natgillin/translations-raw huggingface dataset:
Concomitant use of preparations containing St. John's wort (see sections 4.4 and 4.5).
Sočasna uporaba preparatov, ki vsebujejo šentjanževko (glejte poglavji 4.4 in 4.5).
If a patient misses a dose by more than 8 hours, the patient should not take the missed dose and should resume the usual dosing schedule the following day.
Če je bolnik izpustil odmerek in od časa, ko ga običajno vzame, mine več kot 8 ur, naj ne vzame izpuščenega odmerka in naj naslednji dan nadaljuje z običajno shemo odmerjanja.
Your doctor may need to reduce your dose of Venclyxto
Zdravnik vam bo morda moral znižati odmerek zdravila Venclyxto.
At baseline, 53% of patients had one or more nodes ≥5 cm, and 51% had ALC ≥25 x 109/l.
Izhodiščno je imelo 53 % bolnikov eno ali več bezgavk velikih ≥ 5 cm in 51 % je imelo ALC ≥ 25 x 109/l.
Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with venetoclax (see section 4.5).
Med zdravljenjem z venetoklaksom se je treba izogibati izdelkom iz grenivke, seviljskim pomarančam in zvezdnemu sadežu (karamboli) (glejte poglavje 4.5).
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING CARTON multipack (without blue box)
PODATKI NA PRIMARNI OVOJNINI ŠKATLA - večkratno pakiranje (brez modrega okenca)
Median time since diagnosis was 6.7 years (range: 0.3 to 29.5).
Mediana časa od diagnoze je bila 6,7 let (razpon: 0,3 do 29,5).
The median number of prior anti-CLL treatments was 2 (range: 1 to 10 treatments); 49.5% with a prior nucleoside analogue, 38% with prior rituximab, and 94% with a prior alkylator (including 33% with prior bendamustine).
Mediano število predhodnih zdravljenj KLL, ki so jih prejemali bolniki, je bilo 2 (razpon: od 1 do 10 zdravljenj), in sicer 49,5 % z nukleozidnim analogom, 38 % z rituksimabom in 94 % z alkilirajočim sredstvom (vključuje 33 % z bendamustinom).
In a dedicated hepatic impairment study, venetoclax Cmax and AUC in subjects with mild (Child-Pugh A; n=6) or moderate (Child-Pugh B; n=6) hepatic impairment were similar to subjects with normal hepatic function, after receiving a 50 mg single dose of venetoclax.
V namenski študiji okvare jeter, sta bila Cmax in AUC venetoklaksa pri preiskovancih z blago (ChildPugh A; n=6) ali zmerno (Child-Pugh B; n=6) okvaro jeter podobna kot pri preiskovancih z normalnim delovanjem jeter, po prejemu 50 mg enojnega odmerka venetoklaksa.
Concomitant use of venetoclax with moderate CYP3A inhibitors at initiation and during the dose-titration phase should be avoided.
Sočasni uporabi venetoklaksa z zmernimi zaviralci CYP3A na začetku zdravljenja in med fazo titracije odmerka se je treba izogibati.
- you are taking any of the medicines listed below when you start your treatment and while your dose is gradually being increased (usually over 5 weeks).
- na začetku vašega zdravljenja ali v obdobju postopnega povečevanja odmerka (običajno v
If you forget to take Venclyxto
Če ste pozabili vzeti zdravilo Venclyxto
The European Medicines Agency has waived the obligation to submit the results of studies with Venclyxto in all subsets of the paediatric population in CLL (see section 4.2 for information on paediatric use).
Venclyxto za vse podskupine pediatrične populacije pri KLL (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
• muscle pain or uncomfortable joints
• bolečina v mišicah ali nelagodje v sklepih
Venetoclax as monotherapy for the treatment of patients with CLL who have failed a B-cell receptor pathway inhibitor - study M14-032
Venetoklaks kot monoterapija za zdravljenje bolnikov s KLL, pri katerih zdravljenje z zaviralcem receptorske poti celic B ni bilo uspešno - študija M14-032
Toxicities observed in animal studies with venetoclax included dose -dependent reductions in lymphocytes and red blood cell mass.
