FrancophonIA/ELRC3.0 huggingface dataset:
English: Round wide mouth high density polyethylene (HDPE) bottles with two-piece polypropylene child resistant screw cap closures with foil induction seal liner, containing either 60 or 120 film-coated tablets, together with one HDPE canister containing a molecular sieve desiccant.
Croatian: Bočice od polietilena visoke gustoće (HDPE) okruglog širokog otvora s dvodijelnim polipropilenskim navojnim sigurnosnim zatvaračem za djecu s indukcijski zavarenom zaštitnom folijom, sadržavaju 60 ili 120 filmom obloženih tableta zajedno sa HDPE spremnikom koji sadrži molekularno sito kao sredstvo za sušenje.
English: The concomitant use of strong CYP3A inducers with Alunbrig, including but not limited to rifampicin, carbamazepine, phenytoin, rifabutin, phenobarbital, and St. John's wort should be avoided.
Croatian: Potrebno je izbjegavati istodobnu primjenu snažnih induktora CYP3A s lijekom Alunbrig, uključujući između ostalog rifampicin, karbamezapin, fenitoin, rifabutin, fenobarbital i gospinu travu.
English: • Alunbrig 90 mg: 7 or 28 film-coated tablets
Croatian: • Alunbrig 90 mg: 7 ili 28 filmom obloženih tableta
English: Alunbrig 90 mg film-coated tablets 2 years
Croatian: Alunbrig 90 mg filmom obložene tablete 2 godine
English: Neutrophil count decreased Decreased platelet count
Croatian: Smanjen broj neutrofila Smanjen broj trombocita
English: • The film-coated tablets are approximately 15 mm long with “U7” on one side and plain on the other side.
Croatian: • Filmom obložene tablete približne su dužine 15 mm s oznakom „U7“ na jednoj strani i bez oznaka na drugoj strani.
English: In ALTA, elevations of amylase and lipase were reported in 43% and 50% of patients treated with Alunbrig, respectively at the 180 mg regimen.
Croatian: U ispitivanju ALTA prijavljen je porast razina amilaze i lipaze u 43 % odnosno 50 % bolesnika liječenih lijekom Alunbrig u režimu doziranja 180 mg.
English: • Alunbrig 90 mg: 7 or 30 film-coated tablets
Croatian: • Alunbrig 90 mg: 7 ili 30 filmom obloženih tableta
English: • If contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, Alunbrig should be resumed at the next lower dose level per Table 1 upon recovery to asymptomatic bradycardia or to a resting heart rate of 60 bpm or above, with frequent monitoring as clinically indicated.
Croatian: • Ako se identificira istodobno primjenjivani lijek koji pridonosi stanju i prekine se njegova primjena ili mu se prilagodi doza, nakon oporavka do asimptomatske bradikardije ili postizanja srčane frekvencije u mirovanju od 60 ili više otkucaja u minuti, liječenje lijekom Alunbrig treba nastaviti sljedećom nižom razinom doze prema Tablici 1, uz učestali nadzor kako je klinički indicirano.
English: • dabigatran: a medicine to inhibit blood clotting
Croatian: • dabigatran: lijek za sprečavanje zgrušavanja krvi
English: Clear thermoformable poly-chloro-tri-fluoro-ethylene (PCTFE) blister with heat sealable paper-laminated foil lidding in a carton, containing either 28, 56 or 112 film-coated tablets.
Croatian: Prozirni blister od termoformabilnog poliklorotrifluoroetilena (PCTFE) s toplinski zalijepljenom višeslojnom pokrovnom folijom u kutiji koja sadrži 28, 56 ili 112 filmom obloženih tableta.
English: • If no concomitant medicinal product known to cause bradycardia is identified, or if contributing concomitant medications are not discontinued or dose modified, Alunbrig should be resumed at the next lower dose level per Table 1 upon recovery to asymptomatic bradycardia or to a resting heart rate of 60 bpm or above.
Croatian: • Ako se ne identificira istodobno primjenjivani lijek za kojeg je poznato da uzrokuje bradikardiju ili ako se ne prekine njegova primjena niti mu se izmijeni doza, nakon oporavka do asimptomatske bradikardije ili postizanja srčane frekvencije u mirovanju od 60 ili više otkucaja u minuti, liječenje lijekom Alunbrig treba nastaviti sljedećom nižom razinom doze prema Tablici 1.
English: The pharmacokinetics of brigatinib is similar in patients with normal renal function and in patients with mild or moderate renal impairment (eGFR ≥ 30 mL/min) based on the results of population pharmacokinetic analyses.
