natgillin/translations-raw huggingface dataset:
Appropriate measures/prophylaxis in accordance with local guidelines should be taken prior to treatment with Polivy.
Pred zdravljenjem z zdravilom Polivy je treba uporabiti ustrezne profilaktične ukrepe v skladu z lokalnimi smernicami.
Women should discontinue breast-feeding during treatment with Polivy.
Ženske morajo med zdravljenjem z zdravilom Polivy prenehati dojiti.
In the BR arm, serious infections were reported in 30.8% of patients and fatal infections were reported in 10.3% of patients.
V skupini, zdravljeni z BR, so o resnih okužbah poročali pri 30,8 % bolnikov in o okužbah s smrtnim izidom pri 10,3 % bolnikov.
For dose modifications for Infusion-related reactions see Table 3.
Za prilagoditve odmerka v primeru reakcij, povezanih z infundiranjem, glejte preglednico 3.
Polivy is administered as an intravenous infusion.
Zdravilo Polivy se aplicira kot intravenska infuzija.
Patients should be monitored for symptoms of PN such as hypoesthesia, hyperesthesia, paraesthesia, dysesthesia, neuropathic pain, burning sensation, muscle weakness, or gait disturbance.
Bolnike je treba nadzorovati glede simptomov periferne nevropatije, kot so hipestezije, hiperestezije, parestezije, dizestezije, nevropatske bolečine, pekoč občutek, šibkost mišic in motnje hoje.
Delayed IRRs as late as 24 hours after receiving Polivy have occurred.
Zapoznele reakcije, povezane z infundiranjem, so se pojavile tudi 24 ur po prejetju zdravila Polivy.
The recommended dose of Polivy is 1.8 mg/kg, given as an intravenous infusion every 21 days in combination with bendamustine and rituximab for 6 cycles.
Priporočeni odmerek zdravila Polivy je 1,8 mg/kg v intravenski infuziji na 21 dni v kombinaciji z bendamustinom in rituksimabom v trajanju 6 ciklov.
No dedicated carcinogenicity studies have been performed with polatuzumab vedotin and/or MMAE.
Namenskih študij kancerogenosti s polatuzumabom vedotinom in/ali MMAE niso izvedli.
In vitro data indicate that MMAE is a P-gp substrate but does not inhibit P-gp at clinically relevant concentrations.
Podatki in vitro kažejo, da je MMAE substrat za P-gp, vendar v klinično pomembnih koncentracijah ne zavira P-gp.
In order to further confirm the safety and efficacy of polatuzumab vedotin in combination with BR the MAH will provide the primary CSR for study GO29365 including the primary analysis of Arm H (n=64) as well as a pooled analysis of Arm G (n=42) and Arm H (n=64).
Za dodatno potrditev varnosti in učinkovitosti polatuzumaba vedotina v kombinaciji z BR bo imetnik dovoljenja za promet predložil primarno poročilo kliničnega preskušanja (CSR) za študijo GO29365, vključno s primarno analizo skupine H (n = 64), kot tudi združeno analizo skupin G (n = 42) in H (n = 64).
• The other ingredients are: succinic acid, sodium hydroxide, sucrose, polysorbate 20.
• Druge sestavine so: sukcinska kislina, natrijev hidroksid, saharoza, polisorbat 20.
Tell your doctor or nurse if you notice any of the following side effects:
Zdravniku ali medicinski sestri morate povedati, če opazite katerega od naslednjih neželenih učinkov:
• feel tired
• utrujenost,
What Polivy looks like and contents of the pack
Izgled zdravila Polivy in vsebina pakiranja
Polivy contains a cytotoxic component which is covalently attached to the monoclonal antibody.
Zdravilo Polivy vsebuje citotoksično komponento, ki je kovalentno vezana na monoklonsko protitelo.
20 mL vial (colourless Type 1 glass) closed with a stopper (fluororesin laminate), with an aluminum seal with plastic flip-off cap containing 140 mg polatuzumab vedotin.
20-ml viala (brezbarvno steklo tipa 1), zaprta z zamaškom (laminat fluorove smole) z aluminijasto zaporo s plastično snemno zaporko, ki vsebuje 140 mg polatuzumaba vedotina.
