FrancophonIA/ELRC3.0 huggingface dataset:
English: Population pharmacokinetic analysis included patients with normal renal function (n=65), and pre-existing mild (n=61), moderate (n=23), or severe (n=l) renal impairment (according to draft FDA guidance criteria 2010).
Croatian: Analiza populacijske farmakokinetike uključila je bolesnike s normalnom bubrežnom funkcijom (n = 65) i one s prethodnim blagim (n = 61), umjerenim (n = 23) ili teškim (n = 1) oštećenjem bubrežne funkcije (prema nacrtu kriterija za smjernice američke Agencije za hranu i lijekove (FDA) iz 2010.).
English: In patients aged 75 years and older who received Abraxane and gemcitabine, there was a higher incidence of serious adverse reactions and adverse reactions that led to treatment discontinuation (see section 4.4).
Croatian: U bolesnika u dobi od 75 i više godina koji su primali Abraxane i gemcitabin, bila je veća incidencija ozbiljnih nuspojava i nuspojava koje su dovele do prekida liječenja (vidjeti dio 4.4).
English: There was a significant difference in overall response rate in the Abraxane/carboplatin arm compared to the control arm in patients with non-small cell lung cancer of squamous histology (N=450, 41% vs. 24%, p<0.001), however this difference did not translate into a difference in PFS or OS.
Croatian: Stopa sveukupnog odgovora pokazala je značajnu razliku u skupini koja je primala Abraxane/karboplatin u usporedbi s kontrolnom skupinom u bolesnika s karcinomom nemalih stanica pluća skvamoznog histološkog tipa (N = 450, 41% naspram 24%, p < 0,001), međutim, ta se razlika nije odrazila kao razlika u preživljenju bez progresije bolesti ili sveukupnom preživljenju.
English: Beginning immediately after the end of Abraxane administration, carboplatin at a dose of AUC = 6 mg•min/mL was administered intravenously on Day 1 only of each 21-day cycle.
Croatian: Počevši odmah nakon završetka primjene Abraxanea, karboplatin je davan intravenski u dozi AUC = 6 mg•min/ml samo 1. dana svakog 21-dnevnog ciklusa.
English: • Itching, dry skin, nail disorder
Croatian: • svrbež, suha koža, poremećaji noktiju
English: This analysis included patients with normal hepatic function (n=130), and pre-existing mild (n=8), moderate (n=7), or severe (n=5) hepatic impairment (according to NCI Organ Dysfunction Working Group criteria).
Croatian: Ta je analiza uključila bolesnike s normalnom jetrenom funkcijom (n = 130) i prethodnim blagim (n = 8), umjerenim (n = 7) ili teškim (n = 5) oštećenjem jetrene funkcije (prema kriterijima radne skupine za procjenu organske disfunkcije Organ Dysfunction Working Group, američkog Nacionalnog instituta za rak (NCI)).
English: • Coughing with phlegm, shortness of breath when walking or climbing stairs, runny nose, or dry nose, decreased breath sounds, water on the lung, loss of voice, blood clot in the lung, dry throat
Croatian: • kašalj sa sluzi, nedostatak zraka prilikom hodanja ili penjanja stepenicama, curenje iz nosa ili suhi nos, utišano disanje, voda u plućima, gubitak glasa, krvni ugrušak u plućima, suhoća grla
English: Table 9: Adverse reactions reported with Abraxane in combination with carboplatin (N = 514) Infections and infestations
Croatian: Tablica 9: Nuspojave zabilježene uz Abraxane u kombinaciji s karboplatinom (N = 514) Infekcije i infestacije
English: • Chest or throat pain
Croatian: • bol u prsima ili grlu
English: A multicenter, randomized, open-label study was conducted in 1052 chemotherapy-naive patients with Stage IIIb/IV non-small cell lung cancer.
