natgillin/translations-raw huggingface dataset:
Tell your doctor immediately if you have signs of an infection while taking this medicine.
Takoj povejte zdravniku, če med jemanjem tega zdravila opazite znake okužbe.
The effect of multiple doses of venetoclax up to 1200 mg once daily on the QTc interval was evaluated in an open-label, single-arm study in 176 patients.
Vpliv večkratnih odmerkov do 1200 mg venetoklaksa enkrat na dan na interval QTc so ocenili v odprti študiji z eno skupino 176 bolnikov.
Fatigue has been reported in some patients taking venetoclax and should be considered when assessing a patient's ability to drive or operate machines.
Pri nekaterih bolnikih, ki so jemali venetoklaks, so poročali o utrujenosti, kar je treba upoštevati, ko se ocenjuje bolnikovo sposobnost vožnje in upravljanja strojev.
The instructions for “Prevention of tumour lysis syndrome” should be followed (see section 4.2).
Upoštevajte navodila za »Preprečevanje sindroma tumorske lize« (glejte poglavje 4.2).
The overall safety profile of Venclyxto is based on data from 546 patients with CLL treated in clinical trials with venetoclax in combination with rituximab or as monotherapy.
Celoten varnostni profil zdravila Venclyxto temelji na podatkih 546 bolnikov s KLL, ki so v kliničnih študijah bili zdravljeni z venetoklaksom v kombinaciji z rituksimabom ali z monoterapijo.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine.
Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden vzamete to zdravilo.
Take the next dose at the usual time the next day.
Naslednji odmerek vzemite naslednji dan ob običajnem času.
No human data on the effect of venetoclax on fertility are available.
Podatki o vplivu venetoklaksa na plodnost pri ljudeh niso na voljo.
Venetoclax also caused single cell necrosis in various tissues, including the gallbladder and exocrine pancreas, with no evidence of disruption of tissue integrity or organ dysfunction; these findings were minimal to mild in magnitude.
Venetoklaks je povzročil tudi nekrozo posamičnih celic v različnih tkivih, med drugim v žolčniku in eksokrinem pankreasu, a brez prizadetosti integritete tkiv in brez motenega delovanja organov; te spremembe so bile minimalne do blage.
Changes in electrolytes consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of venetoclax and at each dose increase.
Spremembe v elektrolitih, ki so skladne s TLS in zahtevajo takojšnje ukrepanje, se lahko pojavijo že v 6 do 8 urah po prvem odmerku venetoklaksa in ob vsakem povečanju odmerka.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake Uporabno do.
Treatment with venetoclax should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
4.2 Odmerjanje in način uporabe Zdravljenje z venetoklaksom mora začeti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
The pharmacokinetics of venetoclax do not change over time.
Farmakokinetika venetoklaksa se sčasoma ne spreminja.
24-month PFS estimate (95% CI) CI = confidence interval; NR = not reached aStratified P-value.
12-mesečna ocena PFS (95% IZ) 24- mesečna ocena PFS (95% IZ) IZ = interval zaupanja; NR = ni doseženo arazčlenjena P-vrednost.
If you vomit after taking Venclyxto, do not take an extra dose that day.
Če ste po jemanju zdravila Venclyxto bruhali, tisti dan ne vzemite nobenega dodatnega odmerka.
During dose-titration phase, treatment should be interrupted and patients should be monitored carefully for signs and symptoms of TLS (fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, muscle or joint pain, abdominal pain and distension) along with other toxicities (see section 4.2).
Med fazo titracije odmerka je treba zdravljenje prekiniti in bolnike skrbno spremljati glede znakov in simptomov TLS (zvišana telesna temperatura, mrzlica, navzea, bruhanje, zmedenost, kratka sapa, napadi krčev, neenakomeren srčni utrip, temen ali moten urin, nenavadna utrujenost, bolečina v mišicah ali sklepih, bolečina v trebuhu in napihnjenost) poleg drugih toksičnosti (glejte poglavje 4.2).
Supportive measures including antimicrobials for any signs of infection should be considered.
V primeru kakršnih koli znakov okužbe je treba razmisliti o podpornih ukrepih, vključno z antibiotiki.
Women of childbearing potential must use a highly effective method of contraception while taking venetoclax (see section 4.6).
Ženske v rodni dobi morajo med jemanjem venetoklaksa uporabljati visoko učinkovito metodo kontracepcije (glejte poglavje 4.6).
