FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no clinical data on the use of Alunbrig in pregnant women.
Slovenian: Klinični podatki za uporabo zdravila Alunbrig pri nosečnicah niso na voljo.
English: Unchanged brigatinib represented 41% and 86% of the total radioactivity in faeces and urine, respectively, the remainder being metabolites.
Slovenian: Nespremenjen brigatinib predstavlja 41% celotne radioaktivnosti v blatu in 86% celotne radioaktivnosti v urinu, pri čemer so preostanek presnovki.
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.
Slovenian: Če se zdravilo Alunbrig uporablja med nosečnostjo ali če bolnica zanosi med jemanjem tega zdravila, je treba bolnico seznaniti s potencialno nevarnostjo za plod.
English: In healthy subjects, compared to overnight fasting, a high fat meal reduced brigatinib Cmax by 13% with no effect on AUC.
Slovenian: Pri zdravih osebah, ki so zavžile izjemno mastni obrok, v primerjavi s postom preko noči, je bil Cmaks brigatiniba znižan za 13%, brez učinka na AUC.
English: 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.
Slovenian: Brigatinib je in vitro in in vivo zaviral preživetje celic, ki izražajo mutantne oblike EML4-ALK, povezane z odpornostjo proti inhibitorjem ALK, vključno z G1202R in L1196M.
English: Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitors, ATC code: L01XE43
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), zaviralci proteinskih kinaz, koda ATC: L01XE43
English: • mibefradil: a medicine to treat irregular heart rhythm and high blood pressure
Slovenian: • mibefradil: zdravilo za zdravljenje nepravilnega srčnega ritma in visokega krvnega tlaka
English: Table 3: Adverse reactions reported in patients treated with Alunbrig in ALTA and Study 101 (per Common Terminology Criteria for Adverse Events (CTCAE) version 4.0) System organ class
Slovenian: Preglednica 3: Neželeni učinki, o katerih so poročali pri bolnikih, zdravljenih z zdravilom Alunbrig v ALTA, in študiji 101 (v skladu s skupnimi terminološkimi kriteriji za neželene učinke (CTCAE) različica 4.0)
English: Assessment for ALK-positive NSCLC should be performed by laboratories with demonstrated proficiency in the specific technology being utilised.
Slovenian: Za ocenjevanje ALK pozitivnega nedrobnoceličnega pljučnega raka se priporoča uporaba laboratorija z dokazano usposobljenostjo za uporabo specifične tehnologije.
English: 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).
Slovenian: Dodatno se je pri 2,3% bolnikov, ki so se zdravili z zdravilom v študiji ALTA pojavil pnevmonitis, pri čemer sta imela 2 bolnika pnevmonitis stopnje 3 (glejte poglavji 4.2 in 4.4).
English: Heart rate should be monitored more frequently in patients if concomitant use of a medicinal product known to cause bradycardia cannot be avoided.
Slovenian: Pri bolnikih je treba pogosteje nadzirati srčni utrip, če se sočasni uporabi zdravil, za katera je znano, da povzročajo bradikardijo, ni mogoče izogniti.
English: No human data on the effect of Alunbrig on fertility are available.
Slovenian: Na voljo ni nobenih podatkov o vplivu zdravila Alunbrig na plodnost.
English: Symptomatic bradycardia
Slovenian: Simptomatska bradikardija
English: Brigatinib is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) in vitro.
Slovenian: Brigatinib je substrat P-glikoproteina (P-gp) in proteina na odpornost za raka dojke (BCRP-breast cancer resistance protein) in vitro.
English: These effects were generally reversible during the non-dosing recovery period; however, effects in the eyes and testes were notable exceptions due to lack of recovery.
Slovenian: Ti učinki so bili ponavadi reverzibilni med obdobjem okrevanja brez prejemanja odmerka; z izjemo učinkov na oči in modih, kjer okrevanje ni bilo opaženo.
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).
