FrancophonIA/ELRC3.0 huggingface dataset:
English: After withhold, IMFINZI can be resumed within 12 weeks if the adverse reactions improved to ≤ Grade 1 and the corticosteroid dose has been reduced to ≤ 10 mg prednisone or equivalent per day.
Danish: Efter tilbageholdelse kan IMFINZI genoptages inden for 12 uger, hvis bivirkningerne forbedres til ≤Grad 1, og kortikosteroiddosis er reduceret til ≤10 mg prednison eller tilsvarende pr. dag.
English: Upon resolution (Grade 0), corticosteroid taper should be initiated and continued over at least 1 month, after which IMFINZI can be resumed based on clinical judgment.
Danish: Ved resolution (Grad 0) skal nedtrapning af kortikosteroider indledes og fortsættes i mindst 1 måned, hvorefter IMFINZI kan genoptages på baggrund af en klinisk vurdering.
English: Of the 1570 patients who were treated with IMFINZI 10 mg/kg every 2 weeks and evaluable for the presence of anti-drug antibodies (ADAs), 2.9% (45/1570) of patients tested positive for treatment-emergent ADAs.
Danish: Af de 1570 patienter, der blev behandlet med IMFINZI 10 mg/kg hver anden uge og evalueret for tilstedeværelsen af anti-lægemiddelantistof (ADA'er) blev 2,9 % (45/1570) af patienterne testet positive for behandlingsrelaterede ADA'er.
English: Nervous System Disorders Myasthenia gravis
Danish: Nervesystemet Myasthenia gravis
English: Overall the safety profile of durvalumab in PD-L1 TC ≥ 1% subgroup was consistent with the intent to treat population, as was the PD-L1 TC < 1% subgroup.
Danish: Samlet set var sikkerhedsprofilen for durvalumab i PD-L1 TC ≥ 1 %-undergruppen konsistent med intent to treat-populationen, og det samme var PD-L1 TC < 1 %-undergruppen.
English: If refrigerated, intravenous bags must be allowed to come to room temperature prior to use.
Danish: Hvis det har været opbevaret køligt, skal de intravenøse poser ligge til de har stuetemperatur før brug.
English: Month 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 IMFINZI 212 208 193 187 178 171 165 156 134 105 62 34 12 1 0 0 Placebo 91 81 75 67 64 58 52 46 41 29 17 7 5 2 0 0
Danish: Måned 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 IMFINZI 212 208 193 187 178 171 165 156 134 105 62 34 12 1 0 0 Placebo 91 81 75 67 64 58 52 46 41 29 17 7 5 2 0 0
English: Negligible levels of durvalumab was found in milk of cynomolgous monkey on Day 28 after birth.
Danish: Ubetydelige niveauer af durvalumab blev fundet i mælk fra cynomolgousaber på dag 28 efter fødsel.
English: Common Injury, poisoning and procedural complications Infusion related reaction
Danish: Almindelig Traumer, forgiftninger og behandlingskomplikationer Infusionsrelaterede reaktioner
English: This includes herbal medicines and medicines obtained without a prescription.
Danish: Dette gælder også naturlægemidler og medicin, som ikke er købt på recept.
English: IMFINZI is for intravenous use.
Danish: IMFINZI er beregnet til intravenøs anvendelse.
English: Resolution occurred for 27 patients in the IMFINZI treated group vs 6 in placebo.
Danish: Resolution forekom hos 27 patienter i gruppen, der fik IMFINZI, versus 6 i placebogruppen.
English: Data from patients with moderate and severe hepatic impairment are limited.
Danish: Data fra patienter med moderat og svært nedsat leverfunktion er begrænsede.
English: Expression of programmed cell death ligand-1 (PD-L1) protein is an adaptive immune response that helps tumours evade detection and elimination by the immune system.
Danish: Ekspression af programmeret celledødsligand 1 (PD-L1)-protein er et adaptivt immunrespons, der hjælper tumorer med at undgå at blive detekteret og elimineret af immunsystemet.
English: Dose withholding 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: Adverse drug reactions are listed according to system organ class in MedDRA.
Danish: Bivirkningerne er opført efter MEDRA systemorganklasse.
