natgillin/translations-raw huggingface dataset:
Across all arms of study GO29365, 8 out of 134 (6.0%) patients tested positive for anti-polatuzumab vedotin antibodies at one or more post-baseline time points.
V vseh skupinah študije GO29365 je imelo na eni ali več časovnih točkah po izhodišču prisotna protitelesa proti polatuzumabu vedotinu 8 od 134 (6,0 %) bolnikov.
Polivy must only be administered under the supervision of a healthcare professional experienced in the diagnosis and treatment of cancer patients.
Zdravilo Polivy se sme uporabljati le pod nadzorom zdravnika, ki ima izkušnje z diagnosticiranjem in zdravljenjem onkoloških bolnikov.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder for concentrate for solution for infusion contains 140 mg of polatuzumab vedotin.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala s praškom za koncentrat za raztopino za infundiranje vsebuje 140 mg polatuzumaba vedotina.
Discard diluted Polivy solution if storage time exceeds the limits specified in Table 1.
Razredčeno raztopino zdravila Polivy zavrzite, če čas shranjevanja preseže meje, navedene v preglednici 1.
Store in a refrigerator (2 °C - 8 °C).
Shranjujte v hladilniku (2 do 8 °C.
Polatuzumab vedotin is expected to undergo catabolism in patients, resulting in the production of small peptides, amino acids, unconjugated MMAE, and unconjugated MMAE related catabolites.
Polatuzumab vedotin se pri bolnikih predvidoma katabolizira, pri čemer nastanejo majhni peptidi, aminokisline, nekonjugirani MMAE in z nekonjugiranim MMAE povezani presnovki.
The efficacy of Polivy was evaluated in an international, multicentre, open-label study (GO29365) which included a randomized cohort of 80 patients with previously treated DLBCL.
Učinkovitost zdravila Polivy so ocenjevali v mednarodni, multicentrični, odprti študiji (GO29365), v katero je bila vključena randomizirana kohorta 80 bolnikov s predhodno zdravljenim difuznim velikoceličnim limfomom B. Bolnike so v razmerju 1 : 1 randomizirali v skupino, ki je prejela zdravilo Polivy skupaj z bendamustinom in rituksimabom (BR), in skupino, ki je prejela kombinacijo
Patients experiencing new or worsening PN may require a delay, dose reduction, or discontinuation of Polivy (see section 4.2).
Bolnikom, pri katerih se pojavi novonastala periferna nevropatija ali se poslabša obstoječa periferna nevropatija, bo morda treba odmerek zdravila Polivy odložiti, zmanjšati ali uporabo zdravila Polivy ukiniti (glejte poglavje 4.2).
Liver damage
Poškodba jeter
Tell your doctor or nurse straight away if you:
Nemudoma obvestite zdravnika ali medicinsko sestro, če:
How Polivy works
Kako deluje zdravilo Polivy
Using a sterile syringe, slowly inject 7.2 mL of sterile water for injection into the 140 mg Polivy vial to yield a single-dose solution containing 20 mg/mL polatuzumab vedotin.
S sterilno brizgo počasi injicirajte 7,2 ml sterilne vode za injekcije v 140-mg vialo zdravila Polivy, da dobite raztopino za en odmerek, ki vsebuje 20 mg/ml polatuzumaba vedotina.
Therefore, men being treated with Polivy are advised to have sperm samples preserved and stored before treatment (see section 4.6).
Za moške, ki se bodo zdravili z zdravilom Polivy, je priporočljivo pred zdravljenjem shraniti seme (glejte poglavje 4.6).
In the Polivy plus BR arm, the median onset to first event of PN was 1.8 months, and 61.1% of patients with PN events reported event resolution.
V skupini, zdravljeni z zdravilom Polivy in BR, je bil mediani čas do prvega dogodka periferne nevropatije 1,8 meseca; 61,1 % bolnikov, pri katerih se je pojavila periferna nevropatija, je navedlo, da so simptomi minili.
Very common (may affect more than 1 in 10 people)
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): • zvišana telesna temperatura ali mrzlica
Bendamustine + rituximab N = 40 Median observation time 22 months
Bendamustin + rituksimab n = 40
In the Polivy plus BR arm, Grade 3 or higher neutropenia, thrombocytopenia, and anaemia were reported in 40%, 37.8%, and 24.4% of patients, respectively.