Croatian: Na temelju rezultata populacijske farmakokinetičke analize, farmakokinetika brigatiniba slična je u bolesnika s normalnom funkcijom bubrega i u bolesnika s blagim ili umjerenim oštećenjem bubrega (eGFR ≥ 30 ml/min).
English: • If Grade 3 elevation of lipase or amylase recurs, Alunbrig should be withheld until recovery to Grade ≤ 1 (≤ 1.5 × ULN) or to baseline, then resumed at the next lower dose level per Table 1.
Croatian: • Ako se vrati porast vrijednosti lipaze ili amilaze 3. stupnja, potrebno je prekinuti primjenu lijeka Alunbrig do oporavka na stupanj ≤ 1 (≤ 1,5 × GGN) ili na početnu vrijednost, a potom nastaviti liječenje sljedećom nižom razinom doze prema Tablici 1.
English: Round wide mouth high density polyethylene (HDPE) bottles with two-piece polypropylene child resistant screw cap with foil induction seal liner closures, containing either 7 or 30 film-coated tablets, together with one HDPE canister containing a molecular sieve desiccant.
Croatian: Bočice od polietilena visoke gustoće (HDPE) okruglog širokog otvora s dvodijelnim polipropilenskim navojnim sigurnosnim zatvaračem za djecu s indukcijski zavarenom zaštitnom folijom, sadržavaju 7 ili 30 filmom obloženih tableta zajedno sa HDPE spremnikom koji sadrži molekularno sito kao sredstvo za sušenje.
English: Oval, white to off-white film-coated tablet of approximately 19 mm in length with debossed “U13” on one side and plain on the other side.
Croatian: Ovalna, bijela do gotovo bijela filmom obložena tableta duljine oko 19 mm s utisnutom oznakom „U13“ na jednoj strani i bez oznaka na drugoj strani.
English: Round wide mouth high density polyethylene (HDPE) bottles with two-piece polypropylene child resistant screw cap with foil induction seal liner closures, containing 30 film-coated tablets, together with one HDPE canister containing a molecular sieve desiccant.
Croatian: Bočice od polietilena visoke gustoće (HDPE) okruglog širokog otvora s dvodijelnim polipropilenskim navojnim sigurnosnim zatvaračem za djecu s indukcijski zavarenom zaštitnom folijom, sadržavaju 30 filmom obloženih tableta zajedno sa HDPE spremnikom koji sadrži molekularno sito kao sredstvo za sušenje.
English: Outer carton: Do not swallow the desiccant canister found in the bottle.
Croatian: Nemojte progutati spremnik sa sredstvom za sušenje koji se nalazi u bočici.
English: Brigatinib inhibited autophosphorylation of ALK and ALK-mediated phosphorylation of the downstream signalling protein STAT3 in in vitro and in vivo assays.
Croatian: U in vitro i in vivo testovima brigatinib je inhibirao autofosforilaciju ALK i ALK-posredovanu fosforilaciju signalnog proteina STAT3 nizvodne kaskade.
English: Each film-coated tablet contains 56 mg of lactose monohydrate.
Croatian: Pomoćne tvari s poznatim učinkom Jedna filmom obložena tableta sadrži 56 mg laktoze hidrata.
English: Based on the severity of the laboratory abnormalities, treatment with Alunbrig should be withheld, and the dose modified accordingly (see section 4.2).
Croatian: Na temelju težine odstupanja u laboratorijskim nalazima, potrebno je prekinuti primjenu lijeka Alunbrig, i odgovarajuće prilagoditi dozu (vidjeti dio 4.2).
English: In ALTA, elevations of CPK were reported in 50% of patients treated with Alunbrig at the 180 mg regimen.
Croatian: U ispitivanju ALTA, porast razine CPK prijavljen je u 50 % bolesnika liječenih lijekom Alunbrig u režimu doziranja 180 mg.
English: Blood pressure should be monitored regularly during treatment with Alunbrig.
Croatian: Tijekom liječenja lijekom Alunbrig mora se redovito pratiti krvni tlak.
English: Each film-coated tablet contains 168 mg of lactose monohydrate.
Croatian: Pomoćne tvari s poznatim učinkom Jedna filmom obložena tableta sadrži 168 mg laktoze hidrata.
English: Tell your doctor if you get headaches, dizziness, blurred vision, chest pain or shortness of breath.
Croatian: • visoki krvni tlak Obavijestite svog liječnika ako dobijete glavobolje, omaglicu, zamagljen vid, bol u prsnom košu ili nedostatak zraka.
