FrancophonIA/ELRC3.0 huggingface dataset:
English: Paclitaxel clearance is primarily determined by CYP2C8 and CYP3A4 mediated metabolism followed by biliary excretion, while gemcitabine is inactivated by cytidine deaminase followed by urinary excretion.
Slovenian: Očistek paklitaksela določa predvsem presnova s CYP2C8 in CYP3A4, ki ji sledi izločanje z žolčem, medtem ko se gemcitabin inaktivira s citidin-deaminazo, čemur sledi izločanje z urinom.
English: After ruling out infectious etiology and upon making a diagnosis of pneumonitis, permanently discontinue treatment with Pazenir 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 Pazenir in gemcitabinom in nemudoma uvedite ustrezno zdravljenje in podporne ukrepe (glejte poglavje 4.2).
English: Day 15: If Day 8 doses were given without modification:
Slovenian: 15. dan: Če so bili odmerki 8. dne dani brez sprememb:
English: In a repeat dose study with 12 patients receiving human serum albumin-paclitaxel nanoparticles 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 paklitaksel, vezan na nanodelce humanega serumskega albumina, intravensko v odmerku 260 mg/m2, je bila variabilnost AUC med bolniki 19 % (razpon = 3,21 %-37,70 %).
English: Population pharmacokinetic analyses for human serum albumin-paclitaxel nanoparticles 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 paklitaksel, vezan na nanodelce humanega serumskega albumina, kažejo, da spol, rasa (azijska proti beli) in vrsta čvrstih tumorjev nimajo klinično pomembnega vpliva na sistemsko izpostavljenost paklitakselu (AUC in Cmax).
English: Day 15: If Day 8 doses were reduced:
Slovenian: 15. dan: Če so bili odmerki 8. dne zmanjšani:
English: Sixty-four percent of patients had impaired performance status (ECOG 1 or 2) at study entry; 79% had visceral metastases; and 76% had > 3 sites of metastases.
Slovenian: Pri vstopu v raziskavo je imelo 64 % bolnikov zmanjšano telesno zmogljivost (ECOG 1 ali 2), 79 % jih je imelo visceralne metastaze in 76 % jih je imelo > 3 mesta metastaz.
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 jemati.
English: Animal studies with human serum albumin-paclitaxel nanoparticles showed non-reversible, toxic effects on the male reproductive organs at clinically relevant exposure levels.
Slovenian: Raziskave s paklitakselom, vezanim na nanodelce humanega serumskega albumina, na živalih so pokazale ireverzibilne, toksične učinke na moške reproduktivne organe pri klinično pomembnih stopnjah izpostavljenosti.
English: • if you are allergic (hypersensitive) to paclitaxel or any of the other ingredients of Pazenir (listed in section 6);
Slovenian: • če ste alergični (preobčutljivi) na paklitaksel ali katero koli sestavino zdravila Pazenir
English: The effectiveness and safety of human serum albumin-paclitaxel nanoparticles in patients with central nervous system (CNS) metastases has not been established.
Slovenian: Učinkovitost in varnost paklitaksela, vezanega na nanodelce humanega serumskega albumina, pri bolnikih z metastazami v centralnem živčnem sistemu (CŽS) nista bili dokazani.
English: Common: Hyperbilirubinaemia
Slovenian: Pogosti: hiperbilirubinemija
English: Because the toxicity of paclitaxel can be increased with hepatic impairment, administration of Pazenir in patients with hepatic impairment should be performed with caution.
Slovenian: Ker jetrna okvara lahko poveča toksičnost paklitaksela, je treba zdravilo Pazenir pri bolnikih z okvaro jeter dajati previdno.
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 human serum albumin-paclitaxel nanoparticles 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 paklitakselu, vezanem na nanodelce humanega serumskega albumina.
English: Paclitaxel at doses below the human therapeutic dose was associated with low fertility when administered prior and during mating in male and female rats and foetal toxicity in rats.
Slovenian: Paklitaksel v odmerkih, manjših od terapevtskega odmerka pri ljudeh, so povezovali z nizko plodnostjo, kadar so ga dajali samcem in samicam podgan pred parjenjem in med njim, in fetalno toksičnostjo pri podganah.
English: Ask your doctor for advice before taking this medicine.
Slovenian: Pred jemanjem zdravila se posvetujte z zdravnikom.