English: Of 451 patients with PD L1 expression available, 67% were TC ≥ 1% [PD-L1 TC 1-24% (32%), PD L1 TC ≥ 25% (35%)] and 33% were TC < 1%.
Danish: Af 451 patienter med tilgængelig PD L1-ekspression var 67% TC ≥ 1 % [PD-L1 TC 1-24% (32%), PD L1 TC ≥ 25% (35%)] og 33 % var TC < 1 %.
English: The primary elimination pathways of durvalumab are protein catabolism via reticuloendothelial system or target mediated disposition.
Danish: De primære elimineringsveje for durvalumab er proteinkatabolisme via det reticuloendotheliale system eller målmedieret disposition.
English: Month 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 IMFINZI 476 464 431 415 385 364 343 319 274 210 115 57 23 2 0 0 Placebo 237 220 198 178 170 155 141 130 117 78 42 21 9 3 1 0
Danish: Måned 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 IMFINZI 476 464 431 415 385 364 343 319 274 210 115 57 23 2 0 0 Placebo 237 220 198 178 170 155 141 130 117 78 42 21 9 3 1 0
English: The safety and efficacy of IMFINZI in children and adolescents aged below 18 years of age have not been established.
Danish: IMFINZIs sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: For suspected immune-mediated adverse reactions, adequate evaluation should be performed to confirm etiology or exclude alternate etiologies.
Danish: For formodede immunmedierede bivirkninger bør der foretages en passende evaluering for at bekræfte ætiologi eller udelukke alternative ætiologier.
English: includes infusion related reaction and urticaria with onset on the day of dosing or 1 day after dosing.
Danish: q omfatter infusionsrelateret reaktion og urticaria med debut på doseringsdagen eller 1 dag efter dosering.
English: Events of StevensJohnson Syndrome or toxic epidermal necrolysis have been reported in patients treated with PD-1 inhibitors.
Danish: Tilfælde af Stevens-Johnsons syndrom eller toksisk epidermal nekrolyse er rapporteret hos patienter behandlet med PD-1-hæmmere.
English: If you miss an appointment to get IMFINZI
Danish: Hvis du har glemt en aftale om at få IMFINZI
English: The recommended dose of IMFINZI is 10 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks, until disease progression or unacceptable toxicity, or a maximum of 12 months.
Danish: Den anbefalede dosis IMFINZI er 10 mg/kg administreret som en intravenøs infusion over 60 minutter hver anden uge indtil sygdomsprogression eller uacceptabel toksicitet, eller i maksimalt 12 måneder.
English: When you are given IMFINZI, you can have some serious side effects.
Danish: Når du får IMFINZI, kan du få nogle alvorlige bivirkninger.
English: Do not freeze or shake the solution.
Danish: Nedfrys ikke og ryst ikke opløsningen.
English: Grade 2 or 3 Withhold dose
Danish: Grad 2 eller 3 Tilbagehold dosis
English: Guidelines for management of immune-mediated adverse reactions are described in Table 1 (see section 4.4).
Danish: Retningslinjerne for behandling af immunmedierede bivirkninger er beskrevet i Tabel 1 (se pkt.
English: The data for the following immune-mediated adverse reactions reflect the combined safety database of 1889 patients which includes the PACIFIC Study and two additional studies (a multi-cohort, open-label clinical trial in patients with advanced solid tumours, and an open-label study in patients with locally advanced or metastatic NSCLC).
Danish: Data for følgende immunmedierede bivirkninger afspejler den samlede sikkerhedsdatabase for 1889 patienter, der omfatter PACIFIC-studiet og to yderligere studier (et openlabel klinisk studie med flere kohorter hos patienter med fremskredne solide tumorer og et open-label studie hos patienter med lokalt fremskreden eller metastatisk NSCLC).
English: PD-L1 blocks T-cell function and activation through interaction with PD-1 and CD80 (B7.1).
Danish: PD-L1 blokerer T-cellefunktion og aktivering gennem interaktion med PD-1 og CD80 (B7.1).
English: Compliance was similar between the IMFINZI and placebo treatment groups (83% vs 85.1% overall of evaluable forms completed).
