FrancophonIA/ELRC3.0 huggingface dataset:
English: Modest accumulation was observed upon repeated dosing (geometric mean accumulation ratio: 1.9 to 2.4).
Danish: Der blev observeret moderat akkumulering efter gentagen dosering (geometrisk middelakkumuleringsforhold: 1,9 til 2,4).
English: Treatment with Alunbrig is not recommended in persons under 18 years of age.
Danish: Behandling med Alunbrig frarådes til personer under 18 år.
English: Liver function, including AST, ALT and total bilirubin should be assessed prior to the initiation of Alunbrig and then every 2 weeks during the first 3 months of treatment.
Danish: Leverfunktion, herunder ASAT, ALAT og total bilirubin, skal vurderes inden indledning af behandling med Alunbrig og derefter hver 2. uge under de første 3 måneders behandling.
English: This effect was observed at approximately five fold the human exposure at the 180 mg once daily dose.
Danish: Denne virkning blev observeret ved ca. fem gange den humane eksponering ved dosen på 180 mg en gang daglig.
English: Carcinogenicity studies have not been performed with brigatinib.
Danish: Der er ikke udført karcinogenicitetsforsøg med brigatinib.
English: Additional outcome measures included confirmed ORR as evaluated by an Independent Review Committee (IRC); time to response; progression free survival (PFS); duration of response (DOR); overall survival; and intracranial ORR and intracranial DOR as evaluated by an IRC.
Danish: Yderligere effektmål omfattede bekræftet ORR som bedømt af en uafhængig undersøgelseskomité (IRC), tid til respons, progressionsfri overlevelse (PFS), varighed af respons (DOR), samlet overlevelse samt intrakraniel ORR og intrakraniel DOR som bedømt af en IRC.
English: Alunbrig may be taken with or without food.
Danish: Alunbrig kan tages sammen med eller uden mad.
English: Bradycardia with life-threatening consequences, urgent intervention indicated
Danish: Bradykardi med livstruende konsekvenser, akut behandling indiceret
English: Figure 1: Investigator-Assessed Systemic Progression-Free Survival: ITT Population by Treatment Arm (ALTA)
Danish: Figur 1: Investigator-bedømt systemisk progressionsfri overlevelse: ITT-population efter behandlingsarm (ALTA)
English: Alunbrig may cause foetal harm when administered to a pregnant woman.
Danish: Alunbrig kan forårsage fosterskader, når det administreres til en gravid kvinde.
English: The median duration of peripheral neuropathy adverse reactions was 4.5 months, with a maximum duration of 28.7 months.
Danish: Den mediane varighed af bivirkninger med perifer neuropati var 4,5 måneder, og den maksimale varighed var 28,7 måneder.
English: After a single dose and at steady state, systemic exposure was dose proportional over the dose range of 60-240 mg once daily.
Danish: Efter en enkelt dosis og ved steady state var systemisk eksponering proportionel over dosisintervallet på 60-240 mg en gang daglig.
English: Eligibility criteria permitted enrolment of patients with a documented ALK rearrangement based on a validated test, ECOG Performance Status of 0-2, and prior chemotherapy.
Danish: Udvælgelseskriterierne gav mulighed for at medtage patienter med dokumenteret ALK-omarrangering på baggrund af en valideret test, ECOG-performancestatus på 0-2 og tidligere kemoterapi.
English: Grade 3 hyperglycemia occurred in 7.3% of patients.
Danish: Grad 3-hyperglykæmi forekom hos 7,3 % af patienterne.
English: Alunbrig may also induce other enzymes and transporters (e.g., CYP2C, P-gp) via the same mechanisms responsible for induction of CYP3A (e.g., pregnane X receptor activation).
Danish: Alunbrig kan også inducere andre enzymer og transportører (f.eks. CYP2C, P-gp) via de samme mekanismer, der er ansvarlige for induktion af CYP3A (f.eks. pregnan X-receptor-aktivering).
English: Alunbrig should not be used during pregnancy unless the clinical condition of the mother requires treatment.
Danish: Alunbrig bør ikke anvendes under graviditeten, medmindre kvindens kliniske tilstand kræver behandling.
English: It is unknown if brigatinib passes into breast milk and could potentially harm the baby.
