FrancophonIA/ELRC3.0 huggingface dataset:
English: For elevations to Grade 3 and 4, the incidences for amylase and lipase were 8.2% and 10%, respectively.
Croatian: Incidencija porasta razina 3. i 4. stupnja bila je 8,2 % za amilazu i 10 % za lipazu.
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).
Croatian: U bolesnika s bilo kakvim metastazama na početku liječenja stopa kontrole intrakranijske bolesti bila je 77,8 % (95 % CI 67,2 -86,3) u skupini liječenoj s 90 mg (N = 81) i 85,1 % (95 % CI 75 -92,3) u skupini s 180 mg (N = 74).
English: • low platelet counts in blood tests, which may increase the risk of bleeding and bruising
Croatian: • nizak broj trombocita u nalazima krvi, što može povećati rizik za krvarenje i nastanak modrica
English: Pneumoniaa
Croatian: Pneumonitisi
English: No human data on the effect of Alunbrig on fertility are available.
Croatian: Nisu dostupni podaci o učinku lijeka Alunbrig na plodnost u ljudi.
English: Patients should be monitored for new or worsening respiratory symptoms (e.g., dyspnoea, cough, etc.), particularly in the first week of treatment.
Croatian: Bolesnike se mora pažljivo nadzirati zbog pojave novih ili pogoršanih respiratornih simptoma (npr. dispneja, kašalj, itd.), posebice u prvom tjednu liječenja.
English: • nafcillin: a medicine to treat bacterial infections
Croatian: • nafcilin: lijek za liječenje bakterijskih infekcija
English: • Alunbrig should be permanently discontinued if no contributing concomitant medicinal product is identified.
Croatian: • Liječenje lijekom Alunbrig se mora trajno prekinuti ako se ne identificira istodobno primjenjivani lijek koji pridonosi stanju.
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).
Croatian: AUC0INF za nevezani lijek bio je 37 % viši u bolesnika s teškim oštećenjem jetre (Child-Pugh stadij C) u usporedbi sa zdravim ispitanicima s normalnom funkcijom jetre (vidjeti dio 4.2).
English: 180 mg regimen† (N = 18)
Croatian: režim od 180 mg† (N = 18)
English: • increased blood sugar
Croatian: • povišeni šećer u krvi
English: Grade 3 hyperglycemia occurred in 7.3% of patients.
Croatian: U 7,3 % bolesnika javila se hiperglikemija 3. stupnja.
English: CPK levels should be monitored regularly during Alunbrig treatment.
Croatian: Razine CPK moraju se redovito pratiti za vrijeme liječenja lijekom Alunbrig.
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.
Croatian: Ako se optimalnim terapijskim mjerama ne može postići adekvatna kontrola glikemije, primjenu lijeka Alunbrig treba prekinuti dok se ne postigne odgovarajuća kontrola glikemije; nakon oporavka može se razmotriti smanjenje doze kako je opisano u tablici 1 ili liječenje lijekom Alunbrig treba trajno prekinuti.
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.
Croatian: Sigurnost i djelotvornost lijeka Alunbrig procijenjena je u randomiziranom (1:1), otvorenom, multicentričnom ispitivanju (ALTA) u 222 odrasla bolesnika s lokalno uznapredovalim ili metastatskim ALK-pozitivnim NSCLC-om koji je progredirao uz krizotinib.
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.
Croatian: • Drugi sastojci su laktoza hidrat, mikrokristalična celuloza, natrijev škroboglikolat (vrsta A), hidrofobni koloidni silicijev dioksid, magnezijev stearat, talk, makrogol, poli(vinilni alkohol) i titanijev dioksid.
English: APTT increased Anaemia
Croatian: Povišen APTT Anemija
English: No patients had dose reductions due to hyperglycaemia.
Croatian: Ni u jednog bolesnika doza nije smanjena zbog hiperglikemije.
English: Tell your doctor of any new or worsening symptoms including breathing discomfort, shortness of breath, chest pain, cough and fever.
Croatian: Obavijestite svog liječnika ako se jave novi ili pogoršani simptomi uključujući nelagodu prilikom disanja, nedostatak zraka, bol u prsnom košu, kašalj i vrućicu.
English: • methotrexate: a medicine to treat severe joint inflammation, cancer and the skin disease psoriasis
Croatian: • metotreksat: lijek za liječenje teške upale zglobova, raka i kožne bolesti psorijaze
English: Nausea Dyspepsia Pancreatitis
Croatian: Mučnina Dispepsija Pankreatitis
English: Alunbrig contains lactose monohydrate.
