FrancophonIA/ELRC3.0 huggingface dataset:
English: If air is removed, an infusion set with a vented spike is required to ensure accurate dosing during the infusion.
Slovenian: Če je zrak odstranjen, je potreben infuzijski komplet s konico za dovajanje zraka za zagotovitev točnega odmerjanja med infundiranjem.
English: • if a bendamustine dose reduction to 50 mg/m2 has already occurred, discontinue all treatment.
Slovenian: • če je bil odmerek bendamustina že zmanjšan na 50 mg/m2, celotno zdravljenje ukinite.
English: If you have symptoms of peripheral neuropathy, your doctor may lower your dose.
Slovenian: Če imate simptome periferne nevropatije, vam lahko zdravnik zmanjša odmerek tega zdravila.
English: Your doctor will do blood tests to check your blood cell count.
Slovenian: Zdravnik vam bo opravil preiskave krvi, da bo preveril število krvnih celic.
English: Tell your doctor or nurse straight away if you have any problems with a change in the sensitivity of your skin, especially in your hands or feet, such as:
Slovenian: Zdravnika ali medicinsko sestro nemudoma obvestite, če imate težave s spremenjeno občutljivostjo kože, zlasti kože dlani ali stopal, na primer:
English: • problems with your eyesight.
Slovenian: • imate težave z vidom.
English: Procedures for proper handling and disposal of antineoplastic and cytotoxic medicines should be used.
Slovenian: Upoštevati je treba postopke za pravilno ravnanje in odlaganje antineoplastičnih in citotoksičnih zdravil.
English: • unusual sensations
Slovenian: • neobičajne zaznave
English: Avoid transportation of the prepared solution for infusion as agitation stress can result in aggregation.
Slovenian: Izogibajte se transportiranju pripravljene raztopine za infundiranje, ker lahko tresenje povzroči agregacijo.
English: This medicine can cause inflammation or damage to cells in the liver that affect the normal function of the liver.
Slovenian: To zdravilo lahko povzroči vnetje ali okvaro jetrnih celic in tako prizadene normalno delovanje jeter.
English: Sixty-four out of 80 patients (80%) had ECOG performance score (PS) of 0-1 and 14 out of 80 patients (18%) had ECOG PS of 2.
Slovenian: Štiriinšestdeset od 80 bolnikov (80 %) je imelo oceno stanja zmogljivosti po ECOG 0 ali 1, 14 od 80 bolnikov (18 %) pa je imelo to oceno 2.
English: • restart all treatment with a dose reduction of bendamustine from 90 mg/m2 to 70 mg/m2 or 70 mg/m2 to 50 mg/m2.
Slovenian: • ponovno začnite celotno zdravljenje in odmerek bendamustina zmanjšajte z 90 mg/m2 na 70 mg/m2 ali s 70 mg/m2 na 50 mg/m2.
English: Swirl the vial gently until completely dissolved.
Slovenian: Vialo rahlo vrtite, dokler se zdravilo povsem ne raztopi.
English: If the prior infusion was well tolerated, the subsequent dose of Polivy may be administered as a 30-minute infusion and patients should be monitored during the infusion and for at least 30 minutes after completion of the infusion.
Slovenian: Če je bolnik prejšnje infundiranje dobro prenesel, je mogoče nadaljnje odmerke zdravila Polivy dati v 30-minutni infuziji, bolnika pa je treba nadzirati med infundiranjem in vsaj še 30 minut po končani infuziji.
English: Polivy has not been evaluated in patients with HIV.
Slovenian: Zdravila Polivy niso preskušali pri bolnikih z okužbo s HIV.
English: No significant difference was observed in the pharmacokinetics of acMMAE and unconjugated MMAE among patients < 65 years of age (n = 187) and patients ≥ 65 years of age (n = 273).
Slovenian: Farmakokinetika acMMAE in nekonjugiranega MMAE se ni značilno razlikovala med bolniki, starimi < 65 let (n = 187) in ≥ 65 let (n = 273).
English: Signs and symptoms of infections vary between individuals, tell your doctor or nurse straight away if you develop symptoms of an infection such as:
Slovenian: Znaki in simptomi okužbe se lahko od osebe do osebe razlikujejo; zdravnika ali medicinsko sestro morate nemudoma obvestiti, če se pri vas pojavijo simptomi okužbe, na primer:
English: The total storage plus transportation times of the diluted product should not exceed the storage duration specified in Table 6 (see section 6.3).
