FrancophonIA/ELRC3.0 huggingface dataset:
English: Early results from an ongoing study looking at the effects of Bavencio in patients with metastatic MCC who had not received previous chemotherapy showed that the overall response rate at the time of analysis was 62% (18 out of 29 patients).
Slovenian: Pri opazovanju učinkov zdravila Bavencio pri bolnikih z metastatskim KMC, ki predhodno niso bili zdravljeni s kemoterapijo, so zgodnji rezultati potekajoče študije pokazali, da je stopnja skupnega odziva v času analize znašala 62 % (18 od 29 bolnikov).
English: Bavencio has been shown to be of benefit in one main study that showed the cancer shrank in patients with MCC and one that showed patients with RCC could live longer without their disease getting worse.
Slovenian: Zdravilo Bavencio se je izkazalo koristno v eni glavni študiji, kjer se je rak pri bolnikih s KMC zmanjšal, v drugi glavni študiji pri bolnikih z KLC pa so bolniki živeli dlje brez poslabšanja bolezni.
English: Treatment may need to be delayed or stopped if certain side effects occur.
Slovenian: Če se pojavijo nekateri neželeni učinki, bo zdravljenje morda treba ustaviti ali prekiniti.
English: Bavencio is also used in combination with another cancer medicine, axitinib, for the initial treatment of patients with advanced renal cell carcinoma (RCC, a cancer of the kidney).
Slovenian: Uporablja se tudi v kombinaciji z drugim zdravilom za zdravljenje raka, aksitinibom, za začetno zdravljenje bolnikov z napredovalim karcinomom ledvičnih celic (KLC, rakom ledvic) Zdravilo Bavencio vsebuje učinkovino avelumab.
English: The most common side effects with Bavencio used alone (which may affect more than 1 in 10 people) include tiredness, nausea (feeling sick), diarrhoea, decreased appetite, constipation, infusion-related reactions, weight loss and vomiting.
Slovenian: Najpogostejši neželeni učinki zdravila Bavencio, uporabljenega samostojno, (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so utrujenost, navzeja (siljenje na bruhanje), driska, zmanjšan apetit, zaprtost, z infuzijo povezane reakcije, izguba telesne mase in bruhanje.
English: How is Bavencio used?
Slovenian: Kako se zdravilo Bavencio uporablja?
English: Drink plenty of water
Slovenian: Pijte veliko vode
English: Each cycle was 28 days.
Slovenian: Vsak cikel je trajal 28 dni.
English: For the first 4 weeks you will get a new pack each week.
Slovenian: prvih 4 tednih boste vsak teden dobili novo pakiranje.
English: It also slows down the worsening of the disease.
Slovenian: Upočasni tudi poslabšanje bolezni.
English: This is because it has not been studied in these age groups.
Slovenian: To pa zato, ker njegove uporabe pri teh starostnih skupinah niso preučevali.
English: • you think you may have an infection or have had a long-lasting or repeated infection
Slovenian: • menite, da bi lahko imeli okužbo ali pa ste v preteklosti imeli dolgotrajno ali ponavljajočo okužbo,
English: Overall Survivale
Slovenian: Celokupno preživetjee
English: Date of first authorisation: 5 December 2016 Date of latest renewal: 6 September 2018
Slovenian: Datum prve odobritve: 5. december 2016 Datum zadnjega podaljšanja: 6. september 2018
English: This may affect your ability to father a child.
Slovenian: To lahko vpliva na vašo sposobnost, da zaplodite otroka.
English: This is because they can increase the amount of venetoclax in your blood.
Slovenian: To pa zato, ker lahko povečajo količino venetoklaksa v krvi.
English: Blood tests may also show
Slovenian: Krvne preiskave lahko pokažejo tudi
English: This is to see if you can continue to take this medicine safely.
Slovenian: To je zato, da se ugotovi, ali lahko še naprej varno jemljete to zdravilo.
English: NE=not evaluable.
Slovenian: NE=ni možno oceniti (not evaluable).
English: The prophylaxis measures listed below should be followed.
Slovenian: Upoštevati je treba spodaj navedene ukrepe za profilakso.
English: Reversibility of this finding has not been demonstrated.
Slovenian: Reverzibilnost te spremembe ni dokazana.
English: 17p deletion status was determined based on central laboratory test results.
Slovenian: Status delecije 17p je določen na osnovi rezultatov osrednjih laboratorijskih testov.
English: A risk to the breast-feeding child cannot be excluded.
Slovenian: Tveganja za dojene otroke ni mogoče izključiti.
English: Take the tablets and this leaflet with you.
Slovenian: Vzemite tablete in to navodilo s seboj.
