FrancophonIA/ELRC3.0 huggingface dataset:
English: Alunbrig is available in plastic foil strips (blisters) packed in a carton with:
Slovenian: Zdravilo Alunbrig je na voljo v plastičnih folijskih trakovih (pretisni omot), ki so pakirani v škatlo z:
English: Bradycardia (HR less than 60 bpm)
Slovenian: Bradikardija (srčni utrip manj kot 60 utripov na minuto)
English: 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.
Slovenian: Varnost in učinkovitost zdravila Alunbrig so ovrednotili v randomiziranem (1:1), odprtem, multicentričnem preskušanju (ALTA) pri 222 odraslih bolnikih z lokalno napredovalim ali metastatskim ALK pozitivnim NSCLC, ki jim je bolezen napredovala po uporabi krizotiniba.
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.
Slovenian: V študijah toksičnosti pri ponavljajočih se odmerkih so pri opicah ugotovili pljučne spremembe (penaste alveolarne makrofage) pri ≥ 0,2-kratni vrednosti AUC pri človeku; vendar so bili ti minimalni in podobni tistim, ki so bili opaženi kot ugotovitve pri opicah, ki zdravila niso prejemale.
English: Patients with a history of pulmonary interstitial disease or drug-related pneumonitis were excluded.
Slovenian: Bolniki z anamnezo pljučne intersticijske bolezni ali pnevmonitisa, povezanega z drugimi zdravili, so bili izključeni.
English: 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.
Slovenian: Zato je treba pri sočasni uporabi zdravila Alunbrig s substrati CYP3A z ozkim terapevtskim indeksom (npr. alfentanilom, fentanilom, kinidinom, ciklosporinom, sirolimusom, takrolimusom) izogibati, ker se lahko zmanjša njihova učinkovitost.
English: No patients had dose reductions due to hyperglycaemia.
Slovenian: Pri nobenem bolniku ni bilo potrebno znižati odmerka zaradi hiperglikemije.
English: • 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.
Slovenian: • Druge pomožne snovi so laktoza monohidrat, mikrokristalna celuloza, natrijev karboksimetilškrob (tipa A), koloidni silicijev dioksid, magnezijev stearat, smukec, makrogol, polivinilalkohol in titanov dioksid.
English: 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.
Slovenian: Pri šestih zdravih moških, ki so prejeli enkratni 180 mg peroralni odmerek [14C] brigatiniba, se je v blatu izločilo 65% uporabljenega odmerka in 25% z urinom.
English: Do not use this medicine after the expiry date which is stated on either the bottle label or blister and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki ali pretisnem omotu in škatli za oznako EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Alunbrig contains lactose monohydrate.
Slovenian: Zdravilo Alunbrig vsebuje laktozo monohidrat.
English: • nafcillin: a medicine to treat bacterial infections
Slovenian: • nafcilin: zdravilo za zdravljenje bakterijskih okužb
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%
Slovenian: IZ = interval zaupanja; NO = ni mogoče oceniti; NA = navedba smiselno ni potrebna *Režim 90 mg enkrat na dan †90 mg enkrat na dan v obdobju prvih 7 dni, nato 180 mg enkrat na dan ‡ Interval zaupanja za preiskovalca, kjer je ocenjeni ORR 97,5% ter za IRC, kjer je ocenjeni ORR
English: • quinidine: a medicine to treat irregular heart rhythm
Slovenian: • kinidin: zdravilo za zdravljenje nepravilnega srčnega ritma
English: Your doctor may stop Alunbrig treatment and refer you to an ophthalmologist.
Slovenian: Zdravnik vam lahko prekine zdravljenje z zdravilom Alunbrig in vas napoti k oftalmologu.
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).
Slovenian: Farmakokinetiko brigatiniba so določili pri zdravih osebah z normalnim delovanjem jeter (N = 9) in pri bolnikih z blago okvaro jeter (Child-Pugh razred A, N = 6), zmerno okvaro jeter (Child-Pugh razred B, N = 6) ali hudo okvaro jeter (Child-Pugh razred C, N = 6).
