FrancophonIA/ELRC3.0 huggingface dataset:
English: 1st dose level reduction 2nd dose level reduction If additional dose reduction required
Slovenian: Celotni odmerek Prvo zmanjšanje ravni odmerka Drugo zmanjšanje ravni odmerka Če je potrebno še dodatno zmanjšanje odmerka
English: Pharmacokinetic/pharmacodynamic modeling indicates that there is no correlation between hepatic function (as indicated by the baseline albumin or total bilirubin level) and neutropenia after adjusting for Abraxane exposure.
Slovenian: Farmakokinetično/farmakodinamično modeliranje kaže, da ni korelacije med delovanjem jeter (na katerega so sklepali iz izhodiščne koncentracije albumina ali koncentracije celokupnega bilirubina) in nevtropenijo po prilagoditvi na izpostavljenost zdravilu Abraxane.
English: • Decreased liver function, increased size of liver
Slovenian: • zmanjšano delovanje jeter, povečanje jeter
English: 1On Day 1 of the 21-day cycle reduce the dose of Abraxane and carboplatin simultaneously.
Slovenian: 1 1. dan 21-dnevnega cikla zmanjšajte odmerek zdravila Abraxane in karboplatina sočasno.
English: Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during administration of the medicinal product.
Slovenian: Zaradi možnosti ekstravazacije se priporoča skrbno nadziranje mesta infundiranja zaradi možne infiltracije med dajanjem zdravila.
English: First Second
Slovenian: prvo drugo
English: However, a subsequent analysis in 981 patients receiving Abraxane monotherapy for metastatic breast cancer, of which 15% were ≥ 65 years old and 2% were ≥ 75 years old, showed a higher incidence of epistaxis, diarrhoea, dehydration, fatigue and peripheral oedema in patients ≥ 65 years.
Slovenian: Vendar je poznejša analiza pri 981 bolnikih, ki so prejemali monoterapijo z zdravilom Abraxane za metastatski rak dojk, od katerih je bilo 15 % starih 65 let in več, 2 % pa 75 let in več, pokazala večjo incidenco epistakse, driske, dehidracije, utrujenosti in perifernega edema pri bolnikih, starih 65 let in več.
English: Take care and speak to your doctor when taking Abraxane at the same time as any of the following:
Slovenian: Bodite pozorni in se posvetujte s svojim zdravnikom, če jemljete zdravilo Abraxane skupaj s katerimi od naslednjih zdravil:
English: In this phase III randomized, controlled, open-label trial, adverse reactions resulting in death within 30 days of the last dose of study drug were reported for 4% of patients receiving Abraxane in combination with gemcitabine and for 4% of patients receiving gemcitabine monotherapy.
Slovenian: V tem randomiziranem, kontroliranem, odprtem preskušanju faze III so poročali o neželenih učinkih, ki so se končali s smrtjo v 30 dneh po zadnjem odmerku zdravila v kliničnem preskušanju, pri 4 % bolnikov, zdravljenih z zdravilom Abraxane skupaj z gemcitabinom, in pri 4 % bolnikov, ki so prejemali monoterapijo z gemcitabinom.
English: Table 13: Non-inferiority analyses on progression-free survival and overall survival in randomized non-small cell lung cancer trial (intent-to-treat population)
Slovenian: Preglednica 13: Analize neinferiornosti o preživetju brez napredovanja bolezni in celokupnem preživetju v randomiziranem preskušanju nedrobnoceličnega pljučnega raka ( populacija z namenom zdravljenja)
English: Paclitaxel is an antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilises microtubules by preventing depolymerisation.
Slovenian: Paklitaksel je antimikrotubulno sredstvo, ki pospešuje sestavljanje mikrotubulov iz dimerov tubulina in jih stabilizira s preprečevanjem njihove depolimerizacije.
English: Abraxane is supplied as a sterile lyophilised powder for reconstitution before use.
Slovenian: Abraxane se dobavlja kot sterilen liofiliziran prašek za rekonstitucijo pred uporabo.
English: • if you are allergic (hypersensitive) to paclitaxel or any of the other ingredients of Abraxane (listed in section 6);
Slovenian: • če ste alergični (preobčutljivi) na paklitaksel ali katero koli sestavino zdravila Abraxane
English: 2 As reported in the post-marketing surveillance of Abraxane.