English: Do not stop taking this medicine unless your doctor tells you to.
Slovenian: Ne prenehajte jemati tega zdravila, razen če vam zdravnik ne naroči tako.
English: In CLL, the lymphocytes multiply too quickly and live for too long, so that there are too many of them in the blood.
Slovenian: Pri KLL se limfociti množijo prehitro in živijo predolgo, tako da jih je v krvi preveč.
English: Grade ≥3a
Slovenian: Stopnja ≥3a
English: Alternative treatments should be considered.
Slovenian: Treba je razmisliti o alternativnih zdravljenjih.
English: Response assessments were performed at 8 weeks, 24 weeks, and every 12 weeks thereafter.
Slovenian: Odziv so ocenili po 8 in 24 tednih, nato pa vsakih 12 tednov.
English: More intensive measures should be employed as overall risk increases.
Slovenian: Ob povečanju celokupnega tveganja je treba uporabiti bolj intenzivne ukrepe.
English: Electrolyte abnormalities should be corrected promptly.
Slovenian: Nepravilnosti elektrolitov je treba popraviti takoj.
English: It is important to follow all of the instructions in the ‘how to take' section of the leaflet.
Slovenian: Pomembno je, da sledite navodilom v poglavju ‘Kako jemati' navodila za uporabo.
English: IRC assessed
Slovenian: Ocena IRC
English: Hospitalisation should be considered for subsequent dose increases based on reassessment of risk.
Slovenian: O hospitalizaciji je treba razmisliti pri naslednjih povečanjih odmerka, in sicer na podlagi ponovne ocene tveganja.
English: The population estimate for the terminal phase elimination half-life of venetoclax was approximately 26 hours.
Slovenian: Populacijska ocena eliminacijskega razpolovnega časa terminalne faze venetoklaksa je približno 26 ur.
English: Complete blood counts should be monitored throughout the treatment period.
Slovenian: Skozi celotno obdobje zdravljenja je treba spremljati kompletno krvno sliko.
English: • lower number of red blood cells
Slovenian: • manjše število rdečih krvnih celic
English: Efficacy results are shown in Table 6.
Slovenian: Rezultati učinkovitosti so prikazani v preglednici 6.
English: After approximately 3 months of daily dosing in dogs, venetoclax caused progressive white discoloration of the hair coat, due to loss of melanin pigment in the hair.
Slovenian: Po približno 3 mesecih vsakodnevne uporabe pri psih je venetoklaks povzročil progresivno belo razbarvanje dlake zaradi izgube melaninskega barvila v dlaki.
English: The tablets should not be chewed, crushed, or broken before swallowing.
Slovenian: Tablet se ne sme žvečiti, drobiti ali lomiti, preden se jih pogoltne.
English: • During the first 5 weeks of treatment, you should take the tablets in the morning to help you follow-up with blood tests, if needed.
Slovenian: • v prvih 5 tednih zdravljenja jemljite tablete zjutraj, da se boste lažje dogovorili glede krvnih preiskav, če bo potrebno.
English: Low white blood cell count can increase your risk for infection.
Slovenian: Majhno število belih krvnih celic lahko poveča tveganje za okužbo.
English: Blocking this protein helps to kill and lower the number of cancer cells.
Slovenian: Zaviranje te beljakovine pomaga pri ubijanju in zmanjševanju števila rakavih celic.
English: • severe infection in the blood (sepsis)
Slovenian: • huda okužba krvi (sepsa)
English: Live vaccines should not be administered during treatment and thereafter until B-cell recovery.
Slovenian: Živih cepiv se ne sme dajati med zdravljenjem in pozneje, vse do povrnitve celic B.
English: Investigator assessment (N=158)b
Slovenian: Ocena raziskovalca (N = 158)b
English: The safety and efficacy of venetoclax in children aged less than 18 years have not been established.
Slovenian: Varnost in učinkovitost venetoklaksa pri otrocih, starih manj kot 18 let, nista bili dokazani.
English: • ritonavir for HIV infection.
Slovenian: • ritonavir pri okužbi s HIV.
English: Results of subgroup analyses
Slovenian: Rezultati analize podskupin
English: When your Venclyxto dose has been increased to the full standard dose, check with your doctor if you can start taking these medicines again.
Slovenian: Ko bo odmerek zdravila Venclyxto povečan do celotnega standardnega odmerka, s svojim zdravnikom preverite, če lahko znova začnete jemati ta zdravila.
English: The estimated PFS rate at 6 months post treatment was 92%.
Slovenian: Ocenjena vrednost PFS 6 mesecev po zdravljenju je bila 92 %.
