natgillin/translations-raw huggingface dataset:
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:
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:
Der er ikke udført kliniske lægemiddelinteraktionsforsøg med CYP3A-følsomme substrater.
Clinical drug-drug interaction studies with CYP3A sensitive substrates have not been conducted.
Tabletterne må ikke knuses eller opløses.
Do not crush or dissolve the tablets.
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).
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).
Pakning til behandlingsopstart Hver pakning indeholder to primære æsker i en ydre æske.
Treatment initiation pack Each pack contains two cartons in an outer carton.
Tabletterne skal synkes hele sammen med et glas vand.
The tablets should be swallowed whole and with water.
Det gives til patienter med en form for lungekræft, som er relateret til en defekt i et gen, der kaldes anaplastisk lymfom-kinase (ALK).
It is given to patients whose lung cancer is related to an abnormal form of a gene called anaplastic lymphoma kinase (ALK).
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.
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.
Ingen patienter fik dosisreduktion som følge af forhøjet ALAT eller ASAT.
No patients had dose reductions due to elevation of ALT or AST.
• carbamazepin: et lægemiddel til behandling af epilepsi, maniske/depressive episoder og visse smertelidelser
• carbamazepine: a medicine to treat epilepsy, euphoric/depressive episodes and certain pain conditions
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).
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).
I urin og fæces kombineret blev henholdsvis 48 %, 27 % og 9,1 % af den radioaktive dosis udskilt som uændret brigatinib, N-desmethyl-brigatinib (AP26123) og brigatinib-cystein-konjugat.
In urine and faeces combined, 48%, 27%, and 9.1% of the radioactive dose was excreted as unchanged brigatinib, N-desmethyl brigatinib (AP26123), and brigatinib cysteine conjugate, respectively.
Alunbrig fås som en pakning til behandlingsopstart.
Alunbrig is available as a treatment initiation pack.
I Studie 101 blev Alunbrigs potentiale for forlængelse af QT-intervallet vurderet hos 123 patienter med fremskredne maligniteter efter doser af 30 mg til 240 mg brigatinib en gang daglig.
In Study 101, the QT interval prolongation potential of Alunbrig was assessed in 123 patients with advanced malignancies following once daily brigatinib doses of 30 mg to 240 mg.
Alunbrig indeholder lactose
Alunbrig contains lactose
• rifabutin, rifampicin: lægemidler til behandling af tuberkulose eller visse andre infektioner
• rifabutin, rifampicin: medicines to treat tuberculosis or certain other infections
Samtidig administration af brigatinib og substrater af P-gp (f.eks. digoxin, dabigatran, colchicin, pravastatin), BCRP (f.eks. methotrexat, rosuvastatin, sulfasalazin), OCT1 (organic cation transporter 1), MATE1 (multidrug and toxin extrusion protein 1) og MATE2K kan øge deres plasmakoncentrationer.
Coadministration of brigatinib with substrates of P-gp, (e.g., digoxin, dabigatran, colchicine, pravastatin), BCRP (e.g., methotrexate, rosuvastatin, sulfasalazine), organic cation transporter 1 (OCT1), multidrug and toxin extrusion protein 1 (MATE1), and 2K (MATE2K) may increase their plasma concentrations.
Der skal udvises forsigtighed ved administration af Alunbrig i kombination med andre stoffer, der vides at forårsage bradykardi.
Caution should be exercised when administering Alunbrig in combination with other agents known to cause bradycardia.
Moderate CYP3A-induktorer kan reducere brigatinibs AUC med ca. 50 % baseret på simuleringer fra en fysiologisk baseret farmakokinetisk model.
Moderate CYP3A inducers may decrease the AUC of brigatinib by approximately 50% based on simulations from a physiologically-based pharmacokinetic model.
Der skal dog udvises forsigtighed, hvis patienten fører motorkøretøj eller betjener maskiner, da der kan forekomme synsforstyrrelser, svimmelhed eller træthed under behandling med Alunbrig.
