FrancophonIA/ELRC3.0 huggingface dataset:
English: It is unknown whether nivolumab is secreted in human milk.
Danish: Det er ukendt, om nivolumab udskilles i human mælk.
English: As with all therapeutic proteins, there is a potential for an immune response to nivolumab.
Danish: Som det er tilfældet med alle terapeutiske proteiner, er dannelse af antistoffer mod nivolumab en mulighed.
English: Be aware of important symptoms of inflammation.
Danish: Vær opmærksom på vigtige symptomer på inflammation (betændelseslignende tilstand).
English: Inflammation of the liver (hepatitis).
Danish: Leverbetændelse (hepatitis).
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:
Danish: I alle de medlemslande, hvor Nivolumab BMS markedsføres, skal indehaveren af markedsføringstilladelsen sikre, at al plejepersonale og patienter/omsorgspersoner, som forventes at udskrive og/eller anvende Nivolumab BMS, har adgang til/har modtaget følgende uddannelsespakke:
English: These may be signs of inflammation of the lungs (pneumonitis or interstitial lung disease).
Danish: Det kan være tegn på en betændelsestilstand (inflammation) i lungerne (pneumonitis eller interstitiel lungesygdom).
English: There was no evidence of altered pharmacokinetic or toxicity profile associated with anti-product-antibody development.
Danish: Der sås ingen tegn på ændret farmakokinetisk profil eller toksicitetsprofil i forbindelse med dannelsen af antistoffer mod
English: Recommended treatment modifications for Nivolumab BMS
Danish: Anbefalede sændringer i Nivolumab BMS-behandling
English: Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of nivolumab (see “Description of selected adverse reactions” below).
Danish: De fleste af disse bivirkninger, hvoraf nogle er alvorlige, forsvandt efter initiering af passende medicinsk behandling eller seponering af nivolumab (se nedenstående ”Beskrivelse af udvalgte bivirkninger”).
English: If immunosuppression with corticosteroids is used to treat an adverse reaction, a taper of at least 1 month duration should be initiated upon improvement.
Danish: Hvis immunsuppression med kortikosteroider anvendes til behandling af en bivirkning, skal nedtrapning over mindst 1 måned initieres, når der er opnået bedring.
English: It is very important for you to keep all your appointments to receive Nivolumab BMS.
Danish: Det er meget vigtigt, at du overholder alle dine aftaler om behandling med Nivolumab BMS.
English: 31st March 2017
Danish: 31. marts 2017
English: This medicine contains 2.5 mg sodium per mL of concentrate.
Danish: Denne medicin indeholder 2,5 mg natrium pr. ml koncentrat.
English: Studies to evaluate the effect of nivolumab on fertility have not been performed.
Danish: Der er ikke udført studier til vurdering af nivolumabs virkning på fertilitet.
English: Problems with your hormone producing glands (including the pituitary, the thyroid and adrenal glands) that may affect how these glands work.
Danish: Problemer med hormonproducerende kirtler (herunder hypofysen, skjoldbruskkirtlen og binyrerne), som kan påvirke, hvordan disse kirtler fungerer.
English: As monoclonal antibodies are not metabolised by cytochrome P450 (CYP) enzymes or other drug metabolising enzymes, inhibition or induction of these enzymes by co-administered medicinal products is not anticipated to affect the pharmacokinetics of nivolumab.
Danish: Eftersom monoklonale antistoffer ikke metaboliseres af cytochrom P450 (CYP)-enzymer eller andre lægemiddelmetaboliserende enzymer, forventes det ikke, at nivolumabs farmakokinetik vil blive påvirket af samtidigt administrerede lægemidlers hæmning eller induktion af disse enzymer.
English: Of the 497 patients who were treated with nivolumab 3 mg/kg every 2 weeks and evaluable for the presence of anti-product-antibodies, 51 (10.3%) patients tested positive for treatment-emergent anti-product antibodies by an electrochemiluminescent (ECL) assay.