English: General disorders and administration site conditions Asthenia/Fatigue was reported in 40% of the patients.
Slovenian: Splošne težave in spremembe na mestu aplikacije Astenija/utrujenost je bila opažena pri 40 % bolnikov.
English: In patients aged 75 years and older who received human serum albumin-paclitaxel nanoparticles and gemcitabine, there was a higher incidence of serious adverse reactions and adverse reactions that led to treatment discontinuation (see section 4.4).
Slovenian: Pri bolnikih, starih 75 let in več, ki so prejemali paklitaksel, vezan na nanodelce humanega serumskega albumina, in gemcitabin, je bila večja incidenca resnih neželenih učinkov in neželenih učinkov, ki so povzročili prekinitev zdravljenja (glejte poglavje 4.4).
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.
Slovenian: Farmakokinetično/farmakodinamično modeliranje z uporabo podatkov 125 bolnikov z napredovalimi čvrstimi tumorji kaže, da utegnejo biti bolniki, stari 65 let in več, dovzetnejši za nastanek nevtropenije v prvem ciklu zdravljenja.
English: Pharmacotherapeutic group: Antineoplastic agents, plant alkaloids and other natural products, taxanes, ATC Code: L01CD01
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), rastlinski alkaloidi in druge naravne učinkovine (zaviralci mitoze), taksani, oznaka ATC: L01CD01
English: Following human serum albumin-paclitaxel nanoparticles 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 paklitaksela, vezanega na nanodelce humanega serumskega albumina, bolnikom s čvrstimi tumorji se paklitaksel enakomerno porazdeli v krvne celice in plazmo ter je v veliki meri vezan na plazemske beljakovine (94 %).
English: • if you experience any abnormal bruising, bleeding, or signs of infections such as a sore throat or a fever;
Slovenian: • če se pojavijo kakšne nenormalne modrice, krvavitev ali znaki okužbe, na primer vneto žrelo ali zvišana telesna temperatura;
English: If foaming or clumping occurs, the dispersion should stand for at least 15 minutes until foam subsides.
Slovenian: Če se pojavi pena ali skupki, naj raztopina stoji vsaj 15 minut, dokler se pena ne posede.
English: CI = confidence interval, HRA+G/G = hazard ratio of Paclitaxel human serum albumin-paclitaxel nanoparticles+gemcitabine/gemcitabine, pA+G/pG=response rate ratio of human serum albumin-paclitaxel nanoparticles+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 paklitaksel, vezan na nanodelce humanega serumskega albumina+gemcitabin/gemcitabin, pA+G/pG = razmerje stopnje odziva na paklitaksel, vezan na nanodelce humanega serumskega albumina+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
English: 95% CI pA+G/pG(95% Cl) P-value (chi-square test)
Slovenian: 95-% IZ pA+G/pG (95-% IZ) p-vrednost (test hi kvadrat)
English: For treatment of advanced pancreatic cancer, Pazenir is given on days 1, 8 and 15 of each 28day treatment cycle with gemcitabine being given immediately after the Pazenir.
Slovenian: Pri napredovalem raku trebušne slinavke se zdravilo Pazenir daje 1., 8. in 15. dan vsakega 28dnevnega cikla zdravljenja, skupaj z gemcitabinom, ki se daje takoj za zdravilom Pazenir.
English: Patients with pancreatic adenocarcinoma aged 75 years and older should be carefully assessed for their ability to tolerate Pazenir 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 Pazenir skupaj z gemcitabinom, še posebej upoštevajte stanje zmogljivosti, sočasne druge bolezni in zvečano tveganje za okužbe (glejte poglavji 4.2 in 4.8).
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 s 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: Because of potential serious adverse reactions in breast-feeding infants, Pazenir is contraindicated during lactation.
Slovenian: Zaradi morebitnih hudih neželenih učinkov pri dojenčkih je zdravilo Pazenir med dojenjem kontraindicirano.
English: In the comparator treatment arm, gemcitabine monotherapy was administered to patients (N = 430) in accordance with the recommended dose and regimen.
Slovenian: V skupini zdravljenja s primerjalnim zdravilom so bolnikom (N = 430) dajali monoterapijo z gemcitabinom v skladu s priporočenim odmerkom in shemo zdravljenja.
English: For patients with metastatic adenocarcinoma of the pancreas that have moderate to severe hepatic impairment, there are insufficient data to permit dosage recommendations (see sections 4.4 and 5.2).
