents.
Slovenian: Pri pripravi morate upoštevati običajne previdnostne ukrepe za varno rokovanje z učinkovinami za intravensko
English: No Grade 4 or 5 cases reported in these studies.
Slovenian: primerih stopnje 4 ali 5 v teh študijah niso poročali.
English: Clear to opalescent, colourless to pale yellow liquid that may contain few light particles.
Slovenian: brezbarvna do svetlorumena tekočina, ki lahko vsebuje manjše število neznatnih delcev.
English: NAME OF THE MEDICINAL PRODUCT Nivolumab BMS 10 mg/mL concentrate for solution for infusion nivolumab
Slovenian: IME ZDRAVILA Nivolumab BMS 10 mg/ml koncentrat za raztopino za infundiranje
English: 6.4 Special precautions for storage
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
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
Slovenian: alergijska reakcija, reakcije, povezane z dajanjem zdravila nepravilno delovanje nadledvičnih žlez, vnetje ščitnice stanje pri katerem mišice oslabijo in se hitro utrudijo (miastenijski sindrom), okvara živcev v različnih delih telesa, kar lahko povzroči zmanjšanje občutka ali prizadene gibanje vnetje črevesa (kolitis), razjeda tankega črevesa vnetje mišic, ki povzroči bolečino ali okorelost
English: One patient required permanent discontinuation of nivolumab due to Grade 2 increases in transaminases.
Slovenian: Pri enem bolniku je bilo zaradi zvišanja vrednosti aminotransferaz stopnje 2 treba zdravljenje z nivolumabom trajno ukiniti.
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.
Slovenian: Če se stanje kljub uvedbi zdravljenja s kortikosteroidi poslabša ali ne izboljša, je treba odmerek kortikosteroida povečati do odmerka, ki ustreza 1 do 2 mg/kg/dan metilprednizolona, zdravljenje z nivolumabom pa trajno ukiniti.
English: Ask your doctor if you can breast-feed during or after treatment with Nivolumab BMS.
Slovenian: O dojenju med ali po zdravljenju z zdravilom Nivolumab BMS se posvetujte z zdravnikom.
English: Nivolumab BMS 10 mg/mL concentrate for solution for infusion nivolumab
Slovenian: Navodilo za uporabo Nivolumab BMS 10 mg/ml koncentrat za raztopino za infundiranje nivolumab
English: Nivolumab BMS concentrate is a clear to opalescent, colourless to pale yellow liquid that may contain few light particles.
Slovenian: koncentrat za raztopino za infundiranje (sterilni koncentrat) Bistra do opalescentna, brezbarvna do svetlorumena tekočina, ki lahko vsebuje manjše število neznatnih delcev.
English: The Grade 3 case required permanent discontinuation of nivolumab.
Slovenian: Pri bolniku s primerom stopnje 3 je bilo treba zdravljenje z nivolumabom trajno ukiniti.
English: This medicine contains 2.5 mg sodium per mL of concentrate.
Slovenian: En mililiter koncentrata tega zdravila vsebuje 2,5 mg natrija.
English: Withhold Nivolumab BMS until symptoms resolve and management with corticosteroids, if needed, is complete
Slovenian: zadržite dokler simptomi ne izzvenijo in zdravljenje s kortikosteroidi, če je bilo potrebno, ni končano.
English: Withhold dose until symptoms resolve and management with corticosteroids is complete
Slovenian: Aplikacijo odmerka zadržite dokler simptomi ne izzvenijo in zdravljenje s kortikosteroidi ni končano.
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.
Slovenian: Če se te laboratorijske vrednosti ne znižajo, je treba uvesti zdravljenje s kortikosteroidi v odmerku, ki ustreza 0,5 do 1 mg/kg/dan metilprednizolona.
English: Severity
Slovenian: Resnost
English: Problems with your hormone producing glands (including the pituitary, the thyroid and adrenal glands) that may affect how these glands work.