Danish: Det er ukendt, om brigatinib udskilles i human mælk, og det kan muligvis skade barnet.
English: No apparent adverse effects on female reproductive organs were observed in general toxicology studies in rats and monkeys.
Danish: Der blev ikke observeret tydelige bivirkninger på hundyrs forplantningsorganer i generelle toksikologiforsøg hos rotter og aber.
English: The mechanism of micronucleus induction was abnormal chromosome segregation (aneugenicity) and not a clastogenic effect on chromosomes.
Danish: Mikrokerneinduktionsmekanismen var unormal kromosomsegregering (aneugenicitet) og ikke en klastogen virkning på kromosomerne.
English: Grade 4 hypertension (life threatening consequences, urgent intervention indicated)
Danish: Grad 4-hypertension (livstruende konsekvenser, akut behandling indiceret)
English: Treatment initiation pack
Danish: Pakning til behandlingsopstart
English: Table 4: Efficacy results in ALTA (ITT population) Efficacy parameter
Danish: Tabel 4: Effektresultater i ALTA (ITT-population) Effektparameter
English: IRC assessments of intracranial ORR and duration of intracranial response in patients from ALTA with measurable brain metastases (≥ 10 mm in longest diameter) at baseline are summarised in Table 5.
Danish: IRC-bedømmelse af intrakraniel ORR og varighed af intrakranielt respons hos patienter i ALTA med målbare hjernemetastaser (længste diameter ≥ 10 mm) ved baseline er opsummeret i tabel 5.
English: Unchanged brigatinib represented 41% and 86% of the total radioactivity in faeces and urine, respectively, the remainder being metabolites.
Danish: Uændret brigatinib repræsenterede henholdsvis 41 % og 86 % af den totale radioaktivitet i fæces og urin, og resten var metabolitter.
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLERE ANSVARLIG FOR BATCHFRIGIVELSE
English: Testicular toxicity was observed in repeat-dose animal studies.
Danish: Testikeltoksicitet blev observeret i dyreforsøg med gentagne doser.
English: Unchanged brigatinib was the major circulating radioactive component (92%) along with AP26123 (3.5%), the primary metabolite also observed in vitro.
Danish: Uændret brigatinib var den største cirkulerende radioaktive komponent (92 %) sammen med AP26123 (3,5 %), som er den primære metabolit, der også er observeret in vitro.
English: Adverse reactions† all grades
Danish: Bivirkninger† alle grader
English: Increased age and shorter interval (less than 7 days) between the last dose of crizotinib and the first dose of Alunbrig were independently associated with an increased rate of these pulmonary adverse reactions.
Danish: Høj alder og kortere intervaller (under 7 dage) mellem den sidst indtagede dosis crizotinib og første indtagede dosis Alunbrig blev uafhængigt af hinanden forbundet med en øget forekomst af disse pulmonale bivirkninger.
English: • If you vomit after taking Alunbrig, do not take any more tablets until your next scheduled dose.
Danish: • Hvis du kaster op efter at have taget Alunbrig, må du ikke tage flere tabletter, før det er tid til den næste planlagte dosis.
English: • The active substance is brigatinib.
Danish: • Aktivt stof: brigatinib.
English: Of these, three Grade 3 adverse reactions (2.7%) including macular oedema and cataract were reported.
Danish: Af disse blev der rapporteret tre Grad 3-bivirkninger (2,7 %), herunder maculaødem og katarakt.
English: Alunbrig is not recommended during pregnancy unless the benefit outweighs the risk to the baby.
Danish: Alunbrig frarådes under graviditeten, medmindre fordelene opvejer risikoen for barnet.
English: • inflammation of the mouth and lips (stomatitis)
Danish: • betændelse i munden og på læberne (stomatit)
English: If Alunbrig is used during pregnancy, or if the patient becomes pregnant while taking this medicinal product, the patient should be apprised of the potential hazard to a foetus.
Danish: Hvis Alunbrig anvendes under graviditeten, eller hvis patienten bliver gravid, under behandling med dette lægemiddel, skal patienten informeres om den potentielle risiko for et foster.
English: Intracranial disease control rate
Danish: Intrakraniel sygdomskontrolrate
English: The median time to onset for amylase elevations and lipase elevations was 17 days and 29 days, respectively.