Croatian: Multicentrično, randomizirano, otvoreno ispitivanje provedeno je u 1052 bolesnika s karcinomom nemalih stanica pluća IIIb/IV stadija, koji prije nisu bili liječeni kemoterapijom.
English: Upon diagnosis of cystoid macular oedema, treatment with Abraxane should be discontinued.
Croatian: Kada se postavi dijagnoza cistoidnog makularnog edema, primjenu lijeka Abraxane treba obustaviti.
English: The effect of hepatic impairment on population pharmacokinetics of Abraxane was studied in patients with advanced solid tumours.
Croatian: Učinak oštećenja jetrene funkcije na populacijsku farmakokinetiku lijeka Abraxane ispitivan je u bolesnika s uznapredovalim soldinim tumorima.
English: For each subsequent weekly dose of Abraxane, patients must have an ANC ≥500 cells/mm3 and platelets >50,000 cells/mm3 or the dose is to be withheld until counts recover.
Croatian: Pri svakoj sljedećoj tjednoj dozi Abraxanea, bolesnici moraju imati vrijednosti ABN ≥ 500 stanica/mm3 i trombocita > 50 000 stanica/mm3 ili dozu treba obustaviti dok se broj tih stanica ne oporavi.
English: For patients ≥ 75 years of age in the Abraxane/gemcitabine and gemcitabine arms the survival Hazard Ratio (HR) was 1.08 (95% CI 0.653, 1.
Croatian: ≥ 75 godina u skupini koja je primala Abraxane/gemcitabin i skupinama koje su primale gemcitabin, omjer hazarda preživljenja (HR) iznosio je 1,08 (95% CI 0,653; 1, 797).
English: decreased calcium in the blood, decreased sugar in the blood, decreased sodium in the blood
Croatian: snižena razina kalcija u krvi, snižen šećer u krvi, snižena razina natrija u krvi
English: *Median time to disease progression [95% CI] (weeks)
Croatian: *Medijan vremena do progresije bolesti [95% CI] (tjedni)
English: Arthralgia occurred in 32% of patients on Abraxane and was severe in 6% of cases.
Croatian: Artralgija se javila u 32% bolesnika koji su primali Abraxane i bila je teška u 6% slučajeva.
English: Adjustment of the starting Abraxane dose is not required for patients with mild to moderate renal impairment (estimated creatinine clearance ≥30 to <90 ml/min).
Croatian: Prilagodba početne doze lijeka Abraxane nije potrebna u bolesnika s blagim do umjerenim oštećenjem bubrežne funkcije (procijenjeni klirens kreatinina od ≥ 30 do < 90 ml/min).
English: Adverse reactions were assessed in 421 patients treated with Abraxane in combination with gemcitabine and 402 gemcitabine monotherapy-treated patients receiving first-line systemic treatment for metastatic adenocarcinoma of the pancreas in a phase III randomized, controlled, open-label trial.
Croatian: Nuspojave su procijenjene u 421 bolesnika liječenog Abraxaneom u kombinaciji s gemcitabinom i 402 bolesnika liječena gemcitabinom kao monoterapijom koji su primali prvu liniju sistemskog liječenja za metastatski adenokarcinom pankreasa u randomiziranom kontroliranom otvorenom ispitivanju faze III.
English: *Survival [95% CI] (weeks)
Croatian: *Preživljenje [95% CI] (tjedni)
English: For patients with mild hepatic impairment (total bilirubin > 1 to ≤ 1.5 x ULN and aspartate aminotransferase [AST] ≤ 10 x ULN), no dose adjustments are required, regardless of indication.
Croatian: U bolesnika s blagim oštećenjem jetrene funkcije (ukupni bilirubin od > 1 do ≤ 1,5 x GGN i aspartat aminotransferaza [AST] ≤ 10 x GGN), prilagodbe doze nisu potrebne bez obzira na indikaciju.
