natgillin/translations-raw huggingface dataset:
Tell your doctor or pharmacist if you take any of the following medicines as they can increase or decrease the amount of venetoclax in your blood: 
Obvestite zdravnika ali farmacevta, če jemljete katero od naslednjih zdravil, ker lahko ta zvečajo ali zmanjšajo količino venetoklaksa v krvi:
All events of TLS occurred during the venetoclax dose-titration phase and resolved within two days. 
Vsi primeri TLS so se pojavili med fazo titracije odmerka venetoklaksa in so bili odpravljeni v dveh dneh.
The tablets should be taken with a meal in order to avoid a risk for lack of efficacy (see section 5.2). 
Tablete je potrebno vzeti ob obroku, tako se izognemo tveganju za pomanjkanje učinkovitosti (glejte poglavje 5.2).
Of the 130 patients, 92 patients completed the 6-month post treatment follow-up visit. 
Od 130 bolnikov je 92 bolnikov opravilo kontrolni obisk 6 mesecev po zdravljenju.
During the dose-titration phase, venetoclax should be taken in the morning to facilitate laboratory monitoring. 
Med fazo titracije odmerka je treba venetoklaks vzeti zjutraj, da se olajša izvajanje laboratorijskih preiskav.
The mean blood-to-plasma ratio was 0.57. 
Povprečno razmerje med krvjo in plazmo je bilo 0,57.
You may also include non-alcoholic and non-caffeinated drinks in this amount, but exclude grapefruit, Seville orange, or starfruit (carambola) juices. 
V to količino lahko vključite tudi brezalkoholne in brezkofeinske pijače, toda izključite sokove iz grenivke, seviljske pomaranče ali zvezdnega sadeža (karambole).
At the time of data cut-off (26 July 2017), 127 patients were enrolled and treated with venetoclax. 
V času zamejitve podatkov (26 julij 2017) je bilo vključenih in z venetoklaksom zdravljenih
Some people may develop unusual levels of some body salts (such as potassium and uric acid) in the blood caused by the fast breakdown of cancer cells during treatment. 
Pri nekaterih ljudeh se lahko razvijejo nenavadne vrednosti nekaterih soli (kot so kalijeve soli in soli sečne kisline) v krvi zaradi hitrega razpada rakavih celic med zdravljenjem.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic safety update reports 
C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM • Redno posodobljena poročila o varnosti zdravila (PSUR)
If you are using hormonal contraceptive pills or devices, you must also use a barrier method of contraception (such as condoms) as the effect of hormonal contraceptive pills or devices may be affected by Venclyxto. 
Če uporabljate hormonske kontracepcijske tabletke ali pripomočke, morate uporabiti tudi pregradno metodo kontracepcije (kot so kondomi), ker lahko zdravilo Venclyxto vpliva na učinke kontracepcijskih tabletk ali pripomočkov.
Take your dose in the morning with a meal and water. 
Vzemite vaš odmerek zjutraj z vodo ob obroku.
Patients should be monitored more closely for signs of toxicities and the dose may need to be further adjusted. 
Bolnike je treba bolj skrbno spremljati glede znakov toksičnosti in odmerek je morda potrebno dodatno prilagoditi.
EU/1/16/1138/001 (10 mg, 10 tablets) EU/1/16/1138/002 (10 mg, 14 tablets) EU/1/16/1138/003 (50 mg, 5 tablets) EU/1/16/1138/004 (50 mg, 7 tablets) EU/1/16/1138/005 (100 mg 7 tablets) EU/1/16/1138/006 (100 mg, 14 tablets) EU/1/16/1138/007 (100 mg, 112 (4 x 28) tablets) 
EU/1/16/1138/001 (10 mg, 10 tablet) EU/1/16/1138/002 (10 mg, 14 tablet) EU/1/16/1138/003 (50 mg, 5 tablet) EU/1/16/1138/004 (50 mg, 7 tablet) EU/1/16/1138/005 (100 mg 7 tablet) EU/1/16/1138/006 (100 mg, 14 tablet) EU/1/16/1138/007 (100 mg, 112 (4 x 28) tablet)
Unchanged venetoclax accounted for 20.8% of the administered radioactive dose excreted in faeces. 