Slovenian: Celotni čas shranjevanja in transporta razredčenega zdravila skupno ne sme preseči trajanja shranjevanja, navedenega v preglednici 6 (glejte poglavje 6.3).
English: ANNEX IV CONCLUSIONS ON THE GRANTING OF THE CONDITIONAL MARKETING AUTHORISATION PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Slovenian: SKLEPNE UGOTOVITVE O PRIDOBITVI POGOJNEGA DOVOLJENJA ZA PROMET Z ZDRAVILOM, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: The initial dose of Polivy should be administered as a 90-minute intravenous infusion.
Slovenian: Začetni odmerek zdravila Polivy je treba dati v 90-minutni intravenski infuziji.
English: • If you have peripheral neuropathy, your doctor may lower your dose to 1.4 mg for each kilogram of your body weight.
Slovenian: • Če imate periferno nevropatijo, vam zdravnik lahko odmerek zmanjša na 1,4 mg na kilogram telesne mase.
English: The median number of prior therapies was 2 (range: 1-7), with 29% (n = 23) receiving one prior therapy, 25% (n = 20) receiving 2 prior therapies, and 46% (n = 37) receiving 3 or more prior therapies.
Slovenian: Mediano število predhodnih zdravljenj je bilo 2 (razpon: od 1 do 7); 29 % (n = 23) je prejelo eno predhodno zdravljenje, 25 % (n = 20) 2 predhodni zdravljenji in 46 % (n = 37) 3 predhodna zdravljenja ali več.
English: This includes any possible side effects not listed in this leaflet you can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: Immunogenicity assay results are highly dependent on several factors including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications and underlying disease.
Slovenian: Rezultati preizkusov imunogenosti so zelo odvisni od številnih dejavnikov, vključno z občutljivostjo in specifičnostjo preizkusa, metodologijo preizkusa, ravnanjem z vzorcem, časom odvzema vzorca, sočasnimi zdravili in osnovno boleznijo.
English: In the absence of infusion-related symptoms, the rate of infusion may be escalated in increments of 50 mg/hour every 30 minutes.
Slovenian: Če ni simptomov, povezanih z infundiranjem, se lahko hitrost infundiranja povečuje v korakih po 50 mg/h vsakih 30 minut.
English: What Polivy is and what it is used for
Slovenian: Kaj je zdravilo Polivy in za kaj ga uporabljamo
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 140 mg
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 140 mg
English: For dose modifications for peripheral neuropathy (section 4.4) see Table 1 below.
Slovenian: Za prilagoditve odmerka v primeru periferne nevropatije (poglavje 4.4) glejte spodnjo preglednico 1.
English: Withhold Polivy dosing until improvement to ≤ Grade 1.
Slovenian: Odložite uporabo zdravila Polivy, dokler se učinek ne izboljša na ≤ 1. stopnjo.
English: Administer premedication for all cycles.
Slovenian: V vseh ciklih aplicirajte premedikacijo.
English: Polivy can cause some serious side effects that you need to tell your doctor or nurse about straight away.
Slovenian: Zdravilo Polivy lahko povzroči nekatere resne neželene učinke, o katerih morate nemudoma obvestiti zdravnika ali medicinsko sestro.
English: The majority of patients (98%) had DLBCL not otherwise specified (NOS).
Slovenian: Večina bolnikov (98 %) je imela DVCLB brez drugih oznak (BDO).
English: Primary reasons patients were not candidates for HSCT included age (40%), insufficient response to salvage therapy (26%) and prior transplant failure (20%).
Slovenian: Med glavnimi razlogi za neustreznost bolnikov za presaditev PKMC so bili starost (40 %), nezadosten odgovor na reševalno (angl. salvage) zdravljenje (26 %) in predhodno neuspešna presaditev (20 %).
English: The primary endpoint of the study was complete response (CR) rate at end of treatment (6-8 weeks after Day 1 of Cycle 6 or last study treatment) as assessed by PET-CT by an Independent Review Committee (IRC).