Slovenian: Bolnike je treba skrbno spremljati, ko je zdravilo Alunbrig sočasno uporabljeno s substrati teh transporterjev z ozkim terapevtskim indeksom (npr. digoksin, dabigatran, metotreksat).
English: • cold-like symptoms (upper respiratory tract infection)
Slovenian: • simptomi prehlada (okužba zgornjih dihalnih poti)
English: 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).
Slovenian: Če sumite na pnevmonitis, je treba odmerjanje zdravila Alunbrig začasno prekiniti, bolnika pa oceniti glede morebitnih drugih vzrokov simptomov (npr. pljučna embolija, napredovanje tumorja, infekcijska pljučnica).
English: The median time to onset for amylase elevations and lipase elevations was 17 days and 29 days, respectively.
Slovenian: Mediani čas do začetka zvišanja je bil za amilazo 17 dni in za lipazo 29 dni.
English: Do not stop taking Alunbrig before talking to your doctor.
Slovenian: Zdravila Alunbrig ne prenehajte jemati, brez da bi se posvetovali s svojim zdravnikom.
English: • high blood sugar
Slovenian: • zvišan krvni sladkor
English: What Alunbrig is and what it is used for What you need to know before you take Alunbrig How to take Alunbrig
Slovenian: Kaj je zdravilo Alunbrig in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Alunbrig Kako jemati zdravilo Alunbrig Možni neželeni učinki
English: 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.
Slovenian: Sočasna uporaba brigatiniba s substrati P-gp (npr. digoksin, dabigatran, kolhicin, pravastatin), BCRP (npr. metotreksat, rosuvastatin, sulfasalazin), organskim kationskim prenašalcem 1 (OCT1), proteini za ekstruzijo več zdravil in toksinov 1 (Mate1), in 2K (MATE2K) lahko poveča njihovo koncentracijo v plazmi.
English: Alunbrig film-coated tablets are white to off-white, oval (90 mg and 180 mg) or round (30 mg).
Slovenian: Filmsko obložene tablete Alunbrig so bele do umazano bele, ovalne (90 mg in 180 mg) ali okrogle (30 mg).
English: 180 mg once daily reduce to 120 mg once daily reduce to 90 mg once daily reduce to 60 mg once daily
Slovenian: 180 mg enkrat na dan zmanjšanje na 120 mg enkrat na dan zmanjšanje na 90 mg enkrat na dan zmanjšanje na 60 mg enkrat na dan
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.
Slovenian: V študiji ALTA so se pri 6,4% bolnikov pojavili neželeni učinki na pljuča (vseh stopenj), vključno z IPB/pnevmonitisom, pljučnico in dispnejo, v zgodnjem obdobju zdravljenja (v 9 dneh, mediana pojava: 2 dni); 2,7% bolnikov je imelo neželene učinke na pljuča stopnje 3-4 in 1 bolnik (0,5%)
English: • abdominal (belly) pain
Slovenian: • abdominalne (trebušne) bolečine
English: Creatine phosphokinase (CPK) elevation
Slovenian: Zvišanje kreatin fosfokinaze (CPK)
English: In patients, at steady state, the plasma AUC of AP26123 was < 10% of brigatinib exposure.
Slovenian: Pri bolnikih je bila plazemska AUC AP26123 v stanju dinamičnega ravnovesja < 10% izpostavljenosti brigatinibu.
English: Moderate CYP3A inducers may decrease the AUC of brigatinib by approximately 50% based on simulations from a physiologically-based pharmacokinetic model.
Slovenian: Zmerni induktorji CYP3A lahko zmanjšajo AUC brigatiniba za približno 50% na osnovi simulacij iz farmakološko določenega farmakokinetičnega modela.
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.
Slovenian: Če odmerek ni bil zaužit ali se je po zaužitju pojavilo bruhanje, se dodatnega odmerka ne sme zaužiti in je potrebno naslednji odmerek zaužiti ob predhodno načrtovanem času.