English: Oval, white to off-white film-coated tablet of approximately 15 mm in length with debossed “U7” on one side and plain on the other side.
Croatian: Ovalna, bijela do gotovo bijela filmom obložena tableta duljine oko 15 mm s utisnutom oznakom „U7“ na jednoj strani i bez oznaka na drugoj strani.
English: Film-coated tablets 7 film-coated tablets 30 film-coated tablets
Croatian: OBLIK I SADRŽAJ Filmom obložene tablete 7 filmom obložene tablete 30 filmom obložene tablete
English: No dose adjustment is required for Alunbrig during coadministration with P-gp and BCRP inhibitors.
Croatian: Za vrijeme istodobne primjene lijeka Alunbrig i inhibitora P-gp-a i BCRP-a nije potrebna prilagodba doze.
English: 13.9 mmol/L) or greater
Croatian: Za 3. stupanj (više od 250 mg/dl ili 13,9 mmol/l) ili viši
English: Hypomagnesaemia Hyponatraemia
Croatian: Hipomagnezijemija Hiponatrijemija Hiperkalcijemija
English: Each 30 mg film-coated tablet contains 30 mg brigatinib.
Croatian: Jedna filmom obložena tableta od 30 mg sadrži 30 mg brigatiniba.
English: • lung inflammation
Croatian: • upala pluća
English: Alunbrig 90 mg film-coated tablets Each film-coated tablet contains 90 mg of brigatinib.
Croatian: Alunbrig 90 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 90 mg brigatiniba.
English: Alunbrig 30 mg film-coated tablets
Croatian: Alunbrig 30 mg filmom obložene tablete
English: Visual disturbancee
Croatian: Poremećaj vida
English: Lactose monohydrate Microcrystalline cellulose Sodium starch glycolate (type A) Silica colloidal hydrophobic Magnesium stearate
Croatian: Mikrokristalična celuloza Natrijev škroboglikolat, vrsta A Silicijev dioksid, koloidni, hidrofobni Magnezijev stearat
English: Takeda Pharma A/S.
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Takeda Pharma A/S.
English: Common Pain in extremity Musculoskeletal stiffness
Croatian: Bol u udovima Mišićno-koštana ukočenost
English: Bradycardia has occurred in patients treated with Alunbrig (see section 4.8).
Croatian: U bolesnika liječenih lijekom Alunbrig javila se bradikardija (vidjeti dio 4.8).
English: • The film-coated tablets are approximately 7 mm in diameter with “U3” on one side and plain on the other side.
Croatian: • Filmom obložene tablete približnog su promjera 7 mm s oznakom „U3“ na jednoj strani i bez oznaka na drugoj strani.
English: Based on the severity of the laboratory abnormalities, treatment should be withheld, and the dose modified accordingly (see section 4.2).
Croatian: Na temelju težine odstupanja u laboratorijskim nalazima, potrebno je prekinuti primjenu, i odgovarajuće prilagoditi dozu (vidjeti dio 4.2).
English: Hypophosphataemia Hyperglycaemia Hyponatraemia Hypokalaemia Decreased appetite
Croatian: Hipofosfatemija Hiperglikemija Hiponatrijemija Hipokalijemija
English: Bradycardiag
Croatian: Tahikardijaf
English: In ALTA, elevations of ALT and AST were reported in 46% and 65% of patients treated with Alunbrig, respectively at the 180 mg regimen.
Croatian: U ispitivanju ALTA, prijavljen je porast razine ALT-a i AST-a u 46 % odnosno 65 % bolesnika liječenih lijekom Alunbrig u režimu doziranja 180 mg.
English: Alunbrig 30 mg film-coated tablets brigatinib
Croatian: Alunbrig 30 mg filmom obložene tablete brigatinib
English: • If Grade 3 elevation of CPK recurs, Alunbrig should be withheld until recovery to Grade ≤ 1 (≤ 2.5 × ULN) or to baseline, then resumed at the next lower dose level per Table 1.
Croatian: • Ako se vrati porast vrijednosti CPK 3. stupnja, potrebno je prekinuti primjenu lijeka Alunbrig do oporavka na stupanj ≤ 1 (≤ 2,5 × GGN) ili na početnu vrijednost, a potom nastaviti liječenje sljedećom nižom razinom doze prema Tablici 1.