English: Table 8: Haematologic laboratory-detected abnormalities in pancreatic adenocarcinoma trial
Croatian: Tablica 8: Hematološke abnormalnosti ustanovljene laboratorijskim pretragama u ispitivanju adenokarcinoma pankreasa
English: Table 6 lists adverse reactions associated with the administration of Abraxane to patients from studies in which Abraxane has been administered as monotherapy at any dose in any indication (N = 789).
Croatian: Tablica 6 navodi nuspojave povezane s primjenom lijeka Abraxane u ispitivanjima u kojima je Abraxane davan bolesnicima kao monoterapija, u bilo kojoj dozi i za bilo koju indikaciju (N = 789).
English: For treatment of non-small cell lung cancer Abraxane is given once every week (i.e. on days 1, 8 and 15 of a 21 day cycle), with carboplatin being given once every three weeks (i.e. only on day 1 of each 21-day cycle), immediately after the Abraxane dose has been given.
Croatian: Za liječenje raka nemalih stanica pluća, Abraxane se daje jednom svaki tjedan (tj. 1., 8. i 15. dana 21-dnevnog ciklusa), s tim da se karboplatin daje jednom svaka tri tjedna (tj. samo 1. dana svakog 21-dnevnog ciklusa) odmah nakon primjene lijeka Abraxane.
English: 3 The frequency of pneumonitis is calculated based on pooled data in 1310 patients in clinical trials receiving Abraxane monotherapy for breast cancer and for other indications using MedDRA SMQ Interstitial lung disease.
Croatian: 3 Učestalost pneumonitisa izračunata je na temelju objedinjenih podataka kliničkih ispitivanja u kojima je 1310 bolesnika primalo Abraxane kao monoterapiju za karcinom dojke i za druge indikacije prema onome kako ih MedDRA SMQ navodi za intersticijsku bolest pluća.
English: Such side effects occur far less with Abraxane.
Croatian: Takve nuspojave javljaju se mnogo rjeđe kad se primjenjuje Abraxane.
English: 2 Pneumonitis is evaluated using the SMQ interstitial lung disease (broad scope)
Croatian: 2 Pneumonitis je procijenjen na temelju SMQ-a za intersticijsku bolest pluća (široki raspon).
English: ≥ 500 but < 1000 OR ≥ 50,000 but < 75,000
Croatian: ≥ 500 ali < 1000 ILI ≥ 50 000 ali < 75 000
English: Pancreatic adenocarcinoma (Abraxane administered in combination with gemcitabine)
Croatian: Adenokarcinom pankreasa (Abraxane primijenjen u kombinaciji s gemcitabinom)
English: For patients treated with Abraxane in combination with gemcitabine, the median time to first occurrence of Grade 3 peripheral neuropathy was 140 days.
Croatian: Za bolesnike liječene Abraxaneom u kombinaciji s gemcitabinom medijan vremena do prve pojave periferne neuropatije 3. stupnja iznosio je 140 dana.
English: Very common: Alopecia, rash
Croatian: Vrlo često: alopecija, osip
English: After ruling out infectious etiology and upon making a diagnosis of pneumonitis, permanently discontinue treatment with Abraxane and gemcitabine and promptly initiate appropriate treatment and supportive measures (see section 4.2).
Croatian: Kada se isključi etiologija infekcije te nakon postavljene dijagnoze pneumonitisa, liječenje Abraxaneom i gemcitabinom treba trajno obustaviti i brzo započeti s odgovarajućim liječenjem i potpornim mjerama (vidjeti dio 4.2).