Patients should be instructed to drink plenty of water daily starting 2 days before and throughout the dose-titration phase.
Bolnikom je treba naročiti, naj na dan popijejo veliko vode; začnejo naj 2 dni pred in nadaljujejo vso fazo titracije odmerka.
Grade 3 neutropenia was reported in 32% of patients and grade 4 neutropenia in 26% of patients.
O nevtropeniji 3. stopnje so poročali pri 32 % bolnikov in o nevtropeniji 4. stopnje pri 26 % bolnikov.
What you need to know before you take Venclyxto Do not take Venclyxto if:
Kaj morate vedeti, preden boste vzeli zdravilo Venclyxto Ne jemljite zdravila Venclyxto, če:
Adverse reactions are listed below by MedDRA body system organ class and by frequency.
Neželeni učinki so spodaj navedeni po organskih sistemih MedDRA in pogostnosti.
Minimal residual disease (MRD) was evaluated using flow cytometry in 93 of 158 patients who achieved complete remission (CR), complete remission with incomplete marrow recovery (CRi), or partial remission (PR) with limited remaining disease with venetoclax treatment.
Stanje minimalne rezidualne bolezni (MRD - Minimal Residual Disease) so ocenili s pretočno citometrijo pri 93 od 158 bolnikov, ki so z venetoklaksom dosegli popolno remisijo (CR), popolno remisijo z nepopolnim okrevanjem kostnega mozga (CRi) ali delno remisijo (PR) z omejeno preostalo boleznijo.
All six patients completed the dose titration and reached the recommended daily dose of 400 mg of venetoclax.
Vseh šest bolnikov je zaključilo titracijo odmerka in doseglo priporočeni dnevni odmerek 400 mg venetoklaksa.
It is very important that you drink plenty of water when taking Venclyxto during the first 5 weeks of treatment.
Zelo pomembno je, da v prvih 5 tednih jemanja zdravila Venclyxto pijete veliko vode.
It is unknown whether venetoclax or its metabolites are excreted in human milk.
Ni znano ali se venetoklaks ali njegovi presnovki izločajo v materino mleko.
Venclyxto film-coated tablets are supplied in PVC/PE/PCTFE aluminium foil blisters containing either 1, 2 or 4 film-coated tablets.
Filmsko obložene tablete zdravila Venclyxto so pakirane v pretisnem omotu iz PVC/PE/PCTFE in aluminijaste folije, ki vsebuje 1, 2 ali 4 filmsko obložene tablete.
Patients in the Venclyxto + rituximab arm completed the Venclyxto 5-week dose-titration schedule and then received 400 mg once daily for 24 months from Cycle 1 Day 1 of rituximab in the absence of disease progression or unacceptable toxicity.
Bolniki v skupini Venclyxto + rituksimab so zaključili 5-tedensko shemo titracije odmerka zdravila Venclyxto in so nato prejemali 400 mg enkrat na dan 24 mesecev od 1. dne 1. cikla rituksimaba v odsotnosti napredovanja bolezni ali nesprejemljive toksičnosti.
MURANO was a randomised, controlled trial in which 194 patients with previously treated CLL received venetoclax in combination with rituximab.
MURANO je bilo randomizirano, kontrolirano preskušanje, v katerem je 194 bolnikov s predhodno zdravljeno KLL, prejelo venetoklaks v kombinaciji z rituksimabom.
Take your dose at the same time each day with a meal and water.
Vzemite vaš odmerek vsak dan ob istem času z vodo ob obroku.
Because venetoclax was not dosed to steady state, it is recommended that the international normalized ratio (INR) be monitored closely in patients receiving warfarin.
Ker venetoklaks ni bil odmerjan do stalnega odmerka, se pri bolnikih, ki prejemajo varfarin, priporoča skrbno spremljanje mednarodnega normaliziranega razmerja (INR).
Reduced renal function (creatinine clearance [CrCl] <80 ml/min) further increases the risk.
Zmanjšano delovanje ledvic (očistek kreatinina [CrCL] <80 ml/min) dodatno poveča tveganje.
Your doctor will advise what your dose should be.
Zdravnik vam bo svetoval,
No TLS with clinical consequences such as acute renal failure, cardiac arrhythmias or sudden death and/or seizures was observed in these patients.