Slovenian: Primarni cilj študije je bil delež popolnega odgovora (CR) na koncu zdravljenja (od 6 do 8 tednov po 1. dnevu 6. cikla ali zadnjega zdravljenja v študiji), ki ga je s PET-CT ocenil neodvisni odbor za pregled (NOP).
English: This includes run-in phase patients (n=6) and randomized patients (n=39) who received Polivy in combination with bendamustine and rituximab (BR) compared to randomized patients (n=39) who received BR alone.
Slovenian: To vključuje bolnike v obdobju uvajanja (n = 6) in randomizirane bolnike (n = 39), ki so prejemali zdravilo Polivy v kombinaciji z bendamustinom in rituksimabom (BR) v primerjavi z randomiziranimi bolniki (n = 39), ki so prejemali samo BR.
English: Interrupt POLIVY infusion and give supportive treatment.
Slovenian: Prekinite infundiranje zdravila Polivy in uvedite podporno zdravljenje.
English: Patients with high tumour burden and rapidly proliferative tumour may be at increased risk of TLS.
Slovenian: Bolniki z velikim tumorskim bremenom in hitro proliferirajočim tumorjem imajo lahko večje tveganje za sindrom razpada tumorja.
English: Polivy is not recommended during pregnancy and in women of childbearing potential not using contraception unless the potential benefit for the mother outweighs the potential risk to the foetus.
Slovenian: Zdravila Polivy ni priporočljivo uporabljati med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije, razen če možna korist za mater odtehta možno tveganje za plod.
English: A recommended dose has not been determined for patients with CrCL < 30mL/min due to limited data.
Slovenian: Priporočeni odmerek za bolnike z očistkom kreatinina < 30 ml/min zaradi omejenih podatkov ni določen.
English: • have unusual bleeding, bruising under the skin, bleeding longer than usual after your blood has been drawn, or bleeding from your gums.
Slovenian: • se vam pojavljajo nenavadne krvavitve, podplutbe pod kožo, dolgotrajnejše krvavitve po odvzemu krvi ali krvavitve iz dlesni.
English: Due to the limited number of anti-polatuzumab vedotin antibody positive patients, no conclusions can be drawn concerning a potential effect of immunogenicity on efficacy or safety.
Slovenian: Zaradi majhnega števila bolnikov, ki so imeli prisotna protitelesa proti polatuzumabu vedotinu, ni mogoče sklepati o možnem vplivu imunogenosti na učinkovitost ali varnost.
English: If you stop receiving Polivy
Slovenian: Če ste prenehali dobivati zdravilo Polivy
English: Once attached to B cells, the medicine releases MMAE into the B cells and kills them.
Slovenian: Ko je pritrjeno na celice B, vanje sprosti MMAE in jih ubije.
English: Based on a population PK analysis, the conjugate (acMMAE) is primarily eliminated by non-specific linear clearance pathway with a value of 0.9 L/day.
Slovenian: Na podlagi populacijske farmakokinetične analize se konjugat (acMMAE) odstrani predvsem z nespecifično linearno potjo očistka z vrednostjo 0,9 l/dan.
English: • you have ever had brain or nerve problems such as: memory problems difficulty moving or sensations in your body such as feeling pins and needles, burning, pain and discomfort even from slight touch eyesight problems
Slovenian: • če imate ali ste kdaj imeli težave z možgani ali živci, na primer: težave s spominom, težave z gibanjem ali zaznave v telesu, kot so občutki zbadanja, pekoča bolečina, bolečina in neugodje, celo ob rahlemu dotiku, težave z vidom;
English: • feeling tired (anaemia)
Slovenian: • občutek utrujenosti (anemija)
English: Patients should be monitored closely for new or worsening neurological, cognitive, or behavioural changes suggestive of PML.
Slovenian: Bolnike je treba skrbno nadzorovati glede novonastalih nevroloških, kognitivnih ali vedenjskih sprememb, ki nakazujejo na PML, oziroma glede poslabšanja takšnih sprememb.
English: The levels of MMAE metabolites have not been measured in human plasma.
Slovenian: Koncentracije presnovkov MMAE v človeški plazmi niso merili.
English: CD79b expression is restricted to normal cells within the B-cell lineage (with the exception of plasma cells) and malignant B-cells; it is expressed in > 95% of diffuse large B-cell lymphoma.
