natgillin/translations-raw huggingface dataset:
≥ 500 but < 1000 OR ≥ 50,000 but < 75,000
≥ 500 ali < 1000 ILI ≥ 50 000 ali < 75 000
Pancreatic adenocarcinoma (Abraxane administered in combination with gemcitabine)
Adenokarcinom pankreasa (Abraxane primijenjen u kombinaciji s gemcitabinom)
For patients treated with Abraxane in combination with gemcitabine, the median time to first occurrence of Grade 3 peripheral neuropathy was 140 days.
Za bolesnike liječene Abraxaneom u kombinaciji s gemcitabinom medijan vremena do prve pojave periferne neuropatije 3. stupnja iznosio je 140 dana.
Very common: Alopecia, rash
Vrlo često: alopecija, osip
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).
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).
Dose adjustments during treatment of non-small cell lung cancer:
Prilagodbe doze tijekom liječenja karcinoma nemalih stanica pluća:
• Fingernail pain, fingernail discomfort, loss of fingernails, hives, skin pain, red skin from sunlight,
• bol i nelagoda oko noktiju, gubitak noktiju, koprivnjača, bolna koža, crvena koža od sunca,
Overall Response Rate (independent review) Confirmed complete or partial overall response, n (%) 95% CI (%) pA/pT (95.1% CI)
Potvrđen potpuni ili djelomični ukupni odgovor, n (%) 95% CI (%) pA/pT (95,1% CI)
Withhold doses until fever resolves and ANC ≥ 1500; resume at next lower dose levela
Obustava doza dok se vrućica ne povuče i dosegne ABN ≥ 1500; nastaviti sa sljedećom nižom razinom dozaa
Common: Tachycardia, arrhythmia, supraventricular tachycardia Rare: bradycardia, cardiac arrest, left ventricular dysfunction, congestive heart failure, atrioventricular block2
Često: tahikardija, aritmija, supraventrikularna tahikardija Rijetko: bradikardija, srčani arest, disfunkcija lijeve klijetke, kongestivno zatajenje srca, atrioventrikularni blok2
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).
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).
The protein binding of paclitaxel following Abraxane was evaluated by ultrafiltration in a within-patient comparison study.
Vezanje paklitaksela na proteine nakon primjene lijeka Abraxane procijenjeno je postupkom ultrafiltracije u ispitivanju s usporedbom nalaza istog bolesnika.
The use of specialized DEHP-free solution containers or administration sets is not necessary to prepare or administer Abraxane infusions.
Uporaba posebnih spremnika ili kompleta za primjenu otopine bez DEHP nije nužna za pripremu ili primjenu infuzije lijeka Abraxane.
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.
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.
Breast cancer (Abraxane administered as monotherapy)
Karcinom dojke (Abraxane primijenjen kao monoterapija)
Abraxane in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.
Abraxane je indiciran u kombinaciji s gemcitabinom kao prva linija liječenja u odraslih bolesnika s metastatskim adenokarcinomom pankreasa.
What Abraxane looks like and contents of the pack Abraxane is a white to yellow powder for suspension for infusion.
Abraxane je prašak bijele do žute boje za suspenziju za infuziju.
Warnings and precautions Talk to your doctor or nurse before using Abraxane
Obratite se svom liječniku ili medicinskoj sestri prije nego primijenite Abraxane:
When reconstituted, each ml of Abraxane concentrate contains 0.183 mmol sodium, which is 4.2 mg of sodium.
Nakon rekonstitucije svaki ml koncentrata lijeka Abraxane sadrži 0,183 mmol natrija što odgovara 4,2 mg natrija.
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.
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.
Common: Acute renal failure Uncommon: Haemolytic uraemic syndrome
Često: akutno zatajenje bubrega Manje često: hemolitički uremijski sindrom
Myalgia occurred in 24% of patients on Abraxane and was severe in 7% of cases.
Mijalgija se javila u 24% bolesnika koji su primali Abraxane i bila je teška u 7% slučajeva.