Croatian: Alunbrig sadrži laktozu hidrat.
English: Grapefruit or grapefruit juice may also increase plasma concentrations of brigatinib and should be avoided (see section 4.2).
Croatian: Grejp ili sok od grejpa također može povećati koncentracije brigatiniba u plazmi pa ga treba izbjegavati (vidjeti dio 4.2).
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.
Croatian: Alunbrig je indiciran kao monoterapija za liječenje odraslih bolesnika s uznapredovalim rakom pluća nemalih stanica (engl. non-small cell lung cancer, NSCLC) pozitivnim na kinazu anaplastičnog limfoma (engl. anaplastic lymphoma kinase, ALK) prethodno liječenog krizotinibom.
English: If symptomatic bradycardia occurs, treatment with Alunbrig should be withheld and concomitant medicinal products known to cause bradycardia should be evaluated.
Croatian: Ako se javi simptomatska bradikardija, potrebno je prekinuti primjenu lijeka Alunbrig i procijeniti istodobnu primjenu lijekova za koje je poznato da uzrokuju bradikardiju.
English: • bosentan: a medicine to treat pulmonary hypertension
Croatian: • bosentan: lijek za liječenje plućne hipertenzije
English: Method of use
Croatian: Način uporabe
English: Lung problems, some severe, are more frequent within the first 7 days of treatment.
Croatian: • probleme s plućima ili disanjem Problemi s plućima, neki od njih teški, češći su unutar prvih 7 dana liječenja.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA ZA BLISTER
English: • quinidine: a medicine to treat irregular heart rhythm
Croatian: • kinidin: lijek za liječenje nepravilnog srčanog ritma
English: The dose should be modified accordingly (see section 4.2).
Croatian: Potrebno je odgovarajuće prilagoditi dozu (vidjeti dio 4.2).
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.
Croatian: Brigatinib je inhibirao in vitro proliferaciju staničnih linija koje eksprimiraju fuzijske proteine EML4-ALK i NPM-ALK i pokazao o dozi ovisnu inhibiciju rasta EML4-ALK-pozitivnog NSCLC ksenografta u miševa.
English: Patients should be advised to report any unexplained muscle pain, tenderness, or weakness.
Croatian: Bolesnike treba savjetovati da prijave sve neobjašnjive bolove u mišićima, osjetljivost ili slabost.
English: Treatment initiation pack Each pack contains two cartons in an outer carton.
Croatian: Svako pakiranje sadrži dvije kutije unutar vanjske kutije.
English: Grapefruit or grapefruit juice may increase plasma concentrations of brigatinib and should be avoided (see section 4.5).
Croatian: Grejp ili sok od grejpa mogu povećati koncentracije brigatiniba u plazmi pa ih treba izbjegavati (vidjeti dio 4.5).
English: • modafinil: a medicine to treat narcolepsy
Croatian: • modafinil: lijek za liječenje narkolepsije
English: • alfentanil, fentanyl: medicines to treat pain
Croatian: • alfentanil, fentanil: lijekovi za ublažavanje bola
English: • increased blood level of the enzyme alkaline phosphatase - may indicate organ malfunction or injury
Croatian: • povišena razina enzima alkalna fosfataza u krvi - može ukazivati na nepravilan rad ili oštećenje organa
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON FOR TREATMENT INITIATION PACK - 7 TABLETS, 90 MG - 7 DAY TREATMENT (WITHOUT BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA POČETNOG PAKIRANJA - 7 TABLETA, 90 mg - 7-DNEVNO LIJEČENJE (BEZ PLAVOG OKVIRA)
English: Following Grade 1-2 pulmonary adverse reactions, treatment with Alunbrig was either interrupted and then restarted or the dose was reduced.
Croatian: Zbog nuspojava na plućima 1 - 2. stupnja, liječenje lijekom Alunbrig je ili prekinuto i zatim nastavljeno ili je doza smanjena.
English: A validated ALK assay is necessary for the selection of ALK-positive NSCLC patients (see section 5.1).
Croatian: Za probir bolesnika sa ALK-pozitivnim NSCLC-om nužan je validirani ALK test (vidjeti dio 5.1).
English: EU/1/18/1264/012 7 x 90 mg + 21 x 180 mg tablets
Croatian: EU/1/18/1264/012 7 x 90 mg + 21 x 180 mg tableta u kutiji
English: Dose reduction for hypertension occurred in 0.9% at the 180 mg regimen.
Croatian: Doza je zbog hipertenzije smanjena u 0,9 % bolesnika na režimu doziranja od 180 mg.