Pri teh bolnikih niso opazili nobenega primera TLS s kliničnimi posledicami kot so akutna odpoved ledvic, srčne aritmije ali nenadna smrt in/ali napadi krčev.
The efficacy and safety of venetoclax in patients with CLL who had been previously treated with and failed ibrutinib or idelalisib therapy were evaluated in an open-label, multi-center, non-randomised, phase 2 study
Učinkovitost in varnost venetoklaksa pri bolnikih s KLL, predhodno neuspešno zdravljenih z ibrutinibom ali idelalisibom, so ovrednotili v odprti, multicentrični nerandomizirani študiji 2. faze
If your doctor thinks that you are at risk of TLS, you may be treated in the hospital so that you can be given extra fluids into the vein if needed, have your blood tests more often and be checked for side effects.
Če vaš zdravnik meni, da pri vas obstaja tveganje za TLS, vas bodo morda zdravili v bolnišnici, da boste lahko prejeli dodatno tekočino v veno, če bo potrebno, pogosteje vam bodo opravljali preiskave krvi in vas spremljali glede neželenih učinkov.
Signs may include fever, chills, feeling weak or confused, cough, pain or burning feeling when passing urine.
Znaki lahko vključujejo zvišano telesno temperaturo, mrzlico, občutek šibkosti ali zmedenosti, kašelj, bolečino ali pekoči občutek pri uriniranju.
The primary efficacy endpoint was ORR according to IWCLL updated NCI-WG guidelines.
Primarni opazovani dogodek učinkovitost je bil ORR na podlagi smernic NCI-WG v posodobitvi
• higher level of a body salt (electrolyte) called phosphate
• povečane vrednosti soli v telesu (elektrolita), imenovane fosfat • nizko vrednost kalcija
• feeling short of breath
• občutek kratke sape
• If it is less than 8 hours since the time you usually take your dose, take it as soon as possible.
• Če je od časa, ko običajno vzamete vaš odmerek, minilo manj kot 8 ur, ga vzemite čim prej.
If a narrow therapeutic index P-gp or BCRP substrate must be used, it should be used with caution.
Če je uporaba P-gp ali BCRP substrata z ozkim terapevtskim indeksom nujna, ga je treba uporabiti previdno.
This protein helps cancer cells survive.
Ta beljakovina rakavim celicam pomaga preživeti.
Total (N=127)
Skupaj (N = 127)
A 17p deletion was detected in 26.9% of patients, TP53 mutations in 26.3%, 11q deletion in 36.5%, and unmutated IgVH gene in 68.3%.
Pri 26,9 % bolnikov je bila ugotovljena 17p delecija, TP53 mutacije pri 26,3 %, delecija 11q pri 36,5 % in nemutirani IgVH gen pri 68,3 %.
Post-dose: For patients at risk of TLS, blood chemistries should be monitored at 6 to 8 hours and at 24 hours after the first dose of venetoclax.
Po odmerku: Pri bolnikih, pri katerih obstaja tveganje za TLS, je treba krvne preiskave narediti 6 do 8 ur in 24 ur po prvem odmerku venetoklaksa.
- you are taking a herbal medicine called St. John's wort, used for depression.
- jemljete zdravilo rastlinskega izvora iz šentjanževke, ki se uporablja pri depresiji.
Venetoclax is a substrate for P-gp and BCRP.
Venetoklaks je substrat za P-gp in BCRP.
Tell your doctor if you notice any of the following side effects: Very common
Povejte zdravniku, če opazite katerega od naslednjih neželenih učinkov:
The film-coated tablets are supplied in cartons containing either 7 (in blisters of 1 tablet) or 14 tablets (in blisters of 2 tablets); or a multipack containing 112 tablets (4 x 28 tablets (in blisters of 4 tablets)).
Filmsko obložene tablete so pakirane v škatlah, ki vsebujejo 7 (v pretisnih omotih po 1 tableto) ali 14 tablet (v pretisnih omotih po 2 tableti); ali v večkratnem pakiranju, ki vsebuje 112 tablet (4 x 28 tablet (v pretisnih omotih po 4 tablete)).
This may lead to changes in kidney function, abnormal heartbeat, or seizures.
To lahko povzroči spremembo v delovanju ledvic, do neenakomernega srčnega utripa ali napada krčev.