Slovenian: Pri bolnikih z metastatskim adenokarcinomom trebušne slinavke, ki imajo zmerno do hudo okvaro jeter, je na voljo premalo podatkov, da bi omogočili priporočila za odmerjanje (glejte poglavji 4.4
English: There are insufficient data available to recommend dose modifications of Pazenir in patients with severe renal impairment or end stage renal disease (estimated creatinine clearance <30 ml/min) (see section 5.2).
Slovenian: Na voljo je premalo podatkov, da bi omogočili priporočila za odmerjanje zdravila Pazenir pri bolnikih s hudo okvaro ledvic ali s končno ledvično odpovedjo (ocenjeni očistek kreatinina < 30 ml/min) (glejte poglavje 5.2).
English: GA-2031 Haarlem Netherlands
Slovenian: GA-2031 Haarlem Nizozemska
English: Adjustment of the starting Pazenir dose is not required for patients with mild to moderate renal impairment (estimated creatinine clearance ≥30 to <90 ml/min).
Slovenian: Prilagajanje začetnega odmerka zdravila Pazenir ni potrebno pri bolnikih z blago do zmerno okvaro ledvic (ocenjeni očistek kreatinina ≥ 30 do < 90 ml/min).
English: It should not be substituted for or with other paclitaxel formulations.
Slovenian: Ne sme se ga zamenjati z drugimi pripravki paklitaksela.
English: Such side effects occur far less with Pazenir.
Slovenian: Taki neželeni učinki se pri zdravilu Pazenir pojavljajo mnogo redkeje.
English: Hepatic impairment has no effect on mean paclitaxel Cmax.
Slovenian: Okvara jeter ne vpliva na povprečno Cmax paklitaksela.
English: Blood and lymphatic system disorders1
Slovenian: Bolezni krvi in limfatičnega sistema1
English: Common: Febrile neutropenia Rare: Pancytopenia
Slovenian: Pogosti: febrilna nevtropenija Redki: pancitopenija
English: CI = confidence interval; HRA/T = hazard ratio of Human serum albumin-paclitaxel nanoparticles/carboplatin to solventbased paclitaxel/carboplatin; pA/pT = response rate ratio of Human serum albumin-paclitaxel nanoparticles/carboplatin to solvent-based paclitaxel/carboplatin.
Slovenian: IZ = interval zaupanja; HRA/T = razmerje tveganja za paklitaksel, vezan na nanodelce humanega serumskega albumina/karboplatin proti paklitakselu na bazi topila/karboplatinu; pA/pT = razmerje odzivnosti paklitaksela, vezanega na nanodelce humanega serumskega albumina/karboplatina proti paklitakselu na bazi topila/karboplatinu.
English: For each subsequent weekly dose of Pazenir, patients must have an ANC ≥500 cells/mm3 and platelets >50,000 cells/mm3 or the dose is to be withheld until counts recover.
Slovenian: Za vsak naslednji tedenski odmerek zdravila Pazenir morajo bolniki imeti ANC ≥ 500 celic/mm3 in število trombocitov > 50.000 celic/mm3 ali pa odmerka ne smemo dati, dokler se obe vrednosti ne normalizirata.
English: 50 ml vial (type 1 glass) with a stopper (butyl rubber), with an overseal (aluminium), containing 100 mg of paclitaxel formulated as albumin bound nanoparticles.
Slovenian: Viala 50 ml (steklo tipa 1) z zamaškom (butilna guma), z zaporko (aluminij), ki vsebuje 100 mg paklitaksela, vezanega na albuminske nanodelce.
English: Gemcitabine Dose
Slovenian: Odmerek gemcitabina
English: Grade 4 neutropenia (< 500 cells/mm3) occurred in 9% of patients treated with human serum albuminpaclitaxel nanoparticles.
Slovenian: Nevtropenija 4. stopnje (< 500 celic/mm3) se je pojavila pri 9 % bolnikov, ki so prejemali paklitaksel, vezan na nanodelce humanega serumskega albumina.
English: Frequent monitoring of blood cell counts should be performed during Pazenir therapy.
Slovenian: Med zdravljenjem z zdravilom Pazenir je treba pogosto preverjati število krvnih celic.
English: If the dispersion contacts the skin, the skin should be washed immediately and thoroughly with soap and water.