Inspect the suspension in the vial for particulate matter.
Pregledajte suspenziju u bočici zbog prisutnosti stranih čestica.
Day 15: If Day 8 doses were given without modification: Day 15 ≥ 500 but < 1000 OR ≥ 50,000 but < 75,000
15. dan: Ako doze 8. dana nisu bile promijenjene: 15. dan ≥ 500 ali < 1000 ILI ≥ 50 000 ali < 75 000
P-valuea
P-vrijednosta
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.
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.
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.
Pneumonitis se razvio u 1% bolesnika kada je Abraxane primjenjivan kao monoterapija i u 4% bolesnika kada se Abraxane primjenjivao u kombinaciji s gemcitabinom.
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).
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).
Dose adjustments during treatment of breast cancer
Prilagodbe doze tijekom liječenja karcinoma dojke
A pharmacokinetic study was conducted with Abraxane and carboplatin in non-small cell lung cancer patients.
Farmakokinetičko ispitivanje provedeno je s lijekom Abraxane i karboplatinom u bolesnika s karcinomom nemalih stanica pluća.
Abraxane should only be prepared and administered by personnel appropriately trained in the handling of cytotoxic agents.
Abraxane treba pripremati i primjenjivati samo osoblje obučeno za rukovanje citotoksičnim lijekovima.
Very common: Peripheral neuropathy, neuropathy, hypoaesthesia, paraesthesia
Vrlo često: periferna neuropatija, neuropatija, hipoestezija, parestezije
Gemcitabine Dose (mg/m2)
Doza gemcitabina (mg/m2)
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.
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.
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).
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).
Abraxane is available in glass vials containing 100 mg or 250 mg of paclitaxel formulated as albumin bound nanoparticles.
Abraxane je dostupan u staklenim bočicama koje sadrže 100 mg ili 250 mg paklitaksela u obliku nanočestica vezanih na albumin.
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.
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.
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.
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.
SMQ = Standardized MedDRA Query; SMQ is a grouping of several MedDRA preferred terms to capture a medical concept.
Standardized MedDRA Query); SMQ je skupina od nekoliko standardnih izraza MedDRA-e kojima se opisuje neki medicinski pojam.
Each ml of Abraxane contains approximately 4.2 mg of sodium.
Svaki ml ovoga lijeka sadrži približno 4,2 mg natrija.
Common: Peripheral sensory neuropathy, headache, dysgeusia, dizziness, peripheral motor neuropathy, ataxia, sensory disturbance, somnolence
Često: periferna senzorna neuropatija, glavobolja, disgeuzija, omaglica, periferna motorička neuropatija, ataksija, poremećaj osjeta, somnolencija
Cutaneous Toxicity: Grade 2 or 3
Kožna toksičnost: 2. ili 3. stupnja
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.
Pripremljenu suspenziju u intravenskom dripu može se čuvati u hladnjaku (2°C - 8°C) do 24 sata uz zaštitu od svjetlosti.
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.
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.
Table 7 lists adverse reactions assessed in patients with pancreatic adenocarcinoma treated with Abraxane in combination with gemcitabine.
Tablica 7 navodi nuspojave procijenjene u bolesnika s adenokarcinomom pankreasa koji su liječeni Abraxaneom u kombinaciji s gemcitabinom.
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.
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.
Day 15: IF Day 8 doses were withheld: Day 15 ≥ 1000
15. dan: Ako su doze 8. dana bile obustavljene: 15. dan ≥ 1000
Table 8 provides the frequency and severity of haematologic laboratory-detected abnormalities for patients treated with Abraxane in combination with gemcitabine or with gemcitabine.
U tablici 8 navedene su učestalosti i težine hematoloških abnormalnosti ustanovljenih laboratorijskim pretragama u bolesnika liječenih Abraxaneom u kombinaciji s gemcitabinom ili samo gemcitabinom.