Slovenian: 2 Kot je bilo poročano pri spremljanju zdravila Abraxane po začetku trženja.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Abraxane should not be substituted for or with other paclitaxel formulations.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Zdravila Abraxane se ne sme zamenjati z drugimi pripravki paklitaksela.
English: Based on non-compartmental PK analysis, the plasma clearance of paclitaxel with Abraxane was larger (43%) than that following a solvent-based paclitaxel injection and its volume of distribution was also higher (53%).
Slovenian: Na podlagi nerazdelčne farmakokinetične analize je bil plazemski očistek paklitaksela z zdravilom Abraxane večji (43 %) kot očistek po injiciranju paklitaksela na bazi topila, prav tako pa je bil večji tudi volumen porazdelitve (53 %).
English: Administering paclitaxel concomitantly with medicines known to induce either CYP2C8 or CYP3A4 (e.g. rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine) is not recommended because efficacy may be compromised because of lower paclitaxel exposures.
Slovenian: Sočasno dajanje paklitaksela in zdravil, ki znano inducirajo CYP2C8 oziroma CYP3A4 (npr. rifampicin, karbamazepin, fenitoin, efavirenz, nevirapin), se ne priporoča, ker je učinkovitost zaradi manjše izpostavljenosti paklitakselu lahko ogrožena.
English: The results show that mild hepatic impairment (total bilirubin >1 to ≤1.5 x ULN) has no clinically important effect on pharmacokinetics of paclitaxel.
Slovenian: Rezultati kažejo, da blaga okvara jeter (celokupni bilirubin > 1 do ≤ 1,5 x ULN) nima klinično pomembnega vpliva na farmakokinetiko paklitaksela.
English: Asthenia/Fatigue was reported in 40% of the patients.
Slovenian: Astenija/utrujenost je bila opažena pri 40 % bolnikov.
English: Progression-free Survivala (independent review)
Slovenian: Preživetje brez napredovanja boleznia (neodvisen pregled)
English: Rare: Pancytopenia
Slovenian: Redki: pancitopenija
English: Do not use Abraxane
Slovenian: Ne uporabljajte zdravila Abraxane
English: In the very elderly (≥75 years) who received Abraxane and gemcitabine, there was a higher incidence of serious adverse reactions and adverse reactions that led to treatment discontinuation including haematologic toxicities, peripheral neuropathy, decreased appetite and dehydration.
Slovenian: Pri zelo starih bolnikih (≥ 75 let), ki so prejemali zdravilo Abraxane in gemcitabin, je bila zvečana incidenca resnih neželenih učinkov in neželenih učinkov, ki so povzročili prekinitev zdravljenja, med drugim hematoloških toksičnosti, periferne nevropatije, zmanjšanega apetita in dehidracije.
English: For treatment of metastatic breast cancer, Abraxane is usually given once every three weeks (on day 1 of a 21-day cycle).
Slovenian: Pri metastatskem raku dojk se zdravilo Abraxane navadno daje enkrat na tri tedne (1. dan 21dnevnega cikla).
English: Reduce doses 1 dose level
Slovenian: Zmanjšajte odmerke za eno raven odmerka
English: Not known side effects (frequency cannot be estimated from the available data):
Slovenian: Neželeni učinki neznane pogostnosti (pogostosti ni mogoče oceniti iz razpoložljivih podatkov) • otrdela/odebeljena koža (sklerodermija)
English: • Abraxane is used in metastatic breast cancer when at least one other therapy has been tried but has not worked and you are unsuitable for treatments containing a group of medicines called “anthracyclines”.
Slovenian: • Zdravilo Abraxane se uporablja pri metastatskem raku dojk, kadar je bila uporabljena vsaj ena drugačna oblika zdravljenja, ki pa ni bila uspešna, zdravljenje z drugimi zdravili, ki vsebujejo skupino zdravil, imenovano "antraciklini", pa za vas ni primerno.
English: Data from 106 patients accrued in two single-arm open-label studies and from 454 patients treated in a randomised Phase III comparative study are available to support the use of Abraxane in metastatic breast cancer.