Very common hypokalaemia, hypocalcaemia, hypoalbuminemia, decreased appetite Nervous system disorders
Zelo pogosti hipokaliemija, hipokalciemija, hipoalbuminemija, zmanjšan apetit
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar pomeni, da je v bistvu “brez natrija”.
MMAE plasma concentrations followed formation rate limited kinetics.
Koncentracija MMAE v plazmi je sledila kinetiki, omejeni s hitrostjo tvorbe.
Withhold all treatment until ANC recovers to > 1000/µL.
Odložite celotno zdravljenje, dokler se absolutno število nevtrofilcev ne povrne na > 1000/µl.
Based on the mechanism of action and nonclinical studies, Polivy can be harmful to the foetus when administered to a pregnant woman (see section 5.3).
Glede ne mehanizem delovanja in rezultate predkliničnih študij lahko pri nosečnici uporabljeno zdravilo Polivy škoduje plodu (glejte poglavje 5.3).
The active substance in Polivy is made up of a monoclonal antibody linked to MMAE, a substance that can kill cancer cells.
Učinkovina v zdravilu Polivy je iz monoklonskega protitelesa, povezanega z MMAE - snovjo, ki lahko uniči rakave celice.
Proper aseptic technique throughout the handling of this medicinal product should be followed.
Med celotnim ravnanjem s tem zdravilom je treba upoštevati ustrezen aseptični postopek.
This is called tumour lysis syndrome.
To imenujemo sindrom razpada tumorja.
In the Polivy plus BR arm, serious infections were reported in 28.9% of patients and fatal infections were reported in 8.9% of patients.
V skupini, zdravljeni z zdravilom Polivy in BR, so o resnih okužbah poročali pri 28,9 % bolnikov in o okužbah s smrtnim izidom pri 8,9 % bolnikov.
MMAE was not mutagenic in the bacterial reverse mutation assay (Ames test) or the L5178Y mouse lymphoma forward mutation assay.
MMAE ni bil mutagen ne v bakterijskem preizkusu reverznih mutacij (Amesov test) ne v preizkusu za povečano tveganje za nastanek nadaljnjih mutacij v celicah mišjega limfoma L5178Y.
Due to limited clinical experience in patients treated with 1.8 mg/kg Polivy at a total dose >240 mg, it is recommended not to exceed the dose 240 mg/cycle.
Podatkov pri bolnikih, zdravljenih z 1,8 mg/kg zdravila Polivy v skupnem odmerku > 240 mg, je malo, zato ni priporočljivo prekoračiti odmerka
If you are a woman of childbearing age, you must use effective contraception during treatment and for 9 months after the last dose of Polivy.
Če ste ženska v rodni dobi, morate uporabljati učinkovito kontracepcijo med zdravljenjem in še 9 mesecev po zadnjem odmerku zdravila Polivy.
Patients aged ≥65 had a numerically higher incidence of serious adverse reactions (64%) than patients aged
Bolniki, stari 65 let ali več, so imeli številčno večjo incidenco resnih neželenih učinkov (64 %) kot bolniki, mlajši od 65 let (53 %).
Talk to your doctor or nurse before you are given Polivy if any of the following apply to you (or you are not sure):
Preden boste začeli dobivati zdravilo Polivy, se posvetujte z zdravnikom ali medicinsko sestro, če za vas velja kar koli od spodaj naštetega (ali če niste prepričani):
An antihistamine and antipyretic should be administered prior to the administration of Polivy, and patients should be monitored closely throughout the infusion.
Pred zdravilom Polivy je treba aplicirati antihistaminik in antipiretik in skrbno spremljati bolnike ves čas infundiranja.
Inspect the intravenous bag for particulates and discard if present.
Intravensko vrečko preglejte glede prisotnosti delcev; če so delci prisotni, jo zavrzite.
For the first instance of Grade 3 wheezing, bronchospasm, or generalized urticaria, permanently discontinue Polivy.
Ob prvem primeru piskanja, bronhospazma ali generalizirane urtikarije 3. stopnje ukinite zdravilo Polivy.
If platelets recover to > 75,000/µL after Day 7:
Če se število trombocitov povrne na > 75.000/µl po 7. dnevu:
There are no data in pregnant women using Polivy.
Podatkov o nosečnicah, ki bi prejemale zdravilo Polivy, ni.
Complete blood counts should be monitored prior to each dose of Polivy.
Pred vsakim odmerkom zdravila Polivy je treba kontrolirati celotno krvno sliko.
