FrancophonIA/ELRC3.0 huggingface dataset:
English: Grapefruit or grapefruit juice may increase plasma concentrations of brigatinib and should be avoided (see section 4.5).
Danish: Grapefrugt eller grapefrugtjuice kan øge plasmakoncentrationerne af brigatinib og skal undgås (se pkt.
English: Keep the desiccant canister in the bottle.
Danish: Lad tørrekapslen blive i beholderen.
English: 180 mg regimen† N = 110
Danish: 180 mg-regime† N = 110
English: Post-authorisation efficacy study (PAES): In order to further characterise the efficacy and safety of brigatinib in the treatment of patients with ALK positive NSCLC, the MAH should submit the clinical study report of the phase III study AP26113-13-301 comparing brigatinib versus crizotinib in patients with advanced ALK+ NSCLC who have not previously received ALK-directed therapy.
Danish: Effektforsøg efter udstedt markedsføringsføringstilladelse (PAES): Med henblik på en yderligere karakterisering af sikkerhed og effekt af brigatinib ved behandling af ALK-positiv NSCLC (ikke småcellet lungecancer), skal markedsføringsindehaver indsende kliniske forsøgsrapporter for fase III-forsøget AP26113-301 Sammenligning af brigatinib med crizotinib hos patienter med avanceret ALK+NSCLC, som ikke tidligere har modtaget behandling målrettet mod ALK.
English: No dose adjustment is required for Alunbrig in combination with moderate CYP3A inhibitors.
Danish: Der kræves ingen dosisjustering for Alunbrig i kombination med moderate CYP3A-hæmmere.
English: Grade ≥ 2 elevation (> 3 × ULN) of ALT or AST with concurrent total bilirubin elevation > 2 × ULN in the absence of cholestasis or haemolysis
Danish: Grad ≥ 2-forhøjet(> 3 × ULN) ALAT eller ASAT med samtidig forhøjet total bilirubin > 2 × ULN ved fravær af cholestase eller hæmolyse
English: bpm = beats per minute; CPK = Creatine Phosphokinase; DBP = diastolic blood pressure; HR = heart rate; SBP = systolic blood pressure; ULN = upper limit of normal *Graded per National Cancer Institute Common Terminology Criteria for Adverse Events.
Danish: bpm = slag pr. minut, CK = kreatinkinase, DIA = diastolisk blodtryk, HF = hjertefrekvens, SYS = systolisk blodtryk, ULN = øvre grænse for normal *Klassificeret iht.
English: Tell your doctor if you are feeling very thirsty, need to urinate more than usual, feeling very hungry, sick to your stomach, weak or tired, or confused.
Danish: • forhøjet blodsukker Fortæl det til lægen, hvis du føler dig meget tørstig, skal lade vandet oftere end sædvanligt, er meget sulten, har kvalme, er svag eller træt eller er forvirret.
English: • nafcillin: a medicine to treat bacterial infections
Danish: • nafcillin: et lægemiddel til behandling af bakterieinfektioner
English: Median (months) 95% CI
Danish: Progressionsfri overlevelse Median (måneder) 95 % CI
English: • increased blood level of the enzyme alkaline phosphatase - may indicate organ malfunction or injury
Danish: • forhøjede niveauer af enzymet alkalisk fosfatase i blodet - kan være tegn på organsvigt eller -skade
English: Elevations of serum glucose have occurred in patients treated with Alunbrig.
Danish: Forhøjet serumglukoseværdier er set hos patienter i behandling med Alunbrig.
English: Patients should be advised to report any unexplained muscle pain, tenderness, or weakness.
Danish: Patienter skal instrueres i at indberette alle uforklarlige muskelsmerter, -ømhed eller -svækkelse.
English: Brigatinib inhibited the in vitro proliferation of cell lines expressing EML4-ALK and NPM-ALK fusion proteins and demonstrated dose-dependent inhibition of EML4-ALK-positive NSCLC xenograft growth in mice.
Danish: Brigatinib hæmmede in vitro-proliferation af cellelinjer, der udtrykker EML4-ALK og NPM-ALK fusionsproteiner, og udviste dosis-afhængig hæmning vækst af EML4-ALK-positiv NSCLC-xenotransplantation i mus.
English: Alunbrig contains lactose monohydrate.
Danish: Alunbrig indeholder lactosemonohydrat.
