natgillin/translations-raw huggingface dataset:
Indehaveren af markedsføringstilladelsen skal derefter fremsende PSUR'er i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for
Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Patienten skal monitoreres for kliniske tegn og symptomer på endokrinopatier og for ændringer i thyroideafunktionen (i begyndelsen af behandlingen, regelmæssigt under behandlingen og som indiceret baseret på klinisk evaluering).
Patients should be monitored for clinical signs and symptoms of endocrinopathies and for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation).
Grad 3 eller 4 pneumonitis
Grade 3 or 4 pneumonitis
Nivolumabs metaboliseringsvej er ikke belyst.
The metabolic pathway of nivolumab has not been characterised.
Kropsvægtnormaliserede doser medførte nogenlunde samme steady state dal-koncentration over et bredt interval af kropsvægt (34-162 kg).
Body weight normalised dosing produced approximately uniform steady-state trough concentration over a wide range of body weights (34-162 kg).
Behandling med nivolumab bør ikke genoptages, mens patienten får immunsuppressive doser af kortikosteroid eller anden immunsuppressiv behandling.
Nivolumab should not be resumed while the patient is receiving immunosuppressive doses of corticosteroids or other immunosuppressive therapy.
I fase 1-studiet MDX1106-03 blev pneumonitis, herunder et grad 4 tilfælde hos 1 patient, rapporteret hos 3/37 patienter (8,1%) med NSCLC, som fik nivolumab 3 mg/kg.
In the phase 1 study MDX1106-03, pneumonitis, including a Grade 4 case in 1 patient, was reported in 3/37 patients (8.1%) with NSCLC receiving nivolumab 3 mg/kg.
Patienten skal have udleveret patient-informationskortet ved hver ordination.
The patient will be provided with the Patient Alert Card with each prescription.
Ingen grad 3-5 thyroidealidelser blev rapporteret.
No Grade 3-5 thyroid disorders were reported.
Svær hepatitis er observeret med nivolumab-behandling.
Severe hepatitis has been observed with nivolumab treatment.
Effektresultater (CA209017)
Efficacy results (CA209017)
Hos to patienter (1 med grad 2 udslæt og 1 med grad 3 udslæt) var det nødvendigt at seponere nivolumab permanent.
Two patients (1 with Grade 2 rash and 1 with Grade 3 rash) required permanent discontinuation of nivolumab.
Uddannelsesmaterialet har til formål at øge opmærksomheden omkring de potentielle immunmedierede bivirkninger, der er forbundet med Nivolumab BMS, hvordan de behandles, og at gøre patienterne eller omsorgspersonerne opmærksomme på tidlige tegn og symptomer på disse bivirkninger.
The educational programme is aimed at increasing the awareness about the potential immune mediated adverse events associated with Nivolumab BMS use, how to manage them and to enhance the awareness of patients or their caregivers on the signs and symptoms relevant to the early those adverse events.
Hyppigheden af bedring i sygdomsrelaterede symptomer, målt med LCSS, var sammenlignelig i nivolumab-gruppen (18,5%) og docetaxel-gruppen (21,2%).
The rate of disease-related symptom improvement, as measured by LCSS, was similar between the nivolumab group (18.5%) and the docetaxel group (21.2%).
Hos otte patienter, herunder de 4 patienter med grad 3 pneumonitis, var det nødvendigt at seponere nivolumab permanent på grund af pneumonitis.
Eight patients, including the 4 patients with a Grade 3 case, required permanent discontinuation of nivolumab due to pneumonitis.
Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med nivolumab i alle undergrupper af den pædiatriske population ved behandling af maligne solide tumorer (se pkt.
The European Medicines Agency has deferred the obligation to submit the results of studies with nivolumab in all subsets of the paediatric population in the treatment of malignant solid tumours (see section 4.2 for information on paediatric use).
Ældre patienter
Most patients
Studiet omfattede patienter (18 år eller ældre), som havde oplevet sygdomsprogression under eller efter et tidligere platinbaseret dublet-kemoterapiregime, og som havde en Eastern Cooperative Oncology Group (ECOG) performance-score på 0 eller 1.
The study included patients (18 years or older) who have experienced disease progression during or after one prior platinum doublet-based chemotherapy regimen and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Nivolumab fremstilles ved rekombinant DNA-teknologi i ovarieceller fra kinesiske hamstre.
Nivolumab is produced in Chinese hamster ovary cells by recombinant DNA technology.
I studie CA209017 blev hyperkalcæmi rapporteret hyppigere i nivolumab-gruppen (31/130, 24%) end i docetaxel-gruppen (9/124, 7%).
In study CA209017, hypercalcaemia was more frequently reported in the nivolumab group (31/130, 24%) than in the docetaxel group (9/124, 7%).
Anvend en separat infusionsslange til infusionen.
Use a separate infusion line for the infusion.
De foreløbige resultater viser, at systemisk immunsuppression efter initiering af nivolumab-behandling ikke synes at
The preliminary results show that systemic immunosuppression after starting nivolumab treatment does not appear to preclude the response on nivolumab.