English: Other medicines and Alunbrig
Slovenian: Druga zdravila in zdravilo Alunbrig
English: 90 mg regimen* (N = 26)
Slovenian: 90 mg režim* (N=26)
English: The population pharmacokinetic analyses showed that body weight, age, and albumin concentration had no clinically relevant impact on the pharmacokinetics of brigatinib.
Slovenian: Analize populacijske farmakokinetike so pokazale, da telesna masa, starost in koncentracija albumina niso imeli klinično pomembnega vpliva na farmakokinetiko brigatiniba.
English: Adverse reaction Severity*
Slovenian: Neželeni učinek Resnost*
English: Dose reduction for hypertension occurred in 0.9% at the 180 mg regimen.
Slovenian: Znižanje odmerka zaradi hipertenzije je bilo potrebno pri 0,9% pri režimu z odmerkom 180 mg.
English: Interstitial lung disease (ILD)/pneumonitis
Slovenian: Intersticijska pljučna bolezen (IPB)/pnevmonitis
English: There is no specific antidote for overdose with Alunbrig.
Slovenian: Specifičnega antidota za prevelik odmerek zdravila Alunbrig ni.
English: The concomitant use of Alunbrig with strong and moderate CYP3A inducers should be avoided (see section 4.5).
Slovenian: Izogibati se je treba sočasni uporabi zdravila Alunbrig z močnimi in zmernimi induktorji CYP3A (glejte poglavje 4.5).
English: Grade 1-2 pulmonary adverse reactions resolved with interruption of treatment or dose modification.
Slovenian: Neželeni učinki na pljuča stopnje 1-2 so bili odpravljeni s prekinitvijo zdravljenja ali spremembo odmerka.
English: • increased blood levels of liver enzymes (aspartate aminotransferase, alanine aminotransferase) in tests -may indicate liver cell damage.
Slovenian: • zvišane koncentracije jetrnih encimov v krvi pri preiskavah (aspartat- aminotransferaza, alanin-aminotransferaza) lahko kažejo na poškodbe jetrnih celic.
English: These factors should be considered when initiating treatment with Alunbrig.
Slovenian: Te dejavnike je treba upoštevati pri odločanju o zdravljenju z zdravilom Alunbrig.
English: The dose should be modified accordingly (see section 4.2).
Slovenian: Odmerek je treba ustrezno spremeniti (glejte poglavje 4.2).
English: Grade 3 or 4
Slovenian: Stopnja 3 ali 4
English: • If adequate hyperglycaemic control cannot be achieved with optimal medical management, Alunbrig should be withheld until adequate hyperglycaemic control is achieved.
Slovenian: • Če ustreznega hiperglikemičnega nadzora z optimalnim zdravljenjem ni mogoče doseči, je treba zdravilo Alunbrig prenehati uporabljati, dokler ne dosežemo ustreznega hiperglikemičnega nadzora.
English: • low platelet counts in blood tests, which may increase the risk of bleeding and bruising
Slovenian: • nizko število trombocitov pri preiskavah krvi, kar lahko poveča tveganje za krvavitev in podplutbe
English: Very common Pneumoniaa Upper respiratory tract infection
Slovenian: Zelo pogosti pljučnicaa okužba zgornjih dihalnih poti
English: Brigatinib may reduce plasma levels of coadministered medicinal products that are predominantly metabolised by CYP3A.
Slovenian: Brigatinib lahko zmanjša koncentracije v plazmi pri sočasno uporabljenih zdravilih, ki se v glavnem presnavljajo s CYP3A.
English: 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).
Slovenian: Če se sočasni uporabi močnih zaviralcev CYP3A ni mogoče izogniti, je treba odmerek zdravila Alunbrig zmanjšati za približno 50% (to je s 180 mg na 90 mg ali z 90 mg na 60 mg).