However, caution should be exercised when driving or operating machines as patients may experience visual disturbance, dizziness, or fatigue while taking Alunbrig.
Farmakokinetiske populationsanalyser viste, at race og køn ikke har nogen indvirkning på brigatinibs farmakokinetik.
Population pharmacokinetic analyses showed that race and gender had no impact on the pharmacokinetics of brigatinib.
Hvis samtidig brug af kraftige CYP3A-hæmmere ikke kan undgås, skal dosis af Alunbrig reduceres med ca. 50 % (dvs. fra 180 mg til 90 mg eller fra 90 mg til 60 mg).
If concomitant use of strong CYP3A inhibitors cannot be avoided, the dose of Alunbrig should be reduced by approximately 50% (i.e. from 180 mg to 90 mg, or from 90 mg to 60 mg).
Brigatinib hæmmede levedygtigheden in vitro og in vivo af celler, der udtrykker mutantformer af EML4-ALK forbundet med resistens over for ALK-hæmmere, herunder G1202R og L1196M.
Brigatinib inhibited the in vitro and in vivo viability of cells expressing mutant forms of EML4-ALK associated with resistance to ALK inhibitors, including G1202R and L1196M.
Lactosemonohydrat Mikrokrystallinsk cellulose Natriumstivelsesglykolat (type A) Kolloid hydrofob silica Magnesiumstearat
Lactose monohydrate Microcrystalline cellulose Sodium starch glycolate (type A) Silica colloidal hydrophobic Magnesium stearate
Efter pulmonale bivirkninger af Grad 1-2 blev behandling med Alunbrig enten afbrudt og derefter genopstartet, eller dosis blev reduceret.
Following Grade 1-2 pulmonary adverse reactions, treatment with Alunbrig was either interrupted and then restarted or the dose was reduced.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af forsøg med Alunbrig i alle undergrupper af den pædiatriske population med lungekarcinom (småcellet og ikke-småcellet karcinom) (se pkt.
The European Medicines Agency has waived the obligation to submit the results of studies with Alunbrig in all subsets of the paediatric population in lung carcinoma (small cell and non-small cell carcinoma) (see section 4.2 for information on paediatric use).
Hos patienter med hjernemetastaser uanset type ved baseline var kontrolraten for intrakraniel sygdom 77,8 % (95 % CI 67,2-86,3) i 90 mg-armen (N = 81) og 85,1 % (95 % CI 75-92,3) i 180 mg-armen (N = 74).
In patients with any brain metastases at baseline, intracranial disease control rate was 77.8% (95% CI 67.2-86.3) in the 90 mg arm (N = 81) and 85.1% (95% CI 75-92.3) in the 180 mg arm (N=74).
Alunbrig bruges til behandling af voksne med fremskredne stadier af lungekræft af typen ikke-småcellet lungekræft.
Alunbrig is used to treat adults with advanced stages of a lung cancer called non-small cell lung cancer.
Desuden fik 2,3 % af patienterne i ALTA pneumonitis senere i behandlingen, og 2 patienter fik Grad 3-pneumonitis (se pkt.
Additionally, 2.3% of patients in ALTA experienced pneumonitis later in treatment, with 2 patients having Grade 3 pneumonitis (see sections 4.2 and 4.4).
Brigatinib er et substrat af P-glykoprotein (P-gp) og brystcancer-resistensprotein (BCRP) in vitro.
Brigatinib is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) in vitro.
Hver flaske indeholder en kapsel med tørremiddel og er pakket i en ydre karton med:
Each bottle contains one canister of a desiccant and is packed in a carton with:
Anbefalet dosis
The recommended dose is
• forkølelsessymptomer (infektion i de øvre luftveje)
• cold-like symptoms (upper respiratory tract infection)
Forekomsten af forhøjede ALAT- og ASAT-værdier af Grad 3 og 4 var henholdsvis 5,5 % og 3,6 %.
