FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of advanced or metastatic squamous NSCLC were evaluated in a phase 3, randomised, open-label study (CA209017).
Danish: Sikkerheden og virkningen af nivolumab 3 mg/kg som enkeltstof til behandling af fremskreden eller metastatisk planocellulært NSCLC blev undersøgt i et randomiseret, åbent fase 3-studie (CA209017).
English: Detailed guidelines for the management of immune-related adverse reactions are described in section 4.4.
Danish: Detaljerede retningslinjer for håndtering af immunrelaterede bivirkninger er beskrevet i pkt.
English: The prescriber must discuss the risks of Nivolumab BMS therapy with the patient.
Danish: Den ordinerende læge skal tale med patienten om de risici, der er forbundet med behandling med Nivolumab BMS.
English: The incidence of adrenal insufficiency was 0.4% (1/248; Grade 3).
Danish: Hyppigheden af binyrebarkinsufficiens var 0,4% (1/248; grad 3).
English: Nivolumab 3 mg/kg showed an overall response rate of 14.5% (95% CI: 8.7-22.2%), a median OS of 8.21 months (95% CI: 6.05-10.9 months ), and a median PFS of 1.87 months (95% CI 1.77-3.15 months.
Danish: Nivolumab 3 mg/kg viste en overordnet responsrate på 14,5% (95% CI: 8,7-22,2%), en median OS på 8,21 måneder (95% CI: 6,0510,9 måneder) og en median PFS på 1,87 måneder (95% CI: 1,77-3,15 måneder).
English: Blockade of PD-L1 signalling has been shown in murine models of pregnancy to disrupt tolerance to the foetus and to increase foetal loss.
Danish: I murine drægtighedsmodeller er blokering af PD-L1 signalering vist at ødelægge tolerancen for fosteret og øge fosterdødeligheden.
English: Inspect the Nivolumab BMS concentrate for particulate matter or discoloration.
Danish: Kontroller Nivolumab BMS-koncentratet for partikler eller misfarvning.
English: For Grade 2 transaminase or total bilirubin elevation, nivolumab should be withheld.
Danish: Ved grad 2 forhøjelse af aminotransferase eller total-bilirubin udsættes nivolumabdosering.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendte lægemidler samt affald heraf bør bortskaffes i henhold til lokale retningslinjer.
English: Inflammation or problems with your kidneys.
Danish: Betændelsestilstand i nyrerne eller problemer med nyrerne.
English: One patient required permanent discontinuation of nivolumab due to Grade 3 diarrhoea.
Danish: Hos en patient var det nødvendigt at seponere nivolumab permanent på grund af grad 3 diarre.
English: If you miss an appointment, ask your doctor when to schedule your next dose.
Danish: Hvis du glemmer en aftale, skal du bede lægen om at få en ny aftale.
English: Treatment was continued as long as clinical benefit was observed or until treatment was no longer tolerated.
Danish: Behandlingen fortsatte så længe, der kunne observeres kliniske fordele, eller indtil patienten ikke længere tålte behandlingen.
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: Description
Danish: • Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre følgende
English: Each mL of this medicinal product contains 0.1 mmol (or 2.5 mg) sodium.
Danish: En ml af dette lægemiddel indeholder 0,1 mmol (eller 2,5 mg) natrium.
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).
Danish: Sukkersyge (diabetes) (symptomer omfatter overdreven tørst, stærkt forøget urinproduktion, øget appetit med vægttab, træthedsfølelse, sløvhed, svaghedsfølelse, nedtrykthed, irritabilitet og generel utilpashed eller diabetisk ketoacidose (syre i blodet som følge af diabetes).
English: 30th September 2017
Danish: 30. september 2017
English: Patients should be monitored for signs and symptoms of nephritis and renal dysfunction.
Danish: Patienter bør monitoreres for tegn og symptomer på nefritis og nedsat nyrefunktion.