Grade 2 or 3 cutaneous toxicity Grade 3 diarrhoea Grade 3 mucositis ≥ Grade 3 peripheral neuropathy Any other Grade 3 or 4 nonhaematologic toxicity
Mukozitis 3. stupnja Periferna neuropatija ≥ 3. stupnja Svaka druga nehematološka toksičnost 3. ili 4. stupnja
56.4 [45.1, 76.9] (n = 131)
> 1. linije terapije 56,4 [45,1; 76,9] (n = 131)
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.
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.
• Dry mouth, difficulty in swallowing
• suha usta, otežano gutanje
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).
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).
Non-small cell lung cancer:
Karcinom nemalih stanica pluća:
The recommended dose of Abraxane is 260 mg/m2 administered intravenously over 30 minutes every 3 weeks.
Preporučena doza lijeka Abraxane iznosi 260 mg/m2, primijenjena intravenski kroz 30 minuta, svaka 3 tjedna.
Day 15: If Day 8 doses were reduced: Day 15 ≥ 1000
15. dan: Ako su doze 8. dana bile smanjene: 15. dan ≥ 1000
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.
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%.
Uncommon: Oral candidiasis, nasopharyngitis, cellulitis, herpes simplex, viral infection, pneumonia, catheter-related infection, fungal infection, herpes zoster, injection site infection, sepsis2, neutropenic sepsis2
Manje često: oralna kandidijaza, nazofaringits, celulitis, herpes simplex, virusna infekcija, pneumonija, infekcija povezana s kateterom, gljivična infekcija, herpes zoster, infekcija na mjestu injekcije, sepsa2, neutropenijska sepsa2
Women of childbearing potential should use effective contraception during treatment and up to 1 month after receiving treatment with Abraxane.
Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja i do mjesec dana nakon završetka liječenja lijekom Abraxane.
Table 1: Dose level reductions for patients with pancreatic adenocarcinoma Dose Level
Tablica 1: Smanjivanje razine doza u bolesnika s adenokarcinomom pankreasa Razina doze
The study compared Abraxane in combination with carboplatin versus solvent-based paclitaxel in combination with carboplatin as first-line treatment in patients with advanced non-small cell lung cancer.
U ispitivanju se uspoređivao Abraxane u kombinaciji s karboplatinom i paklitaksel na bazi otapala u kombinaciji s karboplatinom kao prva linija liječenja bolesnika s uznapredovalim karcinomom nemalih stanica pluća.
Abraxane should only be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents.
Abraxane treba primjenjivati samo pod nadzorom kvalificiranog onkologa na odjelima koji su specijalizirani za primjenu citotoksičnih lijekova.
For febrile neutropenia, withhold Abraxane and gemcitabine until fever resolves and ANC ≥ 1500 cells/mm3, then resume treatment at reduced dose levels (see section 4.2).
U slučaju febrilne neutropenije, treba obustaviti Abraxane i gemcitabin dok se vrućica ne povuče i ne dosegne ABN ≥ 1500 stanica/mm3, a potom nastaviti liječenje pri smanjenoj razini doza (vidjeti dio 4.2).
If Abraxane contacts mucous membranes, the membranes should be flushed thoroughly with water.
Ako Abraxane dođe u dodir sa sluznicama, potrebno ih je temeljito isprati vodom.
No patients treated with Abraxane and carboplatin experienced Grade 4 peripheral neuropathy.
Nijedan bolesnik liječen Abraxaneom s karboplatinom nije imao perifernu neuropatiju 4. stupnja.
Abraxane contains sodium
Abraxane sadrži natrij.
Common: Increased lacrimation, blurred vision, dry eye, keratoconjunctivitis sicca, madarosis
Često: pojačano suzenje, zamućeni vid, suho oko, keratokonjunktivitis sicca, madaroza
Women of childbearing potential should have a pregnancy test prior to starting treatment with Abraxane.
Žene u reproduktivnoj dobi trebaju se testirati na trudnoću prije početka liječenja lijekom Abraxane.