V skupini, zdravljeni z zdravilom Polivy in BR, so o nevtropeniji 3. ali višje stopnje poročali pri 40 % bolnikov, o trombocitopeniji 3. ali višje stopnje pri 37,8 % bolnikov in o anemiji 3. ali višje stopnje pri
NAME OF THE MEDICINAL PRODUCT Polivy 140 mg powder for concentrate for solution for infusion.
IME ZDRAVILA Polivy 140 mg prašek za koncentrat za raztopino za infundiranje
Polivy is for intravenous use.
Način uporabe Zdravilo Polivy je namenjeno intravenski uporabi.
If ANC recovers to > 1000/µL after Day 7:
Če se absolutno število nevtrofilcev povrne na > 1000/µl po 7. dnevu:
Chemical and physical in-use stability of the reconstituted solution has been demonstrated for up to 72 hours refrigerated (2 °C − 8 °C) and up to 24 hours at room temperature (9 °C − 25 °C).
Kemijska in fizikalna stabilnost rekonstituirane raztopine med uporabo sta dokazani za do 72 ur v hladilniku (2 do 8 °C) in do 24 ur pri sobni temperaturi (9 do 25 °C).
Based on the population PK analysis, Cycle 3 acMMAE AUC increased by approximately 30% over Cycle 1
Na podlagi populacijske farmakokinetične analize je bila AUC acMMAE v 3. ciklu približno 30 % večja od AUC v 1. ciklu in je dosegla več kot 90 % AUC v 6. ciklu.
Based on the population PK analysis there is a decrease of plasma unconjugated MMAE exposure (AUC) after repeated every-three-week dosing.
Na podlagi populacijske farmakokinetične analize se po ponavljajoči uporabi na tri tedne izpostavljenost nekonjugiranemu MMAE v plazmi (AUC) zmanjša.
Severity of IRR on Day 1 of any cycle
Izraženost periferne nevropatije na 1. dan katerega koli cikla
Caution is advised in case of concomitant treatment with CYP3A4 inhibitor.
Pri sočasnem zdravljenju z zaviralcem CYP3A4 je potrebna previdnost.
Very common neuropathy peripheral, peripheral sensory neuropathy, dizziness Common gait disturbance, paraesthesia, hypoaesthesia
Zelo pogosti periferna nevropatija, periferna senzorična nevropatija, omotica
White to greyish-white lyophilized cake.
Bela do sivkasta liofilizirana pogača.
Most events were Grade 1-2, and Grade 3-4 events were reported in 22.2% of patients in the Polivy plus BR arm compared to 12.8% of patients in the BR arm.
Večina učinkov je bila 1. do 2. stopnje; o učinkih 3. do 4. stopnje so poročali pri 22,2 % bolnikov v skupini, zdravljeni z zdravilom Polivy in BR, in pri 12,8 % bolnikov v skupini, zdravljeni z BR. Najpogostejša toksična učinka na prebavila sta bila diareja in navzea.
Polivy is given to treat “diffuse large B-cell lymphoma” that has come back or has not got better with at least one previous therapy and when you cannot receive a stem cell transplant.
Zdravilo Polivy uporabljamo za zdravljenje difuznega velikoceličnega limfoma B, če se je bolezen pri vas ponovila ali se na vsaj eno predhodno zdravljenje niste odzvali in presaditev matičnih celic za vas ne pride v poštev.
In patients with mild hepatic impairment [AST or ALT >1.0 to 2.5 × ULN or total bilirubin >1.0 to 1.5 × ULN], n = 54], acMMAE exposures are similar whereas unconjugated MMAE AUC are 40% higher compared to patients with normal hepatic function (n = 399), based on a population PK analysis.
Okvara jeter Pri bolnikih z blago okvaro jeter (vrednost AST ali ALT > 1,0 do 2,5 × ZNM ali vrednost celokupnega bilirubina > 1,0 do 1,5 × ZNM, n = 54) je bila na podlagi populacijske farmakokinetične analize izpostavljenost acMMAE podobna, AUC nekonjugiranega MMAE pa 40 % večja kot pri bolnikih z normalnim delovanjem jeter (n = 399).
See section 4 for more information about side effects.
Za več podatkov o teh neželenih učinkih glejte poglavje 4.
Polivy in combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant.
Zdravilo Polivy je v kombinaciji z bendamustinom in rituksimabom indicirano za zdravljenje odraslih bolnikov z difuznim velikoceličnim limfomom B (DVCLB), ki se na prejšnje zdravljenje niso odzvali ali pa se je bolezen pri njih ponovila in niso primerni za presaditev krvotvornih matičnih celic.