English: The most common adverse reactions (≥ 25%) reported in patients treated with Alunbrig at the recommended dosing regimen were increased AST, hyperglycaemia, hyperinsulinaemia, anaemia, increased CPK, nausea, increased lipase, decreased lymphocyte count, increased ALT, diarrhoea, increased amylase, fatigue, cough, headache, increased alkaline phosphatase, hypophosphataemia,
Slovenian: Najpogostejši neželeni učinki (≥25%), o katerih so poročali pri bolnikih, ki so se zdravili z zdravilom Alunbrig pri priporočenem režimu odmerjanja, so zvišana AST, hiperglikemija, hiperinsulinemija, anemija, zvišana CPK, navzea, povečana lipaza, zmanjšano število limfocitov, povečana ALT, diareja, povečana amilaza, utrujenost, kašelj, glavobol, povečana alkalna fosfataza, hipofosfatemija, zvišana vrednost APTT, izpuščaj, bruhanje, dispneja, hipertenzija, zmanjšano število belih krvnih celic, mialgija in periferna nevropatija.
English: Brigatinib inhibited autophosphorylation of ALK and ALK-mediated phosphorylation of the downstream signalling protein STAT3 in in vitro and in vivo assays.
Slovenian: Brigatinib zavira avtofosforilacijo ALK in ALK posredovano fosforilacijo zaviralnega signalizacijskega proteina STAT3 v analizah in vitro in in vivo.
English: Patients should be advised to report any unexplained muscle pain, tenderness, or weakness.
Slovenian: Bolnikom je treba svetovati, naj poročajo o kakršnih koli nepojasnjenih bolečinah v mišicah, občutljivosti ali šibkosti mišic.
English: • lung infection (pneumonia)
Slovenian: • okužba dihal (pljučnica)
English: • alfentanil, fentanyl: medicines to treat pain
Slovenian: • alfentanil, fentanil: zdravila za zdravljenje bolečin
English: If adequate hyperglycaemic control cannot be achieved with optimal medical management, Alunbrig should be withheld until adequate hyperglycaemic control is achieved; upon recovery reducing the dose as described in Table 1 may be considered or Alunbrig may be permanently discontinued.
Slovenian: Če ustreznega hiperglikemičnega nadzora ni mogoče doseči z optimalnim zdravljenjem, je treba zdravljenje z zdravilom Alunbrig začasno prekiniti, dokler se ne doseže ustrezen hiperglikemični nadzor; po okrevanju razmisliti o zmanjšanju odmerka, kot je opisano v preglednici 1, ali pa zdravljenje z zdravilom Alunbrig opustiti.
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.
Slovenian: Brigatinib zavira in vitro proliferacijo celičnih linij, ki izražajo fuzijske proteine EML4-ALK in NPM-ALK ter izkazuje od odmerka odvisno zaviranje rasti EML4-ALK pozitivnega NSCLC ksenotransplantata pri miših.
English: Adverse reactions Grade 3-4
Slovenian: Neželeni učinki stopnja 3-4
English: Do not breast-feed during treatment with Alunbrig.
Slovenian: Med zdravljenjem z zdravilom Alunbrig ne dojite.
English: 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.
Slovenian: Zdravilo Alunbrig se uporablja kot monoterapija za zdravljenje odraslih bolnikov z napredovalim nedrobnoceličnim pljučnim rakom (NSCLC- non-small cell lung cancer) pozitivnim na anaplastično limfomsko kinazo (ALK), ki so bili predhodno zdravljeni z zdravilom krizotinib.
English: Thirty percent of patients had resolution of all peripheral neuropathy adverse reactions.
Slovenian: Pri tridesetih odstotkih bolnikov so se vsi neželeni učinki povezani s periferno nevropatijo razrešili.
English: In patients given brigatinib 180 mg once daily, the geometric mean apparent volume of distribution (Vz/F) of brigatinib at steady state was 153 L, indicating moderate distribution into tissues.