Danish: Mediantiden til debut for forhøjet amylase og lipase var henholdsvis 17 dage og 29 dage.
English: Elevation of lipase or amylase
Danish: Forhøjet lipase eller amylase
English: The effect of gemfibrozil on the pharmacokinetics of brigatinib is not clinically meaningful and the underlying mechanism for the decreased exposure of brigatinib is unknown.
Danish: Virkningen af gemfibrozil på farmakokinetikken for brigatinib er ikke klinisk betydningsfuld, og den underliggende mekanisme for reduceret eksponering for brigatinib er ukendt.
English: They are convex on the upper and lower side.
Danish: De er hvælvede på over- og undersiden.
English: Do not stop taking Alunbrig before talking to your doctor.
Danish: Hold ikke op med at tage Alunbrig uden at tale med lægen.
English: In ALTA, 69% of patients experienced hyperglycaemia.
Danish: I ALTA fik 69 % af patienterne hyperglykæmi.
English: Take your next dose at your regular time.
Danish: Tag den næste dosis på det næste planlagte tidspunkt.
English: No human data on the effect of Alunbrig on fertility are available.
Danish: Der foreligger ingen humane data om Alunbrigs virkning på fertilitet.
English: Alunbrig film-coated tablets are white to off-white, oval (90 mg and 180 mg) or round (30 mg).
Danish: Alunbrig filmovertrukne tabletter er hvide til offwhite og ovale (90 mg og 180 mg) eller runde (30 mg).
English: ALK-positive NSCLC status should be known prior to initiation of Alunbrig therapy.
Danish: Status for ALK-positiv NSCLC skal være kendt, inden indledning af behandling med Alunbrig.
English: No patients had dose reductions due to hyperglycaemia.
Danish: Ingen patienter fik dosisreduktion som følge af hyperglykæmi.
English: If you are pregnant or think you may be pregnant or are planning to have a baby, talk to your doctor to discuss the risks of taking Alunbrig during pregnancy.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds om risikoen ved at tage Alunbrig under graviditeten.
English: Some patients experienced pneumonitis later in treatment with Alunbrig.
Danish: Nogle patienter fik pneumonitis senere i behandlingsforløb med Alunbrig.
English: Grade 3 hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg, medical intervention indicated, more than one anti-hypertensive medicinal product, or more intensive therapy than previously used indicated)
Danish: Hypertension Grad 3-hypertension (SYS ≥ 160 mmHg eller DIA ≥ 100 mmHg, medicinsk behandling indiceret, mere end ét antihypertensivum eller mere intensiv behandling end tidligere indiceret anvendt)
English: Patients should be advised to report any visual symptoms.
Danish: Patienter skal instrueres i at indberette alle synsrelaterede symptomer.
English: The abnormal gene produces a protein known as a kinase that stimulates the growth of the cancer cells.
Danish: Det defekte gen danner et unormalt protein, som kaldes en kinase, der stimulerer væksten af kræftcellerne.
English: Ask your doctor about the birth control methods that may be right for you.
Danish: Spørg lægen om den form for prævention, der er bedst egnet til dig.
English: Patients with measurable brain metastases at baseline
Danish: Patienter med målbare hjernemetastaser ved baseline
English: Study 101: An open-label multicentre phase 1/2 dose escalation/expansion trial in patients with advanced malignancies.
Danish: Studie 101: Et åbent fase 1/2-multicenterforsøg med dosiseskalering/udvidelse med patienter med fremskredne maligniteter.
English: If Alunbrig is interrupted for 14 days or longer for reasons other than adverse reactions, treatment should be resumed at 90 mg once daily for 7 days before increasing to the previously tolerated dose.
Danish: Hvis behandling med Alunbrig afbrydes i 14 dage eller længere tid, af andre årsager end bivirkninger, genoptages behandlingen med 90 mg en gang daglig i 7 dage, inden den øges til den tidligere tolererede dosis.
English: Heart rate and blood pressure should be monitored regularly.
Danish: Hjertefrekvens og blodtryk skal overvåges og måles regelmæssigt.
