natgillin/translations-raw huggingface dataset:
I alt 272 patienter blev randomiseret til at få enten nivolumab (n = 135) 3 mg/kg intravenøst over 60 minutter hver 2. uge eller docetaxel (n = 137) 75 mg/m2 hver 3. uge.
A total of 272 patients were randomised to receive either nivolumab 3 mg/kg (N = 135) administered intravenously over 60 minutes every 2 weeks or docetaxel (n = 137) 75 mg/m2 every 3 weeks.
Disse analyser vil blive udført i studierne CA 209037 og CA209066 hos patienter med
These analyses will be conducted in Studies CA 209037 and CA209066 in patients with advanced melanoma.
Det skal administreres som intravenøs infusion over 60 minutter.
It is to be administered as an intravenous infusion over a period of 60 minutes.
Hætteglassene skal opbevares i den originale yderpakning for at beskytte mod lys.
The vials must be kept in the original package in order to protect from light.
Nivolumab BMS indeholder natrium
Nivolumab BMS contains sodium
Patienten skal monitoreres for tegn og symptomer på pneumonitis, som f.eks. radiografiske ændringer (f.eks. små fokale matglasforandringer (ground glass opacities), pletvis infiltration), dyspnø og hypoxi.
Patients should be monitored for signs and symptoms of pneumonitis such as radiographic changes (e.g., focal ground glass opacities, patchy filtrates), dyspnoea, and hypoxia.
I de puljede data fra to studier hos patienter med planocellulært NSCLC (CA209017 og CA209063) var de hyppigste bivirkninger (≥ 10% af patienterne) træthed (33%), nedsat appetit (15%) og kvalme (12%).
In the pooled dataset of two studies in squamous NSCLC (CA209017 and CA209063), the most frequent adverse reactions (≥ 10% of patients) were fatigue (33%), decreased appetite (15%), and nausea (12%).
Derfor er nivolumabs påvirkning af fertiliteten hos hanner og hunner ukendt.
Thus, the effect of nivolumab on male and female fertility is unknown.
ECOG performance status ved baseline var 0 (24%) eller 1 (76%).
Baseline ECOG performance status score was 0 (24%) or
Nivolumab viste numerisk mindre effekt på OS (HR=1,85; 95% CI: 0,76; 4,51), PFS (HR=1,76; 95% CI: 0,77; 4,05 ) og ORR (9,1% versus 16,7%).
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%).
Behandlingen skal initieres og superviseres af en læge med erfaring i cancerbehandling.
4.2 Posology and method of administration Treatment must be initiated and supervised by physicians experienced in the treatment of cancer.
Randomiseret fase 3-studie versus docetaxel (CA209017)
Randomised phase 3 study vs. docetaxel (CA209017)
Behandlingen bør fortsættes, så længe der observeres en klinisk gavnlig effekt, eller indtil patienten ikke længere tolererer behandlingen.
Treatment should be continued as long as clinical benefit is observed or until treatment is no longer tolerated by the patient.
Tegn og symptomer på hepatitis kan være unormale prøver for leverfunktionen, gulfarvning af øjnene eller huden (gulsot), smerter i den højre side af maven eller træthed.
Signs and symptoms of hepatitis may include abnormal liver function tests, eye or skin yellowing (jaundice), pain on the right side of your stomach area, or tiredness.
Studie CA209063 var et åbent enkeltarmsstudie med 117 patienter med lokalt fremskredent eller metastatisk planocellulært NSCLC efter to eller flere tidligere behandlingsforløb; derudover blev de samme inklusionskriterier som i studie CA209017 anvendt.
Study CA209063 was a single-arm, open-label study conducted in 117 patients with locally advanced or metastatic squamous-NSCLC after two or more lines of therapy; otherwise similar inclusion criteria as study CA209017 were applied.