English: Dose adjustments during treatment of non-small cell lung cancer:
Croatian: Prilagodbe doze tijekom liječenja karcinoma nemalih stanica pluća:
English: • Fingernail pain, fingernail discomfort, loss of fingernails, hives, skin pain, red skin from sunlight,
Croatian: • bol i nelagoda oko noktiju, gubitak noktiju, koprivnjača, bolna koža, crvena koža od sunca,
English: Overall Response Rate (independent review) Confirmed complete or partial overall response, n (%) 95% CI (%) pA/pT (95.1% CI)
Croatian: Potvrđen potpuni ili djelomični ukupni odgovor, n (%) 95% CI (%) pA/pT (95,1% CI)
English: Withhold doses until fever resolves and ANC ≥ 1500; resume at next lower dose levela
Croatian: Obustava doza dok se vrućica ne povuče i dosegne ABN ≥ 1500; nastaviti sa sljedećom nižom razinom dozaa
English: Common: Tachycardia, arrhythmia, supraventricular tachycardia Rare: bradycardia, cardiac arrest, left ventricular dysfunction, congestive heart failure, atrioventricular block2
Croatian: Često: tahikardija, aritmija, supraventrikularna tahikardija Rijetko: bradikardija, srčani arest, disfunkcija lijeve klijetke, kongestivno zatajenje srca, atrioventrikularni blok2
English: In addition, Abraxane is not recommended in patients with metastatic adenocarcinoma of the pancreas that have moderate to severe hepatic impairment (total bilirubin > 1.5 x ULN and AST ≤ 10 x ULN) (see section 5.2).
Croatian: Nadalje, Abraxane se ne preporučuje u bolesnika s metastatskim adenokarcinomom pankreasa i umjerenim do teškim oštećenjem jetrene funkcije (ukupni bilirubin > 1,5 x GGN i AST ≤ 10 x GGN) (vidjeti dio 5.2).
English: The protein binding of paclitaxel following Abraxane was evaluated by ultrafiltration in a within-patient comparison study.
Croatian: Vezanje paklitaksela na proteine nakon primjene lijeka Abraxane procijenjeno je postupkom ultrafiltracije u ispitivanju s usporedbom nalaza istog bolesnika.
English: The use of specialized DEHP-free solution containers or administration sets is not necessary to prepare or administer Abraxane infusions.
Croatian: Uporaba posebnih spremnika ili kompleta za primjenu otopine bez DEHP nije nužna za pripremu ili primjenu infuzije lijeka Abraxane.
English: If not used immediately, the suspension may be stored in a refrigerator (2°C-8°C) for up to 24 hours in the vial when kept in the outer carton in order to protect it from light.
Croatian: Ako se ne upotrijebi odmah, suspenzija se može čuvati u hladnjaku (2°C - 8°C) do 24 sata u bočici koja se čuva u vanjskom pakiranju radi zaštite od svjetlosti.
English: Breast cancer (Abraxane administered as monotherapy)
Croatian: Karcinom dojke (Abraxane primijenjen kao monoterapija)
English: Abraxane in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.
Croatian: Abraxane je indiciran u kombinaciji s gemcitabinom kao prva linija liječenja u odraslih bolesnika s metastatskim adenokarcinomom pankreasa.
English: What Abraxane looks like and contents of the pack Abraxane is a white to yellow powder for suspension for infusion.
Croatian: Abraxane je prašak bijele do žute boje za suspenziju za infuziju.
English: Warnings and precautions Talk to your doctor or nurse before using Abraxane
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije nego primijenite Abraxane:
English: When reconstituted, each ml of Abraxane concentrate contains 0.183 mmol sodium, which is 4.2 mg of sodium.
Croatian: Nakon rekonstitucije svaki ml koncentrata lijeka Abraxane sadrži 0,183 mmol natrija što odgovara 4,2 mg natrija.
English: Of the 229 patients in the randomized study who received Abraxane monotherapy for breast cancer, 13% were at least 65 years of age and < 2% were 75 years and older.
Croatian: Od 229 ispitanika koji su u randomiziranom ispitivanju primali Abraxane kao monoterapiju za karcinom dojke, 13% ih je imalo najmanje 65 godina, a < 2% bilo je u dobi od 75 i više godina.