Med toksičnimi učinki, opaženimi v študijah venetoklaksa na živalih, sta bili od odmerka odvisno zmanjšanje števila limfocitov in zmanjšanje mase eritrocitov.
At baseline, 41% of patients had one or more nodes ≥5 cm and 31% had ALC ≥25 x 109/l.
Izhodiščno je imelo 41 % bolnikov eno ali več bezgavk velikih ≥ 5 cm in 31 % je imelo ALC ≥ 25 x 109/l.
All patients had CrCl ≥50 ml/min.
≥ 50 ml/min.
The film-coated tablets are supplied in cartons containing either 5 or 7 tablets(in blisters of 1 tablet).
Filmsko obložene tablete so pakirane v škatlah, ki vsebujejo 5 ali 7 tablet (v pretisnih omotih po 1 tableto).
In a drug-drug interaction study, administration of a single 100 mg dose of venetoclax with 0.5 mg digoxin, a P-gp substrate, resulted in a 35% increase in digoxin Cmax and a 9% increase in digoxin AUC∞.
V študiji medsebojnega delovanja zdravil je dajanje enkratnega odmerka 100 mg venetoklaksa z 0,5 mg digoksina, substratom P-gp, povečalo Cmax digoksina za 35 % in AUC∞ digoksina za 9 %.
Of the 127 patients who were evaluated for efficacy from M14-032 study, 58% were 65 years or older.
Med 127 bolniki, pri katerih so v študiji M14-032 ocenjevali učinkovitost, je bilo 58 % starih
Therefore, women of childbearing potential must use highly effective contraceptive measures while taking venetoclax and for 30 days after stopping treatment.
Zato morajo ženske v rodni dobi med jemanjem venetoklaksa in še 30 dni po končanem zdravljenju uporabljati visoko učinkovito metodo kontracepcije.
Your doctor may need to stop certain medicines when you first start taking Venclyxto and during the first five weeks when your dose is gradually increased to the full standard dose.
Venclyxto in v prvih petih tednih, ko vam bo odmerek postopoma povečeval do celotnega standardnega odmerka.
If the toxicity recurs, and for any subsequent occurrences, the dose reduction guidelines in Table 2 should be followed when resuming treatment with venetoclax following resolution.
Če se toksičnost znova pojavi ali v primeru kasnejših ponovitev, je treba ob ponovni uvedbi zdravljenja z venetoklaksom in po izginotju znakov toksičnosti upoštevati smernice za zmanjšanje odmerka v preglednici 2.
Do not breast-feed while you are taking this medicine.
Med jemanjem tega zdravila ne smete dojiti.
Co-administration of a 600 mg single dose of rifampin, a P-gp inhibitor, in 11 healthy subjects increased venetoclax Cmax by 106% and AUC∞ by 78%.
Sočasno dajanje 600 mg enkratnega odmerka rifampina, zaviralca P-gp, je pri 11 zdravih osebah povečalo Cmax venetoklaksa za 106 % in AUC∞ za 78 %.
In a drug-drug interaction study in three healthy volunteers, administration of a single dose of 400 mg venetoclax with 5 mg warfarin resulted in an 18% to 28% increase in Cmax and AUC∞ of R-warfarin and S-warfarin.
V študiji medsebojnega delovanja zdravil pri treh zdravih prostovoljcih, ki so jim dali enkratni odmerek 400 mg venetoklaksa s 5 mg varfarina, je prišlo do povečanja Cmax in AUC∞ R-varfarina ter S-varfarina za 18 % do 28 %.
