natgillin/translations-raw huggingface dataset:
Study E2100 was an open-label, randomised, active controlled, multicentre clinical trial evaluating Avastin in combination with paclitaxel for locally recurrent or metastatic breast cancer in patients who had not previously received chemotherapy for locally recurrent and metastatic disease.
Študija E2100 je bilo odprto, randomizirano, aktivno kontrolirano multicentrično klinično preskušanje, ki je proučevalo zdravilo Avastin v kombinaciji s paklitakselom pri bolnikih z lokalno ponovitvijo ali razsojem raka dojk, ki predhodno niso prejeli kemoterapije za lokalno recidivno ali metastatsko bolezen.
Patients were randomised to paclitaxel alone (90 mg/ m2 IV over 1 hour once weekly for three out of four weeks) or in combination with Avastin (10 mg/ kg IV infusion every two weeks).
Bolniki so bili randomizirani v skupino, ki je prejemala le paklitaksel (90 mg/ m2 i. v. v 1 uri enkrattedensko tri od štirih tednov) ali v skupino, ki je prejemala kombinacijo paklitaksela in zdravila Avastin (10 mg/ kg z intravensko infuzijo vsaka dva tedna).
Adjuvant taxane therapy was allowed only if it was completed at least 12 months prior to study entry.
Adjuvantno zdravljenje s taksani je bilo dovoljeno le, če je bilo zaključeno najmanj 12 mesecev pred vstopom v študijo.
Of the 722 patients in the study, the majority of patients had HER2-negative disease (90%), with a small number of patients with unknown (8%) or confirmed HER2-positive status (2%), who had previously been treated with or were considered unsuitable for trastuzumab therapy.
Slednji so bili predhodno zdravljeni s transtuzumabom ali pa so bili neprimerni za zdravljenje s transtuzumabom.
Furthermore, 65% of patients had received adjuvant chemotherapy including 19% prior taxanes and 49% prior anthracyclines.
Adjuvantno kemoterapijo je prejelo 65% bolnikov, od tega 19% taksane in 49% antracikline.
Patients with central nervous system metastasis, including previously treated or resected brain lesions, were excluded.
Bolniki z metastazami v centralnem živčnem sistemu, vključno s predhodno zdravljenimi ali odstranjenimi lezijami v možganih, niso bili vključeni.
In Study E2100, patients were treated until disease progression.
V študiji E2100 so bolnike zdravili do napredovanja bolezni.
In situations where early discontinuation of chemotherapy was required, treatment with Avastin as a single agent continued until disease progression.
V
The patient characteristics were similar across the study arms.
18 vseh preiskovanih skupinah so bile karakteristike bolnikov podobne.
The primary endpoint of this trial was progression free survival (PFS), based on study investigators’ assessment of disease progression.
Primarni cilj tega preskušanja je bilo preživetje brez napredovanja bolezni (PFS, progression free survival), osnovano na oceni napredovanja bolezni s strani raziskovalcev.
The results of this study are presented in Table 8.
Rezultati te študije so predstavljeni v preglednici 8.
18 Table 8
Preglednica 8.
Study E2100 Efficacy Results:
Rezultati učinkovitosti študije E2100
Investigator Assessment*
Ocena raziskovalca *
IRF Assessment
Ocena IRF **
Paclitaxel/ Avastin Paclitaxel (n=368) (n=354)
paklitaksel/ Avastin paklitaksel (n = 368) (n = 354)
Paclitaxel/ Avastin (n=368)
paklitaksel/ Avastin (n = 368)
Median PFS (months)
mediana preživetja brez napredovanja bolezni (meseci))
HR
razmerje ogroženosti
(95% CI) p-value
(95 -% interval zaupanja) p- vrednost
IRF Assessment
Ocena IRF
Paclitaxel (n=243)
paklitaksell (n = 243)
Paclitaxel/ Avastin Paclitaxel (n=229) (n=243)
paklitaksel/ Avastin paklitaksel (n = 229) (n = 243)
Paclitaxel/ Avastin (n=229)
paklitaksel/ Avastin (n = 229)
% pts with objective response
% bolnikov z
* primary analysis
* primarna analiza; ** IRF – Ustanova za neodvisni pregled (Independent Review Facility)
Median OS (months) HR
mediana celokupnega preživetja (meseci)
The clinical benefit of Avastin as measured by PFS was seen in all pre-specified subgroups tested (including disease-free interval, number of metastatic sites, prior receipt of adjuvant chemotherapy and estrogen receptor (ER) status).