English: No Grade 4 or 5 nephritis or renal dysfunction was reported in these studies.
Danish: Ingen grad 4 eller 5 nefritis eller nedsat nyrefunktion blev rapporteret i disse studier.
English: 4 mL of concentrate in a 10 mL vial (Type I glass) with a stopper (coated butyl rubber) and a dark blue flip-off seal (aluminium).
Danish: 4 ml koncentrat i et 10 ml hætteglas (type I-glas) med en prop (coated butylgummi) og et mørkeblåt flip-off låg (aluminium).
English: Data for the following immune-related adverse reactions are based on patients who received nivolumab 3 mg/kg in two NSCLC studies (CA209017 and CA209063, see section 5.1).
Danish: Data for følgende immunrelaterede bivirkninger er baseret på patienter, som fik nivolumab 3 mg/kg i to NSCLC-studier (CA209017 og CA209063, se pkt.
English: Post-authorisation efficacy study (PAES): The MAH should submit an updated OS data for Study CA209017: a Phase 3, randomized study of nivolumab vs docetaxel in subjects with advanced or metastatic squamous NSCLC who have experienced disease progression during or after one prior platinum doublet-based chemotherapy regimen.
Danish: Virkningsstudie efter godkendelse (Post-authorisation efficacy study): Indehaveren af markedsføringstilladelsen skal indsende opdaterede OS-data for studie CA209017: et randomiseret, åbent, fase 3-studie med nivolumab versus docetaxel hos patienter med fremskredent eller metastatisk planocellulært NSCLC, som har oplevet sygdomsprogression under eller efter et tidligere platinbaseret dublet-kemoterapi regime.
English: Nivolumab 3 mg/kg (events : 86/135), median and 95% CI : 9.23 (7.33, 13.27)
Danish: Nivolumab 3 mg/kg (hændelser: 86/135), median og 95% CI: 9,23 (7,33; 13,27)
English: If not used immediately, chemical and physical in-use stability of Nivolumab BMS has been demonstrated for 24 hours at 2ºC to 8ºC protected from light and a maximum of 4 hours at 20°C-25°C and room light (this 4-hour period of the total 24 hours should be inclusive of the product administration period).
Danish: Hvis Nivolumab BMS ikke anvendes straks, er der påvist kemisk og fysisk stabilitet under anvendelse i 24 timer ved 2°C-8°C og beskyttet mod lys og i højst 4 timer ved 20°-25 °C og dagslys (de 4 timer af de i alt 24 timer er
English: Before you are given Nivolumab BMS, tell your doctor if you are taking any medicines that suppress your immune system, such as corticosteroids, since these medicines may interfere with the effect of Nivolumab BMS.
Danish: Brug af anden medicin sammen med Nivolumab BMS Fortæl det til lægen, inden du får Nivolumab BMS, hvis du tager medicin, der hæmmer immunsystemet, som f.eks. kortikosteroider, da denne type medicin kan påvirke Nivolumab BMS' virkning.
English: Tell your doctor if you are on a low-sodium (low-salt) diet before you are given Nivolumab BMS.
Danish: Fortæl det til lægen, inden du får Nivolumab BMS, hvis du er på en diæt med lavt natriumindhold (lavt saltindhold).
English: Severe pneumonitis or interstitial lung disease, including fatal cases, has been observed with nivolumab treatment (see section 4.8).
Danish: Svær pneumonitis eller interstitiel lungesygdom, herunder dødelige tilfælde, er observeret med nivolumab-behandling (se pkt.
English: Abnormal kidney function tests (increased amounts of creatinine in your blood) Abnormal levels of calcium, potassium, magnesium, or sodium in your blood An increased level of the enzyme that breaks down lipids and of the enzyme that breaks down
Danish: Unormale prøver for nyrefunktionen (øget mængde kreatinin i blodet) Unormalt indhold af calcium, kalium, magnesium eller natrium i blodet Øget mængde af enzymet, der nedbryder fedtstoffer og af enzymet, der nedbryder stivelse.