At baseline, 46.6% of patients had one or more nodes ≥5 cm, and
Na začetku je imelo 46,6 % bolnikov eno ali več limfnih vozlov ≥ 5 cm, 67,6 % pa
P-gp and BCRP inhibitors
Zaviralci P-gp in BCRP
Dose modifications for use with CYP3A inhibitors
Prilagoditve odmerka zaradi uporabe z zaviralci CYP3A
What Venclyxto is and what it is used for What Venclyxto is
Kaj je zdravilo Venclyxto in za kaj ga uporabljamo Kaj je zdravilo Venclyxto
If a patient vomits following dosing, no additional dose should be taken that day.
Če bolnik po vzetem odmerku bruha, naj ta dan ne vzame dodatnega odmerka.
In the monotherapy studies, the most frequently reported serious adverse reactions (≥2%) were pneumonia and febrile neutropenia.
V študijah z monoterapijo sta bila najpogosteje poročana resna neželena učinka (≥ 2 %) pljučnica in vročinska nevtropenija.
Table 6: Efficacy results in patients with previously treated CLL with 17p deletion (study M13-982) Endpoint
Preglednica 6: Rezultati učinkovitosti pri bolnikih s predhodno zdravljeno KLL z delecijo 17p (študija M13-982)
Median prior lines of therapy was 1 (range: 1 to 5); and included alkylating agents (94%), anti-CD20 antibodies (77%), B-cell receptor pathway inhibitors (2%) and prior purine analogs (81%, including 55% FCR).
Mediana predhodnih vrst zdravljenja je bila 1 (razpon: od 1 do 5); in je vključevala alkilirajoče učinkovine (94 %), anti-CD20 protitelesa (77 %), zaviralce receptorske poti celic B (2 %) in purinske analoge (81 %, vključno s 55 %
What Venclyxto looks like and contents of the pack
Izgled zdravila Venclyxto in vsebina pakiranja
Venetoclax + rituximab N = 194
venetoklaks + rituksimab N = 194
The film-coated tablets are supplied in cartons containing either 10 or 14 tablets (in blisters of 2 tablets).
Filmsko obložene tablete so pakirane v škatlah, ki vsebujejo 10 ali 14 tablet (v pretisnih omotih po 2 tableti).
Blood chemistries should be reassessed prior to each subsequent dose increase during the titration phase.
Med fazo titracije je treba pred vsakim naslednjim povečanjem odmerka znova oceniti rezultate krvnih preiskav.
In a drug-drug interaction study in 12 healthy subjects, co-administration of 500 mg of azithromycin on the first day followed by 250 mg of azithromycin once daily for 4 days decreased venetoclax Cmax by 25% and AUC∞ by 35%.
V študiji medsebojnega delovanja zdravil pri dvanajstih zdravih osebah, ki so jim prvi dan sočasno dali 500 mg azitromicina, v naslednjih 4 dneh pa 250 mg azitromicina enkrat na dan, se je Cmax venetoklaksa zmanjšala za 25 % in AUC∞ za 35 %.
Based on a population pharmacokinetic analysis that included 219 subjects with mild renal impairment (CrCl ≥60 and <90 ml/min), 86 subjects with moderate renal impairment (CrCl ≥30 and <60 ml/min) and 217 subjects with normal renal function (CrCl ≥90 ml/min), venetoclax exposures in subjects with mild or moderate renal impairment are similar to those with normal renal function.
Opravljena je bila analiza populacijske farmakokinetike, ki je zajela 219 preiskovancev z blago okvaro ledvic (očistek kreatinina [CrCL] ≥ 60 in < 90 ml/min), 86 preiskovancev z zmerno okvaro ledvic (CrCL ≥ 30 in < 60 ml/min) in 217 preiskovancev z normalnim delovanjem ledvic (CrCL ≥ 90 ml/min).
Also inhibitors of P-gp or BCRP may increase venetoclax exposure (see section 4.5).
Tudi zaviralci P-gp ali BCRP lahko povečajo izpostavljenost venetoklaksu
aOne patient did not harbour the 17p deletion.
TTR, meseci, mediana (razpon) aEn bolnik ni imel delecije 17p.