Pharmacotherapeutic group: other antineoplastic agents, ATC code: L01XX52
Farmakoterapevtska skupina: druga zdravila z delovanjem na novotvorbe, oznaka ATC: L01XX52 Mehanizem delovanja
Patients with reduced renal function (CrCl <80 ml/min) may require more intensive prophylaxis and monitoring to reduce the risk of TLS at initiation and during the dose-titration phase (see “Prevention of tumour lysis syndrome” above).
Bolniki z zmanjšanim delovanjem ledvic (CrCL < 80 ml/min) bodo morda potrebovali bolj intenzivno profilakso in spremljanje, da se zmanjša tveganje za TLS na začetku zdravljenja in med fazo titracije odmerka (glejte »Preprečevanje sindroma tumorske lize« zgoraj).
MRD negativity rate at end of combination treatmentb
MRD negativni rezultati ob koncu kombiniranega zdravljenjab
The starting dose is 20 mg of venetoclax once daily for 7 days.
Začetni odmerek je 20 mg venetoklaksa enkrat na dan, 7 dni.
The next venetoclax dose should not be administered until the 24-hour blood chemistry results have been evaluated.
Naslednjega odmerka venetoklaksa se ne sme dati, dokler niso ocenjeni rezultati preiskave krvi, ki je bila odvzeta 24 ur po prvem odmerku.
Laboratory assessments
Laboratorijski izvidi
Venetoclax in combination with rituximab for the treatment of patients with CLL who have received at least one prior therapy - study GO28667 (MURANO)
Venetoklaks v kombinaciji z rituksimabom za zdravljenje bolnikov s KLL, ki so predhodno prejeli vsaj eno zdravljenje - študija GO28667 (MURANO)
In the open-label, randomised phase 3 study (MURANO), the incidence of TLS was 3% (6/194) in patients treated with venetoclax + rituximab.
V odprti, randomizirani študiji 3. faze (MURANO), je bila pojavnost TLS 3 % (6/194) pri bolnikih zdravljenih z venetoklaksom + rituksimabom.
• feeling unusually tired
• občutek nenavadne utrujenosti
Mild hepatic impairment was defined as normal total bilirubin and aspartate transaminase (AST) > upper limit of normal (ULN) or total bilirubin >1.0 to 1.5 times ULN, moderate hepatic impairment as total bilirubin >1.5 to 3.0 times ULN, and severe hepatic impairment as total bilirubin >3.0 ULN.
Blaga okvara jeter je bila opredeljena kot normalen celokupni bilirubin in aspartat-transaminaza (AST) nad zgornjo normalno mejo (ZNM) ali kot celokupni bilirubin > 1,0- do 1,5-kratna ZNM, zmerna okvara kot celokupni bilirubin > 1,5- do 3,0kratna ZNM in huda okvara jeter kot celokupni bilirubin > 3,0-kratna ZNM.
Also some other medicines can affect the way Venclyxto works.
Tudi druga zdravila lahko vplivajo na način delovanja zdravila Venclyxto.
Venclyxto in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
Zdravilo Venclyxto v kombinaciji z rituksimabom je indicirano za zdravljenje odraslih bolnikov s kronično limfocitno levkemijo (KLL), ki so predhodno prejeli vsaj eno zdravljenje.
Based on embryo-foetal toxicity studies in animals (see section 5.3), venetoclax may harm the foetus when administered to pregnant women.
Nosečnost Na podlagi študij embriofetalne toksičnosti na živalih (glejte poglavje 5.3) lahko venetoklaks, če se ga da nosečnicam, škoduje plodu.
Based on testicular toxicity in dogs at clinically relevant exposures, male fertility may be compromised by treatment with venetoclax (see section 5.3).
Na podlagi toksičnosti za testise pri psih pri klinično pomembni izpostavljenosti lahko zdravljenje z venetoklaksom vpliva na plodnost pri moških (glejte poglavje 5.3).
Substrates of P-gp, BCRP, and OATP1B1
Substrati P-gp, BCRP in OATP1B1
Blood chemistry (potassium, uric acid, phosphorus, calcium, and creatinine) should be assessed and pre-existing abnormalities corrected.
Oceniti je treba rezultate krvnih preiskav (kalij, sečna kislina, fosfor, kalcij in kreatinin) in popraviti obstoječe nepravilnosti.