English: Dose reduction levels First
Danish: Dosisreduktionstrin Første trin
English: Brigatinib is a tyrosine kinase inhibitor that targets ALK, c-ros oncogene 1 (ROS1), and insulin-like growth factor 1 receptor (IGF-1R).
Danish: Brigatinib er en tyrosinkinase-hæmmer, som er målrettet ALK, c-ros onkogen 1 (ROS1), og insulin-lignende vækstfaktor 1-receptor (IGF-1R).
English: Your doctor may stop Alunbrig treatment and refer you to an ophthalmologist.
Danish: Din læge vil muligvis stoppe behandling med Alunbrig og henvise dig til en øjenlæge.
English: Adverse reactions seen in animals at exposure levels similar to clinical exposure levels with possible relevance to clinical use were as follows: gastrointestinal system, bone marrow, eyes, testes, liver, kidney, bone, and heart.
Danish: Der blev set bivirkninger hos dyr ved eksponeringsniveauer, der svarede til kliniske eksponeringsniveauer med mulig relevans for klinisk brug, på følgende områder: mave-tarm-kanalen, knoglemarv, øjne, testes, lever, nyre, knogle og hjerte.
English: Patients should be closely monitored when Alunbrig is coadministered with substrates of these transporters with a narrow therapeutic index (e.g., digoxin, dabigatran, methotrexate).
Danish: Patienter skal overvåges tæt ved samtidig administration af Alunbrig og substrater af disse transportører, som har et smalt terapeutisk indeks (f.eks. digoxin, dabigatran, methotrexat).
English: Outer Carton: PC:
Danish: Ydre karton: PC:
English: Tell your doctor if you have kidney problems or you are on dialysis.
Danish: Fortæl det til lægen, hvis du har problemer med nyrerne eller er i dialyse.
English: Alunbrig should be permanently discontinued if patient is unable to tolerate the 60 mg once daily dose.
Danish: Behandlingen med Alunbrig skal seponeres, hvis en patient ikke tolererer en dosis på 60 mg en gang daglig.
English: • reduced number of red blood cells (anaemia)
Danish: • nedsat antal røde blodlegemer (anæmi)
English: • pravastatin, rosuvastatin: medicines to lower elevated cholesterol levels
Danish: • pravastatin, rosuvastatin: lægemidler, der sænker forhøjede kolesterolniveauer
English: Of these, 19 patients had an investigator-assessed confirmed objective response (76%; 95% CI: 55, 91) and the KM estimate median duration of response among the 19 responders was 26.1 months (95% CI: 7.9, 26.1).
Danish: Af disse havde 19 patienter et investigator-bedømt bekræftet objektivt respons (76 %; 95 % CI: 55, 91), og den KM-estimerede mediane varighed af respons blandt de 19 patienter med respons var 26,1 måneder (95 % CI: 7,9; 26,1).
English: In ALTA, 6.4% of patients experienced pulmonary adverse reactions of any grade, including ILD/pneumonitis, pneumonia and dyspnoea, early in treatment (within 9 days, median onset: 2 days); 2.7% of patients had Grade 3-4 pulmonary adverse reactions and 1 patient (0.5%) had fatal pneumonia.
Danish: I ALTA fik 6,4 % af patienterne pulmonale bivirkninger uanset Grad, herunder ILD/pneumonitis, pneumoni og dyspnø, tidligt i behandlingen (inden for 9 dage, median debut: 2 dage), 2,7 % af patienterne fik pulmonale bivirkninger af Grad 3-4 og 1 patient (0,5 %) fik letal pneumoni.
English: Penn Pharmaceutical Services Limited Units 23-24
Danish: Penn Pharmaceutical Services Limited.
English: Alunbrig contains the active substance brigatinib, a type of cancer medicine called a kinase inhibitor.
Danish: Alunbrig indeholder det aktive stof brigatinib, som er type kræftmedicin som kaldes en kinase-hæmmer.
English: Findings included embryo-lethality, reduced foetal growth, and skeletal variations.
Danish: Fundene omfattede embryo-letalitet, hæmmet fostervækst og knoglevariationer.
English: In patients, at steady state, the plasma AUC of AP26123 was < 10% of brigatinib exposure.
Danish: Hos patienterne var plasma-AUC for AP26123 ved steady state < 10 % af brigatinib-eksponeringen.