English: Very common Pneumoniaa Upper respiratory tract infection
Croatian: Vrlo često Upala plućaa Infekcija gornjih dišnih puteva
English: P-gp and BCRP inhibitors
Croatian: Inhibitori Pgp i BCRP
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,
Croatian: Najčešće nuspojave (≥ 25 %) prijavljene u bolesnika liječenih lijekom Alunbrig u preporučenom režimu doziranja bile su povišeni AST, hiperglikemija, hiperinzulinemija, anemija, povišen CPK, mučnina, povišena lipaza, smanjen broj limfocita, povišen ALT, proljev, povišena amilaza, umor, kašalj, glavobolja, povišena alkalna fosfataza, hipofosfatemija, povišen APTT, osip, povraćanje, dispneja, hipertenzija, smanjen broj bijelih krvnih stanica, mialgija i periferna neuropatija.
English: Common Blood lactate dehydrogenase increased
Croatian: Povišena laktat dehidrogenaza u krvi
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.
Croatian: Geometrijska sredina Cmax brigatiniba u stanju dinamičke ravnoteže u dozama od 90 mg i 180 mg jedanput dnevno bila je 552, odnosno 1452 ng/ml, a pripadajući AUC0 - bio je 8165, odnosno 20 276 h∙ng/ml.
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.
Croatian: U bolesnika kojima je davano 180 mg brigatiniba jedanput dnevno, geometrijska sredina prividnog volumena distribucije (Vz/F) brigatiniba u stanju dinamičke ravnoteže iznosila je 153 l, ukazujući na umjerenu distribuciju u tkiva.
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).
Croatian: Farmakokinetika brigatiniba karakterizirana je u zdravih ispitanika s normalnom funkcijom jetre (N = 9) i bolesnika s blagim oštećenjem jetre (Child-Pugh stadij A, N = 6), umjerenim oštećenjem jetre (Child-Pugh stadij B, N = 6) ili teškim oštećenjem jetre (Child-Pugh stadij C, N = 6).
English: Very common Blood creatinine increased
Croatian: Vrlo često Povišen kreatinin u krvi
English: (18.2, NE)
Croatian: (18,2; NP)
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.
Croatian: U zasebnom ispitivanju određivanja doze, 25 bolesnika s ALK-pozitivnim NSCLC-om sa progresijom na krizotinibu, primalo je 180 mg lijeka Alunbrig jedanput dnevno uz uvodni režim 7-dnevnog uzimanja 90 mg jedanput dnevno.
English: Patients should be closely monitored when Alunbrig is coadministered with moderate CYP3A inhibitors.
Croatian: Bolesnike se treba pažljivo nadzirati kad se Alunbrig daje istovremeno s umjerenim inhibitorima CYP3A.
English: • increased blood level of creatinine - may indicate reduced kidney function
Croatian: • povišena razina kreatinina u krvi - može ukazivati na smanjenu funkciju bubrega
English: • memory impairment
Croatian: • poremećaj pamćenja
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR TREATMENT INITIATION PACK (INCLUDING BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA POČETNOG PAKIRANJA (SADRŽI PLAVI OKVIR)
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.
Croatian: Nakon prekida liječenja s jakim inhibitorom CYP3A, treba nastaviti liječenje lijekom Alunbrig u dozi koja je bila podnošljiva prije početka liječenja jakim inhibitorom CYP3A.
English: Alunbrig is used to treat adults with advanced stages of a lung cancer called non-small cell lung cancer.
Croatian: Alunbrig se koristi za liječenje odraslih bolesnika s uznapredovalim stadijima raka pluća koji se naziva rakom pluća nemalih stanica.
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
Croatian: Alunbrig 90 mg filmom obložene tablete EU/1/18/1264/005 7 tableta u bočici EU/1/18/1264/006 30 tableta u bočici EU/1/18/1264/007 7 tableta u kutiji EU/1/18/1264/008 28 tableta u kutiji Alunbrig 180 mg filmom obložene tablete EU/1/18/1264/009 30 tableta u bočici EU/1/18/1264/010 28 tableta u kutiji Alunbrig početno pakiranje
English: Takeda Belgium Tel/Tél: +32 2 464 06 11 takeda-belgium@takeda.com
Croatian: België/Belgique/Belgien Takeda Belgium Tel/Tél: +32 2 464 06 11 takeda-belgium@takeda.com
English: Dose reduction levels First
Croatian: Razine smanjenje doze Prva
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.