English: Common: Acute renal failure Uncommon: Haemolytic uraemic syndrome
Croatian: Često: akutno zatajenje bubrega Manje često: hemolitički uremijski sindrom
English: Myalgia occurred in 24% of patients on Abraxane and was severe in 7% of cases.
Croatian: Mijalgija se javila u 24% bolesnika koji su primali Abraxane i bila je teška u 7% slučajeva.
English: Inspect the suspension in the vial for particulate matter.
Croatian: Pregledajte suspenziju u bočici zbog prisutnosti stranih čestica.
English: Day 15: If Day 8 doses were given without modification: Day 15 ≥ 500 but < 1000 OR ≥ 50,000 but < 75,000
Croatian: 15. dan: Ako doze 8. dana nisu bile promijenjene: 15. dan ≥ 500 ali < 1000 ILI ≥ 50 000 ali < 75 000
English: P-valuea
Croatian: P-vrijednosta
English: For combination use of Abraxane and gemcitabine, if Grade 3 or higher peripheral neuropathy develops, withhold Abraxane; continue treatment with gemcitabine at the same dose.
Croatian: Kod primjene Abraxanea u kombinaciji s gemcitabinom, u slučaju razvoja periferne neuropatije 3. ili višeg stupnja, Abraxane treba obustaviti, a liječenje gemcitabinom nastaviti u istoj dozi.
English: Pneumonitis occurred in 1% of patients when Abraxane was used as monotherapy and in 4% of patients when Abraxane was used in combination with gemcitabine.
Croatian: Pneumonitis se razvio u 1% bolesnika kada je Abraxane primjenjivan kao monoterapija i u 4% bolesnika kada se Abraxane primjenjivao u kombinaciji s gemcitabinom.
English: There are insufficient data available to recommend dose modifications of Abraxane in patients with severe renal impairment or end stage renal disease (estimated creatinine clearance <30 ml/min) (see section 5.2).
Croatian: Nema dovoljno podataka za preporuku prilagodbe doze lijeka Abraxane u bolesnika s teškim oštećenjem bubrežne funkcije ili s krajnjim stadijem bubrežne bolesti (procijenjeni klirens kreatinina < 30 ml/min) (vidjeti dio 5.2).
English: Dose adjustments during treatment of breast cancer
Croatian: Prilagodbe doze tijekom liječenja karcinoma dojke
English: A pharmacokinetic study was conducted with Abraxane and carboplatin in non-small cell lung cancer patients.
Croatian: Farmakokinetičko ispitivanje provedeno je s lijekom Abraxane i karboplatinom u bolesnika s karcinomom nemalih stanica pluća.
English: Abraxane should only be prepared and administered by personnel appropriately trained in the handling of cytotoxic agents.
Croatian: Abraxane treba pripremati i primjenjivati samo osoblje obučeno za rukovanje citotoksičnim lijekovima.
English: Very common: Peripheral neuropathy, neuropathy, hypoaesthesia, paraesthesia
Croatian: Vrlo često: periferna neuropatija, neuropatija, hipoestezija, parestezije
English: Gemcitabine Dose (mg/m2)
Croatian: Doza gemcitabina (mg/m2)
English: Abraxane should not be administered on Day 1 of a cycle until absolute neutrophil count (ANC) is ≥1500 cells/mm3 and platelet count is ≥100,000 cells/mm3.
Croatian: Abraxane se ne smije primjenjivati 1.dana ciklusa sve dok apsolutni broj neutrofila (ABN) ne bude ≥ 1500 stanica/mm3 a broj trombocita ≥ 100 000 stanica/mm3.
English: A higher median cumulative dose of gemcitabine was delivered in the Abraxane/gemcitabine arm (11400 mg/m2) when compared with the gemcitabine arm (9000 mg/m2).
Croatian: Bolesnici u skupini Abraxane/gemcitabin (11 400 mg/m2) primili su veći medijan kumulativne doze gemcitabina u usporedbi sa skupinom koja je primala gemcitabin (9000 mg/m2).
