natgillin/translations-raw huggingface dataset:
PD-L1 test for patienter med lokalt fremskreden NSCLC Patienter med lokalt fremskreden NSCLC skal evalueres for behandling på baggrund af PD-L1tumorekspression bekræftet af en valideret test (pkt.
PD-L1 testing for patients with locally advanced NSCLC Patients with locally advanced NSCLC should be evaluated for treatment based on the tumour expression of PD-L1 confirmed by a validated test (section 5.1).
I tilfælde af overdosering bør patienterne monitoreres tæt for tegn eller symptomer på bivirkninger, og passende symptomatisk behandling påbegyndes straks.
In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted immediately.
Inden for hver frekvensgruppe er bivirkningerne opstillet efter faldende alvorlighed.
Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
Studiet viste en statistisk signifikant forbedring i OS i den IMFINZI-behandlede gruppe sammenlignet med placebogruppen [HR = 0,68 (95 % CI: 0,53, 0,87), p = 0,00251].
The study demonstrated a statistically significant improvement in OS in the IMFINZI-treated group compared with the placebo group [HR = 0.68 (95% CI: 0.53, 0.87), p = 0.00251].
Studiet viste en statistisk signifikant forbedring i PFS i den IMFINZI-behandlede gruppe sammenlignet med placebogruppen [hazard ratio (HR) = 0,52 (95 % CI: 0,42; 0,65), p < 0,0001].
The study demonstrated a statistically significant improvement in PFS in the IMFINZI-treated group compared with the placebo group [hazard ratio (HR) = 0.52 (95% CI: 0.42, 0.65), p < 0.0001].
IMFINZI er mest almindeligt associeret med immunmedierede bivirkninger.
IMFINZI is most commonly associated with immune-mediated adverse reactions.
Immunmedieret pneumonitis forekom oftere hos patienter i PACIFIC-studiet, som også havde gennemført samtidig kemostrålebehandling indenfor 1 til 42 dage før studiestart (10,7 %) end hos de andre patienter i den samlede sikkerhedsdatabase (2,0 %).
Immune-mediated pneumonitis occurred more frequently in patients in the PACIFIC Study who had completed treatment with concurrent chemoradiation within 1 to 42 days prior to initiation of the study (10.7%), than in the other patients in the combined safety database (2.0%).
Hvis du får noget af følgende, skal du straks ringe til eller gå til lægen.
If you have any of the following, call or see your doctor straight away.
Sikkerheden ved IMFINZI (10 mg/kg) er blevet evalueret i PACIFIC-studiet (n = 475) hos patienter med lokalt fremskreden, inoperabel NSCLC, som har gennemført behandling med mindst 2 cykler af samtidig kemostrålebehandling inden for 1 til 42 dage før studiestart.
The safety of IMFINZI (10 mg/kg) has been evaluated in the PACIFIC Study (n = 475) in patients with locally advanced, unresectable NSCLC who had completed treatment with at least 2 cycles of concurrent chemoradiation within 1 to 42 days prior to initiation of the study.
Anbefalede behandlingsmodifikationer for IMFINZI og anbefalinger til behandling af bivirkninger
Recommended treatment modifications for IMFINZI and management recommendations
d omfatter gingivitis, oral infektion, periodontitis, dental pulpitis, tandbylder og tandinfektion.
d includes gingivitis, oral infection, periodontitis, pulpitis dental, tooth abscess and tooth infection.
• betændelse i hjertet
• inflammation of the heart
Immunmedieret colitis eller diarré
Immune-mediated colitis or diarrhoea
Mediantiden til debut i IMFINZI-gruppen var 53 dage (interval: 1-341 dage) versus 55,5 dage (interval: 0-231 dage) i placebogruppen.
The median time to onset in the IMFINZI-treated group was 53 days (range: 1-341 days) vs. 55.5 days (range: 0-231 days) in the placebo group.
• nedsat hypofysefunktion (hypopituitarisme inklusive diabetes insipidus), der kan forårsage træthed og en stigning i mængden af urin
• underactive function of pituitary gland (hypopituitarism including diabetes insipidus) that can cause tiredness, an increase in the amount of your urine
Durvalumab kan muligvis forårsage fosterskader, når det gives til en gravid kvinde og bør ikke anvendes under graviditeten og til fertile kvinder, som ikke anvender effektiv kontraception under behandlingen og i mindst 3 måneder efter den sidste dosis.
