FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 2: Adverse reactions in patients with squamous NSCLC treated with nivolumab 3 mg/kg (CA209017 and CA209063)
Danish: Tabel 2: Bivirkninger hos patienter med planocellulært NSCLC, som behandles med nivolumab 3 mg/kg (CA209017 og CA209063) Infektioner og parasitære sygdomme
English: The amount of Nivolumab BMS you will be given will be calculated based on your body weight.
Danish: Dosis af Nivolumab BMS afhænger af din legemsvægt.
English: All prescribers of Nivolumab BMS must be familiar with the Physician Information and Management Guidelines.
Danish: Alle læger, der ordinerer Nivolumab BMS, skal kende behandlingsguiden.
English: Corticosteroids at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents should also be considered if acute inflammation of the thyroid is suspected.
Danish: Kortikosteroid i en dosis ækvivalent med 1-2 mg/kg/dag methylprednisolon bør også overvejes, hvis der er mistanke om akut inflammation i thyroidea.
English: Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody (HuMAb), which binds to the programmed death-1 (PD-1) receptor and blocks its interaction with PD-L1 and PD-L2.
Danish: Nivolumab er et humant immunglobulin G4 (IgG4) monoklonalt antistof (HuMAb), som bindes til programmeret celledød-1- (PD-1)-receptor og blokerer dets interaktion med liganderne PD-L1 og PD-L2. PD-1-receptoren er en negativ regulator af T-celleaktivitet, som er vist at være medvirkende til at kontrollere T-celleimmunresponset.
English: Administer the Nivolumab BMS infusion intravenously over a period of 60 minutes.
Danish: Nivolumab BMS-infusion administreres intravenøst over en periode på 60 minutter.
English: Data from patients 75 years of age or older are too limited to draw conclusions on this population.
Danish: Data fra patienter på 75 år og derover er for begrænsede til at kunne drage konklusioner for denne population.
English: It is important that you keep the Alert Card with you during treatment.
Danish: - Det er vigtigt, at du har altid har patient-informationskortet på dig, så længe du er i behandling
English: Grade 2 cases were reported in 3.6% (9/248) of patients.
Danish: Grad 2 tilfælde blev rapporteret hos 3,6% (9/248) af patienterne.
English: No dose adjustment is required for elderly patients (≥ 65 years) (see sections 5.1 and 5.2).
Danish: Dosisjustering er ikke nødvendig til ældre patienter (≥ 65 år) (se pkt.
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.
Danish: Resolution forekom hos 2 patienter (67%) med en mediantid til resolution på 4,1 uger (2,9-22,3+); + betegner en censureret observation.
English: Nivolumab has not been studied in patients with moderate (total bilirubin > 1.5 × to 3 × ULN and any AST) or severe hepatic impairment (total bilirubin > 3 × ULN and any AST) (see section 4.2).
Danish: Nivolumab er ikke undersøgt hos patienter med moderat (total-bilirubin > 1,5-3 × ULN og enhver ASAT) eller svært nedsat leverfunktion (total-bilirubin > 3 × ULN og enhver ASAT) (se pkt.
English: Withhold Nivolumab BMS until creatinine returns to baseline and management with corticosteroids is complete
Danish: Nivolumab BMS udsættes, indtil kreatinin vender tilbage til baseline, og behandling med kortikosteroid er afsluttet
English: • Physician educational material • Patient alert card
Danish: • Undervisningsmateriale til lægen
English: Because of potential adverse reactions such as fatigue (see section 4.8), patients should be advised to use caution when driving or operating machinery until they are certain that nivolumab does not adversely affect them.
Danish: 4.8) bør patienterne tilrådes at udvise forsigtighed, når de fører motorkøretøj eller betjener maskiner, indtil de er sikre på, at de ikke har bivirkninger af nivolumab.
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.
Danish: Infusionen skal administreres gennem et sterilt, ikke-pyrogent, minimalt proteinbindende in-line filter med en porestørrelse på 0,2-1,2 µm.
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.
Danish: Der skal udvises forsigtighed, hvis nivolumab-behandling overvejes hos patienter, der har oplevet en alvorlig eller livstruende hudrelateret bivirkning under tidligere behandling med andre
English: Permanently discontinue Nivolumab BMS
Danish: Nivolumab BMS seponeres permanent
English: Diarrhoea (watery, loose or soft stools), mouth ulcers and cold sores (stomatitis), vomiting, stomach pain, constipation, dry mouth
Danish: Diarre (vandig, løs eller blød afføring), mundsår og forkølelsessår (stomatitis), opkastning, mavesmerter, forstoppelse, mundtørhed
English: Nivolumab BMS 10 mg/mL concentrate for solution for infusion nivolumab
Danish: Nivolumab BMS 10 mg/ml koncentrat til infusionsvæske, opløsning nivolumab
English: Severe diarrhoea or colitis has been observed with nivolumab treatment (see section 4.8).