vseh preiskovanih, vnaprej določenih podskupinah (vključno z intervalom brez bolezni, številom metastatskih mest, predhodnim prejetjem adjuvantne kemoterapije in statusom estrogenskih receptorjev).
The safety and efficacy of Avastin, in addition to platinum-based chemotherapy, in the first-line treatment of patients with non-squamous non-small cell lung cancer (NSCLC), was investigated in studies E4599 and BO17704.
Varnost in učinkovitost zdravila Avastin v prvi liniji zdravljenja bolnikov z neskvamoznim nedrobnoceličnim rakom pljuč so v študijah E4599 in BO17704 proučevali skupaj z dodano kemoterapijo na osnovi platine.
An overall survival benefit has been demonstrated in study E4599 with a 15 mg/ kg/ q3wk dose of bevacizumab.
Korist v celokupnem preživetju so dokazali v študiji E4599 z odmerkom bevacizumaba 15 mg/ kg telesne mase, danim enkrat na tri tedne.
Study BO17704 has demonstrated that both 7.5 mg/ kg/ q3wk and 15 mg/ kg/ q3wk bevacizumab doses increase progression free survival and response rate.
Študija BO17704 pa je pokazala, da oba odmerka, 7, 5 mg/ kg telesne mase in 15 mg/ kg telesne mase, dana enkrat na tri tedne, podaljšata preživetje brez napredovanja bolezni in povečata delež odgovora na zdravljenje.
Due to the short duration of follow-up in study BO17704 no conclusions can be drawn regarding a benefit in overall survival.
Zaradi kratkotrajnega sledenja v študiji BO17704 ne moremo sklepati o koristi v celokupnem preživetju.
E4599 was an open-label, randomised, active-controlled, multicentre clinical trial evaluating Avastin as first-line treatment of patients with locally advanced (stage IIIb with malignant pleural effusion), metastatic or recurrent NSCLC other than predominantly squamous cell histology.
E4599 je bilo odprto, randomizirano, aktivno nadzorovano, multicentrično klinično preskušanje, v katerem so proučevali zdravilo Avastin v prvi liniji zdravljenja bolnikov z lokalno napredovalim (stadij IIIB z malignim plevralnim izlivom), metastatskim ali ponavljajočim se neskvamoznim nedrobnoceličnim rakom pljuč.
Patients were randomized to platinum-based chemotherapy (paclitaxel 200 mg/ m2 and carboplatin AUC = 6.0, both by IV infusion) (PC) on day 1 of every 3-week cycle for up to 6 cycles or PC in combination with Avastin at a dose of 15 mg/ kg IV infusion day 1 of every 3-week cycle.
19 Randomizirani bolniki so na dan 1 vsakega tritedenskega cikla do skupno 6 ciklov, prejeli kemoterapijo na osnovi platine (paklitaksel 200 mg/ m2 in karboplatin AUC = 6, 0, oboje z i. v. infuzijo) ali kemoterapijo na osnovi platine v kombinaciji z zdravilom Avastin v odmerku 15 mg/ kg v obliki intravenske infuzije na dan 1 vsakega tritedenskega cikla.
After completion of six cycles of carboplatin-paclitaxel chemotherapy or upon premature discontinuation of chemotherapy, patients on the Avastin + carboplatin– paclitaxel arm continued to receive Avastin as a single agent every 3 weeks until disease progression.