Nespremenjeni venetoklaks je predstavljal 20,8 % uporabljenega radioaktivnega odmerka, izločenega v blatu.
If you have problems taking this medicine, talk to your doctor. 
Če imate težave z jemanjem tega zdravila, se posvetujte z zdravnikom.
12-month estimate 
12- mesečna ocena
• a medicine for cancer known as everolimus 
• zdravilo za zdravljenje raka poznano kot everolimus
The dose must be gradually increased over a period of 5 weeks up to the daily dose of 400 mg as shown in Table 1. 
Odmerek je treba v obdobju 5 tednov postopoma povečevati do dnevnega odmerka 400 mg kot je prikazano v preglednici 1.
Venetoclax had no effect on QTc interval and there was no relationship between venetoclax exposure and change in QTc interval. 
Venetoklaks ni vplival na interval QTc in ugotovili niso nobene povezave med izpostavljenostjo venetoklaksu in spremembo intervala QTc.
Patients should be monitored more closely for signs and symptoms of TLS. 
Bolnike je treba bolj skrbno spremljati glede znakov in simptomov TLS.
The next prescribed dose should be taken at the usual time the following day. 
Naslednji predpisani odmerek je treba vzeti naslednji dan ob običajnem času.
The risk for TLS is in the first 5 weeks of treatment with Venclyxto. 
Tveganje za pojav TLS je v prvih 5 tednih zdravljenja z zdravilom Venclyxto.
Kaplan-Meier curves of investigator-assessed PFS from the updated efficacy analysis are shown in Figure 1. 
Krivulje Kaplan-Meier za vrednosti PFS iz posodobljene analize učinkovitosti ocenjene s strani raziskovalca so prikazane na sliki 1.
The safety and efficacy of immunisation with live attenuated vaccines during or following venetoclax therapy have not been studied. 
Varnosti in učinkovitosti imunizacije z živimi oslabljenimi cepivi med ali po zdravljenju z venetoklaksom niso preučevali.
Table 1: Dose increase schedule 
Preglednica 1: Načrt za povečevanje odmerka
Effects of age, sex, and weight 
Vplivi starosti, spola in telesne mase
It belongs to a group of medicines called “BCL-2 inhibitors”. 
Spada v skupino zdravil, imenovanih “zaviralci BCL-2”.
Tell your doctor, pharmacist or nurse immediately if you get any of the symptoms of TLS listed in section 4. 
Takoj obvestite zdravnika, farmacevta ali medicinsko sestro, če se pri vas pojavi kateri od simptomov TLS, navedenih v poglavju 4.
Drink the same amount of water (at least 1.5 to 2 litres daily) two days before and on the day that your dose is increased. 
Enako količino vode popijte (vsaj 1,5 do 2 litrov na dan) dva dni pred in na dan, ko vam bodo povečali odmerek zdravila.
Efficacy data are presented for 107 patients with data cutoff date 30 April 2015. 
Podatki o učinkovitosti so predstavljeni za 107 bolnikov z datumom zamejitve podatkov 30. aprila
Additional efficacy results in MURANO Investigator assessed 
Dodatni rezultati učinkovitosti v študiji MURANO
Bone marrow, % (95% CI)d 15.5(10.7, 21.3) 
Kostni mozeg, %(95 % IZ)d 15.5(10.7, 21.3)
If resolved within 24 to 48 hours of last dose, treatment with venetoclax can be resumed at the same dose. 
Če se stanje popravi v 24 do 48 urah po zadnjem odmerku, se lahko zdravljenje z venetoklaksom nadaljuje z enakim odmerkom.
Venclyxto with food and drink 
Zdravilo Venclyxto skupaj s hrano in pijačo
There is no information about the safety of venetoclax in pregnant women. 
Ni informacij o varnosti venetoklaksa pri nosečnicah.
The efficacy data were further evaluated by an IRC demonstrating a combined ORR of 70% (Arm A: 70%; 
Podatke o učinkovitosti je dodatno ocenil neodvisen odbor za pregled (IRC), ki je ugotovil kombinirani ORR 70 % (skupina A: 70 %, skupina B: 69 %).