Nivolumab BMS-infusionsvæske er kompatibel med PVC-og polyolefin-beholdere, glasflasker, PVC-infusionssæt og in-line filtre af polyethersulfonmembraner med en porestørrelse på 0,2 μm til 1,2 μm.
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.
Nivolumab BMS skal opbevares i køleskab (2°C til 8°C).
Nivolumab BMS must be stored in a refrigerator (2°C to 8°C).
I kliniske studier blev der på tværs af doser og tumortyper rapporteret følgende immunrelaterede bivirkninger hos færre end 1% af de nivolumab-behandlede patienter: pancreatitis, uveitis, demyelinisering, autoimmun neuropati (herunder facial og nervus abducens parese), Guillain-Barré syndrom, hypopituitarisme og myastenisk syndrom.
The following immune-related adverse reactions were reported in less than 1% of patients treated with nivolumab in clinical trials across doses and tumour types: pancreatitis, uveitis, demyelination, autoimmune neuropathy (including facial and abducens nerve paresis), Guillain-Barré syndrome, hypopituitarism, and myasthenic syndrome.
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).
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).
Detaljerede retningslinjer for håndtering af immunrelaterede bivirkninger er beskrevet i pkt.
Detailed guidelines for the management of immune-related adverse reactions are described in section 4.4.
Den ordinerende læge skal tale med patienten om de risici, der er forbundet med behandling med Nivolumab BMS.
The prescriber must discuss the risks of Nivolumab BMS therapy with the patient.
Hyppigheden af binyrebarkinsufficiens var 0,4% (1/248; grad 3).
The incidence of adrenal insufficiency was 0.4% (1/248; Grade 3).
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).
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.
I murine drægtighedsmodeller er blokering af PD-L1 signalering vist at ødelægge tolerancen for fosteret og øge fosterdødeligheden.
Blockade of PD-L1 signalling has been shown in murine models of pregnancy to disrupt tolerance to the foetus and to increase foetal loss.
Kontroller Nivolumab BMS-koncentratet for partikler eller misfarvning.
Inspect the Nivolumab BMS concentrate for particulate matter or discoloration.
Ved grad 2 forhøjelse af aminotransferase eller total-bilirubin udsættes nivolumabdosering.
For Grade 2 transaminase or total bilirubin elevation, nivolumab should be withheld.
Ikke anvendte lægemidler samt affald heraf bør bortskaffes i henhold til lokale retningslinjer.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Betændelsestilstand i nyrerne eller problemer med nyrerne.
Inflammation or problems with your kidneys.
Hos en patient var det nødvendigt at seponere nivolumab permanent på grund af grad 3 diarre.
One patient required permanent discontinuation of nivolumab due to Grade 3 diarrhoea.
Hvis du glemmer en aftale, skal du bede lægen om at få en ny aftale.
If you miss an appointment, ask your doctor when to schedule your next dose.
Behandlingen fortsatte så længe, der kunne observeres kliniske fordele, eller indtil patienten ikke længere tålte behandlingen.
Treatment was continued as long as clinical benefit was observed or until treatment was no longer tolerated.
• Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre følgende
• Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: Description
En ml af dette lægemiddel indeholder 0,1 mmol (eller 2,5 mg) natrium.
Each mL of this medicinal product contains 0.1 mmol (or 2.5 mg) sodium.
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).
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).
30. september 2017
30th September 2017
Patienter bør monitoreres for tegn og symptomer på nefritis og nedsat nyrefunktion.
Patients should be monitored for signs and symptoms of nephritis and renal dysfunction.
Ingen grad 4 eller 5 nefritis eller nedsat nyrefunktion blev rapporteret i disse studier.
No Grade 4 or 5 nephritis or renal dysfunction was reported in these studies.
4 ml koncentrat i et 10 ml hætteglas (type I-glas) med en prop (coated butylgummi) og et mørkeblåt flip-off låg (aluminium).
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).
Data for følgende immunrelaterede bivirkninger er baseret på patienter, som fik nivolumab 3 mg/kg i to NSCLC-studier (CA209017 og CA209063, se pkt.