Po zaključku 6 ciklov kemoterapije s karboplatinom in paklitakselom ali po predčasnem zaključku kemoterapije, so bolniki v skupini, ki je prejemala zdravilo Avastin s karboplatinom in paklitakselom do napredovanja bolezni prejemali samo zdravilo Avastin vsake 3 tedne.
During the study, of the patients who received trial treatment, 32.2% (136/ 422) of patients received 7-12 administrations of Avastin and 21.1% (89/ 422) of patients received 13 or more administrations of Avastin.
Med študijo je od bolnikov, ki so prejemali zdravilo v preskušanju, 32, 2% bolnikov (136/ 422) prejelo 7 do 12 odmerkov zdravila Avastin, 21, 1% (89/ 422) bolnikov pa je prejelo 13 ali več odmerkov zdravila Avastin.
19 The primary endpoint was duration of survival.
Primarni cilj študije je bilo trajanje preživetja.
Results are presented in Table 9.
Rezultati so predstavljeni v preglednici 9.
Table 9
Preglednica 9.
Efficacy results for study E4599
Rezultati učinkovitosti za študijo E4599
Carboplatin/ Paclitaxel
karboplatin in paklitaksel
15
karboplatin, paklitaksel in Avastin 15 mg/ kg na 3 tedne
0.80 (p=0.003)
0, 80 (p = 0, 003)
95% CI (0.69, 0.93) Progression-Free Survival
95 -% interval zaupanja (0, 69; 0, 93) Preživetje brez napredovanja bolezni
Median (months) Hazard ratio
mediana (meseci) razmerje ogroženosti
95% CI (0.56, 0.76) Overall Response Rate
95 -% interval zaupanja (0, 56; 0, 76) Celokupni odgovor
Study BO17704 was a randomised, double-blind phase III study of Avastin in addition to cisplatin and gemcitabine versus placebo, cisplatin and gemcitabine in patients with locally advanced (stage IIIb with supraclavicular lymph node metastases or with malignant pleural or pericardial effusion), metastatic or recurrent non-squamous NSCLC, who had not received prior chemotherapy.
Bolniki predhodno niso prejeli kemoterapije.
The primary endpoint was progression free survival (PFS).
Primarni končni cilj študije je bilo preživetje brez napredovanja bolezni.
Patients were randomised to platinum-based chemotherapy, cisplatin 80 mg/ m2 i. v. infusion on day 1 and gemcitabine 1250 mg/ m2 i. v. infusion on days 1 and 8 of every 3-week cycle for up to 6 cycles (CG) with placebo or CG with Avastin at a dose of 7.5 or 15 mg/ kg IV infusion day 1 of every 3-week cycle.
Randomizirani bolniki so prejeli kemoterapijo na osnovi platine, cisplatin 80 mg/ m2 v obliki i. v. infuzije na dan 1 in gemcitabin 1250 mg/ m2 v obliki i. v. infuzije na dneva 1 in 8 vsakega tritedenskega cikla do skupno 6 ciklov ali cisplatin in gemcitabin v kombinaciji z zdravilom Avastin v odmerku 7, 5 ali 15 mg/ kg v obliki i. v. infuzije na dan 1 vsakega tritedenskega cikla.
Study results show that 94% (277 / 296) of eligible patients went on to receive single agent bevacizumab at cycle 7.
Rezultati študije kažejo, da je 94% (277/ 296) primernih bolnikov s 7. ciklom nadaljevalo s samostojnim zdravljenjem z bevacizumabom.
The efficacy results are presented in Table 10.
Rezultati učinkovitosti so predstavljeni v preglednici 10.