Co-administration of CYP3A4 inducers may lead to decreased venetoclax exposure and consequently a risk for lack of efficacy. 
Sočasno dajanje induktorjev CYP3A4 lahko vodi v zmanjšano izpostavljenost venetoklaksu in posledično tveganje za pomanjkanje učinkovitosti.
One patient (ibrutinib failure) achieved complete remission with incomplete marrow recovery. 
En bolnik (po neuspehu z ibrutinibom) je dosegel popolno remisijo z nepopolnim okrevanjem kostnega mozga.
After completion of titration phase 
Po zaključeni fazi titracije
Venetoclax should be taken for 24 months from Cycle 1 Day 1 of rituximab (see section 5.1). 
Venetoklaks je potrebno jemati 24 mesecev od 1. dne 1. cikla rituksimaba (glejte poglavje 5.1).
Do not eat grapefruit products, Seville oranges (bitter oranges), or starfruit (carambola) while you are taking Venclyxto - this includes eating them, drinking the juice or taking a supplement that might contain them. 
Ne jejte izdelkov iz grenivke, seviljskih pomaranč (grenke pomaranče) ali zvezdnega sadeža (karambole), med jemanjem zdravila Venclyxto - to vključuje njihovo uživanje, pitje soka iz teh sadežev ali jemanje dopolnil, ki jih lahko vsebujejo.
MRD negativity was defined as a result below 0.0001 (<1 CLL cell per 104 leukocytes in the sample). 
Negativna MRD je bila opredeljena kot izvid pod 0,0001 (< 1 KLL-celica na 104 levkocitov v vzorcu).
The rates of grade ≥3 laboratory abnormalities relevant to TLS were hyperkalaemia 1%, hyperphosphataemia 1%, and hyperuricaemia 1%. 
Laboratorijske nepravilnosti stopnje ≥ 3, ki so pomembne za TLS, so bile hiperkaliemija 1%, hiperfosfatemija 1% in hiperurikemija 1%.
• medicines that prevent blood clots, warfarin, dabigatran 
• zdravili, ki preprečujeta krvne strdke, varfarin, dabigatran
This includes medicines obtained without a prescription, herbal medicines and supplements. 
To vključuje zdravila brez recepta, zdravila rastlinskega izvora in dopolnila.
In the film-coating: 
Filmska obloga:
For events of clinical TLS or blood chemistry changes requiring more than 48 hours to resolve, treatment should be resumed at a reduced dose (see Table 2). 
V primerih kliničnega TLS ali sprememb krvnih parametrov, ki potrebujejo več kot 48 ur, da se razrešijo, je treba zdravljenje nadaljevati z zmanjšanim odmerkom (glejte preglednico 2).
If a statin (OATP substrate) is used concomitantly with venetoclax, close monitoring of statin-related toxicity is recommended. 
Če se statin (OATP substrat) daje sočasno z venetoklaksom, je priporočljivo skrbno spremljanje s statini povezane toksičnosti.
Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), 
Frekvence so definirane kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), ni znano (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
The safety analysis included patients from one phase 3 study (MURANO), two phase 2 studies (M13-982 and M14-032), and one phase 1 study (M12-175). 
Analiza varnosti je vključevala bolnike iz ene študije 3. faze (MURANO), iz dveh študij 2. faze (M13-982 in M14-032) in ene študije 1. faze (M12-175).
Venclyxto tablets are provided in blisters which are packed in cartons as follows: 
Venclyxto tablete so na voljo v pretisnih omotih, ki so pakirani v škatle, kot sledi:
Based on population pharmacokinetic analyses, age, sex, and weight do not have an effect on venetoclax clearance. 
Na podlagi analiz populacijske farmakokinetike starost, spol in telesna masa ne vplivajo na očistek venetoklaksa.
The risk of TLS was reduced after revision of the dosing regimen and modification to prophylaxis and monitoring measures. 
Tveganje za TLS se je zmanjšalo po reviziji režima odmerjanja in prilagoditvi profilakse ter ukrepov za spremljanje bolnika.
This is because Venclyxto may affect the way some other medicines work. 