Croatian: Muškarcima koji primaju Alunbrig savjetuje se da ne začinju dijete tijekom liječenja i da koriste učinkovitu kontracepciju za vrijeme i 3 mjeseca nakon prestanka liječenja.
English: • efavirenz, etravirine: medicines to treat HIV infection
Croatian: • efavirenz, etravirin: lijekovi za liječenje HIV infekcije
English: Common Dyspepsia Flatulence
Croatian: Dispepsija Flatulencija
English: Tell your doctor if you have kidney problems or you are on dialysis.
Croatian: Obavijestite svog liječnika ako imate probleme s bubrezima ili ste na dijalizi.
English: No patients had dose reductions due to elevation of ALT or AST.
Croatian: Ni u jednog bolesnika doza nije smanjena zbog porasta razine ALT-a ili AST-a.
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.
Croatian: = Interval pouzdanosti; NP = Ne može se procijeniti *režim 90 mg jedanput dnevno †180 mg jedanput dnevno uz uvodno 7-dnevno uzimanje 90 mg jedanput dnevno ‡Događaji uključuju progresiju intrakranijske bolesti (nove lezije, rast promjera intrakranijske ciljne lezije ≥ 20 % od najniže vrijednosti, ili utvrđenu progresiju intrakranijskih ne-ciljnih lezija) ili smrtni ishod.
English: • increased blood level of lactate dehydrogenase - may indicate tissue breakdown
Croatian: • povišena razina laktat dehidrogenaze u krvi - može ukazivati na razgradnju tkiva
English: Patients with a history of ILD or drug-induced pneumonitis were excluded from the pivotal trial.
Croatian: Bolesnici s anamnezom IBP-a ili pneumonitisa izazvanog lijekom bili su isključeni iz pivotalnih ispitivanja.
English: Very common Blood CPK increased Myalgian
Croatian: Vrlo često Povišen CPK u krvi Mialgijan
English: Caution should be exercised when administering Alunbrig in combination with other agents known to cause bradycardia.
Croatian: Potreban je oprez kad se Alunbrig primjenjuje u kombinaciji s drugim lijekovima za koje je poznato da uzrokuju bradikardiju.
English: Common Memory impairment Dysgeusia
Croatian: Poremećaj pamćenja Disgeuzija
English: 180 mg regimen† N = 110
Croatian: režim od 180 mg† N = 110
English: How to take Alunbrig
Croatian: Kako uzimati Alunbrig
English: Alunbrig is for oral use.
Croatian: Alunbrig je namijenjen za peroralnu primjenu.
English: • clarithromycin, telithromycin, troleandomycin: medicines to treat bacterial infections
Croatian: • klaritromicin, telitromicin, troleandomicin: lijekovi za liječenje bakterijskih infekcija
English: Tell your doctor or pharmacist if you notice any of the following side effects
Croatian: Odmah obavijestite svog liječnika ili ljekarnika ako imate bilo koju od sljedećih ozbiljnih nuspojava:
English: Breast-feeding should be stopped during treatment with Alunbrig.
Croatian: Dojenje treba prekinuti za vrijeme liječenja lijekom Alunbrig.
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.
Croatian: • Ako se događaj javi tijekom prvih 7 dana liječenja, uzimanje lijeka Alunbrig treba prekinuti do oporavka na početno stanje, a potom nastaviti istom dozom i ne je povećati na 180 mg jedanput dnevno.
English: Outer Carton PC:
Croatian: Vanjska kutija PC:
English: • a slow heartbeat (bradycardia)
Croatian: • usporene otkucaje srca (bradikardija)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER - TREATMENT INITIATION PACK - 180 MG
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER - KUTIJA ZA POČETNO LIJEČENJE - 180 MG
English: Keep the desiccant canister in the bottle.
Croatian: Spremnik sa sredstvom za sušenje držite u bočici.
English: • sulfasalazine: a medicine to treat severe bowel and rheumatic joint inflammation
Croatian: • sulfasalazin: lijek za liječenje teške upale crijeva i reumatske upale zglobova
English: In ALTA, hypertension was reported in 28% of patients treated with Alunbrig at the 180 mg regimen with 10% having Grade 3 hypertension.
Croatian: U ispitivanju ALTA, hipertenzija je prijavljena u 28 % bolesnika liječenih lijekom Alunbrig u režimu doziranja od 180 mg, od kojih je 10 % imalo hipertenziju 3. stupnja.