Slovenian: Pri bolnikih, ki so prejemali brigatinib 180 mg enkrat na dan, je bil povprečen navidezni volumen porazdelitve (Vz/F) brigatiniba v stanju dinamičnega ravnovesja 153 l, kar kaže na zmerno porazdelitev v tkiva.
English: Alunbrig is available as a treatment initiation pack.
Slovenian: Zdravilo Alunbrig je na voljo v uvajalnem pakiranju.
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.
Slovenian: % IZ = interval zaupanja; NO = ni mogoče oceniti *Režim 90 mg enkrat na dan †90 mg enkrat na dan v obdobju prvih 7 dni, nato 180 mg enkrat na dan ‡Dogodki vključujejo napredovanje intrakranialne bolezni (nove lezije, porast premera intrakranialne ciljne lezije ≥20% od najmanjšega števila ali nedvoumno napredovanje intrakranialnih neciljnih lezij) ali smrt.
English: • musculoskeletal chest pain
Slovenian: • mišično-skeletnega bolečine v prsnem košu
English: • modafinil: a medicine to treat narcolepsy
Slovenian: • modafinil: zdravilo za zdravljenje narkolepsije
English: 180 mg regimen† (N = 18)
Slovenian: 180 mg režim† (N = 18)
English: In ALTA, 69% of patients experienced hyperglycaemia.
Slovenian: Pri študiji ALTA se je pri 69% pojavila hiperglikemija.
English: Patients with severe renal impairment should be closely monitored for new or worsening respiratory symptoms that may indicate ILD/pneumonitis (e.g., dyspnoea, cough, etc.) particularly in the first week (see section 4.4).
Slovenian: Bolnike s hudo okvaro ledvic je zlasti v prvem tednu treba skrbno spremljati zaradi novih ali poslabšanih simptomov dihal (npr. dispneja, kašelj itd.), ki lahko nakazujejo na IPB/pnevmonitis (glejte poglavje 4.4).
English: Each bottle contains one canister of a desiccant and is packed in a carton with:
Slovenian: Vsaka plastenka vsebuje vsebnik s sušilnim sredstvom, je pakirana v škatli in vsebuje:
English: Takeda Pharmaceuticals Czech Republic s.r.o.
Slovenian: Česká republika Takeda Pharmaceuticals Czech Republic s.r.o.
English: If you forget to take Alunbrig
Slovenian: Če ste pozabili vzeti zdravilo Alunbrig
English: • bosentan: a medicine to treat pulmonary hypertension
Slovenian: • bosentan: zdravilo za zdravljenje pljučne hipertenzije
English: Median (months)
Slovenian: Celokupno preživetje Povprečno (mesecev)
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.
Slovenian: Po prekinitvi jemanja močnega inhibitorja CYP3A je treba zdravljenje z zdravilom Alunbrig nadaljevati z odmerkom, ki ga je bolnik še prenašal pred začetkom jemanja močnega inhibitorja CYP3A.
English: Patients with a history of ILD or drug-induced pneumonitis were excluded from the pivotal trial.
Slovenian: Bolniki z anamnezo IPB ali s pnevmonitisom induciranim z zdravili so bili izključeni iz ključnega preskušanja.
English: Alunbrig contains lactose
Slovenian: Zdravilo Alunbrig vsebuje laktozo
English: Alunbrig may be taken with or without food.
Slovenian: Zdravilo Alunbrig se lahko jemlje s hrano ali brez nje.
English: Upon recovery, the dose should be modified accordingly (see section 4.2).
Slovenian: Po okrevanju je treba odmerek ustrezno spremeniti (glejte poglavje 4.2).
English: • efavirenz, etravirine: medicines to treat HIV infection
Slovenian: • efavirenz, etravirin: zdravila za zdravljenje okužbe s HIV
English: Alunbrig contains the active substance brigatinib, a type of cancer medicine called a kinase inhibitor.
Slovenian: Zdravilo Alunbrig vsebuje učinkovino brigatinib, ki je zdravilo proti raku in se imenuje zaviralec kinaze.