English: • indinavir, nelfinavir, ritonavir, saquinavir: medicines to treat HIV infection
Danish: • indinavir, nelfinavir, ritonavir, saquinavir: lægemidler til behandling af hiv-infektion
English: Mean systolic and diastolic blood pressure, in all patients, increased over time (see sections 4.2 and 4.4).
Danish: Det systoliske og diastoliske middelblodtryk forhøjedes med tiden hos alle patienter (se pkt.
English: CI = Confidence Interval; NE = Not Estimable; NA = Not Applicable *90 mg once daily regimen †180 mg once daily with 7-day lead-in at 90 mg once daily ‡Confidence Interval for investigator assessed ORR is 97.5% and for IRC assessed ORR is 95%
Danish: CI = konfidensinterval, NE = kan ikke estimeres, NA = ikke relevant *Regime med 90 mg en gang daglig †180 mg en gang daglig med 7-dages opstartsperiode med 90 mg en gang daglig ‡Konfidensintervallet er 97,5 % for investigator-bedømt ORR og 95 % for IRC-bedømt ORR.
English: • abnormal electrical activity of the heart (prolonged electrocardiogram QT interval)
Danish: • unormal hjerte-aktivitet (forlænget QT-interval målt med et elektrokardiogram (EKG))
English: • phenobarbital, phenytoin: medicines to treat epilepsy
Danish: • phenobarbital, phenytoin: lægemidler til behandling af epilepsi
English: % CI = Confidence Interval; NE = Not Estimable *90 mg once daily regimen †180 mg once daily with 7-day lead-in at 90 mg once daily ‡Events include intracranial disease progression (new lesions, intracranial target lesion diameter growth ≥ 20% from nadir, or unequivocal progression of intracranial non-target lesions) or death.
Danish: %CI = konfidensinterval, NE = kan ikke estimeres *Regime med 90 mg en gang daglig †180 mg en gang daglig med 7-dages opstartsperiode med 90 mg en gang daglig ‡Hændelser omfatter progression af intrakraniel sygdom (nye læsioner, vækst af intrakraniel mållæsions diameter ≥ 20 % fra nadir eller utvetydig progression af intrakranielle læsioner, som ikke er mållæsioner) eller dødsfald.
English: The pharmacokinetics of brigatinib was characterised in healthy subjects with normal hepatic function (N = 9), and patients with mild hepatic impairment (Child-Pugh class A, N = 6), moderate hepatic impairment (Child-Pugh class B, N = 6), or severe hepatic impairment (Child-Pugh class C, N = 6).
Danish: Brigatinibs farmakokinetik blev karakteriseret hos raske forsøgspersoner med normal leverfunktion (N = 9) samt patienter med let nedsat leverfunktion (Child-Pugh-klasse A, N = 6), moderat nedsat leverfunktion (Child-Pugh-klasse B, N = 6) eller svært nedsat leverfunktion (Child-Pugh-klasse C, N = 6).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER - TREATMENT INITIATION PACK - 180 MG
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER-TIL BEHANDLINGSOPSTARTSPAKNING - 180 MG
English: No dose adjustment is required during coadministration with strong CYP2C8 inhibitors.
Danish: Der kræves ingen dosisjustering ved samtidig administration med kraftige CYP2C8-hæmmere.
English: Other medicines and Alunbrig
Danish: Brug af anden medicin sammen med Alunbrig
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON TIL BLISTER
English: Hepatotoxicity Grade ≥ 3 elevation (> 5.0 × ULN) of either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) with bilirubin ≤ 2 × ULN
Danish: Grad ≥ 3-forhøjet (> 5,0 × ULN) enten alaninaminotransferase (ALAT) eller aspartataminotransferase (ASAT) med bilirubin  2 × ULN
English: APTT increased Anaemia
Danish: Øget APTT Anæmi
English: Patients with a history of ILD or drug-induced pneumonitis were excluded from the pivotal trial.
Danish: Patienter med tidligere ILD eller lægemiddelinduceret pneumonitis i anamnesen blev udelukket fra det pivotale kliniske forsøg.
English: For severe hypertension (≥ Grade 3), Alunbrig should be withheld until hypertension has recovered to Grade 1 or to baseline.
Danish: Ved svær hypertension (≥ Grad 3) skal behandling med Alunbrig indstilles indtil opnået bedring til Grad 1 eller til baseline.