English: Recommendations for dose modifications of Alunbrig for the management of adverse reactions are summarised in Table 2.
Slovenian: Priporočila za prilagajanje odmerka zdravila Alunbrig za obvladovanje neželenih učinkov so povzeta v preglednici 2.
English: For elevations to Grade 3 and 4, the incidences for amylase and lipase were 8.2% and 10%, respectively.
Slovenian: Zvišanje na stopnjo 3 in 4 se je pojavilo za amilazo v 8,2% in za lipazo v 10%.
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).
Slovenian: Nevezan AUC0-INF je bil za 37% višji pri bolnikih s hudo okvaro jeter (Child-Pugh razred C) v primerjavi z zdravimi osebami z normalnim delovanjem jeter (glejte poglavje 4.2).
English: Alunbrig 30 mg film-coated tablets EU/1/18/1264/001 60 tablets in bottle EU/1/18/1264/002 120 tablets in bottle EU/1/18/1264/011 28 tablets in carton EU/1/18/1264/003 56 tablets in carton EU/1/18/1264/004 112 tablets in carton Alunbrig 90 mg film-coated tablets EU/1/18/1264/005 7 tablets in bottle EU/1/18/1264/006 30 tablets in bottle EU/1/18/1264/007 7 tablets in carton EU/1/18/1264/008 28 tablets in carton Alunbrig 180 mg film-coated tablets EU/1/18/1264/009 30 tablets in bottle EU/1/18/1264/010 28 tablets in carton Alunbrig treatment initiation pack EU/1/18/1264/012 7 x 90 mg + 21 x 180 mg tablets in carton
Slovenian: Alunbrig 90 mg filmsko obložene tablete EU/1/18/1264/005 7 tablet v plastenki EU/1/18/1264/006 30 tablet v plastenki EU/1/18/1264/007 7 tablet v škatli EU/1/18/1264/008 28 tablet v škatli Alunbrig 180 mg filmsko obložene tablete EU/1/18/1264/009 30 tablet v plastenki EU/1/18/1264/010 28 tablet v škatli Uvajalno pakiranje zdravila Alunbrig EU/1/18/1264/012 7 x 90 mg + 21 x 180 mg tablet v škatli
English: 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.
Slovenian: Obvestite svojega zdravnika, če imate bolečine na desni strani predela želodca, porumenelo kožo ali beločnico ali temen urin.
English: In in vitro kinase and cellular assays, the metabolite, AP26123, inhibited ALK with approximately 3-fold lower potency than brigatinib.
Slovenian: V in vitro kinaznih in celičnih testih je presnovek AP26123 zaviral ALK s približno 3-krat manjšim potencialom kot brigatinib.
English: Based on repeat-dose toxicity studies in male animals, Alunbrig may cause reduced fertility in males (see section 5.3).
Slovenian: Na podlagi študij toksičnosti ponavljajočih se odmerkov pri samcih lahko zdravilo Alunbrig pri moških zmanjša plodnost (glejte poglavje 5.3).
English: However, caution should be exercised when driving or operating machines as patients may experience visual disturbance, dizziness, or fatigue while taking Alunbrig.
Slovenian: Vendar pa je pri vožnji ali upravljanju strojev potrebna previdnost, ker lahko bolniki med zdravljenjem z zdravilom Alunbrig doživljajo motnje vida, omotico ali utrujenost.
English: Patients with measurable brain metastases at baseline
Slovenian: Bolniki z merljivimi metastazami v možganih na izhodišču
English: If symptomatic bradycardia occurs, treatment with Alunbrig should be withheld and concomitant medicinal products known to cause bradycardia should be evaluated.
Slovenian: Če pride do simptomatske bradikardije, je treba zdravljenje z zdravilom Alunbrig začasno prekiniti in ovrednotiti sočasno uporabljena zdravila, za katera je znano, da povzročajo bradikardijo.