English: Takeda Belgium Tel/Tél: +32 2 464 06 11 takeda-belgium@takeda.com
Slovenian: België/Belgique/Belgien Takeda Belgium Tel/Tél: +32 2 464 06 11 takeda-belgium@takeda.com
English: 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.
Slovenian: Geometrično povprečna Cmaks brigatiniba v stanju dinamičnega ravnovesja pri odmerkih 90 mg je bila 552 ng/mL in pri odmerku 180 mg enkrat na dan 1.452 ng/mL, in ustrezen AUC0- je bil za odmerek 90 mg 8165 in za odmerek 180 mg 20.276 h*ng/mL.
English: Tell your doctor of any new or worsening symptoms including breathing discomfort, shortness of breath, chest pain, cough and fever.
Slovenian: Obvestite svojega zdravnika o novih ali poslabšanih bolezenskih znakih, vključno z neugodjem pri dihanju, težkim dihanjem, bolečinami v prsih, kašljem in zvišano telesno temperaturo.
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:
Slovenian: Uvajalno pakiranje zdravila Alunbrig 90 mg in 180 mg filmsko obložene tablete Eno pakiranje je sestavljeno iz kartonskega ovoja, v katerem sta dve škatli, ki skupaj vsebujeta:
English: Table 5: Intracranial efficacy in patients with measurable brain metastases at baseline in ALTA IRC-assessed efficacy parameter
Slovenian: Preglednica 5: Intrakranialna učinkovitost pri bolnikih z merljivimi metastazami v možganih na izhodišču v študiji ALTA
English: What Alunbrig looks like and contents of the pack
Slovenian: Izgled zdravila Alunbrig in vsebina pakiranja
English: • increased blood level of creatinine - may indicate reduced kidney function
Slovenian: • zvišana koncentracija kreatinina v krvi - lahko nakazuje na zmanjšano delovanje ledvic
English: Each pack consists of an outer carton with two inner cartons containing:
Slovenian: Eno pakiranje je sestavljeno iz kartonskega ovoja, v katerem sta dve škatli, ki skupaj vsebujeta:
English: • a slow heartbeat (bradycardia)
Slovenian: • počasen srčni utrip (bradikardija)
English: Alunbrig should be resumed at next lower dose level as described in Table 1.
Slovenian: Zdravljenje z zdravilom Alunbrig se nato nadaljuje v skladu z naslednjim nižjim odmerkom, kot je opisano v preglednici 1.
English: In Study 101, following administration of a single oral dose of brigatinib (30-240 mg) in patients, the median time to peak concentration (Tmax) was 1-4 hours postdose.
Slovenian: V študiji 101 je bila pri bolnikih, po odmerjanju enkratnega peroralnega odmerka brigatiniba (30-240 mg), mediana časa do najvišje koncentracije (Tmaks) 1-4 ur po prejemu odmerka.
English: if you are allergic to brigatinib or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Alunbrig Ne jemljite zdravila Alunbrig: če ste alergični na brigatinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Hepatotoxicity Grade ≥ 3 elevation (> 5.0 × ULN) of either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) with bilirubin ≤ 2 × ULN
Slovenian: Stopnja zvišanja ≥3 (>5,0 × ULN) alaninaminotransferaze (ALT) ali aspartataminotransferaze (AST) z bilirubinom  2 × ULN
English: Patients should be closely monitored when Alunbrig is coadministered with moderate CYP3A inhibitors.
Slovenian: Bolnike je treba skrbno spremljati, ko je zdravilo Alunbrig sočasno odmerjano z zmernimi zaviralci CYP3A.
English: Alunbrig is for oral use.
Slovenian: Zdravilo Alunbrig je namenjeno za peroralno uporabo.
English: • clarithromycin, telithromycin, troleandomycin: medicines to treat bacterial infections
Slovenian: • klaritromicin, telitromicin, troleandomicin: zdravila za zdravljenje bakterijskih okužb
English: The concomitant use of moderate CYP3A inducers with Alunbrig, including but not limited to efavirenz, modafinil, bosentan, etravirine, and nafcillin should be avoided.