Polivy powder for concentrate for solution for infusion is a white to slightly greyish-white cake provided in a glass vial.
Zdravilo Polivy prašek za koncentrat za raztopino za infundiranje je bela do rahlo sivkasta pogača v stekleni viali.
You will be given 6 treatment cycles of Polivy in combination with two other medicines called rituximab and bendamustine.
Dobili boste 6 ciklov zdravljenja z zdravilom Polivy, in sicer skupaj z dvema drugima zdraviloma, rituksimabom in bendamustinom.
Total Polivy dose (mL) to be further diluted = Polivy dose (mg/kg) X patient's weight (kg)
odmerek zdravila Polivy (mg/kg) x bolnikova telesna masa (kg)
• severe infections
• hude okužbe
PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial
FARMACEVTSKA OBLIKA IN VSEBINA Prašek za koncentrat za raztopino za infundiranje
• burning pain when passing urine
• pekoče bolečine pri uriniranju,
Live or live-attenuated vaccines should not be given concurrently with the treatment.
Sočasno z zdravljenjem se bolnikom ne sme dajati živih in živih oslabljenih cepiv.
Anti-infective prophylaxis should be considered throughout treatment with Polivy.
Razmisliti je treba o profilaksi z zdravili proti okužbam v celotnem obdobju zdravljenja z zdravilom Polivy.
• Keep the container in the outer carton in order to protect from light.
• Vsebnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
• viral infections
• virusne okužbe
The unadjusted estimate for OS HR was 0.42.
Neprilagojena ocena za razmerje ogroženosti za OS je bila 0,42.
Serious, life threatening or fatal infections, including opportunistic infections, such as pneumonia (including pneumocystis jirovecii and other fungal pneumonia), bacteraemia, sepsis, herpes infection, and cytomegalovirus infection have been reported in patients treated with Polivy (see section 4.8).
Pri bolnikih, zdravljenih z zdravilom Polivy, so poročali o resnih, življenje ogrožajočih ali smrtnih okužbah, vključno z oportunističnimi okužbami, kot so pljučnica (vključno s Pneumocystis jirovecii in drugimi glivnimi pljučnicami), bakteriemija, sepsa, herpesna okužba in citomegalovirusna okužba (glejte poglavje 4.8).
Each pack of Polivy consists of one vial.
Eno pakiranje zdravila Polivy vsebuje eno vialo.
Serious and severe neutropenia and febrile neutropenia have been reported in patients treated with Polivy as early as the first cycle of treatment.
Pri bolnikih, zdravljenih z zdravilom Polivy, so poročali o resni in hudi nevtropeniji in febrilni nevtropeniji že v prvem ciklu zdravljenja.
When accounting for the influence of baseline covariates the OS HR was adjusted to 0.59.
Ob upoštevanju vpliva izhodiščnih sospremenljivk, je bilo razmerje ogroženosti za OS prilagojeno na 0,59.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
Testicular seminiferous tubule degeneration did not reverse following a 6-week treatment-free period and correlated with decreased testes weight and gross findings at recovery necropsy of small and/or soft testes in males given ≥ 2 mg/kg.
Degeneracija semenskih cevk v modih se po 6-tedenskem obdobju brez zdravila ni popravila in je korelirala z zmanjšanjem mase mod in makroskopskim zmanjšanjem in/ali zmehčanjem mod pri samcih, ki so prejemali ≥ 2 mg/kg, kar je bilo ugotovljeno na obdukciji po okrevanju.
Common arthralgia
Pogosti artralgija
Elderly No dose adjustment of Polivy is required in patients ≥ 65 years of age (see section 5.2).
Starejši bolniki Bolnikom, starim 65 let ali več, odmerka zdravila Polivy ni treba prilagoditi (glejte poglavje 5.2).
Sodium hydroxide (for pH-adjustment) Sucrose
Natrijev hidroksid (za uravnavanje pH)
When administered with Polivy, the recommended dose of bendamustine is 90 mg/m2/day on Day 1 and Day 2 of each cycle and the recommended dose of rituximab is 375 mg/m2 on Day 1 of each cycle.
Med uporabo z zdravilom Polivy je priporočeni odmerek bendamustina 90 mg/m2/dan 1. in 2. dan vsakega cikla, priporočeni odmerek rituksimaba pa 375 mg/m2 1. dan vsakega cikla.