English: Carcinogenicity/genotoxicity
Slovenian: Kancerogenost/genotoksičnost
English: - you are allergic to the active substance venetoclax or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - ste alergični na učinkovino venetoklaks ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Additional efficacy results for the pre-specified primary analysis are shown in Table 5 and Figure 2 and Figure 3.
Slovenian: Dodatni rezultati učinkovitosti za vnaprej določeno primarno analizo so prikazani v preglednici 5, na sliki 2 in sliki 3.
English: Table 2: Dose modification for TLS and other toxicities
Slovenian: Preglednica 2: Prilagoditev odmerka zaradi TLS in drugih toksičnosti
English: Frequency (all grades)a
Slovenian: Pogostnost (vse stopnje)a
English: Summary of safety profile
Slovenian: Povzetek varnostnega profila zdravila
English: This will help to remove cancer cell breakdown products from your blood through your urine.
Slovenian: To bo pomagalo, da se produkti razgradnje rakavih celic iz krvi odstranjujejo z urinom.
English: Your doctor will gradually increase the dose over the next 4 weeks to the full standard dose.
Slovenian: Zdravnik vam bo v naslednjih štirih tednih postopoma povečal odmerek do celotnega standardnega odmerka.
English: Your doctor, pharmacist or nurse will do blood tests to check for TLS.
Slovenian: Zdravnik, farmacevt ali medicinska sestra vam bodo opravili krvne preiskave za ugotavljanje TLS.
English: Unstratified hazard ratio is displayed on the X-axis with logarithmic scale.
Slovenian: Nerazčlenjeno razmerje tveganja je prikazano na osi X z logaritmično lestvico.
English: Time to next anti-leukaemic therapy Number of events (%)
Slovenian: Čas do naslednjega zdravljenja levkemije Število dogodkov (%)
English: Dose at interruption (mg)
Slovenian: Odmerek ob prekinitvi (mg)
English: Patients should be assessed for risk and should receive appropriate prophylaxis for TLS, including hydration and anti-hyperuricaemics.
Slovenian: Bolnike je treba oceniti glede tveganja in dobiti morajo ustrezno profilakso za TLS, vključno s hidracijo in antihiperurikemiki.
English: This is because serious and life-threatening effects can occur when Venclyxto is taken with these medicines:
Slovenian: To je zato, ker se lahko pojavijo resni in življenje ogrožajoči učinki, če se zdravilo Venclyxto vzame s temi zdravili:
English: Arm B (idelalisib failures) (N=36)
Slovenian: Skupina B (neuspeh z idelalisibom) (N = 36)
English: Both B- and T-cells were affected, but the most significant decreases occurred with B-cells.
Slovenian: Prizadete so bile tako celice B kot celice T, toda najpomembnejše je bilo zmanjšanje števila celic B.
English: There are no adequate and well-controlled data from the use of venetoclax in pregnant women.
Slovenian: Ni dovolj ustreznih in dobro preverjenih podatkov o uporabi venetoklaksa pri nosečnicah.
English: Venclyxto should not be used in children and adolescents.
Slovenian: Zdravila Venclyxto se pri otrocih in mladostnikih ne sme uporabljati.
English: Patients who experience overdose should be closely monitored and appropriate supportive treatment provided.
Slovenian: Bolnike, pri katerih je prišlo do prevelikega odmerjanja, je treba skrbno spremljati in jim nuditi ustrezno podporno zdravljenje.
English: For patients who require dose reductions to less than 100 mg for more than 2 weeks, discontinuation of venetoclax should be considered.
Slovenian: Pri bolnikih, pri katerih je treba odmerek zmanjšati na manj kot 100 mg za več kot 2 tedna, je treba razmisliti o prekinitvi zdravljenja z venetoklaksom.
English: Patients should be instructed to swallow the tablets whole with water at approximately the same time each day.
Slovenian: Bolnike je treba poučiti, naj tablete pogoltnejo cele z vodo, vsak dan ob približno istem času.
English: Dosing should be interrupted if needed (see section 4.2).
Slovenian: Odmerjanje naj se prekine, če je potrebno (glejte poglavje 4.2).
English: Investigator-assessed efficacy results are presented for 158 patients with a later data cutoff date 10 June 2016.
Slovenian: Rezultati učinkovitosti, ocenjeni s strani raziskovalca, so predstavljeni za 158 bolnikov s kasnejšim datumom zamejitve podatkov, 10. junija 2016.
English: It is currently unknown whether venetoclax may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method.
Slovenian: Trenutno ni znano, ali lahko venetoklaks zmanjša učinkovitost hormonske kontracepcije, zato naj ženske k hormonski kontracepciji dodajo še pregradno metodo.