English: Alunbrig 30 mg film-coated tablets Alunbrig 90 mg film-coated tablets Alunbrig 180 mg film-coated tablets
Croatian: Alunbrig 30 mg filmom obložene tablete Alunbrig 90 mg filmom obložene tablete Alunbrig 180 mg filmom obložene tablete
English: • If Grade 3 hypertension recurs, Alunbrig should be withheld until hypertension has recovered to Grade ≤ 1 then resumed at the next lower dose level per Table 1 or permanently discontinued
Croatian: • Ako se vrati hipertenzija 3. stupnja potrebno je prekinuti primjenu lijeka Alunbrig dok se hipertenzija ne vrati na stupanj ≤ 1, a potom nastaviti liječenje sljedećom nižom razinom doze prema Tablici 1 ili ga trajno prekinuti.
English: 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).
Croatian: Nuspojave na plućima na početku liječenja također su se javile u ispitivanju povišenja doze u bolesnika (N = 137) (Ispitivanje 101),
English: • Alunbrig should be withheld until recovery to Grade ≤ 1 (≤ 1.5 × ULN), then resumed at the next lower dose level per Table 1.
Croatian: • Potrebno je prekinuti primjenu lijeka Alunbrig do oporavka na stupanj ≤ 1 (≤ 1,5 × GGN), a potom nastaviti liječenje sljedećom nižom razinom doze prema Tablici 1.
English: Round, white to off-white film-coated tablet of approximately 7 mm in diameter with debossed “U3” on one side and plain on the other side.
Croatian: Okrugla, bijela do gotovo bijela filmom obložena tableta promjera oko 7 mm s utisnutom oznakom „U3“ na jednoj strani i bez oznaka na drugoj strani.
English: Each 90 mg film-coated tablet contains 90 mg brigatinib.
Croatian: Jedna filmom obložena tableta od 90 mg sadrži 90 mg brigatiniba.
English: • reduced blood level of sodium
Croatian: • snižena razina natrija u krvi
English: Takeda Oy
Croatian: Suomi/Finland Takeda Oy
English: Alunbrig 180 mg film-coated tablets brigatinib
Croatian: Alunbrig 180 mg filmom obložene tablete brigatinib
English: Each pack contains 7 film-coated tablets of Alunbrig 90 mg
Croatian: 7 filmom obložene tablete lijeka Alunbrig 90 mg
English: Each 180 mg film-coated tablet contains 180 mg brigatinib.
Croatian: Jedna 180 mg filmom obložena tableta sadrži 180 mg brigatiniba.
English: Alunbrig 180 mg film-coated tablets Each film-coated tablet contains 180 mg of brigatinib.
Croatian: Alunbrig 180 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 180 mg brigatiniba.
English: Alunbrig 90 mg film-coated tablets
Croatian: Alunbrig 90 mg filmom obložene tablete
English: Alunbrig 180 mg film-coated tablets
Croatian: Alunbrig 180 mg filmom obložene tablete
English: • liver problems
Croatian: • probleme s jetrom
English: • Alunbrig should be withheld until recovery to baseline, then resumed at the same dose level.
Croatian: • Potrebno je prekinuti primjenu lijeka Alumbrig do oporavka na početno stanje, a potom nastaviti liječenje istom dozom.
English: • increased blood level of insulin
Croatian: • povišena razina inzulina u krvi
English: Film-coated tablets 7 film-coated tablets 28 film-coated tablets
Croatian: OBLIK I SADRŽAJ Filmom obložene tablete 7 filmom obložene tablete 28 filmom obložene tablete
English: Common Pain Non-cardiac chest pain Chest discomfort
Croatian: Nesrčana bol u prsištu Nelagoda u prsištu
English: EU/1/18/1264/011 28 tablets EU/1/18/1264/003 56 tablets EU/1/18/1264/004 112 tablets
Croatian: EU/1/18/1264/001 60 tableta u bočici EU/1/18/1264/002 120 tableta u bočici EU/1/18/1264/011 28 tableta u kutiji EU/1/18/1264/003 56 tableta u kutiji EU/1/18/1264/004 112 tableta u kutiji
English: Common Tachycardiaf Electrocardiogram QT prolonged
Croatian: Produljeni QT interval u elektrokardiogramu Bradikardijag Palpitacije
English: Alunbrig 90 mg film-coated tablets brigatinib
Croatian: Alunbrig 90 mg filmom obložene tablete brigatinib
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.