In women of childbearing potential, the pregnancy status shall be checked prior to treatment.
Pri ženskah v rodni dobi je treba izključiti nosečnost pred zdravljenjem.
In patients with mild (CrCL 60-89 mL/min, n = 161) or moderate (CrCL 30- 59 mL/min, n = 109) renal impairment, acMMAE and unconjugated MMAE exposures are similar to patients with normal renal function (CrCL ≥ 90 mL/min, n = 185), based on a population PK analysis.
Pri bolnikih z blago (očistek kreatinina 60-89 ml/min, n = 161) ali zmerno (očistek kreatinina 3059 ml/min, n = 109) okvaro ledvic je bila na podlagi populacijske farmakokinetične analize izpostavljenost acMMAE in nekonjugiranemu MMAE podobna kot pri bolnikih z normalnim delovanjem ledvic (očistek kreatinina ≥ 90 ml/min, n = 185).
Eligible patients were not candidates for autologous haematopoietic stem cell transplant (HSCT) and had relapsed or refractory disease after receiving at least one prior systemic chemotherapy regimen.
Primerni bolniki niso bili kandidati za avtologno presaditev krvotvornih matičnih celic (PKMC) in se na prejšnje zdravljenje z vsaj eno shemo sistemske kemoterapije niso odzvali ali se je bolezen pri njih ponovila.
Precaution to be taken before manipulating or administering the product
Previdnostni ukrepi, potrebni pred ravnanjem z zdravilom ali dajanjem zdravila
After the first 1.8 mg/kg polatuzumab vedotin dose, the Cmax was 6.82 (± 4.73) ng/mL, the time to maximum plasma concentration is approximately 2.5 days, and the terminal half-life is approximately 4 days.
Po prvem odmerku polatuzumaba vedotina 1,8 mg/kg je bila Cmax 6,82 (± 4,73) ng/ml, čas do največje koncentracije v plazmi je približno 2,5 dneva in končni razpolovni čas je približno 4 dni.
If an IRR occurs, the infusion should be interrupted and appropriate medical management should be instituted (see section 4.2).
Če se pojavi reakcija, povezana z infundiranjem, infundiranje prekinite in ustrezno ravnajte oziroma zdravite (glejte poglavje 4.2).
Polivy contains a cytotoxic component.
Zdravilo Polivy vsebuje citotoksično komponentno.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours refrigerated (2 °C − 8 °C), unless reconstitution has taken place in controlled and validated aseptic conditions.
Če ni uporabljena takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika; čas običajno ne sme presegati 24 ur v hladilniku (2 do 8 °C), razen če je rekonstitucija opravljena v nadzorovanih in preverjenih aseptičnih pogojih.
After the first 1.8 mg/kg polatuzumab vedotin dose, the acMMAE mean maximum concentration (Cmax) was 803 (± 233) ng/mL and the area under the concentration-time curve from time zero to infinity (AUCinf) was 1860 (±966) day•ng/mL.
Po prvem odmerku polatuzumaba vedotina 1,8 mg/kg je bila povprečna največja koncentracija acMMAE (Cmax) 803 (± 233) ng/ml, površina pod krivuljo koncentracije skozi čas od nič do neskončno (AUCinf) pa je bila 1860 (± 966) dan x ng/ml.
• herpes infection
• okužba s herpesom
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours refrigerated (2 °C − 8 °C), unless dilution has taken place in controlled and validated aseptic conditions.
Če ni uporabljena takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika; čas običajno ne sme presegati 24 ur v hladilniku (2 do 8 °C), razen če je razredčenje opravljeno v nadzorovanih in preverjenih aseptičnih pogojih.
Your doctor will check your blood to test your liver function before and regularly during treatment.
Zdravnik vam bo pred zdravljenjem in redno med zdravljenjem kontroliral kri zaradi preverjanja delovanja jeter.
Patients should be monitored for IRRs/hypersensitivity reactions during the infusion and for at least 90 minutes following completion of the initial dose.
Bolnike je treba med infundiranjem in vsaj še 90 minut po končani infuziji začetnega odmerka nadzorovati glede reakcij, povezanih z infundiranjem in preobčutljivostnih reakcij.
This mechanism is consistent with the pharmacological effect of MMAE as a microtubule disrupting agent.