To pa zato, ker zdravilo Venclyxto lahko vpliva na način delovanja drugih zdravil.
Venclyxto may be given to you in combination with rituximab or alone. 
Zdravilo Venclyxto vam lahko dajo v kombinaciji z rituksimabom ali samo.
IRC assessment (N=107)a 
Ocena neodvisnega odbora za pregled (IRC) (N = 107)a
Patients should be adequately hydrated during the dose-titration phase to reduce the risk of TLS. 
Bolniki morajo biti med fazo titracije odmerka ustrezno hidrirani, da se zmanjša tveganje za TLS.
When resuming treatment after interruption due to TLS, the instructions for prevention of TLS should be followed (see “Prevention of tumour lysis syndrome” above). 
Ob vnovični uvedbi zdravljenja po prekinitvi zaradi TLS, je treba upoštevati navodila za preprečevanje TLS (glejte »Preprečevanje sindroma tumorske lize« zgoraj).
The cut-off for a negative status was one CLL cell per 104 leukocytes. 
Mejna vrednost za negativno stanje je bila ena KLL celica na 104 levkocitov.
Patients received venetoclax via a recommended dose-titration schedule. 
Bolniki so prejemali venetoklaks po priporočeni shemi titracije odmerka.
Median DOR was not reached with median follow up of approximately 23.8 months. 
Mediana trajanja odziva (duration of response - DOR) ni bila dosežena s spremljanjem mediane približno 23,8 mesecev.
• medicines to lower cholesterol levels in the blood known as statins 
• zdravila za zniževanje vrednosti holesterola v krvi, poznana kot statini
Carcinogenicity studies have not been conducted with venetoclax. 
Študij kancerogenosti z venetoklaksom niso izvedli.
• a medicine used to prevent organ rejection known as sirolimus 
• zdravilo, ki se uporablja za preprečevanje zavračanja organov, poznano kot sirolimus
An additional 51 patients were enrolled in a safety expansion cohort. 
Dodatnih 51 bolnikov je bilo vključenih v razširjeni kohorti študije o varnosti.
Drinking plenty of water, at least 1.5 to 2 litres per day, helps to remove cancer cell breakdown products from your body through urine, and may decrease your risk of getting TLS (see section 3). 
Pitje večjih količin vode, najmanj 1,5 do 2 litrov vode na dan, pomaga pri odstranjevanju razpadnih produktov rakavih celic iz telesa z urinom in lahko zmanjša tveganje, da se pri vas razvije TLS (glejte poglavje 3).
• you have liver problems as this may increase your risk for side effects. 
• imate težave z jetri, ker je tveganje za neželene učinke pri vas lahko povečano.
After 77/389 patients were enrolled in the study, the protocol was amended to incorporate the current TLS prophylaxis and monitoring measures described in Posology (see section 4.2). 
Po vključitvi 77/389 bolnikov v študijo, je bil protokol spremenjen tako, da so se vključili sedanja profilaksa TLS in ukrepi spremljanja, ki so opisani v poglavju Odmerjanje (glejte poglavje 4.2).
Both effects were reversible after cessation of dosing with venetoclax, with recovery of lymphocytes occurring 18 weeks post treatment. 
Oba učinka sta bila po prenehanju uporabe venetoklaksa reverzibilna in okrevanje števila limfocitov se je pojavilo 18 tednov po zdravljenju.
Intravenous fluids should be administered as indicated based on overall risk of TLS or for those who cannot maintain an adequate level of oral hydration. 
Dajanje tekočine intravensko je potrebno, če je indicirano na podlagi celokupnega tveganja za TLS, ali pri tistih, pri katerih ni mogoče vzdrževati primerne stopnje hidracije peroralno.
Safety in patients with severe renal impairment (CrCl <30 ml/min) or on dialysis has not been established, and a recommended dose for these patients has not been determined. 
Varnost pri bolnikih s hudo okvaro ledvic (CrCL < 30 ml/min) ali pri tistih na dializi ni bila dokazana in priporočeni odmerek za te bolnike ni bil določen.