English: Abraxane is available in glass vials containing 100 mg or 250 mg of paclitaxel formulated as albumin bound nanoparticles.
Croatian: Abraxane je dostupan u staklenim bočicama koje sadrže 100 mg ili 250 mg paklitaksela u obliku nanočestica vezanih na albumin.
English: Solventbased paclitaxel was administered to patients (N=531) at a dose of 200 mg/m2 as an intravenous infusion over 3 hours with standard premedication, immediately followed by carboplatin administered intravenously at AUC = 6 mg•min/mL.
Croatian: Paklitaksel baziran na otapalu primijenjen je bolesnicima (N = 531) u dozi od 200 mg/m2 kao intravenska infuzija tijekom 3 sata uz standardnu premedikaciju, iza čega je odmah slijedila intravenska primjena karboplatina u dozi AUC = 6 mg•min/ml.
English: The following are the most common and clinically relevant adverse reactions related to 229 patients with metastatic breast cancer who were treated with 260 mg/m2 Abraxane once every three weeks in the pivotal phase III clinical study.
Croatian: Slijede najčešće i klinički značajne nuspojave zabilježene u 229 bolesnika s metastatskim karcinomom dojke koji su bili liječeni s 260 mg/m2 lijeka Abraxane jednom u svaka tri tjedna u fazi III ključnog kliničkog ispitivanja.
English: SMQ = Standardized MedDRA Query; SMQ is a grouping of several MedDRA preferred terms to capture a medical concept.
Croatian: Standardized MedDRA Query); SMQ je skupina od nekoliko standardnih izraza MedDRA-e kojima se opisuje neki medicinski pojam.
English: Each ml of Abraxane contains approximately 4.2 mg of sodium.
Croatian: Svaki ml ovoga lijeka sadrži približno 4,2 mg natrija.
English: Common: Peripheral sensory neuropathy, headache, dysgeusia, dizziness, peripheral motor neuropathy, ataxia, sensory disturbance, somnolence
Croatian: Često: periferna senzorna neuropatija, glavobolja, disgeuzija, omaglica, periferna motorička neuropatija, ataksija, poremećaj osjeta, somnolencija
English: Cutaneous Toxicity: Grade 2 or 3
Croatian: Kožna toksičnost: 2. ili 3. stupnja
English: The reconstituted suspension in the intravenous drip may be stored in a refrigerator (2°C-8°C) for up to 24 hours protected from light.
Croatian: Pripremljenu suspenziju u intravenskom dripu može se čuvati u hladnjaku (2°C - 8°C) do 24 sata uz zaštitu od svjetlosti.
English: The following are the most common and important incidences of adverse reactions related to 421 patients with metastatic adenocarcinoma of the pancreas who were treated with 125 mg/m2 Abraxane in combination with gemcitabine at a dose of 1000 mg/m2 given on Days 1, 8 and 15 of each 28-day cycle in the phase III clinical study.
Croatian: Slijede najčešće i najvažnije incidencije nuspojava u 421 bolesnika s metastatskim adenokarcinomom pankreasa koji su bili liječeni sa 125 mg/m2 lijeka Abraxane u kombinaciji s gemcitabinom u dozi od 1000 mg/m2, davanoj 1., 8. i 15. dana svakog 28-dnevnog ciklusa u fazi III kliničkog ispitivanja.
English: Table 7 lists adverse reactions assessed in patients with pancreatic adenocarcinoma treated with Abraxane in combination with gemcitabine.
Croatian: Tablica 7 navodi nuspojave procijenjene u bolesnika s adenokarcinomom pankreasa koji su liječeni Abraxaneom u kombinaciji s gemcitabinom.
English: Abraxane was administered to patients (N = 431) as an intravenous infusion over 30-40 minutes at a dose of 125 mg/m2 followed by gemcitabine as an intravenous infusion over 30-40 minutes at a dose of 1000 mg/m2 given on Days 1, 8 and 15 of each 28-day cycle.