Durvalumab may cause foetal harm when administered to a pregnant woman and is not recommended during pregnancy and in women of childbearing potential not using effective contraception during treatment and for at least 3 months after the last dose.
IMFINZI som monoterapi er indiceret til behandling af lokalt fremskreden, inoperabel ikke-småcellet lungecancer (NSCLC) hos voksne med PD-L1-tumorekspression ≥ 1 % og hvis sygdom ikke er progredieret efter platinbaseret kemostrålebehandling (se pkt.
IMFINZI as monotherapy is indicated for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy (see section 5.1).
Hvor det var muligt blev arkiverede tumorvævsprøver, som blev taget før kemostrålebehandling, testet retrospektivt for PD-L1-ekspression på tumorceller (TC) under anvendelse af VENTANA PD-L1 (SP263) IHC-analyse.
Where available, archival tumour tissue specimens taken prior to chemoradiation therapy were retrospectively tested for PD-L1 expression on tumour cells (TC) using the VENTANA PD-L1 (SP263) IHC assay.
Grad 2 med serumkreatinin >1,5-3 x (ULN eller baseline)
Grade 2 with serum creatinine > 1.5-3 x (ULN or baseline)
Nyrer og urinveje Forhøjet kreatinin i blodet
Renal and urinary disorders Blood creatinine increased
(95 % CI) HR (95 % CI) p-værdi p < 0,0001
(95% CI) HR (95% CI) p-value p < 0.0001
I denne patientpopulation var de hyppigste bivirkninger hoste (40,2 % vs. 30,3 % i placebo-armen), øvre luftvejsinfektioner (26,1 % vs. 11,5 % i placebo-armen) og udslæt (21,7 % vs. 12,0 % i placebo-armen).
In this patient population, the most frequent adverse reactions were cough (40.2% vs 30.3% in placebo), upper respiratory tract infections (26.1% vs 11.5% in placebo) and rash (21.7% vs 12.0% in placebo).
26 ud af de 34 patienter fik medicinsk behandling (thiamazol, carbimazol, propylthiouracil eller beta-blokker), 12 patienter fik thyroxin, da hyperthyreoidisme overgik til hypothyreoidisme, 12 patienter fik systemisk kortikosteroid, og 3 ud af de 12 patienter fik højdosis-kortikosteroidbehandling (mindst 40 mg prednison eller tilsvarende per dag).
Twenty-six of the 34 patients received medical therapy (thiamazole, carbimazole, propylthiouracil or beta-blocker), 12 patients received thyroxine when hyperthyroidism transitioned to hypothyroidism, 12 patients received systemic corticosteroids and 3 of the 12 patients received high-dose systemic corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
k omfatter colitis, enteritis, enterocolitis og proktit.
k includes colitis, enteritis, enterocolitis, and proctitis.
Immunmedieret hypothyreoidisme og hyperthyreoidisme (inklusive thyroiditis) bør behandles som anbefalet i pkt.
Immune-mediated hypothyroidism and hyperthyroidism (including thyroiditis) should be managed as recommended in section 4.2.
Kaplan-Meier-kurve over OS
Kaplan-Meier curve of OS
Den hypigste Grad 3-4 bivirkning var pneumoni (6,5 % vs. 5,6 % i placbo-armen).
The most frequent Grade 3-4 adverse reaction was pneumonia (6.5% vs 5.6% in placebo).
Afbryd eller nedsæt infusionshastigheden
Grade 1 or 2 Interrupt or slow the rate of infusion
• unormale leverprøver (øget aspartataminotransferase, øget alaninaminotransferase)
• abnormal liver tests (aspartate aminotransferase increased; alanine aminotransferase increased)
Du må ikke få IMFINZI
You should not be given IMFINZI
Hvis du får nogen af ovenstående symptomer, skal du straks ringe til eller gå til lægen.
If you have any of the symptoms listed above, call or see your doctor straight away.
Kaplan-Meier-kurve over PFS
Kaplan-Meier curve of PFS
• hæshed (dysfoni)
• hoarse voice (dysphonia)
Trafik- og arbejdssikkerhed IMFINZI påvirker sandsynligvis ikke din evne til at fører motorkøretøj og betjene maskiner.