Danish: Compliance var ens mellem IMFINZI- og placebobehandlingsgrupperne (83 % versus 85,1 % af de samlede, evaluerbare og udfyldte skemaer).
English: Age (19-96 years), body weight (34-149 kg), gender, positive anti-drug antibody (ADA) status, albumin levels, LDH levels, creatinine levels, soluble PD-L1, tumour type, race or ECOG status had no clinically significant effect on the PK of durvalumab.
Danish: Alder (19-96 år), legemsvægt (34-149 kg), køn, positiv anti-lægemiddelantistof (ADA)-status, albuminniveauer, LDH-niveauer, kreatininniveauer, opløselig PD-L1, tumortype, race eller ECOG-status havde ingen klinisk signifikant virkning på farmakokinetikken af durvalumab.
English: Patients had completed at least 2 cycles of definitive platinum-based chemotherapy with radiation therapy within 1 to 42 days prior to initiation of the study and had a ECOG performance status of 0 or 1.
Danish: Patienterne havde gennemført mindst 2 behandlingscykler med definitiv platinbaseret kemoterapi med strålebehandling indenfor 1 til 42 dage forud for initiering af studiet og havde en ECOG performance status på 0 eller 1.
English: IMFINZI was discontinued due to type 1 diabetes mellitus.
Danish: IMFINZI blev seponeret på grund af type 1-diabetes mellitus.
English: For non-immune-mediated adverse reactions, consider withholding IMFINZI for Grade 2 and 3 adverse reactions until ≤ Grade 1 or baseline.
Danish: Ved ikke-immunmedierede bivirkninger skal det overvejes at tilbageholde IMFINZI ved Grad 2 eller 3 bivirkninger indtil ≤ Grad 1 eller baseline.
English: • reaction to the infusion of the medicine that can cause fever or flushing
Danish: • reaktion på infusion af medicinen, der kan forårsage feber eller rødme
English: AstraZeneca Pharma Poland Sp. z o.o.
Danish: Polska AstraZeneca Pharma Poland Sp. z o.o.
English: Disease characteristics were as follows: Stage IIIA (53%), Stage IIIB (45%), histological sub-groups of squamous (46%), non-squamous (54%).
Danish: Sygdomskarakteristika var som følger: Stadie IIIA (53 %), Stadie IIIB (45 %), histologiske subtyper af planocellulært karcinom (46 %), ikke-planocellulært (54 %).
English: • type 1 diabetes: symptoms may include high blood sugar, feeling more hungry or thirsty than usual, passing urine more often than usual;
Danish: • type 1-diabetes: Symptomerne kan omfatte højt blodsukker, at føle sig mere sulten eller tørstig end normalt og lade vandet oftere end normalt
English: Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og hætteglassets etiket efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: A decision must be made whether to discontinue breast feeding or to discontinue or abstain from durvalumab therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Der skal tages en beslutning om, hvorvidt amning skal afbrydes eller om behandling med durvalumab skal seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: The efficacy of IMFINZI was evaluated in the PACIFIC Study, a randomised, double-blind, placebo-controlled, multicentre study in 713 patients with locally advanced, unresectable NSCLC.
Danish: Virkningen af IMFINZI blev evalueret i PACIFIC-studiet, et randomiseret, dobbeltblindet, placebokontrolleret, multicenterstudie med 713 patienter med lokalt fremskreden inoperabel NSCLC.
English: If not used immediately, chemical and physical in-use stability of IMFINZI has been demonstrated for no more than 24 hours at 2°C to 8°C or 12 hours at room temperature up to 25°C from the time of vial puncture to the start of administration.
Danish: Hvis IMFINZI ikke anvendes straks, er den kemiske og fysiske stabilitet påvist i højest 24 timer ved 2 °C til 8 °C eller 12 timer ved stuetemperatur op til 25 °C fra tidspunktet for hætteglassets anbrud til start af administrationen.
English: Animal studies with durvalumab are not indicative of reproductive toxicity (see section 5.3).
Danish: Dyreforsøg med durvalumab indikerer ikke reproduktionstoksicitet (se pkt.