Venetoclax was not genotoxic in bacterial mutagenicity assay, in vitro chromosome aberration assay and in vivo mouse micronucleus assay.
Venetoklaks ni bil genotoksičen v preizkusu mutagenosti pri bakterijah, preizkusu kromosomskih aberacij in vitro in mikrojedrnem preizkusu pri miših in vivo.
The median time since diagnosis was 6.8 years (range: 0.1 to 32 years; N=106).
Mediani čas od diagnoze je bil 6,8 let (razpon: od 0,1 do 32 let, N = 106).
No dose adjustment is needed for patients with mild or moderate renal impairment (CrCl ≥30 ml/min and <90 ml/min) (see section 5.2).
Pri bolnikih z blago do zmerno okvaro ledvic (CrCL ≥ 30 ml/min in < 90 ml/min) prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
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PODATKI NA ZUNANJI OVOJNINI ŠKATLA - večkratno pakiranje (z modrim okencem)
Neutropenia is an identified risk with Venclyxto treatment.
Nevtropenija je ugotovljeno tveganje pri zdravljenju z venetoklaksom.
27.5 (26.5, NR)
27,5 (26,5, ND)
Efficacy results for the pre-specified primary analysis (data cut-off date 8 May 2017) were also assessed by an Independent Review Committee (IRC) demonstrating a statistically significant 81% reduction in the risk of progression or death for patients treated with venetoclax + rituximab (hazard ratio: 0.19 [95% CI: 0.13,
ki jih je ocenil tudi neodvisni odbor za pregled (Independent Review Committee - IRC), so pokazali statistično značilno 81 % zmanjšanje tveganja za napredovanje bolezni ali smrt za bolnike, zdravljene z venetoklaksom + rituksimabom (razmerje tveganja: 0,19 [95 % IZ: 0,13, 0,28], P <0,0001).
The primary efficacy endpoint was overall response rate (ORR) as assessed by an Independent Review Committee (IRC) using the IWCLL updated NCI-WG guidelines (2008).
Rate), kot ga je ocenil neodvisni odbor za pregled (IRC - Independent Review Committee) z uporabo smernic NCI-WG v posodobitvi IWCLL (2008).
Administration with a low-fat meal increased venetoclax exposure by approximately 3.4-fold and administration with a high-fat meal increased venetoclax exposure by 5.1- to 5.3-fold compared to fasting conditions.
V primerjavi z jemanjem na tešče je jemanje zdravila z malo mastnim obrokom povečalo izpostavljenost venetoklaksu za približno 3,4-krat, z zelo mastnim obrokom pa za 5,1- do 5,3-krat.
Of the 296 patients evaluated for safety from 3 open-label monotherapy trials, 57% were 65 years or older.
Med 296 bolniki, pri katerih so ocenjevali varnost v 3 odprtih študijah z monoterapijo, je bilo 57 %
Concomitant use of venetoclax with strong CYP3A inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, ritonavir) at initiation and during the dose-titration phase is contraindicated due to increased risk for TLS (see section 4.3).
Sočasna uporaba venetoklaksa z močnimi zaviralci CYP3A (npr. itrakonazolom, ketokonazolom, posakonazolom, vorikonazolom, klaritromicinom, ritonavirjem) na začetku zdravljenja in med fazo titracije odmerka je kontraindicirana zaradi povečanega tveganja za TLS (glejte poglavje 4.3).
Co-administration of 600 mg once daily rifampin, a strong CYP3A inducer, for 13 days in 10 healthy subjects decreased venetoclax Cmax by 42% and AUC∞ by 71%.
Sočasno dajanje 600 mg rifampina, močnega induktorja CYP3A, enkrat na dan 13 dni, je pri 10 zdravih osebah zmanjšalo Cmax venetoklaksa za 42 % in AUC∞ za 71 %.
• low number of white blood cells with fever (febrile neutropenia)
• majhno število belih krvnih celic s povišano telesno temperaturo (febrilna nevtropenija) Krvni testi lahko pokažejo tudi:
Dose interruptions or reductions are recommended for patients with severe neutropenia (see section 4.2).