Driving and using machines IMFINZI is not likely to affect you being able to drive and use machines.
• nedsat udskillelse af hormoner produceret af binyrerne, der kan forårsage træthed
• decreased secretion of hormones produced by the adrenal glands that can cause tiredness
b omfatter lungeinfektion, pneumocystis jirovecii pneumoni, pneumoni, adenoviral pneumoni, bakteriel pneumoni, cytomegalovirus pneumoni, haemophilus pneumoni, klebsiella pneumoni, nekrotiserende pneumoni, pneumokok pneumoni og streptokok pneumoni.
includes lung infection, pneumocystis jirovecii pneumonia, pneumonia, pneumonia adenoviral, pneumonia bacterial, pneumonia cytomegaloviral, pneumonia haemophilus, pneumonia klebsiella, pneumonia necrotising, pneumonia pneumococcal and pneumonia streptococcal.
Administrer infusionsopløsningen intravenøst i løbet af 60 minutter ved anvendelse af et sterilt 0,2 eller 0,22 mikron linjefilter med lav proteinbinding.
Administer the infusion solution intravenously over 60 minutes using a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.
Virkningen af moderat nedsat leverfunktion (bilirubin> 1,5 til 3 x ULN og enhver ASAT) eller svært nedsat leverfunktion (bilirubin >3,0 x ULN og enhver ASAT) på farmakokinetikken for durvalumab er ukendt, men da IgG-monoklonale antistoffer ikke primært udskilles via leveren, forventes det ikke, at en ændring i leverfunktionen vil påvirke eksponeringen for durvalumab.
The effect of moderate hepatic impairment (bilirubin > 1.5 to 3 x ULN and any AST) or severe hepatic impairment (bilirubin > 3.0 x ULN and any AST) on the pharmacokinetics of durvalumab is unknown; however, as IgG monoclonal antibodies are not primarily cleared via hepatic pathways, a change in hepatic function is not expected to influence durvalumab exposure.
Luftveje, thorax og mediastinum Hoste/Produktiv hoste
Rare Respiratory, thoracic and mediastinal disorders Cough/Productive Cough
• Ryst ikke hætteglasset.
• Do not shake the vial.
• betændelse i nyrerne (nefritis), der kan reducere mængden af urin
• inflammation of the kidneys (nephritis) that can decrease the amount of your urine
• infektioner i de øvre luftveje
• infections of the upper respiratory tract
Ved myasthenia gravis skal IMFINZI seponeres permanent, hvis der er tegn på muskelsvaghed eller respiratorisk insufficiens.
For myasthenia gravis, if there are signs of muscular weakness or respiratory insufficiency, IMFINZI should be permanently discontinued.
I dyrereproduktionsstudier, hvor der blev anvendt doser svarende til eksponeringsniveauer der er ca. 18 gange højere end de observerede ved den kliniske dosis på 10 mg/kg durvalumab (baseret på AUC), var administration af durvalumab til gravide cynomolgusaber, fra bekræftelse af graviditet til fødsel, forbundet med overførsel via placenta, men ikke med maternel toksicitet eller virkninger på embryoføtal udvikling, graviditetsresultat eller postnatal udvikling.
In animal reproduction studies, administration of durvalumab to pregnant cynomolgus monkeys from the confirmation of pregnancy through delivery, at exposure levels approximately 18 times higher than those observed at the clinical dose of 10 mg/kg of durvalumab (based on AUC), was associated with placental transfer but not with maternal toxicity or effects on embryofoetal development, pregnancy outcome or postnatal development.
m omfatter hepatitis, autoimmun hepatitis, toksisk hepatitis, hepatocellulær skade, akut hepatitis og hepatotoksicitet.
m includes hepatitis, autoimmune hepatitis, hepatitis toxic, hepatocellular injury, hepatitis acute, and hepatotoxicity.
• Administrer infusionsopløsningen intravenøst i løbet af 60 minutter ved anvendelse af en intravenøs slange indeholdende et sterilt 0,2 eller 0,22 mikron in-line-filter med lav proteinbinding.
• Administer the infusion solution intravenously over 60 minutes through an intravenous line containing a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.