Den ordinerede dosis til patienten angives i mg/kg.
The prescribed dose for the patient is given in mg/kg.
På trods af, at ECOG-status, glomerulær filtrationshastighed (GFR) ved baseline, albumin, kropsvægt og let nedsat leverfunktion havde en effekt på nivolumabs CL, var effekten uden klinisk relevans.
Although ECOG status, baseline glomerular filtration rate (GFR), albumin, body weight, and mild hepatic impairment had an effect on nivolumab CL, the effect was not clinically meaningful.
Det er ukendt, om nivolumab udskilles i human mælk.
It is unknown whether nivolumab is secreted in human milk.
Som det er tilfældet med alle terapeutiske proteiner, er dannelse af antistoffer mod nivolumab en mulighed.
As with all therapeutic proteins, there is a potential for an immune response to nivolumab.
Vær opmærksom på vigtige symptomer på inflammation (betændelseslignende tilstand).
Be aware of important symptoms of inflammation.
Leverbetændelse (hepatitis).
Inflammation of the liver (hepatitis).
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:
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:
Det kan være tegn på en betændelsestilstand (inflammation) i lungerne (pneumonitis eller interstitiel lungesygdom).
These may be signs of inflammation of the lungs (pneumonitis or interstitial lung disease).
Der sås ingen tegn på ændret farmakokinetisk profil eller toksicitetsprofil i forbindelse med dannelsen af antistoffer mod
There was no evidence of altered pharmacokinetic or toxicity profile associated with anti-product-antibody development.
Anbefalede sændringer i Nivolumab BMS-behandling
Recommended treatment modifications for Nivolumab BMS
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”).
Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of nivolumab (see “Description of selected adverse reactions” below).
Hvis immunsuppression med kortikosteroider anvendes til behandling af en bivirkning, skal nedtrapning over mindst 1 måned initieres, når der er opnået bedring.
If immunosuppression with corticosteroids is used to treat an adverse reaction, a taper of at least 1 month duration should be initiated upon improvement.
Det er meget vigtigt, at du overholder alle dine aftaler om behandling med Nivolumab BMS.
It is very important for you to keep all your appointments to receive Nivolumab BMS.
31. marts 2017
31st March 2017
Denne medicin indeholder 2,5 mg natrium pr. ml koncentrat.
This medicine contains 2.5 mg sodium per mL of concentrate.
Der er ikke udført studier til vurdering af nivolumabs virkning på fertilitet.
Studies to evaluate the effect of nivolumab on fertility have not been performed.
Problemer med hormonproducerende kirtler (herunder hypofysen, skjoldbruskkirtlen og binyrerne), som kan påvirke, hvordan disse kirtler fungerer.
Problems with your hormone producing glands (including the pituitary, the thyroid and adrenal glands) that may affect how these glands work.
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.
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.
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).
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.
Administration af Nivolumab BMS-infusion skal være afsluttet inden for 24 timer efter klargøring.
Nivolumab BMS infusion must be completed within 24 hours of preparation.
Docetaxel (hændelser: 113/137), median og 95% CI: 6,01 (5,13; 7,33)
Docetaxel (events : 113/137), median and 95% CI : 6.01 (5.13, 7.33)
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.
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.
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.
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.
Neutraliserende antistoffer blev kun påvist i 5 (1,0%) af det samlede antal af de prøver, der var testet positive for antistoffer mod lægemidlet.
Neutralising antibodies were detected in only 5 (1.0% of the total) of the positive anti-product-antibody patients.
Patienter med aktiv autoimmun sygdom, symptomatisk interstitiel lungesygdom eller ubehandlede hjernemetastaser blev ekskluderet fra studiet.
Patients with active autoimmune disease, symptomatic interstitial lung disease, or untreated brain metastasis were excluded from the study.
Den færdige koncentration i infusionsvæsken bør være fra 1 til 10 mg/ml.
The final infusion concentration should range between 1 and 10 mg/mL.
Alvorlige infusionsreaktioner er blevet rapporteret i kliniske forsøg (se pkt.
Severe infusion reactions have been reported in clinical trials (see section 4.8).
Et hætteglas indeholder enten 40 mg (i 4 ml) eller 100 mg (i 10 ml) nivolumab.
Each vial contains either 40 mg (in 4 mL) or 100 mg (in 10 mL) of nivolumab.
Nivolumab BMS anvendes til behandling af fremskreden ikke små-cellet lungekræft (en bestemt type lungekræft) hos voksne.
Nivolumab BMS is a medicine used to treat advanced non-small cell lung cancer (a type of lung cancer) in adults.
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).
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).
I tilfælde af en svær infusionsreaktion skal nivolumab-infusionen afbrydes og passende medicinsk behandling administreres.
In case of a severe infusion reaction, nivolumab infusion must be discontinued and appropriate medical therapy administered.
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.