In the initial Phase 1 dose-finding studies, which had a shorter (2 to 3 week) titration phase and higher starting dose, the incidence of TLS was 13% (10/77; 5 laboratory TLS; 5 clinical TLS), including 2 fatal events and 3 events of acute renal failure, 1 requiring dialysis.
začetni 1. fazi študij za določanje odmerka, ki so imele krajšo fazo titracije (2 do 3 tedne) in večji začetni odmerek, je bila pojavnost TLS 13 % (10/77; 5 laboratorijskih TLS; 5 kliničnih TLS), vključno z 2 smrtnima primeroma in 3 primeri akutne odpovedi ledvic, 1 od teh je zahteval dializo.
This is called tumour lysis syndrome (TLS).
To se imenuje sindrom tumorske lize (TLS- tumour lysis syndrome).
• itraconazole ketoconazole, posaconazole, or voriconazole for fungal infections
• itrakonazol, ketokonazol, posakonazol ali vorikonazol za zdravljenje glivičnih okužb,
Based on physician assessment, some patients, especially those at greater risk of TLS, may require hospitalisation on the day of the first dose of venetoclax for more intensive prophylaxis and monitoring during the first 24 hours (see section 4.8).
Nekateri bolniki, še posebno tisti pri katerih obstaja večje tveganje za TLS, bodo na podlagi ocene zdravnika, na dan, ko bodo prejeli prvi odmerek venetoklaksa, morda potrebovali hospitalizacijo za intenzivnejšo profilakso in spremljanje v prvih 24 urah (glejte poglavje 4.8).
It is not known whether the active substance in Venclyxto passes into breast milk.
Ni znano ali učinkovina v zdravilu Venclyxto prehaja v materino mleko.
You should start drinking at least 1.5 to 2 litres of water daily two days before starting Venclyxto.
Začnite s pitjem vsaj 1,5 do 2 litrov vode na dan dva dni pred začetkom zdravljenja z zdravilom Venclyxto.
Patients should be monitored more closely for signs of toxicities (see sections 4.4 and 4.5).
Bolnike je treba bolj skrbno spremljati glede znakov toksičnosti (glejte poglavji 4.4 in 4.5).
Venetoclax is predominantly metabolised by CYP3A.
Venetoklaks se presnavlja predvsem s CYP3A.
Efficacy results for PFS at the time of pre-specified primary analysis (data cut-off date 8 May 2017) are shown in Table 4.
Rezultati učinkovitosti za preživetje brez napredovanja bolezni v času vnaprej določene primarne analize (upoštevani so podatki do 8. maja 2017) so prikazani v tabeli 4.
At the time of evaluation, median duration of treatment with venetoclax was 14.3 months (range: 0.1 to 31.4 months).
Ob času ovrednotenja je zdravljenje z venetoklaksom mediano trajalo 14,3 mesecev (razpon: od 0,1 do 31,4 mesecev).
Blood creatinine increased aOnly the highest frequency observed in the trials is reported (based on studies MURANO, M13-982, M14032, and M12-175).
Preiskave pogosti povečana vrednost kreatinina v krvi občasni povečana vrednost kreatinina v krvi aPoroča se samo o najvišji frekvenci, ugotovljeni v preskušanjih (na podlagi študij MURANO, M13-982, M14-032 in M12-175).
Venetoclax steady state AUC increased proportionally over the dose range of 150-800 mg.
AUC venetoklaksa se je v stanju dinamičnega ravnovesja v razponu odmerkov od 150 do 800 mg povečevala sorazmerno.
In venetoclax clinical studies, patients with any measurable lymph node ≥10 cm or those with both an ALC ≥25 x 109/l and any measurable lymph node ≥5 cm were hospitalised to enable more intensive hydration and monitoring for the first day of dosing at 20 mg and 50 mg during the titration phase (see section 4.2).
V kliničnih študijah z venetoklaksom so bili bolniki s katero koli bezgavko, ki je merila ≥ 10 cm, ali tisti z ALC ≥ 25 x 109/l in katero koli bezgavko, ki je merila ≥ 5 cm, hospitalizirani, da je bila možna intenzivnejša hidracija in spremljanje na prvi dan odmerjenja 20 mg in 50 mg med fazo titracije (glejte poglavje 4.2).
Eighteen patients in the venetoclax + rituximab arm and 3 patients in the bendamustine + rituximab arm had negative bone marrow and lymph nodes <2 cm. bMinimal residual disease was evaluated using allele-specific oligonucleotide polymerase chain reaction (ASO-PCR) and/or flow cytometry.
