FrancophonIA/ELRC3.0 huggingface dataset:
English: Chemical and physical stability of the prepared solution for infusion has been demonstrated for the durations listed in Table 6.
Slovenian: Kemijska in fizikalna stabilnost pripravljene raztopine za infundiranje sta dokazani za trajanja, navedena v preglednici 6.
English: Polivy must not be administered as intravenous push or bolus.
Slovenian: Zdravila Polivy se ne sme aplicirati kot hiter intravenski odmerek ali bolus.
English: If not already premedicated, premedication with an antihistamine and anti-pyretic should be administered to patients prior to Polivy.
Slovenian: Če bolnik še ni prejel premedikacije, mora pred uporabo zdravila Polivy prejeti premedikacijo z antihistaminikom in antipiretikom.
English: However, results of the 4-week rat toxicity study indicate the potential for polatuzumab vedotin to impair male reproductive function and fertility.
Slovenian: Toda rezultati 4-tedenske študije toksičnosti pri podganah kažejo, da lahko polatuzumab vedotin pri moških okvari reproduktivno funkcijo in plodnost.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Mediano število prejetih ciklov pri bolnikih, randomiziranih v terapevtsko skupino, je bilo 5, pri bolnikih, randomiziranih v primerjalno skupino, pa 3.
English: The diluted solution must be discarded if storage time exceeds the limits specified in Table 6.
Slovenian: Razredčeno raztopino zdravila Polivy je treba zavreči, če čas shranjevanja preseže meje, navedene v preglednici 6.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Nekaterim osebam se zaradi hitre razgradnje rakavih celic med zdravljenjem lahko pojavi nenormalna koncentracija nekaterih snovi (na primer kalija in sečne kisline) v krvi.
English: LIST OF EXCIPIENTS succinic acid, sodium hydroxide, sucrose, polysorbate 20.
Slovenian: SEZNAM POMOŽNIH SNOVI sukcinska kislina, natrijev hidroksid, saharoza, polisorbat 20
English: If not recovered to Grade ≤ 1 on or before Day 14, discontinue Polivy.
Slovenian: Če do (vključno) 14. dne ni izboljšanja na ≤ 1. stopnjo, zdravilo Polivy ukinite.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: (npr. boceprevir, klaritromicin, kobicistat, indinavir, itrakonazol, nefazodon, nelfinavir, posakonazol, ritonavir, sakvinavir, telaprevir, telitromicin, vorikonazol), je treba skrbneje nadzorovati glede znakov toksičnosti.
English: PML has been reported with Polivy treatment (see section 4.8).
Slovenian: Progresivna multifokalna levkoencefalopatija (PML) Med zdravljenjem z zdravilom Polivy so poročali o pojavu PML (glejte poglavje 4.8).
English: It is not known whether polatuzumab vedotin or its metabolites are excreted in human breast milk.
Slovenian: Ni znano, ali se polatuzumab vedotin ali njegovi presnovki pri človeku izločajo v materinem mleku.
English: Chemical and physical stability of the prepared solution for infusion has been demonstrated for the durations listed in Table 1.
Slovenian: Kemijska in fizikalna stabilnost pripravljene raztopine za infundiranje sta dokazani za trajanja, navedena v preglednici 1.
English: 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).
Slovenian: 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.
English: Rituximab was administered at 375 mg/m2 on Day 1 of Cycles 1-6.
Slovenian: Rituksimab je bil uporabljen v odmerku 375 mg/m2 1. dan od 1. do 6. cikla.
English: 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.
Slovenian: 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.
English: 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]
Slovenian: 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]
English: 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.
Slovenian: 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.
English: Polivy must only be administered under the supervision of a healthcare professional experienced in the diagnosis and treatment of cancer patients.
Slovenian: Zdravilo Polivy se sme uporabljati le pod nadzorom zdravnika, ki ima izkušnje z diagnosticiranjem in zdravljenjem onkoloških bolnikov.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder for concentrate for solution for infusion contains 140 mg of polatuzumab vedotin.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala s praškom za koncentrat za raztopino za infundiranje vsebuje 140 mg polatuzumaba vedotina.
English: Discard diluted Polivy solution if storage time exceeds the limits specified in Table 1.
Slovenian: Razredčeno raztopino zdravila Polivy zavrzite, če čas shranjevanja preseže meje, navedene v preglednici 1.
English: Store in a refrigerator (2 °C - 8 °C).