English: 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:
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete katero od naslednjih zdravil, ker lahko ta zvečajo ali zmanjšajo količino venetoklaksa v krvi:
English: All events of TLS occurred during the venetoclax dose-titration phase and resolved within two days.
Slovenian: Vsi primeri TLS so se pojavili med fazo titracije odmerka venetoklaksa in so bili odpravljeni v dveh dneh.
English: The tablets should be taken with a meal in order to avoid a risk for lack of efficacy (see section 5.2).
Slovenian: Tablete je potrebno vzeti ob obroku, tako se izognemo tveganju za pomanjkanje učinkovitosti (glejte poglavje 5.2).
English: Of the 130 patients, 92 patients completed the 6-month post treatment follow-up visit.
Slovenian: Od 130 bolnikov je 92 bolnikov opravilo kontrolni obisk 6 mesecev po zdravljenju.
English: During the dose-titration phase, venetoclax should be taken in the morning to facilitate laboratory monitoring.
Slovenian: Med fazo titracije odmerka je treba venetoklaks vzeti zjutraj, da se olajša izvajanje laboratorijskih preiskav.
English: The mean blood-to-plasma ratio was 0.57.
Slovenian: Povprečno razmerje med krvjo in plazmo je bilo 0,57.
English: You may also include non-alcoholic and non-caffeinated drinks in this amount, but exclude grapefruit, Seville orange, or starfruit (carambola) juices.
Slovenian: V to količino lahko vključite tudi brezalkoholne in brezkofeinske pijače, toda izključite sokove iz grenivke, seviljske pomaranče ali zvezdnega sadeža (karambole).
English: At the time of data cut-off (26 July 2017), 127 patients were enrolled and treated with venetoclax.
Slovenian: V času zamejitve podatkov (26 julij 2017) je bilo vključenih in z venetoklaksom zdravljenih
English: 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.
Slovenian: 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.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic safety update reports
Slovenian: C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM • Redno posodobljena poročila o varnosti zdravila (PSUR)
English: 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.
Slovenian: 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.
English: Take your dose in the morning with a meal and water.
Slovenian: Vzemite vaš odmerek zjutraj z vodo ob obroku.
English: Patients should be monitored more closely for signs of toxicities and the dose may need to be further adjusted.
Slovenian: Bolnike je treba bolj skrbno spremljati glede znakov toksičnosti in odmerek je morda potrebno dodatno prilagoditi.
English: 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)
Slovenian: 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)
English: Unchanged venetoclax accounted for 20.8% of the administered radioactive dose excreted in faeces.
Slovenian: Nespremenjeni venetoklaks je predstavljal 20,8 % uporabljenega radioaktivnega odmerka, izločenega v blatu.
English: If you have problems taking this medicine, talk to your doctor.
Slovenian: Če imate težave z jemanjem tega zdravila, se posvetujte z zdravnikom.
English: 12-month estimate
Slovenian: 12- mesečna ocena
English: • a medicine for cancer known as everolimus
Slovenian: • zdravilo za zdravljenje raka poznano kot everolimus
English: 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.
Slovenian: Odmerek je treba v obdobju 5 tednov postopoma povečevati do dnevnega odmerka 400 mg kot je prikazano v preglednici 1.
English: Venetoclax had no effect on QTc interval and there was no relationship between venetoclax exposure and change in QTc interval.
Slovenian: Venetoklaks ni vplival na interval QTc in ugotovili niso nobene povezave med izpostavljenostjo venetoklaksu in spremembo intervala QTc.
English: Patients should be monitored more closely for signs and symptoms of TLS.
Slovenian: Bolnike je treba bolj skrbno spremljati glede znakov in simptomov TLS.
English: The next prescribed dose should be taken at the usual time the following day.
Slovenian: Naslednji predpisani odmerek je treba vzeti naslednji dan ob običajnem času.
English: The risk for TLS is in the first 5 weeks of treatment with Venclyxto.
Slovenian: Tveganje za pojav TLS je v prvih 5 tednih zdravljenja z zdravilom Venclyxto.
English: Kaplan-Meier curves of investigator-assessed PFS from the updated efficacy analysis are shown in Figure 1.
Slovenian: Krivulje Kaplan-Meier za vrednosti PFS iz posodobljene analize učinkovitosti ocenjene s strani raziskovalca so prikazane na sliki 1.
English: The safety and efficacy of immunisation with live attenuated vaccines during or following venetoclax therapy have not been studied.
Slovenian: Varnosti in učinkovitosti imunizacije z živimi oslabljenimi cepivi med ali po zdravljenju z venetoklaksom niso preučevali.