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.
Danish: Derudover blev symptombedring og overordnet helbredsstatus vurderet ved hjælp af henholdsvis det gennemsnitlige symptombyrde-indeks fra Lung Cancer Symptom Score (LCSS) og
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nivolumab BMS 10 mg/mL sterile concentrate nivolumab
Danish: LÆGEMIDLETS NAVN, STYRKE OG ADMINISTRATIONSVEJ(E) Nivolumab BMS 10 mg/ml sterilt koncentrat nivolumab
English: Patients with a baseline performance score ≥ 2, active brain metastases or autoimmune disease, symptomatic interstitial lung disease, and patients who had been receiving systemic immunosuppressants prior to study entry were excluded from the clinical trials of NSCLC (see sections 4.5 and 5.1).
Danish: Patienter med performance-score ≥ 2 ved baseline, aktive hjernemetastaser, autoimmun sygdom eller symptomatisk interstitiel lungesygdom og patienter, som havde fået systemiske immunsuppressiva før studieinklusion, blev udelukket fra de kliniske NSCLC-forsøg (se pkt.
English: Recommendation for the use of hormone replacement therapy is provided in section 4.4.
Danish: Anbefalinger for hormonsubstitutionsbehandling er beskrevet i pkt.
English: However, systemic corticosteroids and other immunosuppressants can be used after starting nivolumab to treat immune-related adverse reactions.
Danish: Systemiske kortikosteroider og andre immunsuppressiva kan imidlertid anvendes til behandling af immunrelaterede bivirkninger efter initiering af nivolumab.
English: To further investigate at post-approval the relation between PDL-1 and PDL-2 expression in Phase 1 (CA209009, CA209038 and
Danish: Yderligere at undersøge sammenhængen mellem PDL-1- og PDL2-ekspression i fase 1 (CA209009, CA209038 og CA209064) efter
English: No Grade 4 or 5 cases were reported in these studies.
Danish: Ingen grad 4 eller 5 tilfælde blev rapporteret i disse studier.
English: Patients should be monitored for diarrhoea and additional symptoms of colitis, such as abdominal pain and mucus or blood in stool.
Danish: Patienten bør monitoreres for diarre og yderligere symptomer på immunrelateret colitis som f.eks. abdominalsmerter og slim eller blod i afføringen.
English: Patients should be monitored for signs and symptoms of hepatitis such as transaminase and total bilirubin elevations.
Danish: Patienten bør monitoreres for tegn og symptomer på hepatitis som f.eks. forhøjet aminotransferase og total-bilirubin.
English: For Grade 2 diarrhoea or colitis, nivolumab should be withheld.
Danish: Ved grad 2 diarre eller colitis udsættes nivolumab.
English: Do not use this medicine after the expiry date which is stated on the carton and the vial label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken og etiketten på hætteglasset efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • Contact details of the Nivolumab BMS prescriber
Danish: • Kontaktoplysninger på den læge, der har ordineret Nivolumab BMS
English: The total nivolumab dose in mg = the patient's weight in kg × the prescribed dose in mg/kg.
Danish: Den totale nivolumab dosis i mg = patientens vægt i kg × den ordinerede dosis i mg/kg.
English: The effect of hepatic impairment on the CL of nivolumab was evaluated in patients with mild hepatic impairment (total bilirubin 1.0 × to 1.5 × ULN or AST > ULN as defined using the National Cancer Institute criteria of hepatic dysfunction; n = 92) compared to patients with normal hepatic function (total bilirubin and AST ≤ ULN; n = 804) in the population PK analyses.
Danish: Effekten af nedsat leverfunktion på nivolumabs CL blev undersøgt hos patienter med let nedsat leverfunktion (total-bilirubin 1,0-1,5 × ULN eller ASAT > ULN i henhold til kriterierne fra National Cancer Institute for hepatisk dysfunktion; n = 92) i forhold til patienter med normal leverfunktion (total-bilirubin og ASAT ≤ ULN; n = 804) i de farmakokinetiske populationsanalyser.