Slovenian: Podatki o 106 bolnikih, ki so jih zbrali v dveh odprtih študijah z eno skupino in o 454 bolnikih, ki so jih zdravili v randomizirani primerjalni študiji faze III, podpirajo uporabo zdravila Abraxane pri metastatskem raku dojk.
English: • Severe inflammation/eruption of the skin and mucous membranes (Stevens-Johnson syndrome,
Slovenian: • hudo vnetje/izbruh izpuščajev na koži in sluznici (Stevens-Johnsonov sindrom, toksična epidermalna nekroliza)
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.
Slovenian: 3 Pogostnost pnevmonitisa je izračunana na osnovi združenih podatkov pri 1.310 bolnikih v kliničnih preskušanjih, ki so prejemali monoterapijo z zdravilom Abraxane pri raku dojk in drugih indikacijah z uporabo SMQ MedDRA ‘intersticijska bolezen pljuč'.
English: Anemia and thrombocytopenia were more commonly reported in the Abraxane arm than in the Taxol arm (54% versus 28% and 45% versus 27% respectively).
Slovenian: O anemiji in trombocitopeniji so pogosteje poročali v skupini z zdravilom Abraxane kot v skupini z zdravilom Taxol (54 % proti 28 % oziroma 45 % proti 27 %).
English: Two hundred and twenty nine patients treated with Abraxane in the randomized, controlled clinical trial were evaluated for safety.
Slovenian: Pri 229 bolnikih, ki so bili zdravljeni z zdravilom Abraxane v randomiziranem kontroliranem kliničnem preskušanju, so ocenili varnost zdravila.
English: Each ml of Abraxane contains approximately 4.2 mg of sodium.
Slovenian: En ml zdravila Abraxane vsebuje približno 4,2 mg natrija.
English: Unopened vials of Abraxane are stable until the date indicated on the package when the vial is kept in the outer carton in order to protect from light.
Slovenian: Neodprte viale zdravila Abraxane so stabilne do datuma, ki je naveden na ovojnini, če vialo shranjujete v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: 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.
Slovenian: IZ = interval zaupanja; HRA/T = razmerje tveganja za zdravilo Abraxane/karboplatin proti paklitakselu na bazi topila/karboplatinu; pA/pT = razmerje odzivnosti zdravila Abraxane/karboplatina proti paklitakselu na bazi topila/karboplatinu.
English: The protein binding of paclitaxel following Abraxane was evaluated by ultrafiltration in a within-patient comparison study.
Slovenian: Vezava paklitaksela na beljakovine po dajanju zdravila Abraxane je bila ocenjena z ultrafiltracijo v študiji intraindividualne primerjave bolnikov.
English: Paclitaxel and/or its metabolites were excreted into the milk of lactating rats (see section 5.3).
Slovenian: Paklitaksel in/ali njegovi presnovki so se izločali v mleko doječih podgan (glejte poglavje 5.3).
English: Anaemiaa,b Neutropenia a,b Thrombocytopeniab,c a 405 patients assessed in Abraxane/gemcitabine-treated group b 388 patients assessed in gemcitabine-treated group c 404 patients assessed in Abraxane/gemcitabine-treated group
Slovenian: 3.-4. stopnje anemijaa,b nevtropenija a,b trombocitopenijab,c a 405 bolnikov ocenjenih v skupini, zdravljeni z zdravilom Abraxane in gemcitabinom b 388 bolnikov ocenjenih v skupini, zdravljeni z gemcitabinom c 404 bolniki ocenjeni v skupini, zdravljeni z zdravilom Abraxane in gemcitabinom
English: Pharmacokinetic interactions between Abraxane and gemcitabine have not been evaluated in humans.
Slovenian: Farmakokinetičnega medsebojnega delovanja med zdravilom Abraxane in gemcitabinom pri ljudeh niso proučevali.
English: Other medicines and Abraxane
Slovenian: Druga zdravila in zdravilo Abraxane
English: Such side effects occur far less with Abraxane.
Slovenian: Taki neželeni učinki se pri zdravilu Abraxane pojavljajo mnogo redkeje.