Danish: Svær diarre eller colitis er observeret med nivolumab-behandling (se pkt.
English: Based on the population PK results, no dose adjustment is required in patients with mild hepatic impairment (see section 5.2).
Danish: Baseret på populationsfarmakokinetiske resultater er dosisjustering ikke nødvendig hos patienter med let nedsat leverfunktion (se pkt.
English: Monitoring of blood sugar should continue to ensure appropriate insulin replacement is utilised.
Danish: Blodglucose bør fortsat monitoreres for at sikre, at passende insulinbehandling anvendes.
English: Resolution occurred in 24 patients (83%), including the 2 patients with a Grade 3 case, with a median time to resolution of 5.7 weeks (range: 0.1- 46.9+); + denotes a censored observation.
Danish: Resolution forekom hos 24 patienter (83%), inklusive de 2 patienter med grad 3 tilfælde, med en mediantid til resolution på 5,7 uger (0,1- 46,9+); + betegner en censureret observation.
English: Withhold Nivolumab BMS until symptoms resolve and management with corticosteroids (if needed for symptoms of acute inflammation) is complete.
Danish: Nivolumab BMS udsættes, indtil symptomerne forsvinder, og eventuel behandling med kortikosteroid (for symptomer på akut inflammation) er afsluttet.
English: Median time to onset was 25.1 weeks (range: 4.1-31.1).
Danish: Mediantiden til indtræden var 25,1 uger (4,1-31,1).
English: Median time to onset was 8.1 weeks (range: 0.3-51.9).
Danish: Mediantid til indtræden var 8,1 uger (0,3-51,9).
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).
Danish: Der skal anvendes et infusionssæt og et sterilt, ikke-pyrogent, minimalt proteinbindende in-line filter (porrestørrelse 0,2 μm til 1,2 μm).
English: The management guidelines for these adverse reactions are described in section 4.4.
Danish: Retningslinjer for behandling af disse bivirkninger er beskrevet i pkt.
English: Monitoring of adrenal function and hormone levels should continue to ensure appropriate corticosteroid replacement is utilised.
Danish: Binyrebarkfunktion og hormonniveauer bør fortsat monitoreres for at sikre, at passende kortikosteroidsubstitution anvendes.
English: Median time to onset was 10.5 weeks (range: 2.1-27.0).
Danish: Mediantiden til indtræden var 10,5 uger (2,1-27,0).
English: Monitoring of thyroid function should continue to ensure appropriate hormone replacement is utilised.
Danish: Thyroideafunktionen bør fortsat monitoreres for at sikre, at passende hormonsubstitution anvendes.
English: The Grade 3 case required permanent discontinuation of nivolumab.
Danish: Hos patienten med grad 3 tilfældet var det nødvendigt at seponere nivolumab permanent.
English: You must use effective contraception while you are being treated with Nivolumab BMS and for at least 5 months following the last dose of Nivolumab BMS, if you are a woman who could
Danish: Man kender ikke Nivolumab BMS' virkning hos gravide kvinder, men det er muligt, at det aktive Du skal anvende sikker prævention, mens du er i behandling med Nivolumab BMS og i mindst 5 måneder efter, du har fået den sidste dosis Nivolumab BMS, hvis du er en kvinde i den Fortæl det til lægen, hvis du bliver gravid, mens du bruger Nivolumab BMS.
English: Tell your doctor immediately if you get any of the side effects listed above.
Danish: Fortæl det straks til lægen, hvis du får en eller flere af disse bivirkninger.
English: Monitoring of pituitary function and hormone levels should continue to ensure appropriate hormone replacement is utilised.
Danish: Hypofysefunktion og hormonniveauer bør fortsat monitoreres for at sikre, at passende hormonsubstitution anvendes.
English: Nivolumab BMS concentrate is a clear to opalescent, colourless to pale yellow liquid that
Danish: Nivolumab BMS-koncentrat er en klar til opaliserende, farveløs til lysegul væske, der
English: Nivolumab BMS should be continued in the presence of hormone replacement therapy a as long as no symptoms are present
Danish: Nivolumab BMS bør fortsættes under hormonsubstitutionsbehandlinga så længe, der ikke er symptomer Nivolumab BMS udsættes, indtil symptomerne forsvinder, og behandling med kortikosteroid er afsluttet
English: What you need to know before you use Nivolumab BMS You should not be given Nivolumab BMS if you are allergic to nivolumab or any of the other ingredients of this medicine (listed in section 6 "Contents of the pack and other information").