Croatian: Nakon peroralne primjene jednokratne doze od 180 mg [14C]brigatiniba zdravim ispitanicima, N
English: Alunbrig 90 mg film-coated tablets Alunbrig 180 mg film-coated tablets brigatinib
Croatian: Alunbrig 90 mg filmom obložene tablete Alunbrig 180 mg filmom obložene tablete brigatinib
English: Each pack contains 21 film-coated tablets of Alunbrig 180 mg
Croatian: 21 filmom obložena tableta lijeka Alunbrig 180 mg
English: Clear thermoformable poly-chloro-tri-fluoro-ethylene (PCTFE) blister with heat sealable paper-laminated foil lidding in a carton, containing either 7 or 28 film-coated tablets.
Croatian: Prozirni blister od termoformabilnog poliklorotrifluoroetilena (PCTFE) s toplinski zalijepljenom višeslojnom pokrovnom folijom u kutiji koja sadrži 7 ili 28 filmom obloženih tableta.
English: Very common Hyperglycaemia Hyperinsulinaemiab Hypophosphataemia Decreased appetite Hypokalaemia
Croatian: Hipofosfatemija Smanjen apetit Hipokalijemija
English: EU/1/18/1264/009 30 tablets
Croatian: EU/1/18/1264/006 30 tableta
English: Alunbrig 30 mg film-coated tablets Each film-coated tablet contains 30 mg of brigatinib.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Alunbrig 30 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 30 mg brigatiniba.
English: • muscle and joint stiffness
Croatian: • ukočenost mišića i zglobova
English: Tell your doctor if you have upper abdominal pain, including abdominal pain that gets worse with eating and may spread to the back, weight loss or nausea.
Croatian: • povišene razine amilaze ili lipaze u nalazima krvi - mogu ukazivati na upalu gušterače Obavijestite svog liječnika ako imate bol u gornjem dijelu abdomena, uključujući bol u abdomenu koja se pogoršava dok jedete i može se širiti na leđa, gubitak težine ili mučninu.
English: Film-coated tablets 30 film-coated tablets
Croatian: OBLIK I SADRŽAJ Filmom obložene tablete 30 filmom obložene tablete
English: EU/1/18/1264/001 60 tablets EU/1/18/1264/002 120 tablets
Croatian: EU/1/18/1264/002 120 tableta
English: • Alunbrig should be withheld until recovery to Grade ≤ 1 (≤ 2.5 × ULN) or to baseline, then resumed at the same dose.
Croatian: • Potrebno je prekinuti primjenu lijeka Alunbrig do oporavka na stupanj ≤ 1 (≤ 2,5 × GGN) ili na početnu vrijednost, a potom nastaviti liječenje u istoj dozi.
English: Elevations of pancreatic enzymes
Croatian: Porast razina enzima gušterače
English: • Alunbrig should be withheld until recovery to Grade ≤ 1 (≤ 2.5 × ULN) or to baseline, then resumed at the next lower dose level per Table 1.
Croatian: • Potrebno je prekinuti primjenu lijeka Alunbrig do oporavka na stupanj ≤ 1 (≤ 2,5 × GGN) ili na početnu vrijednost, a potom nastaviti liječenje sljedećom nižom razinom doze prema Tablici 1.
English: EU/1/18/1264/010 28 tablets
Croatian: EU/1/18/1264/008 28 tableta
English: Stomatitisl
Croatian: Nuspojava
English: No dose adjustment is required for Alunbrig in combination with moderate CYP3A inhibitors.
Croatian: Za kombinaciju lijeka Alunbrig i umjerenih inhibitora CYP3A nije potrebna prilagodba doze.
English: • Alunbrig should be withheld until recovery to Grade ≤ 1 (≤ 1.5 × ULN) or to baseline, then resumed at same dose.
Croatian: • Potrebno je prekinuti primjenu lijeka Alunbrig do oporavka na stupanj ≤ 1 (≤ 1,5 × GGN) ili na početnu vrijednost, a potom nastaviti liječenje u istoj dozi.
English: • Alunbrig should be withheld until recovery to baseline or less than or equal to 3 × ULN, then resumed at next lower dose per Table 1.
Croatian: • Potrebno je prekinuti primjenu lijeka Alunbrig do oporavka na početne vrijednosti ili vrijednosti jednake 3 × GGN ili niže i potom nastaviti liječenje sljedećom nižom razinom doze prema Tablici 1.
English: • pancreas problems
Croatian: • probleme s gušteračom
English: • Alunbrig should be withheld until recovery to Grade 1 or baseline, then resumed at the next lower dose level per Table 1.
Croatian: • Potrebno je prekinuti primjenu lijeka Alunbrig do oporavka na 1. stupanj ili početno stanje, a potom nastaviti liječenje sljedećom nižom razinom doze prema Tablici 1.