English: Unbound AUC0-INF was 37% higher in patients with severe hepatic impairment (Child-Pugh class C) as compared to healthy subjects with normal hepatic function (see section 4.2).
Danish: Ubundet AUC0-INF var 37 % højere hos patienter med svært nedsat leverfunktion (Child-Pugh-klasse C) sammenlignet med raske forsøgspersoner med normal leverfunktion (se pkt.
English: After discontinuation of a strong CYP3A inhibitor, Alunbrig should be resumed at the dose that was tolerated prior to the initiation of the strong CYP3A inhibitor.
Danish: Efter seponering af en kraftig CYP3A-hæmmer skal behandling med Alunbrig genoptages med den dosis, der blev tolereret inden indledning af behandling med den kraftige CYP3A-hæmmer.
English: Tell your doctor of any new or worsening symptoms including breathing discomfort, shortness of breath, chest pain, cough and fever.
Danish: Fortæl det til lægen, hvis du får nye symptomer eller dine symptomer bliver værre, herunder at du føler ubehag ved vejrtrækning, åndenød, brystsmerter, hoste og feber.
English: In patients given brigatinib 180 mg once daily, the geometric mean apparent oral clearance (CL/F) of brigatinib at steady state was 13 L/h and the median plasma elimination half-life was 24 h.
Danish: Hos patienter, der fik 180 mg brigatinib en gang daglig, var den tilsyneladende geometriske middelværdi for oral clearance (CL/F) for brigatinib ved steady state 13 l/t, og median for halveringstid for plasmaelimination var 24 t.
English: Elevations of hepatic enzymes (aspartate aminotransferase, alanine aminotransferase) and bilirubin have occurred in patients treated with Alunbrig (see section 4.8).
Danish: Der er forekommet forhøjede leverenzymer (aspartataminotransferase, alaninaminotransferase) og bilirubin hos patienter i behandling med Alunbrig (se pkt.
English: • increased blood level of calcium
Danish: • forhøjet niveau af calcium i blodet
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON FOR TREATMENT INITIATION PACK - 7 TABLETS, 90 MG - 7 DAY TREATMENT (WITHOUT BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PRIMÆR ÆSKE TIL BEHANDLINGSOPSTARTSPAKNING - 7 TABLETTER, 90 MG7 DAGES BEHANDLING (UDEN BLÅ BOKS INFORMATION)
English: Film-coated tablets 28 film-coated tablets 56 film-coated tablets 112 film coated tablets
Danish: Filmovertrukne tabletter 28 filmovertrukne tabletter 56 filmovertrukne tabletter 112 filmovertrukne tabletter
English: • chest pain and discomfort
Danish: • smerter og ubehag i brystet
English: Grade 3 elevation of lipase or amylase (> 2.0 × ULN)
Danish: Grad 3-forhøjetlipase eller amylase (> 2,0 × ULN)
English: If a dose is missed or vomiting occurs after taking a dose, an additional dose should not be administered and the next dose should be taken at the scheduled time.
Danish: Hvis en dosis springes over, eller hvis patienten kaster op efter at have taget en dosis, må der ikke administreres en ny dosis.
English: • clarithromycin, telithromycin, troleandomycin: medicines to treat bacterial infections
Danish: • clarithromycin, telithromycin, troleandomycin: lægemidler til behandling af bakterieinfektioner
English: The concomitant use of strong CYP3A inhibitors with Alunbrig, including but not limited to certain antivirals (e.g., indinavir, nelfinavir, ritonavir, saquinavir), macrolide antibiotics (e.g., clarithromycin, telithromycin, troleandomycin), antifungals (e.g., ketoconazole, voriconazole), mibefradil, and nefazodone should be avoided.
Danish: Samtidigt indtag af kraftige CYP3A-hæmmere og Alunbrig, herunder men ikke begrænset til visse antivirale lægemidler (f.eks. indinavir, nelfinavir, ritonavir, saquinavir), makrolide antibiotika (f.eks. clarithromycin, telithromycin, troleandomycin), antimykotika (f.eks. ketoconazol, voriconazol), mibefradil og nefazodon, skal undgås.