English: Table 1: Dose increase schedule
Slovenian: Preglednica 1: Načrt za povečevanje odmerka
English: Effects of age, sex, and weight
Slovenian: Vplivi starosti, spola in telesne mase
English: It belongs to a group of medicines called “BCL-2 inhibitors”.
Slovenian: Spada v skupino zdravil, imenovanih “zaviralci BCL-2”.
English: Tell your doctor, pharmacist or nurse immediately if you get any of the symptoms of TLS listed in section 4.
Slovenian: Takoj obvestite zdravnika, farmacevta ali medicinsko sestro, če se pri vas pojavi kateri od simptomov TLS, navedenih v poglavju 4.
English: 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.
Slovenian: Enako količino vode popijte (vsaj 1,5 do 2 litrov na dan) dva dni pred in na dan, ko vam bodo povečali odmerek zdravila.
English: Efficacy data are presented for 107 patients with data cutoff date 30 April 2015.
Slovenian: Podatki o učinkovitosti so predstavljeni za 107 bolnikov z datumom zamejitve podatkov 30. aprila
English: Additional efficacy results in MURANO Investigator assessed
Slovenian: Dodatni rezultati učinkovitosti v študiji MURANO
English: Bone marrow, % (95% CI)d 15.5(10.7, 21.3)
Slovenian: Kostni mozeg, %(95 % IZ)d 15.5(10.7, 21.3)
English: If resolved within 24 to 48 hours of last dose, treatment with venetoclax can be resumed at the same dose.
Slovenian: Če se stanje popravi v 24 do 48 urah po zadnjem odmerku, se lahko zdravljenje z venetoklaksom nadaljuje z enakim odmerkom.
English: Venclyxto with food and drink
Slovenian: Zdravilo Venclyxto skupaj s hrano in pijačo
English: There is no information about the safety of venetoclax in pregnant women.
Slovenian: Ni informacij o varnosti venetoklaksa pri nosečnicah.
English: The efficacy data were further evaluated by an IRC demonstrating a combined ORR of 70% (Arm A: 70%;
Slovenian: Podatke o učinkovitosti je dodatno ocenil neodvisen odbor za pregled (IRC), ki je ugotovil kombinirani ORR 70 % (skupina A: 70 %, skupina B: 69 %).
English: Co-administration of CYP3A4 inducers may lead to decreased venetoclax exposure and consequently a risk for lack of efficacy.
Slovenian: Sočasno dajanje induktorjev CYP3A4 lahko vodi v zmanjšano izpostavljenost venetoklaksu in posledično tveganje za pomanjkanje učinkovitosti.
English: One patient (ibrutinib failure) achieved complete remission with incomplete marrow recovery.
Slovenian: En bolnik (po neuspehu z ibrutinibom) je dosegel popolno remisijo z nepopolnim okrevanjem kostnega mozga.
English: After completion of titration phase
Slovenian: Po zaključeni fazi titracije
English: Venetoclax should be taken for 24 months from Cycle 1 Day 1 of rituximab (see section 5.1).
Slovenian: Venetoklaks je potrebno jemati 24 mesecev od 1. dne 1. cikla rituksimaba (glejte poglavje 5.1).
English: 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.
Slovenian: 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.
English: MRD negativity was defined as a result below 0.0001 (<1 CLL cell per 104 leukocytes in the sample).
Slovenian: Negativna MRD je bila opredeljena kot izvid pod 0,0001 (< 1 KLL-celica na 104 levkocitov v vzorcu).
English: The rates of grade ≥3 laboratory abnormalities relevant to TLS were hyperkalaemia 1%, hyperphosphataemia 1%, and hyperuricaemia 1%.
Slovenian: Laboratorijske nepravilnosti stopnje ≥ 3, ki so pomembne za TLS, so bile hiperkaliemija 1%, hiperfosfatemija 1% in hiperurikemija 1%.
English: • medicines that prevent blood clots, warfarin, dabigatran
Slovenian: • zdravili, ki preprečujeta krvne strdke, varfarin, dabigatran
English: This includes medicines obtained without a prescription, herbal medicines and supplements.
Slovenian: To vključuje zdravila brez recepta, zdravila rastlinskega izvora in dopolnila.
English: In the film-coating:
Slovenian: Filmska obloga:
English: 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).
Slovenian: 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).
English: If a statin (OATP substrate) is used concomitantly with venetoclax, close monitoring of statin-related toxicity is recommended.
Slovenian: Če se statin (OATP substrat) daje sočasno z venetoklaksom, je priporočljivo skrbno spremljanje s statini povezane toksičnosti.