Danish: Af de 497 patienter, som blev behandlet med nivolumab 3 mg/kg hver 2. uge og undersøgt for antistoffer mod lægemidlet, blev 51 patienter (10,3%) testet positive for behandlingsrelaterede antistoffer mod lægemidlet ved hjælp af en elektrokemiluminescensanalyse (ECL).
English: Nivolumab BMS infusion must be completed within 24 hours of preparation.
Danish: Administration af Nivolumab BMS-infusion skal være afsluttet inden for 24 timer efter klargøring.
English: Docetaxel (events : 113/137), median and 95% CI : 6.01 (5.13, 7.33)
Danish: Docetaxel (hændelser: 113/137), median og 95% CI: 6,01 (5,13; 7,33)
English: Patients with treated brain metastases were eligible if neurologically returned to baseline at least 2 weeks prior to enrolment, and either off corticosteroids, or on a stable or decreasing dose of <10 mg daily prednisone equivalents.
Danish: Patienter med behandlede hjernemetastaser var egnede til at deltage, hvis de neurologisk var vendt tilbage til baseline mindst 2 uger før studieoptagelse og enten havde afsluttet kortikosteroid-behandling eller var på en stabil eller faldende dosis ækvivalent med <10 mg prednison dagligt.
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.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Klargøring af lægemidlet skal foretages af uddannet personale i overensstemmelse med god praksis, især med henblik på aseptik.
English: Neutralising antibodies were detected in only 5 (1.0% of the total) of the positive anti-product-antibody patients.
Danish: Neutraliserende antistoffer blev kun påvist i 5 (1,0%) af det samlede antal af de prøver, der var testet positive for antistoffer mod lægemidlet.
English: Patients with active autoimmune disease, symptomatic interstitial lung disease, or untreated brain metastasis were excluded from the study.
Danish: Patienter med aktiv autoimmun sygdom, symptomatisk interstitiel lungesygdom eller ubehandlede hjernemetastaser blev ekskluderet fra studiet.
English: The final infusion concentration should range between 1 and 10 mg/mL.
Danish: Den færdige koncentration i infusionsvæsken bør være fra 1 til 10 mg/ml.
English: Severe infusion reactions have been reported in clinical trials (see section 4.8).
Danish: Alvorlige infusionsreaktioner er blevet rapporteret i kliniske forsøg (se pkt.
English: Each vial contains either 40 mg (in 4 mL) or 100 mg (in 10 mL) of nivolumab.
Danish: Et hætteglas indeholder enten 40 mg (i 4 ml) eller 100 mg (i 10 ml) nivolumab.
English: Nivolumab BMS is a medicine used to treat advanced non-small cell lung cancer (a type of lung cancer) in adults.
Danish: Nivolumab BMS anvendes til behandling af fremskreden ikke små-cellet lungekræft (en bestemt type lungekræft) hos voksne.
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).
Danish: Nivolumabs effekt på prænatal og postnatal udvikling blev undersøgt hos aber, der fik nivolumab to gange ugentligt fra starten af organogenesen i første trimester indtil fødslen ved eksponeringsniveauer, der var enten 8 eller 35 gange højere end eksponeringen ved den kliniske dosis af nivolumab på 3 mg/kg (baseret på AUC).
English: In case of a severe infusion reaction, nivolumab infusion must be discontinued and appropriate medical therapy administered.
Danish: I tilfælde af en svær infusionsreaktion skal nivolumab-infusionen afbrydes og passende medicinsk behandling administreres.
English: By attaching to PD-1, nivolumab blocks its action and prevents it from switching off your T cells.
Danish: Ved at binde sig til PD-1 blokerer nivolumab PD-1's aktivitet og hindrer det i at slukke for aktiviteten af dine T-celler.
English: In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted immediately.
Danish: I tilfælde af overdosering skal patienten monitoreres tæt for tegn og symptomer på bivirkninger og passende symptomatisk behandling straks iværksættes.
English: The use of systemic corticosteroids and other immunosuppressants at baseline, before starting nivolumab, should be avoided because of their potential interference with the pharmacodynamic activity.
Danish: Brug af systemiske kortikosteroider og andre immunsuppressiva bør undgås ved baseline, inden behandling med nivolumab indledes, på grund af den potentielle risiko for påvirkning af den farmakodynamiske aktivitet.