English: At baseline, no differences in patient reported symptoms, function and HRQoL were observed between IMFINZI and placebo groups.
Danish: Ved baseline blev der ikke observeret forskelle i patientrapporterede symptomer, funktion og HRQoL mellem IMFINZI og placebogrupperne.
English: Patients were randomised 2:1 to receive 10 mg/kg IMFINZI (n = 476) or 10 mg/kg placebo (n = 237) via intravenous infusion every 2 weeks for up to 12 months or until unacceptable toxicity or confirmed disease progression.
Danish: Patienterne blev randomiseret 2:1 til at modtage 10 mg/kg IMFINZI (n = 476) eller 10 mg/kg placebo (n = 237) via intravenøs infusion hver anden uge i op til 12 måneder eller indtil uacceptabel toksicitet eller bekræftet sygdomsprogression.
English: Initiate thyroid hormone replacement as clinically indicated
Danish: Initiér substitutionsbehandling med thyroidea hormon som klinisk indiceret
English: The use of systemic corticosteroids or immunosuppressants before starting durvalumab, except physiological dose of systemic corticosteroids (≤ 10 mg/day prednisone or equivalent), is not recommended because of their potential interference with the pharmacodynamic activity and efficacy of durvalumab.
Danish: Anvendelse af systemiske kortikosteroider eller immunosuppressiva før opstart med durvalumab, med undtagelse af fysiologisk dosis af systemiske kortikosteroider (≤ 10 mg/dag prednison eller tilsvarende) anbefales ikke på grund af deres potentielle interferens med den farmakodynamiske aktivitet og virkning af durvalumab.
English: As reported in the literature, the PD-1/PD-L1 pathway plays a central role in preserving pregnancy by maintaining maternal immune tolerance to the foetus, and in mouse allogeneic pregnancy models disruption of PD-L1 signalling was shown to result in an increase in foetal loss.
Danish: Som beskrevet i litteraturen spiller PD-1/PD-L1-vejen en central rolle i bevarelsen af graviditeten ved at opretholde moderens immuntolerance over for fosteret, og i allogene graviditetsmodeller med mus blev det vist, at forstyrrelse af PD-L1-signalet resulterede i en stigning i fostertab.
English: Histidine hydrochloride monohydrate Trehalose dihydrate Polysorbate 80
Danish: Histidinhydrochloridmonohydrat Trehalosedihydrat Polysorbat 80
English: • you have lung problems or breathing problems;
Danish: • du har lungeproblemer eller åndedrætsbesvær
English: Due to minor involvement of hepatic processes in the clearance of durvalumab no dose adjustment of IMFINZI is recommended for patients with hepatic impairment as no difference in exposure is expected (see section 5.2).
Danish: På grund af leverprocessers mindre involvering i clearance af durvalumab anbefales der ikke dosisjustering af IMFINZI til patienter med nedsat leverfunktion, da der ikke forventes nogen forskel i eksponering (se pkt.
English: OS Number of deaths (%) Median (months) (95% CI)
Danish: Antal dødsfald (%) Median (måneder) (95 % CI)
English: Selective blockade of PD-L1/PD-1 and PD-L1/CD80 interactions enhances antitumour immune responses and increases T-cell activation.
Danish: Selektiv blokade af PD-L1/PD-1 og PDL1/CD80-interaktioner forbedrer antitumor immunresponset og øger T-celleaktivering.
English: Uncommon General disorders and administration site conditions Pyrexia
Danish: Ikke almindelig Almene symptomer og reaktioner på administrationsstedet Pyreksi
English: Durvalumab is a fully human, immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that selectively blocks the interaction of PD-L1 with PD-1 and CD80 (B7.1).
Danish: Durvalumab er et fuldt humant immunoglobulin G1 kappa (IgG1)-monoklonalt antistof, der selektivt blokerer PD-L1's interaktionen med PD-1 og CD80 (B7.1).
English: Adverse drug reactions in patients with locally advanced unresectable NSCLC treated with IMFINZI at 10 mg/kg
Danish: Bivirkninger hos patienter med lokalt fremskreden inoperabel NSCLC behandlet med IMFINZI 10 mg/kg
English: It is unknown whether durvalumab is secreted in human breast milk.