Slovenian: Izraženost CD79b je omejena na normalne celice v B-celični vrsti (razen plazmatk) in na maligne celice B; izražen je na > 95 % celic difuznega velikoceličnega limfoma B. Po vezavi na
English: • if you are allergic to polatuzumab vedotin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na polatuzumab vedotin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: The terminal half-life at Cycle 6 was approximately 12 days (95% CI of 8.1-19.5 days) for acMMAE.
Slovenian: Končni razpolovni čas acMMAE v 6. ciklu je bil približno 12 dni (95-% IZ: 8,1-19,5 dneva).
English: Polivy, bendamustine and rituximab can be administered in any order on Day 1 of each cycle.
Slovenian: Zdravila Polivy, bendamustin in rituksimab je mogoče aplicirati v kakršnem koli zaporedju 1. dan vsakega cikla.
English: There is no experience with overdose in human clinical trials.
Slovenian: Izkušenj s prevelikim odmerjanjem iz kliničnih preskušanj pri človeku ni.
English: For the clinical development program of Polivy as a whole, an estimated total of 588 patients have received Polivy.
Slovenian: Ocenjeno skupno število bolnikov, ki so med celotnim programom kliničnega razvoja zdravila Polivy prejemali zdravilo Polivy, je 588.
English: In vitro studies indicate that MMAE is a substrate for CYP3A4/5 but does not induce major CYP enzymes.
Slovenian: In vitro študije kažejo, da je MMAE substrat za CYP3A4/5, vendar ne inducira pomembnih encimov CYP.
English: Your doctor or nurse will check for side effects during your infusion and for 30 to 90 minutes afterwards.
Slovenian: Zdravnik ali medicinska sestra bo spremljala morebiten pojav neželenih učinkov med infundiranjem in še 30 do 90 minut po njem.
English: Grade 2-3
Slovenian: 2.-3. stopnja
English: MMAE is a weak time-dependent inhibitor of CYP3A4/5 but does not competitively inhibit CYP3A4/5 at clinically relevant concentrations.
Slovenian: MMAE je šibek časovno odvisen zaviralec CYP3A4/5, vendar v klinično pomembnih koncentracijah kompetitivno ne zavira CYP3A4/5.
English: In another study, two cases of serious hepatic toxicity (hepatocellular injury and hepatic steatosis) were reported and were reversible.
Slovenian: V drugi študiji so poročali o dveh reverzibilnih primerih resne hepatotoksičnosti (okvara jetrnih celic in steatoza jeter).
English: Dose modification1
Slovenian: Prilagoditev odmerka1
English: Investigator-assessed progression free survival (PFS) was an exploratory endpoint which was not type 1 error controlled.
Slovenian: Preživetje brez napredovanja bolezni (PFS) po raziskovalčevi oceni je bilo eksplorativni cilj, ki ni bil kontroliran glede napake tipa 1.
English: In vivo studies in rats dosed with polatuzumab vedotin (radiolabel on MMAE) demonstrate that the majority of radioactivity is excreted in faeces and the minority of radioactivity is excreted in urine.
Slovenian: Študije in vivo, izvedene na podganah s polatuzumabom vedotinom (radioaktivno označenim na MMAE), kažejo da se večina radioaktivnosti izloči v blatu, majhen del pa v urinu.
English: • yellowing of skin or whites of your eyes
Slovenian: • porumenelost kože ali očesnih beločnic
English: Stop Polivy infusion immediately.
Slovenian: Takoj ustavite infundiranje zdravila Polivy.
English: However, treatment of pregnant rats with MMAE at 0.2 mg/kg caused embryolethality and foetal malformations (including protruding tongue, malrotated limbs, gastroschisis, and agnathia).
Slovenian: Toda uporaba MMAE v odmerku 0,2 mg/kg je pri brejih podganah povzročila smrt zarodkov (embrioletalnost) in malformacije pri plodovih (vključno s protruzijo jezika, malrotacijo udov, gastroshizo in agnatijo).
English: Prophylactic granulocyte colony stimulating factor (G-CSF) administration was required in the clinical development and should be considered.
Slovenian: Treba je pretehtati profilaktično uporabo granulocitnega rastnega dejavnika (G-CSF), saj je bila potrebna med kliničnim razvojem zdravila.