English: SN:
Slovenian: GEM :
English: There is no relevant use of Abraxane in the paediatric population in the indication of metastatic breast cancer or pancreatic adenocarcinoma or non-small cell lung cancer.
Slovenian: Zdravilo Abraxane ni primerno za uporabo pri pediatrični populaciji za indikacijo metastatskega raka dojk ali adenokarcinoma trebušne slinavke ali nedrobnoceličnega pljučnega raka.
English: Of the 17 cases of pneumonitis reported in patients treated with Abraxane in combination with gemcitabine, 2 had a fatal outcome.
Slovenian: Od 17 primerov pnevmonitisa, o katerih so poročali pri bolnikih, zdravljenih z zdravilom Abraxane skupaj z gemcitabinom, je bil pri dveh bolnikih izid smrten.
English: If foaming or clumping occurs, the suspension should stand for at least 15 minutes until foam subsides.
Slovenian: Če se pojavi pena ali skupki, naj suspenzija stoji vsaj 15 minut, dokler se pena ne posede.
English: Using repeated measure analysis, 3 of the 4 subscales (peripheral neuropathy, pain hands/feet, and hearing) favored Abraxane and carboplatin (p ≤ 0.002).
Slovenian: Z analizo večkrat izmerjenih spremenljivk so bile 3 od štirih podlestvic (periferna nevropatija, bolečina v rokah/nogah in sluh) v korist zdravilu Abraxane in karboplatinu (p ≤ 0,002).
English: • Swelling of mucosal and soft tissues
Slovenian: • otekanje sluznic in mehkih tkiv
English: Of the 431 patients with pancreatic adenocarcinoma who were randomized to receive Abraxane in combination with gemcitabine, the majority (93%) were white, 4% were black and 2% were Asian.
Slovenian: Od 431 bolnikov z adenokarcinomom trebušne slinavke, ki so bili randomizirani na prejemanje zdravila Abraxane skupaj z gemcitabinom, jih je bila večina (93 %) belcev, 4 % črncev in 2 % Azijcev.
English: • Pain at site of tumour, death of the tumour
Slovenian: • bolečina na mestu tumorja, odmrtje tumorja
English: • if you experience numbness, tingling, pricking sensations, sensitivity to touch, or muscle weakness;
Slovenian: • če začutite odrevenelost, mravljinčenje, zbadanje, občutljivost za dotik ali šibkost mišic;
English: Because of potential serious adverse reactions in breast-feeding infants, Abraxane is contraindicated during lactation.
Slovenian: Zaradi morebitnih hudih neželenih učinkov pri dojenčkih je zdravilo Abraxane med dojenjem kontraindicirano.
English: In patients with metastatic breast cancer, after a 30-minute infusion of Abraxane at 260 mg/m2, the mean value for cumulative urinary excretion of unchanged active substance accounted for 4% of the total administered dose with less than 1% as the metabolites 6-hydroxypaclitaxel and 3'-p-hydroxypaclitaxel, indicating extensive non-renal clearance.
Slovenian: Pri bolnikih z metastatskim rakom dojk je po 30 minutni infuziji zdravila Abraxane v odmerku 260 mg/m2 povprečna vrednost kumulativnega izločanja nespremenjene učinkovine z urinom predstavljala 4 % celotnega danega odmerka z manj kot 1 % v obliki presnovkov 6-hidroksipaklitaksela in 3'-p- hidroksipaklitaksela, kar kaže na obsežen neledvični očistek.
English: • Loss of hair (the majority of cases of hair loss happened less than one month after starting
Slovenian: • izpadanje las (Pri večini primerov izpadanja las je do tega prišlo manj kot en mesec po začetku zdravljenja z zdravilom Abraxane.
English: Pregnant staff should not handle Abraxane.
Slovenian: Nosečnice ne smejo rokovati z zdravilom Abraxane.
English: The most common clinically significant adverse reactions associated with the use of Abraxane have been neutropenia, peripheral neuropathy, arthralgia/myalgia and gastrointestinal disorders.
Slovenian: Najpogostejši klinično pomembni neželeni učinki, povezani z uporabo zdravila Abraxane, so bili nevtropenija, periferna nevropatija, artralgija/mialgija in bolezni prebavil.
English: Abraxane is not recommended in patients that have total bilirubin > 5 x ULN or AST > 10 x ULN.