English: Dyspnoeah
Danish: Dyspnøh
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER - TREATMENT INITIATION PACK - 90 MG
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER-TIL BEHANDLINGSOPSTARTSPAKNING- 90 MG
English: Alunbrig is available in plastic foil strips (blisters) packed in a carton with:
Danish: Alunbrig fås i blisterpakninger med:
English: 180 mg regimen† (N = 18)
Danish: 180 mg regime† (N = 18)
English: • a slow heartbeat (bradycardia)
Danish: • langsom puls (bradykardi)
English: No dose adjustment is required for Alunbrig during coadministration with P-gp and BCRP inhibitors.
Danish: Der kræves ingen dosisjustering for Alunbrig ved samtidig administration af P-gp- og BCRP-hæmmere.
English: • low platelet counts in blood tests, which may increase the risk of bleeding and bruising
Danish: • lave blodpladetal, som kan øge risikoen for blødninger og blå mærker
English: Dose reduction for hypertension occurred in 0.9% at the 180 mg regimen.
Danish: Dosis blev reduceret ved hypertension for 0,9 % behandlet med 180 mg-regimet.
English: Takeda Pharmaceuticals Czech Republic s.r.o.
Danish: Česká republika Takeda Pharmaceuticals Czech Republic s.r.o.
English: • ketoconazole, itraconazole, voriconazole: medicines to treat fungal infections
Danish: • ketoconazol, itraconazol, voriconazol: lægemidler til behandling af svampeinfektioner
English: In ALTA, hypertension was reported in 28% of patients treated with Alunbrig at the 180 mg regimen with 10% having Grade 3 hypertension.
Danish: I ALTA blev hypertension rapporteret hos 28 % af patienterne i behandling med Alunbrig med 180 mg-regimet, hvoraf 10 % fik Grad 3-hypertension.
English: • alfentanil, fentanyl: medicines to treat pain
Danish: • alfentanil, fentanyl: et lægemiddel til behandling af smerter
English: Treatment initiation pack Alunbrig 90 mg and 180 mg film-coated tablets Each pack consists of an outer carton with two inner cartons containing:
Danish: Pakning til behandlingsopstart Alunbrig 90 mg of 180 mg filmovertrukne tabletter Hver pakning indeholder to pakninger i en ydre samlepakning:
English: Elevations of pancreatic enzymes
Danish: Forhøjede pancreasenzymer
English: The concomitant use of moderate CYP3A inducers with Alunbrig, including but not limited to efavirenz, modafinil, bosentan, etravirine, and nafcillin should be avoided.
Danish: Samtidig brug af moderate CYP3A-induktorer sammen med Alunbrig, herunder men ikke begrænset til efavirenz, modafinil, bosentan, etravirin, og nafcillin, bør undgås.
English: • quinidine: a medicine to treat irregular heart rhythm
Danish: • quinidin: et lægemiddel til behandling af uregelmæssig hjerterytme
English: • nefazodone: a medicine to treat depression
Danish: • nefazodon: et lægemiddel til behandling af depression
English: Nausea Dyspepsia Pancreatitis
Danish: Kvalme Dyspepsi Pankreatit
English: • If adequate hyperglycaemic control cannot be achieved with optimal medical management, Alunbrig should be withheld until adequate hyperglycaemic control is achieved.
Danish: • Ved utilstrækkelig glykæmisk kontrol med optimal medicinsk behandling, skal behandling med Alunbrig afbrydes, indtil der er opnået tilstrækkelig glykæmisk kontrol.
English: In case of life-threatening bradycardia, if no contributing concomitant medication is identified or in case of recurrence, treatment with Alunbrig should be discontinued (see section 4.2).
Danish: I tilfælde af livstruende bradykardi, hvor der ikke identificeres andre bidragende samtidigt indtagede lægemidler, skal behandling med Alunbrig seponeres (se pkt.
English: • If Grade 4 hypertension recurs, Alunbrig should be permanently discontinued.
Danish: • Hvis Grad 4 hypertension forekommer igen, skal behandling med Alunbrig seponeres.
English: A reduced starting dose of 60 mg once daily for the first 7 days, then 120 mg once daily is recommended for patients with severe hepatic impairment (Child-Pugh class C) (see section 5.2).
Danish: Der anbefales en reduceret startdosis på 60 mg en gang daglig i de første 7 dage og derefter 120 mg en gang daglig for patienter med svært nedsat leverfunktion (Child-Pugh-klasse C) (se pkt.