Danish: hvis du er allergisk over for nivolumab eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: Upon improvement, nivolumab may be resumed after corticosteroid taper, if needed.
Danish: Når der indtræder bedring, kan nivolumab genoptages efter nedtrapning af eventuelt kortikosteroid.
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.
Danish: Vedvarende forhøjelser af disse laboratorieværdier bør behandles med kortikosteroid med en dosis ækvivalent med 0,5-1 mg/kg/dag methylprednisolon.
English: Data from patients with severe renal impairment are too limited to draw conclusions on this population (see section 4.2).
Danish: Data fra patienter med svært nedsat nyrefunktion er for begrænsede til at kunne drage konklusioner for denne population (se pkt.
English: Median time to onset was 5.6 weeks (range: 0.1-91.0).
Danish: Mediantiden til indtræden var 5,6 uger (0,1-91,0).
English: Each mL of concentrate for solution for infusion contains 10 mg of nivolumab.
Danish: En ml koncentrat til infusionsvæske, opløsning indeholder 10 mg nivolumab.
English: Excipient with known effect Each mL of concentrate contains 0.1 mmol (or 2.5 mg) sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på En ml koncentrat indeholder 0,1 mmol (eller 2,5 mg) natrium.
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.
Danish: Nivolumab BMS koncentrat til infusion, opløsning (sterilt koncentrat) er en klar til opaliserende, farveløs til lysegul væske, der kan indeholde få lyse partikler.
English: Uncommon bronchitis, upper respiratory tract infection Neoplasms benign, malignant and unspecified (including cysts and polyps) Uncommon histocytic necrotising lymphadenitis (Kikuchi lymphadenitis) Immune system disorders
Danish: cyster og polypper) Ikke almindelig histocytisk nekrotiserende lymfadenitis (Kikuchi lymfadenitis) Immunsystemet
English: Resolution occurred in 5 patients (71%), including the Grade 3 case, with a median time to resolution of 5.9 weeks (range: 0.7- 37.6+); + denotes a censored observation.
Danish: Resolution forekom hos 5 patienter (71%), herunder den ene patient med et grad 3 tilfælde, med en mediantid til resolution på 5,9 uger (0,7-37,6+); + betegner en censureret
English: One vial of 10 mL contains 100 mg of nivolumab.
Danish: Et 10 ml hætteglas indeholder 100 mg nivolumab.
English: Κύπρος
Danish: Beskrivelse
English: Nivolumab BMS should not be infused concomitantly in the same intravenous line with other medicinal products.
Danish: Nivolumab BMS må ikke infunderes samtidigt med andre lægemidler i samme
English: PVC infusion sets In-line filters with polyethersulfone membranes with pore sizes of 0.2 µm to 1.2 µm.
Danish: In-line filtre af polyethersulfonmembraner med en porestørrelse på 0,2 μm til 1,2 μm.
English: The recommended dose is 3 mg of nivolumab per kilogram of your body weight.
Danish: Den anbefalede dosis er 3 mg nivolumab pr.
English: To be taken into consideration when treating patients on a controlled sodium diet.
Danish: Hvis patienten er på natriumkontrolleret diæt, skal der tages hensyn hertil.
English: Grade 2 cases were reported in 0.4% (1/248) of patients.
Danish: Grad 2 tilfælde blev rapporteret hos 0,4% (1/248) af patienterne.
English: Nivolumab BMS will be given to you as an infusion (a drip) into a vein (intravenously) over a period of 60 minutes, every 2 weeks.
Danish: Du vil få Nivolumab BMS som ved intravenøs infusion (som drop i en vene) over en periode på 60 minutter.
English: Data from patients with moderate or severe hepatic impairment are too limited to draw conclusions on these populations.
Danish: Data fra patienter med moderat eller svært nedsat leverfunktion er for begrænsede til at kunne drage konklusioner for denne population.
English: NAME OF THE MEDICINAL PRODUCT Nivolumab BMS 10 mg/mL concentrate for solution for infusion.
Danish: LÆGEMIDLETS NAVN Nivolumab BMS 10 mg/ml koncentrat til infusionsvæske, opløsning.
English: Do not shake the vial.
Danish: Hætteglasset må ikke rystes.
English: Belgique/België/Belgien N.V. Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
Danish: Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
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.