English: Engagement of PD-1 with the ligands PD-L1 and PD-L2, which are expressed in antigen presenting cells and may be expressed by tumours or other cells in the tumour microenvironment, results in inhibition of T-cell proliferation and cytokine secretion.
Danish: PD-1s interaktion med liganderne PD-L1 og PD-L2, der udtrykkes i antigenpræsenterende celler og muligvis af tumorer eller andre celler i tumors mikromiljø, medfører hæmning af T-celleproliferation og udskillelse af cytokiner.
English: This helps increase their activity against the lung cancer cells.
Danish: Dette medvirker til at øge T-cellernes aktivitet mod
English: A population PK analysis suggested no difference in CL of nivolumab based on age, gender, race, tumour type, tumour size, and hepatic impairment.
Danish: En farmakokinetisk populationsanalyse tydede ikke på nogen forskel i nivolumabs CL på basis af alder, køn, race, tumortype, tumorstørrelse og nedsat leverfunktion.
English: In syngeneic mouse models, blocking PD-1 activity resulted in decreased tumour growth.
Danish: I syngene musemodeller resulterede blokering af PD-1-aktivitet i nedsat tumorvækst.
English: A decision must be made whether to discontinue breast-feeding or to discontinue from nivolumab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Amning skal besluttes, om amning skal ophøre eller behandling med nivolumab seponeres, idet der tages hensyn til fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: In CA209017 and CA209063, the proportion of patients who experienced a shift from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 13.2% for decreased lymphocytes, 9% for hyponatraemia, 2.9% for hypercalcaemia and hyperkalaemia, 2.5% for decreased haemoglobin (all Grade 3), 2.0% for hypokalaemia, 1.6% for decreased neutrophil count, 1.3% for hypomagnesaemia, 1.2% for hypocalcaemia, 0.8% for increased total bilirubin, and 0.4% for increased AST, decreased platelet, hypermagnesaemia, and hypernatraemia.
Danish: I CA209017 og CA209063 var andelen af patienter, som oplevede et skift fra baseline til en grad 3 eller 4 laboratorietestabnormitet, følgende: 13,2% for nedsat lymfocyttal, 9% for hyponatriæmi, 2,9% for hyperkalciæmi og hyperkaliæmi, 2,5% for nedsat hæmoglobin (alle grad 3), 2,0% for hypokaliæmi, 1,6% for nedsat neutrofiltal, 1,3% for hypomagnesiæmi, 1,2% for hypokalcæmi, 0,8% for forhøjet total-bilirubin og 0,4% for forhøjet ASAT, nedsat trombocyttal, hypermagnesiæmi og hypernatriæmi.
English: Dosing delay or discontinuation may be required based on individual safety and tolerability.
Danish: På baggrund af individuel sikkerhed og tolerance kan udsættelse af dosis eller seponering være nødvendig.
English: From a microbiological point of view, once opened, the medicinal product should be infused or diluted and infused immediately.
Danish: Ud fra en mikrobiologisk betragtning bør lægemidlet infunderes eller fortyndes og infunderes
English: The recommended dose of Nivolumab BMS is 3 mg/kg administered intravenously over 60 minutes every 2 weeks.
Danish: Den anbefalede dosis Nivolumab BMS er 3 mg/kg administreret intravenøst over en periode på 60 minutter hver 2. uge.
English: Check with your doctor or nurse before you are given Nivolumab BMS if: you have been told that your cancer has spread to your brain you have an autoimmune disease (a condition where the body attacks its own cells); you have any history of inflammation of the lungs; you have been taken medicines to suppress your immune system.
Danish: Tal med lægen eller sygeplejersken, inden du får Nivolumab BMS, hvis: du har fået at vide, at kræften har spredt sig til hjernen; du har en autoimmun sygdom (en tilstand, hvor kroppen angriber sine egne celler);
English: 31st December 2017 30th September 2017
Danish: 31. december 2017 30. september 2017
English: Disease-related aetiologies should be ruled out.
Danish: Sygdomsrelaterede ætiologier skal udelukkes.