Ta učinek se sklada s farmakološkim učinkom MMAE, ki okvarja normalno strukturo in funkcijo mikrotubulov.
Up to 24 hours refrigerated (2 °C − 8 °C) or up to 4 hours at room temperature (9 °C − 25 °C) Sodium chloride 4.5 mg/mL (0.45%) Up to 72 hours refrigerated (2 °C − 8 °C) or up to 8 hours at room temperature (9 °C − 25 °C)
Do 24 ur v hladilniku (2 do 8 °C) ali do 4 ure pri sobni temperaturi (9 do 25 °C) Natrijev klorid 4,5 mg/ml (0,45 %) Do 72 ur v hladilniku (2 do 8 °C) ali do 8 ur pri sobni temperaturi (9 do 25 °C)
The ADRs are listed below by MedDRA system organ class (SOC) and categories of frequency.
Neželeni učinki zdravila so navedeni po organskih sistemih MedDRA in kategorijah pogostnosti spodaj.
Lonza Ltd.
Lonza Ltd. Lonzastrasse
Polivy has a minor influence on your ability to drive, cycle or use any tools or machines.
Zdravilo Polivy ima lahko blag vpliv na sposobnost upravljanja vozil, koles ter orodij in strojev.
The median OS in the Polivy+BR arm was 12.4 months (95% CI: 9.0, NE) vs 4.7 months (95% CI: 3.7, 8.3) in the control arm.
OS v skupini, zdravljeni z zdravilom Polivy in BR, je bilo 12,4 meseca (95-% IZ: 9,0; NO), v primerjalni skupini pa 4,7 meseca (95-% IZ: 3,7; 8,3).
Polivy is for single-use only.
Odlaganje Zdravilo Polivy je le za enkratno uporabo.
• pneumonia (lung infection)
• pljučnica (okužba pljuč)
Chemical and physical stability of the prepared solution for infusion has been demonstrated for the durations listed in Table 6.
Kemijska in fizikalna stabilnost pripravljene raztopine za infundiranje sta dokazani za trajanja, navedena v preglednici 6.
Polivy must not be administered as intravenous push or bolus.
Zdravila Polivy se ne sme aplicirati kot hiter intravenski odmerek ali bolus.
If not already premedicated, premedication with an antihistamine and anti-pyretic should be administered to patients prior to Polivy.
Če bolnik še ni prejel premedikacije, mora pred uporabo zdravila Polivy prejeti premedikacijo z antihistaminikom in antipiretikom.
However, results of the 4-week rat toxicity study indicate the potential for polatuzumab vedotin to impair male reproductive function and fertility.
Toda rezultati 4-tedenske študije toksičnosti pri podganah kažejo, da lahko polatuzumab vedotin pri moških okvari reproduktivno funkcijo in plodnost.
Gastrointestinal toxicity events were reported in 80.0% of patients in the Polivy plus BR arm compared to 64.1% of patients in the BR arm.
O toksičnih učinkih na prebavila so poročali pri 80,0 % bolnikov v skupini, zdravljeni z zdravilom Polivy in BR, in pri 64,1 % bolnikov v skupini, zdravljeni z BR.
Randomized patients in the treatment arm received a median of 5 cycles of treatment while randomized patients in the comparator arm received a median of 3 cycles of treatment.
Mediano število prejetih ciklov pri bolnikih, randomiziranih v terapevtsko skupino, je bilo 5, pri bolnikih, randomiziranih v primerjalno skupino, pa 3.
The diluted solution must be discarded if storage time exceeds the limits specified in Table 6.
Razredčeno raztopino zdravila Polivy je treba zavreči, če čas shranjevanja preseže meje, navedene v preglednici 6.
Bendamustine was administered at 90 mg/m2 intravenously daily on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6.
Bendamustin so prejemali v odmerku 90 mg/m2 intravensko 2. in 3. dan 1. cikla ter 1. in 2. dan od 2. do 6. cikla.
Some people may develop unusual levels of some substances (such as potassium and uric acid) in the blood caused by the fast breakdown of cancer cells during treatment.
Nekaterim osebam se zaradi hitre razgradnje rakavih celic med zdravljenjem lahko pojavi nenormalna koncentracija nekaterih snovi (na primer kalija in sečne kisline) v krvi.