Pri bolnikih s hudo nevtropenijo je priporočljivo prekiniti odmerjanje ali zmanjšati odmerek (glejte poglavje 4.2).
Do not stop taking Venclyxto
Ne prenehajte jemati zdravilo Venclyxto
• higher level of creatinine
• povečano vrednost kreatinina • povečano vrednost sečnine
Patients with high tumour burden (e.g., any lymph node with a diameter ≥5 cm or high absolute lymphocyte count [ALC ≥25 x 109/l]) are at greater risk of TLS when initiating venetoclax.
Pri bolnikih z veliko tumorsko obremenitvijo (npr. bezgavka s premerom ≥ 5 cm ali veliko absolutno število limfocitov (ALC - Absolute Lymphocyte Count) [ALC ≥25 x 109/l]) je tveganje za TLS večje na začetku zdravljenja z venetoklaksom.
In the monotherapy studies with venetoclax, 11% of patients discontinued due to adverse reactions.
V študijah z monoterapijo z venetoklaksom je prišlo do prekinitve zdravljenja zaradi neželenih učinkov pri 11 % bolnikov.
cOf those with MRD assay results available in peripheral blood, 72.5% (121/167) in the venetoclax + rituximab arm and 20% (26/128) in the bendamustine + rituximab arm were found to be MRD negative.
cPri tistih z rezultati MRD testa, ki so bili na voljo v periferni krvi, je bilo ugotovljeno, da je MRD negativen pri 72,5 % (121/167) v skupini venetoklaks + rituksimab in pri 20 % (26/128) v skupini bendamustin + rituksimab.
Hazard ratio (95% CI) P-valuea
razmerje tveganj (95% IZ) P-vrednosta
The median age was 66 years (range: 28 to 85 years), 70% were male, and 92% were white.
Mediana starost je bila 66 let (razpon: od 28 do 85 let), 70 % je bilo moških in 92 % je bilo belcev.
- medicines for fungal infections - fluconazole, itraconazole, ketoconazole, posaconazole, or voriconazole - antibiotics to treat bacterial infections - ciprofloxacin, clarithromycin, erythromycin, nafcillin, or rifampicin - medicines to prevent seizures or to treat epilepsy - carbamazepine, phenytoin - medicines for HIV infection - efavirenz, etravirine, ritonavir - medicines to treat raised blood pressure or angina - diltiazem, verapamil - medicines to lower cholesterol levels in the blood - cholestyramine, colestipol, colesevelam - a medicine used to treat a lung condition called pulmonary arterial hypertension - bosentan - a medicine to treat sleep disorder (narcolepsy) known as modafinil - a herbal medicine known as St. John's wort
- zdravila za zdravljenje okužbe s HIV - efavirenz, etravirin, ritonavir - zdravila za zdravljenje zvišanega krvnega tlaka ali angine pektoris - diltiazem, verapamil - zdravila za znižanje ravni holesterola v krvi - holestiramin, kolestipol, kolesevelam
Number of events (%) Disease progression Death events
Število dogodkov (%) napredovanje bolezni smrtni dogodki mediana (meseci) (95% IZ)
No dose adjustment is needed during short-term use of azithromycin when administered concomitantly with venetoclax.
Pri kratkotrajni uporabi azitromicina sočasno z venetoklaksom prilagajanje odmerka ni potrebno.
If a patient experiences blood chemistry changes suggestive of TLS, the following day's venetoclax dose should be withheld.
Prilagoditve odmerka zaradi sindroma tumorske lize Če se pri bolniku pojavijo spremembe v rezultatih krvnih preiskav, ki kažejo na TLS, se naslednji dan ne sme dati odmerka venetoklaksa.
• the starting dose is 20 mg (two 10 mg tablets) once a day for 7 days.