English: The geometric mean clearance (CL), terminal half-life, and average exposure at steady state at 3 mg/kg every 2 weeks of nivolumab were 9.5 mL/h, 26.7 days, and 75.3 µg/mL, respectively, based on a population PK analysis.
Danish: Baseret på en farmakokinetisk populationsanalyse var nivolumabs gennemsnitlige geometriske clearance (CL), terminale halveringstid og gennemsnitlige eksponering ved steady state med 3 mg/kg hver 2. uge henholdsvis 9,5 ml/t, 26,7 dage og 75,3 µg/ml.
English: 10 mL of concentrate in a 10 mL vial (Type I glass) with a stopper (coated butyl rubber) and a grey flip-off seal (aluminium).
Danish: 10 ml koncentrat i et 10 ml hætteglas (type I-glas) med en prop (coated butylgummi) og et gråt flip-off låg (aluminium).
English: One patient required permanent discontinuation of nivolumab due to Grade 2 increases in transaminases.
Danish: Hos en patient var det nødvendigt at seponere nivolumab permanent på grund af grad 2 forhøjelse af aminotransferase.
English: The effect of renal impairment on the CL of nivolumab was evaluated in patients with mild (GFR < 90 and ≥ 60 mL/min/1.73 m2; n = 379), moderate (GFR < 60 and ≥ 30 mL/min/1.73 m2; n = 179), or severe (GFR < 30 and ≥ 15 mL/min/1.73 m2; n = 2) renal impairment compared to patients with normal renal function (GFR ≥ 90 mL/min/1.73 m2; n = 342) in population PK analyses.
Danish: I farmakokinetiske populationsanalyser blev effekten af nedsat nyrefunktion på nivolumabs CL vurderet hos patienter med let (90 > GFR ≥ 60 ml/min/1,73 m2; n = 379), moderat (60 > GFR ≥ 30 ml/min/1,73 m2; n = 179) eller svært (30 > GFR ≥ 15 ml/min/1,73 m2; n = 2) nedsat nyrefunktion i forhold til patienter med normal nyrefunktion (GFR ≥ 90 ml/min/1,73 m2; n = 342).
English: The other ingredients are sodium citrate dihydrate, sodium chloride (see section 2 " Nivolumab BMS contains sodium"), mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid and water for injections.
Danish: Øvrige indholdsstoffer: Natriumcitratdihydrat, natriumchlorid (se afsnit 2 ”Nivolumab BMS indeholder natrium”), mannitol (E421), diethylentriaminpentaeddikesyre, polysorbat 80, natriumhydroxid, saltsyre og vand til injektionsvæsker.
English: Nivolumab BMS must not be administered as an intravenous push or bolus injection.
Danish: Nivolumab BMS må ikke administreres som intravenøs bolus- eller push-injektion.
English: Resolution occurred in all 13 patients with a median time to resolution of 3.9 weeks (range: 0.6-13.4).
Danish: Resolution forekom hos alle 13 patienter med en mediantid til resolution på 3,9 uger (0,6-13,4).
English: Do not use Nivolumab BMS after the expiry date which is stated on the carton and on the vial label after EXP.
Danish: Brug ikke Nivolumab BMS efter den udløbsdato, der står på æsken og etiketten på hætteglasset efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Excipients: sodium citrate dihydrate, sodium chloride, mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid, water for injections.
Danish: Hjælpestoffer: natriumcitratdihydrat, natriumchlorid, mannitol (E421), diethylentriaminpentaeddikesyre, polysorbat 80, natriumhydroxid, saltsyre, vand til injektionsvæsker.
English: Nivolumab is associated with immune-related adverse reactions.
Danish: Nivolumab er associeret med immunrelaterede bivirkninger.