By attaching to PD-1, nivolumab blocks its action and prevents it from switching off your T cells.
I tilfælde af overdosering skal patienten monitoreres tæt for tegn og symptomer på bivirkninger og passende symptomatisk behandling straks iværksættes.
In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted immediately.
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.
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.
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.
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.
Dette medvirker til at øge T-cellernes aktivitet mod
This helps increase their activity against the lung cancer cells.
En farmakokinetisk populationsanalyse tydede ikke på nogen forskel i nivolumabs CL på basis af alder, køn, race, tumortype, tumorstørrelse og nedsat leverfunktion.
A population PK analysis suggested no difference in CL of nivolumab based on age, gender, race, tumour type, tumour size, and hepatic impairment.
I syngene musemodeller resulterede blokering af PD-1-aktivitet i nedsat tumorvækst.
In syngeneic mouse models, blocking PD-1 activity resulted in decreased tumour growth.
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.
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.
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.
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.
På baggrund af individuel sikkerhed og tolerance kan udsættelse af dosis eller seponering være nødvendig.
Dosing delay or discontinuation may be required based on individual safety and tolerability.
Ud fra en mikrobiologisk betragtning bør lægemidlet infunderes eller fortyndes og infunderes
From a microbiological point of view, once opened, the medicinal product should be infused or diluted and infused immediately.
Den anbefalede dosis Nivolumab BMS er 3 mg/kg administreret intravenøst over en periode på 60 minutter hver 2. uge.
The recommended dose of Nivolumab BMS is 3 mg/kg administered intravenously over 60 minutes every 2 weeks.
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);
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.
31. december 2017 30. september 2017
31st December 2017 30th September 2017
Sygdomsrelaterede ætiologier skal udelukkes.
Disease-related aetiologies should be ruled out.
• Tegn og symptomer på bivirkningerne, og hvornår patienten skal kontakte sundhedspersonalet
• Signs or symptoms of the safety concern and when to seek attention from a HCP
Infektiøse og sygdomsrelaterede ætiologier skal udelukkes.
Infectious and disease-related aetiologies should be ruled out.
Nivolumab forstærker T-celleresponset, herunder anti-tumorresponset, ved at blokere PD-1-binding til PD-L1- og PD-L2-ligander.
Nivolumab potentiates T-cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands.
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].
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].
Tegn og symptomer på at disse kirtler ikke virker korrekt kan være udmattelse (voldsom træthed), vægtændringer, hovedpine og synsforstyrrelser.
Signs and symptoms that these glands are not working properly may include fatigue (extreme tiredness), weight change or headache and visual disturbances.
Udtag det nødvendige volumen Nivolumab BMS-koncentrat ved brug af en passende steril
Withdraw the required volume of Nivolumab BMS concentrate using an appropriate sterile
Svære endokrinopatier, herunder hypotyroidisme, hypertyroidisme, binyrebarkinsufficiens, hypofysitis, diabetes mellitus og diabetisk ketoacidose er observeret med nivolumab-behandling.
Severe endocrinopathies, including hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis, diabetes mellitus, and diabetic ketoacidosis have been observed with nivolumab treatment.
Man ved ikke, om nivolumab udskilles i mælk.
It is not known whether nivolumab gets into breast milk.
Totaldosis beregnes på baggrund af den ordinerede dosis.
Based on this prescribed dose, calculate the total dose to be given.
Tegn og symptomer kan være unormale prøver for nyrefunktionen eller nedsat urinmængde.
Signs and symptoms may include abnormal kidney function tests, or decreased volume of urine.
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.
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.
Bivirkninger, der blev rapporteret i de puljede datasæt (n = 248) fra CA209017 og CA209063 er vist i tabel 2.
Adverse reactions reported in the pooled dataset (n=248) of CA209017 and CA209063 are presented in Table 2.
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.
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.
Figur 1: Kaplan-Meier kurver over OS (CA209017)
Figure 1: Kaplan-Meier curves of OS (CA209017)
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).
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).
Mediantiden til indtræden af disse endokrinopatier var 17,8 uger (6,1-33,1).
Median time to onset of these endocrinopathies was 17.8 weeks (range: 6.1-33.1).
Nivolumabdosering skal udsættes ved grad 3 udslæt og seponeres ved grad 4 udslæt.
Nivolumab should be withheld for Grade 3 rash and discontinued for Grade 4 rash.
Nivolumab BMS er indiceret til behandling af lokalt fremskredent eller metastatisk planocellulært ikke-småcellet lungecancer (NSCLC) hos voksne efter tidligere behandling med kemoterapi.
Nivolumab BMS is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.
Nivolumab er et humant monoklonalt antistof, og egentlige interaktionsstudier er ikke udført.
Nivolumab is a human monoclonal antibody, as such pharmacokinetic interaction studies have not been conducted.
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
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
Glasflasker
Glass bottles
Det kan ikke udelukkes, at der er en risiko for det ammede barn.
A risk to the breast-fed infant cannot be excluded.