Slovenian: Izogibati se je treba sočasni uporabi zmernih induktorjev CYP3A z zdravilom Alunbrig, vključno z, vendar ne omejeno na efavirenz, modafinil, bosentan, etravirin in nafcilin.
English: In ALTA, hypertension was reported in 28% of patients treated with Alunbrig at the 180 mg regimen with 10% having Grade 3 hypertension.
Slovenian: V študiji ALTA se je pri 28% bolnikov, ki so prejemali zdravilo Alunbrig, pojavila hipertenzija pri režimu z odmerkom 180 mg, pri čemer je 10% bolnikov imelo hipertenzijo stopnje 3.
English: Tell your doctor if you have any unexplained muscle pain, tenderness or weakness.
Slovenian: Obvestite svojega zdravnika, če imate kakršnekoli nepojasnjene mišične bolečine, občutljivost ali šibkost.
English: EU/1/18/1264/012 7 x 90 mg + 21 x 180 mg tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1264/012 7 x 90 mg + 21 x 180 mg tablet
English: Men receiving treatment with Alunbrig are advised not to father a child during treatment and to use effective contraception during treatment and for 3 months after stopping.
Slovenian: Moškim, ki se zdravijo z zdravilom Alunbrig, svetujemo naj med zdravljenjem ne zaplodijo otroka in med zdravljenjem in 3 mesece po prekinitvi zdravljenja uporabljajo učinkovito kontracepcijo.
English: For severe hypertension (≥ Grade 3), Alunbrig should be withheld until hypertension has recovered to Grade 1 or to baseline.
Slovenian: V primeru resne stopnje hipertenzije (≥ stopnja 3) je treba zdravljenje z zdravilom Alunbrig začasno prekiniti, dokler se hipertenzija ne povrne na stopnjo 1 ali na izhodiščno vrednost.
English: If you stop taking Alunbrig
Slovenian: Če ste prenehali jemati zdravilo Alunbrig
English: 90 mg regimen* N = 112
Slovenian: 90 mg režim* N = 112
English: Table 2: Recommended Alunbrig dose modifications for adverse reactions Adverse reaction Severity*
Slovenian: Preglednica 2: Priporočeni odmerek zdravila Alunbrig ob pojavu neželenega učinka Neželeni učinek Resnost*
English: 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.
Slovenian: V ločeni študiji za določanje odmerka je 25 bolnikov z ALK-pozitivnim NSCLC, pri katerih je bolezen napredovala ob uporabi krizotiniba, prejemalo zdravilo Alunbrig 180 mg enkrat na dan z začetnim odmerkom 90 mg enkrat na dan v prvih 7 dneh.
English: Outer Carton PC:
Slovenian: Zunanja ovojnina PC:
English: Lactose monohydrate Microcrystalline cellulose Sodium starch glycolate (type A) Silica colloidal hydrophobic Magnesium stearate
Slovenian: Jedro tablete laktoza monohidrat mikrokristalna celuloza natrijev karboksimetil škrob (tip A) hidrofobni koloidni silicijev dioksid magnezijev stearat
English: • If Grade 4 hypertension recurs, Alunbrig should be permanently discontinued.
Slovenian: • Če se hipertenzija stopnje 4 ponovi, je potrebno zdravljenje z zdravilom Alunbrig trajno ukiniti.
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.
Slovenian: Sočasni uporabi močnih zaviralcev CYP3A z zdravilom Alunbrig, vključno z nekaterimi protivirusnimi zdravili (npr. indinavirjem, nelfinavirjem, ritonavirjem, sakvinavirjem), makrolidnimi antibiotiki (npr. klaritromicinom, telitromicinom, troleandomicinom), antimikotiki (npr. ketokonazolom, vorikonazolom), mibefradilom in nefazodonom, se je treba izogibati.
English: In vitro studies demonstrated that brigatinib is a substrate of CYP2C8.
Slovenian: Študije in vitro so pokazale, da je brigatinib substrat CYP2C8.