20 Table 10
20 Preglednica 10.
Efficacy results for study BO17704
Rezultati učinkovitosti za študijo BO17704
Cisplatin/ Gemcitabine
gemcitabin /
Cisplatin/ Gemcitabine + placebo
gemcitabin / placebo
+ Avastin 7.5 mg/ kg q 3 weeks
7, 5 mg/ kg na 3 tedne
+ Avastin 15 mg/ kg q 3 weeks
15 mg/ kg na 3 tedne
Number of
Število bolnikov
Progression-Free Survival
Preživetje brez napredovanja bolezni
6.7 0.0026)
razmerje ogroženosti
0.75
0, 0301) 0, 82
0.82
Najboljši celokupni odgovor
[0.62; 0.91]
(p = 0, 62; 0, 91)
[0.68; 0.98]
(p = 0, 68; 0, 98)
Best Overall Response Rate a
deleža
30.4% (p=0.0023)
30, 4% (p = 0, 0023)
Avastin in Combination with Interferon alfa-2a for the First-Line Treatment of Advance and/ or Metastatic Renal Cell Cancer (BO17705)
Zdravilo Avastin v kombinaciji z interferonom alfa 2- a v prvi liniji zdravljenja napredovalega in/ ali metastatskega raka ledvičnih celic (BO17705)
This was a phase III randomised double-blind trial conducted to evaluate the efficacy and safety of Avastin in combination with interferon (IFN) alfa-2a (Roferon®) versus IFN alfa-2a alone as first-line treatment in mRCC.
Učinkovitost in varnost zdravila Avastin v kombinaciji z interferonom alfa- 2a (Roferon®) v primerjavi s samim interferonom alfa- 2a v prvi liniji zdravljenja metastatskega raka ledvičnih celic sta bili ovrednoteni v randomiziranem, dvojno slepem kliničnem preskušanju faze III.
The 649 randomized patients (641 treated) had Karnofsky Performance Status (KPS) of ≥ 70%, no CNS metastases and adequate organ function.
V klinično preskušanje je bilo randomiziranih 649 bolnikov (641 pa zdravljenih), njihovo stanje zmogljivosti po Karnofskem je bilo ≥ 70%, bili so brez zasevkov v centralnem živčnem sistemu, imeli so ustrezno organsko funkcijo.
Avastin 10 mg/ kg was given every 2 weeks until disease progression.
Zdravilo Avastin so prejemali v odmerku 10 mg/ kg vsaka dva tedna do napredovanja bolezni.
IFN alfa-2a was given up to 52 weeks or until disease progression at a recommend starting dose of 9 MIU three times a week, allowing a dose reduction to 3 MIU three times a week in 2 steps.
Interferon alfa- 2a so prejemali do 52 tednov ali do napredovanja bolezni, priporočeni začetni odmerek je bil 9 mio i. e. trikrat na teden, dovoljeno pa ga je bilo zmanjšati v dveh korakih na 3 mio i. e. trikrat na teden.
Patients were stratified according to country and Motzer score and the treatment arms were shown to be well balanced for the prognostic factors.
Bolnike so stratificirali po državah in glede na oceno napovednih dejavnikov po Motzer- ju; glede slednjih sta bili obe skupini dobro uravnoteženi.
28% with IFN alfa-2a +Avastin), and 251 died.
Ob zaključku zbiranja podatkov je bilo zabeleženih 505 dogodkov napredovanja bolezni, 111 bolnikov se je v tem času še zdravilo, 287 jih je z zdravljenjem že prenehalo (pri bolnikih, ki so jemali interferon alfa- 2a, je prišlo do ukinitve zdravljenja zaradi neželenih dogodkov v 12%, pri bolnikih, ki so jemali interferon alfa- 2a in zdravilo Avastin, pa v 28%), 251 bolnikov pa je že umrlo.
Ninety seven (97) patients in the IFN alfa-2a arm and 131 patients in the Avastin arm reduced the dose of IFN alfa-2a from 9 MIU to either 6 or 3 MIU three times a week as pre-specified in the protocol.
Sedemindevetdesetim (97) bolnikom iz skupine, ki je prejemala interferon alfa- 2a in 131 bolnikom iz skupine, ki je prejemala zdravilo Avastin, so v skladu s protokolom zmanjšali odmerek interferona alfa- 2a z 9 mio i. e. na 6 ali 3 mio i. e. trikrat na teden.
Dose-reduction of IFN alfa-2a did not appear to affect the efficacy of the combination of Avastin and IFN alfa-2a based on PFS event free rates over time, as shown by a sub-group analysis.