English: Common Memory impairment Dysgeusia
Danish: Almindelig Hukommelsesbesvær Dysgeusi
English: The incidence of Grade 3-4 elevations of CPK was 13.6%.
Danish: Forekomsten af Grad 3-4-forhøjet CK var 13,6 %.
English: Interstitial lung disease (ILD)/pneumonitis
Danish: Interstitiel lungesygdom (ILD)/pneumonitis
English: The most common serious adverse reactions (≥ 2%) reported in patients treated with Alunbrig at the recommended dosing regimen other than events related to neoplasm progression were pneumonitis, pneumonia, and dyspnoea.
Danish: De mest almindelige alvorlige bivirkninger (≥ 2 %), der blev rapporteret hos patienter i behandling med det anbefalede dosisregime for Alunbrig, bortset fra hændelser relateret til tumorprogression, var pneumonitis, pneumoni og dyspnø.
English: Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitors, ATC code: L01XE43
Danish: Farmakoterapeutisk klassifikation: antineoplastiske stoffer, proteinkinase-hæmmere, ATC-kode: L01XE43
English: Women of childbearing age being treated with Alunbrig should avoid becoming pregnant.
Danish: Kvinder i den fødedygtige alder, der er i behandling med Alunbrig, skal undgå at blive gravide.
English: The safety and efficacy of Alunbrig in patients less than 18 years of age have not been established.
Danish: Pædiatrisk population Alunbrigs sikkerhed og virkning hos patienter under 18 år er ikke klarlagt.
English: Symptomatic bradycardia
Danish: Symptomatisk bradykardi
English: In repeated dose toxicity studies, lung changes (foamy alveolar macrophages) were noted in monkeys at ≥ 0.2 times the human AUC; however, these were minimal and similar to those reported as background findings in naive monkeys, and there was no clinical evidence of respiratory distress in these monkeys.
Danish: I forsøg med toksicitet ved gentagne doser blev der set lungeforandringer (skummende alveolære makrofager) hos aber ved ≥ 0,2 gange humant AUC; disse var dog minimale og svarede til dem, der blev rapporteret som baggrundsfund hos naive aber, og der var ingen klinisk dokumentation for respirationsbesvær hos disse aber.
English: reduce to 60 mg once daily permanently discontinue not applicable
Danish: reducer til 60 mg en gang daglig seponer behandlingen ikke relevant
English: Given that brigatinib exhibits high solubility and high permeability, inhibition of P-gp and BCRP is not expected to result in a clinically meaningful change in the systemic exposure of brigatinib.
Danish: Under forudsætning af, at brigatinib udviser høj opløselighed og høj permeabilitet, forventes hæmning af P-gp og BCRP ikke at medføre klinisk relevante ændringer i den systemiske eksponering af brigatinib.
English: Baseline demographics and disease characteristics in ALTA were median age 54 years old (range 18 to 82; 23% 65 and over), 67% White and 31% Asian, 57% female, 36% ECOG PS 0 and 57% ECOG PS 1, 7% ECOG PS2, 60% never smoker, 35% former smoker, 5% current smoker, 98% Stage IV, 97% adenocarcinoma, and 74% prior chemotherapy.
Danish: Baseline-demografi og sygdomskarakteristika i ALTA var en medianalder på 54 år (interval 18 til 82; 23 % 65 og ældre), 67 % var hvide og 31 % var asiater, 57 % var kvinder, 36 % havde ECOG PS 0 og 57 % havde ECOG PS 1, 7 % havde ECOG PS2, 60 % havde aldrig røget, 35 % var tidligere rygere, 5 % var rygere, 98 % havde stadie IV, 97 % havde adenokarcinom og 74 % havde tidligere fået kemoterapi.
English: Brigatinib may reduce plasma levels of coadministered medicinal products that are predominantly metabolised by CYP3A.
Danish: Brigatinib kan reducere plasmakoncentrationen af samtidigt administrerede lægemidler, som fortrinsvis metaboliseres af CYP3A.
English: Evidence of pneumonitis in any patient with worsening respiratory symptoms should be promptly investigated.
Danish: Tegn på pneumonitis skal straks udredes hos enhver patient med symptomer på forværret åndedræt.