English: Upon improvement, nivolumab may be resumed after corticosteroid taper.
Danish: Når der indtræder bedring, kan nivolumab genoptages efter nedtrapning af kortikosteroid.
English: Nivolumab BMS infusion must not be administered as an intravenous push or bolus injection.
Danish: Nivolumab BMS-infusion må ikke administreres som intravenøs bolus- eller push-injektion.
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.
Danish: Nivolumab BMS kan gives som intravenøs administration enten: ufortyndet, efter overførsel til en infusionsbeholder ved brug af en passende steril sprøjte; eller efter fortynding til koncentrationer ned til 1 mg/ml.
English: Marketing Authorisation Holder Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park
English: Resolution occurred in 6 patients (50%) with a median time to resolution of 20.6 weeks (0.4-47.6+); +
Danish: Resolution forekom hos 6 patienter (50%) med en mediantid til resolution på 20,6 uger (0,4-47,6+); +
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.
Danish: Der blev ikke fundet klinisk relevante forskelle i nivolumabs CL hos patienter med let eller moderat nedsat nyrefunktion og patienter med normal nyrefunktion.
English: Nivolumab must be permanently discontinued for any severe immune-related adverse reaction that recurs and for any life-threatening immune-related adverse reaction.
Danish: Nivolumab skal seponeres permanent i tilfælde af enhver recidiverende alvorlig immunrelateret bivirkning og enhver livstruende immunrelateret bivirkning.
English: Resolution occurred in 19 patients (83%) with a median time to resolution of 2.0 weeks (range: 0.1-31.0).
Danish: Resolution forekom hos 19 patienter (83%) med en mediantid til resolution på 2,0 uger (0,1-31,0).
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
Danish: Meget almindelig forhøjet ASATb, forhøjet ALATb, forhøjet alkalisk fosfataseb, forhøjet kreatininb, nedsat antal lymfocytterb, nedsat antal blodpladerb, nedsat hæmoglobinb, hyperkalcæmib, hypokalcæmib, hyperkaliæmib, hypokaliæmib,
English: Permanently discontinue Nivolumab BMS Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4).
Danish: Nivolumab BMS seponeres permanent Bemærk: Toksicitetsgrader er i henhold til National Cancer Institute Common Terminology Criteria for Adverse
English: STEP 2 Transfer the concentrate into a sterile, evacuated glass bottle or intravenous container (PVC or
Danish: Overfør koncentratet til en steril, tom glasflaske eller intravenøs beholder (PVC eller polyolefin).
English: Nivolumab is most commonly associated with immune-related adverse reactions.
Danish: Nivolumab er som oftest forbundet med immunrelaterede bivirkninger.
English: Common increased total bilirubin,b decreased absolute neutrophil count,b hypermagnesaemia,b, hypernatraemiab
Danish: forhøjet total-bilirubinb, forhøjet absolut neutrofiltalb, hypermagnesiæmib,
English: If worsening or no improvement occurs despite initiation of corticosteroids, nivolumab must be permanently discontinued.
Danish: Hvis der opstår forværring, eller der ikke sker bedring, på trods af anvendelse af kortikosteroid, skal nivolumab seponeres permanent.
English: Median time to onset was 11.6 weeks (range: 2.6-85.1).
Danish: Mediantiden til indtræden var 11,6 uger (2,6-85,1).
English: Musculoskeletal pain is a composite term which includes back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, myalgia, neck pain, pain in extremity, pain in jaw, spinal pain.
Danish: Muskuloskeletale smerter er en sammensat term, der omfatter rygsmerter, knoglesmerter, muskuloskeletale brystsmerter, muskuloskeletale gener, myalgi, nakkesmerter, smerter i arme og ben, smerter i kæben, smerter i rygsøjlen.
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.
Danish: Nivolumab BMS skal administreres med forsigtighed til patienter med moderat nedsat leverfunktion (total-bilirubin > 1,5-3 × den øvre grænse for normalområdet [ULN] og hvilken som helst ASAT) og svært nedsat leverfunktion (total-bilirubin > 3 × ULN og hvilken som helst ASAT).