English: MMAE was genotoxic in the rat bone marrow micronucleus study probably through an aneugenic mechanism.
Slovenian: MMAE je bil v mikrojedrnem testu v kostnem mozgu podgan genotoksičen, verjetno zaradi anevgeničnega učinka.
English: • Do not use this medicine after the expiry date which is stated on the carton and the vial after
Slovenian: • Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na viali poleg oznake Uporabno do/EXP.
English: ADRs leading to treatment regimen discontinuation in >5% of patients were thrombocytopenia (8.9%) and neutropenia (6.7%).
Slovenian: Neželena učinka, ki sta povzročila prenehanje sheme zdravljenja pri > 5 % bolnikov, sta bila trombocitopenija (8,9 %) in nevtropenija (6,7 %).
English: Pre-existing liver disease, elevated baseline liver enzymes, and concomitant medicinal products may increase the risk.
Slovenian: Predhodna bolezen jeter, izhodiščno zvišani jetrni encimi in uporaba sočasnih zdravil lahko tveganje povečajo.
English: The highest dose tested to date is 2.4 mg/kg administered as an intravenous infusion; it was associated with a higher frequency and severity of PN events.
Slovenian: Največji do zdaj testirani odmerek je 2,4 mg/kg v intravenski infuziji, ki je bil povezan z večjo pogostnostjo in izraženostjo periferne nevropatije.
English: Based on population PK analysis, the predicted acMMAE concentration at the end of cycle 6 is approximately 80% of the theoretical steadystate value.
Slovenian: Glede na populacijsko farmakokinetično analizo je pričakovana koncentracija acMMAE na koncu 6. cikla približno 80 % teoretične vrednosti v dinamičnem ravnovesju.
English: See section “Polivy contains sodium”.
Slovenian: Glejte poglavje “Zdravilo Polivy vsebuje natrij”.
English: 80% of patients had refractory disease.
Slovenian: 80 % bolnikov se na prejšnje zdravljenje ni odzvalo.
English: • raised liver enzymes
Slovenian: • zvišanje jetrnih encimov
English: MMAE does not significantly partition into human red blood cells in vitro; the blood to plasma ratio is 0.79 to 0.98.
Slovenian: MMAE se in vitro ne porazdeli pomembno v človeške eritrocite; razmerje med krvjo in plazmo je od 0,79 do
English: Withdraw the required volume of reconstituted solution from the Polivy vial using a sterile syringe and dilute into the intravenous infusion bag.
Slovenian: Izvlecite potrebno količino rekonstituirane raztopine iz viale zdravila Polivy s sterilno brizgo in to količino razredčite v intravenski infuzijski vrečki.
English: What you need to know before you are given Polivy You must not be given Polivy
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo Polivy Zdravila Polivy ne smete dobiti:
English: If no infusionrelated reaction occurs, subsequent infusions may be administered over 30 minutes.
Slovenian: Če se reakcija, povezana z infundiranjem, ne pojavi, lahko nadaljnje infuzije dajete v 30 minutah.
English: Patients should be closely monitored during treatment for signs of bacterial, fungal, or viral infections and seek medical advice if signs and symptoms appear.
Slovenian: Bolnike je treba med zdravljenjem skrbno nadzorovati glede znakov bakterijskih, glivnih ali virusnih okužb; če se pojavijo znaki in simptomi okužbe, mora bolnik poiskati zdravniško pomoč.
English: Bendamustine does not affect acMMAE and unconjugated MMAE plasma AUC.
Slovenian: Bendamustin ne vpliva na plazemsko AUC acMMAE ali nekonjugiranega MMAE.
English: Polivy can cause IRRs , including severe cases.
Slovenian: Zdravilo Polivy lahko povzroči reakcije, povezane z infundiranjem, vključno s hudimi primeri.
English: Discontinue Polivy.
Slovenian: Ukinite zdravilo Polivy.
English: If a planned dose of Polivy is missed, it should be administered as soon as possible and the schedule of administration should be adjusted to maintain a 21-day interval between doses.
Slovenian: Zapozneli ali izpuščeni odmerki Če je načrtovani odmerek zdravila Polivy izpuščen, ga je treba dati čim prej, urnik dajanja pa prilagoditi tako, da se ohrani 21-dnevni presledek med odmerki.