Zmanjšanje odmerka interferona alfa- 2a ni vplivalo na učinkovitost kombinacije zdravila Avastin in interferona alfa- 2a, kar je z deležem preživetja brez napredovanja bolezni v tem času potrdila analiza podskupine.
The 131 patients in the Avastin + IFN alfa-2a arm who reduced and maintained the IFN alfa-2a dose at 6 or 3 MIU during the study, exhibited at 6, 12 and 18 months PFS event free rates of 73, 52 and 21% respectively, as compared to 61, 43 and 17% in the total population of patients receiving Avastin + IFN alfa-2a.
Pri 131 bolnikih, pri katerih so v skupini, ki je prejemala zdravilo Avastin in interferon alfa- 2a, zmanjšali in vzdrževali odmerek interferona alfa- 2a med študijo na 6 ali 3 mio i. e., so deleži preživetja brez napredovanja bolezni znašali: po 6 mesecih 73%, po 12 mesecih 52% in po 18 mesecih 21%.
The addition of Avastin to IFN alfa-2a significantly increased PFS and objective tumour response rate (Table 11).
Dodatek zdravila Avastin k interferonu alfa- 2a je pomembno podaljšal preživetje brez napredovanja bolezni in pomembno povečal objektivni odgovor na zdravljenje (preglednica 11).
The overall survival (OS) data were not mature at the time of the interim analysis.
Celokupnega preživetja v času vmesne analize še ni bilo mogoče oceniti.
21 Table 11
21 Preglednica 11.
Efficacy Results for Study BO17705
Rezultati učinkovitosti študije BO17705
Placebo+ IFNa
bevacizumabb + a interferona placebo + interferon
Number of Patients
Število bolnikov Preživetje brez napredovanja bolezni
(p-value < 0.0001) Objective Response Rate (%) in Patients with Measurable Disease n
(p- vrednost < 0, 0001) Objektivni odgovor (%) pri bolnikih z merljivo boleznijo
Response rate
odgovor
Interferon alfa-2a 9 MIU 3x/ week b Bevacizumab 10 mg/ kg q 2 wk
interferon alfa- 2a 9 mio 3x/ teden b bevacizumab 10 mg/ kg vsake 2 tedna
This was a randomised, double-blind, phase II clinical study investigating Avastin 10 mg/ kg in a 2 weekly schedule with the same dose of Avastin in combination with 150 mg daily erlotinib, in patients with metastatic clear cell RCC.
To je bilo randomizirano, dvojno slepo klinično preskušanje faze II, ki je pri bolnikih z metastatskim svetloceličnim karcinomom ledvičnih celic proučevalo zdravilo Avastin, dajano v odmerku 10 mg/ kg v dvotedenski shemi in enak odmerek zdravila Avastin v kombinaciji s 150 mg erlotiniba na dan.
A total of 104 patients were randomised to treatment in this study, 53 to Avastin 10 mg/ kg every 2 weeks plus placebo and 51 to Avastin 10 mg/ kg every 2 weeks plus erlotinib 150 mg daily.
Skupno so v zdravljenje v tej študiji randomizirali 104 bolnike; 53 v skupino, ki je prejemala zdravilo Avastin 10 mg/ kg vsake 2 tedna in placebo ter 51 v skupino, ki je prejemala zdravilo Avastin 10 mg/ kg vsake 2 tedna in 150 mg erlotiniba na dan.
The analysis of the primary endpoint showed no difference between the Avastin + Placebo arm and the Avastin + Erlotinib arm (median PFS 8.5 versus 9.9 months).
Analiza primarnega cilja raziskave ni pokazala razlik med skupino z zdravilom Avastin + placebom in skupino z zdravilom Avastin + erlotinibom (mediana preživetja brez napredovanja bolezni 8, 5 v primerjavi z 9, 9 meseca).