Slovenian: Zdravilo Abraxane ni priporočljivo pri bolnikih, ki imajo celokupni bilirubin > 5 x ULN ali AST > 10 x ULN.
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.
Slovenian: Preglednica 8 kaže pogostnost in resnost hematoloških laboratorijskih nenormalnosti pri bolnikih, zdravljenih z zdravilom Abraxane v kombinaciji z gemcitabinom ali samo z gemcitabinom.
English: Paclitaxel may cause serious birth defects and should therefore not be used if you are pregnant.
Slovenian: Paklitaksel lahko povzroči hude prirojene okvare, zato ga nosečnice ne smejo prejemati.
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).
Slovenian: V to analizo so bili vključeni bolniki z normalnim delovanjem jeter (n=130) in s predobstoječo blago (n=8), zmerno (n=7) ali hudo (n=5) okvaro jeter (po merilih delovne skupine za disfunkcijo organov Nacionalnega inštituta za raka (NCI Organ Dysfunction Working Group)).
English: Pharmacokinetic/pharmacodynamic modelling using data from 125 patients with advanced solid tumours indicates that patients ≥ 65 years of age may be more susceptible to development of neutropenia within the first treatment cycle, although the plasma paclitaxel exposure is not affected by age.
Slovenian: Farmakokinetično/farmakodinamično modeliranje z uporabo podatkov od 125 bolnikov z napredovalimi čvrstimi tumorji kaže, da utegnejo biti bolniki, stari 65 let in več, dovzetnejši za nastanek nevtropenije v prvem ciklu zdravljenja, čeprav starost ne vpliva na izpostavljenost paklitakselu v plazmi.
English: To be taken into consideration by patients on a controlled sodium diet.
Slovenian: To morajo upoštevati bolniki, ki so na dieti z omejenim vnosom natrija.
English: What Abraxane looks like and contents of the pack Abraxane is a white to yellow powder for suspension for infusion.
Slovenian: Izgled zdravila Abraxane in vsebina pakiranja Zdravilo Abraxane je bel do rumen prašek za suspenzijo za infundiranje.
English: Abraxane induced infertility in male rats (see section 5.3).
Slovenian: Zdravilo Abraxane je povzročilo neplodnost pri samcih podgan (glejte poglavje 5.3).
English: • Abraxane is used in non-small cell lung cancer where surgery or radiotherapy would not be suitable to treat the disease.
Slovenian: • Zdravilo Abraxane se uporablja pri nedrobnoceličnem pljučnem raku, kadar operacija ali obsevanje nista primerna za zdravljenje bolezni.
English: Febrile Neutropenia: Grade 3 or 4
Slovenian: Febrilna nevtropenija: 3. ali 4. stopnje
English: For patients with total bilirubin > 5 x ULN or AST > 10 x ULN, there are insufficient data to permit dosage recommendations regardless of indication (see sections 4.4 and 5.2).
Slovenian: Pri bolnikih s celokupnim bilirubinom > 5 x ULN ali AST > 10 x ULN je na voljo premalo podatkov, da bi omogočili priporočila za odmerjanje ne glede na indikacijo (glejte poglavji 4.4 in 5.2).
English: There was a statistically significant improvement in OS for patients treated with Abraxane/gemcitabine versus gemcitabine alone, with 1.8 months increase in median OS, 28% overall reduction in risk of death, 59% improvement in 1-year survival, and 125% improvement in 2-year survival rates.
Slovenian: Celokupno preživetje se je statistično značilno izboljšalo pri bolnikih, zdravljenih z zdravilom Abraxane/gemcitabinom, v primerjavi z zdravljenimi samo z gemcitabinom, pri čemer se je mediano celokupno preživetje zvečalo za 1,8 meseca, celokupno zmanjšanje tveganja smrti je bilo 28 %, enoletno preživetje se je zvečalo za 59 %, dvoletno preživetje pa za 125 %.
English: The frequencies of adverse reactions associated with the administration of Abraxane are listed in Table 6 (Abraxane as monotherapy) and Table 7 (Abraxane in combination with gemcitabine), and Table 9 (Abraxane in combination with carboplatin).