Slovenian: težave z žlezami, ki izločajo hormone (vključno s hipofizo, ščitnico in nadledvičnimi žlezami).
English: To further investigate at post-approval the relation between PDL-1 and PDL-2 expression in Phase 1 (CA209009, CA209038 and
Slovenian: PDL-2 v študijah 1. faze (CA209009, CA209038 in CA209064).
English: Concentrate for solution for infusion.
Slovenian: koncentrat za raztopino za infundiranje
English: In CA209017 and CA209063, the incidence of thyroid disorders, including hypothyroidism or thyroiditis, was 4.4% (11/248).
Slovenian: V študijah CA209017 in CA209063 je pojavnost bolezni ščitnice, vključno s hipotiroidizmom ali vnetjem ščitnice, znašala 4,4 % (11/248).
English: In CA209017 and CA209063, the incidence of hypersensitivity/infusion reactions was 1.6% (4/248).
Slovenian: V študijah CA209017 in CA209063 je pojavnost preobčutljivostnih/infuzijskih reakcij znašala 1,6 % (4/248).
English: Disposal
Slovenian: Aplikacija
English: Upon improvement, nivolumab may be resumed after corticosteroid taper.
Slovenian: Po izboljšanju in postopnem zmanjšanju odmerka kortikosteroida se zdravljenje z nivolumabom lahko nadaljuje.
English: Nivolumab should be withheld for Grade 3 rash and discontinued for Grade 4 rash.
Slovenian: V primeru izpuščaja stopnje 3 je treba zdravljenje z nivolumabom zadržati, v primeru izpuščaja stopnje 4 pa zdravljenje ukiniti.
English: Nivolumab BMS must be administered with caution in patients with moderate (total bilirubin > 1.5 × to 3 × the upper limit of normal [ULN] and any AST) or severe (total bilirubin > 3 × ULN and any AST) hepatic impairment.
Slovenian: Pri bolnikih z zmerno (vrednost skupnega bilirubina > 1,5 × do 3 × zgornja meja normalne vrednosti [ZMN] in katera koli vrednost AST) ali s hudo (vrednost skupnega bilirubina > 3 × ZMN in katera koli vrednost AST) okvaro jeter je treba zdravilo Nivolumab BMS uporabljati previdno.
English: Nivolumab must be permanently discontinued for any severe immune related adverse reaction that recurs and for any life threatening immune related adverse reaction.
Slovenian: Če se kateri koli resni imunsko pogojeni neželeni učinek ponovi, ali pojavi kateri koli resni imunsko pogojeni neželeni učinek, ki ogrozi življenje, je treba zdravljenje z nivolumabom trajno ukiniti.
English: Nivolumab BMS can be used for intravenous administration either: without dilution, after transfer to an infusion container using an appropriate sterile syringe; or after diluting to concentrations as low as 1 mg/mL.
Slovenian: brez redčenja, po prenosu v infuzijski vsebnik z ustrezno sterilno injekcijsko brizgo, ali po redčenju do najnižje koncentracije 1 mg/ml.
English: Very common increased AST,bincreased ALT,b increased alkaline phosphatase,b increased creatinine,b decreased lymphocytes,b decreased platelet count,b decreased haemoglobin,b hypercalcaemia,b hypocalcaemia,b hyperkalaemia,b hypokalaemia,b hypomagnesaemia,b hyponatraemiab
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva tubulointersticijski nefritis, odpoved ledvic Splošne težave in spremembe na mestu aplikacije zvišanje vrednosti ASTb, zvišanje vrednosti ALTb, zvišanje vrednosti alkalne fosfatazeb, zvišanje vrednosti kreatininab, zmanjšanje števila limfocitovb, zmanjšanje števila trombocitovb, zmanjšanje vrednosti hemoglobinab, hiperkalciemijab, hipokalciemijab, hiperkaliemijab, hipokaliemijab,
English: Non-corticosteroid immunosuppressive therapy should be added if there is worsening or no improvement despite corticosteroid use.