Danish: Det vides ikke, om durvalumab udskilles i human modermælk.
English: Baseline demographics of the overall study population were as follows: male (70%), age ≥ 65 years (45%), age ≥ 75 years (8%), White (69%), Asian (27%), other (4%), current smoker (16%), past-smoker (75%), never smoker (9%), ECOG Performance Status 0 (49%), ECOG Performance Status 1 (51%).
Danish: Baseline demografi for den overordnede studiepopulation var som følger: mænd (70 %), alder ≥65 år (45 %), alder ≥ 75 år (8 %), hvide (69 %), asiater (27 %), andre (4 %), nuværende ryger (16 %), eks-ryger (75 %), aldrig røget (9 %), ECOG Performance Status 0 (49 %), ECOG Performance Status 1 (51 %).
English: Additional subgroup analyses were conducted to evaluate the efficacy by tumour PD-L1 expression (≥ 25%, 1-24%, ≥ 1%, < 1%) and for patients whose PD-L1 status cannot be established (PD-L1 unknown).
Danish: Post-hoc-undergruppeanalyse baseret på PD-L1-ekspression Der blev udført yderligere undergruppeanalyser for at evaluere effekten baseret på tumor PD-L1-ekspression (≥ 25 %, 1-24 %, ≥ 1 %, < 1 %) og for patienter, hvis PD-L1-status ikke kan fastslås (PD-L1 ukendt).
English: e includes autoimmune hypothyroidism and hypothyroidism.
Danish: e omfatter autoimmun hypothyreoidisme og hypothyreoidisme.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with durvalumab in all subsets of the paediatric population in the treatment of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms) (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med durvalumab i alle undergrupper af den pædiatriske population i behandling af maligne neoplasmer (undtagen tumorer i centralnervesystemet, hæmatopoietiske og lymfoide neoplasmer) (se pkt.
English: Table 2 lists the incidence of adverse reactions in patients with locally advanced, unresectable NSCLC in the PACIFIC Study, based on the frequency of that adverse reaction type regardless of investigator assessed causality.
Danish: Tabel 2 viser forekomsten af bivirkninger hos patienter med lokalt fremskreden inoperabel NSCLC i PACIFIC-studiet, baseret på hyppigheden af denne bivirkningstype, uanset investigator-vurderet årsagssammenhæng.
English: The overall incidence of Grade 3 or 4 adverse reactions was 12.8% in the IMFINZI arm vs 9.8% in placebo.
Danish: Den samlede forekomst af Grad 3 eller 4 bivirkninger var 12,8 % i IMFINZI-armen vs. 9,8 % i placebo-armen.
English: The PK of durvalumab was studied in 1902 patients with solid tumours with doses ranging from 0.1 to 20 mg/kg administered intravenously once every two, three or four weeks.
Danish: De farmakokinetiske (PK) egenskaber af durvalumab blev undersøgt i 1.902 patienter med solide tumorer med doser fra 0,1 til 20 mg/kg administreret intravenøst en gang hver anden, tredje eller fjerde uge.
English: Durvalumab does not induce antibody dependent cell-mediated cytotoxicity (ADCC).
Danish: Durvalumab inducerer ikke antistofafhængig cellemedieret cytotoksicitet (ADCC).
English: • inflammation of the liver that can cause nausea or feeling less hungry
Danish: • betændelse i leveren, der kan forårsage kvalme eller at man føler sig mindre sulten
English: Immune-mediated myositis/polymyositis
Danish: Immunmedieret myositis/polymyositis
English: Permanently discontinue IMFINZI if adverse reaction does not resolve to ≤ Grade 1 within 30 days or if there are signs of respiratory insufficiency.
Danish: Seponer IMFINZI permanent, hvis bivirkningen ikke reduceres til ≤ Grad 1 inden for 30 dage, eller hvis der er tegn på nedsat respiration.
English: Neutralising antibodies (nAbs) against durvalumab were detected in 0.5% (8/1570) of patients.
Danish: Neutraliserende antistoffer mod durvalumab blev påvist hos 0,5 % (8/1570) patienter.