The addition of erlotinib to bevacizumab did not result in an improvement in OS (HR = 1.764; p=0.1789), duration of objective response (6.7 vs 9.1 months) or time to symptom progression (HR = 1.172; p = 0.5076).
Dodatek erlotiniba bevacizumabu ni prispeval k izboljšanju celokupnega preživetja (HR = 1, 74; p = 0, 1789), trajanja objektivnega odgovora na zdravljenje (6, 7 v primerjavi z 9, 1 meseca) ali časa do napredovanja simptomov (HR = 1, 172; p = 0, 5076).
A total of 116 patients were randomized to receive bevacizumab 3 mg/ kg every 2 weeks (n=39), 10 mg/ kg every 2 weeks; (n=37), or placebo (n=40).
Skupno so 116 bolnikov randomizirali v skupino, ki je prejemala 3 mg/ kg bevacizumaba na 2 tedna (n = 39), v skupino, ki je prejamala 10 mg/ kg bevacizumaba na 2 tedna (n = 37) in v skupino, ki je prejemala placebo (n = 40).
An interim analysis showed there was a significant prolongation of the time to progression of disease in the 10 mg/ kg group as compared with the placebo group (hazard ratio, 2.55; p < 0.001).
Vmesna analiza je pokazala, da je čas do napredovanja bolezni pomembno podaljšan v skupini, ki je prejemala 10 mg/ kg v primerjavi s skupino, ki je prejemala placebo (razmerje ogroženosti 2, 55; p < 0, 001).
There was a small difference, of borderline significance, between the time to progression of disease in the 3 mg/ kg group and that in the placebo group (hazard ratio, 1.26; p=0.053).
Med skupino, ki je prejemala 3 mg/ kg bevacizumaba in skupino, ki je prejemala placebo, je obstajala majhna, mejna statistično značilna razlika v času do napredovanja bolezni (razmerje ogroženosti 1, 26; p = 0, 053).
Four patients had objective (partial) response, and all of these had received the 10 mg/ kg dose bevacizumab; the ORR for the 10 mg/ kg dose was 10%.
Celokupen odgovor za odmerek 10 mg/ kg je znašal 10%.
The pharmacokinetic data for bevacizumab are available from eight clinical trials in patients with solid tumours.
Na voljo so farmakokinetični podatki o bevacizumabu iz osmih kliničnih preskušanj pri bolnikih s solidnimi tumorji.
The pharmacokinetics of bevacizumab was linear at doses ranging from 1 to 10 mg/ kg.
Farmakokinetika bevacizumaba je bila linearna pri odmerkih v intervalu od 1 do 10 mg/ kg.
Absorption Not applicable.
22 Absorpcija Navedba smiselno ni potrebna.
22 Distribution Based on a population pharmacokinetic analysis of 491 subjects receiving Avastin weekly, every 2 weeks, or every 3 weeks, in doses ranging from 1 to 20 mg/ kg, the volume of the central compartment (Vc) was 2.92 l.
Porazdelitev Glede na analizo populacijske farmakokinetike 491 bolnikov, ki so prejemali zdravilo Avastin tedensko, vsake 2 tedna ali vsake 3 tedne, v odmerkih od 1 do 20 mg/ kg, je volumen osrednjega prostora (Vc) 2, 92 l.
Results also indicated that, after correcting for body weight, male subjects had a larger Vc (+ 22%) than females.
Rezultati kažejo, da imajo moški večji Vc (+ 22%) kot ženske, ko rezultate prilagodimo glede na telesno maso.
Metabolism Assessment of bevacizumab metabolism in rabbits following a single IV dose of 125I-bevacizumab indicated that its metabolic profile was similar to that expected for a native IgG molecule which does not bind VEGF.
Presnova Ocena presnove pri kuncih po enkratnem intravenskem odmerku 125I- bevacizumaba je pokazala, da ima bevacizumab podoben presnovni profil kot pričakovani za nativne molekule IgG, ki se ne vežejo na VEGF.
The metabolism and elimination of bevacizumab is similar to endogenous IgG i. e. primarily via proteolytic catabolism throughout the body, including endothelial cells, and does not rely primarily on elimination through the kidneys and liver.