Slovenian: Če se stanje kljub uporabi kortikosteroida poslabša ali ne izboljša, je treba dodatno uvesti še nekortikosteroidno imunosupresivno zdravljenje.
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.
Slovenian: Odvisno od potrebnega odmerka bodo ustrezno količino zdravila Nivolumab BMS pred uporabo razredčili z 0,9-odstotno (9 mg/ml) raztopino natrijevega klorida za injiciranje ali s 5-odstotno
English: For symptomatic hyperthyroidism, nivolumab should be withheld and methimazole should be initiated as needed.
Slovenian: V primeru simptomatskega hipertiroidizma je treba zdravljenje z nivolumabom zadržati in po potrebi uvesti zdravljenje z metimazolom.
English: Tell your doctor if you are on a low-sodium (low-salt) diet before you are given Nivolumab BMS.
Slovenian: Če ste na dieti z nadzorovanim vnosom natrija (soli), o tem pred prvim prejemom zdravila
English: To further investigate the associative analyses between PDL-1 and PDL-2 expression conducted in Study CA209-066.
Slovenian: Dodatno raziskati analize povezave med ekspresijo PDL-1 in PDL-2,
English: If applicable, dilute with the required volume of sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose solution for injection.
Slovenian: Po potrebi koncentrat razredčite s potrebno količino 0,9-odstotne (9 mg/ml) raztopine natrijevega klorida za injiciranje ali 5-odstotne (50 mg/ml) raztopine glukoze za injiciranje.
English: Fertility studies have not been performed with nivolumab.
Slovenian: Študij o vplivu nivolumaba na plodnost niso izvedli.
English: For Grade 2 (symptomatic) pneumonitis, nivolumab should be withheld and corticosteroids initiated at a dose of 1 mg/kg/day methylprednisolone equivalents.
Slovenian: V primeru pljučnice stopnje 2 (simptomatska) je treba zdravljenje z nivolumabom zadržati in uvesti zdravljenje s kortikosteroidi v odmerku, ki ustreza 1 mg/kg/dan metilprednizolona.
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.
Slovenian: V primeru zvišanja serumskega kreatinina stopnje 2 ali 3 je treba zdravljenje z nivolumabom zadržati in uvesti zdravljenje s kortikosteroidi v odmerku, ki ustreza 0,5 do 1 mg/kg/dan metilprednizolona.
English: Table 2: Adverse reactions in patients with squamous NSCLC treated with nivolumab 3 mg/kg (CA209017 and CA209063)
Slovenian: Preglednica 2: Neželeni učinki pri bolnikih s ploščatoceličnim NSCLC, ki so se zdravili z nivolumabom v odmerku 3 mg/kg (študija CA209017 in študija CA209063) Infekcijske in parazitske bolezni občasni bronhitis, okužba zgornjih dihal
English: Nivolumab BMS infusion
Slovenian: Nivolumab BMS.
English: Severe rash should be managed with high-dose corticosteroid at a dose of 1 to 2 mg/kg/day prednisone equivalents.
Slovenian: V primeru hudega izpuščaja je treba uvesti zdravljenje z visokim odmerkom kortikosteroidov v odmerku, ki ustreza 1 do 2 mg/kg/dan prednizona.
English: Immune-related nephritis and renal dysfunction
Slovenian: Imunsko pogojeni nefritis in okvara delovanja ledvic
English: In CA209017 and CA209063, the incidence of rash was 12.1% (30/248).
Slovenian: V študijah CA209017 in CA209063 je pojavnost izpuščaja znašala 12,1 % (30/248).
English: No Grade 4 or 5 nephritis or renal dysfunction was reported in these studies.
Slovenian: O primerih nefritisa ali okvare delovanja ledvic stopnje 4 ali 5 v teh študijah
English: Severe nephritis or renal dysfunction has been observed with nivolumab treatment (see section 4.8).
Slovenian: Pri zdravljenju z nivolumabom so poročali o hudem nefritisu ali okvari delovanja ledvic (glejte poglavje 4.8).