Slovenian: Shranjujte v hladilniku (2 do 8 °C.
English: 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.
Slovenian: Polatuzumab vedotin se pri bolnikih predvidoma katabolizira, pri čemer nastanejo majhni peptidi, aminokisline, nekonjugirani MMAE in z nekonjugiranim MMAE povezani presnovki.
English: 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.
Slovenian: 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
English: Patients experiencing new or worsening PN may require a delay, dose reduction, or discontinuation of Polivy (see section 4.2).
Slovenian: 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).
English: Liver damage
Slovenian: Poškodba jeter
English: Tell your doctor or nurse straight away if you:
Slovenian: Nemudoma obvestite zdravnika ali medicinsko sestro, če:
English: How Polivy works
Slovenian: Kako deluje zdravilo Polivy
English: 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.
Slovenian: 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.
English: Therefore, men being treated with Polivy are advised to have sperm samples preserved and stored before treatment (see section 4.6).
Slovenian: Za moške, ki se bodo zdravili z zdravilom Polivy, je priporočljivo pred zdravljenjem shraniti seme (glejte poglavje 4.6).
English: 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.
Slovenian: 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.
English: Very common (may affect more than 1 in 10 people)
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): • zvišana telesna temperatura ali mrzlica
English: Bendamustine + rituximab N = 40 Median observation time 22 months
Slovenian: Bendamustin + rituksimab n = 40
English: 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.
Slovenian: 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
English: NAME OF THE MEDICINAL PRODUCT Polivy 140 mg powder for concentrate for solution for infusion.
Slovenian: IME ZDRAVILA Polivy 140 mg prašek za koncentrat za raztopino za infundiranje
English: Polivy is for intravenous use.
Slovenian: Način uporabe Zdravilo Polivy je namenjeno intravenski uporabi.
English: If ANC recovers to > 1000/µL after Day 7:
Slovenian: Če se absolutno število nevtrofilcev povrne na > 1000/µl po 7. dnevu:
English: 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).
Slovenian: 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).
English: Based on the population PK analysis, Cycle 3 acMMAE AUC increased by approximately 30% over Cycle 1
Slovenian: 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.
English: Based on the population PK analysis there is a decrease of plasma unconjugated MMAE exposure (AUC) after repeated every-three-week dosing.
Slovenian: Na podlagi populacijske farmakokinetične analize se po ponavljajoči uporabi na tri tedne izpostavljenost nekonjugiranemu MMAE v plazmi (AUC) zmanjša.
English: Severity of IRR on Day 1 of any cycle
Slovenian: Izraženost periferne nevropatije na 1. dan katerega koli cikla
English: Caution is advised in case of concomitant treatment with CYP3A4 inhibitor.
Slovenian: Pri sočasnem zdravljenju z zaviralcem CYP3A4 je potrebna previdnost.
English: Very common neuropathy peripheral, peripheral sensory neuropathy, dizziness Common gait disturbance, paraesthesia, hypoaesthesia
Slovenian: Zelo pogosti periferna nevropatija, periferna senzorična nevropatija, omotica
English: White to greyish-white lyophilized cake.
Slovenian: Bela do sivkasta liofilizirana pogača.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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).
English: See section 4 for more information about side effects.
Slovenian: Za več podatkov o teh neželenih učinkih glejte poglavje 4.
English: 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.
Slovenian: 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.
English: No dose adjustment of Polivy is required in patients with creatinine clearance (CrCL) ≥ 30 mL/min.
Slovenian: Bolnikom z očistkom kreatinina ≥ 30 ml/min odmerka zdravila Polivy ni treba prilagoditi.
English: Roche S.p.A.
Slovenian: Italia Roche S.p.A.
English: Day 1 of any cycle
Slovenian: Izraženost mielosupresije na 1. dan katerega koli cikla
English: Grade 3 or 4 thrombocytopenia or anaemia can also occur with Polivy.
Slovenian: Med uporabo zdravila Polivy se lahko pojavi tudi trombocitopenija ali anemija 3. ali 4. stopnje.
English: 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.
Slovenian: 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.
English: Table 6 Durations for which chemical and physical stability of the prepared solution for infusion have been demonstrated
Slovenian: Trajanja, za katera sta dokazani kemijska in fizikalna stabilnost pripravljene raztopine za infundiranje
English: In the Polivy plus BR arm, Grade 1 PN and Grade 2 PN were reported in 26.7% and 13.3% of patients, respectively.