English: • Signs or symptoms of the safety concern and when to seek attention from a HCP
Danish: • Tegn og symptomer på bivirkningerne, og hvornår patienten skal kontakte sundhedspersonalet
English: Infectious and disease-related aetiologies should be ruled out.
Danish: Infektiøse og sygdomsrelaterede ætiologier skal udelukkes.
English: Nivolumab potentiates T-cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands.
Danish: Nivolumab forstærker T-celleresponset, herunder anti-tumorresponset, ved at blokere PD-1-binding til PD-L1- og PD-L2-ligander.
English: If not used immediately, the solution may be stored under refrigeration conditions (2°C-8°C) and protected from light for up to 24 hours [a maximum of 4 hours of the total 24 hours can be at room temperature (20°C-25°C) and room light].
Danish: Hvis Nivolumab BMS ikke anvendes straks, kan den opbevares i køleskab (2°C-8°C) og beskyttet mod lys i op til 24 timer [højst 4 timer ud af de 24 timer ved stuetemperatur (20°C-25°C) og dagslys].
English: Signs and symptoms that these glands are not working properly may include fatigue (extreme tiredness), weight change or headache and visual disturbances.
Danish: Tegn og symptomer på at disse kirtler ikke virker korrekt kan være udmattelse (voldsom træthed), vægtændringer, hovedpine og synsforstyrrelser.
English: Withdraw the required volume of Nivolumab BMS concentrate using an appropriate sterile
Danish: Udtag det nødvendige volumen Nivolumab BMS-koncentrat ved brug af en passende steril
English: Severe endocrinopathies, including hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis, diabetes mellitus, and diabetic ketoacidosis have been observed with nivolumab treatment.
Danish: Svære endokrinopatier, herunder hypotyroidisme, hypertyroidisme, binyrebarkinsufficiens, hypofysitis, diabetes mellitus og diabetisk ketoacidose er observeret med nivolumab-behandling.
English: It is not known whether nivolumab gets into breast milk.
Danish: Man ved ikke, om nivolumab udskilles i mælk.
English: Based on this prescribed dose, calculate the total dose to be given.
Danish: Totaldosis beregnes på baggrund af den ordinerede dosis.
English: Signs and symptoms may include abnormal kidney function tests, or decreased volume of urine.
Danish: Tegn og symptomer kan være unormale prøver for nyrefunktionen eller nedsat urinmængde.
English: To further investigate the value biomarkers other than PD-L1 expression status at tumour cell membrane level by IHC (e.g., other methods / assays, and associated cut-offs, that might prove more sensitive and specific in predicting response to treatment based on PD-L1, PD-L2, tumour infiltrating lymphocytes with measurement of CD8+T density, RNA signature, etc.) as predictive of nivolumab efficacy.
Danish: At undersøge værdien af andre biomarkører end PD-L1-ekspressionstatus ved tumorcellemembran-niveau ved immunhistokemisk (IHC) analyse (f.eks. andre metoder / analyser og relaterede cut-offs, som kan vise sig at være mere følsomme og specifikke til at forudse respons på behandlingen, baseret på PD-L1, PD-L2, tumorinfiltrerende lymfocytter med måling af CD8+T-densitet, RNA-signatur etc.) som prædiktive for nivolumabs virkning.
English: Adverse reactions reported in the pooled dataset (n=248) of CA209017 and CA209063 are presented in Table 2.
Danish: Bivirkninger, der blev rapporteret i de puljede datasæt (n = 248) fra CA209017 og CA209063 er vist i tabel 2.
English: Patients may present with fatigue, headache, mental status changes, abdominal pain, unusual bowel habits, and hypotension, or nonspecific symptoms which may resemble other causes such as brain metastasis or underlying disease.
Danish: Patienten kan opleve træthed, hovedpine, ændring i mental tilstand, abdominalsmerter, ændret afføringsmønster og hypotension eller uspecifikke symptomer, der kan minde om andre ætiologier, som f.eks. hjernemetastaser eller underliggende sygdom.