English: • efavirenz, etravirine: medicines to treat HIV infection
Danish: • efavirenz, etravirin: lægemidler til behandling af hiv-infektion
English: • reduced number of white blood cells, called neutrophils and lymphocytes, in blood tests
Danish: • nedsat antal hvide blodlegemer i tests (neutrofiler og lymfocytter)
English: Takeda Belgium Tel/Tél: +32 2 464 06 11 takeda-belgium@takeda.com
Danish: België/Belgique/Belgien Takeda Belgium Tel/Tél: +32 2 464 06 11 takeda-belgium@takeda.com
English: Bradycardiag
Danish: Bradykardi
English: • increased blood level of creatinine - may indicate reduced kidney function
Danish: • forhøjet niveau af kreatinin i blodet - kan være tegn på nedsat nyrefunktion
English: The concomitant use of Alunbrig with strong CYP3A inhibitors should be avoided.
Danish: Samtidig brug af Alunbrig og kraftige CYP3A-hæmmere skal undgås.
English: Pneumonitisi Dyspnoeah
Danish: Pneumonitisi Dyspnøh
English: Alkaline phosphatase increased Hyperbilirubinaemia
Danish: Forhøjet ALAT Forhøjet ASAT Forhøjet alkalisk phosphatase Hyperbilirubinæmi
English: Alunbrig is available in plastic bottles with child resistant screw top closures.
Danish: Alunbrig fås i plastbeholdere med børnesikret skruelåg.
English: Tell your doctor if you have any new or worsening lung or breathing problems, including chest pain, cough, and fever, especially within the first week of taking Alunbrig, as they may be a sign of serious lung problems.
Danish: • lungebetændelse Fortæl det til lægen, hvis du får nye problemer med lungerne eller vejrtrækningen, eller hvis eksisterende problemer bliver værre, herunder brystsmerter, hoste og feber, især i den første uge med Alunbrig, da det kan være tegn på alvorlige lungeproblemer.
English: In monkeys, findings included reduced size of testes along with microscopic evidence of hypospermatogenesis; these effects were reversible during the recovery period.
Danish: Fund hos aber omfattede reduceret størrelse af testiklerne sammen med tegn på hypospermatogenese i mikroskopiundersøgelser.
English: In ALTA, peripheral neuropathy adverse reactions were reported in 27.3% of patients treated at the 180 mg regimen.
Danish: I ALTA blev perifer neuropati rapporteret hos 27,3 % af patienterne i behandling med 180 mg-regimet.
English: Patients should be closely monitored when Alunbrig is coadministered with moderate CYP3A inhibitors.
Danish: Patienter skal overvåges tæt ved samtidig administration af Alunbrig og moderate CYP3A-hæmmere.
English: • modafinil: a medicine to treat narcolepsy
Danish: • modafinil: et lægemiddel til behandling af narkolepsi
English: Adverse reactions Grade 3-4
Danish: Bivirkninger Grad 3-4
English: No dose adjustment of Alunbrig is required for patients with mild hepatic impairment (Child-Pugh class A) or moderate hepatic impairment (Child-Pugh class B).
Danish: Det er ikke nødvendigt at justere dosis af Alunbrig for patienter med let nedsat leverfunktion (Child-Pugh-klasse A) eller moderat nedsat leverfunktion (Child-Pugh-klasse B).
English: Grade 4 elevation of lipase or amylase (> 5.0 x ULN)
Danish: Grad 4-forhøjet lipase eller amylase (> 5,0 × ULN)
English: One 90 mg tablet once daily for the first 7 treatment days; thereafter, one 180 mg tablet once daily.
Danish: En 90 mg tablet en gang daglig i de første 7 dage af behandlingen, og derefter en 180 mg tablet en gang daglig.
English: • rapid heartbeat (tachycardia)
Danish: • hurtig puls (takykardi)
English: Effective non-hormonal contraception must be used during treatment and for 4 months after stopping Alunbrig.
Danish: Der skal bruges effektiv ikke-hormonbaseret prævention under behandlingen og i 4 måneder efter endt behandling med Alunbrig.
English: Lung problems, some severe, are more frequent within the first 7 days of treatment.
Danish: • problemer med lungerne eller vejrtrækningen Problemer med lungerne, som kan være alvorlige, forekommer hyppigst i de første 7 dage af behandlingen.
English: Women of childbearing age being treated with Alunbrig should be advised not to become pregnant and men being treated with Alunbrig should be advised not to father a child during treatment.