Grad 3 med ASAT eller ALAT >5-≤8 x ULN eller total bilirubin >3-≤5 x ULN Grad 3 med ASAT eller ALAT >8 x ULN eller total bilirubin >5 x ULN
Grade 3 with AST or ALT > 5-≤ 8 x ULN or total bilirubin > 3≤ 5x ULN Grade 3 with AST or ALT > 8 x ULN or total bilirubin > 5 x ULN
Almindelig a omfatter laryngitis, nasopharyngitis, abscessus peritonsillaris, pharyngitis, rhinitis, sinuitis, tonsillitis, tracheobronchitis og øvre luftvejsinfektion.
Common includes laryngitis, nasopharyngitis, peritonsillar abscess, pharyngitis, rhinitis, sinusitis, tonsillitis, tracheobronchitis and upper respiratory tract infection.
l omfatter forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjede leverenzymer og forhøjede transaminaser.
l includes alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzyme increased and transaminases increased.
Patienterne bør monitoreres for kliniske tegn og symptomer på type 1-diabetes mellitus.
Patients should be monitored for clinical signs and symptoms of type 1 diabetes mellitus.
Der findes begrænsede data for patienter i alderen 75 år og derover.
Data on patients aged 75 years of age or older are limited.
PD-L1 reducerer cytotoksisk T-celleaktivitet, proliferation og cytokinproduktion ved at binde til dets receptorer.
By binding to its receptors, PD-L1 reduces cytotoxic T-cell activity, proliferation and cytokine production.
Immunmedieret hypothyreoidisme og hyperthyreoidisme (inklusive thyroiditis) forekom hos patienter, der fik IMFINZI, og hypothyreoidisme kan følge hyperthyreoidisme (se pkt.
Immune-mediated hypothyroidism and hyperthyroidism (including thyroiditis) occurred in patients receiving IMFINZI, and hypothyroidism may follow hyperthyroidism (see section 4.8).
Infektioner og parasitære sygdomme Øvre luftvejsinfektioner
Infections and infestations Upper respiratory tract infections
Studiet ekskluderede patienter, der havde progression efter kemostrålebehandling, patienter med tidligere eksponering for ethvert anti-PD-1- eller anti-PD-L1-antistof, patienter med aktiv eller tidligere dokumenteret autoimmun sygdom inden for 2 år for initiering af studiet; anamnese med immundefekt, anamnese med svære immunmedierede bivirkninger; medicinske tilstande, der krævede systemisk immunosuppression, undtagen fysiologisk dosis af systemiske kortikosteroider; aktiv tuberkulose eller hepatitis B eller C eller hiv-infektion eller patienter, der fik levende svækket vaccine inden for 30 dage før eller efter start på IMFINZI.
The study excluded patients who had progressed following chemoradiation therapy, patients with prior exposure to any anti-PD-1 or anti-PD-L1 antibody, patients with active or prior documented autoimmune disease within 2 years of initiation of the study; a history of immunodeficiency; a history of severe immune-mediated adverse reactions; medical conditions that required systemic immunosuppression, except physiological dose of systemic corticosteroids; active tuberculosis or hepatitis B or C or HIV infection or patients receiving live attenuated vaccine within 30 days before or after the start of IMFINZI.
Hos patienter, der blev behandlet med durvalumab i PACIFIC-studiet, var andelen af patienter, der oplevede en laboratorieafvigelse forværret fra baseline som følger: 38,5 % (alle grader), 2,3 % (Grad 3-4) for forøget alaninaminotransferase; 36,0 % (alle grader), 2,8 % (Grad 3-4) for forøget aspartataminotransferase; 16,3 % (alle grader) for forøget kreatinin; 26,5 % (alle grader) for forhøjet TSH >ULN og over baseline; 31,9 % (alle grader) for nedsat nedsat TSH <LLN og under baseline.
In patients treated with durvalumab in the PACIFIC Study, the proportion of patients who experienced a laboratory abnormality worsening from baseline was as follows: 38.5% (all Grades), 2.3% (Grades 3-4) for alanine aminotransferase increased, 36.0% (all Grades), 2.8% (Grade 3-4) for aspartate aminotransferase increased, 16.3% (all Grades) for creatinine increased, 26.5% (all Grades) for TSH elevated > ULN and above baseline, 31.9% (all Grades) for TSH decreased < LLN and below baseline.