For combination use of Abraxane and carboplatin, if Grade 3 or higher peripheral neuropathy develops, treatment should be withheld until improvement to Grade 0 or 1 followed by a dose reduction for all subsequent courses of Abraxane and carboplatin (see section 4.2).
Ako se kod primjene Abraxanea u kombinaciji s karboplatinom razvije periferna neuropatija 3. ili višeg stupnja, liječenje se mora obustaviti do poboljšanja na stupanj 0 ili 1, iza čega slijedi smanjenje doze u svim sljedećim ciklusima primjene Abraxanea i karboplatina (vidjeti dio 4.2).
Patients who have baseline neutrophil counts <1500 cells/mm3.
Bolesnici s početnim brojem neutrofila < 1500 stanica/mm3.
• Nausea, diarrhoea, constipation, sore mouth, loss of appetite
• mučnina, proljev, zatvor, rane u ustima, gubitak apetita
Common: Dehydration, decreased appetite, hypokalaemia Uncommon: Hypophosphataemia, fluid retention, hypoalbuminaemia, polydipsia, hyperglycaemia, hypocalcaemia, hypoglycaemia, hyponatraemia
Često: dehidracija, smanjeni apetit, hipokalijemija Manje često: hipofosfatemija, retencija tekućine, hipoalbuminemija, polidipsija, hiperglikemija, hipokalcijemija, hipoglikemija, hiponatrijemija
This multi-centre trial was conducted in patients with metastatic breast cancer, who were treated every 3 weeks with single-agent paclitaxel, either as solvent-based paclitaxel 175 mg/m2 given as a 3-hour infusion with premedication to prevent hypersensitivity (N = 225), or as Abraxane 260 mg/m2 given as a
Ovo multicentrično ispitivanje provedeno je na bolesnicima s metastatskim karcinomom dojke liječenim svaka tri tjedna paklitakselom kao jedinim lijekom, bilo paklitakselom baziranom na otapalu u dozi od 175 mg/m2 u obliku trosatne infuzije s premedikacijom za sprječavanje preosjetljivosti (N = 225) ili lijekom Abraxane u dozi od 260 mg/m2 u obliku 30-minutne infuzije bez premedikacije
Non-small cell lung cancer (Abraxane administered in combination with carboplatin)
Karcinom nemalih stanica pluća (Abraxane primijenjen u kombinaciji s karboplatinom)
Two hundred and twenty nine patients treated with Abraxane in the randomized, controlled clinical trial were evaluated for safety.
U randomiziranom, kontroliranom kliničkom ispitivanju 229 bolesnika liječenih lijekom Abraxane podvrgnuto je procjeni sigurnosti.
In a study in patients with advanced solid tumours, the pharmacokinetic characteristics of paclitaxel following Abraxane administered intravenously at 260 mg/m2 over 30 minutes were compared with those following 175 mg/m2 of the solvent-based paclitaxel injection administered over 3 hours.
U ispitivanju na bolesnicima s uznapredovalim solidnim tumorima uspoređivane su farmakokinetičke značajke paklitaksela nakon intravenske primjene lijeka Abraxane u dozi od 260 mg/m2 tijekom 30 minuta s onima nakon primjene injekcije paklitaksela baziranog na otapalu u dozi od 175 mg/m2
Withhold doses until improves to ≤ Grade 1; resume at next lower dose levela a. See Table 1 for dose level reductions
Obustaviti doze do poboljšanja na ≤ 1. stupnja; nastaviti sa sljedećom nižom razinom dozaa aZa smanjenje razina doza vidjeti tablicu 1.
The other ingredient is human albumin (containing sodium, sodium caprylate and N-acetyl DL tryptophanate).
Drugi sastojak je ljudski albumin (koji sadrži natrij, natrijev kaprilat i N-acetil DL triptofanat).
Progression-free Survivala (independent review)
Preživljenje bez progresije bolestia (neovisna procjena)
The recommended dose of carboplatin is AUC = 6 mg•min/mL on Day 1 only of each 21-day cycle, beginning immediately after the end of Abraxane administration.