For elevations to Grade 3 and 4, the incidences for ALT and AST were 5.5% and 3.6%, respectively.
Blodtrykket skal overvåges regelmæssigt under behandling med Alunbrig.
Blood pressure should be monitored regularly during treatment with Alunbrig.
Mediantiden til debut af forhøjet CK var 27 dage.
The median time to onset for CPK elevations was 27 days.
Alunbrig kan give synsforstyrrelser, svimmelhed eller træthed.
Alunbrig may cause visual disturbances, dizziness or tiredness.
Almindelig Pneumonitisi
Common Pneumonitisi
Moderate CYP3A-hæmmere (f.eks. diltiazem og verapamil) kan øge AUC for brigatinib med ca. 40 % baseret på simuleringer fra en fysiologisk baseret farmakokinetisk model.
Moderate CYP3A inhibitors (e.g., diltiazem and verapamil) may increase the AUC of brigatinib by approximately 40% based on simulations from a physiologically-based pharmacokinetic model.
Ved mistanke om pneumonitis skal behandling med Alunbrig tilbageholdes og patienten skal evalueres for andre årsager til symptomer (for eksempel lungeemboli, tumorprogression og infektiøs pneumoni).
If pneumonitis is suspected, the dose of Alunbrig should be withheld, and the patient evaluated for other causes of symptoms (e.g., pulmonary embolism, tumour progression, and infectious pneumonia).
Almindelig Smerter i ekstremitet Muskel- og knoglestivhed
Common Pain in extremity Musculoskeletal stiffness
Tabel 4 viser en oversigt over effektresultater fra ALTA-analyser, og figur 1 viser Kaplan-Meier-kurven (KM) for investigator-bedømt PFS.
Efficacy results from ALTA analysis are summarised in Table 4. and the Kaplan-Meier (KM) curve for investigator-assessed PFS is shown in Figure 1.
90 mg regime* (N = 26)
90 mg regimen* (N = 26)
Samlet set forekom disse virkninger på handyrs forplantningsorganer hos rotter og aber ved eksponeringer ≥ 0,2 gange det AUC, der er observeret hos patienter, som fik en dosis på 180 mg en gang daglig.
Overall, these effects on the male reproductive organs in rats and monkeys occurred at exposures ≥ 0.2-times the AUC observed in patients at the 180 mg once daily dose.
I in vitro- kinase og cellebaserede analyse hæmmede metabolitten AP26123 ALK med ca. 3 gange lavere potens end brigatinib.
In in vitro kinase and cellular assays, the metabolite, AP26123, inhibited ALK with approximately 3-fold lower potency than brigatinib.
Brigatinib var ikke mutagent in vitro i analyserne af bakteriel revers mutation (Ames) eller kromosomforandringer af pattedyrsceller, men øgede antallet af mikrokerner i en test af mikrokerner i rotteknoglemarv.
Brigatinib was not mutagenic in vitro in the bacterial reverse mutation (Ames) or the mammalian cell chromosomal aberration assays, but slightly increased the number of micronuclei in a rat bone marrow micronucleus test.
Hvis du har glemt at tage Alunbrig
If you forget to take Alunbrig
Hvis du holder op med at tage Alunbrig
If you stop taking Alunbrig
hvis du får smerter i højre side af maven, hvis din hud eller det hvide i dine øjne bliver gulfarvet, eller hvis din urin er mørk.
Tell your doctor if you have pain on the right side of your stomach area, yellowing of your skin or the whites of your eyes, or dark urine.
Hos seks raske mandlige forsøgspersoner, som fik en enkelt oral dosis på 180 mg [14C]brigatinib, blev 65 % af den administrerede dosis genfundet i fæces, og 25 % af den administrerede dosis blev genfundet i urin.
In six healthy male subjects given a single 180 mg oral dose of [14C]brigatinib, 65% of the administered dose was recovered in faeces and 25% of the administered dose was recovered in urine.