LIST OF EXCIPIENTS succinic acid, sodium hydroxide, sucrose, polysorbate 20.
SEZNAM POMOŽNIH SNOVI sukcinska kislina, natrijev hidroksid, saharoza, polisorbat 20
If not recovered to Grade ≤ 1 on or before Day 14, discontinue Polivy.
Če do (vključno) 14. dne ni izboljšanja na ≤ 1. stopnjo, zdravilo Polivy ukinite.
In both rats and cynomolgus monkeys, the predominant systemic toxicities associated with administration of MMAE and polatuzumab vedotin included reversible bone marrow toxicity and associated peripheral blood cell effects.
Tako pri podganah kot pri opicah cynomolgus so bili med prevladujočimi sistemskimi toksičnimi učinki, povezanimi z uporabo MMAE in polatuzumaba vedotina, reverzibilna toksičnost za kostni mozeg in s tem povezani učinki na celice v periferni krvi.
Serious cases of hepatic toxicity that were consistent with hepatocellular injury, including elevations of transaminases and/or bilirubin, have occurred in patients treated with Polivy (see section 4.8).
Pri bolnikih, zdravljenih z zdravilom Polivy, so se pojavili resni primeri hepatotoksičnosti, skladni z okvaro hepatocitov, vključno z zvišanjem transaminaz in/ali bilirubina (glejte poglavje 4.8).
Patients receiving concomitant strong CYP3A4 inhibitors (e.g., boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole) should be monitored more closely for signs of toxicities.
(npr. boceprevir, klaritromicin, kobicistat, indinavir, itrakonazol, nefazodon, nelfinavir, posakonazol, ritonavir, sakvinavir, telaprevir, telitromicin, vorikonazol), je treba skrbneje nadzorovati glede znakov toksičnosti.
PML has been reported with Polivy treatment (see section 4.8).
Progresivna multifokalna levkoencefalopatija (PML) Med zdravljenjem z zdravilom Polivy so poročali o pojavu PML (glejte poglavje 4.8).
It is not known whether polatuzumab vedotin or its metabolites are excreted in human breast milk.
Ni znano, ali se polatuzumab vedotin ali njegovi presnovki pri človeku izločajo v materinem mleku.
Chemical and physical stability of the prepared solution for infusion has been demonstrated for the durations listed in Table 1.
Kemijska in fizikalna stabilnost pripravljene raztopine za infundiranje sta dokazani za trajanja, navedena v preglednici 1.
Polatuzumab vedotin is an antibody-drug conjugate composed of the anti-mitotic agent monomethyl auristatin E (MMAE) covalently conjugated to a CD79b-directed monoclonal antibody (recombinant humanized immunoglobulin G1 [IgG1], produced in Chinese Hamster Ovary cells by recombinant DNA technology).
Polatuzumab vedotin je konjugat protitelesa in zdravila, sestavljen iz antimitotičnega sredstva monometil-avristatina E (MMAE), kovalentno konjugiranega na monoklonsko protitelo (rekombinantni humanizirani imunoglobulin G1 [IgG1], pridobljen iz celic jajčnika kitajskega hrčka s tehnologijo rekombinantne DNA), ki je usmerjeno proti CD79b.
Rituximab was administered at 375 mg/m2 on Day 1 of Cycles 1-6.
Rituksimab je bil uporabljen v odmerku 375 mg/m2 1. dan od 1. do 6. cikla.
The administration of Polivy in patients with moderate or severe hepatic impairment (bilirubin greater than 1.5 × upper limit of normal [ULN]) should be avoided.
Pri bolnikih z zmerno ali hudo okvaro (vrednost bilirubina večja od 1,5-kratne zgornje normalne meje [ZNM]) se je treba uporabi zdravila Polivy izogibati.
Primary endpoint Complete Response Rate* (IRC-assessed) at End of treatment** Responders (%) Difference in response rate (%) [95% CI] p-value (CMH chi-squared test***) Key secondary and exploratory endpoints Duration of response (INV-assessed) Number of patients included in analysis Number (%) of patients with event Median DOR (95% CI), months HR [95% CI]
Ključni sekundarni in eksplorativni cilji Trajanje odgovora [DOR] (po raziskovalčevi oceni) Število bolnikov, vključenih v analizo Število (%) bolnikov z doseženim ciljem Mediano DOR (95-% IZ), meseci HR [95-% IZ]