No dose adjustment of Polivy is required in patients with creatinine clearance (CrCL) ≥ 30 mL/min.
Bolnikom z očistkom kreatinina ≥ 30 ml/min odmerka zdravila Polivy ni treba prilagoditi.
Day 1 of any cycle
Izraženost mielosupresije na 1. dan katerega koli cikla
Grade 3 or 4 thrombocytopenia or anaemia can also occur with Polivy.
Med uporabo zdravila Polivy se lahko pojavi tudi trombocitopenija ali anemija 3. ali 4. stopnje.
Polivy must be reconstituted using sterile water for injection and diluted into an intravenous infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection, or sodium chloride 4.5 mg/ml (0.45%) solution for injection, or 5% glucose prior to administration.
Zdravilo Polivy je treba pred aplikacijo rekonstituirati s sterilno vodo za injekcije in razredčiti v intravenski vrečki, ki vsebuje raztopino natrijevega klorida za injiciranje z 9 mg/ml (0,9 %) ali raztopino natrijevega klorida za injiciranje s 4,5 mg/ml (0,45 %) ali 5-% raztopino glukoze.
Table 6 Durations for which chemical and physical stability of the prepared solution for infusion have been demonstrated
Trajanja, za katera sta dokazani kemijska in fizikalna stabilnost pripravljene raztopine za infundiranje
In the Polivy plus BR arm, Grade 1 PN and Grade 2 PN were reported in 26.7% and 13.3% of patients, respectively.
V skupini, zdravljeni z zdravilom Polivy in BR, so o primerih periferne nevropatije 1. stopnje poročali pri 26,7 % in 2. stopnje pri 13,3 % bolnikov.
In the BR arm, Grade 1 and 2 PN events were reported in 2.6% and 5.1% of patients, respectively.
V skupini, zdravljeni z BR, so o primerih periferne nevropatije 1. stopnje poročali pri 2,6 % in 2. stopnje pri 5,1 % bolnikov.
Patients who experience overdose should have immediate interruption of their infusion and be closely monitored.
V primeru prevelikega odmerjanja je treba infundiranje nemudoma prekiniti in bolnika skrbno nadzorovati.
The adverse drug reactions (ADRs) described in this section were identified during treatment and follow-up of previously treated DLBCL patients from the pivotal clinical trial GO29365.
Neželene učinke zdravila, opisane v tem poglavju, so ugotovili med zdravljenjem in spremljanjem predhodno zdravljenih bolnikov z difuznim velikoceličnim limfomom B
Exposures of unconjugated MMAE, the cytotoxic component of polatuzumab vedotin, increased dose proportionally over the 0.1 to 2.4 mg/kg polatuzumab vedotin dose range.
Izpostavljenost nekonjugiranemu MMAE, citotoksični sestavini polatuzumaba vedotina, se je v razponu odmerkov polatuzumaba vedotina od 0,1 do 2,4 mg/kg povečevala sorazmerno z odmerkom.
Up to 72 hours refrigerated (2 °C − 8 °C) or up to 8 hours at room temperature (9 °C − 25 °C)
Do 72 ur v hladilniku (2 do 8 °C) ali do 8 ur pri sobni temperaturi (9 do 25 °C)
Women of childbearing potential should be advised to use effective contraception during treatment with Polivy and for at least 9 months after the last dose (see section 4.6).
Ženskam v rodni dobi je treba svetovati, naj uporabljajo učinkovito kontracepcijo med zdravljenjem z zdravilom Polivy in še vsaj 9 mesecev po zadnjem odmerku (glejte poglavje 4.6).
Across seven clinical studies, 14 out of 536 (2.6%) patients tested positive for anti-polatuzumab vedotin antibodies at one or more post-baseline time points.
V sedmih kliničnih študijah je imelo na eni ali več časovnih točkah po izhodišču prisotna protitelesa proti polatuzumabu vedotinu 14 od 536 bolnikov (2,6 %).
Among the 80 patients who were randomized to receive Polivy plus BR (n=40) or BR alone (n = 40) the majority were white (71%) and male (66%).
same (n = 40), je bila večina belcev (71 %) in moških (66 %).
For dose modifications for myelosuppression see Table 2.
Za prilagoditve odmerka v primeru mielosupresije glejte preglednico 2.