English: • increased blood level of creatine phosphokinase in tests - may indicate muscle damage, such as of the heart.
Slovenian: • zvišana koncentracija kreatinfosfokinaze v krvi pri preiskavah - lahko nakazuje na poškodbe mišic, na primer srca.
English: Very common Insomnia
Slovenian: Zelo pogosti nespečnost
English: The primary route of excretion of brigatinib is in faeces.
Slovenian: Glavna pot izločanja brigatiniba je z blatom.
English: Grade ≥ 2 elevation (> 3 × ULN) of ALT or AST with concurrent total bilirubin elevation > 2 × ULN in the absence of cholestasis or haemolysis
Slovenian: Stopnja zvišanja ≥2 (>3 × ULN) ALT ali AST s sočasno skupnim zvišanjem bilirubina >2 × ULN v odsotnosti holestaze ali hemolize
English: 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.
Slovenian: Brigatinib ni bil mutagen in vitro v preskusu bakterijskih povratnih mutacij (Ames) ali testih kromosomskih aberacij celic sesalcev, ampak je vplival na manjše zvišanje števila mikronukleusov v mikrojedrskem testu kostnega mozga pri podganah.
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.
Slovenian: Ženskam v rodni dobi, ki se zdravijo z zdravilom Alunbrig je treba svetovati, naj ne zanosijo in moškim, ki se zdravijo z zdravilom Alunbrig je treba svetovati, naj med zdravljenjem ne zaplodijo otroka.
English: • chest pain and discomfort
Slovenian: • bolečina v prsnem košu in nelagodje
English: Very common Blood creatinine increased
Slovenian: Zelo pogosti zvišan kreatinin v krvi
English: • digoxin: a medicine to treat heart problems
Slovenian: • digoksin: zdravilo za zdravljenje težav s srcem
English: In rats, findings included lower weight of testes, seminal vesicles and prostate gland, and testicular tubular degeneration; these effects were not reversible during the recovery period.
Slovenian: Pri podganah so ugotovitve vključevale manjšo maso mod, semenskih mešičkov in prostate ter degeneracijo tubulov v modih; ti učinki niso izginili med obdobjem okrevanja.
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.
Slovenian: Da bi dodatno opredelili učinkovitost in varnost brigatiniba pri zdravljenju bolnikov z ALK-pozitivnim NSCLC, mora imetnik dovoljenja za promet z zdravilom predložiti naslednje poročilo klinične študije faze III AP26113-13-301, ki primerja brigatinib in krizotinib pri bolnikih z napredovalim ALK-pozitivnim NSCLC, ki še niso prejeli ALK-usmerjenega zdravljenja.
English: Mean systolic and diastolic blood pressure, in all patients, increased over time (see sections 4.2 and 4.4).
Slovenian: Povprečni sistolični in diastolični krvni tlak se je pri vseh bolnikih sčasoma zvišal (glejte poglavji 4.2 in 4.4).
English: For new or worsening severe visual symptoms, an ophthalmologic evaluation and dose reduction should be considered (see section 4.2).
Slovenian: Pri novih ali poslabšanju hudih motenj vida je treba upoštevati oftalmološko oceno in razmisliti o zmanjšanju odmerka (glejte poglavje 4.2).
English: 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).
Slovenian: Pri bolnikih z metastazami v možganih na začetku je bila stopnja kontrole intrakranialne bolezni 77,8% (95% IZ 67,2-86,3) v skupini z odmerkom 90 mg (N = 81) in 85,1% (95% IZ 75-92,3) v skupini z odmerkom 180 mg (N = 74).
English: 180 mg regimen† N = 110
Slovenian: 180 mg režim† N = 110
English: • nefazodone: a medicine to treat depression
Slovenian: • nefazodon: zdravilo za zdravljenje depresije
English: Following Grade 1-2 pulmonary adverse reactions, treatment with Alunbrig was either interrupted and then restarted or the dose was reduced.