Der kræves en valideret ALK-analysemetode som grundlag for udvælgelse af ALK-positive NSCLC-patienter (se pkt.
A validated ALK assay is necessary for the selection of ALK-positive NSCLC patients (see section 5.1).
Brigatinib er et substrat af transportørproteinerne P-gp og BCRP.
Brigatinib is a substrate of the transporter proteins P-gp and BCRP.
• mibefradil: et lægemiddel til behandling af uregelmæssig hjerterytme og for højt blodtryk
• mibefradil: a medicine to treat irregular heart rhythm and high blood pressure
De farmakokinetiske populationsanalyser viste, at legemsvægt, alder og albuminkoncentration ikke havde klinisk relevant indvirkning på brigatinibs farmakokinetik.
The population pharmacokinetic analyses showed that body weight, age, and albumin concentration had no clinically relevant impact on the pharmacokinetics of brigatinib.
Patienter med interstitiel lungesygdom eller lægemiddel-relateret pneumonitis blev udelukket.
Patients with a history of pulmonary interstitial disease or drug-related pneumonitis were excluded.
180 mg en gang daglig reducer til 120 mg en gang daglig reducer til 90 mg en gang daglig reducer til 60 mg en gang daglig
180 mg once daily reduce to 120 mg once daily reduce to 90 mg once daily reduce to 60 mg once daily
Grapefrugt eller grapefrugtjuice kan også øge plasmakoncentrationen for brigatinib og bør undgås (se pkt.
Grapefruit or grapefruit juice may also increase plasma concentrations of brigatinib and should be avoided (see section 4.2).
Niveauerne af lipase og amylase skal overvåges regelmæssigt under behandling med Alunbrig.
Lipase and amylase should be monitored regularly during treatment with Alunbrig.
Ved nye eller forværrede svære synsrelaterede symptomer skal det overvejes at foretage en oftalmologisk evaluering og reduktion af dosis skal overvejes (se pkt.
For new or worsening severe visual symptoms, an ophthalmologic evaluation and dose reduction should be considered (see section 4.2).
• Øvrige indholdsstoffer: lactosemonohydrat, mikrokrystallinsk cellulose, natriumstivelsesglykolat (type A), kolloid hydrofob silica, magnesiumstearat, talkum, macrogol, polyvinylalkohol og titandioxid.
• The other excipients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), silica colloidal hydrophobic, magnesium stearate, talc, macrogol, polyvinyl alcohol, and titanium dioxide.
Pneumonia
Pneumoniaa
Derfor skal samtidig administration af Alunbrig og CYP3A-substrater med et smalt terapeutisk indeks (f.eks. alfentanil, fentanyl, quinidin, ciclosporin, sirolimus, tacrolimus) undgås, da deres virkning kan blive hæmmet.
Therefore, coadministration of Alunbrig with CYP3A substrates with a narrow therapeutic index (e.g., alfentanil, fentanyl, quinidine, cyclosporine, sirolimus, tacrolimus) should be avoided as their effectiveness may be reduced.
Investigatorbedømmelse
Investigator assessment
På baggrund af toksicitetsundersøgelser med flere doser hos handyr kan Alunbrig medføre nedsat fertilitet hos handyr (se pkt.
Based on repeat-dose toxicity studies in male animals, Alunbrig may cause reduced fertility in males (see section 5.3).
Pulmonale bivirkninger af Grad 1-2 forsvandt med afbrydelse af behandling eller en dosisjustering.
Grade 1-2 pulmonary adverse reactions resolved with interruption of treatment or dose modification.
Geometrisk middelværdi for steady state Cmax for brigatinib ved doser på 90 mg og 180 mg en gang daglig var henholdsvis 552 og 1452 ng/ml, og det tilhørende AUC0- var henholdsvis 8.165 og 20.276 t∙ng/ml.