English: Women of childbearing potential should use effective contraception during treatment with durvalumab and for at least 3 months after the last dose of durvalumab.
Danish: Fertile kvinderFertile kvinder skal anvende sikker kontraception under behandlingen med durvalumab og i mindst 3 måneder efter den sidste dosis af durvalumab.
English: Since the primary elimination pathways of durvalumab are protein catabolism via reticuloendothelial system or target-mediated disposition, no metabolic drug-drug interactions are expected.
Danish: Da de primære eliminationsveje for durvalumab er proteinkatabolisme via det reticuloendotheliale system eller target-medieret fordeling, forventes ingen metaboliske lægemiddelinteraktioner.
English: No dose adjustment is required for elderly patients (≥ 65 years of age) (see section 5.1).
Danish: Dosisjustering er ikke nødvendig til ældre patienter (≥65 år) (se pkt.
English: Durvalumab has no or negligible influence on the ability to drive and use machines.
Danish: Durvalumab påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: • Visually inspect the medicinal product for particulate matter and discolouration.
Danish: • Inspicer lægemidlet visuelt for partikler og misfarvning.
English: Available toxicological data in cynomolgus monkeys have shown low levels of durvalumab in breast milk on Day 28 after birth (see section 5.3).
Danish: Tilgængelige toksikologiske data hos cynomolgus-aber har vist lave niveauer af durvalumab i modermælk på dag 28 efter fødslen (se pkt.
English: • Your doctor will give you IMFINZI through an infusion (drip) into your vein for about
Danish: • Din læge vil give dig IMFINZI gennem en infusion (drop) i en vene i ca. 60 minutter hver anden uge.
English: Based on its mechanism of action, durvalumab has the potential to impact maintenance of pregnancy, and in a mouse allogeneic pregnancy model, disruption of PD-L1 signaling was shown to result in an increase in foetal loss.
Danish: På baggrund af dets virkningsmekanisme har durvalumab potentialet til at påvirke graviditeten, og i en muse-allogen graviditetsmodel viste forstyrrelsen af PD-L1 signalet at resultere i en stigning i fostertab.
English: • serious lung infections (pneumonia)
Danish: • alvorlige lungeinfektioner (lungebetændelse)
English: Immune-mediated adrenal insufficiency or hypophysitis/hypopituitarism
Danish: Immunmedieret adrenal insufficiens eller hypofysitis/ hypopituitarisme
English: Grade 2-4
Danish: Grad 2-4
English: No dose adjustment of IMFINZI is recommended in patients with mild or moderate renal impairment.
Danish: Dosisjustering af IMFINZI anbefales ikke til patienter med let eller moderat nedsat nyrefunktion.
English: Based on population PK analysis that included 1878 patients in the dose range of ≥ 10 mg/kg every 2 weeks, the geometric mean steady state volume of distribution (Vss) was 5.64 L. Durvalumab clearance (CL) decreased over time resulting in a geometric mean steady state clearance (CLss) of 8.16 mL/h at Day 365; the decrease in CLss was not considered clinically relevant.
Danish: Baseret på populationens PK-analyse, der inkluderede 1.878 patienter i dosisområdet ≥ 10 mg/kg hver 2. uge, var det geometriske gennemsnitlige fordelingsvolumen ved steady-state (Vss) 5,64 l. Durvalumab-clearance (CL) faldt over tid, hvilket resulterede i en geometrisk gennemsnitlig steadystate clearance (CLss) på 8,16 ml/time ved dag 365; faldet i CLss blev ikke betragtet som klinisk relevant.
English: However, systemic corticosteroids or other immunosuppressants can be used after starting durvalumab to treat immune-related adverse reactions (see section 4.4).
Danish: Dog kan systemiske kortikosteroider eller andre immunosuppressiva anvendes efter opstart med durvalumab til behandling af immunrelaterede bivirkninger (se pkt.
English: • abnormal kidney function tests (blood creatinine increased)
Danish: • unormale nyrefunktionstest (forhøjet blodkreatinin)
English: Do not use if this medicine is cloudy, discoloured or contains visible particles.
Danish: Brug ikke lægemidlet, hvis opløsningen er uklar, misfarvet eller indeholder synlige partikler.