English: The pharmacokinetics (PK) of nivolumab is linear in the dose range of 0.1 to 10 mg/kg.
Slovenian: V razponu odmerkov od 0,1 do 10 mg/kg je farmakokinetika nivolumaba linearna.
English: The Adverse Reaction Management Guide shall contain the following key elements:
Slovenian: • Priročnik za ukrepanje v primeru pojava neželenih učinkov Priročnik za ukrepanje v primeru pojava neželenih učinkov mora vsebovati naslednje ključne
English: o Immune-related nephritis or renal dysfunction
Slovenian: o imunsko pogojeni nefritis ali okvaro delovanja ledvic
English: Nivolumab BMS concentrate is a clear to opalescent, colourless to pale yellow liquid that
Slovenian: Koncentrat zdravila Nivolumab BMS je bistra do opalescentna,
English: Your doctor will continue giving you Nivolumab BMS for as long as you keep benefitting from it or until you no longer tolerate the treatment.
Slovenian: bo trajalo dokler bo prisotna njegova korist oziroma dokler boste zdravilo prenašali.
English: In CA209017 and CA209063, the incidence of nephritis or renal dysfunction was 3.2% (8/248).
Slovenian: V študijah CA209017 in CA209063 je pojavnost nefritisa ali okvare delovanja ledvic znašala 3,2 % (8/248).
English: If worsening or no improvement occurs despite initiation of corticosteroids, nivolumab must be permanently discontinued.
Slovenian: Če se stanje kljub uvedbi zdravljenja s kortikosteroidi poslabša ali ne izboljša, je treba zdravljenje z
English: For symptomatic hypophysitis, nivolumab should be withheld, and hormone replacement should be initiated as needed.
Slovenian: V primeru simptomatskega vnetja hipofize je treba zdravljenje z nivolumabom zadržati in po potrebi uvesti zdravljenje z nadomeščanjem hormonov.
English: In CA209017 and CA209063, the incidence of diarrhoea or colitis was 9.3% (23/248).
Slovenian: V študijah CA209017 in CA209063 je pojavnost driske ali kolitisa znašala 9,3 % (23/248).
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.
Slovenian: Če se stanje kljub uvedbi zdravljenja s kortikosteroidi poslabša ali ne izboljša, je treba odmerek kortikosteroida povečati do odmerka, ki ustreza 2 do 4 mg/kg/dan metilprednizolona, zdravljenje z
English: Nivolumab should not be resumed while the patient is receiving immunosuppressive doses of corticosteroids or other immunosuppressive therapy.
Slovenian: Dokler bolnik prejema imunosupresivne odmerke kortikosteroidov ali drugih zdravil za zaviranje imunske odzivnosti, se zdravljenje z nivolumabom ne sme nadaljevati.
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.
Slovenian: V primeru zvišanja serumskega kreatinina stopnje 4 je treba zdravljenje z nivolumabom trajno ukiniti in uvesti zdravljenje s kortikosteroidi v odmerku, ki ustreza 1 do 2 mg/kg/dan metilprednizolona.
English: BRISTOL-MYERS SQUIBB A.E. Τηλ: + 357 800 92666
Slovenian: Τηλ: + 357 800 92666
English: Persistent diarrhoea or colitis should be managed with corticosteroids at a dose of 0.5 to 1 mg/kg/day methylprednisolone equivalents.
Slovenian: Če driska ali kolitis ne mineta, je treba uvesti zdravljenje s kortikosteroidi v odmerku, ki ustreza 0,5 do 1 mg/kg/dan metilprednizolona.
English: Caution should be used when considering the use of nivolumab in a patient who has previously experienced a severe or life-threatening skin adverse reaction on prior treatment with other immunestimulatory anticancer agents.
Slovenian: Pri bolnikih z resnimi ali s smrtno nevarnimi kožnimi neželenimi učinki pri predhodnem zdravljenju raka z drugimi zdravili za imunsko stimulacijo je treba možnost uporabe nivolumaba previdno