To poteka v glavnem s proteolitično razgradnjo po celem telesu, tudi v endotelijskih celicah, ni pa predvsem odvisno od izločanja preko ledvic in jeter.
Binding of the IgG to the FcRn receptor result in protection from cellular metabolism and the long terminal half-life.
Z vezavo na receptor FcRn se IgG zaščiti pred celično presnovo, zato se podaljša njegov končni razpolovni čas.
Elimination Bevacizumab clearance was 0.231 l/ day.
Izločanje Očistek bevacizumaba je bil 0, 231 l/ dan.
The volume of the central compartment (Vc) and clearance correspond to an initial half-life of 1.4 days and a terminal half-life of about 20 days.
Volumen osrednjega prostora (Vc) in očistek ustrezata začetni razpolovni dobi 1, 4 dneva in končni razpolovni dobi približno 20 dni.
This half-life is consistent with the terminal elimination half-life for human endogenous IgG, which is 18 to 23 days.
Ta razpolovna doba je primerljiva s končno razpolovno dobo izločanja za humani endogeni IgG, ki je od 18 do 23 dni.
In patients with low albumin (≤ 29g/ l) and high alkaline phosphatase (≥ 484U/ l) (both markers of disease severity), clearance was approximately 20% higher than in patients with median laboratory values.
Pri bolnikih z nizkimi vrednostmi albuminov (≤ 29 g/ l) in visokimi vrednostmi za alkalno fosfatazo (≥ 484 e/ l) (oba sta kazalca obsežnosti bolezni), je bil očistek za približno 20% večji kot pri bolnikih s srednjimi laboratorijskimi vrednostmi.
Pharmacokinetics in Special Populations The population pharmacokinetics were analysed to evaluate the effects of demographic characteristics.
Farmakokinetika pri posebnih populacijah Vpliv demografskih značilnosti na farmakokinetiko so proučili z analizo populacijske farmakokinetike.
The pharmacokinetics of bevacizumab have been studied in a limited number of paediatric patients.
Otroci in mladostniki: študije za proučevanje farmakokinetike bevacizumaba so bile izvedene pri omejenem številu pediatričnih bolnikov.
The resulting pharmacokinetic data suggest that the volume of distribution and clearance of bevacizumab were comparable to that in adults with solid tumours.
Končni izsledki farmakokinetičnih podatkov kažejo, da sta bila volumen porazdelitve in očistek bevacizumaba primerljiva s tistima pri odraslih bolnikih s solidnimi tumorji.
No studies have been conducted to investigate the pharmacokinetics of bevacizumab in renally impaired patients since the kidneys are not a major organ for bevacizumab metabolism or excretion.
Ledvična okvara: študij za proučevanje farmakokinetike bevacizumaba pri bolnikih z zmanjšanim delovanjem ledvic niso opravili, ker ledvice niso glavni organ za presnovo ali izločanje bevacizumaba.
No studies have been conducted to investigate the pharmacokinetics of bevacizumab in patients with hepatic impairment since the liver is not a major organ for bevacizumab metabolism or excretion.
Jetrna okvara: študij za proučevanje farmakokinetike bevacizumaba pri bolnikih z zmanjšanim delovanjem jeter niso opravili, ker jetra niso glavni organ za presnovo ali izločanje bevacizumaba.
An adverse effect on female fertility can however be expected as repeat dose toxicity studies in animals have shown inhibition of the maturation of ovarian follicles and a decrease/ absence of corpora lutea and associated decrease in ovarian and uterus weight as well as a decrease in the number of menstrual cycles.
Pričakovan pa je škodljivi učinek na plodnost žensk, saj so študije toksičnosti pri večkratnih odmerkih na živalih pokazale zaviranje zorenja ovarijskih foliklov in zmanjšanje/ odsotnost rumenega telesca ter s tem povezano zmanjšanje mase jajčnika in maternice ter zmanjšanje števila menstrualnih ciklov.