Preporučena doza karboplatina je AUC = 6 mg•min/ml, odmah nakon završene primjene lijeka Abraxane, samo 1. dana svakog 21-dnevnog ciklusa.
Sepsis was reported at a rate of 5% in patients with or without neutropenia who received Abraxane in combination with gemcitabine during the conduct of a trial in pancreatic adenocarcinoma.
Sepsa u stopi od 5% zabilježena je u bolesnika s neutropenijom ili bez nje koji su primali Abraxane u kombinaciji s gemcitabinom u ispitivanju adenokarcinoma pankreasa.
The pharmacokinetics of total paclitaxel following 30- and 180-minute infusions of Abraxane at dose levels of 80 to 375 mg/m2 were determined in clinical studies.
Farmakokinetika ukupnog paklitaksela određena je u kliničkim ispitivanjima nakon infuzija lijeka Abraxane od 30 i 180 minuta u rasponima doze od 80 do 375 mg/m2.
Survival (months) Progression-free Survival Death or progression, n (%) Median Progression-free Survival, months (95% CI) HRA+G/G (95% CI)a P-valueb
75. percentil sveukupnog preživljenja (mjeseci) Preživljenje bez progresije bolesti Smrt ili progresija, n (%) Medijan preživljenja bez progresije, mjeseci (95% CI) HRA+G/G (95% CI)a P-vrijednostb
Reconstituted suspension: It can be stored refrigerated at 2°C to 8°C for up to 24 hours in either the vial or an infusion bag, protected from light.
Rekonstituirana suspenzija: može se čuvati u hladnjaku na temperaturi od 2°C do 8°C do 24 sata u bočici ili vrećici za infuziju, zaštićena od svjetlosti.
Sepsis was reported at a rate of 5% in patients with or without neutropenia who received Abraxane in combination with gemcitabine.
Sepsa u stopi od 5% zabilježena je u bolesnika s neutropenijom ili bez nje koji su primali Abraxane u kombinaciji s gemcitabinom.
• Reduction in the number of platelets in the blood
• smanjenje broja trombocita u krvi
Abraxane should not be administered until neutrophil counts recover to >1500 cells/mm3.
Abraxane se ne smije primjenjivati sve dok broj neutrofila ne poraste na > 1500 stanica/mm3.
Common: Insomnia, depression, anxiety Uncommon: Restlessness
Često: nesanica, depresija, anksioznost Manje često: anksioznost
No patients treated with Abraxane in combination with gemcitabine had Grade 4 peripheral neuropathy.
Nijedan bolesnik liječen Abraxaneom s gemcitabinom nije imao perifernu neuropatiju 4. stupnja.
100 ml vial (type 1 glass) with a stopper (butyl rubber), with an overseal (aluminium), containing 250 mg of paclitaxel formulated as albumin bound nanoparticles.
Bočica od 100 ml (staklo tipa 1) s čepom (od butilne gume), s prstenom (aluminij), koja sadrži 250 mg paklitaksela u obliku nanočestica vezanih na albumin.
CI = confidence interval; HRA/T = hazard ratio of Abraxane/carboplatin to solvent-based paclitaxel/carboplatin; pA/pT = response rate ratio of Abraxane/carboplatin to solvent-based paclitaxel/carboplatin.
CI = interval pouzdanosti, HRA/T = omjer hazarda za Abraxane/karboplatin naspram paklitaksel baziran na otapalu/karboplatin; pA/pT = omjer stope odgovora za Abraxane/karboplatin naspram paklitaksel baziran na otapalu/karboplatin a P-vrijednost se temelji na hi-kvadrat testu
Table 9 lists adverse reactions associated with the administration of Abraxane in combination with carboplatin.
Tablica 9 navodi nuspojave povezane s primjenom lijeka Abraxane u kombinaciji s karboplatinom.
Very common: Arthralgia, myalgia Common: Back pain, pain in extremity, musculoskeletal pain
Vrlo često: artralgija, mijalgija Često: bol u leđima, bol u udovima, mišićno-koštani bol