Osemnajst bolnikov v skupini venetoklaks + rituksimab in 3 bolniki v skupini bendamustin + rituksimab je imelo negativne rezultate po izvidu kostnega mozga in limfne vozle <2 cm. bMinimalna rezidualna bolezen je bila ovrednotena z verižno reakcijo z alel-specifično oligonukleotidno polimerazo (ASO-PCR) in/ali s pretočno citometrijo.
Patients continued to receive venetoclax 400 mg once daily until disease progression or unacceptable toxicity was observed.
Bolniki so nato prejemali 400 mg venetoklaksa enkrat na dan do napredovanja bolezni ali pojava nesprejemljivih toksičnih učinkov.
Co-administration of bile acid sequestrants with venetoclax is not recommended as this may reduce the absorption of venetoclax.
Sočasno dajanje izmenjevalcev žolčnih kislin z venetoklaksom ni priporočljivo, saj lahko zmanjša absorpcijo venetoklaksa.
The risk may decrease as tumour burden decreases with venetoclax treatment (see section 4.4).
Tveganje se lahko zmanjša z zmanjšanjem tumorske obremenitve pri zdravljenju z venetoklaksom (glejte poglavje 4.4).
You will begin treatment with Venclyxto at a low dose for 1 week.
Zdravljenje z zdravilom Venclyxto boste začeli z majhnim odmerkom, kar bo trajalo 1 teden.
• you are due to have a vaccine.
• boste cepljeni.
Venclyxto is a cancer medicine that contains the active substance venetoclax.
Zdravilo Venclyxto je zdravilo za zdravljenje raka, ki vsebuje učinkovino venetoklaks.
- Do not get pregnant while you are taking this medicine.
Nosečnost - Ne zanosite med jemanjem tega zdravila.
Tumour lysis syndrome is an important identified risk when initiating venetoclax.
Sindrom tumorske lize Sindrom tumorske lize je pomembno ugotovljeno tveganje ob začetku zdravljenja z venetoklaksom.
aThe discrepancy between IRC- and investigator-assessed CR rate was due to interpretation of residual adenopathy on CT scans.
aRazlika med CR vrednostjo ocenjeno s strani IRC in tisto s strani raziskovalca je bila posledica interpretacije preostale adenopatije pri računalniški tomografiji (CT).
Grade 3 or 4 neutropenia has been reported in patients treated with venetoclax in the combination study with rituximab (GO28667/MURANO) and in the monotherapy studies (see section 4.8).
Pri bolnikih, ki so se zdravili z venetoklaksom, so poročali o nevtropeniji 3. ali 4. stopnje v kombinirani študiji z rituksimabom (GO28667/MURANO) in v študijah z monoterapijo (glejte poglavje 4.8).
Rituximab was initiated after the 5-week dose-titration schedule at 375 mg/m2 for Cycle 1 and 500 mg/m2 for Cycles 26.
Rituksimab so začeli prejemati po 5-tedenski shemi titriracije odmerka pri 375 mg/m2 za 1. cikel in 500 mg/m2 pri ciklusih 2-6.
Testicular toxicity (germ cell loss) was observed in general toxicity studies in dogs at exposures of 0.5 to 18 times the human AUC exposure at the recommended dose.
Toksičnost za moda (izguba zarodnih celic) je bila opažena v splošnih študijah toksičnosti pri psih pri 0,5- do 18-kratni izpostavljenosti glede na izpostavljenost pri človeku (AUC) ob uporabi priporočenega odmerka.
Venetoclax is not expected to inhibit OATP1B3, OCT1, OCT2, OAT1, OAT3, MATE1 or MATE2K at clinically relevant concentrations.
Ni pričakovati, da bi venetoklaks v klinično pomembni koncentraciji zaviral OATP1B3, OCT1, OCT2, OAT1, OAT3, MATE1 ali MATE2K.
In embryo-foetal development studies in mice, venetoclax was associated with increased post-implantation loss and decreased foetal body weight at exposures of 1.1 times the human AUC exposure at the recommended dose.
V študijah embrio-fetalnega razvoja pri miših je bil venetoklaks povezan z večjo postimplantacijsko izgubo in zmanjšanjem mase telesa ploda pri 1,1-kratni izpostavljenosti glede na izpostavljenost pri človeku (AUC) ob uporabi priporočenega odmerka.