• clarithromycin for bacterial infections 
• klaritromicin za zdravljenje bakterijskih okužb,
• upper respiratory tract infection - signs include runny nose, sore throat or cough 
• okužbe zgornjih dihal - znaki vključujejo izcedek iz nosu, vneto žrelo ali kašelj • driska
There is no specific antidote for venetoclax. 
Za venetoklaks ni specifičnega antidota.
To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder. 
Če želite poslušati ali želite kopijo navodila za uporabo v Braillovi pisavi, natisnjeno z večjo pisavo ali v zvočni obliki, se obrnite na predstavništvo imetnika dovoljenja za promet z zdravilom.
The same monitoring schedule should be followed at the start of the 50 mg dose and then for patients who continue to be at risk, at subsequent dose increases. 
Enaka shema kontrole krvi je potrebna ob začetku 50 mg odmerka in nato pri bolnikih, ki so še naprej izpostavljeni tveganju ob vsakem naslednjem povečanju odmerka.
No specific dose adjustment is required for elderly patients (aged ≥65 years) (see section 5.1). 
Posebna prilagoditev odmerka pri starejših bolnikih (stari ≥ 65 let) ni potrebna (glejte poglavje 5.1).
Tell your doctor if you take any of the following medicines as Venclyxto may affect how they work: 
Obvestite zdravnika, če jemljete katero od naslednjih zdravil, ker lahko zdravilo Venclyxto vpliva na njihovo delovanje:
The risk of TLS is a continuum based on multiple factors, including comorbidities. 
Tveganje za TLS je stalno prisotno in temelji na več dejavnikih, vključno s pridruženimi boleznimi.
More intensive measures (intravenous hydration, frequent monitoring, hospitalisation) should be employed as overall risk increases. 
Ob povečanju celokupnega tveganja je treba uporabiti bolj intenzivne ukrepe (intravensko hidracijo, pogosto spremljanje, hospitalizacijo).
Venclyxto is used to treat patients with chronic lymphocytic leukaemia (CLL) when the disease has come back or has not responded to other treatment. 
Zdravilo Venclyxto se uporablja za zdravljenje bolnikov s kronično limfocitno levkemijo (KLL), ko se je bolezen vrnila ali se ni odzvala na drugo zdravljenje.
• feeling confused 
• občutek zmedenosti
The 5-week dose-titration schedule is designed to gradually reduce tumour burden (debulk) and decrease the risk of tumour lysis syndrome. 
5-tedenska shema titracije odmerka je načrtovana za postopno zmanjšanje tumorske obremenitve (delna odstranitev) in zmanjšanje tveganja za sindrom tumorske lize.
Based on findings in animals, Venclyxto may cause male infertility (low or no sperm count). 
Na podlagi ugotovitev pri živalih lahko zdravilo Venclyxto povzroči neplodnost pri moških (majhno število ali brez spermijev).
Once the toxicity has resolved to grade 1 or baseline level (recovery), therapy with venetoclax may be restarted at the same dose. 
Čim se toksičnost povrne na 1. stopnjo ali na izhodiščno vrednost (ozdravitev), se lahko znova začne zdravljenje z venetoklaksom v enakem odmerku.
Based on venetoclax large volume of distribution and extensive protein binding, dialysis is unlikely to result in significant removal of venetoclax. 
Glede na velik volumen distribucije venetoklaksa in obsežno vezavo na beljakovine, je malo verjetno, da bi z dializo dosegli pomembno odstranitev venetoklaksa.
• a medicine used to treat heart problems known as digoxin 
• zdravilo za zdravljenje težav s srcem poznano kot digoksin
If you are not sure about this, talk to your doctor, pharmacist or nurse before taking Venclyxto. 
Če o tem niste prepričani, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro preden vzamete zdravilo Venclyxto.
Venetoclax is not recommended during pregnancy and in women of childbearing potential not using highly effective contraception. 
Uporaba venetoklaksa ni priporočljiva med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo visoko učinkovite kontracepcije.
Overexpression of BCL-2 has been demonstrated in CLL cells where it mediates tumour cell survival and has been associated with resistance to chemotherapeutics. 
Prekomerna izraženost BCL-2 je bila dokazana v celicah KLL, kjer posreduje preživetje tumorskih celic in je povezana z odpornostjo proti kemoterapevtikom.