Croatian: Abraxane je primijenjen bolesnicima (N = 431) kao intravenska infuzija u trajanju od 30 do 40 minuta u dozi od 125 mg/m2, nakon čega je primijenjen gemcitabin kao intravenska infuzija u trajanju od 30 do 40 minuta u dozi od 1000 mg/m2 davanoj 1., 8. i 15. dana svakog 28-dnevnog ciklusa.
English: Day 15: IF Day 8 doses were withheld: Day 15 ≥ 1000
Croatian: 15. dan: Ako su doze 8. dana bile obustavljene: 15. dan ≥ 1000
English: Table 8 provides the frequency and severity of haematologic laboratory-detected abnormalities for patients treated with Abraxane in combination with gemcitabine or with gemcitabine.
Croatian: U tablici 8 navedene su učestalosti i težine hematoloških abnormalnosti ustanovljenih laboratorijskim pretragama u bolesnika liječenih Abraxaneom u kombinaciji s gemcitabinom ili samo gemcitabinom.
English: Grade 2 or 3 cutaneous toxicity Grade 3 diarrhoea Grade 3 mucositis ≥ Grade 3 peripheral neuropathy Any other Grade 3 or 4 nonhaematologic toxicity
Croatian: Mukozitis 3. stupnja Periferna neuropatija ≥ 3. stupnja Svaka druga nehematološka toksičnost 3. ili 4. stupnja
English: 56.4 [45.1, 76.9] (n = 131)
Croatian: > 1. linije terapije 56,4 [45,1; 76,9] (n = 131)
English: Of the 514 patients with non-small cell lung cancer in the randomized study who received Abraxane in combination with carboplatin, 31% were 65 years or older and 3.5% were 75 years or older.
Croatian: Od 514 bolesnika s karcinomom nemalih stanica pluća koji su u randomiziranom ispitivanju primali Abraxane u kombinaciji s karboplatinom, 31% bolesnika bili su u dobi od 65 ili više godina, a 3,5% u dobi od 75 ili više godina.
English: • Dry mouth, difficulty in swallowing
Croatian: • suha usta, otežano gutanje
English: When Abraxane is used as monotherapy, if Grade 3 sensory neuropathy develops, treatment should be withheld until resolution to Grade 1 or 2 followed by a dose reduction for all subsequent courses of Abraxane is recommended (see section 4.2).
Croatian: Kada se Abraxane primjenjuje kao monoterapija, u slučaju razvoja senzorne neuropatije 3. stupnja liječenje treba obustaviti do oporavka na 1. ili 2. stupanj, nakon čega se preporučuje smanjenje doze za sve naredne cikluse liječenja lijekom Abraxane (vidjeti dio 4.2).
English: Non-small cell lung cancer:
Croatian: Karcinom nemalih stanica pluća:
English: The recommended dose of Abraxane is 260 mg/m2 administered intravenously over 30 minutes every 3 weeks.
Croatian: Preporučena doza lijeka Abraxane iznosi 260 mg/m2, primijenjena intravenski kroz 30 minuta, svaka 3 tjedna.
English: Day 15: If Day 8 doses were reduced: Day 15 ≥ 1000
Croatian: 15. dan: Ako su doze 8. dana bile smanjene: 15. dan ≥ 1000
English: For metastatic breast cancer patients and non-small cell lung cancer patients with moderate to severe hepatic impairment (total bilirubin > 1.5 to ≤ 5 x ULN and AST ≤ 10 x ULN), a 20% reduction in dose is recommended.
Croatian: Za bolesnike s metastatskim karcinomom dojke i bolesnike s karcinomom nemalih stanica pluća s umjerenim do teškim oštećenjem jetrene funkcije (ukupni bilirubin od > 1,5 do ≤ 5 x GGN i AST ≤ 10 x GGN), preporuka je smanjiti dozu za 20%.