FrancophonIA/ELRC3.0 huggingface dataset:
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Slovenian: Če se zdravila ne uporabi takoj, je za čas in pogoje shranjevanja med uporabo odgovoren uporabnik.
English: Very common: Anorexia
Slovenian: Zelo pogosti: anoreksija
English: When it happens, hair loss is pronounced (over 50%) in the majority of patients)
Slovenian: Kadar pride do tega, je pri večini bolnikov izpadanje las izrazito (več kot 50 %).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Celgene Europe B.V.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Celgene Europe B.V.
English: The effectiveness and safety of Abraxane in patients with central nervous system (CNS) metastases has not been established.
Slovenian: Učinkovitost in varnost zdravila Abraxane pri bolnikih z metastazami v centralnem živčnem sistemu (CŽS) nista bili dokazani.
English: The reconstituted suspension has a pH of 6-7.5 and an osmolality of 300-360 mOsm/kg.
Slovenian: Rekonstituirana suspenzija ima pH vrednost 6-7,5 in osmolalnost 300-360 mOsm/kg.
English: The symptoms were usually transient, typically occurred three days after Abraxane administration and resolved within a week.
Slovenian: Simptomi, ki so bili večinoma prehodne narave, so se navadno pojavili tri dni po prejemu zdravila Abraxane in izginili v enem tednu.
English: ANNEX IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
Slovenian: PRILOGA IV Znanstveni zaključki in podlaga za spremembo pogojev dovoljenja (dovoljenj) za promet z zdravilom
English: • Small bleedings in your skin due to blood clots
Slovenian: • majhne krvavitve v koži zaradi krvnih strdkov
English: The natural course of peripheral neuropathy to resolution to baseline due to cumulative toxicity of Abraxane after > 6 courses of treatment was not evaluated and remains unknown.
Slovenian: Naravni potek periferne nevropatije do resolucije na izhodiščno raven zaradi kumulativne toksičnosti zdravila Abraxane po > 6 zdravljenjih ni bil raziskan in ostaja neznan.
English: Treatment may be resumed at the next lower dose level in subsequent cycles according to the guidelines in Table 5.
Slovenian: V poznejših ciklih se lahko zdravljenje nadaljuje z naslednjo nižjo ravnijo odmerka v skladu s smernicami v preglednici 5.
English: 15 of each 21-day cycle without any steroid premedication and without granulocyte colony stimulating factor prophylaxis.
Slovenian: 8. in 15. dan vsakega 21-dnevnega cikla brez kakršne koli steroidne premedikacije in brez profilakse z granulocitne kolonije spodbujajočim faktorjem.
English: Pharmacokinetic data are insufficient for patients with severe renal impairment and not available for patients with end stage kidney disease.
Slovenian: Farmakokinetični podatki so nezadostni pri bolnikih s hudo okvaro ledvic in niso na voljo pri bolnikih s končno odpovedjo ledvic.
English: • medicines used to help you stabilize your mood also sometimes referred to as anti-depressants (e.g.
Slovenian: • zdravila, ki se uporabljajo za stabilizacijo razpoloženja, imenovani tudi antidepresivi (npr.
English: The median relative dose intensity of Abraxane was 81%.
Slovenian: Mediana relativne intenzivnosti odmerka zdravila Abraxane je bila 81 %.
English: The primary efficacy endpoint was overall response rate defined as the percentage of patients who achieved an objective confirmed complete response or partial response based on an independent, central, blinded radiological review using RECIST (Version 1.0).
Slovenian: Primarni cilj študije za dokaz učinkovitosti je bil stopnja celokupnega odziva, opredeljena kot odstotni delež bolnikov, ki so dosegli objektiven potrjen popoln odziv ali delen odziv na podlagi neodvisnega, centralnega, slepega radiološkega pregleda po smernicah RECIST (različica 1.0).
English: What Abraxane is used for Abraxane is used to treat the following types of cancer:
Slovenian: Za kaj se zdravilo Abraxane uporablja Zdravilo Abraxane se uporablja za zdravljenje naslednjih vrst raka:
English: Abraxane has minor or moderate influence on the ability to drive and use machines.
Slovenian: Zdravilo Abraxane ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja strojev.
English: Anaemia (Hb < 10 g/dl) was observed in 46% of patients on Abraxane, and was severe (Hb < 8 g/dl) in three cases.
Slovenian: Anemijo (Hb < 10 g/dl) so opazili pri 46 % bolnikov, ki so prejemali zdravilo Abraxane; v treh primerih pa je bila huda (Hb < 8 g/dl).
English: • a medicine called clopidogrel used to prevent blood clots.
Slovenian: • zdravilo, ki se imenuje klopidogrel in se uporablja za preprečevanje krvnih strdkov.
English: The response rates in all patients were 39.5% (95% CI: 24.9%-54.2%) and 47.6% (95% CI: 35.3%-60.0%), respectively.
Slovenian: Stopnji odzivnosti pri vseh bolnikih sta bili 39,5 % (95 % IZ: 24,9 % - 54,2 %) oziroma 47,6 % (95 % IZ: 35,3 % - 60,0 %).
English: Reconstitution of 250 mg:
Slovenian: Rekonstitucija 250 mg:
English: • Increased liver function tests
Slovenian: • zvišani testi jetrne funkcije
English: Do not administer the reconstituted suspension if particulate matter is observed in the vial.
Slovenian: Ne uporabite rekonstituirane suspenzije, če v viali opazite vidne delce.
English: OR < 50,000
Slovenian: ALI < 50.000
English: Nausea occurred in 29% of the patients and diarrhoea in 25% of the patients.
Slovenian: Navzea se je pojavila pri 29 % bolnikov, diareja pa pri 25 % bolnikov.
English: ABRAXANE+Gemcitabine Gemcitabine
Slovenian: ABRAXANE+gemcitabin gemcitabin
English: This should be taken into consideration if you are on a controlled sodium diet.
Slovenian: To morate upoštevati, če ste na dieti z omejenim vnosom natrija.
English: a Per EMA methodological considerations for PFS endpoint, missing observations or initiation of subsequent new therapy were not used for censoring.
Slovenian: a Na podlagi metodoloških ugotovitev EMA za končni cilj PFS , manjkajoča opazovanja ali uvedba poznejšega novega zdravljenja pri oceni niso bili uporabljeni.
English: Abraxane may cause adverse reactions such as tiredness (very common) and dizziness (common) that may affect the ability to drive and use machinery.
Slovenian: Zdravilo Abraxane lahko povzroča neželene učinke, kot je utrujenost (zelo pogosto) in omotičnost (pogosto), ki lahko vplivajo na sposobnost upravljanja vozil in strojev.
English: No additional dosage reductions, other than those for all patients, are recommended for patients 65 years and older.
Slovenian: Za bolnike, stare 65 let in več, se ne priporoča dodatnih zmanjševanj odmerjanja, poleg tistih, ki so priporočljiva za vse bolnike.
English: This resulted in significantly higher exposure to unbound paclitaxel with Abraxane compared with solvent-based paclitaxel, even though the total exposure is comparable.
Slovenian: To je povzročilo značilno večjo izpostavljenost nevezanemu paklitakselu z zdravilom Abraxane v primerjavi s paklitakselom na bazi topila, čeprav je bila celotna izpostavljenost primerljiva.
English: • Infection, fever with decrease in the number of a type of white blood cell (neutrophils) in the blood,
Slovenian: • okužba, vročica z znižanim številom ene vrste belih krvnih celic (nevtrofilcev) v krvi,
English: Also, some other medicines can affect the way Abraxane works.
Slovenian: Tudi druga zdravila lahko vplivajo na način delovanja zdravila Abraxane.
English: • medicines for treating infections (i.e. antibiotics such erythromycin, rifampicin, etc.; ask your doctor, nurse or pharmacist if you are unsure whether the medicine you are taking is an antibiotic),
Slovenian: • zdravila za zdravljenje okužb (tj. antibiotiki, kot so eritromicin, rifampicin itd.; posvetujte se s svojim zdravnikom, medicinsko sestro ali farmacevtom, če niste prepričani, ali je zdravilo, ki ga jemljete, antibiotik), in tudi zdravila za zdravljenje glivičnih bolezni (npr. ketokonazol)
English: Pronounced hair loss ≥50% is expected for the majority of patients who experience alopecia.
Slovenian: Izrazito izpadanje las (≥ 50 %) se pričakuje pri večini bolnikov, pri katerih se pojavi alopecija.
English: Alopecia was observed in >80% of the patients treated with Abraxane.
Slovenian: Alopecijo so opazili pri > 80 % bolnikov, ki so prejemali zdravilo Abraxane.
English: Inspect the suspension in the vial for particulate matter.
Slovenian: Preglejte suspenzijo v viali glede vidnih delcev.
English: The median time to disease progression was 5.3 months (175 mg/m2; 95% CI: 4.6-6.2 months) and 6.1 months (300 mg/m2; 95% CI: 4.2-9.8 months).
Slovenian: Mediani čas do napredovanja bolezni je bil 5,3 meseca (175 mg/m2; 95 % IZ: 4,6 - 6,2 meseca) in 6,1 meseca (300 mg/m2; 95 % IZ: 4,2 - 9,8 meseca).
English: The key secondary endpoints were progressionfree survival (PFS) and overall response rate (ORR), both assessed by independent, central, blinded radiological review using RECIST guidelines (Version 1.0).
Slovenian: Ključna sekundarna cilja sta bila čas preživetja brez napredovanja bolezni (PFS - progression free survival) in stopnja celokupnega odziva (ORR - overall response rate), oba so ocenili z neodvisnim, centralnim, slepim radiološkim pregledom po smernicah RECIST (različica 1.0).
English: On the basis of the scientific conclusions for paclitaxel albumin the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing paclitaxel albumin is unchanged subject to the proposed changes to the product information
Slovenian: Na podlagi znanstvenih zaključkov za paklitaksel albumin Odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil, ki vsebujejo paklitaksel albumin, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: Do not breast feed when taking Abraxane as it is not known if the active ingredient paclitaxel passes into the mother's milk.
Slovenian: Med prejemanjem zdravila Abraxane ne smete dojiti, saj ni znano, ali učinkovina paklitaksel prehaja v materino mleko.
English: Following Abraxane administration to patients with solid tumours, paclitaxel is evenly distributed into blood cells and plasma and is highly bound to plasma proteins (94%).
Slovenian: Po dajanju zdravila Abraxane bolnikom s čvrstimi tumorji se paklitaksel enakomerno porazdeli v krvne celice in plazmo ter je v veliki meri vezan na plazemske beljakovine (94 %).
English: How often will you receive Abraxane?
Slovenian: Kako pogosto bom prejemal zdravilo Abraxane?
English: This may be followed by storage in the infusion bag for 4 hours below 25°C.
Slovenian: Temu lahko sledijo še 4 ure shranjevanja v infuzijski vrečki pri temperaturi do 25 °C.
English: It is hypothesised that this enhanced transendothelial caveolar transport is mediated by the gp-60 albumin receptor, and that there is enhanced accumulation of paclitaxel in the area of tumour due to the albumin-binding protein Secreted Protein Acidic Rich in Cysteine (SPARC).
Slovenian: Obstaja hipoteza, da ta izboljšani transendotelijski kaveolarni transport posreduje albuminski receptor gp-60, in da izboljšano akumulacijo paklitaksela v območju tumorja povzroča izločena, albumin-vezajoča beljakovina, kisla, bogata s cisteinom (SPARC - Secreted Protein Acidic Rich in Cysteine).
English: Sensory neuropathy occurs frequently with Abraxane, although development of severe symptoms is less common.
Slovenian: Ob uporabi zdravila Abraxane se pogosto pojavi senzorična nevropatija, vendar pa je pojav hudih simptomov manj običajen.
English: • if you have a low white blood cell count (baseline neutrophil counts <1500 cells/mm3 - your doctor will advise you on this).
Slovenian: • če imate nizko število belih krvnih celic (izhodiščno število nevtrofilcev < 1.500 celic/mm3 - o tem se boste pogovorili z vašim zdravnikom).
English: • Pain and swelling in the nose, skin infections, infection due to catheter line
Slovenian: • bolečine in otekline v nosu, okužba kože, okužba zaradi katetra
English: Following the analysis of case reports of scleroderma, published in literature during the reporting period, describing the temporal relationship with administration of the drug or reduction of the dose, a causal association for nab-paclitaxel is considered likely.
Slovenian: Po analizi poročil o primerih sklerodermije, objavljenih v literaturi v obdobju poročanja, ki opisuje časovno povezanost z jemanjem zdravila ali zmanjšanjem odmerka, je vzročna povezanost z nabpaklitakselom verjetna.
English: • Abraxane is also used together with a medicine called carboplatin if you have the most common type of lung cancer, called “non-small cell lung cancer”.
Slovenian: • Zdravilo Abraxane se uporablja tudi skupaj z zdravilom, ki se imenuje karboplatin, če imate najpogostejšo vrsto pljučnega raka, imenovano “nedrobnocelični pljučni rak”.
English: Animal studies with Abraxane showed non-reversible, toxic effects on the male reproductive organs at clinically relevant exposure levels.
Slovenian: Raziskave na živalih so pokazale ireverzibilne, toksične učinke na moške reproduktivne organe pri klinično pomembnih stopnjah izpostavljenosti.
English: Grade 4 neutropenia (< 500 cells/mm3) occurred in 9% of patients treated with Abraxane.
Slovenian: Nevtropenija 4. stopnje (< 500 celic/mm3) se je pojavila pri 9 % bolnikov, ki so prejemali zdravilo Abraxane.
English: • Diminished muscular coordination or difficulty in reading, increased or decreased tears, loss of eyelashes
Slovenian: • zmanjšana mišična koordinacija ali težave pri branju, zvečano ali zmanjšano solzenje, izguba trepalnic
English: Gloves, goggles and protective clothing should be used.
Slovenian: Nositi morate zaščitne rokavice, zaščitna očala in zaščitna oblačila.
English: Of the patients with treatment interrupted due to peripheral neuropathy, 44% (31/70 patients) were able to resume Abraxane at a reduced dose.
Slovenian: Od bolnikov, pri katerih je bilo zdravljenje prekinjeno zaradi periferne nevropatije, jih je lahko 44 % (31 od 70 bolnikov) nadaljevalo s prejemanjem zdravila Abraxane v zmanjšanem odmerku.
English: OR Nadir ANC <500/mm3 for > 1 week
Slovenian: ALI najmanjše ANC <500/mm3 za > 1 teden tretje
English: People with metastatic pancreatic cancer (pancreatic cancer that has spread to other parts of the body) who received Abraxane with gemcitabine in a clinical trial lived longer than people who had only received gemcitabine.
Slovenian: Ljudje z metastatskim rakom trebušne slinavke (rak trebušne slinavke, ki se je razširil v druge dele telesa), ki so v kliničnem preskušanju prejemali zdravilo Abraxane z gemcitabinom, so živeli dlje kot ljudje, ki so prejemali samo gemcitabin.
English: CI = confidence interval, HRA+G/G = hazard ratio of Abraxane+gemcitabine/gemcitabine, pA+G/pG=response rate ratio of Abraxane+gemcitabine/gemcitabine a stratified Cox proportional hazard model b stratified log-rank test, stratified by geographic region (North America versus others), KPS (70 to 80 versus 90 to 100), and presence of liver metastasis (yes versus no).
Slovenian: IZ = interval zaupanja, HRA+G/G = razmerje tveganja za zdravilo Abraxane+gemcitabin/gemcitabin, pA+G/pG = razmerje stopnje odziva na zdravilo Abraxane+gemcitabin/gemcitabin a stratificirani Coxov model proporcionalnega tveganja b stratificirani test log-rank, stratificiran po zemljepisnem območju (Severna Amerika proti drugim), KPS (70 do 80 proti 90 do 100) in prisotnosti metastaz v jetrih (da proti ne).
English: On Days 8 or 15 of the 21-day cycle reduce the dose of Abraxane; reduce the dose of carboplatin in the subsequent cycle.
Slovenian: 8. ali 15. dan 21-dnevnega cikla zmanjšajte odmerek zdravila Abraxane; odmerek karboplatina zmanjšajte v naslednjem ciklu.
English: Reduce to next lower dose levela; discontinue treatment if ADR persists
Slovenian: Zmanjšajte na naslednjo nižjo raven odmerkova; ukinite zdravljenje, če neželeni učinek vztraja
English: • Decreased blood pressure when standing up, coldness in your hands and feet
Slovenian: • znižan krvni tlak v stoječem položaju, mrazenje v dlaneh in stopalih
English: Table 2: Dose modifications for neutropenia and/or thrombocytopenia at the start of a cycle or within a cycle for patients with pancreatic adenocarcinoma
Slovenian: Preglednica 2: Prilagajanje odmerka pri nevtropeniji in/ali trombocitopeniji v začetku cikla ali med ciklom pri bolnikih z adenokarcinomom trebušne slinavke
English: If precipitates or settling are visible, the vial should be gently inverted again to ensure complete resuspension prior to use.
Slovenian: Če pride do tvorbe oborin ali usedanja, vialo ponovno pazljivo obračajte navzgor in navzdol, da boste zagotovili popolno resuspendiranje pred uporabo.
English: The fraction of free paclitaxel was significantly higher with Abraxane (6.2%) than with solvent-based paclitaxel (2.3%).
Slovenian: Delež prostega paklitaksela je bil značilno višji pri zdravilu Abraxane (6,2 %) kot pri paklitakselu na bazi topila (2,3 %).
English: PHARMACEUTICAL FORM AND CONTENTS Powder for suspension for infusion.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Prašek za suspenzijo za infundiranje.
English: Abraxane should not be used in pregnancy, and in women of childbearing potential not using effective contraception, unless the clinical condition of the mother requires treatment with paclitaxel.
Slovenian: Zdravila Abraxane ne smete uporabljati pri nosečnicah in ženskah v rodni dobi, ki ne uporabljajo zanesljive kontracepcije, razen če klinično stanje nosečnice zahteva zdravljenje s paklitakselom.
English: Albumin is known to mediate endothelial caveolar transcytosis of plasma constituents, and in vitro studies demonstrated that the presence of albumin in Abraxane enhances transport of paclitaxel across endothelial cells.
Slovenian: Znano je, da albumin posreduje endotelijsko kaveolarno transcitozo sestavin plazme; in vitro raziskave pa so pokazale, da prisotnost albumina v zdravilu Abraxane izboljša transport paklitaksela preko endotelijskih celic.
English: Response rate [95% CI] (%)
Slovenian: Stopnja odziva [95 % IZ] ( %)
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).
Slovenian: Potem, ko izključite infekcijsko etiologijo in ko postavite diagnozo pnevmonitisa, trajno ukinite zdravljenje z zdravilom Abraxane in gemcitabinom in nemudoma uvedite ustrezno zdravljenje in podporne ukrepe (glejte poglavje 4.2).
English: Abraxane contains, as its active substance, paclitaxel attached to the human protein albumin, in the form of tiny particles known as nanoparticles.
Slovenian: Zdravilo Abraxane vsebuje učinkovino paklitaksel, pritrjeno na humano beljakovino albumin, v obliki drobnih delcev, znanih kot nanodelci.
English: Population pharmacokinetic analyses for Abraxane indicate that gender, race (Asian vs. White), and type of solid tumours do not have a clinically important effect on systemic exposure (AUC and Cmax) of paclitaxel.
Slovenian: Analize populacijske farmakokinetike za zdravilo Abraxane kažejo, da spol, rasa (azijska proti beli) in vrsta čvrstih tumorjev nimajo klinično pomembnega vpliva na sistemsko izpostavljenost paklitakselu (AUC in Cmax).
English: This is because Abraxane can affect the way some other medicines work.
Slovenian: Zdravilo Abraxane lahko namreč vpliva na način delovanja drugih zdravil.
English: The effect of hepatic impairment on population pharmacokinetics of Abraxane was studied in patients with advanced solid tumours.
Slovenian: Učinek okvare jeter na populacijsko farmakokinetiko zdravila Abraxane so proučevali pri bolnikih z napredovalimi čvrstimi tumorji.
English: Based on the published literature, in vitro studies with human liver microsomes and tissue slices show that paclitaxel is metabolised primarily to 6-hydroxypaclitaxel; and to two minor metabolites, 3'-p-hydroxypaclitaxel and 6-3'-p-dihydroxypaclitaxel.
Slovenian: Kot je navedeno v objavljeni literaturi, in vitro raziskave z mikrosomi humanih jeter in rezin tkiva kažejo, da se paklitaksel večinoma metabolizira v 6-hidroksipaklitaksel in v dva manjša metabolita, in sicer, 3'-p-hidroksipaklitaksel in 6-3'-p-dihidroksipaklitaksel.
English: • if you experience breathing problems, like shortness of breath or dry cough.
Slovenian: • če se pojavijo težave z dihanjem, kot sta zasoplost ali suh kašelj.
English: Nadir ANC <500/mm3 with neutropenic fever > 38°C
Slovenian: najmanjše ANC <500/mm3 z vročino zaradi nevtropenije > 38 °C
English: For patients of 75 years and older, no benefit for the combination treatment of Abraxane and gemcitabine in comparison to gemcitabine monotherapy has been demonstrated.
Slovenian: Pri bolnikih, starih 75 let in več, niso dokazali nikakršne koristi kombiniranega zdravljenja z zdravilom Abraxane in gemcitabinom v primerjavi z monoterapijo z gemcitabinom.
English: Abraxane should not be used in combination with other anticancer agents.
Slovenian: Zdravilo Abraxane se ne sme uporabljati v kombinaciji z drugimi zdravili proti raku.
English: However, from a microbiological point of view, unless the method of reconstituting and filling of the infusion bags precludes the risks of microbial contamination, the product should be used immediately after reconstitution and filling of the infusion bags.
Slovenian: Z mikrobiološkega vidika je treba zdravilo po rekonstituciji in polnjenju infuzijskih vrečk uporabiti takoj, razen če način rekonstitucije in polnjenja infuzijskih vrečk izključuje tveganje za mikrobiološko kontaminacijo.
English: Therefore, in the absence of a PK drug-drug interaction study, caution should be exercised when administering paclitaxel concomitantly with medicines known to inhibit either CYP2C8 or CYP3A4 (e.g. ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, clopidogrel, cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir) because toxicity of paclitaxel may be increased due to higher paclitaxel exposure.
Slovenian: Zato je treba ob pomanjkanju FK študije medsebojnega delovanja med zdravili paziti pri sočasnem dajanju paklitaksela in zdravil, ki znano zavirajo CYP2C8 oziroma CYP3A4 (npr. ketokonazol in drugi imidazolni antimikotiki, eritromicin, fluoksetin, gemfibrozil, klopidogrel, cimetidin, ritonavir, sakvinavir, indinavir in nelfinavir), ker se toksičnost paklitaksela zaradi večje izpostavljenosti paklitakselu lahko poveča.
English: In a repeat dose study with 12 patients receiving Abraxane administered intravenously at 260 mg/m2, intrapatient variability in AUC was 19% (range = 3.21%-37.70%).
Slovenian: V študiji s ponavljajočimi odmerki z 12 bolniki, ki so prejemali zdravilo Abraxane intravensko v odmerku 260 mg/m2, je bila variabilnost AUC med bolniki 19 % (razpon = 3,21 % - 37,70 %).
English: Treatment effects on OS favoured the Abraxane/gemcitabine arm across the majority of pre-specified subgroups (including gender, KPS, geographic region, primary location of pancreatic cancer, stage at diagnosis, presence of liver metastases, presence of peritoneal carcinomatosis, prior Whipple procedure, presence of biliary stent at baseline, presence of pulmonary metastases, and number of metastatic sites).
Slovenian: Učinki zdravljenja na celokupno preživetje so bili ugodnejši v skupini z zdravilom Abraxane/gemcitabinom v večini vnaprej določenih podskupin (ki so vključevale spol, KPS, zemljepisno območje, primarno lokacijo adenokarcinoma trebušne slinavke, stadij ob diagnozi, prisotnost metastaz v jetrih, prisotnost peritonealne karcinomatoze, predhodni Whipplov postopek, prisotnost biliarnega stenta v izhodišču, prisotnost pljučnih metastaz in število lokacij z metastazami).
English: Patients in the Abraxane/carboplatin arm had a significantly higher overall response rate compared with patients in the control arm: 33% versus 25%, p = 0.005 (Table 12).
Slovenian: Bolniki v skupini z zdravilom Abraxane/karboplatinom so imeli značilno višjo stopnjo celokupnega odziva kot bolniki v kontrolni skupini: 33 % proti 25 %, p = 0,005 (preglednica 12).
English: • Reduction in all blood cell counts
Slovenian: • zmanjšanje števila vseh krvnih celic