• have headaches
• imate glavobole,
The most frequently-reported (≥ 30%) ADRs in patients treated with Polivy in combination with BR were anaemia (46.7%), thrombocytopenia (46.7%), neutropenia (46.7%), fatigue (40.0%), diarrhoea (37.8%), nausea (33.3%), and pyrexia (33.3%).
Najpogosteje zabeleženi neželeni učinki (≥ 30 %) pri bolnikih, zdravljenih z zdravilom Polivy v kombinaciji z BR, so bili anemija (46,7 %), trombocitopenija (46,7 %), nevtropenija (46,7 %),
The median PFS in the Polivy+BR arm was 7.6 months (95% CI: 6.0, 17.0) vs 2.0 months (95% CI: 1.5, 3.7) in the control arm.
7,6 meseca (95-% IZ: 6,0; 17,0), v primerjalni skupini pa 2 meseca (95-% IZ: 1,5; 3,7).
Overall, 48% of patients had activated B-cell (ABC) DLBCL and 40% had germinal center B-cell like (GCB) DLBCL.
V celoti je imelo 48 % bolnikov ABC-podtip (podtip aktiviranih limfocitov B)
Antibody-conjugated MMAE (acMMAE) plasma exposure increased dose-proportionally over the 0.1 to 2.4 mg/kg polatuzumab vedotin dose range.
Izpostavljenost s protitelesi konjugiranemu MMAE (acMMAE) v plazmi se je v razponu odmerkov od 0,1 do 2,4 mg/kg polatuzumaba vedotina povečevala sorazmerno z odmerkom.
All except one patient in the pola+BR arm of the randomized Phase II were naïve to bendamustine treatment.
Vsi bolniki v skupini, razen enega, zdravljeni s polatuzumabom vedotinom in BR v randomizirani študiji faze II, predhodno še niso prejeli bendamustina.
It should be administered as an intravenous infusion through a dedicated infusion line equipped with a sterile, non-pyrogenic, low-protein binding in-line or add-on filter (0.2 or 0.22 micrometer pore size) and catheter.
Treba ga je aplicirati v intravenski infuziji po namenski infuzijski liniji, opremljeni s sterilnim nepirogenim filtrom (v sami liniji ali kot dodatek), ki malo veže beljakovine (velikost por 0,2 ali 0,22 mikrona) in s katetrom.
Drug interactions with concomitant medicines that are CYP3A4 inhibitors, substrates or inducers and co-medications that are P-gp inhibitors
Medsebojna delovanja s sočasno uporabljenimi zdravili, ki so zaviralci, induktorji ali substrati
If you are not sure, talk to your doctor or nurse before you are given Polivy.
Če kar koli od naštetega velja za vas (ali niste prepričani), se posvetujte z zdravnikom ali medicinsko sestro, preden boste dobili zdravilo Polivy.
Concomitant rituximab is associated with increased antibody conjugated MMAE (acMMAE) plasma AUC by 24% and decreased unconjugated MMAE plasma AUC by 37%, based on population PK analysis.
Sočasni rituksimab je na podlagi populacijske farmakokinetične analize povezan s povečanjem AUC s protitelesom konjugiranega MMAE (acMMAE) v plazmi za 24 % in zmanjšanjem AUC
Therefore, men being treated with this medicine are advised to have sperm samples preserved and stored before treatment.
Priporočljivo je, da moški, ki se zdravijo s tem zdravilom, pred zdravljenjem dajo vzorce semena v hrambo.
Polivy was given intravenously at 1.8 mg/kg administered on Day 2 of Cycle 1 and on Day 1 of Cycles 2-6.
Bolniki so zdravilo Polivy prejemali intravensko v odmerku 1,8 mg/kg, in sicer 2. dan 1. cikla in 1. dan od 2. do 6. cikla.
Patients with pre-existing PN may experience worsening of this condition.
Bolnikom z že obstoječo periferno nevropatijo se nevropatija lahko poslabša.
Injured liver cells may leak high amounts of certain substances (liver enzymes and bilirubin) into the bloodstream, in which can be detected by blood tests.
Okvarjene jetrne celice v kri sproščajo velike količine določenih snovi (jetrnih encimov in bilirubina),
Polivy must be diluted to a final concentration of 0.72-2.7 mg/mL in an intravenous infusion bag, with a minimum volume of 50 mL, containing 9 mg/mL sodium chloride solution for injection, or 4.5 mg/mL sodium chloride solution for injection, or 5% glucose.