English: At the beginning of your treatment with Alunbrig your doctor may prescribe a treatment initiation pack.
Danish: Når du starter behandlingen med Alunbrig, vil lægen muligvis ordinere en pakning til behandlingsopstart.
English: The most common sites of extra-thoracic metastasis included 69% brain (of whom 62% had received prior radiation to the brain), 39% bone, and 26% liver.
Danish: De fleste ekstra-torakale metastaser var i hjernen (69 %, hvoraf 62 % tidligere havde fået strålebehandling af hjernen), 39 % var i knoglerne og 26 % var i leveren.
English: Table 1: Recommended Alunbrig dose reduction levels Dose
Danish: Tabel 1: Anbefalede reduktionstrin for dosering af Alunbrig Anbefalet dosis
English: The MAH shall ensure that in each Member State where Alunbrig is marketed, all healthcare professionals and patients/carers who are expected to prescribe and use Alunbrig have access to/are provided with the following educational package:
Danish: Markedsføringsindehaver skal sikre sig, at enhver sundhedsprofessionel, behandler eller patient, der forventes at udskrive, give eller anvende Alunbrig, har adgang til eller er forsynet med den nedennævnte uddannelsespakke:
English: Clinical drug-drug interaction studies with CYP3A sensitive substrates have not been conducted.
Danish: Der er ikke udført kliniske lægemiddelinteraktionsforsøg med CYP3A-følsomme substrater.
English: Do not crush or dissolve the tablets.
Danish: Tabletterne må ikke knuses eller opløses.
English: The KM median PFS was 16.3 months (95% CI: 9.2, NE) and the 12-month probability of overall survival was 84.0% (95% CI: 62.8, 93.7).
Danish: Den KM-estimerede mediane PFS var 16,3 måneder (95 % CI: 9,2, NE), og sandsynligheden for samlet overlevelse efter 12 måneder var 84,0 % (95 % CI: 62,8; 93,7).
English: Treatment initiation pack Each pack contains two cartons in an outer carton.
Danish: Pakning til behandlingsopstart Hver pakning indeholder to primære æsker i en ydre æske.
English: The tablets should be swallowed whole and with water.
Danish: Tabletterne skal synkes hele sammen med et glas vand.
English: It is given to patients whose lung cancer is related to an abnormal form of a gene called anaplastic lymphoma kinase (ALK).
Danish: Det gives til patienter med en form for lungekræft, som er relateret til en defekt i et gen, der kaldes anaplastisk lymfom-kinase (ALK).
English: Safety pharmacology studies with brigatinib identified potential for pulmonary effects (altered respiration rate; 1-2 times the human Cmax), cardiovascular effects (altered heart rate and blood pressure; at 0.5 times the human Cmax), and renal effects (reduced renal function; at 1-2.5 times the human Cmax), but did not indicate any potential for QT prolongation or neurofunctional effects.
Danish: Sikkerhedsfarmakologiske forsøg af brigatinib identificerede et potentiale for pulmonale virkninger (ændring i respirationsfrekvens; 1-2 gange human Cmax), kardiovaskulære virkninger (ændret hjertefrekvens og blodtryk, 0,5 gange human Cmax) og nyrerelaterede virkninger (nedsat nyrefunktion, 1-2,5 gange human Cmax), men indikerede ikke et potentiale for QT-forlængelse eller neurofunktionelle virkninger.
English: No patients had dose reductions due to elevation of ALT or AST.
Danish: Ingen patienter fik dosisreduktion som følge af forhøjet ALAT eller ASAT.
English: • carbamazepine: a medicine to treat epilepsy, euphoric/depressive episodes and certain pain conditions
Danish: • carbamazepin: et lægemiddel til behandling af epilepsi, maniske/depressive episoder og visse smertelidelser
English: Early pulmonary adverse reactions also occurred in a dose escalation study in patients (N = 137) (Study 101) including three fatal cases (hypoxia, acute respiratory distress syndrome and pneumonia).
Danish: Der opstod også tidlige pulmonale bivirkninger i et dosiseskaleringsforsøg med patienter (N = 137) (Studie 101), herunder tre letale tilfælde (hypoksi, ARDS (acute respiratory distress syndrome) og pneumoni).