Slovenian: Če disperzija pride v stik s kožo, takoj sperite kožo in jo temeljito umijte z milnico in vodo.
English: The most common clinically significant adverse reactions associated with the use of human serum albumin-paclitaxel nanoparticles have been neutropenia, peripheral neuropathy, arthralgia/myalgia and gastrointestinal disorders.
Slovenian: Najpogostejši klinično pomembni neželeni učinki, povezani z uporabo paklitaksela, vezanega na nanodelce humanega serumskega albumina, so bili nevtropenija, periferna nevropatija, artralgija/mialgija in bolezni prebavil.
English: Grade 2 or 3
Slovenian: 2. ali 3. stopnje
English: Second
Slovenian: Drugo
English: Patients with moderate (total bilirubin >1.5 to ≤3 x ULN) or severe (total bilirubin >3 to ≤5 x ULN) hepatic impairment have a 22% to 26% decrease in the maximum elimination rate of paclitaxel and approximately 20% increase in mean paclitaxel AUC compared with patients with normal hepatic function.
Slovenian: Bolniki z zmerno (celokupni bilirubin > 1,5 do ≤ 3 x ULN) ali hudo (celokupni bilirubin > 3 do ≤ 5 x ULN) okvaro jeter imajo 22 % do 26 % zmanjšanje največje hitrosti izločanja paklitaksela in približno 20 % zvečanje povprečne AUC paklitaksela v primerjavi z bolniki z normalnim delovanjem jeter.
English: Contains sodium, see package leaflet for further information.
Slovenian: Vsebuje natrij, glejte navodilo za uporabo za dodatne podatke.
English: Patients in the human serum albumin-paclitaxel nanoparticles/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 s paklitakselom, vezanim na nanodelce humanega serumskega albumina/karboplatinom so imeli značilno višjo stopnjo celokupnega odziva kot bolniki v kontrolni skupini: 33 % proti 25 %, p = 0,005 (Preglednica 12).
English: Pazenir contains, as its active substance, paclitaxel attached to the human protein albumin, in the form of tiny particles known as nanoparticles.
Slovenian: Zdravilo Pazenir vsebuje učinkovino paklitaksel, pritrjeno na humano beljakovino albumin, v obliki drobnih delcev, znanih kot nanodelci.
English: Unopened vials of Pazenir 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 Pazenir so stabilne do datuma, ki je naveden na ovojnini, če vialo shranjujete v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: • Small bleedings in your skin due to blood clots
Slovenian: • nemirnost • majhne krvavitve v koži zaradi krvnih strdkov
English: Anemia and thrombocytopenia were more commonly reported in the human serum albumin-paclitaxel nanoparticles arm than in the Taxol arm (54% versus 28% and 45% versus 27% respectively).
Slovenian: O anemiji in trombocitopeniji so pogosteje poročali v skupini s paklitakselom, vezanim na nanodelce humanega serumskega albumina, kot v skupini z zdravilom Taxol (54 % proti 28 % oziroma 45 % proti 27 %).
English: Non-haematologic Toxicity
Slovenian: Nehematološka toksičnost
English: For any other Grade 3 or 4 non-haematologic toxicity, interrupt treatment until the toxicity improves to ≤ Grade 2, then restart treatment according to the guidelines in Table 5.
Slovenian: Pri kateri koli drugi nehematološki toksičnosti 3. ali 4. stopnje prekinite zdravljenje, dokler se toksičnost ne izboljša na ≤ 2. stopnjo, nato spet začnite z zdravljenjem v skladu s smernicami v preglednici 5.
English: Pazenir should only be prepared and administered by personnel appropriately trained in the handling of cytotoxic agents.
Slovenian: Pazenir sme pripraviti in dajati le osebje, ki je ustrezno usposobljeno za rokovanje s citotoksiki.
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 doječ ih podgan (glejte poglavje 5.3).
English: • Pain in the muscles
Slovenian: • bolečine v mišicah
English: • if you have a low white blood cell count (baseline neutrophil counts <1500 cells/mm3
Slovenian: • če dojite, • če imate nizko število belih krvnih celic (izhodiščno število nevtrofilcev < 1.500 celic/mm3
English: Central nervous system metastases
Slovenian: Metastaze v centralnem živčnem sistemu
English: Survival Rate % (95% CI) at
Slovenian: Preživetje % (95-% IZ) pri
English: • Chest or throat pain
Slovenian: • bolečine v prsih ali žrelu
English: Pazenir is a white to yellow powder for dispersion for infusion.