Zdravilo Polivy je treba na končno koncentracijo od 0,72 do 2,7 mg/ml razredčiti v intravenski infuzijski vrečki z minimalno količino 50 ml raztopine 9 mg/ml natrijevega klorida za infundiranje ali raztopino 4,5 mg/ml natrijevega klorida za infundiranje ali 5-% raztopino glukoze.
• diarrhoea or constipation
• zvišana telesna temperatura in mrzlica
Do not use if the reconstituted solution is discoloured, is cloudy, or contains visible particulates.
Če je rekonstituirana raztopina spremenjene barve, motna ali vsebuje vidne delce, je ne uporabite.
Tell your doctor or nurse straight away if you notice any of the following serious side effects - you may need urgent medical treatment.
Če opazite katerega od naslednjih resnih neželenih učinkov, nemudoma obvestite zdravnika ali medicinsko sestro - morda boste potrebovali nujno zdravniško pomoč.
Men being treated with Polivy are advised not to father a child during treatment and for up to 6 months following the last dose.
Moški, ki prejemajo zdravilo Polivy, naj ne spočnejo otroka med zdravljenjem in še 6 mesecev po zadnjem odmerku zdravila.
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Za pogoje shranjevanja zdravila po rekonstituciji in razredčenju glejte poglavje 6.3. 6.5 Vrsta ovojnine in vsebina
Polivy has minor influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Polivy ima blag vpliv na sposobnost vožnje in upravljanja strojev.
Very common diarrhoea, nausea, constipation, vomiting, abdominal pain, upper abdominal pain
Zelo pogosti diareja, navzea, zaprtost, bruhanje, bolečine v trebuhu, bolečine v zgornjem delu trebuha
To be administered under the supervision of a physician experienced in the use of cytotoxic agents.
Aplicira se lahko le pod nadzorom zdravnika, ki ima izkušnje z uporabo citotoksičnih zdravil.
**6-8 weeks after Day 1 of Cycle 6 or last study treatment *** Stratification by duration of response to prior therapy (≤ 12 months vs > 12 months)
*** Stratifikacija glede na trajanje odgovora na predhodno zdravljenje (≤ 12 mesecev in > 12 mesecev).
Polivy and any concomitant chemotherapy should be withheld if PML is suspected and permanently discontinued if the diagnosis is confirmed.
V primeru suma na PML je treba uporabo zdravila Polivy in morebitne sočasne kemoterapije odložiti, v primeru potrjene diagnoze pa ukiniti.
Polivy must be administered using a dedicated infusion line equipped with sterile, non-pyrogenic, low-protein binding in-line or add-on filter (0.2 or 0.22 micrometer pore size) and catheter.
Zdravilo Polivy je treba aplicirati po namenski infuzijski liniji, opremljeni s sterilnim nepirogenim filtrom (v sami liniji ali kot dodatek), ki malo veže beljakovine (velikost por 0,2 ali 0,22 mikrona) in s katetrom.
Male patients with female partners of childbearing potential should be advised to use effective contraception during treatment with Polivy and for at least 6 months after the last dose (see section 4.6).
Moškim, ki imajo partnerke v rodni dobi, je treba svetovati, naj uporabljajo učinkovito kontracepcijo med zdravljenjem z zdravilom Polivy in še vsaj 6 mesecev po zadnjem odmerku (glejte poglavje 4.6).
More frequent lab monitoring and/or Polivy delays or discontinuation should be considered for patients with Grade 3 or Grade 4 neutropenia and thrombocytopenia (see section 4.2).
Pri bolnikih z nevtropenijo oziroma trombocitopenijo 3. ali 4. stopnje je treba pretehtati opravljanje pogostejših laboratorijskih kontrol in/ali odložitev ali ukinitev uporabe zdravila Polivy (glejte poglavje 4.2).
Procedures for proper handling and disposal of anticancer medicinal products should be considered.
Naslednje informacije so namenjene samo zdravstvenemu osebju: Treba je upoštevati postopke za primerno ravnanje in odstranjevanje zdravil za zdravljenje raka.
Tabulated list of ADRs from clinical trials
Povzetek neželenih učinkov iz kliničnih preskušanj v preglednici
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Namenskih kliničnih študij medsebojnega delovanja zdravil s polatuzumabom vedotinom pri človeku niso izvedli.
Myelosuppression is a condition in which the production of blood cells is decreased, resulting in fewer red blood cells, white blood cells, and platelets.