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).
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.
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.
Nivolumab 3 mg/kg (hændelser: 86/135), median og 95% CI: 9,23 (7,33; 13,27)
Nivolumab 3 mg/kg (events : 86/135), median and 95% CI : 9.23 (7.33, 13.27)
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
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).
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.
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.
Fortæl det til lægen, inden du får Nivolumab BMS, hvis du er på en diæt med lavt natriumindhold (lavt saltindhold).
Tell your doctor if you are on a low-sodium (low-salt) diet before you are given Nivolumab BMS.
Svær pneumonitis eller interstitiel lungesygdom, herunder dødelige tilfælde, er observeret med nivolumab-behandling (se pkt.
Severe pneumonitis or interstitial lung disease, including fatal cases, has been observed with nivolumab treatment (see section 4.8).
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.
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
Derudover blev symptombedring og overordnet helbredsstatus vurderet ved hjælp af henholdsvis det gennemsnitlige symptombyrde-indeks fra Lung Cancer Symptom Score (LCSS) og
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.
LÆGEMIDLETS NAVN, STYRKE OG ADMINISTRATIONSVEJ(E) Nivolumab BMS 10 mg/ml sterilt koncentrat nivolumab
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nivolumab BMS 10 mg/mL sterile concentrate nivolumab
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.
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).
Anbefalinger for hormonsubstitutionsbehandling er beskrevet i pkt.
Recommendation for the use of hormone replacement therapy is provided in section 4.4.
Systemiske kortikosteroider og andre immunsuppressiva kan imidlertid anvendes til behandling af immunrelaterede bivirkninger efter initiering af nivolumab.
However, systemic corticosteroids and other immunosuppressants can be used after starting nivolumab to treat immune-related adverse reactions.
Yderligere at undersøge sammenhængen mellem PDL-1- og PDL2-ekspression i fase 1 (CA209009, CA209038 og CA209064) efter
To further investigate at post-approval the relation between PDL-1 and PDL-2 expression in Phase 1 (CA209009, CA209038 and
Ingen grad 4 eller 5 tilfælde blev rapporteret i disse studier.
No Grade 4 or 5 cases were reported in these studies.
Patienten bør monitoreres for diarre og yderligere symptomer på immunrelateret colitis som f.eks. abdominalsmerter og slim eller blod i afføringen.
Patients should be monitored for diarrhoea and additional symptoms of colitis, such as abdominal pain and mucus or blood in stool.
Patienten bør monitoreres for tegn og symptomer på hepatitis som f.eks. forhøjet aminotransferase og total-bilirubin.
Patients should be monitored for signs and symptoms of hepatitis such as transaminase and total bilirubin elevations.
Ved grad 2 diarre eller colitis udsættes nivolumab.
For Grade 2 diarrhoea or colitis, nivolumab should be withheld.
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.
Do not use this medicine after the expiry date which is stated on the carton and the vial label after EXP.
• Kontaktoplysninger på den læge, der har ordineret Nivolumab BMS
• Contact details of the Nivolumab BMS prescriber
Den totale nivolumab dosis i mg = patientens vægt i kg × den ordinerede dosis i mg/kg.
The total nivolumab dose in mg = the patient's weight in kg × the prescribed dose in mg/kg.
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.
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.
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.
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.
10 ml koncentrat i et 10 ml hætteglas (type I-glas) med en prop (coated butylgummi) og et gråt flip-off låg (aluminium).
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).
Hos en patient var det nødvendigt at seponere nivolumab permanent på grund af grad 2 forhøjelse af aminotransferase.
One patient required permanent discontinuation of nivolumab due to Grade 2 increases in transaminases.
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).
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.
Øvrige indholdsstoffer: Natriumcitratdihydrat, natriumchlorid (se afsnit 2 ”Nivolumab BMS indeholder natrium”), mannitol (E421), diethylentriaminpentaeddikesyre, polysorbat 80, natriumhydroxid, saltsyre og vand til injektionsvæsker.