Slovenian: Zdravilo Pazenir je bel do rumen prašek za disperzijo za infundiranje.
English: The effect of hepatic impairment on population pharmacokinetics of human serum albumin-paclitaxel nanoparticles was studied in patients with advanced solid tumours.
Slovenian: Učinek okvare jeter na populacijsko farmakokinetiko paklitaksela, vezanega na nanodelce humanega serumskega albumina, so proučevali pri bolnikih z napredovalimi čvrstimi tumorji.
English: Common: Hypotension, hypertension
Slovenian: Pogosti: hipotenzija, hipertenzija
English: Uncommon1: Hypersensitivity Rare: Severe hypersensitivity
Slovenian: Občasni1: preobčutljivost Redki: huda preobčutljivost
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 human serum albumin-paclitaxel nanoparticles 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 paklitaksela, vezanega na nanodelce humanega serumskega albumina, pri metastatskem raku dojk.
English: For patients with normal baseline CA 19-9 levels the survival HR was 1.07 (95% CI 0.692, 1.661).
Slovenian: Pri bolnikih z normalno izhodiščno ravnijo CA 19-9 je bilo razmerje tveganja za preživetje 1,07 (95-% IZ 0,692; 1,661).
English: Solvent-based paclitaxel (175 mg/m2)
Slovenian: Paklitaksel na bazi topila (175 mg/m2)
English: Of the 431 patients with pancreatic adenocarcinoma who were randomized to receive human serum albumin-paclitaxel nanoparticles 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 paklitaksela, vezanega na nanodelce humanega serumskega albumina, skupaj z gemcitabinom, jih je bila večina (93 %) belcev, 4 % črncev in 2 % Azijcev.
English: Pazenir is not recommended in patients that have total bilirubin > 5 x ULN or AST > 10 x ULN.
Slovenian: Zdravilo Pazenir ni priporočljivo pri bolnikih, ki imajo celokupni bilirubin > 5 x ULN ali AST > 10 x ULN.
English: Pazenir in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.
Slovenian: Zdravilo Pazenir je v kombinaciji z gemcitabinom indicirano kot zdravilo prvega izbora za zdravljenje odraslih bolnikov z metastatskim adenokarcinomom trebušne slinavke.
English: The formation of these hydroxylated metabolites is catalysed by CYP2C8, CYP3A4, and both CYP2C8 and CYP3A4 isoenzymes, respectively.
Slovenian: Formacijo teh hidroksiliranih metabolitov katalizirajo izoencimi CYP2C8, -CYP3A4 ter oba -CYP2C8 in -CYP3A4.
English: The protein binding of paclitaxel following human serum albumin-paclitaxel nanoparticles was evaluated by ultrafiltration in a within-patient comparison study.
Slovenian: Vezava paklitaksela na beljakovine po dajanju paklitaksela, vezanega na nanodelce humanega serumskega albumina, je bila ocenjena z ultrafiltracijo v študiji intraindividualne primerjave bolnikov.
English: Dose of carboplatin (AUC mg•min/mL)1
Slovenian: Odmerek karboplatina (AUC mg•min/ml)1
English: In patients with metastatic breast cancer, after a 30-minute infusion of human serum albuminpaclitaxel nanoparticles 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 6α-hydroxypaclitaxel and 3'-p-hydroxypaclitaxel, indicating extensive non-renal clearance.
Slovenian: Pri bolnikih z metastatskim rakom dojk je po 30 minutni infuziji paklitaksela, vezanim na nanodelce humanega serumskega albumina, 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 6α-hidroksipaklitaksela in 3'-p-hidroksipaklitaksela, kar kaže na obsežen neledvični očistek.
English: Common: Cardiac failure congestive, tachycardia
Slovenian: Pogosti: kongestivno popuščanje srca, tahikardija
English: Male patients treated with Pazenir are advised to use effective contraception and to avoid fathering a child during and up to six months after treatment.
Slovenian: Moškim, ki so se zdravili z zdravilom Pazenir, se svetuje uporaba zanesljive kontracepcije in odsvetuje spočetje otroka med zdravljenjem in šest mesecev po njem.