English: Rashm Photosensitivity reaction
Croatian: Osipm Reakcija fotoosjetljivosti
English: Elevation of CPK Grade 3 elevation of CPK (> 5.0 × ULN)
Croatian: Porast vrijednosti CPK-a Porast vrijednosti CPK 3. stupnja (> 5,0 × GGN)
English: 90 mg regimen* N = 112
Croatian: režim od 90 mg* N = 112
English: In vitro studies in hepatocytes have shown that brigatinib is an inducer of CYP3A4.
Croatian: In vitro ispitivanja na hepatocitima pokazala su da je brigatinib induktor CYP3A4.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER - TREATMENT INITIATION PACK - 90 MG
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER - KUTIJA ZA POČETNO LIJEČENJE - 90 MG
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.
Croatian: U bolesnika kojima je davano 180 mg brigatiniba jedanput dnevno, geometrijska sredina prividnog peroralnog klirensa (CL/F) brigatiniba u stanju dinamičke ravnoteže iznosila je 13 l/h, a medijan poluvijeka eliminacije iz plazme iznosio je 24 sati.
English: In vitro studies demonstrated that brigatinib is a substrate of CYP2C8.
Croatian: In vitro ispitivanja pokazala su da je brigatinib supstrat CYP2C8.
English: Agents that may increase brigatinib plasma concentrations
Croatian: Tvari koje mogu povećati koncentracije brigatiniba u plazmi
English: Alkaline phosphatase increased Hyperbilirubinaemia
Croatian: Povišeni ALT Povišeni AST Povišena alkalna fosfataza Hiperbilirubinemija
English: • cyclosporine, sirolimus, tacrolimus: medicines to suppress the immune system
Croatian: • ciklosporin, sirolimus, takrolimus: lijekovi za potiskivanje imunološkog sustava
English: Fasting serum glucose should be assessed prior to initiation of Alunbrig and monitored periodically thereafter.
Croatian: Prije početka liječenja lijekom Alunbrig potrebno je odrediti glukozu u serumu natašte i nakon toga je periodički pratiti.
English: Very common Insomnia
Croatian: Vrlo često Nesanica
English: Bradycardia (HR less than 60 bpm)
Croatian: Bradikardija (srčana frekvencija niža od 60 otkucaja u minuti)
English: *90 mg once daily regimen †180 mg once daily with 7-day lead-in at 90 mg once daily
Croatian: *režim 90 mg jedanput dnevno †180 mg jedanput dnevno uz uvodno 7-dnevno uzimanje 90 mg jedanput dnevno
English: Grade 4 elevation of CPK (> 10.0 × ULN)
Croatian: Porast vrijednosti CPK 4. stupnja (> 10,0 × GGN)
English: Upon recovery, the dose should be modified accordingly (see section 4.2).
Croatian: Nakon oporavka, potrebno je odgovarajuće prilagoditi dozu (vidjeti dio 4.2).
English: • phenobarbital, phenytoin: medicines to treat epilepsy
Croatian: • fenobarbital, fenitoin: lijekovi za liječenje epilepsije
English: Treatment initiation pack
Croatian: Početno pakiranje
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).
Croatian: Nije potrebna prilagodba doze lijeka Alunbrig u bolesnika s blagim oštećenjem jetre (Child-Pugh stadij A) ili umjerenim oštećenjem jetre (Child-Pugh stadij B).
English: Hepatotoxicity Grade ≥ 3 elevation (> 5.0 × ULN) of either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) with bilirubin ≤ 2 × ULN
Croatian: Porast vrijednosti alanin aminotransferaze (ALT) ili aspartat aminotransferaze (AST) ≥ 3. stupnja (> 5,0 × GGN) s bilirubinom  2 × GGN
English: if you are allergic to brigatinib or any of the other ingredients of this medicine (listed in section 6).
Croatian: Što morate znati prije nego počnete uzimati Alunbrig Nemojte uzimati Alunbrig: ako ste alergični na brigatinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: • reduced blood level of magnesium
Croatian: • snižena razina magnezija u krvi
English: Agents that may decrease brigatinib plasma concentrations
Croatian: Tvari koje mogu smanjiti koncentracije brigatiniba u plazmi
English: Hyperglycaemia For Grade 3 (greater than 250 mg/dL or
Croatian: Hipertenzija 3. stupnja (SKT ≥ 160 mmHg ili
English: • ketoconazole, itraconazole, voriconazole: medicines to treat fungal infections
Croatian: • ketokonazol, itrakonazol, vorikonazol: lijekovi za liječenje gljivičnih infekcija
English: • vision disturbance
Croatian: • smetnje vida
English: Takeda UK Ltd Tel: +44 (0)1628 537 900
Croatian: United Kingdom Takeda UK Ltd Tel: +44 (0)1628 537 900