• začetni odmerek je 20 mg (dve 10 mg tableti) enkrat na dan, 7 dni
potassium >6 mmol/l, uric acid >476 µmol/l, calcium <1.75 mmol/l, or phosphorus >1.5 mmol/l; or were reported as TLS events) and occurred in patients who had a lymph node(s) ≥5 cm or ALC ≥25 x 109/l.
Vsi primeri TLS so bili laboratorijski (laboratorijske nepravilnosti, ki so ustrezale ≥ 2 od naslednjih kriterijev in so se pojavile v 24 urah: kalij > 6 mmol/l, sečna kislina > 476 µmol/l, kalcij < 1,75 mmol/l ali fosfor > 1,5 mmol/l; ali so bili poročani kot primeri TLS) in so se zgodili pri bolnikih, ki so imeli bezgavk(o)e ≥ 5 cm ali ALC ≥ 25 x 109/l.
dOf those with MRD assay results available in bone marrow, 76.9% (30/39) in the venetoclax + rituximab arm and 6.7% (2/30) in the bendamustine + rituximab arm were found to be MRD negative.
dPri tistih z rezultati MRD testa, ki so bili na voljo v kostnem mozgu, je bilo ugotovljeno, da je MRD negativen pri 76,9 % (30/39) v skupini venetoklaks + rituksimab in pri 6,7 % (2/30) v skupini bendamustin + rituksimab.
Treatment with Venclyxto should be withheld for any grade 3 or 4 non-haematological toxicities, grade 3 or 4 neutropenia with infection or fever, or grade 4 haematological toxicities, except lymphopenia.
4. stopnje, nevtropenije 3. ali 4. stopnje z okužbo ali zvišano telesno temperaturo ali pa hematološke toksičnosti 4. stopnje, z izjemo limfopenije.
Venetoclax is a P-gp, BCRP and OATP1B1 inhibitor in vitro.
Venetoklaks je zaviralec P-gp, BCRP in OATP1B1 in vitro.
With venetoclax + rituximab treatment, febrile neutropenia was reported in 4% of patients, grade ≥3 infections in 18%, and serious infections in 21% of patients.
rituksimabom so poročali o febrilni nevtropeniji pri 4 % bolnikov, o okužbah stopnje ≥ 3 pri 18 %
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PODATKI NA ZUNANJI OVOJNINI ŠKATLA (pakiranje za 5 dni)
The median age was 67 years (range: 37 to 85 years); 65% were male, and 97% were white.
Mediana starost je bila 67 let (razpon: od 37 do 85 let); 65 % je bilo moških in 97 % je bilo belcev.
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PODATKI NA ZUNANJI OVOJNINI ŠKATLA (pakiranje za 7 dni)
Anti-hyperuricaemic agents should be administered 2 to 3 days prior to starting treatment with venetoclax in patients with high uric acid levels or at risk of TLS and may be continued through the titration phase.
Pri bolnikih z velikimi vrednostmi sečne kisline ali pri tistih s tveganjem za TLS je treba antihiperurikemike dati 2 do 3 dni pred začetkom zdravljenja z venetokslaksom in se z njimi lahko nadaljuje skozi vso fazo titracije.
Concomitant use of venetoclax with strong or moderate CYP3A inhibitors increases venetoclax exposure and may increase the risk for TLS at initiation and during the dose-titration phase and for other toxicities (see section 4.5).
Sočasna uporaba venetoklaksa z močnimi ali zmernimi zaviralci CYP3A poveča izpostavljenost venetoklaksu in lahko poveča tveganje za TLS na začetku zdravljenja in med fazo titracije odmerka ter za druge toksičnosti (glejte poglavje 4.5).
Venetoclax is a weak inhibitor of CYP2C8, CYP2C9 and UGT1A1 in vitro, but it is not predicted to cause clinically relevant inhibition.
CYP2C9 in UGT1A1, vendar predvidoma ne povzroči klinično pomembnega zavrtja.