Mielosupresija je motnja, pri kateri je nastajanje krvnih celic zmanjšano.
Upon binding CD79b, polatuzumab vedotin is rapidly internalized and the linker is cleaved by lysosomal proteases to enable intracellular delivery of MMAE.
CD79b polatuzumab vedotin hitro vstopi v celico, kjer lizosomske proteaze razcepijo povezovalno molekulo, kar omogoči znotrajcelično sprostitev MMAE.
Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenobarbital, phenytoin, St John's wort [Hypericum perforatum]) may decrease the exposure of unconjugated MMAE.
Močni induktorji CYP3A4 (npr. rifampicin, karbamazepin, fenobarbital, fenitoin, šentjanževka
Defined as all adverse reactions reported as related to study treatment within 24 hours after treatment infusion Uncommon, rare and very rare ADRs: none
b Opredeljene kot vsi neželeni učinki, o katerih so med preskušanjem poročali v povezavi z zdravljenjem v 24 urah po infundiranju zdravila.
What Polivy is used for
Za kaj uporabljamo zdravilo Polivy
Men
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Each vial contains 140 milligrams (mg) polatuzumab vedotin.
Ena viala vsebuje 140 miligramov (mg) polatuzumaba vedotina.
Age did not have an effect on the pharmacokinetics of acMMAE and unconjugated MMAE based on a population PK analysis with patients aged 20-89 years.
Na podlagi populacijske farmakokinetične analize pri bolnikih, starih od 20 do 89 let, starost ni vplivala na farmakokinetiko acMMAE in nekonjugiranega MMAE.
In nonclinical studies, polatuzumab vedotin has resulted in testicular toxicity, and may impair male reproductive function and fertility (see section 5.3).
V predkliničnih študijah je polatuzumab vedotin toksično deloval na moda, zato sklepamo, da lahko poslabša reproduktivno funkcijo in plodnost pri moških (glejte poglavje 5.3).
Grade 3-4 Neutropenia
3.-4. stopnje
There are insufficient data to assess the impact of severe renal impairment (CrCL 15-29 mL/min, n = 3) on PK. No data are available in patients with end-stage renal disease and/or who are on dialysis.
(očistek kreatinina 15-29 ml/min, n = 3) na farmakokinetiko ni dovolj podatkov.
The study excluded patients with prior allogeneic HSCT, central nervous system lymphoma, transformed indolent lymphoma, grade 3b FL, significant cardiovascular or pulmonary disease, active infections, AST or alanine transaminase (ALT) >2.5× ULN or total bilirubin ≥1.5 x ULN, creatinine >1.5 x ULN (or CrCl <40 mL/min) unless due to underlying lymphoma.
V študijo niso bili vključeni bolniki s predhodno alogenično PKMC, limfomom osrednjega živčevja, transformiranim indolentnim limfomom, folikularnim limfomom gradusa 3b, pomembno srčno-žilno ali pljučno boleznijo, aktivno okužbo, aspartat transaminazo (AST) ali alanin transaminazo
Polivy should be discontinued immediately and permanently if the patient experiences a life-threatening reaction.
Če se pri bolniku pojavi življenje ogrožajoča reakcija, je treba uporabo zdravila Polivy nemudoma in trajno ukiniti.
The infusion rate of Polivy should be slowed or interrupted if the patient develops an infusion-related reaction.
Če se pri bolniku pojavi z infundiranjem povezana reakcija, je treba hitrost infundiranja zdravila Polivy upočasniti ali infundiranje prekiniti.
As with all therapeutic proteins, there is the potential for an immune response in patients treated with polatuzumab vedotin.
Pri bolnikih, zdravljenih s polatuzumabom vedotinom, obstaja možnost imunskega odziva na zdravilo, tako kot pri vseh terapevtskih beljakovinah.
METHOD OF ADMINISTRATION For IV use after reconstitution and dilution
uporabo po rekonstituciji in redčenju
Polivy contains sodium
Zdravilo Polivy vsebuje natrij
IRRs, PN, fatigue, and dizziness may occur during treatment with Polivy (see sections 4.4 and 4.8).
utrujenost in omotica (glejte poglavji 4.4 in 4.8).
Serious adverse reactions were reported in 27% of Polivy plus BR treated patients, which includes febrile neutropenia (6.7%), pyrexia (4.4%), and pneumonia (4.4%).
vključevali so febrilno nevtropenijo (6,7 %), zvišano telesno temperaturo (4,4 %) in pljučnico (4,4 %).