Patienter med mistænkt pneumonitis bør evalueres med røntgenbillede og behandles som anbefalet i pkt.
Patients with suspected pneumonitis should be evaluated with radiographic imaging and managed as recommended in section 4.2.
f omfatter hyperthyreoidisme, autoimmun thyroiditis, thyroiditis, subakut thyroiditis og Basedows sygdom.
f includes hyperthyroidism, autoimmune thyroiditis, thyroiditis, thyroiditis subacute and Basedow's disease.
Immunmedieret colitis
Immune-mediated colitis
Patienter bør monitoreres for tegn og symptomer på infusionsrelaterede reaktioner.
Patients should be monitored for signs and symptoms of infusion related reactions.
Det skal du vide, før du begynder at få IMFINZI
What you need to know before you are given IMFINZI
Forest-plot af OS ved PD-L1-ekspression
Forest plot of OS by PD-L1 expression
Patienterne bør monitoreres for tegn og symptomer på pneumonitis eller strålingspneumonitis.
Patients should be monitored for signs and symptoms of pneumonitis or radiation pneumonitis.
Symptomatisk behandling, se pkt.
Symptomatic treatment, see section 4.8
Den er markedsført i pakninger med 1 hætteglas a 2,4 ml koncentrat eller 1 hætteglas a 10 ml koncentrat.
It is available in packs containing either 1 glass vial of 2.4 mL of concentrate or 1 glass vial of 10 mL of concentrate.
Samtidig ALAT eller ASAT >3 x ULN og total bilirubin >2 x ULN uden anden årsag
Concurrent ALT or AST > 3 x ULN and total bilirubin > 2 x ULN with no other cause
• Træk det ønskede koncentrationsvolumen ud af hætteglasset (hætteglassene), og overfør det til en infusionspose, der indeholder natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning eller glucose 50 mg/ml (5 %) injektionsvæske, opløsning til fremstilling af en fortyndet opløsning med en slutkoncentration i området fra 1 til 15 mg/ml.
• Withdraw the required volume of concentrate from the vial(s) and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9%) solution for injection or glucose 50 mg/mL (5%) solution for injection, to prepare a diluted solution with a final concentration ranging from 1 to 15 mg/mL.
Patienter med følgende blev udelukket fra PACIFIC-studiet: en baseline ECOG-performance score ≥ 2; aktiv eller tidligere dokumenteret autoimmun sygdom inden for 2 år efter studiestart; en immundefekt i anamnesen; alvorlige immunmedierede bivirkninger i anamnesen; medicinske tilstande, der krævede systemisk immunosuppression, undtagen fysiologisk dosis af systemiske kortikosteroider (≤ 10 mg/dag prednison eller tilsvarende); aktiv tuberkulose eller hepatitis B eller C eller hiv-infektion eller patienter, der fik levende svækket vaccine inden for 30 dage før eller efter start af IMFINZI.
Patients with the following were excluded from the PACIFIC Study: a baseline ECOG performance score ≥ 2; active or prior documented autoimmune disease within 2 years of initiation of the study; a history of immunodeficiency; a history of severe immune-mediated adverse reactions; medical conditions that required systemic immunosuppression, except physiological dose of systemic corticosteroids (≤ 10 mg/day prednisone or equivalent); active tuberculosis or hepatitis B or C or HIV infection or patients receiving live attenuated vaccine within 30 days before or after the start of IMFINZI.
120 mg/2,4 ml 500 mg/10 ml 1 hætteglas
120 mg/2.4 ml 500 mg/10 ml 1 vial
10 ml koncentrat i et Type 1-hætteglas med en elastomerprop og en hvid afrivelig aluminiumsforsegling indeholdende 500 mg durvalumab.
10 mL of concentrate in a Type 1 glass vial with an elastomeric stopper and a white flip-off aluminium seal containing 500 mg durvalumab.
Ved symptomatisk type 1-diabetes mellitus bør patienterne behandles som anbefalet i pkt.
For symptomatic type 1 diabetes mellitus, patients should be managed as recommended in section 4.2.
• betændelse i eller problemer med musklerne: Symptomerne kan omfatte muskelsmerter eller svaghed eller hurtig muskeltræthed;
• inflammation or problems of the muscles: symptoms may include muscle pain, or weakness or rapid fatigue of the muscles;
Hvert hætteglas indeholder enten 500 mg durvalumab i 10 ml koncentrat eller 120 mg durvalumab i 2,4 ml koncentrat.