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.
Nivolumab BMS må ikke administreres som intravenøs bolus- eller push-injektion.
Nivolumab BMS must not be administered as an intravenous push or bolus injection.
Resolution forekom hos alle 13 patienter med en mediantid til resolution på 3,9 uger (0,6-13,4).
Resolution occurred in all 13 patients with a median time to resolution of 3.9 weeks (range: 0.6-13.4).
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.
Do not use Nivolumab BMS after the expiry date which is stated on the carton and on the vial label after EXP.
Hjælpestoffer: natriumcitratdihydrat, natriumchlorid, mannitol (E421), diethylentriaminpentaeddikesyre, polysorbat 80, natriumhydroxid, saltsyre, vand til injektionsvæsker.
Excipients: sodium citrate dihydrate, sodium chloride, mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid, water for injections.
Nivolumab er associeret med immunrelaterede bivirkninger.
Nivolumab is associated with immune-related adverse reactions.
Når der indtræder bedring, kan nivolumab genoptages efter nedtrapning af kortikosteroid.
Upon improvement, nivolumab may be resumed after corticosteroid taper.
Nivolumab BMS-infusion må ikke administreres som intravenøs bolus- eller push-injektion.
Nivolumab BMS infusion must not be administered as an intravenous push or bolus injection.
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.
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.
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park
Marketing Authorisation Holder Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road
Resolution forekom hos 6 patienter (50%) med en mediantid til resolution på 20,6 uger (0,4-47,6+); +
Resolution occurred in 6 patients (50%) with a median time to resolution of 20.6 weeks (0.4-47.6+); +
Der blev ikke fundet klinisk relevante forskelle i nivolumabs CL hos patienter med let eller moderat nedsat nyrefunktion og patienter med normal nyrefunktion.
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.
Nivolumab skal seponeres permanent i tilfælde af enhver recidiverende alvorlig immunrelateret bivirkning og enhver livstruende immunrelateret bivirkning.
Nivolumab must be permanently discontinued for any severe immune-related adverse reaction that recurs and for any life-threatening immune-related adverse reaction.
Resolution forekom hos 19 patienter (83%) med en mediantid til resolution på 2,0 uger (0,1-31,0).
Resolution occurred in 19 patients (83%) with a median time to resolution of 2.0 weeks (range: 0.1-31.0).
Meget almindelig forhøjet ASATb, forhøjet ALATb, forhøjet alkalisk fosfataseb, forhøjet kreatininb, nedsat antal lymfocytterb, nedsat antal blodpladerb, nedsat hæmoglobinb, hyperkalcæmib, hypokalcæmib, hyperkaliæmib, hypokaliæmib,
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
Nivolumab BMS seponeres permanent Bemærk: Toksicitetsgrader er i henhold til National Cancer Institute Common Terminology Criteria for Adverse
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).
Overfør koncentratet til en steril, tom glasflaske eller intravenøs beholder (PVC eller polyolefin).
STEP 2 Transfer the concentrate into a sterile, evacuated glass bottle or intravenous container (PVC or
Nivolumab er som oftest forbundet med immunrelaterede bivirkninger.
Nivolumab is most commonly associated with immune-related adverse reactions.
forhøjet total-bilirubinb, forhøjet absolut neutrofiltalb, hypermagnesiæmib,
Common increased total bilirubin,b decreased absolute neutrophil count,b hypermagnesaemia,b, hypernatraemiab
Hvis der opstår forværring, eller der ikke sker bedring, på trods af anvendelse af kortikosteroid, skal nivolumab seponeres permanent.
If worsening or no improvement occurs despite initiation of corticosteroids, nivolumab must be permanently discontinued.
Mediantiden til indtræden var 11,6 uger (2,6-85,1).
Median time to onset was 11.6 weeks (range: 2.6-85.1).
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.
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.
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).
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.