English: However, once you are treated with Nivolumab BMS, your doctor may give you corticosteroids to reduce any possible side-effects that you may have during your treatment and this will not impact the effect of the medicine.
Danish: Når du først er i behandling med Nivolumab BMS, kan lægen imidlertid godt give dig kortikosteroider for at dæmpe de bivirkninger, du kan få under behandlingen.
English: No clinically important differences in the CL of nivolumab were found between patients with mild hepatic impairment and normal hepatic function.
Danish: Der blev ikke fundet klinisk relevante forskelle i nivolumabs CL hos patienter med let nedsat leverfunktion og patienter med normal leverfunktion.
English: To further investigate at post-approval the possible change in PD-L1 status of the tumour during treatment and/or tumour progression in Studies CA209-009, CA209-038 and CA209-064.
Danish: Yderligere at undersøge den mulige ændring i tumorens PD-L1-status under behandling og/eller tumorprogression i studierne CA209-009,
English: Inflammation of the skin that can lead to rash and itching.
Danish: Betændelseslignende reaktion (inflammation) i huden, som kan medføre udslæt og kløe.
English: It is available in packs containing either 1 vial of 4 mL or 1 vial of 10 mL.
Danish: Det fås i æsker med enten 1 hætteglas med 4 ml eller 1 hætteglas med 10 ml.
English: Clear to opalescent, colourless to pale yellow liquid that may contain few light particles.
Danish: Klar til opaliserende, farveløs til lysegul væske, der kan indeholde få lyse partikler.
English: Based on the population pharmacokinetic (PK) results, no dose adjustment is required in patients with mild or moderate renal impairment (see section 5.2).
Danish: Baseret på populationsfarmakokinetiske resultater er dosisjustering ikke nødvendig hos patienter med let eller moderat nedsat nyrefunktion (se pkt.
English: Withhold Nivolumab BMS until symptoms resolve, radiographic abnormalities improve, and management with corticosteroids is complete
Danish: Nivolumab BMS udsættes, indtil symptomer forsvinder, radiografiske anormaliteter bedres, og behandling med kortikosteroid er afsluttet
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.
Danish: Diarre (vandig, løs eller blød afføring) eller symptomer på betændelse i tarmene (colitis), som f.eks. mavesmerter og slim eller blod i afføringen.
English: The infusion should be prepared in a laminar flow hood or safety cabinet using standard precautions for the safe handling of intravenous agents.
Danish: Infusionen skal klargøres i LAF-bænk eller sikkerhedskabinet under hensyntagen til gældende forholdsregler for sikker
English: For storage conditions after preparation of the infusion, see section 6.3.
Danish: Opbevaringsforhold efter klargøring af infusionsvæsken, se pkt.
English: The pharmacokinetics (PK) of nivolumab is linear in the dose range of 0.1 to 10 mg/kg.
Danish: Nivolumabs farmakokinetik er lineær i dosisintervallet 0,1 til 10 mg/kg.
English: Inflammation of the intestines (colitis), ulcer of the small intestines Inflammation of muscles causing pain or stiffness
Danish: Betændelse i tarmene (colitis), sår på tyndtarmen Inflammation i musklerne med smerter og stivhed
English: • That Nivolumab BMS treatment may increase the risk of:
Danish: • Patient-informationskortet skal indeholde følgende hovedelementer: • At behandling med Nivolumab BMS kan øge risikoen for:
English: Based on the severity of the adverse reaction, nivolumab should be withheld and corticosteroids administered.
Danish: Afhængigt af bivirkningens sværhedsgrad bør nivolumabdosering udsættes og kortikosteroid administreres.
English: o Immune-related nephritis or renal dysfunction
Danish: Immunrelateret nefritis eller nedsat nyrefunktion