English: Eye disorders Very common Visual disturbancee Common
Slovenian: Očesne bolezni Zelo pogosti motnje vidae Pogosti motnje vidae
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON FOR TREATMENT INITIATION PACK - 7 TABLETS, 90 MG - 7 DAY TREATMENT (WITHOUT BLUE BOX)
Slovenian: NOTRANJA ŠKATLA UVAJALNEGA PAKIRANJA - 7 TABLET, 90 MG - 7-DNEVNO ZDRAVLJENJE (BREZ MODREGA OKENCA)
English: • increased blood level of lactate dehydrogenase - may indicate tissue breakdown
Slovenian: • zvišana koncentracija laktat-dehidrogenaze v krvi - lahko nakazuje na razgradnjo tkiva
English: Treatment initiation pack Each pack contains two cartons in an outer carton.
Slovenian: V enem pakiranju sta dve škatli v kartonskem ovoju.
English: Following oral administration of a single 180 mg dose of [14C]brigatinib to healthy subjects, N-demethylation and cysteine conjugation were the two major metabolic clearance pathways.
Slovenian: Po peroralnem odmerjanju enkratnega 180 mg odmerka [14C] brigatiniba pri zdravih osebah sta bila dva glavna presnovna procesa N-demetilacija in konjugacija s cisteinom.
English: Women of childbearing age being treated with Alunbrig should avoid becoming pregnant.
Slovenian: Ženske v rodni dobi, ki se zdravijo z zdravilom Alunbrig, se morajo izogibati zanositvi.
English: • increased blood level of the enzyme alkaline phosphatase - may indicate organ malfunction or injury
Slovenian: • zvišana koncentracija encima alkalna fosfataza v krvi - lahko kaže na okvaro ali poškodbo organa
English: • phenobarbital, phenytoin: medicines to treat epilepsy
Slovenian: • fenobarbital, fenitoin: zdravila za zdravljenje epilepsije
English: Uncommon (may affect up to 1 in 100 people)
Slovenian: Redki (lahko se pojavijo pri največ 1 od 100 bolnikov)
English: Blood pressure should be monitored regularly during treatment with Alunbrig.
Slovenian: Med zdravljenjem z zdravilom Alunbrig je treba redno nadzorovati krvni tlak.
English: Alunbrig is available in plastic bottles with child resistant screw top closures.
Slovenian: Zdravilo Alunbrig je na voljo v plastenkah z za otroke varnimi zaporkami.
English: Men with female partners of childbearing potential should be advised to use effective contraception during treatment and for at least 3 months after the last dose of Alunbrig (see section 4.6).
Slovenian: Moškim s partnericami v rodni dobi je treba svetovati, naj uporabijo učinkovito kontracepcijo med zdravljenjem in vsaj 3 mesece po zadnjem odmerku zdravila Alunbrig (glejte poglavje 4.6).
English: In vitro studies in hepatocytes have shown that brigatinib is an inducer of CYP3A4.
Slovenian: Študije in vitro v hepatocitih so pokazale, da je brigatinib induktor CYP3A4.
English: The concomitant use of Alunbrig with strong CYP3A inhibitors should be avoided.
Slovenian: Izogibati se je treba sočasni uporabi zdravila Alunbrig z močnimi zaviralci CYP3A.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON FOR TREATMENT INITIATION PACK - 21 TABLETS, 180 MG21 DAY TREATMENT (WITHOUT BLUE BOX)
Slovenian: NOTRANJA ŠKATLA UVAJALNEGA PAKIRANJA - 21 TABLET, 180 MG - 21-DNEVNO ZDRAVLJENJE (BREZ MODREGA OKENCA)
English: The pharmacokinetics of brigatinib was similar between healthy subjects with normal hepatic function and patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment.
Slovenian: Farmakokinetika brigatiniba je bila podobna pri zdravih osebah z normalnim delovanjem jeter in pri bolnikih z blago (Child-Pugh razred A) ali z zmerno okvaro jeter (Child-Pugh razred B).