Slovenian: Po neželenih učinkih na pljuča stopnje 1-2 je bilo zdravljenje z zdravilom Alunbrig bodisi prekinjeno, ter se je kasneje nadaljevalo, ali je bil odmerek znižan.
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).
Slovenian: V primeru življenjsko nevarne bradikardije, ko sočasno uporabljena zdravila k temu niso prispevala, ali v primeru ponovitve, je treba zdravljenje z zdravilom Alunbrig prekiniti (glejte poglavje 4.2).
English: 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.
Slovenian: Zmerni zaviralci CYP3A (npr. diltiazem in verapamil) lahko povečajo AUC brigatiniba za približno 40% na podlagi simulacij iz farmakološko določenega farmakokinetičnega modela.
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.
Slovenian: • vnetje pljuč Obvestite svojega zdravnika, če imate nove ali poslabšane težave s pljuči ali dihanjem, vključno z bolečinami v prsnem košu, kašljem in zvišano telesno temperaturo, zlasti v prvem tednu zdravljenja z zdravilom Alunbrig, saj so lahko znak resnih težav s pljuči.
English: Grapefruit or grapefruit juice may increase plasma concentrations of brigatinib and should be avoided (see section 4.5).
Slovenian: Grenivka ali sok grenivke lahko poveča koncentracijo brigatiniba v plazmi in se ji je treba izogibati (glejte poglavje 4.5).
English: 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.
Slovenian: Skupaj v urinu in blatu se je 48% radioaktivnega odmerka izločilo kot nespremenjeni brigatinib, 27% kot N-demetiliran brigatinib (AP26123) in 9,1% kot konjugat brigatiniba in cisteina.
English: In vitro studies demonstrated that brigatinib is primarily metabolised by CYP2C8 and CYP3A4, and to a much lesser extent by CYP3A5.
Slovenian: Študije in vitro so pokazale, da se brigatinib pretežno presnavlja s CYP2C8 in CYP3A4 ter v veliko manjšem obsegu s CYP3A5.
English: Fasting serum glucose should be assessed prior to initiation of Alunbrig and monitored periodically thereafter.
Slovenian: Pred začetkom zdravljenja z zdravilom Alunbrig je treba oceniti glukozo v serumu, ter jo nato redno spremljati.
English: 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).
Slovenian: Pri farmakokinetični študiji so bili pri bolnikih s hudo okvaro ledvic (eGFR < 30 ml/min, N = 6) nevezani AUC0-INF za 94% višji kot pri bolnikih z normalnim delovanjem ledvic (eGFR ≥ 90 ml/min, N = 8) (glejte poglavje 4.2).
English: Note: Progression-Free survival was defined as time from initiation of treatment until the date at which disease progression was first evident or death, whichever comes first.
Slovenian: Kratice: ITT = populacija vseh vključenih bolnikov Opomba: Preživetje brez napredovanja bolezni je bilo opredeljeno kot čas od začetka zdravljenja do datuma, ko je bilo napredovanje bolezni znova odkrito ali smrt, kar je nastopilo prej.
English: Grapefruit or grapefruit juice may also increase plasma concentrations of brigatinib and should be avoided (see section 4.2).
Slovenian: Grenivka ali sok grenivke lahko prav tako zviša koncentracije brigatiniba v plazmi in se ji je treba izogibati (glejte poglavje 4.2).
English: Tell your doctor if you have kidney problems or you are on dialysis.
Slovenian: Obvestite svojega zdravnika, če imate težave z ledvicami ali ste na dializi.
English: Common Dry skin Photosensitivity reaction
Slovenian: Pogosti uha koža fotosenzitivna reakcija izpuščajm fotosenzitivna reakcija
English: Talk to your doctor before taking Alunbrig or during treatment if you have:
Slovenian: Pred začetkom jemanja zdravila Alunbrig ali med zdravljenjem se posvetujte z zdravnikom, če imate: