natgillin/translations-raw huggingface dataset:
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).
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).
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).
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).
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
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.
Do not breast feed when taking Abraxane as it is not known if the active ingredient paclitaxel passes into the mother's milk.
Med prejemanjem zdravila Abraxane ne smete dojiti, saj ni znano, ali učinkovina paklitaksel prehaja v materino mleko.
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%).
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 %).
How often will you receive Abraxane?
Kako pogosto bom prejemal zdravilo Abraxane?
This may be followed by storage in the infusion bag for 4 hours below 25°C.
Temu lahko sledijo še 4 ure shranjevanja v infuzijski vrečki pri temperaturi do 25 °C.
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).
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).
Sensory neuropathy occurs frequently with Abraxane, although development of severe symptoms is less common.
Ob uporabi zdravila Abraxane se pogosto pojavi senzorična nevropatija, vendar pa je pojav hudih simptomov manj običajen.
• if you have a low white blood cell count (baseline neutrophil counts <1500 cells/mm3 - your doctor will advise you on this).
• če imate nizko število belih krvnih celic (izhodiščno število nevtrofilcev < 1.500 celic/mm3 - o tem se boste pogovorili z vašim zdravnikom).
• Pain and swelling in the nose, skin infections, infection due to catheter line
• bolečine in otekline v nosu, okužba kože, okužba zaradi katetra
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.
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.
• 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”.
• Zdravilo Abraxane se uporablja tudi skupaj z zdravilom, ki se imenuje karboplatin, če imate najpogostejšo vrsto pljučnega raka, imenovano “nedrobnocelični pljučni rak”.
Animal studies with Abraxane showed non-reversible, toxic effects on the male reproductive organs at clinically relevant exposure levels.
Raziskave na živalih so pokazale ireverzibilne, toksične učinke na moške reproduktivne organe pri klinično pomembnih stopnjah izpostavljenosti.
Grade 4 neutropenia (< 500 cells/mm3) occurred in 9% of patients treated with Abraxane.
Nevtropenija 4. stopnje (< 500 celic/mm3) se je pojavila pri 9 % bolnikov, ki so prejemali zdravilo Abraxane.
• Diminished muscular coordination or difficulty in reading, increased or decreased tears, loss of eyelashes
• zmanjšana mišična koordinacija ali težave pri branju, zvečano ali zmanjšano solzenje, izguba trepalnic
Gloves, goggles and protective clothing should be used.
Nositi morate zaščitne rokavice, zaščitna očala in zaščitna oblačila.
Of the patients with treatment interrupted due to peripheral neuropathy, 44% (31/70 patients) were able to resume Abraxane at a reduced dose.
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.
OR Nadir ANC <500/mm3 for > 1 week
ALI najmanjše ANC <500/mm3 za > 1 teden tretje
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.
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.
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).
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).
On Days 8 or 15 of the 21-day cycle reduce the dose of Abraxane; reduce the dose of carboplatin in the subsequent cycle.
8. ali 15. dan 21-dnevnega cikla zmanjšajte odmerek zdravila Abraxane; odmerek karboplatina zmanjšajte v naslednjem ciklu.
Reduce to next lower dose levela; discontinue treatment if ADR persists
Zmanjšajte na naslednjo nižjo raven odmerkova; ukinite zdravljenje, če neželeni učinek vztraja
• Decreased blood pressure when standing up, coldness in your hands and feet
• znižan krvni tlak v stoječem položaju, mrazenje v dlaneh in stopalih
Table 2: Dose modifications for neutropenia and/or thrombocytopenia at the start of a cycle or within a cycle for patients with pancreatic adenocarcinoma
Preglednica 2: Prilagajanje odmerka pri nevtropeniji in/ali trombocitopeniji v začetku cikla ali med ciklom pri bolnikih z adenokarcinomom trebušne slinavke
If precipitates or settling are visible, the vial should be gently inverted again to ensure complete resuspension prior to use.
Če pride do tvorbe oborin ali usedanja, vialo ponovno pazljivo obračajte navzgor in navzdol, da boste zagotovili popolno resuspendiranje pred uporabo.
The fraction of free paclitaxel was significantly higher with Abraxane (6.2%) than with solvent-based paclitaxel (2.3%).
Delež prostega paklitaksela je bil značilno višji pri zdravilu Abraxane (6,2 %) kot pri paklitakselu na bazi topila (2,3 %).
PHARMACEUTICAL FORM AND CONTENTS Powder for suspension for infusion.
FARMACEVTSKA OBLIKA IN VSEBINA Prašek za suspenzijo za infundiranje.
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.
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.
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.
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.
Response rate [95% CI] (%)
Stopnja odziva [95 % IZ] ( %)
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).
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).
Abraxane contains, as its active substance, paclitaxel attached to the human protein albumin, in the form of tiny particles known as nanoparticles.
Zdravilo Abraxane vsebuje učinkovino paklitaksel, pritrjeno na humano beljakovino albumin, v obliki drobnih delcev, znanih kot nanodelci.
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.
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).
This is because Abraxane can affect the way some other medicines work.
Zdravilo Abraxane lahko namreč vpliva na način delovanja drugih zdravil.
The effect of hepatic impairment on population pharmacokinetics of Abraxane was studied in patients with advanced solid tumours.
Učinek okvare jeter na populacijsko farmakokinetiko zdravila Abraxane so proučevali pri bolnikih z napredovalimi čvrstimi tumorji.
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.
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.
• if you experience breathing problems, like shortness of breath or dry cough.
• če se pojavijo težave z dihanjem, kot sta zasoplost ali suh kašelj.
Nadir ANC <500/mm3 with neutropenic fever > 38°C
najmanjše ANC <500/mm3 z vročino zaradi nevtropenije > 38 °C
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.
Pri bolnikih, starih 75 let in več, niso dokazali nikakršne koristi kombiniranega zdravljenja z zdravilom Abraxane in gemcitabinom v primerjavi z monoterapijo z gemcitabinom.
Abraxane should not be used in combination with other anticancer agents.
Zdravilo Abraxane se ne sme uporabljati v kombinaciji z drugimi zdravili proti raku.
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.
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.
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.
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.
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%).
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 %).
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).
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).
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).
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).
• Reduction in all blood cell counts
• zmanjšanje števila vseh krvnih celic
1st dose level reduction 2nd dose level reduction If additional dose reduction required
Celotni odmerek Prvo zmanjšanje ravni odmerka Drugo zmanjšanje ravni odmerka Če je potrebno še dodatno zmanjšanje odmerka
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.
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.
• Decreased liver function, increased size of liver
• zmanjšano delovanje jeter, povečanje jeter
1On Day 1 of the 21-day cycle reduce the dose of Abraxane and carboplatin simultaneously.
1 1. dan 21-dnevnega cikla zmanjšajte odmerek zdravila Abraxane in karboplatina sočasno.
Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during administration of the medicinal product.
Zaradi možnosti ekstravazacije se priporoča skrbno nadziranje mesta infundiranja zaradi možne infiltracije med dajanjem zdravila.
First Second
prvo drugo
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.
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.
Take care and speak to your doctor when taking Abraxane at the same time as any of the following:
Bodite pozorni in se posvetujte s svojim zdravnikom, če jemljete zdravilo Abraxane skupaj s katerimi od naslednjih zdravil:
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.
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.
Table 13: Non-inferiority analyses on progression-free survival and overall survival in randomized non-small cell lung cancer trial (intent-to-treat population)
Preglednica 13: Analize neinferiornosti o preživetju brez napredovanja bolezni in celokupnem preživetju v randomiziranem preskušanju nedrobnoceličnega pljučnega raka ( populacija z namenom zdravljenja)
Paclitaxel is an antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilises microtubules by preventing depolymerisation.
Paklitaksel je antimikrotubulno sredstvo, ki pospešuje sestavljanje mikrotubulov iz dimerov tubulina in jih stabilizira s preprečevanjem njihove depolimerizacije.
Abraxane is supplied as a sterile lyophilised powder for reconstitution before use.
Abraxane se dobavlja kot sterilen liofiliziran prašek za rekonstitucijo pred uporabo.
• if you are allergic (hypersensitive) to paclitaxel or any of the other ingredients of Abraxane (listed in section 6);
• če ste alergični (preobčutljivi) na paklitaksel ali katero koli sestavino zdravila Abraxane
2 As reported in the post-marketing surveillance of Abraxane.
2 Kot je bilo poročano pri spremljanju zdravila Abraxane po začetku trženja.
OTHER SPECIAL WARNING(S), IF NECESSARY Abraxane should not be substituted for or with other paclitaxel formulations.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Zdravila Abraxane se ne sme zamenjati z drugimi pripravki paklitaksela.
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%).
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 %).
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.
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.
The results show that mild hepatic impairment (total bilirubin >1 to ≤1.5 x ULN) has no clinically important effect on pharmacokinetics of paclitaxel.
Rezultati kažejo, da blaga okvara jeter (celokupni bilirubin > 1 do ≤ 1,5 x ULN) nima klinično pomembnega vpliva na farmakokinetiko paklitaksela.
Asthenia/Fatigue was reported in 40% of the patients.
Astenija/utrujenost je bila opažena pri 40 % bolnikov.
Progression-free Survivala (independent review)
Preživetje brez napredovanja boleznia (neodvisen pregled)
Rare: Pancytopenia
Redki: pancitopenija
Do not use Abraxane
Ne uporabljajte zdravila Abraxane
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.
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.
For treatment of metastatic breast cancer, Abraxane is usually given once every three weeks (on day 1 of a 21-day cycle).
Pri metastatskem raku dojk se zdravilo Abraxane navadno daje enkrat na tri tedne (1. dan 21dnevnega cikla).
Reduce doses 1 dose level
Zmanjšajte odmerke za eno raven odmerka
Not known side effects (frequency cannot be estimated from the available data):
Neželeni učinki neznane pogostnosti (pogostosti ni mogoče oceniti iz razpoložljivih podatkov) • otrdela/odebeljena koža (sklerodermija)
• 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”.
• 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.
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.
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.
• Severe inflammation/eruption of the skin and mucous membranes (Stevens-Johnson syndrome,
• hudo vnetje/izbruh izpuščajev na koži in sluznici (Stevens-Johnsonov sindrom, toksična epidermalna nekroliza)
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.
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'.
Anemia and thrombocytopenia were more commonly reported in the Abraxane arm than in the Taxol arm (54% versus 28% and 45% versus 27% respectively).
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 %).
Two hundred and twenty nine patients treated with Abraxane in the randomized, controlled clinical trial were evaluated for safety.
Pri 229 bolnikih, ki so bili zdravljeni z zdravilom Abraxane v randomiziranem kontroliranem kliničnem preskušanju, so ocenili varnost zdravila.
Each ml of Abraxane contains approximately 4.2 mg of sodium.
En ml zdravila Abraxane vsebuje približno 4,2 mg natrija.
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.
Neodprte viale zdravila Abraxane so stabilne do datuma, ki je naveden na ovojnini, če vialo shranjujete v zunanji ovojnini za zagotovitev zaščite pred svetlobo.