English: Electrocardiogram QT prolonged
Croatian: Produljeni QT interval u elektrokardiogramu
English: Clear thermoformable poly-chloro-tri-fluoro-ethylene (PCTFE) blister with heat sealable paper-laminated foil lidding in a carton, containing 28 film-coated tablets.
Croatian: Prozirni blister od termoformabilnog poliklorotrifluoroetilena (PCTFE) s toplinski zalijepljenom višeslojnom pokrovnom folijom u kutiji koja sadrži 28 filmom obloženih tableta.
English: • Alunbrig should be withheld until recovery to baseline, then resumed at the next lower dose level as per Table 1.
Croatian: • Potrebno je prekinuti primjenu lijeka Alunbrig do oporavka na početno stanje, a potom nastaviti liječenje sljedećom nižom razinom doze prema Tablici 1.
English: Elevations of amylase and lipase have occurred in patients treated with Alunbrig (see section 4.8).
Croatian: U bolesnika liječenih lijekom Alunbrig javio se porast razina amilaze i lipaze (vidjeti dio 4.8).
English: • If the Grade 4 event recurs, Alunbrig should be withheld until recovery to baseline, then resumed at the next lower dose level as per Table 1 or permanently discontinued.
Croatian: • Ako se ponovi nuspojava 4. stupnja, potrebno je prekinuti primjenu lijeka Alunbrig do oporavka na početno stanje, a potom nastaviti liječenje sljedećom nižom razinom doze prema Tablici 1 ili ga trajno prekinuti.
English: Elevations of CPK have occurred in patients treated with Alunbrig (see section 4.8).
Croatian: U bolesnika liječenih lijekom Alunbrig javio se porast razina CPK (vidjeti dio 4.8).
English: Hypertension Hypertension has occurred in patients treated with Alunbrig (see section 4.8).
Croatian: U bolesnika liječenih lijekom Alunbrig javila se hipertenzija (vidjeti dio 4.8).
English: Outer Carton: Alunbrig 30 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Alunbrig 30 mg
English: Very common Fatigueo Oedemap
Croatian: Vrlo često Umoro Edemp
English: Each film-coated tablet contains 180 mg brigatinib.
Croatian: Jedna filmom obložena tableta od 180 mg sadrži 180 mg brigatiniba.
English: • If the Grade 3 event recurs, Alunbrig should be withheld until recovery to baseline, then resumed at the next lower dose level as per Table 1 or permanently discontinued.
Croatian: • Ako se ponovi nuspojava 3. stupnja, potrebno je prekinuti primjenu lijeka Alunbrig do oporavka na početno stanje, a potom nastaviti liječenje sljedećom nižom razinom doze prema Tablici 1 ili ga trajno prekinuti.
English: Film-coated tablets 28 film-coated tablets
Croatian: OBLIK I SADRŽAJ Filmom obložene tablete 28 filmom obložene tablete
English: Alunbrig dose modification levels are summarised in Table 1.
Croatian: Tablici 1 prikazane su razine prilagodbe doze lijeka Alunbrig.
English: Outer Carton: Alunbrig 90 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Alunbrig 90 mg
English: If concomitant use of strong CYP3A inhibitors cannot be avoided, the dose of Alunbrig should be reduced from 180 mg to 90 mg, or from 90 mg to 60 mg. 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: Ako nije moguće izbjeći istodobnu primjenu s jakim inhibitorom CYP3A, potrebno je smanjiti dozu lijeka Alunbrig sa 180 mg na 90 mg, ili sa 90 mg na 60 mg.
English: • St. John's wort: a herbal product used to treat depression
Croatian: • gospina trava: biljni lijek za liječenje depresije
English: Elevations of serum glucose have occurred in patients treated with Alunbrig.
Croatian: U bolesnika liječenih lijekom Alunbrig javio se porast razine glukoze u serumu.
English: IRC assessment
Croatian: Parametar djelotvornosti prema procjeni IRC-a
English: • Alunbrig 180 mg film-coated tablets 3 clear thermoformable poly-chloro-tri-fluoro-ethylene (PCTFE) blisters with heat sealable paper-laminated foil lidding in a carton, containing 21 film-coated tablets.
Croatian: 3 prozirna blistera od termoformabilnog poliklorotrifluoroetilena (PCTFE) s toplinski zalijepljenom višeslojnom pokrovnom folijom u kutiji koja sadrži 21 filmom obloženih tableta.