English: If recovered to Grade ≤ 1 on or before Day 14, restart Polivy at a permanently reduced dose of 1.4 mg/kg.
Slovenian: Če se do (vključno) 14. dne izboljša na ≤ 1. stopnjo, ponovno začnite uporabljati zdravilo Polivy v stalno zmanjšanem odmerku 1,4 mg/kg.
English: Unconjugated MMAE is not predicted to alter the AUC of concomitant medicines that are CYP3A4 substrates (e.g., midazolam).
Slovenian: Ne predvidevajo, da bi nekonjugirani MMAE spremenil AUC sočasno uporabljenih zdravil, ki so substrati CYP3A4 (npr. midazolama).
English: The unadjusted estimate for PFS HR was 0.34.
Slovenian: Neprilagojena ocena za razmerje ogroženosti za PFS je bila 0,34.
English: Polivy is compatible with intravenous infusion bags with product contacting materials of polyvinyl chloride (PVC) or polyolefins such as polyethylene (PE) and polypropylene.
Slovenian: Zdravilo Polivy je kompatibilno z intravenskimi infuzijskimi vrečkami iz materialov, ki so vsebovali polivinilklorid (PVC) ali poliolefine, na primer polietilen (PE) in polipropilen.
English: Gently mix the intravenous bag by slowly inverting the bag.
Slovenian: Previdno premešajte vsebino intravenske vrečke, tako da jo počasi obračate.
English: Based on population pharmacokinetics simulations, a sensitivity analysis predicted exposure to unconjugated MMAE for patients with bodyweight over 100 kg to be increased by 27%.
Slovenian: Na podlagi simulacij populacijske farmakokinetike je senzitivnostna analiza napovedala 27-% povečanje izpostavljenosti nekonjugiranemu MMAE pri bolnikih s telesno maso nad 100 kg.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution and dilution Read the package leaflet before use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Za intravensko uporabo po rekonstituciji in redčenju Pred uporabo preberite priloženo navodilo!
English: • trouble speaking
Slovenian: • imate težave z govorjenjem,
English: Solution for infusion storage conditions1
Slovenian: Pogoji shranjevanja raztopine za infundiranje1
English: Embryo-foetal toxicity
Slovenian: Embrio-fetalna toksičnost
English: How much Polivy is given
Slovenian: Koliko zdravila Polivy se daje
English: Polivy is given under the supervision of a doctor experienced in giving such treatments.
Slovenian: Zdravilo Polivy boste prejemali pod nadzorom zdravnika, ki ima izkušnje z dajanjem takšnih zdravil.
English: If the prepared infusion will be transported, remove air from the infusion bag and limit transportation to 30 minutes room temperature (9°C − 25°C) or 24 hours refrigerated (2°C − 8°C).
Slovenian: Če bo pripravljena infuzija transportirana, iz infuzijske vrečke odstranite zrak in omejite transport na 30 minut pri sobni temperaturi (9 do 25 °C) ali na 24 ur v hladilniku(2 do 8 °C).
English: Based on physiological-based pharmacokinetic (PBPK) model simulations of MMAE released from polatuzumab vedotin, strong CYP3A4 and P-gp inhibitors (e.g., ketoconazole) may increase the area under the concentration-time curve (AUC) of unconjugated MMAE by 48%.
Slovenian: Na podlagi simulacij sproščanja MMAE iz polatuzumaba vedotina s farmakokinetičnimi modeli na fiziološki osnovi lahko močni zaviralci CYP3A4 in P-gp (npr. ketokonazol) povečajo površino pod krivuljo koncentracije skozi čas (AUC) nekonjugiranega MMAE za 48 %.
English: IRC: Independent Review Committee; INV: Investigator; HR: Hazard Ratio; CI: Confidence Interval, NE: Not evaluable; CMH Cochran-Mantel-Haenszel *Per modified Lugano 2014 criteria: Bone marrow confirmation of PET-CT CR required.
Slovenian: NOP: neodvisni odbor za pregled, HR: razmerje ogroženosti, IZ: interval zaupanja, NO: ni ocenljivo, CMH: Cochran-Mantel-Haenszel.