Danish: Den totale dosis af Nivolumab BMS kan indgives direkte som 10 mg/ml koncentrat eller kan fortyndes ned til 1 mg/ml med natriumchlorid 9 mg/ml (0,9%) injektionsvæske eller glucose 50 mg/ml (5%)
English: Nivolumab is unlikely to affect your ability to drive or use machines; however, use caution when performing these activities until you are sure that nivolumab does not adversely affect you.
Danish: Du skal imidlertid være forsigtig, når du udfører disse aktiviteter, indtil du er sikker på, hvordan nivolumab påvirker dig.
English: Data from patients with severe renal impairment are too limited to draw conclusions on this population.
Danish: Data fra patienter med svært nedsat nyrefunktion er for begrænsede til at kunne drage konklusioner for denne population.
English: Severe rash has been observed with nivolumab treatment that may be immune-related (see section 4.8).
Danish: Der er observeret alvorligt udslæt, som kan være immunrelateret, ved behandling med nivolumab (se pkt.
English: In CA209017 and CA209063, the incidence of pneumonitis, including interstitial lung disease, was 5.2% (13/248).
Danish: I CA209017 og CA209063 var hyppigheden af pneumonitis, herunder interstitiel lungesygdom, 5,2% (13/248).
English: In CA209017 and CA209063, the incidence of thyroid disorders, including hypothyroidism or thyroiditis, was 4.4% (11/248).
Danish: I CA209017 og CA209063 var hyppigheden af thyroidearelaterede bivirkninger, herunder hypotyroidisme og tyroiditis, 4,4% (11/248).
English: Severe nephritis or renal dysfunction has been observed with nivolumab treatment (see section 4.8).
Danish: Svær nefritis eller nedsat nyrefunktion er observeret med nivolumab-behandling (se pkt.
English: For symptomatic hyperthyroidism, nivolumab should be withheld and methimazole should be initiated as needed.
Danish: Ved symptomatisk hypertyroidisme bør nivolumabdosering udsættes og methimazol initieres efter behov.
English: For symptomatic adrenal insufficiency, nivolumab should be withheld, and physiologic corticosteroid replacement should be initiated as needed.
Danish: Ved symptomatisk binyrebarkinsufficiens bør nivolumab udsættes og fysiologisk kortikosteroidsubstitution initieres efter behov.
English: Withhold Nivolumab BMS until laboratory values return to baseline and management with corticosteroids, if needed, is complete
Danish: Nivolumab BMS udsættes, indtil laboratorieværdierne vender tilbage til baseline, og eventuel behandling med kortikosteroid er afsluttet
English: Renal and urinary disorders Uncommon tubulointerstitial nephritis, renal failure General disorders and administration site conditions Very common
Danish: Ikke almindelig tubulointerstitiel nefritis (shock-nyre), nyresvigt Almene symptomer og reaktioner på administrationsstedet
English: Unless an alternate etiology has been identified, signs or symptoms of endocrinopathies should be considered immune-related.
Danish: Tegn og symptomer på endokrinopatier skal anses for at være immunrelaterede, medmindre en anden ætiologi
English: Persistent diarrhoea or colitis should be managed with corticosteroids at a dose of 0.5 to 1 mg/kg/day methylprednisolone equivalents.
Danish: Vedvarende diarre eller colitis bør behandles med kortikosteroid med en dosis ækvivalent med 0,5-1 mg/kg/dag methylprednisolon.
English: More than one vial of Nivolumab BMS concentrate may be needed to give the total dose for the patient.
Danish: Mere end 1 hætteglas Nivolumab BMS-koncentrat kan være nødvendigt for at kunne give
English: Nivolumab BMS should also be permanently discontinued for Grade 2 or 3 immune-related adverse reactions that persist despite treatment modifications (see section 4.4) or for inability to reduce corticosteroid dose to 10 mg prednisone or equivalent per day.
Danish: Nivolumab BMS bør ligeledes seponeres permanent ved grad 2 eller 3 immunrelaterede bivirkninger, der vedvarer på trods af behandlingsændringer (se pkt.
English: Hazard ratio 96.85% CI p-value Median (95% CI) months Rate (95% CI) at 12 months Confirmed objective response (95% CI)
Danish: Samlet overlevelse Hændelser Hazard ratio 96,85% CI p-værdi
English: Preparation should be performed by trained personnel in accordance with good practices rules, especially with respect to asepsis.
Danish: Klargøring og administration af Nivolumab BMS Klargøring af lægemidlet skal foretages af uddannet personale i overensstemmelse med god praksis, især med henblik på aseptik.