Each vial contains either 500 mg of durvalumab in 10 mL of concentrate or 120 mg of durvalumab in 2.4 mL of concentrate.
• Træk det ønskede volumen ud af IMFINZI hætteglasset (hætteglassene) og overfør det til en infusionspose, der indeholder natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning eller glucose 50 mg/ml (5 %) injektionsvæske opløsning.
• Withdraw the required volume from the vial(s) of IMFINZI and transfer into an intravenous (IV) bag containing sodium chloride 9 mg/mL (0.9%) solution for injection, or glucose 50 mg/mL (5%) solution for injection.
Patienterne bør monitoreres for kliniske tegn og symptomer på adrenal insufficiens.
Patients should be monitored for clinical signs and symptoms of adrenal insufficiency.
Resolution forekom hos 42 patienter.
Resolution occurred in 42 patients.
Immunmedieret hepatitis
Immune-mediated hepatitis
Denne ene patient fik højdosis-kortikosteroidbehandling (mindst 40 mg prednison eller tilsvarende per dag) og IMFINZI blev ikke seponeret.
This 1 patient received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day) and IMFINZI was not discontinued.
• betændelse i kirtler (især skjoldbruskkirtlen, binyren, hypofysen og bugspytkirtlen): Symptomerne kan omfatte hurtig hjerterytme, ekstrem træthed, vægtøgning eller vægttab, svimmelhed eller besvimelse, hårtab, følelse af kulde, forstoppelse, hovedpine, der ikke går væk eller usædvanlig hovedpine
• inflammation of glands (especially the thyroid, adrenal, pituitary and pancreas): symptoms may include fast heart rate, extreme tiredness, weight gain or weight loss, dizziness or fainting, hair loss, feeling cold, constipation, headaches that will not go away or unusual headaches;
Kaplan-Meier kurve over PFS for PD-L1 TC ≥ 1%
Kaplan-Meier curve of PFS for PD-L1 TC ≥ 1%
IMFINZI blev ikke seponeret hos nogen patienter på grund af adrenal insufficiens.
IMFINZI was not discontinued in any patient due to adrenal insufficiency.
Immunmedieret type 1-diabetes mellitus
Immune-mediated type 1 diabetes mellitus
Af de 137 patienter fik 134 patienter hormonsubstitutionsbehandling, og to patienter fik højdosis-kortikosteroidbehandling (mindst 40 mg prednison eller tilsvarende per dag) for hypothyreoidisme efterfulgt af hormonsubstitution.
Of the 137 patients, 134 patients received hormone replacement therapy and two patients received high-dose corticosteroids (at least 40 mg prednisone or equivalent per day) for hypothyroidism followed by hormone replacement.
Forest-plot af PFS ved PD-L1-ekspression
Forest plot of PFS by PD-L1 expression
• betændelse i tarmen (colitis)
• inflammation of the gut or intestine (colitis)
Let (kreatininclearance (CrCL) 60 til 89 ml/min) og moderat nedsat nyrefunktion (kreatininclearance (CrCL) 30 til 59 ml/min) havde ingen klinisk signifikant virkning på farmakokinetikken af durvalumab.
Mild (creatinine clearance (CrCL) 60 to 89 mL/min) and moderate renal impairment (creatinine clearance (CrCL) 30 to 59 mL/min) had no clinically significant effect on the PK of durvalumab.The effect of severe renal impairment (CrCL 15 to 29 mL/min) on the PK of durvalumab is unknown.
• Kassér eventuelt ubrugt lægemiddel, som er tilbage i hætteglasset.
• Discard any unused portion left in the vial.
Let nedsat leverfunktion (bilirubin ≤ ULN og ASAT > ULN eller bilirubin >1,0 til 1,5 × ULN og enhver ASAT) havde ingen klinisk signifikant virkning på farmakokinetikken af durvalumab.
Mild hepatic impairment (bilirubin ≤ ULN and AST > ULN or bilirubin > 1.0 to 1.5 × ULN and any AST) had no clinically significant effect on the PK of durvalumab.
Mediantiden til debut var 95 dage (interval: 28-239 dage).
The median time to onset was 95 days (range: 28-239 days).