Danish: Kvinder i den fødedygtige alder, som er i behandling med Alunbrig, skal instrueres i at undgå graviditet, og mænd, som er i behandling med Alunbrig, skal instrueres i at undgå at gøre en kvinde gravid, så længe de er i behandling.
English: • increased blood level of creatine phosphokinase in tests - may indicate muscle damage, such as of the heart.
Danish: • forhøjede niveauer af kreatinkinase i blodet (set i test) - kan være tegn på muskelskader, for eksempel i hjertemusklen.
English: • Alunbrig should be permanently discontinued in case of recurrence.
Danish: • Behandling med Alunbrig skal seponeres i tilfælde af recidiv.
English: Table 5: Intracranial efficacy in patients with measurable brain metastases at baseline in ALTA IRC-assessed efficacy parameter
Danish: Tabel 5: Intrakraniel effekt hos patienter med målbare hjernemetastaser ved baseline i ALTA
English: Recommendations for dose modifications of Alunbrig for the management of adverse reactions are summarised in Table 2.
Danish: Anbefalet dosisreduktion for Alunbrig ved forekomst af bivirkninger er anført i tabel 2.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON FOR TREATMENT INITIATION PACK - 21 TABLETS, 180 MG21 DAY TREATMENT (WITHOUT BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PRIMÆR ÆSKE TIL BEHANDLINGSOPSTARTSPAKNING21 TABLETTER, 180 MG- 21 DAGES BEHANDLING (UDEN BLÅ BOKS INFORMATION)
English: In vitro studies demonstrated that brigatinib is a substrate of CYP2C8.
Danish: In vitro-forsøg har påvist, at brigatinib er et substrat af CYP2C8.
English: 90 mg regimen* N = 112
Danish: 90 mg-regime* N = 112
English: • Alunbrig should be permanently discontinued.
Danish: • Alunbrig skal seponeres.
English: Common Tachycardiaf Electrocardiogram QT prolonged
Danish: Almindelig Takykardif Forlænget QT på elektrokardiogram Bradykardig
English: • If event occurs during the first 7 days of treatment, Alunbrig should be withheld until recovery to baseline, then resumed at same dose level and not escalated to 180 mg once daily.
Danish: • Hvis hændelsen forekommer inden for de første 7 dages behandling, skal behandling med Alunbrig afbrydes, indtil bedring til baseline-niveau er opnået, og derefter genoptages med samme dosis uden at eskalere til 180 mg daglig.
English: Do not breast-feed during treatment with Alunbrig.
Danish: Undlad at amme under behandling med Alunbrig.
English: Dose reduction for elevation of lipase and amylase occurred in 1.8% and 0.9% of patients, respectively at the 180 mg regimen (see sections 4.2 and 4.4).
Danish: Dosis blev nedsat på grund af forhøjet lipase og amylase hos henholdsvis 1,8 % og 0,9 % af patienterne i 180 mg-regimet (se pkt.
English: *90 mg once daily regimen †180 mg once daily with 7-day lead-in at 90 mg once daily
Danish: *Regime med 90 mg en gang daglig †180 mg en gang daglig med 7-dages opstartsperiode med 90 mg en gang daglig
English: In vitro studies in hepatocytes have shown that brigatinib is an inducer of CYP3A4.
Danish: In vitro-forsøg i hepatocytter har påvist, at brigatinib er induktor af CYP3A4.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR TREATMENT INITIATION PACK (INCLUDING BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON TIL BEHANDLINGSOPSTARTSPAKNING (FORSYNET MED BLÅ BOKS)
English: Do not swallow the desiccant canister contained in the bottle.
Danish: Slug ikke tørrekapslen i beholderen.
English: The concomitant use of strong CYP3A inducers with Alunbrig, including but not limited to rifampicin, carbamazepine, phenytoin, rifabutin, phenobarbital, and St. John's wort should be avoided.
Danish: Samtidigt brug af kraftige CYP3A-induktorer sammen med Alunbrig, herunder men ikke begrænset til rifampicin, carbamazepin, phenytoin, rifabutin, phenobarbital og perikon, bør undgås.
English: The recommended starting dose of Alunbrig is 90 mg once daily for the first 7 days, then 180 mg once daily.
Danish: Den anbefalede startdosis af Alunbrig er 90 mg en gang daglig i de første 7 dage og derefter 180 mg en gang daglig.
English: Alunbrig has not been studied in children or adolescents.
Danish: Der er ikke udført forsøg med Alunbrig til børn og unge.