English: Figure 1: Kaplan-Meier curves of OS (CA209017)
Danish: Figur 1: Kaplan-Meier kurver over OS (CA209017)
English: The volume of Nivolumab BMS concentrate to prepare the dose (mL) = the total dose in mg, divided by 10 (the Nivolumab BMS concentrate strength is 10 mg/mL).
Danish: Volumen (ml) af Nivolumab BMS-koncentrat til klargøring af dosis = den totale dosis i mg, divideret med 10 (styrken af Nivolumab BMS-koncentratet er 10 mg/ml).
English: Median time to onset of these endocrinopathies was 17.8 weeks (range: 6.1-33.1).
Danish: Mediantiden til indtræden af disse endokrinopatier var 17,8 uger (6,1-33,1).
English: Nivolumab should be withheld for Grade 3 rash and discontinued for Grade 4 rash.
Danish: Nivolumabdosering skal udsættes ved grad 3 udslæt og seponeres ved grad 4 udslæt.
English: Nivolumab BMS is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.
Danish: Nivolumab BMS er indiceret til behandling af lokalt fremskredent eller metastatisk planocellulært ikke-småcellet lungecancer (NSCLC) hos voksne efter tidligere behandling med kemoterapi.
English: Nivolumab is a human monoclonal antibody, as such pharmacokinetic interaction studies have not been conducted.
Danish: Nivolumab er et humant monoklonalt antistof, og egentlige interaktionsstudier er ikke udført.
English: These include: A decreased number of red blood cells (which carry oxygen), white blood cells (which are important in fighting infection) or platelets (cells which help the blood to clot) Abnormal liver function tests (increased amounts of the liver enzymes aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase in your blood, higher blood
Danish: Disse kan være: Nedsat mængde røde blodlegemer (som transporter ilt), hvide blodlegemer (som er vigtige for at kunne bekæmpe infektioner) eller blodplader (der hjælper blodet med at størkne) Unormale prøver for leverfunktionen (øget mængde af leverenzymerne aspartataminotransferase, alaninaminotransferase eller alkalisk fosfatase i blodet, øget indhold
English: Glass bottles
Danish: Glasflasker
English: A risk to the breast-fed infant cannot be excluded.
Danish: Det kan ikke udelukkes, at der er en risiko for det ammede barn.
English: 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.
Danish: 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.
English: These analyses will be conducted in Studies CA 209037 and CA209066 in patients with advanced melanoma.
Danish: Disse analyser vil blive udført i studierne CA 209037 og CA209066 hos patienter med
English: It is to be administered as an intravenous infusion over a period of 60 minutes.
Danish: Det skal administreres som intravenøs infusion over 60 minutter.
English: The vials must be kept in the original package in order to protect from light.
Danish: Hætteglassene skal opbevares i den originale yderpakning for at beskytte mod lys.
English: Nivolumab BMS contains sodium
Danish: Nivolumab BMS indeholder natrium
English: 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.
Danish: 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.
English: 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%).
Danish: 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%).
English: Thus, the effect of nivolumab on male and female fertility is unknown.
Danish: Derfor er nivolumabs påvirkning af fertiliteten hos hanner og hunner ukendt.
English: Baseline ECOG performance status score was 0 (24%) or
Danish: ECOG performance status ved baseline var 0 (24%) eller 1 (76%).
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%).
Danish: 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%).
English: 4.2 Posology and method of administration Treatment must be initiated and supervised by physicians experienced in the treatment of cancer.
Danish: Behandlingen skal initieres og superviseres af en læge med erfaring i cancerbehandling.
English: Randomised phase 3 study vs. docetaxel (CA209017)
Danish: Randomiseret fase 3-studie versus docetaxel (CA209017)
English: Treatment should be continued as long as clinical benefit is observed or until treatment is no longer tolerated by the patient.
Danish: Behandlingen bør fortsættes, så længe der observeres en klinisk gavnlig effekt, eller indtil patienten ikke længere tolererer behandlingen.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
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.
Danish: 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.
English: Nivolumab BMS must be stored in a refrigerator (2°C to 8°C).
Danish: Nivolumab BMS skal opbevares i køleskab (2°C til 8°C).
English: 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.
Danish: 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.