Pre-dose: For all patients, blood chemistries should be assessed prior to the initial dose to evaluate kidney function and correct pre-existing abnormalities. 
Pred odmerkom: Pri vseh bolnikih je treba pred začetnim odmerkom oceniti rezultate krvnih preiskav, da se ovrednoti delovanje ledvic in popravi obstoječe nepravilnosti.
- Venclyxto should not be used during pregnancy. 
- Zdravila Venclyxto se med nosečnostjo ne sme uporabljati.
The population estimate for apparent volume of distribution (Vdss/F) of venetoclax ranged from 256-321 L in patients. 
Populacijska ocena navideznega volumna porazdelitve (Vdss/F) venetoklaksa je pri bolnikih segala od 256 do 321 l.
• feeling or being sick (nausea or vomiting) 
• občutek slabosti ali slabost (siljenje na bruhanje ali bruhanje)
You may feel tired after taking Venclyxto, which may affect your ability to drive or use tools or machines. 
Po jemanju zdravila Venclyxto se boste morda počutili utrujeno, kar lahko vpliva na vašo sposobnost upravljanja vozil ali uporabo orodja ali strojev.
17p deletion and/or TP53 mutation status ORR, % (95% CI) 
Status 17p delecija in/ali TP53 mutacija ORR, % (95% IZ)
The frequencies of adverse reactions reported with Venclyxto are summarised in Table 3. 
Pogostnosti neželenih učinkov, ki so jih poročali pri zdravilu Venclyxto, so povzete v preglednici 3.
67.6% had ALC ≥25 x 109/l. 
ALC ≥25 x 109/l.
Of the 194 patients with previously treated CLL who received venetoclax in combination with rituximab, 50% were 65 years or older. 
Med 194 bolniki s predhodno zdravljeno KLL, ki so prejemali venetoklaks v kombinaciji z rituksimabom, je bilo 50 % starih 65 let ali več.
• you have any kidney problems as your risk for a side effect called tumour lysis syndrome may increase 
• imate kakršne koli težave z ledvicami, ker je tveganje za neželeni učinek, imenovan sindrom tumorske lize, pri vas lahko povečano,
eOverall survival data are not yet mature. 
e Podatki o celokupnem preživetju še niso na voljo.
Film-coated tablet Multipack: 112 (4 x 28) film-coated tablets 
filmsko obložena tableta Večkratno pakiranje: 112 (4 x 28) filmsko obloženih tablet
CLL is a type of cancer affecting white blood cells called lymphocytes and the lymph nodes. 
KLL je vrsta raka, ki prizadene bele krvne celice, imenovane limfociti, in bezgavke.
Your dose may need to be adjusted for side effects. 
Vaš odmerek bo zaradi neželenih učinkov morda potrebno prilagoditi.
bIncludes 51 additional patients from the safety expansion cohort. 
bVključuje 51 dodatnih bolnikov iz razširjene kohorte študije o varnosti.
Venclyxto has no or negligible influence on the ability to drive and use machines. 
Zdravilo Venclyxto nima vpliva oziroma ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
In 168 patients with CLL starting with a daily dose of 20 mg and increasing over 5 weeks to a daily dose of 400 mg in studies M13-982 and M14-032, the rate of TLS was 2%. 
Pri 168 bolnikih s KLL, ki so zdravljenje začeli z dnevnim odmerkom 20 mg ter ga nato v 5 tednih povečali do 400 mg v študijah M13-982 in M14-032, je bil delež TLS 2 %.
Alternative treatments with less CYP3A induction should be considered. 
Treba je razmisliti o alternativnih zdravljenjih z manjšo indukcijo CYP3A.
Of these, 91 patients had received prior ibrutinib therapy (Arm A) and 36 had received prior idelalisib therapy (Arm B). 
Od teh jih je 91 predhodno prejemalo ibrutinib (skupina A) in 36 idelalisib (skupina B).
The median duration of grade 3 or 4 neutropenia was 8 days (range: 1-712 days). 
Mediana trajanja nevtropenije 3. ali 4. stopnje je bila 8 dni (razpon: 1-712 dni).
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.