Slovenian: Pogostnosti neželenih učinkov, povezanih z uporabo zdravila Abraxane, so navedene v preglednici 6 (zdravilo Abraxane kot monoterapija), preglednici 7 (zdravilo Abraxane v kombinaciji z gemcitabinom) in preglednici 9 (zdravilo Abraxane v kombinaciji s karboplatinom).
English: If the suspension contacts the skin, the skin should be washed immediately and thoroughly with soap and water.
Slovenian: Če suspenzija pride v stik s kožo, takoj sperite kožo in jo temeljito umijte z milnico in vodo.
English: For treatment of advanced pancreatic cancer, Abraxane is given on days 1, 8 and 15 of each 28-day treatment cycle with gemcitabine being given immediately after the Abraxane.
Slovenian: Pri napredovalem raku trebušne slinavke se zdravilo Abraxane daje 1., 8. in 15. dan vsakega 28dnevnega cikla zdravljenja, skupaj z gemcitabinom, ki se daje takoj za zdravilom Abraxane.
English: 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.
Slovenian: Priporočeni odmerek karboplatina je AUC = 6 mg•min/ml samo 1. dan vsakega 21-dnevnega cikla, začne se takoj po končanem dajanju zdravila Abraxane.
English: Patients with pancreatic adenocarcinoma aged 75 years and older should be carefully assessed for their ability to tolerate Abraxane in combination with gemcitabine with special consideration to performance status, co-morbidities and increased risk of infections (see section 4.2 and 4.8).
Slovenian: Bolnike z adenokarcinomom trebušne slinavke, ki so stari 75 let in več, je treba skrbno oceniti glede njihove sposobnosti za prenašanje zdravila Abraxane skupaj z gemcitabinom, še posebej upoštevajte stanje zmogljivosti, sočasne druge bolezni in zvečano tveganje za okužbe (glejte poglavji 4.2 in 4.8).
English: • People with metastatic breast cancer who received Abraxane where another therapy had failed, were more likely to experience a reduction in tumour size, and lived longer than people who took an alternative therapy.
Slovenian: • Pri ljudeh z metastatskim rakom dojk, ki so po neuspehu drugačne oblike zdravljenja prejemali zdravilo Abraxane, je pogosteje prišlo do zmanjšanja velikosti tumorja, živeli pa so dlje kot bolniki, ki so uporabljali alternativno obliko zdravljenja.
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).
Slovenian: Preglednica 6 navaja neželene učinke, ki so povezani z odmerjanjem zdravila Abraxane bolnikom v študijah, pri katerih so Abraxane dajali kot monoterapijo v katerem koli odmerku, pri kateri koli indikaciji (N = 789).
English: Common: Acute renal failure Uncommon: Haemolytic uraemic syndrome
Slovenian: Pogosti: akutna odpoved ledvic Občasni: hemolitični uremični sindrom
English: For non-small cell lung cancer patients treated with Abraxane and carboplatin, the median time to first occurrence of Grade 3 treatment related peripheral neuropathy was 121 days, and the median time to improvement from Grade 3 treatment related peripheral neuropathy to Grade 1 was 38 days.
Slovenian: Pri bolnikih z nedrobnoceličnim pljučnim rakom, zdravljenih z zdravilom Abraxane in karboplatinom, je bil mediani čas do prvega pojava periferne nevropatije 3. stopnje, povezane z zdravljenjem, 121 dni, mediani čas do izboljšanja periferne nevropatije 3. stopnje, povezane z zdravljenjem, na 1. stopnjo pa 38 dni.
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.
Slovenian: Neželeni učinki so bili ocenjeni pri 421 bolnikih, zdravljenih z zdravilom Abraxane v kombinaciji z gemcitabinom in 402 bolnikih, zdravljenih z monoterapijo z gemcitabinom, ki so prejemali sistemsko zdravljenje prve izbire za metastatski adenokarcinom trebušne slinavke v randomiziranem, kontroliranem, odprtem preskušanju faze III.
English: Upon diagnosis of cystoid macular oedema, treatment with Abraxane should be discontinued.
Slovenian: Po diagnosticiranem cistoidnem makularnem edemu je treba zdravljenje z zdravilom Abraxane ukiniti.