Venetoclax daily dose
Dnevni odmerek venetoklaksa
Restart dose (mga)
Odmerek ob ponovni uvedbi zdravljenja (mga)
• If you are not sure talk to your doctor, pharmacist or nurse.
• Če niste prepričani, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Based on a population pharmacokinetic analysis that included 74 subjects with mild hepatic impairment, 7 subjects with moderate hepatic impairment and 442 subjects with normal hepatic function, venetoclax exposures are similar in subjects with mild and moderate hepatic impairment and normal hepatic function.
Opravljena je bila analiza populacijske farmakokinetike, ki je zajela 74 preiskovancev z blago okvaro jeter, 7 preiskovancev z zmerno okvaro jeter in 442 preiskovancev z normalnim delovanjem jeter.
The venetoclax dose that was used prior to initiating the CYP3A inhibitor should be resumed 2 to 3 days after discontinuation of the inhibitor (see section 4.2).
Odmerek venetoklaksa, ki se je uporabljal pred začetkom zdravljenja z zaviralcem CYP3A, je treba znova uvesti 2 do 3 dni po prenehanju zdravljenja z zaviralcem (glejte poglavje 4.2).
A larger dose reduction may occur at the discretion of the physician.
Zdravnik lahko zaradi previdnosti dodatno zmanjša odmerek.
• In the tablet core: copovidone (K 28), polysorbate 80 (E433), colloidal anhydrous silica (E551),
• Jedro tablete: kopovidon (K 28), polisorbat 80 (E433), brezvodni koloidni silicijev dioksid
Tumour lysis syndrome Hyperkalaemia Hyperphosphataemia Hypocalcaemia
Presnovne in prehranske motnje zelo pogosti hiperkaliemija hiperfosfatemija hipokalciemija pogosti sindrom tumorske lize hiperurikemija sindrom tumorske lize hiperkaliemija hiperfosfatemija hipokalciemija občasni hiperurikemija
OS, % (95% CI)
OS, % (95% IZ)
Patients randomised to BR received bendamustine at 70 mg/m2 on Days 1 and 2
Bolniki, randomizirani na BR, so prejemali bendamustin 70 mg/m2 6 ciklusov na 1. in 2. dan in rituksimab, kot je opisano zgoraj.
Pale yellow, oblong biconvex shaped tablet 17.2 mm long, 9.5 mm wide debossed with V on one side and 100 on the other.
Svetlo rumene, podolgovate, bikonveksne tablete, dolge 17,2 mm in široke 9,5 mm z oznako V na eni in 100 na drugi strani.
• 5 tablets (5 blisters each with 1 tablet)
• 5 tablet (5 pretisnih omotov s po 1 tableto)
Median age was 65 years (range: 22 to 85); 74% were male, and 97% were white.
Mediana starosti je bila 65 let (razpon od 22 do 85 let); 74 % jih je bilo moških in 97 % jih je bilo belcev.
Forest plot of Investigator-Assessed PFS in Subgroups from MURANO
Drevesni diagram za vrednosti preživetja brez napredovanja bolezni ocenjene s strani raziskovalca pri podskupinah v študiji MURANO
• dark or cloudy urine
• neenakomeren srčni utrip • temen ali moten urin
Concomitant use of venetoclax with strong CYP3A inhibitors at initiation and during the dose-titration phase is contraindicated (see sections 4.3, 4.4, and 4.5).
Sočasna uporaba venetoklaksa z močnimi zaviralci CYP3A na začetku zdravljenja in med fazo titracije odmerka je kontraindicirana (glejte poglavja 4.3, 4.4 in 4.5).
Hazard ratio
Razmerje tveganj
Breast-feeding should be discontinued during treatment with Venclyxto.
Med zdravljenjem z zdravilom Venclyxto je treba dojenje prekiniti.
anydrous calcium hydrogen phosphate (E341 (ii)), sodium stearyl fumarate.
(E551), brezvodni kalcijev hidrogenfosfat, brezvodni (E341 (ii)), natrijev stearilfumarat.