English: In CA209017 and CA209063, the incidence of diarrhoea or colitis was 9.3% (23/248).
Danish: I CA209017 og CA209063 var hyppigheden af diarre eller colitis 9,3% (23/248).
English: In CA209017 and CA209063, the incidence of hypersensitivity/infusion reactions was 1.6% (4/248).
Danish: I CA209017 og CA209063 var hyppigheden af overfølsomhed/infusionsreaktioner 1,6% (4/248).
English: For symptomatic hypophysitis, nivolumab should be withheld, and hormone replacement should be initiated as needed.
Danish: Ved symptomatisk hypofysitis bør nivolumabdosering udsættes og hormonsubstitution initieres efter behov.
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.
Danish: Afhængigt af din dosis vil den ønskede mængde Nivolumab BMS blive fortyndet med natriumchlorid 9 mg/ml (0,9%) injektionsvæske eller glucose 50 mg/ml (5%) injektionsvæske før brug.
English: To further investigate the associative analyses between PDL-1 and PDL-2 expression conducted in Study CA209-066.
Danish: Yderligere at undersøge de associative analyser mellem PDL-1- og PDL
English: For Grade 2 (symptomatic) pneumonitis, nivolumab should be withheld and corticosteroids initiated at a dose of 1 mg/kg/day methylprednisolone equivalents.
Danish: Ved grad 2 (symptomatisk) pneumonitis bør nivolumabdosering udsættes og kortikosteroid initieres med en dosis ækvivalent med 1 mg/kg/dag methylprednisolon.
English: More than one vial of Nivolumab BMS may be necessary to obtain the required dose.
Danish: Det kan være nødvendigt at anvende mere end et hætteglas Nivolumab BMS for at opnå den
English: If you stop using Nivolumab BMS
Danish: Det skal du vide, før du begynder at bruge Nivolumab BMS
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).
Danish: To patienter, herunder den ene med et grad 3 tilfælde (tubulointerstitiel nefritis), fik højdosis kortikosteroid (i en dosis mindst ækvivalent med 40 mg prednison) med en median initialdosis på 0,8 mg/kg (0,5-1,2) og en median varighed på 5,3 uger (0,9-9,7).
English: EU/1/15/1026/001-002 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF
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).
Danish: Elleve patienter fik højdosis kortikosteroid (i en dosis mindst ækvivalent med 40 mg prednison) med en median initialdosis på 1,1 mg/kg (0,5-4,0) og en median samlet varighed på 4,3 uger (0,6-13,1).
English: Nivolumab BMS can be used for intravenous administration either: without dilution, after transfer to an infusion container using an appropriate sterile syringe;
Danish: Nivolumab BMS kan gives som intravenøs administration enten: ufortyndet, efter overførsel til en infusionsbeholder ved brug af en passende steril sprøjte; efter fortynding til koncentrationer ned til 1 mg/ml.
English: In CA209017 and CA209063, the incidence of rash was 12.1% (30/248).
Danish: I CA209017 og CA209063 var hyppigheden af udslæt 12,1% (30/248).
English: Infections and infestations
Danish: Infektiøse og
English: In CA209017 and CA209063, the incidence of liver function test abnormalities was 1.2% (3/248).
Danish: I CA209017 og CA209063 var hyppigheden af abnorme leverfunktionstests 1,2% (3/248).
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
Danish: Allergisk reaktion forbundet med indgivelse af medicinen Binyrerne virker ikke, som de skal, betændelse i skjoldbruskkirtlen En sygdom, hvor musklerne bliver svage og hurtigere bliver trætte (myastenisk syndrom), beskadigelse af nerverne forskellige steder i kroppen, som kan medføre følelsesløshed eller
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.
Danish: Ved grad 2 eller 3 forhøjelse af serumkreatinin bør nivolumabdosering udsættes og kortikosteroid initieres med en dosis ækvivalent med 0,5-1 mg/kg/dag methylprednisolon.
English: Immune-related nephritis or renal dysfunction present with asymptomatic increases in serum creatinine.
Danish: Størstedelen af patienterne får asymptomatisk forhøjelse af serumkreatinin.
English: Nivolumab BMS infusion should not be infused at the same time in the same intravenous line with other agents.
Danish: Nivolumab BMS-infusion må ikke infunderes samtidig med andre lægemidler i samme infusionsslange.
English: In CA209017 and CA209063, the incidence of nephritis or renal dysfunction was 3.2% (8/248).
Danish: I CA209017 og CA209063 var hyppigheden af nefritis eller nedsat nyrefunktion 3,2% (8/248).