Slovenian: 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.
English: In the BR arm, Grade 1 and 2 PN events were reported in 2.6% and 5.1% of patients, respectively.
Slovenian: V skupini, zdravljeni z BR, so o primerih periferne nevropatije 1. stopnje poročali pri 2,6 % in 2. stopnje pri 5,1 % bolnikov.
English: Patients who experience overdose should have immediate interruption of their infusion and be closely monitored.
Slovenian: V primeru prevelikega odmerjanja je treba infundiranje nemudoma prekiniti in bolnika skrbno nadzorovati.
English: 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.
Slovenian: Neželene učinke zdravila, opisane v tem poglavju, so ugotovili med zdravljenjem in spremljanjem predhodno zdravljenih bolnikov z difuznim velikoceličnim limfomom B
English: 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.
Slovenian: 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.
English: Up to 72 hours refrigerated (2 °C − 8 °C) or up to 8 hours at room temperature (9 °C − 25 °C)
Slovenian: Do 72 ur v hladilniku (2 do 8 °C) ali do 8 ur pri sobni temperaturi (9 do 25 °C)
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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 %).
English: 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%).
Slovenian: same (n = 40), je bila večina belcev (71 %) in moških (66 %).
English: For dose modifications for myelosuppression see Table 2.
Slovenian: Za prilagoditve odmerka v primeru mielosupresije glejte preglednico 2.
English: • have headaches
Slovenian: • imate glavobole,
English: 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%).
Slovenian: 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 %),
English: 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.
Slovenian: 7,6 meseca (95-% IZ: 6,0; 17,0), v primerjalni skupini pa 2 meseca (95-% IZ: 1,5; 3,7).
English: Overall, 48% of patients had activated B-cell (ABC) DLBCL and 40% had germinal center B-cell like (GCB) DLBCL.
Slovenian: V celoti je imelo 48 % bolnikov ABC-podtip (podtip aktiviranih limfocitov B)
English: Antibody-conjugated MMAE (acMMAE) plasma exposure increased dose-proportionally over the 0.1 to 2.4 mg/kg polatuzumab vedotin dose range.
Slovenian: 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.
English: All except one patient in the pola+BR arm of the randomized Phase II were naïve to bendamustine treatment.
Slovenian: Vsi bolniki v skupini, razen enega, zdravljeni s polatuzumabom vedotinom in BR v randomizirani študiji faze II, predhodno še niso prejeli bendamustina.
English: 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.
Slovenian: 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.
English: Drug interactions with concomitant medicines that are CYP3A4 inhibitors, substrates or inducers and co-medications that are P-gp inhibitors
Slovenian: Medsebojna delovanja s sočasno uporabljenimi zdravili, ki so zaviralci, induktorji ali substrati
English: If you are not sure, talk to your doctor or nurse before you are given Polivy.
Slovenian: Če kar koli od naštetega velja za vas (ali niste prepričani), se posvetujte z zdravnikom ali medicinsko sestro, preden boste dobili zdravilo Polivy.
English: 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.
Slovenian: Sočasni rituksimab je na podlagi populacijske farmakokinetične analize povezan s povečanjem AUC s protitelesom konjugiranega MMAE (acMMAE) v plazmi za 24 % in zmanjšanjem AUC
English: Therefore, men being treated with this medicine are advised to have sperm samples preserved and stored before treatment.
Slovenian: Priporočljivo je, da moški, ki se zdravijo s tem zdravilom, pred zdravljenjem dajo vzorce semena v hrambo.
English: Polivy was given intravenously at 1.8 mg/kg administered on Day 2 of Cycle 1 and on Day 1 of Cycles 2-6.
Slovenian: 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.
English: Patients with pre-existing PN may experience worsening of this condition.
Slovenian: Bolnikom z že obstoječo periferno nevropatijo se nevropatija lahko poslabša.
English: 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.
Slovenian: Okvarjene jetrne celice v kri sproščajo velike količine določenih snovi (jetrnih encimov in bilirubina),
English: 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.
Slovenian: 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.
English: • diarrhoea or constipation
Slovenian: • zvišana telesna temperatura in mrzlica
English: Do not use if the reconstituted solution is discoloured, is cloudy, or contains visible particulates.
Slovenian: Če je rekonstituirana raztopina spremenjene barve, motna ali vsebuje vidne delce, je ne uporabite.