The geometric mean steady state Cmax of brigatinib at doses of 90 mg and 180 mg once daily was 552 and 1,452 ng/mL, respectively, and the corresponding AUC0-τ was 8,165 and 20,276 h∙ng/mL, respectively.
Behandling med Alunbrig skal genoptages med det nærmeste lavere dosistrin, som beskrevet i tabel 1.
Alunbrig should be resumed at next lower dose level as described in Table 1.
Hvis der opstår symptomatisk bradykardi, skal behandling med Alunbrig afbrydes, og samtidig brug af lægemidler, der vides at forårsage bradykardi, skal reevalueres.
If symptomatic bradycardia occurs, treatment with Alunbrig should be withheld and concomitant medicinal products known to cause bradycardia should be evaluated.
• forhøjede niveauer af leverenzymer i blodet (aspartataminotransferase, alaninaminotransferase) (set i test) - kan være tegn på levercelleskader.
• increased blood levels of liver enzymes (aspartate aminotransferase, alanine aminotransferase) in tests -may indicate liver cell damage.
Brigatinib hæmmede autophosphorylering af ALK og ALK-medieret phosphorylering af det nedstrøms-signalerings protein STAT3 i in vitro- og in vivo-analyser.
Brigatinib inhibited autophosphorylation of ALK and ALK-mediated phosphorylation of the downstream signalling protein STAT3 in in vitro and in vivo assays.
• digoxin: et lægemiddel til behandling af hjerteproblemer
• digoxin: a medicine to treat heart problems
• Patientkortet skal indeholde følgende nøglebudskaber: o En advarsel/information til sundhedsprofessionelle, der på et hvilket som helst tidspunkt behandler en patient inklusive under en akut nødsituation, om behandling med Alunbrig, o At behandling med Alunbrig kan øge risikoen for lungelidelser efter kort tids behandling (inklusive interstitiel lungesygdom og pneumonitis).
• The patient alert card shall contain the following key messages: o A warning message for health care professionals treating the patient at any time, including in conditions of emergency, that the patient is using Alunbrig o That Alunbrig treatment may increase the risk of early onset pulmonary events (including interstitial lung disease and pneumonitis) o Signs or symptoms of the safety concern and when to seek attention from a HCP o Contact details of the Alunbrig prescriber
• Behandling med Alunbrig skal seponeres, hvis der ikke er identificeret andre bidragende samtidigt anvendte lægemidler.
• Alunbrig should be permanently discontinued if no contributing concomitant medicinal product is identified.
I et separat forsøg til dosisfastlæggelse fik 25 patienter med ALK-positiv NSCLC, som progredierede med crizotinib, administreret 180 mg Alunbrig en gang daglig med 7-dages opstartsperiode med 90 mg en gang daglig.
In a separate dose finding study, 25 patients with ALK-positive NSCLC that progressed on crizotinib were administered Alunbrig at 180 mg once daily with 7-day lead-in at 90 mg once daily regimen.
I et farmakokinetisk forsøg var ubundet AUC0-INF 94 % højere hos patienter med svært nedsat nyrefunktion (eGFR < 30 ml/min, N = 6) sammenlignet med patienter med normal nyrefunktion (eGFR ≥ 90 ml/min, N = 8) (se pkt.
In a pharmacokinetic study, unbound AUC0-INF was 94% higher in patients with severe renal impairment (eGFR < 30 mL/min, N = 6) as compared to patients with normal renal function (eGFR ≥ 90 mL/min, N = 8) (see section 4.2).
• methotrexat: et lægemiddel til behandling af svær ledbetændelse, kræft og hudsygdommen psoriasis
• methotrexate: a medicine to treat severe joint inflammation, cancer and the skin disease psoriasis
Alunbrig er indiceret som monoterapi til behandling af voksne patienter med fremskreden anaplastisk lymfom-kinase(ALK)-positiv, ikke-småcellet lungecancer (NSCLC), som tidligere har fået behandling med crizotinib.
Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.
Det skal du vide, før du begynder at tage Alunbrig Tag ikke Alunbrig: hvis du er allergisk over for brigatinib eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
if you are allergic to brigatinib or any of the other ingredients of this medicine (listed in section 6).
Forhøjelser i amylase- og lipaseværdier af Grad 3 og 4 var henholdsvis 8,2 % og 10 %.
For elevations to Grade 3 and 4, the incidences for amylase and lipase were 8.2% and 10%, respectively.
Hjertefrekvenser på under 50 slag i minuttet (bpm) blev rapporteret hos 8,2 % af patienterne behandlet med 180 mg-regimet.
Heart rates of less than 50 beats per minute (bpm) were reported in 8.2% of patients at the 180 mg regimen.
• ciclosporin, sirolimus, tacrolimus: lægemidler, der undertrykker immunsystemet
• cyclosporine, sirolimus, tacrolimus: medicines to suppress the immune system
Alunbrigs sikkerhed og virkning blev vurderet i et randomiseret (1:1), åbent multicenterforsøg (ALTA) med 222 voksne patienter med lokalt fremskreden eller metastatisk ALK-positiv NSCLC, som havde progredieret på crizotinib.
The safety and efficacy of Alunbrig was evaluated in a randomised (1:1), open-label, multicenter trial (ALTA) in 222 adult patients with locally advanced or metastatic ALK-positive NSCLC who had progressed on crizotinib.
In vitro-forsøg påviste, at brigatinib primært omsættes af CYP2C8 og CYP3A4 og i langt mindre udstrækning af CYP3A5.
In vitro studies demonstrated that brigatinib is primarily metabolised by CYP2C8 and CYP3A4, and to a much lesser extent by CYP3A5.
Der kræves ingen dosisjustering af Alunbrig hos patienter med let til moderat nedsat nyrefunktion (estimeret glomerulær filtrationsrate (eGFR) ≥ 30 ml/min.).
No dose adjustment of Alunbrig is required for patients with mild or moderate renal impairment (estimated glomerular filtration rate (eGFR) ≥ 30 mL/min).
• blodet er længere tid om at størkne (set i test ved aktiveret partiel protrombintid)
• increased blood clotting time shown by test of activated partial thromboplastin time
• forhøjet niveau af insulin i blodet
• increased blood level of insulin
I et forsøg af embryo-føtal udvikling med administration af daglige doser af brigatinib til drægtige rotter under organogenese blev der observeret dosisrelaterede knogleanomalier ved doser ned til ca. 0,7 gange human eksponering efter AUC med dosen på 180 mg en gang daglig.
In an embryo-foetal development study in which pregnant rats were administered daily doses of brigatinib during organogenesis; dose-related skeletal anomalies were observed at doses as low as approximately 0.7-times the human exposure by AUC at the 180 mg once daily dose.
Hver pakning består af en udvendig æske med to indvendige æsker med:
Each pack consists of an outer carton with two inner cartons containing:
• bosentan: et lægemiddel til behandling af pulmonal hypertension
• bosentan: a medicine to treat pulmonary hypertension
• forhøjet niveau af bilirubin i blodet
• increased blood level of bilirubin
Hos tredive procent af patienterne gik alle bivirkninger med perifer neuropati over igen.
Thirty percent of patients had resolution of all peripheral neuropathy adverse reactions.
Hjertefrekvensen skal overvåges hyppigere hos patienter, der samtidigt behandles med lægemidler, som vides at forårsage bradykardi, hvis brugen af disse lægemidler ikke kan undgås.
Heart rate should be monitored more frequently in patients if concomitant use of a medicinal product known to cause bradycardia cannot be avoided.
Samtidig brug af Alunbrig og kraftige og moderate CYP3A-induktorer bør undgås (se pkt.
The concomitant use of Alunbrig with strong and moderate CYP3A inducers should be avoided (see section 4.5).